Approved
consistent with revised table for question 15 attached. FDA shall
submit the forms newly consolidated under this collection with the
0910-0001 number on them by the end of April for OMB's docket.
Finally follow-up questions have been submitted to FDA (see
attaced) to which FDA will respond by 4-5-02.
Inventory as of this Action
Requested
Previously Approved
03/31/2005
03/31/2005
03/31/2002
20,360
0
21,200
1,984,003
0
2,121,270
0
0
0
Information collection from applicants
who apply for approval of a new drug application in order to market
or to continue to market a drug.
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.