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

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

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

Type of respondent

Form name

Number of

respondents

Number of

responses per

respondent

Average

time per

response

(in hours)

Total

annual

burden hours

Private and Commercial Applicators and Spouses

IA/NC Scripts for Verbal Consent for Buccal

100

1

3/60

5

Private and Commercial Applicators and Spouses

IA/NC Written Consent for Buccal

100

1

5/60

8

Private and Commercial Applicators and Spouses

Buccal Follow-up Scripts (as needed): Reminder, Missing Consent, or Damaged/Missing Sample

30

1

2/60

1

Private Applicators

BEEA CATI Screening Script for RSG, REG or AMG Eligibility

480

1

20/60

160

Private Applicators

IA/NC BEEA Consent for RSG Home Visit or REG Home Visit or AMG Home Visit

196

1

5/60

16

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 & Dust

160

1

90/60

240

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 & Dust

20

3

90/60

90

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 & Dust

16

2

90/60

48

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, Urine, & Dust

67

1

90/60

101

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.

Jane M. Lambert,

Project Clearance Liaison, CIP, NIEHS.

[FR Doc. 2016-08397 Filed 4-11-16; 8:45 am]

BILLING CODE 4140-01-P