Submission for OMB review; Comment Request; Environmental Factors in the Development of Polycystic Ovary Syndrome, 35437 [06-5527]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 71, Number 118 (Tuesday, June 20, 2006)]
[Notices]
[Page 35437]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-5527]


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

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 January 20, 2006, pages 3310-3311 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 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 likely to have Polycystic Ovary Syndrome (PCOS) for 
future study. Potential participants (-2,200) 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 17 simple and direct questions 
and will take about 10 minutes to complete. It 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. A; 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 diygotic 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: 2,200; Estimated Number of Responses Per 
Respondent: 1; Average Burden Hours Per Response: 0.167; and Estimated 
Total Annual Burden Hours Requested: 122 per year for 3 more years. The 
annualized costs to respondents is estimated at $2,050.38. 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 fuction 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 technology 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 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, 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.
    Comments Due Date: Comments regarding this infomation collection 
are best assured of having their full effect if received within 30-days 
of the date of this publication.

    Dated: March 27, 2006.
Richard A. Freed,
NIEHS Associate Director for Management.
[FR Doc. 06-5527 Filed 6-19-06; 8:45 am]
BILLING CODE 4140-01-M