European Marketing Authorizations Granted Based on a Single Pivotal Clinical Trial: The Rule or the Exception?

PubMed

Morant, Anne Vinther; Vestergaard, Henrik Tang

2018-07-01

A minimum of two positive, adequate, and well-controlled clinical trials has historically been the gold standard for providing substantial evidence to support regulatory approval of a new medicine. Nevertheless, the present analysis of European Marketing Authorizations granted between 2012 and 2016 showed that 45% of new active substances were approved based on a single pivotal clinical trial. For therapeutic areas such as oncology and cardiovascular diseases, approvals based on a single pivotal trial are the rule rather than the exception, whereas new medicines within the nervous system area were generally supported by two or more pivotal trials. While overall similar trends have been observed in the US, the recent US Food and Drug Administration approvals of nervous system medicines based on a single pivotal trial suggest that a case-by-case scientific evaluation of the totality of evidence is increasingly applied to facilitate faster access of new medicines to patients suffering from serious diseases. © 2017 American Society for Clinical Pharmacology and Therapeutics.

75 FR 59934 - Amendment to Class E Airspace; Smithfield, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... Class E airspace at Johnston County Airport, Smithfield, NC, by correcting an omission of the geographic coordinates of the Area Navigation (RNAV) Global Positioning System (GPS) Special Standard Instrument Approach... System. DATES: Effective 0901 UTC, January 13, 2011. The Director of the Federal Register approves this...

The Implications of Real Options on ERP-Enabled Adoption

ERIC Educational Resources Information Center

Nwankpa, Joseph K.

2012-01-01

Current research on Enterprise Resource Planning (ERP) systems and real options focuses on valuation and justification issues that manager's face prior to project approval with existing literature attempting to demonstrate that ERP systems as technology positioning investments have option-like characteristics thus making such ERP systems…

Local Geoid Determination Using the Global Positioning System

DTIC Science & Technology

1988-09-01

Positioning System by Ma, Wei-Ming September 1988 Co-Advisor: Kandiah Jeyapalan Co-Advisor: Stevens P. Tucker Approved for public release; distribution is... Jeyapalan and Stevens P. Tucker, my thesis advisors, for their dedicated assistance and guidance during the study. Without their encouragement...method of collocation is [ Jeyapalan , 1977]: x = A*X+S +n +O.S q q P where x the vector of the observation (x = Ah - N0(X,Y,Z) - H) A a given rectangular

5 CFR 532.303 - Specialized industry.

Code of Federal Regulations, 2010 CFR

2010-01-01

....303 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PREVAILING RATE SYSTEMS Determining Rates for Principal Types of Positions § 532.303 Specialized industry. (a)(1) Under... as specialized industries upon approval of the Office of Personnel Management. ...

Human Factors and Operations Issues in GPS and WAAS Sensor Approvals A Review and Comparison of FAA and RTCA Documents

DOT National Transportation Integrated Search

1997-07-01

This report is the culmination of the first task in a project to evaluate human factors and operations issues associated : with the integration of Class C Global Positioning System (GPS) sensors and Class Beta GPS/Wide Area Augmentation System : (WAA...

Human factors and operations issues in GPS and WAAS sensor approvals : a review and comparison of FAA and RTCA documents

DOT National Transportation Integrated Search

1997-07-01

This report is the culmination of the first task in a project to evaluate human factors and operations issues associated with the integration of Class C Global Positioning System (GPS) sensors and Class Beta GPS/Wide Area Augmentation System (WAAS) s...

Relationship between pharmaceutical company user fees and drug approvals in Canada and Australia: a hypothesis-generating study.

PubMed

Lexchin, Joel

2006-12-01

Since the early- to mid-1990s, drug companies have paid fees for a variety of activities carried out by the Therapeutic Products Directorate in Canada and the Therapeutic Goods Administration in Australia. To explore whether changes in approval times for new active substances and in the percentage of new drug submissions receiving positive decisions coincided with the level of user fees. Data were collected from a range of Canadian and Australian government publications on the following topics: total funding for and workload of the regulatory agencies, the percentage of income that came from tax revenue and user fees, the percentage of new drug submissions that received a positive decision, and-for Canada only-the percent of submissions that were approved on first review. In both countries, there was a moderate-to-strong positive association between the level of industry funding and the percent of submissions that received a positive decision and a moderate-to-strong (Canada) and moderate (Australia) negative association between the level of industry funding and approval times. Changes observed in both countries are favorable to the pharmaceutical industry. Other than user fees leading to a pro-industry bias in the regulatory authorities, other possible explanations include a more efficient use of resources, a smaller workload (Canada), an improvement in the quality of drug submissions (Canada), and more resources (Australia). Further research strategies are needed to either confirm or refute the hypothesis that the level of industry funding affects decisions made in drug regulatory systems.

Impressive Words: Linguistic Predictors of Public Approval of the U.S. Congress.

PubMed

Decter-Frain, Ari; Frimer, Jeremy A

2016-01-01

What type of language makes the most positive impression within a professional setting? Is competent/agentic language or warm/communal language more effective at eliciting social approval? We examined this basic social cognitive question in a real world context using a "big data" approach-the recent record-low levels of public approval of the U.S. Congress. Using Linguistic Inquiry and Word Count (LIWC), we text analyzed all 123+ million words spoken by members of the U.S. House of Representatives during floor debates between 1996 and 2014 and compared their usage of various classes of words to their public approval ratings over the same time period. We found that neither agentic nor communal language positively predicted public approval. However, this may be because communion combines two disparate social motives (belonging and helping). A follow-up analysis found that the helping form of communion positively predicted public approval, and did so more strongly than did agentic language. Next, we conducted an exploratory analysis, examining which of the 63 standard LIWC categories predict public approval. We found that the public approval of Congress was highest when politicians used tentative language, expressed both positive emotion and anxiety, and used human words, numbers, prepositions, numbers, and avoided conjunctions and the use of second-person pronouns. These results highlight the widespread primacy of warmth over competence as the primary dimensions of social cognition.

Impressive Words: Linguistic Predictors of Public Approval of the U.S. Congress

PubMed Central

Decter-Frain, Ari; Frimer, Jeremy A.

2016-01-01

What type of language makes the most positive impression within a professional setting? Is competent/agentic language or warm/communal language more effective at eliciting social approval? We examined this basic social cognitive question in a real world context using a “big data” approach—the recent record-low levels of public approval of the U.S. Congress. Using Linguistic Inquiry and Word Count (LIWC), we text analyzed all 123+ million words spoken by members of the U.S. House of Representatives during floor debates between 1996 and 2014 and compared their usage of various classes of words to their public approval ratings over the same time period. We found that neither agentic nor communal language positively predicted public approval. However, this may be because communion combines two disparate social motives (belonging and helping). A follow-up analysis found that the helping form of communion positively predicted public approval, and did so more strongly than did agentic language. Next, we conducted an exploratory analysis, examining which of the 63 standard LIWC categories predict public approval. We found that the public approval of Congress was highest when politicians used tentative language, expressed both positive emotion and anxiety, and used human words, numbers, prepositions, numbers, and avoided conjunctions and the use of second-person pronouns. These results highlight the widespread primacy of warmth over competence as the primary dimensions of social cognition. PMID:26941691

Pipe overpack container for trasuranic waste storage and shipment

DOEpatents

Geinitz, Richard R.; Thorp, Donald T.; Rivera, Michael A.

1999-01-01

A Pipe Overpack Container for transuranic waste storage and shipment. The system consists of a vented pipe component which is positioned in a vented, insulated 55 gallon steel drum. Both the vented pipe component and the insulated drum are capable of being secured to prevent the contents from leaving the vessel. The vented pipe component is constructed of 1/4 inch stainless steel to provide radiation shielding. Thus, allowing shipment having high Americium-241 content. Several Pipe Overpack Containers are then positioned in a type B, Nuclear Regulatory Commission (NRC) approved, container. In the current embodiment, a TRUPACT-II container was employed and a maximum of fourteen Pipe Overpack Containers were placed in the TRUPACT-II. The combination received NRC approval for the shipment and storage of transuranic waste.

Descriptive Summaries of the Research Development Test & Evaluation Army Appropriation FY 1982. Supporting Data FY 1982, Budget Estimate Submitted to Congress January 1981 (Amended 30 April 1981). Volume II.

DTIC Science & Technology

1981-01-01

the Position Location Reporting System/Joint Tactical Information Distributlo:; System Hybrid (ADDS) was approved by the Combat and Materiel Developers...Programs program. The establishment of a hybrid testbed will be Initiated in FY 1981 integrating the engint-ciag development models of Position...ad anticipated. 0.110 - This project was Increased by $1999 thousand in FT 1980 to support additional AD work on the hybrid collective protec- tion

Systemic therapy for intermediate and advanced hepatocellular carcinoma: Sorafenib and beyond.

PubMed

Raoul, Jean-Luc; Kudo, Masatoshi; Finn, Richard S; Edeline, Julien; Reig, Maria; Galle, Peter R

2018-05-17

The hepatocellular carcinoma (HCC) treatment landscape changed a decade ago, with sorafenib demonstrating survival benefit in the first-line setting and becoming the first systemic therapy to be approved for HCC. More recently, regorafenib and nivolumab have received approval in the second-line setting after sorafenib, with further positive phase 3 studies emerging in the first line (lenvatinib non-inferior to sorafenib) and second line versus placebo (cabozantinib and ramucirumab). A key recommendation in the management of patients receiving sorafenib is to promote close communication between the patient and the physician so that adverse events (AEs) are detected early and severe AEs can be prevented. Sorafenib-related AEs have been identified as clinical biomarkers for sorafenib efficacy. Healthcare professionals have become more efficient in managing AEs, identifying patients who are likely to benefit from treatment, and assessing response to treatment, resulting in a trend towards increased overall survival in the sorafenib arms of clinical studies. The rapidly changing treatment landscape due to the emergence of new treatment options (sorafenib and lenvatinib equally effective in first line; regorafenib, cabozantinib, and ramucirumab showing OS benefit in second line with nivolumab approved by the FDA based on response rate) underscores the importance of re-assessing the role of the first approved systemic agent in HCC, sorafenib. Copyright © 2018. Published by Elsevier Ltd.

77 FR 55691 - Establishment of Class E Airspace; Circle Town, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-11

... (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Circle Town County Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective date, 0901 UTC, November 15, 2012. The Director of the Federal Register approves...

Fiber Optic Safeguards Sealing System

DTIC Science & Technology

1978-01-01

8217 or trade names does not constitute an official indorsement or approval of the use thereof. Destroy this report when it is no longer needed. Do not...an intergrity check of a seal than to photograph the seal’s fingerprints and to match positive/negative overlays. The seal identification time and

Modification of General Research Corporation (GRC) Dynatup 8200 Drop Tower Rebounding Brake System

DTIC Science & Technology

2016-08-01

Having 1.5-inch stroke low-volume actuators, retracted t t Approved for public release; distribution is unlimited. 3 multiple impacts from...rebound period at 1000 fps. Fig. 5 New upgraded 3-inch pneumatic cylinders 3.0-inch stroke high-volume actuators Retracted Position Extended

76 FR 75448 - Establishment of Class D and E Airspace; Frederick, MD

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-02

... and E airspace at Frederick, MD, to accommodate new Area Navigation (RNAV) Global Positioning System... enhances the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport. DATES: Effective 0901 UTC, February 9, 2012. The Director of the Federal Register approves this...

75 FR 37294 - Modification of Class E Airspace; Kelso, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-29

... airspace at Kelso, WA, to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System... improve the safety and management of Instrument Flight Rules (IFR) operations at the airport. DATES: Effective date, 0901 UTC, September 23, 2010. The Director of the Federal Register approves this...

76 FR 75523 - Vessel Monitoring Systems; Approved Mobile Transmitting Units and Communications Service...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-02

... communications (email, eforms) and position services. This configuration is enabled through the Iridium Short... relevant features of the enhanced mobile transmitting unit (E-MTU) VMS and communications service providers... communications service providers (including specifications), please contact the VMS Support Center at phone (888...

Purification and Characteriztion of the Type III Secretion System Protein from Burkholderia mallei

DTIC Science & Technology

2013-08-01

official Department of the Army position unless so designated by other authorizing documents. REPORT DOCUMENTATION PAGE Form Approved OMB No...HP column), the procedure was performed in an automated mode using the following four steps: eluting through a HisTrap crude FF column, desalting

The Submersible Threat to Maritime Homeland Security

DTIC Science & Technology

2013-09-01

government . IRB Protocol number ____N/A____. 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public release; distribution is unlimited 12b...20 Figure 8. Privately Owned Tourist Submersible (From Atlantis Submarine off Maui...Armed Forces of Colombia (Spanish) FLIR Forward Looking Infrared Radar GAO Government Accountability Office GPS Global Positioning System

NRL Review 1989-1990

DTIC Science & Technology

1990-06-01

NancY L. Garland, James W. Fleming, and Herbert H. N¢’so, Epoxy Coatings for Shipboard Copper-Nickel Piping 113 Robert F. Brady, Jr. ELECTROMAGNETIC...carrier collection-holding-transfer Positioning System. Today, NRL is the Navy’s discharge piping systems. Laboratory researchers lead laboratory in space...several confinement fusion target heating at short years, congressionally approved military wavelengths. A new 3-MJ, 10-MA pulsed- construction

Pipe overpack container for transuranic waste storage and shipment

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

Geinitz, R.R.; Thorp, D.T.; Rivera, M.A.

1999-12-07

A Pipe Overpack Container is described for transuranic waste storage and shipment. The system consists of a vented pipe component which is positioned in a vented, insulated 55 gallon steel drum. Both the vented pipe component and the insulated drum are capable of being secured to prevent the contents from leaving the vessel. The vented pipe component is constructed of 1/4 inch stainless steel to provide radiation shielding, thus allowing shipment having high Americium-241 content. Several Pipe Overpack Containers are then positioned in a type B, Nuclear Regulatory Commission (NRC) approved, container. In the current embodiment, a TRUPACT-II container wasmore » employed and a maximum of fourteen Pipe Overpack Containers were placed in the TRUPACT-II. The combination received NRC approval for the shipment and storage of transuranic waste.« less

Verification and Validation of Rural Propagation in the Sage 2.0 Simulation

DTIC Science & Technology

2016-08-01

position unless so designated by other authorized documents. Citation of manufacturer’s or trade names does not constitute an official endorsement or...Approved for public release; distribution unlimited. 1 1. Introduction The System of Systems Survivability Simulation (S4) is designed to be...materiel developers. The Sage model, part of the S4 simulation suite, has been developed primarily to support SLAD analysts in pretest planning and

The Next Generation of State Assessment and Accountability

ERIC Educational Resources Information Center

Rothman, Robert; Marion, Scott F.

2016-01-01

A pilot program in New Hampshire models innovative ways creating and applying state assessments and educator accountability. A study of New Hampshire's new system, which has already received approval by the U.S. Department of Education under a waiver from NCLB, finds some positive results and also suggests challenges states might face in putting…

5 CFR 293.303 - The roles and responsibilities of the Office, agencies, and custodians.

Code of Federal Regulations, 2012 CFR

2012-01-01

... contained within a document management system approved by the Office. (2) A custodian shall be responsible... MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL RECORDS Official Personnel Folder § 293.303 The roles and... such a position is part of the records of the Office of Personnel Management (Office). (b) The Office...

5 CFR 293.303 - The roles and responsibilities of the Office, agencies, and custodians.

Code of Federal Regulations, 2014 CFR

2014-01-01

... contained within a document management system approved by the Office. (2) A custodian shall be responsible... MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL RECORDS Official Personnel Folder § 293.303 The roles and... such a position is part of the records of the Office of Personnel Management (Office). (b) The Office...

SU-E-T-599: Patient Safety Enhancements Through a Study of R&V System Override Data

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

Hendrickson, K; Vimolchalao, S

2015-06-15

Purpose: Record and verify (R&V) software systems include safety checks that compare actual machine parameters with prescribed values for a patient’s treatment, such as treatment couch position, linac, energy, and MUs. The therapist is warned of a mismatch with a pop-up and prompted to approve an override in order to continue without changes. Override approval is often legitimate, but the pop-up can also genuinely indicate a problem that would Result in the wrong treatment. When there are numerous pop-up warnings, human nature leads us to approve any override without careful reading, undermining the effectiveness of the safety mechanism. Methods: Overridemore » data was collected from our R&V system for all patients treated between October 8 and 29, 2012, on four linacs and entered into a spreadsheet. Additional data collected included treatment technique, disease site, immobilization, time, linac, and whether localization images were obtained. Data were analyzed using spreadsheet tools to reveal trends, patterns and associations that might suggest appropriate process changes that could decrease the total number of overrides. Results: 76 out of 113 patients had overrides. Out of the 944 treatments, 599 override items were generated. The majority were due to couch positions. 74 of the 84 overrides on a linac equipped with a 6D couch were due to the use of the rotational corrections and the fact that the 6D couch control does not communicate with the R&V system; translations required to rotate the couch appear to the R&V system as translations outside the tolerance range. Conclusion: Many findings were interesting but did not suggest a process change. Proposed process changes include creating site-specific instead of just technique-specific tolerance tables for couch shifts. Proposed improvements to the vendor are to facilitate direct communication between the 6D couch and the R&V system to eliminate those override warnings related to lack of communication.« less

Evaluation of application for approval of alternative methodology for compliance with the NESHAP for shipbuilding and ship repair and recommended requirements for compliance (application submitted by Metro Machine Corporation, Norfolk, Virginia). Final report

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

Serageldin, M.A.

1999-07-01

The US Environmental Protection Agency is providing background information that supports the use of Metro Machine Corporation`s (MMC) compliant all position enclosure (CAPE) plus air management system and regenerative thermal oxidizer (RTO) (CAPE + RTO System) as an alternative means of limiting the emissions of volatile organic hazardous air pollutants per volume of applied solids (nonvolatiles). This document also explains how the authors arrived at the operating, recordkeeping, and reporting conditions that MMC must meet for approval. The add-on control system they used consists of a pollution capture unit operation (CAPE) plus air management system and a destruction unit operationmore » (RTO). When operated according to the specified procedures, it will control emissions to a level no greater than that from using coatings which comply with the limits in Table 2 of 40 CFR Part 63, Subpart II.« less

75 FR 79085 - Notice and Request for Comments on the Clarification of the Fireworks Approvals Policy

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-17

...., Washington, DC 20590. Background The pyrotechnic industry is a global logistics supply chain comprised of... position in the supply chain. It is unclear as to what was the justification for this action. Regardless... Docket Management System (FDMS), including any personal information. Docket: For access to the dockets to...

40 CFR 141.402 - Ground water source microbial monitoring and analytical methods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... approves the use of E. coli as a fecal indicator for source water monitoring under this paragraph (a). If the repeat sample collected from the ground water source is E.coli positive, the system must comply... listed in the in paragraph (c)(2) of this section for the presence of E. coli, enterococci, or coliphage...

Perceived and desired facilitativeness of one's closest friend, need for approval and self-esteem.

PubMed

Cramer, D

1993-03-01

The hypothesis that the positive association between self-esteem and the perceived facilitativeness of one's closest friend can be explained by the presumed greater desire of low self-esteem individuals for a facilitative relationship was not confirmed in 262 16-17-year-old females, who completed the Rosenberg (1965) Self-Esteem Scale and a shortened version of the Barrett-Lennard (1964) Relationship Inventory. Although desired facilitativeness correlated significantly positively with self-esteem, the correlation between perceived facilitativeness and self-esteem remained significantly positive when desired facilitativeness was partialled out. The further prediction that the correlation between perceived facilitativeness and self-esteem would be more positive for those scoring higher on the Jones' (1969) Need for Approval Scale was also not confirmed. The opposite result was obtained in that this correlation was significantly positive for those with low need for approval but not for those with a high need.

Use of Placebo in Clinical Trials of Psychotropic Medication.

PubMed

Hasnain, Mehrul; Rudnick, Abraham; Bonnell, Weldon S; Remington, Gary; Lam, Raymond W

2018-05-01

This position paper has been substantially revised by the Canadian Psychiatric Association's Research Committee and approved for republication by the CPA's Board of Directors on March 31, 2017. The original position paper 1 was developed by the Scientific and Research Council and approved by the Board of Directors on October 4, 1996.

46 CFR 162.060-16 - Changes to an approved ballast water management system (BWMS).

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Changes to an approved ballast water management system...) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Ballast Water Management Systems § 162.060-16 Changes to an approved ballast water management system (BWMS). (a) The...

46 CFR 162.060-16 - Changes to an approved ballast water management system (BWMS).

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Changes to an approved ballast water management system...) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Ballast Water Management Systems § 162.060-16 Changes to an approved ballast water management system (BWMS). (a) The...

Parental Antecedents of Need for Approval: A Longitudinal Study.

ERIC Educational Resources Information Center

Lobel, Thalma E.

1982-01-01

Examined antecedents of two components of need for approval (the approach component and the avoidance component) on a longitudinal basis. For females, need for approval was positively related to mothers' withdrawal of love and the avoidance component was negatively related to mothers' encouragement of their daughters to fight back. (Author)

Insight into drug resistance mechanisms and discovery of potential inhibitors against wild-type and L1196M mutant ALK from FDA-approved drugs.

PubMed

Li, Jianzong; Liu, Wei; Luo, Hao; Bao, Jinku

2016-09-01

Anaplastic lymphoma kinase (ALK) plays a crucial role in multiple malignant cancers. It is known as a well-established target for the treatment of ALK-dependent cancers. Even though substantial efforts have been made to develop ALK inhibitors, only crizotinib, ceritinib, and alectinib had been approved by the U.S. Food and Drug Administration for patients with ALK-positive non-small cell lung cancer (NSCLC). The secondary mutations with drug-resistance bring up difficulties to develop effective drugs for ALK-positive cancers. To give a comprehensive understanding of molecular mechanism underlying inhibitor response to ALK tyrosine kinase mutations, we established an accurate assessment for the extensive profile of drug against ALK mutations by means of computational approaches. The molecular mechanics-generalized Born surface area (MM-GBSA) method based on molecular dynamics (MD) simulation was carried out to calculate relative binding free energies for receptor-drug systems. In addition, the structure-based virtual screening was utilized to screen effective inhibitors targeting wild-type ALK and the gatekeeper mutation L1196M from 3180 approved drugs. Finally, the mechanism of drug resistance was discussed, several novel potential wild-type and L1196M mutant ALK inhibitors were successfully identified.

Systems pharmacology augments drug safety surveillance

PubMed Central

Lorberbaum, Tal; Nasir, Mavra; Keiser, Michael J.; Vilar, Santiago; Hripcsak, George; Tatonetti, Nicholas P.

2014-01-01

Small molecule drugs are the foundation of modern medical practice yet their use is limited by the onset of unexpected and severe adverse events (AEs). Regulatory agencies rely on post-marketing surveillance to monitor safety once drugs are approved for clinical use. Despite advances in pharmacovigilance methods that address issues of confounding bias, clinical data of AEs are inherently noisy. Systems pharmacology– the integration of systems biology and chemical genomics – can illuminate drug mechanisms of action. We hypothesize that these data can improve drug safety surveillance by highlighting drugs with a mechanistic connection to the target phenotype (enriching true positives) and filtering those that do not (depleting false positives). We present an algorithm, the modular assembly of drug safety subnetworks (MADSS), to combine systems pharmacology and pharmacovigilance data and significantly improve drug safety monitoring for four clinically relevant adverse drug reactions. PMID:25670520

Ordinal Position, Approval Motivation, and Interpersonal Attraction

ERIC Educational Resources Information Center

Nowicki, Stephen, Jr.

1971-01-01

Results of the study suggest that birth-order effects might be included within the wider framework of approval-dependency theory. Females tend to account for a significant share of birth-order effects. More particularly, firstborn females accounted for much of the differences in expressed attraction as well as need for social approval. (Author)

30 CFR 77.803-2 - Ground check systems not employing pilot check wires; approval by the Secretary.

Code of Federal Regulations, 2011 CFR

2011-07-01

... wires; approval by the Secretary. 77.803-2 Section 77.803-2 Mineral Resources MINE SAFETY AND HEALTH... check systems not employing pilot check wires; approval by the Secretary. Ground check systems not employing pilot check wires shall be approved by the Secretary only if it is determined that the system...

30 CFR 77.803-2 - Ground check systems not employing pilot check wires; approval by the Secretary.

Code of Federal Regulations, 2010 CFR

2010-07-01

... wires; approval by the Secretary. 77.803-2 Section 77.803-2 Mineral Resources MINE SAFETY AND HEALTH... check systems not employing pilot check wires; approval by the Secretary. Ground check systems not employing pilot check wires shall be approved by the Secretary only if it is determined that the system...

30 CFR 77.803-2 - Ground check systems not employing pilot check wires; approval by the Secretary.

Code of Federal Regulations, 2013 CFR

2013-07-01

... wires; approval by the Secretary. 77.803-2 Section 77.803-2 Mineral Resources MINE SAFETY AND HEALTH... check systems not employing pilot check wires; approval by the Secretary. Ground check systems not employing pilot check wires shall be approved by the Secretary only if it is determined that the system...

30 CFR 77.803-2 - Ground check systems not employing pilot check wires; approval by the Secretary.

Code of Federal Regulations, 2014 CFR

2014-07-01

... wires; approval by the Secretary. 77.803-2 Section 77.803-2 Mineral Resources MINE SAFETY AND HEALTH... check systems not employing pilot check wires; approval by the Secretary. Ground check systems not employing pilot check wires shall be approved by the Secretary only if it is determined that the system...

30 CFR 77.803-2 - Ground check systems not employing pilot check wires; approval by the Secretary.

Code of Federal Regulations, 2012 CFR

2012-07-01

... wires; approval by the Secretary. 77.803-2 Section 77.803-2 Mineral Resources MINE SAFETY AND HEALTH... check systems not employing pilot check wires; approval by the Secretary. Ground check systems not employing pilot check wires shall be approved by the Secretary only if it is determined that the system...

Investor Outlook: Rising from the Ashes; GSK's European Approval of Strimvelis for ADA-SCID.

PubMed

Schimmer, Joshua; Breazzano, Steven

2016-06-01

GlaxoSmithKline's (GSK) and partner San Raffaele Telethon Institute for Gene Therapy's recent positive European approval for Strimvelis for treatment of severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID) represents the second EU-approved gene therapy and the first γ-retrovirus and first ex vivo gene therapy. In this article we discuss the significance and implications of this historic approval for the broader gene therapy field.

Medical Device Plug-and-Play Interoperability Standards & Technology Leadership

DTIC Science & Technology

2011-10-01

official Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved...biomedical engineering students completed their senior design project on the X-Ray / Ventilator Use Case. We worked closely with the students to...Supporting Medical Device Adverse Event Analysis in an Interoperable Clinical Environment: Design of a Data Logging and Playback System,” Publication in

9 CFR 146.13 - Testing.

Code of Federal Regulations, 2012 CFR

2012-01-01

...) Enzyme-linked immunosorbent assay (ELISA). ELISA must be conducted using test kits approved by the... conducted on all ELISA-positive samples. (B) The AGID test must be conducted using reagents approved by the...

9 CFR 146.13 - Testing.

Code of Federal Regulations, 2013 CFR

2013-01-01

...) Enzyme-linked immunosorbent assay (ELISA). ELISA must be conducted using test kits approved by the... conducted on all ELISA-positive samples. (B) The AGID test must be conducted using reagents approved by the...

9 CFR 146.13 - Testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) Enzyme-linked immunosorbent assay (ELISA). ELISA must be conducted using test kits approved by the... conducted on all ELISA-positive samples. (B) The AGID test must be conducted using reagents approved by the...

9 CFR 146.13 - Testing.

Code of Federal Regulations, 2014 CFR

2014-01-01

...) Enzyme-linked immunosorbent assay (ELISA). ELISA must be conducted using test kits approved by the... conducted on all ELISA-positive samples. (B) The AGID test must be conducted using reagents approved by the...

