Under the terms
of 5 CFR 1320, OMB considers this collection to have been
improperly submitted. FDA has failed to meet the previously
established terms of clearance. The Agency has neither made this
collection available electronically, nor has it submitted to OMB a
timeline for coming into compliance with GEPA. Please resubmit with
a detailed timeline for GEPA compliance.
Inventory as of this Action
Requested
Previously Approved
10/31/2010
36 Months From Approved
12/31/2010
24,272
0
24,272
39,333
0
39,333
0
0
0
Section 801(e)(4) of the act provides
that persons exporting certain FDA-regulated products may request
FDA to certify that the products meet the requirements of Sections
801(e) or 802 of the FD&C Act, or other requirements of the
act. This section of the law requires FDA to issue export
certificates within 20 days of receipt of the request and to charge
firms up to $175 for the certificates.
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.