[Federal Register Volume 69, Number 6 (Friday, January 9, 2004)]
[Notices]
[Page 1589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request, Determinants of Male and 
Female Fecundity and Fertility

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 Child 
Health and Human Development (NICHD), 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: Determinants of Male and Female 
Fecundity and Fertility. Type of Information Collection Request: New. 
Need and Use of Information Collection: This study will assess the 
relation between select environmental factors and human fecundity and 
fertility. This research proposes to recruit 960 couples who are 
interested in becoming pregnant and willing to participate in a 
longitudinal study. Fecundity will be measured by the time required for 
the couples to achieve pregnancy, while fertility will be measured by 
the ability of couples to have a live born infant. Couples who are 
unable to conceive within 12 months of trying or who experience a 
miscarriage also will be identified and considered to have fecundity-
related impairments. The study's primary environmental exposures 
include: organochlorine pesticides and polychlorinated biphenyls; 
metals; fluorinated compounds; phytoestrogens; and phthalates. A 
growing body of literature suggests these compounds may exert effects 
on human reproduction and development; however, definitive data are 
lacking serving as the impetus for this study. Couples will participate 
in a 20-30 minute baseline interview and be instructed in the use of 
home fertility monitors and pregnancy kits for counting the time 
required for pregnancy and detecting pregnancy. Blood and urine samples 
will be collected at baseline from both partners of the couple for 
measurement of the environmental exposures. Two semen samples from male 
partners and two saliva samples from female partners also will be 
requested. Semen samples will be used to assess male fecundity as 
measured primarily by sperm concentration and morphology. Saliva 
samples will be used for the measurement of cortisol levels as a marker 
of stress among female partners so that the relation between 
environmental factors, stress and human reproduction can be assessed. 
The findings will provide valuable information regarding the effect of 
environmental contaminants on sensitive markers of human reproduction 
and development, filling critical data gaps. Moreover, these 
environmental exposures will be analyzed in the context of other 
lifestyle exposures, consistent with the manner in which human beings 
are exposed. Frequency of Response: Following the baseline interview, 
couples will each complete a five-minute daily diary on select 
lifestyle factors. Women will perform daily fertility testing and 
pregnancy testing at day of expected menses using a dipstick test in 
urine. Each test will require approximately five minutes for 
completion. This testing and diary reporting is required only up to the 
time women become pregnant, which on average should be in 2-3 months. 
Men will provide two semen samples, a month apart, requiring 
approximately 20 minutes for each collection, and women will collect 
two saliva samples, a month apart, requiring approximately five 
minutes. Participating couples will be given a choice to submit their 
information by mail or to send it electronically to the Data 
Coordinating Center. This option will be available throughout data 
collection in the event couples change their minds about how they would 
like to submit information. Biospecimens will be collected by study 
participants and research nurses, where appropriate, and forwarded in 
prepaid delivery packages to the study's laboratories. Affected Public: 
Individuals from participating communities. Type of Respondents: Men 
and women aged 18-40 years. Estimated Number of Respondents: 1,920. 
Estimated Number of Response Sets Per Respondent: 6 per women and 3 per 
men over approximately two years. Average Burden Hours Per Response: 
.1947 for women and .31975 for men. Estimated Total Annual Burden Hours 
Requested: 3,183 for women and 1,706 for men. There is no cost to 
respondents. 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.

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. Germaine Buck, Chief, Epidemiology Branch, 
DESPR, NICHD, NIH, 6100 Executive Blvd., Room 7B03, Rockville, Maryland 
20852, or call non-toll-free number (301) 496-6155 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: December 30, 2003.
Ayesha Giles,
Project Clearance Liaison, NICHD, National Institutes of Health.
[FR Doc. 04-453 Filed 1-8-04; 8:45 am]
BILLING CODE 4140-01-P