OMB notes
compliance with the prior terms of clearance. At the time of the
next submission, FDA is encouraged to provide descriptive titles
for the "information collections" listed in the system. It is not
appropropriate to use provision numbers to identify an IC. FDA must
also properly identify the nature of the information collection:
reporting, recordkeeping, or third-party disclosure. Failure to do
so will result in improper submission.
Inventory as of this Action
Requested
Previously Approved
04/30/2015
36 Months From Approved
04/30/2012
64,805,294
0
64,805,294
2,629,106
0
2,629,106
0
0
0
This collection is intended to achieve
the goals and ensure compliance with the regulations implementing
the Prescription Drug Marketing Act of 1987 (PDMA) (Pub. L.
100-293).
Johnny Vilela 301 796-3792
juanmanuel.vilela@fda.hhs.gov
No
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.
Terms of Clearance and FDA's Response to OMB's Comment - 0910-0435.doc
203.11 Applications for reimportation to provide emergency care