9 CFR 146.13 - Testing.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) Enzyme-linked immunosorbent assay (ELISA). ELISA must be conducted using test kits approved by the... conducted on all ELISA-positive samples. (B) The AGID test must be conducted using reagents approved by the...

42 CFR 433.117 - Initial approval of replacement systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... and Information Retrieval Systems § 433.117 Initial approval of replacement systems. (a) A replacement system must meet all conditions of initial approval of a mechanized claims processing and information retrieval system. (b) The agency must submit a APD that includes— (1) The date the replacement system will...

Design Validation Methodology Development for an Aircraft Sensor Deployment System

NASA Astrophysics Data System (ADS)

Wowczuk, Zenovy S.

The OCULUS 1.0 Sensor Deployment concept design, was developed in 2004 at West Virginia University (WVU), outlined the general concept of a deployment system to be used on a C-130 aircraft. As a sequel, a new system, OCULUS 1.1, has been developed and designed. The new system transfers the concept system design to a safety of flight design, and also enhanced to a pre-production system to be used as the test bed to gain full military certification approval. The OCULUS 1.1 system has an implemented standard deployment system/procedure to go along with a design suited for military certification and implementation. This design process included analysis of the system's critical components and the generation of a critical component holistic model to be used as an analysis tool for future payload modification made to the system. Following the completion of the OCULUS 1.1 design, preparations and procedures for obtaining military airworthiness certification are described. The airworthiness process includes working with the agency overseeing all modifications to the normal operating procedures made to military C-130 aircraft and preparing the system for an experimental flight test. The critical steps in his process include developing a complete documentation package that details the analysis performed on the OCULUS 1.1 system and also the design of experiment flight test plan to analyze the system. Following the approval of the documentation and design of experiment an experimental flight test of the OCULUS 1.1 system was performed to verify the safety and airworthiness of the system. This test proved successfully that the OCULUS 1.1 system design was airworthy and approved for military use. The OCULUS 1.1 deployment system offers an open architecture design that is ideal for use as a sensor testing platform for developmental airborne sensors. The system's patented deployment methodology presents a simplistic approach to reaching the systems final operating position which offers the most robust field of view area of rear ramp deployment systems.

75 FR 69150 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... Process in Providing Trustee Access to the Security Position Report Service November 4, 2010. I.... The current review process to approve a trustee's access to the SPR service for a security is done... a trustee's access to DTC's SPR service for an issue with an automated approval process, DTC will be...

Biosimilars: Primer for the Health-System Pharmacist

PubMed Central

Lucio, Steven D.; Stevenson, James G.; Hoffman, James M.

2014-01-01

Purpose Basic information pharmacists and other clinicians must know to successfully manage the introduction of biosimilars into health systems is summarized, including manufacturing, regulatory, and medication use policy concepts. Summary Under development for more than a decade, the biosimilar market in the United States is now closer to becoming a reality than ever before. Legislation granting the Food and Drug Administration (FDA) authority to approve lower cost, follow-on versions of previously approved biologics was signed into law in March 2010. Additional draft guidance further clarifying the requirements of the biosimilars approval pathway was published in February 2012, and FDA is currently conducting multiple preparatory meetings with potential biosimilar applicants. While intended to occupy a position similar to that of small molecule generics, biosimilars will present new challenges given that biologic medications are manufactured, regulated, and marketed differently from small molecules. As a result, it is critically important for pharmacists to be knowledgeable on the unique characteristics of biologics and prepare their organizations for the introduction of biosimilars, including use of the formulary system.. Biosimilars will pose questions of medication use policy around therapeutic interchange, pharmacovigilance, and in the transitions of care for health system patients. Conclusion As stewards of appropriate medication use, pharmacists must take the initiative to educate themselves, physicians, other clinicians and patients on these products to ensure an accurate understanding of this new category of drugs and to assure the safe and optimal use of biosimilars. PMID:24173009

48 CFR 32.409-1 - Recommendation for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Recommendation for approval. 32.409-1 Section 32.409-1 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... Recommendation for approval. If recommending approval, the contracting officer shall transmit the following...

30 CFR 75.803-2 - Ground check systems not employing pilot check wires; approval by the Secretary.

Code of Federal Regulations, 2011 CFR

2011-07-01

... wires; approval by the Secretary. 75.803-2 Section 75.803-2 Mineral Resources MINE SAFETY AND HEALTH... Underground High-Voltage Distribution § 75.803-2 Ground check systems not employing pilot check wires; approval by the Secretary. Ground check systems not employing pilot check wires will be approved only if it...

30 CFR 75.803-2 - Ground check systems not employing pilot check wires; approval by the Secretary.

Code of Federal Regulations, 2010 CFR

2010-07-01

... wires; approval by the Secretary. 75.803-2 Section 75.803-2 Mineral Resources MINE SAFETY AND HEALTH... Underground High-Voltage Distribution § 75.803-2 Ground check systems not employing pilot check wires; approval by the Secretary. Ground check systems not employing pilot check wires will be approved only if it...

30 CFR 75.803-2 - Ground check systems not employing pilot check wires; approval by the Secretary.

Code of Federal Regulations, 2012 CFR

2012-07-01

... wires; approval by the Secretary. 75.803-2 Section 75.803-2 Mineral Resources MINE SAFETY AND HEALTH... Underground High-Voltage Distribution § 75.803-2 Ground check systems not employing pilot check wires; approval by the Secretary. Ground check systems not employing pilot check wires will be approved only if it...

30 CFR 75.803-2 - Ground check systems not employing pilot check wires; approval by the Secretary.

Code of Federal Regulations, 2013 CFR

2013-07-01

... wires; approval by the Secretary. 75.803-2 Section 75.803-2 Mineral Resources MINE SAFETY AND HEALTH... Underground High-Voltage Distribution § 75.803-2 Ground check systems not employing pilot check wires; approval by the Secretary. Ground check systems not employing pilot check wires will be approved only if it...

30 CFR 75.803-2 - Ground check systems not employing pilot check wires; approval by the Secretary.

Code of Federal Regulations, 2014 CFR

2014-07-01

... wires; approval by the Secretary. 75.803-2 Section 75.803-2 Mineral Resources MINE SAFETY AND HEALTH... Underground High-Voltage Distribution § 75.803-2 Ground check systems not employing pilot check wires; approval by the Secretary. Ground check systems not employing pilot check wires will be approved only if it...

Spanish Defense Policy under the Socialist Government 1982-1990

DTIC Science & Technology

1990-12-01

despite the opposition of many party members. The result was publication of the document, Paz y Seguridad en Espaha, approved by the executive...of reduction in retirement ages, a merit promotion system, and the professional en - hancement of personnel; and it failed to reorganize the armed...his position from foreign criticism. He would often emphasize 13Narcfs Serra, " La Polftica Espaftola de Defensa", Revista Espafiola de

Development of the Integrated Info Tech System

DTIC Science & Technology

2006-01-01

automated data gathering John Schaefer, MD Q&A LUNCH- Military Medicine Simulation Working Group (Open session, bring buffet lunch into designated ...Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No... designed to not only demonstrate the utility ofWSI as a technology, but also to show that WSI can be used reliably in the real-world, clinical environment

75 FR 69665 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-15

... FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval... approval of proposed information collection by the Board of Governors of the Federal Reserve System (Board... the Public). Board-approved collections of information are incorporated into the official OMB...

75 FR 72664 - System Personnel Training Reliability Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-26

...Under section 215 of the Federal Power Act, the Commission approves two Personnel Performance, Training and Qualifications (PER) Reliability Standards, PER-004-2 (Reliability Coordination--Staffing) and PER-005-1 (System Personnel Training), submitted to the Commission for approval by the North American Electric Reliability Corporation, the Electric Reliability Organization certified by the Commission. The approved Reliability Standards require reliability coordinators, balancing authorities, and transmission operators to establish a training program for their system operators, verify each of their system operators' capability to perform tasks, and provide emergency operations training to every system operator. The Commission also approves NERC's proposal to retire two existing PER Reliability Standards that are replaced by the standards approved in this Final Rule.

75 FR 38096 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-01

... FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval... approval of a proposed information collection by the Board of Governors of the Federal Reserve System... Burdens on the Public). Board-approved collections of information are incorporated into the official OMB...

46 CFR 199.261 - Survival craft.

Code of Federal Regulations, 2013 CFR

2013-10-01

... a SOLAS A pack. (3) Each rigid liferaft must be approved under approval series 160.118 and be... or more. (5) Each marine evacuation system must be approved under approval series 160.175. (b) Each... least one side of the vessel being served by launching appliances or marine evacuation systems. (d...

46 CFR 199.261 - Survival craft.

Code of Federal Regulations, 2014 CFR

2014-10-01

... a SOLAS A pack. (3) Each rigid liferaft must be approved under approval series 160.118 and be... or more. (5) Each marine evacuation system must be approved under approval series 160.175. (b) Each... least one side of the vessel being served by launching appliances or marine evacuation systems. (d...

46 CFR 199.261 - Survival craft.

Code of Federal Regulations, 2012 CFR

2012-10-01

... a SOLAS A pack. (3) Each rigid liferaft must be approved under approval series 160.118 and be... or more. (5) Each marine evacuation system must be approved under approval series 160.175. (b) Each... least one side of the vessel being served by launching appliances or marine evacuation systems. (d...

46 CFR 199.261 - Survival craft.

Code of Federal Regulations, 2011 CFR

2011-10-01

... a SOLAS A pack. (3) Each rigid liferaft must be approved under approval series 160.118 and be... or more. (5) Each marine evacuation system must be approved under approval series 160.175. (b) Each... least one side of the vessel being served by launching appliances or marine evacuation systems. (d...

49 CFR 1544.231 - Airport-approved and exclusive area personnel identification systems.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 9 2012-10-01 2012-10-01 false Airport-approved and exclusive area personnel... AIRCRAFT OPERATOR SECURITY: AIR CARRIERS AND COMMERCIAL OPERATORS Operations § 1544.231 Airport-approved... carry out a personnel identification system for identification media that are airport-approved, or...

49 CFR 1544.231 - Airport-approved and exclusive area personnel identification systems.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 9 2011-10-01 2011-10-01 false Airport-approved and exclusive area personnel... AIRCRAFT OPERATOR SECURITY: AIR CARRIERS AND COMMERCIAL OPERATORS Operations § 1544.231 Airport-approved... carry out a personnel identification system for identification media that are airport-approved, or...

49 CFR 1544.231 - Airport-approved and exclusive area personnel identification systems.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 9 2014-10-01 2014-10-01 false Airport-approved and exclusive area personnel... AIRCRAFT OPERATOR SECURITY: AIR CARRIERS AND COMMERCIAL OPERATORS Operations § 1544.231 Airport-approved... carry out a personnel identification system for identification media that are airport-approved, or...

Self-Aligned, Extremely High Frequency III-V Metal-Oxide-Semiconductor Field-Effect Transistors on Rigid and Flexible Substrates

DTIC Science & Technology

2012-06-29

resistances, respectively, and gd is the output conductance. The reduced parasitic capacitances and resistances provided by the self-aligned T-gate design ...Department of the Army position, policy or decision, unless so designated by other documentation. 12. DISTRIBUTION AVAILIBILITY STATEMENT Approved for...position, policy or decision, unless so designated by other documentation. Approved for public release; distribution is unlimited. ... 59654.5-MS-DRP Self

77 FR 69504 - Agency Information Collection Activities; Emergency Reinstatement of Previously Approved Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-19

... MERIT SYSTEMS PROTECTION BOARD Agency Information Collection Activities; Emergency Reinstatement of Previously Approved Collection AGENCY: Merit Systems Protection Board. ACTION: Notice of emergency reinstatement. SUMMARY: The Merit Systems Protection Board (MSPB) is requesting approval from the Office of...

Spectral Characterization of RDX, ETN, PETN, TATP, HMTD, HMX, and C-4 in the Mid-Infrared Region

DTIC Science & Technology

2014-04-01

Samuels Joseph A. Domanico Joseph May Ronald W. Miles, Jr. Augustus W. Fountain III RESEARCH AND TECHNOLOGY DIRECTORATE April 2014 Approved for public ...position unless so designated by other authorizing documents. REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188 Public reporting...AVAILABILITY STATEMENT Approved for public release; distribution is unlimited. 13. SUPPLEMENTARY NOTES *Science Applications International Corporation

23 CFR 810.308 - Approval of urban system nonhighway public mass transit projects.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 23 Highways 1 2011-04-01 2011-04-01 false Approval of urban system nonhighway public mass transit... PUBLIC TRANSPORTATION MASS TRANSIT AND SPECIAL USE HIGHWAY PROJECTS Federal-Aid Urban System Nonhighway Public Mass Transit Projects § 810.308 Approval of urban system nonhighway public mass transit projects...

40 CFR 35.928-1 - Approval of the industrial cost recovery system.

Code of Federal Regulations, 2013 CFR

2013-07-01

... recovery system. 35.928-1 Section 35.928-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GRANTS...-Clean Water Act § 35.928-1 Approval of the industrial cost recovery system. The Regional Administrator may approve an industrial cost recovery system if it meets the following requirements: (a) General...

40 CFR 35.928-1 - Approval of the industrial cost recovery system.

Code of Federal Regulations, 2014 CFR

2014-07-01

... recovery system. 35.928-1 Section 35.928-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GRANTS...-Clean Water Act § 35.928-1 Approval of the industrial cost recovery system. The Regional Administrator may approve an industrial cost recovery system if it meets the following requirements: (a) General...

40 CFR 35.928-1 - Approval of the industrial cost recovery system.

Code of Federal Regulations, 2012 CFR

2012-07-01

... recovery system. 35.928-1 Section 35.928-1 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GRANTS...-Clean Water Act § 35.928-1 Approval of the industrial cost recovery system. The Regional Administrator may approve an industrial cost recovery system if it meets the following requirements: (a) General...

78 FR 59754 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-27

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... of a signal system. FRA assigned the petition Docket Number FRA-2013-0095. Applicant: Grenada Railway... seeks approval of the proposed discontinuance and removal of the automatic block signal (ABS) system...

78 FR 14874 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-07

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... of a signal system. FRA assigned the petition Docket Number FRA-2013-0017. Applicant: Norfolk..., Georgia 30309. NS seeks approval of the proposed temporary discontinuance of the signal system at the...

77 FR 9296 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-16

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... or modification of a signal system. FRA assigned the petition Docket Number FRA-2012-0012. UP seeks approval of the proposed discontinuance of the automatic block signal (ABS) system between Control Point...

78 FR 37656 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-21

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... of a signal system. FRA assigned the petition Docket Number FRA-2013-0059. Applicant: Long Island... approval of the proposed modification of the railroad signal interlocking systems at DB & Cabin M...

30 CFR 77.902-2 - Approved ground check systems not employing pilot check wires.

Code of Federal Regulations, 2010 CFR

2010-07-01

... pilot check wires. 77.902-2 Section 77.902-2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... Approved ground check systems not employing pilot check wires. Ground check systems not employing pilot check wires shall be approved by the Secretary only after it has been determined that the system...

30 CFR 77.902-2 - Approved ground check systems not employing pilot check wires.

Code of Federal Regulations, 2011 CFR

2011-07-01

... pilot check wires. 77.902-2 Section 77.902-2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... Approved ground check systems not employing pilot check wires. Ground check systems not employing pilot check wires shall be approved by the Secretary only after it has been determined that the system...

30 CFR 77.902-2 - Approved ground check systems not employing pilot check wires.

Code of Federal Regulations, 2012 CFR

2012-07-01

... pilot check wires. 77.902-2 Section 77.902-2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... Approved ground check systems not employing pilot check wires. Ground check systems not employing pilot check wires shall be approved by the Secretary only after it has been determined that the system...

30 CFR 77.902-2 - Approved ground check systems not employing pilot check wires.

Code of Federal Regulations, 2013 CFR

2013-07-01

... pilot check wires. 77.902-2 Section 77.902-2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... Approved ground check systems not employing pilot check wires. Ground check systems not employing pilot check wires shall be approved by the Secretary only after it has been determined that the system...

30 CFR 77.902-2 - Approved ground check systems not employing pilot check wires.

Code of Federal Regulations, 2014 CFR

2014-07-01

... pilot check wires. 77.902-2 Section 77.902-2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... Approved ground check systems not employing pilot check wires. Ground check systems not employing pilot check wires shall be approved by the Secretary only after it has been determined that the system...

42 CFR 84.33 - Approval labels and markings; approval of contents; use.

Code of Federal Regulations, 2011 CFR

2011-10-01

... position on the harness, container, canister, cartridge, filter, or other component, together with... Respirator container and filter container. Abbreviated Filters. Chemical-cartridge respirator Entire Respirator container, cartridge container, and filter containers (where applicable). Abbreviated Cartridges...

42 CFR 84.33 - Approval labels and markings; approval of contents; use.

Code of Federal Regulations, 2014 CFR

2014-10-01

... position on the harness, container, canister, cartridge, filter, or other component, together with... Respirator container and filter container. Abbreviated Filters. Chemical-cartridge respirator Entire Respirator container, cartridge container, and filter containers (where applicable). Abbreviated Cartridges...

42 CFR 84.33 - Approval labels and markings; approval of contents; use.

Code of Federal Regulations, 2012 CFR

2012-10-01

... position on the harness, container, canister, cartridge, filter, or other component, together with... Respirator container and filter container. Abbreviated Filters. Chemical-cartridge respirator Entire Respirator container, cartridge container, and filter containers (where applicable). Abbreviated Cartridges...

42 CFR 84.33 - Approval labels and markings; approval of contents; use.

Code of Federal Regulations, 2013 CFR

2013-10-01

... position on the harness, container, canister, cartridge, filter, or other component, together with... Respirator container and filter container. Abbreviated Filters. Chemical-cartridge respirator Entire Respirator container, cartridge container, and filter containers (where applicable). Abbreviated Cartridges...

42 CFR 84.33 - Approval labels and markings; approval of contents; use.

Code of Federal Regulations, 2010 CFR

2010-10-01

... position on the harness, container, canister, cartridge, filter, or other component, together with... Respirator container and filter container. Abbreviated Filters. Chemical-cartridge respirator Entire Respirator container, cartridge container, and filter containers (where applicable). Abbreviated Cartridges...

A Systems Architecture and Advanced Sensors Application for Real-Time Aircraft Structural Health Monitoring

DTIC Science & Technology

2011-03-01

DEPARTMENT OF THE AIR FORCE AIR UNIVERSITY AIR FORCE INSTITUTE OF TECHNOLOGY Wright-Patterson Air Force Base, Ohio APPROVED FOR PUBLIC RELEASE...position of the United States Air Force, Department of Defense, or the United States Government. This material is declared a work of the United...Management Graduate School of Engineering and Management Air Force Institute of Technology Air University Air Education and Training Command In

Space nuclear power: Key to outer solar system exploration

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

Bennett, G.L.; Allen, D.M.

1998-07-01

In 1995, in response to threatened budget cuts, the American Institute of Aeronautics and Astronautics (AIAA) approved a position paper supporting the maintenance of the technology base for space nuclear power. The position paper contained four recomemndations: (1) DOE, NASA, and DoD should develop and support an integrated program that maintains the nuclear option and develops the needed high-payoff technologies; (2) Congress should provide strong, continuing financial and political support for the agencies' program; (3) Government and industry leaders should voice their advocacy for a strong space nuclear power program to support future system requirements; and (4) The US shouldmore » continue to maintain its cooperation and technical interchanges with other countries to advance nuclear power source technology and to promote nuclear safety.« less

Approval of Modified Seating Systems Initially Approved Under A Technical Standard Order

DOT National Transportation Integrated Search

1997-06-03

The Advisory Circular (AC) provides information, clarification, and procedural : guidance concerning the approval and installation of modified Technical Standard : Order (TSO) seating systems in U.S. type certificated aircraft.

Functional neural correlates of social approval in schizophrenia

PubMed Central

Lepage, Martin

2016-01-01

Social approval is a reward that uses abstract social reinforcers to guide interpersonal interactions. Few studies have specifically explored social reward processing and its related neural substrates in schizophrenia. Fifteen patients with schizophrenia and fifteen healthy controls participated in a two-part study to explore the functional neural correlates of social approval. In the first session, participants were led to believe their personality would be assessed based on their results from various questionnaires and an interview. Participants were then presented with the results of their supposed evaluation in the scanner, while engaging in a relevant fMRI social approval task. Subjects provided subjective reports of pleasure associated with receiving self-directed positive or negative feedback. Higher activation of the right parietal lobe was found in controls compared with individuals with schizophrenia. Both groups rated traits from the high social reward condition as more pleasurable than the low social reward condition, while intergroup differences emerged in the low social reward condition. Positive correlations were found in patients only between subjective ratings of positive feedback and right insula activation, and a relevant behavioural measure. Evidence suggests potential neural substrates underlying the cognitive representation of social reputation in schizophrenia. PMID:26516171

A novel Web-based graduate medical education management system including ACGME compliance algorithms.

PubMed

Gauger, Paul G; Davis, Janice W; Orr, Peter J

2002-09-01

Administration of graduate medical education programs has become more difficult as compliance with ACGME work guidelines has assumed increased importance. These guidelines have caused many changes in the resident work environment, including the emergence of complicated cross-cover arrangements. Many participating residents (each with his or her own individual scheduling requirements) usually generate these schedules. Accordingly, schedules are often not submitted in a timely fashion and they may not be in compliance with the ACGME guidelines for maximum on-call assignments and mandatory days off. Our objective was the establishment of a Web-based system that guides residents in creating on-call schedules that follow ACGME guidelines while still allowing maximum flexibility -- thus allowing each resident to maintain an internal locus of control. A versatile and scalable system with password-protected user (resident) and administrator interfaces was created. An entire academic year is included, and past months and years are automatically archived. The residents log on within the first 15 days of the preceding month and choose their positions in a schedule template. They then make adjustments while receiving immediate summary feedback on compliance with ACGME guidelines. The schedule is electronically submitted to the educational administrator for final approval. If a cross-cover system is required, the program automatically generates an optimal schedule using both of the approved participating service schedules. The residents then have an additional five-day period to make adjustments in the cross-cover schedule while still receiving compliance feedback. The administrator again provides final approval electronically. The communication interface automatically pages or e-mails the residents when schedules are updated or approved. Since the information exists in a relational database, simple reporting tools are included to extract the information necessary to generate records for institutional GME management. Implementation of this program has been met with great enthusiasm from the institutional stakeholders. Specifically, residents have embraced the ability to directly control their schedules and have gained appreciation for the regulatory matrix in which they function. Institutional administrators have praised the improvement in compliance and the ease of documentation. We anticipate that the system will also meet with approval from reviewing regulatory bodies, as it generates and stores accurate information about the resident work environment. This program is robust and versatile enough to be modified for any GME training program in the country.

77 FR 10621 - Changes to the In-Bond Process

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... submit in-bond applications electronically using a CBP-approved electronic data interchange (EDI) system... electronically submit the in-bond application to CBP via a CBP-approved EDI system. \\6\\ Due to the unique... as the CBP-approved EDI system for submitting the in-bond application and other information that is...

75 FR 6251 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-08

... Discontinuance or Modification of a Railroad Signal System or Relief From the Requirements of Title 49 Code of... approval for the discontinuance or modification of the signal system or relief from the requirements of 49... Company (BNSF) seeks approval of the proposed modification to the traffic control signal system over the...

78 FR 47822 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-06

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... approval for the discontinuance or modification of a signal system. FRA assigned the petition Docket Number... block signal (ABS) system on Main Line 1 and 2, from Milepost (MP) 1.2 Bliss to MP 7.3 Jay Interlocking...

78 FR 46679 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-01

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... of a signal system. FRA assigned the petition Docket Number FRA-2013-0073. Applicant: Norfolk..., Georgia 30309. NS seeks approval of the proposed discontinuance of automatic signals within traffic...

77 FR 74736 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-17

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... discontinuance or modification of a signal system. FRA assigned the petition docket number FRA-2012-0087... Street NE., Atlanta, Georgia 30309. NS seeks approval of the proposed discontinuance of automatic signals...

48 CFR 227.7107-3 - Approval of restricted designs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 3 2014-10-01 2014-10-01 false Approval of restricted designs. 227.7107-3 Section 227.7107-3 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Rights in Technical Data 227.7107-3 Approval of...

48 CFR 227.7107-3 - Approval of restricted designs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 3 2013-10-01 2013-10-01 false Approval of restricted designs. 227.7107-3 Section 227.7107-3 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE GENERAL CONTRACTING REQUIREMENTS PATENTS, DATA, AND COPYRIGHTS Rights in Technical Data 227.7107-3 Approval of...

44 CFR 6.52 - Approval of requests to amend records.

Code of Federal Regulations, 2010 CFR

2010-10-01

... § 6.52 Approval of requests to amend records. If the system manager determines that amendment of a... of disclosure has been maintained, the system manager shall advise all previous recipients of the..., the system manager shall advise the Privacy Appeals Officer that a request to amend has been approved. ...

Category (CAT) IIIb Level 1 Test Plan for Global Positioning System (GPS)

DTIC Science & Technology

1993-09-01

applications. CAT 11Tb is defined in Advisory Circular ( AC ) 120-28C [1] as "a precision instrument approach and landing with no decision height (DH), or...2) FAA AC 20-57A (Automatic Landing Systems) [31, AC 120-28C (Criteria for Approval of CAT III Landing Weather Minima) [I] and the FAA tunnel-in...AD-A274 098I I~II l~iiUIRII 11111ilIII2 DOT/FAA/RD-93/21 Category ( CAT ) IIb Level 1 MTR 93W0000102 Research and Test Plan for Global Development

Osimertinib: First Global Approval.

PubMed

Greig, Sarah L

2016-02-01

Osimertinib (Tagrisso(™), AZD9291) is an oral, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that is being developed by AstraZeneca for the treatment of advanced non-small cell lung cancer (NSCLC). Osimertinib has been designed to target the EGFR T790M mutation that is often present in NSCLC patients with acquired EGFR TKI resistance, while sparing wild-type EGFR. In November 2015, the tablet formulation of osimertinib was granted accelerated approval in the USA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC (as detected by an FDA-approved test) who have progressed on or after EGFR TKI therapy. Osimertinib has also been granted accelerated assessment status for this indication in the EU, and is in phase III development for first- and second-line and adjuvant treatment of advanced EGFR mutation-positive NSCLC in several countries. Phase I trials in patients with advanced solid tumours are also being conducted. This article summarizes the milestones in the development of osimertinib leading to this first approval for NSCLC.

The Possibility of Improved and Higher Tc Superconductors in Hybrid Systems

DTIC Science & Technology

2014-10-15

Approved for public release; distribution is unlimited. of the oxygen sub-lattice precisely in thin films and heterostrutures; which plays a pivotal role...to influence the structure-property affair in complex oxide thin films. We have focused our study to effectively control the oxygen position...that by varying precisely the thickness of SCO layers grown on SrTiO3, one can re-arrange the oxygen ions. In particular, we show that it is possible

78 FR 73456 - List of Approved Spent Fuel Storage Casks: HI-STORM 100 Cask System; Amendment No. 9

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-06

...-2012-0052] RIN 3150-AJ12 List of Approved Spent Fuel Storage Casks: HI-STORM 100 Cask System; Amendment... International HI-STORM 100 Cask System listing within the ``List of Approved Spent Fuel Storage Casks'' to... requirements for the HI-STORM 100U part of the HI-STORM 100 Cask System and updates the thermal model and...

33 CFR 149.421 - What is the requirement for a previously approved fire detection and alarm system on a deepwater...

Code of Federal Regulations, 2010 CFR

2010-07-01

... previously approved fire detection and alarm system on a deepwater port? 149.421 Section 149.421 Navigation... Requirements § 149.421 What is the requirement for a previously approved fire detection and alarm system on a deepwater port? An existing fire detection and alarm system on a deepwater port need not meet the...

