The Consortium for Plant Biotechnology Research, Inc. Semi-Annual Technical Report for April 1, 2000 - September 30, 2000

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

NONE

2000-10-02

Scientific progress reports submitted by university researchers conducting projects funded through CPBR and metrics reports submitted by industry sponsors that provided matching funds to the projects.

SU-E-P-02: Imaging and Radiation Oncology Core (IROC) Houston QA Center (RPC) Credentialing

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

Amador, C; Keith, T; Nguyen, T

2014-06-01

Purpose: To provide information pertaining to IROC Houston QA Center's (RPC) credentialing process for institutions participating in NCI-sponsored clinical trials. Methods: IROC Houston issues credentials for NCI sponsored study groups. Requirements for credentialing might include any combination of questionnaires, knowledge assessment forms, benchmarks, or phantom irradiations. Credentialing requirements for specific protocols can be found on IROC Houston's website (irochouston.mdanderson.org). The website also houses the credentialing status inquiry (CSI) form. Once an institution has reviewed the protocol's credentialing requirements, a CSI form should be completed and submitted to IROC Houston. This form is used both to request whether requirements have beenmore » met as well as to notify IROC Houston that the institution requests credentialing for a specific protocol. IROC Houston will contact the institution to discuss any delinquent requirements. Once the institution has met all requirements IROC Houston issues a credentialing letter to the institution and will inform study groups and other IROC offices of the credentials. Institutions can all phone the IROC Houston office to initiate credentialing or ask any credentialing related questions. Results: Since 2010 IROC has received 1313 credentialing status inquiry forms. We received 317 in 2010, 266 in 2011, 324 in 2012, and 406 in 2013. On average we receive 35 phone calls per week with multiple types of credentialing questions. Decisions regarding credentialing status are based on the protocol specifications and previous completed credentialing by the institution. In some cases, such as for general IMRT credentialing, up to 5 sites may be credentialed based on the credentialing of one main center. Each of these situations is handled individually. Conclusion: IROC Houston will issue radiation therapy credentials for the NCI trials in the National Clinical Trials Network. Credentialing requirements and the CSI form can be found online at the IROC Houston's website. Work supported by PHS grant CA10953 and CA081647 (NCI, DHHS)« less

Redactions in protocols for drug trials: what industry sponsors concealed.

PubMed

Marquardsen, Mikkel; Ogden, Michelle; Gøtzsche, Peter C

2018-04-01

Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.

Continuing oversight through site monitoring: experiences of an institutional ethics committee in an Indian tertiary-care hospital.

PubMed

Shetty, Yashashri C; Marathe, Padmaja; Kamat, Sandhya; Thatte, Urmila

2012-01-01

WHO-TDR and the Indian Council of Medical Research recommend site visits by institutional ethics committees (IECs) for continued oversight, to ensure the ethical conduct of research. Our IEC conducted seven site visits in 2008-2009 using a standardised format to monitor adherence to protocol and the informed consent process. The study identified issues related to informed consent (6/7), deviation from protocol (5/7), reporting of study progress to the IEC (3/7), recruiting additional participants without IEC approval (2/7), reporting of serious adverse events (1/7), investigator's lack of awareness of protocol and the informed consent document (2/7) and other findings. Investigators were informed about the findings and were asked to submit an explanation. The IEC issued warnings about not repeating such lapses in the future (5/7), restricted enrollment of new participants (2/7), recommended continued good clinical practice training to the study team (4/7), advised the recruitment of additional study coordinators (2/7), and requested the submission of adverse event reports (2/7) or sponsors' audit reports (2/7). Our study showed that the ethical conduct of studies can be ensured by conducting routine site monitoring.

The National Research Service Award: strategies for developing a successful proposal.

PubMed

Parker, Barbara; Steeves, Richard

2005-01-01

An important experience for doctoral students is developing and submitting an application for a National Research Service Award (NRSA) from the National Institutes of Health (NIH). This article provides an overview of the process of developing and submitting an NRSA proposal from the perspective of a sponsor of successful proposals as well as a member of the Scientific Review Section. Topics included are suggestions for writing and rewriting the proposal, developing a training plan specific to the proposal, selection of sponsors consultants and references, the review process, and revising and resubmitting a proposal. Tables give examples of (a) applicants identifying strengths and areas for growth, (b) activities to address areas for growth (c), and responses to a previous review. The intended audience is beginning doctoral students and novice sponsors.

42 CFR 423.265 - Submission of bids and related information.

Code of Federal Regulations, 2010 CFR

2010-10-01

... calendar year. (2) Substantial differences between bids. Potential Part D sponsors' bid submissions must reflect differences in benefit packages or plan costs that CMS determines to represent substantial...) General. Not later than the first Monday in June, each potential Part D sponsor must submit bids and...

42 CFR 423.265 - Submission of bids and related information.

Code of Federal Regulations, 2011 CFR

2011-10-01

... calendar year. (2) Substantial differences between bids. Potential Part D sponsors' bid submissions must reflect differences in benefit packages or plan costs that CMS determines to represent substantial...) General. Not later than the first Monday in June, each potential Part D sponsor must submit bids and...

14 CFR 152.315 - Reporting on accrual basis.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) Except as provided in paragraph (b) of this section each sponsor or planning agency shall submit all financial reports on an accrual basis. (b) If records are not maintained on an accrual basis by a sponsor or planning agency, reports may be based on an analysis of records or best estimates. ...

78 FR 12054 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; EPA's...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... ENERGY STAR's HVAC Quality Installation program, sponsors promote the installation of HVAC systems in new... Energy Raters), and the Heating, Ventilation, and Cooling (HVAC) contractor. These organizations complete... (5900-08) Partnership Agreement for HVAC QI Sponsor (5900-183) Partnership Agreement for Home...

MSIAC Journal. Volume 4, Issue 1, March 2009

DTIC Science & Technology

2009-03-01

CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ... PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR’S ACRONYM(S) 11. SPONSOR...education courses, publications, help desk, and projects . Contact the MSIAC at 888-566-7672 or at http://www.dod-msiac.org If you would like to submit

76 FR 56453 - Information Collection Being Submitted for Review and Approval to the Office of Management and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-13

... required. Privacy Impact Assessment(s): No impact(s). Needs and Uses: 47 CFR 73.1212 requires a broadcast... time of the telecast, shall identify the sponsor. For both sections, for advertising commercial... sponsorship announcements that are waived when the broadcast/origination cablecast of ``want ads'' sponsored...

14 CFR 151.25 - Procedures: Application; information as to property interests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... time it submits the application. In the case of a joint project, any one or more of the sponsors may... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Procedures: Application; information as to... Development Projects § 151.25 Procedures: Application; information as to property interests. (a) Each sponsor...

8 CFR 213a.2 - Use of affidavit of support.

Code of Federal Regulations, 2014 CFR

2014-01-01

... the form designated by USCIS for this purpose. (ii) An affidavit of support is executed when a sponsor... days to submit the additional evidence. An immigration judge may direct the intending immigrant to... sponsor shall be deemed to have established a domicile in the United States for purposes of this paragraph...

8 CFR 213a.2 - Use of affidavit of support.

Code of Federal Regulations, 2012 CFR

2012-01-01

... the form designated by USCIS for this purpose. (ii) An affidavit of support is executed when a sponsor... days to submit the additional evidence. An immigration judge may direct the intending immigrant to... sponsor shall be deemed to have established a domicile in the United States for purposes of this paragraph...

8 CFR 213a.2 - Use of affidavit of support.

Code of Federal Regulations, 2013 CFR

2013-01-01

... the form designated by USCIS for this purpose. (ii) An affidavit of support is executed when a sponsor... days to submit the additional evidence. An immigration judge may direct the intending immigrant to... sponsor shall be deemed to have established a domicile in the United States for purposes of this paragraph...

14 CFR Appendix D to Part 152 - Assurances

Code of Federal Regulations, 2014 CFR

2014-01-01

... assurances that the sponsor or planning agency must submit with its application in accordance with §§ 152.111... airport planning grant shall submit the following assurance: The applicant hereby assures and certifies..., including, but not limited to charter flights, pilot training, aircraft rental and sightseeing, aerial...

14 CFR Appendix D to Part 152 - Assurances

Code of Federal Regulations, 2012 CFR

2012-01-01

... assurances that the sponsor or planning agency must submit with its application in accordance with §§ 152.111... airport planning grant shall submit the following assurance: The applicant hereby assures and certifies..., including, but not limited to charter flights, pilot training, aircraft rental and sightseeing, aerial...

14 CFR Appendix D to Part 152 - Assurances

Code of Federal Regulations, 2013 CFR

2013-01-01

... assurances that the sponsor or planning agency must submit with its application in accordance with §§ 152.111... airport planning grant shall submit the following assurance: The applicant hereby assures and certifies..., including, but not limited to charter flights, pilot training, aircraft rental and sightseeing, aerial...

14 CFR Appendix D to Part 152 - Assurances

Code of Federal Regulations, 2010 CFR

2010-01-01

... assurances that the sponsor or planning agency must submit with its application in accordance with §§ 152.111... airport planning grant shall submit the following assurance: The applicant hereby assures and certifies..., including, but not limited to charter flights, pilot training, aircraft rental and sightseeing, aerial...

14 CFR Appendix D to Part 152 - Assurances

Code of Federal Regulations, 2011 CFR

2011-01-01

... assurances that the sponsor or planning agency must submit with its application in accordance with §§ 152.111... airport planning grant shall submit the following assurance: The applicant hereby assures and certifies..., including, but not limited to charter flights, pilot training, aircraft rental and sightseeing, aerial...

76 FR 44047 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Workforce...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

... of Labor (DOL) is submitting the revised Employment and Training Administration (ETA) sponsored... Training Administration (ETA), Office of Management and Budget, Room 10235, Washington, DC 20503, Telephone... Investment Act Title I programs. Applications are submitted to the ETA National Office on behalf of states...

Benchmark Credentialing Results for NRG-BR001: The First National Cancer Institute-Sponsored Trial of Stereotactic Body Radiation Therapy for Multiple Metastases

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

Al-Hallaq, Hania A., E-mail: halhallaq@radonc.uchicago.edu; Chmura, Steven J.; Salama, Joseph K.

Purpose: The NRG-BR001 trial is the first National Cancer Institute–sponsored trial to treat multiple (range 2-4) extracranial metastases with stereotactic body radiation therapy. Benchmark credentialing is required to ensure adherence to this complex protocol, in particular, for metastases in close proximity. The present report summarizes the dosimetric results and approval rates. Methods and Materials: The benchmark used anonymized data from a patient with bilateral adrenal metastases, separated by <5 cm of normal tissue. Because the planning target volume (PTV) overlaps with organs at risk (OARs), institutions must use the planning priority guidelines to balance PTV coverage (45 Gy in 3 fractions) againstmore » OAR sparing. Submitted plans were processed by the Imaging and Radiation Oncology Core and assessed by the protocol co-chairs by comparing the doses to targets, OARs, and conformity metrics using nonparametric tests. Results: Of 63 benchmarks submitted through October 2015, 94% were approved, with 51% approved at the first attempt. Most used volumetric arc therapy (VMAT) (78%), a single plan for both PTVs (90%), and prioritized the PTV over the stomach (75%). The median dose to 95% of the volume was 44.8 ± 1.0 Gy and 44.9 ± 1.0 Gy for the right and left PTV, respectively. The median dose to 0.03 cm{sup 3} was 14.2 ± 2.2 Gy to the spinal cord and 46.5 ± 3.1 Gy to the stomach. Plans that spared the stomach significantly reduced the dose to the left PTV and stomach. Conformity metrics were significantly better for single plans that simultaneously treated both PTVs with VMAT, intensity modulated radiation therapy, or 3-dimensional conformal radiation therapy compared with separate plans. No significant differences existed in the dose at 2 cm from the PTVs. Conclusions: Although most plans used VMAT, the range of conformity and dose falloff was large. The decision to prioritize either OARs or PTV coverage varied considerably, suggesting that the toxicity outcomes in the trial could be affected. Several benchmarks met the dose-volume histogram metrics but produced unacceptable plans owing to low conformity. Dissemination of a frequently-asked-questions document improved the approval rate at the first attempt. Benchmark credentialing was found to be a valuable tool for educating institutions about the protocol requirements.« less

Benchmark Credentialing Results for NRG-BR001: The First National Cancer Institute-Sponsored Trial of Stereotactic Body Radiation Therapy for Multiple Metastases.

PubMed

Al-Hallaq, Hania A; Chmura, Steven J; Salama, Joseph K; Lowenstein, Jessica R; McNulty, Susan; Galvin, James M; Followill, David S; Robinson, Clifford G; Pisansky, Thomas M; Winter, Kathryn A; White, Julia R; Xiao, Ying; Matuszak, Martha M

2017-01-01

The NRG-BR001 trial is the first National Cancer Institute-sponsored trial to treat multiple (range 2-4) extracranial metastases with stereotactic body radiation therapy. Benchmark credentialing is required to ensure adherence to this complex protocol, in particular, for metastases in close proximity. The present report summarizes the dosimetric results and approval rates. The benchmark used anonymized data from a patient with bilateral adrenal metastases, separated by <5 cm of normal tissue. Because the planning target volume (PTV) overlaps with organs at risk (OARs), institutions must use the planning priority guidelines to balance PTV coverage (45 Gy in 3 fractions) against OAR sparing. Submitted plans were processed by the Imaging and Radiation Oncology Core and assessed by the protocol co-chairs by comparing the doses to targets, OARs, and conformity metrics using nonparametric tests. Of 63 benchmarks submitted through October 2015, 94% were approved, with 51% approved at the first attempt. Most used volumetric arc therapy (VMAT) (78%), a single plan for both PTVs (90%), and prioritized the PTV over the stomach (75%). The median dose to 95% of the volume was 44.8 ± 1.0 Gy and 44.9 ± 1.0 Gy for the right and left PTV, respectively. The median dose to 0.03 cm 3 was 14.2 ± 2.2 Gy to the spinal cord and 46.5 ± 3.1 Gy to the stomach. Plans that spared the stomach significantly reduced the dose to the left PTV and stomach. Conformity metrics were significantly better for single plans that simultaneously treated both PTVs with VMAT, intensity modulated radiation therapy, or 3-dimensional conformal radiation therapy compared with separate plans. No significant differences existed in the dose at 2 cm from the PTVs. Although most plans used VMAT, the range of conformity and dose falloff was large. The decision to prioritize either OARs or PTV coverage varied considerably, suggesting that the toxicity outcomes in the trial could be affected. Several benchmarks met the dose-volume histogram metrics but produced unacceptable plans owing to low conformity. Dissemination of a frequently-asked-questions document improved the approval rate at the first attempt. Benchmark credentialing was found to be a valuable tool for educating institutions about the protocol requirements. Copyright © 2016 Elsevier Inc. All rights reserved.

77 FR 3266 - Information Collection Being Reviewed by the Federal Communications Commission

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-23

... business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of... advise the FCC contact listed below as soon as possible. ADDRESSES: Submit your PRA comments to Judith B.Herman, Federal Communications Commission, via the Internet at [email protected]fcc.gov . To submit your...

77 FR 43620 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Instituting Proceedings to Determine...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-25

..., United States Senator Carl Levin submitted a comment letter on the proposed rule change.\\8\\ \\1\\ 15 U.S.C... governs the listing and trading of commodity-based trust shares. J.P. Morgan Commodity ETF Services LLC is the sponsor of the Trust (``Sponsor'').\\9\\ J.P. Morgan Treasury Securities Services, a division of...

42 CFR 423.520 - Prompt payment by Part D sponsors.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Construction. A determination under this section that a claim submitted by a network pharmacy is a clean claim... respect to all clean claims, as defined in paragraph (b) of this section, submitted by network pharmacies... claim is received, as defined in paragraph (a)(2)(i) of this section, for an electronic claim; or (ii...

42 CFR 423.520 - Prompt payment by Part D sponsors.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) Construction. A determination under this section that a claim submitted by a network pharmacy is a clean claim... respect to all clean claims, as defined in paragraph (b) of this section, submitted by network pharmacies... claim is received, as defined in paragraph (a)(2)(i) of this section, for an electronic claim; or (ii...

42 CFR 423.520 - Prompt payment by Part D sponsors.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) Construction. A determination under this section that a claim submitted by a network pharmacy is a clean claim... respect to all clean claims, as defined in paragraph (b) of this section, submitted by network pharmacies... claim is received, as defined in paragraph (a)(2)(i) of this section, for an electronic claim; or (ii...

42 CFR 423.520 - Prompt payment by Part D sponsors.

Code of Federal Regulations, 2012 CFR

2012-10-01

...) Construction. A determination under this section that a claim submitted by a network pharmacy is a clean claim... respect to all clean claims, as defined in paragraph (b) of this section, submitted by network pharmacies... claim is received, as defined in paragraph (a)(2)(i) of this section, for an electronic claim; or (ii...

Bioelectrocatalyzed Nitrogen Fixation under Standard Conditions

DTIC Science & Technology

2016-11-07

SUPPLEMENTARY NOTES 12. DISTRIBUTION AVAILIBILITY STATEMENT 6. AUTHORS 7. PERFORMING ORGANIZATION NAMES AND ADDRESSES 15. SUBJECT TERMS b. ABSTRACT...PAGE 11. SPONSOR/MONITOR’S REPORT NUMBER(S) 10. SPONSOR/MONITOR’S ACRONYM(S) ARO 8. PERFORMING ORGANIZATION REPORT NUMBER 19a. NAME OF...chemical manufacturing for fuel, propellants and fertilizer . (a) Papers published in peer-reviewed journals (N/A for none) Enter List of papers submitted

Blade Sections in Streamwise Oscillations into Reverse Flow

DTIC Science & Technology

2015-05-07

NC 27709-2211 Reverse Flow, Oscillating Airfoils , Oscillating Freesteam REPORT DOCUMENTATION PAGE 11. SPONSOR/MONITOR’S REPORT NUMBER(S) 10. SPONSOR...plate or bluff body rather than an airfoil . Reverse flow operation requires investigation and quantification to accurately capture these Submitted for... airfoil integrated quantities (lift, drag, moment) in reverse flow and developed new algorithms for comprehensive codes, reducing errors from 30 %–50

Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

PubMed

Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

2016-08-01

Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of seven papers stated that "all adverse events were recorded." For one trial, we identified an additional 1,318 adverse events that were not listed or mentioned in the CSR itself but could be identified through manually counting individual adverse events reported in an appendix. We discovered that the majority of patients had multiple episodes of the same adverse event that were only counted once, though this was not described in the CSRs. We also discovered that participants treated with orlistat experienced twice as many days with adverse events as participants treated with placebo (22.7 d versus 14.9 d, p-value < 0.0001, Student's t test). Furthermore, compared with the placebo group, adverse events in the orlistat group were more severe. None of this was stated in the CSR or in the published paper. Our analysis was restricted to one drug tested in the mid-1990s; our results might therefore not be applicable for newer drugs. In the orlistat trials, we identified important disparities in the reporting of adverse events between protocols, clinical study reports, and published papers. Reports of these trials seemed to have systematically understated adverse events. Based on these findings, systematic reviews of drugs might be improved by including protocols and CSRs in addition to published articles.

A Legion Apart

DTIC Science & Technology

2012-03-16

NUMBER Colonel Robert Mundell Department of Command, Leadership, & Management 9. SPONSORING...Colonel Robert Mundell Project Adviser This SRP is submitted in partial fulfillment of the requirements of the Master of

Optimizing Citizen Engagement During Emergencies Through Use of Web 2.0 Technologies

DTIC Science & Technology

2009-03-01

Technologies 6. AUTHOR( S ) Laurie J. Van Leuven 5. FUNDING NUMBERS 7. PERFORMING ORGANIZATION NAME( S ) AND ADDRESS(ES) Naval Postgraduate School...Monterey, CA 93943-5000 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING /MONITORING AGENCY NAME( S ) AND ADDRESS(ES) N/A 10. SPONSORING...Van Leuven Security and Emergency Management Strategic Advisor, City of Seattle B.A., University of Washington, 1998 Submitted in partial

76 FR 30369 - Announcement of the Award of a Replacement Grant

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-25

...'s Office on Economic Development in California. California Volunteers, Inc., Sacramento CA was..., California Volunteers submitted a letter relinquishing their grant. Humboldt State University Sponsored...

Protocol Development | Division of Cancer Prevention

Cancer.gov

The chemoprevention Phase I and II consortia must submit Letters of Intent for review and approval prior to the submission and review of the protocol. Letter of Intent (LOI) Process The chemoprevention Phase I and II consortia must submit Letters of Intent for review and approval prior to the submission and review of the protocol. DCP will solicit Letters of Intent from

DOE MARC Records System | OSTI, US Dept of Energy Office of Scientific and

Science.gov Websites

: Sponsoring Org: Update Date: to Limit to INIS / NSA records only Search Submit Submit Research Results Search page is being shared by OSTI.GOV. DOE MARC Records System We could not detect that JavaScript is enabled in your browser. Please click the link below to continue. https://www.osti.gov/marc-records U.S

42 CFR 423.586 - Opportunity to submit evidence.

Code of Federal Regulations, 2010 CFR

2010-10-01

... limited by the short timeframe for making a decision. Therefore, the Part D plan sponsor must inform the... (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Grievances, Coverage Determinations...

SU-E-T-148: Benchmarks and Pre-Treatment Reviews: A Study of Quality Assurance Effectiveness

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

Lowenstein, J; Nguyen, H; Roll, J

Purpose: To determine the impact benchmarks and pre-treatment reviews have on improving the quality of submitted clinical trial data. Methods: Benchmarks are used to evaluate a site’s ability to develop a treatment that meets a specific protocol’s treatment guidelines prior to placing their first patient on the protocol. A pre-treatment review is an actual patient placed on the protocol in which the dosimetry and contour volumes are evaluated to be per protocol guidelines prior to allowing the beginning of the treatment. A key component of these QA mechanisms is that sites are provided timely feedback to educate them on howmore » to plan per the protocol and prevent protocol deviations on patients accrued to a protocol. For both benchmarks and pre-treatment reviews a dose volume analysis (DVA) was performed using MIM softwareTM. For pre-treatment reviews a volume contour evaluation was also performed. Results: IROC Houston performed a QA effectiveness analysis of a protocol which required both benchmarks and pre-treatment reviews. In 70 percent of the patient cases submitted, the benchmark played an effective role in assuring that the pre-treatment review of the cases met protocol requirements. The 35 percent of sites failing the benchmark subsequently modified there planning technique to pass the benchmark before being allowed to submit a patient for pre-treatment review. However, in 30 percent of the submitted cases the pre-treatment review failed where the majority (71 percent) failed the DVA. 20 percent of sites submitting patients failed to correct their dose volume discrepancies indicated by the benchmark case. Conclusion: Benchmark cases and pre-treatment reviews can be an effective QA tool to educate sites on protocol guidelines and to minimize deviations. Without the benchmark cases it is possible that 65 percent of the cases undergoing a pre-treatment review would have failed to meet the protocols requirements.Support: U24-CA-180803.« less

On the Use of Offensive Cyber Capabilities: A Policy Analysis on Offensive US Cyber Policy

DTIC Science & Technology

2012-03-20

greater success in addressing systemic issues with the current networking structures in cyberspace (such as IPv4 , and border gateway protocol (BGP...PERFORMING ORGANIZATION NAME(S) AND ADDRESS (ES) Harvard Kennedy School,79 John F. Kennedy Street,Cambridge,MA,02138 8. PERFORMING ORGANIZATION...REPORT NUMBER 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS (ES) 10. SPONSOR/MONITOR’S ACRONYM(S) 11. SPONSOR/MONITOR’S REPORT NUMBER(S) 12

National Site for the Regional IPM Centers

Science.gov Websites

see above Submit United States Department of Agriculture - National Institute of Food and Agriculture . Regional IPM Centers are sponsored by the USDA National Institute of Food and Agriculture.

8 CFR 332.2 - Establishment of photographic studios.

Code of Federal Regulations, 2010 CFR

2010-01-01

... naturalization laws. Such studios must be in a building occupied by the Service and be conducted under the supervision of the district director. Each sponsoring organization shall submit an annual accounting of the...

Navy Force Structure and Shipbuilding Plans: Background and Issues for Congress

DTIC Science & Technology

2006-08-14

number. 1. REPORT DATE 14 AUG 2006 2. REPORT TYPE 3. DATES COVERED 00-00-2006 to 00-00-2006 4. TITLE AND SUBTITLE Navy Force Structure and...ES) 10. SPONSOR/MONITOR’S ACRONYM(S) 11. SPONSOR/MONITOR’S REPORT NUMBER(S) 12. DISTRIBUTION/ AVAILABILITY STATEMENT Approved for public release...MPF(F), squadron with 12 new-construction amphibious and sealift- type ships. In conjunction with this proposed 313-ship fleet, the Navy submitted a

Cross-sectional study of Pfizer-sponsored clinical trials: assessment of time to publication and publication history.

PubMed

Mooney, LaVerne A; Fay, Lorna

2016-07-18

To estimate the proportion of Pfizer-sponsored clinical trials that completed in 2010 and are published as manuscripts in the peer-reviewed literature, and to assess the manuscript development history. Retrospective, cross-sectional analysis. Clinical trials registered in ClinicalTrials.gov that completed in 2010 for approved, Pfizer prescription products in patients or vaccines in healthy participants. The proportion of studies for which the primary outcome(s) was published and the median time from study completion to publication. The manuscript development history included the number of times a manuscript was submitted before it was accepted for publication. Among registered clinical trials for which Pfizer was the sponsor that completed in 2010, 76 met all inclusion criteria. The primary outcome(s) for 65 (85%) studies was published in 71 manuscripts; the median time to publication was 31 months (range 3-63 months). Of the remaining 11 studies, 2 had been submitted to at least one journal, 2 had not yet been submitted and 7 had no plans to publish because the study had terminated early due to recruitment challenges. Manuscripts accepted at the first choice journal were published at median time of 28 months (range 8-63, n=31), those accepted at second choice journal were published at 32 months (3-45, n=19), and for those accepted at third choice journal, it was 40 months (range 24-53, n=13). The publication rate and median time to publication from study completion for Pfizer-sponsored studies were comparable to those previously reported for combined analyses of industry and non-industry sectors. Opportunities exist for sponsors, authors and journals to explore ideas that would facilitate more timely publication for clinical trial results. However, to be effective, such changes may need to revisit the entire publication process. 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/

78 FR 25477 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Trade Act...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-01

... Federal agencies, and to improve the effectiveness of job training programs. This ICR requests minor... of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information...

A Robust Open Ascending-price Multi-unit Auction Protocol against False-name Bids

NASA Astrophysics Data System (ADS)

Iwasaki, Atsushi; Yokoo, Makoto; Terada, Kenji

This paper develops a new ascending-price multi-unit auction protocol that has following characteristics: (i) it has an open format, (ii) sincere bidding is an equilibrium strategy even if the marginal utilities of each agent can increase and agents can submit false-name bids. False-name bids are bids submitted under fictitious names such as multiple e-mail addresses, which can be done easily in the Internet. This is the first protocol that has these two characteristics. We show that our new protocol outperforms an existing protocol, which satisfies (ii), with respect to the social surplus and the seller's revenue.

78 FR 4412 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-22

... 42 CFR parts 422 and 423, Medicare Part D plan sponsors and Medicare Advantage organizations are... sponsors selected for audit 4 weeks prior to starting the audit. In addition, the protocols will be... (business or other for-profit and not-for-profit institutions). Number of Respondents: 195. Total Annual...

Total Army Analysis Supporting Maximization of National Resources

DTIC Science & Technology

2013-03-01

Robert M. Mundell Department of Command Leadership and Management 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY...Colonel Robert M. Mundell Department of Command Leadership and Management Project Adviser This manuscript is submitted in partial fulfillment

Good clinical practice regulatory inspections: Lessons for Indian investigator sites

PubMed Central

Marwah, R.; Van de Voorde, K.; Parchman, J.

2010-01-01

Regulatory inspections are important to evaluate the integrity of the data submitted to health authorities (HAs), protect patient safety, and assess adequacy of site/sponsor quality systems to achieve the same. Inspections generally occur after submission of data for marketing approval of an investigational drug. In recent years, there has been a significant increase in number of inspections by different HAs, including in India. The assessors/inspectors generally do a thorough review of site data before inspections. All aspects of ICH-GCP, site infrastructure, and quality control systems are assessed during the inspection. Findings are discussed during the close out meeting and a detailed inspection report issued afterward, which has to be responded to within 15–30 days with effective Corrective and Preventive Action Plan (CAPA). Protocol noncompliance, inadequate/inaccurate records, inadequate drug accountability, informed consent issues, and adverse event reporting were some of the most common findings observed during recent Food and Drug Administration (FDA) inspections. Drug development is being increasingly globalized and an increased number of patients enrolled in studies submitted as part of applications come from all over the world including India. Because of the steep increase in research activity in the country, inexperienced sites, and more stakeholders, increased efforts will be required to ensure continuous quality and compliance. HAs have also made clear that enforcement will be increased and be swift, aggressive, and effective. PMID:21350732

Detection of QT prolongation using a novel electrocardiographic analysis algorithm applying intelligent automation: prospective blinded evaluation using the Cardiac Safety Research Consortium electrocardiographic database.

PubMed

Green, Cynthia L; Kligfield, Paul; George, Samuel; Gussak, Ihor; Vajdic, Branislav; Sager, Philip; Krucoff, Mitchell W

2012-03-01

The Cardiac Safety Research Consortium (CSRC) provides both "learning" and blinded "testing" digital electrocardiographic (ECG) data sets from thorough QT (TQT) studies annotated for submission to the US Food and Drug Administration (FDA) to developers of ECG analysis technologies. This article reports the first results from a blinded testing data set that examines developer reanalysis of original sponsor-reported core laboratory data. A total of 11,925 anonymized ECGs including both moxifloxacin and placebo arms of a parallel-group TQT in 181 subjects were blindly analyzed using a novel ECG analysis algorithm applying intelligent automation. Developer-measured ECG intervals were submitted to CSRC for unblinding, temporal reconstruction of the TQT exposures, and statistical comparison to core laboratory findings previously submitted to FDA by the pharmaceutical sponsor. Primary comparisons included baseline-adjusted interval measurements, baseline- and placebo-adjusted moxifloxacin QTcF changes (ddQTcF), and associated variability measures. Developer and sponsor-reported baseline-adjusted data were similar with average differences <1 ms for all intervals. Both developer- and sponsor-reported data demonstrated assay sensitivity with similar ddQTcF changes. Average within-subject SD for triplicate QTcF measurements was significantly lower for developer- than sponsor-reported data (5.4 and 7.2 ms, respectively; P < .001). The virtually automated ECG algorithm used for this analysis produced similar yet less variable TQT results compared with the sponsor-reported study, without the use of a manual core laboratory. These findings indicate that CSRC ECG data sets can be useful for evaluating novel methods and algorithms for determining drug-induced QT/QTc prolongation. Although the results should not constitute endorsement of specific algorithms by either CSRC or FDA, the value of a public domain digital ECG warehouse to provide prospective, blinded comparisons of ECG technologies applied for QT/QTc measurement is illustrated. Copyright © 2012 Mosby, Inc. All rights reserved.

Detection of QT prolongation using a novel ECG analysis algorithm applying intelligent automation: Prospective blinded evaluation using the Cardiac Safety Research Consortium ECG database

PubMed Central

Green, Cynthia L.; Kligfield, Paul; George, Samuel; Gussak, Ihor; Vajdic, Branislav; Sager, Philip; Krucoff, Mitchell W.

2013-01-01

Background The Cardiac Safety Research Consortium (CSRC) provides both “learning” and blinded “testing” digital ECG datasets from thorough QT (TQT) studies annotated for submission to the US Food and Drug Administration (FDA) to developers of ECG analysis technologies. This manuscript reports the first results from a blinded “testing” dataset that examines Developer re-analysis of original Sponsor-reported core laboratory data. Methods 11,925 anonymized ECGs including both moxifloxacin and placebo arms of a parallel-group TQT in 191 subjects were blindly analyzed using a novel ECG analysis algorithm applying intelligent automation. Developer measured ECG intervals were submitted to CSRC for unblinding, temporal reconstruction of the TQT exposures, and statistical comparison to core laboratory findings previously submitted to FDA by the pharmaceutical sponsor. Primary comparisons included baseline-adjusted interval measurements, baseline- and placebo-adjusted moxifloxacin QTcF changes (ddQTcF), and associated variability measures. Results Developer and Sponsor-reported baseline-adjusted data were similar with average differences less than 1 millisecond (ms) for all intervals. Both Developer and Sponsor-reported data demonstrated assay sensitivity with similar ddQTcF changes. Average within-subject standard deviation for triplicate QTcF measurements was significantly lower for Developer than Sponsor-reported data (5.4 ms and 7.2 ms, respectively; p<0.001). Conclusion The virtually automated ECG algorithm used for this analysis produced similar yet less variable TQT results compared to the Sponsor-reported study, without the use of a manual core laboratory. These findings indicate CSRC ECG datasets can be useful for evaluating novel methods and algorithms for determining QT/QTc prolongation by drugs. While the results should not constitute endorsement of specific algorithms by either CSRC or FDA, the value of a public domain digital ECG warehouse to provide prospective, blinded comparisons of ECG technologies applied for QT/QTc measurement is illustrated. PMID:22424006

Effect of using reporting guidelines during peer review on quality of final manuscripts submitted to a biomedical journal: masked randomised trial

PubMed Central

Cortés, J; Ribera, J M; Cardellach, F; Selva-O’Callaghan, A; Kostov, B; García, L; Cirugeda, L; Altman, D G; González, J A; Sànchez, J A; Miras, F; Urrutia, A; Fonollosa, V; Rey-Joly, C; Vilardell, M

2011-01-01

Objective To investigate the effect of an additional review based on reporting guidelines such as STROBE and CONSORT on quality of manuscripts. Design Masked randomised trial. Population Original research manuscripts submitted to the Medicina Clínica journal from May 2008 to April 2009 and considered suitable for publication. Intervention Control group: conventional peer reviews alone. Intervention group: conventional review plus an additional review looking for missing items from reporting guidelines. Outcomes Manuscript quality, assessed with a 5 point Likert scale (primary: overall quality; secondary: average quality of specific items in paper). Main analysis compared groups as allocated, after adjustment for baseline factors (analysis of covariance); sensitivity analysis compared groups as reviewed. Adherence to reviewer suggestions assessed with Likert scale. Results Of 126 consecutive papers receiving conventional review, 34 were not suitable for publication. The remaining 92 papers were allocated to receive conventional reviews alone (n=41) or additional reviews (n=51). Four papers assigned to the conventional review group deviated from protocol; they received an additional review based on reporting guidelines. We saw an improvement in manuscript quality in favour of the additional review group (comparison as allocated, 0.25, 95% confidence interval –0.05 to 0.54; as reviewed, 0.33, 0.03 to 0.63). More papers with additional reviews than with conventional reviews alone improved from baseline (22 (43%) v eight (20%), difference 23.6% (3.2% to 44.0%), number needed to treat 4.2 (from 2.3 to 31.2), relative risk 2.21 (1.10 to 4.44)). Authors in the additional review group adhered more to suggestions from conventional reviews than to those from additional reviews (average increase 0.43 Likert points (0.19 to 0.67)). Conclusions Additional reviews based on reporting guidelines improve manuscript quality, although the observed effect was smaller than hypothesised and not definitively demonstrated. Authors adhere more to suggestions from conventional reviews than to those from additional reviews, showing difficulties in adhering to high methodological standards at the latest research phases. To boost paper quality and impact, authors should be aware of future requirements of reporting guidelines at the very beginning of their study. Trial registration and protocol Although registries do not include trials of peer review, the protocol design was submitted to sponsored research projects (Instituto de Salud Carlos III, PI081903). PMID:22108262

Research ethics review at University Eduardo Mondlane (UEM)/Maputo Central Hospital, Mozambique (2013-2016): a descriptive analysis of the start-up of a new research ethics committee (REC).

