[Federal Register: March 21, 2008 (Volume 73, Number 56)]
[Notices]
[Page 15162-15163]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21mr08-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Longitudinal
Investigation of Fertility and the Environment
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Eunice Kennedy Shriver National Institute of
Child Health and Human Development, the National Institutes of Health
has submitted to the Office of Management and Budget (OMB) a request
for renewal of an information collection request. The original
information collection request was approved (OMB Clearance 0925-0543)
following publication in the Federal Register on January 9, 2004, page
1589 and December 2, 2004, page 70153. The proposed collection
extension was previously published in the Federal Register on January
16, 2008, page 2925 and allowed 60 days for public comment. Only one
public comment was received during the previous comment period. It was
received via e-mail from a concerned citizen who stated that she felt
that the study should no longer continue because it is not a good use
of tax dollars.
5 CFR 1320.5 (General Requirements) Reporting and Recordkeeping
Requirements: Final Rule requires that the agency inform the potential
persons who are to respond to the collection of information that such
persons are not required to respond to the collection of information
unless it displays a currently valid OMB control number. This
information is required to be stated in the 30-day Federal Register
Notice.
Proposed Collection: Title: Longitudinal Investigation of Fertility
and the Environment (LIFE Study). Type of Information Collection
Request: EXTENSION (OMB control number 0925-0543, expiration date,
March 30, 2008). Need and Use of Information Collection: The purpose of
the LIFE Study is to assess the impact of environmental factors,
broadly defined to include lifestyle factors, on human reproduction and
development. The LIFE Study is consistent with the mission of the
Eunice Kennedy Shriver National Institute of Child Health and Human
Development that includes conducting basic, clinical and epidemiologic
research focusing on factors and processes associated with human
reproduction and development thereby, ensuring the birth of healthy
infants capable of reaching full adult potential unimpaired by physical
or mental disabilities. This study will assess the relation between
select environmental factors and human reproduction and development.
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. Couples will be selected from geographic regions that were
chosen from peer reviewed competitive proposals. 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. Infertility will be recognized for couples unable to
conceive within 12 months of trying. The study's primary environmental
exposures include: Organochlorine pesticides; polychlorinated
biphenyls; polybrominated diphenyl ethers; metals; perfluorinated
compounds; cotinine; and phytoestrogens. A growing body of literature
suggests these compounds may exert adverse effects on human
reproduction and development; however, definitive data are lacking
especially for sensitive endpoints. Couples will participate in a 25-
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 globally 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 such as use of cigarettes and alcohol, consistent
with the manner in which human beings are exposed. Frequency of
Response: Following the baseline interview (25 minutes), couples will
each complete a 2-minute daily diary on select lifestyle factors. Women
will perform daily fertility testing (7 minutes) approximately 11 days
per cycle and pregnancy testing (4 minutes) at day of expected menses
using a dipstick test in urine. Approximately 60% of women will become
pregnant after 2 to 3 months, at which point they will switch to the
less intensive portion of the protocol. 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 6 minutes each. 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. Study
participants will collect semen and saliva samples and forward them in
prepaid delivery packages to the study's
[[Page 15163]]
laboratories. Research nurses will collect blood and urine samples and
return them to the study's laboratories. Affected Public: Individuals
from participating communities. Type of Respondents: Men aged 18+ years
and women aged 18-40 years. Estimated Number of Respondents:
Approximately 500 couples enrolling (minimum of 400 completing the
study). Estimated Number of Response Sets Per Respondent: 7 per woman
and 4 per man over approximately two years. Average Burden Hours Per
Response: (1) 0.17 hours for completing the screening instrument; (2)
0.42 hours for baseline interviews with men and women; (3) 2.5 hours
for daily journal while attempting pregnancy for men and women; (4)
0.38 and 0.7 hours for biospecimen collection for women and men,
respectively; (5) 2.6 hours for fertility monitors; (6) 0.27 hours for
pregnancy testing for women; and (7) 0.29 hours for pregnancy journals
for women. Estimated Total Annual Burden Hours Requested: 1,640 to
4,950 hours for female participants and 1,050 to 2,740 hours for male
participants depending upon the length of time required for pregnancy.
There is no cost to respondents. There are no Capital Costs, Operating
Costs, and/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) Evaluate 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) Evaluate 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) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) 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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov, or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Dr. Germaine M. Buck Louis, Epidemiology Branch,
Division of Epidemiology, Statistics & Prevention Research, NICHD, 6100
Executive Blvd., Room 7B03, Rockville, MD 20852, 301-496-6155. You may
also e-mail your request to louisg@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: March 12, 2008.
Paul L. Johnson,
Project Clearance Liaison, The Eunice Kennedy Shriver National
Institute of Child Health and Human Development, National Institutes of
Health.
[FR Doc. E8-5700 Filed 3-20-08; 8:45 am]
BILLING CODE 4140-01-P