Sample records for year regulatory period

  1. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the dates...

  2. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the dates...

  3. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the dates...

  4. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the dates...

  5. 21 CFR 60.20 - FDA action on regulatory review period determinations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on regulatory review period... SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.20 FDA action on regulatory review period determinations. (a) FDA will consult its records and experts to verify the dates...

  6. 75 FR 55332 - Determination of Regulatory Review Period for Purposes of Patent Extension; ULORIC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-10

    ... extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins... the length of a regulatory review period for a human drug product will include all of the testing...

  7. 75 FR 53315 - Determination of Regulatory Review Period for Purposes of Patent Extension; ONGLYZA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins... the length of a regulatory review period for a human drug product will include all of the testing...

  8. 75 FR 54344 - Determination of Regulatory Review Period for Purposes of Patent Extension; EFFIENT

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins... the length of a regulatory review period for a human drug product will include all of the testing...

  9. 75 FR 55331 - Determination of Regulatory Review Period for Purposes of Patent Extension; SAPHRIS

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-10

    ... extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins... the length of a regulatory review period for a human drug product will include all of the testing...

  10. 75 FR 19407 - Determination of Regulatory Review Period for Purposes of Patent Extension; SAVELLA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-14

    ... extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins... the length of a regulatory review period for a human drug product will include all of the testing...

  11. 21 CFR 60.28 - Time frame for determining regulatory review periods.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Time frame for determining regulatory review periods. 60.28 Section 60.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.28 Time frame for...

  12. 9 CFR 124.22 - Revision of regulatory review period determination.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Revision of regulatory review period determination. 124.22 Section 124.22 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PATENT TERM RESTORATION Regulatory Review...

  13. 9 CFR 124.22 - Revision of regulatory review period determination.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Revision of regulatory review period determination. 124.22 Section 124.22 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PATENT TERM RESTORATION Regulatory Review...

  14. 9 CFR 124.22 - Revision of regulatory review period determination.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Revision of regulatory review period determination. 124.22 Section 124.22 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PATENT TERM RESTORATION Regulatory Review...

  15. 9 CFR 124.22 - Revision of regulatory review period determination.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Revision of regulatory review period determination. 124.22 Section 124.22 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PATENT TERM RESTORATION Regulatory Review...

  16. 9 CFR 124.23 - Final action on regulatory review period determination.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 180-day period for filing a due diligence petition under § 124.30 unless it receives: (a) New... request under § 124.22 for revision of the regulatory review period determination; (c) A due diligence...

  17. 75 FR 32479 - Determination of Regulatory Review Period for Purposes of Patent Extension; ABLAVAR

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2009-E-0165 and FDA-2009-E-0169] Determination of Regulatory Review Period for Purposes of Patent Extension... Administration (FDA) has determined the regulatory review period for ABLAVAR (previously the trade name of the...

  18. 9 CFR 124.23 - Final action on regulatory review period determination.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND... request under § 124.22 for revision of the regulatory review period determination; (c) A due diligence...

  19. 78 FR 70905 - Extension of Comment Period for the Water Quality Standards Regulatory Clarifications Proposed Rule

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... Comment Period for the Water Quality Standards Regulatory Clarifications Proposed Rule AGENCY... Environmental Protection Agency (EPA) is extending the comment period for the proposed rule ``Water Quality... published the proposed rule ``Water Quality Standards Regulatory Clarifications'' in the Federal Register...

  20. 77 FR 6517 - Economic Development Administration Regulatory Revision; Comment Period Extension

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-08

    ... DEPARTMENT OF COMMERCE Economic Development Administration 13 CFR Parts 300, 301, 302, 303, 304... Development Administration Regulatory Revision; Comment Period Extension AGENCY: Economic Development.... SUMMARY: On December 7, 2011, the Department of Commerce's Economic Development Administration (EDA...

  1. Revealing cell cycle control by combining model-based detection of periodic expression with novel cis-regulatory descriptors

    PubMed Central

    Andersson, Claes R; Hvidsten, Torgeir R; Isaksson, Anders; Gustafsson, Mats G; Komorowski, Jan

    2007-01-01

    Background We address the issue of explaining the presence or absence of phase-specific transcription in budding yeast cultures under different conditions. To this end we use a model-based detector of gene expression periodicity to divide genes into classes depending on their behavior in experiments using different synchronization methods. While computational inference of gene regulatory circuits typically relies on expression similarity (clustering) in order to find classes of potentially co-regulated genes, this method instead takes advantage of known time profile signatures related to the studied process. Results We explain the regulatory mechanisms of the inferred periodic classes with cis-regulatory descriptors that combine upstream sequence motifs with experimentally determined binding of transcription factors. By systematic statistical analysis we show that periodic classes are best explained by combinations of descriptors rather than single descriptors, and that different combinations correspond to periodic expression in different classes. We also find evidence for additive regulation in that the combinations of cis-regulatory descriptors associated with genes periodically expressed in fewer conditions are frequently subsets of combinations associated with genes periodically expression in more conditions. Finally, we demonstrate that our approach retrieves combinations that are more specific towards known cell-cycle related regulators than the frequently used clustering approach. Conclusion The results illustrate how a model-based approach to expression analysis may be particularly well suited to detect biologically relevant mechanisms. Our new approach makes it possible to provide more refined hypotheses about regulatory mechanisms of the cell cycle and it can easily be adjusted to reveal regulation of other, non-periodic, cellular processes. PMID:17939860

  2. Developmental gene regulatory network architecture across 500 million years of echinoderm evolution

    NASA Technical Reports Server (NTRS)

    Hinman, Veronica F.; Nguyen, Albert T.; Cameron, R. Andrew; Davidson, Eric H.

    2003-01-01

    Evolutionary change in morphological features must depend on architectural reorganization of developmental gene regulatory networks (GRNs), just as true conservation of morphological features must imply retention of ancestral developmental GRN features. Key elements of the provisional GRN for embryonic endomesoderm development in the sea urchin are here compared with those operating in embryos of a distantly related echinoderm, a starfish. These animals diverged from their common ancestor 520-480 million years ago. Their endomesodermal fate maps are similar, except that sea urchins generate a skeletogenic cell lineage that produces a prominent skeleton lacking entirely in starfish larvae. A relevant set of regulatory genes was isolated from the starfish Asterina miniata, their expression patterns determined, and effects on the other genes of perturbing the expression of each were demonstrated. A three-gene feedback loop that is a fundamental feature of the sea urchin GRN for endoderm specification is found in almost identical form in the starfish: a detailed element of GRN architecture has been retained since the Cambrian Period in both echinoderm lineages. The significance of this retention is highlighted by the observation of numerous specific differences in the GRN connections as well. A regulatory gene used to drive skeletogenesis in the sea urchin is used entirely differently in the starfish, where it responds to endomesodermal inputs that do not affect it in the sea urchin embryo. Evolutionary changes in the GRNs since divergence are limited sharply to certain cis-regulatory elements, whereas others have persisted unaltered.

  3. 78 FR 66980 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Designation of Longer Period...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70797; File No. SR-BOX-2013-43] Self-Regulatory... Proposed Rule Change To Permit Complex Orders To Participate in Price Improvement Periods November 1, 2013... to permit Complex Orders to participate in Price Improvement Periods (the ``COPIP'') and to make...

  4. Metabolic status and resistin in chronic schizophrenia over a 2-year period with continuous atypical antipsychotics

    PubMed Central

    Kawabe, Kentaro; Ochi, Shinichiro; Yoshino, Yuta; Mori, Yoko; Onuma, Hiroshi; Osawa, Haruhiko; Hosoda, Yoshiki; Ueno, Shu-ichi

    2015-01-01

    Background: Common adverse effects of atypical antipsychotic treatments for schizophrenia are weight gain and lipid metabolism abnormality. We aimed to identify the signs of metabolic problems with continuous atypical antipsychotic treatment for schizophrenia over a 2-year period. Methods: The participants were 68 schizophrenic patients (29 males, 39 females; ages 53.4 ± 13.5 years old). Changes in carbohydrate metabolism and changes in physical characteristics were studied over a 2-year period. In addition, functional single nucleotide polymorphisms in the transcriptional regulatory region of the resistin gene were examined. Results: We found no changes in the mental state of the participants over a 2-year period. Patients did show a significant decrease in total cholesterol and hemoglobin A1c levels, although physical changes such as body mass index and abdominal girth, were not observed. The amount of resistin may not be associated with mental states and physical parameters. Conclusions: We could not find physical factors related to metabolic changes of antipsychotics in this 2-year study. However, several psychological factors, such as health-related thoughts and behaviors, should be studied in the future. PMID:26557983

  5. 76 FR 31349 - Determination of Regulatory Review Period for Purposes of Patent Extension; ACTEMRA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ... Administration (FDA) has determined the regulatory review period for ACTEMRA and is publishing this notice of... applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents... actual amount of extension that the Director of Patents and Trademarks may award (for example, half the...

  6. 76 FR 15323 - Determination of Regulatory Review Period for Purposes of Patent Extension; ATRYN

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-21

    ... regulatory review period for ATRYN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents... of extension that the Director of Patents and Trademarks may award (for example, half the testing...

  7. 77 FR 26017 - Determination of Regulatory Review Period for Purposes of Patent Extension; KALBITOR

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... Administration (FDA) has determined the regulatory review period for KALBITOR and is publishing this notice of... applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent... actual amount of extension that the Director of Patents and Trademarks may award (for example, half the...

  8. 75 FR 75678 - Determination of Regulatory Review Period for Purposes of Patent Extension; STELARA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

    ... Administration (FDA) has determined the regulatory review period for STELARA and is publishing this notice of... application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent... toward the actual amount of extension that the Director of Patents and Trademarks may award (for example...

  9. 75 FR 76739 - Determination of Regulatory Review Period for Purposes of Patent Extension; ILARIS

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-09

    ... regulatory review period for ILARIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents... of extension that the Director of Patents and Trademarks may award (for example, half the testing...

  10. 77 FR 20830 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIIBRYD

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ...) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a..., animal drug product, medical device, food additive, or color additive) was subject to regulatory review... consists of two periods of time: A testing phase and an approval phase. For human drug products, the...

  11. 77 FR 75466 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Designation of a Longer Period...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-20

    ...-Regulatory Organizations; ICE Clear Europe Limited; Notice of Designation of a Longer Period for Commission... October 15, 2012, ICE Clear Europe Limited (``ICE Clear Europe'') filed with the Securities and Exchange...-day time period. \\5\\ 15 U.S.C. 78s(b)(2). The proposed rule change would permit ICE Clear Europe to...

  12. 77 FR 26016 - Determination of Regulatory Review Period for Purposes of Patent Extension; Alair Bronchial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ...) has determined the regulatory review period for Alair Bronchial Thermoplasty System and is publishing... submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the... may count toward the actual amount of extension that the Director of Patents and Trademarks may award...

  13. 75 FR 77878 - Determination of Regulatory Review Period for Purposes of Patent Extension; FREESTYLE NAVIGATOR

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ... determined the regulatory review period for FREESTYLE NAVIGATOR and is publishing this notice of that... the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which... toward the actual amount of extension that the Director of Patents and Trademarks may award (half the...

  14. 75 FR 54152 - Determination of Regulatory Review Period for Purposes of Patent Extension; NEURX DIAPHRAGM...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ... determined the regulatory review period for NEURX DIAPHRAGM PACING SYSTEM and is publishing this notice of... application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent... toward the actual amount of extension that the Director of Patents and Trademarks may award (half the...

  15. 75 FR 54887 - Determination of Regulatory Review Period for Purposes of Patent Extension; REPEL-CV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

    ... regulatory review period for REPEL-CV and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents... extension that the Director of Patents and Trademarks may award (half the testing phase must be subtracted...

  16. Dynamic RSA: Examining parasympathetic regulatory dynamics via vector-autoregressive modeling of time-varying RSA and heart period.

    PubMed

    Fisher, Aaron J; Reeves, Jonathan W; Chi, Cyrus

    2016-07-01

    Expanding on recently published methods, the current study presents an approach to estimating the dynamic, regulatory effect of the parasympathetic nervous system on heart period on a moment-to-moment basis. We estimated second-to-second variation in respiratory sinus arrhythmia (RSA) in order to estimate the contemporaneous and time-lagged relationships among RSA, interbeat interval (IBI), and respiration rate via vector autoregression. Moreover, we modeled these relationships at lags of 1 s to 10 s, in order to evaluate the optimal latency for estimating dynamic RSA effects. The IBI (t) on RSA (t-n) regression parameter was extracted from individual models as an operationalization of the regulatory effect of RSA on IBI-referred to as dynamic RSA (dRSA). Dynamic RSA positively correlated with standard averages of heart rate and negatively correlated with standard averages of RSA. We propose that dRSA reflects the active downregulation of heart period by the parasympathetic nervous system and thus represents a novel metric that provides incremental validity in the measurement of autonomic cardiac control-specifically, a method by which parasympathetic regulatory effects can be measured in process. © 2016 Society for Psychophysiological Research.

  17. 77 FR 61462 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-09

    ...-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Change Proposing a Pilot Program To... change to create and implement, on a pilot basis, a Lead Market Maker (``LMM'') Issuer Incentive Program...

  18. 76 FR 17951 - Notice of Regulatory Waiver Requests Granted for the Fourth Quarter of Calendar Year 2010

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-31

    ...Section 106 of the Department of Housing and Urban Development Reform Act of 1989 (the HUD Reform Act) requires HUD to publish quarterly Federal Register notices of all regulatory waivers that HUD has approved. Each notice covers the quarterly period since the previous Federal Register notice. The purpose of this notice is to comply with the requirements of section 106 of the HUD Reform Act. This notice contains a list of regulatory waivers granted by HUD during the period beginning on October 1, 2010, and ending on December 31, 2010.

  19. 75 FR 81292 - Notice of Regulatory Waiver Requests Granted for the Third Quarter of Calendar Year 2010

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ...Section 106 of the Department of Housing and Urban Development Reform Act of 1989 (the HUD Reform Act) requires HUD to publish quarterly Federal Register notices of all regulatory waivers that HUD has approved. Each notice covers the quarterly period since the previous Federal Register notice. The purpose of this notice is to comply with the requirements of section 106 of the HUD Reform Act. This notice contains a list of regulatory waivers granted by HUD during the period beginning on July 1, 2010, and ending on September 30, 2010.

  20. 77 FR 14817 - Notice of Regulatory Waiver Requests Granted for the Fourth Quarter of Calendar Year 2011

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ...Section 106 of the Department of Housing and Urban Development Reform Act of 1989 (the HUD Reform Act) requires HUD to publish quarterly Federal Register notices of all regulatory waivers that HUD has approved. Each notice covers the quarterly period since the previous Federal Register notice. The purpose of this notice is to comply with the requirements of section 106 of the HUD Reform Act. This notice contains a list of regulatory waivers granted by HUD during the period beginning on October 1, 2011, and ending on December 31, 2011.

  1. 77 FR 64180 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of Designation of a Longer Period...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-18

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68049; File No. SR-BYX-2012-019] Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of Designation of a Longer Period for Commission..., 2012, BATS Y-Exchange, Inc. (the ``Exchange'' or ``BYX'') filed with the Securities and Exchange...

  2. 77 FR 72429 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-05

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68320; File No. SR-NYSEArca-2012-108] Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of Longer Period for Commission Action on Proposed Rule Change, as Modified by Amendment No. 1 Thereto, Relating to the Listing and Trading of Shares of the NYSE Arca U.S. Equity Synthetic...

  3. 77 FR 72429 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-05

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68319; File No. SR-NYSEArca-2012-109] Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of Longer Period for Commission Action on Proposed Rule Change Relating to the Listing and Trading of Shares of the U.S. Equity High Volatility Put Write Index Fund Under NYSE Arca Equitie...

  4. 78 FR 36290 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Designation of a Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69733; File No. SR-NYSEMKT-2013-25] Self-Regulatory Organizations; NYSE MKT LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Amending NYSE MKT Rule 104--Equities To Codify Certain Traditional Trading Floor Functions That May Be Performed by Designated...

  5. 77 FR 38116 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-26

    ...-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Proposing a Pilot Program To Create a Lead Market Maker Issuer Incentive Program for...'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to create and implement, on a pilot basis, a...

  6. 78 FR 50476 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Designation of a Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70166; File No. SR-BATS-2013-035] Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To Amend the Competitive Liquidity Provider Program August 13, 2013. On June 17,...

  7. 77 FR 77152 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Designation of a Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-31

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68521; File No. SR-NYSEMKT-2012-58] Self-Regulatory Organizations; NYSE MKT LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Deleting NYSE MKT Rules 95(c) and (d)--Equities and Related Supplementary Material December 21, 2012. On October 26, 2012, NYSE...

  8. 77 FR 50740 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Designation of a Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67677; File No. SR-EDGA-2012-28] Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Amend EDGA Rules To Add the Route Peg Order August 16, 2012. On June 26, 2012, EDGA Exchange, Inc. (``Exchange'') filed...

  9. 77 FR 50740 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Designation of a Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67676; File No. SR-EDGX-2012-25] Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Amend EDGX Rules To Add the Route Peg Order August 16, 2012. On June 26, 2012, EDGX Exchange, Inc. (``Exchange'') filed...

  10. 77 FR 66896 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Designation of a Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68135; File No. SR-NYSEMKT-2012-41] Self-Regulatory Organizations; NYSE MKT LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Amend Commentary .04 to NYSE Amex Options Rule 903 To Permit the Exchange To List Additional Strike Prices Until the Close of...

  11. 77 FR 66896 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68136; File No. SR-NYSEArca-2012-94] Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Amend Commentary .06 to NYSE Arca Options Rule 6.4 To Permit the Exchange To List Additional Strike Prices Until the Clos...

  12. 78 FR 10652 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Designation of a Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-14

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68881; File No. SR-ICC-2012-24] Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Designation of a Longer Period for Commission Action on Proposed.... On December 6, 2012, ICE Clear Credit LLC (``ICC'') filed with the Securities and Exchange Commission...

  13. 78 FR 10646 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Designation of a Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-14

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68882; File No. SR-ICC-2012-23] Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Designation of a Longer Period for Commission Action on Proposed... December 6, 2012, ICE Clear Credit LLC (``ICC'') filed with the Securities and Exchange Commission...

  14. QUASI-PERIODICITIES AT YEAR-LIKE TIMESCALES IN BLAZARS

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sandrinelli, A.; Treves, A.; Covino, S.

    2016-03-15

    We searched for quasi-periodicities on year-like timescales in the light curves of six blazars in the optical—near-infrared bands and we made a comparison with the high energy emission. We obtained optical/NIR light curves from Rapid Eye Mounting photometry plus archival Small and Moderate Aperture Research Telescope System data and we accessed the Fermi light curves for the γ-ray data. The periodograms often show strong peaks in the optical and γ-ray bands, which in some cases may be inter-related. The significance of the revealed peaks is then discussed, taking into account that the noise is frequency dependent. Quasi-periodicities on a year-likemore » timescale appear to occur often in blazars. No straightforward model describing these possible periodicities is yet available, but some plausible interpretations for the physical mechanisms causing periodic variabilities of these sources are examined.« less

  15. The development of regulatory functions from birth to 5 years: insights from premature infants.

    PubMed

    Feldman, Ruth

    2009-01-01

    This study examined physiological, emotional, and attentional regulatory functions as predictors of self-regulation in 125 infants followed 7 times from birth to 5 years. Physiological regulation was assessed by neonatal vagal tone and sleep-wake cyclicity; emotion regulation by response to stress at 3, 6, and 12 months; and attention regulation by focused attention and delayed response in the 2nd year. Executive functions, behavior adaptation, and self-restraint were measured at 5 years. Regulatory functions showed stability across time, measures, and levels. Structural modeling demonstrated both mediated paths from physiological to self-regulation through emotional and attentional processes and direct continuity between vagal tone and each level of regulation. Results support the coherence of the regulation construct and are consistent with neurobiological models on self and consciousness.

  16. 77 FR 43620 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-25

    ... self-regulatory organization consents, the Commission shall either approve the proposed rule change...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to the Handling of Stop and Stop Limit...

  17. Lomb-Scargle periodogram analysis of the periods around 5.5 year and 11 year in the international sunspot numbers

    NASA Astrophysics Data System (ADS)

    Zhu, F. R.; Jia, H. Y.

    2018-07-01

    The New International Sunspot Numbers (NISNs) have been successfully compiled and can be downloaded from the World Data Center-Sunspot index and Long-term Solar Observations, Royal Observatory of Belgium, Brussels. The periods in these NISNs have been studied by using the Lomb-Scargle periodogram. The results show that the international sunspot numbers have a lot of periods. Of the various periods, the most outstanding period around 11 year is 10.108 year after removing the 10.862 year signal from the time series of sunspot numbers, while the periods of 11.988 year, 7.990 year, 9.612 year, 5.445 year, 8.915 year, 5.792 year are also found with the period of 5.445 year being stronger than those of 5.792 year and 8.915 year. However, the period of 5.445 year is still much weaker than the period of 10.862 year. It is evident that the periods around 11 year and 5.5 year in the revised international sunspot numbers obtained by using the Lomb-Scargle periodogram method is somewhat different from the ones in previous studies.

  18. 47 CFR 22.947 - Five year build-out period.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... MOBILE SERVICES Cellular Radiotelephone Service § 22.947 Five year build-out period. Except for systems...-out period, the licensee of the first cellular system on each channel block in each market may enter...-out period begins on the date the initial authorization for the first cellular system is granted, and...

  19. Period, Place and Mental Space: Using Historical Scholarship to Develop Year 7 Pupils' Sense of Period

    ERIC Educational Resources Information Center

    Smith, Dan

    2014-01-01

    What is a sense of period? And how can pupils' sense of period be developed? Questions such as these have troubled history teachers for many years, often revolving around debates over the role played by empathy and imagination in coming to know a period on its own terms. Rather than adopt a comparative approach, Dan Smiths decided in his teaching…

  20. 77 FR 32703 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... organization consents, the Commission shall either approve the proposed rule change, disapprove the proposed...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to Post-Trade Transparency for Agency Pass...

  1. 78 FR 62784 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-22

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change Relating to Wash Sale Transactions and FINRA Rule...-4 thereunder,\\2\\ a proposed rule change to amend FINRA Rule 5210. The proposed rule change was...

  2. 77 FR 3019 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-20

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to Post-Trade Transparency for Agency Pass... 19b-4 thereunder,\\2\\ a proposed rule change related to post-trade transparency for agency pass-through...

  3. 78 FR 17969 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Require Members To Report OTC Equity Transactions... (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to amend FINRA trade reporting rules...

  4. Epidemiology of Achilles tendon ruptures: increasing incidence over a 33-year period.

    PubMed

    Lantto, I; Heikkinen, J; Flinkkilä, T; Ohtonen, P; Leppilahti, J

    2015-02-01

    We investigated the epidemiology of total Achilles tendon ruptures and complication rates after operative and nonoperative treatments over a 33-year period in Oulu, Finland. Patients with Achilles tendon ruptures from 1979 to 2011 in Oulu were identified from hospital patient records. Demographic data, treatment method, and complications were collected retrospectively from medical records. Overall and sex- and age-specific incidence rates were calculated with 95% confidence intervals (CIs). The overall incidence per 100,000 person-years increased from 2.1 (95% CI 0.3-7.7) in 1979 to 21.5 (95% CI 14.6-30.6) in 2011. The incidence increased in all age groups. The mean annual increase in incidence was 2.4% (95% CI 1.3-4.7) higher for non-sports-related ruptures than for sports-related ruptures (P = 0.036). The incidence of sports-related ruptures increased during the second 11-year period whereas the incidence of non-sports-related ruptures increased steadily over the entire study period. Infection was four times more common after operative treatment compared with nonoperative treatment, re-rupture rates were similar. The incidence of Achilles tendon ruptures increased in all age groups over a 33-year period. Increases were mainly due to sports-related injuries in the second 11-year period and non-sports-related injuries in the last 11-year period. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  5. Solar wind oscillations with a 1.3 year period

    NASA Technical Reports Server (NTRS)

    Richardson, John D.; Paularena, Karolen I.; Belcher, John W.; Lazarus, Alan J.

    1994-01-01

    The Interplanetary Monitoring Platform 8 (IMP-8) and Voyager 2 spacecraft have recently detected a very strong modulation in the solar wind speed with an approximately 1.3 year period. Combined with evidence from long-term auroral and magnetometer studies, this suggests that fundamental changes in the Sun occur on a roughly 1.3 year time scale.

  6. The Development of Regulatory Functions from Birth to 5 Years: Insights from Premature Infants

    ERIC Educational Resources Information Center

    Feldman, Ruth

    2009-01-01

    This study examined physiological, emotional, and attentional regulatory functions as predictors of self-regulation in 125 infants followed 7 times from birth to 5 years. Physiological regulation was assessed by neonatal vagal tone and sleep-wake cyclicity; emotion regulation by response to stress at 3, 6, and 12 months; and attention regulation…

  7. 77 FR 5084 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-01

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66254; File No. SR-FINRA-2012-005] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Pilot Period of Amendments to FINRA Rule 11892 Governing Clearly Erroneous Transactions January 26,...

  8. Pesticide Residue Monitoring on South African Fresh Produce Exported over a 6-Year Period.

    PubMed

    Mutengwe, M T; Chidamba, L; Korsten, L

    2016-10-01

    Six years of pesticide residue data from fresh produce destined for the export market were analyzed for the period 2009 to 2014. A total of 37,838 fruit (99.27%) and vegetable (0.73%) data sets analyzed for the presence of 73 pesticides were compared. Pesticides were detected on 56.46% of samples, of which 0.78% had multiple residues. Noncompliances detected were because of the use of unregistered pesticides (0.73%), values that exceeded established maximum residue levels (MRLs) (0.32%), or the combination of values that exceeded MRLs and the use of unregistered pesticide residues (0.003%). The most commonly detected pesticides that exceeded established MRLs were imazalil (37.71%), prochloraz (28.69%), and iprodione (5.74%). The unregistered pesticide most often found on grapes and avocados was also imazalil (62.23%) and, on nectarines and avocados, diphenylamine (11.15%). Exceedances of MRL values were mostly associated with oranges (43.44%), avocados (27.87%), grapefruits (7.38%), and lemons (6.56%). Residual pesticide monitoring on fruits and vegetables is a key tool to ensure conformity with regulatory requirements and compliance with good agricultural practices and the trade requirements set by the importing country.

  9. Patch test reactivity to metal allergens following regulatory interventions: a 33-year retrospective study.

    PubMed

    Thyssen, Jacob Pontoppidan; Ross-Hansen, Katrine; Menné, Torkil; Johansen, Jeanne Duus

    2010-08-01

    Contact allergy epidemics to chromate and nickel were addressed in Denmark in 1983 and 1990 by regulatory interventions. To evaluate whether regulatory interventions on nickel and chromate exposure have reduced the proportion of strong patch test reactions. 22 506 patients with dermatitis aged 4-99 years were patch tested with nickel sulfate, potassium dichromate, or cobalt chloride between 1977 and 2009. The proportion of 3+ reactions to nickel sulfate was reduced and almost disappeared after the mid- and late 1980s (P-trend = 0.001). Today, 1+ and 2+ nickel reactions occur equally frequent. Cobalt chloride patch test reactivity reflected the nickel development to some degree. The proportion of 3+ reactions to potassium dichromate was reduced during the 1980s (P-trend = 0.13), whereas the proportion of 2+ reactions to potassium dichromate have increased in recent years. The decrease in nickel sulfate and cobalt chloride 3+ patch test reactivity began long before the Danish nickel regulation came into effect. This could be because of research activity at the time as well as political attention in Northern Europe. The chromate content in cement regulation may have changed the epidemiology of patch test reactivity; however, in recent years, 2+ reactions to chromate have increased markedly, a development that should be carefully followed.

  10. 76 FR 40150 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... Commission publishes its semiannual regulatory flexibility agenda. In addition, this document includes an...) requires each agency to publish twice each year a regulatory flexibility agenda containing a brief... 12866 requires each agency to publish twice each year a regulatory agenda of regulations under...

  11. Evapotranspiration response to multi-year dry periods in the semi-arid western United States

    NASA Astrophysics Data System (ADS)

    Rungee, J. P., II; Bales, R. C.

    2017-12-01

    Analysis of measured evapotranspiration shows multi-year regolith water storage can support evapotranspiration for years into a multi-year dry period. Measurements at 25 flux-tower sites in the semi-arid western United States, distributed across five primary land-cover types, show both resilience and vulnerability to multi-year dry periods. Average evapotranspiration ranged from about 700+200 mm per water year (October-September) in evergreen needleleaf forests to 350+150 mm per water year in grasslands and open shrublands. On average, in California's Mediterranean climate almost half of the water-year evapotranspiration is supported by seasonal and/or multi-year regolith water storage, compared to a characteristic 20 to 30 percent value of energy-limited and inland sites. Below 35oN latitude, water-year evapotranspiration exceeded estimated precipitation in over half of the years on record. For non-energy-limited sites, water-year evapotranspiration increased with precipitation up to a maximum water-year evapotranspiration value of about 900, 750, 600, 425 and 300 mm per water year for evergreen needleleaf forests, mixed forests, woody savannas, grasslands and open shrublands, respectively. There were 15 multi-year dry periods on record that exhibited either an attenuation in evapotranspiration, defined as an annual value below 80% of the wet-year average, or withdrawal from multi-year storage. A multi-year dry period was defined as three or more consecutive water years in which all water-year precipitation values and the mean period value were in the lower 50 and 35 percent of the historical record, respectively. For sites exhibiting evapotranspiration attenuation, resistance to multi-year dry periods ranged from 9 to 49 months, drafting as much as 444 mm of regolith storage. At some mountain sites regolith storage provided up to 678 mm, almost the equivalent of the average water-year evapotranspiration for these sites, over the extent of the multi-year dry

  12. What are the new challenges, goals, and tasks of occupational health in China's Thirteenth Five-Year Plan (13th FYP) period?

    PubMed Central

    Wang, Bing; Wu, Chao; Kang, Liangguo; Huang, Lang; Pan, Wei

    2018-01-01

    Objective: In recent years, the Chinese government has attached great importance to occupational health under the guidance of people-oriented concept. This paper introduces the current status and future development of occupational health in China's Thirteenth Five-Year Plan (13th FYP) period (2016-2020) to promote the cooperation and exchange on occupational health between China and other countries. Methods: We collected statistical data about occupational diseases and information addressing occupational diseases. We included all types of official reports, guidelines, policies, and relevant laws published by the Chinese government. Results: China has carried out a series of strategies and measures to reduce the incidence of occupational diseases, and has made progress in occupational health protection. However, occupational health in China still faces severe conditions and challenges for occupational diseases that have not been prevented and controlled effectively. To actively promote the future development of occupational health during the 13th FYP period, China has issued a series of important policy documents (such as the Plan for a Healthy China 2030, the 13th FYP for Occupational Disease Prevention and Control, and the 13th FYP for Occupational Health Hazard Prevention and Control) in the last two years. Conclusion: The overall situation condition of occupational health in China is still serious. Occupational health in China's 13th FYP period faces a series of challenges, future tasks include plans to add the employer and regulatory levels of occupational health management, and occupational health education and publicity to the current technology-dominated approaches. PMID:29563366

  13. Development of a novel regulatory pharmacovigilance prioritisation system: an evaluation of its performance at the UK Medicines and Healthcare products Regulatory Agency.

    PubMed

    Seabroke, Suzie; Wise, Lesley; Waller, Patrick

    2013-10-01

    The prioritisation of drug safety issues for further evaluation or regulatory action is critical to ensure that acceptable timelines and appropriate resource allocation are defined to meet public health and regulatory obligations. Our objective was to develop, pilot and implement a novel tool for prioritising pharmacovigilance issues within the Medicines and Healthcare products Regulatory Agency (MHRA). An initial system was developed empirically and then piloted over a 10-month period in the pharmacovigilance signal management meeting at the MHRA that discusses potential pharmacovigilance issues, and determines, through consensus, their priority and a timescale for action. The priority assigned by the tool was compared with the priority decided by collective judgement at the meeting. Once an acceptable level of concordance between the tool and the meeting had been achieved, the finalised tool was implemented into routine use at the MHRA, with an evaluation of its performance conducted after the first year. The Regulatory Pharmacovigilance Prioritisation System (RPPS) tool prioritises pharmacovigilance issues according to the following four broad categories, each with four inputs: strength of evidence, public health implications, agency regulatory obligations and public perceptions. A weighted scoring system links the inputs to a pre-defined number of points where if a threshold is reached then the points are awarded. The overall priority is determined by the sum of all points obtained from each of the inputs. The pilot study included a total of 73 pharmacovigilance issues during the 10-month study period, with an overall exact agreement between the RPPS priority and the collective judgement of the meeting of 60.3 %. Where exact agreement was not obtained, the RPPS generally prioritised the issues slightly higher than the meeting. Over the first year following implementation, the RPPS achieved an overall exact agreement of 82.2 %. Following the pilot study and

  14. Annual incidences of visual impairment during 10-year period in Mie prefecture, Japan.

    PubMed

    Ikesugi, Kengo; Ichio, Takako; Tsukitome, Hideyuki; Kondo, Mineo

    2017-07-01

    To determine the annual incidence of visual impairment in a Japanese population during a 10-year period. We examined the physical disability certificates issued yearly between 2004 and 2013 in Mie prefecture, Japan. During this period 2468 visually impaired people were registered under the newly defined Act on Welfare of the Physically Disabled Persons' criteria. The age, sex distribution, and causes of visual impairment were determined from the certificates. The major causes of visual impairment during the ten-year period were glaucoma (23.3%), diabetic retinopathy (17.3%), retinitis pigmentosa (12.2%), macular degeneration (9.0%), chorioretinal degeneration or high myopia (7.4%), optic atrophy (5.8%), stroke or brain tumor (5.4%) and cataracts (3.7%). The incidence of glaucoma was significantly higher throughout the period (2004-2013), and that of diabetic retinopathy was lower between 2007 and 2013. The incidence of retinitis pigmentosa did not change significantly during the 10-year period. The incidence of macular degeneration tended to increase between 2004 and 2007, but it decreased significantly between 2007 and 2013. The results indicate that in Japan, the rates of the major causes of visual impairment altered in the most recent 10-year period reflecting the recent changes in the social background and advances in ocular and systemic treatment.

  15. 75 FR 53314 - Determination of Regulatory Review Period for Purposes of Patent Extension; PRISTIQ

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-E-0084...

  16. 77 FR 26557 - Determination of Regulatory Review Period for Purposes of Patent Extension; FERAHEME

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  17. 77 FR 26288 - Determination of Regulatory Review Period for Purposes of Patent Extension; HALAVEN

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-E-0156...

  18. Regulatory T Cells Show Dynamic Behavior During Late Pregnancy, Delivery, and the Postpartum Period.

    PubMed

    Lima, Jorge; Martins, Catarina; Nunes, Glória; Sousa, Maria-José; Branco, Jorge C; Borrego, Luís-Miguel

    2017-07-01

    Regulatory T cells (Tregs) are critical immunomodulators during early pregnancy by preventing maternal T-cell activation against fetal cells. However, how populations of maternal Tregs vary during and after pregnancy in humans is still unclear. Therefore, we investigated Treg subsets in the peripheral blood of pregnant women from late pregnancy through the postpartum period. To accomplish this, the following circulating Treg subsets were analyzed in 43 healthy pregnant women and 35 nonpregnant women by flow cytometry during the third trimester, on the day of delivery, and postpartum: CD4 Dim CD25 Hi , CD4 + CD25 Hi Foxp3 + , and CD4 + CD25 Hi CD127 -/dim . Additionally, the expression levels of the transcription factor Foxp3 in CD4 Dim CD25 Hi Treg were analyzed. We have found that CD4 Dim CD25 Hi Treg subset significantly decreased in the pregnant women on the day of delivery relative to the third trimester ( P < .05), and that all Treg subsets significantly increased postpartum compared to the third trimester and the day of delivery ( P < .05). Moreover, the Foxp3 expression ratios within the CD4 Dim CD25 Hi Treg subset decreased during pregnancy and until delivery compared to those measured in the nonpregnant women and significantly increased postpartum compared to the third trimester and the day of delivery ( P < .05). Thus, despite their established role in offering immunoprotection to the fetus in early pregnancy, the number of circulating Tregs also varies from late pregnancy to the postpartum period. Our results offer an explanation for the possible effects of pregnancy on the clinical outcomes of some autoimmune diseases during the postpartum period.

  19. 75 FR 76991 - Determination of Regulatory Review Period for Purposes of Patent Extension; MULTAQ

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  20. 77 FR 26554 - Determination of Regulatory Review Period for Purposes of Patent Extension; GILENYA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  1. 76 FR 35899 - Determination of Regulatory Review Period for Purposes of Patent Extension; MYFORTIC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-20

    ... Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  2. 75 FR 77877 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIBATIV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ... Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  3. 75 FR 77879 - Determination of Regulatory Review Period for Purposes of Patent Extension; SAMSCA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ... Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  4. 76 FR 12974 - Determination of Regulatory Review Period for Purposes of Patent Extension; AMPYRA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  5. 77 FR 26555 - Determination of Regulatory Review Period for Purposes of Patent Extension; EGRIFTA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  6. 77 FR 52035 - Determination of Regulatory Review Period for Purposes of Patent Extension; TORISEL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  7. 77 FR 26558 - Determination of Regulatory Review Period for Purposes of Patent Extension; JEVTANA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  8. 75 FR 17142 - Determination of Regulatory Review Period for Purposes of Patent Extension; LUSEDRA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  9. 77 FR 20827 - Determination of Regulatory Review Period for Purposes of Patent Extension; TEFLARO

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  10. 77 FR 20829 - Determination of Regulatory Review Period for Purposes of Patent Extension; NATROBA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  11. 75 FR 1301 - Periodic Reporting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... POSTAL REGULATORY COMMISSION 39 CFR Part 3050 [Docket No. RM2010-7; Order No. 372] Periodic... in the analytical methods approved for use in periodic reporting.\\1\\ Proposal Thirty would modify the... Analytical Principles Used in Periodic Reporting (Proposals Three through Nineteen), November 13, 2009, at 36...

  12. 76 FR 297 - Periodic Reporting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ... POSTAL REGULATORY COMMISSION 39 CFR Part 3050 [Docket No. RM2011-5; Order No. 625] Periodic... certain analytical methods used in periodic reporting. This action responds to a Postal Service rulemaking... changes in the analytical methods approved for use in periodic reporting.\\1\\ Four separate proposals...

  13. 77 FR 56176 - Analytical Methods Used in Periodic Reporting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-12

    ... POSTAL REGULATORY COMMISSION 39 CFR Part 3001 [Docket No. RM2012-7; Order No. 1459] Analytical Methods Used in Periodic Reporting AGENCY: Postal Regulatory Commission. ACTION: Notice of proposed... analytical methods approved for use in periodic reporting.\\1\\ \\1\\ Petition of the United States Postal...

  14. 7 CFR 1210.310 - Fiscal period and marketing year.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Fiscal period and marketing year. 1210.310 Section 1210.310 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE WATERMELON RESEARCH AND PROMOTION PLAN Watermelon...

  15. 7 CFR 1219.10 - Fiscal period or marketing year.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Fiscal period or marketing year. 1219.10 Section 1219.10 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE HASS AVOCADO PROMOTION, RESEARCH, AND INFORMATION Hass...

  16. Maternal vitamin D, DNA methylation at imprint regulatory regions, and offspring weight at birth, 1 year, and 3 years

    PubMed Central

    Neelon, Sara E Benjamin; White, Alexandra J; Vidal, Adriana C; Schildkraut, Joellen M; Murtha, Amy P; Murphy, Susan K; Kullman, Seth W; Hoyo, Cathrine

    2017-01-01

    Background/Objective Vitamin D deficiency during pregnancy is associated with poor birth outcomes in some studies, but few have examined weight beyond birth. Additionally, little is known about how vitamin D influences DNA methylation of regulatory regions known to be involved in growth, as possible mediators to weight status in offspring. Subjects/Methods We conducted linear regressions to assess maternal plasma 25-hydroxyvitamin D (25(OH)D) by quartile and birth weight for gestational age z-score, 1-year weight-for-length z-score, and 3-year body mass index (BMI) z-score among 476 mother/infant dyads from a prospective cohort. We assessed maternal 25(OH)D and infant DNA methylation at 9 differentially methylated regions (DMRs) of genomically imprinted genes with known functions in fetal growth, including H19, IGF2, MEG3, MEG3-IG, MEST, NNAT, PEG3, PLAGL1, and SGCE/PEG10. Results Mean (standard deviation, SD) maternal 25(OH)D was 41.1 (14.2) nmol/L at a mean (SD) of 13.2 (5.5) weeks gestation. After adjustment for potential confounders, the first (Q1) and second (Q2) quartiles of 25(OH)D, compared to the fourth (Q4), were associated with lower birth weight for gestational age z-scores (−0.43 units; CI −0.79, −0.07; p=0.02 for Q1 and −0.56 units; CI −0.89, −0.23; p=0.001 for Q2). Q1 compared to Q4 was associated with higher 1-year weight-for-length z-scores (0.78 units; 0.08, 1.54; p=0.04) and higher 3-year BMI z-scores (0.83 units; 0.11, 0.93; p=0.02). We did not observe associations between maternal 25(OH)D and methylation for any of the 9 DMRs after correcting for multiple testing. Conclusions Reduced maternal 25(OH)D was associated with lower birth weight for gestational age z-scores but higher 1-year weight-for-length and 3-year BMI z-scores in offspring. However, 25(OH)D does not appear to be operating through the regulatory sequences of the genomically imprinted genes we examined. PMID:28676681

  17. Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

    PubMed

    Jullian, Sandra; Jaskiewicz, Lukasz; Pfannkuche, Hans-Jürgen; Parker, Jeremy; Lalande-Luesink, Isabelle; Lewis, David J; Close, Philippe

    2015-09-01

    Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas. All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies." The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system. A total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as "Requests for regulatory actions," 309 (65%) as "Requests for medical and scientific information," and 118 (25%) comments were related to "Data deficiencies." The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs. The authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety. Copyright © 2015 John Wiley & Sons, Ltd.

  18. Federal/State Regulatory Enhancement, Cost Allocation, and CATV/TELCO Distance Learning Initiatives in Connecticut.

    ERIC Educational Resources Information Center

    Pietras, Jesse John

    Connecticut has adopted a moderate approach to communications infrastructure modernization, covering a 4-year implementation period from 1993 to 1996. The state's remote educational framework, with regulatory enhancements, will allow the state to be technologically competitive with neighboring states as it allows subscribers to use evolving…

  19. One hundred years of return period: Strengths and limitations

    NASA Astrophysics Data System (ADS)

    Volpi, E.; Fiori, A.; Grimaldi, S.; Lombardo, F.; Koutsoyiannis, D.

    2015-10-01

    One hundred years from its original definition by Fuller, the probabilistic concept of return period is widely used in hydrology as well as in other disciplines of geosciences to give an indication on critical event rareness. This concept gains its popularity, especially in engineering practice for design and risk assessment, due to its ease of use and understanding; however, return period relies on some basic assumptions that should be satisfied for a correct application of this statistical tool. Indeed, conventional frequency analysis in hydrology is performed by assuming as necessary conditions that extreme events arise from a stationary distribution and are independent of one another. The main objective of this paper is to investigate the properties of return period when the independence condition is omitted; hence, we explore how the different definitions of return period available in literature affect results of frequency analysis for processes correlated in time. We demonstrate that, for stationary processes, the independence condition is not necessary in order to apply the classical equation of return period (i.e., the inverse of exceedance probability). On the other hand, we show that the time-correlation structure of hydrological processes modifies the shape of the distribution function of which the return period represents the first moment. This implies that, in the context of time-dependent processes, the return period might not represent an exhaustive measure of the probability of failure, and that its blind application could lead to misleading results. To overcome this problem, we introduce the concept of Equivalent Return Period, which controls the probability of failure still preserving the virtue of effectively communicating the event rareness.

  20. 77 FR 26556 - Determination of Regulatory Review Period for Purposes of Patent Extension; EQUIDONE GEL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... of two periods of time: A testing phase and an approval phase. For animal drug products, the testing... Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal... for a period of up to 5 years so long as the patented item (human drug product, animal drug product...

  1. 76 FR 36927 - Determination of Regulatory Review Period for Purposes of Patent Extension; Fusilev, Levoleucovorin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-23

    ... Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  2. 76 FR 37128 - Determination of Regulatory Review Period for Purposes of Patent Extension; INVEGA SUSTENNA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  3. Solar wind variations in the 60-100 year period range: A review

    NASA Technical Reports Server (NTRS)

    Feynman, J.

    1983-01-01

    The evidence for and against the reality of a solar wind variation in the period range of 60-100 years is reexamined. Six data sets are reviewed; sunspot numbers, geomagnetic variations, two auroral data sets and two (14)C data sets. These data are proxies for several different aspects of the solar wind and the presence or absence of 60-100 year cyclic behavior in a particular data set does not necessarily imply the presence or absence of this variation in other sets. It was concluded that two different analyses of proxy data for a particular characteristic of the heliospheric solar wind yielded conflicting results. This conflict can be resolved only by future research. It is also definitely confirmed that proxy data for the solar wind in the ecliptic at 1 A.U. undergo a periodic variation with a period of approximately 87 years. The average amplitude and phase of this variation as seen in eleven cycles of proxy data are presented.

