[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Notices]
[Pages 20436-20441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07451]


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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; Public Meeting; Request for 
Comments

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing a virtual public meeting entitled ``Medical Device User Fee 
Amendments.'' The purpose of the meeting is to discuss proposed 
recommendations for the

[[Page 20437]]

reauthorization of the Medical Device User Fee Amendments (MDUFA) for 
fiscal years (FYs) 2023 through 2027. MDUFA authorizes FDA to collect 
fees and use them for the process for the review of device 
applications. The current legislative authority for MDUFA expires 
September 30, 2022. At that time, new legislation will be required for 
FDA to continue collecting device user fees in future fiscal years. 
Following discussions with the device industry and periodic 
consultations with public stakeholders, the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for 
the reauthorized program in the Federal Register, provide for a period 
of 30 days for the public to provide written comments on such 
recommendations, and hold a meeting at which the public may present its 
views on such recommendations. FDA will then consider such public views 
and comments and revise such recommendations as necessary.

DATES: The public meeting will be held virtually on April 19, 2022, 
from 12 p.m. to 4:30 p.m. Eastern Time. Submit electronic or written 
comments to the public docket by April 21, 2022.

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/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022.
    You may submit written comments on the recommendations as follows. 
Please note that late, untimely filed comments will not be considered. 
Electronic comments must be submitted on or before April 21, 2022. The 
https://www.regulations.gov electronic filing system will accept 
comments until 11:59 p.m. Eastern Time at the end of April 21, 2022. 
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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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; Public 
Meeting.'' FDA published the commitment letter on March 22, 2022. The 
commitment letter can be found in the docket and on this website at 
https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v. The docket will close 
on April 21, 2022. 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 available 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.
    <bullet> 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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Mimi Nguyen, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5547, Silver Spring, MD 20993, 301-796-4125, 
<a href="/cdn-cgi/l/email-protection#723f362734332420171307061a1d001b0813061b1d1c321416135c1a1a015c151d04"><span class="__cf_email__" data-cfemail="5d1019081b1c0b0f383c282935322f34273c293432331d3b393c7335352e733a322b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of proposed recommendations for 
the reauthorization of MDUFA, which authorizes FDA to collect user fees 
and use them for the process for the review of device applications. We 
are also announcing a virtual public meeting to discuss such 
recommendations. The current authorization of the MDUFA program 
continues until September 30, 2022. Without new legislation, FDA will 
no longer be able to collect user fees for future fiscal years to 
provide funds for the process for the review of device applications.
    Section 738A(b)(4) of the FD&C Act (21 U.S.C. 379j-1(b)(4)) 
requires that, after holding negotiations with regulated industry, we 
take the following actions: (1) Present the recommendations to the 
Committee on Energy and Commerce of the U.S. House of Representatives 
and the Committee on Health, Education, Labor, and

[[Page 20438]]

Pensions of the U.S. Senate; (2) publish the recommendations in the 
Federal Register; (3) provide a period of 30 days for the public to 
submit written comments on the recommendations; (4) hold a meeting at 
which the public may present its views on the recommendations; and (5) 
after consideration of public views and comments, revise the 
recommendations as necessary. This notice, the 30-day comment period, 
and the public meeting will satisfy parts of these requirements. After 
the public meeting, we will revise the recommendations as necessary. In 
addition, the Agency will present the recommendations to the 
Congressional committees.
    The purpose of the meeting is for the public to present its views 
on the proposed recommendations for the reauthorized program (MDUFA V). 
The meeting format will include presentations by FDA and different 
stakeholder interest groups (such as industry, patient and consumer 
advocates, healthcare professionals, and scientific and academic 
experts). The Agency will also provide an opportunity for other 
interested individuals to make presentations at the meeting.
    The following information is provided to help potential meeting 
participants better understand the history and evolution of the medical 
device user fee program and the current status of the proposed MDUFA V 
recommendations.

