[Federal Register: January 31, 2003 (Volume 68, Number 21)]
[Notices]
[Page 5029-5030]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31ja03-94]
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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: chulada@niehs.nih.gov.
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