06-5527. Submission for OMB review; Comment Request; Environmental Factors in the Development of Polycystic Ovary Syndrome

Summary: 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 [phone] or e-mail your request, including your address to: [e-mail].

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.

Dated: March 27, 2006.

Richard A. Freed,

NIEHS Associate Director for Management.