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)

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:

sandler@niehs.nih.gov

. 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

Type of respondent

Form name

Estimated

annual number of respondents

Number of

responses per

respondent

Average time per response

(in hours)

Total annual

burden hours

Private and Commercial Applicators and Spouses

Reminder, Missing, and Damaged Scripts for Buccal Cell

100

1

5/60

8

Private Applicators

BEEA CATI Eligibility Script

480

1

20/60

160

Private Applicators

Mailed Consent, Pre-Visit Show Card, and Paper/Pen Dust Questionnaire

160

1

20/60

53

Private Applicators

BEEA Home Visit CAPI, Blood, Buccal cell, Urine & Dust

160

1

90/60

240

Private Applicators

BEEA Pre-Visit Scripts

20

3

5/60

5

Private Applicators

BEEA Home Visit CAPI, Blood, Buccal cell, Urine, & Dust x 3

20

3

90/60

90

Private Applicators

BEEA Mailed Consents (Home Visit & Farm Visit), Pre-Visit Show Card, and Paper/Pen Dust Questionnaire

16

1

25/60

7

Private Applicators

BEEA Home Visit CAPI, Blood, Urine, Buccal cell & Dust x 2

16

2

90/60

16

Controls

BEEA CATI Control Eligibility Script

215

1

20/60

72

Controls

BEEA Mailed Consent, Pre-Visit Show Card, and Paper/Pen Dust Questionnaire

67

1

20/60

22

Controls

BEEA Control Home Visit CAPI, Blood, Buccal cell, Urine, & Dust

67

1

90/60

101

Private Applicators

`Life in a Day' Smartphone Application x 25

100

25

10/60

417

Private Applicators

Paper/pen, CAWI or CATI

13,855

1

25/60

5,773

Spouses

Paper/pen, CAWI or CATI

10,201

1

25/60

4,250

Proxy

Paper/pen, CAWI or CATI (Attachment 26)

635

1

15/60

159

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