80_FR_34795 80 FR 34679 - Medical Device User Fee Amendments; Public Meeting; Request for Comments

80 FR 34679 - Medical Device User Fee Amendments; Public Meeting; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 116 (June 17, 2015)

Page Range34679-34681
FR Document2015-14885

Federal Register, Volume 80 Issue 116 (Wednesday, June 17, 2015)
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34679-34681]
From the Federal Register Online  [www.thefederalregister.org]
[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: 
Aaron.Josephson@fda.hhs.gov.
    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: Susan.Monahan@fda.hhs.gov, 
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

[[Page 34680]]

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

[[Page 34681]]

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]
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                                                                                 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices                                            34679

                                                    Format for Abbreviated 510(k)s for Early                ACTION: Notice of public meeting;                      registration on the day of the meeting
                                                    Growth Response 1 (EGR1) Gene                           request for comments.                                  will be provided beginning at 8 a.m.
                                                    Fluorescence In-Situ Hybridization                                                                                If you have registered and need
                                                    (FISH) Test System for Specimen                            The Food and Drug Administration                    special accommodations, please contact
                                                    Characterization Devices.’’ It does not                 (FDA) is announcing a public meeting                   Susan Monahan, 301–796–5661, email:
                                                    establish any rights for any person and                 on the reauthorization of the Medical                  Susan.Monahan@fda.hhs.gov, no later
                                                    is not binding on FDA or the public.                    Device User Fee Amendments (MDUFA)                     than July 1, 2015.
                                                    You can use an alternative approach if                  for fiscal years 2018 through 2022. The                   To register for the public meeting,
                                                    it satisfies the requirements of the                    current legislative authority for the                  please visit FDA’s Medical Devices
                                                    applicable statutes and regulations.                    medical device user fee program expires                News & Events—Workshops &
                                                                                                            on October 1, 2017, and new legislation                Conferences calendar at http://
                                                    III. Electronic Access                                  will be required for FDA to continue                   www.fda.gov/MedicalDevices/
                                                                                                            collecting user fees for the medical                   NewsEvents/WorkshopsConferences/
                                                      Persons with access to the Internet
                                                                                                            device program in future fiscal years.                 default.htm. (Select this public meeting
                                                    may obtain the document at either
                                                                                                            The Federal Food, Drug, and Cosmetic                   from the posted events list.) Please
                                                    http://www.fda.gov/Drugs/Guidance
                                                                                                            Act (FD&C Act) requires that before FDA                provide complete contact information
                                                    ComplianceRegulatoryInformation/
                                                                                                            begins negotiations with the regulated                 for each attendee, including name, title,
                                                    Guidances/default.htm or http://
                                                                                                            industry on MDUFA reauthorization, we                  affiliation, email, and telephone
                                                    www.regulations.gov.
                                                                                                            publish a notice in the Federal Register               number. Those without Internet access
                                                    IV. Paperwork Reduction Act of 1995                     requesting public input on the                         should contact Susan Monahan to
                                                                                                            reauthorization, hold a public meeting                 register. All registrants will receive
                                                      This guidance refers to currently
                                                                                                            at which the public may present its                    confirmation after they have been
                                                    approved collections of information
                                                                                                            views on the reauthorization, provide a                successfully registered. Registrants not
                                                    found in FDA regulations. These
                                                                                                            period of 30 days after the public                     confirmed to participate, but added to a
                                                    collections of information are subject to
                                                                                                            meeting to obtain written comments                     waiting list, will be notified of that as
                                                    review by the Office of Management and
                                                                                                            from the public suggesting changes to                  well.
                                                    Budget (OMB) under the Paperwork
                                                                                                            MDUFA, and publish the comments on                        Streaming Webcast of the Public
                                                    Reduction Act of 1995 (44 U.S.C. 3501–                                                                         Meeting: This public meeting will be
                                                                                                            FDA’s Web site. FDA invites public
                                                    3520). The collections of information in                                                                       Webcast. Persons interested in viewing
                                                                                                            comment on the medical device user fee
                                                    21 CFR part 807, subpart E, are                                                                                the Webcast must register online (see
                                                                                                            program and suggestions regarding the
