Department of Health and Human Services May 20, 2005 – Federal Register Recent Federal Regulation Documents

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.