Department of Health and Human Services December 1, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Draft Compliance Policy Guide Sec. 527.300 Dairy Products-Microbial Contaminants and Alkaline Phosphatase Activity (Compliance Policy Guide 7106.08); Availability
The Food and Drug Administration (FDA) is announcing the availability of draft Compliance Policy Guide Sec. 527.300 Dairy ProductsMicrobial Contaminants and Alkaline Phosphatase Activity (CPG 7106.08) (the draft CPG). The draft CPG, when finalized, will provide guidance for FDA staff on its enforcement policies for pathogens and other indicators of inadequate pasteurization or post-pasteurization contamination of dairy products.
Organization, Functions, and Delegations of Authority; Office of the National Coordinator for Health Information Technology
Statement of Organization, Functions, and Delegations of Authority The Office of the National Coordinator for Health Information Technology has reorganized its substructure components in order to more effectively meet the mission outlined by The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA). The reorganization affects all four of the original Director-level offices: the Office of Health Information Technology Adoption (OHITA); the Office of Interoperability and Standards (OIS); Office of Programs and Coordination (OPC); and the Office of Policy and Research (OPR). The new organizational structure is composed of five offices with direct reporting capability to the National Coordinator for Health Information Technology (National Coordinator): the Office of Economic Modeling and Analysis; the Office of the Chief Scientist; the Office of the Deputy National Coordinator for Programs & Policy; the Office of the Deputy National Coordinator for Operations, and the Office of the Chief Privacy Officer.
Guidance for Industry on Listing of Ingredients in Tobacco Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Listing of Ingredients in Tobacco Products.'' The guidance document is intended to assist persons making tobacco product ingredient submissions to FDA under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Studies of Nutrition Symbols on Food Packages
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 (PRA).
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold six teleconference meetings. The meetings are open to the public. Pre- registration is NOT required, however, individuals who wish to participate in the public comment sessions should either e-mail nvpo@hhs.gov or call 202-690-5566 to RSVP.
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product- specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
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