                                                    currently approved under OMB control                                                                           Web link above) by July 2, 2015, at 4
                                                                                                            commitments FDA should propose for
                                                    number 0910–0120 and the collections                                                                           p.m. Early registration is recommended
                                                                                                            the next reauthorized program.
                                                    of information in 21 CFR 809.10 are                        Date and Time: The public meeting                   because Webcast connections are
                                                    currently approved under 0910–0485.                     will be held on July 13, 2015, from 9                  limited. FDA requests that organizations
                                                    V. Comments                                             a.m. to 5 p.m.                                         with multiple registrants in the same
                                                                                                               Location: The public meeting will be                location register all participants
                                                       Interested persons may submit either                 held at FDA’s White Oak Campus,                        individually but view the Webcast using
                                                    electronic comments regarding this                      10903 New Hampshire Ave., Building                     one connection per location. Webcast
                                                    document to http://www.regulations.gov                  31 Conference Center, the Great Room                   participants will be sent technical
                                                    or written comments to the Division of                  (Rm. 1503), Silver Spring, MD 20993.                   system requirements upon confirmation
                                                    Dockets Management (see ADDRESSES). It                  Entrance for public meeting participants               and will be sent connection access
                                                    is only necessary to send one set of                    (non-FDA employees) is through                         information after July 6, 2015. If you
                                                    comments. Identify comments with the                    Building 1 where routine security                      have not previously attended an event
                                                    docket number found in brackets in the                  screening procedures will be performed.                hosted by Connect Pro, it is
                                                    heading of this document. Received                      For parking and security information,                  recommended that you test your
                                                    comments may be seen in the Division                    please refer to http://www.fda.gov/                    connection in advance at https://
                                                    of Dockets Management between 9 a.m.                    AboutFDA/WorkingatFDA/                                 collaboration.fda.gov/common/help/en/
                                                    and 4 p.m., Monday through Friday, and                  BuildingsandFacilities/                                support/meeting_test.htm. A short
                                                    will be posted to the docket at http://                 WhiteOakCampusInformation/                             overview of the Connect Pro program is
                                                    www.regulations.gov.                                    ucm241740.htm.                                         available at http://www.adobe.com/go/
                                                      Dated: June 12, 2015.                                    Contact Person: Aaron Josephson,                    connectpro_overview.
                                                    Leslie Kux,                                             Center for Devices and Radiological                       Requests for Oral Presentations: This
                                                    Associate Commissioner for Policy.                      Health, Food and Drug Administration,                  public meeting includes public
                                                                                                            10903 New Hampshire Ave., Bldg. 66,                    comment and topic-focused sessions.
                                                    [FR Doc. 2015–14881 Filed 6–16–15; 8:45 am]
                                                                                                            Rm. 5449, Silver Spring, MD 20993,                     During registration you may indicate if
                                                    BILLING CODE 4164–01–P
                                                                                                            301–796–5178, email:                                   you wish to present during a public
                                                                                                            Aaron.Josephson@fda.hhs.gov.                           comment session or participate in a
                                                    DEPARTMENT OF HEALTH AND                                   Registration: Registration is required              topic-focused session, and specify the
                                                    HUMAN SERVICES                                          to attend this meeting in person or to                 topic(s) you wish to address. FDA has
                                                                                                            view the Webcast. Registration is free                 included general topics in this
                                                                                                            and available on a first-come, first-                  document. FDA will do its best to
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                                                    Food and Drug Administration
                                                                                                            served basis. Persons interested in                    accommodate all persons who wish to
                                                                                                            participating in the meeting must                      speak. FDA encourages individuals and
                                                    [Docket No. FDA–2010–N–0389]
                                                                                                            register online by July 2, 2015, at 4 p.m.             organizations with common interests to
                                                    Medical Device User Fee Amendments;                     Early registration is recommended                      consolidate or coordinate their
                                                    Public Meeting; Request for Comments                    because space is limited and, therefore,               presentations, and request time for a
                                                                                                            FDA may limit the number of                            joint presentation, or submit requests for
                                                    AGENCY:    Food and Drug Administration,                participants from each organization. If                designated representatives to participate
                                                    HHS.                                                    time and space permit, onsite                          in the topic-focused sessions. After


