Department of Health and Human Services June 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program.'' One of the performance goals, referenced in a letter to Congress from the Secretary of Health and Human Services that accompanied the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) legislation, includes a commitment to improve FDA's scheduling and timeliness of preapproval inspections. This draft guidance document is intended to assist applicants in understanding the process involved in the bioresearch monitoring (BIMO) review of the clinical and nonclinical information in their premarket approval application (PMA) and the process involved in any related inspections. Premarket notification (510(k)) submissions are not addressed in this draft guidance because a premarket inspection is not ordinarily conducted for 510(k)s. This draft guidance is not final nor is it in effect at this time.

The Office on Women's Health, Office of Public Health and Science, Office of the Secretary, published a notice in the Federal Register on Tuesday, June 6, 2006 announcing the availability of funds for approximately two grants. This notice is to correct the following information contained in that announcement: (1) Corrects the Anticipated Award date for the grant awards. (2) Amends the expected increase of funding available for this grant; thereby, increasing the number of grants to be awarded, and also increasing the funding amount for each individual grant award. (3) Corrects the number of pages to be submitted for the Project Narrative description to be submitted in the grant application. (4) Corrects the omission of the Office on Minority Health as a partner during the performance period of this grant. (5) Corrects some statistical data provided in the announcement. (6) Corrects some page numbers listed in the Reference section in the announcement.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), 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 January 20, 2006, pages 3310-3311 and allowed 60-days for public comment. No public 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: Environmental Factors in the Development of Polycystic Ovary Syndrome. Type of Information Collection Request: Revision of OMB No. 0925- 0483 and expiration date 3/31/2006. Need and Use of Information Collection: The purpose of this study is to identify a cohort of living female twin pairs in which at least one member is likely to have Polycystic Ovary Syndrome (PCOS) for future study. Potential participants (-2,200) will come from the Mid- Atlantic Twin Registry (MATR) and were chosen based on their answers to several questions (in a preliminary MATR survey) concerning irregular periods and a history of polycystic cystic ovaries. The instrument to be used here will be administered by telephone by professional interviewers at the MATR. It contains 17 simple and direct questions and will take about 10 minutes to complete. It contents deal with the frequency of menstrual periods, a history of polycystic ovaries, obesity, excess facial hair and other evidence of hyperandrogenism. Since this is such a short telephone survey, participants will receive no prior notification. Informed consent will be asked for verbally over the phone at the time of the interview. A; participants will be asked about their willingness to participate in future studies if their answers meet certain criteria. The major objectives of future studies using this cohort are to determine more reliable concordance rates for PCOS in monozygotic and diygotic twins, establish baseline heritability estimates, and develop hypotheses concerning possible pathogenetic and/ or environmental factors. The findings from this study will aid in developing: (1) Genetic tests to identify high risk women; (2) preventative strategies; and (3) more effective therapies for PCOS and related syndromes such as type 2 diabetes, obesity, idiopathic hyperandrogenism, and male pattern baldness. Frequency of Response: One time. Affected Public: Individuals or households. Type of Respondents: Adult women. The annual reporting burden is as follows: Estimated Number of Respondents: 2,200; Estimated Number of Responses Per Respondent: 1; Average Burden Hours Per Response: 0.167; and Estimated Total Annual Burden Hours Requested: 122 per year for 3 more years. The annualized costs to respondents is estimated at $2,050.38. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the fuction of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality utility and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technology collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Patricia C. Chulada, Clinical Research Scientist, Clinical Research Office, NIEHS, P.O. Box 12233, Research Triangle Park, NC 27709 or call non-toll-free number (919) 541-7736 or e-mail your request, including your address to: chulada@niehs.nih.gov. Comments Due Date: Comments regarding this infomation collection are best assured of having their full effect if received within 30-days of the date of this publication.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations.'' One of the performance goals, referenced in a letter that accompanied the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) legislation, includes a commitment to improve FDA's scheduling and timeliness of preapproval inspections. This draft guidance document is intended to assist manufacturers in preparing for FDA's review of their premarket approval application (PMA) manufacturing section and in the coordination of the preapproval inspection of the manufacturing operations described in the PMA or PMA supplement. This draft guidance document does not address premarket notification (510(k)) submissions because a premarket inspection is not ordinarily conducted for 510(k) submissions. This draft guidance is not final nor is it in effect at this time.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is withdrawing approval of 65 new drug applications (NDAs) and 52 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA) has determined the regulatory review period for INSPRA 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 that claims that human drug product.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (177) entitled ``Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products'' (VICH GL40). This guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document provides general principles through recommendations on the setting and justification, to the extent possible, of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.

The Food and Drug Administration (FDA) is announcing that Georgia-Pacific Resins, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of glycerol ester of tall oil rosin to adjust the density of citrus oils used in the preparation of beverages and to provide for the use of steam stripping as a purification method for producing glycerol ester of wood rosin, gum rosin, or tall oil rosin.

The Administration for Children and Families published a notice in the Federal Register on June 6, 2006, requesting comments on reporting requirements contained in the Interim Final Rule for the Reauthorization of the Temporary Assistance for Needy Families Program. As the subject rule has not yet been published, the Administration for Children and Families is retracting the notice.