[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34679-34681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14885]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0389]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
meeting on the reauthorization of the Medical Device User Fee 
Amendments (MDUFA) for fiscal years 2018 through 2022. The current 
legislative authority for the medical device user fee program expires 
on October 1, 2017, and new legislation will be required for FDA to 
continue collecting user fees for the medical device program in future 
fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) 
requires that before FDA begins negotiations with the regulated 
industry on MDUFA 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 to MDUFA, 
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.
    Date and Time: The public meeting will be held on July 13, 2015, 
from 9 a.m. to 5 p.m.
    Location: The public meeting will be held at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for public 
meeting participants (non-FDA employees) is through Building 1 where 
routine security screening procedures will be performed. For parking 
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Aaron Josephson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5449, Silver Spring, MD 20993, 301-796-5178, email: 
[email protected].
    Registration: Registration is required to attend this meeting in 
person or to view the Webcast. Registration is free and available on a 
first-come, first-served basis. Persons interested in participating in 
the meeting must register online by July 2, 2015, at 4 p.m. Early 
registration is recommended because space is limited and, therefore, 
FDA may limit the number of participants from each organization. If 
time and space permit, onsite registration on the day of the meeting 
will be provided beginning at 8 a.m.
    If you have registered and need special accommodations, please 
contact Susan Monahan, 301-796-5661, email: [email protected], 
no later than July 1, 2015.
    To register for the public meeting, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public meeting from the posted events list.) Please 
provide complete contact information for each attendee, including name, 
title, affiliation, email, and telephone number. Those without Internet 
access should contact Susan Monahan to register. All registrants will 
receive confirmation after they have been successfully registered. 
Registrants not confirmed to participate, but added to a waiting list, 
will be notified of that as well.
    Streaming Webcast of the Public Meeting: This public meeting will 
be Webcast. Persons interested in viewing the Webcast must register 
online (see Web link above) by July 2, 2015, at 4 p.m. Early 
registration is recommended because Webcast connections are limited. 
FDA requests that organizations with multiple registrants in the same 
location register all participants individually but view the Webcast 
using one connection per location. Webcast participants will be sent 
technical system requirements upon confirmation and will be sent 
connection access information after July 6, 2015. If you have not 
previously attended an event hosted by Connect Pro, it is recommended 
that you test your connection in advance at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. A short 
overview of the Connect Pro program is available at http://www.adobe.com/go/connectpro_overview.
    Requests for Oral Presentations: This public meeting includes 
public comment and topic-focused sessions. During registration you may 
indicate if you wish to present during a public comment session or 
participate in a topic-focused session, and specify the topic(s) you 
wish to address. FDA has included general topics in this document. FDA 
will do its best to accommodate all persons who wish to speak. FDA 
encourages individuals and organizations with common interests to 
consolidate or coordinate their presentations, and request time for a 
joint presentation, or submit requests for designated representatives 
to participate in the topic-focused sessions. After

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registration closes, FDA will determine the amount of time allotted to 
each presenter and the approximate time each oral presentation is to 
begin, and will notify selected speakers by July 7, 2015. All requests 
to make oral presentations must be received by the close of 
registration on July 2, 2015, at 4 p.m. Presenters should submit all 
presentation materials via email to Aaron Josephson (see Contact 
Person) no later than July 10, 2015. No commercial or promotional 
material should be presented or distributed at the public meeting.
    Comments: FDA is holding this public meeting to hear stakeholder 
views on the medical device user fee program. In order to obtain a 
broad range of public comment, FDA is soliciting either electronic or 
written comments on all aspects of the public meeting topics. The 
deadline for submitting comments related to this public meeting is 
August 12, 2015.
    Regardless of attendance at the public meeting, interested persons 
may submit either electronic comments regarding reauthorization of 
MDUFA to http://www.regulations.gov or 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. Identify comments with the docket number 
found in brackets in the heading of this document. In addition, when 
responding to specific questions as outlined in section I, please 
identify the question you are addressing. Received comments may be 
viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: As soon as a transcript is available, it will be 
accessible at http://www.regulations.gov. It may also be viewed in 
person at the Division of Dockets Management (see Comments). A link to 
the transcript will also be available approximately 45 days after the 
public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public 
meeting from the posted events list.)

