81 FR 21583 - 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)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 70 (April 12, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 70 (April 12, 2016)
| Page Range | 21583-21584 | |
| FR Document | 2016-08397 |
[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)] [Notices] [Pages 21583-21584] From the Federal Register Online [www.thefederalregister.org] [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, [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
![Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices 21583
Dated: April 6, 2016. this notice. The statement should include the collection that has been extended,
Anna Snouffer, name, address, telephone number and when revised, or implemented on or after
Deputy Director, Office of Federal Advisory applicable, the business or professional October 1, 1995, unless it displays a
affiliation of the interested person.
Committee Policy.
In the interest of security, NIH has
currently valid OMB control number.
[FR Doc. 2016–08294 Filed 4–11–16; 8:45 am] instituted stringent procedures for entrance Direct Comments to OMB: Written
BILLING CODE 4140–01–P onto the NIH campus. All visitor vehicles, comments and/or suggestions regarding
including taxicabs, hotel, and airport shuttles the item(s) contained in this notice,
will be inspected before being allowed on especially regarding the estimated
DEPARTMENT OF HEALTH AND campus. Visitors will be asked to show one public burden and associated response
HUMAN SERVICES form of identification (for example, a time, should be directed to the: Office
government-issued photo ID, driver’s license, of Management and Budget, Office of
National Institutes of Health or passport) and to state the purpose of their
Regulatory Affairs, OIRA_submission@
visit.
Information is also available on the omb.eop.gov or by fax to 202–395–6974,
Fogarty International Center; Notice of Attention: NIH Desk Officer.
Meeting Institute’s/Center’s home page: http://
www.fic.nih.gov/About/Advisory/Pages/ Comment Due Date: Comments
Pursuant to section 10(d) of the default.aspx, where an agenda and any regarding this information collection are
Federal Advisory Committee Act, as additional information for the meeting will best assured of having their full effect if
amended (5 U.S.C. App.), notice is be posted when available. received within 30-days of the date of
hereby given of a meeting of the Fogarty (Catalogue of Federal Domestic Assistance this publication.
International Center Advisory Board. Program Nos. 93.106, Minority International
FOR FURTHER INFORMATION CONTACT: To
Research Training Grant in the Biomedical
The meeting will be open to the public obtain a copy of the data collection
and Behavioral Sciences; 93.154, Special
as indicated below, with attendance International Postdoctoral Research Program plans and instruments or request more
limited to space available. Individuals in Acquired Immunodeficiency Syndrome; information on the proposed project
who plan to attend and need special 93.168, International Cooperative contact: Dale Sandler, Ph.D., Chief,
assistance, such as sign language Biodiversity Groups Program; 93.934, Fogarty Epidemiology Branch, National Institute
interpretation or other reasonable International Research Collaboration Award; of Environmental Health Sciences, NIH,
accommodations, should notify the 93.989, Senior International Fellowship 111 T.W. Alexander Drive, P.O. Box
Contact Person listed below in advance Awards Program, National Institutes of
12233, MD A3–05, Research Triangle
Health HHS)
of the meeting. Park, NC 27709, or call non-toll-free
The meeting will be closed to the Dated: April 6, 2016. number 919–541–4668, or email your
public in accordance with the Natasha M. Copeland, request, including your address to:
provisions set forth in sections Program Analyst, Office of Federal Advisory sandler@niehs.nih.gov. Formal requests
552b(c)(4) and 552b(c)(6), title 5 U.S.C., Committee Policy. for additional plans and instruments
as amended. The grant applications and [FR Doc. 2016–08292 Filed 4–11–16; 8:45 am] must be requested in writing.
the discussions could disclose BILLING CODE 4140–01–P Proposed Collection: The Agricultural
confidential trade secrets or commercial Health Study: A Prospective Cohort
property such as patentable materials, Study of Cancer and Other Diseases
and personal information concerning DEPARTMENT OF HEALTH AND Among Men and Women in Agriculture,
individuals associated with the grant HUMAN SERVICES 0925–0406 (Expiration Date 9/30/2016,
applications the disclosure of which REVISION), National Institute of
would constitute a clearly unwarranted National Institutes of Health Environmental Health Sciences
invasion of personal privacy. (NIEHS), National Institutes of Health
Submission for OMB Review; 30-day
Name of Committee: Fogarty International (NIH).
