Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture (NCI)
Revision of a currently approved collection
No
Regular
Approved without change
04/19/2013
02/15/2013
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
04/30/2016
36 Months From Approved
05/31/2013
25,551
0
1,780
10,465
0
550
0
0
0
The Agricultural Health Study (AHS) program staff is requesting approval of this revision to begin information collection in February, 2013. AHS is a cohort study of 89,568 licensed pesticide applicators (both private and commercial applicators) and the spouses of the private applicators in Iowa and North Carolina that is to be followed for 20 years or more. The stimulus for this prospective investigation comes from the growing evidence that, despite a low mortality overall, farmers experience an excess of several cancers, including lymphatic and hematopoietic system, connective tissue, skin, brain, prostate, stomach and lips. This suggests a common set of exposures which may explain the high rates in farmers and rising rates in the general population. NCI is primarily interested in cancer outcomes and NIEHS is interested in other disease outcomes. For this phase of the data collection, NIEHS will be taking the lead role in collecting information for this phase of the study. This revision is to initiate and complete the phase IV follow-up interview (2013-2015) as well as to continue and complete the ongoing Study of Biomarkers of Exposures Effects in Agriculture (BEEA) and buccal cell collections. The primary objective of the AHS study remains to be determination of the health effects resulting from occupational and environmental exposures in agriculture. Similar questionnaires are being used as in previous AHS interviews to obtain information on non-cancer outcomes. New for phase IV, questionnaire data will be collected by using one of three methods of the cohort member's choosing: self-administered computer assisted web survey; self-administered paper-and-pen; or an interviewer administered computer assisted telephone interview. Additionally, because loss to follow up of diseased individuals is a critical issue, we have added proxy interviews for those deceased or too ill to complete themselves will be completed by using one of the three methods.
US Code:
42 USC 285l
Name of Law: Public Health Service Act
This revision is a program change due to agency discretion and represents an increase in burden from the previous submission approved in 2010. The increase in burden for this revision is accounted for by the initiation of the phase IV follow up scheduled from February 2013 through December 2015. As well, this is a continuation to complete the information collection related to the Study of Biomarkers of Exposures Effects in Agriculture (BEEA) and buccal cells. Similar questionnaires are being used to ones that have been employed in previous AHS interviews to obtain information on non-cancer outcomes. New for phase IV, questionnaire data will be collected by using one of three methods of the cohort member's choosing: self-administered computer assisted web survey; self-administered paper-and-pen; or an interviewer administered computer assisted telephone interview. Additionally, because loss to follow up of diseased individuals is a critical issue, we have added proxy interviews for those deceased or too ill to complete themselves will be completed by using one of the three methods. The Agricultural Health Study has been conducted through contractors since its inception. An additional change is that the National Institutes of Environmental Health (NIEHS) will be taking the lead role in collecting updated health information for this phase of the study. For this reason, the OMB clearance number is being transferred from that National Cancer Institute to NIEHS.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form 8 CAWI-CATI
Supporting State B_1107012.docx
Attachment 28_AHS_PrivacyImpactAssessments.pdf
Attachment 22_BEEA_Objectives.doc
Attachment 07_Contractor_Confidentialiy_Agreement.dot
Attachment 25: Paper/pen, CAWI or CATI Instruments for Private Applicators for AHS