[Federal Register Volume 68, Number 61 (Monday, March 31, 2003)]
[Notices]
[Pages 15462-15463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7578]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review, Comment Request; Organochlorine 
Exposure in Relation to Timing of Natural Menopause: The North Carolina 
Menopause Study

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 23, 2002, pages 65132-65133 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 number.

Proposed Collection: Title: Organochlorine Exposure in Relation to 
Timing of Natural menopause (The North Carolina Menopause Study) Type 
of Information Collection Request: New. Need and Use of Information 
Collection: Smoking has been shown in many studies to be associated 
with a 1-2 year decrease in age at natural menopause. However, 
relatively little is known about the effect of other potential 
toxicants, including organochlorines such as polychlorinated biphenyls 
(PCBs), and 1,1 dichloro-2,2-bis(p-

[[Page 15463]]

chlorophenyl) ethylene (p,p'-DDE (DDE). We will assess timing of 
menopause among women who previously participated in the North Carolina 
Infant Feeding Study. PCB and DDE levels were analyzed in blood and 
breast milk samples around delivery and after pregnancy. The median age 
of the women as of March 2002 is 50 years. Data will be collected in a 
telephone interview focusing on reproductibve and menstrual history 
with additional information collected on demographic, social and 
behavioral factors that could affecting time of menopause. 
Approximately 50% of participants based on sampling strata that involve 
criteria relating to age and menopausal status will also have a blood 
sample collection. The purpose of this study is to assess the 
association between the baseline organochlorine measurements and timing 
of natural menopause. A secondary aim will be to conduct exploratory 
analyses of the association between specific factors (e.g., pregnancy 
history, weight change) and rate of change in organochlorine levels. 
Frequency of Response: 1.1 responses per respondent. There also will be 
a yearly assessment of menopausal status based on a short interview 
(fifteen minute telephone interview) targeting women who are pre-
menopausal based on the initial interview. Affected Public: Individuals 
or households. Types of Respondents: Women who participated in the 
North Carolina Infant Feeding Study. The annual reporting burden is as 
follows: Estimated Number of Respondents: 642 Estimated Number of 
Responses per Respondent: 1.1. Average Burden Hours Per Response: 0.66. 
Estimated Total Burden Hours Requested: 426. Annualized cost to 
respondents is $6,816. 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 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. Glinda Cooper, Epidemiology Branch, 
NIEHS, Building 101, A3-05, P.O. Box 12233, Research Triangle Park, NC 
27709 or call non-toll-free number (919) 541-0799 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 30 days of 
the date of this publication.

    Dated: March 20, 2003.
Francine Little,
NIEHS, Associate Director for Management.
[FR Doc. 03-7578 Filed 3-28-03; 8:45 am]
BILLING CODE 4140-01-M