PubMed

Sacarlal, Jahit; Muchanga, Vasco; Mabutana, Carlos; Mabui, Matilde; Mariamo, Arlete; Cuamba, Assa Júlio; Fumo, Leida Artur; Silveira, Jacinta; Heitman, Elizabeth; Moon, Troy D

2018-05-23

Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee's respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master's degree research (42%). Descriptive cross-sectional studies were the most frequently reviewed research (61%). The majority were prospective (71%) and used quantitative methodologies (51%). The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS's average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens.

Parafricta Bootees and Undergarments to Reduce Skin Breakdown in People with or at Risk of Pressure Ulcers: A NICE Medical Technologies Guidance.

PubMed

Meads, Catherine; Glover, Matthew; Dimmock, Paul; Pokhrel, Subhash

2016-12-01

As part of the development of the National Institute for Health and Care Excellence (NICE) Medical Technologies Guidance on Parafricta Bootees and Undergarments to reduce skin breakdown in people with, or at risk of, pressure ulcers, the manufacturer (APA Parafricta Ltd) submitted clinical and economic evidence, which was critically appraised by an External Assessment Centre (EAC) and subsequently used by the Medical Technologies Advisory Committee (MTAC) to develop recommendations for further research. The University of Birmingham and Brunel University, acting as a consortium, were commissioned to act as the EAC, independently appraising the submission. This article is an overview of the original evidence submitted, the EAC's findings and the final NICE guidance. Very little comparative evidence was submitted to demonstrate the effectiveness of Parafricta Bootees or Undergarments. The sponsor submitted a simple cost analysis to estimate the costs of using Parafricta in addition to current practice-in comparison with current practice alone-in hospital and community settings separately. The analysis took a National Health Service (NHS) perspective. The basis of the analysis was a previously published comparative study, which showed no statistical difference in average lengths of stay between patients who wore Parafricta Undergarments and Bootees, and those who did not. The economic model incorporated the costs of Parafricta but assumed shorter lengths of stay with Parafricta. The sponsor concluded that Parafricta was cost saving relative to the comparators. The EAC made amendments to the sponsor's analysis to correct for errors and to reflect alternative assumptions. Parafricta remained cost saving in most analyses, and the savings per prevalent case ranged from £757 in the hospital model to £3455 in the community model. All analyses were severely limited by the available data on effectiveness-in particular, a lack of good-quality comparative studies.

77 FR 62449 - Approval and Promulgation of Implementation Plans; Alabama; Disapproval of 110(a)(2)(E)(ii...

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[Independent ethics committees for clinical research in Argentina. An evaluation and a system to guarantee their independence].

PubMed

Gonorazky, Sergio E

2008-01-01

The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.

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Tribal Resource Institute in Business, Engineering, and Science (T.R.I.B.E.S.). Part I, TRIBES Energy and Resource Management Simulation. Part II, Creative Writing--Essays submitted by the T.R.I.B.E.S. Students.

ERIC Educational Resources Information Center

Veirs, Val; And Others

The expository and creaive writing of Native American high school students enrolled in a summer program at Colorado College sponsored by TRIBES (Tribal Resource Institute in Business, Engineering, and Science) is featured in this document. Part 1 presents a simulation problem in energy and resource management followed by reports submitted by 28…

Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.

PubMed

Perez, Raymond; Archdeacon, Patrick; Roach, Nancy; Goodwin, Robert; Jarow, Jonathan; Stuccio, Nina; Forrest, Annemarie

2017-06-01

The Food and Drug Administration's final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative-nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. The investigative site's responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors'"filtering" of reports and increased sponsor communication. Sponsors replied that their greatest challenges include (1) lack of global harmonization in reporting rules, (2) determining causality, and (3) fear of regulatory repercussions. Interaction with the Food and Drug Administration has helped improve sponsors' adherence to the final rule, and sponsors would benefit from increased communication with the Food and Drug Administration and educational materials. The goal of the final rule is to minimize uninformative safety reports so that important safety signals can be captured and communicated early enough in a clinical program to make changes that help ensure patient safety. Investigative staff and sponsors acknowledge that the rule has not been fully implemented although they agree with the intention. Clinical Trials Transformation Initiative will use the results from the surveys and interviews to develop new recommendations and educational materials that will be available to sponsors to increase compliance with the final rule and facilitate discussion between sponsors, investigators, and Food and Drug Administration representatives.

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Transforming the Army Service Component Command to a Theater Army

DTIC Science & Technology

2013-03-01

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10th international conference on high-occupancy vehicle systems : compendium of technical papers

DOT National Transportation Integrated Search

2001-08-01

This report provides the technical papers submitted as part of the 10th International High-Occupancy Vehicle (HOV) Systems Conference held in Dallas, Texas on August 27-30, 2000. The Conference was sponsored by the Transportation Research Board (TRB)...

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Draelos, Timothy John; Dautenhahn, Nathan; Schroeppel, Richard Crabtree

The security of the widely-used cryptographic hash function SHA1 has been impugned. We have developed two replacement hash functions. The first, SHA1X, is a drop-in replacement for SHA1. The second, SANDstorm, has been submitted as a candidate to the NIST-sponsored SHA3 Hash Function competition.

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Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval.

PubMed

Giezen, Thijs J; Mantel-Teeuwisse, Aukje K; Straus, Sabine M J M; Egberts, Toine C G; Blackburn, Stella; Persson, Ingemar; Leufkens, Hubert G M

2009-01-01

Since November 2005, an EU Risk Management Plan (EU-RMP) has had to be submitted as part of a marketing application for all new chemical entities in the EU. In the EU-RMP, the safety profile of the medicine has to be described and pharmacovigilance activities should be proposed to study further safety concerns during use of the drug in the real-world setting. These activities include, for example, collection of spontaneously reported adverse events and post-authorization safety studies (PASS). Since the submission of an EU-RMP is a relatively new requirement, there is limited knowledge on the quality and completeness of the study protocols of PASS at the time of approval and there are no data on the influence of certain drug characteristics on the proposed pharmacovigilance activities. To examine the types of proposed pharmacovigilance activities in a sample of EU-RMPs, describe and evaluate the methodology of PASS, identify problems and propose remedies, and compare characteristics between biologicals and small molecules. Eighteen EU-RMPs (nine for biologicals, nine for small molecules) given a positive decision regarding the marketing application by the Committee for Medicinal Products for Human Use between November 2005 and May 2007 were included in this descriptive cohort study. The EU-RMPs were selected over time and different therapeutic areas. Classification of the safety concerns ('important identified risks', 'important potential risks', 'important missing information' within the EU-RMP was studied. For PASS, data source (registry, population-based database, sponsor-owned clinical trial database), source of study population to be included in PASS and comprehensiveness of study protocol (full protocol, limited protocol, study synopsis, short description, commitment without further information) were studied. Compared to small molecules, safety concerns for biologicals were less frequently classified as important identified risks (relative risk [RR] 0.6; 95% CI 0.3, 1.0) and more frequently as important missing information (RR 1.6; 95% CI 1.0, 2.7). Forty-seven PASS were proposed; 31 for biologicals and 16 for small molecules. Compared with studies proposed in population-based databases (4 for biologicals, 8 for small molecules), studies in registries (18 for biologicals, 4 for small molecules) were more frequently proposed for biologicals than for small molecules (RR 2.5; 95% CI 1.1, 5.7). About 60% of the proposed PASS will include EU inhabitants. No full study protocols were submitted; 26% involved a limited study protocol, 33% a study synopsis, 37% a short description and 4% a commitment without further information. Approximately 40% of the study proposals for PASS were classified as a short description or a commitment to perform a study without further information, precluding an adequate scientific assessment. Studying non-EU populations may give rise to difficulties with generalizability of the results to the EU due to differences in patient characteristics, differences in the indication for the medicine and different healthcare systems. This study emphasizes the need for more complete study proposals to be submitted earlier on in the evaluation period and for the inclusion of EU inhabitants in PASS. In addition, differences in the characteristics between biologicals and small molecules, e.g. in the data source proposed, support the need for individualized tailored PASS depending on the type of drug.

Pharmacotherapeutics of Intranasal Scopolamine: FDA Regulations and Procedures for Clinical Applications

NASA Technical Reports Server (NTRS)

Das, H.; Daniels, V. R.; Vaksman, Z.; Boyd, J. L.; Buckey, J. C.; Locke, J. P.; Putcha, L.

2007-01-01

Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.

A Novel Approach to Assay DNA Methylation in Prostate Cancer

DTIC Science & Technology

2016-10-01

prepared into libraries according to standard protocols using Bioo Scientific’s DNA Sample Kit (cat. no. 514101, Austin , TX , USA). Libraries were...Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for Public Release; Distribution Unlimited...ADDRESS(ES) 10. SPONSOR/MONITOR’S ACRONYM(S) U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 11. SPONSOR/MONITOR’S

Biodiversity gains from efficient use of private sponsorship for flagship species conservation.

PubMed

Bennett, Joseph R; Maloney, Richard; Possingham, Hugh P

2015-04-22

To address the global extinction crisis, both efficient use of existing conservation funding and new sources of funding are vital. Private sponsorship of charismatic 'flagship' species conservation represents an important source of new funding, but has been criticized as being inefficient. However, the ancillary benefits of privately sponsored flagship species conservation via actions benefiting other species have not been quantified, nor have the benefits of incorporating such sponsorship into objective prioritization protocols. Here, we use a comprehensive dataset of conservation actions for the 700 most threatened species in New Zealand to examine the potential biodiversity gains from national private flagship species sponsorship programmes. We find that private funding for flagship species can clearly result in additional species and phylogenetic diversity conserved, via conservation actions shared with other species. When private flagship species funding is incorporated into a prioritization protocol to preferentially sponsor shared actions, expected gains can be more than doubled. However, these gains are consistently smaller than expected gains in a hypothetical scenario where private funding could be optimally allocated among all threatened species. We recommend integrating private sponsorship of flagship species into objective prioritization protocols to sponsor efficient actions that maximize biodiversity gains, or wherever possible, encouraging private donations for broader biodiversity goals. © 2015 The Author(s) Published by the Royal Society. All rights reserved.

Biodiversity gains from efficient use of private sponsorship for flagship species conservation

PubMed Central

Bennett, Joseph R.; Maloney, Richard; Possingham, Hugh P.

2015-01-01

To address the global extinction crisis, both efficient use of existing conservation funding and new sources of funding are vital. Private sponsorship of charismatic ‘flagship’ species conservation represents an important source of new funding, but has been criticized as being inefficient. However, the ancillary benefits of privately sponsored flagship species conservation via actions benefiting other species have not been quantified, nor have the benefits of incorporating such sponsorship into objective prioritization protocols. Here, we use a comprehensive dataset of conservation actions for the 700 most threatened species in New Zealand to examine the potential biodiversity gains from national private flagship species sponsorship programmes. We find that private funding for flagship species can clearly result in additional species and phylogenetic diversity conserved, via conservation actions shared with other species. When private flagship species funding is incorporated into a prioritization protocol to preferentially sponsor shared actions, expected gains can be more than doubled. However, these gains are consistently smaller than expected gains in a hypothetical scenario where private funding could be optimally allocated among all threatened species. We recommend integrating private sponsorship of flagship species into objective prioritization protocols to sponsor efficient actions that maximize biodiversity gains, or wherever possible, encouraging private donations for broader biodiversity goals. PMID:25808885

Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

PubMed Central

Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

2017-01-01

Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the sponsor. High remuneration and strict confidentiality clauses in these studies could influence the physicians’ reporting behaviours of adverse drug reactions. PMID:28174182

IMPACT OF BODY WEIGHT CHANGE ON THE EDSTAC TIER 1 MALE AND FEMALE PUBERTAL PROTOCOLS

EPA Science Inventory

IMPACT OF BODY WEIGHT CHANGE ON THE EDSTAC TIER I MALE AND FEMALE PUBERTAL PROTOCOLS. R.L. Cooper, T.E. Stoker, K. McElroy, J. Ferrell, K. Leffler, K. Bremser and S.C. Laws. Endocrinology Branch, Reproductive Toxicology Division, NHEERL, ORD, USEPA, RTP, NC. Sponsor: R.J. Kavl...

76 FR 81982 - Agency Information Collection Activities; Submission for OMB Review; Comment Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-29

... Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information... Administration (ETA), Office of Management and Budget, Room 10235, Washington, DC 20503, Telephone: (202) 395... Insurance statutory and regulatory requirements, ETA 581 provides quarterly data on State agencies' volume...

76 FR 35914 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Voluntary...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-20

... Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored... Labor, Occupational Safety and Health Administration (OSHA), Office of Management and Budget, Room 10235... submission of responses. Agency: Occupational Safety and Health Administration (OSHA). Title of Collection...

78 FR 41953 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Labor...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-12

... DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Labor Organization and Auxiliary Reports ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Office of Labor Management Standards (OLMS) sponsored information...

10 CFR 609.4 - Submission of Pre-Applications.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Submission of Pre-Applications. 609.4 Section 609.4 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS LOAN GUARANTEES FOR PROJECTS THAT EMPLOY INNOVATIVE... Pre-Applications, either Project Sponsors or Applicants may submit Pre-Applications to DOE. Pre...

10 CFR 609.4 - Submission of Pre-Applications.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Submission of Pre-Applications. 609.4 Section 609.4 Energy DEPARTMENT OF ENERGY (CONTINUED) ASSISTANCE REGULATIONS LOAN GUARANTEES FOR PROJECTS THAT EMPLOY INNOVATIVE... Pre-Applications, either Project Sponsors or Applicants may submit Pre-Applications to DOE. The...

78 FR 67196 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Annual...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-08

... DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Annual Refiling Survey ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Bureau of Labor Statistics (BLS) sponsored information collection request...

78 FR 17233 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Process...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-20

... ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Process Safety Management of...., permitting electronic submission of responses. Agency: DOL-OSHA. Title of Collection: Process Safety...

77 FR 5060 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Bloodborne...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-01

... of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored..., Occupational Safety and Health Administration (OSHA), Office of Management and Budget, Room 10235, Washington... electronic submission of responses. Agency: Occupational Safety and Health Administration (OSHA). Title of...

77 FR 5278 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Commercial...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-02

... Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored..., Occupational Safety and Health Administration (OSHA), Office of Management and Budget, Room 10235, Washington... submission of responses. Agency: Occupational Safety and Health Administration (OSHA). Title of Collection...

76 FR 66996 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Forging...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-28

... (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information... submission of responses. Agency: Occupational Safety and Health Administration (OSHA). Title of Collection... Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor, Occupational Safety and Health...

78 FR 16538 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Standard on...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-15

.... SUMMARY: The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Standard on 4,4'-Methylenedianiline in...'-Methylenedianiline (MDA) in Construction protects workers from adverse health effects associated with occupational...

78 FR 78385 - Agency Information Collection Activities; Submission for OMB Review; Comment Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-26

... Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored... pertaining to noise exposure-monitoring and audiometric testing. The Occupational Safety and Health Act... submission of responses. Agency: DOL-OSHA. Title of Collection: Occupational Noise Exposure Standard. OMB...

78 FR 7456 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Hexavalent...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-01

... submit the Occupational Safety and Health Administration (OSHA) sponsored information collection request... of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and..., e.g., permitting electronic submission of responses. Agency: DOL-OSHA. Title of Collection...

76 FR 30971 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Underground...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-27

... Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored... Labor, Occupational Safety and Health Administration (OSHA), Office of Management and Budget, Room 10235... submission of responses. Agency: Occupational Safety and Health Administration (OSHA). Title of Collection...

78 FR 19313 - Office of the Secretary

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-29

... Department of Labor (DOL) will submit the Occupational Safety and Health Administration (OSHA) sponsored... request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office... Standard at 29 CFR 1910.269 address safety procedures for the use of electrical protective equipment and...

77 FR 5277 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Shipyard...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-02

... of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored... and Health Administration (OSHA), Office of Management and Budget, Room 10235, Washington, DC 20503... Health Administration (OSHA). Title of Collection: Standard on Shipyard Employment (29 CFR part 1915...

77 FR 9945 - Draft Guidance for Industry on Providing Submissions in Electronic Format-Standardized Study Data...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-21

...] Draft Guidance for Industry on Providing Submissions in Electronic Format--Standardized Study Data... Submissions in Electronic Format--Standardized Study Data.'' This draft guidance establishes FDA's recommendation that sponsors and applicants submit nonclinical and clinical study data in a standardized...

Developing Financial Resources for School Arts Programs.

ERIC Educational Resources Information Center

Green, Alan C.; Ambler, Nancy Morison

This document provides a sampling of financial resources for fine arts programs in the schools and lists methods for submitting proposals and dealing with sponsors of funds. Financial sources for arts programs include school districts, organizations and institutions, special events, direct mail, individuals, associations and clubs, businesses and…

78 FR 16870 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Benefit...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-19

... for OMB Review; Comment Request; Benefit Rights and Experience Report ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) titled, ``Benefit Rights and Experience Report,'' to the Office of...

Enhancing the Pharmacokinetic Profile of Protein-Based Drugs

DTIC Science & Technology

2014-06-12

policy or decision, unless so designated by other documentation. 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS (ES) U.S. Army Research Office P.O...activated carrier. The reactions were deglycosylated, desalted by ZipTip, and submitted for MALDI-TOF MS analysis. The 0 equivalent control reaction

14 CFR 151.21 - Procedures: Application; general information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... TRANSPORTATION (CONTINUED) AIRPORTS FEDERAL AID TO AIRPORTS Rules and Procedures for Airport Development Projects... Federal aid for eligible airport development must submit to the Area Manager of the area in which the... the project development; and (2) The sponsor's written assurance, if the project involves displacement...

76 FR 29793 - Agency Information Collection Activities: Proposed Collection; Comments Requested: Controlled...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-23

... Declaration; DEA Form 236 ACTION: 30-Day notice of information collection under review. The Department of Justice (DOJ), Drug Enforcement Administration (DEA) will be submitting the following information... the applicable component of the Department sponsoring the collection: Form number: DEA Form 236...

76 FR 10392 - Agency Information Collection Activities: Proposed Collection; Comments Requested

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-24

... collection under review; Registrants' Inventory of Drugs Surrendered--DEA Form 41. The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information collection...--DEA Form 41. (3) Agency form number, if any, and the applicable component of the Department sponsoring...

75 FR 56545 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-16

... produced household and person-level data to monitor health-related areas. Questionnaire content is drawn... sponsor needs. Examples of topical areas include infant, child, adolescent, parent, and family health, well-being, and knowledge, attitude, and behaviors; children with special health care needs (CSHCN...

76 FR 18582 - Agency Information Collection Activities: Proposed Collection: Comments Requested

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-04

... (OJP), Bureau of Justice Statistics (BJS), will be submitting the following information collection... Christine Eith, Bureau of Justice Statistics, 810 Seventh Street, NW., Washington, DC 20531 (phone: 202- 305... applicable component of the Department sponsoring the collection: PPCS-1. Bureau of Justice Statistics...

75 FR 45665 - Justice Management Division; Office of Attorney Recruitment and Management; Agency Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... Recruitment and Management; Agency Information Collection Activities: Proposed Collection; Comments Requested... Recruitment and Management (OARM), will be submitting the following information collection request for review... component of the Department sponsoring the collection: Form Number: none. Office of Attorney Recruitment and...

77 FR 64962 - Privacy Act of 1974, as Amended

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-24

... social media, and recipients of other public relations materials issued by the CFPB about CFPB sponsored... Financial Protection Bureau, 1700 G Street NW., Washington, DC 20552. Comments will be available for public... the public record and subject to public disclosure. You should submit only information that you wish...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

76 FR 29796 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Refuse...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-23

... for OMB Review; Comment Request; Refuse Piles and Impounding Structures, Recordkeeping and Reporting... Administration (MSHA) sponsored information collection request (ICR) titled, ``Refuse Piles and Impounding... to submit annual reports and certification on refuse piles and impoundments to the agency and to keep...

78 FR 31581 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Registered...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-24

...: The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored... of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and... electronic submission of responses. Agency: DOL-ETA. Title of Collection: Registered Apprenticeship College...

78 FR 15740 - Agency Information Collection Activities; Submission for OMB Review; Comment Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-12

... of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information... Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th...). SUPPLEMENTARY INFORMATION: Information collected on the Occupational Code Assignment Form (Form ETA-741) is...

78 FR 68095 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; American...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

...) is submitting the Employment and Training Administration (ETA) sponsored information collection... Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC... INFORMATION: The ICR seeks continued PRA authorization for the ETA to conduct the American Recovery and...

77 FR 55227 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Veterans...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-07

... Department of Labor (DOL) is submitting the Employment and Training Administration (ETA sponsored information... Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room... electronic submission of responses. Agency: DOL-ETA. Title of Collection: Veterans Retraining Assistance...

77 FR 58581 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Claims and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-21

... of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored Information... Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room.... 3507(a)(1)(D). SUPPLEMENTARY INFORMATION: Form ETA-5159 provides important program information on...

78 FR 76656 - Agency Information Collection Activities; Submission for OMB Review; Comment Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-18

... to provide the OSHA, National Institute for Occupational Safety and Health, affected workers, and... Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information... Occupational Safety and Health Act authorizes this information collection. See 29 U.S.C. 651, 655, and 657...

76 FR 32988 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Grain...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-07

... Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information..., Occupational Safety and Health Administration (OSHA), Office of Management and Budget, Room 10235, Washington... directed toward assuring the safety of workers in grain handling through development of a housekeeping plan...

78 FR 36276 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Regulations...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-17

... Complaints ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) revision titled... Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995...

77 FR 38322 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Training...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-27

... Department of Labor (DOL) is submitting the Mine Safety and Health Administration sponsored information... significant safety regulations affecting this industry sector. Training informs miners of safety and health... production demands; and increased demand for contractors who may be less familiar with the dangers on mine...

7 CFR 225.14 - Requirements for sponsor participation.

Code of Federal Regulations, 2010 CFR

2010-01-01

... an unanticipated school closure during the period from October through April (or at any time of the..., from submitting a new application if they have participated in the program at any time during the... and have the capability and the facilities to provide the meal service planned for the number of...

7 CFR 225.14 - Requirements for sponsor participation.

Code of Federal Regulations, 2011 CFR

2011-01-01

... an unanticipated school closure during the period from October through April (or at any time of the..., from submitting a new application if they have participated in the program at any time during the... and have the capability and the facilities to provide the meal service planned for the number of...

77 FR 73683 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Escape and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-11

... for OMB Review; Comment Request; Escape and Evacuation Plans for Surface Coal Mines and Surface Facilities and Surface Work Areas of Underground Coal Mines ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Mine safety and Health Administration (MSHA) sponsored information collection...

77 FR 37440 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Mine...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-21

... for OMB Review; Comment Request; Mine Mapping and Records of Opening, Closing, and Reopening of Mines ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, ``Mine Mapping and Records of...

42 CFR 423.2325 - Provision of applicable discounts.

Code of Federal Regulations, 2012 CFR

2012-10-01

...) Pharmacy prompt payment. Part D sponsors must reimburse a network pharmacy (as defined in § 423.100) the... dispensing of an applicable drug. For long-term care and home infusion pharmacies, the date of dispensing can be interpreted as the date the pharmacy submits the discounted claim for reimbursement. ...

42 CFR 423.2325 - Provision of applicable discounts.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) Pharmacy prompt payment. Part D sponsors must reimburse a network pharmacy (as defined in § 423.100) the... dispensing of an applicable drug. For long-term care and home infusion pharmacies, the date of dispensing can be interpreted as the date the pharmacy submits the discounted claim for reimbursement. ...

42 CFR 423.2325 - Provision of applicable discounts.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) Pharmacy prompt payment. Part D sponsors must reimburse a network pharmacy (as defined in § 423.100) the... dispensing of an applicable drug. For long-term care and home infusion pharmacies, the date of dispensing can be interpreted as the date the pharmacy submits the discounted claim for reimbursement. ...

76 FR 81983 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Cognitive...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-29

... Statistics (BLS). Title of Collection: Cognitive and Psychological Research. OMB Control Number: 1220-0141... Department of Labor (DOL) is submitting the Bureau of Labor Statistics (BLS) sponsored information collection... Statistics (BLS), Office of Management and Budget, Room 10235, Washington, DC 20503, Telephone: (202) 395...

78 FR 75946 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Loans to...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-13

... for OMB Review; Comment Request; Loans to Plan Participants and Beneficiaries Who Are Parties in... submitting the Employee Benefits Security Administration (EBSA) sponsored information collection request (ICR) titled, ``Loans to Plan Participants and Beneficiaries Who Are Parties In Interest With Respect to the...

14 CFR 60.16 - Additional qualifications for a currently qualified FSTD.

Code of Federal Regulations, 2010 CFR

2010-01-01

... TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE... required to undergo an additional qualification process if a user intends to use the FSTD for meeting... that FSTD. This process consists of the following: (1) The sponsor: (i) Must submit to the NSPM all...

14 CFR 152.323 - Budget revision: Airport development.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Budget revision: Airport development. 152... TRANSPORTATION (CONTINUED) AIRPORTS AIRPORT AID PROGRAM Accounting and Reporting Requirements § 152.323 Budget... change in the budget estimates, the sponsor shall submit a request for budget revision on a form...

78 FR 77497 - Agency Information Collection Activities; Submission for OMB Review; Comment Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-23

... Training Requirements ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled... Occupational Safety and Health Act authorizes this information collection. See 29 U.S.C. 651 and 657. This...

76 FR 67225 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Standard on...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-31

... (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information... Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor, Occupational Safety and Health... Health Administration (OSHA). Title of Collection: Standard on Slings. OMB Control Number: 1218-0223...

77 FR 38832 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Marine...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-29

...: On June 29, 2012, the Department of Labor (DOL) will submit the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Marine Terminals and Longshoring... request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office...

78 FR 52214 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Derricks...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-22

... (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information... Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room 10235, 725...., permitting electronic submission of responses. Agency: DOL-OSHA. Title of Collection: Derricks Standard. OMB...

77 FR 65414 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Lead in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-26

... of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored... Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room... occupational exposure to lead. Employers must monitor exposure to lead, provide medical surveillance, train...

77 FR 31878 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Blasting...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-30

.... SUMMARY: The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Blasting Operations and Use of... this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA...

78 FR 77496 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Student...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-23

... (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information... maintain PRA authorization for the Student Data Form, Form OSHA-182. The Occupational Safety and Health Act... education in occupational safety and health for Federal and State compliance officers, OSHA professionals...

78 FR 23785 - Agency Information Collection Activities; Submission for OMB Review; Comment Request: Standard on...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-22

...: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Standard on 4,4...-OSHA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503, Fax: 202...

76 FR 4369 - Renewal of OMB Control Number 1004-0041

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

...] Renewal of OMB Control Number 1004-0041 AGENCY: Bureau of Land Management, Interior. ACTION: 60-Day Notice... collection activity, and assigned it control number 1004- 0041. DATES: Submit comments on the proposed... conduct or sponsor a collection of information unless it displays a currently valid OMB control number...

14 CFR 151.21 - Procedures: Application; general information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... (built, if necessary), without regard to their race, color, religion, sex, or national origin, before the... may be withdrawn if the sponsor fails to submit an acceptable project application as provided in paragraph (c) of this section or fails to proceed diligently with the project, or if adequate replacement...

14 CFR 151.21 - Procedures: Application; general information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... (built, if necessary), without regard to their race, color, religion, sex, or national origin, before the... may be withdrawn if the sponsor fails to submit an acceptable project application as provided in paragraph (c) of this section or fails to proceed diligently with the project, or if adequate replacement...

14 CFR 151.21 - Procedures: Application; general information.

Code of Federal Regulations, 2013 CFR

2013-01-01

... (built, if necessary), without regard to their race, color, religion, sex, or national origin, before the... may be withdrawn if the sponsor fails to submit an acceptable project application as provided in paragraph (c) of this section or fails to proceed diligently with the project, or if adequate replacement...

14 CFR 151.21 - Procedures: Application; general information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... (built, if necessary), without regard to their race, color, religion, sex, or national origin, before the... may be withdrawn if the sponsor fails to submit an acceptable project application as provided in paragraph (c) of this section or fails to proceed diligently with the project, or if adequate replacement...

77 FR 39264 - Agency Information Collection Activities; Proposed Collection; Comments Requested: Census of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-02

... Programs, Office of Juvenile Justice and Delinquency Prevention, has submitted the following information... Brecht Donoghue, (202) 305-1270, Office of Juvenile Justice and Delinquency Prevention, Office of Justice... Department sponsoring the collection: The form number is CJ-17, Office of Juvenile Justice and Delinquency...

77 FR 54613 - Agency Information Collection Activities; Proposed Collection; Comments Requested: Census of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-05

... Programs, Office of Juvenile Justice and Delinquency Prevention, will be submitting the following... Brecht Donoghue, (202) 305-1270, Office of Juvenile Justice and Delinquency Prevention, Office of Justice... Department sponsoring the collection: The form number is CJ-17, Office of Juvenile Justice and Delinquency...

76 FR 38699 - Agency Information Collection Activities: Proposed Collection; Comments Requested

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

... Forfeiture and Money Laundering Section (AFMLS) will be submitting the following information collection... of Justice sponsoring the collection: Form Number: N/A. Criminal Division, Asset Forfeiture and Money Laundering Section. (4) Affected public who will be asked or required to respond, as well as a brief abstract...

29 CFR 4231.9 - Request for compliance determination.

Code of Federal Regulations, 2011 CFR

2011-07-01

... address set forth in § 4231.8(c). (2) Single request permitted for all de minimis transactions. Because the plan solvency test for de minimis mergers and transfers is based on the most recent valuation (without adjustment for intervening de minimis transactions), a plan sponsor may submit a single request...

10 CFR 950.21 - Notification of covered event.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Energy DEPARTMENT OF ENERGY STANDBY SUPPORT FOR CERTAIN NUCLEAR PLANT DELAYS Claims Administration Process § 950.21 Notification of covered event. (a) A sponsor shall submit in writing to the Claims Administrator a notification that a covered event has occurred that has delayed the schedule for construction or...

10 CFR 950.21 - Notification of covered event.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Energy DEPARTMENT OF ENERGY STANDBY SUPPORT FOR CERTAIN NUCLEAR PLANT DELAYS Claims Administration Process § 950.21 Notification of covered event. (a) A sponsor shall submit in writing to the Claims Administrator a notification that a covered event has occurred that has delayed the schedule for construction or...

10 CFR 950.21 - Notification of covered event.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Energy DEPARTMENT OF ENERGY STANDBY SUPPORT FOR CERTAIN NUCLEAR PLANT DELAYS Claims Administration Process § 950.21 Notification of covered event. (a) A sponsor shall submit in writing to the Claims Administrator a notification that a covered event has occurred that has delayed the schedule for construction or...

10 CFR 950.21 - Notification of covered event.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Energy DEPARTMENT OF ENERGY STANDBY SUPPORT FOR CERTAIN NUCLEAR PLANT DELAYS Claims Administration Process § 950.21 Notification of covered event. (a) A sponsor shall submit in writing to the Claims Administrator a notification that a covered event has occurred that has delayed the schedule for construction or...

77 FR 71196 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Jobs for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-29

... for OMB Review; Comment Request; Jobs for Veterans State Grants Reports ACTION: Notice. SUMMARY: On November 30, 2012, the Department of Labor (DOL) will submit the Veterans' Employment and Training Service (VETS) sponsored information collection request (ICR) revision titled, ``Jobs for Veterans State Grants...

78 FR 67198 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Job Corps...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-08

... for OMB Review; Comment Request; Job Corps Application Data ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) titled, ``Job Corps Application Data,'' to the Office of Management and Budget (OMB...

77 FR 77111 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Reporting...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-31

... for OMB Review; Comment Request; Reporting for the National Farmworker Jobs Program under Section 167... submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, ``Reporting for the National Farmworker Jobs Program under Section 167 of Title I of the...

76 FR 35913 - Agency Information Collection Activities: Proposed Collection; Comments Requested: U.S. Official...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-20

... II Controlled Substances (Accountable Forms); Order Form Requisition; DEA Form 222, 222a, Controlled... Justice (DOJ), Drug Enforcement Administration (DEA) will be submitting the following information... applicable component of the Department sponsoring the collection: Form number: DEA Forms 222 and 222a...

77 FR 47666 - Agency Information Collection Activities: Proposed Collection; Comments Requested: Import/Export...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-09

... II Chemicals; DEA Forms 486 and 486A ACTION: 60-Day Notice of Information Collection Under Review. The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the... Justice sponsoring the collection: Form Number: DEA Forms 486 and 486A. Component: Office of Diversion...

78 FR 27214 - Notice of Call for Nominations for Appointment to the Environmental Management Advisory Board

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

... nuclear weapons development and government- sponsored nuclear energy research. EMAB provides advice to the... DEPARTMENT OF ENERGY Notice of Call for Nominations for Appointment to the Environmental... open call to the public to submit nominations for membership on the Environmental Management Advisory...

76 FR 82321 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-30

... for OMB Review; Comment Request; Notice of Controversion of Right to Compensation ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, Notice of Controversion of Right to Compensation...

21 CFR 601.28 - Annual reports of postmarketing pediatric studies.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Annual reports of postmarketing pediatric studies. 601.28 Section 601.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... pediatric studies. Sponsors of licensed biological products shall submit the following information each year...

21 CFR 601.28 - Annual reports of postmarketing pediatric studies.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Annual reports of postmarketing pediatric studies. 601.28 Section 601.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... pediatric studies. Sponsors of licensed biological products shall submit the following information each year...

76 FR 44960 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Report on...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-27

... for OMB Review; Comment Request; Report on Current Employment Statistics ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the revised Bureau of Labor Statistics (BLS) sponsored information collection request (ICR) titled, ``Report on Current Employment Statistics,'' to the Office of Management and...

77 FR 16047 - Agency Information Collection Activities: Form I-589; Extension of an Existing Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information... Immigration Services (USCIS) will be submitting the following information collection request for review and... Security sponsoring the collection: Form I-589; U.S. Citizenship and Immigration Services (USCIS). (4...

77 FR 50710 - Agency Information Collection Activities: Employment Eligibility Verification, Form I-9, OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information...), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information... sponsoring the collection: Form I-9. U.S. Citizenship and Immigration Services. (4) Affected public who will...

77 FR 27474 - Agency Information Collection Activities: Form I-687; Extension of an Existing Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-10

... DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information... Immigration Services (USCIS) has submitted the following information collection request for review and... sponsoring the collection: Form I-687; U.S. Citizenship and Immigration Services (USCIS). (4) Affected public...

77 FR 3484 - Agency Information Collection Activities: Form I-914, Extension of a Currently Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-24

... DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information... Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) will be submitting the... Security sponsoring the collection: Form I-914. U.S. Citizenship and Immigration Services. (4) Affected...