  4. Exposure to antibacterial agents with QT liability in 14 European countries: trends over an 8-year period

    PubMed Central

    Raschi, Emanuel; Poluzzi, Elisabetta; Zuliani, Chiara; Muller, Arno; Goossens, Herman; De Ponti, Fabrizio

    2009-01-01

    AIMS (i) To classify antibacterial agents with QT liability on the basis of the available evidence, and (ii) to assess trends in their consumption over an 8-year period (1998–2005) in 14 European countries. METHODS Current published evidence on QT liability of antibiotics was retrieved through MEDLINE search and joined to official warnings from regulatory agencies. Each drug was classified according to an already proposed algorithm based on the strength of evidence: from group A (any evidence) to group E (clinical reports of torsades de pointes and warnings on QT liability). Consumption data were provided by the European Surveillance of Antibacterial Consumption (ESAC) project and were expressed as defined daily doses per 1000 inhabitants per day (DID). RESULTS Among 21 detected compounds, nine [six fluoroquinolones (FQs) and three macrolides (MACs)] belonged to group E. Use of group E drugs ranged from 1.3 (Sweden) to 4.1 DID (Italy) in 1998 and from 1.2 (Sweden) to 6.5 DID (Italy) in 2005. Significant exposure was observed in Italy and Spain (6.5 and 3.8 DID, respectively, in 2005). Only Denmark, Sweden and UK showed a slight decrease in use. Exposure to clarithromycin increased in 10 out of 14 countries, with a marked increment in Italy (3 DID in 2005). CONCLUSIONS Notwithstanding regulatory measures, in 2005 there was still significant exposure to antibacterials with strong evidence of QT liability and, in most countries, it was even increased. This warrants further investigation of appropriateness of use and suggests closer monitoring of group E drugs. Physicians should be aware when prescribing them to susceptible patients. PMID:19076158

  5. 10 CFR 76.31 - Periodic application requirement.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Periodic application requirement. 76.31 Section 76.31 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Application § 76.31 Periodic application requirement. The Corporation shall periodically apply to the Commission...

  6. 10 CFR 76.31 - Periodic application requirement.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Periodic application requirement. 76.31 Section 76.31 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Application § 76.31 Periodic application requirement. The Corporation shall periodically apply to the Commission...

  7. 10 CFR 76.31 - Periodic application requirement.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Periodic application requirement. 76.31 Section 76.31 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Application § 76.31 Periodic application requirement. The Corporation shall periodically apply to the Commission...

  8. 10 CFR 76.31 - Periodic application requirement.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Periodic application requirement. 76.31 Section 76.31 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Application § 76.31 Periodic application requirement. The Corporation shall periodically apply to the Commission...

  9. 10 CFR 76.31 - Periodic application requirement.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Periodic application requirement. 76.31 Section 76.31 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Application § 76.31 Periodic application requirement. The Corporation shall periodically apply to the Commission...

  10. 75 FR 38757 - Periodic Reporting Exceptions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-06

    ... POSTAL REGULATORY COMMISSION 39 CFR 3055 [Docket No. RM2010-11; Order No. 481] Periodic Reporting...-permanent exceptions to certain rules on periodic reporting of service performance measurement. DATES... 202-789-6820 or [email protected] . SUPPLEMENTARY INFORMATION: Table of Contents I...

  11. Evidence for Periodicity in 43 year-long Monitoring of NGC 5548

    NASA Astrophysics Data System (ADS)

    Bon, E.; Zucker, S.; Netzer, H.; Marziani, P.; Bon, N.; Jovanović, P.; Shapovalova, A. I.; Komossa, S.; Gaskell, C. M.; Popović, L. Č.; Britzen, S.; Chavushyan, V. H.; Burenkov, A. N.; Sergeev, S.; La Mura, G.; Valdés, J. R.; Stalevski, M.

    2016-08-01

    We present an analysis of 43 years (1972 to 2015) of spectroscopic observations of the Seyfert 1 galaxy NGC 5548. This includes 12 years of new unpublished observations (2003 to 2015). We compiled about 1600 Hβ spectra and analyzed the long-term spectral variations of the 5100 Å continuum and the Hβ line. Our analysis is based on standard procedures, including the Lomb-Scargle method, which is known to be rather limited to such heterogeneous data sets, and a new method developed specifically for this project that is more robust and reveals a ˜5700 day periodicity in the continuum light curve, the Hβ light curve, and the radial velocity curve of the red wing of the Hβ line. The data are consistent with orbital motion inside the broad emission line region of the source. We discuss several possible mechanisms that can explain this periodicity, including orbiting dusty and dust-free clouds, a binary black hole system, tidal disruption events, and the effect of an orbiting star periodically passing through an accretion disk.

  12. 18 CFR 154.403 - Periodic rate adjustments.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Periodic rate adjustments. 154.403 Section 154.403 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Changes § 154.403 Periodic rate adjustments. (a) This section applies to the passthrough, on a periodic...

  13. 18 CFR 154.403 - Periodic rate adjustments.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Periodic rate adjustments. 154.403 Section 154.403 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Changes § 154.403 Periodic rate adjustments. (a) This section applies to the passthrough, on a periodic...

  14. 18 CFR 154.403 - Periodic rate adjustments.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Periodic rate adjustments. 154.403 Section 154.403 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Changes § 154.403 Periodic rate adjustments. (a) This section applies to the passthrough, on a periodic...

  15. 18 CFR 154.403 - Periodic rate adjustments.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Periodic rate adjustments. 154.403 Section 154.403 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Changes § 154.403 Periodic rate adjustments. (a) This section applies to the passthrough, on a periodic...

  16. Content analysis of 150 years of British periodicals.

    PubMed

    Lansdall-Welfare, Thomas; Sudhahar, Saatviga; Thompson, James; Lewis, Justin; Cristianini, Nello

    2017-01-24

    Previous studies have shown that it is possible to detect macroscopic patterns of cultural change over periods of centuries by analyzing large textual time series, specifically digitized books. This method promises to empower scholars with a quantitative and data-driven tool to study culture and society, but its power has been limited by the use of data from books and simple analytics based essentially on word counts. This study addresses these problems by assembling a vast corpus of regional newspapers from the United Kingdom, incorporating very fine-grained geographical and temporal information that is not available for books. The corpus spans 150 years and is formed by millions of articles, representing 14% of all British regional outlets of the period. Simple content analysis of this corpus allowed us to detect specific events, like wars, epidemics, coronations, or conclaves, with high accuracy, whereas the use of more refined techniques from artificial intelligence enabled us to move beyond counting words by detecting references to named entities. These techniques allowed us to observe both a systematic underrepresentation and a steady increase of women in the news during the 20th century and the change of geographic focus for various concepts. We also estimate the dates when electricity overtook steam and trains overtook horses as a means of transportation, both around the year 1900, along with observing other cultural transitions. We believe that these data-driven approaches can complement the traditional method of close reading in detecting trends of continuity and change in historical corpora.

  17. Content analysis of 150 years of British periodicals

    PubMed Central

    Lansdall-Welfare, Thomas; Sudhahar, Saatviga; Thompson, James; Lewis, Justin; Cristianini, Nello

    2017-01-01

    Previous studies have shown that it is possible to detect macroscopic patterns of cultural change over periods of centuries by analyzing large textual time series, specifically digitized books. This method promises to empower scholars with a quantitative and data-driven tool to study culture and society, but its power has been limited by the use of data from books and simple analytics based essentially on word counts. This study addresses these problems by assembling a vast corpus of regional newspapers from the United Kingdom, incorporating very fine-grained geographical and temporal information that is not available for books. The corpus spans 150 years and is formed by millions of articles, representing 14% of all British regional outlets of the period. Simple content analysis of this corpus allowed us to detect specific events, like wars, epidemics, coronations, or conclaves, with high accuracy, whereas the use of more refined techniques from artificial intelligence enabled us to move beyond counting words by detecting references to named entities. These techniques allowed us to observe both a systematic underrepresentation and a steady increase of women in the news during the 20th century and the change of geographic focus for various concepts. We also estimate the dates when electricity overtook steam and trains overtook horses as a means of transportation, both around the year 1900, along with observing other cultural transitions. We believe that these data-driven approaches can complement the traditional method of close reading in detecting trends of continuity and change in historical corpora. PMID:28069962

  18. Regulatory and Quality Considerations for Continuous Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

    PubMed

    Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

    2015-03-01

    This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  19. Aflatoxin control--how a regulatory agency managed risk from an unavoidable natural toxicant in food and feed.

    PubMed

    Park, D L; Stoloff, L

    1989-04-01

    The control by the Food and Drug Administration (FDA) of aflatoxin, a relatively recently discovered, unavoidable natural contaminant produced by specific molds that invade a number of basic food and feedstuffs, provides an example of the varying forces that affect risk assessment and management by a regulatory Agency. This is the story of how the FDA responded to the initial discovery of a potential carcinogenic hazard to humans in a domestic commodity, to the developing information concerning the nature of the hazard, to the economic and political pressures that are created by the impact of natural forces on regulatory controls, and to the restraints of laws within which the Agency must work. This story covers four periods: the years of discovery and action decisions on the basis of meager knowledge and the fear of cancer; the years of tinkering on paper with the regulatory process, the years of digestion of the accumulating knowledge, and the application of that knowledge to actions forced by natural events; and an audit of the current status of knowledge about the hazard from aflatoxin, and proposals for regulatory control based on that knowledge.

  20. 75 FR 54345 - Determination of Regulatory Review Period for Purposes of Patent Extension; BRYAN CERVICAL DISC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug... periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with...

  1. Cruise design for a 5-year period of the 50-year timber sales in Alaska.

    Treesearch

    John W. Hazard

    1985-01-01

    Sampling rules and estimation procedures are described for a new cruise design that was developed for 50-year timber sales in Alaska. An example is given of the rate redetermination cruise and analysis for the 1984-1989 period of the Ketchikan Pulp Company sale. In addition, methodology is presented for an alternative sampling technique of sampling with probability...

  2. First-Year Chemistry in the Context of the Periodic Table.

    ERIC Educational Resources Information Center

    Woodgate, Sheila D.

    1995-01-01

    Describes the methods that have been developed to blend descriptive chemistry and principles in a first-year chemistry course. The key is active teaching of the subject using the periodic table as a template. Inorganic chemistry is taught using a group approach: developing trends that help teaching and learning become obvious if all elements of…

  3. Regulatory effects on particulate pollution in the early hours of Chinese New Year, 2015.

    PubMed

    Lai, Yonghang; Brimblecombe, Peter

    2017-08-23

    Human activities are a key driver of air pollution, so it is hardly surprising that celebrations affect air quality. The use of fireworks contributes to high particulate concentrations in many parts of the world, with the Chinese Lunar New Year (spring festival) particularly noticeable, as firecrackers are traditionally used to drive off evil spirits. Fireworks lead to short-term peaks in the concentration of PM10, PM2.5 and SO 2 . Regulatory actions that restrict the use of fireworks have been evident in China since the 1990s. This paper investigates the particulate concentrations in nine Chinese cities (Beijing, Chengdu, Chongqing, Tianjin, Xi'an, Nanjing, Shanghai, Guangzhou and Shenzhen, along with Hong Kong (a Special Administrative Region) and Taipei and Kaohsiung (Taiwan) with a particular focus on the celebrations of 2015. Extremely high concentrations of particulate matter were observed, with some sites revealing peak PM10 concentrations in excess of 1000 μg m -3 in the early hours of the New Year. In Beijing, Tianjin and Chongqing, the activities caused high particulate matter concentrations at most sites throughout the city. These peaks in particulate load in the early hours of Chinese New Year do not appear to be closely related to meteorological parameters. However, in cities where fireworks appear to be better regulated, there are fewer sharp pollution peaks just after midnight, although lowered air quality can still be found in the outer parts of some cities, remote from regulatory pressures. A few cities seem to have been effective at reducing the impact of the celebrations on air quality, with Nanjing a recent example. An increasing focus on light displays and electric lanterns also seems to offer a sense of celebration with much reduced impacts on air quality.

  4. Which emotional regulatory strategy makes Chinese adolescents happier? A longitudinal study.

    PubMed

    Sang, Biao; Deng, Xinmei; Luan, Ziyan

    2014-12-01

    Growing interest in emotion regulation is reflected in the studies of cognitive and social development. However, the extant studies mainly highlight how emotion regulation develops based on a western value system. This study utilised a longitudinal design to examine the development of emotion regulation and explored the contributions of different regulatory strategies to emotion experience regarding the early adolescent development period in a Chinese population. A total of 303 Chinese adolescents (age range = 10-14 years) were followed up in a three-phase longitudinal study for 3 years. In each phase of the study, participants completed Adolescents Emotion Regulation Questionnaire and Daily Emotion Scale. Results of hierarchical linear regressions revealed that Chinese adolescents reported more down-regulation. Down-regulation is more effective than up-regulation in enhancing desirable emotion experience and reducing undesirable emotion experience during adolescents' development. Also, the adaptive functions of emotional regulatory strategies in Chinese background were discussed. © 2014 International Union of Psychological Science.

  5. The limits of regulatory toxicology

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Carrington, Clark D.; Bolger, P. Michael, E-mail: mike.bolger@fda.hhs.go

    2010-03-01

    The Acceptable Daily Intake (ADI) has been used by regulatory and public health organizations (e.g., the U.S. Food and Drug and Administration, and the World Health Organization) for chemicals for more than 50 years. The ADI concept was also initially employed at the U.S. Environmental Protection Agency at its inception in 1971, although with the adoption of newer terminology, it later became known as the Reference Dose (RfD). It is clear from the literature that both were first devised as instruments of regulatory policy. In the intervening years, it has become common to use language that implies that these standardsmore » are statements of scientific fact. Similarly, some of the discretionary or default values that are used to derive regulatory standards are represented as scientific assumptions when in fact they also represent regulatory policy. This confusion impedes both the best use of the available science and informed public participation in policy making. In addition, the misconception of the ADI or the RfD as statements of scientific fact may impede the consideration of alternative means to reduce exposure to chemicals that may be harmful, including regulatory measures that do not involve prescribing a regulatory concentration limit.« less

  6. Organizational performance and regulatory compliance as measured by clinical pertinence indicators before and after implementation of Anesthesia Information Management System (AIMS).

    PubMed

    Choi, Clark K; Saberito, Darlene; Tyagaraj, Changa; Tyagaraj, Kalpana

    2014-01-01

    Previous studies have suggested that electronic medical records (EMR) can lead to a greater reduction of medical errors and better adherence to regulatory compliance than paper medical records (PMR). In order to assess the organizational performance and regulatory compliance, we tracked different clinical pertinence indicators (CPI) in our anesthesia information management system (AIMS) for 5 years. These indicators comprised of the protocols from the Surgical Care Improvement Project (SCIP), elements of performance (EP) from The Joint Commission (TJC), and guidelines from the Centers for Medicare and Medicaid Services (CMS). A comprehensive AIMS was initiated and the CPI were collected from October 5, 2009 to December 31, 2010 (EMR period) and from January 1, 2006 to October 4, 2009 (PMR period). Fourteen CPI were found to be common between the EMR and PMR periods. Based on the statistical analysis of the 14 common CPI, there was a significant increase (p < 0.001) in overall compliance after the introduction of EMR compared to the PMR period. The increase in overall compliance was significantly progressive (p = 0.013) from year to year over 2006 and 2010. Of the 14 CPI, Documentation of a) medication doses, and b) monitoring of postoperative physiological status, mental status, and pain scores showed significant improvement (p < 0.001) during the EMR period compared to the PMR period.

  7. Spurious One-Month and One-Year Periods in Visual Observations of Variable Stars

    NASA Astrophysics Data System (ADS)

    Percy, J. R.

    2015-12-01

    Visual observations of variable stars, when time-series analyzed with some algorithms such as DC-DFT in vstar, show spurious periods at or close to one synodic month (29.5306 days), and also at about a year, with an amplitude of typically a few hundredths of a magnitude. The one-year periods have been attributed to the Ceraski effect, which was believed to be a physiological effect of the visual observing process. This paper reports on time-series analysis, using DC-DFT in vstar, of visual observations (and in some cases, V observations) of a large number of stars in the AAVSO International Database, initially to investigate the one-month periods. The results suggest that both the one-month and one-year periods are actually due to aliasing of the stars' very low-frequency variations, though they do not rule out very low-amplitude signals (typically 0.01 to 0.02 magnitude) which may be due to a different process, such as a physiological one. Most or all of these aliasing effects may be avoided by using a different algorithm, which takes explicit account of the window function of the data, and/or by being fully aware of the possible presence of and aliasing by very low-frequency variations.

  8. [TRENDS OF PERMANENT PACEMAKER IMPLANTATION IN A SINGLE CENTER OVER A 20-YEAR PERIOD].

    PubMed

    Antonelli, Dante; Ilan, Limor Bushar; Freedberg, Nahum A; Feldman, Alexander; Turgeman, Yoav

    2015-05-01

    To review the changes in permanent pacemaker implantation indications, pacing modes and patients' demographics over a 20-year period. We retrospectively retrieved data on patients who underwent first implantation of the pacemaker between 1-1-1991 and 31-12-2010. One thousand and nine (1,009) patients underwent a first pacemaker implantation during that period; 535 were men (53%), their mean age was 74.6±19.5 years; the highest rate of implanted pacemaker was in patients ranging in age from 70-79 years, however there was an increasing number of patients aged over 80 years. The median survival time after initial pacemaker implantation was 8 years. Syncope was the most common symptom (62.5%) and atrioventricular block was the most common electrocardiographic indication (56.4%) leading to pacemaker implantation. There was increased utilization of dual chamber and rate responsive pacemakers over the years. There was no difference regarding mode selection between genders. Pacemaker implantation rates have increased over a 20-year period. Dual chamber replaced most of the single ventricular chamber pacemaker and rate responsive pacemakers became the norm. The data of a small volume center are similar to those reported in pacemaker surveys of high volume pacemaker implantation centers. They confirm adherence to the published guidelines for pacing.

  9. [Influence of geomagnetic storms on the balance of autonomic regulatory mechanisms].

    PubMed

    Chichinadze, G; Tvildiani, L; Kvachadze, I; Tarkhan-Mouravi, I

    2005-09-01

    The investigation aimed to evaluate autonomic regulatory mechanisms in practically healthy persons during the geomagnetically quiet periods and during geomagnetic storms. The examinations were conducted among the volunteer young men (n=64) 18-22 years of age. The autonomic function was studied on the basis of the heart rate variability. The geomagnetically quiet periods were considered when the value of the K-index was no more then 2 and a geomagnetic storm was considered when the value of the index was 5 and more. It is ascertained that in the both cases the basic statistical indices of the heart rate were identical. The analysis of R-R intervals spectral power gave the possibility to sort the persons examined into the three different groups. The data obtained allowed to suggest that geomagnetic storms influence human organisms through the vagus centers by means of their excitation. This phenomenon may be considered as a self-regulatory physiologic mechanism of the adaptive character. The analysis of the spectral power of R-R intervals may be considered as a sensitive method for the detection of the magnitolabile persons.

  10. 78 FR 13685 - Determination of Regulatory Review Period for Purposes of Patent Extension; LAVIV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal... for a period of up to 5 years so long as the patented item (human drug product, animal drug product... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-E-0162...

  11. 76 FR 15322 - Determination of Regulatory Review Period for Purposes of Patent Extension; VPRIV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-21

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  12. 77 FR 26290 - Determination of Regulatory Review Period for Purposes of Patent Extension; KRYSTEXXA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal... for a period of up to 5 years so long as the patented item (human drug product, animal drug product... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-E-0168...

  13. 75 FR 76990 - Determination of Regulatory Review Period for Purposes of Patent Extension; COARTEM

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  14. 77 FR 20644 - Determination of Regulatory Review Period for Purposes of Patent Extension; FLECTOR

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-05

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  15. 76 FR 14671 - Determination of Regulatory Review Period for Purposes of Patent Extension; ISTODAX

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-17

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  16. 77 FR 20829 - Determination of Regulatory Review Period for Purposes of Patent Extension; DATSCAN

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal... for a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  17. 78 FR 6826 - Determination of Regulatory Review Period for Purposes of Patent Extension; XALKORI

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  18. 77 FR 20828 - Determination of Regulatory Review Period for Purposes of Patent Extension; LATUDA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  19. 77 FR 26018 - Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  20. 77 FR 26291 - Determination of Regulatory Review Period for Purposes of Patent Extension; LASTACAFT

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  1. 76 FR 36928 - Determination of Regulatory Review Period for Purposes of Patent Extension; BROVANA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-23

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  2. 78 FR 6826 - Determination of Regulatory Review Period for Purposes of Patent Extension; BEYAZ

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  3. 78 FR 13684 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZYTIGA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  4. 75 FR 79382 - Determination of Regulatory Review Period for Purposes of Patent Extension; LIVALO

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  5. 75 FR 78714 - Determination of Regulatory Review Period for Purposes of Patent Extension; ANGIOMAX

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal... for a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  6. 75 FR 79381 - Determination of Regulatory Review Period for Purposes of Patent Extension; FOLOTYN

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  7. 75 FR 76740 - Determination of Regulatory Review Period for Purposes of Patent Extension; BEPREVE

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-09

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  8. 77 FR 26289 - Determination of Regulatory Review Period for Purposes of Patent Extension; PRADAXA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  9. 75 FR 75679 - Determination of Regulatory Review Period for Purposes of Patent Extension; BESIVANCE

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  10. 75 FR 76741 - Determination of Regulatory Review Period for Purposes of Patent Extension; SABRIL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-09

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  11. 76 FR 25357 - Determination of Regulatory Review Period for Purposes of Patent Extension; VOTRIENT

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  12. 77 FR 26768 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ... Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-E-0014...

  13. 76 FR 37127 - Determination of Regulatory Review Period for Purposes of Patent Extension; XYZAL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug... a period of up to 5 years so long as the patented item (human drug product, animal drug product... of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  14. 18 CFR 154.303 - Test periods.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Test periods. 154.303 Section 154.303 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT... Changes § 154.303 Test periods. Statements A through M, O, P, and supporting schedules, in § 154.312 and...

  15. 18 CFR 154.303 - Test periods.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Test periods. 154.303 Section 154.303 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT... Changes § 154.303 Test periods. Statements A through M, O, P, and supporting schedules, in § 154.312 and...

  16. 18 CFR 367.5 - Accounting period.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Accounting period. 367.5 Section 367.5 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION... Instructions § 367.5 Accounting period. Each service company must keep its books on a monthly basis so that for...

  17. Public Concern about the Sale of High-Caffeine Drinks to Children 12 Years or Younger: An Australian Regulatory Perspective

    PubMed Central

    Pollard, Christina Mary; McStay, Catrina Lisa; Meng, Xingqiong

    2015-01-01

    Background. Dietary exposure to high caffeine is a health risk for children. Governments are considering measures to restrict the sale of formulated caffeinated beverages (FCB) to children. Objectives. To investigate community concern about sales of high-caffeine drinks to children among Western Australian adults and describe Australian and New Zealand regulatory processes regarding FCB. Methods. Data from the 2009 and 2012 Department of Health's Nutrition Monitoring Survey Series of 2,832 Western Australians aged 18–64 years was pooled with descriptive and ordinal logistic regression analysis performed. Current regulatory processes for FCB are reported. Results. Most (85%) participants were concerned about the sale of high-caffeine drinks to children; 77.4% were very concerned in 2012 compared to 66.5% in 2009, p < .008. Females and those living with children had higher concern (odds ratio (OR) 2.11; 95% confidence interval (CI) 1.44–3.10; OR 2.16; 95% CI 1.51–3.09, resp., p < .001). Concern increased with each year of age (OR 1.04; 95% CI 1.02, 1.05, p < .001). Conclusions. Community concern regarding sale of high-caffeine energy drinks to children is high and increasing. Being female and living with children were associated with greater concern. These findings support the Australian and New Zealand regulatory controls of FCB, including labelling, promotion, and advertising to children. PMID:26504823

  18. Public Concern about the Sale of High-Caffeine Drinks to Children 12 Years or Younger: An Australian Regulatory Perspective.

    PubMed

    Pollard, Christina Mary; McStay, Catrina Lisa; Meng, Xingqiong

    2015-01-01

    Dietary exposure to high caffeine is a health risk for children. Governments are considering measures to restrict the sale of formulated caffeinated beverages (FCB) to children. Objectives. To investigate community concern about sales of high-caffeine drinks to children among Western Australian adults and describe Australian and New Zealand regulatory processes regarding FCB. Data from the 2009 and 2012 Department of Health's Nutrition Monitoring Survey Series of 2,832 Western Australians aged 18-64 years was pooled with descriptive and ordinal logistic regression analysis performed. Current regulatory processes for FCB are reported. Most (85%) participants were concerned about the sale of high-caffeine drinks to children; 77.4% were very concerned in 2012 compared to 66.5% in 2009, p < .008. Females and those living with children had higher concern (odds ratio (OR) 2.11; 95% confidence interval (CI) 1.44-3.10; OR 2.16; 95% CI 1.51-3.09, resp., p < .001). Concern increased with each year of age (OR 1.04; 95% CI 1.02, 1.05, p < .001). Community concern regarding sale of high-caffeine energy drinks to children is high and increasing. Being female and living with children were associated with greater concern. These findings support the Australian and New Zealand regulatory controls of FCB, including labelling, promotion, and advertising to children.

  19. Dura mater graft-associated Creutzfeldt-Jakob disease with 30-year incubation period.

    PubMed

    Shijo, Masahiro; Honda, Hiroyuki; Koyama, Sachiko; Ishitsuka, Koji; Maeda, Koichiro; Kuroda, Junya; Tanii, Mitsugu; Kitazono, Takanari; Iwaki, Toru

    2017-06-01

    Over 60% of all patients with dura mater graft-associated Creutzfeldt-Jakob disease (dCJD) have been diagnosed in Japan. The incubation period has ranged from 1 to 30 years and the age at onset from 15 to 80 years. Here, we report a 77-year-old male Japanese autopsied dCJD case with the longest incubation period so far in Japan. He received a cadaveric dural graft at the right cranial convexity following a craniotomy for meningioma at the age of 46. At 30 years post-dural graft placement, disorientation was observed as an initial symptom of dCJD. He rapidly began to present with inconsistent speech, cognitive impairment and tremor of the left upper extremity. Occasional myoclonic jerks were predominantly observed on the left side. Brain MRI presented hyperintense signals on diffusion-weighted and T2-weighted images, at the right cerebral cortex. The most hyperintense lesion was located at the right parietal lobe, where the dura mater graft had been transplanted. Single-photon emission CT scan showed markedly decreased cerebral blood flow at the right parietal lobe. EEG revealed diffuse and slow activities with periodic sharp-wave complex discharges seen in the right parietal, temporal and occipital lobes. He died of pneumonia 9 months after onset. Brain pathology revealed non-plaque-type dCJD. Laterality of neuropathological changes, including spongiform change, neuronal loss, gliosis or PrP deposits, was not evident. Western blot analysis showed type 1 PrP CJD . Alzheimer-type pathology and PSP-like pathology were also observed. © 2016 Japanese Society of Neuropathology.

  20. Review of the Journal Acta Informatica Medica During Eight Year Period: 2008-2015

    PubMed Central

    Masic, Izet; Begic, Edin; Zunic, Lejla

    2016-01-01

    Introduction: Acta Informatica Medica is official journal of the Academy for Medical Sciences of Bosnia and Herzegovina (from 2014 Acta Inform Med is published bimonthly). Aim: To evaluate journal “Acta Informatica Medica” in 2015 and compare findings to previous years. Material and methods: The study has retrospective and descriptive character, and included the period 2008-2015 (included 36 issues of journal). Results: A total of 83 (average 13,8 articles per journal) articles were published in Acta Informatica Medica during 2015. Analyzing the type of articles, original articles are present in majority during 2015 (68,6%) (by analyzing last eight years, 310 (67,3%) were original). During 2015, 27,7% of articles were related to the applied of Health informatics in field of clinical medicine, 63,8% preclinical medicine and 8,5% to public health. Collaboration rate in 2015 was 0,84. Most often the time required for decision on acceptance of article in 2015 is between 50 and 60 days. Articles came from 16 countries. According to scimagojr.com for 2014, Acta Informatica Medica has SCImago Journal Rank 0,166, while Cites / Doc. (2 years) parameter (widely used as impact index) is 0,70. According to GoogleScholar, h5 index is 11 and h5 median is 19. We analyzed the Acta Informatica Medica by “Publish or Perish” software - H index was 14, g index was 19 and e-index was 10.39. Conclusion: Year after year the highest number of original articles are published. Although the period of revision of articles is acceptable, the period up to two months is certainly not long, the goal is to reduce this period. Although the magazine in mentioned field found its place, although it is indexed in numerous bases, including: PubMed, PubMed Central, SCOPUS, EMBASE, EBSCO, etc. The main goal for next year is that the magazine becomes part of the Web of Science. Imperative is further internationalization of the magazine. PMID:27147796

  1. Review of the Journal Acta Informatica Medica During Eight Year Period: 2008-2015.

    PubMed

    Masic, Izet; Begic, Edin; Zunic, Lejla

    2016-04-01

    Acta Informatica Medica is official journal of the Academy for Medical Sciences of Bosnia and Herzegovina (from 2014 Acta Inform Med is published bimonthly). To evaluate journal "Acta Informatica Medica" in 2015 and compare findings to previous years. The study has retrospective and descriptive character, and included the period 2008-2015 (included 36 issues of journal). A total of 83 (average 13,8 articles per journal) articles were published in Acta Informatica Medica during 2015. Analyzing the type of articles, original articles are present in majority during 2015 (68,6%) (by analyzing last eight years, 310 (67,3%) were original). During 2015, 27,7% of articles were related to the applied of Health informatics in field of clinical medicine, 63,8% preclinical medicine and 8,5% to public health. Collaboration rate in 2015 was 0,84. Most often the time required for decision on acceptance of article in 2015 is between 50 and 60 days. Articles came from 16 countries. According to scimagojr.com for 2014, Acta Informatica Medica has SCImago Journal Rank 0,166, while Cites / Doc. (2 years) parameter (widely used as impact index) is 0,70. According to GoogleScholar, h5 index is 11 and h5 median is 19. We analyzed the Acta Informatica Medica by "Publish or Perish" software - H index was 14, g index was 19 and e-index was 10.39. Year after year the highest number of original articles are published. Although the period of revision of articles is acceptable, the period up to two months is certainly not long, the goal is to reduce this period. Although the magazine in mentioned field found its place, although it is indexed in numerous bases, including: PubMed, PubMed Central, SCOPUS, EMBASE, EBSCO, etc. The main goal for next year is that the magazine becomes part of the Web of Science. Imperative is further internationalization of the magazine.

  2. 75 FR 34749 - Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-18

    ... Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal... periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins...

  3. Technical Letter Report: Evaluation and Analysis of a Few International Periodic Safety Review Summary Reports

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Chopra, Omesh K.; Diercks, Dwight R.; Ma, David Chia-Chiun

    At the request of the United States (U.S.) government, the International Atomic Energy Agency (IAEA) assembled a team of 20 senior safety experts to review the regulatory framework for the safety of operating nuclear power plants in the United States. This review focused on the effectiveness of the regulatory functions implemented by the NRC and on its commitment to nuclear safety and continuous improvement. One suggestion resulting from that review was that the U.S. Nuclear Regulatory Commission (NRC) incorporate lessons learned from periodic safety reviews (PSRs) performed in other countries as an input to the NRC’s assessment processes. In themore » U.S., commercial nuclear power plants (NPPs) are granted an initial 40-year operating license, which may be renewed for additional 20-year periods, subject to complying with regulatory requirements. The NRC has established a framework through its inspection, and operational experience processes to ensure the safe operation of licensed nuclear facilities on an ongoing basis. In contrast, most other countries do not impose a specific time limit on the operating licenses for NPPs, they instead require that the utility operating the plant perform PSRs, typically at approximately 10-year intervals, to assure continued safe operation until the next assessment. The staff contracted with Argonne National Laboratory (Argonne) to perform a pilot review of selected translated PSR assessment reports and related documentation from foreign nuclear regulatory authorities to identify any potential new regulatory insights regarding license renewal-related topics and NPP operating experience (OpE). A total of 14 PSR assessment documents from 9 countries were reviewed. For all of the countries except France, individual reports were provided for each of the plants reviewed. In the case of France, three reports were provided that reviewed the performance assessment of thirty-four 900-MWe reactors of similar design commissioned

  4. 77 FR 41336 - Analytical Methods Used in Periodic Reporting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... Methods Used in Periodic Reporting AGENCY: Postal Regulatory Commission. ACTION: Notice of filing. SUMMARY... proceeding to consider changes in analytical methods used in periodic reporting. This notice addresses... informal rulemaking proceeding to consider changes in the analytical methods approved for use in periodic...

  5. Socioemotional Development in the Toddler Years: Transitions and Transformations

    ERIC Educational Resources Information Center

    Brownell, Celia A., Ed.; Kopp, Claire B., Ed

    2007-01-01

    This volume explores the key developmental transitions that take place as 1- to 3-year-olds leave infancy behind and begin to develop the social and emotional knowledge, skills, and regulatory abilities of early childhood. Leading investigators examine the multiple, interacting factors that lead to socioemotional competence in this pivotal period,…

  6. [Regulatory Framework for Approval of PET Drug in Korea: A Survey Report].

    PubMed

    Kurihara, Chieko; Inoue, Tomio

    2015-11-01

    To identify regulatory framework for approval of PET drugs in Korea. Interview and literature survey. In Korea Good Manufacturing Practice (GMP) regulation specific to radiopharmaceuticals, including PET (Positron Emission Tomography) drugs, under the Pharmaceutical Affairs Act was issued in August 2014, to be enforced on July 1, 2015, and its guidance was issued in December 2014. The new facilities to be established after July 1 of 2015 have to be compatible with this new regulation and already established facilities have two years grace period until June 30 of 2017. During this period, the regulatory authority will inspect all of the production sites which hold or submit approvals of radiopharmaceuticals. As of September 2015 in Korea, there are 7 commercial companies and 15 hospitals and institutes, which have approvals of PET drugs mainly FDG, and these companies and/or hospitals can supply PET drugs outside institutions. In this article we introduce the Korean regulations of development and approval of radiopharmaceuticals. The Korean regulatory authorization policy for radiopharmaceuticals are to some extent similar to the policy which the U.S. regulators set as the new regulations of PET drug. It is expected that the situations of production sites in Korea are to be improved through actual discussions among regulators and PET community through the process of actual inspection.

  7. NATIONAL EVALUATION OF THE WEATHERIZATION ASSISTANCE PROGRAM DURING THE ARRA PERIOD: PROGRAM YEARS 2009-2011

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Tonn, Bruce Edward; Rose, Erin M; Schmoyer, Richard L

    This report describes the third major evaluation of the Program, encompassing program years 2009 to 2011. In this report, this period of time is referred to as the ARRA Period. This is a special period of time for the Program because the American Recovery and Reinvestment Act (ARRA) of 2009 has allocated $5 billion of funding for the Program. In normal program years, WAP s annual appropriation is in the range of $200-250 million, supporting the weatherization of approximately 100,000 homes. With the addition of ARRA funding during these program years, the expectation is that weatherization activity will exceed 300,000more » homes per year. In addition to saving energy and reducing low-income energy bills, expanded WAP funding is expected to stimulate the economy by providing new jobs in the weatherization field and allowing low-income households to spend more money on goods and services by spending less on energy.« less

  8. Current Status of Regulatory Science Education in Faculties of Pharmaceutical Science in Japan.

    PubMed

    Tohkin, Masahiro

    2017-01-01

    I introduce the current pharmaceutical education system in Japan, focusing on regulatory science. University schools or faculties of pharmaceutical science in Japan offer two courses: a six-year course for pharmacists and a four-year course for scientists and technicians. Students in the six-year pharmaceutical course receive training in hospitals and pharmacies during their fifth year, and those in the four-year life science course start research activities during their third year. The current model core curriculum for pharmaceutical education requires them to "explain the necessity and significance of regulatory science" as a specific behavior object. This means that pharmacists should understand the significance of "regulatory science", which will lead to the proper use of pharmaceuticals in clinical practice. Most regulatory science laboratories are in the university schools or faculties of pharmaceutical sciences; however, there are too few to conduct regulatory science education. There are many problems in regulatory science education, and I hope that those problems will be resolved not only by university-based regulatory science researchers but also by those from the pharmaceutical industry and regulatory authorities.

  9. Deciphering the transcriptional cis-regulatory code.

    PubMed

    Yáñez-Cuna, J Omar; Kvon, Evgeny Z; Stark, Alexander

    2013-01-01

    Information about developmental gene expression resides in defined regulatory elements, called enhancers, in the non-coding part of the genome. Although cells reliably utilize enhancers to orchestrate gene expression, a cis-regulatory code that would allow their interpretation has remained one of the greatest challenges of modern biology. In this review, we summarize studies from the past three decades that describe progress towards revealing the properties of enhancers and discuss how recent approaches are providing unprecedented insights into regulatory elements in animal genomes. Over the next years, we believe that the functional characterization of regulatory sequences in entire genomes, combined with recent computational methods, will provide a comprehensive view of genomic regulatory elements and their building blocks and will enable researchers to begin to understand the sequence basis of the cis-regulatory code. Copyright © 2012 Elsevier Ltd. All rights reserved.

  10. Temporal trends in inflammatory bowel disease publications over a 19-years period.

    PubMed

    Weintraub, Yael; Mimouni, Francis B; Cohen, Shlomi

    2014-11-28

    To determine whether temporal changes occurred in the pediatric vs adult inflammatory bowel disease (IBD), both in terms of number and type of yearly published articles. We aimed to evaluate all PubMed-registered articles related to the field of IBD from January 1, 1993 and until December 31, 2011. We searched for articles using the key words "inflammatory bowel disease" or "Crohn's disease" or "ulcerative colitis" or "undetermined colitis", using the age filters of "child" or "adult". We repeated the search according to the total number per year of articles per type of article, for each year of the specified period. We studied randomized controlled trials, clinical trials, case reports, meta-analyses, letters to the editor, reviews, systematic reviews, practice guidelines, and editorials. We identified 44645 articles over the 19 year-period. There were 8687 pediatric-tagged articles vs 19750 adult-tagged articles. Thus 16208 articles were unaccounted and not assigned a "pediatric" or "adult" tag by PubMed. There was an approximately 3-fold significant increase in all articles recorded both in pediatric and adult articles. This significant increase was true for nearly every category of article but the number of clinical trials, meta-analysis, and randomized controlled trials increased proportionally more than the number of "lower quality" articles such as editorials or letters to the editor. Very few guidelines were published every year. There is a yearly linear increase in publications related to IBD. Relatively, there are more and more clinical trials and higher quality articles.

  11. 26 CFR 1.1382-4 - Taxable income of cooperatives; payment period for each taxable year.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... taxable year is the period beginning with the first day of such taxable year and ending with the fifteenth day of the ninth month following the close of such year. [T.D. 6643, 28 FR 3156, Nov. 26, 1963] ...

  12. 76 FR 64047 - Montana Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Montana regulatory program (hereinafter, the ``Montana program'') under the Surface Mining...

  13. 76 FR 36040 - Wyoming Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Wyoming regulatory program (hereinafter, the ``Wyoming program'') under the Surface Mining...

  14. 78 FR 16204 - Wyoming Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-14

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Wyoming regulatory program (hereinafter, the ``Wyoming program'') under the Surface Mining...

  15. 76 FR 80310 - Wyoming Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-23

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Wyoming regulatory program (hereinafter, the ``Wyoming program'') under the Surface Mining...

  16. 76 FR 67635 - Alaska Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-02

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 902... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Alaska regulatory program (hereinafter, the ``Alaska program'') under the Surface Mining...

  17. 76 FR 64045 - Montana Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Montana regulatory program (hereinafter, the ``Montana program'') under the Surface Mining...

  18. 76 FR 76111 - Montana Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-06

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Montana regulatory program (hereinafter, the ``Montana program'') under the Surface Mining...

  19. Trends in U.S., Past-Year Marijuana Use from 1985–2009; An Age-Period-Cohort Analysis

    PubMed Central

    Miech, Richard; Koester, Stephen

    2014-01-01

    Background We present a formal age-period-cohort analysis to examine if the recent increase in past-year marijuana use among the young is specific to the younger generation or if, instead, it is part of a general increase present across cohorts of all ages. This is the first age-period-cohort analysis of past-year marijuana use that includes adult trends from 2001–09. Methods Data come from the National Survey on Drug Use and Health, a series of annual, nationally-representative, cross-sectional surveys of the U.S. civilian, non-institutionalized population. The analysis focuses on the 25 year time span from 1985–2009 and uses the recently developed ‘intrinsic estimator’ algorithm to estimate independent effects of age, period, and cohort. Results The recent increase in past-year marijuana use is not unique to the youngest birth cohorts. An independent, positive influence of cohort membership on past-year marijuana use, net of historical period and age effects, is smaller for today’s youngest cohorts than it was for the cohorts that came immediately before, and, in fact, is at its lowest level in three decades. The recent increase in marijuana use among the young is more consistent with a historical period effect that has acted across all cohorts. Period and cohort trends differ substantially for Hispanics. Conclusions The major forces that drive trends in past-year marijuana use are moving away from cohort-specific factors and toward broad-based influences that affect cohorts of all ages. Strategic public health and policy efforts aimed at countering the recent increase in past-year marijuana use should do the same. PMID:22361212

  20. Long-term variation analysis of a tropical river's annual streamflow regime over a 50-year period

    NASA Astrophysics Data System (ADS)

    Seyam, Mohammed; Othman, Faridah

    2015-07-01

    Studying the long-term changes of streamflow is an important tool for enhancing water resource and river system planning, design, and management. The aim of this work is to identify the long-term variations in annual streamflow regime over a 50-year period from 1961 to 2010 in the Selangor River, which is one of the main tropical rivers in Malaysia. Initially, the data underwent preliminary independence, normality, and homogeneity testing using the Pearson correlation coefficient and Shapiro-Wilk and Pettitt's tests, respectively. The work includes a study and analysis of the changes through nine variables describing the annual streamflow and variations in the yearly duration of high and low streamflows. The analyses were conducted via two time scales: yearly and sub-periodic. The sub-periods were obtained by segmenting the 50 years into seven sub-periods by two techniques, namely the change-point test and direct method. Even though analysis revealed nearly negligible changes in mean annual flow over the study period, the maximum annual flow generally increased while the minimum annual flow significantly decreased with respect to time. It was also observed that the variables describing the dispersion in streamflow continually increased with respect to time. An obvious increase was detected in the yearly duration of danger level of streamflow, a slight increase was noted in the yearly duration of warning and alert levels, and a slight decrease in the yearly duration of low streamflow was found. The perceived changes validate the existence of long-term changes in annual streamflow regime, which increase the probability of floods and droughts occurring in future. In light of the results, attention should be drawn to developing water resource management and flood protection plans in order to avert the harmful effects potentially resulting from the expected changes in annual streamflow regime.

  1. Factors associated with regulatory action involving investigation of illnesses associated with Shiga toxin-producing Escherichia coli in products regulated by the Food Safety and Inspection Service.

    PubMed

    Green, Alice L; Seys, Scott; Douris, Aphrodite; Levine, Jeoff; Robertson, Kis

    2014-07-01

    We described characteristics of the Escherichia coli O157 and Escherichia coli non-O157 illness investigations conducted by the United States Department of Agriculture's Food Safety and Inspection Service (FSIS) during the 5-year period from 2006 through 2010. We created a multivariable logistic regression model to determine characteristics of these investigations that were associated with FSIS regulatory action, which was defined as having occurred if a product recall occurred or if FSIS personnel performed an environmental health assessment (Food Safety Assessment) at the implicated establishment. During this period, FSIS took regulatory action in 38 of 88 (43%) investigations. Illness investigations in which FoodNet states were involved were more likely to result in regulatory action. Illness investigations in which state and local traceback, or FSIS traceback occurred were more likely to result in regulatory action. Reasons for lack of action included evidence of cross-contamination after the product left a regulated establishment, delayed notification, lack of epidemiological information, and insufficient product information.

  2. 47 CFR 1.1163 - Adjustments to regulatory fees.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Adjustments to regulatory fees. 1.1163 Section... of Statutory Charges and Procedures for Payment § 1.1163 Adjustments to regulatory fees. (a) For Fiscal Year 1995, the amounts assessed for regulatory fees are set forth in §§ 1.1152 through 1.1156. (b...

  3. Periodic Analysis Between Solar Variability and the Earth's Temperature From Centuries to Ten Thousand Years

    NASA Astrophysics Data System (ADS)

    Zhao, X.; Feng, X. S.

    2014-12-01

    The global warming is one of the hottest topics for both scientists and the public at present. Strong evidences have shown that the global warming is related to the man-made increasing greenhouse gas levels. Besides the artificial factors, natural forces also contribute to the Earth's climate change. Among them, solar activity is an important ingredient of the natural driving forces of the Earth's climate. In this study, two data sets are adopted to investigate the periodicities of both solar activity and the variation of the Earth temperature as well as their correlations based on the wavelet analysis and cross correlation method. The first one is a directly measured data set covering centuries, while the second one is the reconstructed data during the past 11,000 years. The obtained results demonstrate that solar activity and the Earth's temperature have significant resonance cycles, and the Earth's temperature has periodic variations similar to those of solar activity. For centuries, these common periodicities include the 22-year cycle and the 50-year cycle. While for 11,000 years, they are the 200-year, 500-year, 1000-year, and 2000-year cycles. Correlation analysis reveals that the correlations between solar variability and the Earth's temperature are statistically significant. The correlation coefficient (C.C.) between the 11-year running averaged Total Solar Irradiance (TSI) and the ocean temperature is 0.88 during the past 133 years of global warming. While for 11,000 years, the C.C. between the 500-year running averages of sunspot number (SSN) and the Earth temperature (r=0.51, p=1%) is stronger than that between the temperature and the atmospheric CO2 concentration (r=0.35, p=10%). All these support that solar activity should have non-ignorable effects on the Earth's climate change, especially before the modern industrial time.

