[Federal Register Volume 65, Number 171 (Friday, September 1, 2000)]
[Notices]
[Page 53326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22479]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Environmental Health Sciences; Proposed 
Collection; Comment Request; Environmental Factors in the Development 
of Polycystic Ovary Syndrome

SUMMARY: 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 
Environmental Health Sciences (NIEHS), 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.

Proposed Collection

    Title: Environmental Factors in the Development of Polycystic Ovary 
Syndrome. Type of Information Collection Request: NEW. New 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 (2,100) will come from the Mid-
Atlantic Twin Registry (MATRA) 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 MATRA. It contains 15 simple and 
direct questions and will take about 10 minutes to complete. Its 
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. All 
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 dizygotic 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 PCSO 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: 2,100. 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 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 
technological collection techniques or other forms of information 
technology.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
propose 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: [email protected].
    Comments due date: Comments regarding this information collection 
are best assured of having their full effect if received on or before 
October 31, 2000.

    Dated: August 10, 2000.
Francine Little,
Associate Director for Management, NIEHS.
[FR Doc. 00-22479 Filed 8-31-00; 8:45 am]
BILLING CODE 4140-01-M