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing its intention to hold a public meeting on the 
reauthorization of the Medical Device User Fee Amendments of 2012 
(MDUFA III), which currently authorizes FDA to collect user fees and 
use them for the process for the review of device applications until 
October 1, 2017. Without new legislation, referred to as 
reauthorization, FDA will not be able to collect user fees after fiscal 
year (FY) 2017 to fund the medical device review process.
    Prior to reauthorization, FDA must consult with the regulated 
industry and make recommendations to Congress regarding the goals for 
the process for the review of device applications (see 21 U.S.C. 379j-
1(b)(1)(F)). Before beginning negotiations with the regulated industry 
on user fee reauthorization, section 738A(b)(2) of the FD&C Act (21 
U.S.C. 379j-1(b)(2)) requires that FDA 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 set under MDUFA III; (3) provide a 
period of 30 days after the public meeting to obtain written comments 
from the public suggesting changes to MDUFA; and (4) publish the 
comments on FDA's Web site. This notice, the public meeting, the 30-day 
comment period after the meeting, and the posting of the comments on 
FDA's 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 FDA's recommendation to 
Congress for 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 under MDUFA III?
    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 the Medical Device User Fee and 
Modernization Act of 2002 (MDUFMA) (Pub. L. 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 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 point in time, and to ensure that 
reprocessed medical devices are as safe and effective as original 
devices'' (H. Rept. 107-728 at 21 (2002)). MDUFMA had a 5-year life and 
contained two particularly important features which relate to 
reauthorization:
     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 
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 
submitters. The ultimate goal was for FDA 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 included 
FDA decision goals and cycle goals (cycle goals refer to FDA actions 
prior to a final action on a submission). Under MDUFMA, FDA also agreed 
to several other commitments that did 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 had not been identified, and publication of 
additional guidance documents.
    Medical device user fees and increased appropriations are 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 qualifying 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 user fees on this sector of the medical device 
industry, which plays an important role in fostering innovation.
    Since MDUFMA was first passed in 2002, it has been reauthorized 
twice: The 2007 Medical Device User Fee Amendments (MDUFA II) and the 
2012 Medical Device User Fee Amendments (MDUFA III). Under MDUFA III, 
which

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has been in effect since 2012 and will expire in 2017, FDA has met or 
exceeded nearly all submission performance goals while implementing 
program enhancements designed to ensure more timely access to safe and 
effective medical devices.
     Premarket Notifications (510(k)s): Comparison of outcomes 
for receipt cohorts at the same levels of completion (or ``closure'') 
show a 16 percent decrease in total review time between FY 2010 and FY 
2013 when the cohort is 99.8 percent closed, and 10 percent decrease in 
total review time between FY 2010 and FY 2014 when the cohort is 75.8 
percent closed.
     Premarket Approvals (PMAs): Comparison of outcomes for 
receipt cohorts at the same closure levels show a 32 percent decrease 
in total review times between FY 2009 and FY 2012 when the cohort is 98 
percent closed, and a 26 percent decrease in total review times between 
FY 2009 and FY 2014 when the cohort is 41 percent closed.
    FDA has met or exceeded all MDUFA III performance goals for FDA 
time to decisions in FY 2013 and FY 2014. More information about FDA's 
performance is available in the yearly MDUFA performance reports, which 
are available online at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/UCM2007450.htm.
    User fees and related performance goals have played an important 
role in providing resources and supporting the process for the review 
of device applications.

III. What information should you know about the meeting?

    Through this notice, we are announcing a public meeting to hear 
stakeholder views on the reauthorization of MDUFA for fiscal years 2018 
through 2022, including specific suggestions for any changes to the 
program that we should consider. We will conduct the meeting on July 
13, 2015. 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 groups, 
industry, health care professionals, and academic researchers). FDA 
will also provide an opportunity for individuals to make presentations 
during the meeting and for organizations and individuals to submit 
written comments to the docket after the meeting. The presentations 
should focus on program improvements and funding issues, including 
specific suggestions for changes to performance goals, and not focus on 
other general policy issues.

    Dated: June 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14885 Filed 6-16-15; 8:45 am]
 BILLING CODE 4164-01-P