  4. Functional analysis of regulatory single-nucleotide polymorphisms.

    PubMed

    Pampín, Sandra; Rodríguez-Rey, José C

    2007-04-01

    The identification of regulatory polymorphisms has become a key problem in human genetics. In the past few years there has been a conceptual change in the way in which regulatory single-nucleotide polymorphisms are studied. We revise the new approaches and discuss how gene expression studies can contribute to a better knowledge of the genetics of common diseases. New techniques for the association of single-nucleotide polymorphisms with changes in gene expression have been recently developed. This, together with a more comprehensive use of the old in-vitro methods, has produced a great amount of genetic information. When added to current databases, it will help to design better tools for the detection of regulatory single-nucleotide polymorphisms. The identification of functional regulatory single-nucleotide polymorphisms cannot be done by the simple inspection of DNA sequence. In-vivo techniques, based on primer-extension, and the more recently developed 'haploChIP' allow the association of gene variants to changes in gene expression. Gene expression analysis by conventional in-vitro techniques is the only way to identify the functional consequences of regulatory single-nucleotide polymorphisms. The amount of information produced in the last few years will help to refine the tools for the future analysis of regulatory gene variants.

  5. 78 FR 13002 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938... Mining Reclamation and Enforcement (``OSM''), Interior. ACTION: Proposed rule; public comment period and... regulatory program under the Surface Mining Control and Reclamation Act of 1977 (``SMCRA'' or the ``Act...

  6. Changing trends of chronic myeloid leukemia in greater Mumbai, India over a period of 30 years

    PubMed Central

    Dikshit, Rajesh P.; Nagrani, Rajini; Yeole, Balkrishna; Koyande, Shravani; Banawali, Shripad

    2011-01-01

    Background: Little is known about burden of chronic myeloid leukemia (CML) in India. There is a recent interest to observe incidence and mortality because of advent of new diagnostic and treatment policies for CML. Materials and Methods: We extracted data from the oldest population-based cancer registry of Mumbai for 30 years period from 1976−2005 to observe incidence and mortality rates of CML. We classified the data into four age groups 0–14, 15–29, 30–54 and 55–74 to observe incidence rates in the respective age groups. Results: The age specific rates were highest for the age group of 55–74 years. No significant change in trends of CML was observed for 30 years period. However, there was a significant reduction in incidence rate for recent 15-years period (Estimated average annual percentage change=-3.9). No significant reduction in mortality rate was observed till 2005. Conclusion: The study demonstrates that age-specific rates for CML are highest in age group of 55-74 years, although they are lower compared to western populations. Significant reduction in incidence of CML in recent periods might be because of reduced misclassification of leukemias. The data of CML has to be observed for another decade to witness reduction in mortality because of changes in treatment management. PMID:22174498

  7. Trends in National Emergency Medicine Conference Didactic Lectures Over a 6-Year Period.

    PubMed

    Gottlieb, Michael; Riddell, Jeff; Njie, Abdoulie

    2017-01-01

    National conference didactic lectures have traditionally featured hour-long lecture-based presentations. However, there is evidence that longer lectures can lead to both decreased attention and retention of information. The authors sought to identify trends in lecture duration, lecture types, and number of speakers at four national emergency medicine (EM) conferences over a 6-year period. The authors performed a retrospective analysis of the length, number of speakers, and format of didactic lectures at four different national EM conferences over 6 years. The authors abstracted data from the national academic assemblies for the four largest not-for-profit EM organizations in the United States: American Academy of Emergency Medicine, American College of Emergency Physicians, Council of Emergency Medicine Residency Directors, and Society for Academic Emergency Medicine. There was a significant yearly decrease in the mean lecture lengths for three of the four conferences. There was an increase in the percentage of rapid fire sessions over the preceding 2 years with a corresponding decrease in the percentage of general educational sessions. There was no significant difference in the mean number of speakers per lecture. An analysis of 4210 didactic lecture sessions from the annual meetings of four national EM organizations over a 6-year period showed significant decreases in mean lecture length. These findings can help to guide EM continuing medical education conference planning and research.

  8. The Changes of Pulmonary Function in COPD During Four-Year Period

    PubMed Central

    Cukic, Vesna; Lovre, Vladimir; Ustamujic, Aida

    2013-01-01

    Conflict of interest: none declared. Introduction COPD (chronic obstructive pulmonary disease) is characterized by airflow limitation that is not fully reversible. OBJECTIVE: to show the changes of pulmonary function in COPD during the 4 -year evolution of illness. Material and Methods The research was done on patients suffering from COPD treated at the Clinic “Podhrastovi” during 2006 and 2007. The tested parameters were examined from the date of receiving patient with COPD to hospital treatment in 2006 and 2007 and then followed prospectively until 2010 or 2011 (the follow-up period was 4 years). There were total 199 treated patients who were chosen at random and regularly attended the control examinations. The study was conducted on adult patients of both sexes, different age group. In each patient the duration of illness was recorded so is sex, age, data of smoking habits, information about the regularity of taking bronchodilator therapy during remissions of disease, about the treatment of disease exacerbations, results of pulmonary functional tests as follows: FVC (forced vital capacity), FEV1 (forced expiratory volume in one second) and bronchodilator reversibility testing. All these parameters were measured at the beginning and at the end of each hospital treatment on the apparatuses of Clinic “Podhrastovi”. We took in elaboration those data obtained in the beginning of the first hospitalization and at the end of the last hospitalization or at the last control in outpatient department when patient was in stable state. Patients were divided into three groups according to the number of exacerbations per year. Results airflow limitation in COPD is progressive; both FVC and FEV1 shows the statistically significant decrease during follow-up period of 4 years (p values / for both parameters/ =0.05) . But in patients regularly treated in phases of remission and exacerbations of illness the course of illness is slower. The fall of FVC and FEV1 is

  9. Point and 5-year period prevalence of neuropsychiatric symptoms in dementia: the Cache County Study.

    PubMed

    Steinberg, Martin; Shao, Huibo; Zandi, Peter; Lyketsos, Constantine G; Welsh-Bohmer, Kathleen A; Norton, Maria C; Breitner, John C S; Steffens, David C; Tschanz, Joann T

    2008-02-01

    Neuropsychiatric symptoms are nearly universal in dementia, yet little is known about their longitudinal course in the community. To estimate point and 5-year period prevalence of neuropsychiatric symptoms in an incident sample of 408 dementia participants from the Cache County Study. The Neuropsychiatric Inventory assessed symptoms at baseline and at 1.5 years, 3.0 years, 4.1 years, and 5.3 years. Point prevalence, period prevalence and mean symptom severity at each time point were estimated. Point prevalence for delusions was 18% at baseline and 34-38% during the last three visits; hallucinations, 10% at baseline and 19-24% subsequently; agitation/aggression fluctuated between 13% and 24%; depression 29% at baseline and 41-47% subsequently; apathy increased from 20% at baseline to 51% at 5.3 years; elation never rose above 1%; anxiety 14% at baseline and 24-32% subsequently; disinhibition fluctuated between 2% and 15%; irritability between 17% and 27%; aberrant motor behavior gradually increased from 7% at baseline to 29% at 5.3 years. Point prevalence for any symptom was 56% at baseline and 76-87% subsequently. Five-year period prevalence was greatest for depression (77%), apathy (71%), and anxiety (62%); lowest for elation (6%), and disinhibition (31%). Ninety-seven percent experienced at least one symptom. Symptom severity was consistently highest for apathy. Participants were most likely to develop depression, apathy, or anxiety, and least likely to develop elation or disinhibition. Give converging evidence that syndromal definitions may more accurately capture neuropsychiatric co-morbidity in dementia, future efforts to validate such syndromes are warranted. Copyright (c) 2007 John Wiley & Sons, Ltd.

  10. Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

    PubMed

    Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

    2015-03-01

    This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  11. The operative treatment of pressure sores in the pelvic region: A 10-year period overview

    PubMed Central

    Jósvay, János; Klauber, András; Both, Béla; Kelemen, Péter B.; Varga, Zsombor Z.; Pesthy, Pál Cs.

    2015-01-01

    Context Pelvic region pressure sores often develop following spinal cord injury. Surgery is often necessary for long standing, large-sized pressure sores not responding to conservative treatment. Authors analyze their results of a 10-year period, and identify factors contributing to the reduction of the recurrence rate. Methods A total of 119 pressure sores were operated on 98 patients in two institutions during a 10-year period (1 January 2003 to 31 December 2012). The encountered perioperative complications are summarized, and the recurrence rate is analyzed with a patient follow-up questionnaire. Results We experienced 15 perioperative complications (12.6%). All complications were fully resolved by conservative treatment. Fifty-eight returned patient replies were processed. The average follow-up time after surgery was 5.2 years. The recurrence rate was 5.47%. Conclusion The strict adherence to surgical indications, full patient compliance, specialized pre- and post-operative patient care, our routinely used preferred surgical method, all contribute to a low post-operative complication rate, long-term flap survival, and an extended recurrence free period. PMID:25299238

  12. The operative treatment of pressure sores in the pelvic region: A 10-year period overview.

    PubMed

    Jósvay, János; Klauber, András; Both, Béla; Kelemen, Péter B; Varga, Zsombor Z; Pesthy, Pál Cs

    2015-07-01

    Pelvic region pressure sores often develop following spinal cord injury. Surgery is often necessary for long standing, large-sized pressure sores not responding to conservative treatment. Authors analyze their results of a 10-year period, and identify factors contributing to the reduction of the recurrence rate. A total of 119 pressure sores were operated on 98 patients in two institutions during a 10-year period (1 January 2003 to 31 December 2012). The encountered perioperative complications are summarized, and the recurrence rate is analyzed with a patient follow-up questionnaire. We experienced 15 perioperative complications (12.6%). All complications were fully resolved by conservative treatment. Fifty-eight returned patient replies were processed. The average follow-up time after surgery was 5.2 years. The recurrence rate was 5.47%. The strict adherence to surgical indications, full patient compliance, specialized pre- and post-operative patient care, our routinely used preferred surgical method, all contribute to a low post-operative complication rate, long-term flap survival, and an extended recurrence free period.

  13. A periodic table for cancer.

    PubMed

    Epstein, Richard J

    2015-01-01

    Cancers exhibit differences in metastatic behavior and drug sensitivity that correlate with certain tumor-specific variables such as differentiation grade, growth rate/extent and molecular regulatory aberrations. In practice, patient management is based on the past results of clinical trials adjusted for these biomarkers. Here, it is proposed that treatment strategies could be fine-tuned upfront simply by quantifying tumorigenic spatial (cell growth) and temporal (genetic stability) control losses, as predicted by genetic defects of cell-cycle-regulatory gatekeeper and genome-stabilizing caretaker tumor suppressor genes, respectively. These differential quantifications of tumor dysfunction may in turn be used to create a tumor-specific 'periodic table' that guides rational formulation of survival-enhancing anticancer treatment strategies.

  14. Prenatal Tobacco Exposure: Developmental Outcomes in the Neonatal Period

    ERIC Educational Resources Information Center

    Espy, Kimberly Andrews; Fang, Hua; Johnson, Craig; Stopp, Christian; Wiebe, Sandra A.; Respass, Jennifer

    2011-01-01

    Smoking during pregnancy is a persistent public health problem that has been linked to later adverse outcomes. The neonatal period--the first month of life--carries substantial developmental change in regulatory skills and is the period when tobacco metabolites are cleared physiologically. Studies to date mostly have used cross-sectional designs…

  15. Age, period, and birth cohort-specific effects on cervical cancer mortality rates in Japanese women and projections for mortality rates over 20-year period (2012-2031).

    PubMed

    Uchida, Hiroyuki; Kobayashi, Mizuki; Hosobuchi, Ami; Ohta, Ayano; Ohtake, Kazuo; Yamaki, Tutomu; Uchida, Masaki; Odagiri, Youichi; Natsume, Hideshi; Kobayashi, Jun

    2014-01-01

    We aimed to determine the effects of age, period, and birth cohort on cervical cancer mortality rate trends in Japanese women, by age-period-cohort (APC) analysis. Additionally, we analyzed projected mortality rates. We obtained data on the number of cervical cancer deaths in Japanese women from 1975-2011 from the national vital statistics and census population data. A cohort table of mortality rate data was analyzed on the basis of a Bayesian APC model. We also projected the mortality rates for the 2012-2031 period. The period effect was relatively limited, compared with the age and cohort effects. The age effect increased suddenly from 25-29 to 45-49 years of age and gently increased thereafter. An analysis of the cohort effect on mortality rate trends revealed a steep decreasing slope for birth cohorts born from 1908-1940 and a subsequent sudden increase after 1945. The mortality rate projections indicated increasing trends from 40 to 74 years of age until the year 2031. The age effect increased from 25-29 years of age. This could be attributable to the high human papilloma virus (HPV) infection risk and the low cervical cancer screening rate. The cohort effect changed from decreasing to increasing after the early 1940s. This might be attributable to the spread of cervical cancer screening and treatment before 1940 and the high HPV infection risk and reduced cervical cancer screening rate after 1945. The projected mortality rate indicated an increasing trend until the year 2031.

  16. Evolution of Salmonella Cerro on a dairy farm over an eight-year period

    USDA-ARS?s Scientific Manuscript database

    Salmonella enterica subsp. enterica serovar Cerro, frequently isolated from dairy cattle and an occasional pathogen of humans, was recurrently isolated over an eight-year period on a dairy farm in south-central Pennsylvania. The genomes of 18 S. Cerro isolates recovered directly from the feces of in...

  17. [Smoking among psychology students over a ten-year period (1996-2006)].

    PubMed

    Míguez Varela, María del Carmen; Becoña Iglesias, Elisardo

    2009-11-01

    The purpose of this study was to analyze the evolution of smoking among Psychology students at the University of Santiago de Compostela (Spain) over a ten-year period (1986-2006). We also assessed the extent of knowledge of the Spanish health legislation on tobacco (Ley 28/2005) and its effect on smoking. We administered a questionnaire to representative samples of students from the 1st year of their Psychology course to the 5th year, on four occasions. In the academic year 1996-1997 (N = 835), 34% of the sample claimed to be daily smokers; in 1999-2000 (N = 842), the figure was 35.2%; in 2003-2004 (N = 835) it was 31.9%; and in 2006-2007 (N = 688), it was 22.8%. Moreover, in the last assessment, 97.1% of the sample reported being aware of the legislation (Ley 28/2005) and 41.9% of the smokers claimed that it had some degree of influence on their smoking. It can be stated that, although overall current prevalence of smoking is similar to that of 10 years ago, a significant change is observed in the profile of smokers. This change is expressed in lower levels of nicotine dependence and a decrease in the percentage of daily smokers, together with an increase in occasional smokers.

  18. Regulatory heterochronies and loose temporal scaling between sea star and sea urchin regulatory circuits.

    PubMed

    Gildor, Tsvia; Hinman, Veronica; Ben-Tabou-De-Leon, Smadar

    2017-01-01

    It has long been argued that heterochrony, a change in relative timing of a developmental process, is a major source of evolutionary innovation. Heterochronic changes of regulatory gene activation could be the underlying molecular mechanism driving heterochronic changes through evolution. Here, we compare the temporal expression profiles of key regulatory circuits between sea urchin and sea star, representative of two classes of Echinoderms that shared a common ancestor about 500 million years ago. The morphologies of the sea urchin and sea star embryos are largely comparable, yet, differences in certain mesodermal cell types and ectodermal patterning result in distinct larval body plans. We generated high resolution temporal profiles of 17 mesodermally-, endodermally- and ectodermally-expressed regulatory genes in the sea star, Patiria miniata, and compared these to their orthologs in the Mediterranean sea urchin, Paracentrotus lividus. We found that the maternal to zygotic transition is delayed in the sea star compared to the sea urchin, in agreement with the longer cleavage stage in the sea star. Interestingly, the order of gene activation shows the highest variation in the relatively diverged mesodermal circuit, while the correlations of expression dynamics are the highest in the strongly conserved endodermal circuit. We detected loose scaling of the developmental rates of these species and observed interspecies heterochronies within all studied regulatory circuits. Thus, after 500 million years of parallel evolution, mild heterochronies between the species are frequently observed and the tight temporal scaling observed for closely related species no longer holds.

  19. Changes in physical fitness and nutritional status of schoolchildren in a period of 30 years (1980-2010)

    PubMed Central

    Ferrari, Gerson Luis de Moraes; Matsudo, Victor Keihan Rodrigues; Fisberg, Mauro

    2015-01-01

    Objective: To analyze and compare the changes in physical fitness according to the nutritional status and gender of schoolchildren during a period of 30 years (1980-2010). Methods: Four cross-sectional evaluations were performed every 10 years in a period of 30 years from 1978 to 1980 (baseline), 1988-1990 (10 years), 1998-2000 (20 years) and 2008-2010 (30 years). The sample consisted of 1291 schoolchildren (188 in baseline, 307 in 10 years; 375 in 20 years; 421 in 30 years) of 10 and 11 years old. The variables assessed were: body weight (kg), height (cm), upper limb strength (ULS; kg), lower limb strength (LLS; cm), agility (seconds) and velocity (seconds). Schoolchildren were classified as normal weight and overweight according to World Health Organization reference of body mass index for age and gender. Comparisons among periods applied ANOVA followed by Bonferroni test, with a significance level set at of p<0.01. Variation between baseline and 30 years was assessed by the percentage delta. Seven different percentile values were presented for each variable. Results: In eutrophic boys and girls, mean values of ULS (−16.7%; −3.2%), agility (−1.5%; −1.6%) decreased significantly after 30 years (p<0.001). In the overweight boys and girls, only the average ULS (−15.5%; −12.5%) decreased significantly over time (p<0.001). After 30 years, the ULS percentile changed in boys. Conclusions: The decline in physical fitness was greater in schoolchildren with normal weight than in those with overweight. PMID:26298653

  20. Time-Line in HFEA Developments and Regulatory Challenges: 20 Years of Overseeing Fertility Practices and Research in the UK.

    PubMed

    Agrawal, Rina; Burt, Elizabeth; Homburg, Roy

    2013-12-01

    In the wake of political upheaval, the Human Fertilisation and Embryo Authority (HFEA) has faced increasing insecurity over its future as a pivotal regulatory body of fertility practices in the UK. HFEA regulates activities by means of licensing, audit, and inspection of fertility centers and maintaining the Code of Practice, which ensures the optimum undertaking of licensed activities by fertility centers. In 2009, amendments to the 1990 Act came into force representing an amalgamation of cumulative proposals, debates, and changes in legislation, which have shaped the world of reproductive medicine. The medical world has, in many cases, adapted to righteous political and social demands, and continues to evolve at a rapid rate. The HFEA has faced many regulatory challenges and changes, and through this study, we aim to provide an overview of some of these changes, particularly those during the last 10 years and the implications that they may have had to fertility practices.

  1. The importance of regulatory data protection or exclusive use and other forms of intellectual property rights in the crop protection industry.

    PubMed

    Carroll, Michael J

    2016-09-01

    In order for a chemical plant protection product to be authorised for sale a registration dossier has to be assembled to demonstrate safety and efficacy to the satisfaction of government regulators. These studies and tests are protected for a period of 10 years in Europe, North America and some other jurisdictions from the date of first product authorisation so that only the data owner can gain commercial benefit from the data. Subsequent regulatory reviews which require new studies should not result in further periods of regulatory data protection exclusive use for the new data but compensation should be payable to the data generator. © 2016 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry. © 2016 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

  2. Distribution of 10 periodontal bacterial species in children and adolescents over a 7-year period.

    PubMed

    Nakano, K; Miyamoto, E; Tamura, K; Nemoto, H; Fujita, K; Nomura, R; Ooshima, T

    2008-10-01

    There is scant information available regarding the distribution of periodontal bacterial species in children and adolescents over an extended period. The purpose of this study was to compare bacterial profiles in the same individuals over a period of 7 years. Twenty-six children and adolescents from whom dental plaque and saliva specimens were obtained during both the first (1999-2000) and second (2006-2007) periods, were analyzed. Bacterial DNA was extracted from each specimen and the presence of 10 periodontal bacterial species was determined using a PCR method, with a focus on the red complex species of Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia. Subjects with red complex species in saliva specimens obtained during the second collection possessed a significantly higher number of total bacterial species than those without. The detection rate of the red complex species in the second collection period samples was significantly greater in subjects who had two or more species detected in samples taken during the first collection compared with the other subjects. Subjects possessing red complex species may be at possible risk for infection with a high number of periodontal bacterial species during adolescent and younger adult years.

  3. 78 FR 12330 - Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN TRANSCATHETER...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ...) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a..., animal drug product, medical device, food additive, or color additive) was subject to regulatory review... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-E-0196...

  4. Arm anthropometry indices in Turkish children and adolescents: changes over a three-year period.

    PubMed

    Çiçek, Betül; Öztürk, Ahmet; Mazıcıoğlu, Mustafa Mümtaz; Kurtoğlu, Selim

    2014-12-01

    Time-related changes and comparisons for mid-upper arm circumference (MUAC), triceps skinfold thickness (TSF), arm fat area (AFA) are lacking for Turkish children and adolescents. To determine the arm anthropometry indices (MUAC, TSF, AFA) in children and adolescents and to also assess the changes in these indices over a 3-year time period. The data of the Anthropometry of Turkish Children Aged 0-6 Years (ATCA-06) study and the Second Study of Determination of the Anthropometric Measurements of Turkish Children and Adolescents (DAMTCA-II) were used to calculate the arm anthropometry percentiles in a total group of 6982 children and adolescents aged 28 days to 17 years. The 3rd-97th percentiles were computed by the LMS method. In girls, 50th percentile MUAC values linearly increased with age. In boys, 50th percentile TSF values linearly increased until 10 years of age and decreased after age 11 years, while in girls, TSF values increased linearly with age. 50th percentile values for AFA showed a linear increase in both genders with age. Significant differences were found between the 5th, 50th and 95th percentile values for MUAC and AFA obtained in the two studies (DAMTCA-II and DAMTCA-I) in both boys and girls. The prominent finding was the significant and alarming increase in arm anthropometry indices in both genders within as short period of time as three years.

  5. Musculoskeletal symptoms and job strain among nursing personnel: a study over a three year period.

    PubMed Central

    Josephson, M; Lagerström, M; Hagberg, M; Wigaeus Hjelm, E

    1997-01-01

    OBJECTIVES: To examine the variation of symptoms from the neck, shoulders, and back over a three year period among female nursing personnel and the relation between job strain and musculoskeletal symptoms. METHODS: At a county hospital the female nursing personnel answered a questionnaire at baseline and then once a year over a period of three years. There were 565, 553, 562, and 419 subjects who answered the questionnaire at the first, second, third, and fourth survey, respectively. Of the study group, 285 nursing personnel answered the questionnaire on four occasions. Ongoing symptoms of the neck, shoulders, and back were assessed by means of a 10 point (0-9) scale with the verbal end points "no symptoms" and "very intense symptoms." Cases were defined as nursing personnel reporting ongoing symptoms, score > 6, from at least one of the body regions. For assessments of job strain, a Swedish version of Karasek and Theorell's model was used. RESULTS: Of the 285 subjects, 13% were defined as cases at all four assessments, and 46% varied between cases and not cases during the study period. In the repeated cross sectional surveys the estimated rate ratio (RR) for being a case was between 1.1 and 1.5 when comparing the group with job strain and the group without job strain. For the combination of job strain and perceived high physical exertion the estimated RR was between 1.5 and 2.1. When the potential risk factors were assessed one, two, or three years before the assessment of symptoms the estimated RR for becoming a case was between 1.4 and 2.2 when comparing the group with job strain and the group without job strain. CONCLUSION: Almost half of the healthcare workers varied between being a case and not, over a three year period. The analysis indicated that job strain is a risk factor for musculoskeletal symptoms and that the risk is higher when it is combined with perceived high physical exertion. PMID:9423583

  6. A Study of the Utilization Patterns of an Elementary School-Based Health Clinic over a 5-Year Period

    ERIC Educational Resources Information Center

    Johnson, Veda; Hutcherson, Valerie

    2006-01-01

    The purpose of this study was to determine the utilization pattern of an elementary school-based clinic over a 5-year period. It involved a retrospective analysis of computer-based data for all patient visits during this study period. Results revealed high clinic utilization with an average of over 5 encounters for all users each year. The most…

  7. [Changes in physical fitness and nutritional status of schoolchildren in a period of 30 years (1980-2010)].

    PubMed

    de Moraes Ferrari, Gerson Luis; Matsudo, Victor Keihan Rodrigues; Fisberg, Mauro

    2015-12-01

    To analyze and compare the changes in physical fitness according to the nutritional status and gender of schoolchildren during a period of 30 years (1980-2010). Four cross-sectional evaluations were performed every 10 years in a period of 30 years from 1978 to 1980 (baseline), 1988-1990 (10 years), 1998-2000 (20 years) and 2008-2010 (30 years). The sample consisted of 1,291 schoolchildren (188 in baseline, 307 in 10 years; 375 in 20 years; 421 in 30 years) of 10 and 11 years old. The variables assessed were: body weight (kg), height (cm), upper limb strength (ULS; kg), lower limb strength (LLS; cm), agility (seconds) and velocity (seconds). Schoolchildren were classified as normal weight and overweight according to World Health Organization reference of body mass index for age and gender. Comparisons among periods applied ANOVA folled by Bonferroni test, with a significance level set at of p<0.01. Variation between baseline and 30 years was assessed by the percentage delta. Seven different percentile values were presented for each variable. In eutrophic boys and girls, mean values of ULS (-16.7%; -3.2%), agility (-1.5%; -1.6%) decreased significantly after 30 years (p<0,001). In the overweight boys and girls, only the average ULS (-15.5%; -12.5%) decreased significantly over time (p<0,001). After 30 years, the ULS percentile changed in boys. the decline in physical fitness was greater in schoolchildren with normal weight than in those with overweight. Copyright © 2015 Sociedade de Pediatria de São Paulo. Publicado por Elsevier Editora Ltda. All rights reserved.

  8. 76 FR 61402 - Draft Nuclear Regulatory Commission Fiscal Year 2012-2016 Strategic Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-04

    ... waste. The draft Strategic Plan also describes the agency's Organizational Excellence Objectives of Openness, Regulatory Effectiveness, and Operational Excellence, which characterize the manner in which the...

  9. 10 CFR 35.642 - Periodic spot-checks for teletherapy units.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Periodic spot-checks for teletherapy units. 35.642 Section 35.642 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units § 35.642 Periodic spot-checks...

  10. 10 CFR 35.642 - Periodic spot-checks for teletherapy units.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Periodic spot-checks for teletherapy units. 35.642 Section 35.642 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units § 35.642 Periodic spot-checks...

  11. 10 CFR 35.642 - Periodic spot-checks for teletherapy units.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Periodic spot-checks for teletherapy units. 35.642 Section 35.642 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units § 35.642 Periodic spot-checks...

  12. 10 CFR 35.642 - Periodic spot-checks for teletherapy units.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Periodic spot-checks for teletherapy units. 35.642 Section 35.642 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units § 35.642 Periodic spot-checks...

  13. 75 FR 45677 - Draft Regulatory Guide, DG-1216,”Plant-Specific Applicability of Transition Break Size Specified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0229] Draft Regulatory Guide, DG-1216,''Plant-Specific... Commission (NRC) is extending the public comment period for DG-1216 from August 25, 2010 to November 8, 2010... [email protected] . The Draft Regulatory Guide, DG-1216, ``Plant- Specific Applicability of...

  14. 21 CFR 60.26 - Final action on regulatory review period determinations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... final upon expiration of the 180-day period for filing a due diligence petition under § 60.30 unless FDA... determination; (3) A due diligence petition filed under § 60.30; or (4) A request for a hearing filed under § 60... expiration of the 180-day period for filing a due diligence petition; or (2) If FDA has received a request...

  15. Abdominal injuries in a major Scandinavian trauma center – performance assessment over an 8 year period

    PubMed Central

    2014-01-01

    Introduction Damage control surgery and damage control resuscitation have reduced mortality in patients with severe abdominal injuries. The shift towards non-operative management in haemodynamically stable patients suffering blunt abdominal trauma has further contributed to the improved results. However, in many countries, low volume of trauma cases and limited exposure to trauma laparotomies constitute a threat to trauma competence. The aim of this study was to evaluate the institutional patient volume and performance for patients with abdominal injuries over an eight-year period. Methods Data from 955 consecutive trauma patients admitted in Oslo University Hospital Ulleval with abdominal injuries during the eight-year period 2002-2009 were retrospectively explored. A separate analysis was performed on all trauma patients undergoing laparotomy during the same period, whether abdominal injuries were identified or not. Variable life-adjusted display (VLAD) was used in order to describe risk-adjusted survival trends throughout the period and the patients admitted before (Period 1) and after (Period 2) the institution of a formal Trauma Service (2005) were compared. Results There was a steady increase in admitted patients with abdominal injuries, while the number of patients undergoing laparotomy was constant exposing the surgical trauma team leaders to an average of 8 trauma laparotomies per year. No increase in missed injuries or failures of non-operative management was detected. Unadjusted mortality rates decreased from period 1 to period 2 for all patients with abdominal injuries as well as for the patients undergoing laparotomy. However, this apparent decrease was not confirmed as significant in TRISS-based analysis of risk-adjusted mortality. VLAD demonstrated a steady performance throughout the study period. Conclusion Even in a high volume trauma center the exposure to abdominal injuries and trauma laparotomies is limited. Due to increasing NOM, an increasing

  16. [Congenital heart disease mortality in Spain during a 10 year period (2003-2012)].

    PubMed

    Pérez-Lescure Picarzo, Javier; Mosquera González, Margarita; Latasa Zamalloa, Pello; Crespo Marcos, David

    2018-05-01

    Congenital heart disease is a major cause of infant mortality in developed countries. In Spain, there are no publications at national level on mortality due to congenital heart disease. The aim of this study is to analyse mortality in infants with congenital heart disease, lethality of different types of congenital heart disease, and their variation over a ten-year period. A retrospective observational study was performed to evaluate mortality rate of children under one year old with congenital heart disease, using the minimum basic data set, from 2003 to 2012. Mortality rate and relative risk of mortality were estimated by Poisson regression. There were 2,970 (4.58%) infant deaths in a population of 64,831 patients with congenital heart disease, with 73.8% of deaths occurring during first week of life. Infant mortality rate in patients with congenital heart disease was 6.23 per 10,000 live births, and remained constant during the ten-year period of the study, representing 18% of total infant mortality rate in Spain. The congenital heart diseases with highest mortality rates were hypoplastic left heart syndrome (41.4%), interruption of aortic arch (20%), and total anomalous pulmonary drainage (16.8%). Atrial septal defect (1%) and pulmonary stenosis (1.1%) showed the lowest mortality rate. Congenital heart disease was a major cause of infant mortality with no variations during the study period. The proportion of infants who died in our study was similar to other similar countries. In spite of current medical advances, some forms of congenital heart disease show very high mortality rates. Copyright © 2017 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. Sustained attention in infancy as a longitudinal predictor of self-regulatory functions.

    PubMed

    Johansson, Maria; Marciszko, Carin; Gredebäck, Gustaf; Nyström, Pär; Bohlin, Gunilla

    2015-11-01

    Previous literature suggests that attention processes such as sustained attention would constitute a developmental foundation for the self-regulatory functions executive functioning and effortful control (e.g., Garon, Bryson, & Smith, 2008; Rothbart, Derryberry, & Posner, 1994). Our main aim was to test this hypothesis by studying whether sustained attention at age 1 year can predict individual differences in self-regulatory functions at age 2 years. Longitudinal data from 66 infants and their parents were included in the study. Sustained attention was assessed during free play at age 1 year; executive functioning, measured using an eye-tracking version of the A-not-B task, and effortful control, measured using parental ratings, were assessed at both age 1 and age 2 years. The results did support a longitudinal prediction of individual differences in 2-year-olds' self-regulatory functions as a function of sustained attention at age 1 year. We also found significant improvement in both executive functioning and effortful control over time, and the two self-regulatory constructs were related in toddlerhood but not in infancy. The study helps increase our understanding of the early development of self-regulatory functions necessary for identifying developmental risks and, in the future, for developing new interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Binge Eating Behavior and Weight Loss Maintenance over a 2-Year Period

    PubMed Central

    Pacanowski, Carly R.; Senso, Meghan M.; Crain, A. Lauren; Sherwood, Nancy E.

    2014-01-01

    Objective. To investigate the relationship between binge eating behavior and weight loss maintenance over a two-year period in adults. Design. Secondary data analysis using the Keep It Off study, a randomized trial evaluating an intervention to promote weight loss maintenance. Participants. 419 men and women (ages: 20 to 70 y; BMI: 20–44 kg/m2) who had intentionally lost ≥10% of their weight during the previous year. Measurements. Body weight was measured and binge eating behavior over the past 6 months was reported at baseline, 12 months and 24 months. Height was measured at baseline. Results. Prevalence of binge eating at baseline was 19.4% (n = 76). Prevalence of binge eating at any time point was 30.1% (n = 126). Although rate of weight regain did not differ significantly between those who did or did not report binge eating at baseline, binge eating behavior across the study period (additive value of presence or absence at each time point) was significantly associated with different rates of weight regain. Conclusion. Tailoring weight loss maintenance interventions to address binge eating behavior is warranted given the prevalence and the different rates of weight regain experienced by those reporting this behavior. PMID:24891946

  19. Children Treated for Nocturnal Enuresis: Characteristics and Trends over a 15-Year Period

    ERIC Educational Resources Information Center

    Kushnir, Jonathan; Kushnir, Baruch; Sadeh, Avi

    2013-01-01

    Background: Nocturnal Enuresis (NE) is one of the most prevalent childhood disorders and has significant negative psychosocial impact on the child and family. Objective: To assess the characteristics of children with NE and trends over a 15-year period. Methods: The study included 18,677 children [11,205 (60%) boys and 7,472 (40%) girls] referred…

  20. 76 FR 40046 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    .... ACTION: Semiannual regulatory agenda. SUMMARY: The Secretary of Education publishes a semiannual agenda..., 1993, requires the Department of Education (ED) to publish, at a time and in a manner specified by the... ED to publish, in October and April of each year, a regulatory flexibility agenda. The regulatory...

  1. Cognitive changes in people with temporal lobe epilepsy over a 13-year period.

    PubMed

    Mameniškienė, Rūta; Rimšienė, Justė; Puronaitė, Roma

    2016-10-01

    The aims of our study were to evaluate cognitive decline in people with temporal lobe epilepsy over a period of 13years and to determine what clinical and treatment characteristics may have been associated with these. Thirty-three individuals with temporal lobe epilepsy underwent the same neuropsychological assessment of verbal and nonverbal memory, attention, and executive functions using the same cognitive test battery as one used 13years ago. Long-term verbal and nonverbal memory was tested four weeks later. Results were compared with those carried out 13years earlier. There was no significant change in verbal and verbal-logical memory tests; however, nonverbal memory worsened significantly. Long-term verbal memory declined for 21.9% of participants, long-term verbal-logical memory for 34.4%, and long-term nonverbal memory for 56.3%. Worsening of working verbal and verbal-logical memory was associated with longer epilepsy duration and lower levels of patients' education; worsening of verbal delayed recall and long-term verbal-logical memory was associated with higher seizure frequency. Decline in long-term nonverbal memory had significant association with a longer duration of epilepsy. The worsening of reaction and attention inversely correlated with the symptoms of depression. Over a 13-year period, cognitive functions did not change significantly. Good seizure control and reduced symptoms of depression in this sample of people with temporal lobe epilepsy were associated with better cognitive functioning. The predictors of change of cognitive functions could be complex and require further study. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Measuring and Modeling the U.S. Regulatory Ecosystem

    NASA Astrophysics Data System (ADS)

    Bommarito, Michael J., II; Katz, Daniel Martin

    2017-09-01

    Over the last 23 years, the U.S. Securities and Exchange Commission has required over 34,000 companies to file over 165,000 annual reports. These reports, the so-called "Form 10-Ks," contain a characterization of a company's financial performance and its risks, including the regulatory environment in which a company operates. In this paper, we analyze over 4.5 million references to U.S. Federal Acts and Agencies contained within these reports to measure the regulatory ecosystem, in which companies are organisms inhabiting a regulatory environment. While individuals across the political, economic, and academic world frequently refer to trends in this regulatory ecosystem, far less attention has been paid to supporting such claims with large-scale, longitudinal data. In this paper, in addition to positing a model of regulatory ecosystems, we document an increase in the regulatory energy per filing, i.e., a warming "temperature." We also find that the diversity of the regulatory ecosystem has been increasing over the past two decades. These findings support the claim that regulatory activity and complexity are increasing, and this framework contributes an important step towards improving academic and policy discussions around legal complexity and regulation.

  3. Ten Years of Addressing Children’s Health through Regulatory Policy at the U.S. Environmental Protection Agency

    PubMed Central

    Payne-Sturges, Devon; Kemp, Debra

    2008-01-01

    Background Executive Order (EO) 13045, Protection of Children From Environmental Health Risks and Safety Risks, directs each federal agency to ensure that its policies, programs, activities, and standards address disproportionate environmental health and safety risks to children. Objectives We reviewed regulatory actions published by U.S. Environmental Protection Agency (EPA) in the Federal Register from April 1998 through December 2006 to evaluate applicability of EO 13045 to U.S. EPA actions and consideration of children’s health issues in U.S. EPA rulemakings. Discussion Although virtually all actions discussed EO 13045, fewer than two regulations per year, on average, were subject to the EO requirement to evaluate children’s environmental health risks. Nonetheless, U.S. EPA considered children’s environmental health in all actions addressing health or safety risks that may disproportionately affect children. Conclusion The EO does not apply to a broad enough set of regulatory actions to ensure protection of children’s health and safety risks, largely because of the small number of rules that are economically significant. However, given the large number of regulations that consider children’s health issues despite not being subject to the EO, other statutory requirements and agency policies reach a larger set of regulations to ensure protection of children’s environmental health. PMID:19079726

  4. 10 CFR 35.643 - Periodic spot-checks for remote afterloader units.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Periodic spot-checks for remote afterloader units. 35.643 Section 35.643 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units § 35.643 Periodic...

  5. 10 CFR 35.643 - Periodic spot-checks for remote afterloader units.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Periodic spot-checks for remote afterloader units. 35.643 Section 35.643 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units § 35.643 Periodic...

  6. 10 CFR 35.643 - Periodic spot-checks for remote afterloader units.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Periodic spot-checks for remote afterloader units. 35.643 Section 35.643 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units § 35.643 Periodic...

  7. 10 CFR 35.643 - Periodic spot-checks for remote afterloader units.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Periodic spot-checks for remote afterloader units. 35.643 Section 35.643 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units § 35.643 Periodic...

  8. [Fatal poisonings during a 5-year period in Eastern Denmark].

    PubMed

    Worm, K; Steentoft, A; Toft, J

    1999-11-29

    In the period 1992-1996, both years included, 1079 cases of deaths from poisoning by drugs or poisons were found by forensic-chemical analyses at The Institute of Forensic Medicine, Dept. of Forensic Chemistry, in Copenhagen, covering a population of 2.4 million. Morphine was by far the most frequently occurring compound accounting for 421 deaths, followed by methadone with 185 deaths. Then alcohol, ketobemidone, and carbon monoxide were represented with 80, 74 and 66 deaths, respectively. Drug addicts dominated in the survey with 549 cases. According to Danish law, autopsy with following chemical analyses must be performed on all dead drug addicts, whereas many other deaths by poisoning are defined only from the medicine found in the vicinity of the dead body.

  9. Mortality from Cardiovascular Diseases in the Elderly: Comparative Analysis of Two Five-year Periods

    PubMed Central

    Piuvezam, Grasiela; Medeiros, Wilton Rodrigues; Costa, Andressa Vellasco; Emerenciano, Felipe Fonseca; Santos, Renata Cristina; Seabra, Danilo Silveira

    2015-01-01

    Background Cardiovascular diseases are the leading cause of death in Brazil. The better understanding of the spatial and temporal distribution of mortality from cardiovascular diseases in the Brazilian elderly population is essential to support more appropriate health actions for each region of the country. Objective To describe and to compare geospatially the rates of mortality from cardiovascular disease in elderly individuals living in Brazil by gender in two 5-year periods: 1996 to 2000 and 2006 to 2010. Methods This is an ecological study, for which rates of mortality were obtained from DATASUS and the population rates from the Brazilian Institute of Geography and Statistics (Instituto Brasileiro de Geografia e Estatística). An average mortality rate for cardiovascular disease in elderly by gender was calculated for each period. The spatial autocorrelation was evaluated by TerraView 4.2.0 through global Moran index and the formation of clusters by the index of local Moran-LISA. Results There was an increase, in the second 5-year period, in the mortality rates in the Northeast and North regions, parallel to a decrease in the South, South-East and Midwest regions. Moreover, there was the formation of clusters with high mortality rates in the second period in Roraima among females, and in Ceará, Pernambuco and Roraima among males. Conclusion The increase in mortality rates in the North and Northeast regions is probably related to the changing profile of mortality and improvement in the quality of information, a result of the increase in surveillance and health care measures in these regions. PMID:26559984

  10. Hydrologic drought of water year 2011 compared to four major drought periods of the 20th century in Oklahoma

    USGS Publications Warehouse

    Shivers, Molly J.; Andrews, William J.

    2013-01-01

    Water year 2011 (October 1, 2010, through September 30, 2011) was a year of hydrologic drought (based on streamflow) in Oklahoma and the second-driest year to date (based on precipitation) since 1925. Drought conditions worsened substantially in the summer, with the highest monthly average temperature record for all States being broken by Oklahoma in July (89.1 degrees Fahrenheit), June being the second hottest and August being the hottest on record for those months for the State since 1895. Drought conditions continued into the fall, with all of the State continuing to be in severe to exceptional drought through the end of September. In addition to effects on streamflow and reservoirs, the 2011 drought increased damage from wildfires, led to declarations of states of emergency, water-use restrictions, and outdoor burning bans; caused at least $2 billion of losses in the agricultural sector and higher prices for food and other agricultural products; caused losses of tourism and wildlife; reduced hydropower generation; and lowered groundwater levels in State aquifers. The U.S. Geological Survey, in cooperation with the Oklahoma Water Resources Board, conducted an investigation to compare the severity of the 2011 drought with four previous major hydrologic drought periods during the 20th century – water years 1929–41, 1952–56, 1961–72, and 1976–81. The period of water years 1925–2011 was selected as the period of record because few continuous record streamflow-gaging stations existed before 1925, and gaps in time existed where no streamflow-gaging stations were operated before 1925. In water year 2011, statewide annual precipitation was the 2d lowest, statewide annual streamflow was 16th lowest, and statewide annual runoff was 42d lowest of those 87 years of record. Annual area-averaged precipitation totals by the nine National Weather Service climate divisions from water year 2011 were compared to those during four previous major hydrologic drought

  11. Hydrazine levels in formulations of hydralazine, isoniazid, and phenelzine over a 2-year period.

    PubMed

    Lovering, E G; Matsui, F; Curran, N M; Robertson, D L; Sears, R W

    1983-08-01

    Hydrazine levels in formulations of hydralazine, isoniazid, and phenelzine have been measured over a 2-year period under ambient conditions and under temperature and humidity stress. Hydralazine tablets are stable under ambient conditions, but the hydrazine level in an injectable formulation increased from 4.5 to 10 micrograms/ml over a 23-month period. Isoniazid tablets are also stable, but hydrazine levels in an elixir and a pyridoxine combination product doubled to 44 micrograms/ml and 19 micrograms/tablet, respectively. Levels in phenelzine tablets appeared to remain constant at approximately 60 micrograms/tablet, with considerable tablet-to-tablet variation.

  12. 77 FR 34389 - Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ...) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide... product, animal drug product, medical device, food additive, or color additive) was subject to regulatory... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-E-0399...

  13. Windsurfing vs kitesurfing: Injuries at the North Sea over a 2-year period.

    PubMed

    van Bergen, Christiaan J A; Commandeur, Joris P; Weber, Rik I K; Haverkamp, Daniel; Breederveld, Roelf S

    2016-12-18

    To analyze all windsurfing and kitesurfing (kiteboarding) injuries presented at our coastal hospital over a 2-year period. Twenty-five windsurfers (21 male; aged 31 ± 8 years) and 32 kitesurfers (23 male; aged 29 ± 11 years) presented at our hospital during the 2-year study period. Various injury data were recorded, including transport to hospital and treatment. After a median follow-up of 16 mo (range, 7-33 mo), 18 windsurfers (72%) and 26 kitesurfers (81%) completed questionnaires on the trauma mechanisms, the use of protective gear, time spent on windsurfing or kitesurfing, time to return to sports, additional injuries, and chronic disability. Most patients sustained minor injuries but severe injuries also occurred, including vertebral and tibial plateau fractures. The lower extremities were affected the most, followed by the head and cervical spine, the upper extremities, and the trunk. The injury rates were 5.2 per 1000 h of windsurfing and 7.0 per 1000 h of kitesurfing ( P = 0.005). The injury severity was the same between groups ( P = 1.0). Less than 30% of the study population used protective gear. Kitesurfers had a higher number of injuries, and required transport by ambulance, inpatient hospital stay and operative treatment more often than windsurfers, but these differences were not statistically significant ( P > 0.05). The median time to return to windsurfing and kitesurfing was 5 and 4 wk, respectively ( P = 0.79). Approximately one-third of the patients in each group experienced chronic symptoms. Kitesurfing results in a significantly higher injury rate than windsurfing in the same environmental conditions but the severity of the injuries does not differ.

  14. 76 FR 40208 - Regulatory Flexibility Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    .... ACTION: Semiannual regulatory agenda. SUMMARY: The Securities and Exchange Commission is publishing an... INFORMATION: The RFA requires each Federal agency, during April and October of each year, to publish in the...

