[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43215-43216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17362]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB review; 30-day Comment Request: The 
Agricultural Health Study: A Prospective Cohort Study of Cancer and 
Other Disease Among Men and Women in Agriculture (NCI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH), 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 on April 23, 2013, Vol. 78, page 23942 and allowed 60-days for 
public comment. One public comment was received on April 23, 2013, that 
questioned spending taxpayer money for this research. An email response 
was sent on April 24, 2013, stating, ``We received your comment. We 
will take your comments into consideration''. The purpose of this 
notice is to allow an additional 30 days for public comment. The 
National Cancer Institute (NCI), National Institutes of Health may not 
conduct or sponsor, and the respondent is not required to respond to, 
an information collection that has been extended, revised, or 
implemented on or after October 1, 1995, unless it displays a currently 
valid OMB control number.
    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, [email protected] or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment 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.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments or request more information on the 
proposed project contact: Jane Hoppin, Sc.D., Epidemiology Branch, 
National Institute of Environmental Health Sciences, NIH, 111 T.W. 
Alexander Drive, PO Box 12233, MD A3-05, Research Triangle Park, NC 
27709, or call non-toll-free number 919-541-7622, or email your 
request, including your address to: [email protected]. Formal 
requests for additional plans and instruments must be requested in 
writing.
    Proposed Collection: The Agricultural Health Study: A Prospective 
Cohort Study of Cancer and Other Disease Among Men and Women in 
Agriculture, 0925-0406--REVISION--National Institute of Environmental 
Health Sciences (NIEHS), National Institutes of Health (NIH).
    Need and Use of Information Collection: The purpose of this 
information collection is to request initiation of a new dust specimen 
component as part of the ongoing Study of Biomarkers of Exposures and 
Effects in Agriculture (BEEA) as well as continue and complete phase IV 
(2013-2015) of the Agricultural Health Study (AHS) and continue buccal 
cell collection. Phase IV will continue to update the occupational and 
environmental exposure information as well as medical history 
information for licensed pesticide applicators and their spouses 
enrolled in the AHS. The new BEEA dust component will include a brief 
paper-and-pen questionnaire mailed to the participant in advance of the 
home visit; at the home visit, the study phlebotomist will to collect 
and review the questionnaire, and collect the participant's disposable 
vacuum bag (or empty the dust from vacuums without disposable bags). 
The dust component will use similar procedures to ones that have been 
employed on other NCI studies to obtain information about the dust 
specimen and to collect and ship the dust specimen. The primary 
objectives of the study are to determine the health effects resulting 
from occupational and environmental exposures in the agricultural 
environment. Secondary objectives include evaluating biological markers 
that may be associated with agricultural exposures and risk of certain 
types of cancer. Phase IV questionnaire data are collected by using 
self-administered computer assisted web survey (CAWI); self-
administered paper-and-pen (Paper/pen); or an interviewer administered 
computer assisted telephone interview (CATI) and in-person interview 
(CAPI) systems for telephone screeners and home visit interviews, 
respectively. Some respondents are also asked to participate in the 
collection of biospecimens and environmental samples, including blood, 
urine, buccal cells (loose cells from the respondent's mouth), and 
vacuum dust. The findings will provide valuable information concerning 
the potential link between agricultural exposures and cancer and other 
chronic diseases among Agricultural Health Study cohort members, and 
this information may be generalized to the entire agricultural 
community.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 10,679.

                                                            Estimated Annualized Burden Hours
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                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total annual
                   Form name                                Type of respondent              respondents    responses per   response  (in   burden hours
                                                                                                            respondent        hours)
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Reminder, Missing, and Damaged Scripts for       Private and Commercial Applicators and              100               1            5/60               8
 Buccal Cell.                                     Spouses.
BEEA CATI Eligibility Script...................  Private Applicators....................             480               1           20/60             160
Mailed Consent, Pre-Visit Show Card, and Paper/  Private Applicators....................             160               1           20/60              53
 Pen Dust Questionnaire.
BEEA Home Visit CAPI, Blood, Urine, & Dust x 1.  Private Applicators....................             160               1           90/60             240
BEEA Schedule Home Visit Scripts...............  Private Applicators....................              20               3            5/60               5
BEEA Home Visit CAPI, Blood, & Urine x 3.......  Private Applicators....................              20               3           30/60              30
Paper/pen, CAWI or CATI........................  Private Applicators....................          13,855               1           25/60           5,773

[[Page 43216]]

 
Paper/pen, CAWI or CATI........................  Spouses................................          10,201               1           25/60           4,250
Paper/pen, CAWI or CATI........................  Proxy..................................             635               1           15/60             159
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     Dated: July 10, 2013.
Rick Woychik,
Deputy Director, NIEHS.
[FR Doc. 2013-17362 Filed 7-18-13; 8:45 am]
BILLING CODE 4140-01-P