[Federal Register Volume 67, Number 205 (Wednesday, October 23, 2002)]
[Notices]
[Pages 65132-65133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27029]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health/National Institute of Environmental 
Health Sciences


Proposed Collection; Comment Request; Organochlorine Exposure in 
Relation to Timing of Natural Menopause

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: Organochlorine Exposure in Relation to Timing of Natural 
Menopause. 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-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 
reproductive and menstrual history with additional information samples 
in order to classify menopausal status of women who had undergone 
hysterectomy with retention of at least one ovary, women who are 
currently using hormone replacement therapy whose use began while still 
having periods, and women who report very short, very long, or 
irregular menstrual cycle lengths during the past 12 months. PCB and 
DDE levels will also be determined in these samples, allowing us to 
assess the correlation between current and baseline (1978-1982) PCB and 
DDE measures. 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 collected and demographic, social 
and behavioral factors that could affect timing 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. Follicle stimulating hormone and luteinizing hormone 
will be measured in these organochlorine levels. Frequency of Response: 
On occasion (one half-hour long telephone interview and ten minutes for 
biological specimens collection for half of the study population). 
Affected Public: Individuals. Type of Respondents: We will enroll women 
who participated in the North Carolina Infant Feeding Study. The annual 
reporting burden is as follows: Estimated Number of Respondents: 857. 
Estimated Number of Responses per Respondent: See table below. Average 
Burden Hours Per Response: 0.5 for the telephone interview and 0.334 
for the blood collection; and Estimated Total Burden Hours Requested: 
571.45. The average annual burden hours requested is 428.5 for the 
telephone interview and 142.95 for the blood collection. The annualized 
cost to respondents is estimated at $10 (assuming $20 hourly wage x 
0.50 hours) for the interview and $6.658 (assuming a $20 hourly wage x 
0.334 hours) for blood collection. There are no Capital Costs to 
report. There are no Operating or Maintenance Costs to report.

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                                                                     Estimated                       Estimated
                                                     Estimated       number of    Average burden   total burden
               Type of respondents                   number of     responses per     hours per         hours
                                                    respondents     respondent       response        requested
----------------------------------------------------------------------------------------------------------------
Telephone Interview (CATI)......................             857               1            .5            428.5
Biological Collections..........................           * 428               1            .334          142.95
                                                 -----------------
    Total.......................................           1,285  ..............  ..............          571.45 
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* Expect approximately 50% of the (n=857) participants to complete the blood draw.


[[Page 65133]]

    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 collection of information on whose 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. Glinda Cooper, Epidemiology Branch, NIEHS, 
Building 101, AE-05, P.O. Box 12233, Research Triangle Park, NC 27709 
or call non-toll-free number (929) 541-0799 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 60 days of the 
date of this publication.

    Dated: October 12, 2002.
Francine Little,
NIEHS, Associate Director for Management.
[FR Doc. 02-27029 Filed 10-22-02; 8:45 am]
BILLING CODE 4140-01-M