Department of Health and Human Services February 2010 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 249
Submission for OMB Review; Comment Request; The Atherosclerosis Risk in Communities Study (ARIC)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on November 16, 2009, page 58962, and allowed 60 days for public comment. Only one comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Office of the Commissioner Reorganization; Statement of Organizations, Functions, and Delegations of Authority
The Food and Drug Administration (FDA) is announcing the reorganization of the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This notice was previously published in the Federal Register of August 18, 2009, but it contained several errors. For the convenience of the reader, the reorganization is being published again in its entirety.
Reporting Information Regarding Falsification of Data
The Food and Drug Administration (FDA) is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. A sponsor would be required to report this information to the appropriate FDA center promptly, but no later than 45 calendar days after the sponsor becomes aware of the information. This proposal is necessary because ambiguity in the current reporting scheme has caused confusion among sponsors. The proposed rule is intended to help ensure the validity of data that the agency receives in support of applications and petitions for FDA product approvals and authorization of certain labeling claims and to protect research subjects.
NIOSH Current Intelligence Bulletin-Asbestos Fibers and Other Elongate Mineral Particles: State of the Science and Roadmap for Research, Version 4
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following revised draft document available for public comment entitled ``NIOSH Current Intelligence BulletinAsbestos Fibers and Other Elongate Mineral Particles: State of the Science and Roadmap for Research, Version 4.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/public/099-C/.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Product Standard on Flavored Cigarettes
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed extension of an existing collection of information pertaining to registration and product listing for owners and operators of domestic tobacco product establishments and to listing of ingredients in tobacco products under the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff: Humanitarian Device Exemption Regulation: Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled ``Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.
Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements for the information collection activity ``Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Exception From General Requirements for Informed Consent
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances.
President's Advisory Council on Faith-Based and Neighborhood Partnerships
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the President's Advisory Council on Faith-based and Neighborhood Partnerships announces a meeting. The meeting is titled President's Advisory Council on Faith-based and Neighborhood Partnerships Council Meetings.
HIV/AIDS Bureau; Policy Notice 99-02 Amendment #1
The HRSA HIV/AIDS Bureau (HAB) Policy Notice 99-02 established general policies regarding the use of Title XXVI of the Public Health Service (PHS) Act, Ryan White HIV/AIDS Program funds for housing referral services and short-term or emergency housing needs. Amendment 1 to Policy Notice 99-02, effective March 27, 2008, modified Policy Notice 99-02 by imposing a 24-month cumulative cap on short-term and emergency housing assistance. HRSA's Administrator is undertaking a comprehensive review of the Housing Policy, and is therefore directing that Amendment 1 to Policy Notice 99-02 be rescinded, effective immediately.
Expert Meeting on Measurement Criteria for Children's Health Insurance Program; Reauthorization Act Pediatric Quality Measures
This notice announces a meeting to identify measurement criteria for use in carrying out the Pediatric Quality Measures Program (PQMP) under Section 1139A(b) of the Social Security Act as enacted in the Children's Health Insurance Program Reauthorization Act (CHIPRA).
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