II. What is MDUFA and what does it do?

    MDUFA is the law that authorizes FDA to collect fees from device 
companies that register their establishments, submit applications to 
market devices, and make other types of device submissions. 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.R. Rep. 107-728 at p. 21 (October 7, 2002). MDUFMA was 
authorized for 5 years and contained two important features that relate 
to reauthorization:
    <bullet> 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. User fees and other 
appropriations for the medical device program helped FDA expand 
available expertise, modernize its information management systems, 
provide new review options, and provide more guidance to prospective 
submitters. The ultimate goal was for FDA to clear or approve safe and 
effective medical devices more rapidly and predictably, benefiting 
applicants, the healthcare community, and most importantly, patients.
    <bullet> 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 were viewed 
by FDA, Congress, and industry stakeholders as essential to support 
high-quality, timely medical device reviews, and other activities 
critical to the device review program.
    MDUFMA provided for--and reauthorizations have maintained--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 device industry, which plays an important role in 
fostering innovation.
    Since MDUFMA was first enacted in 2002, it has been reauthorized 
three times through the Medical Device User Fee Amendments of 2007 
(MDUFA II), the Medical Device User Fee Amendments of 2012 (MDUFA III), 
and the Medical Device User Fee Amendments of 2017 (MDUFA IV). MDUFA IV 
has been in effect since 2017 and will expire on September 30, 2022 
(https://www.fda.gov/media/100848/download). The MDUFA IV agreement 
enabled FDA to continue making progress on reducing review times and 
bringing devices to patients more quickly, while also enabling FDA to 
move forward in critical areas, including:
    <bullet> Building a sustainable infrastructure for efficient, 
consistent, transparent, and high-quality regulation of devices 
throughout the total product lifecycle;
    <bullet> Accessing and using real-world evidence in the regulatory 
decision-making process;
    <bullet> Advancing patient engagement and the regulatory science of 
patient input;
    <bullet> Advancing the smart oversight of digital health 
technologies in ways that support innovation, balance innovation and 
safety, and show promise as a potential blueprint for future regulatory 
approaches to emerging technologies.
    In terms of review goals, FDA's performance was strong during the 
initial years of MDUFA IV (FY 2018 and FY2019), continuing to meet and 
exceed performance goals and working to reduce the time for patients to 
have access to safe, new, innovative devices. During this time, FDA 
achieved all of our submission review goals, met 21 of 24 performance 
enhancement goals, and FDA and industry met three of four shared 
outcome goals. Starting in FY 2020, the strain from the pandemic, as 
well as a workload that exceeded assumptions underlying the MDUFA IV 
agreement, resulted in failure to meet certain MDUFA IV goals.
    Preliminary performance data through September 30, 2021, including 
completed and pending reviews, indicate that FDA has met (or has the 
potential to meet) 13 of the 16 FY 2020 review goals and 9 of the 13 FY 
2021 review goals for which FDA had a sufficient MDUFA cohort to 
calculate performance. FDA also completed, on time, all eight 
performance enhancement goals due in FY 2021. However, FDA's response 
to the unprecedented COVID-19 public health emergency has impacted 
FDA's MDUFA performance, resulting in three missed FY 2020 review goals 
and four missed FY 2021 review goals. Information about FDA's 
performance is available in the yearly and quarterly MDUFA performance 
reports, which are online at: https://www.fda.gov/about-fda/user-fee-performance-reports/mdufa-performance-reports and https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/mdufa-reports.

III. Proposed MDUFA V Recommendations

    In preparing the proposed recommendations to Congress for MDUFA 
reauthorization, FDA conducted discussions with the device

[[Page 20439]]

industry and consulted with stakeholders, as required by the FD&C Act. 
The Agency began the MDUFA reauthorization process by publishing a 
notice in the Federal Register requesting public input on the 
reauthorization and announcing a public meeting that was held on 
October 27, 2020. The meeting included presentations by FDA (which 
complemented videos released ahead of the public meeting highlighting 
FDA's efforts and accomplishments under the MDUFA IV agreement) and a 
series of panels with representatives of different stakeholder groups, 
including patient and consumer advocacy groups, regulated industry, and 
healthcare professionals. The materials from the meeting, including a 
transcript and webcast recording, can be found at https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-10272020.
    From February 2021 through March 2022, FDA conducted negotiations 
with representatives of the device industry: The Advanced Medical 
Technology Association; the Medical Device Manufacturers Association; 
the Medical Imaging and Technology Alliance; and the American Clinical 
Laboratory Association. During its negotiations with industry, FDA also 
held monthly consultations with representatives of patient and consumer 
advocacy groups and other public stakeholders. Meeting minutes are 
posted on FDA's website at: https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v.
    The proposed recommendations for MDUFA V address many priorities 
identified by industry and other stakeholders. While some of the 
proposed recommendations are new, many either build on successful 
enhancements or refine elements from the existing program. FDA posted 
the full text of the proposed MDUFA V commitment letter at: https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v. Each significant new or 
modified recommendation is briefly described below with reference to 
the applicable section of the proposed commitment letter.

