[Federal Register Volume 75, Number 156 (Friday, August 13, 2010)]
[Notices]
[Pages 49502-49504]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19843]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2010-N-0389]


Medical Device User Fee Act; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting on the reauthorization of the medical device user fee program. 
The current legislative authority for the medical device user fee 
program expires in September 2012 and new legislation will be required 
for FDA to continue collecting user fees for the medical device 
program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires 
that before FDA begins negotiations with the regulated industry on 
medical device user fee program reauthorization, we publish a notice in 
the Federal Register requesting public input on the reauthorization, 
hold a public meeting at which the public may present its views on the 
reauthorization, provide a period of 30 days after the public meeting 
to obtain written comments from the public suggesting changes, and 
publish the comments on FDA's Web site. FDA invites public comment on 
the medical device user fee program and suggestions regarding the 
commitments FDA should propose for the next reauthorized program.

[[Page 49503]]

    Date and Time: The public meeting will be held on September 14, 
2010, from 9 a.m. to 5 p.m.
    Location: FDA is currently in the process of determining the 
meeting location, which will be in the Washington DC metropolitan area. 
When the location has been determined, FDA plans to publish a notice in 
the Federal Register that will provide the address of the meeting 
location.
    Contact Person: James Swink, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. 1609, Silver Spring, MD 20993, 301-796-6313, FAX: 301-847-8121, 
James.Swink@fda.hhs.gov.
    Registration and Requests for Oral Presentations: If you wish to 
attend and/or present at the meeting, please register by August 31, 
2010. Please register at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm218250.htm. Those without e-mail access may 
register by contacting James Swink (see Contact Person). Please provide 
complete contact information for each attendee, including name, title, 
firm name, address, e-mail address, telephone and fax number. 
Registrants wishing to make a presentation or provide public comments 
should note that when registering. Registration is free and will be on 
a first-come, first-served basis. Early registration is recommended 
because seating is limited. FDA may limit the number of participants 
from each organization, as well as the total number of participants, 
based on space limitations to ensure representation of all stakeholder 
interest groups. Registrants will receive confirmation once they have 
been accepted. Onsite registration on the day of the meeting will be 
based on space availability. We will try to accommodate all persons who 
wish to make a presentation or public comments. The time allotted for 
presentations may depend on the number of persons who wish to speak.
    If you need special accommodations due to a disability, please 
contact James Swink at least 7 days in advance.
    Comments: Regardless of attendance at the public meeting, 
interested persons may submit either electronic or written comments by 
October 14, 2010. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of 
comments. It is no longer necessary to send two copies of mailed 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing its intention to hold a public meeting on the 
reauthorization of the medical device user fee program. The authority 
for such program expires in September 2012. Without new legislation, 
user fees can no longer be collected by FDA to fund the medical device 
review process. Section 738A(b)(2) of the FD&C Act (21 U.S.C. 379j-
1(b)(2)) requires that, before FDA begins negotiations with the 
regulated industry on user fee reauthorization, we do the following: 
(1) Publish a notice in the Federal Register requesting public input on 
the reauthorization; (2) hold a public meeting at which the public may 
present its views on the reauthorization, including specific 
suggestions for changes to the goals referred to in section 738A(a)(1); 
(3) provide a period of 30 days after the public meeting to obtain 
written comments from the public suggesting changes to this part; and 
(4) publish the comments on the Food and Drug Administration's Web 
site. This notice, the public meeting, the 30 day comment period after 
the meeting, and the posting of the comments on the FDA Web site will 
satisfy these requirements. The purpose of the meeting is to hear 
stakeholder views on medical device user fee reauthorization as we 
consider the features to propose in the next medical device user fee 
program. FDA is interested in responses to the following two general 
questions and welcomes any other pertinent information stakeholders 
would like to share:
    1. What is your assessment of the overall performance of the 
medical device user fee program thus far?
    2. What aspects of the medical device user fee program should be 
retained, changed, or discontinued to further strengthen and improve 
the program?
    The following information is provided to help potential meeting 
participants better understand the history and evolution of the medical 
device user fee program and its current status.

