[Federal Register: October 4, 2005 (Volume 70, Number 191)]
[Notices]
[Page 57881-57883]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc05-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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[[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.
SUPPLEMENTARY INFORMATION:
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)
programs.
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
fees.
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
SUDs.
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
ADDRESSES).
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]
BILLING CODE 4160-01-S