00-32221. 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 September 1, 2000, page 53326 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, 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: NEW. Need and Use of Information Collection: We will administer a brief telephone survey to 2032 twin women from the Mid-Atlantic Twin Registry (MATR) who previously reported having irregular periods and/or cystic ovaries on a MATR General Health History Survey. Question in the proposed survey focus on the two hallmark features of Polycystic Ovary Syndrome (PCOS), hyperandrogenism and anovulation, other relevant physical characteristics, and if the woman has a living female twin sister. Women will also be asked for permission to recontact them for potential participation in future PCOS studies. The data will be used in statistical modeling analyses to identify those women with a high probability of having PCOS and estimate the number of potential candidates for future PCOS studies. Frequency of Response: One time. Affected Public: Individuals; Type of Respondents: Adult women. The annual reporting burden is as follows: Estimated Number of Respondents: 2,100; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.167; and Estimated Total Annual Burden Hours Requested: 350.7. The annualized cost to respondents is estimated at: $3,507.00. 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 function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of 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 technological collection techniques or other forms of information technology.

Direct Comments to OMB

Written comment 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].

DATES:

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received on or before January 18, 2001.

Dated: December 7, 2000.

Francine Little,

Associate Director for Management, NIEHS.