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

The Health Resources and Services Administration (HRSA) will be transferring the Florida Family-to-Family Health Information Center (F2F HIC) grant (H84MC00006) from the Florida Institute of Family Involvement (FIFI) to the Family Caf[eacute] in Tallahassee due to financial difficulties resulting in closure of FIFI facilities and programs. This action ensures the continued provision of health resources, financing, related services and parent-to-parent support for families with children and youth with special health care needs (CYSHCN) in the state of Florida.

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.

The Food and Drug Administration (FDA) has determined the regulatory review period for REPEL-CV 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 medical device.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on May 10, 2010, pages 25863-4, and allowed 60-days for public comment. No comments were 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. Proposed Collection: Title: The Framingham Heart Study. Type of Information Request: Revision (OMB No. 0925-0216). Need and Use of Information Collection: The Framingham Heart Study will conduct examinations and morbidity and mortality follow-up for the purpose of studying the determinants of cardiovascular disease. Examinations will be conducted on the original, offspring, and Omni Cohorts. Morbidity and mortality follow-up will also occur in all of the cohorts (original, offspring, third generation, and Omni). Frequency of response: The participants will be contacted annually. Affected public: Individuals or households; businesses or other for profit; small businesses or organizations. Types of Respondents: Adult men and women; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows: Estimated Number of Respondents: 6,921; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .88; and Estimated Total Annual Burden Hours Requested: 6,091. The annualized cost to respondents is estimated at: $222,040. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Suicidality: Prospective Assessment of Occurrence in Clinical Trials.'' The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidality in clinical trials of drug and biological products. Specifically, this guidance addresses FDA's current thinking regarding the importance of suicidality assessment in psychiatric and nonpsychiatric drug trials and the general principles for how best to accomplish this assessment during drug development.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.'' The guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls). This guidance describes a means by which PTCA catheters, other than cutting/scoring PTCA catheters, may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule that codifies the reclassification of this device type from class III (premarket approval) into class II (special controls).

The Food and Drug Administration (FDA) is amending the animal drug regulations to codify the conditions of use of an approved new animal drug application (NADA) for gentamicin sulfate and betamethasone acetate ophthalmic solution. This action is being taken to comply with the Federal Food, Drug, and Cosmetic Act and to improve the accuracy of the regulations.