Department of Health and Human Services September 10, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is withdrawing approval of five new drug applications (NDAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of the applications have repeatedly failed to file required annual reports for the applications.

In accordance with Title IX of the Public Health Service Act, see 42 U.S.C. 299c-1, and AHRQ's grant and contract regulations, 42 CFR part 67, applications submitted to AHRQ will be evaluated using the AHRQ peer review process to ensure a fair, equitable, and unbiased evaluation of their scientific and technical merit. The initial peer review of grant applications involves an assessment conducted by panels of experts established to include pertinent scientific disciplines and medical specialty areas. The confidential part of the peer review meetings devoted to critical evaluations will be closed meetings in accordance with section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2). AHRQ is seeking nominations to fill approximately 20 to 30 percent of its study section membership, across the following study sections: (1) Health System Research (HSR), (2) Health Care Technology and Decision Sciences (HCTDS), (3) Health Care Quality and Effectiveness Research (HCQER), and (4) Health Care Research Training (HCRT). The primary research foci and functions of these four study sections are described on the AHRQ Web site: (http:Ilwww.AHRQ .qovlfundlpeerrevlpeerdesc. htm). Individuals from the health services research and health care community who could serve as peer reviewers on these study sections are sought to replace study section members whose terms have expired. In sending your nomination, please specify the nominee's professional/ scientific/technical expertise, affiliations and full contact information, if this information is available. Factors that will be considered in the selection of individuals to serve on study sections include: competence in a scientific, technical or clinical discipline or research specialty, particularly in health services research; fairness and evenhandedness in judgment and review; ability to work effectively in a group context; and commitment to complete work assignments. A diversity of perspectives is valuable to AHRQ's work. To help obtain a diversity of perspectives among nominees, AHRQ encourages nominations of women and members of minority populations. AHRQ also seeks broad geographic representation.

The Food and Drug Administration (FDA) has determined the regulatory review period for SAPHRIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.