[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21583-21584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08397]


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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 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 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: 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

[[Page 21584]]

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       Total
                                                               Number of    responses     time per      annual
        Type of respondent                 Form name          respondents      per        response      burden
                                                                            respondent   (in hours)     hours
----------------------------------------------------------------------------------------------------------------
Private and Commercial             IA/NC Scripts for Verbal           100            1         3/60            5
 Applicators and Spouses.           Consent for Buccal.
Private and Commercial             IA/NC Written Consent for          100            1         5/60            8
 Applicators and Spouses.           Buccal.
Private and Commercial             Buccal Follow-up Scripts            30            1         2/60            1
 Applicators and Spouses.           (as needed): Reminder,
                                    Missing Consent, or
                                    Damaged/Missing Sample.
Private Applicators..............  BEEA CATI Screening                480            1        20/60          160
                                    Script for RSG, REG or
                                    AMG Eligibility.
Private Applicators..............  IA/NC BEEA Consent for             196            1         5/60           16
                                    RSG Home Visit or REG
                                    Home Visit or AMG Home
                                    Visit.
Private Applicators..............  IA/NC BEEA RSG Pre-Visit           160            1         5/60           13
                                    Show Card.
Private Applicators..............  IA/NC BEEA RSG Paper/Pen           160            1        10/60           27
                                    Dust Questionnaire.
Private Applicators..............  BEEA RSG Pre-Home Visit            160            1         2/60            5
                                    Script.
Private Applicators..............  BEEA RSG Home Visit CAPI,          160            1        90/60          240
                                    Blood, Buccal cell,
                                    Urine & Dust.
Private Applicators..............  IA/NC BEEA REG Pre-Visit            20            3         5/60            5
                                    Show Card.
Private Applicators..............  IA/NC BEEA REG Paper/Pen            20            3        10/60           10
                                    Dust Questionnaire.
Private Applicators..............  BEEA REG Pre-Home Visit             20            3         2/60            2
                                    Script.
Private Applicators..............  BEEA REG Home Visit CAPI,           20            3        90/60           90
                                    Blood, Buccal cell,
                                    Urine & Dust.
Private Applicators..............  IA/NC BEEA REG Post-                20            1         2/60            1
                                    Exposure Scheduling
                                    Script.
Private Applicators..............  IA/NC BEEA AMG Pre-Visit            16            2         5/60            3
                                    Show Card.
Private Applicators..............  IA/NC BEEA AMG Paper/Pen            16            2        10/60            5
                                    Dust Questionnaire.
Private Applicators..............  BEEA AMG Pre-Home Visit             16            2         2/60            1
                                    Script.
Private Applicators..............  BEEA AMG Home Visit CAPI,           16            2        90/60           48
                                    Blood, Urine, Buccal
                                    cell & Dust.
Private Applicators..............  IA/NC BEEA Consent for              16            1         5/60            3
                                    AMG Farm Visit.
Private Applicators..............  BEEA Pre-Farm Visit                 16            2         2/60            1
                                    Script.
Controls.........................  BEEA CATI Control                  215            1        20/60           72
                                    Eligibility Script.
Controls.........................  IA/NC BEEA Control Home             67            1         5/60            6
                                    Visit Consent.
Controls.........................  IA/NC BEEA Pre-Visit Show           67            1         5/60            6
                                    Card.
Controls.........................  IA/NC BEEA Paper/Pen Dust           67            1        10/60           11
                                    Questionnaire.
Controls.........................  BEEA REG Pre-Visit Script           67            1         2/60            2
Controls.........................  BEEA Control Home Visit             67            1        90/60          101
                                    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-up CAWI,        13,855            1        25/60        5,773
                                    CATI, or Paper/pen.
Spouses..........................  Phase IV Follow-up CAWI,        10,201            1        25/60        4,250
                                    CATI, or Paper/pen.
Proxy............................  Phase IV Follow-up CAWI,           635            1        15/60          159
                                    CATI, or Paper/pen.
                                                             ---------------------------------------------------
    Total........................  .........................       27,139       29,641  ...........       11,440
----------------------------------------------------------------------------------------------------------------


    Dated: April 4, 2016.
Jane M. Lambert,
Project Clearance Liaison, CIP, NIEHS.
[FR Doc. 2016-08397 Filed 4-11-16; 8:45 am]
BILLING CODE 4140-01-P