[Federal Register: October 4, 2005 (Volume 70, Number 191)]
[Page 57881-57883]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0364]

Third Annual Stakeholder Meeting on the Medical Device User Fee 
and Modernization Act of 2002; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.


[[Page 57882]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public meeting: Third Annual Stakeholder Meeting on the 
Medical Device User Fee and Modernization Act of 2002 (MDUFMA). On 
October 1, 2007, the user fee provisions of MDUFMA will expire. In 
preparation for discussions regarding legislation to reauthorize and 
possibly modify MDUFMA user fees, the agency is holding this public 
meeting to obtain stakeholder input and recommendations on various 
issues related to this future legislation.

DATES: The public meeting will be held on November 17, 2005, from 9 
a.m. to 5 p.m. However, depending upon the level of public 
participation, the meeting may end early. Registration is required by 
October 28, 2005. All individuals wishing to make a presentation or to 
speak on an issue should indicate their intent and the topic to be 
addressed and provide an abstract of the topic to be presented by 
October 28, 2005.

ADDRESSES: The public meeting will be held at the Gaithersburg Hilton, 
620 Perry Pkwy., Gaithersburg, MD.
    Submit written requests to make an oral presentation to Cindy 
Garris (see FOR FURTHER INFORMATION CONTACT). Include your name, title, 
firm name, address, telephone, and fax number with your request. All 
requests and presentation materials should include the docket number 
found in brackets in the heading of this document. Submit all requests 
for suggestions and recommendations to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cindy Garris, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 121, FAX: 301-443-
8818, e-mail: cxg@cdrh.fda.gov.


I. Background

    On October 26, 2002, MDUFMA amended the Federal Food, Drug, and 
Cosmetic Act (the act) to include several new significant provisions. 
In addition to authorizing user fees for the review of certain 
premarket applications, MDUFMA authorizes the following provisions: (1) 
Establishment of performance goals (cycle and decision) for premarket 
approval applications (PMAs), biologics license applications, and 
premarket notifications (510(k)), (2) authorization of good 
manufacturing practice (GMP) inspections by FDA-accredited persons 
(third-parties), and (3) establishment of new requirements for 
reprocessed single-use devices. In a letter that accompanied the user 
fee legislation, the agency also committed to developing performance 
goals for modular PMAs, maintaining performance in those programs 
without MDUFMA performance goals, and improving the timeliness of 
inspections conducted under the GMP and Bioresearch Monitoring (BIMO) 
    MDUFMA has been amended twice since its enactment. The Medical 
Devices Technical Corrections Act (Public Law 108-214) (April 1, 2004), 
clarified Congress's intent in areas where MDUFMA was unclear, and 
improved and expanded some features of MDUFMA. The Medical Device User 
Fee Stabilization Act of 2005 (Public Law 109-43) (August 1, 2005) 
provides a new fee structure and a new definition of ``small business'' 
for FY 2006 and FY 2007; it also limits section 301 of MDUFMA (section 
502(u) of the act (21 U.S.C. 352(u)) to reprocessed single-use devices.
    Since its passage in October 2002, the agency has been working to 
implement MDUFMA. An important part of this process has been the annual 
stakeholder meetings. Each year, FDA has held public meetings to afford 
interested persons the opportunity to share information and views on 
the implementation of MDUFMA.
    On October 1, 2007, the user fee provisions of MDUFMA will expire. 
In order to help the agency and all stakeholders to evaluate the 
program and prepare for possible new legislation to reauthorize MDUFMA, 
FDA would like to hear from interested parties about those aspects of 
MDUFMA that worked well and those areas for which change should be 
considered. Specifically, FDA is looking for input and recommendations 
that may help to improve the device review program. FDA is holding this 
public meeting to gather such information from its stakeholders.
    For additional information on MDUFMA, please see the document 
entitled ``Background on MDUFMA'' at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/mdufma/whitepaper.html

II. Agenda

    On November 17, 2005, FDA is providing the opportunity for 
interested persons to share their views on the following topics:
     User Fee Structure--During this session, the agency will 
seek comments on possible user fee structures for MDUFMA II that will 
provide for an adequate and stable revenue base and predictable user 
     Premarket Review Performance Goals--During this session, 
interested persons may discuss the current performance goals and make 
recommendations for additional or alternative goals that would help to 
provide for timely and predictable reviews.
     Qualitative Performance Goals (e.g., Modular PMA, GMP, and 
BIMO Inspection Programs)--During this session, stakeholders may 
comment on the current qualitative performance goals and make 
recommendations for agency consideration of new initiatives of 
importance to stakeholders.
     Third-Party Inspection Program--During this session, FDA 
will seek recommendations for improving the participation of eligible 
manufacturers in the inspection program.
     Reprocessing of Single-Use Devices (SUDs)--During this 
session, interested stakeholders may comment on current requirements 
for reprocessing SUDs and make recommendations for ways the agency can 
provide for the continuing assurance of safe and effective reprocessed 
     Other Provisions--At the conclusion of the meeting, there 
will be an opportunity for a general discussion from the floor.
    As stated previously, although the meeting is scheduled for a full 
day, depending upon the level of public participation, the meeting may 
end early.

III. Registration

    Online registration for the meeting is required by October 28, 
2005. Acceptance will be on a first-come, first-served basis. There 
will be no onsite registration. Please register online at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/meetings/120303.html.
 FDA is pleased to provide the 

opportunity for interested persons to listen from a remote location to 
the live proceedings of the meeting. In order to ensure that a 
sufficient number of call-in lines are available, please register to 
listen to the meeting at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/meetings/120303.html 

by October 28, 2005. Persons without Internet access may register for 
the onsite meeting or to listen remotely by calling 301-443-6597, ext. 
121 by October 28, 2005.
    If you need special accommodations due to a disability, please 
contact Cindy Garris at least 7 days in advance of the meeting.

IV. Request for Input and Materials

    FDA is also interested in receiving input from stakeholders on 
other issues

[[Page 57883]]

related to future user fee legislation. Send suggestions or 
recommendations to the Division of Dockets Management (see ADDRESSES).
    FDA will place an additional copy of any material it receives on 
the docket for this document (2005N-0364). Suggestions, 
recommendations, and materials may be seen at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday (see 

V. Transcripts

    Following the meeting, transcripts will be available for review at 
the Division of Dockets Management (see ADDRESSES).

    Dated: September 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19864 Filed 9-29-05; 3:11 pm]