Extrudable Gel-Forming Bioabsorbable Hemostatic Tissue Adhesives for Traumatic and Burn Wounds

DTIC Science & Technology

1996-12-01

DAMD17-96-1-6241 6. AUTHOR(S) Shalaby W. Shalaby, Ph.D. 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS( ES ) B. PERFORMING ORGANIZATION Poly-Med...Incorporated REPORT NUMBER Anderson, South Carolina 29625 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS( ES ) 10. SPONSORING/MONITORING Commander AGENCY...the wound breaking strength. This was done using a Satec universal testing machine. Details of the animal protocol are given in Appendix A. The

Whole Exome Analysis of Early Onset Alzheimer’s Disease

DTIC Science & Technology

2017-04-01

manufacturer’s protocol at the HIHG Center for Genome Technology. After capture, the DNA was tested for uniform enrichment of targets via quantitative PCR...CONTRACTING ORGANIZATION: University of Miami Miami, FL 33136 REPORT DATE: April 2017 TYPE OF REPORT: Annual PREPARED FOR: U.S. Army Medical Research ...U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 10. SPONSOR/MONITOR’S ACRONYM(S) 11. SPONSOR/MONITOR’S REPORT NUMBER

21 CFR 316.25 - Refusal to grant orphan-drug designation.

Code of Federal Regulations, 2012 CFR

2012-04-01

... following reasons apply: (1) The drug is not intended for a rare disease or condition because: (i) There is insufficient evidence to support the estimate that the drug is intended for treatment of a disease or condition... the same rare disease or condition and the sponsor has not submitted a medically plausible hypothesis...

21 CFR 316.25 - Refusal to grant orphan-drug designation.

Code of Federal Regulations, 2013 CFR

2013-04-01

... following reasons apply: (1) The drug is not intended for a rare disease or condition because: (i) There is insufficient evidence to support the estimate that the drug is intended for treatment of a disease or condition... the same rare disease or condition and the sponsor has not submitted a medically plausible hypothesis...

21 CFR 316.25 - Refusal to grant orphan-drug designation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... following reasons apply: (1) The drug is not intended for a rare disease or condition because: (i) There is insufficient evidence to support the estimate that the drug is intended for treatment of a disease or condition... the same rare disease or condition and the sponsor has not submitted a medically plausible hypothesis...

21 CFR 316.25 - Refusal to grant orphan-drug designation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... following reasons apply: (1) The drug is not intended for a rare disease or condition because: (i) There is insufficient evidence to support the estimate that the drug is intended for treatment of a disease or condition... the same rare disease or condition and the sponsor has not submitted a medically plausible hypothesis...

40 CFR 790.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... substance or mixture is able to represent or substitute for another in a test or series of tests, and that... submitted to EPA and ends after an amount of time equal to that which had been required to develop data or after five years, whichever is later. Sponsor means the person or persons who design, direct and finance...

40 CFR 790.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... substance or mixture is able to represent or substitute for another in a test or series of tests, and that... submitted to EPA and ends after an amount of time equal to that which had been required to develop data or after five years, whichever is later. Sponsor means the person or persons who design, direct and finance...

40 CFR 790.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... substance or mixture is able to represent or substitute for another in a test or series of tests, and that... submitted to EPA and ends after an amount of time equal to that which had been required to develop data or after five years, whichever is later. Sponsor means the person or persons who design, direct and finance...

49 CFR 80.11 - Investment-grade ratings.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false Investment-grade ratings. 80.11 Section 80.11... § 80.11 Investment-grade ratings. (a) At the time a project sponsor submits an application, the DOT... investment-grade rating. (b) The full funding of a secured (direct) loan, loan guarantee, or line of credit...

78 FR 67199 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Resource...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-08

... of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information... Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th...(a)(1)(D). SUPPLEMENTARY INFORMATION: This ICR seeks to extend PRA authorization for the ETA to...

77 FR 27485 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Experience...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-10

... Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information... Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235... INFORMATION: The Experience Rating Report (Form ETA-204) provides data to the ETA for the study of seasonality...

49 CFR 80.11 - Investment-grade ratings.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false Investment-grade ratings. 80.11 Section 80.11... § 80.11 Investment-grade ratings. (a) At the time a project sponsor submits an application, the DOT... investment-grade rating. (b) The full funding of a secured (direct) loan, loan guarantee, or line of credit...

78 FR 52803 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Additional...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-26

... Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled... Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). DATES: Submit comments on or before... Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room...

Annual Report: Discipline, Crime, and Violence. School Year. 2002-2003.

ERIC Educational Resources Information Center

Virginia State Department of Education, 2004

2004-01-01

The Code of Virginia requires school divisions statewide to submit data annually to the Department of Education (DOE) on incidents of discipline, crime, and violence. These incidents shall include: (1) those that occurred on school property, on a school bus, or at a school-sponsored activity; and (2) offenses, wherever committed, by students…

76 FR 10406 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-24

... information collection on November 12, 2010 (75 FR 69474). No comments were received. NARA has submitted the... information collection: Title: Application and Permit for Use of Space in Presidential Library and Grounds... to request the use of space in the library for a privately sponsored activity. NARA uses the...

75 FR 48348 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-10

... of the redesigned National Hospital Discharge Survey, as well as a pretest of data collection on... followed by data for 2012 and 2013. A pretest of a survey supplement on acute coronary syndrome sponsored... financial information. The pretest of the supplement on acute coronary syndrome will be conducted in a...

75 FR 75473 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-03

... Services Social Marketing Campaigns--Extension--(0920-0775, exp. 4/30/2011), National Center for HIV/AIDS... CDC-sponsored social marketing campaigns: Social Marketing Campaign to Make HIV Testing a Routine Part... living with HIV. The goal of the Partner Services component of the PIC social marketing campaign is to...

78 FR 69448 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Crawler...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-19

.... SUMMARY: The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Crawler, Locomotive, and Truck Cranes... must be generated. Occupational Safety and Health Act sections 6(b)(7), 29 U.S.C. 655(b)(7), and 8(c...

78 FR 25476 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Benzene...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-01

... Department of Labor (DOL) will submit the Occupational Safety and Health Administration (OSHA) sponsored... Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room 10235, 725... submission of responses. Agency: DOL-OSHA. Title of Collection: Benzene Standard. OMB Control Number: 1218...

77 FR 36296 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Cadmium in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-18

... Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored... Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room... submission of responses. Agency: DOL-OSHA. Title of Collection: Cadmium in Construction Standard. OMB Control...

78 FR 71666 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Cranes and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

...: On November 29, 2013, the Department of Labor (DOL) will submit the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) revision titled, ``Cranes and Derricks in... to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL- OSHA, Office of...

77 FR 45689 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; The 1,2...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-01

... Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored... Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room..., e.g., permitting electronic submission of responses. Agency: DOL-OSHA. Title of Collection: The 1,2...

77 FR 65415 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Lead in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-26

... Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored... Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room... associated with occupational exposure to lead. Employers must monitor exposure to lead, provide medical...

77 FR 17097 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; The 13...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-23

... of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored... Institute for Occupational Safety and Health. This information collection is subject to the PRA. A Federal... Information and Regulatory Affairs, Attention: OMB Desk Officer for DOL-OSHA, Office of Management and Budget...

77 FR 56232 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Temporary...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-12

... Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored... Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room... mandatory for covered employers to report to the local public health officer the name and address of any...

77 FR 16265 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Permit...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-20

... Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored... . SUPPLEMENTARY INFORMATION: Under the authority granted by the Occupational Safety and Health Act, 29 U.S.C. 651 et seq., the OSHA published at 29 CFR 1910.146 a safety standard for general industry regulating...

77 FR 36295 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Cadmium in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-18

... Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored... Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room... submission of responses. Agency: DOL-OSHA. Title of Collection: Cadmium in General Industry Standard. OMB...

78 FR 77715 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Access to...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

.... SUMMARY: The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Access to Employee Exposure and Medical... Occupational Safety and Health Act authorizes this information collection. See 29 U.S.C. 651, 655, and 657...

42 CFR 423.272 - Review and negotiation of bid and approval of plans submitted by potential Part D sponsors.

Code of Federal Regulations, 2012 CFR

2012-10-01

...-PD plans with the following exceptions: (1) Exemption from negotiations. These plans are exempt from... prescription drug coverage and actuarial determinations. (1) Application of revenue requirements standard. CMS... in benefits offered under the plan. (c) Limited risk plans. (1) Application of limited risk plans...

42 CFR 423.272 - Review and negotiation of bid and approval of plans submitted by potential Part D sponsors.

Code of Federal Regulations, 2014 CFR

2014-10-01

...-PD plans with the following exceptions: (1) Exemption from negotiations. These plans are exempt from... prescription drug coverage and actuarial determinations. (1) Application of revenue requirements standard. CMS... in benefits offered under the plan. (c) Limited risk plans. (1) Application of limited risk plans...

76 FR 19741 - Draft Environmental Assessment; Giant Miscanthus in Arkansas, Missouri, Ohio, and Pennsylvania

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-08

... Aloterra Energy and MFA Oil Biomass Company (project sponsors) proposed project areas in Arkansas, Missouri, Ohio, and Pennsylvania as part of the Biomass Crop Assistance Program (BCAP). This notice provides a... Energy and MFA Oil Biomass Company submitted a proposal to FSA to establish BCAP project areas in...

Various Assessments Utilized in California Preliminary Administrative Services Preparation Programs

ERIC Educational Resources Information Center

Erickson, Deborah E.

2016-01-01

Every two years, institutions sponsoring credentialing programs in California are required to submit a detailed biennial report, which includes data on at least four key assessments showing 1) candidate competence and/or 2) program efficacy. This article reports the types of assessments used from 25 institutions that completed biennial reports for…

76 FR 66085 - Agency Information Collection Activities; Proposed Collection, Comments Requested: Application...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-25

... for Registration Renewal DEA Forms 363 and 363a ACTION: 60-Day Notice of Information Collection Under Review. The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the... Department of Justice sponsoring the collection: Form Number: DEA forms 363 and 363a. Component: Office of...

77 FR 14566 - Agency Information Collection Activities: Submitted for Office of Management and Budget (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-12

... paperwork requirements for the USGS Earthquake Report. We may not conduct or sponsor and a person is not.... SUPPLEMENTARY INFORMATION: OMB Control Number: 1028-0048. Title: USGS Earthquake Report. Type of Request...: Voluntary. Frequency of Collection: On occasion, after an earthquake. Estimated Completion Time: 6 minutes...

Fasting: a major limitation for resistance exercise training effects in rodents

PubMed Central

das Neves, W.; de Oliveira, L.F.; da Silva, R.P.; Alves, C.R.R.; Lancha, A.H.

2017-01-01

Protocols that mimic resistance exercise training (RET) in rodents present several limitations, one of them being the electrical stimulus, which is beyond the physiological context observed in humans. Recently, our group developed a conditioning system device that does not use electric shock to stimulate rats, but includes fasting periods before each RET session. The current study was designed to test whether cumulative fasting periods have some influence on skeletal muscle mass and function. Three sets of male Wistar rats were used in the current study. The first set of rats was submitted to a RET protocol without food restriction. However, rats were not able to perform exercise properly. The second and third sets were then randomly assigned into three experimental groups: 1) untrained control rats, 2) untrained rats submitted to fasting periods, and 3) rats submitted to RET including fasting periods before each RET session. While the second set of rats performed a short RET protocol (i.e., an adaptation protocol for 3 weeks), the third set of rats performed a longer RET protocol including overload (i.e., 8 weeks). After the short-term protocol, cumulative fasting periods promoted loss of weight (P<0.001). After the longer RET protocol, no difference was observed for body mass, extensor digitorum longus (EDL) morphology or skeletal muscle function (P>0.05 for all). Despite no effects on EDL mass, soleus muscle displayed significant atrophy in the fasting experimental groups (P<0.01). Altogether, these data indicate that fasting is a major limitation for RET in rats. PMID:29185588

Fasting: a major limitation for resistance exercise training effects in rodents.

PubMed

das Neves, W; de Oliveira, L F; da Silva, R P; Alves, C R R; Lancha, A H

2017-11-17

Protocols that mimic resistance exercise training (RET) in rodents present several limitations, one of them being the electrical stimulus, which is beyond the physiological context observed in humans. Recently, our group developed a conditioning system device that does not use electric shock to stimulate rats, but includes fasting periods before each RET session. The current study was designed to test whether cumulative fasting periods have some influence on skeletal muscle mass and function. Three sets of male Wistar rats were used in the current study. The first set of rats was submitted to a RET protocol without food restriction. However, rats were not able to perform exercise properly. The second and third sets were then randomly assigned into three experimental groups: 1) untrained control rats, 2) untrained rats submitted to fasting periods, and 3) rats submitted to RET including fasting periods before each RET session. While the second set of rats performed a short RET protocol (i.e., an adaptation protocol for 3 weeks), the third set of rats performed a longer RET protocol including overload (i.e., 8 weeks). After the short-term protocol, cumulative fasting periods promoted loss of weight (P<0.001). After the longer RET protocol, no difference was observed for body mass, extensor digitorum longus (EDL) morphology or skeletal muscle function (P>0.05 for all). Despite no effects on EDL mass, soleus muscle displayed significant atrophy in the fasting experimental groups (P<0.01). Altogether, these data indicate that fasting is a major limitation for RET in rats.

40 CFR 721.4472 - Phenyl, alkyl, hydroxyalkyl substituted imidazole (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... percent), and (c). (ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c... protocol. (3) TSCA Good Laboratory Practice Standards at 40 CFR part 792. (4) Using methodologies generally..., the person must obtain approval of test protocols from EPA by submitting written protocols. EPA will...

Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

PubMed Central

Perez, Raymond; Archdeacon, Patrick; Roach, Nancy; Goodwin, Robert; Jarow, Jonathan; Stuccio, Nina; Forrest, Annemarie

2017-01-01

Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. Methods: In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative–nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. Results: The investigative site’s responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors’“filtering” of reports and increased sponsor communication. Sponsors replied that their greatest challenges include (1) lack of global harmonization in reporting rules, (2) determining causality, and (3) fear of regulatory repercussions. Interaction with the Food and Drug Administration has helped improve sponsors’ adherence to the final rule, and sponsors would benefit from increased communication with the Food and Drug Administration and educational materials. Conclusion: The goal of the final rule is to minimize uninformative safety reports so that important safety signals can be captured and communicated early enough in a clinical program to make changes that help ensure patient safety. Investigative staff and sponsors acknowledge that the rule has not been fully implemented although they agree with the intention. Clinical Trials Transformation Initiative will use the results from the surveys and interviews to develop new recommendations and educational materials that will be available to sponsors to increase compliance with the final rule and facilitate discussion between sponsors, investigators, and Food and Drug Administration representatives. PMID:28345368

76 FR 7563 - Notice of Public Information Collection(s) Being Submitted for Review and Approval to the Office...

Federal Register 2010, 2011, 2012, 2013, 2014

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... necessary for the proper performance of the functions of the Commission, including whether the information... small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of... Review: Extension of a currently approved collection. Respondents: Business or other for-profit. [[Page...

78 FR 67196 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Worker...

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... employees at least the Federal minimum wage for all hours worked and overtime premium pay of time and one-half the regular rate of pay for all hours worked over forty (40) in a workweek. However, the FLSA...: The Department of Labor (DOL) is submitting the Wage and Hour Division (WHD) sponsored information...

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... small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of... households; business or other for- profit. Number of Respondents: 5,100 respondents; 5,100 responses. Estimated Time Per Response: .33 hours. Frequency of Response: On occasion reporting requirement. Obligation...

Interdisciplinary Distinguished Seminar Series

DTIC Science & Technology

2014-08-29

official Department of the Army position, policy or decision, unless so designated by other documentation. 9. SPONSORING/MONITORING AGENCY NAME(S) AND...Received Book TOTAL: Patents Submitted Patents Awarded Awards Graduate Students Names of Post Doctorates Names of Faculty Supported Names of Under...capabilities, estimation and optimization techniques, image and color standards, efficient programming methods and efficient ASIC designs . This seminar will

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Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

... information shall have practical utility; the accuracy of the Commission's burden estimates; ways to enhance... burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a..., 2013. OMB Control Number: 3060-XXXX. Title: Study Area Boundary Maps Reported in Esri Shapefile Format...

42 CFR 403.816 - Special rules concerning long-term care and I/T/U pharmacies.

Code of Federal Regulations, 2012 CFR

2012-10-01

... pharmacies. 403.816 Section 403.816 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF.../U pharmacies. (a) In general. (1) An applicant for endorsement may submit an application to become a special endorsed sponsor for long-term care and/or for I/T/U pharmacies. (2) Of qualified applicants, the...

42 CFR 403.816 - Special rules concerning long-term care and I/T/U pharmacies.

Code of Federal Regulations, 2014 CFR

2014-10-01

... pharmacies. 403.816 Section 403.816 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF.../U pharmacies. (a) In general. (1) An applicant for endorsement may submit an application to become a special endorsed sponsor for long-term care and/or for I/T/U pharmacies. (2) Of qualified applicants, the...

42 CFR 403.816 - Special rules concerning long-term care and I/T/U pharmacies.

Code of Federal Regulations, 2010 CFR

2010-10-01

... pharmacies. 403.816 Section 403.816 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF.../U pharmacies. (a) In general. (1) An applicant for endorsement may submit an application to become a special endorsed sponsor for long-term care and/or for I/T/U pharmacies. (2) Of qualified applicants, the...

42 CFR 403.816 - Special rules concerning long-term care and I/T/U pharmacies.

Code of Federal Regulations, 2011 CFR

2011-10-01

... pharmacies. 403.816 Section 403.816 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF.../U pharmacies. (a) In general. (1) An applicant for endorsement may submit an application to become a special endorsed sponsor for long-term care and/or for I/T/U pharmacies. (2) Of qualified applicants, the...

42 CFR 403.816 - Special rules concerning long-term care and I/T/U pharmacies.

Code of Federal Regulations, 2013 CFR

2013-10-01

... pharmacies. 403.816 Section 403.816 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF.../U pharmacies. (a) In general. (1) An applicant for endorsement may submit an application to become a special endorsed sponsor for long-term care and/or for I/T/U pharmacies. (2) Of qualified applicants, the...

THE ROLE OF THE NONPROFESSIONAL IN THE MANPOWER DEVELOPMENT PROGRAMS. SUBMITTED FOR OPERATION RETRIEVAL.

ERIC Educational Resources Information Center

GROSSER, CHARLES

BASED ON A REVIEW OF REPORTS AND OTHER DOCUMENTS PREPARED BY VARIOUS MANPOWER DEVELOPMENT TRAINING ACT-SPONSORED YOUTH-TRAINING PROJECTS AND ON INTERVIEWS WITH ADMINISTRATORS AND COMMUNITY RESIDENTS AT FIVE PROJECT SITES, THIS STUDY EVALUATES THE USE OF NONPROFESSIONAL STAFF IN THE OPERATION OF MANPOWER PROGRAMS. THE CONSEQUENCES OF SUCH…

76 FR 559 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-05

..., 2012, and 2013 of the redesigned National Hospital Discharge Survey, as well as a pretest of data... be transmitted from all 500 hospitals on a quarterly basis. A pretest of a survey supplement on acute coronary syndrome sponsored by the National Heart Lung and Blood will also be fielded in 2011. The pretest...

Virginia Annual Report. Discipline, Crime, and Violence: School Year 2003-2004

ERIC Educational Resources Information Center

Virginia Department of Education, 2005

2005-01-01

The Code of Virginia requires school divisions statewide to submit data annually to the Virginia Department of Education (VDOE) on incidents of discipline, crime, and violence. Incidents reported include those that occurred on school property, on a school bus, or at a school-sponsored activity. The federal Gun-Free Schools Act of 1994 (GFSA, Sec.…

14 CFR 152.415 - Records and reports.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Opportunity Commission (EEOC) or any superseding EEOC form. If a grantee already is submitting a Form EEO-1 to... includes the employment of sponsors with less than 15 employees, on an EEO-1 or any superseding EEOC form... of $10,000 or more, which is not subject to E.O. 11246 and the regulations of the Department of Labor...

14 CFR 152.415 - Records and reports.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Opportunity Commission (EEOC) or any superseding EEOC form. If a grantee already is submitting a Form EEO-1 to... includes the employment of sponsors with less than 15 employees, on an EEO-1 or any superseding EEOC form... of $10,000 or more, which is not subject to E.O. 11246 and the regulations of the Department of Labor...

14 CFR 152.415 - Records and reports.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Opportunity Commission (EEOC) or any superseding EEOC form. If a grantee already is submitting a Form EEO-1 to... includes the employment of sponsors with less than 15 employees, on an EEO-1 or any superseding EEOC form... of $10,000 or more, which is not subject to E.O. 11246 and the regulations of the Department of Labor...

Center for Telemetering and Telecommunications Systems (1999-2000)

NASA Technical Reports Server (NTRS)

Horan, Stephen

2000-01-01

This Final Report summarizes the research activities of the faculty and students at New Mexico State University sponsored under NASA research grant NAG5-7520. This report covers the period between 1 May 1999 and 30 April 2000. Individual copies of the technical reports, theses, and dissertations have been submitted under separate covers as they were completed.

77 FR 27796 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Statement...

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2012-05-11

... of Labor (DOL) is submitting the Office of RUN FRFMWorkers' Compensation Programs (OWCP) sponsored... work-related injury. A Federal employee can sustain a work-related injury, for which he or she is... create a legal liability for some third party to pay damages for the same injury. When this occurs, the...

77 FR 33549 - 30-Day Notice of Proposed Information Collection: Form DS-7002, Training/Internship Placement...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-06

... our estimate of the burden of the proposed collection, including the validity of the methodology and... conduct of the training or internship. Methodology: The collection will be submitted to the Department by... sponsor organization, or during the investigation of a complaint or incident. Dated: May 22, 2012. Robin J...

A False-name-Proof Double Auction Protocol for Arbitrary Evaluation Values

NASA Astrophysics Data System (ADS)

Sakurai, Yuko; Yokoo, Makoto

We develop a new false-name-proof double auction protocol called the Generalized Threshold Price Double auction (GTPD) protocol. False-name-proofness generalizes strategy-proofness by incorporating the possibility of false-name bids, e.g., bids submitted using multiple e-mail addresses. An existing protocol called TPD protocol is false-name-proof but can handle only the cases where marginal utilities of each agent always decrease, while our new GTPD protocol can handle arbitrary evaluation values. When marginal utilities can increase, some bids cannot be divided into a single unit (e.g., an all-or-nothing bid). Due to the existence of such indivisible bids, meeting supply/demand becomes difficult. Furthermore, a seller/buyer can submit a false-name-bid by pretending to be a potential buyer/seller to manipulate allocations and payments. In the GTPD protocol, the auctioneer is required to absorb the supply-demand imbalance up to a given upper-bound. Also, the GTPD incorporate a new false-name-proof one-sided auction protocol that is guaranteed to sell/buy a certain number of units. Simulation results show that when the threshold price is set appropriately, this protocol can obtain a good social surplus, and the number of absorbed units is much smaller than the given upper-bound.

78 FR 11640 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

... Protocol on Substances That Deplete the Ozone Layer (Protocol) and Title VI of the Clean Air Act Amendments (CAAA) established limits on total U.S. production, import, and export of class I and class II... transformed, destroyed, or exported to developing countries. The Protocol also establishes limits and...

Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.

PubMed

Spelsberg, Angela; Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

2017-02-07

 To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act.  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10.  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany.  Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions.  Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals.  Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the sponsor. High remuneration and strict confidentiality clauses in these studies could influence the physicians' reporting behaviours of adverse drug reactions. 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.

Internet-Based Cervical Cytology Screening Program

DTIC Science & Technology

2005-04-01

and Second Trials of Each Pathologist. * Reference diagnostic category: NEG, ASCUS , LSIL > HSIL Pathologist 1 Interpretation. Negative or LSIL 24 (22...Principal Investigator: David C. Wdlbbur, M.D. Description of Subject Population: Women above the age of l18 years having Pap tests performe PURPOSE We...Subject Population: Women above the age of 18 years having Pay tests performed IRB Protocol Number: 2003P-001658 Sponsor Protocol Number: n/a Consent Form

Benefits of Addressing HFCs under the Montreal Protocol 2014

EPA Pesticide Factsheets

The United States, Canada, and Mexico together submitted a proposal in April 2015 to phase-down production and consumption of hydrofluorocarbons (HFCs) under the Montreal Protocol. This paper presents an analysis of the potential benefits of such action.

Quality assurance of research protocols conducted in the community: the National Institute on Drug Abuse Clinical Trials Network experience.

PubMed

Rosa, Carmen; Campbell, Aimee; Kleppinger, Cynthia; Sampson, Royce; Tyson, Clare; Mamay-Gentilin, Stephanie

2009-04-01

Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials. This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. The authors reviewed internal records maintained by the sponsor, a coordinating site (Lead Nodes), and a local site detailing procedural development, training sessions, protocol violation monitoring, and site visit reporting. Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6560 participants randomized across the sites. During this time 1937 QA site visits were reported across the three tiers of monitoring and the cost depended on the location of the sites and the salaries of the staff involved. One study reported 109 protocol violations (M = 15.6). Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. : QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. The lessons learned from the CTN's experience include the need for balancing thoroughness with efficiency, monitoring early, assessing research staff abilities in order to judge the need for proactive, focused attention, providing targeted training sessions, and developing flexible tools. The CTN model can work for sponsors overseeing studies at sites with limited research experience that require more frequent, in-depth monitoring. We recommend that sponsors not develop a rigid monitoring approach, but work with the study principal investigators to determine the intensity of monitoring needed depending on trial complexity, the risks of the intervention(s), and the experience of the staff with clinical research. After careful evaluation, sponsors should then determine the best approach to site monitoring and what resources will be needed.

Quality assurance of research protocols conducted in the community: The National Institute on Drug Abuse Clinical Trials Network Experience

PubMed Central

Rosa, Carmen; Campbell, Aimee; Kleppinger, Cynthia; Sampson, Royce; Tyson, Clare; Mamay-Gentilin, Stephanie

2009-01-01

Background: Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials. Purpose: This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. Methods: The authors reviewed internal records maintained by the sponsor, a coordinating site (Lead Nodes), and a local site detailing procedural development, training sessions, protocol violation monitoring, and site visit reporting. Results: Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6560 participants randomized across the sites. During this time 1937 QA site visits were reported across the three tiers of monitoring and the cost depended on the location of the sites and the salaries of the staff involved. One study reported 109 protocol violations (M = 15.6). Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. Limitations: QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. Conclusions: The lessons learned from the CTN's experience include the need for balancing thoroughness with efficiency, monitoring early, assessing research staff abilities in order to judge the need for proactive, focused attention, providing targeted training sessions, and developing flexible tools. The CTN model can work for sponsors overseeing studies at sites with limited research experience that require more frequent, in-depth monitoring. We recommend that sponsors not develop a rigid monitoring approach, but work with the study principal investigators to determine the intensity of monitoring needed depending on trial complexity, the risks of the intervention(s), and the experience of the staff with clinical research. After careful evaluation, sponsors should then determine the best approach to site monitoring and what resources will be needed. PMID:19342468

21 CFR 316.20 - Content and format of a request for orphan-drug designation.

Code of Federal Regulations, 2013 CFR

2013-04-01

... designation of a drug for a specified rare disease or condition shall submit each request in the form and... and obtain orphan-drug designation for the subsequent drug for the same rare disease or condition if.... More than one sponsor may receive orphan-drug designation of the same drug for the same rare disease or...

21 CFR 316.20 - Content and format of a request for orphan-drug designation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... designation of a drug for a specified rare disease or condition shall submit each request in the form and... and obtain orphan-drug designation for the subsequent drug for the same rare disease or condition if.... More than one sponsor may receive orphan-drug designation of the same drug for the same rare disease or...

21 CFR 316.20 - Content and format of a request for orphan-drug designation.

Code of Federal Regulations, 2012 CFR

2012-04-01

... designation of a drug for a specified rare disease or condition shall submit each request in the form and... and obtain orphan-drug designation for the subsequent drug for the same rare disease or condition if.... More than one sponsor may receive orphan-drug designation of the same drug for the same rare disease or...

21 CFR 316.20 - Content and format of a request for orphan-drug designation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... designation of a drug for a specified rare disease or condition shall submit each request in the form and... and obtain orphan-drug designation for the subsequent drug for the same rare disease or condition if.... More than one sponsor may receive orphan-drug designation of the same drug for the same rare disease or...

The Role of Women in Foreign-Language Textbooks: A Collection of Essays. Collection d'"Etudes linguistiques" No. 24.

ERIC Educational Resources Information Center

Freudenstein, R., Ed.

Essays that consider the way that women are portrayed in foreign language textbooks are presented. The selected essays were submitted to a competition sponsored by the Federation Internationale des Professeurs de Langues Vivantes, which requested that language teachers assess such concerns as: (1) whether women were described in a stereotyped way;…

Reducing patient stress in theatre. Alison Bell Memorial Award.

PubMed

Welsh, J

2000-06-01

For most patients, admission to hospital for surgery can be very stressful. It is well recognised that stress, created by prolonged anxiety, can produce harmful effects and may even delay a patient's recovery following surgery. This article, submitted for the 1999 Alison Bell award (sponsored by NATN and Regent Medical), looks at key ways to reduce the effects of such stress.

1973 Winter Simulation Conference. Sponsored by ACM/AIIE/SHARE/SCi/TIMS.

ERIC Educational Resources Information Center

Hoggatt, Austin Curwood, Ed.

A record of the current state of the art of simulation and the major part it now plays in policy formation in large organizations is provided by these conference proceedings. The 40 papers presented reveal an emphasis on the applications of simulation. In addition, the abstracts of 28 papers submitted to a more informal "paper fair" are also…

76 FR 41253 - Information Collections Being Submitted for Review and Approval to the Office of Management and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-13

... small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of... should advise the FCC contact listed below as soon as possible. ADDRESSES: Direct all PRA comments [email protected] and to the Federal Communications Commission via e-mail to [email protected]fcc.gov and Paul...

76 FR 38175 - Information Collections Being Submitted for Review and Approval to the Office of Management and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

... request for comments. SUMMARY: The Federal Communications Commission (FCC), as part of its continuing... small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of...-mail [email protected] ; and to Cathy Williams, FCC, via e-mail [email protected]fcc.gov and to Cathy...

75 FR 48334 - Notice of Public Information Collection(s) Being Submitted for Review and Approval to the Office...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-10

... small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of... should advise the FCC contact listed below as soon as possible. ADDRESSES: Direct all PRA comments to... [email protected] and to the Federal Communications Commission via email to [email protected]fcc.gov . To...

76 FR 45565 - Information Collections Being Submitted for Review and Approval to the Office of Management and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-29

... request for comments. SUMMARY: The Federal Communications Commission (FCC), as part of its continuing... small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of... via e-mail [email protected] ; and to Cathy Williams, FCC, via e-mail [email protected]fcc.gov and to...

Militancy in Pakistan: Rebottling the Genie

DTIC Science & Technology

2013-03-01

of Command, Leadership and Management 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) U.S...Martin Department of Command, Leadership and Management Project Adviser This manuscript is submitted in partial fulfillment of the requirements of...dictatorship. “Governance is the exercise of power or authority– political, economic, administrative, or otherwise– to manage a country’s resources and

75 FR 66097 - Notice of Public Information Collection(s) Being Submitted for Review and Approval to the Office...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-27

... small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of... of a currently approved collection. Respondents: Business or other for-profit. Number of Respondents... Commission is allowing companies offering one or two handset models over the GSM air interface, if they would...

President Lincoln and His Vice-Presidents. Lincoln Era Essay Contest Eleventh Annual Winners-1992.

ERIC Educational Resources Information Center

Cagle, William, Ed.

Sponsored by an endowment to Indiana University, the Lincoln Era Essay Contest has been held since 1982. Students in grades 6 to 12 may submit essays that address some topic dealing with Abraham Lincoln's presidency. A new topic is chosen each year. Written by middle school/junior high and high school students, this year's 19 essays concern…

Visionary leader 2009: Deborah Kumar.

PubMed

Zuppa, Barbara

2010-01-01

The following manuscript is the winning Visionary Leader 2009 entry submitted to Nursing Management in recognition of Deborah Kumar, MSN, RN, NEA-BC, Director, Medical Division, The Reading Hospital and Medical Center, West Reading, Pa. Deborah was formally recognized for her achievements during the opening ceremony of Congress 2009, September 9, in Chicago, Ill. There, she received the award, sponsored this year by B.E. Smith.

Pathfinder Technologies Specialist, X-37

NASA Technical Reports Server (NTRS)

French, James R.

2001-01-01

The X-37 is a technology demonstrator sponsored by NASA. It includes a number of experiments both imbedded (i.e., essential aspects of the vehicle) and separate. The technologies demonstrated will be useful in future operational versions as well as having broad applications to other programs. Mr. James R. French, of JRF Engineering Services and as a consultant to SAIC, has provided technical support to the X-37 NASA Program office since the beginning of the program. In providing this service, Mr. French has maintained close contact with the Boeing Seal Beach and Rocketdyne technical teams via telephone, e-mail, and periodic visits. His interfaces were primarily with the working engineers in order to provide NASA sponsors with a different view than that achieved through management channels. Mr. French's periodic and highly detailed technical reports were submitted to NASA and SAIC (Science Applications International Corporation) on a weekly/monthly basis. These reports addressed a wide spectrum of programmatic and technical interests related to the X-37 Program including vehicle design, flight sciences, propulsion, thermal protection, Guidance Navigation & Control (GN&C), structures, and operations. This deliverable is presented as a consolidation of the twelve monthly reports submitted during the Contract's Option Year,

The Biological Macromolecule Crystallization Database and NASA Protein Crystal Growth Archive

PubMed Central

Gilliland, Gary L.; Tung, Michael; Ladner, Jane

1996-01-01

The NIST/NASA/CARB Biological Macromolecule Crystallization Database (BMCD), NIST Standard Reference Database 21, contains crystal data and crystallization conditions for biological macromolecules. The database entries include data abstracted from published crystallographic reports. Each entry consists of information describing the biological macromolecule crystallized and crystal data and the crystallization conditions for each crystal form. The BMCD serves as the NASA Protein Crystal Growth Archive in that it contains protocols and results of crystallization experiments undertaken in microgravity (space). These database entries report the results, whether successful or not, from NASA-sponsored protein crystal growth experiments in microgravity and from microgravity crystallization studies sponsored by other international organizations. The BMCD was designed as a tool to assist x-ray crystallographers in the development of protocols to crystallize biological macromolecules, those that have previously been crystallized, and those that have not been crystallized. PMID:11542472

NASA Exercise Physiology and Countermeasures Project Overview

NASA Technical Reports Server (NTRS)

Loerch, Linda; Ploutz-Snyder, Lori

2009-01-01

Efficient exercise countermeasures are necessary to offset or minimize spaceflight-induced deconditioning and to maximize crew performance of mission tasks. These countermeasure protocols should use the fewest crew and vehicle resources. NASA s Exercise Physiology and Countermeasures (ExPC) Project works to identify, collect, interpret, and summarize evidence that results in effective exercise countermeasure protocols which protect crew health and performance during International Space Station (ISS) and future exploration-class missions. The ExPC and NASA s Human Research Program are sponsoring multiple studies to evaluate and improve the efficacy of spaceflight exercise countermeasures. First, the Project will measure maximal aerobic capacity (VO2max) during cycle ergometry before, during, and after ISS missions. Second, the Project is sponsoring an evaluation of a new prototype harness that offers improved comfort and increased loading during treadmill operations. Third, the Functional Tasks Test protocol will map performance of anticipated lunar mission tasks with physiologic systems before and after short and long-duration spaceflight, to target system contributions and the tailoring of exercise protocols to maximize performance. In addition to these studies that are actively enrolling crewmember participants, the ExPC is planning new studies that include an evaluation of a higher-intensity/lower-volume exercise countermeasure protocol aboard the ISS using the Advanced Resistive Exercise Device and second-generation treadmill, studies that evaluate bone loading during spaceflight exercise, and ground-based studies that focus on fitness for duty standards required to complete lunar mission tasks and for which exercise protocols need to protect. Summaries of these current and future studies and strategies will be provided to international colleagues for knowledge sharing and possible collaboration.

