[Federal Register Volume 67, Number 207 (Friday, October 25, 2002)]
[Notices]
[Pages 65590-65591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27187]


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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: Revision of OMB No. 0925-0483 and expiration date 
2/28/2003. 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 ([sim]3,700) 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 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 PCOS and related syndromes such as type 2 
diabetes, obesity, idiopathic hyperanrogenism, 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: 3,700 Estimated 
Number of Responses per Respondent: 1; Average Burden Hours Per 
Response: 0.167; and Estimated Total Annual Burden Hours Requested: 206 
per year for 3 years. The annualized cost to respondents is estimated 
at $6,179.00. 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 
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, PO Box 12233, Research 
Triangle Park, NC 27709 or call non-toll-free number (919)

[[Page 65591]]

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 within 60-days 
of the date of this publication.

    Dated: October 11, 2002.
Francine Little,
Associate Director for Management.
[FR Doc. 02-27187 Filed 10-24-02; 8:45 am]
BILLING CODE 4140-01-M