Department of Health and Human Services February 11, 2008 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk; Extension of the Comment Period
The Food and Drug Administration (FDA) is extending the comment period until April 11, 2008, for a proposed rule that was published in the Federal Register of October 19, 2005 (70 FR 60751). FDA issued a Federal Register notice to reopen the comment period on this proposal on December 11, 2007 (72 FR 70251), to seek further comment on only two specific issues raised by the comments concerning the proposed ingredient declaration. The agency is extending this comment period in response to a request to give interested parties additional time to provide the information requested by FDA in that notice.
Announcement of the Third Meeting of the Physical Activity Guidelines Advisory Committee
The U.S. Department of Health and Human Services (HHS) announces the final in a series of three federal advisory committee meetings on the Physical Activity Guidelines for Americans, to be held in Washington, DC. This meeting will be open to the public. The Physical Activity Guidelines Advisory Committee has been charged with reviewing existing scientific literature to identify where there is sufficient evidence to develop a comprehensive set of specific physical activity recommendations. The Committee will prepare a report to the Secretary of HHS that documents the scientific background and rationale for the issuance of Physical Activity Guidelines for Americans. The report will also identify areas where further scientific research is needed. The Committee's recommendations will be utilized by the Department to prepare the final Physical Activity Guidelines. The intent is to issue physical activity recommendations for all Americans that will be tailored as necessary for specific subgroups of the population.
Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products,'' dated February 2008. The draft guidance document provides manufacturers of cellular and gene therapy products with recommendations on the validation of growth-based Rapid Microbiological Methods (RMMs) for sterility testing of their products. This draft guidance addresses considerations for method validation and determining equivalence of an RMM to sterility assays. This draft guidance applies to somatic cellular therapy and gene therapy products.
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Request for Nominations
The Health Resources and Services Administration (HRSA) is requesting nominations to fill five (5) upcoming vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). Authority: 42 U.S.C. 294f, section 756 of the PHS Act, as amended. The Advisory Committee is governed by provisions of Public Law (Pub. L.) 92-463, as amended (5 U.S.C. Appendix 2) which sets forth standards for the formation and use of advisory committees.
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