Skylab

NASA Image and Video Library

1972-06-02

One of the most successful of the Skylab educational efforts was the Skylab Student Project. A nationwide scientific competition was sponsored by the National Science Teachers Association and the National Aeronautics and Space Administration (NASA) in which secondary students were encouraged to submit proposals for experiments to be conducted on Skylan in Earth orbit the following year. After the official announcement of this project, over 4,000 students responded with 3,409 proposals. The winning 25 students, along with their parents and sponsor teachers, visited Marshall Space Flight Center (MSFC), the lead center for Skylab, where they met with scientists and engineers, participated in design reviews for their experiments, and toured MSFC facilities. Of the 25 students, 6 did not see their experiments conducted on Skylab because the experiments were not compatible with Skylab hardware and timelines. Of the 19 remaining, 11 experiments required the manufacture of additional equipment. This photograph is a group shot of the 25 winners, parents, and sponsors when they met for the first time on the steps of Building 4200 at MSFC in the Spring of 1972.

77 FR 45411 - Letters of Interest for Credit Assistance Under the Transportation Infrastructure Finance and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

...Pursuant to the recently enacted Moving Ahead for Progress in the 21st Century Act (MAP-21), DOT announces the availability of funding authorized in the amount of $1.75 billion ($750 million in Federal Fiscal Year (FY) 2013 funds and $1 billion in FY 2014 funds (and any funds that may be available from prior fiscal years)) to provide TIFIA credit assistance for eligible projects. The FY 2013 and FY 2014 funds are subject to an annual obligation limitation that may be established in appropriations law. The amount of TIFIA budget authority available in a given year may be less than the amount authorized for that fiscal year. Under TIFIA, DOT provides secured (direct) loans, lines of credit, and loan guarantees to public and private applicants for eligible surface transportation projects. Projects must meet statutorily specified eligibility criteria to receive credit assistance. This notice outlines the process that project sponsors must follow in seeking TIFIA credit assistance. DOT is publishing this notice to give project sponsors an opportunity to submit Letters of Interest for the newly authorized funding as soon as possible. However, in addition to authorizing more funding for TIFIA credit assistance, MAP-21 made some significant changes to the TIFIA program's structure, including the terms and conditions pursuant to which DOT can provide TIFIA credit assistance. While this notice provides guidance about how DOT will implement some of the changes made by MAP-21, it does not provide guidance about how DOT will implement all of these changes. Further information about the changes made by MAP-21 and additional DOT guidance for implementation of these provisions is provided in Part VII below. Also, Part VII invites interested parties to submit comments about DOT's implementation of MAP-21 and DOT's guidance for awarding TIFIA credit assistance. Unless otherwise noted, statutory section references in this notice are to sections of title 23 of the U.S. Code, as amended by MAP-21, which takes effect on October 1, 2012. Letter of Interest Submission: All project sponsors wishing to apply for TIFIA credit assistance must first submit a Letter of Interest, as more fully described in this notice of funding availability. Letters of Interest will be received on a rolling basis commencing on the date hereof, using the form on the TIFIA Web site: http://www.fhwa.dot.gov/ipd/tifia/guidance_applications/index.htm. Project sponsors that have previously submitted Letters of Interest for a prior fiscal year's funding, but have not been asked by DOT to submit an application as of the date of this notice, must submit a new Letter of Interest to be considered for the funding described in this notice of funding availability. Addresses for Letters of Interest: Submit all Letters of Interest to the attention of Mr. Duane Callender via email at: [email protected] Submitters should receive a confirmation email, but are advised to request a return receipt to confirm transmission. Only Letters of Interest received via email, as provided above, shall be deemed properly filed. Addresses for Comments: You must include the agency name (Office of the Secretary of Transportation) and the docket number DOT-OST-2012- 0130 with your comments. To ensure your comments are not entered into the docket more than once, please submit comments, identified by the docket number DOT-OST-2012-0130, by only one of the following methods: Web site: The U.S. Government electronic docket site is www.regulations.gov. Go to this Web site and follow the instructions for submitting comments into docket number DOT-OST-2012-0130; Fax: Telefax comments to: 202-366-2908. Mail: Mail your comments to U.S. Department of Transportation, 1200 New Jersey Avenue SE., Docket Operations, M-30, Room W12-140, Washington, DC 20590; or Hand Delivery: Bring your comments to the U.S. Department of Transportation, 1200 New Jersey Avenue SE., Docket Operations, M-30, West Building Ground Floor, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Instructions for Submitting Comments: You must include the agency name (Office of the Secretary of Transportation) and Docket number DOT- OST-2012-0130 for this notice at the beginning of your comments. You should submit two copies of your comments if you submit them by mail or courier. For confirmation that the Office of the Secretary of Transportation has received your comments you must include a self- addressed stamped postcard. Note that all comments received will be posted without change to www.regulations.gov, including any personal information provided, and will be available to Internet users. You may review the Department's complete Privacy Act Statement in the Federal Register published April 11, 2000 (65 FR 19477), or you may visit www.regulations.gov.

Problematic protocols: An overview of medical research protocols not approved by the LUMC medical ethics review committee.

PubMed

Tersmette, Derek Gideon; Engberts, Dirk Peter

2017-01-01

The Committee for Medical Ethics (CME) of Leiden University Medical Center (LUMC) was established as the first medical ethics reviewing committee (MREC) in the Netherlands. In the period 2000-2010 the CME received 2,162 protocols for review. Some of these protocols were never approved. Until now, there has existed neither an overview of these failed protocols nor an overview of the reasons for their failure. This report draws on data from the digital database, the physical archives, and the minutes of the meetings of the CME. Additional information has been obtained from the Central Committee on Research involving Human Subjects (CCRH) and survey-based research. Protocols were itemized based on characteristic features and their reviewing procedures were analyzed. In total, 1,952 out of 2,162 research protocols submitted during 2000-2010 (90.3%) were approved by the CME; 210 of 2,162 protocols (9.7%) were not approved. Of these 210 protocols, 177 failed due to reasons not related to CME reviewing. In 15 cases CME reviewing led to protocol failure, while another 10 protocols were rejected outright. Eight of the 210 submitted protocols without approval had been conducted prior to submission. In the aforementioned period, little protocol failure occurred. For the most part, protocol failure was caused by problems that are not CME related. This type of failure has several identifiable factors, none of which have anything to do with the ethical reviewing procedure by the CME. A mere 1.2% of protocols failed due to ethical review. Unacceptable burden and risks to the subject and an inadequate methodology are the most common reasons for this CME-related protocol failure.

Medicare program; prohibition of midyear benefit enhancements for Medicare Advantage organizations. Final rule.

PubMed

2008-07-28

This final rule prohibits Medicare Advantage (MA) organizations, including organizations offering MA plans to employer and union group health plan sponsors, from making midyear changes to nonprescription drug benefits, premiums, and cost-sharing submitted in their approved bids for a given contract year. This final rule also clarifies that MA organizations offering certain kinds of plans restricted to employer and union group health plan sponsors and not open to general enrollment may continue to offer benefit enhancements as they do currently, through means other than midyear benefit enhancements (MYBEs). Programs of all-inclusive care for elderly (PACE) are not subject to the provisions of this final rule and may continue to offer enhanced benefits as specified in our guidance for PACE plans.

21 CFR 50.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...

21 CFR 50.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...

21 CFR 50.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...

21 CFR 50.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...

21 CFR 50.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... section 515. (19) A product development protocol for a medical device, described in section 515. (20) Data...) Data and information about a clinical study of an infant formula when submitted as part of an infant... investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of...

49 CFR 579.29 - Manner of reporting.

Code of Federal Regulations, 2013 CFR

2013-10-01

... identified on NHTSA's Internet homepage (www.nhtsa.dot.gov). A manufacturer must use templates provided at... templates. (2) Each report required under § 579.27 of this part may be submitted to NHTSA's early warning... through 579.26 of this part may be submitted in digital form using a graphic compression protocol...

49 CFR 579.29 - Manner of reporting.

Code of Federal Regulations, 2011 CFR

2011-10-01

... identified on NHTSA's Internet homepage (www.nhtsa.dot.gov). A manufacturer must use templates provided at... templates. (2) Each report required under § 579.27 of this part may be submitted to NHTSA's early warning... through 579.26 of this part may be submitted in digital form using a graphic compression protocol...

49 CFR 579.29 - Manner of reporting.

Code of Federal Regulations, 2012 CFR

2012-10-01

... identified on NHTSA's Internet homepage (www.nhtsa.dot.gov). A manufacturer must use templates provided at... templates. (2) Each report required under § 579.27 of this part may be submitted to NHTSA's early warning... through 579.26 of this part may be submitted in digital form using a graphic compression protocol...

49 CFR 579.29 - Manner of reporting.

Code of Federal Regulations, 2014 CFR

2014-10-01

... identified on NHTSA's Internet homepage (www.nhtsa.dot.gov). A manufacturer must use templates provided at... templates. (2) Each report required under § 579.27 of this part may be submitted to NHTSA's early warning... through 579.26 of this part may be submitted in digital form using a graphic compression protocol...

40 CFR 766.35 - Reporting requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... protocol for the test as follows: (A) The protocols for each chlorinated chemical substance produced by... be submitted 12 months after manufacture or importation begins for chlorinated chemical substances... exclusion for chlorinated chemical substances, and 24 months after expiration of the exemption, waiver or...

40 CFR 766.35 - Reporting requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... protocol for the test as follows: (A) The protocols for each chlorinated chemical substance produced by... be submitted 12 months after manufacture or importation begins for chlorinated chemical substances... exclusion for chlorinated chemical substances, and 24 months after expiration of the exemption, waiver or...

Maternal immunomodulation of the offspring's immunological system.

PubMed

Campos, Sylvia M N; de Oliveira, Vivian L; Lessa, Leonardo; Vita, Melissa; Conceição, Marcia; Andrade, Luiz Antonio Botelho; Teixeira, Gerlinde Agate Platais Brasil

2014-11-01

The mother's and the offspring's immunological system are closely related thus one can influence the other. This hypothesis drove our aim to study the impact of the mother's immunological status over the immunological response of their offspring. For this, female mice tolerant or allergic to peanuts were exposed or not to a challenge diet containing peanuts during the gestation-lactation period (TEP/AEP; TNEP/ANEP, respectively). After weaning the offspring was submitted to the peanut allergy or peanut tolerization protocol and then challenged with a peanut diet. Our results showed that when the offspring is submitted to the allergy induction protocol, they behave differently depending on their mother's immunological status. Offspring born to TEP mothers produced the lowest antibody titters while those born to AEP mothers produced the highest antibody titters compared to mice born to TNEP and ANEP. On the other hand when the offspring was submitted to the tolerization protocol all groups presented low antibody titers with no significant difference between groups, independent of the mothers immunological status and/or contact with peanuts during the gestation-lactation period. The analysis of the histological profile of the offspring correlates well to the serological response. In other words, offspring born to TEP mothers and submitted to the allergy induction protocol presented a normal histological profile, while the offspring born to AEP mothers produced the worst gut inflammation. These results indicate that mothers, exposed to the antigen (by the oral route) during gestation, actively influence the immune response of their offspring. This work sheds some light on the importance of the immunomodulation induced by dietary antigens during gestation and their influence on the immunological response of their offspring. However, more work is needed to elucidate the molecular and cellular components of this regulatory phenomenon. Copyright © 2014 Elsevier GmbH. All rights reserved.

The U.S. Army Division: The Continuous Evolution to Remain Relevant

DTIC Science & Technology

2013-03-01

Dr. John A. Bonin Center for Strategic Leader Development 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY...United States Army Dr. John A. Bonin Center for Strategic Leader Development Project Adviser This manuscript is submitted in...to resolve. As Dr. John Bonin and Lieutenant Colonel Telford Crisco noted in their paper on the modular army, soon after General Schoomaker’s

76 FR 11281 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Radiation...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-01

...The Department of Labor (DOL) is submitting the Mine Safety and Health Administration sponsored information collection request (ICR) titled, ``Radiation Sampling and Exposure Records,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35).

77 FR 56232 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Forms for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-12

...The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, ``Forms for Agricultural Recruitment System Affecting Migratory Farm Workers,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).

Justification of Estimates for Fiscal Year 1984 Submitted to Congress.

DTIC Science & Technology

1983-01-01

sponsoring different aspects related to unique manufacturing methods than those pursued by DARPA, and duplication of effort is prevented by direct...weapons systems. Rapid and economical methods of satisfying these requirements must significantly precede weapons systems developments to prevent... methods for obtaining accurate and efficient geodetic measurements. Also, a major advanced sensor/G&G data collection capability is being urdertaken by DNA

75 FR 17140 - Notice of Public Information Collection(s) Being Submitted for Review and Approval to the Office...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-05

... small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of....gov/public/do/PRAMain , (2) look for the section of the web page called ``Currently Under Review'', (3...'' box, and (6) when the list of FCC ICRs currently under review appears, look for the title of this ICR...

75 FR 38523 - Notice of Public Information Collection(s) Being Submitted for Review and Approval to the Office...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-02

... small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of... advise the FCC contact listed below as soon as possible. ADDRESSES: Direct all PRA comments to Nicholas A....eop.gov and to the Federal Communications Commission via email to [email protected]fcc.gov and [email protected]fcc...

78 FR 1860 - Information Collections Being Submitted for Review and Approval to the Office of Management and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-09

... request for comments. SUMMARY: The Federal Communications Commission (FCC), as part of its continuing... than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a....gov ; and to Cathy Williams, FCC, via email [email protected]fcc.gov and to [email protected]fcc.gov . Include in the...

The United States’ Role in Combating Militant Islam in France

DTIC Science & Technology

2011-03-16

United States Army DISTRIBUTION STATEMENT A : Approved for Public Release. Distribution is Unlimited. This SRP is submitted in partial...provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently...SPONSOR/MONITOR’S REPORT NUMBER(S) 12. DISTRIBUTION / AVAILABILITY STATEMENT Distribution A : Unlimited 13. SUPPLEMENTARY NOTES

Canadian Pacific Railway Investigation of Safety-Related Occurrences Protocol considered helpful by both labor and management.

DOT National Transportation Integrated Search

2006-09-01

The Federal Railroad Administration (FRA) Human Factors Research and Development (R&D) Program sponsored an Alternative Safety Measures Program designed to explore alternative methods for evaluating whether safety programs improve safety outcomes and...

34 CFR Appendix to Part 5 - Unknown Title

Code of Federal Regulations, 2010 CFR

2010-07-01

... the Department. Research protocol, design, processing, and other technical information to the extent... report submitted for comment prior to acceptance. Research protocol, design, processing, and other...-10) Pt. 5, App. Appendix to Part 5 [The following are some examples of specific records (or specific...

49 CFR 579.29 - Manner of reporting.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) REPORTING OF INFORMATION AND COMMUNICATIONS ABOUT... through 579.26 of this part may be submitted in digital form using a graphic compression protocol...) Graphic compression protocol. Not later than 30 days prior to the date of its first quarterly submission...

Specification, Synthesis, and Verification of Software-based Control Protocols for Fault-Tolerant Space Systems

DTIC Science & Technology

2016-08-16

Force Research Laboratory Space Vehicles Directorate AFRL /RVSV 3550 Aberdeen Ave, SE 11. SPONSOR/MONITOR’S REPORT Kirtland AFB, NM 87117-5776 NUMBER...Ft Belvoir, VA 22060-6218 1 cy AFRL /RVIL Kirtland AFB, NM 87117-5776 2 cys Official Record Copy AFRL /RVSV/Richard S. Erwin 1 cy... AFRL -RV-PS- AFRL -RV-PS- TR-2016-0112 TR-2016-0112 SPECIFICATION, SYNTHESIS, AND VERIFICATION OF SOFTWARE-BASED CONTROL PROTOCOLS FOR FAULT-TOLERANT

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2015-12-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

PubMed Central

Chan, An-Wen; Tetzlaff, Jennifer M.; Altman, Douglas G.; Laupacis, Andreas; Gøtzsche, Peter C.; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A.; Doré, Caroline J.; Parulekar, Wendy R.; Summerskill, William S.M.; Groves, Trish; Schulz, Kenneth F.; Sox, Harold C.; Rockhold, Frank W.; Rennie, Drummond; Moher, David

2016-01-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders. PMID:23295957

SPIRIT 2013 statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Doré, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2013-02-05

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Colour stability of denture teeth submitted to different cleaning protocols and accelerated artificial aging.

PubMed

Freire, T S; Aguilar, F G; Garcia, L da Fonseca Roberti; Pires-de-Souza, F de Carvalho Panzeri

2014-03-01

Acrylic resin is widely used for artificial teeth manufacturing due to several important characteristics; however, this material do not present acceptable colour stability over the course of time. This study evaluated the effect of different cleaning protocols and accelerated artificial aging on colour stability of denture teeth made of acrylic resin. Sixty denture teeth in dark and light shades were used, and separated according to the treatment to which they were submitted. Results demonstrated that colour stability of artificial teeth is influenced by the cleaning solution and artificial aging, being dark teeth more susceptible to colour alteration than lighter ones.

Workshop to develop deep-life continental scientific drilling projects

DOE PAGES

Kieft, T. L.; Onstott, T. C.; Ahonen, L.; ...

2015-05-29

The International Continental Scientific Drilling Program (ICDP) has long espoused studies of deep subsurface life, and has targeted fundamental questions regarding subsurface life, including the following: "(1) What is the extent and diversity of deep microbial life and what are the factors limiting it? (2) What are the types of metabolism/carbon/energy sources and the rates of subsurface activity? (3) How is deep microbial life adapted to subsurface conditions? (4) How do subsurface microbial communities affect energy resources? And (5) how does the deep biosphere interact with the geosphere and atmosphere?" (Horsfield et al., 2014) Many ICDP-sponsored drilling projects have includedmore » a deep-life component; however, to date, not one project has been driven by deep-life goals, in part because geomicrobiologists have been slow to initiate deep biosphere-driven ICDP projects. Therefore, the Deep Carbon Observatory (DCO) recently partnered with the ICDP to sponsor a workshop with the specific aim of gathering potential proponents for deep-life-driven ICDP projects and ideas for candidate drilling sites. Twenty-two participants from nine countries proposed projects and sites that included compressional and extensional tectonic environments, evaporites, hydrocarbon-rich shales, flood basalts, Precambrian shield rocks, subglacial and subpermafrost environments, active volcano–tectonic systems, megafan deltas, and serpentinizing ultramafic environments. The criteria and requirements for successful ICDP applications were presented. Deep-life-specific technical requirements were discussed and it was concluded that, while these procedures require adequate planning, they are entirely compatible with the sampling needs of other disciplines. As a result of this workshop, one drilling workshop proposal on the Basin and Range Physiographic Province (BRPP) has been submitted to the ICDP, and several other drilling project proponents plan to submit proposals for ICDP-sponsored drilling workshops in 2016.« less

76 FR 65721 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... Stratospheric Ozone Protection regulations, the science of ozone layer depletion, and related topics... Layer (Protocol) and the CAA. Entities applying for this exemption are asked to submit to EPA... Substances that Deplete the Ozone Layer (Protocol). The information collection request is required to obtain...

77 FR 52060 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Health...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-28

...The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, ``Health Standards for Diesel Particulate Matter Exposure (Underground Metal and Nonmetal Mines),'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).

The Roles of the Bone Marrow Microenvironment in Controlling Tumor Dormancy

DTIC Science & Technology

2015-10-01

Shiozawa, M.D., Ph.D. CONTRACTING ORGANIZATION: Wake Forest School of Medicine Ann Arbor, MI 48109 REPORT DATE: October 2015 TYPE OF REPORT...PERFORMING ORGANIZATION REPORT NUMBER Wake Forest University Health Sciences Medical Center Blvd. Winston-Salem NC 27157 9. SPONSORING... Wake Forest School of Medicine as of 03/01/15. The PI obtained the necessary institutional approvals (IACUC, IRB, IBC) and submitted the grant

Electronics: Mott Transistor: Fundamental Studies and Device Operation Mechanisms

DTIC Science & Technology

2016-03-21

display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. Harvard University Office for Sponsored Programs...including journal references , in the following categories: (b) Papers published in non-peer-reviewed journals (N/A for none) 03/21/2016 03/21/2016 03...limited kinetics of electron doping in correlated oxides, Applied Physics Letters (07 2015) TOTAL: 1 Books Number of Manuscripts: Patents Submitted

76 FR 60533 - Agency Information Collection Activities; Submission for OMB Review; Comment Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-29

...The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, ``Representative Payee Report, Representative Payee Report, Short Form, Physician's/Medical Officer's Statement,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).

2017 Visionary Leader: Maureen Maurano.

PubMed

Floyd, Tara

2018-01-01

The following manuscript is the winning 2017 Richard Hader Visionary Leader Award entry submitted to Nursing Management in recognition of Maureen Maurano, BSN, RN, nurse manager of the neonatal intensive care unit at Children's National Health System in Washington, D.C. Ms. Maurano was formally recognized for her achievements before the Keynote Address at Congress2017, October 4, in Las Vegas, Nev. There, she received the award, sponsored by Hackensack Meridian Health.

Informal and formal trail monitoring protocols and baseline conditions: Acadia National Park

USGS Publications Warehouse

Marion, Jeffrey L.; Wimpey, Jeremy F.; Park, L.

2011-01-01

At Acadia National Park, changing visitor use levels and patterns have contributed to an increasing degree of visitor use impacts to natural and cultural resources. To better understand the extent and severity of these resource impacts and identify effective management techniques, the park sponsored this research to develop monitoring protocols, collect baseline data, and identify suggestions for management strategies. Formal and informal trails were surveyed and their resource conditions were assessed and characterized to support park planning and management decision-making.

Bridging the age gap in breast cancer: evaluation of decision support interventions for older women with operable breast cancer: protocol for a cluster randomised controlled trial.

PubMed

Collins, Karen; Reed, Malcolm; Lifford, Kate; Burton, Maria; Edwards, Adrian; Ring, Alistair; Brain, Katherine; Harder, Helena; Robinson, Thompson; Cheung, Kwok Leung; Morgan, Jenna; Audisio, Riccardo; Ward, Susan; Richards, Paul; Martin, Charlene; Chater, Tim; Pemberton, Kirsty; Nettleship, Anthony; Murray, Christopher; Walters, Stephen; Bortolami, Oscar; Armitage, Fiona; Leonard, Robert; Gath, Jacqui; Revell, Deirdre; Green, Tracy; Wyld, Lynda

2017-07-31

While breast cancer outcomes are improving steadily in younger women due to advances in screening and improved therapies, there has been little change in outcomes among the older age group. It is inevitable that comorbidities/frailty rates are higher, which may increase the risks of some breast cancer treatments such as surgery and chemotherapy, many older women are healthy and may benefit from their use. Adjusting treatment regimens appropriately for age/comorbidity/frailty is variable and largely non-evidence based, specifically with regard to rates of surgery for operable oestrogen receptor-positive disease and rates of chemotherapy for high-risk disease. This multicentre, parallel group, pragmatic cluster randomised controlled trial (RCT) (2015-18) reported here is nested within a larger ongoing 'Age Gap Cohort Study' (2012-18RP-PG-1209-10071), aims to evaluate the effectiveness of a complex intervention of decision support interventions to assist in the treatment decision making for early breast cancer in older women. The interventions include two patient decision aids (primary endocrine therapy vs surgery/antioestrogen therapy and chemotherapy vs no chemotherapy) and a clinical treatment outcomes algorithm for clinicians. National and local ethics committee approval was obtained for all UK participating sites. Results from the trial will be submitted for publication in international peer-reviewed scientific journals. 115550. European Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2015-004220-61;Pre-results. Sponsor's Protocol Code Number Sheffield Teaching Hospitals STH17086. ISRCTN 32447*. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Bridging the age gap in breast cancer: evaluation of decision support interventions for older women with operable breast cancer: protocol for a cluster randomised controlled trial

PubMed Central

Collins, Karen; Reed, Malcolm; Lifford, Kate; Burton, Maria; Edwards, Adrian; Ring, Alistair; Brain, Katherine; Harder, Helena; Robinson, Thompson; Cheung, Kwok Leung; Morgan, Jenna; Audisio, Riccardo; Ward, Susan; Richards, Paul; Martin, Charlene; Chater, Tim; Pemberton, Kirsty; Nettleship, Anthony; Murray, Christopher; Walters, Stephen; Bortolami, Oscar; Armitage, Fiona; Leonard, Robert; Gath, Jacqui; Revell, Deirdre; Green, Tracy; Wyld, Lynda

2017-01-01

Introduction While breast cancer outcomes are improving steadily in younger women due to advances in screening and improved therapies, there has been little change in outcomes among the older age group. It is inevitable that comorbidities/frailty rates are higher, which may increase the risks of some breast cancer treatments such as surgery and chemotherapy, many older women are healthy and may benefit from their use. Adjusting treatment regimens appropriately for age/comorbidity/frailty is variable and largely non-evidence based, specifically with regard to rates of surgery for operable oestrogen receptor-positive disease and rates of chemotherapy for high-risk disease. Methods and analysis This multicentre, parallel group, pragmatic cluster randomised controlled trial (RCT) (2015-18) reported here is nested within a larger ongoing ‘Age Gap Cohort Study’ (2012-18RP-PG-1209-10071), aims to evaluate the effectiveness of a complex intervention of decision support interventions to assist in the treatment decision making for early breast cancer in older women. The interventions include two patient decision aids (primary endocrine therapy vs surgery/antioestrogen therapy and chemotherapy vs no chemotherapy) and a clinical treatment outcomes algorithm for clinicians. Ethics and dissemination National and local ethics committee approval was obtained for all UK participating sites. Results from the trial will be submitted for publication in international peer-reviewed scientific journals. IRAS reference 115550. Trial registration number European Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2015-004220-61;Pre-results. Sponsor's Protocol Code Number Sheffield Teaching Hospitals STH17086. ISRCTN 32447*. PMID:28760787

Description of the Protocols for Randomized Controlled Trials on Cancer Drugs Conducted in Spain (1999–2003)

PubMed Central

Bonfill, Xavier; Ballesteros, Mónica; Gich, Ignasi; Serrano, María Antonia; García López, Fernando; Urrútia, Gerard

2013-01-01

Objective To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols. Methods We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (Spanish Agency for Medicines and Medical Devices) during 1999-2003. A descriptive analysis was completed and the association between variables based on the study setting and sponsorship were assessed. Results We identified a total of 303 protocols, which included 176,835 potentially eligible patients. Three-quarter of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%), overall survival (20.7%), and progression-free survival (14.5%). Of all protocols, 10.6% intended to include more than 1000 patients (mean: 2442, SD: 2724). Compared with their national counterparts, internationally-based studies were significantly larger (p<0.001) and were more likely to implement centralized randomization (p<0.001), blinding of the intervention (p<0.001), and survival as primary outcome (p<0.001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (p<0.01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at www.clinicaltrials.gov (7%) was lower. Conclusion RCTs on cancer drugs conducted in Spain between 1999 and 2003 were more likely to be promoted by pharmaceutical companies rather than by non-profit national groups. The former were more often part of international studies, which generally had better methodological quality than national ones. There are some worldwide on-going initiatives that aim to increase the transparency and quality of future research. PMID:24236154

21 CFR 660.6 - Samples; protocols; official release.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Hepatitis B Surface Antigen § 660.6 Samples; protocols; official release. (a) Samples. (1) For the purposes... of official release is no longer required under paragraph (c)(2) of this section. (ii) One sample at... required under paragraph (c)(2) of this section. The sample submitted at the 90-day interval shall be from...

21 CFR 660.6 - Samples; protocols; official release.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Hepatitis B Surface Antigen § 660.6 Samples; protocols; official release. (a) Samples. (1) For the purposes... of official release is no longer required under paragraph (c)(2) of this section. (ii) One sample at... required under paragraph (c)(2) of this section. The sample submitted at the 90-day interval shall be from...

21 CFR 660.6 - Samples; protocols; official release.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Hepatitis B Surface Antigen § 660.6 Samples; protocols; official release. (a) Samples. (1) For the purposes... of official release is no longer required under paragraph (c)(2) of this section. (ii) One sample at... required under paragraph (c)(2) of this section. The sample submitted at the 90-day interval shall be from...

40 CFR 8.7 - Initial environmental evaluation.

Code of Federal Regulations, 2014 CFR

2014-07-01

... documentation requirements under Article 8 and Annex I to the Protocol and the provisions of this part or a CEE... documentation submitted does not meet the requirements of Article 8 and Annex I of the Protocol and the provisions of this part. This finding will be made with the concurrence of the National Science Foundation...

40 CFR 8.7 - Initial environmental evaluation.

Code of Federal Regulations, 2012 CFR

2012-07-01

... documentation requirements under Article 8 and Annex I to the Protocol and the provisions of this part or a CEE... documentation submitted does not meet the requirements of Article 8 and Annex I of the Protocol and the provisions of this part. This finding will be made with the concurrence of the National Science Foundation...

40 CFR 8.7 - Initial environmental evaluation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... documentation requirements under Article 8 and Annex I to the Protocol and the provisions of this part or a CEE... documentation submitted does not meet the requirements of Article 8 and Annex I of the Protocol and the provisions of this part. This finding will be made with the concurrence of the National Science Foundation...

40 CFR 8.7 - Initial environmental evaluation.

Code of Federal Regulations, 2013 CFR

2013-07-01

... documentation requirements under Article 8 and Annex I to the Protocol and the provisions of this part or a CEE... documentation submitted does not meet the requirements of Article 8 and Annex I of the Protocol and the provisions of this part. This finding will be made with the concurrence of the National Science Foundation...

40 CFR 8.7 - Initial environmental evaluation.

Code of Federal Regulations, 2011 CFR

2011-07-01

... documentation requirements under Article 8 and Annex I to the Protocol and the provisions of this part or a CEE... documentation submitted does not meet the requirements of Article 8 and Annex I of the Protocol and the provisions of this part. This finding will be made with the concurrence of the National Science Foundation...

SNAr-Based, facile synthesis of a library of Benzothiaoxazepine-1,1’-dioxides

PubMed Central

Rolfe, Alan; Samarakoon, Thiwanka B.; Klimberg, Sarra V.; Brzozowski, Marek; Neuenswander, Benjamin; Lushington, Gerald H.

2011-01-01

The construction of a library of benzothiaoxazepine-1,1’-dioxides utilizing a one-pot, SNAr diversification – ODCT50 scavenging protocol is reported. This protocol combines microwave irradiation to facilitate the reaction, in conjunction with a soluble ROMP-derived scavenger (ODCT) to afford the desired products in good overall purity. Utilizing this protocol, a 78-member library was successfully synthesized and submitted for biological evaluation. PMID:20879738

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees

PubMed Central

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-01-01

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. PMID:26811365

77 FR 31055 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-24

... order is no longer converted to a Non-Displayed Order, but rather is displayed at the most aggressive... cases, a member will submit a Price to Comply Order at an aggressive price that it anticipates will be... typically submit additional aggressive orders, which likewise are not executed. Because the OUCH protocol is...

An Economic Analysis of the Truth in Negotiations Act

DTIC Science & Technology

2016-01-27

SPONSORED REPORT SERIES An Economic Analysis of the Truth in Negotiations Act 27 January 2016 Dr. Chong Wang, Associate Professor Dr. Rene G. Rendon...source) to submit “cost or pricing data” when they negotiate the price of a contract with the federal government. The contractors must certify that...SERIES An Economic Analysis of the Truth in Negotiations Act 27 January 2016 Dr. Chong Wang, Associate Professor Dr. Rene G. Rendon, Associate

Grassroots Environmentalism in Vietnam: How Communities Can Initiate Change

DTIC Science & Technology

2013-11-01

5d. PROJECT NUMBER Boll, Christian D., CDR, USN 5e. TASK NUMBER Paper Advisor: Prof. William McDonald 5f. WORK UNIT NUMBER 7...number of IGO environmental funds that are administered by the World Bank . The Climate Investment Fund, for example, sponsors a number of projects in...Distribution is unlimited. Reference: DOD Directive 5230.24 13. SUPPLEMENTARY NOTES A paper submitted to the Naval War College faculty in partial

Acute and Chronic Toxicities of TNT and RDX to the Enchytraeid Worm, Enchytraeus crypticus, in Natural Soils

DTIC Science & Technology

2012-11-01

21010-5424 8. PERFORMING ORGANIZATION REPORT NUMBER ECBC-TR-981 9. SPONSORING / MONITORING AGENCY NAME(S) AND ADDRESS(ES) Strategic Environmental ...triazine (RDX) to the potworm Enchytraeus crypticus using the Enchytraeid Reproduction Test (ISO 16387:2004). Studies were designed to identify and...clay loam soils. Toxicity benchmarks established in TSL and SSL will be submitted to the U.S. Environmental Protection Agency Eco-SSL Workgroup for

Nursing Management Visionary Leader 2006: North Carolina chief nurse officer earns journal's annual leadership award.

PubMed

Wessman, Joan

2007-01-01

The following manuscript is the winning Visionary Leader 2006 entry submitted to Nursing Management by the staff of Moses Cone Health System, Greensboro, N.C., in recognition of Joan Wessman, chief nurse officer at the organization. Joan was formally recognized for her achievements during the opening ceremony of Congress 2006, October 15, in Philadelphia, Pa., during which she received the award, sponsored this year by B.E. Smith.

2016 Visionary Leader: Bob Dent.

PubMed

Bredimus, Brandon Kit

2017-01-01

The following manuscript is the winning Richard Hader Visionary Leader 2016 entry submitted to Nursing Management in recognition of Dr. Bob Dent, DNP, MBA, RN, NEA-BC, CENP, FACHE, senior vice president, chief operating officer, and CNO for Midland Memorial Hospital in Midland, Tex. Dr. Dent was formally recognized for his achievements before the Keynote Address at Congress2016, November 8, in Las Vegas, Nev. There, he received the award, sponsored by Hackensack Meridian Health.

Forest bird monitoring protocol for strategic habitat conservation and endangered species management on O'ahu Forest National Wildlife Refuge, Island of O'ahu, Hawai'i

USGS Publications Warehouse

Camp, Richard J.; Gorresen, P. Marcos; Banko, Paul C.

2011-01-01

This report describes the results of a pilot forest bird survey and a consequent forest bird monitoring protocol that was developed for the O'ahu Forest National Wildlife Refuge, O'ahu Island, Hawai'i. The pilot survey was conducted to inform aspects of the monitoring protocol and to provide a baseline with which to compare future surveys on the Refuge. The protocol was developed in an adaptive management framework to track bird distribution and abundance and to meet the strategic habitat conservation requirements of the Refuge. Funding for this research was provided through a Science Support Partnership grant sponsored jointly by the U.S. Geological Survey (USGS) and the U.S. Fish and Wildlife Service (USFWS).

