2013-09527. 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 (NCI)

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 Cancer Institute (NCI), 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: Jane Hoppin, Sc.D., Epidemiology Branch, National Institute of Environmental Health Sciences, NIH, 111 T.W. Alexander Drive, PO Box 12233, MD A3-05, Research Triangle Park, NC 27709, or call non-toll-free number 919-541-7622, or email your request, including your address to: [e-mail]. Formal requests for additional plans and instruments must be requested in writing.

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 5/31/2013, 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 initiation of a new dust specimen component as part of the ongoing Study of Biomarkers of Exposures and Effects in Agriculture (BEEA) as well as continue and complete phase IV (2013-2015) 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 dust component will include a brief paper-and-pen questionnaire mailed to the participant in advance of the home visit; at the home visit, the study phlebotomist will to collect and review the questionnaire, and collect the participant's disposable vacuum bag (or empty the dust from vacuums without disposable bags). The dust component will use similar procedures to ones that have been employed on other NCI studies to obtain information about the dust specimen and to collect and ship the dust specimen. 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 10,679.

Estimated Annualized Burden Hours

Type of respondent	Instrument	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 Paper/Pen Dust Questionnaire	160	1	10/60	27
Private Applicators	BEEA Home Visit CAPI, Blood, Urine, & Dust × 1	160	1	100/60	267
Private Applicators	BEEA Schedule Home Visit Scripts	20	3	5/60	5
Private Applicators	BEEA Home Visit CAPI, Blood, & Urine × 3	20	3	30/60	30
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	635	1	15/60	159

Dated: April 16, 2013.

Vivian Horovitch-Kelley,

NCI Project Clearance Liaison, NCI, NIH.