[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]
 BILLING CODE 4140-01-P