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                                                    34680                        Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices

                                                    registration closes, FDA will determine                 applications until October 1, 2017.                    regulatory reforms so that medical
                                                    the amount of time allotted to each                     Without new legislation, referred to as                device manufacturers can bring their
                                                    presenter and the approximate time                      reauthorization, FDA will not be able to               safe and effective devices to the
                                                    each oral presentation is to begin, and                 collect user fees after fiscal year (FY)               American people at an earlier point in
                                                    will notify selected speakers by July 7,                2017 to fund the medical device review                 time, and to ensure that reprocessed
                                                    2015. All requests to make oral                         process.                                               medical devices are as safe and effective
                                                    presentations must be received by the                      Prior to reauthorization, FDA must                  as original devices’’ (H. Rept. 107–728 at
                                                    close of registration on July 2, 2015, at               consult with the regulated industry and                21 (2002)). MDUFMA had a 5-year life
                                                    4 p.m. Presenters should submit all                     make recommendations to Congress                       and contained two particularly
                                                    presentation materials via email to                     regarding the goals for the process for                important features which relate to
                                                    Aaron Josephson (see Contact Person)                    the review of device applications (see 21              reauthorization:
                                                    no later than July 10, 2015. No                         U.S.C. 379j–1(b)(1)(F)). Before beginning                 • User fees for the review of medical
                                                    commercial or promotional material                      negotiations with the regulated industry               device premarket applications, reports,
                                                    should be presented or distributed at the               on user fee reauthorization, section                   supplements, and premarket
                                                    public meeting.                                         738A(b)(2) of the FD&C Act (21 U.S.C.                  notification submissions provided
                                                       Comments: FDA is holding this public                 379j–1(b)(2)) requires that FDA do the                 additional resources to make FDA
                                                    meeting to hear stakeholder views on                    following: (1) Publish a notice in the                 reviews more timely, predictable, and
                                                    the medical device user fee program. In                 Federal Register requesting public input               transparent to applicants. MDUFMA
                                                    order to obtain a broad range of public                 on the reauthorization; (2) hold a public              fees and appropriations for the medical
                                                    comment, FDA is soliciting either                       meeting at which the public may                        device program helped FDA expand
                                                    electronic or written comments on all                   present its views on the reauthorization,              available expertise, modernized its
                                                    aspects of the public meeting topics.                   including specific suggestions for                     information management systems,
                                                    The deadline for submitting comments                    changes to the goals set under MDUFA                   provided new review options, and
                                                    related to this public meeting is August                III; (3) provide a period of 30 days after             provided more guidance to prospective
                                                    12, 2015.                                               the public meeting to obtain written                   submitters. The ultimate goal was for
                                                       Regardless of attendance at the public               comments from the public suggesting                    FDA to approve and clear safe and
                                                    meeting, interested persons may submit                  changes to MDUFA; and (4) publish the                  effective medical devices more rapidly,
                                                    either electronic comments regarding                    comments on FDA’s Web site. This                       benefiting applicants, the health care
                                                    reauthorization of MDUFA to http://                     notice, the public meeting, the 30-day                 community, and most importantly,
                                                    www.regulations.gov or written                          comment period after the meeting, and                  patients.
                                                    comments to the Division of Dockets                     the posting of the comments on FDA’s                      • Negotiated performance goals for
                                                    Management (HFA–305), Food and Drug                     Web site will satisfy these requirements.              many types of premarket reviews
                                                    Administration, 5630 Fishers Lane, Rm.                     The purpose of the meeting is to hear               provided FDA with benchmarks for
                                                    1061, Rockville, MD 20852. It is only                   stakeholder views on medical device                    measuring review improvements. These
                                                    necessary to send one set of comments.                  user fee reauthorization as we consider                quantifiable goals became more
                                                    Identify comments with the docket                       FDA’s recommendation to Congress for                   demanding each year and included FDA
                                                    number found in brackets in the                         the next medical device user fee                       decision goals and cycle goals (cycle
                                                    heading of this document. In addition,                  program. FDA is interested in responses                goals refer to FDA actions prior to a
                                                    when responding to specific questions                   to the following two general questions                 final action on a submission). Under
                                                    as outlined in section I, please identify               and welcomes any other pertinent                       MDUFMA, FDA also agreed to several
                                                    the question you are addressing.                        information stakeholders would like to                 other commitments that did not have
                                                    Received comments may be viewed in                      share:                                                 specific timeframes or direct measures
                                                    the Division of Dockets Management                         1. What is your assessment of the                   of performance, such as expanding the
                                                    between 9 a.m. and 4 p.m., Monday                       overall performance of the medical                     use of meetings with industry,
                                                    through Friday, and will be posted to                   device user fee program under MDUFA                    maintenance of current performance in
                                                    the docket at http://                                   III?                                                   review areas where specific
                                                    www.regulations.gov.                                       2. What aspects of the medical device               performance goals had not been
                                                       Transcripts: As soon as a transcript is              user fee program should be retained,                   identified, and publication of additional
                                                    available, it will be accessible at                     changed, or discontinued to further                    guidance documents.
                                                    http://www.regulations.gov. It may also                 strengthen and improve the program?                       Medical device user fees and
                                                    be viewed in person at the Division of                     The following information is provided               increased appropriations are essential to
                                                    Dockets Management (see Comments). A                    to help potential meeting participants                 support high-quality, timely medical
                                                    link to the transcript will also be                     better understand the history and                      device reviews, and other activities
                                                    available approximately 45 days after                   evolution of the medical device user fee               critical to the device review program.
                                                    the public workshop on the Internet at                  program and its current status.                           MDUFMA provided for fee discounts
                                                    http://www.fda.gov/MedicalDevices/                                                                             and waivers for qualifying small
                                                    NewsEvents/WorkshopsConferences/                        II. What is the Medical Device User Fee                businesses. Small businesses make up a
                                                    default.htm. (Select this public meeting                Program? What does it do?                              large proportion of the medical device
                                                    from the posted events list.)                              In the years preceding enactment of                 industry, and these discounts and
                                                    SUPPLEMENTARY INFORMATION:                              the Medical Device User Fee and                        waivers helped reduce the financial
                                                                                                            Modernization Act of 2002 (MDUFMA)                     impact of user fees on this sector of the
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    I. Background                                           (Pub. L. 107–250), FDA’s medical device                medical device industry, which plays an
                                                       FDA is announcing its intention to                   program suffered a long-term,                          important role in fostering innovation.
                                                    hold a public meeting on the                            significant loss of resources that                        Since MDUFMA was first passed in
                                                    reauthorization of the Medical Device                   undermined the program’s capacity and                  2002, it has been reauthorized twice:
                                                    User Fee Amendments of 2012 (MDUFA                      performance. MDUFMA was enacted                        The 2007 Medical Device User Fee
                                                    III), which currently authorizes FDA to                 ‘‘in order to provide FDA with the                     Amendments (MDUFA II) and the 2012
                                                    collect user fees and use them for the                  resources necessary to better review                   Medical Device User Fee Amendments
                                                    process for the review of device                        medical devices, to enact needed                       (MDUFA III). Under MDUFA III, which