  15. Epidemic of fractures during a period of snow and ice: has anything changed 33 years on?

    PubMed Central

    Al-Azzani, Waheeb; Adam Maliq Mak, Danial; Hodgson, Paul; Williams, Rhodri

    2016-01-01

    Objectives We reproduced a frequently cited study that was published in the British Medical Journal (BMJ) in 1981 assessing the extent of ‘snow-and-ice’ fractures during the winter period. Setting This study aims to provide an insight into how things have changed within the same emergency department (ED) by comparing the findings of the BMJ paper published 33 years ago with the present date. Participants As per the original study, all patients presenting to the ED with a radiological evidence of fracture during three different 4-day periods were included. The three 4-day periods included 4 days of snow-and-ice conditions and two control 4-day periods when snow and ice was not present; the first was 4 days within the same year, with a similar amount of sunshine hours, and the second was 4 days 1 calendar year later. Primary and secondary outcome measures To identify the frequency, distribution and pattern of fractures sustained in snow-and-ice conditions compared to control conditions as well as comparisons with the index study 33 years ago. Results A total of 293 patients with fractures were identified. Overall, there was a 2.20 (CI 1.7 to 3.0, p <0.01) increase in risk of fracture during snow-and-ice periods compared to control conditions. There was an increase (p <0.01) of fractures of the arm, forearm and wrist (RR 3.2 (CI 1.4 to 7.6) and 2.9 (CI 1.5 to 5.4) respectively). Conclusions While the relative risk was not of the magnitude 33 years ago, the overall number of patients presenting with a fracture during snow-and-ice conditions remains more than double compared to control conditions. This highlights the need for improved understanding of the impact of increased fracture burden on hospitals and more effective preventative measures. PMID:27630066

  16. Epidemic of fractures during a period of snow and ice: has anything changed 33 years on?

    PubMed

    Al-Azzani, Waheeb; Adam Maliq Mak, Danial; Hodgson, Paul; Williams, Rhodri

    2016-09-14

    We reproduced a frequently cited study that was published in the British Medical Journal (BMJ) in 1981 assessing the extent of 'snow-and-ice' fractures during the winter period. This study aims to provide an insight into how things have changed within the same emergency department (ED) by comparing the findings of the BMJ paper published 33 years ago with the present date. As per the original study, all patients presenting to the ED with a radiological evidence of fracture during three different 4-day periods were included. The three 4-day periods included 4 days of snow-and-ice conditions and two control 4-day periods when snow and ice was not present; the first was 4 days within the same year, with a similar amount of sunshine hours, and the second was 4 days 1 calendar year later. To identify the frequency, distribution and pattern of fractures sustained in snow-and-ice conditions compared to control conditions as well as comparisons with the index study 33 years ago. A total of 293 patients with fractures were identified. Overall, there was a 2.20 (CI 1.7 to 3.0, p <0.01) increase in risk of fracture during snow-and-ice periods compared to control conditions. There was an increase (p <0.01) of fractures of the arm, forearm and wrist (RR 3.2 (CI 1.4 to 7.6) and 2.9 (CI 1.5 to 5.4) respectively). While the relative risk was not of the magnitude 33 years ago, the overall number of patients presenting with a fracture during snow-and-ice conditions remains more than double compared to control conditions. This highlights the need for improved understanding of the impact of increased fracture burden on hospitals and more effective preventative measures. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  17. IMPACT OF MICROBIOLOGICAL CHANGES ON SPONTANEOUS BACTERIAL PERITONITIS IN THREE DIFFERENT PERIODS OVER 17 YEARS.

    PubMed

    Almeida, Paulo Roberto Lerias de; Leão, Gabriel Stefani; Gonçalves, Charlles David Gonçalves; Picon, Rafael Veiga; Tovo, Cristiane Valle

    2018-01-01

    Spontaneous bacterial peritonitis is a serious complication in cirrhotic patients, and changes in the microbiological characteristics reported in the last years are impacting the choice of antibiotic used for treatment. The aim of the present study is to evaluate the changes in the epidemiology and bacterial resistance of the germs causing spontaneous bacterial peritonitis over three different periods over 17 years. All cirrhotic patients with spontaneous bacterial peritonitis and positive culture of ascites fluid were retrospectively studied in a reference Hospital in Southern Brazil. Three periods were ramdomly evaluated: 1997-1998, 2002-2003 and 2014-2015. The most frequent infecting organisms and the sensitivity in vitro to antibiotics were registered. In the first period (1997-1998) there were 33 cases, the most common were: E. coli in 13 (36.11%), Staphylococcus coagulase-negative in 6 (16.66%), K. pneumoniae in 5 (13.88%), S. aureus in 4 (11.11%) and S. faecalis in 3 (8.33%). In the second period (2002-2003), there were 43 cases, the most frequent were: Staphylococus coagulase-negative in 16 (35.55%), S. aureus in 8 (17.77%), E. coli in 7 (15.55%) and K. pneumoniae in 3 (6.66%). In the third period (2014-2015) there were 58 cases (seven with two bacteria), the most frequent were: E. coli in 15 (23.1%), S. viridans in 12 (18.5%), K. pneumoniae in 10 (15.4%) and E. faecium 5 (7.7%). No one was using antibiotic prophylaxis. Considering all staphylococci, the prevalence increased to rates of the order of 50% in the second period, with a reduction in the third period evaluated. Likewise, the prevalence of resistant E. coli increased, reaching 14%. There was a modification of the bacterial population causing spontaneous bacterial peritonitis, with high frequency of gram-positive organisms, as well as an increase in the resistance to the traditionally recommended antibiotics. This study suggests a probable imminent inclusion of a drug against gram

  18. Change in Maternal Criticism and Behavior Problems in Adolescents and Adults with Autism Across a Seven-Year Period

    PubMed Central

    Baker, Jason K.; Smith, Leann E.; Greenberg, Jan S.; Seltzer, Marsha Mailick; Taylor, Julie Lounds

    2010-01-01

    In a previous study from our laboratory, high levels of maternal criticism predicted increased behavior problems in adolescents and adults with autism spectrum disorders (ASD) over an 18-month period (Greenberg, Seltzer, Hong, & Orsmond, 2006). The current investigation followed these families over a period of seven years to examine the longitudinal course of criticism and behavior problems, to assess the association between their trajectories, and to determine the degree to which change in each of these factors predicted levels of criticism and behavior problems at the end of the study period. A sample of 118 mothers co-residing with their adolescents and adults with ASD provided open-ended narratives about their children and reported on the children's behavior problems at four waves. Maternal criticism was derived from expressed emotion ratings of the narratives. Criticism exhibited low but significant stability over the seven year period and behavior problems exhibited high stability. Using latent growth curve modeling, (a) criticism was found to have increased over time, but only for the group of families in which the sons or daughters transitioned from high school services during the study period, (b) individual changes in criticism and behavior problems were positively correlated over the seven-year period, and (c) changes in criticism predicted levels of behavior problems at the conclusion of the study. Changes in behavior problems were not predictive of end levels of criticism. Implications for intervention and prevention efforts are discussed. PMID:21319925

  19. Regulatory Snapshots: integrative mining of regulatory modules from expression time series and regulatory networks.

    PubMed

    Gonçalves, Joana P; Aires, Ricardo S; Francisco, Alexandre P; Madeira, Sara C

    2012-01-01

    Explaining regulatory mechanisms is crucial to understand complex cellular responses leading to system perturbations. Some strategies reverse engineer regulatory interactions from experimental data, while others identify functional regulatory units (modules) under the assumption that biological systems yield a modular organization. Most modular studies focus on network structure and static properties, ignoring that gene regulation is largely driven by stimulus-response behavior. Expression time series are key to gain insight into dynamics, but have been insufficiently explored by current methods, which often (1) apply generic algorithms unsuited for expression analysis over time, due to inability to maintain the chronology of events or incorporate time dependency; (2) ignore local patterns, abundant in most interesting cases of transcriptional activity; (3) neglect physical binding or lack automatic association of regulators, focusing mainly on expression patterns; or (4) limit the discovery to a predefined number of modules. We propose Regulatory Snapshots, an integrative mining approach to identify regulatory modules over time by combining transcriptional control with response, while overcoming the above challenges. Temporal biclustering is first used to reveal transcriptional modules composed of genes showing coherent expression profiles over time. Personalized ranking is then applied to prioritize prominent regulators targeting the modules at each time point using a network of documented regulatory associations and the expression data. Custom graphics are finally depicted to expose the regulatory activity in a module at consecutive time points (snapshots). Regulatory Snapshots successfully unraveled modules underlying yeast response to heat shock and human epithelial-to-mesenchymal transition, based on regulations documented in the YEASTRACT and JASPAR databases, respectively, and available expression data. Regulatory players involved in functionally enriched

  20. Regulatory Snapshots: Integrative Mining of Regulatory Modules from Expression Time Series and Regulatory Networks

    PubMed Central

    Gonçalves, Joana P.; Aires, Ricardo S.; Francisco, Alexandre P.; Madeira, Sara C.

    2012-01-01

    Explaining regulatory mechanisms is crucial to understand complex cellular responses leading to system perturbations. Some strategies reverse engineer regulatory interactions from experimental data, while others identify functional regulatory units (modules) under the assumption that biological systems yield a modular organization. Most modular studies focus on network structure and static properties, ignoring that gene regulation is largely driven by stimulus-response behavior. Expression time series are key to gain insight into dynamics, but have been insufficiently explored by current methods, which often (1) apply generic algorithms unsuited for expression analysis over time, due to inability to maintain the chronology of events or incorporate time dependency; (2) ignore local patterns, abundant in most interesting cases of transcriptional activity; (3) neglect physical binding or lack automatic association of regulators, focusing mainly on expression patterns; or (4) limit the discovery to a predefined number of modules. We propose Regulatory Snapshots, an integrative mining approach to identify regulatory modules over time by combining transcriptional control with response, while overcoming the above challenges. Temporal biclustering is first used to reveal transcriptional modules composed of genes showing coherent expression profiles over time. Personalized ranking is then applied to prioritize prominent regulators targeting the modules at each time point using a network of documented regulatory associations and the expression data. Custom graphics are finally depicted to expose the regulatory activity in a module at consecutive time points (snapshots). Regulatory Snapshots successfully unraveled modules underlying yeast response to heat shock and human epithelial-to-mesenchymal transition, based on regulations documented in the YEASTRACT and JASPAR databases, respectively, and available expression data. Regulatory players involved in functionally enriched

  1. Retrospective Integration of Research Conducted on a Multi-Section Educational Psychology Course over a Fifteen-Year Period

    ERIC Educational Resources Information Center

    Williams, Robert L.

    2017-01-01

    This article integrates a series of studies conducted over a 15-year period in a multi-section educational course taught by the same supervising professor and his GTAs . The purpose of each study was to determine whether particular interventions or student characteristics affected performance levels in the course. Over the extended period of…

  2. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

    PubMed

    Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

    2013-01-22

    The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5

  3. How to make stripes: deciphering the transition from non-periodic to periodic patterns in Drosophila segmentation

    PubMed Central

    Schroeder, Mark D.; Greer, Christina; Gaul, Ulrike

    2011-01-01

    The generation of metameric body plans is a key process in development. In Drosophila segmentation, periodicity is established rapidly through the complex transcriptional regulation of the pair-rule genes. The ‘primary’ pair-rule genes generate their 7-stripe expression through stripe-specific cis-regulatory elements controlled by the preceding non-periodic maternal and gap gene patterns, whereas ‘secondary’ pair-rule genes are thought to rely on 7-stripe elements that read off the already periodic primary pair-rule patterns. Using a combination of computational and experimental approaches, we have conducted a comprehensive systems-level examination of the regulatory architecture underlying pair-rule stripe formation. We find that runt (run), fushi tarazu (ftz) and odd skipped (odd) establish most of their pattern through stripe-specific elements, arguing for a reclassification of ftz and odd as primary pair-rule genes. In the case of run, we observe long-range cis-regulation across multiple intervening genes. The 7-stripe elements of run, ftz and odd are active concurrently with the stripe-specific elements, indicating that maternal/gap-mediated control and pair-rule gene cross-regulation are closely integrated. Stripe-specific elements fall into three distinct classes based on their principal repressive gap factor input; stripe positions along the gap gradients correlate with the strength of predicted input. The prevalence of cis-elements that generate two stripes and their genomic organization suggest that single-stripe elements arose by splitting and subfunctionalization of ancestral dual-stripe elements. Overall, our study provides a greatly improved understanding of how periodic patterns are established in the Drosophila embryo. PMID:21693522

  4. [Contraceptive practice in Mexico: two five-year periods, two different patterns (1976-1977 to 1987)].

    PubMed

    Llera, S

    1990-01-01

    This work uses data from the 1976-77 Mexican Fertility Survey, the 1982 National Demographic Survey, and the 1987 National Fertility and Health Survey to analyze fertility and contraceptive behavior among Mexican women in the 2 5-year periods from 1976-82 and 1982-87. The proportion of fertile-aged women in union using a method increased from 41.6% in 1976-77 to 58.8% in 1982 and 61.4% in 1989. The most significant gains in use of the more effective methods as in contraceptive prevalence occurred in the 1st 5-year period. The proportion of women sterilized increased from 3.73% in 1977 to 16.6% in 1982 and 21.7% in 1987, equivalent to increases over the 2 5-year periods of 345.7% and 30.7%. Female sterilization was the only method whose use increased constantly over the period. Use of the IUD was almost unchanged between 1977-82, while use of oral contraceptives and injectables both declined from 1982 to 1987 after increasing over the preceding 5 years. Contraceptive usage increased intensely in all subgroups of women studied between 1976-82, but in the 2nd period from 1982 to 1987 contraceptive usage declined significantly in some subgroups. Contraceptive prevalence among women in urban and metropolitan areas increased systematically after 1977. Rural women increased their use from 22.5% in 1977 to 48.6% in 1982. 5 years later the proportion of rural users had declined to 45.3% although it was still well above the level of 1976-77. The most significant increase in contraceptive usage among illiterate women and those with primary educations occurred from 1976 to 1982. In 1987 women with primary and higher levels of education demonstrated increases in contraceptive usage compared with 1982, but contraceptive usage among illiterate women declined from 40.8% in 1982 to 28.9% in 1987. Data from the 3 surveys demonstrate low but increasing rates of use among women 15-19 years old, who may be in the process of developing a new fertility pattern characterized by longer

  5. Drug Development for Pediatric Populations: Regulatory Aspects

    PubMed Central

    Zisowsky, Jochen; Krause, Andreas; Dingemanse, Jasper

    2010-01-01

    Pediatric aspects are nowadays integrated early in the development process of a new drug. The stronger enforcement to obtain pediatric information by the regulatory agencies in recent years resulted in an increased number of trials in children. Specific guidelines and requirements from, in particular, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) form the regulatory framework. This review summarizes the regulatory requirements and strategies for pediatric drug development from an industry perspective. It covers pediatric study planning and conduct, considerations for first dose in children, appropriate sampling strategies, and different methods for data generation and analysis to generate knowledge about the pharmacokinetics (PK) and pharmacodynamics (PD) of a drug in children. The role of Modeling and Simulation (M&S) in pediatrics is highlighted—including the regulatory basis—and examples of the use of M&S are illustrated to support pediatric drug development. PMID:27721363

  6. Investigating Maternal Touch and Infants' Self-Regulatory Behaviours during a Modified Face-to-Face Still-Face with Touch Procedure

    ERIC Educational Resources Information Center

    Jean, Amélie D. L.; Stack, Dale M.; Arnold, Sharon

    2014-01-01

    Maternal touch and infants' self-regulatory behaviours were examined during a modified Still-Face with Touch (SF?+?T) procedure. Mothers and their 5½-month-old infants participated in one period of Normal interaction followed by three SF?+?T periods. Maternal functions of touch, and infants' self-regulatory behaviour, affect, and…

  7. Age-specific characterization of spinal cord injuries over a 19-year period at a Japanese rehabilitation center.

    PubMed

    Toda, Mitsunori; Nakatani, Eiji; Omae, Kaoru; Fukushima, Masanori; Chin, Takaaki

    2018-01-01

    Regional demographics of spinal cord injuries (SCIs) are fundamental to identifying and implementing appropriate preventive measures. The current study was conducted as a longitudinal analysis of all patients with SCIs admitted to the Hyogo Rehabilitation Center over a 19-year period. The sex and age of the patient, time and nature of injury (i.e., cause, level, and extent), and period from injury to admission were evaluated retrospectively. Pertinent tests, including Poisson regression analysis, and the Cochran-Armitage, Kruskal-Wallis, and chi-square tests, were applied to assess demographic variables, with statistical significance set at p < 0.05. Between 1995 and 2013, a total of 632 patients with SCIs (predominantly male and largely < 60 years old) were admitted to our center for rehabilitation. Although the male: female ratio remained unchanged throughout the study period, the ratio of older adults increased over time. In assessing the cause of injury, the majority of the patients involved in road traffic accidents were aged ≤ 44 years, whereas patients aged ≥ 45 years accounted for the majority of low-distance falls and disease-related SCIs, the proportions of which gradually increased. Complete paralysis and paraplegia primarily occurred in patients aged ≤ 44 years, whereas the majority of incomplete injuries and tetraplegia were limited to those aged ≥ 45 years. The patient age at the time of SCI and the nature of the injury sustained were interrelated. Age-specific strategies thus offered the best means of preventing/reducing the incidence of SCIs in Hyogo prefecture.

  8. Changes in plant species composition of coastal dune habitats over a 20-year period

    PubMed Central

    Del Vecchio, Silvia; Prisco, Irene; Acosta, Alicia T. R.; Stanisci, Angela

    2015-01-01

    Coastal sandy ecosystems are increasingly being threatened by human pressure, causing loss of biodiversity, habitat degradation and landscape modifications. However, there are still very few detailed studies focussing on compositional changes in coastal dune plant communities over time. In this work, we investigated how coastal dune European Union (EU) habitats (from pioneer annual beach communities to Mediterranean scrubs on the landward fixed dunes) have changed during the last 20 years. Using phytosociological relevés conducted in 1989–90 and in 2010–12, we investigated changes in floristic composition over time. We then compared plant cover and the proportion of ruderal, alien and habitat diagnostic species (‘focal species’) in the two periods. Finally, we used Ellenberg indicator values to define the ‘preferences’ of the plant species for temperature and moisture. We found that only fore dune habitats showed significant differences in species cover between the two time periods, with higher plant cover in the more recent relevés and a significant increase in thermophilic species. Although previous studies have demonstrated consistent habitat loss in this area, we observed that all coastal dune plant communities remain well represented, after a 20-year period. However, fore dunes have been experiencing significant compositional changes. Although we cannot confirm whether the observed changes are strictly related to climatic changes, to human pressure or to both, we hypothesize that a moderate increment in average yearly temperature may have promoted the increase in plant cover and the spread of thermophilic species. Thus, even though human activities are major driving forces of change in coastal dune vegetation, at the community scale climatic factors may also play important roles. Our study draws on re-visitation studies which appear to constitute a powerful tool for the assessment of the conservation status of EU habitats. PMID:25750408

  9. 42 CFR 457.610 - Period of availability for State allotments for a fiscal year.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Period of availability for State allotments for a fiscal year. 457.610 Section 457.610 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STATE CHILDREN'S HEALTH INSURANCE PROGRAMS (SCHIPs) ALLOTMENTS AND GRANTS TO STATES Payments to States §...

  10. Regulatory environment and its impact on the market value of investor-owned electric utilities

    NASA Astrophysics Data System (ADS)

    Vishwanathan, Raman

    While other regulated industries have one by one been exposed to competitive reform, electric power, for over eighty years, has remained a great monopoly. For all those years, the vertically integrated suppliers of electricity in the United States have been assigned exclusive territorial (consumer) franchises and have been closely regulated. This environment is in the process change because the electric power industry is currently undergoing some dramatic adjustments. Since 1992, a number of states have initiated regulatory reform and are moving to allow retail customers to choose their energy supplier. There has also been a considerable federal government role in encouraging competition in the generation and transmission of electricity. The objective of this research is to investigate the reaction of investors to the prevailing regulatory environment in the electric utility industry by analyzing the market-to-book value for investor-owned electric utilities in the United States as a gauge of investor concern or support for change. In this study, the variable of interest is the market valuation of utilities, as it captures investor confidence to changes in the regulatory environment. Initially a classic regression model is analyzed on the full sample (of the 96 investor-owned utilities for the years 1992 through 1996), providing a total number of 480 (96 firms over 5 years) observations. Later fixed- and random-effects models are analyzed for the same full-sample model specified in the previous analysis. Also, the analysis is carried forward to examine the impact of the size of the utility and its degree of reliability on nuclear power generation on market values. In the period of this study, 1992--1996, the financial security markets downgraded utilities that were still operating in a regulated environment or had a substantial percentage of their power generation from nuclear power plants. It was also found that the financial market was sensitive to the size of

  11. French firefighter mortality: analysis over a 30-year period.

    PubMed

    Amadeo, Brice; Marchand, Jean-Luc; Moisan, Frédéric; Donnadieu, Stéphane; Gaëlle, Coureau; Simone, Mathoulin-Pélissier; Lembeye, Christian; Imbernon, Ellen; Brochard, Patrick

    2015-04-01

    To explore mortality of French professional male firefighters. Standardized mortality ratios (SMR) were calculated for 10,829 professional male firefighters employed in 1979 and compared with the French male population between 1979-2008. Firefighters were identified from 89 French administrative departments (93% of population). One thousand six hundred forty two deaths were identified, representing significantly lower all-cause mortality than in the general population (SMR = 0.81; 95%CI: 0.77-0.85). SMR increased with age and was not different from 1 for firefighters >70 years. No significant excess of mortality was observed for any specific cause, but a greater number of deaths than expected were found for various digestive neoplasms (rectum/anus, pancreas, buccal-pharynx, stomach, liver, and larynx). We observed lower all and leading-cause mortality likely due to the healthy worker effect in this cohort, with diseases of the respiratory system considerably lower (SMR = 0.57). Non-significant excesses for digestive neoplasms are notable, but should not be over-interpreted at this stage. © 2015 Wiley Periodicals, Inc.

  12. 76 FR 30605 - Assessment and Collection of Regulatory Fees For Fiscal Year 2011

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... the Wireless Telecommunications Bureau's Numbering Resource Utilization Forecast and Annual CMRS... compute their fee payment using the standard methodology \\32\\ that is currently in place for CMRS Wireless... Commission, Regulatory Fees Fact Sheet: What You Owe--Commercial Wireless Services for FY 2010 at 1 (released...

  13. 26 CFR 53.4943-6 - Five-year period to dispose of gifts, bequests, etc.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Business Holdings § 53.4943-6 Five-year period to dispose of gifts, bequests, etc. (a) In general—(1..., but for such paragraph, would have excess business holdings as a result of a change in the holdings in a business enterprise after May 26, 1969 (other than by purchase by such private foundation or by a...

  14. A review of diazinon use, contamination in surface waters, and regulatory actions in California across water years 1992-2014.

    PubMed

    Wang, Dan; Singhasemanon, Nan; Goh, Kean S

    2017-07-01

    Diazinon is an organophosphorus insecticide that has been widely used in the USA and in California resulting in contamination of surface waters. Several federal and state regulations have been implemented with the aim of reducing its impact to human health and the environment, e.g., the cancellation of residential use products by the USEPA and dormant spray regulations by the California Department of Pesticide Regulation. This study reviewed the change in diazinon use and surface water contamination in accordance with the regulatory actions implemented in California over water years 1992-2014. We observed that use amounts began declining when agencies announced the intention to regulate certain use patterns and continued to decline after the implementation of those programs and regulations. The reduction in use amounts led to a downward trend in concentration data and exceedance frequencies in surface waters. Moreover, we concluded that diazinon concentrations in California's surface waters in recent years (i.e., water years 2012-2014) posed a de minimis risk to aquatic organisms.

  15. Oceanic crustal carbon cycle drives 26-million-year atmospheric carbon dioxide periodicities.

    PubMed

    Müller, R Dietmar; Dutkiewicz, Adriana

    2018-02-01

    Atmospheric carbon dioxide (CO 2 ) data for the last 420 million years (My) show long-term fluctuations related to supercontinent cycles as well as shorter cycles at 26 to 32 My whose origin is unknown. Periodicities of 26 to 30 My occur in diverse geological phenomena including mass extinctions, flood basalt volcanism, ocean anoxic events, deposition of massive evaporites, sequence boundaries, and orogenic events and have previously been linked to an extraterrestrial mechanism. The vast oceanic crustal carbon reservoir is an alternative potential driving force of climate fluctuations at these time scales, with hydrothermal crustal carbon uptake occurring mostly in young crust with a strong dependence on ocean bottom water temperature. We combine a global plate model and oceanic paleo-age grids with estimates of paleo-ocean bottom water temperatures to track the evolution of the oceanic crustal carbon reservoir over the past 230 My. We show that seafloor spreading rates as well as the storage, subduction, and emission of oceanic crustal and mantle CO 2 fluctuate with a period of 26 My. A connection with seafloor spreading rates and equivalent cycles in subduction zone rollback suggests that these periodicities are driven by the dynamics of subduction zone migration. The oceanic crust-mantle carbon cycle is thus a previously overlooked mechanism that connects plate tectonic pulsing with fluctuations in atmospheric carbon and surface environments.

  16. Oceanic crustal carbon cycle drives 26-million-year atmospheric carbon dioxide periodicities

    PubMed Central

    Müller, R. Dietmar; Dutkiewicz, Adriana

    2018-01-01

    Atmospheric carbon dioxide (CO2) data for the last 420 million years (My) show long-term fluctuations related to supercontinent cycles as well as shorter cycles at 26 to 32 My whose origin is unknown. Periodicities of 26 to 30 My occur in diverse geological phenomena including mass extinctions, flood basalt volcanism, ocean anoxic events, deposition of massive evaporites, sequence boundaries, and orogenic events and have previously been linked to an extraterrestrial mechanism. The vast oceanic crustal carbon reservoir is an alternative potential driving force of climate fluctuations at these time scales, with hydrothermal crustal carbon uptake occurring mostly in young crust with a strong dependence on ocean bottom water temperature. We combine a global plate model and oceanic paleo-age grids with estimates of paleo-ocean bottom water temperatures to track the evolution of the oceanic crustal carbon reservoir over the past 230 My. We show that seafloor spreading rates as well as the storage, subduction, and emission of oceanic crustal and mantle CO2 fluctuate with a period of 26 My. A connection with seafloor spreading rates and equivalent cycles in subduction zone rollback suggests that these periodicities are driven by the dynamics of subduction zone migration. The oceanic crust-mantle carbon cycle is thus a previously overlooked mechanism that connects plate tectonic pulsing with fluctuations in atmospheric carbon and surface environments. PMID:29457135

  17. Self-Regulatory Fatigue, Quality of Life, Health Behaviors, and Coping in Patients with Hematologic Malignancies

    PubMed Central

    Ehlers, Shawna L.; Patten, Christi A.; Gastineau, Dennis A.

    2015-01-01

    Background Self-regulatory fatigue may play an important role in a complex medical illness. Purpose Examine associations between self-regulatory fatigue, quality of life, and health behaviors in patients pre- (N=213) and 1-year post-hematopoietic stem cell transplantation (HSCT; N=140). Associations between self-regulatory fatigue and coping strategies pre-HSCT were also examined. Method Pre- and 1-year post-HSCT data collection. Hierarchical linear regression modeling. Results Higher self-regulatory fatigue pre-HSCT associated with lower overall, physical, social, emotional, and functional quality of life pre- (p’s<.001) and 1-year post-HSCT (p’s<.01); lower physical activity pre-HSCT (p<.02) and post-HSCT (p<.03) and less healthy nutritional intake post-HSCT (p<.01); changes (i.e., decrease) in quality of life and healthy nutrition over the follow-up year; and use of avoidance coping strategies pre-HSCT (p’s<.001). Conclusion This is the first study to show self-regulatory fatigue pre-HSCT relating to decreased quality of life and health behaviors, and predicting changes in these variables 1-year post-HSCT. PMID:24802991

  18. 76 FR 36900 - Request for Public Comments Concerning Regulatory Cooperation Between the United States and the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-23

    ... Regulatory Cooperation Between the United States and the European Union That Would Help Eliminate or Reduce... cooperation activities between the United States and the European Union. The comment period is reopened from... cooperative regulatory activities between the United States and the European Union: Information-sharing...

  19. 77 FR 3745 - Establishment of a One-Year Retention Period for Trademark-Related Papers That Have Been Scanned...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... to the USPTO's past practice of indefinitely retaining papers that have been scanned into TICRS stems... One-Year Retention Period for Trademark- Related Papers That Have Been Scanned Into the Trademark... retention period that began on September 26, 2011, for papers scanned into the Trademark Initial Capture...

  20. Low-income minority fathers' control strategies and children's regulatory skills

    PubMed Central

    Malin, Jenessa L.; Cabrera, Natasha J.; Karberg, Elizabeth; Aldoney, Daniela; Rowe, Meredith

    2015-01-01

    The current study explored the bidirectional association of children's individual characteristics, fathers' control strategies at 24-months and children's regulatory skills at pre-kindergarten (pre-K). Using a sample of low-income minority families with 2-year-olds from the Early Head Start Evaluation Research Program (n = 71) we assessed the association between child gender and vocabulary skills, fathers' control strategies at 24-months (e.g., regulatory behavior and regulatory language), and children's sustained attention and emotion regulation at pre-kindergarten. There were three main findings. First, fathers' overwhelmingly use commands (e.g., do that) to promote compliance in their 24-month old children. Second, children's vocabulary skills predict fathers' regulatory behaviors during a father-child interaction, whereas children's gender predicts fathers' regulatory language during an interaction. Third, controlling for maternal supportiveness, fathers' regulatory behaviors at 24-months predict children's sustained attention at pre-kindergarten whereas fathers' regulatory language at 24-months predicts children's emotion regulation at pre-kindergarten. Our findings highlight the importance of examining paternal contributions to children's regulatory skills. PMID:25798496

  1. Evolution of periodicity in periodical cicadas.

    PubMed

    Ito, Hiromu; Kakishima, Satoshi; Uehara, Takashi; Morita, Satoru; Koyama, Takuya; Sota, Teiji; Cooley, John R; Yoshimura, Jin

    2015-09-14

    Periodical cicadas (Magicicada spp.) in the USA are famous for their unique prime-numbered life cycles of 13 and 17 years and their nearly perfectly synchronized mass emergences. Because almost all known species of cicada are non-periodical, periodicity is assumed to be a derived state. A leading hypothesis for the evolution of periodicity in Magicicada implicates the decline in average temperature during glacial periods. During the evolution of periodicity, the determinant of maturation in ancestral cicadas is hypothesized to have switched from size dependence to time (period) dependence. The selection for the prime-numbered cycles should have taken place only after the fixation of periodicity. Here, we build an individual-based model of cicadas under conditions of climatic cooling to explore the fixation of periodicity. In our model, under cold environments, extremely long juvenile stages lead to extremely low adult densities, limiting mating opportunities and favouring the evolution of synchronized emergence. Our results indicate that these changes, which were triggered by glacial cooling, could have led to the fixation of periodicity in the non-periodical ancestors.

  2. Evolution of periodicity in periodical cicadas

    PubMed Central

    Ito, Hiromu; Kakishima, Satoshi; Uehara, Takashi; Morita, Satoru; Koyama, Takuya; Sota, Teiji; Cooley, John R.; Yoshimura, Jin

    2015-01-01

    Periodical cicadas (Magicicada spp.) in the USA are famous for their unique prime-numbered life cycles of 13 and 17 years and their nearly perfectly synchronized mass emergences. Because almost all known species of cicada are non-periodical, periodicity is assumed to be a derived state. A leading hypothesis for the evolution of periodicity in Magicicada implicates the decline in average temperature during glacial periods. During the evolution of periodicity, the determinant of maturation in ancestral cicadas is hypothesized to have switched from size dependence to time (period) dependence. The selection for the prime-numbered cycles should have taken place only after the fixation of periodicity. Here, we build an individual-based model of cicadas under conditions of climatic cooling to explore the fixation of periodicity. In our model, under cold environments, extremely long juvenile stages lead to extremely low adult densities, limiting mating opportunities and favouring the evolution of synchronized emergence. Our results indicate that these changes, which were triggered by glacial cooling, could have led to the fixation of periodicity in the non-periodical ancestors. PMID:26365061

  3. A Critique of Cab Regulatory Policy

    NASA Technical Reports Server (NTRS)

    Miller, J. C., III

    1972-01-01

    The regulatory policies of the Civil Aviation Board are discussed. The objectives of the Civil Aviation Board are defined. Specific actions of the Civil Aviation Board with respect to passenger fares, rate levels, and load factors are presented. The decisions on successful and unsuccessful mergers of airlines during the 1938 to 1972 time period are analyzed. Tables of data are presented to show the economic aspects of airline operations during 1955, 1960, and 1970.

  4. [Productivity of Spanish emergency physicians: comparison of the 5-year periods 2010-2014 and 2005-2009].

    PubMed

    Fernández-Guerrero, Inés M; Burbano Santos, Pablo; Martín-Sánchez, Francisco Javier; Hidalgo-Rodríguez, Abraham; Leal-Lobato, María de Las Mercedes; Rivilla-Doce, Celia; Julián-Jiménez, Agustín; Burillo-Putze, Guillermo; Miró, Òscar

    2016-06-01

    To study the publication productivity of Spanish emergency physicians in the 5-year period from 2010 through 2014 and compare it with the previous period (2005-2009). Articles authored by emergency physicians affiliated with institutions in Spain were selected from the Science Citation Index-Expanded; conference presentations were excluded. We collected data for year of publication, author information, journal, the journal's impact factor (IF), type of article, cites received, and area of research. We searched at 2010-2014 period, and these data were compared with historic data from the 2005-2009 period. A total of 1433 articles were published in 2010-2014; 52.4% were original research articles (56% more than in 2005-2009, P=.01). The mean journal IF associated with the publications was slightly higher in 2010-2014 (2.587 vs 2.483 for 2005-2009). The median was slightly lower (2.295 vs 3.085 in the earlier period), but the 90th percentile was higher (4.036 vs 3.085, P=0.01), reflecting an increase in the number of publications in journals with high IFs. Most articles continue to be published in Castilian Spanish (67.8%), although the percentage of articles published in English increased significantly, from 25.2% in the previous period to 32.1% in 2010-2014; P=.001). Scientific publications in emergency medicine come mainly from specialists working in hospital emergency departments (89%). Authors affiliated with a university are in the minority, although their percentage increased significantly from 10.9% in the previous period to 16.2% in the recent one (P=.001). Collaboration increased in the recent period in all categories: between hospitals in the same Spanish autonomous community (from 24.7% to 36%), in different communities (from 10.9% to 19%), or in different countries (from 2.3% to 8.4%) (P=.001, all comparisons). The most productive research areas were cardiovascular conditions (accounting for 13.1% of the publications), infectious diseases (13

  5. 75 FR 41931 - Assessment and Collection of Regulatory Fees for Fiscal Year 2010

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-19

    ... Communications Act of 1934, as amended (the Act). These fees are mandated by Congress and are collected to... 2010, pursuant to section 9 of the Communications Act of 1934, as amended (the ``Act''). Section 9... allocation between submarine cable and satellite/ terrestrial for the bearer circuit regulatory fees for 2010...

  6. Cultural Identities of Adolescent Immigrants: A Three-Year Longitudinal Study Including the Pre-Migration Period

    ERIC Educational Resources Information Center

    Tartakovsky, Eugene

    2009-01-01

    This article investigates the cultural identities of adolescent immigrants in the pre-migration period and during the first 3 years after immigration. The target population consists of high-school Jewish adolescents from Russia and Ukraine participating in an Israeli immigration program. In this program, Jewish adolescents immigrate to Israel…

  7. The Effectiveness of Self-regulatory Speech Training for Planning and Problem Solving in Children with Specific Language Impairment.

    PubMed

    Abdul Aziz, Safiyyah; Fletcher, Janet; Bayliss, Donna M

    2016-08-01

    Self-regulatory speech has been shown to be important for the planning and problem solving of children. Our intervention study, including comparisons to both wait-list and typically developing controls, examined the effectiveness of a training programme designed to improve self-regulatory speech, and consequently, the planning and problem solving performance of 87 (60 males, 27 females) children aged 4-7 years with Specific Language Impairment (SLI) who were delayed in their self-regulatory speech development. The self-regulatory speech and Tower of London (TOL) performance of children with SLI who received the intervention initially or after a waiting period was compared with that of 80 (48 male, 32 female) typically developing children who did not receive any intervention. Children were tested at three time points: Time 1- prior to intervention; Time 2 - after the first SLI group had received training and the second SLI group provided a wait-list control; and Time 3 - when the second SLI group had received training. At Time 1 children with SLI produced less self-regulatory speech and were impaired on the TOL relative to the typically developing children. At Time 2, the TOL performance of children with SLI in the first training group improved significantly, whereas there was no improvement for the second training group (the wait-list group). At Time 3, the second training group improved their TOL performance and the first group maintained their performance. No significant differences in TOL performance were evident between typically developing children and those with SLI at Time 3. Moreover, decreases in social speech and increases in inaudible muttering following self-regulatory speech training were associated with improvements in TOL performance. Together, the results show that self-regulatory speech training was effective in increasing self-regulatory speech and in improving planning and problem solving performance in children with SLI.

  8. Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine".

    PubMed

    O'Reilly, Erin K; Blair Holbein, M E; Berglund, Jelena P; Parrish, Amanda B; Roth, Mary-Tara; Burnett, Bruce K

    2013-12-01

    This study highlights Warning Letter (WL) findings issued to sponsor-investigators (S-Is) by the Food and Drug Administration (FDA). The online index of WLs issued from October 1, 2007 through September 30, 2012 was reviewed [1]. Through a manual screening process, letters were evaluated if specifically issued to 'clinical investigators', 'sponsors' or 'sponsor-investigators'. A particular focus was given to S-Is at Academic Health Centres (AHCs). Each letter was scored for the presence of violations in 40 general regulatory categories. A review of FDA WLs issued over a five-year period (FDA Fiscal Years 2008-2012) revealed that WLs to S-Is represent half of the WLs issued to all sponsors (16 of 32 letters). A review of these letters indicates that S-Is are not aware of, or simply do not meet, their regulatory responsibilities as either investigators or sponsors. In comparing total sponsor letters to those of S-Is, the most cited violation was the same: a lack of monitoring. A review of publicly available inspection data indicates that these 16 letters merely represent the tip of the iceberg. This review of the WL database reveals the potential for serious regulatory violations among S-Is at AHCs. Recent translational funding initiatives may serve to increase the number of S-Is, especially among Academic Health Centres (AHCs) [2]; thus, AHCs must become aware of this S-I role and work to support investigators who assume both roles in the course of their research.

  9. Burden of herpes zoster requiring hospitalization in Spain during a seven-year period (1998–2004)

    PubMed Central

    2009-01-01

    Background A thorough epidemiological surveillance and a good understanding of the burden of diseases associated to VZV are crucial to asses any potential impact of a prevention strategy. A population-based retrospective epidemiological study to estimate the burden of herpes zoster requiring hospitalization in Spain was conducted. Methods This study was conducted by using data from the national surveillance system for hospital data, Conjunto Mínimo Básico de Datos (CMBD). Records of all patients admitted to hospital with a diagnosis of herpes zoster (ICD-9-MC codes 053.0–053.9) during a 7-year period (1998–2004) were selected. Results A total of 23,584 hospitalizations with a primary or secondary diagnosis of herpes zoster in patients ≥ 30 years of age were identified during the study period. Annually there were 13.4 hospitalizations for herpes zoster per 100,000 population in patients ≥ 30 years of age. The rate increases with age reaching a maximum in persons ≥ 80 years of age (54.3 admissions per 100,000 population >80 years of age). The mean cost of a hospitalization for herpes zoster in adult patients was 3,720 €. The estimated annual cost of hospitalizations for herpes zoster in patients ≥ 30 years of age in Spain was 12,731,954 €. Conclusion Herpes zoster imposes an important burden of hospitalizations and result in large cost expenses to the Spanish National Health System, especially in population older than 50 years of age PMID:19422687

  10. Epidemiology of Cervical Spine Injuries in High School Athletes Over a Ten-Year Period.

    PubMed

    Meron, Adele; McMullen, Christopher; Laker, Scott R; Currie, Dustin; Comstock, R Dawn

    2018-04-01

    More than 7 million athletes participate in high school sports annually, with both the benefits of physical activity and risks of injury. Although catastrophic cervical spine injuries have been studied, limited data are available that characterize less-severe cervical spine injuries in high school athletes. To describe and compare cervical spine injury rates and patterns among U.S. high school athletes across 24 sports over a 10-year period. Descriptive epidemiology study. National sample of high schools participating in the High School Reporting Information Online injury surveillance system. Athletes from participating schools injured in a school sanctioned practice, competition, or performance during the 2005-2006 through 2014-2015 academic years. Cervical spine injury data captured by the High School Reporting Information Online system during the 10-year study period were examined. Cervical spine injury was defined as any injury to the cervical spinal cord, bones, nerves, or supporting structures of the cervical spine including muscles, ligaments, and tendons. Cervical spine injury rates, diagnoses, mechanisms, and severities. During the study period, 1080 cervical spine injuries were reported during 35,581,036 athlete exposures for an injury rate of 3.04 per 100,000 athlete exposures. Injury rates were highest in football (10.10), wrestling (7.42), and girls' gymnastics (4.95). Muscle injuries were most common (63.1%), followed by nerve injuries (20.5%). A larger proportion of football injuries were nerve injuries compared with all other sports (injury proportion ratio 3.31; confidence interval 2.33-4.72), whereas in boys' ice hockey fractures represented a greater proportion of injuries compared with all other sports (injury proportion ratio 7.64; confidence interval 2.10-27.83). Overall, the most common mechanisms of injury were contact with another player (70.7%) and contact with playing surface (16.1%). Cervical spine injury rates and patterns vary by sport

  11. Fifty years of the European medicines regulatory network: reflections for strengthening intra-regional cooperation in the Region of the Americas.

    PubMed

    Allchurch, Martin Harvey; Barbano, Dirceu Brás Aparecido; Pinheiro, Marie-Hélène; Lazdin-Helds, Janis

    2016-05-01

    This report considers how the experience of the European regulatory system might be applied to help strengthen the regulatory systems for medicines in the Region of the Americas. The work of the European Medicines Agencies (EMA) is carried out through its scientific committees, composed of members from European Economic Area countries. A robust legal framework allows EMA to coordinate resources from Member States' competent authorities, including, for example, assisting candidate countries as they prepare to join the European Union (EU). Capacity-building programs help countries adjust their regulatory systems ahead of full participation in the European medicines regulatory network. These programs facilitate adoption of common technical requirements, identify areas where action might be needed to ensure the smooth transposition of EU pharmaceutical law into national legislation, and prepare candidate countries for participation in EMA committees and the European regulatory network. The methodology of these programs could be of potential interest to the Pan American Health Organization (PAHO), the Regional Office of the World Health Organization for the Americas. Given resolutions adopted by the World Health Assembly and the PAHO Directing Council, there is a strong indication that the countries of the Region of the Americas wish to assemble a system that uses the existing regulatory capacity of some countries to strengthen local regulatory capacities in others.

  12. Measured airtightness of 24 detached houses over periods of up to three years

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Proskiw, G.

    1995-09-01

    Regular airtightness tests were performed on 24 new houses, over periods of up to three years, to evaluate their air barrier systems and to search for evidence, air barrier degradation. Ten of the houses were constructed with polyethylene air barriers while the remaining 14 used an early version of the Airtight Drywall Approach (ADA). The 24 project houses were architecturally similar and of approximately equal size and general layout; stucco was the predominate exterior wall finish. All were exposed to similar terrain shielding. The study found that the airtightness of the polyethylene air barrier houses remained stable over their respectivemore » monitoring periods. Although two of the ten houses demonstrated possible, albeit slight, evidence of airtightness degradation, the magnitude of these changes was small and judged not to be of practical significance. With respect to the critical issue of air barrier degradation, no evidence could be found to indicate polyethylene is unsuited for use as an air barrier material in residential construction. For example, all but one of the polyethylene houses met the airtightness requirements of the Canadian R-2000 Standard for energy efficient housing at the end of their monitoring periods. The study found that the airtightness of the 14 ADA houses also remained stable over their monitoring periods. Although six of the 14 houses displayed possible, but slight, evidence of airtightness degradation, the magnitude of the changes was small and not of practical significance. It was concluded that no evidence could be found to indicate that the ADA system is unsuited for use in residential construction. All 14 ADA houses met the airtightness requirements of the R-2000 Program at the end of their respective monitoring periods.« less

  13. Environmental Volunteering and Health Outcomes over a 20-Year Period

    PubMed Central

    Pillemer, Karl; Fuller-Rowell, Thomas E.; Reid, M. C.; Wells, Nancy M.

    2010-01-01

    Purpose: This study tested the hypothesis that volunteering in environmental organizations in midlife is associated with greater physical activity and improved mental and physical health over a 20-year period.  Design and Methods: The study used data from two waves (1974 and 1994) of the Alameda County Study, a longitudinal study of health and mortality that has followed a cohort of 6,928 adults since 1965. Using logistic and multiple regression models, we examined the prospective association between environmental and other volunteerism and three outcomes (physical activity, self-reported health, and depression), with 1974 volunteerism predicting 1994 outcomes, controlling for a number of relevant covariates.  Results: Midlife environmental volunteering was significantly associated with physical activity, self-reported health, and depressive symptoms.  Implications: This population-based study offers the first epidemiological evidence for a significant positive relationship between environmental volunteering and health and well-being outcomes. Further research, including intervention studies, is needed to confirm and shed additional light on these initial findings. PMID:20172902

  14. Linkages of periodic climatic and social-economic changes in China during the past 2000 years

    NASA Astrophysics Data System (ADS)

    Fang, Xiuqi; Su, Yu; Yin, Jun; Wei, Zhudeng

    2016-04-01

    Impacts of climate change on rise and fall of human civilization in the history could provide lessons for understanding how impacts of climatic change and human response interacted. However, such a study is highly restricted by lacking in high-resolution series concerning long-term social-economic processes. China is a country that has great potential for providing long-term socio-economic series in high-resolution because it has abundant related historical records as long as thousands of years in the Chinese historical literatures. In this paper, A methodology named Semantic Differential for quantifying historical literal descriptions to grade numbers is developed. Using the methodology, 10-year resolution graded series of social-economic system change of China, including harvest of agriculture, economy, social rise and fall, are reconstructed during the past 2000 years. To compare the periodic changes of climate, harvest, economy, social rise and fall in China during the past 2000 years, it is found that : (1) There are similar periods on multiple time scales among all the series. (2) On the centurial scale, the better economic and social phases generally occurred in the better harvest phases when generally had a warm climate. (3) In the warm phases, both economic and social status were recovered faster and flourished longer than that in the cold phases. (4) The direct impact of climatic change on food security could be enlarged or diminished when it transmitted from harvest I to other social-economic subsystems because of feedbacks of the system.

