[Federal Register Volume 71, Number 71 (Thursday, April 13, 2006)]
[Notices]
[Pages 19192-19193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5494]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0364]


Stakeholder Meeting to Discuss the Possible Implementation of Two 
Review Performance Goals Referenced in 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 19193]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public meeting: Stakeholder Meeting to Discuss the Possible 
Implementation of Two Review Performance Goals referenced in the 
Medical Device User Fee and Modernization Act of 2002 (MDUFMA). In a 
letter that accompanied the user fee legislation, the agency committed 
to a number of review performance goals. These goals include a 
commitment that 50 percent of the premarket approval applications 
received in fiscal year (FY) 2007 will have an FDA decision in 180 days 
and 80 percent of the premarket notifications will have an FDA decision 
in 90 days. The letter states that these goals are to be re-evaluated 
following the end of FY 2005 and FDA is to hold a public meeting to 
consult with its stakeholders and to determine whether the goals are 
appropriate for implementation in FY 2007.

DATES: The public meeting will be held on May 22, 2006, from 9 a.m. to 
12 p.m. However, depending upon the level of public participation, the 
meeting may end early. Registration is required by May 19, 2006. All 
individuals wishing to make a presentation on the implementation of 
these two performance goals in FY 2007 should indicate their intent and 
provide an abstract of their presentation by May 10, 2006.

ADDRESSES: The public meeting will be held at the Center for Devices 
and Radiological Health, 9200 Corporate Blvd., rm. 20B, Rockville, MD 
20850.
    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: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On October 26, 2002, MDUFMA amended the Federal Food, Drug, and 
Cosmetic Act (the act) to authorize user fees for the review of certain 
premarket applications. In addition, in a letter that accompanied the 
user fee legislation (goals letter found at: http://www.fda.gov/cdrh/mdufma/pgoals.html), the agency committed to a number of review 
performance goals for premarket applications, including premarket 
approval applications (PMAs) and premarket notifications (510(k)s) that 
become more challenging with each FY.
    Under the goals letter, 50 percent of the PMAs received in FY 2007 
are to have an FDA decision in 180 days and 80 percent of the 510(k)s 
are to have an FDA decision in 90 days. The goals letter further states 
that these goals are to be re-evaluated following the end of FY 2005, 
and FDA will hold a public meeting to consult with its stakeholders and 
to determine whether this goal is appropriate for implementation in FY 
2007. If FDA determines that the goal is not appropriate, prior to 
August 1, 2006, the Secretary of Health and Human Services will send a 
letter to the Committee on Health, Education, Labor, and Pensions of 
the Senate and to the Energy and Commerce Committee, Subcommittee on 
Health of the House of Representatives, stating that the goal will not 
be implemented and the rationale for its removal.
    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, during which interested persons have been 
afforded the opportunity to share information and views on the 
implementation of MDUFMA. FDA is continuing this outreach to its 
stakeholders by holding this public meeting. During this meeting, FDA 
encourages stakeholders to provide their input and recommendations on 
the implementation of these two performance goals in FY 2007.
    For additional information on MDUFMA, please see the document 
entitled ``Background on MDUFMA'' at http://www.fda.gov/cdrh/mdufma/whitepaper.html.

II. Agenda

    On May 22, 2006, FDA is providing the opportunity for interested 
persons to share their views on the implementation of the FY 2007 PMA 
and 510(k) performance goals discussed previously in this document. FDA 
stakeholders may offer their input and recommendations on these two 
performance goals.

III. Registration

    Online registration for the meeting is required by May 19, 2006. 
Acceptance will be on a first-come, first-served basis. There will be 
no onsite registration. Please register online at http://www.fda.gov/cdrh/meetings/052206.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://www.fda.gov/cdrh/meetings/052206.html by May 19, 
2006. Persons without Internet access may register for the onsite 
meeting or to listen remotely by calling 301-443-6597, ext. 121 by May 
19, 2006.
    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 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 (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through 
Friday.

V. Transcripts

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

    Dated: April 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5494 Filed 4-12-06; 8:45 am]
BILLING CODE 4160-01-S