[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Pages 2925-2926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-609]



National Institutes of Health

 National Institute of Child Health and Human Development; 
Longitudinal Investigation of Fertility and the Environment Study

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. This is a request for renewal of an information collection 
request that was approved (OMB Clearance 0925-0543) following 
publication in the Federal Register on January 9, 2004, page 1589 and 
December 2, 2004, page 70153.
    Proposed Collection: Title: Longitudinal Investigation of Fertility 
and the Environment Study. Type of

[[Page 2926]]

Information Collection Request: Renewal of OMB Clearance 0925-0543.
    Need and Use of Information Collection: This study will assess the 
relation between select environmental factors and human fecundity and 
fertility. This research originally proposed to recruit 960 couples who 
are interested in becoming pregnant and willing to participate in a 
longitudinal study. Fewer than expected couples were enrolled during 
the first three years of the project (n=350), predominantly due to the 
fact that more couples were ineligible for participation than had been 
originally estimated. In light of this fact, the revised study plan is 
to enroll a total of 500 couples (i.e., 150 additional couples), a 
sample size that will not compromise the main study objectives. 
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. Bio-specimens 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. Revised Estimated Number 
of Respondents: 1,000. Revised 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. 
Revised Estimated Total Annual Burden Hours Requested: 1,658 for women 
and 889 for men. The revised burden estimates represent a 48 percent 
reduction in the originally requested burden. 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) The necessity of the proposed collection of 
information for the proper performance of the function of the agency, 
including the practical utility of the information; (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 

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 Louis, Senior Investigator and 
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 collection 
are best assured of having their full effect if received within 60-days 
of the date of this publication.

    Dated: January 3, 2008.
Paul Johnson,
NICHD Project Clearance Liaison, National Institutes of Health.
 [FR Doc. E8-609 Filed 1-15-08; 8:45 am]