[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-

[[Page 13167]]

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