Department of Health and Human Services August 26, 2009 – Federal Register Recent Federal Regulation Documents

This document requests that the public resubmit their comments on the CY 2010 Physician Fee Schedule or CY 2010 Hospital Outpatient Prospective Payment System/Ambulatory Surgical Center Payment System proposed rule before the close of the comment period for these rules (that is, August 31, 2009) if their comments were originally submitted via www.regulations.gov during the period from July 26, 2009 through July 30, 2009.

The Office of HIV/AIDS Policy (OHAP), a program office within the Office of Public Health and Science, Department of Health and Human Services (HHS), is soliciting nominations of qualified candidates to be considered for appointment as members to the Presidential Advisory Council on HIV/AIDS (PACHA). The activities of this council are governed by the Federal Advisory Committee Act (FACA). Management support for the activities of this Council is the responsibility of the OHAP.

The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. Congress provided a statutory definition of ``minor use'' that relied on the phrase ``small number of animals'' to characterize such use. At this time, the Food and Drug Administration (FDA) is amending the implementing regulations of the MUMS Act. In response to Congress' charge to the agency to further define minor use, this amendment establishes a specific ``small number of animals'' for each of the seven major animal species to be used in determining whether any particular intended use in a major species is a minor use.

The Food and Drug Administration (FDA) is requesting comments and scientific data and information on acrylamide in food. Acrylamide is a chemical that can form in some foods during certain types of high- temperature cooking. FDA is seeking information on practices that manufacturers have used to reduce acrylamide in food and the reductions they have been able to achieve in acrylamide levels. FDA is considering issuing guidance for industry on reduction of acrylamide levels in food products.

The Food and Drug Administration (FDA) is announcing the Establishment of the Tobacco Products Scientific Advisory Committee. These actions are needed to implement the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. Elsewhere in this issue of the Federal Register, FDA is publishing two separate documents requesting nominations for voting and non-voting membership on this committee. This document also amends the agency's regulations to add the Tobacco Products Scientific Advisory Committee (the committee) to the agency's list of standing advisory committees.

Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a SOR, System No. 09-17-0004, ``Sanitation Facilities Construction Individual Applicant (SFCIA) Records.'' Under the provisions of the Indian Sanitation Facilities Act, Public Law 86- 121 (42 U.S.C. 2004a), IHS is charged with carrying out the functions to determine basic individual and home eligibility for sanitation services. The primary change to this SOR notice is to delete the reference to the Social Security Numbers (SSNs) under the Categories of Records; Retrievability; Notification; Record Access; and Contesting Record Procedures to comply with the Office of Management and Budget (OMB) Memorandum (M)07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information (May 22, 2007); and the HHS Directive Memorandum of October 6, 2008 to all Operating Division Heads to develop and execute a plan to eliminate the unnecessary collection and use of SSNs.

The National Center for Complementary and Alternative Medicine (NCCAM) invites the research community to participate in a workshop focused on wellness.