[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]


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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

[[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