The cumulative response rate for this study, given the baseline falloff, will be approximately 65 percent. OMB recommends that NIH take any additional steps to raise the response rates to ensure the validity of this portion of the study. In the specific case of commerical applicators, due to a low enrollment rate of 43 percent, and the buccal cell collection, due to an expected response rate of 48 percent (which brings the effective response rate down to about 37 percent), the data from these segments appear to lack practical utility. Thus, OMB approves this study except for the following portions: the collection of data from commercial applicators and the buccal cell collection. If NIH provides information that these response rates were in error and are in fact higher, or if NIH develops new survey protocols to raise rates to an acceptable level for the buccal cell component, or if NIH can demonstrate that commercial applicators are not from a different stratum and separate estimates will not be made from this group, OMB would amend this action without the need to resubmit. Possible means of raising the response rates include financial incentives and/or lower sample sizes with greater efforts of refusal conversion and nonresponse follow-up. Finally, approval of the remainder of this study is made on the condition that NIH conduct comparisons of responders to nonresponders to investigate any potential nonresponse bias. A comparison similar to the one provided to OMB on 10/30/98 should be conducted.
Inventory as of this Action
Requested
Previously Approved
11/30/2001
11/30/2001
1
0
0
33,947
0
0
0
0
0
The Agricultural Health Study is a large prospective cohort study evaluating the roles of agricultural exposures in the development of cancer, neurologic disease with defects, and other chronic disease outcomes among farmers, commercial applicators, and the spouses and children of farmer applicators.
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.
Agricultural Health Study (A Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture)