02-27029. 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 × 0.50 hours) for the interview and $6.658 (assuming a $20 hourly wage × 0.334 hours) for blood collection. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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

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 [phone] or E-mail your request, including your address to: [e-mail].

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.