[Federal Register Volume 75, Number 156 (Friday, August 13, 2010)]
[Notices]
[Pages 49502-49504]
From the Federal Register Online via the Government Publishing 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,
[email protected].
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