[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Notices]
[Pages 74115-74116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30219]
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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 (NIEHS)
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 Institute of
Environmental Health Sciences (NIEHS), 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: Dale
Sandler, Ph.D., Chief, Epidemiology Branch, National Institute of
Environmental Health Sciences, NIH, 111 T.W. Alexander Drive, P.O. Box
12233, MD A3-05, Research Triangle Park, NC 27709, or call non-toll-
free number 919-541-4668, or email your request, including your address
to: [email protected]. Formal requests for additional plans and
instruments must be requested in writing.
DATES: 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 9/30/2016, 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 new components as part of the
ongoing Study of Biomarkers of Exposures and Effects in Agriculture
(BEEA), as well as continue and complete phase IV (2013-2016) 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 components are a control respondent group, and a
smartphone application (app), along with new sample collection (buccal
cell and air monitoring samples). The new components will use similar
procedures to ones already employed on the BEEA study, as well as other
NCI studies. 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.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated Number of Average time
Type of respondent Form name 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 Consent, 160 1 20/60 53
Pre-Visit Show
Card, and Paper/
Pen Dust
Questionnaire.
Private Applicators........... BEEA Home Visit 160 1 90/60 240
CAPI, Blood,
Buccal cell,
Urine & Dust.
Private Applicators........... BEEA Pre-Visit 20 3 5/60 5
Scripts.
Private Applicators........... BEEA Home Visit 20 3 90/60 90
CAPI, Blood,
Buccal cell,
Urine, & Dust x
3.
Private Applicators........... BEEA Mailed 16 1 25/60 7
Consents (Home
Visit & Farm
Visit), Pre-
Visit Show
Card, and Paper/
Pen Dust
Questionnaire.
Private Applicators........... BEEA Home Visit 16 2 90/60 16
CAPI, Blood,
Urine, Buccal
cell & Dust x 2.
Controls...................... BEEA CATI 215 1 20/60 72
Control
Eligibility
Script.
[[Page 74116]]
Controls...................... BEEA Mailed 67 1 20/60 22
Consent, Pre-
Visit Show
Card, and Paper/
Pen Dust
Questionnaire.
Controls...................... BEEA Control 67 1 90/60 101
Home Visit
CAPI, Blood,
Buccal cell,
Urine, & Dust.
Private Applicators........... `Life in a Day' 100 25 10/60 417
Smartphone
Application x
25.
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
(Attachment 26).
---------------------------------------------------------------
Total..................... ................ 25,486 28,608 .............. 11,516
----------------------------------------------------------------------------------------------------------------
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 11,516.
Dated: November 20, 2015.
Chris Long,
Acting Executive Officer, NIEHS.
[FR Doc. 2015-30219 Filed 11-25-15; 8:45 am]
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