II. What is the Medical Device User Fee Program? What Does It Do?

    In the years preceding enactment of Medical Device User Fee and 
Modernization Act of 2002 (MDUFMA) (Public Law 107-250), FDA's medical 
device program suffered a long-term, significant loss of resources that 
undermined the program's capacity and performance. MDUFMA was enacted 
``in order to provide the Food and Drug Administration (FDA) with the 
resources necessary to better review medical devices, to enact needed 
regulatory reforms so that medical device manufacturers can bring their 
safe and effective devices to the American people at an earlier time, 
and to ensure that reprocessed medical devices are as safe and 
effective as original devices.''\1\ MDUFMA had a 5-year life and 
contained two particularly important features which relate to 
reauthorization:
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    \1\ H.R. Rep. No. 107-728, at 21 (2002).
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     User fees for the review of medical device premarket 
applications, reports, supplements, and premarket notification 
submissions provided additional resources to make FDA reviews more 
timely, predictable, and transparent to applicants. MDUFMA fees and 
mandated appropriations for the medical device program helped FDA 
expand available expertise, modernized its information management 
systems, provided new review options, and provided more guidance to 
prospective applicants. The ultimate goal was to approve and clear safe 
and effective medical devices more rapidly, benefiting applicants, the 
health care community, and most importantly, patients.
     Negotiated performance goals for many types of premarket 
reviews provided FDA with benchmarks for measuring review improvements. 
These quantifiable goals became more demanding each year and include 
FDA decision goals and cycle goals (cycle goals refer to FDA actions 
prior to a final action on a submission). Under MDUFMA, FDA must also 
have met several other commitments that do not have specific timeframes 
or direct measures of performance, such as expanding the use of 
meetings with industry, maintenance of current performance in review 
areas where specific performance goals have not been identified, and 
publication of additional guidance documents.
    Medical device user fees and increased appropriations were viewed 
by FDA, Congress, and industry stakeholders as essential to support 
high-quality, timely medical device reviews, and other activities 
critical to the device review program.
    MDUFMA provided for fee discounts and waivers for small businesses. 
Small businesses make up a large proportion of the medical device 
industry, and these discounts and waivers helped reduce the financial 
impact of the user

[[Page 49504]]

fees on this sector of the device industry, which plays an important 
role in fostering innovation.
    The negotiated performance goals and commitments that do not have 
specific timeframes or direct measures of performance set under MDUFMA 
were comprehensive and demanding. By Fiscal Year (FY) 2007, 
approximately 85 performance goals and commitments were in effect. FDA 
provided periodic reports on its progress towards meeting these 
performance goals and commitments to its stakeholders and Congress. FDA 
also provided an annual financial report to Congress that helped to 
ensure transparency and accountability of its use of the additional 
resources provided by MDUFMA.
    In 2007, Congress reauthorized medical device user fees through FY 
2012 under the Medical Device User Fee Amendments of 2007 (MDUFA) 
(title II of the Food and Drug Administration Amendments Act of 2007 
(FDAAA) (Public Law 110-85).
    Under MDUFA, the user fee program remained intact, with a few 
significant modifications to the program. The user fee framework was 
changed to provide a more reliable and stable funding stream. 
Specifically, MDUFA included establishment registration as a new fee 
type that provided a more predictable amount of funds that could be 
collected by the Agency in any given year. MDUFA also saw changes to 
the performance goals. Compared to MDUFMA, there were fewer performance 
goals under MDUFA, yet the goals were more demanding. Specifically, 
individual cycle goals were removed and tighter overall goals were 
implemented. This was done to facilitate a more interactive review 
process. Specific timelines were established under MDUFA for Modular 
Premarket Approvals (PMAs) and Real-Time PMA supplements, which were 
not included under MDUFMA in 2002. The commitment letter outlining the 
goals in the last reauthorization can be found at http://www.fda.gov/MDUFA. FDA published a number of reports that provide the public with 
useful background on MDUFMA, FDAAA, and MDUFA. Key Federal Register 
documents, MDUFA-related guidance documents, legislation, performance 
reports, and financial reports and plans can be found at http://www.fda.gov/MDUFA. FDA will also post a webinar on the medical device 
user fee program to give the public more background information on the 
program. The webinar will be available through the link to the Public 
Meeting at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm218250.htm approximately 10 days before the 
public meeting. FDAAA specific information is available at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm.

III. What Information Should You Know About the Meeting?

A. When and Where Will the Meeting Occur? What Format Will FDA Use?

    Through this notice, we are announcing a public meeting to hear 
stakeholder views on the reauthorization of the medical device user fee 
program, including specific suggestions for any changes to the program 
that we should consider. We will conduct the meeting on September 14, 
2010. In general, the meeting format will include presentations by FDA 
and a series of panels representing different stakeholder interest 
groups (such as patient advocates, consumer protection, industry, 
health professionals, and academic researchers). We will also provide 
an opportunity for individuals to make presentations at the meeting and 
for organizations and individuals to submit written comments to the 
docket after the meeting. FDA policy issues are beyond the scope of 
these reauthorization discussions. Accordingly, the presentations 
should focus on program improvements and funding issues, including 
specific suggestions for changes to performance goals, and not focus on 
policy issues.

B. What Questions Would FDA Like the Public to Consider?

    Please consider the following questions for this meeting:
    1. What is your assessment of the overall performance of the 
medical device user fee program thus far?
    2. What aspects of the medical device user fee program should be 
retained, changed, or discontinued to further strengthen and improve 
the program?

C. Will Meeting Transcripts be Available?

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (see Comments). A transcript will 
also be available in either hard copy or on CD-ROM, after submission of 
a Freedom of Information request. Written requests are to be sent to 
Division of Freedom of Information (HFI-35), Office of Management 
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, 
Rockville, MD 20857.

    Dated: August 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19843 Filed 8-12-10; 8:45 am]
BILLING CODE 4160-01-S