[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Notices]
[Pages 2925-2926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-609]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
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 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]
BILLING CODE 4140-01-P