  15. The Changes of Arterial Blood Gases in COPD During Four-year Period

    PubMed Central

    Cukic, Vesna

    2014-01-01

    ABSTRACT Introduction: COPD (Chronic Obstructive Pulmonary Disease) is characterized by airflow limitation that is not fully reversible and that can lead to respiratory failure. Objective: to show the changes of arterial blood gases in COPD during the 4 -year evolution of illness. Material and Methods: The research was done on patients suffering from COPD treated at the Clinic “Podhrastovi” during 2006 and 2007 year. The tested parameters were examined from the date of receiving patient with COPD to hospital treatment in 2006 and 2007 and then followed prospectively until 2010 or 2011 year (the follow-up period was 4 years). There were total 199 treated patients who were chosen at random and regularly attended the control examinations. The study was conducted on adult patients of both sexes, different age group. In each patient the duration of illness was recorded so is sex, age, data of smoking habits, information about the regularity of taking bronchodilator therapy during remissions of disease, about the treatment of disease exacerbations, results of blood gases analysis as follows : pH value, PaO2 (partial pressure of oxygen in arterial blood), PaCO2 (partial pressure of carbon dioxide in arterial blood). All these parameters were measured at the beginning and at the end of each hospital treatment. We took in elaboration data obtained in the beginning of the first hospitalization and at the end of the last hospitalization or at the last control in outpatient department when patient was in stable state. Patients were divided into three groups according to the number of exacerbations per year. Results: there is the statistically significant decrease of PaO2 (p<0.01) and pH, (p<0.05) and an increase of PaCO2 (p<0.01) during follow-up period. But in patients regularly treated in phases of remission and exacerbations of illness the course of illness is slower. The decrease of pH and PaO2 and increase of PaCO2 is statistically significantly smaller in those

  16. Characterization of the evolution of the pharmaceutical regulatory environment.

    PubMed

    Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

    2013-01-01

    This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main

  17. 76 FR 72492 - Self-Regulatory Organizations; BATS Exchange, Inc.; BATS Y-Exchange, Inc.; NASDAQ OMX BX, Inc...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ...-regulatory organization consents, the Commission shall either approve the proposed rule change, disapprove...-NYSEAmex-2011-73; SR- NYSEArca-2011-68; SR-Phlx-2011-129] Self-Regulatory Organizations; BATS Exchange, Inc... PHLX LLC; Notice of a Designation of a Longer Period for Commission Action on Proposed Rule Changes...

  18. [Strengthening health regulation in the Americas: regulatory authorities of regional reference].

    PubMed

    Ojeda, Lisette Pérez; Cristiá, Rafael Pérez

    2016-05-01

    Health technology regulation and quality assurance are critical to the development of national pharmaceutical policies, and implementing these actions is the responsibility of national regulatory authorities, whose level of development and maturity affect the quality, safety, and effectiveness of the products made available to the public. On the initiative of the regulatory authorities themselves, together with the Pan American Health Organization, the Region of the Americas promotes the strengthening of health regulation through an evaluation and certification process that allows for the designation of regulatory authorities of regional reference for drugs and biological products. Over the period from its implementation to the present, six authorities have been certified and one is in the process of obtaining certification. These authorities work jointly and promote dialogue and regulatory convergence, information-sharing to facilitate regulatory decision making, and regional cooperation to support the establishment of other authorities in the Region--actions having direct impact on access to effective and quality-assured health technologies. Their combined efforts have led to the recognition of this process of evaluation and certification by the World Health Organization (WHO). Among the actions resulting from the International Consultation on Regulatory Systems Strengthening, WHO recommended taking a close look at this model to assess its potential scale-up at the global level.

  19. Nonradial and radial period changes of the δ Scuti star 4 CVn. II. Systematic behavior over 40 years

    NASA Astrophysics Data System (ADS)

    Breger, M.; Montgomery, M. H.; Lenz, P.; Pamyatnykh, A. A.

    2017-03-01

    Aims: Radial and nonradial pulsators on and near the main sequence show period and amplitude changes that are too large to be the product of stellar evolution. The multiperiodic δ Sct stars are well suited to study this, as the period changes of different modes excited in the same star can be compared. This requires a very large amount of photometric data covering years and decades as well as mode identifications. Methods: We have examined over 800 nights of high-precision photometry of the multiperiodic pulsator 4 CVn obtained from 1966 through 2012. Because most of the data were obtained in adjacent observing seasons, it is possible to derive very accurate period values for a number of the excited pulsation modes and to study their systematic changes from 1974 to 2012. Results: Most pulsation modes show systematic significant period and amplitude changes on a timescale of decades. For the well-studied modes, around 1986 a general reversal of the directions of both the positive and negative period changes occurred. Furthermore, the period changes between the different modes are strongly correlated, although they differ in size and sign. For the modes with known values of the spherical degree and azimuthal order, we find a correlation between the direction of the period changes and the identified azimuthal order, m. The associated amplitude changes generally have similar timescales of years or decades, but show little systematic or correlated behavior from mode to mode. Conclusions: A natural explanation for the opposite behavior of the prograde and retrograde modes is that their period changes are driven by a changing rotation profile. The changes in the rotation profile could in turn be driven by processes, perhaps the pulsations themselves, that redistribute angular momentum within the star. In general, different modes have different rotation kernels, so this will produce period shifts of varying magnitude for different modes.

  20. Low-income, minority fathers' control strategies and their children's regulatory skills.

    PubMed

    Malin, Jenessa L; Cabrera, Natasha J; Karberg, Elizabeth; Aldoney, Daniela; Rowe, Meredith L

    2014-01-01

    The current study explored the bidirectional association of children's individual characteristics, fathers' control strategies at 24 months, and children's regulatory skills at prekindergarten (pre-K). Using a sample of low-income, minority families with 2-year-olds from the Early Head Start Research and Evaluation Project (n = 71), we assessed the association between child gender and vocabulary skills, fathers' control strategies at 24 months (e.g., regulatory behavior and regulatory language), and children's sustained attention and emotion regulation at prekindergarten. There were three main findings. First, fathers overwhelmingly used commands (e.g., "Do that.") to promote compliance in their 24-month-old children. Second, children's vocabulary skills predicted fathers' regulatory behaviors during a father-child interaction whereas children's gender predicted fathers' regulatory language during an interaction. Third, controlling for maternal supportiveness, fathers' regulatory behaviors at 24 months predicted children's sustained attention at pre-K whereas fathers' regulatory language at 24 months predicted children's emotion regulation at pre-K. Our findings highlight the importance of examining paternal contributions to children's regulatory skills. © 2014 Michigan Association for Infant Mental Health.

  1. Development of hospital nurses' work ability over a 2 year period.

    PubMed

    Boschman, J S; Nieuwenhuijsen, K; Frings-Dresen, M H W; Sluiter, J K

    2015-10-01

    A new approach to the study of work ability is an individually oriented approach. This approach increases our understanding of how work ability develops over time among individuals with a different level of work ability. To increase knowledge about individuals' work ability trajectories by studying hospital nurses' development of work ability over a 2 year period and factors associated with these trajectories. We used a data set of a prospective cohort study of hospital nurses, which was surveyed for 2 years by means of three questionnaires on work characteristics, health and work ability. The outcome variable was the general work ability trajectory over the course of 2 years (favourable/unfavourable). The predictors were the individual, physical and mental work ability and health characteristics at baseline. A multivariate backwards stepwise logistic regression analysis was used. Of 572 nurses in the cohort, nearly one-third (31%, 179/572) showed an unfavourable general work ability trajectory. Low physical work ability (odds ratio (OR) 1.82; 95% confidence interval (95% CI) 1.12-2.95) and high level of fatigue (OR 1.52; 95% CI 0.97-2.40) at baseline were predictors for the unfavourable course of self-reported general work ability. A substantial proportion of this cohort of hospital nurses experienced a reduction in work ability over the course of 2 years. Baseline physical work ability and level of fatigue were related to this. The next step is to address these factors when counselling nurses and evaluate the effect of interventions aimed at improving physical work ability and reducing fatigue. © The Author 2015. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  2. Clinical epidemiology of ulcerative colitis in Mexico: a single hospital-based study in a 20-year period (1987-2006).

    PubMed

    Yamamoto-Furusho, Jesús K

    2009-03-01

    Ulcerative colitis (UC) is a chronic disease with a heterogeneous clinical evolution. The prevalence and incidence of UC vary widely and depend on multiple factors including ethnicity and geographic location. To determine the frequency of new cases of UC and their clinical characteristics in a large cohort from a referral hospital in Mexico City. Patients with confirmed diagnosis of UC were included during a period between January 1987 and December 2006. Demographic and clinical data were collected from medical records. A total of 848 new cases of UC were diagnosed during a 20-year period. All the patients had endoscopic and histologic confirmation. The mean of annual new UC cases increased from 28.8 in the first period (1987 to 1996) to 76.1 in the second period (1997 to 2006) (P<0.00008). The incidence of new cases increased 2.6-fold comparing both periods of time. This study consisted of 467 females and 382 males, with a mean age at diagnosis of 31.3+/-12.3 years. The clinical manifestations were pancolitis (59.1%), and extraintestinal manifestations (41.5%). Most of the patients, 762 (89.8%) were taking sulfasalazine or 5-aminosalicylic acid, 282 (33.3%) used oral or systemic steroids, 237 (28%) were taking azathioprine. The frequency of new UC cases has increased significantly in the last 10 years in Mexico, largely due to the unique genetic make-up and the environmental factors (infectious diseases including parasites) not found in other countries.

  3. Feather Development Genes and Associated Regulatory Innovation Predate the Origin of Dinosauria

    PubMed Central

    Lowe, Craig B.; Clarke, Julia A.; Baker, Allan J.; Haussler, David; Edwards, Scott V.

    2015-01-01

    The evolution of avian feathers has recently been illuminated by fossils and the identification of genes involved in feather patterning and morphogenesis. However, molecular studies have focused mainly on protein-coding genes. Using comparative genomics and more than 600,000 conserved regulatory elements, we show that patterns of genome evolution in the vicinity of feather genes are consistent with a major role for regulatory innovation in the evolution of feathers. Rates of innovation at feather regulatory elements exhibit an extended period of innovation with peaks in the ancestors of amniotes and archosaurs. We estimate that 86% of such regulatory elements and 100% of the nonkeratin feather gene set were present prior to the origin of Dinosauria. On the branch leading to modern birds, we detect a strong signal of regulatory innovation near insulin-like growth factor binding protein (IGFBP) 2 and IGFBP5, which have roles in body size reduction, and may represent a genomic signature for the miniaturization of dinosaurian body size preceding the origin of flight. PMID:25415961

  4. Survival of ovarian cancer patients in Denmark: excess mortality risk analysis of five-year relative survival in the period 1978-2002.

    PubMed

    Hannibal, Charlotte Gerd; Cortes, Rikke; Engholm, Gerda; Kjaer, Susanne Krüger

    2008-01-01

    To explore the variation in ovarian cancer survival in Denmark in the period 1978-2002 in relation to time since diagnosis, age at diagnosis, period of diagnosis, stage and histology. Register-based cohort study. Denmark in the period 1978-2002. Using the nationwide Danish Cancer Registry, we included a total of 13,035 women diagnosed with invasive ovarian cancer in Denmark in the period 1978-2002. Excess mortality risk analyses of five-year relative survival of ovarian cancer patients diagnosed in the period 1978-2002 with follow-up through 2006 were made based on data from the NORDCAN database. Five-year relative survival, excess mortality rate (ER) and relative excess mortality risk (RER) after an ovarian cancer diagnosis. The relative survival of Danish ovarian cancer patients slightly increased in the period 1978-2002. The ERs were highest in the first year following diagnosis, in particular in the first three months, and among older patients, even for localized and regional tumors. The pattern remained the same when stratified by histological subgroup. Older age at diagnosis, earlier period of diagnosis, more advanced stage at diagnosis and being diagnosed with undifferentiated carcinoma predicted poorer survival among Danish ovarian cancer patients diagnosed in the period 1978-2002. The survival of Danish ovarian cancer patients has slightly increased from 1978 through 2002. Despite this, the mortality rate of ovarian cancer in Denmark is still higher than in the other Nordic countries. Explanations for these differences are still to be identified.

  5. Frequency of EBV associated classical Hodgkin lymphoma decreases over a 54-year period in a Brazilian population.

    PubMed

    Campos, Antonio Hugo Jose Froes Marques; Moreira, Adriana; Ribeiro, Karina Braga; Paes, Roberto Pinto; Zerbini, Maria Claudia; Aldred, Vera; de Souza, Carmino Antonio; Neto, Cristovam Scapulatempo; Soares, Fernando Augusto; Vassallo, Jose

    2018-01-30

    The epidemiology of classical Hodgkin lymphoma varies significantly in populations with different socioeconomic conditions. Among other changes, improvement in such conditions leads to a reduction in the association with EBV infection and predominance of the nodular sclerosis subtype. This study provides an overview of the epidemiology of 817 cases of classical Hodgkin lymphoma diagnosed in five reference hospitals of the State of Sao Paulo, Brazil, over 54 years (1954-2008). The cases were distributed in 3 periods (1954-1979; 1980-1999; and 2000-2008). EBV-positive cases decreased from 87% to 46%. In children and adolescents (<15 years) and in young adults (15-45 years), EBV-positive cases decreased respectively from 96% to 64%, and from 85% to 32%. The percentage of male patients declined from 80% to 58%. In older patients (>45 years), the decrease in EBV infection was not significant. Nodular Sclerosis was the most common subtype in all periods. These results support the hypothesis that, in the Brazilian State of Sao Paulo, classical Hodgkin lymphoma has changed and now shows characteristics consistent with Pattern III observed in populations that experienced a similar socioeconomic transition.

  6. Infrared Spectroscopy of Symbiotic Stars. II. Orbits for Five S-Type Systems with Two-Year Periods

    NASA Astrophysics Data System (ADS)

    Fekel, Francis C.; Hinkle, Kenneth H.; Joyce, Richard R.; Skrutskie, Michael F.

    2000-12-01

    Infrared radial velocities have been used to determine orbital elements for the cool giants of five well-known symbiotic systems, Z And, AG Dra, V443 Her, AX Per, and FG Ser, all of which have orbital periods near the two-year mean period for S-type symbiotics. The new orbits are in general agreement with previous orbits derived from optical velocities. From the combined optical and infrared velocities, improved orbital elements for the five systems have been determined. Each of the orbital periods has been determined solely from the radial-velocity data. The orbits are circular and have quite small mass functions of 0.001-0.03 Msolar. The infrared velocities of AG Dra do not show the large orbital velocity residuals found for its optical radial velocities.

  7. 77 FR 7663 - Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ...The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Executive Order 12866 ``Regulatory Planning and Review,'' signed September 30, 1993 (58 FR 51735), and Office of Management and Budget memoranda implementing section 4 of that Order establish minimum standards for agencies' agendas, including specific types of information for each entry. The Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) helps agencies fulfill these requirements. All Federal regulatory agencies have chosen to publish their regulatory agendas as part of the Unified Agenda. Editions of the Unified Agenda prior to fall 2007 were printed in their entirety in the Federal Register. Beginning with the fall 2007 edition, the Internet is the basic means for conveying regulatory agenda information to the maximum extent legally permissible. The complete Unified Agenda for fall 2011, which contains the regulatory agendas for 59 Federal agencies, is available to the public at http:// reginfo.gov. The fall 2011 Unified Agenda publication appearing in the Federal Register consists of agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act.

  8. 75 FR 17454 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61805; File No. SR-BX-2010-022] Self-Regulatory... Relating to the Price Improvement Period March 31, 2010. Pursuant to Section 19(b)(1) of the Securities... change from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...

  9. Case Study: Body Composition Periodization in an Olympic-Level Female Middle-Distance Runner Over a 9-Year Career.

    PubMed

    Stellingwerff, Trent

    2018-05-25

    This case study features an Olympic-level female middle-distance runner implementing a science-based approach to body composition periodization. Data are emerging to suggest that it is not sustainable from a health and/or performance perspective to be at peak body composition year-round, so body composition needs to be strategically periodized. Anthropometric (n = 44), hematological, other health measures, and 1,500-m race performances (n = 83) were periodically assessed throughout a 9-year career. General preparation phase (September to April) featured the athlete at ∼2-4% over ideal competition phase body weight (BW) and body fat (%), with optimal energy availability being prioritized. The competition body composition optimization phase (May to August) included creating an individualized time frame and caloric deficit with various feedback metrics (BW, performance, and hunger) to guide the process. There were significant seasonal fluctuations in anthropometric outcomes between phases (47.3 ± 0.8 vs. 48.3 ± 0.9 kg BW; 53.6 ± 7.8 vs. 61.6 ± 9.7 mm International Society for the Advancement of Kinanthropometry sum of 8 [So8] skinfolds; p < .01), and a significant correlation of decreasing So8 during the peak competition period over her career (r = -.838; p = .018). The range of body composition during the competition period was 46.0-48.0 kg BW and a So8 range was 42.0-55.9 mm. There were also significant positive correlations between slower 1,500-m race times and increasing So8 (r = .437; p < .01), estimated fat mass (r = .445; p < .01), and BW (r = .511; p < .0001). The athlete only had two career injuries. This case study demonstrates a body composition periodization approach that allowed for targeted peak yearly performances, which improved throughout her career, while maximizing training adaptation and long-term athlete health through optimal energy availability.

  10. 26 CFR 1.121-5 - Suspension of 5-year period for certain members of the uniformed services and Foreign Service.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... official extended duty as a member of the Foreign Service of the United States in Brazil. In 2015 B sells... period of ownership and use during his 8-year period of service with the Foreign Service in Brazil. If B...

  11. 26 CFR 1.121-5 - Suspension of 5-year period for certain members of the uniformed services and Foreign Service.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... official extended duty as a member of the Foreign Service of the United States in Brazil. In 2015 B sells... period of ownership and use during his 8-year period of service with the Foreign Service in Brazil. If B...

  12. 26 CFR 1.121-5 - Suspension of 5-year period for certain members of the uniformed services and Foreign Service.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... official extended duty as a member of the Foreign Service of the United States in Brazil. In 2015 B sells... period of ownership and use during his 8-year period of service with the Foreign Service in Brazil. If B...

  13. 26 CFR 1.121-5 - Suspension of 5-year period for certain members of the uniformed services and Foreign Service.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... official extended duty as a member of the Foreign Service of the United States in Brazil. In 2015 B sells... period of ownership and use during his 8-year period of service with the Foreign Service in Brazil. If B...

  14. 26 CFR 1.121-5 - Suspension of 5-year period for certain members of the uniformed services and Foreign Service.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... official extended duty as a member of the Foreign Service of the United States in Brazil. In 2015 B sells... period of ownership and use during his 8-year period of service with the Foreign Service in Brazil. If B...

  15. Regulatory observations in bioanalytical determinations.

    PubMed

    Viswanathan, C T

    2010-07-01

    The concept of measuring analytes in biological media is a long-established area of the quantitative sciences that is employed in many sectors. While academic research and R&D units of private firms have been in the forefront of developing complex methodologies, it is the regulatory environment that has brought the focus and rigor to the quality control of the quantitative determination of drug concentration in biological samples. In this article, the author examines the regulatory findings discovered during the course of several years of auditing bioanalytical work. The outcomes of these findings underscore the importance of quality method validation to ensure the reliability of the data generated. The failure to ensure the reliability of these data can lead to potential risks in the health management of millions of people in the USA.

  16. [Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

    PubMed

    Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado

    2016-05-01

    Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

  17. THE USEPA'S LANDFILL RESEARCH AND REGULATORY STRATEGY

    EPA Science Inventory

    The priorities and initiatives of Environmental Protection Agency's landfill research and regulatory program over the next five years will be described. This will include municipal solid waste landfills as well as abandoned hazardous waste landfills.

    Regarding municipals s...

  18. Physicochemical Characteristics of Brazilian Green Propolis Evaluated During a Six-Year Period.

    PubMed

    de Figueiredo, Sonia M; Binda, Nancy S; Vieira-Filho, Sidney A; Almeida, Bruno de Moura; Abreu, Sheila R L; Paulino, Niraldo; Pastore, Glaucia M; Sato, Helia H; Theodoropoulos, Viviane C T; Tapia, Eulália V; Park, Yong K; Caligiorne, Rachel B

    2017-01-01

    Propolis has been used as a natural health product mainly due to the presence of polyphenols, flavonoids, phenolic aldehydes, amino acids, vitamins and others bioactive constituents. To this natural substance are attributed different biological and pharmacological properties which are influenced by its chemical composition and organoleptic properties. The aim of this work was to evaluate the physicochemical properties and parameters of green propolis collected during a period of six years (2008-2013) in the state of Minas Gerais, located at the southeastern region of Brazil. The methodology were in accordance with Brazilian legislation on the identity and quality standards of propolis. The evaluated parameters of hydroalcoholic from green propolis were total flavonoids, antioxidant activity - DPPH method, oxidation index, wax content, humidity and insoluble impurities. Propolis samples collected in different seasons during the years 2008 to 2013 presented mean values of total flavonoids (3.4 ± 0.11 mg/g), antioxidant activity DPPH (4.76 ± 0.16 μg/mL), oxidation index (3, 4 ± 0.33 seconds) and wax (15.14 ± 0.78% m/m), which are in accordance with Brazilian legislation. Green propolis did not show abrupt seasonal changes during the six years of investigation, and may be considered as an adequate functional ingredient. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  19. 78 FR 30384 - Federal Regulatory Enforcement Fairness Hearing; Region X Regulatory Fairness Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... SMALL BUSINESS ADMINISTRATION Federal Regulatory Enforcement Fairness Hearing; Region X Regulatory... Regional (Region X) Small Business Regulatory Fairness Board. SUMMARY: The (SBA) Office of the National... Region X Regulatory Fairness Board must contact Jos[eacute] M[eacute]ndez by May 30, 2013 in writing, by...

  20. Susceptibility to tulathromycin in Mannheimia haemolytica isolated from feedlot cattle over a 3-year period

    PubMed Central

    Alexander, Trevor W.; Cook, Shaun; Klima, Cassidy L.; Topp, Ed; McAllister, Tim A.

    2013-01-01

    Mannheimia haemolytica isolated from feedlot cattle were tested for tulathromycin resistance. Cattle were sampled over a 3-year period, starting 12 months after approval of tulathromycin for prevention and treatment of bovine respiratory disease. Nasopharyngeal samples from approximately 5,814 cattle were collected when cattle entered feedlots (N = 4) and again from the same cattle after ≥60 days on feed. The antimicrobial use history for each animal was recorded. Mannheimia haemolytica was isolated from 796 (13.7%) entry samples and 1,038 (20.6%) ≥ 60 days samples. Of the cattle positive for M. haemolytica, 18.5, 2.9, and 2.4% were administered therapeutic concentrations of tulathromycin, tilmicosin, or tylosin tartrate, respectively. In addition, 13.2% were administered subtherapeutic concentrations of tylosin phosphate in feed. In years one and two, no tulathromycin-resistant M. haemolytica were detected, whereas five isolates (0.4%) were resistant in year three. These resistant isolates were collected from three cattle originating from a single pen, were all serotype 1, and were genetically related (≥89% similarity) according to pulsed-field gel electrophoreses patterns. The five tulathromycin-resistant isolates were multi-drug resistant also exhibiting resistance to oxytetracycline, tilmicosin, ampicillin, or penicillin. The macrolide resistance genes erm(42), erm(A), erm(B), erm(F), erm(X) and msr(E)-mph(E), were not detected in the tulathromycin-resistant M. haemolytica. This study showed that tulathromycin resistance in M. haemolytica from a general population of feedlot cattle in western Canada was low and did not change over a 3-year period after tulathromycin was approved for use in cattle. PMID:24130555

  1. Maternal Prenatal Stress and Infant Regulatory Capacity in Mexican Americans

    PubMed Central

    Lin, Betty; Crnic, Keith A.; Luecken, Linda J.; Gonzales, Nancy A.

    2014-01-01

    The early postpartum period lays important groundwork for later self-regulation as infants' dispositional traits interact with caregivers' co-regulatory behaviors to produce the earliest forms of self-regulation. Although emerging literature suggests that fetal exposure to maternal stress may be integral in determining child self-regulatory capacity, the complex pathways that characterize these early developmental processes remain unclear. The current study considers these complex, transactional processes in a low income, Mexican American sample. Data were collected from 295 Mexican American infants and their mothers during prenatal, 6- and 12-week postpartum home interviews. Mother reports of stress were obtained prenatally, and mother reports of infant temperament were obtained at 6 weeks. Observer ratings of maternal sensitivity and infant regulatory behaviors were obtained at the 6- and 12-week time points. Study results indicate that prenatal stress predicts higher levels of infant negativity and surgency, both of which directly or interactively predict later engagement in regulatory behaviors. Unexpectedly, prenatal stress also predicted more engagement in orienting, but not self-comforting behaviors. Advancing understandings about the nature of these developmental pathways may have significant implications for targets of early intervention in this high risk population. PMID:25113917

  2. 40 CFR 91.105 - Useful life period, recall, and warranty periods.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Useful life period, recall, and... Standards and Certification Provisions § 91.105 Useful life period, recall, and warranty periods. (a) The useful life for PWC engines is a period of 350 hours of operation or 5 years of use, whichever first...

  3. 40 CFR 91.105 - Useful life period, recall, and warranty periods.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 21 2012-07-01 2012-07-01 false Useful life period, recall, and... Standards and Certification Provisions § 91.105 Useful life period, recall, and warranty periods. (a) The useful life for PWC engines is a period of 350 hours of operation or 5 years of use, whichever first...

  4. 40 CFR 91.105 - Useful life period, recall, and warranty periods.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 20 2014-07-01 2013-07-01 true Useful life period, recall, and... Standards and Certification Provisions § 91.105 Useful life period, recall, and warranty periods. (a) The useful life for PWC engines is a period of 350 hours of operation or 5 years of use, whichever first...

  5. How effective is the revised regulatory code for alcohol advertising in Australia?

    PubMed

    Jones, Sandra C; Hall, Danika; Munro, Geoffrey

    2008-01-01

    Australia, like several other countries, has a self-regulatory approach to advertising. However, in recent years the effectiveness of the regulatory system has been questioned, and there have been increasing public calls for an overhaul of the system. Following a formal review in 2003, the Ministerial Council on Drug Strategy proposed a revised Alcoholic Beverages Advertising Code (ABAC), which came into operation in 2004. The purpose of the present study was to examine the effectiveness of this revised system. From May 2004 until March 2005 television and magazine advertising campaigns were monitored for alcohol products. Over this period 14 complaints against alcohol advertisements were lodged with the self-regulatory board, and the authors recruited an independent expert panel to assess the advertisements and complaints. In eight of the 14 cases a majority of the judges perceived the advertisement to be in breach of the code, and in no cases did a majority perceive no breach. Conversely, however, none of the complaints were upheld by the Advertising Standards Board (ASB) and only one by the ABAC Panel. The results of this study suggest that the decisions made by the ASB in relation to complaints against alcohol advertisements are not in harmony with the judgement of independent experts, and that the ASB may not be performing an adequate job of representing community standards or protecting the community from offensive or inappropriate advertisements. Further, it appears that the revisions to the ABAC code, and associated processes, have not reduced the problems associated with alcohol advertising in Australia.

  6. Contribution to scientific research in paediatrics in The Netherlands: evaluation according to subspeciality over a 10-year period.

    PubMed

    Verberkmoes, J A; Monnens, L A; Vossen, J M; Weening, R S

    1993-11-01

    The board of the Dutch Paediatric Association requested a survey of the scientific research performed in all academic and non-academic paediatric hospitals, authorized to train medical doctors in paediatrics in the Netherlands. Contributions to the international and the Dutch scientific literature, in the form of regular publications, chapters in books, contributions to proceedings and Ph.D. theses were counted over two 5-year periods, i.e. 1981-1985 and 1986-1990. The quality of publications in the international journals was assessed using the average impact factor of the journals over the 10-year period. The number of publications in the international literature doubled during the observation period 1986-1990 compared to the period 1981-1985. Nevertheless, the quality of the publications remained the same. Metabolism, oncology/haematology, immunology/infectious diseases and cardiology are the subspecializations in which scientific research takes place in four or more academic paediatric hospitals. In total, 84 Ph.D. theses were produced in which a paediatrician was either the project leader (mostly a professor in paediatrics) or the investigator-in-charge. Insight into structure and major research efforts of paediatric hospitals in other countries of Europe may lead to exchange of views and, maybe, profitable co-operation.

  7. Prevalence of overweight and obesity in professional soldiers of the Czech Army over an 11-year period.

    PubMed

    Fajfrová, Jana; Pavlík, Vladimír; Psutka, Jan; Husarová, Michaela; Krutišová, Pavla; Fajfr, Miroslav

    2016-05-01

    Obesity is currently considered to be the most frequent metabolic disease worldwide, not only in developed but also in developing countries. The aim of this work was to describe the development of health status in soldiers of the Armed Forces of the Czech Republic (ACR) and to emphasizethe markers of non-communicable diseases. Our study describes the anthropometric and biochemical parameters of a large group of Czech Army professional soldiers. Data were obtained over a period of 11 years. During the monitored period, from 1999 to 2009, military physicians carried out on the average 6,360 examinations on professional soldiers per year and monitored their health and nutritional status with the aim of preventing the risk factors of non-communicable diseases. These examinations are compulsory for all professional soldiers at the age of 25, 30, 33, and 36 years. From the age of 39, these examinations are carried out every year till the end of their career. Besides taking personal histories and carrying out standard physical examinations, blood was taken for biochemical examination. The following anthropometric parameters were monitored: body constitution using body mass index (BMI) and waist circumference. Our study describes only part of the data concerning anthropometric and biochemical parameters of professional soldiers which were obtained over a period of 11 years. Average BMI values in men were in the overweight range (26.5-27 kg/m2). Average values of waist circumference, however, ranged from 91.9 cm to 93.4 cm. Between the first and the last year of monitoring a statistically significant decrease in these values ranging from 93.4 ± 9.8 cm to 92.7 ± 9.5 cm (p < 0.001) was observed. All monitored anthropometric parameters in female professional soldiers were within normal limits. During the monitored period the proportion of overweight men gradually increased from 52% to 57.1% (p < 0.001). There were no statistically significant changes in the prevalence of

  8. THREE FUNDAMENTAL PERIODS IN AN 87 YEAR LIGHT CURVE OF THE SYMBIOTIC STAR MWC 560

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Leibowitz, Elia M.; Formiggini, Liliana, E-mail: elia@astro.tau.ac.il

    2015-08-15

    We construct a visual light curve of the symbiotic star MWC covering the last 87 years of its history. The data were assembled from the literature and from the AAVSO data bank. Most of the periodic components of the system brightness variation can be accounted for by the operation of three basic clocks of the periods P1 = 19,000 days, P2 = 1943 days, and P3 = 722 days. These periods can plausibly, and consistently with the observations, be attributed to three physical mechanisms in the system: the working of a solar-like magnetic dynamo cycle in the outer layers ofmore » the giant star of the system, the binary orbit cycle, and the sidereal rotation cycle of the giant star. MWC 560 is the seventh symbiotic star with historical light curves that reveal similar basic characteristics of the systems. The light curves of all these stars are well interpreted on the basis of the current understanding of the physical processes that are the major sources of the optical luminosity of these symbiotic systems.« less

  9. Feather development genes and associated regulatory innovation predate the origin of Dinosauria.

    PubMed

    Lowe, Craig B; Clarke, Julia A; Baker, Allan J; Haussler, David; Edwards, Scott V

    2015-01-01

    The evolution of avian feathers has recently been illuminated by fossils and the identification of genes involved in feather patterning and morphogenesis. However, molecular studies have focused mainly on protein-coding genes. Using comparative genomics and more than 600,000 conserved regulatory elements, we show that patterns of genome evolution in the vicinity of feather genes are consistent with a major role for regulatory innovation in the evolution of feathers. Rates of innovation at feather regulatory elements exhibit an extended period of innovation with peaks in the ancestors of amniotes and archosaurs. We estimate that 86% of such regulatory elements and 100% of the nonkeratin feather gene set were present prior to the origin of Dinosauria. On the branch leading to modern birds, we detect a strong signal of regulatory innovation near insulin-like growth factor binding protein (IGFBP) 2 and IGFBP5, which have roles in body size reduction, and may represent a genomic signature for the miniaturization of dinosaurian body size preceding the origin of flight. © The Author 2014. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution.

  10. Trends in Pulmonary Hypertension Over a Period of 30 Years: Experience From a Single Referral Centre.

    PubMed

    Quezada Loaiza, Carlos Andrés; Velázquez Martín, María Teresa; Jiménez López-Guarch, Carmen; Ruiz Cano, María José; Navas Tejedor, Paula; Carreira, Patricia Esmeralda; Flox Camacho, Ángela; de Pablo Gafas, Alicia; Delgado Jiménez, Juan Francisco; Gómez Sánchez, Miguel Ángel; Escribano Subías, Pilar

    2017-11-01

    Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary vascular resistance, right ventricular dysfunction and death. Despite scientific advances, is still associated with high morbidity and mortality. The aim is to describe the clinical approach and determine the prognostic factors of patients with PAH treated in a national reference center over 30 years. Three hundred and seventy nine consecutive patients with PAH (January 1984 to December 2014) were studied. Were divided into 3 periods of time: before 2004, 2004-2009 and 2010-2014. Prognostic factors (multivariate analysis) were analyzed for clinical deterioration. Median age was 44 years (68.6% women), functional class III-IV: 72%. An increase was observed in more complex etiologies in the last period of time: Pulmonary venooclusive disease and portopulmonary hypertension. Upfront combination therapy significantly increased (5% before 2004 vs 27% after 2010; P < .05). Multivariate analysis showed prognostic significance in age, sex, etiology and combined clinical variables as they are independent predictors of clinical deterioration (P < .05). Survival free from death or transplantation for the 1st, 3rd and 5th year was 92.2%, 80.6% and 68.5% respectively. The median survival was 9 years (95% confidence interval, 7.532-11.959) CONCLUSIONS: The PAH is a heterogeneous and complex disease, the median survival free from death or transplantation in our series is 9 years after diagnosis. The structure of a multidisciplinary unit PAH must adapt quickly to changes that occur over time incorporating new diagnostic and therapeutic techniques. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  11. Potential Accumulative Effect of the Herbicide Glyphosate on Glyphosate-Tolerant Maize Rhizobacterial Communities over a Three-Year Cultivation Period

    PubMed Central

    Barriuso, Jorge; Marín, Silvia; Mellado, Rafael P.

    2011-01-01

    Background Glyphosate is a herbicide that is liable to be used in the extensive cultivation of glyphosate-tolerant cultivars. The potential accumulation of the relative effect of glyphosate on the rhizobacterial communities of glyphosate-tolerant maize has been monitored over a period of three years. Methodology/Principal Findings The composition of rhizobacterial communities is known to vary with soil texture, hence, the analyses have been performed in two agricultural fields with a different soil texture. The accumulative effects of glyphosate have been monitored by means of high throughput DNA pyrosequencing of the bacterial DNA coding for the 16S rRNA hypervariable V6 region from rhizobacterial communities. The relative composition of the rhizobacterial communities does vary in each field over the three-year period. The overall distribution of the bacterial phyla seems to change from one year to the next similarly in the untreated and glyphosate-treated soils in both fields. The two methods used to estimate bacterial diversity offered consistent results and are equally suitable for diversity assessment. Conclusions/Significance The glyphosate treatment during the three-year period of seasonal cultivation in two different fields did not seem to significantly change the maize rhizobacterial communities when compared to those of the untreated soil. This may be particularly relevant with respect to a potential authorisation to cultivate glyphosate-tolerant maize in the European Union. PMID:22096595

  12. Increased Regulatory T-Cell Percentage Contributes to Poor CD4(+) Lymphocytes Recovery: A 2-Year Prospective Study After Introduction of Antiretroviral Therapy.

    PubMed

    Saison, Julien; Maucort Boulch, Delphine; Chidiac, Christian; Demaret, Julie; Malcus, Christophe; Cotte, Laurent; Poitevin-Later, Francoise; Miailhes, Patrick; Venet, Fabienne; Trabaud, Mary Anne; Monneret, Guillaume; Ferry, Tristan

    2015-04-01

    Background.  The primary aim of this study was to determine the impact of regulatory T cells (Tregs) percentage on immune recovery in human immunodeficiency virus (HIV)-infected patients after antiretroviral therapy introduction. Methods.  A 2-year prospective study was conducted in HIV-1 chronically infected naive patients with CD4 count <500 cells/mm(3). Regulatory T cells were identified as CD4(+)CD25(high)CD127(low) cells among CD4(+) lymphocytes. Effect of Treg percentage at inclusion on CD4 evolution overtime was analyzed using a mixed-effect Poisson regression for count data. Results.  Fifty-eight patients were included (median CD4 = 293/mm(3), median Treg percentage = 6.1%). Percentage of Treg at baseline and CD4 nadir were independently related to the evolution of CD4 absolute value according to time: (1) at any given nadir CD4 count, 1% increase of initial Treg was associated with a 1.9% lower CD4 absolute value at month 24; (2) at any given Treg percentage at baseline, 10 cell/mm(3) increase of CD4 nadir was associated with a 2.4% increase of CD4 at month 24; and (3) both effects did not attenuate with time. The effect of Treg at baseline on CD4 evolution was as low as the CD4 nadir was high. Conclusions.  Regulatory T-cell percentage at baseline is a strong independent prognostic factor of immune recovery, particularly among patients with low CD4 nadir.

  13. The Regulatory Framework for Privacy and Security

    NASA Astrophysics Data System (ADS)

    Hiller, Janine S.

    The internet enables the easy collection of massive amounts of personally identifiable information. Unregulated data collection causes distrust and conflicts with widely accepted principles of privacy. The regulatory framework in the United States for ensuring privacy and security in the online environment consists of federal, state, and self-regulatory elements. New laws have been passed to address technological and internet practices that conflict with privacy protecting policies. The United States and the European Union approaches to privacy differ significantly, and the global internet environment will likely cause regulators to face the challenge of balancing privacy interests with data collection for many years to come.

  14. Susceptibility of Mycobacterium tuberculosis to sulfamethoxazole, trimethoprim and their combination over a 12 year period in Taiwan.

    PubMed

    Huang, Tsi-Shu; Kunin, Calvin M; Yan, Bo-Shiun; Chen, Yao-Shen; Lee, Susan Shin-Jung; Syu, Wan

    2012-03-01

    This study was designed to determine the susceptibility of clinical isolates of multidrug-resistant (MDR) and non-MDR Mycobacterium tuberculosis to sulfamethoxazole, trimethoprim and trimethoprim/sulfamethoxazole over a 12 year period in Taiwan. We examined a total of 117 clinical isolates of M. tuberculosis collected from Southern Taiwan, 116 from 1995 to 2006 and an extensively drug-resistant (XDR) isolate in 2009. These included 28 isolates susceptible to all four first-line agents, 52 MDR isolates and 36 isolates with a mixed combination of drug resistance patterns other than MDR and 1 XDR isolate. Sulfamethoxazole inhibited 80% growth of all 117 isolates regardless of their susceptibility to the first-line agents at an MIC(90) of 9.5 mg/L. The concentration required to inhibit 99% growth was 38 mg/L. There were no significant changes in the MIC(50) or MIC(90) of sulfamethoxazole over a 12 year period. All 117 isolates were resistant to trimethoprim at >8 mg/L. The combination of trimethoprim/sulfamethoxazole at a ratio of 1:19 had no additive or synergistic effects. Sulfamethoxazole inhibited the growth of clinical isolates of M. tuberculosis at achievable concentrations in plasma after oral administration. Susceptibility to sulfamethoxazole remained constant over a 12 year period. Trimethoprim was inactive against M. tuberculosis and trimethoprim/sulfamethoxazole provided no additional activity. Although the current and prior studies demonstrate that sulfamethoxazole is active against M. tuberculosis the search needs to continue for more active, lipid-soluble sulphonamides that are better absorbed into tissues and have improved therapeutic efficacy.

  15. 75 FR 78302 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-15

    ... last-sale price disseminated by a network processor over a five-minute rolling period measured...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Pilot Period of the Trading Pause for Individual Stocks Contained in the...

  16. Ambulance dispatches to schools during a 5-year period in Fukui Prefecture.

    PubMed

    Takinami, Yoshikazu; Maeda, Shinji

    2017-01-01

    To determine the characteristics and trends of medical emergencies during school activities by analyzing information provided by fire departments. During a 5-year period from January 2009 to December 2013, all nine fire departments in Fukui Prefecture handled 850 emergencies at schools. We investigated the 850 cases with the age range of 0-63 years. It was found that 21.5% of ambulance dispatches to schools were on weekends and there were more dispatches for non-faculty members of all age groups on weekends than on weekdays. The percentage of weekend dispatches was particularly high for students aged ≥19 years. Emergency calls for junior high school students and younger students accounted for the majority of weekday calls. There were a total of 524 ambulance dispatches for the three categories "sprains, contusions, dislocations, and fractures" ( n = 245), "seizures, epilepsy, and syncope" ( n = 171), and "cuts, bruises, lacerations, trauma, amputations, and burns" ( n = 108), with dispatches for these three categories accounting for 61.6% of all dispatches. Almost all dispatches for "heat stroke and dehydration" were during school hours and were concentrated between the months of July and September. Heat stroke was most common among high school students and most often occurred during the summer/fall season and on weekends. Heat stroke was the fourth most frequent condition that required an ambulance dispatch after the above three conditions. Heat stroke is predictable, indicating that it is necessary to prevent heat stroke during high school club activities.

  17. Epidemiological and Clinical Changes in American Tegumentary Leishmaniasis in an Area of Leishmania (Viannia) braziliensis Transmission Over a 20-Year Period

    PubMed Central

    Jirmanus, Lara; Glesby, Marshall J.; Guimarães, Luiz H.; Lago, Ednaldo; Rosa, Maria Elisa; Machado, Paulo R.; Carvalho, Edgar M.

    2012-01-01

    The Health Post of Corte de Pedra is located in a region endemic for American tegumentary leishmaniasis (ATL) in the Brazilian state of Bahia, and it treats 500–1,300 patients annually. To describe temporal changes in the epidemiology of ATL, we reviewed a random sample of 10% of patient charts (N = 1,209) from 1988 to 2008. There was a twofold increase in the number of cases over the 20-year period, with fluctuations in 10-year cycles. Patients were most frequently male, between the ages of 10 and 30 years, and engaged in agricultural labor; 4.3% of patients had mucosal disease, and 2.4% of patients had disseminated disease. Over the study period, the number of disseminated cases increased threefold, the proportion of cases in younger patients and agricultural workers decreased, and the proportion of patients residing in coastal areas increased. ATL is on the rise in Bahia, with a 10-year periodicity and evolving changes in epidemiology and manifestations of disease. PMID:22403312

  18. The frequency of fragrance allergy in a patch-test population over a 17-year period.

    PubMed

    Buckley, D A; Wakelin, S H; Seed, P T; Holloway, D; Rycroft, R J; White, I R; McFadden, J P

    2000-02-01

    Fragrances are widely encountered in our daily environment and are known to be a common cause of allergic contact dermatitis. We have reviewed our patch test data from 1980 to 1996 to establish whether the pattern of fragrance allergy has changed with time. During this period, 25,545 patients (10,450 male, 15,005 female) were patch tested with the European standard series. The mean annual frequency of positive reactions to the fragrance mix was 8.5% in females (range 6.1-10.9) and 6.7% in males (range 5.1-12.9). Females were 1.3 times more likely to be allergic to fragrance (P < 0.001, 95% confidence interval, CI 1.17-1.41). Males with fragrance allergy were older than females by 5.6 years (mean age 48.2 vs. 42.6 years; P < 0.001, 95% CI 3.9-7.3). The incidence of a concomitant positive patch test to balsam of Peru in fragrance-sensitive patients showed wide variation, suggesting that it is not a reliable marker of fragrance allergy. There was a positive correlation between the isomers isoeugenol and eugenol. Oak moss remained the most common overall allergen throughout the study, positive in 38.3% of females and 35.6% of males who were tested to the constituents of the fragrance mix. During the period of the study the incidence of positive tests to oak moss increased by 5% yearly (P = 0.001, 95% CI 2.2-8.7). The frequency of allergic reactions to eugenol and geraniol remained relatively constant. Isoeugenol and alpha-amyl cinnamic aldehyde sensitivity increased and hydroxycitronellal showed a slow decline. There was a striking reduction in the frequency of sensitivity to cinnamic aldehyde (by 18% yearly; P < 0.001, 95% CI 14.3-21.0) and cinnamic alcohol (by 9% yearly; P < 0.001, 95% CI 5.2-12.9); these are now uncommon fragrance allergens. These data show temporal trends which may reflect the frequency of population exposure to individual fragrances.

  19. 26 CFR 31.3402(g)-2 - Wages paid for payroll period of more than one year.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 26 Internal Revenue 15 2010-04-01 2010-04-01 false Wages paid for payroll period of more than one year. 31.3402(g)-2 Section 31.3402(g)-2 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... COLLECTION OF INCOME TAX AT SOURCE Collection of Income Tax at Source § 31.3402(g)-2 Wages paid for payroll...

  20. 26 CFR 31.3402(g)-2 - Wages paid for payroll period of more than one year.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 26 Internal Revenue 15 2012-04-01 2012-04-01 false Wages paid for payroll period of more than one year. 31.3402(g)-2 Section 31.3402(g)-2 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... COLLECTION OF INCOME TAX AT SOURCE Collection of Income Tax at Source § 31.3402(g)-2 Wages paid for payroll...