A. Shared Outcome Goals

    FDA and representatives of the device industry believe that the 
process improvements outlined in the proposed commitment letter, when 
implemented by all parties as intended, should reduce the average Total 
Time to Decision for premarket approval applications (PMAs), and 
premarket notification (510(k)) submissions, provided that the total 
funding of the device review program adheres to the assumptions 
underlying the MDUFA V agreement. Reducing average Total Time to 
Decision, as defined in the commitment letter, is an important aspect 
of the user fee program, so that safe and effective devices reach 
patients and healthcare professionals more quickly. FDA proposes, for 
PMA and 510(k) submissions, with the performance improvement 
adjustments described below, that the Total Time to Decision will reach 
270 calendar days for original PMA and panel-track supplement 
submissions and 108 calendar days for 510(k)s by FY 2027.
    Additional details regarding the shared outcome goals can be found 
in Sections I and III of the proposed commitment letter.

B. Pre-Submissions

    MDUFA V provides additional resources for FDA to address the 
increasing volume of Pre-Submissions requests and to improve the Pre-
submission performance goal. FDA proposes to ramp up to a performance 
goal of providing written feedback on at least 90 percent of Pre-
Submissions within 70 days or 5 calendar days prior to the scheduled 
meeting, whichever comes sooner, by FY 2025. With the performance 
improvement adjustments described below, FDA may continue to improve 
this performance goal in FY 2026-2027. FDA will also update guidance to 
include additional information to assist applicants and review staff in 
identifying the circumstances in which an applicant's question is most 
appropriate for informal communication instead of a Pre-Submission. 
Additional details regarding Pre-Submissions can be found in Sections 
II.A and III.C of the proposed commitment letter.

C. De Novo Requests

    FDA will have an opportunity, with the performance improvement 
adjustments described below, to ramp up to a De Novo decision goal of 
90 percent of De Novo request submissions within 150 days in FY 2027. 
Additional details regarding De Novo requests can be found in Sections 
II.E and III.B of the proposed commitment letter.

D. Opportunity for Performance Improvements

    FDA proposes adding a new performance improvement adjustment for 
MDUFA V that would allow FDA to collect fees in addition to annual 
total revenue in FY 2025, FY 2026, and/or FY 2027, if certain review 
performance and/or shared outcome goals are met for FY 2023, 2024, and/
or 2025. If applicable, these fee increases will apply solely to 
establishment registration fees and support improvements to the 510(k) 
and PMA Shared Outcome Total Time to Decision goals, the Pre-Submission 
Written Feedback goal, and the De Novo decision goal. The following 
examples describe adjustments if goals are met for FY 2023:
    <bullet> If FDA's 510(k) decision goal, the FDA/Industry 510(k) 
Shared Outcome Total Time to Decision goal, FDA's PMA decision goal, 
and the FDA/Industry PMA Shared Outcome Total Time to Decision goal are 
met for FY 2023, and fee revenue above the annual total revenue amount 
is provided in FYs 2026 and 2027, then the 510(k) Shared Outcome Total 
Time to Decision goal and the PMA Shared Outcome Total Time to Decision 
goal will be adjusted. Specifically, the 510(k) Shared Outcome Total 
Time to Decision goal will be improved to 108 days for FYs 2026 and 
2027, and the PMA Shared Outcome Total Time to Decision goal will be 
improved to 275 days for FYs 2026 and 2027.
    <bullet> If the Pre-Submission Written Feedback goal is met for FY 
2023, and fee revenue above the annual total revenue amount is provided 
to support performance improvements in FYs 2025, 2026, and 2027, the 
maximum number of Pre-Submissions subject to the goal will improve to 
4,700 Pre-Submissions in FYs 2025, 2026, and 2027.
    <bullet> If the De Novo decision goal is met for FY 2023, and fee 
revenue above the annual total revenue amount is provided in FYs 2026 
and 2027 to support performance improvements, the goal will improve to 
80 percent of De Novo requests receiving a MDUFA decision within 150 
FDA days for FYs 2026 and 2027.
    Additional details regarding the opportunity for performance 
improvements can be found in Section III of the proposed commitment 
letter. Under the new performance improvement adjustment, FDA may 
receive additional funding up to the following maximum amounts (which 
would be adjusted for inflation):

<bullet> $15,396,600 for FY 2025
<bullet> $44,135,700 for FY 2026
<bullet> $56,244,000 for FY 2027

E. Deficiency Letters

    To support improved communication in FDA letters requesting 
additional

[[Page 20440]]

information, FDA will clarify what constitutes a statement of the basis 
for the deficiency in updated guidance, train staff and managers on the 
updated guidance, and establish a performance goal for providing a 
statement of the basis for the deficiency that ramps up to 95 percent 
by FY 2027.

F. Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot

    FDA will launch a voluntary pilot program to provide more frequent 
and timely interactions for industry and other stakeholders earlier in 
the device development process with a focus on Breakthrough (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program) and Safer Technologies Program devices 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices). Through the TAP 
Pilot, FDA will provide strategic engagement for innovative devices of 
public health importance by facilitating improved strategic decision 
making during product development, including earlier identification, 
assessment, and mitigation of product-development risk. The TAP Pilot 
will also support engagement to better align expectations regarding 
evidence generation, improve submission quality, and improve the 
efficiency of the premarket review process. Additional details 
regarding the TAP Pilot can be found in Section V.J of the proposed 
commitment letter.

G. Patient Science and Engagement

    FDA proposes to continue building the Patient Science and 
Engagement program, which engages patients and supports incorporating 
their perspectives in the regulatory process. In particular, FDA 
proposes to expand the program through the following activities: 
Facilitate patient engagement through patient-friendly educational 
content; explore ways to advance health equity; continue to expand 
patient science review expertise and capacity; improve the regulatory 
predictability and impact of patient science, including shared 
examples; hold a public meeting on patient-generated health data for 
collecting clinical outcome assessment (COA) data and for remote 
clinical trials; and issue draft guidance on incorporating COA into 
premarket studies and update patient preference information guidance. 
Additional details regarding patient science and engagement can be 
found in Section V.E of the proposed commitment letter.

H. Enhanced Use of Consensus Standards

    During MDUFA IV, FDA initiated the voluntary Accreditation Scheme 
for Conformity Assessment (ASCA) pilot to enhance product reviewers' 
and device manufacturers' confidence in medical device testing when 
manufacturers rely on testing completed by ASCA-accredited testing 
laboratories. FDA proposes to use lessons learned from implementation 
of the ASCA pilot in MDUFA IV to transition to a sustainable and 
expanded program in MDUFA V. Additional details regarding the enhanced 
use of consensus standards can be found in Section V.C of the proposed 
commitment letter.

I. International Harmonization

    FDA will enhance international harmonization activities by 
expanding engagement in international harmonization and convergence 
efforts to promote alignment with international best practices and 
internationally developed policies. Additional details regarding 
international harmonization can be found in Section V.I of the proposed 
commitment letter.

J. Third Party Premarket Review Program

    FDA proposes to maintain the Accredited Persons (Third Party 
Review) program in MDUFA V. Additional details regarding the Third 
Party Review program can be found in Section V.D of the proposed 
commitment letter.

K. Real World Evidence (RWE)

    FDA proposes to continue to advance the development of Real-World 
Data (RWD) and RWE methods and policies to advance regulatory 
acceptance for premarket submissions. Additional details regarding RWE 
can be found in Section V.F of the proposed commitment letter.

L. Digital Health

    FDA proposes to continue building its digital health expertise, 
working to streamline and align FDA review processes with software 
lifecycles for digital health products, engaging in international 
harmonization efforts related to software review, and conducting other 
activities related to digital health. Additional details regarding 
digital health can be found in Section V.G of the proposed commitment 
letter.

M. Information Technology (IT)

    FDA proposes to continue to enhance IT infrastructure to support 
the process for the review of device applications, including improving 
a submission progress tracking system and developing electronic 
submission templates for more submission types. Additional details 
regarding IT can be found in Section IV.C of the proposed commitment 
letter.

N. Financial Transparency and Hiring

    FDA proposes to take several new steps to provide additional 
transparency and accountability measures with respect to MDUFA V 
finances and hiring. The Agency proposes to publish a MDUFA 5-year 
financial plan that will be updated annually. In addition, new 
statutory language for an operating reserve adjustment is proposed to 
reflect FDA and industry-agreed measures for managing the amount of 
operating reserves in the MDUFA carryover balance. Under this new 
provision, FDA would decrease registration fees if the amount of 
operating reserves exceeds the designated amount. The designated amount 
for a fiscal year is equal to 13 weeks of operating reserves plus the 1 
month of operating reserves required by statute. Further, the amount of 
carryover user fees intended to support the Third Party Review program 
and TAP Pilot during MDUFA V would be excluded for the period of FY 
2023 through FY 2026 when calculating the amount of operating reserves 
to determine if registration fees will be decreased. User fee funds in 
the carryover balance that are considered unappropriated or unearned 
are not included in the operating reserves.
    To help ensure that FDA accomplishes hiring in accordance with the 
assumptions underlying the MDUFA V agreement, FDA proposes to set 
annual hiring goals for MDUFA V positions. Proposed statutory language 
would provide for the reduction of establishment registration fees for 
FYs 2025, 2026, and 2027, if the Agency does not meet those goals for 
FYs 2023, 2024, and 2025, respectively, by a certain threshold. The 
amount of the hiring adjustment fee decrease would be the product of 
the number of hires by which the hiring goal was missed and one-quarter 
of the inflation-adjusted cost per full time equivalent. Additional 
details regarding financial transparency and hiring can be found in 
Section IV.B of the proposed commitment letter.

