[Federal Register: May 28, 2004 (Volume 69, Number 104)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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.
See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance. Identify
comments with the docket number found in brackets in the heading of
FOR FURTHER INFORMATION CONTACT:
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.
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
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
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
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).
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.
Assistant Commissioner for Policy.
[FR Doc. 04-12103 Filed 5-27-04; 8:45 am]
BILLING CODE 4160-01-S