[Federal Register Volume 68, Number 21 (Friday, January 31, 2003)]
[Notices]
[Pages 5029-5030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2228]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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 October 25, 2002, pages 56690-56691 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 
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, hyperandogenism, 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: 
205.9 hours. The annualized cost to respondents is estimated at 
$3,449.94. 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.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated

[[Page 5030]]

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, PO 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 are best 
assured of having their full effect if received within 30-days of the 
date of this publication.

    Dated: January 17, 2003.
Francine Little,
Associate Director for Management.
[FR Doc. 03-2228 Filed 1-30-03; 8:45 am]
BILLING CODE 4140-01-M