[Federal Register Volume 78, Number 78 (Tuesday, April 23, 2013)]
[Notices]
[Pages 23942-23943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09527]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request: The Agricultural
Health Study: A Prospective Cohort Study of Cancer and Other Disease
Among Men and Women in Agriculture (NCI)
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 Cancer Institute
(NCI), 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.
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
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) 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.
To Submit Comments and for Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
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.
Comment 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.
Proposed Collection: The Agricultural Health Study: A Prospective
Cohort Study of Cancer and Other Disease Among Men and Women in
Agriculture, 0925-0406, Expiration Date 5/31/2013, 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.
[[Page 23943]]
Estimated Annualized Burden Hours
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Estimated Number of Average time
Type of respondent Instrument annual number responses per per response Total annual
of respondents respondent (in hours) burden hours
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Private and Commercial Reminder, 100 1 5/60 8
Applicators and Spouses. Missing, and
Damaged Scripts
for Buccal Cell.
Private Applicators........... BEEA CATI 480 1 20/60 160
Eligibility
Script.
Private Applicators........... Mailed Paper/Pen 160 1 10/60 27
Dust
Questionnaire.
Private Applicators........... BEEA Home Visit 160 1 100/60 267
CAPI, Blood,
Urine, & Dust x
1.
Private Applicators........... BEEA Schedule 20 3 5/60 5
Home Visit
Scripts.
Private Applicators........... BEEA Home Visit 20 3 30/60 30
CAPI, Blood, &
Urine x 3.
Private Applicators........... Paper/pen, CAWI 13,855 1 25/60 5,773
or CATI.
Spouses....................... Paper/pen, CAWI 10,201 1 25/60 4,250
or CATI.
Proxy......................... Paper/pen, CAWI 635 1 15/60 159
or CATI.
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Dated: April 16, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, NCI, NIH.
[FR Doc. 2013-09527 Filed 4-22-13; 8:45 am]
BILLING CODE 4140-01-P