Comment Request; The Agricultural
Center Advisory Board. Need and Use of Information
Date: May 10–11, 2016. Health Study: A Prospective Cohort
Collection: The purpose of this
Closed: May 10, 2016. Study of Cancer and Other Diseases
information collection is to request new
Time: 1:00 p.m. to 5:00 p.m. Among Men and Women in Agriculture
components as part of the ongoing
Agenda: Second level review of grant (NIEHS)
applications.
Study of Biomarkers of Exposures and
Place: National Institutes of Health, Stone SUMMARY: Under the provisions of Effects in Agriculture (BEEA), as well as
House, Building 16, Conference Room, 9000 Section 3507(a)(1)(D) of the Paperwork continue and complete phase IV (2013–
Rockville Pike, Bethesda, MD 20892. Reduction Act of 1995, the National 2016) of the Agricultural Health Study
Open: May 11, 2016. Institutes of Health (NIH), has submitted (AHS) and continue buccal cell
Time: 9:00 a.m. to 3:00 p.m. to the Office of Management and Budget collection. Phase IV will continue to
Agenda: Update and discussion of current (OMB) a request for review and update the occupational and
and planned FIC activities, including an approval of the information collection environmental exposure information as
overview and presentations from grantees of
our Global Environmental and Occupational
listed below. This proposed information well as medical history information for
Health (GEOHealth) Program. collection was previously published in licensed pesticide applicators and their
Place: National Institutes of Health, Stone the Federal Register on November 27, spouses enrolled in the AHS. The new
House, Building 16, Conference Room, 9000 2015, Pages 74115—74116, and allowed BEEA components are a control
Rockville Pike, Bethesda, MD 20892. 60-days for public comment. No public respondent group, and a smartphone
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Contact Person: Kristen Weymouth, comments were received. The purpose application (app), along with new
Executive Secretary, Fogarty International of this notice is to allow an additional sample collection (buccal cell and air
Center, National Institutes of Health, 31 30 days for public comment. The monitoring samples). The new
Center Drive, Room B2C02, Bethesda, MD
20892, (301) 496–1415, weymouthk@
National Institute of Environmental components will use similar procedures
mail.nih.gov. Health Sciences (NIEHS), National to ones already employed on the BEEA
Any interested person may file written Institutes of Health, may not conduct or study, as well as other NCI studies. The
comments with the committee by forwarding sponsor, and the respondent is not primary objectives of the study are to
the statement to the Contact Person listed on required to respond to, an information determine the health effects resulting
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![21584 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
from occupational and environmental (CATI) and in-person interview (CAPI) other chronic diseases among
exposures in the agricultural systems for telephone screeners and Agricultural Health Study cohort
environment. Secondary objectives home visit interviews, respectively. members, and this information may be
include evaluating biological markers Some respondents are also asked to generalized to the entire agricultural
that may be associated with agricultural participate in the collection of community.
exposures and risk of certain types of biospecimens and environmental
OMB approval is requested for 3
cancer. Phase IV questionnaire data are samples, including blood, urine, buccal
collected by using self-administered cells (loose cells from the respondent’s years. There are no costs to respondents
computer assisted web survey (CAWI); mouth), and vacuum dust. The findings other than their time. The total
self-administered paper-and-pen (Paper/ will provide valuable information estimated annualized burden hours are
pen); or an interviewer administered concerning the potential link between 11,440.
computer assisted telephone interview agricultural exposures and cancer and
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 Ap- IA/NC Scripts for Verbal Consent for Buccal ................. 100 1 3/60 5
plicators and Spouses.
Private and Commercial Ap- IA/NC Written Consent for Buccal ................................. 100 1 5/60 8
plicators and Spouses.
Private and Commercial Ap- Buccal Follow-up Scripts (as needed): Reminder, Miss- 30 1 2/60 1
plicators and Spouses. ing Consent, or Damaged/Missing Sample.
Private Applicators .............. BEEA CATI Screening Script for RSG, REG or AMG 480 1 20/60 160
Eligibility.