  1. 26 CFR 31.3402(g)-2 - Wages paid for payroll period of more than one year.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 26 Internal Revenue 15 2011-04-01 2011-04-01 false Wages paid for payroll period of more than one year. 31.3402(g)-2 Section 31.3402(g)-2 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... COLLECTION OF INCOME TAX AT SOURCE Collection of Income Tax at Source § 31.3402(g)-2 Wages paid for payroll...

  2. 26 CFR 31.3402(g)-2 - Wages paid for payroll period of more than one year.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 26 Internal Revenue 15 2013-04-01 2013-04-01 false Wages paid for payroll period of more than one year. 31.3402(g)-2 Section 31.3402(g)-2 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... COLLECTION OF INCOME TAX AT SOURCE Collection of Income Tax at Source § 31.3402(g)-2 Wages paid for payroll...

  3. 26 CFR 31.3402(g)-2 - Wages paid for payroll period of more than one year.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 26 Internal Revenue 15 2014-04-01 2014-04-01 false Wages paid for payroll period of more than one year. 31.3402(g)-2 Section 31.3402(g)-2 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... COLLECTION OF INCOME TAX AT SOURCE Collection of Income Tax at Source § 31.3402(g)-2 Wages paid for payroll...

  4. Retention and readability of radio frequency identification transponders in beef cows over a five-year period

    USDA-ARS?s Scientific Manuscript database

    Objective of this study was to evaluate failure (loss or inability to read) of radio frequency identification (RFID) ear tags in beef cows over a 2 to 5 year period under ranching conditions. One of 5 types of RFID tags was applied in the ear of a total of 4316 cows on 4 separate ranches. Tags wer...

  5. The regulatory sciences for stem cell-based medicinal products.

    PubMed

    Yuan, Bao-Zhu; Wang, Junzhi

    2014-06-01

    Over the past few years, several new achievements have been made from stem cell studies, many of which have moved up from preclinical stages to early, or from early to middle or late, stages thanks to relatively safe profile and preliminary evidence of effectiveness. Moreover, some stem cell-based products have been approved for marketing by different national regulatory authorities. However, many critical issues associated mainly with incomplete understanding of stem cell biology and the relevant risk factors, and lack of effective regulations still exist and need to be urgently addressed, especially in countries where establishment of appropriate regulatory system just commenced. More relevantly, the stem cell regulatory sciences need to be established or improved to more effectively evaluate quality, safety and efficacy of stem cell products, and for building up the appropriate regulatory framework. In this review, we summarize some new achievements in stem cell studies, especially the preclinical and clinical studies, the existing regulations, and the associated challenges, and we then propose some considerations for improving stem cell regulatory sciences with a goal of promoting the steadfast growth of the well-regulated stem cell therapies abreast of evolvement of stem cell sciences and technologies.

  6. Trend in dental research output in Iran over a period of 20 years (1990-2009).

    PubMed

    Sadeghi, Masoumeh; Shahravan, Arash; Haghdoost, Ali Akbar; Asgary, Saeed; Rad, Maryam

    2012-04-01

    The number of scientific papers is a conventional metric for the measurement of a country's research performance in a particular area. To evaluate the trend in Iranian publications of dental research results in peer-reviewed international scientific journals over the period 1999-2009, using national and international databases, and to compare the results with other countries. The search process was performed by two independent persons in PubMed and Iranian Medline (IranMedex). Data extraction included the year of publication, total number of dental papers in each year, total number of Iranian dental papers in each year and number of papers with a high level of evidence; these were compared with those in other Asian countries. The total number of dental articles indexed in PubMed during the studied period was 207,689, with 671 being written by researchers who stated their affiliation as Iran. Although the proportion of Iranian dental articles to all published dental articles was 0.01% in 1990, this increased to 1.4% in 2009. Of all clinical trials indexed in PubMed from 1990 to 2009, only 0.62% had an author from Iran. The collaboration rate of authors ranged between 1 and 10. Turkey and Iran had a larger number of dental research publications compared with other Asian countries assessed in this study. During the last two decades, there has been a considerable increase in the number of dental papers by Iranian researchers indexed in the PubMed database. © 2012 FDI World Dental Federation.

  7. Traumatic episodes experienced during the genocide period in Rwanda influence life circumstances in young men and women 17 years later

    PubMed Central

    2013-01-01

    Background During Rwanda’s genocide period in 1994, about 800,000 people were killed. People were murdered, raped and seriously injured. This retrospective study investigated prevalence and frequency of traumatic episodes and associated psychosocial effects in young adults in Rwanda over the lifetime, during the genocide period and in the past three years. Methods This is a cross-sectional population-based study conducted among men and women, aged 20 to 35 years, residing in the Southern province of Rwanda. The study population, randomly selected in a multi stage procedure, included 477 females and 440 males. Data collection was performed through individual interviewing with a structured questionnaire during the period December 2011- January 2012. The Harvard Trauma Questionnaire was used to assess traumatic episodes. All data was sex-disaggregated. Differences between groups were measured by chi square and Fischer’s exact test. Associations with socio-demographic and psychosocial factors were estimated by use of odds ratios with 95% confidence intervals in bi- and multivariate analyses. Results The participants in this study were 3 to 18 years of age in 1994, the year of the genocide. Our sample size was 917 participants, 440 men and 477 women. Women were to a higher extent exposed to traumatic episodes than men during their lifetime, 83.6% (n = 399) and 73.4% (n = 323), respectively. During the genocide period, 37.5% of the men/boys and 35.4% of the women/girls reported such episodes while in the past three years (2009-2011) 25.0% of the men and 23.1% of the women did. Women were more exposed to episodes related to physical and sexual violence, while men were exposed to imprisonment, kidnapping and mass killings. Victims of such violence during the genocide period were 17 years later less educated although married (men OR 1.47; 0.98-2.19; women OR 1.54; 1.03-2.30), without children (men OR 1.59; 1.08-2.36; women OR 1.86; 1.11-3.08) and living under extremely

  8. 75 FR 63878 - Self-Regulatory Organizations; Self-Regulatory Organizations; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ...-Regulatory Organizations; Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of...(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory...

  9. Regulatory element-based prediction identifies new susceptibility regulatory variants for osteoporosis.

    PubMed

    Yao, Shi; Guo, Yan; Dong, Shan-Shan; Hao, Ruo-Han; Chen, Xiao-Feng; Chen, Yi-Xiao; Chen, Jia-Bin; Tian, Qing; Deng, Hong-Wen; Yang, Tie-Lin

    2017-08-01

    Despite genome-wide association studies (GWASs) have identified many susceptibility genes for osteoporosis, it still leaves a large part of missing heritability to be discovered. Integrating regulatory information and GWASs could offer new insights into the biological link between the susceptibility SNPs and osteoporosis. We generated five machine learning classifiers with osteoporosis-associated variants and regulatory features data. We gained the optimal classifier and predicted genome-wide SNPs to discover susceptibility regulatory variants. We further utilized Genetic Factors for Osteoporosis Consortium (GEFOS) and three in-house GWASs samples to validate the associations for predicted positive SNPs. The random forest classifier performed best among all machine learning methods with the F1 score of 0.8871. Using the optimized model, we predicted 37,584 candidate SNPs for osteoporosis. According to the meta-analysis results, a list of regulatory variants was significantly associated with osteoporosis after multiple testing corrections and contributed to the expression of known osteoporosis-associated protein-coding genes. In summary, combining GWASs and regulatory elements through machine learning could provide additional information for understanding the mechanism of osteoporosis. The regulatory variants we predicted will provide novel targets for etiology research and treatment of osteoporosis.

  10. 75 FR 11166 - Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-10

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD06-6-000] Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission; Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission March 2, 2010. The Federal Energy Regulatory Commission (FERC)...

  11. Mouse regulatory DNA landscapes reveal global principles of cis-regulatory evolution.

    PubMed

    Vierstra, Jeff; Rynes, Eric; Sandstrom, Richard; Zhang, Miaohua; Canfield, Theresa; Hansen, R Scott; Stehling-Sun, Sandra; Sabo, Peter J; Byron, Rachel; Humbert, Richard; Thurman, Robert E; Johnson, Audra K; Vong, Shinny; Lee, Kristen; Bates, Daniel; Neri, Fidencio; Diegel, Morgan; Giste, Erika; Haugen, Eric; Dunn, Douglas; Wilken, Matthew S; Josefowicz, Steven; Samstein, Robert; Chang, Kai-Hsin; Eichler, Evan E; De Bruijn, Marella; Reh, Thomas A; Skoultchi, Arthur; Rudensky, Alexander; Orkin, Stuart H; Papayannopoulou, Thalia; Treuting, Piper M; Selleri, Licia; Kaul, Rajinder; Groudine, Mark; Bender, M A; Stamatoyannopoulos, John A

    2014-11-21

    To study the evolutionary dynamics of regulatory DNA, we mapped >1.3 million deoxyribonuclease I-hypersensitive sites (DHSs) in 45 mouse cell and tissue types, and systematically compared these with human DHS maps from orthologous compartments. We found that the mouse and human genomes have undergone extensive cis-regulatory rewiring that combines branch-specific evolutionary innovation and loss with widespread repurposing of conserved DHSs to alternative cell fates, and that this process is mediated by turnover of transcription factor (TF) recognition elements. Despite pervasive evolutionary remodeling of the location and content of individual cis-regulatory regions, within orthologous mouse and human cell types the global fraction of regulatory DNA bases encoding recognition sites for each TF has been strictly conserved. Our findings provide new insights into the evolutionary forces shaping mammalian regulatory DNA landscapes. Copyright © 2014, American Association for the Advancement of Science.

  12. 76 FR 12769 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...,\\2\\ notice is hereby given that on February 16, 2011, the Financial Industry Regulatory Authority... CFR 240.19b-4(f)(3). I. Self-Regulatory Organization's Statement of the Terms of Substance of the...

  13. [Regulatory T cells].

    PubMed

    Marinić, Igor; Gagro, Alenka; Rabatić, Sabina

    2006-12-01

    Regulatory T-cells are a subset of T cells that have beene extensively studied in modern immunology. They are important for the maintenance of peripheral tolerance, and have an important role in various clinical conditions such as allergy, autoimmune disorders, tumors, infections, and in transplant medicine. Basically, this population has a suppressive effect on the neighboring immune cells, thus contributing to the local modulation and control of immune response. There are two main populations of regulatory T cells - natural regulatory T cells, which form a distinct cellular lineage, develop in thymus and perform their modulatory action through direct intercellular contact, along with the secreted cytokines; and inducible regulatory T cells, which develop in the periphery after contact with the antigen that is presented on the antigen presenting cell, and their primary mode of action is through the interleukin 10 (IL-10) and transforming growth factor beta (TGF-alpha) cytokines. Natural regulatory T cells are activated through T cell receptor after contact with specific antigen and inhibit proliferation of other T cells in an antigen independent manner. One of the major difficulties in the research of regulatory T cells is the lack of specific molecular markers that would identify these cells. Natural regulatory T cells constitutively express surface molecule CD25, but many other surface and intracellular molecules (HLA-DR, CD122, CD45RO, CD62, CTLA-4, GITR, PD-1, Notch, FOXP3, etc.) are being investigated for further phenotypic characterization of these cells. Because regulatory T cells have an important role in establishing peripheral tolerance, their importance is manifested in a number of clinical conditions. In the IPEX syndrome (immunodysregulation, polyendocrinopathy and enteropathy, X-linked), which is caused by mutation in Foxp3 gene that influences the development and function of regulatory T cells, patients develop severe autoimmune reactions that

  14. Periodic, Quasi-periodic and Chaotic Dynamics in Simple Gene Elements with Time Delays

    PubMed Central

    Suzuki, Yoko; Lu, Mingyang; Ben-Jacob, Eshel; Onuchic, José N.

    2016-01-01

    Regulatory gene circuit motifs play crucial roles in performing and maintaining vital cellular functions. Frequently, theoretical studies of gene circuits focus on steady-state behaviors and do not include time delays. In this study, the inclusion of time delays is shown to entirely change the time-dependent dynamics for even the simplest possible circuits with one and two gene elements with self and cross regulations. These elements can give rise to rich behaviors including periodic, quasi-periodic, weak chaotic, strong chaotic and intermittent dynamics. We introduce a special power-spectrum-based method to characterize and discriminate these dynamical modes quantitatively. Our simulation results suggest that, while a single negative feedback loop of either one- or two-gene element can only have periodic dynamics, the elements with two positive/negative feedback loops are the minimalist elements to have chaotic dynamics. These elements typically have one negative feedback loop that generates oscillations, and another unit that allows frequent switches among multiple steady states or between oscillatory and non-oscillatory dynamics. Possible dynamical features of several simple one- and two-gene elements are presented in details. Discussion is presented for possible roles of the chaotic behavior in the robustness of cellular functions and diseases, for example, in the context of cancer. PMID:26876008

  15. Periodic, Quasi-periodic and Chaotic Dynamics in Simple Gene Elements with Time Delays

    NASA Astrophysics Data System (ADS)

    Suzuki, Yoko; Lu, Mingyang; Ben-Jacob, Eshel; Onuchic, José N.

    2016-02-01

    Regulatory gene circuit motifs play crucial roles in performing and maintaining vital cellular functions. Frequently, theoretical studies of gene circuits focus on steady-state behaviors and do not include time delays. In this study, the inclusion of time delays is shown to entirely change the time-dependent dynamics for even the simplest possible circuits with one and two gene elements with self and cross regulations. These elements can give rise to rich behaviors including periodic, quasi-periodic, weak chaotic, strong chaotic and intermittent dynamics. We introduce a special power-spectrum-based method to characterize and discriminate these dynamical modes quantitatively. Our simulation results suggest that, while a single negative feedback loop of either one- or two-gene element can only have periodic dynamics, the elements with two positive/negative feedback loops are the minimalist elements to have chaotic dynamics. These elements typically have one negative feedback loop that generates oscillations, and another unit that allows frequent switches among multiple steady states or between oscillatory and non-oscillatory dynamics. Possible dynamical features of several simple one- and two-gene elements are presented in details. Discussion is presented for possible roles of the chaotic behavior in the robustness of cellular functions and diseases, for example, in the context of cancer.

  16. Repeated measurements of mite and pet allergen levels in house dust over a time period of 8 years.

    PubMed

    Antens, C J M; Oldenwening, M; Wolse, A; Gehring, U; Smit, H A; Aalberse, R C; Kerkhof, M; Gerritsen, J; de Jongste, J C; Brunekreef, B

    2006-12-01

    Studies of the association between indoor allergen exposure and the development of allergic diseases have often measured allergen exposure at one point in time. We investigated the variability of house dust mite (Der p 1, Der f 1) and cat (Fel d 1) allergen in Dutch homes over a period of 8 years. Data were obtained in the Dutch PIAMA birth cohort study. Dust from the child's mattress, the parents' mattress and the living room floor was collected at four points in time, when the child was 3 months, 4, 6 and 8 years old. Dust samples were analysed for Der p 1, Der f 1 and Fel d 1 by sandwich enzyme immuno assay. Mite allergen concentrations for the child's mattress, the parents' mattress and the living room floor were moderately correlated between time-points. Agreement was better for cat allergen. For Der p 1 and Der f 1 on the child's mattress, the within-home variance was close to or smaller than the between-home variance in most cases. For Fel d 1, the within-home variance was almost always smaller than the between-home variance. Results were similar for allergen levels expressed per gram of dust and allergen levels expressed per square metre of the sampled surface. Variance ratios were smaller when samples were taken at shorter time intervals than at longer time intervals. Over a period of 4 years, mite and cat allergens measured in house dust are sufficiently stable to use single measurements with confidence in epidemiological studies. The within-home variance was larger when samples were taken 8 years apart so that over such long periods, repetition of sampling is recommended.

  17. The Regulatory Challenges of Decommissioning Nuclear Power Plants in Korea - 13101

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lee, Jungjoon; Ahn, Sangmyeon; Choi, Kyungwoo

    As of 2012, 23 units of nuclear power plants are in operation, but there is no experience of permanent shutdown and decommissioning of nuclear power plant in Korea. It is realized that, since late 1990's, improvement of the regulatory framework for decommissioning has been emphasized constantly from the point of view of International Atomic Energy Agency (IAEA)'s safety standards. And it is known that now IAEA prepare the safety requirement on decommissioning of facilities, its title is the Safe Decommissioning of Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission tomore » Korea in 2011, it was recommended that the regulatory framework for decommissioning should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became also important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we identify the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is to be established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. After dealing with it, it is expected that the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)« less

  18. Comparative analysis of gene regulatory networks: from network reconstruction to evolution.

    PubMed

    Thompson, Dawn; Regev, Aviv; Roy, Sushmita

    2015-01-01

    Regulation of gene expression is central to many biological processes. Although reconstruction of regulatory circuits from genomic data alone is therefore desirable, this remains a major computational challenge. Comparative approaches that examine the conservation and divergence of circuits and their components across strains and species can help reconstruct circuits as well as provide insights into the evolution of gene regulatory processes and their adaptive contribution. In recent years, advances in genomic and computational tools have led to a wealth of methods for such analysis at the sequence, expression, pathway, module, and entire network level. Here, we review computational methods developed to study transcriptional regulatory networks using comparative genomics, from sequence to functional data. We highlight how these methods use evolutionary conservation and divergence to reliably detect regulatory components as well as estimate the extent and rate of divergence. Finally, we discuss the promise and open challenges in linking regulatory divergence to phenotypic divergence and adaptation.

  19. Authority defied: need for cognitive closure influences regulatory control when resisting authority.

    PubMed

    Damen, Tom G E; van Leeuwen, Matthijs L; Dijksterhuis, Ap; van Baaren, Rick B

    2014-08-01

    The present studies examined whether differences in need for cognitive closure (NCC) were related to differences in regulatory control when confronted with authority. In two studies, levels of regulatory control were measured when participants resisted (Study 1; N = 46) or prepared to resist the influence attempt of an authority figure (Study 2; N = 50). Results showed that resisting the influence attempt from a high-authority figure was more depleting for participants higher in NCC compared to individuals lower in NCC. However, when they were given instructions and time to prepare the act of resistance, individuals high in NCC actually showed an increase in regulatory control. Authority is usually viewed as a general principle of influence; however, the present studies suggest that there are individual differences that influence how people may experience interactions with authorities. © 2013 Wiley Periodicals, Inc.

  20. 7 CFR 1207.310 - Fiscal period and marketing year.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... SERVICE (MARKETING AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan Definitions § 1207.310 Fiscal period and...

  1. 7 CFR 1207.310 - Fiscal period and marketing year.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... SERVICE (MARKETING AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan Definitions § 1207.310 Fiscal period and...

  2. 7 CFR 1207.310 - Fiscal period and marketing year.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... SERVICE (MARKETING AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan Definitions § 1207.310 Fiscal period and...

  3. 7 CFR 1207.310 - Fiscal period and marketing year.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... SERVICE (MARKETING AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan Definitions § 1207.310 Fiscal period and...

  4. 7 CFR 1207.310 - Fiscal period and marketing year.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... SERVICE (MARKETING AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan Definitions § 1207.310 Fiscal period and...

  5. When planning is not enough: the self-regulatory effect of implementation intentions on changing snacking habits.

    PubMed

    Tam, Leona; Bagozzi, Richard P; Spanjol, Jelena

    2010-05-01

    This study examined whether matching implementation intentions to people's regulatory orientation affects the effectiveness of changing unhealthy snacking habits. Participants' regulatory orientation was either measured (as a chronic trait) or manipulated (as a situational state), and participants were randomly assigned to implementation intention conditions to eat more healthy snacks or avoid eating unhealthy ones. A self-reported online food diary of healthy and unhealthy snacks over a 2-day period. Participants with weak unhealthy snacking habits consumed more healthy snacks when forming any type of implementation intentions (regardless of match or mismatch with their regulatory orientation), while participants with strong unhealthy snacking habits consumed more healthy snacks only when forming implementation intentions that matched their regulatory orientations. RESULTS suggest that implementation intentions that match regulatory orientation heighten motivation intensity and put snacking under intentional control for people with strong unhealthy snacking habits. (c) 2010 APA, all rights reserved.

  6. Examining job tenure and lost-time claim rates in Ontario, Canada, over a 10-year period, 1999-2008.

    PubMed

    Morassaei, Sara; Breslin, F Curtis; Shen, Min; Smith, Peter M

    2013-03-01

    We sought to examine the association between job tenure and lost-time claim rates over a 10-year period in Ontario, Canada. Data were obtained from workers' compensation records and labour force survey data from 1999 to 2008. Claim rates were calculated for gender, age, industry, occupation, year and job tenure group. A multivariate analysis and examination of effect modification were performed. Differences in injury event and source of injury were also examined by job tenure. Lost-time claim rates were significantly higher for workers with shorter job tenure, regardless of other factors. Claim rates for new workers differed by gender, age and industry, but remained relatively constant at an elevated rate over the observed time period. This study is the first to examine lost-time claim rates by job tenure over a time period during which overall claim rates generally declined. Claim rates did not show a convergence by job tenure. Findings highlight that new workers are still at elevated risk, and suggest the need for improved training, reducing exposures among new workers, promoting permanent employment, and monitoring work injury trends and risk factors.

  7. 76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...

  8. Hydrologic Drought of Water Year 2006 Compared with Four Major Drought Periods of the 20th Century in Oklahoma

    USGS Publications Warehouse

    Tortorelli, Robert L.

    2008-01-01

    Water Year 2006 (October 1, 2005, to September 30, 2006) was a year of extreme hydrologic drought and the driest year in the recent 2002-2006 drought in Oklahoma. The severity of this recent drought can be evaluated by comparing it with four previous major hydrologic droughts, water years 1929-41, 1952-56, 1961-72, and 1976-81. The U.S. Geological Survey, in cooperation with the Oklahoma Water Resources Board, completed an investigation to summarize the Water Year 2006 hydrologic drought and compare it to the four previous major hydrologic droughts in the 20th century. The period of water years 1925-2006 was selected as the period of record because before 1925 few continuous record streamflow-gaging sites existed and gaps existed where no streamflow-gaging sites were operated. Statewide annual precipitation in Water Year 2006 was second driest and statewide annual runoff in Water Year 2006 was sixth driest in the 82 years of record. Annual area-averaged precipitation totals by the nine National Weather Service Climate Divisions from Water Year 2006 are compared to those during four previous major hydrologic droughts to show how rainfall deficits in Oklahoma varied by region. Only two of the nine climate divisions, Climate Division 1 Panhandle and Climate Division 4 West Central, had minor rainfall deficits, while the rest of the climate divisions had severe rainfall deficits in Water Year 2006 ranging from only 65 to 73 percent of normal annual precipitation. Regional streamflow patterns for Water Year 2006 indicate that Oklahoma was part of the regionwide below-normal streamflow conditions for Arkansas-White-Red River Basin, the sixth driest since 1930. The percentage of long-term stations in Oklahoma (with at least 30 years of record) having below-normal streamflow reached 80 to 85 percent for some days in August and November 2006. Twelve long-term streamflow-gaging sites with periods of record ranging from 62 to 78 years were selected to show how streamflow

  9. Self-Regulatory Private Speech Relates to Children's Recall and Organization of Autobiographical Memories

    ERIC Educational Resources Information Center

    Al-Namlah, Abdulrahman S.; Meins, Elizabeth; Fernyhough, Charles

    2012-01-01

    We investigated relations between 4- and 7-year-olds' (N=58) autobiographical memory and their use of self-regulatory private speech in a non-mnemonic context (a cognitive planning task). Children's use of self-regulatory private speech during the planning task was associated with longer autobiographical narratives which included specific rather…

  10. Patch-test results in children and adolescents: systematic review of a 15-year period*

    PubMed Central

    Rodrigues, Dulcilea Ferraz; Goulart, Eugênio Marcos Andrade

    2016-01-01

    The number of studies on patch-test results in children and adolescents has gradually increased in recent years, thus stimulating reviews. This paper is a systematic review of a 15-year period devoted to studying the issue. Variations pertaining to the number and age groups of tested children and/or adolescents, the number of subjects with atopy/atopic dermatitis history, the quantity, type and concentrations of the tested substances, the test technique and type of data regarding clinical relevance, must all be considered in evaluating these studies, as they make it harder to formulate conclusions. The most common allergens in children were nickel, thimerosal, cobalt, fragrance, lanolin and neomycin. In adolescents, they were nickel, thimerosal, cobalt, fragrance, potassium dichromate, and Myroxylon pereirae. Knowledge of this matter aids health professionals in planning preventive programs aimed at improving children's quality of life and ensuring that their future prospects are not undermined. PMID:26982781

  11. Drug usage by outpatients in Croatia during an 8-year period: Influence of changes in pricing policy.

    PubMed

    Vitezic, Dinko; Madjarevic, Tomislav; Gantumur, Monja; Buble, Tonci; Vitezic, Miomira; Kovacevic, Miljenko; Mrsic-Pelcic, Jasenka; Sestan, Branko

    2012-07-01

    The aim of our study was to investigate the changes in drug usage and financial expenditure according to legal changes in Croatia during the period 2001 - 2008, especially considering pricing policy. The data on outpatient drug usage during the studied period was obtained from the Croatian National Health Insurance (CNHI). CNHI maintains a database on drugs prescribed by primary health care physicians and dispensed by pharmacies. The data was calculated and presented in defined daily doses (DDD) per inhabitant per year for antibiotics and in DDD/1,000 inhabitants/day for other drugs. The data is also presented in Euro/DDD and the financial expenditures are presented in Euros. During the investigated period drug usage increased 81.33%, while financial expenditure increased 77.23%. While total DDD/1,000 increased ~ 10% every year, financial expenditure increased 10 - 20% annually until 2006, but since then there have been no significant changes. Pricing policy changes could influence drug financial expenditure considerably in the short-term, but it is also important to apply a combination of measures for drug expenditure control. Numerous interventions from authorities from different countries all over the world, prove that there is still no so called "gold standard" which could restrain growing usage and expenditure of drugs. Clinical pharmacologists and clinical pharmacists should be included in these processes.

  12. From molecule to market access: drug regulatory science as an upcoming discipline.

    PubMed

    Gispen-de Wied, Christine C; Leufkens, Hubertus G M

    2013-11-05

    Regulatory science as a discipline has evolved over the past years with the object to boost and promote scientific rationale behind benefit/risk and decision making by regulatory authorities. The European Medicines Agency, EMA, the Food and Drug Administration, FDA, and the Japanese Pharmaceutical and Medical Devices Agency, PMDA, highlighted in their distinct ways the importance of regulatory science as a basis of good quality assessment in their strategic plans. The Medicines Evaluation Board, MEB, states: 'regulatory science is the science of developing and validating new standards and tools to evaluate and assess the benefit/risk of medicinal products, facilitating sound and transparent regulatory decision making'. Through analysis of regulatory frameworks itself and their effectiveness, however, regulatory science can also advance knowledge of these systems in general. The comprehensive guidance that is issued to complete an application dossier for regulatory product approval has seldomly been scrutinized for its efficiency. Since it is the task of regulatory authorities to protect and promote public health, it is understood that they take a cautious approach in regulating drugs prior to market access. In general, the authorities are among the first to be blamed if dangerous or useless drugs were allowed to the market. Yet, building a regulatory framework that is not challenged continuously in terms of deliverables for public health and cost-effectiveness, might be counterproductive in the end. Regulatory science and research can help understand how and why regulatory decisions are made, and where renewed discussions may be warranted. The MEB supports regulatory science as an R&D activity to fuel primary regulatory processes on product evaluation and vigilance, but also invests in a 'looking into the mirror' approach. Along the line of the drug life-cycle, publicly available data are reviewed and their regulatory impact highlighted. If made explicit

  13. Team structure and regulatory focus: the impact of regulatory fit on team dynamic.

    PubMed

    Dimotakis, Nikolaos; Davison, Robert B; Hollenbeck, John R

    2012-03-01

    We report a within-teams experiment testing the effects of fit between team structure and regulatory task demands on task performance and satisfaction through average team member positive affect and helping behaviors. We used a completely crossed repeated-observations design in which 21 teams enacted 2 tasks with different regulatory focus characteristics (prevention and promotion) in 2 organizational structures (functional and divisional), resulting in 84 observations. Results suggested that salient regulatory demands inherent in the task interacted with structure to determine objective and subjective team-level outcomes, such that functional structures were best suited to (i.e., had best fit with) tasks with a prevention regulatory focus and divisional structures were best suited to tasks with a promotion regulatory focus. This contingency finding integrates regulatory focus and structural contingency theories, and extends them to the team level with implications for models of performance, satisfaction, and team dynamics.

  14. Risk of low Apgar scores and socioeconomic status over a 30-year period.

    PubMed

    Odd, D; Lewis, G; Gunnell, D; Rasmussen, Finn

    2014-04-01

    The aim of this study was to investigate the stability of associations between social factors, as assessed by maternal occupation and education, and poor birth condition (an Apgar score of below 7 at 1 and 5 minutes) over a 30-year period in Sweden. The dataset was based on infants born in Sweden between 1973 and 2002. Poor birth condition was defined as an Apgar score below 7 at 1 and 5 minutes. Logistic regression was used to investigate the association of between socioeconomic status and poor birth condition. In the adjusted model, mothers in non-manual occupations (OR 0.91 (0.88, 0.95)) or with higher educational status (OR 0.88 (0.84, 0.93)) were less likely to have an infant born in poor condition than the reference group. Limiting the analysis to the last decade showed less evidence for an association (OR 0.94 (0.86, 1.02) and OR 0.94 (0.82, 1.09), respectively). While maternity, delivery and child healthcare are free of charge in Sweden, poor birth condition was more common among infants of mothers in manual occupations or low levels of education. However, this association appeared to attenuate over the calendar period studied.

  15. 75 FR 5157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...

  16. 76 FR 25397 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change To Amend the By- Laws of FINRA Regulation, Inc. With Regard to District Committees April 28, 2011. I. Introduction On February 25, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the...

  17. 77 FR 47470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-08

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal of Proposed Rule Change To Adopt FINRA Rule 2231 (Customer Account Statements) in the Consolidated FINRA Rulebook August 2, 2012. On April 22, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a...

  18. [Formula: see text]A longitudinal analysis of the attention networks in 6- to 11-year-old children.

    PubMed

    Lewis, Frances C; Reeve, Robert A; Johnson, Katherine A

    2018-02-01

    Attention is critical for everyday functioning. Posner and Petersen's model of attention describes three neural networks involved in attention control-the alerting network for arousal, the orienting network for selecting sensory input and reorienting attention, and the executive network for the regulatory control of attention. No longitudinal research has examined relative change in these networks in children. A modified version of the attention network task (ANT) was used to examine changes in the three attention networks, three times over 12 months, in 114 6-, 8- and 10-year-olds. Findings showed that the alerting network continued to develop over this period, the orienting network had stabilized by 6 years, and the conflict network had largely stabilized by 7 years. The reorienting of attention was also assessed using invalid cues, which showed a similar developmental trajectory to the orienting attention network and had stabilized by 6 years. The results confirm that age 6 to 7 years is a critical period in the development of attention, in particular executive attention. The largest improvement over the evaluation period was between 6 and 7 years; however, subtle changes were found in attention beyond 8 years of age.

  19. 14 CFR 271.8 - Rate period.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Rate period. 271.8 Section 271.8... REGULATIONS GUIDELINES FOR SUBSIDIZING AIR CARRIERS PROVIDING ESSENTIAL AIR TRANSPORTATION § 271.8 Rate period. (a) The subsidy rate generally will be set for a 2-year period, or two consecutive 1-year periods...

  20. 14 CFR 271.8 - Rate period.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Rate period. 271.8 Section 271.8... REGULATIONS GUIDELINES FOR SUBSIDIZING AIR CARRIERS PROVIDING ESSENTIAL AIR TRANSPORTATION § 271.8 Rate period. (a) The subsidy rate generally will be set for a 2-year period, or two consecutive 1-year periods...

  1. 14 CFR 271.8 - Rate period.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Rate period. 271.8 Section 271.8... REGULATIONS GUIDELINES FOR SUBSIDIZING AIR CARRIERS PROVIDING ESSENTIAL AIR TRANSPORTATION § 271.8 Rate period. (a) The subsidy rate generally will be set for a 2-year period, or two consecutive 1-year periods...

  2. 20 CFR 1002.101 - Does the five-year service limit include periods of service that the employee performed when he...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Does the five-year service limit include... Section 1002.101 Employees' Benefits OFFICE OF THE ASSISTANT SECRETARY FOR VETERANS' EMPLOYMENT AND...-year period runs as to each employer independently, even if those employers share or co-determine the...

  3. 77 FR 8751 - Table Saw Blade Contact Injuries; Reopening of the Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... Contact Injuries; Reopening of the Comment Period AGENCY: U.S. Consumer Product Safety Commission. ACTION... of injury associated with table saw blade contact, regulatory alternatives, other possible [[Page.... All comments received may be posted without change, including any personal identifiers, contact...

  4. 75 FR 21805 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... FR Cite NPRM 08/00/10 NPRM Comment Period End 10/00/10 Regulatory Flexibility Analysis Required: Yes... pursuant to the requirements of the Chief Financial Officers Act of 1990 (CFO Act), 31 U.S.C. 901-03. The CFO Act requires each agency's chief financial officer (CFO) to ``review, on a biennial basis, the...

  5. Public Regulatory Arrangements for Private Higher Education in the Western Balkans

    ERIC Educational Resources Information Center

    Papadimitriou, Antigoni; Levy, Daniel C.; Stensaker, Bjørn; Kanazir, Sanja

    2017-01-01

    The article presents an analysis of the developments of higher education laws and regulations in the Western Balkans for the period 1990-2015, with the aim of mapping the regulatory arrangements for the private higher education sector and to explore the relationship between public and private higher education in the region. Based on a conceptual…

  6. Molecular epidemiology of enterovirus and parechovirus infections according to patient age over a 4-year period in Spain.

    PubMed

    Cabrerizo, María; Díaz-Cerio, María; Muñoz-Almagro, Carmen; Rabella, Núria; Tarragó, David; Romero, María Pilar; Pena, María José; Calvo, Cristina; Rey-Cao, Sonia; Moreno-Docón, Antonio; Martínez-Rienda, Inés; Otero, Almudena; Trallero, Gloria

    2017-03-01

    The epidemiology and clinical association of enterovirus (EV) and parechovirus (HPeV) infections, as well as the type-distribution-according-to-age, were determined during a 4-year study period in Spain. During 2010-2013, a total of 21,832 clinical samples were screened for EV and the detection frequency was 6.5% (1,430). Of the total EV-negative samples, only 1,873 samples from 2011 to 2013 were available for HPeV testing. HPeV was detected in 42 (2%) of them. Positive samples were genotyped using PCR and sequencing. EV infections occurred in all age groups of patients: neonates (17%), children 28 days to 2 years (29%), children 2-14 years (40%), and adults (14%). Thirty-four different EV types were identified. HPeV infections were detected exclusively in infants <8 m (70% neonates, P < 0.05). All but one HPeV were HPeV-3. Differences in type frequency detection were found according to age and clinical manifestation. Coxsackievirus (CV)-B4 (61%), CV-B5 (83%), and HPeV-3 (64%) were more frequent in neonates than in older patients (P < 0.05). Echovirus (E)-3 (60%), E-18 (47%), E-25 (62%), CV-A6 (61%), CV-A16 (72%), and EV-71 (75%) were mainly detected in children 28 days to 2 years (P < 0.05), whereas, E-6 (79%), E-20 (88%), and E-30 (85%) were predominant in children >2 years and adults (P < 0.05). Clinically, meningitis was associated with EV (P < 0.01) whereas, encephalitis was more frequent in HPeV-infected patients. CV-B types were associated with myocarditis (90%; P < 0.05) and EV species A with hand-foot-mouth-disease/atypical exanthema (88%; P < 0.05). J. Med. Virol. 89:435-442, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  7. 75 FR 6422 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-09

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Incorporated NYSE Rule 411(a)(ii)(5) as Part of the Process of Developing the Consolidated FINRA Rulebook February 2, 2010. On December 4, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a...

  8. Children in pain: recurrent back pain, abdominal pain, and headache in children and adolescents in a four-year-period.

    PubMed

    van Gessel, Hester; Gassmann, Jennifer; Kröner-Herwig, Birgit

    2011-06-01

    To analyze the development of recurrent pain in 3 body locations in children and adolescents (baseline age, 9 to 14 years) in a 4-year period. In a large population-based longitudinal epidemiological study data was collected through annual postal questionnaires (longitudinal, n = 2025). Descriptive statistics and generalized estimating equations were used. Girls were more likely to report recurrent pain, demonstrated a steeper development during the 4-year period, and reported multiple pain more often than boys. Younger children reported less recurrent pain, but displayed a steeper trend of increasing prevalence rates as they grew older. Older children illustrated a more stable development of recurrent pain and reported multiple pain more often. Disability experienced because of recurrent pain was related strongest to pain intensity. Stable patterns of pain were related to higher intensity and disability reports. The children experienced headache as the most disabling of the 3 pains. The results show that boys and girls report recurrent pain in different patterns in the years. To identify risk factors, analysis should be performed separately for boys and girls. Furthermore, it is recommended to include children before the age of 9 years in a prevention study. Copyright © 2011 Mosby, Inc. All rights reserved.

  9. Changes in body size and physical characteristics of South African under-20 rugby union players over a 13-year period.

    PubMed

    Lombard, Wayne P; Durandt, Justin J; Masimla, Herman; Green, Mervin; Lambert, Michael I

    2015-04-01

    This study compared changes in the body size and physical characteristics of South African under-20 rugby union players over a 13-year period. A total of 453 South African under-20 players (forwards: n = 256 and backs: n = 197) underwent measurements of body mass, stature, muscular strength, endurance, and 10- and 40-m sprint times. A 2-way analysis of variance was used to determine significant differences for the main effects of position (forwards vs. backs) and time (1998-2010). The pooled data showed that forwards were significantly heavier (22%), taller (5%), and stronger (18%) than the backs. However, when 1 repetition maximum strength scores were adjusted for body mass, backs were stronger per kg body mass. Stature did not change over the 13-year period for both groups. There were, however, significant increases in muscular strength (50%), body mass (20%), and muscular endurance (50%). Furthermore, an improvement in sprint times over 40 (4%) and 10 m (7%) was evident over the period of the study. In conclusion, the players became heavier, stronger, taller, and improved their upper-body muscular endurance over the 13 years of the study. Furthermore, sprint times over 10 and 40 m improved over the same time period despite the increase in body mass. It can be speculated that the changes in physical characteristics of the players over time are possibly a consequence of (a) adaptations to the changing demands of the game and (b) advancements in training methods.

  10. 10 CFR 35.2642 - Records of periodic spot-checks for teletherapy units.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Records of periodic spot-checks for teletherapy units. 35.2642 Section 35.2642 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Records... of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure...

  11. 10 CFR 35.2642 - Records of periodic spot-checks for teletherapy units.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Records of periodic spot-checks for teletherapy units. 35.2642 Section 35.2642 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Records... of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure...

  12. 10 CFR 35.2642 - Records of periodic spot-checks for teletherapy units.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Records of periodic spot-checks for teletherapy units. 35.2642 Section 35.2642 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Records... of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure...

  13. Correlation Between High-sensitivity C-reactive Protein and Reactive Oxygen Metabolites During A One-year Period Among Asymptomatic Subjects

    PubMed Central

    Kotani, Kazuhiko; Taniguchi, Nobuyuki

    2012-01-01

    Background Inflammation and oxidative stress are associated with human health and the disease status. The present study aimed to investigate the longitudinal correlation between the diacron reactive oxygen metabolites (d-ROMs) level, as an oxidative stress-related marker, and high-sensitivity C-reactive protein (hsCRP), as an inflammatory marker, during a one-year period among asymptomatic subjects. Methods The data, including anthropometric and biochemical markers, were collected at baseline and after the one-year period from 71 participants (male/female = 41/30, mean age 50 years). The correlation between the changes of the d-ROMs and hsCRP levels during the study period was examined. Results A simple correlation analysis showed a significant and positive correlation to exist between the changes of the d-ROMs and hsCRP levels (r = 0.40, P < 0.01). This significant correlation remained independent in a multiple linear regression analysis adjusted for confounding factors. Conclusions The present findings suggest that the relationship between the d-ROMs and hsCRP levels could be prospectively followed, and that monitoring both markers may help to better understand the cooperation of inflammation and oxidative stress in association with health and disease. Further studies are necessary to clarify the biological mechanism(s) responsible for the observed relationship. Keywords Oxidative stress; Oxygen reactive species; Inflammation; CRP PMID:22383928

  14. Canadian regulatory perspectives on genome engineered crops

    PubMed Central

    Smyth, Stuart J.

    2017-01-01

    ABSTRACT New breeding techniques in plant agriculture exploded upon the scene about two years ago, in 2014. While these innovative plant breeding techniques, soon to be led by CRISPR/Cas9, initially appear to hold tremendous promise for plant breeding, if not a revolution for the industry, the question of how the products of these technologies will be regulated is rapidly becoming a key aspect of the technology's future potential. Regulation of innovative technologies and products has always lagged that of the science, but in the past decade, regulatory systems in many jurisdictions have become gridlocked as they try to regulate genetically modified (GM) crops. This regulatory incapability to efficiently assess and approve innovative new agricultural products is particularly important for new plant breeding techniques as if these techniques are classified as genetically modified breeding techniques, then their acceptance and future will diminish considerably as they will be rejected by the European Union. Conversely, if the techniques are accepted as conventional plant breeding, then the future is blindingly bright. This article examines the international debate about the regulation of new plant breeding techniques and then assesses how the Canadian regulatory system has approached the regulation of these technologies through two more public product approvals, GM apples and GM potatoes, then discusses other crop variety approval and those in the regulatory pipeline. PMID:27858499

  15. Morbidity and mortality in the antiphospholipid syndrome during a 10-year period: a multicentre prospective study of 1000 patients.

    PubMed

    Cervera, R; Serrano, R; Pons-Estel, G J; Ceberio-Hualde, L; Shoenfeld, Y; de Ramón, E; Buonaiuto, V; Jacobsen, S; Zeher, M M; Tarr, T; Tincani, A; Taglietti, M; Theodossiades, G; Nomikou, E; Galeazzi, M; Bellisai, F; Meroni, P L; Derksen, R H W M; de Groot, P G D; Baleva, M; Mosca, M; Bombardieri, S; Houssiau, F; Gris, J-C; Quéré, I; Hachulla, E; Vasconcelos, C; Fernández-Nebro, A; Haro, M; Amoura, Z; Miyara, M; Tektonidou, M; Espinosa, G; Bertolaccini, M L; Khamashta, M A

    2015-06-01

    To assess the prevalence of the main causes of morbi-mortality in the antiphospholipid syndrome (APS) during a 10-year-follow-up period and to compare the frequency of early manifestations with those that appeared later. In 1999, we started an observational study of 1000 APS patients from 13 European countries. All had medical histories documented when entered into the study and were followed prospectively during the ensuing 10 years. 53.1% of the patients had primary APS, 36.2% had APS associated with systemic lupus erythematosus and 10.7% APS associated with other diseases. Thrombotic events appeared in 166 (16.6%) patients during the first 5-year period and in 115 (14.4%) during the second 5-year period. The most common events were strokes, transient ischaemic attacks, deep vein thromboses and pulmonary embolism. 127 (15.5%) women became pregnant (188 pregnancies) and 72.9% of pregnancies succeeded in having one or more live births. The most common obstetric complication was early pregnancy loss (16.5% of the pregnancies). Intrauterine growth restriction (26.3% of the total live births) and prematurity (48.2%) were the most frequent fetal morbidities. 93 (9.3%) patients died and the most frequent causes of death were severe thrombosis (36.5%) and infections (26.9%). Nine (0.9%) cases of catastrophic APS occurred and 5 (55.6%) of them died. The survival probability at 10 years was 90.7%. Patients with APS still develop significant morbidity and mortality despite current treatment. It is imperative to increase the efforts in determining optimal prognostic markers and therapeutic measures to prevent these complications. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  16. 42 CFR 457.611 - Period of availability for State allotments for a fiscal year after FY 2008.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 4 2012-10-01 2012-10-01 false Period of availability for State allotments for a fiscal year after FY 2008. 457.611 Section 457.611 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STATE CHILDREN'S HEALTH INSURANCE PROGRAMS (SCHIPs) ALLOTMENTS AND GRANTS TO STATES Payment...

  17. 42 CFR 457.611 - Period of availability for State allotments for a fiscal year after FY 2008.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 4 2011-10-01 2011-10-01 false Period of availability for State allotments for a fiscal year after FY 2008. 457.611 Section 457.611 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STATE CHILDREN'S HEALTH INSURANCE PROGRAMS (SCHIPs) ALLOTMENTS AND GRANTS TO STATES Payment...

  18. 42 CFR 457.611 - Period of availability for State allotments for a fiscal year after FY 2008.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 4 2014-10-01 2014-10-01 false Period of availability for State allotments for a fiscal year after FY 2008. 457.611 Section 457.611 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STATE CHILDREN'S HEALTH INSURANCE PROGRAMS (SCHIPs) ALLOTMENTS AND GRANTS TO STATES Payment...

  19. 42 CFR 457.611 - Period of availability for State allotments for a fiscal year after FY 2008.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 4 2013-10-01 2013-10-01 false Period of availability for State allotments for a fiscal year after FY 2008. 457.611 Section 457.611 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STATE CHILDREN'S HEALTH INSURANCE PROGRAMS (SCHIPs) ALLOTMENTS AND GRANTS TO STATES Payment...