33 CFR 149.421 - What is the requirement for a previously approved fire detection and alarm system on a deepwater...

Code of Federal Regulations, 2011 CFR

2011-07-01

... previously approved fire detection and alarm system on a deepwater port? 149.421 Section 149.421 Navigation... Requirements § 149.421 What is the requirement for a previously approved fire detection and alarm system on a deepwater port? An existing fire detection and alarm system on a deepwater port need not meet the...

33 CFR 149.421 - What is the requirement for a previously approved fire detection and alarm system on a deepwater...

Code of Federal Regulations, 2014 CFR

2014-07-01

... previously approved fire detection and alarm system on a deepwater port? 149.421 Section 149.421 Navigation... Requirements § 149.421 What is the requirement for a previously approved fire detection and alarm system on a deepwater port? An existing fire detection and alarm system on a deepwater port need not meet the...

33 CFR 149.421 - What is the requirement for a previously approved fire detection and alarm system on a deepwater...

Code of Federal Regulations, 2012 CFR

2012-07-01

... previously approved fire detection and alarm system on a deepwater port? 149.421 Section 149.421 Navigation... Requirements § 149.421 What is the requirement for a previously approved fire detection and alarm system on a deepwater port? An existing fire detection and alarm system on a deepwater port need not meet the...

33 CFR 149.421 - What is the requirement for a previously approved fire detection and alarm system on a deepwater...

Code of Federal Regulations, 2013 CFR

2013-07-01

... previously approved fire detection and alarm system on a deepwater port? 149.421 Section 149.421 Navigation... Requirements § 149.421 What is the requirement for a previously approved fire detection and alarm system on a deepwater port? An existing fire detection and alarm system on a deepwater port need not meet the...

40 CFR 35.935-13 - Submission and approval of user charge systems.

Code of Federal Regulations, 2010 CFR

2010-07-01

... approval of the Regional Administrator of its system of user charges. (See also § 35.929 et seq.) (a) Step... paragraph (a)(2) of this section provides, the grantee must obtain the Regional Administrator's approval of its system of user charges based on actual use which complies with § 35.929-1(a). The Regional...

75 FR 6252 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-08

... Discontinuance or Modification of a Railroad Signal System or Relief From the Requirements of Title 49 Code of... approval for the discontinuance or modification of the signal system or relief from the requirements of 49... Transportation, Inc. seeks approval of the proposed modification of the bridge tender controlled signals to...

78 FR 17282 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-20

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... approval from the Federal Railroad Administration (FRA) for the discontinuance or modification of a signal... modifications that it will make to the signal system at the A&R crossing in preparation for the installation of...

30 CFR 75.902-2 - Approved ground check systems not employing pilot check wires.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Approved ground check systems not employing pilot check wires. 75.902-2 Section 75.902-2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... employing pilot check wires. Ground check systems not employing pilot check wires will be approved only if...

30 CFR 75.902-2 - Approved ground check systems not employing pilot check wires.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved ground check systems not employing pilot check wires. 75.902-2 Section 75.902-2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... employing pilot check wires. Ground check systems not employing pilot check wires will be approved only if...

46 CFR 162.060-16 - Changes to an approved ballast water management system (BWMS).

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Changes to an approved ballast water management system (BWMS). 162.060-16 Section 162.060-16 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Ballast Water Management Systems § 162.060-16 Changes to...

77 FR 7558 - Withdrawal of Proposed Rule on Approval of Farm Credit System Lending Institutions in Federal...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

...-AI91 Withdrawal of Proposed Rule on Approval of Farm Credit System Lending Institutions in Federal... withdraws HUD's August 2011 rule that proposed to amend HUD's regulations to enable the direct lending... the direct lending institutions of the Farm Credit System to seek approval to participate in the FHA...

Generic solar photovoltaic system dynamic simulation model specification

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

Ellis, Abraham; Behnke, Michael Robert; Elliott, Ryan Thomas

This document is intended to serve as a specification for generic solar photovoltaic (PV) system positive-sequence dynamic models to be implemented by software developers and approved by the WECC MVWG for use in bulk system dynamic simulations in accordance with NERC MOD standards. Two specific dynamic models are included in the scope of this document. The first, a Central Station PV System model, is intended to capture the most important dynamic characteristics of large scale (> 10 MW) PV systems with a central Point of Interconnection (POI) at the transmission level. The second, a Distributed PV System model, is intendedmore » to represent an aggregation of smaller, distribution-connected systems that comprise a portion of a composite load that might be modeled at a transmission load bus.« less

48 CFR 2022.103-4 - Approvals.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Approvals. 2022.103-4 Section 2022.103-4 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION SOCIOECONOMIC PROGRAMS APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS Basic Labor Policies 2022.103-4 Approvals...

77 FR 21123 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-09

... unsettled positions in classes of securities such as illiquid municipal or corporate bonds, whose volatility... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66731; File No. SR-NSCC-2012-02] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change To...

Need for Social Approval: Impression Management or Self-Deception?

ERIC Educational Resources Information Center

Millham, Jim; Kellogg, Richard W.

1980-01-01

The self- and the other-deceptive components of social desirability responding were independent of each other, but positively and independently related to individual differences in need for approval score. Self-deceptive persons demonstrated diminished recall, while other-deceptive persons exhibited enhanced recall of negatively evaluative…

Delafloxacin: First Global Approval.

PubMed

Markham, Anthony

2017-09-01

Delafloxacin (Baxdela™) is a fluoroquinolone antibacterial with activity against both gram-positive and gram-negative pathogens being developed by Melinta Therapeutics. The drug is being investigated or considered as a treatment for various bacterial infections and in June 2017 received approval in the USA for the treatment of acute bacterial skin and skin structure infections. This article summarizes the milestones in the development of delafloxacin leading to this first global approval for the treatment of acute bacterial skin and skin structure infections.

Trastuzumab emtansine: first global approval.

PubMed

Ballantyne, Anita; Dhillon, Sohita

2013-05-01

Genentech and ImmunoGen are collaborating on the development of trastuzumab emtansine, a HER2 antibody-drug conjugate that comprises Genentech's trastuzumab antibody linked to ImmunoGen's anti-mitotic agent, mertansine (a maytansine derivative; also known as DM1). The conjugate combines two strategies: the anti-HER2 activity of trastuzumab, and the targeted intracellular delivery of mertansine, a tubulin polymerisation inhibitor which interferes with mitosis and promotes apoptosis. The linker in trastuzumab emtansine is a non-reducible thioether linker, N-succinimidyl-4-(N-maleimidomethyl) cyclohexane-1-carboxylate (SMCC, designated MCC after conjugation). Trastuzumab emtansine (Kadcyla™) has been launched in the USA as second-line monotherapy for HER2-positive metastatic breast cancer, and has been filed for approval in the EU and Japan in this indication. Trastuzumab emtansine is in phase III development as first-line combination therapy or monotherapy for metastatic HER2-positive breast cancer, and as third-line monotherapy for metastatic HER2-positive breast cancer. Phase II development is underway for early-stage breast cancer and phase II/III development is underway in patients with HER2-positive gastric cancer. This article summarizes the milestones in the development of trastuzumab emtansine leading to this first approval for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.

Targeted therapies in non-small cell lung cancer: a focus on ALK/ROS1 tyrosine kinase inhibitors.

PubMed

Sgambato, Assunta; Casaluce, Francesca; Maione, Paolo; Gridelli, Cesare

2018-01-01

Anaplastic lymphoma kinase (ALK) and ROS1 rearrangements define important molecular subgroups of advanced non-small cell lung cancer (NSCLC). The identification of these genetic driver alterations created new potential for highly active therapeutic interventions. After discovery of ALK rearrangements in NSCLC, it was recognized that these confer sensitivity to ALK inhibition. Areas covered: Crizotinib, the first-in-class ALK/ROS1/MET inhibitor, was initially approved as second-line treatment of ALK-positive advanced NSCLC but after this, it was firmly established as the standard first-line therapy for advanced ALK-positive NSCLC. After initial response to crizotinib, tumors inevitably relapse. Next-generation ALK inhibitors, more potent and brain-penetrable than crizotinib, may be effective in re-inducing remissions when cancers are still addicted to ALK. Ceritinib and alectinib are approved for metastatic ALK positive NSCLC patients, while brigatinib received granted accelerated approval by the United States Food and Drug Administration. Regarding ROS1 rearrangement, to date crizotinib is the only ALK-tyrosine kinase inhibitor receiving indication as treatment of ROS1 positive advanced NSCLC. Expert commentary: Although novel ALK-inhibitors are under clinical investigation compared to crizotinib as front-line treatment for ALK-positive NSCLC, nowadays the current standard first-line therapy for these patients is crizotinib. Further research will clarify the best management of ALK-positive NSCLC, above all who progress on first-line crizotinib.

49 CFR 236.1031 - Previously approved PTC systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Previously approved PTC systems. 236.1031 Section 236.1031 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD....1005 and 236.1007 and otherwise conform to this subpart. (d) Previous approval or recognition of a...

48 CFR 2822.103-4 - Approvals.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Approvals. 2822.103-4 Section 2822.103-4 Federal Acquisition Regulations System DEPARTMENT OF JUSTICE Socioeconomic Programs APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS Basic Labor Policies 2822.103-4 Approvals. The inclusion...

48 CFR 2922.103-4 - Approvals.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Approvals. 2922.103-4 Section 2922.103-4 Federal Acquisition Regulations System DEPARTMENT OF LABOR SOCIOECONOMIC PROGRAMS APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS Basic Labor Policies 2922.103-4 Approvals. The “agency...

48 CFR 6.304 - Approval of the justification.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Approval of the justification. 6.304 Section 6.304 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION ACQUISITION PLANNING COMPETITION REQUIREMENTS Other Than Full and Open Competition 6.304 Approval of the...

48 CFR 906.304 - Approval of the justification.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Approval of the justification. 906.304 Section 906.304 Federal Acquisition Regulations System DEPARTMENT OF ENERGY COMPETITION ACQUISITION PLANNING COMPETITION REQUIREMENTS Other Than Full and Open Competition 906.304 Approval of the...

Positions: MinnMATYC Position Statements.

ERIC Educational Resources Information Center

Minnesota Mathematical Association of Two Year Colleges.

Developed by the major committees of the Minnesota Mathematical Association of Two-Year Colleges (MinnMATYC) and approved by its Executive Board, these four position statements are intended to guide discussion and influence decisions affecting mathematics in Minnesota's two-year colleges. The first position statement suggests that the prerequisite…

42 CFR 433.117 - Initial approval of replacement systems.

Code of Federal Regulations, 2011 CFR

2011-10-01

... and Information Retrieval Systems § 433.117 Initial approval of replacement systems. (a) A replacement... information retrieval system. (b) The agency must submit a APD that includes— (1) The date the replacement...

42 CFR 433.117 - Initial approval of replacement systems.

Code of Federal Regulations, 2012 CFR

2012-10-01

... and Information Retrieval Systems § 433.117 Initial approval of replacement systems. (a) A replacement... information retrieval system. (b) The agency must submit a APD that includes— (1) The date the replacement...

42 CFR 433.117 - Initial approval of replacement systems.

Code of Federal Regulations, 2013 CFR

2013-10-01

... and Information Retrieval Systems § 433.117 Initial approval of replacement systems. (a) A replacement... information retrieval system. (b) The agency must submit a APD that includes— (1) The date the replacement...

42 CFR 433.117 - Initial approval of replacement systems.

Code of Federal Regulations, 2014 CFR

2014-10-01

... and Information Retrieval Systems § 433.117 Initial approval of replacement systems. (a) A replacement... information retrieval system. (b) The agency must submit a APD that includes— (1) The date the replacement...

23 CFR 645.119 - Alternate procedure.

Code of Federal Regulations, 2011 CFR

2011-04-01

... section, the STD is to act in the relative position of the FHWA for reviewing and approving the... prerequisites for authorizing the utility to proceed with and complete the work. (b) The scope of the STD's... alternate procedure, the STD must file a formal application for approval by the FHWA. The application must...

23 CFR 645.119 - Alternate procedure.

Code of Federal Regulations, 2014 CFR

2014-04-01

... section, the STD is to act in the relative position of the FHWA for reviewing and approving the... prerequisites for authorizing the utility to proceed with and complete the work. (b) The scope of the STD's... alternate procedure, the STD must file a formal application for approval by the FHWA. The application must...

23 CFR 645.119 - Alternate procedure.

Code of Federal Regulations, 2010 CFR

2010-04-01

... section, the STD is to act in the relative position of the FHWA for reviewing and approving the... prerequisites for authorizing the utility to proceed with and complete the work. (b) The scope of the STD's... alternate procedure, the STD must file a formal application for approval by the FHWA. The application must...

23 CFR 645.119 - Alternate procedure.

Code of Federal Regulations, 2013 CFR

2013-04-01

... section, the STD is to act in the relative position of the FHWA for reviewing and approving the... prerequisites for authorizing the utility to proceed with and complete the work. (b) The scope of the STD's... alternate procedure, the STD must file a formal application for approval by the FHWA. The application must...

23 CFR 645.119 - Alternate procedure.

Code of Federal Regulations, 2012 CFR

2012-04-01

... section, the STD is to act in the relative position of the FHWA for reviewing and approving the... prerequisites for authorizing the utility to proceed with and complete the work. (b) The scope of the STD's... alternate procedure, the STD must file a formal application for approval by the FHWA. The application must...

7 CFR 1700.53 - Persons serving as Acting Administrator.

Code of Federal Regulations, 2012 CFR

2012-01-01

...) Eligibility for succession to the position of RUS Administrator shall be limited to officially assigned... the approved order of succession are eligible. Persons appointed on acting basis, or on some other... succession would fall to the next designated official in the approved order of succession. The eligibility of...

7 CFR 1700.53 - Persons serving as Acting Administrator.

Code of Federal Regulations, 2013 CFR

2013-01-01

...) Eligibility for succession to the position of RUS Administrator shall be limited to officially assigned... the approved order of succession are eligible. Persons appointed on acting basis, or on some other... succession would fall to the next designated official in the approved order of succession. The eligibility of...

7 CFR 1700.53 - Persons serving as Acting Administrator.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) Eligibility for succession to the position of RUS Administrator shall be limited to officially assigned... the approved order of succession are eligible. Persons appointed on acting basis, or on some other... succession would fall to the next designated official in the approved order of succession. The eligibility of...

7 CFR 1700.53 - Persons serving as Acting Administrator.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) Eligibility for succession to the position of RUS Administrator shall be limited to officially assigned... the approved order of succession are eligible. Persons appointed on acting basis, or on some other... succession would fall to the next designated official in the approved order of succession. The eligibility of...

7 CFR 1700.53 - Persons serving as Acting Administrator.

Code of Federal Regulations, 2014 CFR

2014-01-01

...) Eligibility for succession to the position of RUS Administrator shall be limited to officially assigned... the approved order of succession are eligible. Persons appointed on acting basis, or on some other... succession would fall to the next designated official in the approved order of succession. The eligibility of...

29 CFR 1952.327 - Changes to approved plans.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 9 2011-07-01 2011-07-01 false Changes to approved plans. 1952.327 Section 1952.327 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Protection Program, with the exception of organizational and position titles. [59 FR 14556, Mar. 29, 1994, as...

29 CFR 1952.327 - Changes to approved plans.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Changes to approved plans. 1952.327 Section 1952.327 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Protection Program, with the exception of organizational and position titles. [59 FR 14556, Mar. 29, 1994, as...

Schools, Parents, and Textbooks.

ERIC Educational Resources Information Center

Bell, T. H.

Publishers, authors, and the schools must be more respectful of parents' values in the preparation and selection of children's books. The use of obscene words, violence, explicit sex, and seeming approval of controversial positions in texts causes many problems. Although the approval of all parents obviously cannot be won, the children's book…

48 CFR 245.7305 - Sale approval and award.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Sale approval and award... SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT GOVERNMENT PROPERTY Sale of Surplus Contractor Inventory 245.7305 Sale approval and award. The plant clearance officer will— (1) Evaluate bids to establish...

48 CFR 232.409-1 - Recommendation for approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 3 2011-10-01 2011-10-01 false Recommendation for approval. 232.409-1 Section 232.409-1 Federal Acquisition Regulations System DEFENSE ACQUISITION... for Non-Commercial Items 232.409-1 Recommendation for approval. Follow the procedures at PGI 232.409-1...

48 CFR 922.103-4 - Approvals.

Code of Federal Regulations, 2010 CFR

2010-10-01

... cost to the Government may be affected, approval of hours of work in excess of the normal workweek is... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Approvals. 922.103-4 Section 922.103-4 Federal Acquisition Regulations System DEPARTMENT OF ENERGY SOCIOECONOMIC PROGRAMS...

48 CFR 2406.304 - Approval of the justification.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Approval of the justification. 2406.304 Section 2406.304 Federal Acquisition Regulations System DEPARTMENT OF HOUSING AND URBAN... 2406.304 Approval of the justification. (c) A class justification for other than full and open...

A Mobile Robot Sonar System with Obstacle Avoidance.

DTIC Science & Technology

1994-03-01

WITH OBSTACLE - AVOIDANCE __ by __ Patrick Gerard Byrne March 1994 Thesis Advisor : Yutaka Kanayama Approved for public release; distribution is...point p is on a line L whose normal has an orientation a and whose distance from the origin is r (Figure 5). This method has an advantage in expressing...sonar(FRONTR); Wine(&pl); while(hitl I >’- 100.0 11 hitl 1 - 0.0 ){ hitl I = sonar(FRONTR); I skipO; line(&p3); gat- robO (&posit 1); while(positl.x

NCCN Guidelines Insights: Breast Cancer, Version 1.2017.

PubMed

Gradishar, William J; Anderson, Benjamin O; Balassanian, Ron; Blair, Sarah L; Burstein, Harold J; Cyr, Amy; Elias, Anthony D; Farrar, William B; Forero, Andres; Giordano, Sharon Hermes; Goetz, Matthew P; Goldstein, Lori J; Isakoff, Steven J; Lyons, Janice; Marcom, P Kelly; Mayer, Ingrid A; McCormick, Beryl; Moran, Meena S; O'Regan, Ruth M; Patel, Sameer A; Pierce, Lori J; Reed, Elizabeth C; Salerno, Kilian E; Schwartzberg, Lee S; Sitapati, Amy; Smith, Karen Lisa; Smith, Mary Lou; Soliman, Hatem; Somlo, George; Telli, Melinda; Ward, John H; Shead, Dorothy A; Kumar, Rashmi

2017-04-01

These NCCN Guidelines Insights highlight the important updates/changes to the surgical axillary staging, radiation therapy, and systemic therapy recommendations for hormone receptor-positive disease in the 1.2017 version of the NCCN Guidelines for Breast Cancer. This report summarizes these updates and discusses the rationale behind them. Updates on new drug approvals, not available at press time, can be found in the most recent version of these guidelines at NCCN.org. Copyright © 2017 by the National Comprehensive Cancer Network.

Dynamics and Control of Mechanical Energy Propagation in Granular Systems

DTIC Science & Technology

2012-01-01

recover the linear approximation made by Job et. al. [2] for this collision. [1] S . Plimpton , J. Comput. Phys, 117, 1 (1995). [2] S . Job, F. Santibanez, F. Tapia, F. Melo, Ultrasonics 48, 506 (2008). ...the author( s ) and should not contrued as an official Department of the Army position, policy or decision, unless so designated by other documentation...12. DISTRIBUTION AVAILIBILITY STATEMENT Approved for Public Release; Distribution Unlimited UU 9. SPONSORING/MONITORING AGENCY NAME( S ) AND ADDRESS

14 CFR 25.145 - Longitudinal control.

Code of Federal Regulations, 2014 CFR

2014-01-01

... complete retraction of the high lift devices from any position is begun during steady, straight, level... retractions of the high-lift devices from any position from the maximum landing position to the first gated... requirements of paragraph (c) of this section also apply to retractions from each approved landing position to...

14 CFR 25.145 - Longitudinal control.

Code of Federal Regulations, 2013 CFR

2013-01-01

... complete retraction of the high lift devices from any position is begun during steady, straight, level... retractions of the high-lift devices from any position from the maximum landing position to the first gated... requirements of paragraph (c) of this section also apply to retractions from each approved landing position to...

Why should ethics approval be required prior to publication of health promotion research?

PubMed

Newson, Ainsley J; Lipworth, Wendy

2015-12-01

Most academic journals that publish studies involving human participants require evidence that the research has been approved by a human research ethics committee (HREC). Yet journals continue to receive submissions from authors who have failed to obtain such approval. In this paper, we provide an ethical justification of why journals should not, in general, publish articles describing research that has no ethics approval, with particular attention to the health promotion context. Using theoretical bioethical reasoning and drawing on a case study, we first rebut some potential criticisms of the need for research ethics approval. We then outline four positive claims to justify a presumption that research should, in most instances, be published only if it has been undertaken with HREC approval. We present four justifications for requiring ethics approval before publication: (1) HREC approval adds legitimacy to the research; (2) the process of obtaining HREC approval can improve the quality of an intervention being investigated; (3) obtaining HREC approval can help mitigate harm; and (4) obtaining HREC approval demonstrates respect for persons. This paper provides a systematic and comprehensive assessment of why research ethics approval should generally be obtained before publishing in the health promotion context. So what? Journals such as the Health Promotion Journal of Australia have recently begun to require research ethics approval for publishing research. Health promotion researchers will be interested in learning the ethical justification for this change.

48 CFR 9903.102 - OMB approval under the Paperwork Reduction Act.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false OMB approval under the Paperwork Reduction Act. 9903.102 Section 9903.102 Federal Acquisition Regulations System COST ACCOUNTING... AND COST ACCOUNTING STANDARDS CONTRACT COVERAGE General 9903.102 OMB approval under the Paperwork...

48 CFR 332.409-1 - Recommendation for approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Recommendation for approval. 332.409-1 Section 332.409-1 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES... Recommendation for approval. The Contracting Officer shall transmit the information in FAR 32.409-1 (or FAR 32...

75 FR 59717 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval... approval of proposed information collection by the Board of Governors of the Federal Reserve System (Board... docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to...

46 CFR 113.10-1 - Approved equipment.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 4 2011-10-01 2011-10-01 false Approved equipment. 113.10-1 Section 113.10-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) ELECTRICAL ENGINEERING COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT Fire and Smoke Detecting and Alarm Systems § 113.10-1 Approved equipment. Each alarm...

46 CFR 113.10-1 - Approved equipment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 4 2010-10-01 2010-10-01 false Approved equipment. 113.10-1 Section 113.10-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) ELECTRICAL ENGINEERING COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT Fire and Smoke Detecting and Alarm Systems § 113.10-1 Approved equipment. Each alarm...

46 CFR 113.10-1 - Approved equipment.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 4 2013-10-01 2013-10-01 false Approved equipment. 113.10-1 Section 113.10-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) ELECTRICAL ENGINEERING COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT Fire and Smoke Detecting and Alarm Systems § 113.10-1 Approved equipment. Each alarm...

46 CFR 113.10-1 - Approved equipment.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 4 2014-10-01 2014-10-01 false Approved equipment. 113.10-1 Section 113.10-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) ELECTRICAL ENGINEERING COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT Fire and Smoke Detecting and Alarm Systems § 113.10-1 Approved equipment. Each alarm...

46 CFR 113.10-1 - Approved equipment.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 4 2012-10-01 2012-10-01 false Approved equipment. 113.10-1 Section 113.10-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) ELECTRICAL ENGINEERING COMMUNICATION AND ALARM SYSTEMS AND EQUIPMENT Fire and Smoke Detecting and Alarm Systems § 113.10-1 Approved equipment. Each alarm...

75 FR 63445 - Vessel Monitoring Systems; Approved Mobile Transmitting Units and Communications Service...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-15

... Monitoring Systems; Approved Mobile Transmitting Units and Communications Service Providers for Use in the... and NOAA-approved VMS communications service providers, please contact the VMS Support Center at... degrees above or below the horizon anywhere on Earth. The GSM/GPRS capability (if activated) gives the...

48 CFR 332.409-1 - Recommendation for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Recommendation for approval. 332.409-1 Section 332.409-1 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES... Recommendation for approval. The Contracting Officer shall transmit the information in FAR 32.409-1 (or FAR 32...

76 FR 78227 - Notice of Request for Extension of Approval of an Information Collection; Emergency Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-16

...] Notice of Request for Extension of Approval of an Information Collection; Emergency Management Response... approval of an information collection associated with the Emergency Management Response System. DATES: We...: For information on the Emergency Management Response System, contact Dr. Steven Finch, Senior Staff...

Quality of life, treatment satisfaction and efficacy of non-biological systemic therapies in patients with plaque psoriasis: study protocol for a prospective observational study.

PubMed

Fink, Christine; Schank, Timo E; Trenkler, Nina; Uhlmann, Lorenz; Schäkel, Knut

2017-06-30

Psoriasis vulgaris often leads to a significant impaired quality of life and dissatisfaction with the existing therapeutic approaches. However, patients' quality of life and treatment satisfaction are of utmost importance, since it is positively related to therapy adherence and encourages patient's compliance. The study described herein evaluates the quality of life, treatment satisfaction and efficacy during the initial 6 months of treatment with a non-biological systemic agent in a real-life clinical setting. This observational study compares quality of life, treatment satisfaction and the efficacy of non-biological systemic therapy between 60 patients suffering from plaque psoriasis receiving the non-biological systemic therapies with apremilast, methotrexate and fumaric acid esters. Ethics approval was provided by the ethics committee of the medical faculty of the University of Heidelberg. Ethics approval number is S-298/2015. The design and the final results of the study will be published and made available to the public. German Clinical Trial Register (DRKS): DRKS00008721 (https://www.germanctr.de/). © 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.

76 FR 15229 - Airworthiness Directives; Goodrich Evacuation Systems Approved Under Technical Standard Order...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-21

... Evacuation Systems Approved Under Technical Standard Order (TSO) TSO-C69b and Installed on Airbus Model A330-200 and -300 Series Airplanes, Model A340-200 and -300 Series Airplanes, and Model A340-541 and -642... evacuation systems approved under TSO- C69b and installed on certain Model A330-200 and -300 series airplanes...

Accurate Identification of ALK Positive Lung Carcinoma Patients: Novel FDA-Cleared Automated Fluorescence In Situ Hybridization Scanning System and Ultrasensitive Immunohistochemistry

PubMed Central

Conde, Esther; Suárez-Gauthier, Ana; Benito, Amparo; Garrido, Pilar; García-Campelo, Rosario; Biscuola, Michele; Paz-Ares, Luis; Hardisson, David; de Castro, Javier; Camacho, M. Carmen; Rodriguez-Abreu, Delvys; Abdulkader, Ihab; Ramirez, Josep; Reguart, Noemí; Salido, Marta; Pijuán, Lara; Arriola, Edurne; Sanz, Julián; Folgueras, Victoria; Villanueva, Noemí; Gómez-Román, Javier; Hidalgo, Manuel; López-Ríos, Fernando

2014-01-01

Background Based on the excellent results of the clinical trials with ALK-inhibitors, the importance of accurately identifying ALK positive lung cancer has never been greater. However, there are increasing number of recent publications addressing discordances between FISH and IHC. The controversy is further fuelled by the different regulatory approvals. This situation prompted us to investigate two ALK IHC antibodies (using a novel ultrasensitive detection-amplification kit) and an automated ALK FISH scanning system (FDA-cleared) in a series of non-small cell lung cancer tumor samples. Methods Forty-seven ALK FISH-positive and 56 ALK FISH-negative NSCLC samples were studied. All specimens were screened for ALK expression by two IHC antibodies (clone 5A4 from Novocastra and clone D5F3 from Ventana) and for ALK rearrangement by FISH (Vysis ALK FISH break-apart kit), which was automatically captured and scored by using Bioview's automated scanning system. Results All positive cases with the IHC antibodies were FISH-positive. There was only one IHC-negative case with both antibodies which showed a FISH-positive result. The overall sensitivity and specificity of the IHC in comparison with FISH were 98% and 100%, respectively. Conclusions The specificity of these ultrasensitive IHC assays may obviate the need for FISH confirmation in positive IHC cases. However, the likelihood of false negative IHC results strengthens the case for FISH testing, at least in some situations. PMID:25248157

Coley's Lessons Remembered: Augmenting Mistletoe Therapy.