Diffusion-Weighted Imaging Outside the Brain: Consensus Statement From an ISMRM-Sponsored Workshop

PubMed Central

Taouli, Bachir; Beer, Ambros J.; Chenevert, Thomas; Collins, David; Lehman, Constance; Matos, Celso; Padhani, Anwar R.; Rosenkrantz, Andrew B.; Shukla-Dave, Amita; Sigmund, Eric; Tanenbaum, Lawrence; Thoeny, Harriet; Thomassin-Naggara, Isabelle; Barbieri, Sebastiano; Corcuera-Solano, Idoia; Orton, Matthew; Partridge, Savannah C.; Koh, Dow-Mu

2016-01-01

The significant advances in magnetic resonance imaging (MRI) hardware and software, sequence design, and postprocessing methods have made diffusion-weighted imaging (DWI) an important part of body MRI protocols and have fueled extensive research on quantitative diffusion outside the brain, particularly in the oncologic setting. In this review, we summarize the most up-to-date information on DWI acquisition and clinical applications outside the brain, as discussed in an ISMRM-sponsored symposium held in April 2015. We first introduce recent advances in acquisition, processing, and quality control; then review scientific evidence in major organ systems; and finally describe future directions. PMID:26892827

76 FR 39377 - Proposed Information Collection; Comment Request; 2012 Survey of Income and Program Participation...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-06

... survey designed as a continuous series of national panels molded around an annual interview structured... DEPARTMENT OF COMMERCE Census Bureau Proposed Information Collection; Comment Request; 2012 Survey... representative and respondent is authentic and follows critical survey protocol as defined by the sponsor and...

GINSU: Guaranteed Internet Stack Utilization

DTIC Science & Technology

2005-11-01

Computer Architecture Data Links, Internet , Protocol Stacks 16. PRICE CODE 17. SECURITY CLASSIFICATION OF REPORT UNCLASSIFIED 18. SECURITY...AFRL-IF-RS-TR-2005-383 Final Technical Report November 2005 GINSU: GUARANTEED INTERNET STACK UTILIZATION Trusted... Information Systems, Inc. Sponsored by Defense Advanced Research Projects Agency DARPA Order No. ARPS APPROVED FOR PUBLIC

THE NEW ENGLAND AIR QUALITY FORECASTING PILOT PROGRAM: DEVELOPMENT OF AN EVALUATION PROTOCOL AND PERFORMANCE BENCHMARK

EPA Science Inventory

The National Oceanic and Atmospheric Administration recently sponsored the New England Forecasting Pilot Program to serve as a "test bed" for chemical forecasting by providing all of the elements of a National Air Quality Forecasting System, including the development and implemen...

The Many Faces of the Economic Bulletin Board.

ERIC Educational Resources Information Center

Boettcher, Jennifer

1996-01-01

The Economic Bulletin Board (EBB), a one-stop site for economic statistics and government-sponsored business information, can be accessed on the World Wide Web, gopher, telnet, file transfer protocol, dial-up, and fax. Each access method has advantages and disadvantages related to connections, pricing, depth of access, retrieval, and system…

The financial implications of employer-sponsored health insurance.

PubMed

Natvig, Deborah; Tolbert, Sam

2005-01-01

The purpose of this study was to analyze utilization and costs of employer-sponsored health insurance in select businesses in a rural community in South Carolina. The study was conducted under the auspices of the HR Roundtable of the local Chamber of Commerce, composed of human resources directors from the larger area businesses. Twenty one companies were invited to participate and eight submitted information that was sufficiently complete to analyze. The participating companies employed 6,265 people, of which 5,712 were insured. The data represents a total of 13,057 covered lives. Although the findings cannot be generalized to a broader population, the descriptive data was sufficient to generate a discussion about health care issues for this community and for the group to make preliminary recommendations for collaborative work that may affect the costs of health care coverage for this community.

Online Error Reporting for Managing Quality Control Within Radiology.

PubMed

Golnari, Pedram; Forsberg, Daniel; Rosipko, Beverly; Sunshine, Jeffrey L

2016-06-01

Information technology systems within health care, such as picture archiving and communication system (PACS) in radiology, can have a positive impact on production but can also risk compromising quality. The widespread use of PACS has removed the previous feedback loop between radiologists and technologists. Instead of direct communication of quality discrepancies found for an examination, the radiologist submitted a paper-based quality-control report. A web-based issue-reporting tool can help restore some of the feedback loop and also provide possibilities for more detailed analysis of submitted errors. The purpose of this study was to evaluate the hypothesis that data from use of an online error reporting software for quality control can focus our efforts within our department. For the 372,258 radiologic examinations conducted during the 6-month period study, 930 errors (390 exam protocol, 390 exam validation, and 150 exam technique) were submitted, corresponding to an error rate of 0.25 %. Within the category exam protocol, technologist documentation had the highest number of submitted errors in ultrasonography (77 errors [44 %]), while imaging protocol errors were the highest subtype error for computed tomography modality (35 errors [18 %]). Positioning and incorrect accession had the highest errors in the exam technique and exam validation error category, respectively, for nearly all of the modalities. An error rate less than 1 % could signify a system with a very high quality; however, a more likely explanation is that not all errors were detected or reported. Furthermore, staff reception of the error reporting system could also affect the reporting rate.

The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

PubMed

Homedes, Núria; Ugalde, Antonio

2015-06-01

To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. 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.

Map of biomedical research in Cameroon; a documentary review of approved protocols from 1997 to 2012.

PubMed

Walter, Ebile Akoh; Jerome, Ateudjieu; Marceline, Djuidje Ngounoue; Yakum, Martin Ndinakie; Pierre, Watcho

2017-11-21

Over the last decade, there has been a rapid increase in biomedical research in Cameroon. However, the question of whether these research projects target major health priorities, vulnerable populations and geographic locations at risk remains to be answered. The aim of this paper is to describe the state of biomedical research in Cameroon which is a key determinant that would guide future health care policies and promote equitable access to healthcare. A documentary review of all approved protocols (proposals) of biomedical research projects, from 1997 through 2012, at the Cameroon National Ethics Committee. Protocols were reviewed systematically by independent reviewers and data were extracted on a grid. Data were analyzed by calculating proportions at 95% confidence interval, chi-square test (chi2) and p-values. Two thousand one hundred seventy two protocols were reviewed for data extraction. One thousand three hundred ninety-five (64.7%) were student projects, 369 (17.0%) projects had international sponsors, and 1528 (72.4%) were hospital-based studies. The most targeted domain was the fight against diseases 1323 (61.3%); mostly HIV 342 (25.8%) and Malaria 136 (10.3%). Over half of the studies were concentrated in the Centre region 1242 (57.2%), with the least projects conducted in the Northern region 15 (0.7%). There was strong evidence that international and local sponsors would influence the research site (p-value = 0.01) and population targets (p-value = 0.00). Although biomedical research targets some important diseases that pose a great burden to Cameroonians, the most vulnerable populations are excluded from research. Biomedical research scarcely addresses other components of the health system and emerging diseases of vital public health importance. We recommend that the government should play a central role, between researchers from academic institutions, sponsors, NGOs and research institutions, to ensure that biomedical research addresses the health priorities of Cameroonians. It should include vulnerable populations, and address other components of the health system for a balance. These recommendations are critical to ensuring that future research informed health policies reflect the health needs of the populations and promote equity in healthcare access.

Evaluation of results obtained with corifollitropin alfa after poor ovarian response in previous cycle using recombinant follicular stimulating hormone in the long-term protocol.

PubMed

Salgueiro, Lister L; Rolim, Juliana R; Moura, Bernardo R L; Machado, Suelen P P; Haddad, Carolina

2016-08-01

This study evaluated the use of Corifollitropin alfa in patients with previous poor response to recombinant follicle stimulating hormone in long-term protocols using gonadotropin-releasing hormone. Twenty-seven poor responders to previous treatment with the long term protocol using the recombinant follicle stimulating hormone (Group 1) were selected and then submitted to a second attempt using the same long term protocol with Corifollitropin alfa instead of the recombinant follicle stimulating hormone (Group 2).Ovarian down-regulation was achieved using subcutaneous administration of Leuprolide Acetate. Ovarian stimulation was performed with recombinant follicle stimulating hormone until the administration of human chorionic gonadotropin, followed by follicular aspiration (Group 1). Group 2 was submitted to this same protocol using Corifollitropin alfa instead of recombinant follicle stimulating hormone. There were significant differences in the number of aspirated oocytes, percentage of mature oocytes, amount of injected oocytes and transferred embryos - with all of these parameters being increased in the Corifollitropin alfa group. In addition, the rates of pregnancy and ongoing pregnancy were also significantly higher in the Corifollitropin alfa group. The present study demonstrated that the use of Corifollitropin alfa in the long-term protocol could be a highly effective alternative for patients with poor ovarian response, who were unsuccessful in a previous treatment with In Vitro Fertilization - Intracytoplasmic Sperm Injection.

Mechanism Design for Multi-slot Ads Auction in Sponsored Search Markets

NASA Astrophysics Data System (ADS)

Deng, Xiaotie; Sun, Yang; Yin, Ming; Zhou, Yunhong

In this paper, we study pricing models for multi-slot advertisements, where advertisers can bid to place links to their sales webpages at one or multiple slots on a webpage, called the multi-slot AD auction problem. We develop and analyze several important mechanisms, including the VCG mechanism for multi-slot ads auction, the optimal social welfare solution, as well as two weighted GSP-like protocols (mixed and hybrid). Furthermore, we consider that forward-looking Nash equilibrium and prove its existence in the weighted GSP-like pricing protocols.

75 FR 22598 - Agency Information Collection Activities; Submission for Office and Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-29

... Electronic Format to the Center for Veterinary Medicine--(OMB Control Number 0910-0524)--Extension Protocols... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0055... Request; Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center...

Harvard Catalyst | The Clinical Translational Science Center IND/IDE Consult Service: providing an IND/IDE consult service in a decentralized network of academic healthcare centers.

PubMed

Kim, Min J; Winkler, Sabune J; Bierer, Barbara E; Wolf, Delia

2014-04-01

The Food and Drug Administration (FDA) regulations require sponsors of clinical investigations involving an investigational drug or device to submit an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. Strict adherence to applicable regulations is vital to the success of clinical research. Unlike most major pharmaceutical sponsors, investigator sponsors often do not fully appreciate their regulatory obligations nor have resources to ensure compliance. As a result they can place themselves and their institutions at risk. Nevertheless, investigator-initiated clinical trials are vital to the further development of innovative drugs, biologics, and medical devices. The IND/IDE Subcommittee under the Regulatory Knowledge and Support Program at Harvard Catalyst, The Harvard Clinical and Translational Science Center worked in collaboration with Harvard and Harvard affiliated institutions to create and launch an IND/IDE Consult Service in a decentralized network of collaborating Academic Healthcare Centers (AHC). The IND/IDE Consult Service offers expertise, resources, and shared experiences to assist sponsor-investigators and IRBs in meeting regulatory requirements for conducting and reviewing investigator-initiated IND/IDE studies. The scope of the services provided by the Harvard Catalyst IND/IDE Consult Service are described, including the specifics of the service, lessons learned, and challenges faced, in a scalable model that builds inter-institutional capacity. © 2014 Wiley Periodicals, Inc.

Post-trial period surveillance for randomised controlled cardiovascular studies: submitted protocols, consent forms and the role of the ethics board.

PubMed

Zia, Mohammad I; Heslegrave, Ronald; Newton, Gary E

2011-12-01

The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised.

Magnetic Nanoparticle-Based Imaging of RNA Transcripts in Breast Cancer Cells

DTIC Science & Technology

2009-06-01

iron oxide NPs via thermal decomposition. - Prepared gold-coated iron oxide NPs. - Developed a click chemistry protocol (i.e. Cu-catalyzed terminal...D.L.J., Elias, D.R., Tsourkas, A. (2009) Comparative analysis of nanoparticle-antibody conjugations: carbodiimide versus click chemistry . Submitted...carbodiimide versus click chemistry . Submitted. APPENDICES: 1) Thorek, D.L.J., Tsourkas, A. (2008) Size, charge, and concentration dependent

The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study.

PubMed

Decullier, Evelyne; Lhéritier, Véronique; Chapuis, François

2005-10-17

Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis. Retrospective cohort of 976 protocols approved by a representative sample of 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives. Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14-17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25-53) and 37 (95% CI: 27-46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise. The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees.

Developing a Training Program in Breast Cancer Research to Decrease the Disparity of Morbidity and Mortality in Underserved/Minority Women

DTIC Science & Technology

2006-10-01

eHealth Promotion Training Institute. As a result of the training, they submitted a grant and received funding from the UNCFSP/NLM-HBCU Access...increase breast cancer screening among African American women eHealth Training Institute, Center for Collaborative Research. June...2006 Received funding and completed 40 hours of the eHealth Promotion Training Institute sponsored by the Center for Excellence in eHealth Promotion

Characterizing the Performance of Nonlinear Differential Operators

DTIC Science & Technology

2012-09-01

differential Riccati equations. Submitted to SIAM J . Control & Optimization, 29 pages, 2012. [B8] P.M. Dower, C.M. Kellett, and H. Zhang. A weak L2-gain...to a penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. 1. REPORT DATE 07...Parkville,Victoria 3010,Australia,NA,NA 8. PERFORMING ORGANIZATION REPORT NUMBER N/ A 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) AOARD, UNIT

21 CFR 312.320 - Treatment IND or treatment protocol.

Code of Federal Regulations, 2010 CFR

2010-04-01

... clinical trial under an IND designed to support a marketing application for the expanded access use, or (ii) All clinical trials of the drug have been completed; and (2) Marketing status. The sponsor is actively pursuing marketing approval of the drug for the expanded access use with due diligence; and (3) Evidence...

Sponsoring Organization | Division of Cancer Prevention

Cancer.gov

The National Cancer Institute (NCI) project officers are responsible for the design and oversight of all aspects of the PLCO trial. These NCI components work directly with the Coordinating Center which provides support for development and implementation of the study protocol; and with the Principal Investigators from each of the Screening Centers to ensure that the technical

From Reactionary to Responsive: Applying the Internal Environmental Scan Protocol to Lifelong Learning Strategic Planning and Operational Model Selection

ERIC Educational Resources Information Center

Downing, David L.

2009-01-01

This study describes and implements a necessary preliminary strategic planning procedure, the Internal Environmental Scanning (IES), and discusses its relevance to strategic planning and university-sponsored lifelong learning program model selection. Employing a qualitative research methodology, a proposed lifelong learning-centric IES process…

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

PubMed

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-04-01

A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. 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/

Overview (this manuscript is an overview of an ASTM symposium. The authors, John Sebroski and Mark Mason, of the overview were the co-chairs of the symposium and co-editors of the manuscripts submitted for ASTM peer review and subsequent publication in the technical proceedings for the symposium)

EPA Science Inventory

The Symposium on Developing Consensus Standards for Measuring Chemical Emissions from Spray Polyurethane Foam (SPF) Insulation was held on April 30th and May 1, 2015. Sponsored by ASTM Committee D22 on Air Quality, the symposium was held in Anaheim, CA, in conjunction with the st...

Clear Air Force Station: Air Force Reviewed Costs and Benefits of Several Options before Deciding to Close the Power Plant

DTIC Science & Technology

2014-05-01

Documentation Page Form ApprovedOMB No. 0704-0188 Public reporting burden for the collection of information is estimated to average 1 hour per response, including...SPONSOR/MONITOR’S REPORT NUMBER(S) 12. DISTRIBUTION/AVAILABILITY STATEMENT Approved for public release; distribution unlimited 13. SUPPLEMENTARY...private-sector entity or public utility. When no lease proposals were submitted, the Air Force pursued the option to close the plant, finding that the

KSC-04pd1292

NASA Image and Video Library

2004-06-08

KENNEDY SPACE CENTER, FLA. - Paul Curto (left), chief technologist with NASA’s Inventions and Contributions Board, learns about research being done in the Space Life Sciences Lab from Jessica Prenger, senior agricultural engineer. Curto is visiting KSC to talk to innovators and encourage workers to submit technologies for future Space Act Awards. The Inventions and Contributions Board, established in 1958, is a major contributor in rewarding outstanding scientific or technical contributions sponsored, adopted, supported or used by NASA that are significant to aeronautics and space activities.

Gallium Nitride (GaN) Monolithic Microwave Integrated Circuit (MMIC) Designs Submitted to Air Force Research Laboratory (AFRL) Sponsored Qorvo Fabrication

DTIC Science & Technology

2017-07-01

of interest to Department of Defense applications, particularly for next-generation radar systems. Broadband, efficient, high-power MMIC amplifiers...handling capability. Figures 1 and 2 show the layouts and simulations of a simple 1-stage 3- to 6-GHz Wilkinson coupler/combiner. A 2-stage broader band...from 4 to nearly 7 GHz for the 2-stage PA design. The simple , compact broadband feedback amplifier that serves as the first-stage driver for the 2

KSC-04pd1294

NASA Image and Video Library

2004-06-08

KENNEDY SPACE CENTER, FLA. - Paul Curto (left), chief technologist with NASA’s Inventions and Contributions Board, learns from bioengineer Tony Rector (right) about a wastewater processing project Rector is working on in the Space Life Sciences Lab. Curto is visiting KSC to talk to innovators and encourage workers to submit technologies for future Space Act Awards. The Inventions and Contributions Board, established in 1958, is a major contributor in rewarding outstanding scientific or technical contributions sponsored, adopted, supported or used by NASA that are significant to aeronautics and space activities.

Quarterly Performance/Technical Report of the National Marrow Donor Program

DTIC Science & Technology

2009-02-10

and epitope level matching for HLA-DPB1. Submitted. o Z Shamim , L Ryder, M Haagenson , S Spellman, T Wang, S Lee, K Müller. Polymorphism in the...3, 4 6. AUTHOR( S ) Setterholm, Michelle 5f. WORK UNIT NUMBER N/A 7. PERFORMING ORGANIZATION NAME( S ) AND ADDRESS(ES) National Marrow Donor...Program 3001 Broadway St., N.E., Ste. 500 Minneapolis, MN 55413 8. PERFORMING ORGANIZATION REPORT NUMBER N/A 10. SPONSOR/MONITOR’S ACRONYM( S ) ONR 9

KSC-04PD-1294

NASA Technical Reports Server (NTRS)

2004-01-01

KENNEDY SPACE CENTER, FLA. Paul Curto (left), chief technologist with NASAs Inventions and Contributions Board, learns from bioengineer Tony Rector (right) about a wastewater processing project Rector is working on in the Space Life Sciences Lab. Curto is visiting KSC to talk to innovators and encourage workers to submit technologies for future Space Act Awards. The Inventions and Contributions Board, established in 1958, is a major contributor in rewarding outstanding scientific or technical contributions sponsored, adopted, supported or used by NASA that are significant to aeronautics and space activities.

The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations.

PubMed

Kelleher, Finnuala

2004-01-01

Pharmaceutical companies increasingly perform clinical trials in developing nations. Governments of host nations see the trials as a way to provide otherwise unaffordable medical care, while trial sponsors are drawn to those countries by lower costs, the prevalence of diseases rare in developed nations, and large numbers of impoverished patients. Local governments, however, fail to police trials, and the FDA does not monitor trials in foreign countries, resulting in the routine violation of international standards for the protection of human subjects. This Note proposes independent accreditation of those institutions involved in clinical trials--the institutional review boards which oversee trial protocol; the organizations, such as pharmaceutical companies, which sponsor the trials; and the research organizations that conduct the trials. Accreditation, similar to that used in the footwear and apparel industries, would increase the transparency of pharmaceutical trials and would enable the United States government and consumers to hold trial sponsors accountable for their actions.

Integrative Lifecourse and Genetic Analysis of Military Working Dogs

DTIC Science & Technology

2013-10-01

Working Dogs 5b. GRANT NUMBER W81XWH-11-2-0226 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Dr. Kun Huang 5d. PROJECT NUMBER 5e. TASK...we submitted final revisions on our IACUC protocol for the collection of biological samples and Lackland veterinary approval was granted ; and...final Lackland AFB oversight approval was granted and those documents were submitted to DoD CDMRP grant administration. Currently, there is one final

Research in computer science

NASA Technical Reports Server (NTRS)

Ortega, J. M.

1984-01-01

The research efforts of University of Virginia students under a NASA sponsored program are summarized and the status of the program is reported. The research includes: testing method evaluations for N version programming; a representation scheme for modeling three dimensional objects; fault tolerant protocols for real time local area networks; performance investigation of Cyber network; XFEM implementation; and vectorizing incomplete Cholesky conjugate gradients.

[Editorial situation of seven Latin American journals on respiratory diseases].

PubMed

Oyarzún G, Manuel; Ramírez V, Alejandra; Agüero F, Adalberto; Baddini-Martínez, José Antonio; Bermúdez G, Mary; Canevá, Jorge O; Morales, Jaime E; Pérez-Padilla, Rogelio

2007-08-01

A survey was conducted in a meeting sponsored by ALAT (Latin American Association of Thoracic Diseases). Each of the seven editors reported about their journal and answered a questionnaire. The improvement in knowledge divulgation is the main motivation of respiratory societies to edit their own journals. To disseminate medical knowledge and report experiences, are the main motivations of authors to submit papers. The most common deficiency of submitted manuscripts is a bad compliance with journal requirements. An improvement in the relationship between author-editor-reviewer should be the best strategy to enhance the quality of the manuscripts. Suggestions to improve the Latin American journals included to professionalize editorial work, to increase the meticulousness of manuscripts reviewers and to reinforce international norms for editing medical journals. Some major problems reported were a lack of a regular and adequate periodicity in publishing the issues, lack of original papers submitted that mean a "milestone" for the specialty a low percentage of submitted papers rejection and a high and frequent turnover of editors. Although several journals are available in electronic indices, they should be maintained in their printed form. Each journal should have printed its subscription fee, even considering that its subscription is included in the annual society membership fee. The feasibility to generate a multinational Latin American Journal on Respiratory Diseases should be explored.

Comparison of three methods of DNA extraction from peripheral blood mononuclear cells and lung fragments of equines.

PubMed

Santos, E M; Paula, J F R; Motta, P M C; Heinemann, M B; Leite, R C; Haddad, J P A; Del Puerto, H L; Reis, J K P

2010-08-17

We compared three different protocols for DNA extraction from horse peripheral blood mononuclear cells (PBMC) and lung fragments, determining average final DNA concentration, purity, percentage of PCR amplification using beta-actin, and cost. Thirty-four samples from PBMC, and 33 samples from lung fragments were submitted to DNA extraction by three different protocols. Protocol A consisted of a phenol-chloroform and isoamylic alcohol extraction, Protocol B used alkaline extraction with NaOH, and Protocol C used the DNAzol((R)) reagent kit. Protocol A was the best option for DNA extraction from lung fragments, producing high DNA concentrations, with high sensitivity in PCR amplification (100%), followed by Protocols C and B. On the other hand, for PBMC samples, Protocol B gave the highest sensitivity in PCR amplification (100%), followed by Protocols C and A. We conclude that Protocol A should be used for PCR diagnosis from lung fragment samples, while Protocol B should be used for PBMC.

Referencing academic assignments.

PubMed

Gopee, N

External examiners often identify inaccurate referencing as a weakness in scripts submitted for assessment. This article explores the main aspects of referencing, and offers a protocol for referencing founded on the Harvard (name-date) system.

Lipid profiles of follicular fluid from cows submitted to ovarian superstimulation.

PubMed

Santos, P H; Fontes, P K; Franchi, F F; Nogueira, M F G; Belaz, K R A; Tata, A; Eberlin, M N; Sudano, M J; Barros, C M; Castilho, A C S

2017-05-01

Ovarian superstimulation with exogenous gonadotropins has been extensively used to produce in vivo-derived embryos for embryo transfer in cattle. This process modifies the antral follicle microenvironment and affects oocyte and embryo quality as well the differentiation of granulosa cells. Lipids play significant roles in the cell, such as energy storage, cell structure, and fine-tuning of the physical properties and functions of biological membranes. The phospholipid (PL) contents as well as the effects of superstimulatory treatments on the PL profile of follicular fluid from cows, however, remain unknown. Therefore, to gain insight into the effects of superstimulation with follicle-stimulating hormone (FSH; P-36 protocol) or FSH combined with equine chorionic gonadotropin (eCG; P-36/eCG protocol) on the profile and abundance of PL from cows submitted or not submitted to superstimulatory protocols, were treated with these two superstimulatory protocols. As a control, non-superstimulated cows were only submitted to estrous synchronization. The follicular fluid was aspirated, the remaining cells removed and the follicular fluid stored at -80 °C until extraction. The lipid screening was performed by matrix-assisted laser desorption ionization mass spectrometry (MALDI-MS) and this technique allowed the identification of sphingomyelins (SM) and phosphatidylcholines (PC) and phosphoethanolamines (PE). The relative abundance of the ions observed in the three experimental groups was analyzed by multivariate and univariate statistical models. The phospholipid SM (16:0) and PC (36:4) and/or PC (34:1) were less (P < 0.05) abundant in the P-36 group compared to the control or P-36/eCG groups. However, the PC (34:2) was more (P < 0.05) abundant in both group of superstimulated cows compared to the control. In summary, ovarian superstimulation seems to modulate the PL content of bovine follicular fluid with a significant increase in PC (34:2), which jointly with others PC and SM, seems to offer a suitable biomarker involved with reproductive processes successful as ovary superstimulation response and embryo development. Copyright © 2017. Published by Elsevier Inc.

Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe

PubMed Central

Farkas, Andreas M.; Mariz, Segundo; Stoyanova-Beninska, Violeta; Celis, Patrick; Vamvakas, Spiros; Larsson, Kristina; Sepodes, Bruno

2017-01-01

In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs). We applied the ATMPs classification definitions in this Regulation to understand the link of this emerging group of medicinal products and the use of the Orphan Regulation. A total of 185 products that can be classified as ATMPs based on this Regulation have been submitted for orphan designation. Prior to its introduction in 2008, 4.5% of the products submitted for orphan designation met these criteria. This percentage went up to 15% after 2008. We analyzed several parameters associated with active ATMP ODDs focusing on sponsor type and EU-Member State origin, therapeutic area targeted, and ATMP classification [i.e., somatic cell therapy medicinal product, tissue-engineered product (TEP), or gene therapy medicinal product (GTMP)] and the use of regulatory services linked to incentives such as the use of protocol assistance (PA) and other Committees [Committee for Advanced Therapies (CAT) and the Pediatric Committee]. The aim here was to gain insight on the use of different services. The UK submits the largest number of ATMPs for ODD representing ~30% of the total to date. Few submissions have been received from central and Eastern European Member States as well as some of the larger Member States such as Germany (3.6%). ATMPs ODDs were primarily GTMPs (48.7%) and SCTMPs (43.3%). TEPs only represented 8% of all submissions for this medicinal class. This is different from non-ODDs ATMPs where GTMPs make only 20% of ATMPs. A total of 11.7% of ATMP ODDs had received formal CAT classification. A total of 29.8% of all orphan drug (OD) ATMPs requested PA. A total of 71.8% did not have an agreed pediatric investigation plan (PIP). Four products (Glybera one PA; Zalmoxis two; Holoclar one; Strimvelis three) have received a marketing authorization (MAA) and a 10-year market exclusivity. Strimvelis also completed their PIP, which was compliant and received the additional 2-year extension to their 10-year market exclusivity. One OD ATMP (Cerepro) received a negative opinion for MAA. The use of services linked to incentives offered by different legislations for ATMP ODDs is low, indicating a need for increasing awareness. PMID:28560211

Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe.

PubMed

Farkas, Andreas M; Mariz, Segundo; Stoyanova-Beninska, Violeta; Celis, Patrick; Vamvakas, Spiros; Larsson, Kristina; Sepodes, Bruno

2017-01-01

In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs). We applied the ATMPs classification definitions in this Regulation to understand the link of this emerging group of medicinal products and the use of the Orphan Regulation. A total of 185 products that can be classified as ATMPs based on this Regulation have been submitted for orphan designation. Prior to its introduction in 2008, 4.5% of the products submitted for orphan designation met these criteria. This percentage went up to 15% after 2008. We analyzed several parameters associated with active ATMP ODDs focusing on sponsor type and EU-Member State origin, therapeutic area targeted, and ATMP classification [i.e., somatic cell therapy medicinal product, tissue-engineered product (TEP), or gene therapy medicinal product (GTMP)] and the use of regulatory services linked to incentives such as the use of protocol assistance (PA) and other Committees [Committee for Advanced Therapies (CAT) and the Pediatric Committee]. The aim here was to gain insight on the use of different services. The UK submits the largest number of ATMPs for ODD representing ~30% of the total to date. Few submissions have been received from central and Eastern European Member States as well as some of the larger Member States such as Germany (3.6%). ATMPs ODDs were primarily GTMPs (48.7%) and SCTMPs (43.3%). TEPs only represented 8% of all submissions for this medicinal class. This is different from non-ODDs ATMPs where GTMPs make only 20% of ATMPs. A total of 11.7% of ATMP ODDs had received formal CAT classification. A total of 29.8% of all orphan drug (OD) ATMPs requested PA. A total of 71.8% did not have an agreed pediatric investigation plan (PIP). Four products (Glybera one PA; Zalmoxis two; Holoclar one; Strimvelis three) have received a marketing authorization (MAA) and a 10-year market exclusivity. Strimvelis also completed their PIP, which was compliant and received the additional 2-year extension to their 10-year market exclusivity. One OD ATMP (Cerepro) received a negative opinion for MAA. The use of services linked to incentives offered by different legislations for ATMP ODDs is low, indicating a need for increasing awareness.

Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project.

PubMed

Levitan, Bennett; Getz, Kenneth; Eisenstein, Eric L; Goldberg, Michelle; Harker, Matthew; Hesterlee, Sharon; Patrick-Lake, Bray; Roberts, Jamie N; DiMasi, Joseph

2018-03-01

While patient groups, regulators, and sponsors are increasingly considering engaging with patients in the design and conduct of clinical development programs, sponsors are often reluctant to go beyond pilot programs because of uncertainty in the return on investment. We developed an approach to estimate the financial value of patient engagement. Expected net present value (ENPV) is a common technique that integrates the key business drivers of cost, time, revenue, and risk into a summary metric for project strategy and portfolio decisions. We assessed the impact of patient engagement on ENPV for a typical oncology development program entering phase 2 or phase 3. For a pre-phase 2 project, the cumulative impact of a patient engagement activity that avoids one protocol amendment and improves enrollment, adherence, and retention is an increase in net present value (NPV) of $62MM ($65MM for pre-phase 3) and an increase in ENPV of $35MM ($75MM for pre-phase 3). Compared with an investment of $100,000 in patient engagement, the NPV and ENPV increases can exceed 500-fold the investment. This ENPV increase is the equivalent of accelerating a pre-phase 2 product launch by 2½ years (1½ years for pre-phase 3). Risk-adjusted financial models can assess the impact of patient engagement. A combination of empirical data and subjective parameter estimates shows that engagement activities with the potential to avoid protocol amendments and/or improve enrollment, adherence, and retention may add considerable financial value. This approach can help sponsors assess patient engagement investment decisions.

Assessing the Financial Value of Patient Engagement

PubMed Central

Levitan, Bennett; Getz, Kenneth; Eisenstein, Eric L.; Goldberg, Michelle; Harker, Matthew; Hesterlee, Sharon; Patrick-Lake, Bray; Roberts, Jamie N.; DiMasi, Joseph

2017-01-01

Background: While patient groups, regulators, and sponsors are increasingly considering engaging with patients in the design and conduct of clinical development programs, sponsors are often reluctant to go beyond pilot programs because of uncertainty in the return on investment. We developed an approach to estimate the financial value of patient engagement. Methods: Expected net present value (ENPV) is a common technique that integrates the key business drivers of cost, time, revenue, and risk into a summary metric for project strategy and portfolio decisions. We assessed the impact of patient engagement on ENPV for a typical oncology development program entering phase 2 or phase 3. Results: For a pre–phase 2 project, the cumulative impact of a patient engagement activity that avoids one protocol amendment and improves enrollment, adherence, and retention is an increase in net present value (NPV) of $62MM ($65MM for pre–phase 3) and an increase in ENPV of $35MM ($75MM for pre–phase 3). Compared with an investment of $100,000 in patient engagement, the NPV and ENPV increases can exceed 500-fold the investment. This ENPV increase is the equivalent of accelerating a pre–phase 2 product launch by 2½ years (1½ years for pre–phase 3). Conclusions: Risk-adjusted financial models can assess the impact of patient engagement. A combination of empirical data and subjective parameter estimates shows that engagement activities with the potential to avoid protocol amendments and/or improve enrollment, adherence, and retention may add considerable financial value. This approach can help sponsors assess patient engagement investment decisions. PMID:29714515

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.

Needing a nudge: the effect of encouragement on submission rates and journal selection.

PubMed

Wendling, Andrea; Brocato, Joseph

2014-06-01

Mentorship within academic institutions influences research productivity; no published studies have addressed whether encouragement on a national level would have similar effects. We studied whether contact by a journal's editorial board members would affect submission rates or journal selection by authors. Authors of potentially publishable conference materials presented at national conferences sponsored by the Society of Teachers of Family Medicine were randomized to receive an invitation to submit work to Family Medicine or to receive no contact. After 2 years, we surveyed authors regarding whether a manuscript had been attempted and, if completed, where it had been submitted and eventually published. A total of 345 submissions were reviewed, 72 met inclusion criteria, and 41 authors responded to the survey (57%). There were no differences in demographics, scholarly activity in general, or faculty status between study groups. There was no significant difference in whether manuscripts based on targeted projects had been written, completed, submitted, or published. There was a significant difference in where manuscripts were submitted with the inviting journal receiving proportionately more submissions from the group of authors that had been contacted (90% Contacted group, 43% No-Contact). Simple encouragement from editorial board members of a national peer-reviewed journal in the form of a single e-mail invitation did not increase the scholarly production of authors. Encouragement may, however, increase the likelihood that completed works are submitted to the inviting journal, which is a useful finding for journals interested in soliciting scholarly works of interest.

Timeline of Actions on HFCs

EPA Pesticide Factsheets

The Kigali amendment to phase down HFCs was the result of years of negotiation by parties to the Montreal Protocol, with numerous HFC amendment proposals submitted by North America, Island States, India, and the European Union.

Restoring Bladder Function by Spinal Cord Neuromodulation in SCI

DTIC Science & Technology

2016-10-01

conduct interviews/ surveys , recruit participants, obtain consent, review records, etc. View For existing protocols: Item 2.0 has been modified and...apply: A mechanism such as Survey Monkey, Zoomerang, or an e-mail anonymizing service will be used to strip off the IP addresses for data submitted via...attach the following: Protocol, Dissertation Proposal or Study Plan Preliminary Data Surveys , Questionnaires or other instruments to be used with

Strategies to improve fertility in post partum Bos indicus cows submitted to a fixed-time insemination protocol with GnRH and PGF2a

USDA-ARS?s Scientific Manuscript database

In Experiment 1, we evaluated the effects of two lengths of progesterone exposure (CIDR; 7 vs. 14 d) prior to a modified CO-Synch protocol, with or without temporary weaning (TW) before GnRH treatments, on fertility of suckled Bos indicus Nelore cows (n = 283) and on calf performance. Timed AI (TAI)...

Use of a web-based image reporting and tracking system for assessing abdominal imaging examination quality issues in a single practice.

PubMed

Rosenkrantz, Andrew B; Johnson, Evan; Sanger, Joseph J

2015-10-01

This article presents our local experience in the implementation of a real-time web-based system for reporting and tracking quality issues relating to abdominal imaging examinations. This system allows radiologists to electronically submit examination quality issues during clinical readouts. The submitted information is e-mailed to a designate for the given modality for further follow-up; the designate may subsequently enter text describing their response or action taken, which is e-mailed back to the radiologist. Review of 558 entries over a 6-year period demonstrated documentation of a broad range of examination quality issues, including specific issues relating to protocol deviation, post-processing errors, positioning errors, artifacts, and IT concerns. The most common issues varied among US, CT, MRI, radiography, and fluoroscopy. In addition, the most common issues resulting in a patient recall for repeat imaging (generally related to protocol deviation in MRI and US) were identified. In addition to submitting quality problems, radiologists also commonly used the tool to provide recognition of a well-performed examination. An electronic log of actions taken in response to radiologists' submissions indicated that both positive and negative feedback were commonly communicated to the performing technologist. Information generated using the tool can be used to guide subsequent quality improvement initiatives within a practice, including continued protocol standardization as well as education of technologists in the optimization of abdominal imaging examinations.

Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners.

PubMed Central

Wise, P.; Drury, M.

1996-01-01

OBJECTIVE: To assess the outcome of 100 general practice based, multicentre research projects submitted to the ethics committee of the Royal College of General Practitioners by pharmaceutical companies or their agents between 1984 and 1989. DESIGN: Analysis of consecutive submitted protocols for stated objectives, study design, and outcomes; detailed review of committee minutes and correspondence in relation to amendment and approval; assessment of final reports submitted at conclusion of studies. SUBJECTS: 82 finally approved protocols, embracing 34,523 proposed trial subjects and 1195 proposed general practice investigators. MAIN OUTCOME MEASURES: Success at enrolling subjects and investigators; commencement and completion data; validity of final report's assessment of efficacy, safety, tolerability, and acceptability; and method of use and dissemination of findings. RESULTS: 18 studies were not approved and 45 had to be amended. Randomised controlled trials comprised 46 of the original submissions. Remuneration considerations, inadequate information or consent sheets, pregnancy safety, the need to discontinue existing therapy, and suboptimal scientific content were major reasons for rejecting studies or asking for amendments. Of the 82 approved studies 8 were not started. Shortfalls of investigators (of 39%) and trial subjects (of 37%) and an overall 23% withdrawal rate were responsible for a significant incidence of inconclusive results. Within the six year follow up interval, only 19 of the studies had been formally published. CONCLUSIONS: This audit identified substantial ethical concerns in the process of approving multicentre general practice pharmaceutical research. PMID:8939118

Sustaining School Improvement through an External and Internal Focus: A Case Study of a High-Need Secondary School in Nepal

ERIC Educational Resources Information Center

Gautam, Chetanath; Alford, Betty J.; Khanal, Manju

2015-01-01

A study of a high-need school in Nepal was conducted by members of the International School Leadership Development Network (ISLDN) using the interview protocol developed by members of the high-need school strand of ISLDN. The International School Leadership Development Network is sponsored by the University Council for Educational Administration…

THE EFFECTS OF ATRAZINE METABOLITES ON PUBERTY AND THYROID FUNCTION IN THE MALE WISTAR RATS: AN EVALUATION IN THE MALE PUBERTAL PROTOCOL

EPA Science Inventory

The Effects of Atrazine Metabolites on Puberty in the Male Wistar Rat. D L Guidici, R L Cooper and T E Stoker. Endocrinology Branch, NHEERL, U.S. Environmental Protection Agency, RTP, NC.
Sponsor: R J Kavlock.
Atrazine (ATR), a chlorotriazine herbicide, alters pubertal pr...

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE FOR STANDARD PROTOCOL FOR CLEANING LABORATORY AND FIELD SAMPLING APPARATUS (UA-L-5.1)

EPA Science Inventory

The purpose of this SOP is to describe the standard approach used for cleaning glassware and plasticware during the Arizona NHEXAS project and the Border study. Keywords: lab; equipment; cleaning.

The U.S.-Mexico Border Program is sponsored by the Environmental Health Workgroup...

Connecting the Force from Space: The IRIS Joint Capability Technology Demonstration

DTIC Science & Technology

2010-01-01

the Joint in Joint Capability Technology Demonstration, we have two sponsors, both U.S. Strategic Command and the Defense Information Systems...Capability Technology Demonstration will provide an excellent source of data on space-based Internet Protocol net- working. Operational... Internet Routing in Space Joint Capability Technology Demonstration Operational Manager, Space and Missile Defense Battle Lab, Colorado Springs

Industry-contract research organization pathology interactions: a perspective of contract research organizations in producing the best quality pathology report.

PubMed

Gosselin, Sylvie J; Palate, Bernard; Parker, George A; Engelhardt, Jeffery A; Hardisty, Jerry F; McDorman, Kevin S; Tellier, Pierre A; Silverman, Lee R

2011-02-01

This article provides observations on the features of sponsor-contract research organization communication that will achieve the best quality pathology report based on our collective experience. Information on the test article and any anticipated findings should be provided, and initial slide examination should be done with knowledge of treatment group (but may be followed by blinded review of target tissues to determine no-effect levels). Only a pathologist should write or revise the pathology report or the pathology section of the overall study report. To address concerns related to undue sponsor influence, comments by sponsors should be presented as suggestions rather than directives. Adversity should be defined for each finding by the study pathologist, but the no-observed adverse effect level should not be discussed in the pathology report. Board-certified pathologists are recommended, but are not essential. Sponsors that have a particular format or report preferences should make them known well in advance. Histologic processing "to glass" of protocol-specified tissues from all dosage groups is recommended for rapid evaluation of target tissues. Telepathology is beneficial in certain situations, but it is usually more efficient for the study pathologist and reviewing pathologist to be in the same physical location to review differences of opinion and reach a consensus.

78 FR 68056 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

...The Environmental Protection Agency has submitted an information collection request (ICR), ``NSPS for Stationary Gas Turbines (Renewal)'' (EPA ICR No. 1071.11, OMB Control No. 2060-0028), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq). This is a proposed extension of the ICR, which is currently approved through December 31, 2013. Public comments were previously requested via the Federal Register (78 FR 33409) on June 4, 2013, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers' perspectives to identify potential barriers.

PubMed

White, Lauren; Ortiz, Zulma; Cuervo, Luis G; Reveiz, Ludovic

2011-11-01

To review and analyze the regulatory framework of clinical trial registration, use of existing tools (publicly accessible national/international registration databases), and users' perspectives to identify possible barriers to registration compliance by sponsors and researchers in Argentina. Internationally registered trials recruiting patients in Argentina were found through clincialtrials.gov and the International Clinical Trial Registration Platform (ICTRP) and compared with publically available clinical trials registered through the National Administration of Drugs, Foods, and Medical Devices (ANMAT). A questionnaire addressing hypothesized attitudinal, knowledge-related, idiomatic, technical, economic, and regulatory barriers that could discourage or impede registration of clinical trials was developed, and semi-structured, in-depth interviews were conducted with a purposively selected sample of researchers (investigators, sponsors, and monitors) in Argentina. A response rate of 74.3% (n = 29) was achieved, and 27 interviews were ultimately used for analysis. Results suggested that the high proportion of foreign-sponsored or multinational trials (64.8% of all protocols approved by ANMAT from 1994-2006) may contribute to a communication gap between locally based investigators and foreign-based administrative officials. A lack of knowledge about available international registration tools and limited awareness of the importance of registration were also identified as limiting factors for local investigators and sponsors. To increase compliance and promote clinical trial registration in Argentina, national health authorities, sponsors, and local investigators could take the following steps: implement a grassroots educational campaign to improve clinical trial regulation, support local investigator-sponsor-initiated clinical trials, and/or encourage local and regional scientific journal compliance with standards from the International Committee of Medical Journal Editors (ICMJE) and/or the World Association of Medical Editors (WAME).

Effect of a cryopreservation protocol on the proliferation of stem cells from human exfoliated deciduous teeth.

PubMed

Ginani, Fernanda; Soares, Diego Moura; Rabêlo, Luciana Maria; Rocha, Hugo Alexandre Oliveira; de Souza, Lélia Batista; Barboza, Carlos Augusto Galvão

2016-11-01

The aim of the present study was to evaluate the influence of a cryopreservation protocol on the proliferation and viability of stem cells from human exfoliated deciduous teeth (SHEDs). Cells from the pulp of three deciduous teeth were isolated and characterized to confirm their stem cell nature. In second passage, part of the cells were submitted to normal conditions of cell culture (Control group), while part of the cells were maintained in 10% DMSO diluted in foetal bovine serum and submitted to the following cryopreservation protocol: 2 h at 4 °C, 18 h at -20 °C and then at -80 °C for two intervals (30 days - Cryopreservation I; and 180 days Cryopreservation II). Cell proliferation and cell cycle were evaluated at intervals of 24, 48 and 72 h after plating, and apoptosis-related events were analyzed at 72 h. All groups exhibited an increase in the number of cells, and no significant differences between the cryopreserved and control groups were observed (p > .05). The distribution of cells in the cell cycle phases was consistent with cell proliferation, and the percentage of viable cells was higher than 99% in all groups, indicating that cell viability was not affected by the cryopreservation protocol throughout the experiment. The proposed cryopreservation protocol is adequate for the storage of SHED, permitting their use in future experimental studies.

Expedition_55_Education_In-flight_Interview_with Boeing_Genes_in Space_2018_130_1615_651411

NASA Image and Video Library

2018-05-10

SPACE STATION CREW MEMBERS DISCUSS RESEARCH WITH TEXAS STUDENTS------- Aboard the International Space Station, Expedition 55 Flight Engineers Drew Feustel and Scott Tingle of NASA discussed research on the orbital laboratory during an in-flight educational event May 10 with students gathered at Space Center Houston. The in-flight event centered around the Boeing-sponsored Genes in Space experiment which enlisted students in grades 7-12 to submit various ideas for DNA research with an eye to future implications for deep space exploration.

KSC-04PD-1293

NASA Technical Reports Server (NTRS)

2004-01-01

KENNEDY SPACE CENTER, FLA. Dr. Gary Stutte explains to Paul Curto (right), chief technologist with NASAs Inventions and Contributions Board, the research being done in this plant growth chamber in the Space Life Sciences Lab. Stutte is a senior research scientist with Dynamac Corp. Curto is visiting KSC to talk to innovators and encourage workers to submit technologies for future Space Act Awards. The Inventions and Contributions Board, established in 1958, is a major contributor in rewarding outstanding scientific or technical contributions sponsored, adopted, supported or used by NASA that are significant to aeronautics and space activities.

78 FR 58349 - Agency Information Collection Activities; Submission for OMB Review; Comment Request: Certificate...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-23

...The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) revision titled, ``Certificate of Electrical Training and Applications for Mine Safety and Health Administration Approved Tests and State Tests Administered as Part of a Mine Safety and Health Administration Approved State Program,'' to the Office of Management and Budget (OMB) for review and approval for use, in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).

Validation of the Australian diagnostic reference levels for paediatric multi detector computed tomography: a comparison of RANZCR QUDI data and subsequent NDRLS data from 2012 to 2015.

PubMed

Anna, Hayton; Wallace, Anthony; Thomas, Peter

2017-03-01

The national diagnostic reference level service (NDRLS), was launched in 2011, however no paediatric data were submitted during the first calendar year of operation. As such, Australian national diagnostic reference levels (DRLs), for paediatric multi detector computed tomography (MDCT), were established using data obtained from a Royal Australian and New Zealand College of Radiologists (RANZCR), Quality Use of Diagnostic Imaging (QUDI), study. Paediatric data were submitted to the NDRLS in 2012 through 2015. An analysis has been made of the NDRLS paediatric data using the same method as was used to analyse the QUDI data to establish the Australian national paediatric DRLs for MDCT. An analysis of the paediatric NDRLS data has also been made using the method used to calculate the Australian national adult DRLs for MDCT. A comparison between the QUDI data and subsequent NDRLS data shows the NDRLS data to be lower on average for the Head and AbdoPelvis protocol and similar for the chest protocol. Using an average of NDRLS data submitted between 2012 and 2015 implications for updated paediatric DRLS are considered.

Influence of artificial accelerated aging on dimensional stability of acrylic resins submitted to different storage protocols.

PubMed

Garcia, Lucas da Fonseca Roberti; Roselino, Lourenço de Moraes Rego; Mundim, Fabrício Mariano; Pires-de-Souza, Fernanda de Carvalho Panzeri; Consani, Simonides

2010-08-01

The aim of this study was to evaluate the influence of artificial accelerated aging on dimensional stability of two types of acrylic resins (thermally and chemically activated) submitted to different protocols of storage. One hundred specimens were made using a Teflon matrix (1.5 cm x 0.5 mm) with four imprint marks, following the lost-wax casting method. The specimens were divided into ten groups, according to the type of acrylic resin, aging procedure, and storage protocol (30 days). GI: acrylic resins thermally activated, aging, storage in artificial saliva for 16 hours, distilled water for 8 hours; GII: thermal, aging, artificial saliva for 16 hours, dry for 8 hours; GIII: thermal, no aging, artificial saliva for 16 hours, distilled water for 8 hours, GIV: thermal, no aging, artificial saliva for 16 hours, dry for 8 hours; GV: acrylic resins chemically activated, aging, artificial saliva for 16 hours, distilled water for 8 hours; GVI: chemical, aging, artificial saliva for 16 hours, dry for 8 hours; GVII: chemical, no aging, artificial saliva for 16 hours, distilled water for 8 hours; GVIII: chemical, no aging, artificial saliva for 16 hours, dry for 8 hours GIX: thermal, dry for 24 hours; and GX: chemical, dry for 24 hours. All specimens were photographed before and after treatment, and the images were evaluated by software (UTHSCSA - Image Tool) that made distance measurements between the marks in the specimens (mm), calculating the dimensional stability. Data were submitted to statistical analysis (two-way ANOVA, Tukey test, p= 0.05). Statistical analysis showed that the specimens submitted to storage in water presented the largest distance between both axes (major and minor), statistically different (p < 0.05) from control groups. All acrylic resins presented dimensional changes, and the artificial accelerated aging and storage period influenced these alterations.

Narrative writing: Effective ways and best practices

PubMed Central

Ledade, Samir D.; Jain, Shishir N.; Darji, Ankit A.; Gupta, Vinodkumar H.

2017-01-01

A narrative is a brief summary of specific events experienced by patients, during the course of a clinical trial. Narrative writing involves multiple activities such as generation of patient profiles, review of data sources, and identification of events for which narratives are required. A sponsor outsources narrative writing activities to leverage the expertise of service providers which in turn requires effective management of resources, cost, time, quality, and overall project management. Narratives are included as an appendix to the clinical study report and are submitted to the regulatory authorities as a part of dossier. Narratives aid in the evaluation of the safety profile of the investigational drug under study. To deliver high-quality narratives within the specified timeframe to the sponsor can be achieved by standardizing processes, increasing efficiency, optimizing working capacity, implementing automation, and reducing cost. This paper focuses on effective ways to design narrative writing process and suggested best practices, which enable timely delivery of high-quality narratives to fulfill the regulatory requirement. PMID:28447014

Narrative writing: Effective ways and best practices.

PubMed

Ledade, Samir D; Jain, Shishir N; Darji, Ankit A; Gupta, Vinodkumar H

2017-01-01

A narrative is a brief summary of specific events experienced by patients, during the course of a clinical trial. Narrative writing involves multiple activities such as generation of patient profiles, review of data sources, and identification of events for which narratives are required. A sponsor outsources narrative writing activities to leverage the expertise of service providers which in turn requires effective management of resources, cost, time, quality, and overall project management. Narratives are included as an appendix to the clinical study report and are submitted to the regulatory authorities as a part of dossier. Narratives aid in the evaluation of the safety profile of the investigational drug under study. To deliver high-quality narratives within the specified timeframe to the sponsor can be achieved by standardizing processes, increasing efficiency, optimizing working capacity, implementing automation, and reducing cost. This paper focuses on effective ways to design narrative writing process and suggested best practices, which enable timely delivery of high-quality narratives to fulfill the regulatory requirement.

[The maximum heart rate in the exercise test: the 220-age formula or Sheffield's table?].

PubMed

Mesquita, A; Trabulo, M; Mendes, M; Viana, J F; Seabra-Gomes, R

1996-02-01

To determine in the maximum cardiac rate in exercise test of apparently healthy individuals may be more properly estimated through 220-age formula (Astrand) or the Sheffield table. Retrospective analysis of clinical history and exercises test of apparently healthy individuals submitted to cardiac check-up. Sequential sampling of 170 healthy individuals submitted to cardiac check-up between April 1988 and September 1992. Comparison of maximum cardiac rate of individuals studied by the protocols of Bruce and modified Bruce, in interrupted exercise test by fatigue, and with the estimated values by the formulae: 220-age versus Sheffield table. The maximum cardiac heart rate is similar with both protocols. This parameter in normal individuals is better predicted by the 220-age formula. The theoretic maximum cardiac heart rate determined by 220-age formula should be recommended for a healthy, and for this reason the Sheffield table has been excluded from our clinical practice.

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

Poston, Ted M.; Thrall, Karla D.; Penner, Jocelyn D.

I was asked to submit a response to the Protocol Review forum for the journal LabAnimal by Dr. Jerald Silverman. This forum request views and opinions on issues that are faced by research animal welfare committees. The particular issue is: Dr. John Smith, a distinguished investigator at Great Eastern University, had spent his career searching for a treatment for hearing loss. After 20 years of research, he developed a drug that potentially could improve auditory function after damage to the inner ear. The drug was administered by injection into the middle ear with the use of a fine needle insertedmore » through the eardrum. Smith submitted a protocol to the IACUC to conduct a small study on cats, proposing to treat one group of animals with the drug and another with saline, to determine if it prevented the changes in the anatomy of the inner ear that normally occur with aging.« less

Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement.

PubMed

Moher, David; Shamseer, Larissa; Clarke, Mike; Ghersi, Davina; Liberati, Alessandro; Petticrew, Mark; Shekelle, Paul; Stewart, Lesley A

2015-01-01

Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.

Rationale of technical requirements for NRG-BR001: The first NCI-sponsored trial of SBRT for the treatment of multiple metastases.

PubMed

Al-Hallaq, Hania A; Chmura, Steven; Salama, Joseph K; Winter, Kathryn A; Robinson, Clifford G; Pisansky, Thomas M; Borges, Virginia; Lowenstein, Jessica R; McNulty, Susan; Galvin, James M; Followill, David S; Timmerman, Robert D; White, Julia R; Xiao, Ying; Matuszak, Martha M

In 2014, the NRG Oncology Group initiated the first National Cancer Institute-sponsored, phase 1 clinical trial of stereotactic body radiation therapy (SBRT) for the treatment of multiple metastases in multiple organ sites (BR001; NCT02206334). The primary endpoint is to test the safety of SBRT for the treatment of 2 to 4 multiple lesions in several anatomic sites in a multi-institutional setting. Because of the technical challenges inherent to treating multiple lesions as their spatial separation decreases, we present the technical requirements for NRG-BR001 and the rationale for their selection. Patients with controlled primary tumors of breast, non-small cell lung, or prostate are eligible if they have 2 to 4 metastases distributed among 7 extracranial anatomic locations throughout the body. Prescription and organ-at-risk doses were determined by expert consensus. Credentialing requirements include (1) irradiation of the Imaging and Radiation Oncology Core phantom with SBRT, (2) submitting image guided radiation therapy case studies, and (3) planning the benchmark. Guidelines for navigating challenging planning cases including assessing composite dose are discussed. Dosimetric planning to multiple lesions receiving differing doses (45-50 Gy) and fractionation (3-5) while irradiating the same organs at risk is discussed, particularly for metastases in close proximity (≤5 cm). The benchmark case was selected to demonstrate the planning tradeoffs required to satisfy protocol requirements for 2 nearby lesions. Examples of passing benchmark plans exhibited a large variability in plan conformity. NRG-BR001 was developed using expert consensus on multiple issues from the dose fractionation regimen to the minimum image guided radiation therapy guidelines. Credentialing was tied to the task rather than the anatomic site to reduce its burden. Every effort was made to include a variety of delivery methods to reflect current SBRT technology. Although some simplifications were adopted, the successful completion of this trial will inform future designs of both national and institutional trials and would allow immediate clinical adoption of SBRT trials for oligometastases. Copyright © 2016 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Agent-Based Computing Integration and Testing

DTIC Science & Technology

2006-12-01

Query Language (DQL). Regrettably, DQL never became a W3C Member Submission itself, but likely had some influence on the SPARQL Protocol And RDF... Query Language ( SPARQL ) subsequently produced by the W3C Data Access Working Group (DAWG) as that working group also contained members from the DAML...Sponsored by Defense Advanced Research Projects Agency DARPA Order No. K536 APPROVED FOR PUBLIC RELEASE

GWOT Vascular Injury Study 2 Supplemental Project: Impact of Prophylactic Fasciotomy

DTIC Science & Technology

2017-10-01

of the project ? The overall goal is to determine the impact of the widespread use of fasciotomies on current medical/surgical practices, management ...Diane Miller Project Role: Program Manager Nearest person month worked: 12 Contribution to Project : Ms. Miller is responsible for the day-to-day...each branch of service. Goals/Milestones CY14 Goal – Protocol/Staffing  Write and submit protocol to IRB  Hire project manager CY15 Goals – Data

The GLOBE Contrail Protocol: Initial Analysis of Results

NASA Technical Reports Server (NTRS)

Chambers, Lin; Duda, David

2004-01-01

The GLOBE contrail protocol was launched in March 2003 to obtain surface observer reports of contrail occurrence to complement satellite and model studies underway at NASA Langley, among others. During the first year, more than 30,000 ground observations of contrails were submitted to GLOBE. An initial analysis comparing the GLOBE observations to weather prediction model results for relative humidity at flight altitudes is in progress. This paper reports on the findings to date from this effort.

[Recording and reporting adverse reactions in clinical trials. New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)].

PubMed

Eckhardt, K; Cremer-Schaeffer, P; König, J; Paeschke, N

2005-02-01

With the 12th Law Amending the German Drug Law and the Ordinance on GCP (GCPV), new legal provisions for clinical trials came into force in August 2004. These include specific definitions and differentiated reporting obligations affecting investigators, sponsors, authorities and ethics committees concerning pharmacovigilance in clinical trials. The definitions according to section sign3 (6-8) GCP-V make clear that these provisions focus on those adverse events and adverse drug reactions, which are related to investigational medicinal products. In the GCP-V for the first time legally binding provisions for investigators are laid down defining obligations to report all serious adverse events to the sponsor. The sponsor of clinical trials plays a decisive role concerning the evaluation, documentation and reporting to the competent higher authorities, ethics committees and investigators involved in the clinical trial. In the GCP-V different time limits concerning the reporting for sponsors are laid down. The requirements concerning expedited reporting focus on suspected unexpected serious adverse reactions (SUSARs), i. e. those adverse serious reactions, which are not described in the information on the investigational medicinal product. The time limit for reporting SUSARs leading to death or life-threatening SUSARs is 7 days, while for other SUSARs the time limit is 15 days. Besides the responsibilities on expedited reporting the sponsor has to submit a line listing of all serious adverse reactions which occurred during the clinical trial and a report on the safety of the trial subjects on an annual basis or on request. On the European level the harmonisation concerning the provisions on pharmacovigilance in clinical trials according to the Directive 2001/20/EC and the Eudravigilance database should contribute to reach a faster and more effective exchange of safety information related to clinical trials between the different competent authorities of the EU member states.

A protocol proposition of cell therapy for the treatment of chronic obstructive pulmonary disease.

PubMed

Ribeiro-Paes, J T; Stessuk, T; Marcelino, M; Faria, C; Marinelli, T; Ribeiro-Paes, M J

2014-01-01

The main feature of pulmonary emphysema is airflow obstruction resulting from the destruction of the alveolar walls distal to the terminal bronchioles. Existing clinical approaches have improved and extended the quality of life of emphysema patients. However, no treatment currently exists that can change the disease course and cure the patient. The different therapeutic approaches that are available aim to increase survival and/or enhance the quality of life of emphysema patients. In this context, cell therapy is a promising therapeutic approach with great potential for degenerative pulmonary diseases. In this protocol proposition, all patients will be submitted to laboratory tests, such as evaluation of heart and lung function and routine examinations. Stem cells will be harvested by means of 10 punctures on each anterior iliac crest, collecting a total volume of 200mL bone marrow. After preparation, separation, counting and labeling (optional) of the mononuclear cells, the patients will receive an intravenous infusion from the pool of Bone Marrow Mononuclear Cells (BMMC). This article proposes a rational and safe clinical cellular therapy protocol which has the potential for developing new projects and can serve as a methodological reference for formulating clinical application protocols related to the use of cellular therapy in COPD. This study protocol was submitted and approved by the Brazilian National Committee of Ethics in Research (CONEP - Brazil) registration number 14764. It is also registered in ClinicalTrials.gov (NCT01110252). Copyright © 2013 Sociedade Portuguesa de Pneumologia. Published by Elsevier España. All rights reserved.

Examination of a Capabilities-based Prioritization Scheme for Service-Oriented Architecture Afloat

DTIC Science & Technology

2012-09-01

Oriented Architecture Afloat 5. FUNDING NUMBERS 6. AUTHOR(S) Matthew C. Horton 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS (ES) Naval...Postgraduate School Monterey, CA 93943–5000 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING /MONITORING AGENCY NAME(S) AND ADDRESS (ES) N/A...within the Internet Protocol Version 4 ( IPv4 ) header (Xiao & Ni, 1999). By manipulating three bits within this byte, applications may specify

The BIMDA shuttle flight mission - A low cost MPS payload

NASA Technical Reports Server (NTRS)

Holemans, Jaak; Cassanto, John M.; Morrison, Dennis; Rose, Alan; Luttges, Marvin

1990-01-01

The design, operation, and experimental protocol of the Bioserve-ITA Materials Dispersion Apparatus Payload (BIMDA) to be flown on the Space Shuttle on STS-37 are described. The aim of BIMDA is to investigate the methods and commercial potential of biomedical and fluid science applications in the microgravity environment. The BIMDA payload operations are diagrammed, and the payload components and experiments are listed, including the investigators and sponsoring institutions.

Harvard Catalyst | The Clinical Translational Science Center IND/IDE Consult Service: Providing an IND/IDE Consult Service in a Decentralized Network of Academic Healthcare Centers

PubMed Central

Winkler, Sabune J.; Bierer, Barbara E.; Wolf, Delia

2014-01-01

Abstract The Food and Drug Administration (FDA) regulations require sponsors of clinical investigations involving an investigational drug or device to submit an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. Strict adherence to applicable regulations is vital to the success of clinical research. Unlike most major pharmaceutical sponsors, investigator sponsors often do not fully appreciate their regulatory obligations nor have resources to ensure compliance. As a result they can place themselves and their institutions at risk. Nevertheless, investigator‐initiated clinical trials are vital to the further development of innovative drugs, biologics, and medical devices. The IND/IDE Subcommittee under the Regulatory Knowledge and Support Program at Harvard Catalyst, The Harvard Clinical and Translational Science Center worked in collaboration with Harvard and Harvard affiliated institutions to create and launch an IND/IDE Consult Service in a decentralized network of collaborating Academic Healthcare Centers (AHC). The IND/IDE Consult Service offers expertise, resources, and shared experiences to assist sponsor‐investigators and IRBs in meeting regulatory requirements for conducting and reviewing investigator‐initiated IND/IDE studies. The scope of the services provided by the Harvard Catalyst IND/IDE Consult Service are described, including the specifics of the service, lessons learned, and challenges faced, in a scalable model that builds inter‐institutional capacity. PMID:24455986

SeaWiFS technical report series. Volume 5: Ocean optics protocols for SeaWiFS validation

NASA Technical Reports Server (NTRS)

Mueller, James L.; Austin, Roswell W.; Hooker, Stanford B. (Editor); Firestone, Elaine R. (Editor)

1992-01-01

Protocols are presented for measuring optical properties, and other environmental variables, to validate the radiometric performance of the Sea-viewing Wide Field-of-view Sensor (SeaWiFS), and to develop and validate bio-optical algorithms for use with SeaWiFS data. The protocols are intended to establish foundations for a measurement strategy to verify the challenging SeaWiFS accuracy goals of 5 percent in water-leaving radiances and 35 percent in chlorophyll alpha concentration. The protocols first specify the variables which must be measured, and briefly review rationale. Subsequent chapters cover detailed protocols for instrument performance specifications, characterizing and calibration instruments, methods of making measurements in the field, and methods of data analysis. These protocols were developed at a workshop sponsored by the SeaWiFS Project Office (SPO) and held at the Naval Postgraduate School in Monterey, California (9-12 April, 1991). This report is the proceedings of that workshop, as interpreted and expanded by the authors and reviewed by workshop participants and other members of the bio-optical research community. The protocols are a first prescription to approach unprecedented measurement accuracies implied by the SeaWiFS goals, and research and development are needed to improve the state-of-the-art in specific areas. The protocols should be periodically revised to reflect technical advances during the SeaWiFS Project cycle.

Comparative analysis of two different models of swimming applied to pregnant rats born small for pregnant age.

PubMed

Corvino, Silvana B; Damasceno, Débora C; Sinzato, Yuri K; Netto, Aline O; Macedo, Nathália C D; Zambrano, Elena; Volpato, Gustavo T

2017-01-01

The aim of this study was to compare two models of swimming applied to pregnant rats born small for pregnancy age (SPA). Diabetes was chemically induced in adult female rats to develop an inadequate intrauterine environment, leading to birth of a SPA offspring. In adulthood, the female SPA rats were mated and submitted to different swimming programs. The exercise program 1 (Ex1) consisted of swimming for 15 minutes, followed by 15 minutes of rest and another 15 minutes of swimming, 3 days a week before and during pregnancy. Another program (Ex2) was applied during 60 minutes uninterrupted a day, 6 days/week during pregnancy. The pregnant rats presented no interference on body weight and glycemia. The rats submitted to Ex2 model showed decreased insulin and blood glucose levels by oral glucose tolerance test, and reduction in area under curve values. The offspring from dams submitted to both exercise protocols presented an increased rate of newborns SPA. However, the offspring from Ex2 dams showed percentage twice higher of newborns SPA than Ex1 offspring. Our data suggests that continuous exercise of 60 min/day ameliorated the enhanced peripheral insulin sensitivity in growth-restricted females. However, this protocol employed at pregnancy leads to intrauterine growth restriction.

Predicting the effect of cytochrome P450 inhibitors on substrate drugs: analysis of physiologically based pharmacokinetic modeling submissions to the US Food and Drug Administration.

PubMed

Wagner, Christian; Pan, Yuzhuo; Hsu, Vicky; Grillo, Joseph A; Zhang, Lei; Reynolds, Kellie S; Sinha, Vikram; Zhao, Ping

2015-01-01

The US Food and Drug Administration (FDA) has seen a recent increase in the application of physiologically based pharmacokinetic (PBPK) modeling towards assessing the potential of drug-drug interactions (DDI) in clinically relevant scenarios. To continue our assessment of such approaches, we evaluated the predictive performance of PBPK modeling in predicting cytochrome P450 (CYP)-mediated DDI. This evaluation was based on 15 substrate PBPK models submitted by nine sponsors between 2009 and 2013. For these 15 models, a total of 26 DDI studies (cases) with various CYP inhibitors were available. Sponsors developed the PBPK models, reportedly without considering clinical DDI data. Inhibitor models were either developed by sponsors or provided by PBPK software developers and applied with minimal or no modification. The metric for assessing predictive performance of the sponsors' PBPK approach was the R predicted/observed value (R predicted/observed = [predicted mean exposure ratio]/[observed mean exposure ratio], with the exposure ratio defined as [C max (maximum plasma concentration) or AUC (area under the plasma concentration-time curve) in the presence of CYP inhibition]/[C max or AUC in the absence of CYP inhibition]). In 81 % (21/26) and 77 % (20/26) of cases, respectively, the R predicted/observed values for AUC and C max ratios were within a pre-defined threshold of 1.25-fold of the observed data. For all cases, the R predicted/observed values for AUC and C max were within a 2-fold range. These results suggest that, based on the submissions to the FDA to date, there is a high degree of concordance between PBPK-predicted and observed effects of CYP inhibition, especially CYP3A-based, on the exposure of drug substrates.

The economic returns of pediatric clinical trials of anti-hypertensive drugs

PubMed Central

Baker-Smith, Carissa M.; Benjamin, Daniel K.; Grabowski, Henry G.; Reid, Elizabeth D.; Mangum, Barry; Goldsmith, John V.; Murphy, M. Dianne; Edwards, Rex; Eisenstein, Eric L.; Sun, Jessica; Califf, Robert M.; Li, Jennifer S.

2012-01-01

Background Congress has authorized the U.S. Food and Drug Administration (FDA) to provide industry sponsors with a 6-month extension of drug marketing rights under the Pediatric Exclusivity Provision if FDA-requested pediatric drug trials are conducted. The cost and economic return of pediatric exclusivity to industry sponsors has been shown to be highly variable. We sought to determine the cost of performing pediatric exclusivity trials within a single therapeutic area and the subsequent economic return to industry sponsors. Methods We evaluated 9 orally administered anti-hypertensive drugs submitted to the FDA under the Pediatric Exclusivity Provision from 1997–2004 and obtained key elements of the clinical trial designs and operations. Estimates of the costs of performing the studies were generated and converted into after-tax cash outflow. Market sales were obtained and converted into after-tax inflows based on 6 months of additional patent protection. Net economic return and net return-to-cost ratios were determined for each drug. Results Of the 9 anti-hypertensive agents studied, an average of 2 studies per drug was performed, including at least 1 pharmacokinetic study and a safety and efficacy study. The median cost of completing a pharmacokinetic trial was $862,000 (range: $556,000–1.8 million). The median cost of performing safety and efficacy trials for these agents was $4.3 million (range: $2.1 million–12.9 million). The ratio of net economic return to cost was 17 (range: 4–64.7). Conclusion We found that, within a cohort of anti-hypertensive drugs, the Pediatric Exclusivity Provision has generated highly variable, yet lucrative returns to industry sponsors. PMID:18926149

Four suggestions for addressing public concern regarding synthetic biology.

PubMed

Hatch, Alex David

2010-06-09

The following essay was written by Mr. Alex Hatch, a junior undergraduate student majoring in Biological Engineering at Utah State University. Mr. Hatch submitted a 1000-1200 word essay to the 5th Annual Bioethics Contest sponsored by the Institute of Biological Engineering (IBE). A group of professionals in Biological Engineering assessed and ranked the essays in a blinded process. Five semi-finalists were invited to present their essays at a session at the annual meeting of IBE in Cambridge, MA on March 6, 2010. Five judges scored all the presentations and selected Mr. Hatch's contribution as the overall winner (first place).

An Information Handbook for Contracting and Manufacturing Officers.

