[Federal Register: March 9, 2005 (Volume 70, Number 45)]
[Page 11678]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0075]

Notice to Industry on the Development of a Web-Based System for
Obtaining a User Fee Payment Identification Number and Prescription
Drug User Fee Cover Sheet (FDA Form 3397); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a new Web-based system to electronically obtain a user
fee payment identification number and to submit your Prescription Drug
User Fee (PDUFA) cover sheet (FDA Form 3397) to the Office of Financial
Management. The system will enable FDA to electronically track your
company's application payments and will allow your organization to
obtain the user fee payment identification number over the Web. By
making the user fee payment identification number and the PDUFA cover
sheet available on-line, we will be able to improve service, one of
PDUFA's performance goals.

DATES: Submit written or electronic comments by April 8, 2005.

ADDRESSES:  Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20857. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets.ecomments.

section for electronic access to the new system.

FOR FURTHER INFORMATION CONTACT:  Martha Louviere, Office of Financial
Management (HFA-100), Food and Drug Administration, 5600 Fishers Lane,
rm. 11-83, Rockville, MD 20857, 301-827-3912, e-mail: userfees@fda.gov.

SUPPLEMENTARY INFORMATION: Under sections 735 and 736 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379g and 379h), FDA has the
authority to assess and collect user fees for certain drug and
biologics license applications and supplements. Under this authority,
pharmaceutical companies pay fees for certain new human drug
applications, biologics applications, and supplements submitted to the
agency for review. Because the submission of user fees concurrently
with applications and supplements is required, review of an application
by FDA cannot begin until the fee has been submitted. Form FDA 3397,
the user fee cover sheet, is designed to provide the minimum necessary
information to determine whether a fee is required for review of an
application, to determine the amount of the fee required, and to help
FDA track payments.
    The form provides a cross-reference of the fee submitted for an
application with the actual application by using a unique number
tracking system to assign the user fee payment identification number.
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 supplemental
    FDA has created an on-line user fee cover sheet which will assist
FDA and pharmaceutical companies by improving service and reducing the
time for applicants and their affiliates to file and comply with PDUFA
through more automated channels. The new system will allow customers to
obtain a user fee payment identification number, create and complete a
user fee cover sheet on-line, and submit it electronically to FDA's
Office of Financial Management. It will decrease the administrative
burden on FDA, improve service by automating the cover sheet
application process, and allow applicants to securely view their
payments received by FDA on-line. This new system, which replaces the
previous process, will be available on February 15, 2005.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    You can access this new system from the http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/pdufa/coversheet.html
 Web site. You may then select ``PDUFA User Fee

Cover Sheet'' from Web site. Detailed instructions on how to use the
user fee system are included at the Web site.

    Dated: March 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4635 Filed 3-8-05; 8:45 am]