PubMed

Orange, Maurice; Reuter, Uwe; Hobohm, Uwe

2016-12-01

The following four observations point in the same direction, namely that there is an unleveraged potential for stimulating the innate immune system against cancer: (1) experimental treatments with bacterial extracts more than 100 years ago by Coley and contemporaries, (2) a positive correlation between spontaneous regressions and febrile infection, (3) epidemiological data suggesting an inverse correlation between a history of infection and the likelihood of developing cancer, and (4) our recent finding that a cocktail of pattern recognition receptor ligands (PRRLs) can eradicate solid tumors in cancer mice if applied metronomically. Because the main immunostimulating component of mistletoe extract (ME), mistletoe lectin, has been shown to be a PRRL as well, we suggest to apply ME in combination with additional PRRLs. Additional PRRLs can be found in approved drugs already on the market. Therefore, augmentation of ME might be feasible, with the aim of reattaining the old successes using approved drugs rather than bacterial extracts. © The Author(s) 2016.

Medtronic, Inc.; premarket approval of the Interstim Sacral Nerve Stimulation (SNS) System--FDA. Notice.

PubMed

1998-01-29

The Food and Drug Administration (FDA) is announcing its approval of the application by Medtronic, Inc., Minneapolis, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Interstim Sacral Nerve Stimulation (SNS) System. After reviewing the recommendation of the Gastroenterology and Urology Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 29, 1997, of the approval of the application.

Neratinib Approved for HER2+ Breast Cancer.

PubMed

2017-09-01

The FDA approved the tyrosine kinase inhibitor neratinib for extended adjuvant treatment of early-stage HER2-positive breast cancer. The decision adds another treatment option to help prevent recurrence, but its relatively small potential benefit must be weighed against the risk of serious side effects. ©2017 American Association for Cancer Research.

76 FR 80831 - Clarification of Policy Regarding Approved Training Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... approval multiple curriculums for a particular crewmember position and aircraft make/model/variant. For example, a part 135 certificate holder may have a an initial new-hire curriculum designed to meet the... may then also apply for a reduced new hire curriculum for pilots that have previous experience as a...

77 FR 7010 - Clarification of Policy Regarding Approved Training Programs; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-10

... approval multiple curriculums for a particular crewmember position and aircraft make/model/variant. For example, a part 135 certificate holder may have a an initial new-hire curriculum designed to meet the... certificate holder may then also apply for a reduced new hire curriculum for pilots that have previous...

75 FR 9988 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Granting Approval of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-04

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61590; File No. SR-Phlx-2009-113] Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Granting Approval of Proposed Rule Change Relating to Index Option Position Limits February 25, 2010. On December 29, 2009, NASDAQ OMX PHLX, Inc. (``Phlx'' or...

75 FR 66121 - Information Collection Sent to the Office of Management and Budget (OMB) for Approval; National...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-27

... and memorials in the world. Applicants for USPP officer positions must complete and pass a competitive... DEPARTMENT OF THE INTERIOR National Park Service [OMB Control Number 1024-0245] Information Collection Sent to the Office of Management and Budget (OMB) for Approval; National Park Police Personal...

Alectinib Approved for ALK+ Lung Cancer.

PubMed

2016-02-01

The FDA has approved a third ALK inhibitor, alectinib, for advanced ALK-positive non-small cell lung cancer. Two phase II studies show that patients who have become resistant to crizotinib respond well to alectinib; the drug is also effective against brain metastases, which are common in this disease subtype. ©2016 American Association for Cancer Research.

5 CFR 575.106 - Authorizing a recruitment incentive.

Code of Federal Regulations, 2011 CFR

2011-01-01

... (b) of this section; (2) Approve a recruitment incentive for an employee under § 575.105; (3... outside the Federal Government for similar positions; (3) Recent turnover in similar positions; (4...

5 CFR 575.106 - Authorizing a recruitment incentive.

Code of Federal Regulations, 2010 CFR

2010-01-01

... (b) of this section; (2) Approve a recruitment incentive for an employee under § 575.105; (3... outside the Federal Government for similar positions; (3) Recent turnover in similar positions; (4...

Converting Existing Copper Wire Firing System to a Fiber Optically Controlled Firing System for Electromagnetic Pulsed Power Experiments

DTIC Science & Technology

2017-12-19

Firing System for Electromagnetic Pulsed Power Experiments by Robert Borys Jr and Colby Adams Approved for public release...Belcamp, MD Approved for public release; distribution is unlimited. ii REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188... Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions

78 FR 77786 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... Federal Railroad Administration (FRA) seeking approval for the discontinuance or modification of a signal..., Inc., Mr. Timothy P. Purcell, Acting Chief Engineer--Signals, One Penn Plaza East, Newark, NJ 07105...

78 FR 12823 - Notice of Joint Application for Approval of Discontinuance or Modification of a Railroad Signal...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-25

... of Joint Application for Approval of Discontinuance or Modification of a Railroad Signal System In... Administration (FRA) seeking approval for the discontinuance or modification of a signal system. FRA assigned the.... David B. Olson, Chief Engineer Communication and Signals, 500 Water Street, Speed Code J-350...

The New Drug Conditional Approval Process in China: Challenges and Opportunities.

PubMed

Yao, Xuefang; Ding, Jinxi; Liu, Yingfang; Li, Penghui

2017-05-01

Our aim was to characterize the newly established new drug conditional approval process in China and discuss the challenges and opportunities with respect to new drug research and development and registration. We examined the new approval program through literature review, law analysis, and data analysis. Data were derived from published materials, such as journal articles, government publications, press releases, and news articles, along with statistical data from INSIGHT-China Pharma Databases, the China Food and Drug Administration website, the Center for Drug Evaluation website, the US Food and Drug Administration website, and search results published by Google. Currently, there is a large backlog of New Drug Applications in China, mainly because of the prolonged review time at the China Food and Drug Administration, resulting in a lag in drug approvals. In 2015, the Chinese government implemented the drug review and registration system reform and tackled this issue through various approaches, such as setting up a drug review fee system, adjusting the drug registration classification, and establishing innovative review pathways, including the conditional approval process. In Europe and the United States, programs comparable to the conditional approval program in China have been well developed. The conditional approval program recently established in China is an expedited new drug approval process that is expected to affect new drug development at home and abroad and profoundly influence the public health and the pharmaceutical industry in China. Like any program in its initial stage, the conditional approval program is facing several challenges, including setting up a robust system, formatting new drug clinical research requirements, and improving the regulatory agency's function for drug review and approval. The program is expected to evolve and improve as part of the government mandate of the drug registration system reform. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

5 CFR 351.702 - Qualifications for assignment.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) Meets the OPM standards and requirements for the position, including any minimum educational requirement... reasonable accommodation where appropriate, to perform the duties of the position; (3) Meets any special qualifying condition which the OPM has approved for the position; and (4) Has the capacity, adaptability, and...

5 CFR 330.208 - Qualification requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... perform the duties and responsibilities of the position. (c) The sex of an individual may not be... qualified for a position if he or she: (1) Meets OPM-established or approved qualification standards and requirements for the position, including any minimum educational requirements, and any selection placement...

48 CFR 32.409-1 - Recommendation for approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Recommendation for... Recommendation for approval. If recommending approval, the contracting officer shall transmit the following... authorization (see 32.410). (g) The recommendation for approval of the advance payment request. (h...

46 CFR 34.01-15 - Incorporation by reference.

Code of Federal Regulations, 2012 CFR

2012-10-01

... for the Installation of Sprinkler Systems, IBR approved for § 34.30-1 (“NFPA 13-1996”). (2) NFPA 2001, Standard on Clean Agent Fire Extinguishing Systems, (2008 Edition), IBR approved for § 34.05-5(a)(4) (“NFPA... Specification for International Shore Connections for Marine Fire Applications, 1987, IBR approved for § 34.10...

40 CFR 141.709 - Developing the disinfection profile and benchmark.

Code of Federal Regulations, 2010 CFR

2010-07-01

... flow or at an alternative location approved by the State. (2) For systems using chlorine, the pH of the... peak hourly flow or at an alternative location approved by the State. (3) The disinfectant contact time... plant based on a protocol approved by the State. (b) Systems with a single point of disinfectant...

5 CFR 330.705 - Order of selection in filling vacancies from outside the agency's workforce.

Code of Federal Regulations, 2010 CFR

2010-01-01

...; (13) The retention of individuals whose positions are brought into the competitive service under § 316... chapter; (14) The retention of an employee for whom OPM has approved a rule 5.1 variation; (15) The... approved by OPM (i.e., interagency job swaps); and (19) Transfer or reinstatement of an individual who...

Self-Esteem, Demand for Approval and the Facilitativeness of a Romantic Relationship

ERIC Educational Resources Information Center

Cramer, Duncan

2009-01-01

There is some empirical support for the person-centred hypothesis that self-esteem is positively associated with having a facilitative relationship. Rational emotive behaviour theory suggests such an association is more likely to occur in people holding the irrational belief that they must be approved by others while person-centred theory may…

30 CFR 71.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... voltage per cell value; (2) Examination of all components of the cyclone to assure that they are clean and free of dust and dirt; (3) Examination of the inner surface of the cyclone on the approved sampling... positioning of the cyclone body, vortex finder and cassette to assure that they are rigid, in alignment, and...

30 CFR 70.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... components of the cyclone to assure that they are clean and free of dust and dirt; (3) Examination of the inner surface of the cyclone on the approved sampling device to assure that it is free of scoring; (4... leaks, and; (5) Examination of the clamping and positioning of the cyclone body, vortex finder and...

30 CFR 90.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... voltage per cell value; (2) Examination of all components of the cyclone to assure that they are clean and free of dust and dirt; (3) Examination of the inner surface of the cyclone on the approved sampling... positioning of the cyclone body, vortex finder and cassette to assure that they are rigid, in alignment, and...

30 CFR 71.204 - Approved sampling devices; maintenance and calibration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... voltage per cell value; (2) Examination of all components of the cyclone to assure that they are clean and free of dust and dirt; (3) Examination of the inner surface of the cyclone on the approved sampling... positioning of the cyclone body, vortex finder and cassette to assure that they are rigid, in alignment, and...

75 FR 60158 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing of a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... Process in Providing Trustee Access to the Security Position Report Service September 24, 2010. Pursuant...'') service with an automated approval process. II. Self-Regulatory Organization's Statement of the Purpose of... approve a Trustee's access to the SPR service for a security is done manually, and the process is...

78 FR 42988 - Self-Regulatory Organizations; New York Stock Exchange LLC; NYSE MKT LLC; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-18

...-2012-58] Self-Regulatory Organizations; New York Stock Exchange LLC; NYSE MKT LLC; Order Approving... Related Supplementary Material July 12, 2013. I. Introduction On October 26, 2012, the New York Stock... cover the position only pursuant to a new order, which must be time-recorded upstairs and upon receipt...

12 CFR 611.510 - Approval procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Approval procedures. 611.510 Section 611.510 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM ORGANIZATION Transfer of Authorities § 611.510 Approval procedures. (a) Upon receipt of approval of a resolution by the Farm Credit...

Aspects of eukaryotic-like signaling in Gram-positive cocci: a focus on virulence

PubMed Central

Burnside, Kellie; Rajagopal, Lakshmi

2011-01-01

Living organisms adapt to the dynamic external environment for their survival. Environmental adaptation in prokaryotes is thought to be primarily accomplished by signaling events mediated by two-component systems, consisting of histidine kinases and response regulators. However, eukaryotic-like serine/threonine kinases (STKs) have recently been described to regulate growth, antibiotic resistance and virulence of pathogenic bacteria. This article summarizes the role of STKs and their cognate phosphatases (STPs) in Gram-positive cocci that cause invasive infections in humans. Given that a large number of inhibitors to eukaryotic STKs are approved for use in humans, understanding how serine/threonine phosphorylation regulates virulence and antibiotic resistance will be beneficial for the development of novel therapeutic strategies against bacterial infections. PMID:21797690

77 FR 24546 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule To Provide...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-24

... the Initial Margin Requirement for Client-Related Positions Cleared in a Clearing Participant's...-related liquidity requirements for client-related positions cleared in a clearing participant's customer...%) of the initial margin requirement for client-related positions cleared in a clearing participant's...

48 CFR 1352.228-76 - Approval of group insurance plans.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Approval of group....228-76 Approval of group insurance plans. As prescribed in 48 CFR 1328.310-70(i), insert the following clause: Approval of Group Insurance Plans (APR 2010) Under cost-reimbursement contracts, before buying...

48 CFR 1352.228-76 - Approval of group insurance plans.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Approval of group....228-76 Approval of group insurance plans. As prescribed in 48 CFR 1328.310-70(i), insert the following clause: Approval of Group Insurance Plans (APR 2010) Under cost-reimbursement contracts, before buying...

48 CFR 552.246-70 - Source Inspection by Quality Approved Manufacturer.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Quality Approved Manufacturer. 552.246-70 Section 552.246-70 Federal Acquisition Regulations System... Provisions and Clauses 552.246-70 Source Inspection by Quality Approved Manufacturer. As prescribed in 546.302-70, insert the following clause: Source Inspection by Quality Approved Manufacturer (JUL 09) (a...

48 CFR 552.246-70 - Source Inspection by Quality Approved Manufacturer.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Quality Approved Manufacturer. 552.246-70 Section 552.246-70 Federal Acquisition Regulations System... Provisions and Clauses 552.246-70 Source Inspection by Quality Approved Manufacturer. As prescribed in 546.302-70, insert the following clause: Source Inspection by Quality Approved Manufacturer (JUL 09) (a...

7 CFR 1737.51 - Approval of loan design.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false Approval of loan design. 1737.51 Section 1737.51... of Application Procedures § 1737.51 Approval of loan design. RUS shall notify the borrower when the preloan data concerning the system design and costs and subscriber projections have been approved. If...

41 CFR 102-75.570 - What happens if the disposal agency does not approve the assignment recommendation?

Code of Federal Regulations, 2010 CFR

2010-07-01

... disposal agency does not approve the assignment recommendation? 102-75.570 Section 102-75.570 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL... approve the assignment recommendation? If the recommendation is not approved, the disposal agency must...

14 CFR 61.67 - Category II pilot authorization requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... and runway lighting system; (ix) Characteristics and limitations of the flight director system, auto approach coupler (including split axis type if equipped), auto throttle system (if equipped), and other... be made with the use of an approved flight control guidance system, except if an approved auto...

FDA-approved drugs that are spermatotoxic in animals and the utility of animal testing for human risk prediction.

PubMed

Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo

2018-02-01

This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.

FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation.

PubMed

Kim, Geoffrey; McKee, Amy E; Ning, Yang-Min; Hazarika, Maitreyee; Theoret, Marc; Johnson, John R; Xu, Qiang Casey; Tang, Shenghui; Sridhara, Rajeshwari; Jiang, Xiaoping; He, Kun; Roscoe, Donna; McGuinn, W David; Helms, Whitney S; Russell, Anne Marie; Miksinski, Sarah Pope; Zirkelbach, Jeanne Fourie; Earp, Justin; Liu, Qi; Ibrahim, Amna; Justice, Robert; Pazdur, Richard

2014-10-01

On August 17, 2011, the U.S. Food and Drug Administration (FDA) approved vemurafenib tablets (Zelboraf, Hoffmann-LaRoche Inc.) for the treatment of patients with unresectable or metastatic melanoma with the BRAF(V600E) mutation as detected by an FDA-approved test. The cobas 4800 BRAF V600 Mutation Test (Roche Molecular Systems, Inc.) was approved concurrently. An international, multicenter, randomized, open-label trial in 675 previously untreated patients with BRAF(V600E) mutation-positive unresectable or metastatic melanoma allocated 337 patients to receive vemurafenib, 960 mg orally twice daily, and 338 patients to receive dacarbazine, 1,000 mg/m(2) intravenously every 3 weeks. Overall survival was significantly improved in patients receiving vemurafenib [HR, 0.44; 95% confidence interval (CI), 0.33-0.59; P < 0.0001]. Progression-free survival was also significantly improved in patients receiving vemurafenib (HR, 0.26; 95% CI, 0.20-0.33; P < 0.0001). Overall response rates were 48.4% and 5.5% in the vemurafenib and dacarbazine arms, respectively. The most common adverse reactions (≥30%) in patients treated with vemurafenib were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, and nausea. Cutaneous squamous cell carcinomas or keratoacanthomas were detected in approximately 24% of patients treated with vemurafenib. Other adverse reactions included hypersensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, uveitis, QT prolongation, and liver enzyme laboratory abnormalities. ©2014 American Association for Cancer Research.

Considerations for an institution for evaluation of diabetes technology devices to improve their quality in the European Union.

PubMed

Heinemann, Lutz; Freckmann, Guido; Koschinsky, Theodor

2013-03-01

All medical devices used for self-monitoring of blood glucose (BG), insulin injection, continuous subcutaneous insulin infusion, and continuous glucose monitoring in the European Union (EU) must have a Communauté Européenne (CE) mark. However, the approval process for obtaining this mark is different from that used by the European Medicines Agency in the EU for drugs or by the Food and Drug Administration in the United States for such medical and in vitro diagnostic devices. The notified bodies involved in the CE mark process perform this evaluation in cooperation with the manufacturers. They have only limited diabetes know-how; they have to handle all kinds of medical devices. There are devices for therapy on the market in the EU (i.e., they have market approval) that do not fulfill quality requirements, as indicated, for example, in the international norm ISO 15197 for BG test systems. Evaluation of the performance of such systems is usually provided by the manufacturers. What is missing in the EU is an independent institution that performs regular and critical evaluation of the quality of devices used for diabetes therapy before and also after their market approval. The work of such an institution would focus on BG test systems (these represent two-thirds of the market of medical devices for diabetes treatment) but would also evaluate the performance of other devices. It has to be clarified what legal framework is required for such an institution and how it can be financed; probably this can be done in a shared manner by the manufacturers of such devices and the health insurance companies. Positive evaluation results should be a prerequisite prior to any reimbursement for such devices. © 2013 Diabetes Technology Society.

Modeling Precheck Parallel Screening Process in the Face of Strategic Applicants with Incomplete Information and Screening Errors.

PubMed

Song, Cen; Zhuang, Jun

2018-01-01

In security check systems, tighter screening processes increase the security level, but also cause more congestion, which could cause longer wait times. Having to deal with more congestion in lines could also cause issues for the screeners. The Transportation Security Administration (TSA) Precheck Program was introduced to create fast lanes in airports with the goal of expediting passengers who the TSA does not deem to be threats. In this lane, the TSA allows passengers to enjoy fewer restrictions in order to speed up the screening time. Motivated by the TSA Precheck Program, we study parallel queueing imperfect screening systems, where the potential normal and adversary participants/applicants decide whether to apply to the Precheck Program or not. The approved participants would be assigned to a faster screening channel based on a screening policy determined by an approver, who balances the concerns of safety of the passengers and congestion of the lines. There exist three types of optimal normal applicant's application strategy, which depend on whether the marginal payoff is negative or positive, or whether the marginal benefit equals the marginal cost. An adversary applicant would not apply when the screening policy is sufficiently large or the number of utilized benefits is sufficiently small. The basic model is extended by considering (1) applicants' parameters to follow different distributions and (2) applicants to have risk levels, where the approver determines the threshold value needed to qualify for Precheck. This article integrates game theory and queueing theory to study the optimal screening policy and provides some insights to imperfect parallel queueing screening systems. © 2017 Society for Risk Analysis.

Utilizing data consortia to monitor safety and effectiveness of biosimilars and their innovator products.

PubMed

Baldziki, Mike; Brown, Jeff; Chan, Hungching; Cheetham, T Craig; Conn, Thomas; Daniel, Gregory W; Hendrickson, Mark; Hilbrich, Lutz; Johnson, Ayanna; Miller, Steven B; Moore, Tom; Motheral, Brenda; Priddy, Sarah A; Raebel, Marsha A; Randhawa, Gurvaneet; Surratt, Penny; Walraven, Cheryl; White, T Jeff; Bruns, Kevin; Carden, Mary Jo; Dragovich, Charlie; Eichelberger, Bernadette; Rosato, Edith; Sega, Todd

2015-01-01

The Biologics Price Competition and Innovation Act, introduced as part of the Affordable Care Act, directed the FDA to create an approval pathway for biologic products shown to be biosimilar or interchangeable with an FDA-approved innovator drug. These biosimilars will not be chemically identical to the reference agent. Investigational studies conducted with biosimilar agents will likely provide limited real-world evidence of their effectiveness and safety. How do we best monitor effectiveness and safety of biosimilar products once approved by the FDA and used more extensively by patients? To determine the feasibility of developing a distributed research network that will use health insurance plan and health delivery system data to detect biosimilar safety and effectiveness signals early and be able to answer important managed care pharmacy questions from both the government and managed care organizations. Twenty-one members of the AMCP Task Force on Biosimilar Collective Intelligence Systems met November 12, 2013, to discuss issues involved in designing this consortium and to explore next steps. The task force concluded that a managed care biosimilars research consortium would be of significant value. Task force members agreed that it is best to use a distributed research network structurally similar to existing DARTNet, HMO Research Network, and Mini-Sentinel consortia. However, for some surveillance projects that it undertakes, the task force recognizes it may need supplemental data from managed care and other sources (i.e., a "hybrid" structure model). The task force believes that AMCP is well positioned to lead the biosimilar-monitoring effort and that the next step to developing a biosimilar-innovator collective intelligence system is to convene an advisory council to address organizational governance.

NASA'S Earth Science Enterprise Embraces Active Laser Remote Sensing from Space

NASA Technical Reports Server (NTRS)

Luther, Michael R.; Paules, Granville E., III

1999-01-01

Several objectives of NASA's Earth Science Enterprise are accomplished, and in some cases, uniquely enabled by the advantages of earth-orbiting active lidar (laser radar) sensors. With lidar, the photons that provide the excitation illumination for the desired measurement are both controlled and well known. The controlled characteristics include when and where the illumination occurs, the wavelength, bandwidth, pulse length, and polarization. These advantages translate into high signal levels, excellent spatial resolution, and independence from time of day and the sun's position. As the lidar technology has rapidly matured, ESE scientific endeavors have begun to use lidar sensors over the last 10 years. Several more lidar sensors are approved for future flight. The applications include both altimetry (rangefinding) and profiling. Hybrid missions, such as the approved Geoscience Laser Altimeter System (GLAS) sensor to fly on the ICESat mission, will do both at the same time. Profiling applications encompass aerosol, cloud, wind, and molecular concentration measurements. Recent selection of the PICASSO Earth System Science Pathfinder mission and the complementary CLOUDSAT radar-based mission, both flying in formation with the EOS PM mission, will fully exploit the capabilities of multiple sensor systems to accomplish critical science needs requiring such profiling. To round out the briefing a review of past and planned ESE missions will be presented.

Brentuximab vedotin: clinical updates and practical guidance

PubMed Central

Yi, Jun Ho; Kim, Seok Jin

2017-01-01

Brentuximab vedotin (BV), a potent antibody-drug conjugate, targets the CD30 antigen. Owing to the remarkable efficacy shown in CD30-positive lymphomas, such as Hodgkin's lymphoma and systemic anaplastic large-cell lymphoma, BV was granted accelerated approval in 2011 by the US Food and Drug Administration. Thereafter, many large-scale trials in various situations have been performed, which led to extensions of the original indication. The aim of this review was to describe the latest updates on clinical trials of BV and the in-practice guidance for the use of BV. PMID:29333400

48 CFR 232.409-1 - Recommendation for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Recommendation for approval. 232.409-1 Section 232.409-1 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE GENERAL CONTRACTING REQUIREMENTS CONTRACT FINANCING Advance Payments...

46 CFR 58.16-10 - Approvals.

Code of Federal Regulations, 2010 CFR

2010-10-01

... RELATED SYSTEMS Liquefied Petroleum Gases for Cooking and Heating § 58.16-10 Approvals. (a) Gas appliances. (1) All gas-consuming appliances used for cooking and heating shall be of a type approved by the...

45 CFR 307.15 - Approval of advance planning documents for computerized support enforcement systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... computerized support enforcement systems. 307.15 Section 307.15 Public Welfare Regulations Relating to Public... CHILDREN AND FAMILIES, DEPARTMENT OF HEALTH AND HUMAN SERVICES COMPUTERIZED SUPPORT ENFORCEMENT SYSTEMS § 307.15 Approval of advance planning documents for computerized support enforcement systems. (a...

7 CFR 400.209 - Electronic transmission and receiving system.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 6 2012-01-01 2012-01-01 false Electronic transmission and receiving system. 400.209... Contract-Standards for Approval § 400.209 Electronic transmission and receiving system. Any Contractor...; (b) Maintain an electronic system which must be tested and approved by the Corporation; (c) Maintain...

7 CFR 400.209 - Electronic transmission and receiving system.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 6 2013-01-01 2013-01-01 false Electronic transmission and receiving system. 400.209... Contract-Standards for Approval § 400.209 Electronic transmission and receiving system. Any Contractor...; (b) Maintain an electronic system which must be tested and approved by the Corporation; (c) Maintain...

7 CFR 400.209 - Electronic transmission and receiving system.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 6 2011-01-01 2011-01-01 false Electronic transmission and receiving system. 400.209... Contract-Standards for Approval § 400.209 Electronic transmission and receiving system. Any Contractor...; (b) Maintain an electronic system which must be tested and approved by the Corporation; (c) Maintain...

7 CFR 400.209 - Electronic transmission and receiving system.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 6 2010-01-01 2010-01-01 false Electronic transmission and receiving system. 400.209... Contract-Standards for Approval § 400.209 Electronic transmission and receiving system. Any Contractor...; (b) Maintain an electronic system which must be tested and approved by the Corporation; (c) Maintain...

A novel governance system for enterprise information services.

PubMed

Shabot, M M; Polaschek, J X; Duncan, R G; Langberg, M L; Jones, D T

1999-01-01

The authors created a novel system for governing the enterprise information services (IS) of a large health care system. The governance organization is comprised of key members of the attending medical staff, hospital and health system administration, and the IS department. A method for defining the requirements and business case for proposed new systems was developed for use by departments requesting new or expanded information services. A Technology Architecture Guideline document was developed and approved to provide a framework for supported hardware and software technologies. IS policies are approved by the main governance council. All project proposals are reviewed by specialized governance committees and, if approved, are launched for further development. Fully developed proposals are reviewed, approved and prioritized for funding by the governance council. This novel organization provides the methodology and structure for enlightened peer review and funding for well developed IS project proposals.

A novel governance system for enterprise information services.

PubMed Central

Shabot, M. M.; Polaschek, J. X.; Duncan, R. G.; Langberg, M. L.; Jones, D. T.