Private Applicators .............. IA/NC BEEA Consent for RSG Home Visit or REG 196 1 5/60 16
Home Visit or AMG Home Visit.
Private Applicators .............. IA/NC BEEA RSG Pre-Visit Show Card ........................ 160 1 5/60 13
Private Applicators .............. IA/NC BEEA RSG Paper/Pen Dust Questionnaire ........ 160 1 10/60 27
Private Applicators .............. BEEA RSG Pre-Home Visit Script ................................. 160 1 2/60 5
Private Applicators .............. BEEA RSG Home Visit CAPI, Blood, Buccal cell, Urine 160 1 90/60 240
& Dust.
Private Applicators .............. IA/NC BEEA REG Pre-Visit Show Card ........................ 20 3 5/60 5
Private Applicators .............. IA/NC BEEA REG Paper/Pen Dust Questionnaire ........ 20 3 10/60 10
Private Applicators .............. BEEA REG Pre-Home Visit Script ................................. 20 3 2/60 2
Private Applicators .............. BEEA REG Home Visit CAPI, Blood, Buccal cell, Urine 20 3 90/60 90
& Dust.
Private Applicators .............. IA/NC BEEA REG Post-Exposure Scheduling Script .... 20 1 2/60 1
Private Applicators .............. IA/NC BEEA AMG Pre-Visit Show Card ........................ 16 2 5/60 3
Private Applicators .............. IA/NC BEEA AMG Paper/Pen Dust Questionnaire ....... 16 2 10/60 5
Private Applicators .............. BEEA AMG Pre-Home Visit Script ................................. 16 2 2/60 1
Private Applicators .............. BEEA AMG Home Visit CAPI, Blood, Urine, Buccal cell 16 2 90/60 48
& Dust.
Private Applicators .............. IA/NC BEEA Consent for AMG Farm Visit .................... 16 1 5/60 3
Private Applicators .............. BEEA Pre-Farm Visit Script ........................................... 16 2 2/60 1
Controls ............................... BEEA CATI Control Eligibility Script .............................. 215 1 20/60 72
Controls ............................... IA/NC BEEA Control Home Visit Consent ..................... 67 1 5/60 6
Controls ............................... IA/NC BEEA Pre-Visit Show Card ................................. 67 1 5/60 6
Controls ............................... IA/NC BEEA Paper/Pen Dust Questionnaire ................. 67 1 10/60 11
Controls ............................... BEEA REG Pre-Visit Script ............................................ 67 1 2/60 2
Controls ............................... BEEA Control Home Visit CAPI, Blood, Buccal cell, 67 1 90/60 101
Urine, & Dust.
Private Applicators .............. ‘Life in a Day’ Smartphone App Consent and Setup ..... 78 1 20/60 26
Private Applicators .............. ‘Life in a Day’ Smartphone Application .......................... 78 30 10/60 390
Private Applicators .............. Phase IV Follow-up CAWI, CATI, or Paper/pen ............ 13,855 1 25/60 5,773
Spouses .............................. Phase IV Follow-up CAWI, CATI, or Paper/pen ............ 10,201 1 25/60 4,250
Proxy ................................... Phase IV Follow-up CAWI, CATI, or Paper/pen ............ 635 1 15/60 159
Total ............................. ......................................................................................... 27,139 29,641 .................... 11,440
Dated: April 4, 2016. DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Jane M. Lambert, HUMAN SERVICES hereby given of the following meeting.
Project Clearance Liaison, CIP, NIEHS. The meeting will be closed to the
National Institutes of Health public in accordance with the
[FR Doc. 2016–08397 Filed 4–11–16; 8:45 am]
BILLING CODE 4140–01–P National Institute on Aging; Notice of provisions set forth in sections
Closed Meeting 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
Pursuant to section 10(d) of the the discussions could disclose
Federal Advisory Committee Act, as confidential trade secrets or commercial
VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\12APN1.SGM 12APN1](https://thefederalregister.org/doc/81_FR_21653/page/2.svg)
Document Created: 2016-04-12 00:47:08
Document Modified: 2016-04-12 00:47:08
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. | |
| 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 | |
| FR Citation | 81 FR 21583 |
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