Clearance is provided to continue the data collection for Phase III of this project, consistent with the prior terms of clearance. NCI/NIH will sumbit a change package that describes the design and protocol for Phase IV of the study before beginning the data collection for that phase.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
10/31/2011
36 Months From Approved
10/31/2008
6,861
0
24,733
4,140
0
44,270
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 (2005-2008) 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 for 20,583 enrolled subjects who were not contacted previously due to a slow release of funding to the field centers resulting in an unexpected slow rate of data collection. The stimulus for this prospective investigation comes from the growing evidence that, despite a low mortality overall, farmers experience an excess of several cancers. A small sub-set of the cohort (N=993) will be asked to participate in the buccal cell collection to assess the effect of inherited polymorphisms and the interaction of environment and genomic predisposition.
US Code:
42 USC 285a-2
Name of Law: Public Health Service Act
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 1 Phase III CATI v. 2 Instrument for Agricultural Health Study
Supporting State B_AHS_4-21-08.doc
Attach 10C_Intro-Consent Letter Spouse.rtf
Attach 14A_Buccal Consent Form Iowa.docx
Attach 12D_IRB NC Knott.pdf
Attach 9_Contractor Confidentialiy Agreement.dot
Phase III CATI v. 2 Instrument for Agricultural Health Study