Proposed Collection; Comment Request; Environmental Factors in the Development of Polycystic Ovary Syndrome, 3310-3311 [06-515]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health/national Institute of Environmental Health Sciences
• National Institutes of Health

[Federal Register Volume 71, Number 13 (Friday, January 20, 2006)]
[Notices]
[Pages 3310-3311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-515]


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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 
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

[[Page 3311]]

likely to have Polycystic Ovary Syndrome (PCOS) for future study. 
Potential participants (~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 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. 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 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: 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, Health Scientist 
Administrator, Program in Clinical Research, 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.
    Comment 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: January 11, 2006.
Richard A. Freed,
Associate Director for Management, NIEHS, National Institutes of 
Health.
[FR Doc. 06-515 Filed 1-19-06; 8:45 am]
BILLING CODE 4140-01-M