Department of Health and Human Services June 8, 2009 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) is issuing non-competitive supplemental funding under the Maternal Child Health Bureau, Healthy Start Eliminating Disparities in Perinatal Health program to ensure that the Northern Manhattan Perinatal Partnership (NMPP), the primary provider of prenatal services in Central Harlem, can continue to provide much needed services to help stem the rise in and ultimately reduce the Infant Mortality Rate (IMR) in the affected service area.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Library of Medicine (NLM), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on March 30, 2009 (Vol. 74, No. 59, Pg. 14137) and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Medication Guides Adding a Toll-Free Number for Reporting Adverse Events.'' Beginning July 1, 2009, manufacturers of prescription drug products approved under the Federal Food, Drug, and Cosmetic Act (the act) that are required to have a Medication Guide must add a verbatim statement to their Medication Guides containing FDA's toll-free number for reporting side effects. These manufacturers are also required to report to FDA that they have complied with this requirement. This guidance explains what statement to add to Medication Guides, where to add it, and how to notify the agency that such a statement has been added.

The Food and Drug Administration (FDA) is announcing the availability of final product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' explaining the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of additional draft and revised draft product-specific BE recommendations.