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)