DTIC Science & Technology

1988-01-01

11 - _ _1L~ ~ IIIfl~ 550 ___ Ow 1*1 lllll~=. urn,,. .5... liii, __ m:~ 5~ b _______ L ,uII1.Q 0~ S. -A. S .5,. b .1~ S .5.. 0 0’ .5-. .5 0 5%’ E * I...CfO FI ropy 00E ,. 77 t6 ODTIC ELECTE JUN 08 18 AIR COMMANI) STFFCOLLEGE ~.mriS-AT: !- E ;-rL AI Ap"ps hed iint public teleasw" Distribution Unlimited 5 A...M. KING, USAF FACULTY ADVISOR MAJOR TRACEY L. GAUCH, ACSC/EDC SPONSOR MAJOR DANIEL E . ELDRIDGE AFMPC/DPMRSA2 Submitted to the faculty in partial

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

Nashold, B.; Rosenblatt, D.; Hau, J.

This summary describes a Supplemental Site Inspection (SSI) conducted by Argonne National Laboratory (ANL) at Air Force Plant 59 (AFP 59) in Johnson City, New York. All required data pertaining to this project were entered by ANL into the Air Force-wide Installation Restoration Program Information System (IRPIMS) computer format and submitted to an appropriate authority. The work was sponsored by the United States Air Force as part of its Installation Restoration Program (IRP). Previous studies had revealed the presence of contaminants at the site and identified several potential contaminant sources. Argonne`s study was conducted to answer questions raised by earliermore » investigations.« less

78 FR 43878 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-22

...The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Stationary Combustion Turbines (40 CFR Part 63, Subpart YYYY) (Renewal)'' (EPA ICR No. 1967.05, OMB Control No. 2060-0540) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq). This is a proposed extension of the ICR, which is currently approved through September 30, 2013. Public comments were previously requested via the Federal Register (77 FR 63813) on October 17, 2012, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Inhibition of angiotensin-converting enzyme increases oestradiol production in ewes submitted to oestrous synchronization protocol.

PubMed

Costa, A s; Junior, A S; Viana, G E N; Muratori, M C S; Reis, A M; Costa, A P R

2014-10-01

This study aimed at evaluating the effects of angiotensin-converting enzyme inhibitor (enalapril) and angiotensin II antagonist (valsartan) on the oestradiol and progesterone production in ewes submitted to oestrous synchronization protocol. The animals were weighed and randomly divided into three groups (n = 7). A pre-experiment conducted to verify the effectiveness and toxicity of enalapril (0.5 mg/kg LW) and valsartan (2.2 mg/kg LW) showed that, in the doses used, these drugs were effective in reducing blood pressure without producing toxic effects. In the experiment, all animals were subjected to oestrous synchronization protocol during 12 days. On D10, D11 and D12, animals received saline, enalapril or valsartan (same doses of the pre-experiment), according to the group randomly divided. The hormonal analysis showed an increase in oestradiol on the last day of the protocol (D12) in animals that received enalapril (p < 0.05), but not in other groups, without changing the concentration of progesterone in any of the treatments. It is concluded that valsartan and enalapril are safe and effective subcutaneously for use in sheep and that the angiotensin-converting enzyme (ACE) inhibition with enalapril leads to an increase in oestradiol production near ovulation without changing the concentration of progesterone. This shows that ACE inhibition may be a useful tool in reproductive biotechnologies involving induction and synchronization of oestrus and ovulation in sheep. © 2014 Blackwell Verlag GmbH.

Increasing value and reducing waste: addressing inaccessible research.

PubMed

Chan, An-Wen; Song, Fujian; Vickers, Andrew; Jefferson, Tom; Dickersin, Kay; Gøtzsche, Peter C; Krumholz, Harlan M; Ghersi, Davina; van der Worp, H Bart

2014-01-18

The methods and results of health research are documented in study protocols, full study reports (detailing all analyses), journal reports, and participant-level datasets. However, protocols, full study reports, and participant-level datasets are rarely available, and journal reports are available for only half of all studies and are plagued by selective reporting of methods and results. Furthermore, information provided in study protocols and reports varies in quality and is often incomplete. When full information about studies is inaccessible, billions of dollars in investment are wasted, bias is introduced, and research and care of patients are detrimentally affected. To help to improve this situation at a systemic level, three main actions are warranted. First, academic institutions and funders should reward investigators who fully disseminate their research protocols, reports, and participant-level datasets. Second, standards for the content of protocols and full study reports and for data sharing practices should be rigorously developed and adopted for all types of health research. Finally, journals, funders, sponsors, research ethics committees, regulators, and legislators should endorse and enforce policies supporting study registration and wide availability of journal reports, full study reports, and participant-level datasets. Copyright © 2014 Elsevier Ltd. All rights reserved.

Increasing value and reducing waste: addressing inaccessible research

PubMed Central

Chan, An-Wen; Song, Fujian; Vickers, Andrew; Jefferson, Tom; Dickersin, Kay; Gøtzsche, Peter C.; Krumholz, Harlan M.; Ghersi, Davina; van der Worp, H. Bart

2015-01-01

The study protocol, publications, full study report detailing all analyses, and participant-level dataset constitute the main documentation of methods and results for health research. However, journal publications are available for only half of all studies and are plagued by selective reporting of methods and results. The protocol, full study report, and participant-level dataset are rarely available. The quality of information provided in study protocols and reports is variable and often incomplete. Inaccessibility of full information for the vast majority of studies wastes billions of dollars, introduces bias, and has a detrimental impact on patient care and research. To help improve this situation at a systemic level, three main actions are warranted. Firstly, it is important that academic institutions and funders reward investigators who fully disseminate their research protocols, reports, and participant-level datasets. Secondly, standards for the content of protocols, full study reports, and data sharing practices should be rigorously developed and adopted for all types of health research. Finally, journals, funders, sponsors, research ethics committees, regulators, and legislators should implement and enforce policies supporting study registration and availability of journal publications, full study reports, and participant-level datasets. PMID:24411650

40 CFR 52.320 - Identification of plan.

Code of Federal Regulations, 2012 CFR

2012-07-01

... of Group II VOC sources were submitted on January 6, 1981, and the supplemental information received... Gasoline Transfer at Bulk Plants-Vapor Balance System), and D (Test Procedures for Annual Pressure/Vacuum... recent EPA capture efficiency protocols, and the commitment to adopt federal capture efficiency test...

40 CFR 52.320 - Identification of plan.

Code of Federal Regulations, 2014 CFR

2014-07-01

... of Group II VOC sources were submitted on January 6, 1981, and the supplemental information received... at Bulk Plants-Vapor Balance System), and D (Test Procedures for Annual Pressure/Vacuum Testing of... recent EPA capture efficiency protocols, and the commitment to adopt federal capture efficiency test...

40 CFR 52.320 - Identification of plan.

Code of Federal Regulations, 2013 CFR

2013-07-01

... of Group II VOC sources were submitted on January 6, 1981, and the supplemental information received... at Bulk Plants-Vapor Balance System), and D (Test Procedures for Annual Pressure/Vacuum Testing of... recent EPA capture efficiency protocols, and the commitment to adopt federal capture efficiency test...

40 CFR 52.2039 - Interstate transport.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Portland shall comply with the following requirements: (1) Perform air modeling to demonstrate that... the effective date of the section 126 finding, submit to the EPA a modeling protocol that is... that includes all units at the Portland Generating Station in the modeling. (ii) Within 15 business...

40 CFR 52.2039 - Interstate transport.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Portland shall comply with the following requirements: (1) Perform air modeling to demonstrate that... the effective date of the section 126 finding, submit to the EPA a modeling protocol that is... that includes all units at the Portland Generating Station in the modeling. (ii) Within 15 business...

40 CFR 52.2039 - Interstate transport.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Portland shall comply with the following requirements: (1) Perform air modeling to demonstrate that... the effective date of the section 126 finding, submit to the EPA a modeling protocol that is... that includes all units at the Portland Generating Station in the modeling. (ii) Within 15 business...

A protocol of rope skipping exercise for primary school children: A pilot test

NASA Astrophysics Data System (ADS)

Radzi, A. N. M.; Rambely, A. S.; Chellapan, K.

2014-06-01

This paper aims to investigate the methods and sample used in rope skipping as an exercise approach. A systematic literature review was approached in identifying skipping performance in the related researches. The methods were compared to determine the best methodological approach for the targeted skipping based research measure. A pilot test was performed among seven students below 12 years old. As the outcome of the review, a skipping protocol design has been proposed for 10 years old primary school students. The proposed protocol design is to be submitted to PPUKM Ethical Committee for approval prior to its implementation in investigation memory enhancement in relation to designed skipping activities.

Inclusion of sex and gender in biomedical research: survey of clinical research proposed at the University of Pennsylvania.

PubMed

Freeman, Anne; Stanko, Patrick; Berkowitz, Lily N; Parnell, Neanta; Zuppe, Anastasia; Bale, Tracy L; Ziolek, Tracy; Epperson, C Neill

2017-01-01

The 2015 National Institutes of Health (NIH) policy that sex be considered as a biological variable (SABV) is now a critical part of the peer-review process for NIH funding as well as publication in several high-impact scientific journals. We sought to determine the degree to which biomedical researchers at the University of Pennsylvania already consider SABV or gender in their research. We reviewed 240 research protocols approved by the University of Pennsylvania Investigational Review Board (IRB) consecutively submitted between January and July 2016. Each protocol was searched for the terms sex, gender, male, female, man, and woman and justifications related to the population under study. A PubMed search was conducted to determine the current state of knowledge regarding potential sex and/or gender differences with respect to protocol topic. Data were summarized using descriptive statistics. Of the 165 (68.8%) protocols that included one of the search terms, only 24 (14.5%) provided justification for the choice of the sex/gender of the population studied. Sixty-three percent ( n  = 151) of the protocols focused on topics for which the extant literature supports at least a moderate degree of sex/gender differences in some aspect of the disorder/condition being studied. Of these, only three (2.0%) indicated that the investigator would consider sex or gender impact on their primary outcomes. Review of a subset of IRB protocols submitted at a major research institution suggests that very few investigators are considering sex or gender as important variables in their clinical research at the stage of protocol development. IRBs are in an excellent position to encourage investigators to consider SABV and gender in order to enhance the rigor of research design, maximize the importance of the resulting knowledge, and ensure that subject selection is equitable. These findings serve as the basis for developing an intervention at the level of IRB protocol development and submission that will promote consideration of SABV and/or gender, factors with critical import to patient safety and efficacy of interventions.

Exercise counteracts fatty liver disease in rats fed on fructose-rich diet

PubMed Central

2010-01-01

Background This study aimed to analyze the effects of exercise at the aerobic/anaerobic transition on the markers of non-alcoholic fatty liver disease (NAFLD), insulin sensitivity and the blood chemistry of rats kept on a fructose-rich diet. Methods We separated 48 Wistar rats into two groups according to diet: a control group (balanced diet AIN-93 G) and a fructose-rich diet group (60% fructose). The animals were tested for maximal lactate-steady state (MLSS) in order to identify the aerobic/anaerobic metabolic transition during swimming exercises at 28 and 90 days of age. One third of the animals of each group were submitted to swimming training at an intensity equivalent to the individual MLSS for 1 hours/day, 5 days/week from 28 to 120 days (early protocol). Another third were submitted to the training from 90 to 120 days (late protocol), and the others remained sedentary. The main assays performed included an insulin tolerance test (ITT) and tests of serum alanine aminotransferase [ALT] and aspartate aminotransferase [AST] activities, serum triglyceride concentrations [TG] and liver total lipid concentrations. Results The fructose-fed rats showed decreased insulin sensitivity, and the late-exercise training protocol counteracted this alteration. There was no difference between the groups in levels of serum ALT, whereas AST and liver lipids increased in the fructose-fed sedentary group when compared with the other groups. Serum triglycerides concentrations were higher in the fructose-fed trained groups when compared with the corresponding control group. Conclusions The late-training protocol was effective in restoring insulin sensitivity to acceptable standards. Considering the markers here evaluated, both training protocols were successful in preventing the emergence of non-alcoholic fatty liver status disease. PMID:20946638

The Phyre2 web portal for protein modelling, prediction and analysis

PubMed Central

Kelley, Lawrence A; Mezulis, Stefans; Yates, Christopher M; Wass, Mark N; Sternberg, Michael JE

2017-01-01

Summary Phyre2 is a suite of tools available on the web to predict and analyse protein structure, function and mutations. The focus of Phyre2 is to provide biologists with a simple and intuitive interface to state-of-the-art protein bioinformatics tools. Phyre2 replaces Phyre, the original version of the server for which we previously published a protocol. In this updated protocol, we describe Phyre2, which uses advanced remote homology detection methods to build 3D models, predict ligand binding sites, and analyse the effect of amino-acid variants (e.g. nsSNPs) for a user’s protein sequence. Users are guided through results by a simple interface at a level of detail determined by them. This protocol will guide a user from submitting a protein sequence to interpreting the secondary and tertiary structure of their models, their domain composition and model quality. A range of additional available tools is described to find a protein structure in a genome, to submit large number of sequences at once and to automatically run weekly searches for proteins difficult to model. The server is available at http://www.sbg.bio.ic.ac.uk/phyre2. A typical structure prediction will be returned between 30mins and 2 hours after submission. PMID:25950237

NASA Microgravity Materials Science Conference

NASA Technical Reports Server (NTRS)

Gillies, D. C. (Compiler); McCauley, D. E. (Compiler)

1999-01-01

The Microgravity Materials Science Conference was held July 14-16, 1998 at the Von Braun Center in Huntsville, AL. It was organized by the Microgravity Materials Science Discipline Working Group, sponsored by the Microgravity Research Division at NASA Headquarters, and hosted by the NASA Marshall Space Flight Center and the Alliance for Microgravity Materials Science and Applications. It was the third NASA conference of this type in the microgravity materials science discipline. The microgravity science program sponsored approximately 125 investigations and 100 principal investigators in FY98, almost all of whom made oral or poster presentations at this conference. The conference's purpose was to inform the materials science community of research opportunities in reduced gravity in preparation for a NASA Research Announcement scheduled for release in late 1998 by the Microgravity Research Division at NASA Headquarters. The conference was aimed at materials science researchers from academia, industry, and government. A tour of the Marshall Space Flight Center microgravity research facilities was held on July 16, 1998. This volume is comprised of the research reports submitted by the principal investigators after the conference.

NASA Microgravity Materials Science Conference

NASA Technical Reports Server (NTRS)

Szofran, Frank R. (Compiler); McCauley, D. (Compiler); Walker, C. (Compiler)

1996-01-01

The Microgravity Materials Science Conference was held June 10-11, 1996 at the Von Braun Civic Center in Huntsville, AL. It was organized by the Microgravity Materials Science Discipline Working Group, sponsored by the Microgravity Science and Applications Division at NASA Headquarters, and hosted by the NASA Marshall Space Flight Center and the Alliance for Microgravity Materials Science and Applications (AMMSA). It was the second NASA conference of this type in the microgravity materials science discipline. The microgravity science program sponsored approximately 80 investigations and 69 principal investigators in FY96, all of whom made oral or poster presentations at this conference. The conference's purpose was to inform the materials science community of research opportunities in reduced gravity in preparation for a NASA Research Announcement (NRA) scheduled for release in late 1996 by the Microgravity Science and Applications Division at NASA Headquarters. The conference was aimed at materials science researchers from academia, industry, and government. A tour of the MSFC microgravity research facilities was held on June 12, 1996. This volume is comprised of the research reports submitted by the principal investigators after the conference and presentations made by various NASA microgravity science managers.

2014 Global Conference on Polymer and Composite Materials (PCM 2014)

NASA Astrophysics Data System (ADS)

2014-08-01

The 2014 Global Conference on Polymer and Composite Materials (PCM 2014) sponsored by Ningbo Adhesives and Products Industry Association, Shanghai Bonding Technology Association, Zhejiang Bonding Technology Association, Wuhan Bonding Technology Association, Hebei Bonding and Coatings Association and Polyurethane Industry Association was held from May 27 to May 29 2014 in Ningbo, China. The technical program consisted of 8 international keynote speakers, oral presentations, and a poster session. The conference also included an industrial exhibition where more than 50 companies displayed in their booths their most recent advanced products and services. The present issue of IOP Conference Series: Materials Science and Engineering (MSE) records the proceedings of PCM 2014 and contains 37 specially selected manuscripts submitted to PCM2014 conference. The electronic submission and handling of manuscripts via the conference website, including the selection of reviewers and evaluation of manuscripts, were identical to the procedures applied to manuscripts submitted as regular contributions for publication. The organization of this conference and the preparation of proceedings volumes would have been impossible without the tremendous efforts and dedication of many individuals, especially from Ms. Yin Pan, who oversaw the organization of the conference and the program; and a large team of reviewers with their timely submission of quality reports. We express our sincere thanks to all authors and presenters for their contributions. We also thank very much our sponsors for their generous support. The 2015 Global Conference on Polymer and Composite Materials (PCM2015) will be held in Beijing, China on May 16-18, 2015. Beijing, the capital of the People's Republic of China and one of the most populous cities in the world, will welcome to all participants for a renewed and vibrant conference. Prof. Dr. Esteban Broitman Linköping University, Sweden Editor in Chief — PCM2014

Robust Multi-unit Auction Protocol against False-name Bids

NASA Astrophysics Data System (ADS)

Yokoo, Makoto; Sakurai, Yuko; Matsubara, Shigeo

This paper presents a new multi-unit auction protocol (IR protocol) that is robust against false-name bids. Internet auctions have become an integral part of Electronic Commerce and a promising field for applying agent and Artificial Intelligence technologies. Although the Internet provides an excellent infrastructure for executing auctions, the possibility of a new type of cheating called false-name bids has been pointed out. A false-name bid is a bid submitted under a fictitious name. A protocol called LDS has been developed for combinatorial auctions of multiple different items and has proven to be robust against false-name bids. Although we can modify the LDS protocol to handle multi-unit auctions, in which multiple units of an identical item are auctioned, the protocol is complicated and requires the auctioneer to carefully pre-determine the combination of bundles to obtain a high social surplus or revenue. For the auctioneer, our newly developed IR protocol is easier to use than the LDS, since the combination of bundles is automatically determined in a flexible manner according to the declared evaluation values of agents. The evaluation results show that the IR protocol can obtain a better social surplus than that obtained by the LDS protocol.

75 FR 36313 - Drawbridge Operation Regulation; Arkansas Waterway, Pine Bluff, AR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-25

... remote drawbridge operator then establishes normal verbal radio communications. This protocol is used to isolate and differentiate these radio communications from the railroad communications that the remote... provide a reason for each suggestion or recommendation. You may submit your comments and material online...

10 CFR 75.11 - Location information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Location information. 75.11 Section 75.11 Energy NUCLEAR... and Location Information § 75.11 Location information. (a) As required by the Additional Protocol, each applicant, licensee, or certificate holder shall submit location information to the Commission as...

Quality of life after antegrade intramedullary nail fixation of humeral fractures: a survey in a selected cohort of Brazilian patients.

PubMed

Cocco, Luiz Fernando; Ejnisman, Benno; Belangero, Paulo Santoro; Cohen, Moises; Dos Reis, Fernando Baldy

2018-01-01

The treatment of humeral fractures remains controversial. Systematic reviews demonstrate similar results between dynamic compression plating and locked intramedullary nailing in the surgical treatment of these fractures. However, it appears that antegrade intramedullary nailing causes higher residual pain in the shoulder. The proposal of this work is to evaluate through the WORC protocol (Western Ontario Rotator Cuff Index) the consequences in the quality of life of patients submitted to osteosynthesis of the humerus with antegrade locked intramedullary nailing. This work is a cohort retrospective study in addition to the application of a questionnaire for self-rated quality of life with its 05 domains (WORC - Western Ontario Rotator Cuff Index) for patients ( N  = 26) classified in the Trauma Sector of the Department of Orthopedics and Traumatology of the Federal University of São Paulo (DOT/UNIFESP) submitted to Humerus Osteosynthesis with Antegrade Locked Intramedullary Nailing. There was also the inclusion of data related to the time since surgery, age, sex, surgical laterality, dominance among members and work leave, which were not considered in the original protocol. After, the data were statistically assessed to evaluate the association between numerical and categorical variables. The overall WORC score was 82.75 ± 17.00 (Mean ± SD) and was not different considering sex, age and postoperative period. Among the WORC domains, both Work and Sport / Recreation Protocols were the most unfavorable factors in the evaluation of patients. Although not statistically significant, those who had the procedure on the dominant side presented a lower quality of life score than those who had the surgery on the non-dominant side. Although non-significant again, those who were away from work had an overall lower quality of life score than those who were not. The WORC Quality of Life Protocol shows good results for evaluating patients submitted to humerus osteosynthesis with antegrade locked intramedullary nailing. The data stratified by domains were good, however, Work and Sport/Recreation domains showed the lowest means compared to the other domains. Research Ethics Commitee (CEP 0676/2016) and Plataforma Brasil 56381216.3.0000.550. CAAE: 56381216.3.0000.5505.

Defense switched network technology and experiments program

NASA Astrophysics Data System (ADS)

Weinstein, C. J.

1983-09-01

This report documents work performed during FY 1983 on the DCA-sponsored Defense Switched Network Technology and Experiments Program. The areas of work reported are: (1) development of routing algorithms for application in the Defense Switched Network (DSN); (2) instrumentation and integration of the Experimental Integrated Switched Network (EISN) test facility; (3) development and test of data communication techniques using DoD-standard data protocols in an integrated voice/data network; and (4) EISN system coordination and experiment planning.

Federal budget process: An overview

NASA Astrophysics Data System (ADS)

Frizzell, Virgil A., Jr.

Much geophysical research funding originates from the federal government, and many who obtain federal funding consider the executive branch to be its source. In fact, the federal budget results from a complex ballet between the executive and legislative branches. Because it is both little understood and essential to our work, this report will review the fundamentals of the three-year budgetary process.The Constitution assigns the power of the purse to the Congress. Before the 1920s, executive branch agencies and departments submitted their own separate budgets to Congress, and deliberate planning and priority setting was minimal. In 1921 Congress empowered the president to submit an executive branch budget reflecting his priorities for the next fiscal year. Following this protocol, former President Reagan submitted his budget for Fiscal Year 1990 in January, and President Bush outlined his FY'90 priorities in February.

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

76 FR 66889 - Closed Captioning of Internet Protocol-Delivered Video Programming: Implementation of the Twenty...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-28

... FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 15 and 79 [MB Docket No. 11-154; DA 11-1766] Closed... Communications and Video Accessibility Act of 2010 AGENCY: Federal Communications Commission. ACTION: Proposed... . Follow the instructions for submitting comments. Federal Communications Commission's Electronic Comment...

75 FR 60107 - Agency Information Collection Activities: Proposed Collection; Comment Request; Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... and provide an emissions inventory, submit cost data, provide copies of recent emissions test reports... the requirement to test that source in accordance with an EPA-approved testing protocol. By conducting... postage for mailing hard copy test reports and confidential survey responses to EPA. The data collected...

75 FR 60843 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-01

... Effectiveness of a Proposed Rule Change Relating to FINRA Trade Reporting Notice on Price Validation and Price... (``Notice'') that explains the price validation protocol of the FINRA trade reporting facilities and sets... trades by comparing the submitted price against price validation parameters established by FINRA...

Four suggestions for addressing public concern regarding synthetic biology

PubMed Central

2010-01-01

The following essay was written by Mr. Alex Hatch, a junior undergraduate student majoring in Biological Engineering at Utah State University. Mr. Hatch submitted a 1000-1200 word essay to the 5th Annual Bioethics Contest sponsored by the Institute of Biological Engineering (IBE). A group of professionals in Biological Engineering assessed and ranked the essays in a blinded process. Five semi-finalists were invited to present their essays at a session at the annual meeting of IBE in Cambridge, MA on March 6, 2010. Five judges scored all the presentations and selected Mr. Hatch's contribution as the overall winner (first place). PMID:20534150

NASA MSU Status Report. [Research on high T(sub c) superconducting compounds

NASA Technical Reports Server (NTRS)

Oliver, Frederick W.

1995-01-01

Our laboratory concentrations consisted of several parts: (1) we made several presentations of the work sponsored by NASA covered under the last status report period; (2) we irradiated and successfully completed Moessbauer measurements on a high temperature superconductor; (3) we continued the improvement of our laboratory with the development of improved software; and (4) we made modifications of equipment to increase the efficiency and decrease the time necessary for completing an experimental investigation. In addition to our research results, this report contains a copy of the last financial report submitted by the University's business office that was related to this grant.

Ethical issues in studying submissions to a medical journal.

PubMed

Olson, C M; Glass, R M; Thacker, S B; Stroup, D F

1998-07-15

A protocol to prospectively study characteristics of meta-analyses submitted to a weekly medical journal raised several ethical issues. In submitting a manuscript for publication, authors do not implicitly consent to have their work used for research. Authors must be free to refuse to consent, without it affecting their chances for publication. Systematically analyzing data on manuscript characteristics might influence the decision to publish. Having investigators who are not on the editorial staff or peer reviewers extract the manuscripts' characteristics breaks the confidentiality of the author-editor-reviewer relationship. In response to these issues, we added a statement to our journal's instructions for authors that submitted manuscripts may be systematically analyzed to improve the quality of the editorial or peer review process. Authors had to actively consent to participate, but editors and external reviewers were unaware of which authors were participating. The manuscript characteristics were not shared with authors, editors, or external reviewers. The investigators were blinded to each manuscript's author and institution. After we addressed ethical issues encountered in studying manuscripts submitted to a medical journal, 99 of 105 authors submitting a meta-analysis during the study's first 24 months agreed to participate.

Informal trail monitoring protocols: Denali National Park and Preserve. Final Report, October 2011

USGS Publications Warehouse

Marion, Jeffrey L.; Wimpey, Jeremy F.

2011-01-01

Managers at Alaska?s Denali National Park and Preserve (DENA) sponsored this research to assess and monitor visitor-created informal trails (ITs). DENA is located in south-central Alaska and managed as a six million acre wilderness park. This program of research was guided by the following objectives: (1) Investigate alternative methods for monitoring the spatial distribution, aggregate lineal extent, and tread conditions of informal (visitor-created) trails within the park. (2) In consultation with park staff, develop, pilot test, and refine cost-effective and scientifically defensible trail monitoring procedures that are fully integrated with the park?s Geographic Information System. (3) Prepare a technical report that compiles and presents research results and their management implications. This report presents the protocol development and field testing process, illustrates the types of data produced by their application, and provides guidance for their application and use. The protocols described provide managers with an efficient means to document and monitor IT conditions in settings ranging from pristine to intensively visited.

Ancillary Care in South African HIV Vaccine Trials: Addressing Needs, Drafting Protocols, and Engaging Community

PubMed Central

Slack, Catherine M.

2014-01-01

There has been debate about sponsor-investigator ethical responsibilities to address participants’ medical needs in trials in resource-constrained contexts. Certain ethical guidelines make detailed recommendations. This study explored whether ethical guideline recommendations for care in HIV vaccine trials were being met, and whether stakeholders were facing difficulties addressed by guidelines. It sampled key stakeholders involved in two trials across five sites in South Africa, and reviewed relevant documentation. It concluded that sites were largely meeting guideline recommendations for addressing needs, with some exceeding these. Recommendations for writing protocols were only partially achieved. Recommendations for engaging participating community were mostly met, except for “moral negotiation” recommendations. Suggestions are made to strengthen practices, and to improve guidelines so they address empirical concerns. PMID:24572086

Ancillary care in South African HIV vaccine trials: addressing needs, drafting protocols, and engaging community.

PubMed

Slack, Catherine M

2014-02-01

There has been debate about sponsor-investigator ethical responsibilities to address participants' medical needs in trials in resource-constrained contexts. Certain ethical guidelines make detailed recommendations. This study explored whether ethical guideline recommendations for care in HIV vaccine trials were being met, and whether stakeholders were facing difficulties addressed by guidelines. It sampled key stakeholders involved in two trials across five sites in South Africa, and reviewed relevant documentation. It concluded that sites were largely meeting guideline recommendations for addressing needs, with some exceeding these. Recommendations for writing protocols were only partially achieved. Recommendations for engaging participating community were mostly met, except for "moral negotiation" recommendations. Suggestions are made to strengthen practices, and to improve guidelines so they address empirical concerns.

SeaWiFS technical report series. Volume 25: Ocean optics protocols for SeaWiFS validation, revision 1

NASA Technical Reports Server (NTRS)

Hooker, Stanford B. (Editor); Firestone, Elaine R. (Editor); Acker, James G. (Editor); Mueller, James L.; Austin, Roswell W.

1995-01-01

This report presents protocols for measuring optical properties, and other environmental variables, to validate the radiometric performance of the Sea-viewing Wide Field-of-view Sensor (SeaWiFS), and to develop and validate bio-optical algorithms for use with SeaWiFS data. The protocols are intended to establish foundations for a measurement strategy to verify the challenging SeaWiFS uncertainty goals of 5 percent in water-leaving radiances and 35 percent in chlorophyll alpha concentration. The protocols first specify the variables which must be measured, and briefly review the rationale for measuring each variable. Subsequent chapters cover detailed protocols for instrument performance specifications, characterizing and calibrating instruments, methods of making measurements in the field, and methods of data analysis. These protocols were developed at a workshop sponsored by the SeaWiFS Project Office (SPO) and held at the Naval Postgraduate School in Monterey, California (9-12 April 1991). This report began as the proceedings of the workshop, as interpreted and expanded by the authors and reviewed by workshop participants and other members of the bio-optical research community. The protocols are an evolving prescription to allow the research community to approach the unprecedented measurement uncertainties implied by the SeaWiFS goals; research and development are needed to improve the state-of-the-art in specific areas. These protocols should be periodically revised to reflect technical advances during the SeaWiFS Project cycle. The present edition (Revision 1) incorporates new protocols in several areas, including expanded protocol descriptions for Case-2 waters and other improvements, as contributed by several members of the SeaWiFS Science Team.

Histomorphometric assessment of bone necrosis produced by two cryosurgery protocols using liquid nitrogen: an experimental study on rat femurs.

PubMed

Costa, Fábio Wildson Gurgel; Brito, Gerly Anne de Castro; Pessoa, Rosana Maria Andrade; Studart-Soares, Eduardo Costa

2011-01-01

The aim of this study was to evaluate the effects of liquid nitrogen cryosurgery on the femoral diaphysis of rats. The femoral diaphyses of 42 Wistar rats were exposed to three local and sequential applications of liquid nitrogen for 1 or 2 min, intercalated with periods of 5 min of passive thawing. The animals were sacrificed after 1, 2, 4 and 12 weeks and the specimens obtained were processed and analyzed histomorphometrically. The depth and extent of peak bone necrosis were 124.509 µm and 2087.094 µm for the 1-min protocol, respectively, and 436.424 µm and 12046.426 µm for the 2-min protocol. Peak necrosis was observed in the second experimental week with both cryotherapy protocols. The present results indicate that the 2-min protocol produced more marked bone necrosis than the 1-min protocol. Although our results cannot be entirely extrapolated to clinical practice, they contribute to the understanding of the behavior of bone tissue submitted to different cycles of liquid nitrogen freezing and may serve as a basis for new studies.

Comparison of Cryopreservation Protocols (Single and Two-steps) and Thawing (Fast and Slow) for Canine Sperm.

PubMed

Brito, Maíra M; Lúcio, Cristina F; Angrimani, Daniel S R; Losano, João Diego A; Dalmazzo, Andressa; Nichi, Marcílio; Vannucchi, Camila I

2017-01-02

In addition to the existence of several cryopreservation protocols, no systematic research has been carried out in order to confirm the suitable protocol for canine sperm. This study aims to assess the effect of adding 5% glycerol during cryopreservation at 37°C (one-step) and 5°C (two-steps), in addition of testing two thawing protocols (37°C for 30 seconds, and 70°C for 8 seconds). We used 12 sperm samples divided into four experimental groups: Single-Step - Slow Thawing Group; Two-Step - Slow Thawing Group; Single-Step - Fast Thawing Group; and Two-Step - Fast Thawing Group. Frozen-thawed samples were submitted to automated analysis of sperm motility, evaluation of plasmatic membrane integrity, acrosomal integrity, mitochondrial activity, sperm morphology, sperm susceptibility to oxidative stress, and sperm binding assay to perivitellinic membrane of chicken egg yolk. Considering the comparison between freezing protocols, no statistical differences were verified for any of the response variables. When comparison between thawing protocols was performed, slow thawing protocol presented higher sperm count bound to perivitelline membrane of chicken egg yolk, compared to fast thawing protocol. Regardless of the freezing process, the slow thawing protocol can be recommended for the large scale cryopreservation of canine semen, since it shows a consistent better functional result.

[Responsibilities of ethics committees].

PubMed

von Bergmann, K

1999-01-15

Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.

[Responsibilities of ethics committees].

PubMed

von Bergmann, K

2000-05-01

Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.

FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing Technologies.

PubMed

Wilson, Carolyn A; Simonyan, Vahan

2014-01-01

Applications of next-generation sequencing (NGS) technologies require availability and access to an information technology (IT) infrastructure and bioinformatics tools for large amounts of data storage and analyses. The U.S. Food and Drug Administration (FDA) anticipates that the use of NGS data to support regulatory submissions will continue to increase as the scientific and clinical communities become more familiar with the technologies and identify more ways to apply these advanced methods to support development and evaluation of new biomedical products. FDA laboratories are conducting research on different NGS platforms and developing the IT infrastructure and bioinformatics tools needed to enable regulatory evaluation of the technologies and the data sponsors will submit. A High-performance Integrated Virtual Environment, or HIVE, has been launched, and development and refinement continues as a collaborative effort between the FDA and George Washington University to provide the tools to support these needs. The use of a highly parallelized environment facilitated by use of distributed cloud storage and computation has resulted in a platform that is both rapid and responsive to changing scientific needs. The FDA plans to further develop in-house capacity in this area, while also supporting engagement by the external community, by sponsoring an open, public workshop to discuss NGS technologies and data formats standardization, and to promote the adoption of interoperability protocols in September 2014. Next-generation sequencing (NGS) technologies are enabling breakthroughs in how the biomedical community is developing and evaluating medical products. One example is the potential application of this method to the detection and identification of microbial contaminants in biologic products. In order for the U.S. Food and Drug Administration (FDA) to be able to evaluate the utility of this technology, we need to have the information technology infrastructure and bioinformatics tools to be able to store and analyze large amounts of data. To address this need, we have developed the High-performance Integrated Virtual Environment, or HIVE. HIVE uses a combination of distributed cloud storage and distributed cloud computations to provide a platform that is both rapid and responsive to support the growing and increasingly diverse scientific and regulatory needs of FDA scientists in their evaluation of NGS in research and ultimately for evaluation of NGS data in regulatory submissions. © PDA, Inc. 2014.

Targeted On-Demand Team Performance App Development

DTIC Science & Technology

2018-02-01

ACCOMPLISHMENTS: Major Goals Task Description Status 1 Project Management Administration, oversight and management of all program tasks, expenditures...reporting charts, financial and project management protocols. Create, complete, and submit all documentation for program office and designated... project provided? All subjects participated in simulated emergency medicine events that included concurrent management of three patients with

Evaluation of Gastrointestinal Motility in Awake Rats: A Learning Exercise for Undergraduate Biomedical Students

ERIC Educational Resources Information Center

Souza, M. A. N.; Souza, M. H. L. P.; Palheta, R. C., Jr.; Cruz, P. R. M.; Medeiros, B. A.; Rola, F. H.; Magalhaes, P. J. C.; Troncon, L. E. A.; Santos, A. A.

