Department of Health and Human Services May 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Phoenix Scientific, Inc. The NADA provides for the oral use of pyrantel pamoate paste for the removal and control of mature infections of tapeworms in horses and ponies.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. This meeting is open to the public. A description of the Council's functions is also included with this notice.

The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) (we, our, the agencies) are proposing to establish a set of general principles for food standards. The adherence to these principles will result in standards that will better promote honesty and fair dealing in the interest of consumers and protect the public, allow for technological advances in food production, be consistent with international food standards to the extent feasible, and be clear, simple, and easy to use for both manufacturers and the agencies that enforce compliance with the standards. The proposed general principles will establish the criteria that the agencies will use in considering whether a petition to establish, revise, or eliminate a food standard will be the basis for a proposed rule. In addition, each agency may propose to establish, revise, or eliminate a food standard on its own initiative or may propose revisions to a food standard in addition to those a petitioner has requested. These proposed general principles are the agencies' first step in instituting a process to modernize their standards of identity (and any accompanying standards of quality and fill of container) and standards of composition.

The Family and Youth Services Bureau (FYSB) is accepting applications to provide support to public and private entities for the development and implementation of the Community-Based Abstinence Education Program for adolescents, ages 12 through 18, in communities across the country. This funding opportunity targets the implementation of community-based abstinence educational programs designed to: (a) Reduce the proportion of adolescents who engage in premarital sexual activity, including but not limited to sexual intercourse; (b) reduce the incidence of out-of-wedlock pregnancies among adolescents; and (c) reduce the incidence of sexually transmitted diseases among adolescents. Priority funding will be given to those entities that demonstrate a strong record of providing abstinence education among adolescents as defined by Section 510(b)(2) of Title V of the Social Security Act, which promotes a strong abstinence until marriage message to youth.

The National Institute on Drug Abuse, a component of the National Institutes of Health, Department of Health and Human Services (DHHS) seeks an agreement with a pharmaceutical or biotechnology company to test the hypotheses that vigabatrin may be a safe and effective medication for the treatment of cocaine and methamphetamine dependence. A body of literature relevant to preclinical studies of vigabatrin as a potential treatment agent for various types of substance dependence (including cocaine and methamphetamine) and a more limited body of literature concerning clinical results exists. As there are currently no medications approved by the U. S. Food and Drug Administration (FDA) for the treatment of cocaine and/or methamphetamine dependence, and cocaine and methamphetamine dependence have substantial negative public health impacts, the National Institute on Drug Abuse is interested in evaluating the safety and efficacy of vigabatrin for the treatment of cocaine and methamphetamine dependence. Rationale for Studying Vigabatrin in Stimulant(s) Dependence

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is requesting comments concerning the establishment of program priorities in the Center for Food Safety and Applied Nutrition (CFSAN) for fiscal year (FY) 2006. As part of its annual planning, budgeting, and resource allocation process, CFSAN is reviewing its programs to set priorities and establish work product expectations. This notice is being published to give the public an opportunity to provide input into the priority- setting process.

This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2006, as required by statute. Annual updates to the PPS rates are required by section 1888(e) of the Social Security Act (the Act), as amended by the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), the Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) Benefits Improvement and Protection Act of 2000 (BIPA), and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), relating to Medicare payments and consolidated billing for SNFs. As part of this year's annual update, we are proposing to introduce refinements in the Resource Utilization Groups, version III (RUG-III), the case-mix classification system used under the SNF PPS.

Notice is hereby given that a noncompetitive grant award is being made to the Rural Community Assistance Program, Inc. to provide training and technical assistance to small communities struggling to deal with the safety and security of small and very small community water and wastewater treatment systems. This award addresses Congressional concern that many small and very small community water and wastewater treatment systems might be most vulnerable to terrorist attack, yet the least prepared to deal with the issues. The application is not within the scope of any existing or expected to be issued program announcement for the Fiscal Year 2005Rural Community Development Activities Program (RF) as authorized under the Community Services Block Grant Act of 1998, as amended; Sections 680(a)(3)(B) of the Community Opportunities Accountability, and Training and Educational Services (COATES) Act (Pub. L. 105-285). This application is expected to provide valuable on-site training and technical assistance to small and very small communities struggling to deal with the safety and security of small community water and wastewater treatment systems. This announcement is inviting application for a 12-month budget period and a 12 month project period. The funds are not being competed due to the Senate appropriation language in FY 2005 that directs the Office of Community Services to support a Rural Community Assistance Program Small Community Infrastructure Safety and Training and Technical project. Congress intends the funds to go to an organization that is capable of conducting a project that is national in scope that provides State, regional and national infrastructure safety training workshops and on- site technical assistance targeted to small and very small community water and wastewater treatment systems. Contact for Further Information: Administration for Children and Families, Office of Community Services, 370 L'Enfant Promenade, SW., Washington, DC 20447, Veronica Terrell(202) 401-5295, vterrell@acf.hhs.gov.