1999-01-01

The authors created a novel system for governing the enterprise information services (IS) of a large health care system. The governance organization is comprised of key members of the attending medical staff, hospital and health system administration, and the IS department. A method for defining the requirements and business case for proposed new systems was developed for use by departments requesting new or expanded information services. A Technology Architecture Guideline document was developed and approved to provide a framework for supported hardware and software technologies. IS policies are approved by the main governance council. All project proposals are reviewed by specialized governance committees and, if approved, are launched for further development. Fully developed proposals are reviewed, approved and prioritized for funding by the governance council. This novel organization provides the methodology and structure for enlightened peer review and funding for well developed IS project proposals. PMID:10566433

Care Planning for Prostate Cancer Patients on Active Surveillance

DTIC Science & Technology

2017-10-01

U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for Public Release...Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704...Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 11. SPONSOR/MONITOR’S REPORT NUMBER(S) 12. DISTRIBUTION / AVAILABILITY

Identification of Immunogenic Targets for Lung Cancer Vaccines

DTIC Science & Technology

2017-09-01

quantitative proteomic analysis to identify proteins overexpressed in non-small cell lung cancer cell lines compared with normal lung epithelial...Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for Public Release; Distribution...Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188

DoD Alcohol and Substance Abuse Consortium Award

DTIC Science & Technology

2017-10-01

ORGANIZATION: RESEARCH TRIANGLE INSTITUTE RESTRIANGLE PARK, NC 27709 REPORT DATE: October 2017 TYPE OF REPORT: Annual PREPARED FOR: U.S. Army Medical... Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for Public Release; Distribution Unlimited The...position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188 Public

COMPARISON OF THE RECOVERIES OF ESCHERICHIA COLI AND TOTAL COLIFORMS FROM DRINKING WATER BY THE MI AGAR METHOD AND THE U.S. ENVIRONMENTAL PROTECTION AGENCY-APPROVED MEMBRANE FILTER METHOD

EPA Science Inventory

Drinking water regulations under the Final Coliform Rule require that total coliform-positive drinking water samples be examined for the presence of Escherichia coli or fecal coliforms. The current U.S. Environmental Protection Agency-approved membrane filter (MF) method for E. c...

The Oviduct and Serous Cancer Risk Assessment

DTIC Science & Technology

2015-10-01

from Singapore National Medical Research Council. Author contribution statement Contributions of the co-authors to design (1), data col- lection (2...U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for Public Release; Distribution...Department of the Army position, policy or decision unless so designated by other documentation. 2 REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704

76 FR 71394 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-17

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65721; File No. SR-DTC-2011-07] Self-Regulatory Organizations; The Depository Trust Company; Order Approving a Proposed Rule Change as Modified by Amendment Nos. 1 and 2 Relating To a New Daily Report Subscription for Security Position Reports November 10, 2011. I. Introduction On August 24, 201...

FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.

PubMed

Beaver, Julia A; Amiri-Kordestani, Laleh; Charlab, Rosane; Chen, Wei; Palmby, Todd; Tilley, Amy; Zirkelbach, Jeanne Fourie; Yu, Jingyu; Liu, Qi; Zhao, Liang; Crich, Joyce; Chen, Xiao Hong; Hughes, Minerva; Bloomquist, Erik; Tang, Shenghui; Sridhara, Rajeshwari; Kluetz, Paul G; Kim, Geoffrey; Ibrahim, Amna; Pazdur, Richard; Cortazar, Patricia

2015-11-01

On February 3, 2015, the FDA granted accelerated approval to palbociclib (IBRANCE, Pfizer Inc.), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The approval is based on a randomized, multicenter, open-label phase I/II trial (PALOMA-1) in 165 patients randomized to palbociclib (125 mg orally daily for 21 consecutive days, followed by 7 days off treatment) plus letrozole (2.5 mg orally daily) or letrozole alone. The phase II portion of the trial was divided into two cohorts: cohort 1 enrolled 66 biomarker-unselected patients and cohort 2 enrolled 99 biomarker-positive patients. The major efficacy outcome measure was investigator-assessed progression-free survival (PFS). A large magnitude of improvement in PFS was observed in patients receiving palbociclib plus letrozole compared with patients receiving letrozole alone (HR, 0.488; 95% confidence interval, 0.319-0.748). Multiple sensitivity analyses were supportive of clinical benefit. The most common adverse reaction in patients receiving palbociclib plus letrozole was neutropenia. This article summarizes the FDA thought process and data supporting accelerated approval based on PALOMA-1 that may be contingent upon verification and description of clinical benefit in the ongoing and fully accrued confirmatory trial PALOMA-2. ©2015 American Association for Cancer Research.

30 CFR 75.700-1 - Approved methods of grounding.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Approved methods of grounding. 75.700-1 Section... SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Grounding § 75.700-1 Approved methods...; in all other systems, the following methods of grounding will be approved: (a) A solid connection to...

30 CFR 75.700-1 - Approved methods of grounding.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Approved methods of grounding. 75.700-1 Section... SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Grounding § 75.700-1 Approved methods...; in all other systems, the following methods of grounding will be approved: (a) A solid connection to...

30 CFR 75.700-1 - Approved methods of grounding.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved methods of grounding. 75.700-1 Section... SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Grounding § 75.700-1 Approved methods...; in all other systems, the following methods of grounding will be approved: (a) A solid connection to...

75 FR 26343 - Request for Expedited Certification and Type Approval of Amtrak Advanced Civil Speed Enforcement...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

... and Type Approval of Amtrak Advanced Civil Speed Enforcement System (ACSES) In accordance with Part... Administration (FRA) received a request for expedited certification and type approval of the Amtrak ACSES. ACSES... request is described below, including the party seeking certification and type approval of ACSES, the...

7 CFR 1717.609 - RUS approval of general manager.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of general manager. 1717.609 Section... Operational Controls § 1717.609 RUS approval of general manager. (a) If a borrower's mortgage or loan contract... general manager of the borrower's system, such approval is hereby granted provided that the borrower is in...

78 FR 70025 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-22

.... Needs and Uses: Administrative contracting officers use this information in making decisions to grant, withhold, or withdraw purchasing system approval at the conclusion of a purchasing system review. Withdrawal of purchasing system approval would necessitate Government consent to individual subcontracts...

Injunctive Norms and Problem Gambling among College Students

PubMed Central

Lostutter, Ty W.; Whiteside, Ursula; Fossos, Nicole; Walker, Denise D.; Larimer, Mary E.

2010-01-01

Two studies examined the relationships among injunctive norms and college student gambling. In study 1 we evaluated the accuracy of perceptions of other students’ approval of gambling and the relationship between perceived approval and gambling behavior. In study 2 we evaluated gambling behavior as a function of perceptions of approval of other students, friends, and family. In study 1, which included 2524 college students, perceptions of other students’ approval of gambling were found to be overestimated and were negatively associated with gambling behavior. The results of study 2, which included 565 college students, replicated the findings of study 1 and revealed positive associations between gambling behavior and perceived approval of friends and family. Results highlight the complexity of injunctive norms and the importance of considering the reference group (e.g., peers, friends, family members) in their evaluation. Results also encourage caution in considering the incorporation of injunctive norms in prevention and intervention approaches. PMID:17394053

Hedonic Benefits of Close and Distant Interaction Partners: The Mediating Roles of Social Approval and Authenticity.

PubMed

Venaglia, Rachel B; Lemay, Edward P

2017-09-01

The current research utilized ecological momentary assessment methodology to examine affective responses to interacting with close versus distant interaction partners during naturally occurring social interactions, and to test predictions regarding the mediating roles of perceived social approval and authenticity. Analysis of 4,602 social interactions reported by 176 participants suggested that, relative to interactions with distant partners, interactions with close partners were characterized by more positive affect. This effect was mediated by perceived social approval and authenticity. These findings suggest that social interactions with close others confer greater hedonic benefits relative to interactions with distant partners due to greater confidence in social approval and feelings of authenticity. Exploratory analyses suggested that interactions with close partners featured warmer and less shy behavior, and that participants who placed more importance on close relationships (as measured by high relational-interdependent self-construal) experienced more approval and authenticity in their interactions, particularly with distant partners.

FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non-Small Cell Lung Cancer Following Crizotinib.

PubMed

Larkins, Erin; Blumenthal, Gideon M; Chen, Huanyu; He, Kun; Agarwal, Rajiv; Gieser, Gerlie; Stephens, Olen; Zahalka, Eias; Ringgold, Kimberly; Helms, Whitney; Shord, Stacy; Yu, Jingyu; Zhao, Hong; Davis, Gina; McKee, Amy E; Keegan, Patricia; Pazdur, Richard

2016-11-01

On December 11, 2015, the FDA granted accelerated approval to alectinib (Alecensa; Genentech) for the treatment of patients with anaplastic lymphoma receptor tyrosine kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This approval was based on two single-arm trials including 225 patients treated with alectinib 600 mg orally twice daily. The objective response rates (ORR) by an independent review committee in these studies were 38% [95% confidence interval (CI), 28-49] and 44% (95% CI, 36-53); the median durations of response (DOR) were 7.5 months and 11.2 months. In a pooled analysis of 51 patients with measurable disease in the central nervous system (CNS) at baseline, the CNS ORR was 61% (95% CI, 46-74); the CNS DOR was 9.1 months. The primary safety analysis population included 253 patients. The most common adverse reactions were fatigue (41%), constipation (34%), edema (30%), and myalgia (29%). The most common laboratory abnormalities were anemia (56%), increased aspartate aminotransferase (51%), increased alkaline phosphatase (47%), increased creatine phosphokinase (43%), hyperbilirubinemia (39%), hyperglycemia (36%), increased alanine aminotransferase (34%), and hypocalcemia (32%). Dose reductions due to adverse reactions occurred in 12% of patients, whereas 27% of patients had alectinib dosing interrupted for adverse reactions. Permanent discontinuation of alectinib due to adverse reactions occurred in only 6% of patients. With the clinically meaningful ORR and DOR as well as the safety profile observed in these trials, alectinib was determined to have a favorable benefit-risk profile for the treatment of the indicated population. Clin Cancer Res; 22(21); 5171-6. ©2016 AACR. ©2016 American Association for Cancer Research.

Are government-approved products containing new psychoactive substances perceived to be safer and more socially acceptable than alcohol, tobacco and illegal drugs? Findings from a survey of police arrestees in New Zealand.

PubMed

Rychert, Marta; Wilkins, Chris; Parker, Karl; Witten, Karen

2018-03-01

In July 2013, New Zealand passed the Psychoactive Substances Act (PSA), which established a legal regulated market for government-approved products containing new psychoactive substances (NPS). One of the aims of the PSA was to separate the market for approved NPS products from unapproved products and illegal drugs. The aim of this study was to explore perceived health risks and social acceptability of government-approved NPS compared to unapproved NPS and other drugs. About 834 police arrestees were surveyed about the health risks and social acceptability of regularly using nine drug types, including approved and unapproved synthetic cannabinoids (SC) and 'party pills' (PP) under the interim PSA regime. Statistical analyses included fitted analysis of variance and logistic ordinal regression models. Approved SC were considered riskier to health than (natural) cannabis, alcohol, approved and unapproved PP, tobacco and ecstasy, but safer than unapproved SC and methamphetamine. Younger participants (16-29 years) were more likely than older participants (30+ years) to give approved SC a high health-risk score. Approved SC were considered less socially acceptable than alcohol, tobacco and cannabis, but more socially acceptable than methamphetamine, unapproved SC and unapproved PP. Frequent SC users were more likely to rate the social acceptability of approved legal SC higher than other drug users. Approved PP received more positive health and social acceptability scores than approved SC. The PSA was partially successful at separating approved NPS from other drugs. High health-risk and low social acceptability scores for approved SC may reflect the absence of product testing during the interim PSA market. © 2017 Australasian Professional Society on Alcohol and other Drugs.

Medicaid program; Medicaid Management Information Systems; conditions of approval and reapproval and procedures for reduction of federal financial participation--Health Care Financing Administration. Proposed rule.

PubMed

1983-03-03

This proposal adds to regulations new conditions and procedures for initial approval and for reapproval of Medicaid Management Information Systems (MMIS) to update the regulations to reflect additional requirements added by section 901 of the Mental Health Systems Act of 1980 (Pub. L. 96-398). The proposal specifies procedures for reducing the level of Federal financial participation in a State's administrative expenditures when a State fails to meet the conditions for initial operation, initial approval or reapproval of an MMIS. It also proposes procedures with respect to waivers of the conditions of approval and reapproval and to appeals of adverse decisions. These provisions are intended to improve States' MMIS, and to ensure efficient system operations, and to detect cases of fraud, waste, and abuse effectively.

77 FR 31429 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-25

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... discontinuance or modification of a signal system. FRA assigned the petition Docket Number FRA-2012-0046... discontinuance of an automatic block signal (ABS) system and a traffic control signal (TCS) system on the...

Treating patients with ALK-positive non-small cell lung cancer: latest evidence and management strategy

PubMed Central

Liao, Bin-Chi; Shih, Jin-Yuan; Yang, James Chih-Hsin

2015-01-01

Rearrangements in anaplastic lymphoma kinase (ALK) gene and echinoderm microtubule-associated protein-like 4 (EML4) gene were first described in a small portion of patients with non-small cell lung cancer (NSCLC) in 2007. Fluorescence in situ hybridization is used as the diagnostic test for detecting an EML4–ALK rearrangement. Crizotinib, an ALK inhibitor, is effective in treating advanced ALK-positive NSCLC, and the US Food and Drug Administration approved it for treating ALK-positive NSCLC in 2011. Several mechanisms of acquired resistance to crizotinib have recently been reported. Second-generation ALK inhibitors were designed to overcome these resistance mechanisms. Two of them, ceritinib and alectinib, were approved in 2014 for advanced ALK-positive NSCLC in the US and Japan, respectively. Heat shock protein 90 (Hsp90) inhibitors also showed activity against ALK-positive NSCLC. Here we review the recent development of crizotinib, ceritinib, alectinib and other second-generation ALK inhibitors as well as Hsp90 inhibitors. We also discuss management strategies for advanced ALK-positive NSCLC. PMID:26327925

40 CFR 35.929-3 - Implementation of the user charge system.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Implementation of the user charge... Water Act § 35.929-3 Implementation of the user charge system. (a) When a grantee's user charge system is approved, implementation of the approved system shall become a condition of the grant. (b) The...

40 CFR 35.929-3 - Implementation of the user charge system.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Implementation of the user charge... Water Act § 35.929-3 Implementation of the user charge system. (a) When a grantee's user charge system is approved, implementation of the approved system shall become a condition of the grant. (b) The...

40 CFR 35.929-3 - Implementation of the user charge system.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Implementation of the user charge... Water Act § 35.929-3 Implementation of the user charge system. (a) When a grantee's user charge system is approved, implementation of the approved system shall become a condition of the grant. (b) The...

40 CFR 35.929-3 - Implementation of the user charge system.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Implementation of the user charge... Water Act § 35.929-3 Implementation of the user charge system. (a) When a grantee's user charge system is approved, implementation of the approved system shall become a condition of the grant. (b) The...

40 CFR 35.928-3 - Implementation of the industrial cost recovery system.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Implementation of the industrial cost...-Clean Water Act § 35.928-3 Implementation of the industrial cost recovery system. (a) When a grantee's industrial cost recovery system is approved, implementation of the approved system shall become a condition...

Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union

PubMed Central

Jokura, Yoji; Yano, Kazuo

2017-01-01

Abstract Legislation for expedited‐approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited‐approval pathways, and obligations to collect and report post‐marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time‐limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre‐ or post‐marketing clinical data. Expedited‐approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post‐marketing study for conditional and time‐limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited‐approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. PMID:28211195

76 FR 81553 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Approving Proposed Rule Change Relating...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-28

... Positions Off the Floor December 21, 2011. I. Introduction On October 20, 2011, NASDAQ OMX PHLX LLC... that would net against an existing offsetting short position could not be transferred), and each member...

41 CFR 102-75.660 - What happens if DOI does not approve any applications or does not submit an assignment...

Code of Federal Regulations, 2010 CFR

2010-07-01

... not approve any applications or does not submit an assignment recommendation? 102-75.660 Section 102-75.660 Public Contracts and Property Management Federal Property Management Regulations System... approve any applications or does not submit an assignment recommendation? If DOI does not approve any...

23 CFR 470.115 - Approval authority.

Code of Federal Regulations, 2010 CFR

2010-04-01

... FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PLANNING AND RESEARCH HIGHWAY SYSTEMS Federal... Federal-aid highway system actions involving the designation, or revision, of routes on the Interstate...) The Federal Highway Administrator will approve functional classification actions. ...

78 FR 32234 - Notice of Request for Extension of a Currently Approved Information Collection: Public Health...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-29

... Request for Extension of a Currently Approved Information Collection: Public Health Information System... rabbit slaughter for the Public Health Information System--Animal Disposition Reporting because the.... SUPPLEMENTARY INFORMATION: Title: Public Health Information System-- Animal Disposition Reporting. Type of...

75 FR 9211 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-01

... FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval... Reserve System heading, the entry for Agency Information Collection Activities: Announcement of Board... information existed on the exposure of the banking system to those firms as this information was obscured by...

78 FR 32077 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-29

... Fuel Storage Casks: MAGNASTOR[supreg] System AGENCY: Nuclear Regulatory Commission. ACTION: Direct... final rule that would have revised its spent fuel storage regulations to include Amendment No. 3 to... All-purpose Storage (MAGNASTOR[supreg]) System listing within the ``List of Approved Spent Fuel...

15 CFR 995.25 - Quality management system.

Code of Federal Regulations, 2012 CFR

2012-01-01

... management system are those defined in this part. The quality management system must ensure that the... type approved conversion software is maintained by a third party, CEVAD shall ensure that no changes made to the conversion software render the type approval of the conversion software invalid, and shall...

15 CFR 995.25 - Quality management system.

Code of Federal Regulations, 2014 CFR

2014-01-01

... management system are those defined in this part. The quality management system must ensure that the... type approved conversion software is maintained by a third party, CEVAD shall ensure that no changes made to the conversion software render the type approval of the conversion software invalid, and shall...

15 CFR 995.25 - Quality management system.

Code of Federal Regulations, 2011 CFR

2011-01-01

... management system are those defined in this part. The quality management system must ensure that the... type approved conversion software is maintained by a third party, CEVAD shall ensure that no changes made to the conversion software render the type approval of the conversion software invalid, and shall...

15 CFR 995.25 - Quality management system.

Code of Federal Regulations, 2013 CFR

2013-01-01

... management system are those defined in this part. The quality management system must ensure that the... type approved conversion software is maintained by a third party, CEVAD shall ensure that no changes made to the conversion software render the type approval of the conversion software invalid, and shall...

14 CFR 171.45 - Minimum requirements for approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... the frequency channel is needed for higher priority common system service. [Doc. No. 5034, 29 FR 11337... (CONTINUED) NAVIGATIONAL FACILITIES NON-FEDERAL NAVIGATION FACILITIES Instrument Landing System (ILS... must be met before the FAA will approve an IFR procedure for a non-Federal Instrument Landing System...

Myeloid-Derived Suppressor Cells in Checkpoint Protein Inhibition for Melanoma

DTIC Science & Technology

2017-09-01

Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for Public Release...official Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved...6402 9. SPONSORING / MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR’S ACRONYM(S) U.S. Army Medical Research and Materiel Command Fort

48 CFR 750.7105 - Approving authorities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Approving authorities. 750.7105 Section 750.7105 Federal Acquisition Regulations System AGENCY FOR INTERNATIONAL DEVELOPMENT CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS Extraordinary Contractual Actions To Protect Foreign...

Rational Clinical Experiment: Assessing Prior Probability and Its Impact on the Success of Phase II Clinical Trials

PubMed Central

Halperin, Daniel M.; Lee, J. Jack; Dagohoy, Cecile Gonzales; Yao, James C.

2015-01-01

Purpose Despite a robust clinical trial enterprise and encouraging phase II results, the vast minority of oncologic drugs in development receive regulatory approval. In addition, clinicians occasionally make therapeutic decisions based on phase II data. Therefore, clinicians, investigators, and regulatory agencies require improved understanding of the implications of positive phase II studies. We hypothesized that prior probability of eventual drug approval was significantly different across GI cancers, with substantial ramifications for the predictive value of phase II studies. Methods We conducted a systematic search of phase II studies conducted between 1999 and 2004 and compared studies against US Food and Drug Administration and National Cancer Institute databases of approved indications for drugs tested in those studies. Results In all, 317 phase II trials were identified and followed for a median of 12.5 years. Following completion of phase III studies, eventual new drug application approval rates varied from 0% (zero of 45) in pancreatic adenocarcinoma to 34.8% (24 of 69) for colon adenocarcinoma. The proportion of drugs eventually approved was correlated with the disease under study (P < .001). The median type I error for all published trials was 0.05, and the median type II error was 0.1, with minimal variation. By using the observed median type I error for each disease, phase II studies have positive predictive values ranging from less than 1% to 90%, depending on primary site of the cancer. Conclusion Phase II trials in different GI malignancies have distinct prior probabilities of drug approval, yielding quantitatively and qualitatively different predictive values with similar statistical designs. Incorporation of prior probability into trial design may allow for more effective design and interpretation of phase II studies. PMID:26261263

75 FR 52711 - Notice of Request for Approval of an Information Collection; National Animal Health Monitoring...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-27

...] Notice of Request for Approval of an Information Collection; National Animal Health Monitoring System... to support the National Animal Health Monitoring System Sheep 2011 Study. DATES: We will consider all... Coordinator, at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: National Animal Health Monitoring System...

23 CFR 810.308 - Approval of urban system nonhighway public mass transit projects.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false Approval of urban system nonhighway public mass transit projects. 810.308 Section 810.308 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PUBLIC TRANSPORTATION MASS TRANSIT AND SPECIAL USE HIGHWAY PROJECTS Federal-Aid Urban System Nonhighway...

39 CFR 501.1 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... limited to postage meters and PC Postage systems. (b) A postage meter is a Postal Service-approved Postage... this part refers to a postage meter. (c) PC Postage products are Postal Service-approved Postage Evidencing Systems that use a personal computer as an integral part of the system. PC Postage products may...

49 CFR 1544.231 - Airport-approved and exclusive area personnel identification systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... carry out a personnel identification system for identification media that are airport-approved, or identification media that are issued for use in an exclusive area. The system must include the following: (1) Personnel identification media that— (i) Convey a full face image, full name, employer, and identification...

77 FR 65433 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Approving a Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-26

...-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Approving a Proposed Rule Change To Amend the Real-Time Transaction Reporting System Information System and Subscription Service October 22...'') information system. The proposed rule change was published for comment in the Federal Register on September 12...

Mobility Demonstrator

DTIC Science & Technology

2013-08-22

charging system for increased power density. Compact two-stage turbocharger systems. UNCLASSIFIED: Distribution Statement A. Approved for public...advanced waste heat recovery, solid state cooling, turbocharging /turbocompounding UNCLASSIFIED: Distribution Statement A. Approved for public release... Turbocharging For Official Use Only For Official Use Only 77 •System – develop components capable of handling multiple roles within thermal

78 FR 34151 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-06

... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket Number FRA-2013-0050] Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... of a signal system. FRA assigned the petition Docket Number FRA-2013-0050. Applicant: Wisconsin...

76 FR 18623 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-04

... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket Number FRA-2011-0023] Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System Pursuant to... of the signal system, as detailed below. Applicant: Elgin, Joliet and Eastern Railway Company, Mr...

42 CFR 403.318 - Approval of State systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Approval of State systems. 403.318 Section 403.318 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS SPECIAL PROGRAMS AND PROJECTS Recognition of State Reimbursement Control Systems § 403.318...

30 CFR 36.49 - Tests of exhaust-gas dilution system.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Tests of exhaust-gas dilution system. 36.49..., EVALUATION, AND APPROVAL OF MINING PRODUCTS APPROVAL REQUIREMENTS FOR PERMISSIBLE MOBILE DIESEL-POWERED TRANSPORTATION EQUIPMENT Test Requirements § 36.49 Tests of exhaust-gas dilution system. The performance and...

30 CFR 36.49 - Tests of exhaust-gas dilution system.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Tests of exhaust-gas dilution system. 36.49..., EVALUATION, AND APPROVAL OF MINING PRODUCTS APPROVAL REQUIREMENTS FOR PERMISSIBLE MOBILE DIESEL-POWERED TRANSPORTATION EQUIPMENT Test Requirements § 36.49 Tests of exhaust-gas dilution system. The performance and...

78 FR 16619 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-18

...-0308] RIN 3150-AJ22 List of Approved Spent Fuel Storage Casks: MAGNASTOR[supreg] System AGENCY: Nuclear... proposing to amend its spent fuel storage regulations by revising the NAC International, Inc., Modular Advanced Generation Nuclear All-purpose Storage (MAGNASTOR[supreg]) Cask System listing within the ``List...

48 CFR 32.503-4 - Approval of progress payment requests.

Code of Federal Regulations, 2010 CFR

2010-10-01

... contractor's accounting system and controls have been established (see 32.503-3 above) the ACO may, in... that accounting system and upon the contractor's certification, without requiring audit or review of... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Approval of progress...

77 FR 69844 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-21

... FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY: Board of Governors of the Federal Reserve System... of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320...

30 CFR 77.700-1 - Approved methods of grounding.

Code of Federal Regulations, 2014 CFR

2014-07-01

... in resistance grounded systems, where the enclosed conductors are a part of the system, will be approved if a solid connection is made to the neutral conductor; in all other systems, the following... earth; (b) A solid connection to a grounding conductor, other than the neutral conductor of a resistance...

30 CFR 77.700-1 - Approved methods of grounding.

Code of Federal Regulations, 2012 CFR

2012-07-01

... in resistance grounded systems, where the enclosed conductors are a part of the system, will be approved if a solid connection is made to the neutral conductor; in all other systems, the following... earth; (b) A solid connection to a grounding conductor, other than the neutral conductor of a resistance...

78 FR 66077 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-04

... Investigation Professional, Technical, and Administrative Positions.'' 2. Current OMB approval number: 3150-0033... 212, ``Qualifications Investigation, Professional, Technical, and Administrative Positions'' is used... writing or in electronic form will be made available for public inspection. Because your comments will not...

76 FR 21943 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-19

... Discontinuance or Modification of a Railroad Signal System Pursuant to Title 49 Code of Federal Regulations (CFR... Administration (FRA) seeking approval for the discontinuance or modification of the signal system, as detailed... block signal system (ABS) on three sections of the Roseburg Subdivision and on one section of the...

Antibodies to watch in 2017

PubMed Central

Reichert, Janice M.

2017-01-01

ABSTRACT Over 50 investigational monoclonal antibody (mAb) therapeutics are currently undergoing evaluation in late-stage clinical studies, which is expected to drive a trend toward first marketing approvals of at least 6–9 mAbs per year in the near-term. In the United States (US), a total of 6 and 9 mAbs were granted first approvals during 2014 and 2015, respectively; all these products are also approved in the European Union (EU). As of December 1, 2016, 6 mAbs (atezolizumab, olaratumab, reslizumab, ixekizumab, bezlotoxumab, oblitoxaximab) had been granted first approvals during 2016 in either the EU or US. Brodalumab, was granted a first approval in Japan in July 2016. Regulatory actions on marketing applications for brodalumab in the EU and US are not expected until 2017. In 2017, first EU or US approvals may also be granted for at least nine mAbs (ocrelizumab, avelumab, Xilonix, inotuzumab ozogamicin, dupilumab, sirukumab, sarilumab, guselkumab, romosozumab) that are not yet approved in any country. Based on announcements of company plans for regulatory submissions and the estimated completion dates for late-stage clinical studies, and assuming the study results are positive, marketing applications for at least 6 antibody therapeutics (benralizumab, tildrakizumab, emicizumab, galcanezumab, ibalizumab, PRO-140) that are now being evaluated in late-stage clinical studies may be submitted during December 2016* or 2017. Other ‘antibodies to watch' in 2017 include 20 mAbs are undergoing evaluation in pivotal studies that have estimated primary completion dates in late 2016 or during 2017. Of these, 5 mAbs are for cancer (durvalumab, JNJ-56022473, ublituximab, anetumab ravtansine, glembatumumab vedotin) and 15 mAbs are for non-cancer indications (caplacizumab, lanadelumab, roledumab, tralokinumab, risankizumab, SA237, emapalumab, suptavumab, erenumab, eptinezumab, fremanezumab, fasinumab, tanezumab, lampalizumab, brolucizumab). Positive results from these studies may enable submission of marketing applications in 2017 or 2018, or provide justification for additional studies. *See note added in proof for update through December 31, 2016. PMID:27960628

Section 609 Technician Training and Certification Programs

EPA Pesticide Factsheets

EPA-approved programs for technicians who service motor vehicle air conditioning (MVAC) systems. Any person who repairs or services a MVAC system for consideration must be certified under section 609 of the Clean Air Act by an EPA-approved program.

