Approved
consistent with clarifications and changes in FDA memos of 9-23-02
and 9-25-02. The additional $80 million in costs associated with
this collection reflects the costs of conducting the studies
required by this regulation. It had previously been omitted from
this icr.
Inventory as of this Action
Requested
Previously Approved
10/31/2005
10/31/2005
09/30/2002
64
0
2,663
18,557
0
40,571
80,000,000
0
0
Requires pediatric studies of certain
n4w drugs and biological products to ensure that those products
that are likely to be commonly used in children or that represent a
meaningful therapeutic benefit over existing treatments contain
adequate pediatric labeling for the approved indications at the
time of, or soon after, approval.
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.