[Federal Register: November 24, 2003 (Volume 68, Number 226)]
[Page 65940-65941]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 65940]]



Food and Drug Administration

[Docket No. 2003D-0512]

Guidance for Industry and Food and Drug Administration Staff; 
User Fees and Refunds for Premarket Approval Applications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``User Fees and Refunds for 
Premarket Approval Applications.'' This guidance outlines the types of 
premarket approval applications (PMAs), including supplements and other 
submissions, that are subject to user fees as well as those that do not 
have an associated fee. The guidance also identifies industry and FDA 
actions on these submissions that may result in a partial refund of the 
fee. The guidance document is immediately in effect, but it remains 
subject to comment in accordance with the agency's good guidance 
practices (GGPs).

DATES: Submit written or electronic comments on agency guidances at any 

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``User Fees and Refunds for 
Premarket Approval Applications'' to the Division of Small 
Manufacturers, International, and Consumer Assistance (HFZ-220), Center 
for Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. 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. Identify comments with the 
docket number found in brackets in the heading of this document.

    Regarding device issues: Thinh Nguyen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186.
    Regarding biologics issues: Sayah Nedjar, Center for Biologics 
Evaluation and Research (HFM-380), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-3524.


I. Background

    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) 
(Public Law 107-250), amends the Federal Food, Drug, and Cosmetic Act 
to allow FDA to collect user fees for certain premarket reviews. The 
new law also permits partial refunds under certain circumstances, such 
as in the case of a non-filing decision for a PMA. In other cases, the 
statute permits a refund but stipulates that it is to be in an amount 
determined by the level of effort expended by the agency during its 
review of the application. The guidance outlines the user fees due with 
certain PMAs, the refunds set by statute, and FDA's plan for 
determining the amount of the fee to be refunded when the exact amount 
is not prescribed by the new law.
    FDA is making this guidance document immediately available because 
prior public participation was not feasible. MDUFMA's user fee 
provisions were effective immediately, and it is essential for the 
agency to provide guidance to its stakeholders on the user fee program 
as quickly as possible. Although it was not feasible to obtain comments 
before issuing the guidance, in accordance with this agency's GGP 
procedures, FDA will accept comments on the guidance at any time.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGPs regulation 
(21 CFR 10.115). The guidance represents the agency's current thinking 
on user fees and refunds for PMAs. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statute and regulations.

III. Electronic Access

    To receive a copy of ``User Fees and Refunds for Premarket Approval 
Applications'' by fax machine, call the Center for Devices and 
Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381 or 
301-827-0111 from a touch-tone telephone. Press 1 to enter the system. 
At the second voice prompt, press 1 to order a document. Enter the 
document number (1224) followed by the pound sign ([numsign]). Follow 
the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. CDRH maintains an entry on the Internet for 
easy access to information including text, graphics, and files that may 
be downloaded to a personal computer with Internet access. Updated on a 
regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's assistance, information on video 
conferencing and electronic submissions, Mammography Matters, and other 
device-oriented information. The CDRH Web site may be accessed at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available on the Division of Dockets 
Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the user fee 
forms (OMB control number 0910-0511), which expires on August 31, 2006, 
and the regulations governing administrative practices and procedures 
(21 CFR part 10, OMB control number 0910-0192).

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
guidance. Submit a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
 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. Comments received may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 65941]]

    Dated: November 14, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-29196 Filed 11-21-03; 8:45 am]