[Federal Register Volume 85, Number 174 (Tuesday, September 8, 2020)]
[Notices]
[Pages 55462-55463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19771]


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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 or the Agency) is 
announcing a virtual public meeting to discuss proposed recommendations 
for the reauthorization of the Medical Device User Fee Amendments 
(MDUFA) for fiscal years (FYs) 2023 through 2027 (MDUFA V). MDUFA 
authorizes FDA to collect user fees to support the process for the 
review of medical device applications. The current legislative 
authority for MDUFA expires after September 30, 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) directs that FDA begin MDUFA 
reauthorization by publishing a notice in the Federal Register 
requesting public input and holding a public meeting where the public 
may present its views on the reauthorization, providing a period of 30 
days after the public meeting to obtain written comments from the 
public suggesting changes to MDUFA, and publishing the comments on 
FDA's website.

DATES: The public meeting will be held on October 27, 2020, from 9 a.m. 
Eastern Time to 2 p.m. Eastern Time. 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 November 27, 2020. Registration to view the meeting must be 
received by October 23, 2020.

ADDRESSES: Registration to attend this virtual public meeting and other 
information can be found at https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/2020-medical-device-meetings-and-workshops. (Select this meeting from the posted events list.) See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.
    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 November 27, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time on November 27, 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 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, 240-402-7500.
     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

[[Page 55463]]

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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Ellen Olson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1664, Silver Spring, MD 20993, 301-796-4322, 
ellen.olson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing its intention to hold a virtual public meeting to 
begin the reauthorization process of MDUFA, the legislation that 
authorizes FDA to collect user fees to support the process for the 
review of device applications. Without new legislation, FDA will no 
longer be able to collect user fees after FY 2022 to fund the medical 
device review process.
    Section 738A(b)(2) of the FD&C Act (21 U.S.C. 379j-1(b)(2)) 
requires that before FDA begins negotiations with the regulated 
industry on MDUFA reauthorization, the Agency perform the following: 
(1) Publish a notice in the Federal Register requesting public input on 
the reauthorization; (2) hold a public meeting where 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; and (4) publish the comments on FDA's website at 
https://www.fda.gov. 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 MDUFA as 
we consider the features to propose, update, and discontinue in the 
next MDUFA and FDA's recommendation to Congress. 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 is your assessment of the overall performance of MDUFA IV 
thus far?
    (2) What programs/commitments under MDUFA IV are working well?
    (3) What programs/commitments can be added or improved to enhance 
the efficiency and effectiveness of the medical device review process 
for MDUFA V?
    (4) 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

    In general, the meeting format will include presentations by FDA 
and a series of panels representing different stakeholder groups (such 
as patient advocates, consumer protection groups, industry, healthcare 
professionals, and academic researchers). FDA will also provide an 
opportunity for public comment at the meeting, and for organizations 
and individuals to submit written comments to the docket. The 
presentations should focus on program improvements and funding issues, 
including specific suggestions for changes to performance goals, and 
not focus on policy issues. We will make the agenda for the public 
meeting available by October 13, 2020, on the internet at https://www.fda.gov/medical-devices/workshops-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 viewing this public 
meeting must register by October 23, 2020, by 4 p.m. Eastern Time. 
Registrants will receive confirmation when their registration has been 
accepted. You will be notified if you are on a waiting list. We will 
update the website if registration closes before the day of the public 
meeting.
    If you need special accommodations due to a disability, 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, susan.monahan@fda.hhs.gov no later than October 
13, 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. All requests to make oral presentations must be received by 
September 28, 2020, at 4 p.m. Eastern Time. 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. 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 October 
5, 2020. If selected for presentation, any presentation materials must 
be emailed to Ellen Olson (see FOR FURTHER INFORMATION CONTACT) no 
later than October 20, 2020. No commercial or promotional material will 
be permitted to be presented or distributed at the public meeting.
    Streaming Webcast of the Public Meeting: The webcast link will be 
available on the registration web page after October 13, 2020.
    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: September 2, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-19771 Filed 9-4-20; 8:45 am]
BILLING CODE 4164-01-P