48 CFR 9.304 - Exceptions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Exceptions. 9.304 Section 9.304 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION ACQUISITION PLANNING CONTRACTOR QUALIFICATIONS First Article Testing and Approval 9.304 Exceptions. Normally, testing and approval...

76 FR 39874 - Information Collection Approved by the Office of Management and Budget

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... FEDERAL COMMUNICATIONS COMMISSION Information Collection Approved by the Office of Management and... Commission has received Office of Management and Budget (OMB) approval for the following public information... the carriers through the Automated Reporting Management Information System (ARMIS). Federal...

48 CFR 752.7032 - International travel approval and notification requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 5 2012-10-01 2012-10-01 false International travel... of USAID Contract Clauses 752.7032 International travel approval and notification requirements. For use in any USAID contract requiring international travel. International Travel Approval and...

48 CFR 752.7032 - International travel approval and notification requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false International travel... of USAID Contract Clauses 752.7032 International travel approval and notification requirements. For use in any USAID contract requiring international travel. International Travel Approval and...

48 CFR 752.7032 - International travel approval and notification requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false International travel... of USAID Contract Clauses 752.7032 International travel approval and notification requirements. For use in any USAID contract requiring international travel. International Travel Approval and...

48 CFR 752.7032 - International travel approval and notification requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false International travel... of USAID Contract Clauses 752.7032 International travel approval and notification requirements. For use in any USAID contract requiring international travel. International Travel Approval and...

48 CFR 752.7032 - International travel approval and notification requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false International travel... of USAID Contract Clauses 752.7032 International travel approval and notification requirements. For use in any USAID contract requiring international travel. International Travel Approval and...

Electronic Approval: Another Step toward a Paperless Office.

ERIC Educational Resources Information Center

Blythe, Kenneth C.; Morrison, Dennis L.

1992-01-01

Pennsylvania State University's award-winning electronic approval system allows administrative documents to be electronically generated, approved, and updated in the university's central database. Campus business can thus be conducted faster, less expensively, more accurately, and with greater security than with traditional paper approval…

Acoustic Differences between Humorous and Sincere Communicative Intentions

ERIC Educational Resources Information Center

Hoicka, Elena; Gattis, Merideth

2012-01-01

Previous studies indicate that the acoustic features of speech discriminate between positive and negative communicative intentions, such as approval and prohibition. Two studies investigated whether acoustic features of speech can discriminate between two positive communicative intentions: humour and sweet-sincerity, where sweet-sincerity involved…

Risk of Using Past to Predict Future: A Case Study of Jamming RCIEDs

DTIC Science & Technology

2009-06-01

Herrera THIS PAGE INTENTIONALLY LEFT BLANK i REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188 Public reporting burden for this...Approved by: Kyle Y. Lin Thesis Advisor Michael A. Herrera Second Reader Robert F. Dell Chairman, Department of Operations...and continue forward. Thank you, CDR Michael Herrera , for your constant positive support and never allowing for me to lose sight of the goal. Dr

Enhancing Quality of Life for Breast Cancer Patients with Bone Metastases

DTIC Science & Technology

2008-04-01

Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188...Approved for Public Release; Distribution Unlimited 13. SUPPLEMENTARY NOTES 14. ABSTRACT See Next Page . 15. SUBJECT TERMS Breast...CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a. NAME OF RESPONSIBLE PERSON USAMRMC a. REPORT U b. ABSTRACT U c. THIS PAGE U

Applying science and strategy to operating room workforce management.

PubMed

Butler, Victoria; Clinton, Christopher; Sagi, Harsha K; Kenney, Robert; Barsoum, Wael K

2012-01-01

The traditional means of planning nurse staffing for operating rooms are either poorly translated to the setting or do not provide decision makers with a platform to defend their needs, especially in an era of health care reform. The surgical operations department of the Cleveland Clinic initiated a quality improvement project aimed at applying a scientific method to operating room staffing. One goal was to provide a defensible plan for allocating direct caregiver positions. A second goal was to provide a quick and easy way for nurse managers and directors to track positions and graphically depict the effect of vacancies and orientation on their staffing budgets. Using an objective, scientific method allows position requests to be approved quickly and allows managers to feel much more comfortable functioning in a "lean" mode because they know needed positions will be approved quickly. Managers and directors also have found that graphically depicting numbers of vacant positions, as well as staff in orientation, could quickly relate a story visually rather than getting "bogged down" in narrative (often losing finance administrators along the way).

76 FR 2277 - List of Approved Spent Fuel Storage Casks: NUHOMS® HD System Revision 1

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-13

... Fuel Storage Casks: NUHOMS[supreg] HD System Revision 1 AGENCY: Nuclear Regulatory Commission. ACTION... amend its spent fuel storage cask regulations by revising the Transnuclear, Inc. (TN) NUHOMS[supreg] HD System listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 1 to...

76 FR 19739 - Approval and Promulgation of Implementation Plans; Texas; System Cap Trading Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-08

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2005-TX-0013; FRL-9290-1] Approval and Promulgation of Implementation Plans; Texas; System Cap Trading Program AGENCY: Environmental Protection Agency... the System Cap Trading (SCT) Program at Title 30 Texas Administrative Code, Chapter 101--General Air...

78 FR 9106 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... modification of a signal system. FRA assigned the petition Docket Number FRA-2012-0099. Applicant: Norfolk...-throw switch. NS seeks to make these proposed changes to modernize its signal equipment and install...

77 FR 2774 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-19

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... modification of a signal system. FRA has reopened and assigned the application Docket Number FRA-2003-15754. Applicant: Reading, Blue Mountain and Northern Railroad, Mr. Jonathan Barket, AVP, Communications & Signals...

77 FR 48204 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... modification of a signal system. FRA assigned the petition docket number FRA-2012-0064. Applicant: Union Pacific Railroad Company, Mr. Phillip A. Danner, AVP Engineering-Signal, 1400 Douglas Street, MS 0910...

78 FR 77785 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... discontinuance or modification of a signal system. FRA assigned the petition Docket Number FRA-2013-0125. Applicants: Union Pacific Railroad, Mr. Phillip A. Danner, AVP Engineering-Signal, 1400 Douglas Street, MS...

75 FR 71488 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-23

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System Pursuant to... of the signal system, as detailed below. Applicant: CSX Transportation, Mr. Joseph Ivanyo, Chief Engineer, Communications and Signals, 500 Water Street, SC J-350, Jacksonville, FL 32202. The CSX...

77 FR 40700 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-10

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... discontinuance or modification of a signal system. FRA assigned the petition Docket Number FRA-2012-0053. Applicant: Alabama and Tennessee River Railway LLC, Mr. Jason Scott, Vice President Signals & Communications...

48 CFR 252.227-7024 - Notice and approval of restricted designs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 3 2013-10-01 2013-10-01 false Notice and approval of restricted designs. 252.227-7024 Section 252.227-7024 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CLAUSES AND FORMS SOLICITATION PROVISIONS AND CONTRACT CLAUSES Text of Provisions And Clauses...

48 CFR 252.227-7024 - Notice and approval of restricted designs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 3 2014-10-01 2014-10-01 false Notice and approval of restricted designs. 252.227-7024 Section 252.227-7024 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CLAUSES AND FORMS SOLICITATION PROVISIONS AND CONTRACT CLAUSES Text of Provisions And Clauses...

14 CFR 25.857 - Cargo compartment classification.

Code of Federal Regulations, 2012 CFR

2012-01-01

... detector or fire detector system to give warning at the pilot or flight engineer station. (c) Class C. A... compartment but in which— (1) There is a separate approved smoke detector or fire detector system to give... a separate approved smoke or fire detector system to give warning at the pilot or flight engineer...

14 CFR 25.857 - Cargo compartment classification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... detector or fire detector system to give warning at the pilot or flight engineer station. (c) Class C. A... compartment but in which— (1) There is a separate approved smoke detector or fire detector system to give... a separate approved smoke or fire detector system to give warning at the pilot or flight engineer...

14 CFR 25.857 - Cargo compartment classification.

Code of Federal Regulations, 2013 CFR

2013-01-01

... detector or fire detector system to give warning at the pilot or flight engineer station. (c) Class C. A... compartment but in which— (1) There is a separate approved smoke detector or fire detector system to give... a separate approved smoke or fire detector system to give warning at the pilot or flight engineer...

14 CFR 25.857 - Cargo compartment classification.

Code of Federal Regulations, 2014 CFR

2014-01-01

... detector or fire detector system to give warning at the pilot or flight engineer station. (c) Class C. A... compartment but in which— (1) There is a separate approved smoke detector or fire detector system to give... a separate approved smoke or fire detector system to give warning at the pilot or flight engineer...

14 CFR 25.857 - Cargo compartment classification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... detector or fire detector system to give warning at the pilot or flight engineer station. (c) Class C. A... compartment but in which— (1) There is a separate approved smoke detector or fire detector system to give... a separate approved smoke or fire detector system to give warning at the pilot or flight engineer...

New Evaluation System Wins Approval

ERIC Educational Resources Information Center

Barrett, Laura

2011-01-01

All Massachusetts school districts will have to adopt new evaluation systems based on a state framework that was approved by the Board of Elementary and Secondary Education on June 28. The new system will be phased in over three years, beginning with Level 4 schools--those designated "underperforming" by the state--in the 2011-12 school…

78 FR 5430 - Extension of Approval Period for Certain Tests Used in the National Reporting System for Adult...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

... DEPARTMENT OF EDUCATION Extension of Approval Period for Certain Tests Used in the National Reporting System for Adult Education AGENCY: Office of Vocational and Adult Education, Department of... National Reporting System for Adult Education (NRS regulations) (73 FR 2306). The NRS regulations...

48 CFR 301.106 - Office of Management and Budget approval under the Paperwork Reduction Act.

Code of Federal Regulations, 2012 CFR

2012-10-01

... approval from the Office of Management and Budget (OMB) before collecting the same information from 10 or... 48 Federal Acquisition Regulations System 4 2012-10-01 2012-10-01 false Office of Management and... Regulations System HEALTH AND HUMAN SERVICES GENERAL HHS ACQUISITION REGULATION SYSTEM Purpose, Authority, and...

48 CFR 301.106 - Office of Management and Budget approval under the Paperwork Reduction Act.

Code of Federal Regulations, 2013 CFR

2013-10-01

... approval from the Office of Management and Budget (OMB) before collecting the same information from 10 or... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Office of Management and... Regulations System HEALTH AND HUMAN SERVICES GENERAL HHS ACQUISITION REGULATION SYSTEM Purpose, Authority, and...

48 CFR 301.106 - Office of Management and Budget approval under the Paperwork Reduction Act.

Code of Federal Regulations, 2014 CFR

2014-10-01

... approval from the Office of Management and Budget (OMB) before collecting the same information from 10 or... 48 Federal Acquisition Regulations System 4 2014-10-01 2014-10-01 false Office of Management and... Regulations System HEALTH AND HUMAN SERVICES GENERAL HHS ACQUISITION REGULATION SYSTEM Purpose, Authority, and...

48 CFR 301.106 - Office of Management and Budget approval under the Paperwork Reduction Act.

Code of Federal Regulations, 2011 CFR

2011-10-01

... approval from the Office of Management and Budget (OMB) before collecting the same information from 10 or... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Office of Management and... Regulations System HEALTH AND HUMAN SERVICES GENERAL HHS ACQUISITION REGULATION SYSTEM Purpose, Authority, and...

78 FR 4144 - Tentative Approval and Solicitation of Request for a Public Hearing for Public Water System...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-18

... Public Hearing for Public Water System Supervision Program Revision for New York AGENCY: Environmental... approved Public Water System Supervision Program to adopt EPA's National Primary Drinking Water Regulations..., 24th Floor Drinking Water Ground Water Protection Section, 290 Broadway, New York, New York 10007-1866...

77 FR 18809 - Notice of Tentative Approval and Opportunity for Public Comment and Public Hearing for Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

... Public Comment and Public Hearing for Public Water System Supervision Program Revision for Virginia... revising its approved Public Water System Supervision Program. The Commonwealth has adopted the drinking... by reducing public water system consumers' risk of microbial illness from drinking water. EPA has...

75 FR 5638 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-03

... Discontinuance or Modification of a Railroad Signal System or Relief From the Requirements of Title 49 Code of... approval for the discontinuance or modification of the signal system or relief from the requirements of 49... Signal System (ABS) on the entire railroad line between, but not including, the point of ownership at the...

Criteria for Operational Approval of Auto Guidance Systems

DOT National Transportation Integrated Search

1997-03-18

This advisory circular (AC) states an acceptable means, but not the only means, : for obtaining operational approval of the initial engagement or use of an Auto : Flight Guidance System (AFGS) under Title 14 of the Code of Federal Regulations : (14 C...

Inventory information approval system certification and flexible spending account purchases.

PubMed

Shuey, Brandon; Williams, La Vonn A

2010-01-01

There is no question that 2009 was a year of change within the pharmacy industry. Several new requirements were implemented, including the need for an Inventory Information Approval System for accepting flexible spending or health reimbursement account cords. Some pharmacies relied on the 90% exemption rule, which is discussed within this article, or an alternative method to avoid the expense of a point of sale. However, with flexible spending or health reimbursement account card participation expected to reach 85% in 2010, now bay be the time for compounding pharmacists to weigh the pros and cons of Inventory Information Approval System certification.

Overall survival with crizotinib and next-generation ALK inhibitors in ALK-positive non-small-cell lung cancer (IFCT-1302 CLINALK): a French nationwide cohort retrospective study.

PubMed

Duruisseaux, Michaël; Besse, Benjamin; Cadranel, Jacques; Pérol, Maurice; Mennecier, Bertrand; Bigay-Game, Laurence; Descourt, Renaud; Dansin, Eric; Audigier-Valette, Clarisse; Moreau, Lionel; Hureaux, José; Veillon, Remi; Otto, Josiane; Madroszyk-Flandin, Anne; Cortot, Alexis; Guichard, François; Boudou-Rouquette, Pascaline; Langlais, Alexandra; Missy, Pascale; Morin, Franck; Moro-Sibilot, Denis

2017-03-28

Overall survival (OS) with the anaplastic lymphoma kinase (ALK) inhibitor (ALKi) crizotinib in a large population of unselected patients with ALK-positive non-small-cell lung cancer (NSCLC) is not documented. We sought to assess OS with crizotinib in unselected ALK-positive NSCLC patients and whether post-progression systemic treatments affect survival outcomes.ALK-positive NSCLC patients receiving crizotinib in French expanded access programs or as approved drug were enrolled. We collected clinical and survival data, RECIST-defined progressive disease (PD) and post-PD systemic treatment efficacy. We performed multivariable analysis of OS from crizotinib initiation and PD under crizotinib.At time of analysis, 209 (65.7%) of the 318 included patients had died. Median OS with crizotinib was 16.6 months. The line of crizotinib therapy did not impact survival outcomes. Of the 263 patients with PD, 105 received best supportive care, 74 subsequent drugs other than next-generation ALKi and 84 next-generation ALKi. Next-generation ALKi treatment correlated with better survival outcomes in multivariate analysis. These patients had a median post-PD survival of 25.0 months and median OS from metastatic disease diagnosis of 89.6 months.Unselected ALK-positive NSCLC patients achieve good survival outcomes with crizotinib therapy. Next-generation ALKi may provide survival improvement after PD under crizotinib.

49 CFR 1544.231 - Airport-approved and exclusive area personnel identification systems.

Code of Federal Regulations, 2013 CFR

2013-10-01

... (Continued) TRANSPORTATION SECURITY ADMINISTRATION, DEPARTMENT OF HOMELAND SECURITY CIVIL AVIATION SECURITY AIRCRAFT OPERATOR SECURITY: AIR CARRIERS AND COMMERCIAL OPERATORS Operations § 1544.231 Airport-approved... 49 Transportation 9 2013-10-01 2013-10-01 false Airport-approved and exclusive area personnel...

Positive Feelings After Casual Sex: The Role of Gender and Traditional Gender-Role Beliefs.

PubMed

Woerner, Jacqueline; Abbey, Antonia

2017-01-01

The purpose of this study was to identify predictors of positive and negative affect following casual sex. Specifically, the primary goal was to investigate how traditional gender-role beliefs, peer approval of casual sex, perceptions of others, sexual assertiveness, and sexual pleasure influence affective experiences. Second, we aimed to determine the extent to which these associations were comparable for men and women. Although we expected mean differences on many of these constructs (e.g., men perceiving more peer approval), we expected the relationships between these constructs to be comparable for women and men. Participants ages 18 to 35 (N = 585) were recruited from a large university and Amazon Mechanical Turk (MTurk) and described their most recent casual sex experience in a self-report questionnaire. Structural equation modeling (SEM) analyses indicated that gender-role beliefs were significantly associated with less sexual assertiveness and more negative perceptions of others; for women they were also associated with less peer approval of casual sex. For women and men, sexual assertiveness predicted sexual pleasure; and sexual pleasure was associated with affect. To decrease the gender discrepancy in positive affect and sexual pleasure, it is important to develop a comprehensive understanding of the interrelationships among norms, casual sex experiences, and affect.

A paper form processing system with an error correcting function for reading handwritten Kanji strings

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

Katsumi Marukawa; Kazuki Nakashima; Masashi Koga

1994-12-31

This paper presents a paper form processing system with an error correcting function for reading handwritten kanji strings. In the paper form processing system, names and addresses are important key data, and especially this paper takes up an error correcting method for name and address recognition. The method automatically corrects errors of the kanji OCR (Optical Character Reader) with the help of word dictionaries and other knowledge. Moreover, it allows names and addresses to be written in any style. The method consists of word matching {open_quotes}furigana{close_quotes} verification for name strings, and address approval for address strings. For word matching, kanjimore » name candidates are extracted by automaton-type word matching. In {open_quotes}furigana{close_quotes} verification, kana candidate characters recognized by the kana OCR are compared with kana`s searched from the name dictionary based on kanji name candidates, given by the word matching. The correct name is selected from the results of word matching and furigana verification. Also, the address approval efficiently searches for the right address based on a bottom-up procedure which follows hierarchical relations from a lower placename to a upper one by using the positional condition among the placenames. We ascertained that the error correcting method substantially improves the recognition rate and processing speed in experiments on 5,032 forms.« less

Marketing Approval of Ethical Kampo Medicines.

PubMed

Hakamatsuka, Takashi

2017-01-01

Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

Nanoparticles in the clinic

PubMed Central

Anselmo, Aaron C.

2016-01-01

Abstract Nanoparticle/microparticle‐based drug delivery systems for systemic (i.e., intravenous) applications have significant advantages over their nonformulated and free drug counterparts. For example, nanoparticle systems are capable of delivering therapeutics and treating areas of the body that other delivery systems cannot reach. As such, nanoparticle drug delivery and imaging systems are one of the most investigated systems in preclinical and clinical settings. Here, we will highlight the diversity of nanoparticle types, the key advantages these systems have over their free drug counterparts, and discuss their overall potential in influencing clinical care. In particular, we will focus on current clinical trials for nanoparticle formulations that have yet to be clinically approved. Additional emphasis will be on clinically approved nanoparticle systems, both for their currently approved indications and their use in active clinical trials. Finally, we will discuss many of the often overlooked biological, technological, and study design challenges that impact the clinical success of nanoparticle delivery systems. PMID:29313004

Collisionless Electrostatic Shock Modeling and Simulation

DTIC Science & Technology

2016-10-21

unlimited. PA#16490 Dissipation Controls Wave Train Under- and Over-damped Shocks – Under-damped: • Dissipation is weak, ripples persist. • High...Density Position – Over-damped: ● Strong dissipation damps ripples . ● Low Density Position 12 Position Distribution A. Approved for public release...distribution unlimited. PA#16490 Model Verification Comparison with Linearized Solution – Evolution of the First Ripple Wavelength: • Simulated

Suborbital commercial spaceflight crewmember medical issues.

PubMed

2011-04-01

As directed by the Council of the Aerospace Medical Association, the Commercial Spaceflight Working Group has developed the following position paper concerning medical issues for commercial suborbital spaceflight crewmembers. This position paper has been approved by the AsMA Council to become a policy of the AsMA.

78 FR 79455 - Information Collection; System for Award Management Registration Requirements for Prime Grant...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

...Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a renewal of the currently approved information collection requirement regarding the pre-award registration requirements for Prime Grant Recipients. The title of the approved information collection is Central Contractor Registration Requirements for Prime Grant Recipients (OMB Control Number 3090-0290). The updated information collection title, based on the migration of the Central Contractor Registration system to the System for Award Management in late July 2012, is System for Award Management Registration Requirements for Prime Grant Recipients.

33 CFR 173.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

...: (a) [Reserved] (b) Issuing authority means a State that has a numbering system approved by the Coast Guard or the Coast Guard where a number system has not been approved. Issuing authorities are listed in..., firm, partnership, corporation, company, association, joint-stock association, or governmental entity...

48 CFR 606.304 - Approval of the justification.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Approval of the justification. 606.304 Section 606.304 Federal Acquisition Regulations System DEPARTMENT OF STATE COMPETITION AND ACQUISITION PLANNING COMPETITION REQUIREMENTS Other Than Full and Open Competition 606.304...

Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

PubMed

Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki

2018-02-01

Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd.

46 CFR 125.160 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... of Inspection. Anti-exposure suit means a protective suit designed for use by rescue boat crews and marine evacuation system parties. Approval series means the first six digits of a number assigned by the..., the approval series corresponds to the number of the subpart. A listing of approved equipment...

46 CFR 125.160 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... of Inspection. Anti-exposure suit means a protective suit designed for use by rescue boat crews and marine evacuation system parties. Approval series means the first six digits of a number assigned by the..., the approval series corresponds to the number of the subpart. A listing of approved equipment...

46 CFR 125.160 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... of Inspection. Anti-exposure suit means a protective suit designed for use by rescue boat crews and marine evacuation system parties. Approval series means the first six digits of a number assigned by the..., the approval series corresponds to the number of the subpart. A listing of approved equipment...

46 CFR 125.160 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... of Inspection. Anti-exposure suit means a protective suit designed for use by rescue boat crews and marine evacuation system parties. Approval series means the first six digits of a number assigned by the..., the approval series corresponds to the number of the subpart. A listing of approved equipment...

14 CFR 77.2 - Definition of terms.

Code of Federal Regulations, 2011 CFR

2011-01-01

... approach system is planned and is so indicated by an FAA approved airport layout plan; a military service approved military airport layout plan; any other FAA planning document, or military service military... layout plan, a military service approved military airport layout plan, or by any planning document...

75 FR 52710 - Notice of Request for Extension of Approval of an Information Collection; National Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-27

...] Notice of Request for Extension of Approval of an Information Collection; National Management Information... approval of an information collection associated with cooperative wildlife damage management programs...: For information on the national management information system for cooperative wildlife damage...

77 FR 71774 - Notice of Request for Extension of Approval of an Information Collection; National Management...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-04

...] Notice of Request for Extension of Approval of an Information Collection; National Management Information... approval of an information collection associated with cooperative wildlife damage management programs... FURTHER INFORMATION CONTACT: For information on the national management information system for cooperative...

48 CFR 2052.215-77 - Travel approvals and reimbursement.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Travel approvals and....215-77 Travel approvals and reimbursement. As prescribed at 2015.209-70(d), the contracting officer shall insert the following clause in cost reimbursement solicitations and contracts which require travel...

48 CFR 2052.215-77 - Travel approvals and reimbursement.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Travel approvals and....215-77 Travel approvals and reimbursement. As prescribed at 2015.209-70(d), the contracting officer shall insert the following clause in cost reimbursement solicitations and contracts which require travel...

48 CFR 2052.215-77 - Travel approvals and reimbursement.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Travel approvals and....215-77 Travel approvals and reimbursement. As prescribed at 2015.209-70(d), the contracting officer shall insert the following clause in cost reimbursement solicitations and contracts which require travel...

48 CFR 2052.215-77 - Travel approvals and reimbursement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Travel approvals and....215-77 Travel approvals and reimbursement. As prescribed at 2015.209-70(d), the contracting officer shall insert the following clause in cost reimbursement solicitations and contracts which require travel...

48 CFR 2052.215-77 - Travel approvals and reimbursement.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Travel approvals and....215-77 Travel approvals and reimbursement. As prescribed at 2015.209-70(d), the contracting officer shall insert the following clause in cost reimbursement solicitations and contracts which require travel...

14 CFR 414.19 - Technical criteria for reviewing a safety approval application.

Code of Federal Regulations, 2011 CFR

2011-01-01

...-developed criteria must define— (i) Design and minimum performance; (ii) Quality assurance system... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Technical criteria for reviewing a safety... AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Safety Approval Review and...

42 CFR 433.113 - Reduction of FFP for failure to operate a system and obtain initial approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Reduction of FFP for failure to operate a system... ADMINISTRATION Mechanized Claims Processing and Information Retrieval Systems § 433.113 Reduction of FFP for failure to operate a system and obtain initial approval. (a) Except as waived under § 433.130 or 433.131...

Safety Arguments for Next Generation, Location Aware Computing

NASA Technical Reports Server (NTRS)

Johnson, C. W.; Holloway, C. M.

2010-01-01

Concerns over accuracy, availability, integrity, and continuity have limited the integration of Global Positioning System (GPS) and Global Navigation Satellite System (GLONASS) for safety-critical applications. More recent augmentation systems, such as the European Geostationary Navigation Overlay Service (EGNOS) and the North American Wide Area Augmentation System (WAAS) have begun to address these concerns. Augmentation architectures build on the existing GPS/GLONASS infrastructures to support location based services in Safety of Life (SoL) applications. Much of the technical development has been directed by air traffic management requirements, in anticipation of the more extensive support to be offered by GPS III and Galileo. WAAS has already been approved to provide vertical guidance for aviation applications. During the next twelve months, the full certification of EGNOS for SoL applications is expected. This paper discusses similarities and differences between the safety assessment techniques used in Europe and North America.

42 CFR 488.68 - State Agency responsibilities for OASIS collection and data base requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... operating the OASIS system: (a) Establish and maintain an OASIS database. The State agency or other entity designated by CMS must— (1) Use a standard system developed or approved by CMS to collect, store, and analyze..., system back-up, and monitoring the status of the database; and (3) Obtain CMS approval before modifying...

30 CFR 285.811 - When must I follow my Safety Management System?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Activities Conducted Under SAPs, COPs and GAPs Safety Management Systems § 285.811 When must I follow my... activities described in your approved COP, SAP, or GAP. You must conduct all activities described in your approved COP, SAP, or GAP in accordance with the Safety Management System you described, as required by...

30 CFR 77.701-2 - Approved methods of grounding metallic frames, casings, and other enclosures of electric...

Code of Federal Regulations, 2010 CFR

2010-07-01

... from a direct-current power system with one polarity grounded will be approved: (1) A solid connection..., casings, and other enclosures of electric equipment receiving power from a direct-current power system. 77... enclosures of electric equipment receiving power from a direct-current power system. (a) The following...

30 CFR 77.701-2 - Approved methods of grounding metallic frames, casings, and other enclosures of electric...

Code of Federal Regulations, 2011 CFR

2011-07-01

... from a direct-current power system with one polarity grounded will be approved: (1) A solid connection..., casings, and other enclosures of electric equipment receiving power from a direct-current power system. 77... enclosures of electric equipment receiving power from a direct-current power system. (a) The following...

75 FR 71487 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-23

... Discontinuance or Modification of a Railroad Signal System Pursuant to Title 49 Code of Federal Regulations (CFR... Administration (FRA) seeking approval for the discontinuance or modification of a signal system, as detailed below. Docket Number FRA-2010-0159 Applicant: BNSF Railway, Mr. James LeVere, AVP Signals, BNSF Railway...

76 FR 4416 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

... Discontinuance or Modification of a Railroad Signal System Pursuant to Title 49 Code of Federal Regulations (CFR... Administration (FRA) seeking approval for the discontinuance or modification of the signal system. [Docket Number...--Signal/Comm./TCO, 1400 Douglas Street, Mail Stop 0910, Omaha, Nebraska 68179. The Union Pacific Railroad...

75 FR 29805 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

... Discontinuance or Modification of a Railroad Signal System or Relief Pursuant to title 49 Code of Federal... Administration (FRA) seeking approval for the discontinuance or modification of the signal system, or relief as... Trump, AVP Engineering--Signal/Comm/TCO, 1400 Douglas Street, STOP 0910, Omaha, Nebraska 68179. The...

75 FR 70771 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-18

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System Pursuant to... of the signal system, as detailed below. Applicant: Twin Cities & Western Railroad Company, Mr. Mark... Granite Falls, Minnesota. The modification consists of the movement of the west bound home signal, 98LA...

75 FR 47880 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-09

... Discontinuance or Modification of a Railroad Signal System or Relief Pursuant to Title 49 Code of Federal... Administration (FRA) seeking approval for the discontinuance or modification of the signal system or relief from... & Louisville Railway, Inc., Mr. C. D. Edwards, General Supervisor of Signals & Structures, 1500 Kentucky Avenue...

75 FR 43610 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-26

... Discontinuance or Modification of a Railroad Signal System Pursuant to Title 49 Code of Federal Regulations (CFR... Administration (FRA), seeking approval for the discontinuance or modification of the signal system or relief from... Transportation, Inc., Mr. Joseph S. Ivanyo, Chief Engineer, Communications and Signals, 500 Water Street, SC J...

76 FR 34801 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-14

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System In... the discontinuance or modification of a signal system. FRA assigned the petition Docket Number FRA... decrease of limits consists of moving the 2S signal on the siding south to the clearance point of the No...

75 FR 21717 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

... Discontinuance or Modification of a Railroad Signal System or Relief From the Requirements of Title 49 Code of... approval for the discontinuance or modification of the signal system or relief from the requirements of 49... signals shall be provided, relative to CN's EJ&E Griffith Connection project involving the Matteson...

42 CFR 403.308 - State systems under demonstration projects-mandatory approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false State systems under demonstration projects..., DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS SPECIAL PROGRAMS AND PROJECTS Recognition of State... approval of a State system are met under § 403.304 (b)(1)-(10) and § 403.304(c), and, if appropriate § 403...

76 FR 792 - Intent To Request Approval From OMB of One New Public Collection of Information: Exercise...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-06

... Exercise Information System (EXIS) is an Internet-accessible knowledge-management system developed by TSA... we will submit to the Office of Management and Budget (OMB) for approval in compliance with the... modes, or their regulated areas of operation. EXIS is a data management system that provides end-to-end...

48 CFR 1401.7001-3 - Administrative review and approval by bureaus and offices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Administrative review and approval by bureaus and offices. 1401.7001-3 Section 1401.7001-3 Federal Acquisition Regulations System DEPARTMENT OF THE INTERIOR GENERAL DEPARTMENT OF THE INTERIOR ACQUISITION REGULATION SYSTEM Acquisition Reviews 1401.7001-3 Administrative review...

Follow-up Evaluation of Air Force Blood Donors Screening Positive for Chagas Disease

DTIC Science & Technology

2017-08-27

abstract, paper. poster and other supporting documentation. 5. Save and forward. via email. the processing form and all supporting documentation to...letter of approval or disapproval. 9. Once your manuscript, poster or presentation has been approved for a one-time public release. you may proceed with...legal reviews. please contact the legal office at (210) 671-5795/3365. DSN 473. NOTE: All abstracts, papers, posters . etc .. should contain the

Logistics Modernization Program Increment 2 (LMP Inc 2)

DTIC Science & Technology

2016-03-01

Executive DoD - Department of Defense DoDAF - DoD Architecture Framework FD - Full Deployment FDD - Full Deployment Decision FY - Fiscal Year IA...Documentation within the LMP Increment 2 MS C ADM, the LMP Increment 2 Business Case was updated for the FDD using change pages to remove information...following approval of the Army Cost Position being developed for the FDD . The LMP Increment 2 Business Case Change Pages were approved and signed by the

A Study on the Feasibility of Creating a Web-Accessible Marine Mammal Sound Library Based upon the Collections at the Woods Hole Oceanographic Institution

DTIC Science & Technology

2008-09-01

NPS-OC-08-005 NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA Approved for public release; distribution is...official policy or position of the Department of Defense or the U.S. Government. 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public...release; distribution is unlimited. 12b. DISTRIBUTION CODE 13. ABSTRACT (maximum 200 words) A universally accessible web-based marine

78 FR 78285 - List of Approved Spent Fuel Storage Casks: HI-STORM 100 Cask System; Amendment No. 9

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-26

...-2012-0052] RIN 3150-AJ12 List of Approved Spent Fuel Storage Casks: HI-STORM 100 Cask System; Amendment... document proposed to amend the NRC's spent fuel storage regulations by revising the Holtec International HI...

48 CFR 1601.106 - OMB approval under the Paperwork Reduction Act.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false OMB approval under the Paperwork Reduction Act. 1601.106 Section 1601.106 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION GENERAL FEDERAL ACQUISITION...

48 CFR 1601.106 - OMB approval under the Paperwork Reduction Act.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false OMB approval under the Paperwork Reduction Act. 1601.106 Section 1601.106 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION GENERAL FEDERAL ACQUISITION...

9 CFR 318.309 - Finished product inspection.

Code of Federal Regulations, 2010 CFR

2010-01-01

... microbiological contamination; (2) An FSIS-approved total quality control system; (3) Alternative documented... associated with microbial contamination, where there is no approved total quality control system, or where... Office of Management and Budget under control number 0583-0015) [51 FR 45619, Dec. 19, 1986, as amended...

30 CFR 75.902-2 - Approved ground check systems not employing pilot check wires.

Code of Federal Regulations, 2014 CFR

2014-07-01

... pilot check wires. 75.902-2 Section 75.902-2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... employing pilot check wires. Ground check systems not employing pilot check wires will be approved only if... ground continuity is broken. ...

30 CFR 75.902-2 - Approved ground check systems not employing pilot check wires.

Code of Federal Regulations, 2012 CFR

2012-07-01

... pilot check wires. 75.902-2 Section 75.902-2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... employing pilot check wires. Ground check systems not employing pilot check wires will be approved only if... ground continuity is broken. ...

30 CFR 75.902-2 - Approved ground check systems not employing pilot check wires.

Code of Federal Regulations, 2013 CFR

2013-07-01

... pilot check wires. 75.902-2 Section 75.902-2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... employing pilot check wires. Ground check systems not employing pilot check wires will be approved only if... ground continuity is broken. ...

48 CFR 1406.304 - Approval of the justification.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Approval of the justification. 1406.304 Section 1406.304 Federal Acquisition Regulations System DEPARTMENT OF THE INTERIOR COMPETITION AND ACQUISITION PLANNING COMPETITION REQUIREMENTS Other Than Full and Open Competition 1406.304...

40 CFR 57.405 - Formulation, approval, and implementation of requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... completion of the measures specified in the approved plan evaluating the performance and adequacy of the SCS.... The reliability study shall include a comprehensive analysis of the system's operation during one or... (CONTINUED) AIR PROGRAMS (CONTINUED) PRIMARY NONFERROUS SMELTER ORDERS Supplementary Control System...

40 CFR 57.405 - Formulation, approval, and implementation of requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... completion of the measures specified in the approved plan evaluating the performance and adequacy of the SCS.... The reliability study shall include a comprehensive analysis of the system's operation during one or... (CONTINUED) AIR PROGRAMS (CONTINUED) PRIMARY NONFERROUS SMELTER ORDERS Supplementary Control System...

40 CFR 57.405 - Formulation, approval, and implementation of requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... completion of the measures specified in the approved plan evaluating the performance and adequacy of the SCS.... The reliability study shall include a comprehensive analysis of the system's operation during one or... (CONTINUED) AIR PROGRAMS (CONTINUED) PRIMARY NONFERROUS SMELTER ORDERS Supplementary Control System...

40 CFR 57.405 - Formulation, approval, and implementation of requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... completion of the measures specified in the approved plan evaluating the performance and adequacy of the SCS.... The reliability study shall include a comprehensive analysis of the system's operation during one or... (CONTINUED) AIR PROGRAMS (CONTINUED) PRIMARY NONFERROUS SMELTER ORDERS Supplementary Control System...

Enhancing Hormonal Therapy for Breast Cancer by Combination with a Well-Known Approved Pharmaceutical with Little Toxicity

DTIC Science & Technology

2008-07-01

node- positive , and estrogen receptor- positive breast cancer patients : a Southwest Oncology Group study. J Clin Oncol 12(10):2078–2085 7. Woods KE...official Department of the Army position , policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form...ER) positive metastatic breast cancer are limited by the phenomenon of hormonal resistance. We have found that valproic acid (VPA), a pharmaceutical

30 CFR 23.7 - Specific requirements for approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.7 Specific requirements for... apply. (g) Line powered telephones and signaling devices or systems shall be equipped with standby power... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Specific requirements for approval. 23.7...

30 CFR 23.7 - Specific requirements for approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.7 Specific requirements for... apply. (g) Line powered telephones and signaling devices or systems shall be equipped with standby power... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Specific requirements for approval. 23.7...

30 CFR 23.7 - Specific requirements for approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.7 Specific requirements for... apply. (g) Line powered telephones and signaling devices or systems shall be equipped with standby power... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Specific requirements for approval. 23.7...

41 CFR 102-38.110 - Who approves our determinations to conduct negotiated sales?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false Who approves our... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 38-SALE OF PERSONAL PROPERTY Sales Process Negotiated Sales § 102-38.110 Who approves our...

41 CFR 102-38.110 - Who approves our determinations to conduct negotiated sales?

Code of Federal Regulations, 2012 CFR

2012-01-01

... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false Who approves our... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 38-SALE OF PERSONAL PROPERTY Sales Process Negotiated Sales § 102-38.110 Who approves our...

41 CFR 102-38.110 - Who approves our determinations to conduct negotiated sales?

Code of Federal Regulations, 2014 CFR

2014-01-01

... 41 Public Contracts and Property Management 3 2014-01-01 2014-01-01 false Who approves our... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 38-SALE OF PERSONAL PROPERTY Sales Process Negotiated Sales § 102-38.110 Who approves our...

41 CFR 102-38.110 - Who approves our determinations to conduct negotiated sales?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Who approves our... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 38-SALE OF PERSONAL PROPERTY Sales Process Negotiated Sales § 102-38.110 Who approves our...

41 CFR 102-38.110 - Who approves our determinations to conduct negotiated sales?

Code of Federal Regulations, 2011 CFR

2011-01-01

... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false Who approves our... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL PROPERTY 38-SALE OF PERSONAL PROPERTY Sales Process Negotiated Sales § 102-38.110 Who approves our...

48 CFR 227.7107-3 - Approval of restricted designs.

Code of Federal Regulations, 2011 CFR

2011-10-01

... designs. 227.7107-3 Section 227.7107-3 Federal Acquisition Regulations System DEFENSE ACQUISITION... Rights in Technical Data 227.7107-3 Approval of restricted designs. The clause at 252.227-7024, Notice and Approval of Restricted Designs, may be included in architect-engineer contracts to permit the...

41 CFR 102-75.1205 - What action must be taken on approved applications?

Code of Federal Regulations, 2010 CFR

2010-07-01

... taken on approved applications? 102-75.1205 Section 102-75.1205 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 75-REAL PROPERTY DISPOSAL Use of Federal Real Property to Assist the Homeless Action on Approved...

41 CFR 102-75.1205 - What action must be taken on approved applications?

Code of Federal Regulations, 2011 CFR

2011-01-01

... taken on approved applications? 102-75.1205 Section 102-75.1205 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 75-REAL PROPERTY DISPOSAL Use of Federal Real Property to Assist the Homeless Action on Approved...

46 CFR 133.40 - Evaluation, testing and approval of lifesaving appliances and arrangements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 4 2014-10-01 2014-10-01 false Evaluation, testing and approval of lifesaving appliances and arrangements. 133.40 Section 133.40 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS LIFESAVING SYSTEMS General § 133.40 Evaluation, testing and approval of...

46 CFR 133.40 - Evaluation, testing and approval of lifesaving appliances and arrangements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 4 2012-10-01 2012-10-01 false Evaluation, testing and approval of lifesaving appliances and arrangements. 133.40 Section 133.40 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS LIFESAVING SYSTEMS General § 133.40 Evaluation, testing and approval of...

48 CFR 252.227-7024 - Notice and approval of restricted designs.

Code of Federal Regulations, 2010 CFR

2010-10-01

... restricted designs. 252.227-7024 Section 252.227-7024 Federal Acquisition Regulations System DEFENSE... CLAUSES Text of Provisions And Clauses 252.227-7024 Notice and approval of restricted designs. As prescribed at 227.7107-3, use the following clause: Notice and Approval of Restricted Designs (APR 1984) In...

48 CFR 1352.235-72 - Protection of human subjects-institutional approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Protection of human... Clauses 1352.235-72 Protection of human subjects—institutional approval. As prescribed in 48 CFR 1335.006(c), insert the following clause: Protection of Human Subjects—Institutional Approval (APR 2010) (a...

48 CFR 1352.235-72 - Protection of human subjects-institutional approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Protection of human... Clauses 1352.235-72 Protection of human subjects—institutional approval. As prescribed in 48 CFR 1335.006(c), insert the following clause: Protection of Human Subjects—Institutional Approval (APR 2010) (a...

48 CFR 1352.235-72 - Protection of human subjects-institutional approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Protection of human... Clauses 1352.235-72 Protection of human subjects—institutional approval. As prescribed in 48 CFR 1335.006(c), insert the following clause: Protection of Human Subjects—Institutional Approval (APR 2010) (a...

48 CFR 1352.235-72 - Protection of human subjects-institutional approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 5 2012-10-01 2012-10-01 false Protection of human... Clauses 1352.235-72 Protection of human subjects—institutional approval. As prescribed in 48 CFR 1335.006(c), insert the following clause: Protection of Human Subjects—Institutional Approval (APR 2010) (a...

48 CFR 1352.235-72 - Protection of human subjects-institutional approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Protection of human... Clauses 1352.235-72 Protection of human subjects—institutional approval. As prescribed in 48 CFR 1335.006(c), insert the following clause: Protection of Human Subjects—Institutional Approval (APR 2010) (a...

48 CFR 2406.304-70 - Approval of the justification-field procurements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Other Than Full and Open Competition 2406.304-70 Approval of the justification—field procurements. (a) The justification for other than full and open competition for field procurements shall be approved in... justification-field procurements. 2406.304-70 Section 2406.304-70 Federal Acquisition Regulations System...

7 CFR 1726.251 - Prior approved contract modification related to price escalation on transmission equipment...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false Prior approved contract modification related to price... SERVICE, DEPARTMENT OF AGRICULTURE ELECTRIC SYSTEM CONSTRUCTION POLICIES AND PROCEDURES Modifications to RUS Standard Contract Forms § 1726.251 Prior approved contract modification related to price...

40 CFR 141.703 - Sampling locations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... multiple plants draw water from the same influent, such as the same pipe or intake, the State may approve...) The State may approve a system to collect a source water sample after chemical treatment. To grant this approval, the State must determine that collecting a sample prior to chemical treatment is not...

14 CFR 417.1 - General information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... safety for a launch if written evidence demonstrates that a Federal launch range has, by the effective... provision. Written evidence includes: (1) Range flight plan approval, (2) Missile system pre-launch safety... email to the FAA stating that the MIC was approved, or (6) Operation approval. (d) Waiver. For a...

46 CFR 167.45-30 - Use of approved fire-fighting equipment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... PUBLIC NAUTICAL SCHOOL SHIPS Special Firefighting and Fire Prevention Requirements § 167.45-30 Use of approved fire-fighting equipment. Portable fire extinguishers or fire-extinguishing systems which conform... 46 Shipping 7 2010-10-01 2010-10-01 false Use of approved fire-fighting equipment. 167.45-30...

A Metric for Reducing False Positives in the Computer-Aided Detection of Breast Cancer from Dynamic Contrast-Enhanced Magnetic Resonance Imaging Based Screening Examinations of High-Risk Women.

PubMed

Levman, Jacob E D; Gallego-Ortiz, Cristina; Warner, Ellen; Causer, Petrina; Martel, Anne L

2016-02-01

Magnetic resonance imaging (MRI)-enabled cancer screening has been shown to be a highly sensitive method for the early detection of breast cancer. Computer-aided detection systems have the potential to improve the screening process by standardizing radiologists to a high level of diagnostic accuracy. This retrospective study was approved by the institutional review board of Sunnybrook Health Sciences Centre. This study compares the performance of a proposed method for computer-aided detection (based on the second-order spatial derivative of the relative signal intensity) with the signal enhancement ratio (SER) on MRI-based breast screening examinations. Comparison is performed using receiver operating characteristic (ROC) curve analysis as well as free-response receiver operating characteristic (FROC) curve analysis. A modified computer-aided detection system combining the proposed approach with the SER method is also presented. The proposed method provides improvements in the rates of false positive markings over the SER method in the detection of breast cancer (as assessed by FROC analysis). The modified computer-aided detection system that incorporates both the proposed method and the SER method yields ROC results equal to that produced by SER while simultaneously providing improvements over the SER method in terms of false positives per noncancerous exam. The proposed method for identifying malignancies outperforms the SER method in terms of false positives on a challenging dataset containing many small lesions and may play a useful role in breast cancer screening by MRI as part of a computer-aided detection system.

30 CFR 33.23 - Mechanical positioning of parts.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Mechanical positioning of parts. 33.23 Section 33.23 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

30 CFR 33.23 - Mechanical positioning of parts.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Mechanical positioning of parts. 33.23 Section 33.23 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

30 CFR 33.23 - Mechanical positioning of parts.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Mechanical positioning of parts. 33.23 Section 33.23 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

30 CFR 33.23 - Mechanical positioning of parts.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Mechanical positioning of parts. 33.23 Section 33.23 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS DUST COLLECTORS FOR USE IN CONNECTION WITH ROCK DRILLING IN COAL...

17 CFR 15.02 - Reporting forms.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Special Accounts 17.00 102 Identification of Special Accounts 17.01 204 Cash Positions of Grain Traders (including Oilseeds and Products) 19.00 304 Cash Positions of Cotton Traders 19.00 (Approved by the Office of Management and Budget under control numbers 3038-0007 and 3038-0009) [69 FR 76397, Dec. 21, 2004] ...

FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia.

PubMed

Norsworthy, Kelly J; Ko, Chia-Wen; Lee, Jee Eun; Liu, Jiang; John, Christy S; Przepiorka, Donna; Farrell, Ann T; Pazdur, Richard

2018-04-12

On September 2, 2017, the U.S. Food and Drug Administration approved gemtuzumab ozogamicin (GO; Mylotarg; Pfizer, New York City, NY) for treatment of relapsed or refractory (R/R) CD33-positive acute myeloid leukemia (AML) in patients 2 years of age and older. GO is a CD33-directed antibody drug conjugate linked to the cytotoxic antibiotic calicheamicin. It originally received accelerated approval for treatment of older patients with relapsed CD33-positive AML in 2000, but it was withdrawn from the market in 2010 when the confirmatory trial failed to demonstrate clinical benefit among safety concerns, such as a higher rate of induction fatalities on the GO combination arm compared with chemotherapy alone. In addition, GO was associated with hepatic veno-occlusive disease (VOD), which has substantial morbidity and mortality. Pharmacokinetic analyses suggested a lower maximum concentration of GO would result in less VOD without affecting target saturation or efficacy. A meta-analysis across dose schedules of GO in patients with R/R AML showed that a lower-dose "fractionated" schedule of 3 mg/m 2 days 1, 4, and 7 was associated with less early mortality, hemorrhage, and VOD, without an apparent decrease in complete remission (CR) rate. MyloFrance 1 was a single-arm study evaluating response rates in patients with relapsed CD33-positive AML treated with the lower-dose fractionated GO regimen. The CR rate was 26% (95% confidence interval 16%-40%). Common adverse reactions were fever, infections, nausea, vomiting, constipation, bleeding, increased liver enzymes, and mucositis. There were no cases of VOD. These results supported the approval of GO as monotherapy for R/R CD33-positive AML using the lower-dose fractionated regimen. Gemtuzumab ozogamicin (GO) 3 mg/m 2 days 1, 4, and 7 is an active regimen for induction of remission when used to treat patients with relapsed or refractory CD33-positive acute myeloid leukemia without curative intent. The risks of hepatic veno-occlusive disease and early mortality with this regimen appear to be lower than reported previously for GO 9 mg/m 2 days 1 and 15. The data were not sufficient to enable conclusions about the safety of GO in children younger than 2 years of age. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.

Certification Archives

EPA Pesticide Factsheets

The requirements of this product certification system are applicable to EPA-approved accreditation bodies (approved accreditation bodies), licensed certifying bodies, and the manufacturers that are obtaining product certification.

NASA-approved rotary bioreactor enhances proliferation of human epidermal stem cells and supports formation of 3D epidermis-like structure.

PubMed

Lei, Xiao-hua; Ning, Li-na; Cao, Yu-jing; Liu, Shuang; Zhang, Shou-bing; Qiu, Zhi-fang; Hu, Hui-min; Zhang, Hui-shan; Liu, Shu; Duan, En-kui

2011-01-01

The skin is susceptible to different injuries and diseases. One major obstacle in skin tissue engineering is how to develop functional three-dimensional (3D) substitute for damaged skin. Previous studies have proved a 3D dynamic simulated microgravity (SMG) culture system as a "stimulatory" environment for the proliferation and differentiation of stem cells. Here, we employed the NASA-approved rotary bioreactor to investigate the proliferation and differentiation of human epidermal stem cells (hEpSCs). hEpSCs were isolated from children foreskins and enriched by collecting epidermal stem cell colonies. Cytodex-3 micro-carriers and hEpSCs were co-cultured in the rotary bioreactor and 6-well dish for 15 days. The result showed that hEpSCs cultured in rotary bioreactor exhibited enhanced proliferation and viability surpassing those cultured in static conditions. Additionally, immunostaining analysis confirmed higher percentage of ki67 positive cells in rotary bioreactor compared with the static culture. In contrast, comparing with static culture, cells in the rotary bioreactor displayed a low expression of involucrin at day 10. Histological analysis revealed that cells cultured in rotary bioreactor aggregated on the micro-carriers and formed multilayer 3D epidermis structures. In conclusion, our research suggests that NASA-approved rotary bioreactor can support the proliferation of hEpSCs and provide a strategy to form multilayer epidermis structure.

48 CFR 1649.101-70 - FEHBP renewal and withdrawal of approval clause.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false FEHBP renewal and withdrawal of approval clause. 1649.101-70 Section 1649.101-70 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION CONTRACT MANAGEMENT...

48 CFR 1652.232-73 - Approval for the Assignment of Claims.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Approval for the Assignment of Claims. 1652.232-73 Section 1652.232-73 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION CLAUSES AND FORMS CONTRACT...

48 CFR 1652.249-70 - Renewal and withdrawal of approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Renewal and withdrawal of approval. 1652.249-70 Section 1652.249-70 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION CLAUSES AND FORMS CONTRACT CLAUSES Texts...

48 CFR 1649.101-70 - FEHBP renewal and withdrawal of approval clause.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false FEHBP renewal and withdrawal of approval clause. 1649.101-70 Section 1649.101-70 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION CONTRACT MANAGEMENT...

48 CFR 1649.101-70 - FEHBP renewal and withdrawal of approval clause.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false FEHBP renewal and withdrawal of approval clause. 1649.101-70 Section 1649.101-70 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION CONTRACT MANAGEMENT...

48 CFR 1649.101-70 - FEHBP renewal and withdrawal of approval clause.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false FEHBP renewal and withdrawal of approval clause. 1649.101-70 Section 1649.101-70 Federal Acquisition Regulations System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION CONTRACT MANAGEMENT...

9 CFR 381.309 - Finished product inspection.

Code of Federal Regulations, 2010 CFR

2010-01-01

... FSIS-approved total quality control system; or (3) Alternative documented procedures that will ensure... contamination, where there is no approved total quality control system, or where the establishment has no... Office of Management and Budget under control number 0583-0015) [51 FR 45634, Dec. 19, 1986, as amended...

29 CFR 1915.509 - Definitions applicable to this subpart.

Code of Federal Regulations, 2010 CFR

2010-07-01

... harmful. Hose systems—fire protection systems consisting of a water supply, approved fire hose, and a... fire protection system consisting of piping and hose connections used to supply water to approved hose... influence shipyard employment (such as mail delivery or office supply services). Dangerous atmosphere—an...

48 CFR 749.111-71 - Required review and approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Required review and approval. 749.111-71 Section 749.111-71 Federal Acquisition Regulations System AGENCY FOR INTERNATIONAL DEVELOPMENT CONTRACT MANAGEMENT TERMINATION OF CONTRACTS General Principles 749.111-71 Required review and...

44 CFR 65.10 - Mapping of areas protected by levee systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... requirement described in paragraph (b)(1)(i) of this section, may be approved. Appropriate engineering... paragraph (b)(1)(iii) of this section, may be approved. Appropriate engineering analyses demonstrating... are structural parts of the system during operation and design according to sound engineering practice...

46 CFR 162.060-22 - Marking requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... effects of normal wear and tear and exposure to water, salt spray, direct sunlight, heat, cold, and any...: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Ballast Water Management Systems § 162.060-22 Marking requirements. (a) Each ballast water management system (BWMS) manufactured under Coast Guard approval must have...

46 CFR 162.060-22 - Marking requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... effects of normal wear and tear and exposure to water, salt spray, direct sunlight, heat, cold, and any...: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Ballast Water Management Systems § 162.060-22 Marking requirements. (a) Each ballast water management system (BWMS) manufactured under Coast Guard approval must have...

46 CFR 162.060-22 - Marking requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... effects of normal wear and tear and exposure to water, salt spray, direct sunlight, heat, cold, and any...: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Ballast Water Management Systems § 162.060-22 Marking requirements. (a) Each ballast water management system (BWMS) manufactured under Coast Guard approval must have...

Potential applications of Erbium:YAG laser in periodontics.

PubMed

Ishikawa, Isao; Aoki, Akira; Takasaki, Aristeo Atsushi

2004-08-01

Since lasers were introduced for the treatment of oral diseases, there has been considerable advancement in technology. As a result, numerous laser systems are currently available for oral use. Neodymium:Yttrium-Aluminum:Garnet (Nd:YAG), carbon dioxide (CO(2)) laser and the semiconductor Diode lasers have already been approved by the US Food and Drug Administration for soft tissue treatment in oral cavity. The Erbium:YAG (Er:YAG) laser was approved in 1997 for hard tissue treatment in dentistry and recent studies have reported positive results. This suggests that the Er:YAG laser system is a promising apparatus, which will be able to revolutionize and improve dental practice, in particular periodontal treatment. In this mini-review, we would like to describe the positive characteristics of the Er:YAG laser which indicate its potential as a new treatment modality in periodontics. Recent findings are summarized briefly to evaluate the potential of the Er:YAG laser for clinical application in periodontics. The Er:YAG laser possesses suitable characteristics for oral soft and hard tissue ablation. Recently, it has been applied for effective elimination of granulation tissue, gingival melanin pigmentation and gingival discoloration. Contouring and cutting of bone with minimal damage and even or faster healing can also be performed with this laser. In addition, irradiation with the Er:YAG laser has a bactericidal effect with reduction of lipopolysaccharide, high ability of plaque and calculus removal, with the effect limited to a very thin layer of the surface and is effective for implant maintenance. The Er:YAG laser seems to be an effective tool for periodontal therapy, however, further clinical and basic investigations are required to confirm its clinical application. Copyright Blackwell Munksgaard, 2004

Ejectors of power plants turbine units efficiency and reliability increasing

NASA Astrophysics Data System (ADS)

Aronson, K. E.; Ryabchikov, A. Yu.; Kuptsov, V. K.; Murmanskii, I. B.; Brodov, Yu. M.; Zhelonkin, N. V.; Khaet, S. I.