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                                                                                 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices                                            34681

                                                    has been in effect since 2012 and will                  suggestions for changes to performance                 Irradiation in the Production,
                                                    expire in 2017, FDA has met or                          goals, and not focus on other general                  Processing, and Handling of Food—21
                                                    exceeded nearly all submission                          policy issues.                                         CFR Part 179 (OMB Control Number
                                                    performance goals while implementing                                                                           0910–0186)—Extension
                                                                                                              Dated: June 11, 2015.
                                                    program enhancements designed to                                                                                  Under sections 201(s) and 409 of the
                                                    ensure more timely access to safe and                   Leslie Kux,
                                                                                                            Associate Commissioner for Policy.
                                                                                                                                                                   Federal Food, Drug, and Cosmetic Act
                                                    effective medical devices.                                                                                     (the FD&C Act) (21 U.S.C. 321(s) and
                                                       • Premarket Notifications (510(k)s):                 [FR Doc. 2015–14885 Filed 6–16–15; 8:45 am]
                                                                                                                                                                   348), food irradiation is subject to
                                                    Comparison of outcomes for receipt                      BILLING CODE 4164–01–P
                                                                                                                                                                   regulation under the food additive
                                                    cohorts at the same levels of completion
                                                                                                                                                                   premarket approval provisions of the
                                                    (or ‘‘closure’’) show a 16 percent
                                                                                                                                                                   FD&C Act. The regulations providing for
                                                    decrease in total review time between                   DEPARTMENT OF HEALTH AND                               uses of irradiation in the production,
                                                    FY 2010 and FY 2013 when the cohort                     HUMAN SERVICES                                         processing, and handling of food are
                                                    is 99.8 percent closed, and 10 percent
                                                                                                                                                                   found in part 179 (21 CFR part 179). To
                                                    decrease in total review time between                   Food and Drug Administration
                                                                                                                                                                   ensure safe use of a radiation source,
                                                    FY 2010 and FY 2014 when the cohort
                                                                                                                                                                   § 179.21(b)(1) requires that the label of
                                                    is 75.8 percent closed.                                 [Docket No. FDA–2012–N–0473]
                                                       • Premarket Approvals (PMAs):                                                                               sources bear appropriate and accurate
                                                    Comparison of outcomes for receipt                                                                             information identifying the source of
                                                                                                            Agency Information Collection                          radiation and the maximum (or
                                                    cohorts at the same closure levels show                 Activities; Submission for Office of
                                                    a 32 percent decrease in total review                                                                          minimum and maximum) energy of the
                                                                                                            Management and Budget Review;                          emitted radiation. Section 179.21(b)(2)
                                                    times between FY 2009 and FY 2012                       Comment Request; Irradiation in the
                                                    when the cohort is 98 percent closed,                                                                          requires that the label or accompanying
                                                                                                            Production, Processing, and Handling                   labeling bear adequate directions for
                                                    and a 26 percent decrease in total                      of Food
                                                    review times between FY 2009 and FY                                                                            installation and use and a statement
                                                    2014 when the cohort is 41 percent                                                                             supplied by us that indicates maximum
                                                                                                            AGENCY:    Food and Drug Administration,               dose of radiation allowed. Section
                                                    closed.                                                 HHS.
                                                       FDA has met or exceeded all MDUFA                                                                           179.26(c) requires that the label or
                                                    III performance goals for FDA time to                   ACTION:   Notice.                                      accompanying labeling bear a logo and
                                                    decisions in FY 2013 and FY 2014.                                                                              a radiation disclosure statement. Section
                                                    More information about FDA’s                            SUMMARY:   The Food and Drug                           179.25(e) requires that food processors
