[Federal Register: May 28, 2004 (Volume 69, Number 104)]
[Page 30672-30673]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003D-0537]

Guidance for Industry and FDA Staff; User Fees and Refunds for 
Premarket Notification Submissions; 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 Notification Submissions (510(k)s).'' This guidance describes 
the user fees and refunds associated with the 510(k) program. 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 this guidance 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 Notification Submissions (510(k)s)'' 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 one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-443-8818.
    Submit written comments on the 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.

section for information on electronic access to the guidance. Identify 
comments with the docket number found in brackets in the heading of 
this document.

    For device issues: Heather S. Rosecrans, Center for Devices and 
Radiological Health (HFZ-404), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1190 ext. 143.
    For biologics issues: Leonard Wilson, Center for Biologics 
Evaluation and Review (HFM-25), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-0373.


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 
(the act) to allow FDA to collect user fees for certain premarket 
reviews. The new law also permits refunds under certain circumstances. 
The guidance outlines the user fees due with 510(k) submissions and the 
circumstances in which FDA plans to provide refunds.
    This guidance document is immediately in effect because the agency 
is already collecting user fees under the new law and wants to provide 
guidance to its stakeholders. On February 4, 2003, FDA published a 
notice in the Federal Register (68 FR 5643) to establish a public 
docket (02N-0534), so that we could share information on the 
implementation of MDUFMA and to provide interested persons an 
opportunity to share their views. On December 3, 2003, the agency held 
an open public meeting to update its stakeholders on its progress in 
implementing the new law, discuss some of MDUFMA's more challenging

[[Page 30673]]

provisions, and obtain input from interested parties. Since 
establishing the docket over a year ago, the agency has received quite 
a few comments from its stakeholders on a number of MDUFMA provisions, 
including the application and refund of user fees. During the drafting 
of this guidance, the agency specifically solicited comments to the 
docket in recognition of the interest in this issue. The agency has 
considered all comments received to date and believes that the approach 
presented below is a fair application of its refund policy. FDA will 
accept comments on the guidance at any time.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on user fees and refunds for 510(k)s. 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 ``User Fees and Refunds for Premarket Notification 
Submissions (510(k)s)'' by fax machine, call the 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 (1511) followed by the 
pound sign (). 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 Dockets Management Branch 
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 (44 USC 3501-3520) (the PRA). The 
collections of information addressed in the guidance document have been 
approved by OMB in accordance with the PRA under the regulations 
governing premarket notification submissions (21 CFR part 807, subpart 
E, OMB No. 0910-0120).

V. Comments

    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 to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Submit two paper copies of any mailed 

comments, except that individuals may submit one 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.

    Dated: May 21, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-12103 Filed 5-27-04; 8:45 am]