Approval for
this collection expired 11/30/99 and has been in use without an OMB
number for nearly 10 years. This is an egregious violation of the
Paperwork Reduction Act and FDA shall take steps to ensure that
such a violation shall not occur in the future. In addition, as a
condition of clearance, FDA shall provide OMB within the next two
weeks documentation substantiating the revised burden
estimates.
Inventory as of this Action
Requested
Previously Approved
03/31/2002
03/31/2002
21,200
0
0
2,121,270
0
0
0
0
0
Under section 505 of the Federal Food,
Drug, and Cosmetic Act (the Act), a new drug may not be
commercially marketed in the United States, imported, or exported
from the United States unless it has been approved as safe and
effective by FDA. Such approval is based on a New Drug Application
(NDA) submitted, under 21 CFR part 314, by the sponsor of the drug,
containing acceptable scientific data, including the results of
tests to evaluate its safety, and substantial evidence of
effectiveness for the conditions for which the drug is to be
offered. Under the Act, it is the sponsor's responsibility to
provide....
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.