[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Notices]
[Pages 13165-13167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04638]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0907]
Medical Device User Fee Amendments for Fiscal Years 2023 Through
2027; 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
Amendments for fiscal years (FYs) 2023 through 2027 (MDUFA V). The
current legislative authority for the medical device user fee program
expires on October 1, 2022, 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 website. FDA invites public comment
on the medical device user fee program and suggestions regarding the
commitments FDA should propose for the next reauthorized program.
DATES: The public meeting will be held on April 7, 2020, from 9 a.m. to
5 p.m. EST. Submit either electronic or written comments on the medical
device user fee program and suggestions regarding the commitments FDA
should propose for the next reauthorized program by May 6, 2020. See
the SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: 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 check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/about-fda/white-oak-campus-information/public-meetings-fda-white-oak-campus.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before May 6, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time on May 6, 2020. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note
[[Page 13166]]
that if you include your name, contact information, or other
information that identifies you in the body of your comments, that
information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket
No.FDA-2020-N-0907 for ``Medical Device User Fee Amendments for Fiscal
Years 2023 Through 2027.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ellen Olson, Center for Devices and
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1664,
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4322,
[email protected].
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 2017
(MDUFA IV), which currently authorizes FDA to collect user fees during
FYs 2018-2022 and use them for the process for the review of device
applications. Without new legislation, referred to as reauthorization,
FDA will not be able to collect user fees after FY 2022 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 IV; (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 website. This notice, the public meeting, the 30-day
comment period after the meeting, and the posting of the comments on
FDA's website 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. Information
about the MDUFA program can be found at https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa.
Information about MDUFA IV can be found at https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2017-mdufa-iv and the MDUFA IV Performance Goals and
Procedures can be found at https://www.fda.gov/media/102699/download.
FDA is interested in responses to the following general questions and
welcomes any other pertinent information stakeholders would like to
share:
1. What programs/commitments under MDUFA IV are currently working
well?
2. What programs/commitments can be improved for MDUFA V?
3. What new programs/commitments should be considered as part of
MDUFA V?
4. Thinking more broadly than the MDUFA program alone, what should
the medical device ecosystem, and our medical device program in
particular, look like at the end of MDUFA V (i.e., September 2027), and
how can MDUFA V support achieving that future state?
II. Topics for Discussion at the Public Meeting
Through this notice, we are announcing a public meeting to hear
stakeholder views on the reauthorization of MDUFA for FYs 2023 through
2027, including specific suggestions for any changes to the user fee
program that we should consider. We will conduct the meeting on April
7, 2020. 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, either during a specific session or the public
comment session, 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. We will make the agenda for the public
meeting available by March 12, 2020, on the internet at https://
www.fda.gov/medical-devices/workshops-
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conferences-medical-devices/2020-medical-device-meetings-and-workshops
(Select this meeting from the posted events list.)
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit
FDA's Medical Devices News & Events--Workshops & Conferences calendar
at https://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.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register by March 26, 2020, by 4 p.m. Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when their registration has been
accepted. You will be notified if you are on a waiting list. If time
and space permit, onsite registration on the day of the public meeting
will be provided beginning at 8 a.m. We will update the website if
registration closes before the day of the public meeting.
If you need special accommodations, please contact Susan Monahan,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-5661, [email protected] no later than March 23, 2020.
Requests for Oral Presentations: During online registration, you
may indicate if you wish to present during a public comment session or
participate in a specific session, and which topic(s) you wish to
address. We will do our best to accommodate requests to make public
comments. Individuals and organizations with common interests are urged
to consolidate or coordinate their presentations, and request time for
a joint presentation, or submit requests for designated representatives
to participate in the focused sessions. Following the close of
registration, we 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 April 1, 2020. All requests to
make oral presentations must be received by the close of registration
on March 26, 2020, at 4 p.m. Eastern Time. If selected for
presentation, any presentation materials must be emailed to Ellen Olson
(see FOR FURTHER INFORMATION CONTACT) no later than March 26, 2020. No
commercial or promotional material will be permitted to be presented or
distributed at the public meeting.
Streaming Webcast of the Public Meeting: This meeting will also be
webcast. The webcast link will be available on the registration web
page after March 26, 2020. Organizations are requested to register all
participants, but to view using one connection per location. If you
have never attended a Connect Pro event before, test your connection at
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.
To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website
addresses in this document, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.
Transcripts: As soon as a transcript of the public meeting is
available, it will be accessible at https://www.regulations.gov. It may
also be viewed at the Dockets Management Staff (see ADDRESSES). A link
to the transcript will also be available on the internet https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this meeting from the posted events list.)
Dated: March 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04638 Filed 3-5-20; 8:45 am]
BILLING CODE 4164-01-P