[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Notices]
[Page 11678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

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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://www.fda.gov/dockets.ecomments. See the SUPPLEMENTARY INFORMATION 
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: [email protected].

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 
applications.
    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://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]
BILLING CODE 4160-01-S