Approved consistent with revised documents uploaded on 5/20/2010. In the event of subsequent phases, NCI/NIH will sumbit a change package that describes the design and protocol for the next phase of the study before beginning the data collection for that phase.
Inventory as of this Action
Requested
Previously Approved
05/31/2013
36 Months From Approved
10/31/2011
1,780
0
6,861
550
0
4,140
0
0
0
The Agricultural Health Study (AHS) is a cohort study of 89,568 licensed pesticide applicators and their spouses in Iowa and North Carolina to be followed for 20 years or more. The focus of the phase III follow-up period (2005-2013) is to update exposure information and health histories by means of a computer assisted telephone interview, and to follow the cohort to determine disease incidence and mortality. This request is to complete the follow-up for phase III including interviews and buccal cell collection, and to incorporate a new biomarker component of the AHS, the Study of Biomarkers of Exposures and Effects in Agriculture (BEEA). In BEEA, we will conduct computer-assisted telephone (CATI) and in-person (CAPI) interviews, and will collect blood and urine samples from a subset of AHS participants. The stimulus for the AHS comes from the growing evidence that, despite a low mortality overall, farmers experience an excess of several cancers. The new biomarker component of the AHS will allow us to evaluate risk of monoclonal gammopathy of undetermined significance (MGUS), a pre-clinical marker for multiple myeloma, and to assess the biological plausibility and mechanism-of-action of associations between pesticides and cancers observed in earlier AHS studies.
US Code:
42 USC 285a
Name of Law: Public Health Service Act
This revision is a program change due to agency discretion and represents a decrease in burden from the previous submission approved in October, 2008. The substantial decrease in burden for this revision is accounted for by fewer Phase III participants being interviewed. The phase III collection was scheduled from November 2005 through November 2011 and has been impacted by restricted scheduling due to the planting season and budgetary issues, resulting in the need for additional time to complete the questionnaire administration. This request will allow the Agricultural Health Study to complete phase III of its research and to add an important additional component, the study of Biomarkers of Exposures and Effects in Agriculture (BEEA) which will help NCI investigators to identify occupational exposures in the agricultural environment that increase the risk of monoclonal gammopathy of undetermined significance (MGUS).
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.
Phase III CATI v. 2 Instrument for Agricultural Health Study