  20. Changes in Social Exclusion Indicators and Psychological Distress Among Homeless People Over a 2.5-Year Period.

    PubMed

    Van Straaten, Barbara; Rodenburg, Gerda; Van der Laan, Jorien; Boersma, Sandra N; Wolf, Judith R L M; Van de Mheen, Dike

    2018-01-01

    Although homelessness is inherently associated with social exclusion, homeless individuals are rarely included in conventional studies on social exclusion. Use of longitudinal survey data from a cohort study on homeless people in four major Dutch cities ( n  = 378) allowed to examine: changes in indicators of social exclusion among homeless people over a 2.5-year period after reporting to the social relief system, and associations between changes in indicators of social exclusion and changes in psychological distress. Multinomial logistic regression analysis was applied to investigate the associations between changes in indicators of social exclusion and changes in psychological distress. Improvements were found in various indicators of social exclusion, whereas financial debts showed no significant improvement. Changes in unmet care needs, health insurance, social support from family and relatedness to others were related to changes in psychological distress. This study demonstrated improvements in various indicators of social exclusion among homeless people over a period of 2.5 years, and sheds light on the concept of social exclusion in relation to homelessness.

  1. International Collaboration and Academic Exchange of the CHAIN Project in this Three Years (Period)

    NASA Astrophysics Data System (ADS)

    Ueno, Satoru; Shibata, Kazunari; Morita, Satoshi; Kimura, Goichi; Asai, Ayumi; Kitai, Reizaburo; Ichimoto, Kiyoshi; Nagata, Shin'ichi; Ishii, Takako; Nakatani, Yoshikazu; Masashi, Yamaguchi; et al.

    2014-02-01

    We will introduce contents of international collaboration and academic exchange of the CHAIN project in recent three years (ISWI period). After April of 2010, we have not obtained any enough budget for new instruments. Therefore, we have not been able to install new Flare Monitoring Telescopes (FMT) in new countries, such as Algeria. On the other hand, however, we have continued international academic exchange through scientific and educational collaboration with mainly Peru, such as data-analysis training, holding scientific workshops etc. Additionally, in this year, King Saudi University of Saudi Arabia and CRAAG of Algeria have planned to build a new FMT in their university by their own budget. Therefore, we have started some collaboration in the field of technical advices of instruments and scientific themes etc. Moreover, Pakistan Space and Upper Atmosphere Research Commission (SUPARCO) also offered us participation in the CHAIN-project. We would like to continue to consider the possibility of academic collaboration with such new positive developing nations, too.

  2. 12 CFR 562.2 - Regulatory reports.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... § 562.2 Regulatory reports. (a) Definition and scope. This section applies to all regulatory reports, as... (TFR) are examples of regulatory reports. Regulatory reports are regulatory documents, not accounting... limited to, the accounting instructions provided in the TFR, guidance contained in OTS regulations...

  3. Regulatory constraints as seen from the pharmaceutical industry.

    PubMed

    Galligani, G; David-Andersen, I; Fossum, B

    2005-01-01

    In Chile, Canada, Europe, Japan, and the USA, which are the main geographical areas for fish farming of high value fish such as salmonids, sea bass, sea bream, yellowtail and catfish, vaccination has been established as an important method for the prevention of infectious diseases. To make new vaccines available to the fish farming industry, pharmaceutical companies must comply with the regulatory framework for licensing of fish vaccines, which in recent years has become more regulated. Considerable scientific and regulatory skills are thus required to develop, document and license vaccines in accordance with the requirements in the different geographical areas. International co-operation to harmonise requirements for the licensing documentation is ongoing. Even though there are obvious benefits to the pharmaceutical industry from the harmonisation process, it may sometimes impose unreasonable requirements. The regulatory framework for fish vaccines clearly has an impact on the time for bringing a new fish vaccine to the market. Several hurdles need to be passed to complete the regulatory process, i.e. obtain a licence. Fulfilment of the rather detailed and extensive requirements for documentation of the production and controls, as well as safety and efficacy of the vaccine, represent a challenge to the pharmaceutical industry, as do the different national and regional licensing procedures. This paper describes regulatory constraints related to the documentation, the licensing process, the site of production and the continuing international harmonisation work, with emphasis on inactivated conventional fish vaccines.

  4. 75 FR 7532 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-19

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... is hereby given that on February 4, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA...) (SEC Approves Consolidated FINRA Rules Governing Financial Responsibility). FINRA announced in...

  5. Future time perspective and health behaviors: temporal framing of self-regulatory processes in physical exercise and dietary behaviors.

    PubMed

    Gellert, Paul; Ziegelmann, Jochen P; Lippke, Sonia; Schwarzer, Ralf

    2012-04-01

    Limitations in perceived lifetime can undermine long-term goal striving. Planning is supposed to translate intentions into health behaviors and to operate as a compensatory strategy to overcome goal striving deficits associated with a limited time perspective. Two longitudinal studies were conducted examining the compensatory role of planning: an online survey on fruit and vegetable consumption (N = 909; 16-78 years; follow-up at 4 months) and a questionnaire study on physical exercise in older adults (N = 289; 60-95 years, over a half-year period). Intentions, planning, and behavior were measured in a behavior-specific, future time perspective in a generic manner. Planning mediated between intentions and both health behaviors. Time perspective operated as a moderator, indicating that in individuals with a more limited time perspective, a stronger effect of planning on health behaviors emerged. Planning as a self-regulatory strategy may compensate for a limited time perspective.

  6. Erosion of mountain hiking trail over a seven-year period in Daisetsuzan National Park, central Hokkaido, Japan

    Treesearch

    Akemi Yoda; Teiji Watanabe

    2000-01-01

    Erosion of mountain hiking trails was investigated in Daisetsuzan National Park over a seven-year period. The amount and rate of erosion were different in the two typical landscape components. Cross-section diagrams revealed that trail depth became deeper in snowy vegetated areas than in wind-beaten bare ground areas. The existence and timing of runoff from snowmelt...

  7. Frequent floods in the European Alps coincide with cooler periods of the past 2500 years.

    PubMed

    Glur, Lukas; Wirth, Stefanie B; Büntgen, Ulf; Gilli, Adrian; Haug, Gerald H; Schär, Christoph; Beer, Jürg; Anselmetti, Flavio S

    2013-09-26

    Severe floods triggered by intense precipitation are among the most destructive natural hazards in Alpine environments, frequently causing large financial and societal damage. Potential enhanced flood occurrence due to global climate change would thus increase threat to settlements, infrastructure, and human lives in the affected regions. Yet, projections of intense precipitation exhibit major uncertainties and robust reconstructions of Alpine floods are limited to the instrumental and historical period. Here we present a 2500-year long flood reconstruction for the European Alps, based on dated sedimentary flood deposits from ten lakes in Switzerland. We show that periods with high flood frequency coincide with cool summer temperatures. This wet-cold synchronism suggests enhanced flood occurrence to be triggered by latitudinal shifts of Atlantic and Mediterranean storm tracks. This paleoclimatic perspective reveals natural analogues for varying climate conditions, and thus can contribute to a better understanding and improved projections of weather extremes under climate change.

  8. Frequent floods in the European Alps coincide with cooler periods of the past 2500 years

    PubMed Central

    Glur, Lukas; Wirth, Stefanie B.; Büntgen, Ulf; Gilli, Adrian; Haug, Gerald H.; Schär, Christoph; Beer, Jürg; Anselmetti, Flavio S.

    2013-01-01

    Severe floods triggered by intense precipitation are among the most destructive natural hazards in Alpine environments, frequently causing large financial and societal damage. Potential enhanced flood occurrence due to global climate change would thus increase threat to settlements, infrastructure, and human lives in the affected regions. Yet, projections of intense precipitation exhibit major uncertainties and robust reconstructions of Alpine floods are limited to the instrumental and historical period. Here we present a 2500-year long flood reconstruction for the European Alps, based on dated sedimentary flood deposits from ten lakes in Switzerland. We show that periods with high flood frequency coincide with cool summer temperatures. This wet-cold synchronism suggests enhanced flood occurrence to be triggered by latitudinal shifts of Atlantic and Mediterranean storm tracks. This paleoclimatic perspective reveals natural analogues for varying climate conditions, and thus can contribute to a better understanding and improved projections of weather extremes under climate change. PMID:24067733

  9. Subjects with impaired fasting glucose: evolution in a period of 6 years.

    PubMed

    Leiva, E; Mujica, V; Orrego, R; Wehinger, S; Soto, A; Icaza, G; Vásquez, M; Díaz, L; Andrews, M; Arredondo, M

    2014-01-01

    To study the evolution of impaired fasting glucose (IFG), considering glucose and HbA1c levels and risk factors associated, in a period of 6 years. We studied 94 subjects with impaired fasting glucose (IFG) that were diagnosed in 2005 and followed up to 2012. Glucose and HbA1c levels were determined. A descriptive analysis of contingence charts was performed in order to study the evolution in the development of type-2 diabetes mellitus (T2DM). Twenty-eight of ninety-four subjects became T2DM; 51/94 remained with IFG; and 20/94 presented normal fasting glucose. From the 28 diabetic subjects, 9 had already developed diabetes and were under treatment with oral hypoglycemic agents; 5 were diagnosed with plasma glucose < 126 mg/dL, but with HbA1c over 6.5%. In those who developed diabetes, 15/28 had a family history of T2DM in first relative degree. Also, diabetic subjects had a BMI significantly higher than nodiabetics (t test: P < 0.01). The individuals that in 2005 had the highest BMI are those who currently have diabetes. The IFG constitutes a condition of high risk of developing T2DM in a few years, especially over 110 mg/dL and in obesity patients.

  10. Subjects with Impaired Fasting Glucose: Evolution in a Period of 6 Years

    PubMed Central

    Leiva, E.; Mujica, V.; Orrego, R.; Wehinger, S.; Soto, A.; Icaza, G.; Vásquez, M.; Díaz, L.; Andrews, M.; Arredondo, M.

    2014-01-01

    Aim. To study the evolution of impaired fasting glucose (IFG), considering glucose and HbA1c levels and risk factors associated, in a period of 6 years. Methods. We studied 94 subjects with impaired fasting glucose (IFG) that were diagnosed in 2005 and followed up to 2012. Glucose and HbA1c levels were determined. A descriptive analysis of contingence charts was performed in order to study the evolution in the development of type-2 diabetes mellitus (T2DM). Results. Twenty-eight of ninety-four subjects became T2DM; 51/94 remained with IFG; and 20/94 presented normal fasting glucose. From the 28 diabetic subjects, 9 had already developed diabetes and were under treatment with oral hypoglycemic agents; 5 were diagnosed with plasma glucose < 126 mg/dL, but with HbA1c over 6.5%. In those who developed diabetes, 15/28 had a family history of T2DM in first relative degree. Also, diabetic subjects had a BMI significantly higher than nodiabetics (t test: P < 0.01). The individuals that in 2005 had the highest BMI are those who currently have diabetes. Conclusion. The IFG constitutes a condition of high risk of developing T2DM in a few years, especially over 110 mg/dL and in obesity patients. PMID:25215305

  11. 75 FR 60157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange... information about the rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook...

  12. Prenatal Diagnosis of Transposition of the Great Arteries over a 20-Year Period: Improved but Imperfect

    PubMed Central

    Escobar-Diaz, Maria C; Freud, Lindsay R; Bueno, Alejandra; Brown, David W; Friedman, Kevin; Schidlow, David; Emani, Sitaram; del Nido, Pedro; Tworetzky, Wayne

    2015-01-01

    Objective To evaluate temporal trends in prenatal diagnosis of transposition of the great arteries with intact ventricular septum (TGA/IVS) and its impact on neonatal morbidity and mortality. Methods Newborns with TGA/IVS referred for surgical management to our center over a 20-year period (1992 – 2011) were included. The study time was divided into 5 four-year periods, and the primary outcome was rate of prenatal diagnosis. Secondary outcomes included neonatal pre-operative status and perioperative survival. Results Of the 340 patients, 81 (24%) had a prenatal diagnosis. Prenatal diagnosis increased over the study period from 6% to 41% (p<0.001). Prenatally diagnosed patients underwent a balloon atrial septostomy (BAS) earlier than postnatally diagnosed patients (0 vs. 1 day, p<0.001) and fewer required mechanical ventilation (56% vs. 69%, p=0.03). There were no statistically significant differences in pre-operative acidosis (16% vs. 26%, p=0.1) and need for preoperative ECMO (2% vs. 3%, p=1.0). There was also no significant mortality difference (1 pre-operative and no post-operative deaths among prenatally diagnosed patients, as compared to 4 pre-operative and 6 post-operative deaths among postnatally diagnosed patients). Conclusion The prenatal detection rate of TGA/IVS has improved but still remains below 50%, suggesting the need for strategies to increase detection rates. The mortality rate was not statistically different between pre- and postnatally diagnosed patients; however, there were significant pre-operative differences with regard to earlier BAS and less mechanical ventilation. Ongoing study is required to elucidate whether prenatal diagnosis confers long-term benefit. PMID:25484180

  13. 77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

    ... electronic submission of individual case safety reports to regulatory authorities, automated data mining... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum...

  14. 76 FR 40412 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-08

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... a more limited application by their terms. For more information about the rulebook consolidation...

  15. 76 FR 20759 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  16. 77 FR 34379 - Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD06-6-000] Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission The Federal Energy Regulatory Commission (FERC) and the Nuclear Regulatory Commission (NRC) will hold a joint meeting...

  17. 75 FR 5834 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-04

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Update Certain Cross-References and Make Other Various Non-Substantive..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange...

  18. 77 FR 36029 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Update Rule Cross-References and Make Non- Substantive Technical..., Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers...

  19. 76 FR 32246 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Update Rule Cross-References and Make Non- Substantive Technical..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  20. 76 FR 60106 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... 14, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  1. Is the Sun a Long Period Variable

    NASA Technical Reports Server (NTRS)

    Sonett, Charles P.

    1990-01-01

    The inventory of atmospheric radiocarbon exhibits quasi-periodic variations of mean period of bar-lambda=269 years over the entire 9000 year record. But the period is inconstant and subject to random variability (sigma m exp. 1/2 = 119 years). The radiocarbon maxima correspond to the quasiperiodic extension of the Maunder minimum throughout the Holocene and resolve the long-standing issue of Maunder cyclicity. The radiocarbon maxima are amplitude modulated by the approx. 2300 year period and thus vary significantly in peak value. The approx. 2300 year period in turn appears to not be modulated by the secular geomagnetic variation. Detection of a Maunder-like sequence of minima in tree ring growth of Bristlecone pine and its correlation with the Maunder (1890, 1922) cyclicity in the radiocarbon record supports the inference that solar forcing of the radiocarbon record is accompanied by a corresponding forcing of growth of timberline Bristlecone pine. Because of the random component of the Maunder period, prediction of climate, if tied to the Maunder cycle other than probabilistically, is significantly hindered. For the mean Maunder period of 269 years, the probability is 67 percent that a given climatic maximum lies anywhere between 150 and 388 years.

  2. Mining Gene Regulatory Networks by Neural Modeling of Expression Time-Series.

    PubMed

    Rubiolo, Mariano; Milone, Diego H; Stegmayer, Georgina

    2015-01-01

    Discovering gene regulatory networks from data is one of the most studied topics in recent years. Neural networks can be successfully used to infer an underlying gene network by modeling expression profiles as times series. This work proposes a novel method based on a pool of neural networks for obtaining a gene regulatory network from a gene expression dataset. They are used for modeling each possible interaction between pairs of genes in the dataset, and a set of mining rules is applied to accurately detect the subjacent relations among genes. The results obtained on artificial and real datasets confirm the method effectiveness for discovering regulatory networks from a proper modeling of the temporal dynamics of gene expression profiles.

  3. Tylosin content in meat and honey samples over a two-year period in Croatia.

    PubMed

    Kolanović, Božica S; Bilandžić, Nina; Varenina, Ivana; Božić, Durđica

    2014-01-01

    A total of 646 meat and 96 honey samples were examined over a 2-year period for the presence of tylosin residues. ELISA method used was validated according to the criteria of Commission Decision 2002/657/EC established for qualitative screening methods. The CCβ values were 32.1 µg kg⁻¹ in muscle and 24.4 µg kg⁻¹ in honey. The recoveries from spiked samples ranged from 66.4-118.6%, with a coefficient of variation between 12.6% and 18.6%. All the investigated samples showed no presence of tylosin. Calculated estimated daily intakes show exposure levels lower than the acceptable daily intakes set by World Health Organization.

  4. 77 FR 39313 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-02

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...,\\2\\ notice is hereby given that on June 26, 2012, Financial Industry Regulatory Authority, Inc..., as FINRA shall designate, to file such additional financial or operational schedules or reports as...

  5. 77 FR 7218 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-10

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... thereunder,\\2\\ notice is hereby given that on January 30, 2012, Financial Industry Regulatory Authority, Inc.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  6. 76 FR 55441 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory... significant aspects of such statements. A. Self-Regulatory Organization's Statement of the Purpose of, and... professional responsibilities, including key regulatory and control themes, as well as the importance of...

  7. Sensitive periods in affective development: nonlinear maturation of fear learning.

    PubMed

    Hartley, Catherine A; Lee, Francis S

    2015-01-01

    At specific maturational stages, neural circuits enter sensitive periods of heightened plasticity, during which the development of both brain and behavior are highly receptive to particular experiential information. A relatively advanced understanding of the regulatory mechanisms governing the initiation, closure, and reinstatement of sensitive period plasticity has emerged from extensive research examining the development of the visual system. In this article, we discuss a large body of work characterizing the pronounced nonlinear changes in fear learning and extinction that occur from childhood through adulthood, and their underlying neural substrates. We draw upon the model of sensitive period regulation within the visual system, and present burgeoning evidence suggesting that parallel mechanisms may regulate the qualitative changes in fear learning across development.

  8. Sensitive Periods in Affective Development: Nonlinear Maturation of Fear Learning

    PubMed Central

    Hartley, Catherine A; Lee, Francis S

    2015-01-01

    At specific maturational stages, neural circuits enter sensitive periods of heightened plasticity, during which the development of both brain and behavior are highly receptive to particular experiential information. A relatively advanced understanding of the regulatory mechanisms governing the initiation, closure, and reinstatement of sensitive period plasticity has emerged from extensive research examining the development of the visual system. In this article, we discuss a large body of work characterizing the pronounced nonlinear changes in fear learning and extinction that occur from childhood through adulthood, and their underlying neural substrates. We draw upon the model of sensitive period regulation within the visual system, and present burgeoning evidence suggesting that parallel mechanisms may regulate the qualitative changes in fear learning across development. PMID:25035083

  9. A Regulatory Framework for Nanotechnology

    DTIC Science & Technology

    informed by a map of the regulatory landscape of nanotechnology and a review of the regulatory frameworks for the aviation and biotechnology industries...aviation and biotechnology and maps the regulatory landscape in the United States by examining stakeholders, regulatory entities, and applicable legislation...state of nanotechnology if the limitations of technical expertise are addressed. This expertise can be provided by advisory committees of technical

  10. Bird Diversity and Composition in Even-Aged Loblolly Pine Stands Relative to Emergence of 13-year Periodical Cicadas and Vegetation Structure

    Treesearch

    Jennifer L. Hestir; Michael D. Cain

    1999-01-01

    In southern Arkansas, l3-year periodical cicadas (Magicicada spp.) were expected to emerge in late April and early May of 1998. Presence of a superabundant food source, such as periodical cicadas, may attract greater numbers of birds and more species of birds than is usually present in a particular area. Three even-aged loblolly pine (Pinus...

  11. Climate impact on airborne particulate matter concentrations in California using seven year analysis periods

    NASA Astrophysics Data System (ADS)

    Mahmud, A.; Hixson, M.; Hu, J.; Zhao, Z.; Chen, S.-H.; Kleeman, M. J.

    2010-11-01

    The effect of global climate change on the annual average concentration of fine particulate matter (PM2.5) in California was studied using a climate-air quality modeling system composed of global through regional models. Output from the NCAR/DOE Parallel Climate Model (PCM) generated under the "business as usual" global emissions scenario was downscaled using the Weather Research and Forecasting (WRF) model followed by air quality simulations using the UCD/CIT airshed model. The system represents major atmospheric processes acting on gas and particle phase species including meteorological effects on emissions, advection, dispersion, chemical reaction rates, gas-particle conversion, and dry/wet deposition. The air quality simulations were carried out for the entire state of California with a resolution of 8-km for the years 2000-2006 (present climate with present emissions) and 2047-2053 (future climate with present emissions). Each of these 7-year analysis periods was analyzed using a total of 1008 simulated days to span a climatologically relevant time period with a practical computational burden. The 7-year windows were chosen to properly account for annual variability with the added benefit that the air quality predictions under the present climate could be compared to actual measurements. The climate-air quality modeling system successfully predicted the spatial pattern of present climate PM2.5 concentrations in California but the absolute magnitude of the annual average PM2.5 concentrations were under-predicted by ~4-39% in the major air basins. The majority of this under-prediction was caused by excess ventilation predicted by PCM-WRF that should be present to the same degree in the current and future time periods so that the net bias introduced into the comparison is minimized. Surface temperature, relative humidity (RH), rain rate, and wind speed were predicted to increase in the future climate while the ultra violet (UV) radiation was predicted to decrease

  12. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders? 120.463 Section 120.463 Business....463 Regulatory accounting—What are SBA's regulatory accounting requirements for SBA Supervised Lenders...

  13. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders? 120.463 Section 120.463 Business....463 Regulatory accounting—What are SBA's regulatory accounting requirements for SBA Supervised Lenders...

  14. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 false Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders? 120.463 Section 120.463 Business....463 Regulatory accounting—What are SBA's regulatory accounting requirements for SBA Supervised Lenders...

  15. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders? 120.463 Section 120.463 Business....463 Regulatory accounting—What are SBA's regulatory accounting requirements for SBA Supervised Lenders...

  16. 75 FR 11605 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-11

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... Reporting Facility and OTC Reporting Facility Fees March 4, 2010. Pursuant to Section 19(b)(1) of the... March 1, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and...

  17. 78 FR 60952 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-02

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... hereby given that, on September 24, 2013, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed... discussed any comments it received on the proposed rule change. The text of these statements may be examined...

  18. 34 CFR 691.64 - Calculation of a grant for a payment period which occurs in two award years.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 4 2012-07-01 2012-07-01 false Calculation of a grant for a payment period which occurs in two award years. 691.64 Section 691.64 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION (CONTINUED...

  19. 34 CFR 691.64 - Calculation of a grant for a payment period which occurs in two award years.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 4 2013-07-01 2013-07-01 false Calculation of a grant for a payment period which occurs in two award years. 691.64 Section 691.64 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION (CONTINUED...

  20. 34 CFR 691.64 - Calculation of a grant for a payment period which occurs in two award years.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false Calculation of a grant for a payment period which occurs in two award years. 691.64 Section 691.64 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION ACADEMIC...

  1. 34 CFR 691.64 - Calculation of a grant for a payment period which occurs in two award years.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 4 2011-07-01 2011-07-01 false Calculation of a grant for a payment period which occurs in two award years. 691.64 Section 691.64 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION (CONTINUED...

  2. 34 CFR 691.64 - Calculation of a grant for a payment period which occurs in two award years.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 4 2014-07-01 2014-07-01 false Calculation of a grant for a payment period which occurs in two award years. 691.64 Section 691.64 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION (CONTINUED...

  3. Stable expression and phenotypic impact of attacin E transgene in orchard grown apple trees over a 12 year period.

    PubMed

    Borejsza-Wysocka, Ewa; Norelli, John L; Aldwinckle, Herb S; Malnoy, Mickael

    2010-06-03

    Transgenic trees currently are being produced by Agrobacterium-mediated transformation and biolistics. The future use of transformed trees on a commercial basis depends upon thorough evaluation of the potential environmental and public health risk of the modified plants, transgene stability over a prolonged period of time and the effect of the gene on tree and fruit characteristics. We studied the stability of expression and the effect on resistance to the fire blight disease of the lytic protein gene, attacin E, in the apple cultivar 'Galaxy' grown in the field for 12 years. Using Southern and western blot analysis, we compared transgene copy number and observed stability of expression of this gene in the leaves and fruit in several transformed lines during a 12 year period. No silenced transgenic plant was detected. Also the expression of this gene resulted in an increase in resistance to fire blight throughout 12 years of orchard trial and did not affect fruit shape, size, acidity, firmness, weight or sugar level, tree morphology, leaf shape or flower morphology or color compared to the control. Overall, these results suggest that transgene expression in perennial species, such as fruit trees, remains stable in time and space, over extended periods and in different organs. This report shows that it is possible to improve a desirable trait in apple, such as the resistance to a pathogen, through genetic engineering, without adverse alteration of fruit characteristics and tree shape.

  4. RSAT 2018: regulatory sequence analysis tools 20th anniversary.

    PubMed

    Nguyen, Nga Thi Thuy; Contreras-Moreira, Bruno; Castro-Mondragon, Jaime A; Santana-Garcia, Walter; Ossio, Raul; Robles-Espinoza, Carla Daniela; Bahin, Mathieu; Collombet, Samuel; Vincens, Pierre; Thieffry, Denis; van Helden, Jacques; Medina-Rivera, Alejandra; Thomas-Chollier, Morgane

    2018-05-02

    RSAT (Regulatory Sequence Analysis Tools) is a suite of modular tools for the detection and the analysis of cis-regulatory elements in genome sequences. Its main applications are (i) motif discovery, including from genome-wide datasets like ChIP-seq/ATAC-seq, (ii) motif scanning, (iii) motif analysis (quality assessment, comparisons and clustering), (iv) analysis of regulatory variations, (v) comparative genomics. Six public servers jointly support 10 000 genomes from all kingdoms. Six novel or refactored programs have been added since the 2015 NAR Web Software Issue, including updated programs to analyse regulatory variants (retrieve-variation-seq, variation-scan, convert-variations), along with tools to extract sequences from a list of coordinates (retrieve-seq-bed), to select motifs from motif collections (retrieve-matrix), and to extract orthologs based on Ensembl Compara (get-orthologs-compara). Three use cases illustrate the integration of new and refactored tools to the suite. This Anniversary update gives a 20-year perspective on the software suite. RSAT is well-documented and available through Web sites, SOAP/WSDL (Simple Object Access Protocol/Web Services Description Language) web services, virtual machines and stand-alone programs at http://www.rsat.eu/.

  5. The incidence of Warthin tumours and pleomorphic adenomas in the parotid gland over a 25-year period.

    PubMed

    Luers, J C; Guntinas-Lichius, O; Klussmann, J P; Küsgen, C; Beutner, D; Grosheva, M

    2016-12-01

    Pleomorphic adenoma (PA) is reported to be the most common benign parotid tumour followed by Warthin tumour (WT), but the proportion of these two entities might have changed. Retrospective file analysis. Tertiary referral head and neck centre. Patients who underwent a parotidectomy within a period of 25 years (1990-2014). Rate of occurrence of PA and WT as well as the development of the PA/WT ratio over the years. Overall, 1818 patients with WT (707, 38.9%) and PA (1111, 61.1%) were identified. There was a dominance of PA over WT in all years. An increase in percentage of WT, from 24% in 1990 to 48% in 2014, in comparison with PA was evident. In our single-institution hospital-based material of parotidectomies, the percentage of WT in comparison with PA has significantly increased over the last 25 years. © 2016 John Wiley & Sons Ltd.

  6. Epidemiological characteristics of children born with Down syndrome in western Herzegovina in the period of the last twenty years (1994-2013).

    PubMed

    Sumanović-Glamuzina, Darinka; Zovko, Ana; Letica, Ivona; Jerković-Raguž, Marjana; Mustapić, Antonija; Božić, Tomica; Vukojević, Mladenka

    2014-12-01

    Children with Down syndrome (DS) are an everyday casuistry of pediatric clinical medicine. The prevalence of DS is dependent on socio-demographic and cultural conditions of a community. Antenatal screening is not carried out mainly due to religious views, and the prevalence of DS in our region is really considered a "natural phenomenon". The aim of the study was to analyze some epidemiological characteristics of infants with Down syndrome in the western region of Herzegovina in the period between year 1994-2013. We performed a retrospective analysis of hospital records of children who were supervised and treated at Children's Hospital through the twenty-year period. In this period there were 44,100 liveborn infants. Down syndrome was detected in 78 children (54 male and 24 female). The prevalence is estimated at 1.8/1,000 of live births. Aborted fetuses and stillbirths were not analyzed. 37 (47%) of the parent couples were over 35 years of age. Out of that 65 cytogenetic analysis, a regular type of trisomy 21 was found in 94% of cases, and the translocation in 6%. From major malformations (MM) heart failure was more often present (47%), then the anomaly of the gastrointestinal and genitourinary systems. Ten children (12%) died, most often in the early period of infancy due to complications of the cardiovascular system. The prevalence of DS throughout these two decades has been uniform in the region of western Herzegovina. Improvement in perinatal care in recent years caused higher survival and a better quality of life for the children with DS and thus their families. DS is less a desirable family tragedy, and increasingly a tolerable family fate.

  7. Ten-Year Summary and Evaluation of Operations and Performance of the Utica Aquifer and North Lake Basin Wetlands Restoration Project, 2004-2014

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    LaFreniere, Lorraine M.

    This document reviews the performance of the groundwater (and wetlands) restoration program implemented by the Commodity Credit Corporation of the U.S. Department of Agriculture (CCC/USDA) at the former CCC/USDA grain storage facility in Utica, Nebraska, during the first ten years of this initiative (2004-2014). The results of the program for the first five-year period of operation were previously discussed in detail (Argonne 2011). The present report focuses on treatment system operational data and regulatory compliance monitoring results for the site during the second five-year period of operation (2010-2014), together with the results of (1) ongoing monitoring and (2) targeted groundwatermore » sampling for volatile organic compounds (VOCs) analyses conducted at Utica in 2015 (following completion of the tenth year of systems operation), to assess the 10-year progress of the Utica remediation effort.« less

  8. The effect of a probiotic Escherichia coli strain on regulatory T-cells in six year-old children.

    PubMed

    Hrdý, J; Kocourková, I; Lodinová-Žádníková, R; Kolářová, L; Prokešová, L

    2016-11-30

    Probiotics are believed to prevent or reduce allergy development but the mechanism of their beneficial effect is still poorly understood. Immune characteristics of regulatory T cells (Tregs) in peripheral blood of perinatally probiotic-supplemented children of allergic mothers (51 children), non-supplemented children of allergic mothers (42 children), and non-supplemented children of healthy mothers (28 children) were compared at the age of 6-7 years. A first dose of a probiotic Escherichia coli strain (E. coli O83:K24:H31) was administered within 2 days after the birth and then 12 times during the first months of life and children were followed longitudinally. Proportion and functional properties of Tregs were estimated by flow cytometry in relation to the children's allergy status. Proportion of Tregs in the peripheral blood of children suffering from allergy tends to be higher whereas median of fluorescence intensity (MFI) of FoxP3 was significantly decreased in allergic group. Intracellular presence of regulatory cytokine interleukin (IL)-10 was also lower in allergic children. Immune functions of Tregs reflected by both MFI of FoxP3 and IL-10 in the group of probiotic-supplemented children of allergic mothers were nearly comparable with children of healthy mothers while probiotic non-supplemented children of allergic mothers have decreased immune function of Tregs. Supplementation by probiotic E. coli strain decreases allergy incidence in high-risk children. In contrast to our expectation, proportion of Tregs has not been increased in probiotic supplemented children. Beneficial effect of probiotics on newborn immature immune system could be, at least partially, explained by the modulating immune function of Tregs. In summary, we detected increased proportion of Tregs in peripheral blood of allergic children, their functional properties were decreased in comparison with the Tregs of healthy children. A unifying hypothesis for these findings is that Treg numbers

  9. Challenges estimating the return period of extreme floods for reinsurance applications

    NASA Astrophysics Data System (ADS)

    Raven, Emma; Busby, Kathryn; Liu, Ye

    2013-04-01

    Mapping and modelling extreme natural events is fundamental within the insurance and reinsurance industry for assessing risk. For example, insurers might use a 1 in 100-year flood hazard map to set the annual premium of a property, whilst a reinsurer might assess the national scale loss associated with the 1 in 200-year return period for capital and regulatory requirements. Using examples from a range of international flood projects, we focus on exploring how to define what the n-year flood looks like for predictive uses in re/insurance applications, whilst considering challenges posed by short historical flow records and the spatial and temporal complexities of flood. First, we shall explore the use of extreme value theory (EVT) statistics for extrapolating data beyond the range of observations in a marginal analysis. In particular, we discuss how to estimate the return period of historical flood events and explore the impact that a range of statistical decisions have on these estimates. Decisions include: (1) selecting which distribution type to apply (e.g. generalised Pareto distribution (GPD) vs. generalised extreme value distribution (GEV)); (2) if former, the choice of the threshold above which the GPD is fitted to the data; and (3) the necessity to perform a cluster analysis to group flow peaks to temporally represent individual flood events. Second, we summarise a specialised multivariate extreme value model, which combines the marginal analysis above with dependence modelling to generate industry standard event sets containing thousands of simulated, equi-probable floods across a region/country. These events represent the typical range of anticipated flooding across a region and can be used to estimate the largest or most widespread events that are expected to occur. Finally, we summarise how a reinsurance catastrophe model combines the event set with detailed flood hazard maps to estimate the financial cost of floods; both the full event set and also

  10. Non-random distribution and co-localization of purine/pyrimidine-encoded information and transcriptional regulatory domains.

    PubMed

    Povinelli, C M

    1992-01-01

    In order to detect sequence-based information predictive for the location of eukaryotic transcriptional regulatory domains, the frequencies and distributions of the 36 possible purine/pyrimidine reverse complement hexamer pairs was determined for test sets of real and random sequences. The distribution of one of the hexamer pairs (RRYYRR/YYRRYY, referred to as M1) was further examined in a larger set of sequences (> 32 genes, 230 kb). Predominant clusters of M1 and the locations of eukaryotic transcriptional regulatory domains were found to be associated and non-randomly distributed along the DNA consistent with a periodicity of approximately 1.2 kb. In the context of higher ordered chromatin this would align promoters, enhancers and the predominant clusters of M1 longitudinally along one face of a 30 nm fiber. Using only information about the distribution of the M1 motif, 50-70% of a sequence could be eliminated as being unlikely to contain transcriptional regulatory domains with an 87% recovery of the regulatory domains present.

  11. Regulatory Compliance in Multi-Tier Supplier Networks

    NASA Technical Reports Server (NTRS)

    Goossen, Emray R.; Buster, Duke A.

    2014-01-01

    Over the years, avionics systems have increased in complexity to the point where 1st tier suppliers to an aircraft OEM find it financially beneficial to outsource designs of subsystems to 2nd tier and at times to 3rd tier suppliers. Combined with challenging schedule and budgetary pressures, the environment in which safety-critical systems are being developed introduces new hurdles for regulatory agencies and industry. This new environment of both complex systems and tiered development has raised concerns in the ability of the designers to ensure safety considerations are fully addressed throughout the tier levels. This has also raised questions about the sufficiency of current regulatory guidance to ensure: proper flow down of safety awareness, avionics application understanding at the lower tiers, OEM and 1st tier oversight practices, and capabilities of lower tier suppliers. Therefore, NASA established a research project to address Regulatory Compliance in a Multi-tier Supplier Network. This research was divided into three major study efforts: 1. Describe Modern Multi-tier Avionics Development 2. Identify Current Issues in Achieving Safety and Regulatory Compliance 3. Short-term/Long-term Recommendations Toward Higher Assurance Confidence This report presents our findings of the risks, weaknesses, and our recommendations. It also includes a collection of industry-identified risks, an assessment of guideline weaknesses related to multi-tier development of complex avionics systems, and a postulation of potential modifications to guidelines to close the identified risks and weaknesses.

  12. THE FREQUENCY OF T(14;18) IN BLOOD LYMPHOCYTES IS STABLE OVER A 2 YEAR PERIOD IN ADULTS

    EPA Science Inventory

    The Frequency of t(14;18) in Blood Lymphocytes Is Stable over a 2 Year Period in Adults

    As part of a multi-endpoint molecular epidemiology study on in utero environmental exposures, umbilical cord and adult blood lymphocytes were examined for the frequency of t(14;18) by ...

  13. 78 FR 12405 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...\\ 17 CFR 240.19b-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of the... Approval of Change in Ownership, Control, or Business Operations) to provide for a refund of the...

  14. Insect growth regulatory activity of Vitex trifolia and Vitex agnus-castus essential oils against Spilosoma obliqua.

    PubMed

    Tandon, Shishir; Mittal, Ashutosh K; Pant, A K

    2008-06-01

    Essential oils of Vitex trifolia and Vitex agnus-castus were evaluated against Vth instar larvae of Spilosoma obliqua, when applied topically on the dorsal side of mesothoracic region, for insect growth regulatory activity. This treatment caused extended larval period and pupal period, increase in larval mortality and adult deformity and decrease in adult emergence, fecundity of female and egg fertility of test insect.

  15. Regulatory uncertainty and the associated business risk for emerging technologies

    NASA Astrophysics Data System (ADS)

    Hoerr, Robert A.

    2011-04-01

    An oversight system specifically concerned with nanomaterials should be flexible enough to take into account the unique aspects of individual novel materials and the settings in which they might be used, while recognizing that heretofore unrecognized safety issues may require future modifications. This article considers a question not explicitly considered by the project team: what is the risk that uncertainty over how regulatory oversight will be applied to nanomaterials will delay or block the development of this emerging technology, thereby depriving human health of potential and substantial benefits? An ambiguous regulatory environment could delay the availability of valuable new technology and therapeutics for human health by reducing access to investment capital. Venture capitalists list regulatory uncertainty as a major reason not to invest at all in certain areas. Uncertainty is far more difficult to evaluate than risk, which lends itself to quantitative models and can be factored into projections of return on possible investments. Loss of time has a large impact on investment return. An examination of regulatory case histories suggests that an increase in regulatory resting requirement, where the path is well-defined, is far less costly than a delay of a year or more in achieving product approval and market launch.

  16. Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

    PubMed

    Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

    2014-01-01

    International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

  17. Interchangeability of counts of cases and hours of cases for quantifying a hospital's change in workload among four-week periods of 1 year.

    PubMed

    Dexter, Franklin; Epstein, Richard H; Ledolter, Johannes; Wanderer, Jonathan P

    2018-05-16

    Recent studies have made longitudinal assessments of case counts using State (e.g., United States) and Provincial (e.g., Canada) databases. Such databases rarely include either operating room (OR) or anesthesia times and, even when duration data are available, there are major statistical limitations to their use. We evaluated how to forecast short-term changes in OR caseload and workload (hours) and how to decide whether changes are outliers (e.g., significant, abrupt decline in anesthetics). Observational cohort study. Large teaching hospital. 35 years of annual anesthesia caseload data. Annual data were used without regard to where or when in the year each case was performed, thereby matching public use files. Changes in caseload or hours among four-week periods were examined within individual year-long periods using 159 consecutive four-week periods from the same hospital. Series of 12 four-week periods of the hours of cases performed on workdays lacked trend or correlation among periods for 49 of 50 series and followed normal distributions for 50 of 50 series. These criteria also were satisfied for 50 of 50 series based on counts of cases. The Pearson r = 0.999 between hours of anesthetics and cases. For purposes of time series analysis of total workload at a hospital within 1-year, hours of cases and counts of cases are interchangeable. Simple control chart methods of detecting sudden changes in workload or caseload, based simply on the sample mean and standard deviation from the preceding year, are appropriate. Copyright © 2018 Elsevier Inc. All rights reserved.

  18. 75 FR 41254 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-15

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62476; File No. SR-FINRA-2010-012] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule Change To Amend FINRA Rule 8312 (FINRA BrokerCheck Disclosure) July 8, 2010. I. Introduction On March 30, 2010, the Financial Industry Regulatory...

  19. Individual Patterns of Complexity in Cystic Fibrosis Lung Microbiota, Including Predator Bacteria, over a 1-Year Period

    PubMed Central

    de Dios Caballero, Juan; Vida, Rafael; Cobo, Marta; Máiz, Luis; Suárez, Lucrecia; Galeano, Javier; Baquero, Fernando; Cantón, Rafael

    2017-01-01

    ABSTRACT Cystic fibrosis (CF) lung microbiota composition has recently been redefined by the application of next-generation sequencing (NGS) tools, identifying, among others, previously undescribed anaerobic and uncultivable bacteria. In the present study, we monitored the fluctuations of this ecosystem in 15 CF patients during a 1-year follow-up period, describing for the first time, as far as we know, the presence of predator bacteria in the CF lung microbiome. In addition, a new computational model was developed to ascertain the hypothetical ecological repercussions of a prey-predator interaction in CF lung microbial communities. Fifteen adult CF patients, stratified according to their pulmonary function into mild (n = 5), moderate (n = 9), and severe (n = 1) disease, were recruited at the CF unit of the Ramón y Cajal University Hospital (Madrid, Spain). Each patient contributed three or four induced sputum samples during a 1-year follow-up period. Lung microbiota composition was determined by both cultivation and NGS techniques and was compared with the patients’ clinical variables. Results revealed a particular microbiota composition for each patient that was maintained during the study period, although some fluctuations were detected without any clinical correlation. For the first time, Bdellovibrio and Vampirovibrio predator bacteria were shown in CF lung microbiota and reduced-genome bacterial parasites of the phylum Parcubacteria were also consistently detected. The newly designed computational model allows us to hypothesize that inoculation of predators into the pulmonary microbiome might contribute to the control of chronic colonization by CF pathogens in early colonization stages. PMID:28951476

  20. A Retrospective Audit of Dental Treatment Provided to Special Needs Patients under General Anesthesia During a Ten-Year Period.

    PubMed

    Mallineni, Sreekanth Kumar; Yiu, Cynthia Kar Y

    The purpose of this study was to perform a comprehensive audit of dental treatment provided to special needs patients (SNP) under general anesthesia (GA) over a ten-year period. Special needs patients who received dental treatment under GA as an in-patient at Queen Mary Hospital, Hong Kong SAR during the time period January 2002 and December 2011 were included in the study. The study population was divided into three groups, based on age (<6years, 6-12 years, >12 years). One-way ANOVA was used to evaluate the effect of "age group" on duration of treatment, post-recovery time, treatment procedures and utilization of different restorative materials. Kappa statistics were used for intra-examiner reliability. A total of 275 patients (174 males and 101 females) were included in the study. The mean age of the patients at the time they received GA was 12.37±10.18 years. Dental procedures performed were mostly restorative in nature (47%). The >12 years group had significantly shorter treatment duration (p<0.05). No significant difference in post-operative recovery time was observed among the three age groups (p>0.05). The <6 years group received significantly less preventive, but more restorative procedures (p<0.05). Significantly fewer extractions were performed in the 6-12 years group (p<0.05). The use of composite restorations was significantly higher in the <6 years group; while amalgam restorations were more frequently used in the >12 years group (P<0.05). Stainless steel crowns were more frequently employed in SNP under 12 years of age (p<0.05). Intra-examiner reliability was good (k=0.94). Most of the dental procedures performed under GA on SNP were restorative procedures. For children less than 6 years of age, had longer treatment time under GA. Composite restorations and stainless steel crowns were more frequently used in the primary dentition and amalgam restorations were more frequently employed in the permanent dentition.

  1. The regulatory framework for safe decommissioning of nuclear power plants in Korea

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sangmyeon Ahn; Jungjoon Lee; Chanwoo Jeong

    We are having 23 units of nuclear power plants in operation and 5 units of nuclear power plants under construction in Korea as of September 2012. However, we don't have any experience on shutdown permanently and decommissioning of nuclear power plants. There are only two research reactors being decommissioned since 1997. It is realized that improvement of the regulatory framework for decommissioning of nuclear facilities has been emphasized constantly from the point of view of IAEA's safety standards. It is also known that IAEA will prepare the safety requirement on decommissioning of facilities; its title is the Safe Decommissioning ofmore » Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission to Korea in 2011, it was recommended that the regulatory framework should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we focus on identifying the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. It is expected that if the things will go forward as planned, the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)« less

  2. Use of age-period-cohort models to estimate effects of vehicle age, year of crash and year of vehicle manufacture on driver injury and fatality rates in single vehicle crashes in New South Wales, 2003-2010.

    PubMed

    Anderson, R W G; Searson, D J

    2015-02-01

    A novel application of age-period-cohort methods are used to explain changes in vehicle based crash rates in New South Wales, Australia over the period 2003-2010. Models are developed using vehicle age, crash period and vehicle cohort to explain changes in the rate of single vehicle driver fatalities and injuries in vehicles less than 13 years of age. Large declines in risk are associated with vehicle cohorts built after about 1996. The decline in risk appears to have accelerated to 12 percent per vehicle cohort year for cohorts since 2004. Within each cohort, the risk of crashing appears to be a minimum at two years of age and increases as the vehicle ages beyond this. Period effects (i.e., other road safety measures) between 2003 and 2010 appear to have contributed to declines of up to about two percent per annum to the driver-fatality single vehicle crash rate, and possibly only negligible improvements to the driver-injury single vehicle crash rate. Vehicle improvements appear to have been responsible for a decline in per-vehicle crash risk of at least three percent per calendar year for both severity levels over the same period. Given the decline in risk associated with more recent vehicle cohorts and the dynamics of fleet turnover, continued declines in per-vehicle crash risk over coming years are almost certain. Copyright © 2014. Published by Elsevier Ltd.

  3. One fish, two fish, we QC fish: controlling data quality among more than 50 organizations over a four-year period.

    PubMed

    Riddick, L; Simbanin, C

    2001-01-01

    EPA is conducting a National Study of Chemical Residues in Lake Fish Tissue. The study involves five analytical laboratories, multiple sampling teams from each of the 47 participating states, several tribes, all 10 EPA Regions and several EPA program offices, with input from other federal agencies. To fulfill study objectives, state and tribal sampling teams are voluntarily collecting predator and bottom-dwelling fish from approximately 500 randomly selected lakes over a 4-year period. The fish will be analyzed for more than 300 pollutants. The long-term nature of the study, combined with the large number of participants, created several QA challenges: (1) controlling variability among sampling activities performed by different sampling teams from more than 50 organizations over a 4-year period; (2) controlling variability in lab processes over a 4-year period; (3) generating results that will meet the primary study objectives for use by OW statisticians; (4) generating results that will meet the undefined needs of more than 50 participating organizations; and (5) devising a system for evaluating and defining data quality and for reporting data quality assessments concurrently with the data to ensure that assessment efforts are streamlined and that assessments are consistent among organizations. This paper describes the QA program employed for the study and presents an interim assessment of the program's effectiveness.

