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), 21583-21584 [2016-08397]

Download as PDF Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices Dated: April 6, 2016. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2016–08294 Filed 4–11–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Fogarty International Center; Notice of Meeting asabaliauskas on DSK3SPTVN1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Fogarty International Center Advisory Board. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. 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[FR Doc. 2016–08292 Filed 4–11–16; 8:45 am] BILLING CODE 4140–01–P 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) 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 SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 21583 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, OIRA_submission@ omb.eop.gov 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: sandler@niehs.nih.gov. 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 E:\FR\FM\12APN1.SGM 12APN1 21584 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices 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 respondents Number of responses per respondent Average time per response (in hours) Total annual burden hours Type of respondent Form name Private and Commercial Applicators and Spouses. Private and Commercial Applicators and Spouses. Private and Commercial Applicators and Spouses. Private Applicators .............. IA/NC Scripts for Verbal Consent for Buccal ................. 100 1 3/60 5 IA/NC Written Consent for Buccal ................................. 100 1 5/60 8 30 1 2/60 1 480 1 20/60 160 196 1 5/60 16 160 160 160 160 1 1 1 1 5/60 10/60 2/60 90/60 13 27 5 240 20 20 20 20 3 3 3 3 5/60 10/60 2/60 90/60 5 10 2 90 20 16 16 16 16 1 2 2 2 2 2/60 5/60 10/60 2/60 90/60 1 3 5 1 48 16 16 215 67 67 67 67 67 1 2 1 1 1 1 1 1 5/60 2/60 20/60 5/60 5/60 10/60 2/60 90/60 3 1 72 6 6 11 2 101 Private Applicators .............. Private Applicators .............. Private Applicators .............. Spouses .............................. Proxy ................................... Buccal Follow-up Scripts (as needed): Reminder, Missing Consent, or Damaged/Missing Sample. BEEA CATI Screening Script for RSG, REG or AMG Eligibility. IA/NC BEEA Consent for RSG Home Visit or REG Home Visit or AMG Home Visit. IA/NC BEEA RSG Pre-Visit Show Card ........................ IA/NC BEEA RSG Paper/Pen Dust Questionnaire ........ BEEA RSG Pre-Home Visit Script ................................. BEEA RSG Home Visit CAPI, Blood, Buccal cell, Urine & Dust. IA/NC BEEA REG Pre-Visit Show Card ........................ IA/NC BEEA REG Paper/Pen Dust Questionnaire ........ BEEA REG Pre-Home Visit Script ................................. BEEA REG Home Visit CAPI, Blood, Buccal cell, Urine & Dust. IA/NC BEEA REG Post-Exposure Scheduling Script .... IA/NC BEEA AMG Pre-Visit Show Card ........................ IA/NC BEEA AMG Paper/Pen Dust Questionnaire ....... BEEA AMG Pre-Home Visit Script ................................. BEEA AMG Home Visit CAPI, Blood, Urine, Buccal cell & Dust. IA/NC BEEA Consent for AMG Farm Visit .................... BEEA Pre-Farm Visit Script ........................................... BEEA CATI Control Eligibility Script .............................. IA/NC BEEA Control Home Visit Consent ..................... IA/NC BEEA Pre-Visit Show Card ................................. IA/NC BEEA Paper/Pen Dust Questionnaire ................. BEEA REG Pre-Visit Script ............................................ BEEA Control Home Visit CAPI, Blood, Buccal cell, Urine, & Dust. ‘Life in a Day’ Smartphone App Consent and Setup ..... ‘Life in a Day’ Smartphone Application .......................... Phase IV Follow-up CAWI, CATI, or Paper/pen ............ Phase IV Follow-up CAWI, CATI, or Paper/pen ............ Phase IV Follow-up CAWI, CATI, or Paper/pen ............ 78 78 13,855 10,201 635 1 30 1 1 1 20/60 10/60 25/60 25/60 15/60 26 390 5,773 4,250 159 Total ............................. ......................................................................................... 27,139 29,641 .................... 11,440 Private Applicators .............. Private Private Private Private Applicators Applicators Applicators Applicators .............. .............. .............. .............. Private Private Private Private Applicators Applicators Applicators Applicators .............. .............. .............. .............. Private Private Private Private Private Applicators Applicators Applicators Applicators Applicators .............. .............. .............. .............. .............. asabaliauskas on DSK3SPTVN1PROD with NOTICES Private Applicators .............. Private Applicators .............. Controls ............................... Controls ............................... Controls ............................... Controls ............................... Controls ............................... Controls ............................... Dated: April 4, 2016. Jane M. Lambert, Project Clearance Liaison, CIP, NIEHS. [FR Doc. 2016–08397 Filed 4–11–16; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting BILLING CODE 4140–01–P Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial E:\FR\FM\12APN1.SGM 12APN1

Agencies

[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]


-----------------------------------------------------------------------

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, OIRA_submission@omb.eop.gov 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: sandler@niehs.nih.gov. 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
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