2009-01-01

Current medical curricula devote scarce time for practical activities on digestive physiology, despite frequent misconceptions about dyspepsia and dysmotility phenomena. Thus, we designed a hands-on activity followed by a small-group discussion on gut motility. Male awake rats were randomly submitted to insulin, control, or hypertonic protocols.…

Teacher Compliance and Accuracy in State Assessment of Student Motor Skill Performance

ERIC Educational Resources Information Center

Hall, Tina J.; Hicklin, Lori K.; French, Karen E.

2015-01-01

Purpose: The purpose of this study was to investigate teacher compliance with state mandated assessment protocols and teacher accuracy in assessing student motor skill performance. Method: Middle school teachers (N = 116) submitted eighth grade student motor skill performance data from 318 physical education classes to a trained monitoring…

40 CFR 26.1601 - EPA review of proposed human research.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 1 2011-07-01 2011-07-01 false EPA review of proposed human research... OF HUMAN SUBJECTS Review of Proposed and Completed Human Research § 26.1601 EPA review of proposed human research. (a) EPA shall review all protocols submitted under § 26.1125 in a timely manner. With...

40 CFR 26.1601 - EPA review of proposed human research.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false EPA review of proposed human research... OF HUMAN SUBJECTS Review of Proposed and Completed Human Research § 26.1601 EPA review of proposed human research. (a) EPA shall review all protocols submitted under § 26.1125 in a timely manner. With...

40 CFR 26.1601 - EPA review of proposed human research.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 1 2012-07-01 2012-07-01 false EPA review of proposed human research... OF HUMAN SUBJECTS Review of Proposed and Completed Human Research § 26.1601 EPA review of proposed human research. (a) EPA shall review all protocols submitted under § 26.1125 in a timely manner. With...

76 FR 24854 - Proposed Information Collection; Comment Request; Additional Protocol Report Forms

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-03

... States to submit declaration forms to the International Atomic Energy Agency (IAEA) on a number of... purposes, but also would be necessary elements for a nuclear weapons program. These forms provides the IAEA... and milling of nuclear materials; buildings on sites of facilities selected by the IAEA from the U.S...

A zero-knowledge protocol for nuclear warhead verification

NASA Astrophysics Data System (ADS)

Glaser, Alexander; Barak, Boaz; Goldston, Robert J.

2014-06-01

The verification of nuclear warheads for arms control involves a paradox: international inspectors will have to gain high confidence in the authenticity of submitted items while learning nothing about them. Proposed inspection systems featuring `information barriers', designed to hide measurements stored in electronic systems, are at risk of tampering and snooping. Here we show the viability of a fundamentally new approach to nuclear warhead verification that incorporates a zero-knowledge protocol, which is designed in such a way that sensitive information is never measured and so does not need to be hidden. We interrogate submitted items with energetic neutrons, making, in effect, differential measurements of both neutron transmission and emission. Calculations for scenarios in which material is diverted from a test object show that a high degree of discrimination can be achieved while revealing zero information. Our ideas for a physical zero-knowledge system could have applications beyond the context of nuclear disarmament. The proposed technique suggests a way to perform comparisons or computations on personal or confidential data without measuring the data in the first place.

Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee.

PubMed

Sathar, Aslam; Dhai, Amaboo; van der Linde, Stephan

2014-12-01

Human Biological Materials (HBMs) are an invaluable resource in biomedical research. To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Ethically approved retrospective cross-sectional descriptive audit. Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively. Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. © 2013 John Wiley & Sons Ltd.

Situational study of seven Latin-American pulmonology journals.

PubMed

Oyarzún Gómez, Manuel; Ramírez Venegas, Alejandra; Agüero Fernández, Adalberto; Martínez, José Antônio Baddini; Bermúdez Gómez, Mary; Cáneva, Jorge O; Morales Blandir, Jaime E; Pérez-Padilla, Rogelio

2007-01-01

To characterize the situation of pulmonology journals published in Latin America. A survey was conducted in a meeting sponsored by the Latin American Thoracic Society. Each journal editor presented a report and answered a questionnaire. Improving information acquisition is the main motivation for pulmonology societies to edit their own journals, whereas disseminating medical knowledge and reporting experiences are the main motivations for authors to submit papers. The most common failing in the manuscripts submitted is poor compliance with the journal guidelines. Improving author-editor-reviewer relationships would be the best strategy for improving the quality of manuscripts. Suggestions for improving Latin American journals included the following: promoting professionalism in editorial tasks; encouraging manuscript reviewers to be more meticulous; and embracing international norms for editing medical journals. The following major problems were reported: a lack of regular, appropriate periodicity of issues; a shortage of original papers that are considered 'milestones' in the specialty; a low rejection rate for submitted papers; a high turnover of editors. Based on our findings, we can make the following recommendations: although many journals are available in electronic form, they should also be maintained in print form; each journal should divulge its subscription fee, even if it is included in the annual society membership dues; although each Latin American country might decide to publish its own pulmonology journal, the feasibility of publishing a multinational Latin American pulmonology journal should be explored.

Raising suspicions with the Food and Drug Administration: detecting misconduct.

PubMed

Hamrell, Michael R

2010-12-01

The clinical Bioresearch Monitoring (BIMO) oversight program of the US Food and Drug Administration (FDA) assesses the quality and integrity of data submitted to the FDA for new product approvals and human subjects protection during clinical studies. A comprehensive program of on-site inspections and data verification, the BIMO program routinely performs random inspections to verify studies submitted to the FDA to support a marketing application. On occasion the FDA will conduct a directed inspection of a specific site or study to look for problems that may have previously been identified. The inspection of a clinical study sometimes uncovers evidence of research fraud or misconduct and it must be decided how to deal with the investigator and the suspect data. The prevention of [or] decreasing the incidence of fraud and misconduct through monitoring by the sponsor is one way to manage compliance issues and can help prevent misconduct. A training program is another way to manage compliance issues in clinical research. While training does not guarantee quality, it does help to ensure that all individuals involved understand the rules and the consequences of research misconduct.

ACR/NEMA Digital Image Interface Standard (An Illustrated Protocol Overview)

NASA Astrophysics Data System (ADS)

Lawrence, G. Robert

1985-09-01

The American College of Radiologists (ACR) and the National Electrical Manufacturers Association (NEMA) have sponsored a joint standards committee mandated to develop a universal interface standard for the transfer of radiology images among a variety of PACS imaging devicesl. The resulting standard interface conforms to the ISO/OSI standard reference model for network protocol layering. The standard interface specifies the lower layers of the reference model (Physical, Data Link, Transport and Session) and implies a requirement of the Network Layer should a requirement for a network exist. The message content has been considered and a flexible message and image format specified. The following Imaging Equipment modalities are supported by the standard interface... CT Computed Tomograpy DS Digital Subtraction NM Nuclear Medicine US Ultrasound MR Magnetic Resonance DR Digital Radiology The following data types are standardized over the transmission interface media.... IMAGE DATA DIGITIZED VOICE HEADER DATA RAW DATA TEXT REPORTS GRAPHICS OTHERS This paper consists of text supporting the illustrated protocol data flow. Each layer will be individually treated. Particular emphasis will be given to the Data Link layer (Frames) and the Transport layer (Packets). The discussion utilizes a finite state sequential machine model for the protocol layers.

Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies.

PubMed

Evoniuk, Gary; Mansi, Bernadette; DeCastro, Barbara; Sykes, Jennie

2017-04-21

Objectives  To determine whether the outcome of drug studies influenced submission and/or acceptance rates for publication in peer reviewed medical journals. Design  A six year retrospective review of publication status by study outcome for all human drug research studies conducted by a single industry sponsor (GlaxoSmithKline) that completed from 1 January 2009 to 30 June 2014 and were therefore due for manuscript submission (per the sponsor's policy) to peer reviewed journals within 18 months of study completion-that is, 31 December 2015. In addition, manuscripts from studies completing after 30 June 2014 were included irrespective of outcome if they were submitted before 31 December 2015. Setting  Studies conducted by a single industry sponsor (GlaxoSmithKline) Studies reviewed  1064 human drug research studies. Main outcome measures  All studies were assigned a publication status at 26 February 2016 including (as applicable): study completion date, date of first primary manuscript submission, number of submissions, journal decision(s), and publication date. All studies were also classified with assessors blinded to publication status as "positive" (perceived favorable outcome for the drug under study), "negative" (perceived unfavorable outcome for the drug under study), mixed, or non-comparative based on the presence and outcome of the primary outcome measure(s) for each study. "Negative" studies included safety studies in which the primary outcome was achieved but was adverse for the drug under study. For the total cohort and each of the four study outcomes, measures included descriptive statistics for study phase, time from study completion to submission and publication, and number and outcome (accepted/rejected) of publication submissions. Results  Of the 1064 studies (phase I-IV, interventional and non-interventional) included, 321 had study outcomes classified as positive, 155 as negative, 52 as mixed, and 536 as non-comparative. At the time of publication cut-off date (26 February 2016), 904 (85%) studies had been submitted for publication as full manuscripts and 751 (71%) had been successfully published or accepted, with 100 (9%) still under journal review. An additional 77 (7%) studies were conference abstracts and were not included in submission or publication rates. Submission rates by study outcome were 79% for the 321 studies with positive outcomes, 92% for the 155 with negative outcomes, 94% for the 52 with mixed outcomes, and 85% for the 536 non-comparative studies; while rates of publication at the cut-off date were 66%, 77%, 77%, and 71%, respectively. Median time from study completion to submission was 537 days (interquartile range 396-638 days) and 823 days (650-1063 days) from completion to publication, with similar times observed across study outcomes. First time acceptance rates were 56% for studies with positive outcomes and 48% for studies with negative outcomes. Over 10% of studies across all categories required three or more submissions to achieve successful publication. At the time of analysis, 83 studies had not been submitted for publication, including 49 bioequivalence studies with positive outcomes and 33 non-comparative studies. Most studies (98%, 1041/1064) had results posted to one or more public registers, including all studies subject to FDAAA (Food and Drug Administration Amendments Act) requirements for posting to www.clinicaltrials.gov Conclusions  Over the period studied, there was no evidence of submission or publication bias: 92% of studies with negative outcomes were submitted for publication by the cut-off date versus 79% of those with positive outcomes. Publication rates were slightly higher for studies with a negative (that is, unfavorable) outcome compared with a positive outcome, despite a slightly lower rate of acceptance at first submission. Many studies required multiple submission attempts before they were accepted for publication. Analyses focusing solely on publication rates do not take into account unsuccessful efforts to publish. Sponsors and journal editors should share similar information to contribute to better understanding of issues and barriers to full transparency. 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.

Electronic data collection for the analysis of surgical maneuvers on patients submitted to rhinoplasty

PubMed Central

Berger, Cezar; Freitas, Renato; Malafaia, Osvaldo; Pinto, José Simão de Paula; Mocellin, Marcos; Macedo, Evaldo; Fagundes, Marina Serrato Coelho

2012-01-01

Summary Introduction: In the health field, computerization has become increasingly necessary in professional practice, since it facilitates data recovery and assists in the development of research with greater scientific rigor. Objective: the present work aimed to develop, apply, and validate specific electronic protocols for patients referred for rhinoplasty. Methods: The prospective research had 3 stages: (1) preparation of theoretical data bases; (2) creation of a master protocol using Integrated System of Electronic Protocol (SINPE©); and (3) elaboration, application, and validation of a specific protocol for the nose and sinuses regarding rhinoplasty. Results: After the preparation of the master protocol, which dealt with the entire field of otorhinolaryngology, we idealized a specific protocol containing all matters related to the patient. In particular, the aesthetic and functional nasal complaints referred for surgical treatment (i.e., rhinoplasty) were organized into 6 main hierarchical categories: anamnesis, physical examination, complementary exams, diagnosis, treatment, and outcome. This protocol utilized these categories and their sub-items: finality; access; surgical maneuvers on the nasal dorsum, tip, and base; clinical evolution after 3, 6, and 12 months; revisional surgery; and quantitative and qualitative evaluations. Conclusion: The developed electronic-specific protocol is feasible and important for information registration from patients referred to rhinoplasty. PMID:25991979

Impact of regulatory assessment on clinical studies in Brazil.

PubMed

Russo, Luis Augusto Tavares; Eliaschewitz, Freddy Goldberg; Harada, Vitor; Trefiglio, Roberta Pereira; Picciotti, Raffaella; Machado, Paula Goulart Pinheiro; Kesselring, Gustavo Luiz Ferreira

2016-01-01

Despite the recent expansion of clinical studies allocated to Brazil, the delay of local regulatory deadlines directly impacts their completion. This article examines the allocation process of clinical studies to Brazil in comparison with other countries, as well as the financial impact of studies not completed due to interruption caused by the delay in the regulatory process. The allocation processes of studies were compared in nine countries with similar stages of economic development and countries in Latin America using the websites http://data.worldbank.org/data-catalog/GDP-rankings-table and http://worldpopulationreview.com and clinicaltrials.gov, comprising 185 countries. The 46 studies sponsored by the pharmaceutical industry underwent an analysis of the regulatory review process. 46 studies sponsored by the industry and submitted in the country between June 2007 and June 2013 were analyzed; 18 (39%) were discontinued due to the delay in obtaining the necessary approvals. For the approved studies, patient recruitment began an average of 11 months after the other countries. It is estimated that 530 Brazilians patients did not have the opportunity to participate in these studies. Financial losses were to the order of 14.6 million dollars for the country, including patient, medication and supplies costs, and expenses. Brazil has enormous potential for the realization of clinical studies. Researchers, associations of disabled people and patients with chronic diseases, sponsors and the authorities must work together to develop an approval process that is efficient, predictable and, most of all, transparent. The current regulatory environment must and can be improved and optimized in order to result in tangible benefits for patients, society and the country's scientific development.

Guidance from an NIH Workshop on Designing, Implementing, and Reporting Clinical Studies of Soy Interventions1–4

PubMed Central

Klein, Marguerite A.; Nahin, Richard L.; Messina, Mark J.; Rader, Jeanne I.; Thompson, Lilian U.; Badger, Thomas M.; Dwyer, Johanna T.; Kim, Young S.; Pontzer, Carol H.; Starke-Reed, Pamela E.; Weaver, Connie M.

2010-01-01

The NIH sponsored a scientific workshop, “Soy Protein/Isoflavone Research: Challenges in Designing and Evaluating Intervention Studies,” July 28–29, 2009. The workshop goal was to provide guidance for the next generation of soy protein/isoflavone human research. Session topics included population exposure to soy; the variability of the human response to soy; product composition; methods, tools, and resources available to estimate exposure and protocol adherence; and analytical methods to assess soy in foods and supplements and analytes in biologic fluids and other tissues. The intent of the workshop was to address the quality of soy studies, not the efficacy or safety of soy. Prior NIH workshops and an evidence-based review questioned the quality of data from human soy studies. If clinical studies are pursued, investigators need to ensure that the experimental designs are optimal and the studies properly executed. The workshop participants identified methodological issues that may confound study results and interpretation. Scientifically sound and useful options for dealing with these issues were discussed. The resulting guidance is presented in this document with a brief rationale. The guidance is specific to soy clinical research and does not address nonsoy-related factors that should also be considered in designing and reporting clinical studies. This guidance may be used by investigators, journal editors, study sponsors, and protocol reviewers for a variety of purposes, including designing and implementing trials, reporting results, and interpreting published epidemiological and clinical studies. PMID:20392880

[Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

PubMed

Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

2018-01-01

 Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

Workload and prevalence of open wounds in the community: French Vulnus initiative.

PubMed

Meaume, S; Kerihuel, J C; Fromantin, I; Téot, L

2012-02-01

To calculate the prevalence of open cutaneous wounds presented on a routine working day in community settings in metropolitan France, and to estimate the workload associated with the care of these wounds by nurses, GPs and specialists (dermatologists, diabetologists and phlebologists). A transversal epidemiological survey was conducted on a randomly selected sample of the above practitioners between June and July 2008. The percentage of patients presenting on a routine working day with open a cutaneous lesion of any origin, location, size and duration was assessed. All local and systemic care performed on the patient during that day because of the wound was also recorded. In total, 475 GPs, 453 specialists and 238 nurses participated (n=1166) and saw a total of 29 663 patients, of whom 3037 presented with one or more cutaneous wound. The overall non-weighted prevalence of patients with a wound was 10.2% (95%CI: 9.9%;10.6%). This prevalence was similar for GPs (6.0%) and for specialists (6.9%), but was higher for nurses (22.0%). Forty-three per cent of all wounds had a duration of over 6 weeks. These chronic wounds were predominantly leg ulcers, diabetic foot ulcers or pressure ulcers, but also included wounds of all aetiologies. For 33% of all patients with wounds, the impact on their health status was serious to severe. The overwhelming majority of wounds (95%) required local care, including in 65% of cases cleansing and debridement. Despite its limitations, this initiative, the first of its type in France, strongly suggests that wound care constitutes an important part of routine care given by health professionals in the community, and for a substantial number of these patients, wounds represent a serious morbidity. The non-profit organisation 'Association Vivre avec une Plaie' financially supported this study. This association received unrestricted grants from the French Wound Healing Society (SFFPC) and a consortium of private companies (main sponsors: ConvaTec, Genevrier, Hartmann, KCI, Mölnycke, Smith & Nephew, Urgo; minor sponsors: Coloplast, Covidien, HNE) to fund the costs incurred by the methodological process and statistical analysis but had no input into the findings. The National Health Insurance Organisation provided non-financial support to this initiative. J.C. Kerihuel received support for the submitted work from 'Association Vivre avec une Plaie'. S. Meaume, I. Fromantin and L. Téot have no financial relationship with 'Association Vivre avec une Plaie', for either this or any work submitted in the previous 3 years. The authors have no non-financial interests that may be relevant to the submitted work, and their spouses, partners, or children have no financial relationships that may be relevant to the submitted work

Mapping the moral boundaries of biological engineering.

PubMed

Russ, Zachary N

2009-05-08

The following essay was written by a sophomore undergraduate student majoring in Bioengineering at the University of Maryland, Mr. Zachary Russ. Mr. Russ was one of 174 students who submitted a 1000-1200 word essay to the 4th Annual Bioethics Contest sponsored by the Institute of Biological Engineering (IBE). A group of professionals in Biological Engineering assessed and ranked the essays in a blinded process. Five semi-finalists were invited to present their essays at a session at the annual meeting of IBE in Santa Clara, CA on March 21, 2009. Five judges scored all the presentation at the annual meeting and selected Mr. Russ's contribution as the overall winner (1st Place).

Synthetic biology: enormous possibility, exaggerated perils.

PubMed

Russ, Zachary N

2008-04-25

The following essay was written by a freshman undergraduate student majoring in Bioengineering at the University of Maryland, Mr. Zachary Russ. Mr. Russ was one of 94 students who submitted a 1000 to 1200 word essay to the 3rd Annual Bioethics Essay Contest sponsored by the Institute of Biological Engineering (IBE). A group of professionals in Biological Engineering assessed and ranked the essays in a blinded process. Five semi-finalists were invited to present their essays at a session at the annual meeting of IBE in Chapel Hill, NC on March 8, 2008. Five judges scored the presentations at the annual meeting and selected Mr. Russ's contribution as the overall winner (1st Place). Below is his essay.

Mapping the moral boundaries of biological engineering

PubMed Central

Russ, Zachary N

2009-01-01

The following essay was written by a sophomore undergraduate student majoring in Bioengineering at the University of Maryland, Mr. Zachary Russ. Mr. Russ was one of 174 students who submitted a 1000–1200 word essay to the 4th Annual Bioethics Contest sponsored by the Institute of Biological Engineering (IBE). A group of professionals in Biological Engineering assessed and ranked the essays in a blinded process. Five semi-finalists were invited to present their essays at a session at the annual meeting of IBE in Santa Clara, CA on March 21, 2009. Five judges scored all the presentation at the annual meeting and selected Mr. Russ's contribution as the overall winner (1st Place). PMID:19422721

78 FR 72675 - Proposed Information Collection Request; Comment Request; Recordkeeping and Reporting...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-03

...The Environmental Protection Agency is planning to submit an information collection request (ICR), Recordkeeping and Reporting Requirements Regarding the Sulfur Content of Motor Vehicle Gasoline under the Tier 2 Rule, to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through January 31, 2013. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Synthetic biology: enormous possibility, exaggerated perils

PubMed Central

Russ, Zachary N

2008-01-01

The following essay was written by a freshman undergraduate student majoring in Bioengineering at the University of Maryland, Mr. Zachary Russ. Mr. Russ was one of 94 students who submitted a 1000 to 1200 word essay to the 3rd Annual Bioethics Essay Contest sponsored by the Institute of Biological Engineering (IBE). A group of professionals in Biological Engineering assessed and ranked the essays in a blinded process. Five semi-finalists were invited to present their essays at a session at the annual meeting of IBE in Chapel Hill, NC on March 8, 2008. Five judges scored the presentations at the annual meeting and selected Mr. Russ's contribution as the overall winner (1st Place). Below is his essay. PMID:18439286

KSC-04PD-2190

NASA Technical Reports Server (NTRS)

2004-01-01

KENNEDY SPACE CENTER, FLA. NASA astronaut Patrick Forrester addresses a group of educators assembled for the kickoff of 'The Science in Space Challenge' at the Doubletree Hotel in Orlando, Fla. The national challenge program is sponsored by NASA and Pearson Scott Foresman, publisher of pre-K through grade six educational books. To participate in the challenge, teachers may submit proposals, on behalf of their students, for a science and technology investigation. Astronauts will conduct the winning projects on a Space Shuttle mission or on the International Space Station, while teachers and students follow along via television or the Web. For more information about the announcement, see the news release at http://www.nasa.gov/home/hqnews/2004/oct/HQ_04341_publication.htm l.

The Corporate Coauthor

PubMed Central

Fugh-Berman, Adriane

2005-01-01

Drug marketing techniques include the sponsorship of articles signed by academic physicians or researchers and submitted to peer-reviewed medical journals. Some of these articles are authored or coauthored by ghostwriters who work for pharmaceutical companies or medical education companies hired by pharmaceutical companies. Conflicts of interest may be difficult to detect in the subset of articles and presentations sponsored by pharmaceutical companies that never mention the targeted drug, but focus on stimulating the perceived need for the targeted drug or highlighting problems with competing drugs. The current voluntary standards for declaring conflicts of interest to readers of medical journals and audiences at medical conferences are inadequate. A public database that contains conflicts of interest of physicians and researchers would be useful. PMID:15987332

40 CFR 8.8 - Comprehensive environmental evaluation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... conduct of scientific research and on other existing uses and values; (10) An identification of gaps in... evaluation. (a) Preparation of a CEE. Unless a PERM or an IEE has been submitted and determined to meet the... evaluate the CEE to determine if the CEE meets the requirements under Article 8 and Annex I to the Protocol...

A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital.

PubMed

Shah, Pruthak C; Panchasara, Ashwin K; Barvaliya, Manish J; Tripathi, C B

2016-09-01

Application form of research work is an essential requirement which is required to be submitted along with the research proposal to the Ethics Committee (EC). To check the completeness and to find the errors in application forms submitted to the EC of a tertiary care hospital. The application forms of research projects submitted to the Institutional Review Board (IRB), Government Medical College, Bhavnagar, Gujarat, India from January 2014 to June 2015 were analysed for completeness and errors, with respect to the following - type of study, information about study investigators, sample size, study participants, title of the studies, signatures of all investigators, regulatory approval, recruitment procedure, compensation to study participants, informed consent process, information about sponsor, declaration of conflict of interest, plans for storage and maintenance of data, patient information sheet, informed consent forms and study related documents. Total 100 application forms were analysed. Among them, 98 were academic and 2 were industrial studies. Majority of academic studies were of basic science type. In 63.26% studies, type of study was not mentioned in title. Age group of subjects was not mentioned in 8.16% application forms. In 34.6% informed consent, benefits of the study were not mentioned. Signature of investigators/co-investigators/Head of the Department was missing in 3.06% cases. Our study recommends that the efficiency and speed of review will increase if investigator will increase vigilance regarding filling of application forms. Regular meetings will be helpful to solve the problems related to content of application forms. The uniformity in functioning of EC can be achieved if common application form for all ECs is there.

Static balance and function in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation: Study protocol for prospective, randomized, controlled trial

PubMed Central

2012-01-01

Background The use of botulinum toxin A (BT-A) for the treatment of lower limb spasticity is common in children with cerebral palsy (CP). Following the administration of BT-A, physical therapy plays a fundamental role in potentiating the functionality of the child. The balance deficit found in children with CP is mainly caused by muscle imbalance (spastic agonist and weak antagonist). Neuromuscular electrical stimulation (NMES) is a promising therapeutic modality for muscle strengthening in this population. The aim of the present study is to describe a protocol for a study aimed at analyzing the effects of NMES on dorsiflexors combined with physical therapy on static and functional balance in children with CP submitted to BT- A. Methods/Design Protocol for a prospective, randomized, controlled trial with a blinded evaluator. Eligible participants will be children with cerebral palsy (Levels I, II and III of the Gross Motor Function Classification System) between five and 12 years of age, with independent gait with or without a gait-assistance device. All participants will receive BT-A in the lower limbs (triceps surae). The children will then be randomly allocated for either treatment with motor physical therapy combined with NMES on the tibialis anterior or motor physical therapy alone. The participants will be evaluated on three occasions: 1) one week prior to the administration of BT-A; 2) one week after the administration of BT-A; and 3) four months after the administration of BT-A (end of intervention). Spasticity will be assessed by the Modified Ashworth Scale and Modified Tardieu Scale. Static balance will be assessed using the Medicapteurs Fusyo pressure platform and functional balance will be assessed using the Berg Balance Scale. Discussion The aim of this protocol study is to describe the methodology of a randomized, controlled, clinical trial comparing the effect of motor physical therapy combined with NMES on the tibialis anterior muscle or motor physical therapy alone on static and functional balance in children with CP submitted to BT-A in the lower limbs. This study describes the background, hypotheses, methodology of the procedures and measurement of the results. Trial registration RBR5qzs8h PMID:22591446

Ocean Optics Protocols for Satellite Ocean Color Sensor Validation. Volume 1; Revised

NASA Technical Reports Server (NTRS)

Mueller, James L. (Editor); Fargion, Giulietta (Editor); Mueller, J. L.; Trees, C.; Austin, R. W.; Pietras, C.; Hooker, S.; Holben, B.; McClain, Charles R.; Clark, D. K.;

Ocean Optics Protocols for Satellite Ocean Color Sensor Validation. Volume 2; Revised

NASA Technical Reports Server (NTRS)

Mueller, James L. (Editor); Fargion, Giulietta S. (Editor); Trees, C.; Austin, R. W.; Pietras, C. (Editor); Hooker, S.; Holben, B.; McClain, Charles R.; Clark, D. K.; Yuen, M.

2002-01-01

This document stipulates protocols for measuring bio-optical and radiometric data for the SIMBIOS Project. It supersedes the earlier version, and is organized into four parts: Introductory Background, Instrument Characteristics, Field Measurements and Data Analysis, Data Reporting and Archival. Changes in this revision include the addition of three new chapters: (1) Fundamental Definitions, Relationships and Conventions; (2) MOBY, A Radiometric Buoy for Performance Monitoring and Vicarious Calibration of Satellite Ocean Color Sensors: Measurement and Data Analysis Protocols; and (3) Normalized Water-Leaving Radiance and Remote Sensing Reflectance: Bidirectional Reflectance and Other Factors. Although the present document represents another significant, incremental improvement in the ocean optics protocols, there are several protocols that have either been overtaken by recent technological progress, or have been otherwise identified as inadequate. Revision 4 is scheduled for completion sometime in 2003. This technical report is not meant as a substitute for scientific literature. Instead, it will provide a ready and responsive vehicle for the multitude of technical reports issued by an operational Project. The contributions are published as submitted, after only minor editing to correct obvious grammatical or clerical errors.

Recommendations for safety testing with the in vivo comet assay.

PubMed

Vasquez, Marie Z

2012-08-30

While the in vivo comet assay increases its role in regulatory safety testing, deliberations about the interpretation of comet data continue. Concerns can arise regarding comet assay publications with limited data from non-blind testing of positive control compounds and using protocols (e.g. dose concentrations, sample times, and tissues) known to give an expected effect. There may be a tendency towards bias when the validation or interpretation of comet assay data is based on results generated by widely accepted but non-validated assays. The greatest advantages of the comet assay are its sensitivity and its ability to detect genotoxicity in tissues and at sample times that could not previously be evaluated. Guidelines for its use and interpretation in safety testing should take these factors into account. Guidelines should be derived from objective review of data generated by blind testing of unknown compounds dosed at non-toxic concentrations and evaluated in a true safety-testing environment, where the experimental design and conclusions must be defensible. However, positive in vivo comet findings with such compounds are rarely submitted to regulatory agencies and this data is typically unavailable for publication due to its proprietary nature. To enhance the development of guidelines for safety testing with the comet assay, and with the permission of several sponsors, this paper presents and discusses relevant data from multiple GLP comet studies conducted blind, with unknown pharmaceuticals and consumer products. Based on these data and the lessons we have learned through the course of conducting these studies, I suggest significant adjustments to the current conventions, and I provide recommendations for interpreting in vivo comet assay results in situations where risk must be evaluated in the absence of carcinogenicity or clinical data. Copyright © 2012 Elsevier B.V. All rights reserved.

Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin.

PubMed

Vedula, S Swaroop; Li, Tianjing; Dickersin, Kay

2013-01-01

Details about the type of analysis (e.g., intent to treat [ITT]) and definitions (i.e., criteria for including participants in the analysis) are necessary for interpreting a clinical trial's findings. Our objective was to compare the description of types of analyses and criteria for including participants in the publication (i.e., what was reported) with descriptions in the corresponding internal company documents (i.e., what was planned and what was done). Trials were for off-label uses of gabapentin sponsored by Pfizer and Parke-Davis, and documents were obtained through litigation. For each trial, we compared internal company documents (protocols, statistical analysis plans, and research reports, all unpublished), with publications. One author extracted data and another verified, with a third person verifying discordant items and a sample of the rest. Extracted data included the number of participants randomized and analyzed for efficacy, and types of analyses for efficacy and safety and their definitions (i.e., criteria for including participants in each type of analysis). We identified 21 trials, 11 of which were published randomized controlled trials, and that provided the documents needed for planned comparisons. For three trials, there was disagreement on the number of randomized participants between the research report and publication. Seven types of efficacy analyses were described in the protocols, statistical analysis plans, and publications, including ITT and six others. The protocol or publication described ITT using six different definitions, resulting in frequent disagreements between the two documents (i.e., different numbers of participants were included in the analyses). Descriptions of analyses conducted did not agree between internal company documents and what was publicly reported. Internal company documents provide extensive documentation of methods planned and used, and trial findings, and should be publicly accessible. Reporting standards for randomized controlled trials should recommend transparent descriptions and definitions of analyses performed and which study participants are excluded.

Clock Scan Protocol for Image Analysis: ImageJ Plugins.

PubMed

Dobretsov, Maxim; Petkau, Georg; Hayar, Abdallah; Petkau, Eugen

2017-06-19

The clock scan protocol for image analysis is an efficient tool to quantify the average pixel intensity within, at the border, and outside (background) a closed or segmented convex-shaped region of interest, leading to the generation of an averaged integral radial pixel-intensity profile. This protocol was originally developed in 2006, as a visual basic 6 script, but as such, it had limited distribution. To address this problem and to join similar recent efforts by others, we converted the original clock scan protocol code into two Java-based plugins compatible with NIH-sponsored and freely available image analysis programs like ImageJ or Fiji ImageJ. Furthermore, these plugins have several new functions, further expanding the range of capabilities of the original protocol, such as analysis of multiple regions of interest and image stacks. The latter feature of the program is especially useful in applications in which it is important to determine changes related to time and location. Thus, the clock scan analysis of stacks of biological images may potentially be applied to spreading of Na + or Ca ++ within a single cell, as well as to the analysis of spreading activity (e.g., Ca ++ waves) in populations of synaptically-connected or gap junction-coupled cells. Here, we describe these new clock scan plugins and show some examples of their applications in image analysis.

Fast Entanglement Establishment via Local Dynamics for Quantum Repeater Networks

NASA Astrophysics Data System (ADS)

Gyongyosi, Laszlo; Imre, Sandor

Quantum entanglement is a necessity for future quantum communication networks, quantum internet, and long-distance quantum key distribution. The current approaches of entanglement distribution require high-delay entanglement transmission, entanglement swapping to extend the range of entanglement, high-cost entanglement purification, and long-lived quantum memories. We introduce a fundamental protocol for establishing entanglement in quantum communication networks. The proposed scheme does not require entanglement transmission between the nodes, high-cost entanglement swapping, entanglement purification, or long-lived quantum memories. The protocol reliably establishes a maximally entangled system between the remote nodes via dynamics generated by local Hamiltonians. The method eliminates the main drawbacks of current schemes allowing fast entanglement establishment with a minimized delay. Our solution provides a fundamental method for future long-distance quantum key distribution, quantum repeater networks, quantum internet, and quantum-networking protocols. This work was partially supported by the GOP-1.1.1-11-2012-0092 project sponsored by the EU and European Structural Fund, by the Hungarian Scientific Research Fund - OTKA K-112125, and by the COST Action MP1006.

Changes in morphology of long bone marrow tissue of rats submitted to cryotherapy with liquid nitrogen.

PubMed

Costa, Fábio Wildson Gurgel; Pessoa, Rosana Maria Andrade; Nogueira, Carlos Bruno Pinheiro; Pereira, Karuza Maria Alves; Brito, Gerly Anne de Castro; Soares, Eduardo Costa Studart

2012-02-01

To study the main effects of local use of liquid nitrogen on bone marrow tissue in rats. The femoral diaphyses of 42 Wistar rats were exposed to three local and sequential applications of liquid nitrogen for one or two minutes, intercalated with periods of five minutes of passive thawing. The animals were sacrificed after one, two, four and 12 weeks and the specimens obtained were analyzed histomorphologically. In the second experimental week of one-minute protocol, histological degree of inflammation obtained a mean score of one (mild), ranging from 0 (absent or scarce) and two (moderate) (Kruskal-Wallis test p=0.01). In the second experimental week of two-minute protocol, degree of inflammation to the medullar tissue obtained an average score of two (Kruskal-Wallis test p=0.01). The degree of inflammation of the bone marrow tissue was higher in protocol of three applications of two minutes compared to protocol of three applications of one minute.

Regional Anesthesia and Valproate Sodium for the Prevention of Chronic Post-Amputation Pain

DTIC Science & Technology

2013-10-01

revised documents August Non-perishable Supplies ordered & received DUKE IRB approved study via expedited review September Submitted all revisions...2013 February March April May June July August September October HRPO request for revised, addtn’l docs VA approved protocol...A few candidate gene polymorphisms have been linked to pain susceptibility, including catechol-O-methyltranferase ( COMT ). This gene modulates

[Conflict of interests in clinical research].

PubMed

Alves, Elaine Maria de Oliveira; Tubino, Paulo

2007-01-01

In clinical research there is a real possibility to have some conflict of interests. Even for the researcher, the identification of these conflicts cannot be clear. There are many aspects to be considered, involving all participants of the process: the research subject, the researcher, the institution where the research is carried through, the sponsor, the ethics committees, the regulating agencies, the scientific community and the society. The conclusion is that conflicts of interests are common and inevitable in the academic field. The challenge is not to eradicate them, but to recognize them and to manage them properly. The only acceptable way to do this is to expose clearly the conflicts of interests and always to submit the clinical research projects to the ethics committees.