  4. Using FAIRE (Formaldehyde-Assisted Isolation of Regulatory Elements) to isolate active regulatory DNA

    PubMed Central

    Simon, Jeremy M.; Giresi, Paul G.; Davis, Ian J.; Lieb, Jason D.

    2013-01-01

    Eviction or destabilization of nucleosomes from chromatin is a hallmark of functional regulatory elements of the eukaryotic genome. Historically identified by nuclease hypersensitivity, these regulatory elements are typically bound by transcription factors or other regulatory proteins. FAIRE (Formaldehyde-Assisted Isolation of Regulatory Elements) is an alternative approach to identify these genomic regions and has proven successful in a multitude of eukaryotic cell and tissue types. Cells or dissociated tissues are crosslinked briefly with formaldehyde, lysed, and sonicated. Sheared chromatin is subjected to phenol-chloroform extraction and the isolated DNA, typically encompassing 1–3% of the human genome, is purified. We provide guidelines for quantitative analysis by PCR, microarrays, or next-generation sequencing. Regulatory elements enriched by FAIRE display high concordance with those identified by nuclease hypersensitivity or ChIP, and the entire procedure can be completed in three days. FAIRE exhibits low technical variability, which allows its use in large-scale studies of chromatin from normal or diseased tissues. PMID:22262007

  5. Department of Defense Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Register is mandated for the regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U... the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because... Flexibility Act. Printing of these entries is limited to fields that contain information required by the...

  6. 78 FR 79035 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-71152; File No. SR-CBOE-2013-100] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change Relating to CBSX Trading Permit Holder Eligibility December 20, 2013. I. Introduction On October...

  7. Understanding the Idea of Chemical Elements and Their Periodic Classification in Spanish Students Aged 16-18 Years

    ERIC Educational Resources Information Center

    Franco-Mariscal, Antonio-Joaquín; Oliva-Martínez, José María; Almoraima Gil, M. L.

    2016-01-01

    The work reported here involved a comparative study regarding the understanding that high school students (16-18 years) have of the concept of chemical elements and their periodic classification. More specifically, the level of knowledge on this topic was compared before and after the completion of baccalaureate studies in a sample of Spanish…

  8. 75 FR 52574 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change To Reinstitute Short Exempt Marking for Trade Reporting and OATS August 20, 2010. Pursuant to... is hereby given that on August 6, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA...

  9. 76 FR 60567 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change To Create an Exemption From Certain Reporting Obligations Under the Equity Trade Reporting Rules... September 16, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities...

  10. 75 FR 8169 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change To Amend the Codes of Arbitration Procedure To Provide for Attorney Representation of Non-Party... Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers...

  11. 40 CFR 35.1650-1 - Project period.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Project period. 35.1650-1 Section 35... Lakes § 35.1650-1 Project period. (a) The project period for Phase 1 projects shall not exceed three years. (b) The project period for Phase 2 projects shall not exceed four years. Implementation of...

  12. 40 CFR 35.1650-1 - Project period.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Project period. 35.1650-1 Section 35... Lakes § 35.1650-1 Project period. (a) The project period for Phase 1 projects shall not exceed three years. (b) The project period for Phase 2 projects shall not exceed four years. Implementation of...

  13. 40 CFR 35.1650-1 - Project period.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Project period. 35.1650-1 Section 35... Lakes § 35.1650-1 Project period. (a) The project period for Phase 1 projects shall not exceed three years. (b) The project period for Phase 2 projects shall not exceed four years. Implementation of...

  14. 40 CFR 35.1650-1 - Project period.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Project period. 35.1650-1 Section 35... Lakes § 35.1650-1 Project period. (a) The project period for Phase 1 projects shall not exceed three years. (b) The project period for Phase 2 projects shall not exceed four years. Implementation of...

  15. 40 CFR 35.1650-1 - Project period.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Project period. 35.1650-1 Section 35... Lakes § 35.1650-1 Project period. (a) The project period for Phase 1 projects shall not exceed three years. (b) The project period for Phase 2 projects shall not exceed four years. Implementation of...

  16. Department of Defense Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U.S.C. 602), the Department of Defense's printed agenda entries include only: (1) Rules that are in the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because they are likely to have a significant...

  17. 76 FR 62128 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change to Amend Certain Trade Reporting and Compliance Rules September 30, 2011. Pursuant to Section 19(b... hereby given that on September 22, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA...

  18. [The path of creating TCM female periodicals in the Republican period].

    PubMed

    Ji, Zhenghan; Yan, Jilan; Zu, Na

    2014-03-01

    A"special issue of female physicians" was included in the 1934 Kunghwa Medical Journal. In 1939, Qian Bao-hua, together with a batch of female TCM professional medical workers, inaugurated a "Chinese Feminine Physicians" included in the "Journal of Column of Traditional Chinese Medicine". The former one was published independently in 1941, only for 8 issues and was suspended in the same year. In the Republican period, the 7 years of running the TCM periodicals by the female physicians was the miniature of the campaign of feminine rights in the TCM field from heat to cold, from foolish through confidence to self-realization. As the only extant TCM periodical, the Chinese Feminine Physicians run by females in the upper half of the 20th century, the basic cause of its failure may lie on the wrong evaluation of its audiences.

  19. KWOC (Key-Word-Out-of-Context) Index of US Nuclear Regulatory Commission Regulatory Guide Series

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Jennings, S.D.

    1990-04-01

    To meet the objectives of the program funded by the Department of Energy (DOE)-Nuclear Energy (NE) Technology Support Programs, the Performance Assurance Project Office (PAPO) administers a Performance Assurance Information Program that collects, compiles, and distributes program-related information, reports, and publications for the benefit of the DOE-NE program participants. THE KWOC Index of US Nuclear Regulatory Commission Regulatory Guide Series'' is prepared as an aid in searching for specific topics in the US Nuclear Regulatory Commission, Regulatory Guide Series.

  20. Do Autistic Symptoms Persist across Time? Evidence of Substantial Change in Symptomatology over a 3-Year Period in Cognitively Able Children with Autism

    ERIC Educational Resources Information Center

    Pellicano, Elizabeth

    2012-01-01

    This study investigated the extent and nature of changes in symptomatology in cognitively able children with autism over a 3-year period. Thirty-seven children diagnosed with an autism spectrum condition involved in an earlier study (M age = 5 years, 7 months) were followed and reassessed 3 years later (M age = 8 years, 4 months). Scores on the…

  1. An "Appropriate" Test Taker: The Everyday Classroom during the National Testing Period in School Year Three in Sweden

    ERIC Educational Resources Information Center

    Silfver, Eva; Sjöberg, Gunnar; Bagger, Anette

    2016-01-01

    This article draws on data from a bigger project where we explore what is taking place in the daily life of classrooms during the national testing period in mathematics for 9-10-year-old children in Sweden. Data were produced by observations, video-recordings and interviews with children. The article shows on a micro level how assessment trends,…

  2. [Trends in stroke mortality rates in Russia and the USA over a 15-year period].

    PubMed

    Samorodskaya, I V; Zayratyants, O V; Perkhov, V I; Andreev, E M; Vaisman, D Sh

    2018-01-01

    to comparatively analyze standardized mortality ratios (SMR) from stroke in the populations aged over 30 years in the Russian Federation and in the USA over a 15-year period. The analysis included nontraumatic subarachnoid hemorrhage (NTSH) (a group of ICD-10 codes I60), nontraumatic intracerebral hemorrhage (NTIH) (I61), cerebral infarction (CI) (I63), and stroke, not specified as hemorrhage or infarction (SNSHI) (I64). The new European standard (European Standard Population.2013) was used for standardization. The data of the Federal State Statistics Service of the Russian Federation, those of the World Health Organization Mortality Database (WHO MD) and Human Mortality Database (HMD) for the USA were applied. During the considered period, 30-49-year-old Russian men showed a reduction in SMRs from NTSH (I61) by 9.0% (from 18.9 to 17.2 per 100,000 population), from SNSHI (I64) by 10 times (from 12.5 to 1.3); SMRs from CI (I63) increased by 4.3% (from 6.9 to 7.2). In men aged 50 years and older, SMRs from NTIH and SNSHI decreased by 32.3% (from 143.2 to 97.0) and by 10 times (from 580.8 to 60.6), respectively; those from CI increased by 13.8% (from 229.8 to 261.4). In the USA, 30-49-year-old men displayed 26.1% and 2-fold decreases in SMRs from NTIH (from 2.5 per 100,000 population in 1999 to 1.7 in 2013) and CI (from 1.8 to 0.9), respectively; those from SNSHI remained unchanged (1.3). In men aged 50 years and older, SMRs from NTIH, CI, and SNSHI reduced by 39.7% (from 29.0 to 17.5), by 2 times (from 1.8 to 0.9), and by 2 times (143.0 to 72.5), respectively. 30-49-year-old Russian women exhibited a 22.2% reduction in SMRs from NTIH (from 9.0 to 7.0), a 4.3% increase in those from CI (from 2.7 to 2.8), and an 11-fold decrease in those from SNSHI (from 5.5 to 0.5). Women aged 50 years and older showed changes in SMRs from the codes in the same sequence from 105.6 to 60.5, from 172.8 to 189.6, and from 466.5 to 43.7, respectively. In the USA, 30-49-year-old women

  3. Asthma hospitalization trends in Charleston, South Carolina, 1956 to 1997: twenty-fold increase among black children during a 30-year period.

    PubMed

    Crater, D D; Heise, S; Perzanowski, M; Herbert, R; Morse, C G; Hulsey, T C; Platts-Mills, T

    2001-12-01

    The increase in asthma prevalence has been documented worldwide, affecting many races living in many different climates. Multiple studies have demonstrated that the most striking prevalence and morbidity of asthma in the United States has been in black children, but little research has determined the scale of the increase, or specifically when the disease became severe in this group. This study sought to determine exactly when the rise in asthma hospitalizations among black patients began and what the pattern of asthma hospitalizations has been in different races and age groups over a 40-year period in 1 urban area. A retrospective chart review of discharges from the Medical University of South Carolina was conducted from 1956 to 1997. Charts with the primary discharge diagnosis of asthma were examined for discharge date, race, and age group (0- to 4-year-olds, 5- to 18-year-olds, 19- to 50-year-olds, > or =51-year-olds). The diagnostic codes used were based on the International Classification of Diseases (ICD)-6, 1956-1957; ICD-7, 1958-1967; ICD-8, 1968-1978; and ICD-9, 1979-1997. Over the period studied, this hospital was the primary inpatient provider for children in this area, and the only provider for uninsured children. Between 1960 and 1990, the racial makeup of the area remained stable, as did the percentage of blacks living at the poverty level. The raw number of asthma discharges, rate per 10 000 discharges of the same race, and rate per 100 000 population in Charleston County were tabulated for each age group and racial category. Over the time period examined, there has been a progressive increase in asthma hospitalizations in black individuals of all age groups and in whites under 18 years. The most striking increase has been in black children 0 to 18 years old (figure). The increase either as raw values or as a rate per 100 000 began around 1970, and was linear. This increase in black children discharged with asthma as a rate per 100 000 population was

  4. 76 FR 70523 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-14

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change to Adopt FINRA Rule 4524 (Supplemental FOCUS Information) and Proposed Supplementary Schedule to...). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of the...

  5. Professional and Regulatory Search

    EPA Pesticide Factsheets

    Professional and Regulatory search are designed for people who use EPA web resources to do their job. You will be searching collections where information that is not relevant to Environmental and Regulatory professionals.

  6. Frequency of in-hospital acquired staphylococcus bacteremia/sepsis within ten-year period.

    PubMed

    Pitic, Aida; Lukovac, Enra; Koluder, Nada; Baljic, Rusmir

    2013-01-01

    Analyzing data in the literature, it is noted that in-hospital acquired infections are an increasing problem even in more developed countries. This increasing trend is related to the progress of medical science and introduction of new invasive diagnostic-therapeutic methods, as well as increase of multiresistant types of bacteria, including staphylococci in big percentages. To analyze frequency of in-hospital acquired staphylococcus bacteremia/sepsis. Anamneses of patients who were diagnosed with staphylococcus bacteremia/sepsis were analyzed within a ten-year period. Within the analyzed period from 2001 to 2011, there were 87 patients with diagnosis of staphylococcus bacteremia/sepsis, out of which (20) 77% were diagnosed with sepsis, and (67) 23% with bacteremia. In-hospital outcome was present with 32 (36.8%) patients, while 55 (63.2%) were out of hospital. The chi-square test for independence showed that the diagnosis of bacteremia/sepsis and the place of the infection origin (in hospital/ out of hospital) were independent chi2 = 1.951 df= 1 p=0.162. The cause isolated from hemoculture depends on the place of the infection origin (out of hospital/in hospital); larger percentage of methicillin-resistant types was presented in in-hospital acquired infections chi2 11.352 df=1 p=0.001. And the chi-square test for independence showed both dependence of the preceding antibiotic treatment and the place of the infection origin in both categories of patients. Sepsis: chi2 = 22.92 df=1 p<0.0005; Bacteremia: chi2 = 9.89 df=1 p= 0.005. The results showed larger percentage of methicillin-resistant types in in-hospital acquired infections, as well as significantly larger percentage of hospital infections with the preceding antibiotic therapy, which puts in focus possible rationalization of including antibiotic therapy.

  7. [Regulatory science: modern trends in science and education for pharmaceutical products].

    PubMed

    Beregovykh, V V; Piatigorskaia, N V; Aladysheva, Zh I

    2012-01-01

    This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

  8. Antimony susceptibility of Leishmania isolates collected over a 30-year period in Algeria

    PubMed Central

    Eddaikra, Naouel; Ait-Oudhia, Khatima; Kherrachi, Ihcen; Oury, Bruno; Moulti-Mati, Farida; Benikhlef, Razika; Harrat, Zoubir

    2018-01-01

    Background In Algeria, the treatment of visceral and cutaneous leishmanioses (VL and CL) has been and continues to be based on antimony-containing drugs. It is suspected that high drug selective pressure might favor the emergence of chemoresistant parasites. Although treatment failure is frequently reported during antimonial therapy of both CL and VL, antimonial resistance has never been thoroughly investigated in Algeria. Determining the level of antimonial susceptibility, amongst Leishmania transmitted in Algeria, is of great importance for the development of public health policies. Methodology/Principal findings Within the framework of the knowledge about the epidemiology of VL and CL amassed during the last 30 years, we sampled Leishmania isolates to determine their susceptibility to antimony. We analyzed a total of 106 isolates including 88 isolates collected between 1976 and 2013 in Algeria from humans, dogs, rodents, and phlebotomines and 18 collected from dogs in France. All the Algerian isolates were collected in 14 localities where leishmaniasis is endemic. The 50% inhibitory concentrations (IC50) of potassium antimony tartrate (the trivalent form of antimony, Sb(III)) and sodium stibogluconate (the pentavalent form of antimony, Sb(V)) were determined in promastigotes and intramacrophage amastigotes, respectively. The epidemiological cutoff (ECOFF) that allowed us to differentiate between Leishmania species causing cutaneous or visceral leishmaniases that were susceptible (S+) or insusceptible (S-) to the trivalent form of antimony was determined. The computed IC50 cutoff values were 23.83 μg/mL and 15.91 μg/mL for VL and CL, respectively. We report a trend of increasing antimony susceptibility in VL isolates during the 30-year period. In contrast, an increase in the frequency of S- phenotypes in isolates causing CL was observed during the same period. In our study, the emergence of S- phenotypes correlates with the inclusion of L. killicki (syn: L

  9. Evolutionary conservation of regulatory elements in vertebrate HOX gene clusters

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Santini, Simona; Boore, Jeffrey L.; Meyer, Axel

    2003-12-31

    Due to their high degree of conservation, comparisons of DNA sequences among evolutionarily distantly-related genomes permit to identify functional regions in noncoding DNA. Hox genes are optimal candidate sequences for comparative genome analyses, because they are extremely conserved in vertebrates and occur in clusters. We aligned (Pipmaker) the nucleotide sequences of HoxA clusters of tilapia, pufferfish, striped bass, zebrafish, horn shark, human and mouse (over 500 million years of evolutionary distance). We identified several highly conserved intergenic sequences, likely to be important in gene regulation. Only a few of these putative regulatory elements have been previously described as being involvedmore » in the regulation of Hox genes, while several others are new elements that might have regulatory functions. The majority of these newly identified putative regulatory elements contain short fragments that are almost completely conserved and are identical to known binding sites for regulatory proteins (Transfac). The conserved intergenic regions located between the most rostrally expressed genes in the developing embryo are longer and better retained through evolution. We document that presumed regulatory sequences are retained differentially in either A or A clusters resulting from a genome duplication in the fish lineage. This observation supports both the hypothesis that the conserved elements are involved in gene regulation and the Duplication-Deletion-Complementation model.« less

  10. 10 CFR 35.2645 - Records of periodic spot-checks for gamma stereotactic radiosurgery units.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... radiosurgery units. 35.2645 Section 35.2645 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT...'s name, model number, and serial number for the gamma stereotactic radiosurgery unit and the... and localizing devices (trunnions); and (9) The name of the individual who performed the periodic spot...

  11. 10 CFR 35.2645 - Records of periodic spot-checks for gamma stereotactic radiosurgery units.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... radiosurgery units. 35.2645 Section 35.2645 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT...'s name, model number, and serial number for the gamma stereotactic radiosurgery unit and the... and localizing devices (trunnions); and (9) The name of the individual who performed the periodic spot...

  12. 78 FR 17975 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change Relating to FINRA Rule 8313 (Release of Disciplinary Complaints, Decisions and Other Information... interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's...

  13. 76 FR 9840 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-22

    .... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory..., and C below, of the most significant aspects of such statements. A. Self-Regulatory Organization's...

  14. [Attempted and completed homicide in Hamburg--a comparison of two six-year periods].

    PubMed

    Herrmann, Julia; Gehl, Axel; Püschel, Klaus; Anders, Sven

    2010-01-01

    The present study compared cases of attempted and completed homicide in Hamburg from 1984 to 1989 and from 1995 to 2000 (n = 887). Data collection was performed using the police records. Attempted homicide showed a significant increase (34.8% vs. 57.9%, P < 0.0001). The majority of the victims and offenders were male with the share of male victims increasing from 59.7% to 74.2% (P < 0.0001). The age of the victims and offenders ranged between 22 and 40 years in both periods. The share of persons with a nationality other than German increased both in the victims (23.1% vs. 37.2%, P < 0.0001) and in the offenders (26.8% vs. 37.2%, P < 0.0001). The most common motives were interpersonal conflicts and robbery. The most frequently used forms of violence were sharp force, blunt force and strangulation.

  15. Assessing the relevance of ecotoxicological studies for regulatory decision making.

    PubMed

    Rudén, Christina; Adams, Julie; Ågerstrand, Marlene; Brock, Theo Cm; Poulsen, Veronique; Schlekat, Christian E; Wheeler, James R; Henry, Tala R

    2017-07-01

    Regulatory policies in many parts of the world recognize either the utility of or the mandate that all available studies be considered in environmental or ecological hazard and risk assessment (ERA) of chemicals, including studies from the peer-reviewed literature. Consequently, a vast array of different studies and data types need to be considered. The first steps in the evaluation process involve determining whether the study is relevant to the ERA and sufficiently reliable. Relevance evaluation is typically performed using existing guidance but involves application of "expert judgment" by risk assessors. In the present paper, we review published guidance for relevance evaluation and, on the basis of the practical experience within the group of authors, we identify additional aspects and further develop already proposed aspects that should be considered when conducting a relevance assessment for ecotoxicological studies. From a regulatory point of view, the overarching key aspect of relevance concerns the ability to directly or indirectly use the study in ERA with the purpose of addressing specific protection goals and ultimately regulatory decision making. Because ERA schemes are based on the appropriate linking of exposure and effect estimates, important features of ecotoxicological studies relate to exposure relevance and biological relevance. Exposure relevance addresses the representativeness of the test substance, environmental exposure media, and exposure regime. Biological relevance deals with the environmental significance of the test organism and the endpoints selected, the ecological realism of the test conditions simulated in the study, as well as a mechanistic link of treatment-related effects for endpoints to the protection goal identified in the ERA. In addition, uncertainties associated with relevance should be considered in the assessment. A systematic and transparent assessment of relevance is needed for regulatory decision making. The relevance

  16. Department of Transportation Agency Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] [Department of Transportation Agency Semiannual Regulatory Agenda ] Part XIII Department of Transportation Semiannual Regulatory Agenda [[Page 79812

  17. Increasing Incidence of Herpes Zoster Over a 60-year Period From a Population-based Study

    PubMed Central

    Kawai, Kosuke; Yawn, Barbara P.; Wollan, Peter; Harpaz, Rafael

    2016-01-01

    Background. Temporal increases in the incidence of herpes zoster (HZ) have been reported but studies have examined short study periods, and the cause of the increase remains unknown. We examined the long-term trend of HZ. Methods. A population-based cohort study was conducted in Olmsted County, Minnesota, using data from 1945–1960 and 1980–2007. Medical records review of possible cases was performed to confirm incident cases of HZ, the patient's immune status, and prescribing of antivirals for HZ. We examined the relative change in the temporal trend in the incidence rates before and after the introduction of the varicella vaccination program. Results. Of the 8017 patients with HZ, 58.7% were females and 6.6% were immunocompromised. The age- and sex-adjusted incidence rate of HZ increased from 0.76 per 1000 person-years (PY) (95% confidence interval [CI], .63–.89) in 1945–1949 to 3.15 per 1000 PY (95% CI, 3.04–3.26) in 2000–2007. The rate of increase across the time period was 2.5% per year after adjusting for age and sex (adjusted incidence rate ratio, 1.025 [95% CI, 1.023–1.026]; P < .001). The incidence of HZ significantly increased among all age groups and both sexes. We found no change in the rate of increase before vs after the introduction of the varicella vaccination program. Conclusions. The incidence of HZ has increased >4-fold over the last 6 decades. This increase is unlikely to be due to the introduction of varicella vaccination, antiviral therapy, or change in the prevalence of immunocompromised individuals. PMID:27161774

  18. 77 FR 2103 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Designation of Longer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-13

    ...-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Designation of Longer Period for Commission Action on Proposed Rule Change To Allow the Mortgage-Backed Securities Division To Provide...''), and on November 21, 2011, amended a proposed rule change to allow the Mortgage-Backed Securities...

  19. Department of the Interior Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] [Department of the Interior Semiannual Regulatory Agenda] Part X Department of the Interior Semiannual Regulatory Agenda [[Page 79796

  20. 76 FR 9838 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-22

    .... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance..., and at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of the... in sections A, B, and C below, of the most significant aspects of such statements. A. Self-Regulatory...

  1. Forest structure and tree recruitment changes on a permanent historical Cinder Hills plot over a 130-Year Period

    Treesearch

    Jacob H. Dyer; Andrew J. Sanchez Meador; Margaret M. Moore; Jonathan D. Bakker

    2008-01-01

    We examined forest structure, tree recruitment, and spatial pattern over a 130-year period on cinder soils in northern Arizona. Data were collected from a 3.24 ha permanent, stem-mapped plot established in 1909. This site is unique in that it represents ponderosa pine (Pinus ponderosa Laws. var. scopulorum Engelm.) growing on black cinder soils, which are of limited...

  2. [Cerebrovascular accidents in paediatric care. Our experience gained over an 18-year period].

    PubMed

    Ruiz del Olmo-Izuzquiza, Ignacio; de Arriba-Muñoz, Antonio; López-Pisón, Javier; García-Iñiguez, Juan Pablo; Romero-Gil, Ruth; Monge-Galindo, Lorena; Pérez-Delgado, Raquel; Peña-Segura, José Luis

    This study reviews our experience over the last 18 years with paediatric patients diagnosed with non-haemorrhagic cerebrovascular accidents (CVA) after the perinatal period. Data were collected for the period between May 1990 and May 2008 (n = 10 270 children) and special attention was given to cases with no previous pathology. We found 41 cases that were diagnosed with post-natal non-haemorrhagic CVA, of which 13 did not present any known pathology at the onset of the symptoms. Nine patients were diagnosed as having ischaemic CVA (ICVA), three cases had thrombosis of the venous sinuses and there was one case of haemorrhagic infarction (HI). No causation was found in five cases, three of which were heterozygotic for the C677T mutation of methylenetetrahydrofolate reductase. ICVA was caused by fibromuscular dysplasia, aneurysm of the auricular septum and patent foramen ovale, homocystinuria and chickenpox. A recent ear infection and diminished levels of protein C were noted in two cases of venous thrombosis. Five patients with ICVA and the case of HI were treated with oral antiaggregants, anticoagulants were administered in two of the thromboses, and the remaining cases did not receive any treatment. Seven patients (four ICVA, two thromboses and the HI) did not present any kind of sequelae, four ICVA presented different degrees of hemiparesis and two died (one ICVA and one thrombosis). The scarcity of studies and therapeutic clinical trials in the paediatric age makes it difficult to lay down clear guidelines of conduct, especially from the therapeutic point of view. The different specialists involved must collaborate with each other.

  3. Regulatory sequence analysis tools.

    PubMed

    van Helden, Jacques

    2003-07-01

    The web resource Regulatory Sequence Analysis Tools (RSAT) (http://rsat.ulb.ac.be/rsat) offers a collection of software tools dedicated to the prediction of regulatory sites in non-coding DNA sequences. These tools include sequence retrieval, pattern discovery, pattern matching, genome-scale pattern matching, feature-map drawing, random sequence generation and other utilities. Alternative formats are supported for the representation of regulatory motifs (strings or position-specific scoring matrices) and several algorithms are proposed for pattern discovery. RSAT currently holds >100 fully sequenced genomes and these data are regularly updated from GenBank.

  4. Periodic Impact Cratering and Extinction Events Over the Last 260 Million Years

    NASA Technical Reports Server (NTRS)

    Rampino, Michael R.; Caldeira, Ken

    2015-01-01

    The claims of periodicity in impact cratering and biological extinction events are controversial. Anewly revised record of dated impact craters has been analyzed for periodicity, and compared with the record of extinctions over the past 260 Myr. A digital circular spectral analysis of 37 crater ages (ranging in age from 15 to 254 Myr ago) yielded evidence for a significant 25.8 +/- 0.6 Myr cycle. Using the same method, we found a significant 27.0 +/- 0.7 Myr cycle in the dates of the eight recognized marine extinction events over the same period. The cycles detected in impacts and extinctions have a similar phase. The impact crater dataset shows 11 apparent peaks in the last 260 Myr, at least 5 of which correlate closely with significant extinction peaks. These results suggest that the hypothesis of periodic impacts and extinction events is still viable.

  5. 78 FR 9751 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Designation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68829; File No. SR-NSCC-2012-10] Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Eliminate the Offset of Its Obligations With Institutional Delivery Transactions That Settle at The...

  6. [Changes in the characteristics and incidence of multiple-injury accidents in the Navarre community over a 10-year period].

    PubMed

    Gradin Purroy, Carlos; Belzunegui Otano, Tomás; Bermejo Fraile, Begoña; Teijeira, Rafael; Fortún Moral, Mariano; Reyero Díez, Diego

    2015-06-01

    To compare morbidity and mortality rates, the epidemiologic profile, and survival of patients with multiple injuries attended by the emergency services in the Navarre autonomous community in Spain in the periods of 2002-2003 and 2010-2012. Observational analysis of 2 cohorts of accident patients with Injury Severity Scores of 15 points or more. Logistic regression was used to identify variables related to mortality. A total of 651 patients were attended in the first period; 626 were attended in the second. The annual multiple-injury incidence rate decreased from 58.1 per 100 000 population in the first period to 33.5 per 100 000 population in the second; mortality decreased from 30.3 to 15.3 per 100 000 population. The mean (SD) age was 45 (22) years in the first cohort and 52 (23) years in the second. The gender distribution (75% male) did not change. The percentage injured in traffic accidents decreased from 44% to 24%; the percentage of elderly patients hurt in falls increased from 9% to 26%. The problem of the number of young people injured in accidents in our community has been brought under control, but the proportion of older patients injured in falls has risen. This change may slow the effort to improve mortality rates in patients with multiple injuries and it obliges us to introduce measures to prevent falls in the elderly.

  7. Prescriptions analysis by clinical pharmacists in the post-operative period: a 4-year prospective study.

    PubMed

    Charpiat, B; Goutelle, S; Schoeffler, M; Aubrun, F; Viale, J-P; Ducerf, C; Leboucher, G; Allenet, B

    2012-09-01

    Clinical pharmacists can help prevent medication errors. However, data are scarce on their role in preventing medication prescription errors in the post-operative period, a high-risk period, as at least two prescribers can intervene, the surgeon and the anesthetist. We aimed to describe and quantify clinical pharmacist' intervention (PIs) during validation of drug prescriptions on a computerized physician order entry system in a post-surgical and post-transplantation ward. We illustrate these interventions, focusing on one clearly identified recurrent problem. In a prospective study lasting 4 years, we recorded drug-related problems (DRPs) detected by pharmacists and whether the physician accepted the PI when prescription modification was suggested. Among 7005 orders, 1975 DRPs were detected. The frequency of PIs remained constant throughout the study period, with 921 PIs (47%) accepted, 383 (19%) refused and 671 (34%) not assessable. The most frequent DRP concerned improper administration mode (26%), drug interactions (21%) and overdosage (20%). These resulted in a change in the method of administration (25%), dose adjustment (24%) and drug discontinuation (23%) with 307 drugs being concerned by at least one PI. Paracetamol was involved in 26% of overdosage PIs. Erythromycin as prokinetic agent, presented a recurrent risk of potentially severe drug-drug interactions especially with other QT interval-prolonging drugs. Following an educational seminar targeting this problem, the rate of acceptation of PI concerning this DRP increased. Pharmacists detected many prescription errors that may have clinical implications and could be the basis for educational measures. © 2012 The Authors. Acta Anaesthesiologica Scandinavica © 2012 The Acta Anaesthesiologica Scandinavica Foundation.

  8. Intertemporal Regulatory Tasks and Responsibilities for Greenhouse Gas Reductions

    ERIC Educational Resources Information Center

    Deason, Jeffrey A.; Friedman, Lee S.

    2010-01-01

    Jurisdictions are in the process of establishing regulatory systems to control greenhouse gas emissions. Short-term and sometimes long-term emissions reduction goals are established, as California does for 2020 and 2050, but little attention has yet been focused on annual emissions targets for the intervening years. We develop recommendations for…

  9. Global Summit on Regulatory Science 2013.

    PubMed

    Howard, Paul C; Tong, Weida; Weichold, Frank; Healy, Marion; Slikker, William

    2014-12-01

    Regulatory science has been defined as the science that is used to develop regulatory decisions by government bodies. Regulatory science encompasses many scientific disciplines that oversee many studies producing a wide array of data. These may include fundamental research into the cellular interaction or response to a particular chemical or substance, hazard-assessment and dose-response studies in animal species, neurophysiological or neurobehavioral studies, best practices for the generation and analysis of genomics data, bioinformatics approaches, and mathematical modeling of risk. The Global Summit on Regulatory Science is an international conference with a mission to explore emerging and innovative technologies, and provide a platform to enhance translation of basic science into regulatory applications. The Third Global Summit on Regulatory Science which focused on nanotechnology is discussed. Published by Elsevier Inc.

  10. Effects of Four Different Regulatory Mechanisms on the Dynamics of Gene Regulatory Cascades

    NASA Astrophysics Data System (ADS)

    Hansen, Sabine; Krishna, Sandeep; Semsey, Szabolcs; Lo Svenningsen, Sine

    2015-07-01

    Gene regulatory cascades (GRCs) are common motifs in cellular molecular networks. A given logical function in these cascades, such as the repression of the activity of a transcription factor, can be implemented by a number of different regulatory mechanisms. The potential consequences for the dynamic performance of the GRC of choosing one mechanism over another have not been analysed systematically. Here, we report the construction of a synthetic GRC in Escherichia coli, which allows us for the first time to directly compare and contrast the dynamics of four different regulatory mechanisms, affecting the transcription, translation, stability, or activity of a transcriptional repressor. We developed a biologically motivated mathematical model which is sufficient to reproduce the response dynamics determined by experimental measurements. Using the model, we explored the potential response dynamics that the constructed GRC can perform. We conclude that dynamic differences between regulatory mechanisms at an individual step in a GRC are often concealed in the overall performance of the GRC, and suggest that the presence of a given regulatory mechanism in a certain network environment does not necessarily mean that it represents a single optimal evolutionary solution.

  11. Differential movement patterns of juvenile Tengmalms owls (Aegolius funereus) during the post-fledging dependence period in two years with contrasting prey abundance.

    PubMed

    Kouba, Marek; Bartoš, Luděk; Štastný, Karel

    2013-01-01

    Fledgling behaviour and movement patterns throughout the post-fledging dependence period (PFDP), especially in relation to changing environmental conditions, have been rarely studied, despite the fact that this period is recognized as of crucial significance in terms of high mortality of juveniles. The PFDP can extend over quite a protracted period, particularly in birds of prey, and a knowledge of the movement patterns of individuals is fundamental for understanding mechanisms underlying survival, habitat use and dispersion. We radiotracked 39 fledglings of the Tengmalm's owl (Aegolius funereus) in two years with different availability of prey: 2010 (n = 29) and 2011 (n = 10) and obtained 1455 daily locations. Fledglings reached independence on average in 45 days after fledging in 2010 (n = 22) and 57 days in 2011 (n = 6). Within years, the most important measures influencing the distance moved from the nest box were age of fledglings and number of surviving siblings present. Individual home range size and duration of PFDP in particular were dependent on maximal number of siblings seen outside the nest box. In the season with low prey availability fledglings were observed at greater distances from the nest box than in the year with higher prey availability (mean distance: 350 m in 2010 and 650 m in 2011) and occupied larger home ranges (mean: 30.3 ha in 2010 and 57.7 ha in 2011). The main factor causing these differences between years was probably the different availability of prey in these two years, affecting breeding success and post-fledging survivorship of the Tengmalm's owls.

  12. [Epidemiologic behavior of malignant digestive tract tumors over a five year period in Veracruz, Mexico].

    PubMed

    Roesch-Dietlen, F; Jiménez-García, V A; Remes-Troche, J M; Rubio-Arce, J F; López-Salinas, A; Ruiz-Juárez, I; Grube-Pagola, P; Silva-Cañetas, C F

    2012-01-01

    Tumors of the digestive system are considered to be a public health problem because of their elevated mortality rate. In Mexico, gastric cancer and colon cancer rank fourth and fifth, respectively, following tracheal, bronchial, and lung cancer, and there has been an increase in their frequency in the last few years. However, there are no specific studies that have evaluated their epidemiologic behavior in Veracruz. To determine the frequency of digestive system cancer in five health institutions in the city of Veracruz and to describe its epidemiologic behavior over a five-year period. Annual statistics from the following hospitals were reviewed: the Instituto Mexicano del Seguro Social, the Secretaría de Salud, the Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Petróleos Mexicanos, and the Secretaría de la Defensa Nacional within the time frame of January 2005 to December 2009. Diagnoses based on histopathology were recorded, along with patient age and sex. A total of 1803 cases of digestive tract cancers were detected: 52% were men and 48% were women. A yearly increase in the number of cases was observed with colon cancer being in first place, followed by stomach cancer and rectal cancer. The increase in digestive system cancer cases over the last five years in Veracruz underlines the need to evaluate the implementation of screening programs for the at-risk population and to study the different etiologic factors involved in its manifestation.

  13. Conservative treatment of intraosseous hemangiomas in the mandible: case report with a 17-year follow-up period.

    PubMed

    Frizzera, Fausto; Beccalli, Ivette; Maia, Rosa Maria Lourenço Carlos; Tonetto, Mateus Rodrigues; Zanetti, Liliane Scheidegger da Silva; de Barros, Liliana Pimenta Aparecida

    2014-05-01

    Intraosseous hemangiomas in the jaws are rare lesions and may lead to several complications. The authors present a case of a 12-year-old girl with a radiolucent periapical lesion between tooth 35 and 36 where nocturnal exsanguinating bleeding started to occur from periodontal sulcus during orthodontic treatment. Diagnosis of an intraosseous hemangioma in the mandible was based on positive needle aspiration for blood, computed tomography and arteriography. At first the family chose to only follow-up the lesion but episodes of nocturnal hemorrhage were becoming more frequent and a treatment was requested. Embolization and dental extraction were performed in order to treat the lesion. After a follow-up period of 17 years no more cases of hemorrhage occurred and lesion regressed.

  14. 76 FR 59719 - Notice of Regulatory Waiver Requests Granted for the Second Quarter of Calendar Year 2011

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5529-N-02] Notice of Regulatory Waiver.... ACTION: Notice. SUMMARY: Section 106 of the Department of Housing and Urban Development Reform Act of..., Department of Housing and Urban Development, 451 7th Street, SW., Room 10282, Washington, DC 20410- 0500...

  15. Soil chemistry changes beneath decomposing cadavers over a one-year period.

    PubMed

    Szelecz, Ildikó; Koenig, Isabelle; Seppey, Christophe V W; Le Bayon, Renée-Claire; Mitchell, Edward A D

    2018-05-01

    Decomposing vertebrate cadavers release large, localized inputs of nutrients. These temporally limited resource patches affect nutrient cycling and soil organisms. The impact of decomposing cadavers on soil chemistry is relevant to soil biology, as a natural disturbance, and forensic science, to estimate the postmortem interval. However, cadaver impacts on soils are rarely studied, making it difficult to identify common patterns. We investigated the effects of decomposing pig cadavers (Sus scrofa domesticus) on soil chemistry (pH, ammonium, nitrate, nitrogen, phosphorous, potassium and carbon) over a one-year period in a spruce-dominant forest. Four treatments were applied, each with five replicates: two treatments including pig cadavers (placed on the ground and hung one metre above ground) and two controls (bare soil and bags filled with soil placed on the ground i.e. "fake pig" treatment). In the first two months (15-59 days after the start of the experiment), cadavers caused significant increases of ammonium, nitrogen, phosphorous and potassium (p<0.05) whereas nitrate significantly increased towards the end of the study (263-367 days; p<0.05). Soil pH increased significantly at first and then decreased significantly at the end of the experiment. After one year, some markers returned to basal levels (i.e. not significantly different from control plots), whereas others were still significantly different. Based on these response patterns and in comparison with previous studies, we define three categories of chemical markers that may have the potential to date the time since death: early peak markers (EPM), late peak markers (LPM) and late decrease markers (LDM). The marker categories will enhance our understanding of soil processes and can be highly useful when changes in soil chemistry are related to changes in the composition of soil organism communities. For actual casework further studies and more data are necessary to refine the marker categories along a

  16. Changes of etiology, incidence and outcomes of severe acute kidney injury during a 12-year period (2001-2012) in large university hospital.

    PubMed

    Skarupskiene, Inga; Balciuviene, Vilma; Ziginskiene, Edita; Kuzminskis, Vytautas; Vaiciuniene, Ruta; Bumblyte, Inga Arune

    2016-11-01

    Despite improvement in the quality of critical care, the incidence and mortality of acute kidney injury (AKI) continues to rise. The aim of our study was to analyze the changes during a 12-year period in etiology, incidence and outcomes of severe AKI, which required dialysis, in a large single centre. We performed retrospective analysis of all the patients (n=3215) with severe AKI hospitalized and dialysed in the hospital of Lithuanian university of health sciences Kauno Klinikos (HLUHS KK) during the period of 2001-2012. During a 12-year period, the incidence of severe AKI increased from 154 to 597 cases/p.m.p. The mean age of the patients increased from 58.2±19.2 years in 2001 to 65.7±17 years in 2012 (P<0.001). The number of men (n=2012; 62.6%) was significantly higher than that of women (n=1201; 37.4%; P<0.001). The causes of severe AKI were renal (n=1128; 35.1%), prerenal (n=642; 20%), obstructive (n=310; 9.6%) and in 12.7% of the patients-multifactorial. Overall, the most frequent cause of AKI was acute tubular necrosis (n=1069; 33.2%). The renal replacement therapy (RRT) was discontinued due to improved kidney function in 45.3% of cases. 8.1% of the patients remained dialysis dependent. The mortality rate was 44%. During a 12-year period, the number of the patients with severe AKI increased three times with the predominance of men and elderly people. There was an observed increase in multifactorial causes of severe AKI; however, ATN remained dominant over the decade. The mortality rate remained high, almost half of the patients died, less than 10% remained dialysis dependent, the rest had the improvement of renal function. Copyright © 2016 Association Société de néphrologie. Published by Elsevier SAS. All rights reserved.

  17. A cis-regulatory logic simulator.

    PubMed

    Zeigler, Robert D; Gertz, Jason; Cohen, Barak A

    2007-07-27

    A major goal of computational studies of gene regulation is to accurately predict the expression of genes based on the cis-regulatory content of their promoters. The development of computational methods to decode the interactions among cis-regulatory elements has been slow, in part, because it is difficult to know, without extensive experimental validation, whether a particular method identifies the correct cis-regulatory interactions that underlie a given set of expression data. There is an urgent need for test expression data in which the interactions among cis-regulatory sites that produce the data are known. The ability to rapidly generate such data sets would facilitate the development and comparison of computational methods that predict gene expression patterns from promoter sequence. We developed a gene expression simulator which generates expression data using user-defined interactions between cis-regulatory sites. The simulator can incorporate additive, cooperative, competitive, and synergistic interactions between regulatory elements. Constraints on the spacing, distance, and orientation of regulatory elements and their interactions may also be defined and Gaussian noise can be added to the expression values. The simulator allows for a data transformation that simulates the sigmoid shape of expression levels from real promoters. We found good agreement between sets of simulated promoters and predicted regulatory modules from real expression data. We present several data sets that may be useful for testing new methodologies for predicting gene expression from promoter sequence. We developed a flexible gene expression simulator that rapidly generates large numbers of simulated promoters and their corresponding transcriptional output based on specified interactions between cis-regulatory sites. When appropriate rule sets are used, the data generated by our simulator faithfully reproduces experimentally derived data sets. We anticipate that using simulated

  18. [Study of incidence of osteoporotic fractures in a cohort of individuals older than 50 years from Asturias, Spain, after a 6 year follow-up period].

    PubMed

    Naves Díaz, M; Díaz López, J B; Gómez Alonso, C; Altadill Arregui, A; Rodríguez Rebollar, A; Cannata Andía, J B

    2000-11-18

    The present work, performed as follow-up of the prevalence study of vertebral fractures (EVOS Study), evaluates in a 6 year period the incidence of vertebral fractures and other osteoporotic fractures in Oviedo (Asturias, Spain) in people older than 50 years. The study was performed in a cohort from the Oviedo's local registry in 1986. 624 men and women were followed by 3 postal questionnaires. The first questionnaire referred to the history of falls and fractures that happened during the follow-up period performed. Between the 2nd and 3rd follow-up subjects were invited to repeat the X-rays previously performed in the initial study. The incidence of osteoporotic fractures was higher in women than in men. In both sexes, vertebral fracture was the one which reached the highest incidence. Compared with men, Colles' fracture in women occurred earlier, with 5 times higher incidence. The incidence of hip fracture was twice higher in women than in men. A prevalent vertebral fractures increased until 5 times the incidence of vertebral and hip fracture. Among the osteoporotic fractures, vertebral fracture had a highest incidence values in both sexes. Although vertebral and hip fractures were twice incident in women compared with men, the incidence of Colles fracture was five times higher in women. A pre-existing vertebral fracture is an important risk factor to develop a new vertebral or hip fracture.

  19. Trans-acting translational regulatory RNA binding proteins.

    PubMed

    Harvey, Robert F; Smith, Tom S; Mulroney, Thomas; Queiroz, Rayner M L; Pizzinga, Mariavittoria; Dezi, Veronica; Villenueva, Eneko; Ramakrishna, Manasa; Lilley, Kathryn S; Willis, Anne E

    2018-05-01

    The canonical molecular machinery required for global mRNA translation and its control has been well defined, with distinct sets of proteins involved in the processes of translation initiation, elongation and termination. Additionally, noncanonical, trans-acting regulatory RNA-binding proteins (RBPs) are necessary to provide mRNA-specific translation, and these interact with 5' and 3' untranslated regions and coding regions of mRNA to regulate ribosome recruitment and transit. Recently it has also been demonstrated that trans-acting ribosomal proteins direct the translation of specific mRNAs. Importantly, it has been shown that subsets of RBPs often work in concert, forming distinct regulatory complexes upon different cellular perturbation, creating an RBP combinatorial code, which through the translation of specific subsets of mRNAs, dictate cell fate. With the development of new methodologies, a plethora of novel RNA binding proteins have recently been identified, although the function of many of these proteins within mRNA translation is unknown. In this review we will discuss these methodologies and their shortcomings when applied to the study of translation, which need to be addressed to enable a better understanding of trans-acting translational regulatory proteins. Moreover, we discuss the protein domains that are responsible for RNA binding as well as the RNA motifs to which they bind, and the role of trans-acting ribosomal proteins in directing the translation of specific mRNAs. This article is categorized under: RNA Interactions with Proteins and Other Molecules > RNA-Protein Complexes Translation > Translation Regulation Translation > Translation Mechanisms. © 2018 Medical Research Council and University of Cambridge. WIREs RNA published by Wiley Periodicals, Inc.

  20. 42 CFR 412.73 - Determination of the hospital-specific rate based on a Federal fiscal year 1982 base period.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 2 2013-10-01 2013-10-01 false Determination of the hospital-specific rate based on a Federal fiscal year 1982 base period. 412.73 Section 412.73 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES Determinatio...

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