Department of Health and Human Services March 28, 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco ProductsSmall Entity Compliance Guide'' for a final rule published in the Federal Register of February 2, 2012. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help small businesses understand and comply with the regulation.

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 announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection on financial disclosure by clinical investigators.

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). Qualification Requirements: Qualified applicants and nominees must at a minimum demonstrate knowledge, expertise and national leadership in the following areas: 1. The critical evaluation of research published in peer reviewed literature and in the methods of evidence review; 2. Clinical prevention, health promotion and primary health care; and 3. Implementation of evidence-based recommendations in clinical practice including at the clinician-patient level, practice level, and health system level. Some USPSTF members without primary health care clinical experience may be selected based on their expertise in methodological issues such as meta-analysis, analytic modeling or clinical epidemiology. For individuals with clinical expertise in primary health care, additional qualifications in methodology would enhance their candidacy. Additionally, the Task Force benefits from members with expertise in the following areas: Behavioral medicine Public health Health equity and the reduction of health disparities Application of science to health policy Communication of scientific findings to multiple audiences including health care professionals, policy makers and the general public. Candidates with experience and skills in any of these areas should highlight them in their nomination materials. Applicants must have no substantial conflicts of interest, whether financial, professional, or intellectual, that would impair the scientific integrity of the work of the USPSTF and must be willing to complete regular conflict of interest disclosures. Applicants must have the ability to work collaboratively with a team of diverse professionals who support the mission of the USPSTF. Applicants must have adequate time to contribute substantively to the work products of the USPSTF.