Department of Health and Human Services December 11, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is extending to January 29, 2009, the comment period for the proposed rule that appeared in the Federal Register of October 1, 2009. In the proposed rule, FDA requested comments on postmarketing safety reporting requirements for combination products. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID), 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 October 16, 2009, pages 53259-53260 and allowed 60 days for public comment. Three public comments were received and responses were sent to each person. 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.