[Federal Register Volume 69, Number 231 (Thursday, December 2, 2004)]
[Notices]
[Pages 70153-70155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26539]


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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 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 to review and approve 
the information collection listed below. This proposed information 
collection was previously published in the Federal Register, under the 
title ``Determinants of Male and Female Fecundity and Fertility,'' on 
January 9, 2004, page 1589 and allowed 60-days for public comment. Two 
public comments were received from the American Society for 
Reproductive Medicine and the American Chemistry Council Phthalate 
Esters Panel regarding specific aspects of the proposed methodology. 
Overall, comments from the former group pertained predominantly to 
clinical issues while the latter group's comments provided their 
rationale for the omission of phthalates from the protocol. These 
comments were useful in modifying the proposed study and instruments. 
The purpose of this notice is to allow an additional 30 days for public 
comment.

5 CFR 1320.5 (General Requirements) Reporting and Recordkeeping

    Requirements: Final Rule requires that the agency inform the 
potential

[[Page 70154]]

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: NEW. 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 
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 proposes 
to recruit and retain 800 couples interested in becoming pregnant and 
willing to participate in a longitudinal study. 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 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 1,000 couples 
enrolling (minimum of 800 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: 3,280 to 9,900 hours for female 
participants and 2,100 to 5,480 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, New Executive Office Building, Room 10235, Washington, DC 
20503, 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 and Prevention Research, 
NICHD, 6100 Executive Boulevard, Room 7B03, Rockville, MD 20852, (301) 
496-6155. You may also e-mail your request to [email protected].
    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.


[[Page 70155]]


    Dated: November 19, 2004.
Paul L. Johnson,
Project Clearance Liaison, NICHD, National Institutes of Health.
[FR Doc. 04-26539 Filed 12-1-04; 8:45 am]
BILLING CODE 4140-01-P