Approved
consistent with revised supporting statement submitted by FDA on
11-1-01. As per that supporting statement, FDA will submit
collections to OMB under this clearance and OMB will evaluate these
collections within 15 working days. The collections under this
clearance will meet the two criteria outlined in response one of
the revised supporting statement. Clearance is for 18 months after
which time, FDA and OMB will evaluate how well this generic
clearance is working and if any modifications are necessary.
Inventory as of this Action
Requested
Previously Approved
09/30/2003
09/30/2003
5,000
0
0
6,500
0
0
0
0
0
The purpose of this information
collection is to solicit comments on proposed voluntary surveys of
consumers and producers in order to help FDA comply with Executive
Order 12866, the Regulatory Flexibility Act and the Small Business
Regulatory Enforcement Fairness Act of 1996. These surveys will
identify current business practices, expert opinion, and consumer
of manufacturer attitudes towards existing or proposed
policy.
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.