2017-11-01

The functioning of steam turbines condensation systems influence on the efficiency and reliability of a power plant a lot. At the same time, the condensation system operating is provided by basic ejectors, which maintain the vacuum level in the condenser. Development of methods of efficiency and reliability increasing for ejector functioning is an actual problem of up-to-date power engineering. In the paper there is presented statistical analysis of ejector breakdowns, revealed during repairing processes, the influence of such damages on the steam turbine operating reliability. It is determined, that 3% of steam turbine equipment breakdowns are the ejector breakdowns. At the same time, about 7% of turbine breakdowns are caused by different ejector malfunctions. Developed and approved design solutions, which can increase the ejector functioning indexes, are presented. Intercoolers are designed in separated cases, so the air-steam mixture can’t move from the high-pressure zones to the low-pressure zones and the maintainability of the apparatuses is increased. By U-type tubes application, the thermal expansion effect of intercooler tubes is compensated and the heat-transfer area is increased. By the applied nozzle fixing construction, it is possible to change the distance between a nozzle and a mixing chamber (nozzle exit position) for operating performance optimization. In operating conditions there are provided experimental researches of more than 30 serial ejectors and also high-efficient 3-staged ejector EPO-3-80, designed by authors. The measurement scheme of the designed ejector includes 21 indicator. The results of experimental tests with different nozzle exit positions of the ejector EPO-3-80 stream devices are presented. The pressure of primary stream (water steam) is optimized. Experimental data are well-approved by the calculation results.

Arenavirus reverse genetics for vaccine development

PubMed Central

Ortiz-Riaño, Emilio; Cheng, Benson Yee Hin; Carlos de la Torre, Juan

2013-01-01

Arenaviruses are important human pathogens with no Food and Drug Administration (FDA)-licensed vaccines available and current antiviral therapy being limited to an off-label use of the nucleoside analogue ribavirin of limited prophylactic efficacy. The development of reverse genetics systems represented a major breakthrough in arenavirus research. However, rescue of recombinant arenaviruses using current reverse genetics systems has been restricted to rodent cells. In this study, we describe the rescue of recombinant arenaviruses from human 293T cells and Vero cells, an FDA-approved line for vaccine development. We also describe the generation of novel vectors that mediate synthesis of both negative-sense genome RNA and positive-sense mRNA species of lymphocytic choriomeningitis virus (LCMV) directed by the human RNA polymerases I and II, respectively, within the same plasmid. This approach reduces by half the number of vectors required for arenavirus rescue, which could facilitate virus rescue in cell lines approved for human vaccine production but that cannot be transfected at high efficiencies. We have shown the feasibility of this approach by rescuing both the Old World prototypic arenavirus LCMV and the live-attenuated vaccine Candid#1 strain of the New World arenavirus Junín. Moreover, we show the feasibility of using these novel strategies for efficient rescue of recombinant tri-segmented both LCMV and Candid#1. PMID:23364194

Stability in Pakistan: Realizing the Vision of Enlightened Moderation

DTIC Science & Technology

2006-06-01

official policy or position of the Department of Defense or the U.S. Government. 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public...the region and the United States’ War on Terror as his constraints, President General Pervez Musharraf finds himself in a position where success now...General Pervez Musharraf finds himself in a position where success now is crucial, not optional. vi THIS

Association of the FDA Amendment Act with trial registration, publication, and outcome reporting.

PubMed

Phillips, Adam T; Desai, Nihar R; Krumholz, Harlan M; Zou, Constance X; Miller, Jennifer E; Ross, Joseph S

2017-07-18

Selective clinical trial publication and outcome reporting has the potential to bias the medical literature. The 2007 Food and Drug Administration (FDA) Amendment Act (FDAAA) mandated clinical trial registration and outcome reporting on ClinicalTrials.gov, a publicly accessible trial registry. Using publicly available data from ClinicalTrials.gov, FDA documents, and PubMed, we determined registration, publication, and reporting of findings for all efficacy trials supporting FDA approval of new drugs for cardiovascular disease and diabetes between 2005 and 2014, before and after the FDAAA. For published trials, we compared the published interpretation of the findings (positive, equivocal, or negative) with the FDA reviewer's interpretation. Between 2005 and 2014, the FDA approved 30 drugs for 32 indications of cardiovascular disease (n = 17) and diabetes (n = 15) on the basis of 183 trials (median per indication 5.7 (IQR, 3-8)). Compared with pre FDAAA, post-FDAAA studies were more likely to be registered (78 of 78 (100%) vs 73 of 105 (70%); p < 0.001), to be published (76 of 78 (97%) vs 93 of 105 (89%); p = 0.03), and to present findings concordant with the FDA reviewer's interpretation (74 of 76 (97%) vs 78 of 93 (84%); p = 0.004). Pre FDAAA, the FDA reviewer interpreted 80 (76%) trials as positive and 91 (98%) were published as positive. Post FDAAA, the FDA reviewer interpreted 71 (91%) trials as positive and 71 (93%) were published as positive. FDAAA was associated with increased registration, publication, and FDA-concordant outcome reporting for trials supporting FDA approval of new drugs for cardiovascular disease and diabetes.

Classification of nervous system withdrawn and approved drugs with ToxPrint features via machine learning strategies.

PubMed

Onay, Aytun; Onay, Melih; Abul, Osman

2017-04-01

Early-phase virtual screening of candidate drug molecules plays a key role in pharmaceutical industry from data mining and machine learning to prevent adverse effects of the drugs. Computational classification methods can distinguish approved drugs from withdrawn ones. We focused on 6 data sets including maximum 110 approved and 110 withdrawn drugs for all and nervous system diseases to distinguish approved drugs from withdrawn ones. In this study, we used support vector machines (SVMs) and ensemble methods (EMs) such as boosted and bagged trees to classify drugs into approved and withdrawn categories. Also, we used CORINA Symphony program to identify Toxprint chemotypes including over 700 predefined chemotypes for determination of risk and safety assesment of candidate drug molecules. In addition, we studied nervous system withdrawn drugs to determine the key fragments with The ParMol package including gSpan algorithm. According to our results, the descriptors named as the number of total chemotypes and bond CN_amine_aliphatic_generic were more significant descriptors. The developed Medium Gaussian SVM model reached 78% prediction accuracy on test set for drug data set including all disease. Here, bagged tree and linear SVM models showed 89% of accuracies for phycholeptics and psychoanaleptics drugs. A set of discriminative fragments in nervous system withdrawn drug (NSWD) data sets was obtained. These fragments responsible for the drugs removed from market were benzene, toluene, N,N-dimethylethylamine, crotylamine, 5-methyl-2,4-heptadiene, octatriene and carbonyl group. This paper covers the development of computational classification methods to distinguish approved drugs from withdrawn ones. In addition, the results of this study indicated the identification of discriminative fragments is of significance to design a new nervous system approved drugs with interpretation of the structures of the NSWDs. Copyright © 2017 Elsevier B.V. All rights reserved.

75 FR 34200 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-16

... of Application for Approval of Discontinuance or Modification of a Railroad Signal System Pursuant to... or modification of the signal system, as detailed below. Docket Number: FRA-2010-0083. Applicant: Pan... signal at mile 391.20. The reason given for the proposed change is that the second main track was removed...

75 FR 54220 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

... Discontinuance or Modification of a Railroad Signal System or Relief From the Requirements of Title 49 Code of... approval for the discontinuance or modification of the signal system or relief from the requirements of 49... Engineer Signals, New Jersey Transit, One Penn Plaza East, Newark, New Jersey 07105-2246. The New Jersey...

75 FR 26838 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-12

... Discontinuance or Modification of a Railroad Signal System or Relief From the Requirements of Title 49 Code of... approval for the discontinuance or modification of the signal system or relief from the requirements of 49..., Mr. William E. Van Trump, AVP Engineering -- Signal/Comm/TCO, 1400 Douglas Street, STOP 0910, Omaha...

75 FR 6252 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-08

... Discontinuance or Modification of a Railroad Signal System or Relief From the Requirements of Title 49 Code of... approval for the discontinuance or modification of the signal system or relief from the requirements of 49... the conversion of dispatcher controlled holdout signals, 96L and 96R, to automatic signals, 8221 and...

Biosimilars: Considerations for Oncology Nurses
.

PubMed

Vizgirda, Vida; Jacobs, Ira

2017-04-01

Biosimilars are developed to be highly similar to and treat the same conditions as licensed biologics. As they are approved and their use becomes more widespread, oncology nurses should be aware of their development and unique considerations. This article reviews properties of biosimilars; their regulation and approval process; the ways in which their quality, safety, and efficacy are evaluated; their postmarketing safety monitoring; and their significance to oncology nurses and oncology nursing.
. A search of PubMed and regulatory agency websites was conducted for references related to the development and use of biosimilars in oncology. 
. Because biologics are large, structurally complex molecules, biosimilars cannot be considered generic equivalents to licensed biologic products. Consequently, regulatory approval for biosimilars is different from approval for small-molecule generics. Oncology nurses are in a unique position to educate themselves, other clinicians, and patients and their families about biosimilars to ensure accurate understanding, as well as optimal and safe use, of biosimilars.

78 FR 54891 - Information Collection Request Submitted to OMB for Review and Approval: Comment Request; Great...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-06

... Submitted to OMB for Review and Approval: Comment Request; Great Lakes Accountability System (Reinstatement... Agency has submitted an information collection request (ICR), Great Lakes Accountability System... legislation called for increased accountability for the GLRI and directed EPA to implement a process to track...

76 FR 72674 - Approval for Expansion of Manufacturing Authority, Foreign-Trade Subzone 29F, Hitachi Automotive...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-25

... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1798] Approval for Expansion of Manufacturing Authority, Foreign-Trade Subzone 29F, Hitachi Automotive Systems Americas, Inc., (Automotive... requested an expansion of the scope of manufacturing authority on behalf of Hitachi Automotive Systems...

75 FR 59263 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

... FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval... Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320.16 (OMB Regulations on Controlling... placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent...

42 CFR 403.306 - Additional requirements for State systems-mandatory approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Additional requirements for State systems-mandatory approval. 403.306 Section 403.306 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS SPECIAL PROGRAMS AND PROJECTS Recognition of State...

78 FR 22877 - Agency Information Collection Activities; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-17

... Bank has developed an electronic disbursement approval processing system for guaranteed lenders with... authorized by Ex-Im Bank and legal documentation has been completed, the lender will obtain and review the... application system (ExIm Online). Ex-Im Bank's action (approved or declined) will be posted on the lender's...

78 FR 10169 - Agency Information Collection Activities: Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-13

... Bank has developed an electronic disbursement approval processing system for guaranteed lenders with... authorized by Ex-Im Bank and legal documentation has been completed, the lender will obtain and review the... application system (ExIm Online). Ex-Im Bank's action (approved or declined) will be posted on the lender's...

7 CFR 1724.54 - Requirements for RUS approval of plans and specifications.

Code of Federal Regulations, 2012 CFR

2012-01-01

... specifications for transmission construction projects which are not based on RUS approved line design data or do...) Communications and control facilities. (1) This paragraph (g) covers microwave and powerline carrier communications systems, load control, and supervisory control and data acquisition (SCADA) systems. (2) The...

7 CFR 1724.54 - Requirements for RUS approval of plans and specifications.

Code of Federal Regulations, 2014 CFR

2014-01-01

... specifications for transmission construction projects which are not based on RUS approved line design data or do...) Communications and control facilities. (1) This paragraph (g) covers microwave and powerline carrier communications systems, load control, and supervisory control and data acquisition (SCADA) systems. (2) The...

7 CFR 1724.54 - Requirements for RUS approval of plans and specifications.

Code of Federal Regulations, 2013 CFR

2013-01-01

... specifications for transmission construction projects which are not based on RUS approved line design data or do...) Communications and control facilities. (1) This paragraph (g) covers microwave and powerline carrier communications systems, load control, and supervisory control and data acquisition (SCADA) systems. (2) The...

48 CFR 3009.171-7 - Contract award approval procedures for contractors with felony convictions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 7 2011-10-01 2011-10-01 false Contract award approval... Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND SECURITY ACQUISITION REGULATION (HSAR... for the request, including, at a minimum, the following information: (1) Name and date of birth of...

48 CFR 3009.171-7 - Contract award approval procedures for contractors with felony convictions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Contract award approval... Regulations System DEPARTMENT OF HOMELAND SECURITY, HOMELAND SECURITY ACQUISITION REGULATION (HSAR... for the request, including, at a minimum, the following information: (1) Name and date of birth of...

76 FR 28414 - Notice of Request for Approval of an Information Collection; National Animal Health Monitoring...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-17

...] Notice of Request for Approval of an Information Collection; National Animal Health Monitoring System... information collection; comment request. SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this... Epidemiologic Investigations, an information collection to support the National Animal Health Monitoring System...

78 FR 76840 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-19

...] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval... ``Unique Device Identification System'' has been approved by the Office of Management and Budget (OMB... information entitled ``Unique Device Identification System'' to OMB for review and clearance under 44 U.S.C...

76 FR 75809 - Prior Label Approval System: Generic Label Approval

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-05

... tracking and reporting systems; and (4) design and implement a survey of the effects of the limited generic... and poultry product inspection programs designed to assure consumers that meat and poultry products... mandatory features are designed to ensure that meat and poultry products are accurately and truthfully...

Recycling pool provides innovative financing for an integrated system.

PubMed

Ciolek, R J; Fahy, P A

1997-12-01

Not-for-profit integrated delivery systems require innovative financing mechanisms to compete effectively with expanding for-profit systems. The Massachusetts Health and Educational Facilities Authority (Mass HEFA), in collaboration with Partners HealthCare Systems, Inc., Boston, Massachusetts, developed such a mechanism--a capital asset recycling pool funded through a $150 million bond issue. The recycling pool gives Partners flexible access to tax-exempt capital to fund routine capital expenses across the system and has enabled the system to centralize control of capital resources. Over the pool's 30-year life-span, Partners will be able to issue tax-exempt loans from the pool to any of its affiliates or, with Mass HEFA and insurer approval, transfer the funds to outside organizations. When the loans are repaid, the funds remain available and can be recycled at no additional cost to fund further capital projects. Creation of the pool was made possible by Partners' outstanding credit, strong market position, expanding primary care network, and substantial unrestricted net assets.

A Guide to School Site Selection.

ERIC Educational Resources Information Center

Georgia State Dept. of Education, Atlanta. Facilities Services Unit.

This report presents the guidelines for site evaluation and approval as mandated by the state of Georgia. This guide may be used by the School Site Approval Committee when making school site evaluations for official approval, and also may be used by local school systems as they make preliminary determinations regarding the acceptability of school…

46 CFR 282.21 - Wages of officers and crew.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Definitions. When used in this part. (1) Base period. The first base period under the wage index system, as... employment of the approved manning complement of the subsidized vessel, including payments required by law to... assessments on crew payrolls. (4) Approved manning complement means the complement approved by the Board for...

48 CFR 2052.215-78 - Travel approvals and reimbursement-Alternate 1.

Code of Federal Regulations, 2013 CFR

2013-10-01

... clause of this contract when, at any time, the contractor learns that travel expenses will cause the... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Travel approvals and... Clauses 2052.215-78 Travel approvals and reimbursement—Alternate 1. As prescribed in 2015.209-70(d), the...

48 CFR 2052.215-78 - Travel approvals and reimbursement-Alternate 1.

Code of Federal Regulations, 2012 CFR

2012-10-01

... clause of this contract when, at any time, the contractor learns that travel expenses will cause the... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Travel approvals and... Clauses 2052.215-78 Travel approvals and reimbursement—Alternate 1. As prescribed in 2015.209-70(d), the...

48 CFR 2052.215-78 - Travel approvals and reimbursement-Alternate 1.

Code of Federal Regulations, 2010 CFR

2010-10-01

... clause of this contract when, at any time, the contractor learns that travel expenses will cause the... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Travel approvals and... Clauses 2052.215-78 Travel approvals and reimbursement—Alternate 1. As prescribed in 2015.209-70(d), the...

48 CFR 2052.215-78 - Travel approvals and reimbursement-Alternate 1.

Code of Federal Regulations, 2011 CFR

2011-10-01

... clause of this contract when, at any time, the contractor learns that travel expenses will cause the... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Travel approvals and... Clauses 2052.215-78 Travel approvals and reimbursement—Alternate 1. As prescribed in 2015.209-70(d), the...

48 CFR 2052.215-78 - Travel approvals and reimbursement-Alternate 1.

Code of Federal Regulations, 2014 CFR

2014-10-01

... clause of this contract when, at any time, the contractor learns that travel expenses will cause the... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Travel approvals and... Clauses 2052.215-78 Travel approvals and reimbursement—Alternate 1. As prescribed in 2015.209-70(d), the...

46 CFR 128.120 - Plan approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 4 2010-10-01 2010-10-01 false Plan approval. 128.120 Section 128.120 Shipping COAST... AND SYSTEMS General § 128.120 Plan approval. The plans required by subchapter F of this chapter need not be submitted if the plans required by § 127.110(d) of this subchapter have been. ...

75 FR 54941 - Agency Information Collection Activities; Revision of an Approved Information Collection Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-09

... Management and Budget (OMB) for review and approval and invites public comment. The FMCSA requests approval... principal place of business or readily available to the employees at the company's principal place of.... ADDRESSES: You may submit comments bearing the Federal Docket Management System (FDMS) Docket Number FMCSA...

77 FR 56200 - Agency Information Collection Activities OMB Responses

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-12

... on 08/31/2015; Approved with change. EPA ICR Number 2192.05; Unregulated Contaminant Monitoring in Public Water Systems (Final Rule); 40 CFR 141.35 and 141.40; was approved on 08/06/2012; OMB Number 2040-0270; expires on 08/31/2015; Approved with change. EPA ICR Number 1560.10; National Water Quality...

Alectinib salvages CNS relapses in ALK-positive lung cancer patients previously treated with crizotinib and ceritinib.

PubMed

Gainor, Justin F; Sherman, Carol A; Willoughby, Kathryn; Logan, Jennifer; Kennedy, Elizabeth; Brastianos, Priscilla K; Chi, Andrew S; Shaw, Alice T

2015-02-01

Leptomeningeal metastases (LM) are an increasingly frequent and devastating complication of anaplastic lymphoma kinase (ALK)-rearranged non-small-cell lung cancer (NSCLC). Currently, the optimal management of LM in ALK-positive patients remains poorly understood as these patients have been routinely excluded from clinical trials. We describe four ALK-positive patients with LM who were treated with the next-generation ALK inhibitor alectinib through single-patient, compassionate use protocols at two institutions. All patients had previously been treated with both FDA-approved ALK inhibitors--crizotinib and ceritinib. Patients received alectinib at a starting dose of 600 mg twice daily. Four ALK-positive NSCLC patients with symptomatic leptomeningeal disease were identified. Three of four patients experienced significant clinical and radiographic improvements in LM upon treatment with alectinib. A fourth patient had stable intracranial disease for 4 months before eventual systemic disease progression. Overall, alectinib was well tolerated. One patient required dose reduction due to grade 2 hyperbilirubinemia. Alectinib is active in ALK-rearranged NSCLC patients with LM, including in patients previously treated with crizotinib and ceritinib. Additional prospective studies of alectinib in ALK-positive patients with LM are warranted.

Alectinib Salvages CNS Relapses in ALK-Positive Lung Cancer Patients Previously Treated with Crizotinib and Ceritinib

PubMed Central

Gainor, Justin F.; Sherman, Carol A.; Willoughby, Kathryn; Logan, Jennifer; Kennedy, Elizabeth; Brastianos, Priscilla K.; Chi, Andrew S.; Shaw, Alice T.

2014-01-01

Background Leptomeningeal metastases (LM) are an increasingly frequent and devastating complication of anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC). Currently, the optimal management of LM in ALK-positive patients remains poorly understood as these patients have been routinely excluded from clinical trials. Methods We describe four ALK-positive patients with LM who were treated with the next-generation ALK inhibitor alectinib through single-patient, compassionate use protocols at two institutions. All patients had previously been treated with both FDA-approved ALK inhibitors—crizotinib and ceritinib. Patients received alectinib at a starting dose of 600 mg twice daily. Results Four ALK-positive NSCLC patients with symptomatic leptomeningeal disease were identified. Three of four patients experienced significant clinical and radiographic improvements in LM upon treatment with alectinib. A fourth patient had stable intracranial disease for four months before eventual systemic disease progression. Overall, alectinib was well tolerated. One patient required dose reduction due to grade 2 hyperbilirubinemia. Conclusions Alectinib is active in ALK-rearranged NSCLC patients with LM, including in patients previously treated with crizotinib and ceritinib. Additional prospective studies of alectinib in ALK-positive patients with LM are warranted. PMID:25526238

Digital mammography. Why hasn't it been approved for U.S. hospitals?

PubMed

2000-01-01

Mammography is the only major imaging technique still unavailable in the United States in digital form. This is because the Food and Drug Administration (FDA) has been unable to devise an effective method for manufacturers to demonstrate the safety and efficacy of digital mammography systems. As a result, the agency has been unable to approve any of those systems for marketing in the United States. In this Regulatory Update, we describe FDA's recent efforts to help manufacturers obtain approval and the reasons those efforts have so far proved ineffective.

Inventory of Safety-related Codes and Standards for Energy Storage Systems with some Experiences related to Approval and Acceptance

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

Conover, David R.

The purpose of this document is to identify laws, rules, model codes, codes, standards, regulations, specifications (CSR) related to safety that could apply to stationary energy storage systems (ESS) and experiences to date securing approval of ESS in relation to CSR. This information is intended to assist in securing approval of ESS under current CSR and to identification of new CRS or revisions to existing CRS and necessary supporting research and documentation that can foster the deployment of safe ESS.

Adolescent-specific patterns of behavior and neural activity during social reinforcement learning

PubMed Central

Jones, Rebecca M.; Somerville, Leah H.; Li, Jian; Ruberry, Erika J.; Powers, Alisa; Mehta, Natasha; Dyke, Jonathan; Casey, BJ

2014-01-01

Humans are sophisticated social beings. Social cues from others are exceptionally salient, particularly during adolescence. Understanding how adolescents interpret and learn from variable social signals can provide insight into the observed shift in social sensitivity during this period. The current study tested 120 participants between the ages of 8 and 25 years on a social reinforcement learning task where the probability of receiving positive social feedback was parametrically manipulated. Seventy-eight of these participants completed the task during fMRI scanning. Modeling trial-by-trial learning, children and adults showed higher positive learning rates than adolescents, suggesting that adolescents demonstrated less differentiation in their reaction times for peers who provided more positive feedback. Forming expectations about receiving positive social reinforcement correlated with neural activity within the medial prefrontal cortex and ventral striatum across age. Adolescents, unlike children and adults, showed greater insular activity during positive prediction error learning and increased activity in the supplementary motor cortex and the putamen when receiving positive social feedback regardless of the expected outcome, suggesting that peer approval may motivate adolescents towards action. While different amounts of positive social reinforcement enhanced learning in children and adults, all positive social reinforcement equally motivated adolescents. Together, these findings indicate that sensitivity to peer approval during adolescence goes beyond simple reinforcement theory accounts and suggests possible explanations for how peers may motivate adolescent behavior. PMID:24550063

Adolescent-specific patterns of behavior and neural activity during social reinforcement learning.

PubMed

Jones, Rebecca M; Somerville, Leah H; Li, Jian; Ruberry, Erika J; Powers, Alisa; Mehta, Natasha; Dyke, Jonathan; Casey, B J

2014-06-01

Humans are sophisticated social beings. Social cues from others are exceptionally salient, particularly during adolescence. Understanding how adolescents interpret and learn from variable social signals can provide insight into the observed shift in social sensitivity during this period. The present study tested 120 participants between the ages of 8 and 25 years on a social reinforcement learning task where the probability of receiving positive social feedback was parametrically manipulated. Seventy-eight of these participants completed the task during fMRI scanning. Modeling trial-by-trial learning, children and adults showed higher positive learning rates than did adolescents, suggesting that adolescents demonstrated less differentiation in their reaction times for peers who provided more positive feedback. Forming expectations about receiving positive social reinforcement correlated with neural activity within the medial prefrontal cortex and ventral striatum across age. Adolescents, unlike children and adults, showed greater insular activity during positive prediction error learning and increased activity in the supplementary motor cortex and the putamen when receiving positive social feedback regardless of the expected outcome, suggesting that peer approval may motivate adolescents toward action. While different amounts of positive social reinforcement enhanced learning in children and adults, all positive social reinforcement equally motivated adolescents. Together, these findings indicate that sensitivity to peer approval during adolescence goes beyond simple reinforcement theory accounts and suggest possible explanations for how peers may motivate adolescent behavior.

Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

PubMed Central

Sumathipala, Athula; Siribaddana, Sisira; Hewege, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

2008-01-01

Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal. PMID:18267015

Approving for a community aged care package: experiences and perceptions of six metropolitan aged care assessment service teams.

PubMed

Stephens, Delwyne; Wells, Yvonne; Gardner, Ian

2011-06-01

To establish whether the experiences and perceptions of different metropolitan Aged Care Assessment Service (ACAS) teams when approving people for Community Aged Care Packages (CACPs) were similar. Six semi-structured 30-minute group interviews were completed. ACAS team approval processes for CACPs were similar. The primary criterion for approval was need for case management. Many factors, however, impinged on the approval process. Barriers to making approvals included long waiting times, a lack of confidence in the priority rating system, and consideration of whether a person was better off with Home and Community Care services because of the impact of the Australian Government's Cost Recovery policy. ACAS teams have competing considerations when approving a person for a CACP. In particular, structural barriers, such as cost recovery policies, can have a significant negative impact on approval decisions. © 2010 The Authors. Journal compilation © 2010 ACOTA.

78 FR 13130 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change, as...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-26

... already the case for single-name CDS). Recognizing the highly correlated relationship between long-short...' proprietary positions. ICE Clear Europe does not currently clear CDS positions of customers of its Clearing Members, but it plans to introduce customer clearing for CDS upon receipt of applicable regulatory...

75 FR 20559 - Notice of Request for Extension of Approval of an Information Collection; Communicable Diseases...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-20

... tested positive for equine infectious anemia. DATES: We will consider all comments that we receive on or... have tested positive for equine infectious anemia, contact Dr. Jill Rolland, Assistant Director... activities to protect the health of our Nation's livestock and poultry. Equine infectious anemia (EIA) is an...

40 CFR 142.16 - Special primacy requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... coliform or E. coli testing on a total coliform-positive sample)—A description of how the State will determine whether it is appropriate to waive fecal coliform or E. coli testing on a total coliform-positive... where allowed in State programs. (1) Approve an alternative to the E. coli levels that trigger...

RESNA Position on the Application of Power Wheelchairs for Pediatric Users

ERIC Educational Resources Information Center

Rosen, Lauren; Arva, Julianna; Furumasu, Jan; Harris, Michele; Lange, Michelle L.; McCarthy, Elisabeth; Kermoian, Rosanne; Pinkerton, Heather; Plummer, Teresa; Roos, Jodi; Sabet, Andrina; Vander Schaaf, Paula; Wonsettler, Terri

2009-01-01

This document, approved by the Rehabilitation Engineering & Assistive Technology Society of North America (RESNA) Board of Directors in March 2007, shares typical clinical applications and provides evidence from the literature supporting the use of power wheelchairs for children. It is RESNA's position that age, limited vision or cognition,…