[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23737-23739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09296]
-----------------------------------------------------------------------
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 Diseases Among Men and Women in Agriculture (NIEHS)
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 for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on November 27, 2015, Pages 74115-74116, and allowed 60-days
for public comment. No public comments were received. The purpose of
this notice is to allow an additional 30 days for public comment. The
National Institute of Environmental Health Sciences (NIEHS), National
Institutes of Health, may not conduct or sponsor, and the respondent is
not required to respond to, an information
[[Page 23738]]
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.
DATES: 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: 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.
Proposed Collection: The Agricultural Health Study: A Prospective
Cohort Study of Cancer and Other Diseases 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.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 11,440.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Form name Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Private and Commercial IA/NC Scripts 100 1 3/60 5
Applicators and Spouses. for Verbal
Consent for
Buccal.
Private and Commercial IA/NC Written 100 1 5/60 8
Applicators and Spouses. Consent for
Buccal.
Private and Commercial Buccal Follow-up 30 1 2/60 1
Applicators and Spouses. Scripts (as
needed):
Reminder,
Missing
Consent, or
Damaged/Missing
Sample.
Private Applicators........... BEEA CATI 480 1 20/60 160
Screening
Script for RSG,
REG or AMG
Eligibility.
Private Applicators........... IA/NC BEEA 196 1 5/60 16
Consent for RSG
Home Visit or
REG Home Visit
or AMG Home
Visit.
Private Applicators........... IA/NC BEEA RSG 160 1 5/60 13
Pre-Visit Show
Card.
Private Applicators........... IA/NC BEEA RSG 160 1 10/60 27
Paper/Pen Dust
Questionnaire.
Private Applicators........... BEEA RSG Pre- 160 1 2/60 5
Home Visit
Script.
Private Applicators........... BEEA RSG Home 160 1 90/60 240
Visit CAPI,
Blood, Buccal
cell, Urine &
Dust.
Private Applicators........... IA/NC BEEA REG 20 3 5/60 5
Pre-Visit Show
Card.
Private Applicators........... IA/NC BEEA REG 20 3 10/60 10
Paper/Pen Dust
Questionnaire.
Private Applicators........... BEEA REG Pre- 20 3 2/60 2
Home Visit
Script.
Private Applicators........... BEEA REG Home 20 3 90/60 90
Visit CAPI,
Blood, Buccal
cell, Urine &
Dust.
Private Applicators........... IA/NC BEEA REG 20 1 2/60 1
Post-Exposure
Scheduling
Script.
Private Applicators........... IA/NC BEEA AMG 16 2 5/60 3
Pre-Visit Show
Card.
Private Applicators........... IA/NC BEEA AMG 16 2 10/60 5
Paper/Pen Dust
Questionnaire.
Private Applicators........... BEEA AMG Pre- 16 2 2/60 1
Home Visit
Script.
Private Applicators........... BEEA AMG Home 16 2 90/60 48
Visit CAPI,
Blood, Urine,
Buccal cell &
Dust.
[[Page 23739]]
Private Applicators........... IA/NC BEEA 16 1 5/60 1
Consent for AMG
Farm Visit.
Private Applicators........... BEEA Pre-Farm 16 2 2/60 1
Visit Script.
Controls...................... BEEA CATI 215 1 20/60 72
Control
Eligibility
Script.
Controls...................... IA/NC BEEA 67 1 5/60 6
Control Home
Visit Consent.
Controls...................... IA/NC BEEA Pre- 67 1 5/60 6
Visit Show Card.
Controls...................... IA/NC BEEA Paper/ 67 1 10/60 11
Pen Dust
Questionnaire.
Controls...................... BEEA REG Pre- 67 1 2/60 2
Visit Script.
Controls...................... BEEA Control 67 1 90/60 101
Home Visit
CAPI, Blood,
Buccal cell,
Urine, & Dust.
Private Applicators........... `Life in a Day' 78 1 20/60 26
Smartphone App
Consent and
Setup.
Private Applicators........... `Life in a Day' 78 30 10/60 390
Smartphone
Application.
Private Applicators........... Phase IV Follow- 13,855 1 25/60 5,773
up CAWI, CATI,
or Paper/pen.
Spouses....................... Phase IV Follow- 10,201 1 25/60 4,250
up CAWI, CATI,
or Paper/pen.
Proxy......................... Phase IV Follow- 635 1 15/60 159
up CAWI, CATI,
or Paper/pen.
---------------------------------------------------------------
Total..................... ................ 27,139 29,641 .............. 11,438
----------------------------------------------------------------------------------------------------------------
Dated: April 18, 2016.
Jane M. Lambert,
Project Clearance Liaison, NIEHS.
[FR Doc. 2016-09296 Filed 4-21-16; 8:45 am]
BILLING CODE 4140-01-P