Department of Health and Human Services December 19, 2011 – Federal Register Recent Federal Regulation Documents

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 the information collection provisions of FDA's requirements on content and format of labeling for human prescription drug and biological products.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Evaluation of Sex Differences in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences in medical device clinical trials, with a specific focus on addressing potential differences in study design, conduct, outcomes, and interpretation that should be considered to ensure sex-specific issues are adequately addressed in clinical trials. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or the Agency) is issuing an interim final rule amending its postmarketing reporting regulations implementing certain provisions of the Federal Food, Drug and Cosmetic Act. The provisions of the Federal Food, Drug and Cosmetic Act require manufacturers who are the sole manufacturers of certain drug products to notify FDA at least 6 months before discontinuance of manufacture of the products. This interim final rule modifies the term ``discontinuance'' and clarifies the term ``sole manufacturer'' with respect to notification of discontinuance requirements. The broader reporting resulting from these changes will enable FDA to improve its collection and distribution of drug shortage information to physician and patient organizations and to work with manufacturers and other stakeholders to respond to potential drug shortages.

The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill four positions on the Committee membership that will be vacated during the 2012 calendar year.

The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code 300aa-5 (PDF78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services as the Director of the National Vaccine Program. The ASH has charged the NVAC with developing recommended strategies for annually achieving 90% influenza vaccination coverage among healthcare personnel, as stated in the Healthy People 2020 goals. The Healthcare Personnel Influenza Vaccination Subgroup (HCPIVS), a subgroup of the NVAC Adult Immunization Working Group (AWIG), was established to address this charge on behalf of the NVAC. A draft report and draft recommendations have been developed by the HCPIVS for consideration by the NVAC and will be deliberated on by the NVAC when developing NVAC's final recommendations to the ASH. The National Vaccine Program Office (NVPO) is soliciting public comment on the Healthcare Personnel Influenza Vaccination Subgroup draft report and draft recommendations for increasing vaccination of healthcare personnel to meet the Healthy People 2020 goals. Individuals and organizations are encouraged to submit their comments on the draft report and draft recommendations. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented in February 2012 to the NVAC for deliberation and decision on their final recommendations.

This proposed rule would require applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children's Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (``covered recipients''). In addition, applicable manufacturers and applicable group purchasing organizations (GPOs) are required to report annually certain physician ownership or investment interests. The Secretary is required to publish applicable manufacturers' and applicable GPOs' submitted payment and ownership information on a public Web site.