Department of Health and Human Services May 21, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti- HBc)'' dated May 2008. The draft guidance document provides recommendations to establishments that collect human blood or blood components for a requalification method or process to reenter deferred donors into a donor pool based on a determination that the previous tests that were repeatedly reactive for anti-HBc were falsely positive and that there is no evidence of infection with Hepatitis B virus (HBV).

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 Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF). The USPSTF, a standing, independent panel of outside experts that makes evidence-based recommendations regarding the provision of clinical preventive services, is composed of members appointed to serve for four year terms with an option for reappointment. New members are selected each year to replace approximately one fourth of the USPSTF members, i.e., those who are completing their appointments. Individuals nominated but not appointed in previous years, as well as those newly nominated, are considered in the annual selection process. USPSTF members meet three times a year for two days in the Washington, DC area. Between meetings, member duties include reviewing and preparing comments (off site) on systematic evidence reviews prior to discussing and making recommendations on preventive services, drafting final recommendation documents, and participating in workgroups on specific topics or methods. AHRQ particularly encourages nominations of women, members of minority populations, and persons with disabilities. Interested individuals can self nominate. Organizations and individuals may nominate one or more persons qualified for membership on the USPSTF. Qualification Requirements: The mission of the USPSTF is to produce evidence-based recommendations on the appropriate screening, counseling, and provision of preventive medication for asymptomatic patients seen in the primary care setting. Therefore, in order to qualify for the USPSTF, an applicant or nominee must demonstrate the following: 1. Knowledge and experience in the critical evaluation of research published in peer reviewed literature and in the methods of evidence review; 2. Understanding and experience in the application of synthesized evidence to clinical decision-making and/or policy; 3. Expertise in disease prevention and health promotion; 4. Ability to work collaboratively with peers; and, 5. Clinical expertise in the primary health care of children and/or adults, and/or expertise in counseling and behavioral interventions for primary care patients. Some USPSTF members without primary health care clinical experience may be selected based on their expertise in methodological issues such as medical decision making, clinical epidemiology, behavioral medicine, and health economics. Consideration will be given to individuals who are recognized nationally for scientific leadership within their field of expertise. Applicants must have no substantial conflicts of interest that would impair the scientific integrity of the work of the USPSTF including financial, intellectual, or other conflicts.

Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA; Pub. L. 110-85) mandates the expansion of the existing ClinicalTrials.gov registry and the establishment of a clinical trial results database. This notice announces our intent to implement the expanded registry and the basic results database via rulemaking and to post for public comment on the website identified below preliminary materials related to the basic results database. Comments received on the preliminary basic results materials will be considered in the development of an operational version of the basic results database and in the drafting of the associated regulation and any necessary guidance documents. The regulation will be subject to a separate public comment process.