Department of Health and Human Services September 24, 2009 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on July 17, 2009, Volume 74, Number 136, pages 34760-34761 and allowed 60 days for public comment. Two public comments were received. One questioned the value of this study and suggested that the study could not possibly be completed within the stated cost estimates. We have always conducted extremely efficient studies within stated cost estimates. The value of this research is demonstrated by the involvement of multiple government agencies. The second e-mail simply expressed interest in more information. 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.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

This Federal Register Notice announces the non-competitive extension of Grant Number U69HA07626, Supporting Networks of HIV Care by Enhancing Primary Medical Care (SNHC by EPMC), to the CAEAR Coalition Foundation, Inc., the awardee of record, for one additional year, through August 31, 2010, at a funding level of approximately $1,451,445. The purpose of the award extension is to allow for the completion of ongoing work and an external evaluation assessment of the project's activities undertaken during the project period of September 1, 2006, through August 31, 2009, before a new competitive cycle is started. Evaluation findings will help HRSA frame a new competitive opportunity in fiscal year (FY) 2010. The authority for this funding is the Public Health Service Act, section 2692, 42 U.S.C. Sec. 300ff-111, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Pub. L. 109-415); it can be viewed under the Catalog for Federal Domestic Assistance (CFDA) Number 93.145.

The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of five new drug applications (NDAs) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications.