[Federal Register Volume 67, Number 246 (Monday, December 23, 2002)]
[Notices]
[Pages 78227-78228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32262]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7426-1]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Seven-County Study of Air Quality and Birth Defects: 
Computer-Assisted Telephone Questionnaire for Subset of Study 
Population

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 
et seq.), this document announces that EPA is planning to submit the 
following proposed Information Collection Request (ICR) to the Office 
of Management and Budget (OMB). Title: Seven-County Study of Air 
Quality and Birth Defects: Computer-Assisted Telephone Questionnaire 
for Subset of Study Population. Before submitting the ICR to OMB for 
review and approval, EPA is soliciting comments on specific aspects of 
the proposed information collection as described below.

DATES: Comments must be submitted on or before February 21, 2003.

ADDRESSES: Public comments should be submitted to: Dr. Pauline Mendola, 
US EPA (MD 58A) Research Triangle Park, NC 27711.

FOR FURTHER INFORMATION CONTACT: Interested persons may obtain 
technical information or a copy of the ICR without charge by 
contacting: Dr. Pauline Mendola, (919) 966-6953; FAX: (919) 966-7584; 
E-mail: [email protected], or by mailing a request to the address 
above.

SUPPLEMENTARY INFORMATION:
    Affected entities: Entities potentially affected by this action are 
women who delivered a live-born or stillborn infant or who experienced 
a recorded fetal death in seven Texas counties in 1999 already enrolled 
in the record-linkage component of the Seven-County Study of Air 
Quality and Birth Defects.
    Title: Seven-County Study of Air Quality and Birth Defects: 
Computer-Assisted Telephone Questionnaire for Subset of Study 
Population.
    Abstract: Previous U.S. studies examining the relationship between 
air pollution and adverse reproductive outcomes have not used data 
beyond the Environmental Protection Agency's stationary ambient 
monitors to estimate exposure. The proposed computer-assisted 
questionnaire contains a maximum of 28 questions categorized into 6 
sections: Residential History, Work History, Time Spent Outside the 
Home (Weekdays), Time Spent Outside the Home (Weekends), Multivitamin 
Use, and Tobacco Use. Study participants will be the mothers of infants 
born with and without birth defects in 1999 in seven Texas counties. 
These women will be selected from a larger records-linkage-based case-
control study of air pollution and birth defects in the state.
    Obtaining questionnaire information on maternal residence at 
conception will allow us to more precisely estimate exposure during the 
critical window of gestational weeks three through eight. Maternal work 
history, outdoor activities, and time spent outside the home will be 
used to refine exposure estimates for outdoor air pollution. The 
sections on maternal vitamin use and smoking during pregnancy will 
provide relevant data on potential confounders of the association 
between air pollution and birth defects.
    The study investigators will use this data to help estimate the 
association between air pollution exposure and risk of selected birth 
defects. This will be the first study in this research area to collect 
this type of data, and if it proves useful, will indicate a need for 
such supplemental data collection in future studies.
    The information will appear in the form of final EPA reports, 
dissertation manuscripts, and journal articles, and will also be made 
publicly available.
    The total cost of this study is estimated to be approximately 
$150,000.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
    The EPA would like to solicit comments to:
    (i) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the agency's estimate of the burden 
of the proposed collection of information,

[[Page 78228]]

including the validity of the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information 
to be collected; and
    (iv) Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses.
    Burden Statement: The computer-assisted telephone questionnaire 
will be administered to mothers previously contacted via mail. Each 
interview will last approximately 10 minutes, including the time spent 
eliciting informed consent. A maximum of 1000 mothers will be invited 
to participate (10,000 total minutes or 167 total hours), we estimate 
that approximately 700 mothers will respond, resulting in a total time 
of 7000 minutes, or 117 hours. The data collection will be scheduled 
over approximately 3 months. There are no direct respondent costs for 
this data collection. Burden means the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, or 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; develop, acquire, 
install, and utilize technology and systems for the purposes of 
collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information; 
adjust the existing ways to comply with any previously applicable 
instructions and requirements; train personnel to be able to respond to 
a collection of information; search data sources; complete and review 
the collection of information; and transmit or otherwise disclose the 
information.

    Dated: December 4, 2002.
John Vandenberg,
Director, Human Studies Division, National Health and Environmental 
Effects Research Laboratory, Office of Research and Development.
[FR Doc. 02-32262 Filed 12-20-02; 8:45 am]
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