Under the prescription drug user fee
provisions of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and 379h)), as
amended, FDA has the authority to assess and collect user fees for
certain drug and biologics license applications and supplements.
The Prescription Drug User Fee Cover Sheet, Form FDA 3397, is
required to be included with each applicable new drug application
(NDA), biologics license application (BLA), and supplemental
application to an NDA or BLA submitted to FDA for review. The
Prescription Drug User Fee Cover Sheet is designed to provide the
minimum necessary information to determine whether a fee is
required for the review of an application, to determine the amount
of the fee required, and to account for and track user fees. The
information collected is used by FDA's Center for Drug Evaluation
and Research (CDER) and Center for Biologics Evaluation and
Research (CBER) to initiate the administrative screening of new
drug applications, biologics license applications and/or
supplemental applications to those applications.
US Code:
21
USC 379 Name of Law: Federal Food Drug and Cosmetic Act
ILa Mizrachi 301 796-7726
ila.mizrachi@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.