                                                    performance is available in the yearly                                                                         who treat food with radiation make and
                                                                                                            Administration (FDA) is announcing
                                                    MDUFA performance reports, which are                                                                           retain, for 1 year past the expected shelf
                                                                                                            that a proposed collection of
                                                    available online at http://www.fda.gov/                                                                        life of the products up to a maximum of
                                                                                                            information has been submitted to the                  3 years, specified records relating to the
                                                    AboutFDA/ReportsManualsForms/                           Office of Management and Budget
                                                    Reports/UserFeeReports/                                                                                        irradiation process (e.g., the food
                                                                                                            (OMB) for review and clearance under                   treated, lot identification, scheduled
                                                    PerformanceReports/UCM2007450.htm.                      the Paperwork Reduction Act of 1995.
                                                       User fees and related performance                                                                           process, etc.). The records required by
                                                    goals have played an important role in                  DATES:  Fax written comments on the                    § 179.25(e) are used by our inspectors to
                                                    providing resources and supporting the                  collection of information by July 17,                  assess compliance with the regulation
                                                    process for the review of device                        2015.                                                  that establishes limits within which
                                                    applications.                                                                                                  radiation may be safely used to treat
                                                                                                            ADDRESSES:   To ensure that comments on                food. We cannot ensure safe use without
                                                    III. What information should you know                   the information collection are received,               a method to assess compliance with the
                                                    about the meeting?                                      OMB recommends that written                            dose limits, and there are no practicable
                                                       Through this notice, we are                          comments be faxed to the Office of                     methods for analyzing most foods to
                                                    announcing a public meeting to hear                     Information and Regulatory Affairs,                    determine whether they have been
                                                    stakeholder views on the                                OMB, Attn: FDA Desk Officer, FAX:                      treated with ionizing radiation and are
                                                    reauthorization of MDUFA for fiscal                     202–395–7285, or emailed to oira_                      within the limitations set forth in part
                                                    years 2018 through 2022, including                      submission@omb.eop.gov. All                            179. Records inspection is the only way
                                                    specific suggestions for any changes to                 comments should be identified with the                 to determine whether firms are
                                                    the program that we should consider.                    OMB control number 0910–0186. Also                     complying with the regulations for
                                                    We will conduct the meeting on July 13,                 include the FDA docket number found                    treatment of foods with ionizing
                                                    2015. In general, the meeting format will               in brackets in the heading of this                     radiation.
                                                    include presentations by FDA and a                      document.                                                 In the Federal Register of March 31,
                                                    series of panels representing different                                                                        2015 (80 FR 17055), FDA published a
                                                    stakeholder interest groups (such as                    FOR FURTHER INFORMATION CONTACT:    FDA                60-day notice requesting public
                                                    patient advocates, consumer protection                  PRA Staff, Office of Operations, Food                  comment on the proposed collection of
                                                    groups, industry, health care                           and Drug Administration, 8455                          information. One comment was received
                                                    professionals, and academic                             Colesville Road; COLE–14526, Silver                    but did not respond to any of the four
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    researchers). FDA will also provide an                  Spring, MD 20993–0002 PRAStaff@                        information collection topics solicited
                                                    opportunity for individuals to make                     fda.hhs.gov.                                           and is therefore not addressed by the
                                                    presentations during the meeting and                                                                           Agency.
                                                    for organizations and individuals to                    SUPPLEMENTARY INFORMATION:    In                          Description of respondents:
                                                    submit written comments to the docket                   compliance with 44 U.S.C. 3507, FDA                    Respondents are businesses engaged in
                                                    after the meeting. The presentations                    has submitted the following proposed                   the irradiation of food.
                                                    should focus on program improvements                    collection of information to OMB for                      We estimate the burden of this
                                                    and funding issues, including specific                  review and clearance.                                  collection of information as follows:



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Document Created: 2015-12-15 14:22:33
Document Modified: 2015-12-15 14:22:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public meeting; request for comments.
FR Citation80 FR 34679 

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