August 5, 2008 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 123
Federal Acquisition Regulation; Information Collection; Past Performance Information
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Federal Acquisition Regulation (FAR) Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement concerning past performance information. The clearance currently expires on November 30, 2008. Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Privacy Act of 1974; Amendment of Systems Notice; Modification of Routine Uses
As required by the Privacy Act of 1974, 5 U.S.C. 552(a)(E), notice is hereby given that the Department of Veterans Affairs (VA) is modifying the Routine Uses of this System of Records to add additional uses. Notice is hereby given that VA is revising certain paragraphs in the system of records entitled ``Workers'' Compensation-Occupational Safety and Health/Management Information SystemVA'' (86VA00S1) which was recently published in the Federal Register at Volume 60, Number 60, on September 14, 2000. The Routine Uses are being revised to include additional purposes for which information from this System of Records may be disseminated without the consent of the individual. VA is republishing this system notice in its entirety at this time.
McCormick & Company, Incorporated; Analysis of the Proposed Consent Orders to Aid Public Comment
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order embodied in the consent agreement that would settle these allegations.
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is part C of the fourth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex on Disintegration Test General Chapter; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 5: Disintegration Test General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Disintegration Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is the fifth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is part B of the fourth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Non- Sterile Products: Microbial Enumeration Tests General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is part A of the fourth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).
International Conference on Harmonisation; Draft Guidance on E2F Development Safety Update Report; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``E2F Development Safety Update Report.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes the format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR would serve as a harmonized, annual clinical trial safety report that would be standard among the three ICH regions. The DSUR could be submitted in the United States in place of an annual report for an investigational new drug application (IND). The harmonized DSUR is intended to promote a consistent approach to annual clinical safety reporting among the ICH regions and enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities.
Commercial Driver's License: Commonwealth of Virginia, Department of Motor Vehicles; Application for Exemption
FMCSA has received an application from the Commonwealth of Virginia Department of Motor Vehicles (Virginia DMV) for an exemption from provisions of the Agency's commercial driver's license (CDL) requirement that each CDL issued by the State contain a color photograph of the driver. Virginia DMV proposes that it be allowed to use a black and white, laser-engraved photograph in lieu of a color photograph. Virginia DMV believes that the issuance of CDLs with laser- engraved black and white photographs would enhance the security of the credential and assist law enforcement officials with the identification of the CDL holder. The FMCSA requests public comment on Virginia DMV's application for exemption.
Qualification of Drivers; Exemption Applications; Diabetes
FMCSA announces receipt of applications from 47 individuals for exemptions from the prohibition against persons with insulin- treated diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in interstate commerce. If granted, the exemptions would enable these individuals with ITDM to operate commercial motor vehicles in interstate commerce.
Qualification of Drivers; Exemption Applications; Vision
FMCSA announces its denial of 381 applications from individuals who requested exemptions from the Federal vision standard applicable to interstate truck and bus drivers and the reasons for the denials. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemptions does not provide a level of safety that will be equivalent to, or greater than, the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
Draft Guidance for Industry on Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes.'' This draft guidance provides recommendations to applicants on information to include in support of parametric release for sterile products terminally sterilized by moist heat when submitting a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), or biologics license application (BLA).
Notice of Proposed Information Collection Requests
The IC Clearance Official, Regulatory Information Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
Submission for OMB Review; Comment Request
The IC Clearance Official, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.
Indian Gaming
Notice is given that the State of Oklahoma and the Quapaw Tribe of Oklahoma (O-GAH-PAH) Off-Track Wagering Compact is considered approved and is in effect.
Agency Information Collection (Suspension of Monthly Check) Activities Under OMB Review
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Agency Information Collection (Claim for One Sum Payment (Government Life Insurance)) Activities Under OMB Review
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Agency Information Collection (Certificate as to Assets) Activities Under OMB Review
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Agency Information Collection (Application by Insured Terminally Ill Person for Accelerated Benefit (38 CFR 9.14(e)) Activities Under OMB Review
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Proposed Information Collection (Survey of Veteran Enrollees (Quality and Efficiency of VA Health Care)) Activity; Comment Request
The Veterans Health Administration (VHA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed new collection, and allow 60 days for public comment in response to the notice. This notice solicits comments for information needed to measure the quality of service provided to VHA beneficiaries.
Agency Information Collection (Report of Treatment in Hospital) Activities Under OMB Review
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
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