[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
----------------------------------------------------------------------------------------------------------------
                                                     Estimated       Number of     Average time
      Type of respondent           Instrument      annual number   responses per   per response    Total annual
                                                  of respondents    respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
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