O. Independent Assessments

    FDA and industry propose to participate in a targeted assessment of 
the management of the process for the review of device applications. 
FDA also proposes to retain an independent contractor with expertise in 
assessing public sector workforce data analysis

[[Page 20441]]

and reporting to conduct an assessment of current methodologies and 
data/metrics available to represent the MDUFA workforce. Additional 
details regarding the independent assessments can be found in Section 
VI of the proposed commitment letter.

P. Performance Reports

    FDA proposes to continue to report quarterly and annually on 
performance against commitments. Additionally, FDA proposes to report 
quarterly on progress toward hiring goals and funding intended for RWE 
activities. FDA will report annually on the primary cost drivers for 
changes to personnel compensation and benefits costs. Additional 
details regarding performance reporting can be found in Section VII of 
the proposed commitment letter.

Q. User Fee Revenue and Fee Allocations

    As part of MDUFA V, FDA and industry propose updating the base fee 
amounts for PMAs and annual establishment registrations, as well as the 
annual total revenue amounts, to reflect negotiated fee levels. The 
statutory total revenue amounts, base fee amounts, and amounts for 
potential performance improvement adjustments are proposed in FY 2021 
dollars, such that annual inflation adjustments will be used to inflate 
FY 2021 dollars to the appropriate amounts for each fiscal year in 
MDUFA V. FDA and industry also propose to change the fee for a PMA 
Panel-Track supplement from 75 percent to 80 percent of the fee for an 
original PMA and to change the fee for a 510(k) submission from 3.4 
percent to 4.5 percent of the fee for a PMA. Finally, a minor change is 
proposed to the statutory provisions regarding fee waivers and 
reductions for small businesses to clarify that an applicant seeking a 
waiver or reduction is not required to submit a certification from the 
national taxing authority of the foreign country in which the 
applicant, or its affiliate, is located, if the country has no national 
taxing authority.
    FDA will post the agenda approximately 5 days before the meeting 
at: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022.

IV. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit 
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022. Please provide complete contact information 
for each attendee, including name, title, affiliation, email, and 
telephone number. Registrants will receive confirmation after they have 
been accepted.
    Registration is free. Persons interested in attending by webcast 
the MDUFA virtual public meeting must register online by 4 p.m. Eastern 
Time, April 18, 2022. Early registration is recommended.
    If you need special accommodations because of a disability, please 
contact Susan Monahan at 240-205-2260 or <a href="/cdn-cgi/l/email-protection#21725452404f0f6c4e4f4049404f614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="cc9fb9bfada2e281a3a2ada4ada28caaa8ade2a4a4bfe2aba3ba">[email protected]</span></a> no 
later than April 11, 2022.
    Requests for Oral Presentations: This meeting includes a public 
comment session and topic-focused sessions. During online registration 
you may indicate if you wish to present during the public comment 
session or a specific session, and which topic(s) you wish to address. 
All requests to make oral presentations virtually by webcast must be 
received by April 11, 2022, at 4 p.m. Eastern Time. FDA will do its 
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. FDA will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin 
and will notify speakers by April 12, 2022. If selected for 
presentation, any presentation materials must be emailed to Mimi Nguyen 
(see FOR FURTHER INFORMATION CONTACT) no later than April 13, 2022, at 
4 p.m.. Eastern Time. No commercial or promotional material will be 
permitted to be presented or distributed at the meeting.
    FDA is holding this meeting to provide information on the proposed 
recommendations for the reauthorization of MDUFA for FYs 2023 through 
2027. To permit the widest possible opportunity to obtain public 
comment, FDA is soliciting either electronic or written comments on all 
aspects of the meeting topics. The docket was opened on March 22, 2022. 
The proposed commitment letter was posted in the docket and on this 
website at: https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v. The 
docket will close on April 21, 2022, 30 days after the proposed 
commitment letter was posted.
    Streaming Webcast of the Public Meeting: The webcast link will be 
available on the registration web page after April 11, 2022. 
Organizations are requested to register all participants.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at in the docket at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available 
approximately 45 days after the public workshop on the internet at: 
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022.

    Dated: April 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07451 Filed 4-6-22; 8:45 am]
BILLING CODE 4164-01-P


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