20436 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 

Regarding the guidance: Aisar 

Atrakchi, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 4118, Silver Spring, 

MD 20993–0002, 301–796–1036; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

Regarding the ICH: Jill Adleberg, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6364, Silver Spring, 

MD 20993–0002, 301–796–5259, 

Jill.Adleberg@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Food and Drug Administration 

(FDA or Agency) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘M7(R2) Addendum: 

Application of the Principles of the ICH 

M7 Guideline to Calculation of 

Compound-Specific Acceptable Intakes; 

International Council for 

Harmonisation; Draft Guidance for 

Industry.’’ The draft guidance was 

prepared under the auspices of ICH. ICH 

has the mission of achieving greater 

regulatory harmonization worldwide to 

ensure that safe, effective, high-quality 

medicines are developed, registered, 

and maintained in the most resourceefficient manner. 

By harmonizing the regulatory 

requirements in regions around the 

world, ICH guidelines have 

substantially reduced duplicative 

clinical studies, prevented unnecessary 

animal studies, standardized the 

reporting of important safety 

information, standardized marketing 

application submissions, and made 

many other improvements in the quality 

of global drug development and 

manufacturing and the products 

available to patients. 

The six Founding Members of the ICH 

are the FDA; the Pharmaceutical 

Research and Manufacturers of America; 

the European Commission; the 

European Federation of Pharmaceutical 

Industries Associations; the Japanese 

Ministry of Health, Labour, and Welfare; 

and the Japanese Pharmaceutical 

Manufacturers Association. The 

Standing Members of the ICH 

Association include Health Canada and 

Swissmedic. Additionally, the 

Membership of ICH has expanded to 

include other regulatory authorities and 

industry associations from around the 

world (refer to https://www.ich.org/). 

ICH works by involving technical 

experts from both regulators and 

industry parties in detailed technical 

harmonization work and the application 

of a science-based approach to 

harmonization through a consensusdriven process that results in the 

development of ICH guidelines. The 

regulators around the world are 

committed to consistently adopting 

these consensus-based guidelines, 

realizing the benefits for patients and for 

industry. 

As a Founding Regulatory Member of 

ICH, FDA plays a major role in the 

development of each of the ICH 

guidelines, which FDA then adopts and 

issues as guidance for industry. FDA’s 

guidance documents do not establish 

legally enforceable responsibilities. 

Instead, they describe the Agency’s 

current thinking on a topic and should 

be viewed only as recommendations, 

unless specific regulatory or statutory 

requirements are cited. 

In September 2021, the ICH Assembly 

endorsed the draft guideline entitled 

‘‘M7(R2) Addendum: Application of the 

Principles of the ICH M7 Guideline to 

Calculation of Compound-Specific 

Acceptable Intakes’’ and agreed that the 

guideline should be made available for 

public comment. The draft guideline is 

the product of the Safety Expert 

Working Group of the ICH. Comments 

about this draft will be considered by 

FDA and the Safety Expert Working 

Group. 

The draft guidance adds monographs 

for seven new compounds to the M7 

Guideline which outlines 

considerations for assessment and 

control of DNA reactive (mutagenic) 

impurities to limit potential 

carcinogenic risk. The compounds are: 

Acetaldehyde, dibromoethane, 

epichlorohydrin, ethyl bromide, 

formaldehyde, styrene, and vinyl 

acetate. The addendum is intended to 

update the M7 Guideline in line with 

the ICH process for its maintenance and 

includes other revisions. 

This draft guidance has been left in 

the original ICH format. It contains only 

a list of revisions to the M7(R1) 

Guideline as well as the monographs for 

seven new compounds submitted for 

public consultation. The final guidance 

will include a complete, integrated 

M7(R2) Guideline and Addendum and 

will be reformatted and edited to 

conform with FDA’s good guidance 

practices regulation (21 CFR 10.115) and 

style before publication. 

The draft guidance, when finalized, 

will represent the current thinking of 

FDA on ‘‘M7(R2) Assessment and 

Control of DNA Reactive (Mutagenic) 

Impurities in Pharmaceuticals To Limit 

Potential Carcinogenic Risk’’ and its 

Addendum. It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

While this draft guidance contains no 

collection of information it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, and the collection of information 

under 21 CFR parts 210 and 211 have 

been approved under OMB control 

number 0910–0139. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.regulations.gov, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, or https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances. 

Dated: April 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07395 Filed 4–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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 


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Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 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-medicaldevices/public-meeting-medical-deviceuser-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: 

• 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; 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-feeamendments-mdufa/medical-deviceuser-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. 

• 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, 

MDUFAVReauthorization@fda.hhs.gov. 

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 


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20438 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 

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: 

• 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. 

• 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: 

• Building a sustainable 

infrastructure for efficient, consistent, 

transparent, and high-quality regulation 

of devices throughout the total product 

lifecycle; 

• Accessing and using real-world 

evidence in the regulatory decisionmaking process; 

• Advancing patient engagement and 

the regulatory science of patient input; 

• 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/userfee-performance-reports/mdufaperformance-reports and https://

www.fda.gov/industry/medical-deviceuser-fee-amendments-mdufa/mdufareports. 

III. Proposed MDUFA V 

Recommendations 

In preparing the proposed 

recommendations to Congress for 

MDUFA reauthorization, FDA 

conducted discussions with the device 


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Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 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-medicaldevices/virtual-public-meeting-medicaldevice-user-fee-amendments-fiscalyears-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/medicaldevice-user-fee-amendments-mdufa/ 

medical-device-user-fee-amendments2023-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-deviceuser-fee-amendments-mdufa/medicaldevice-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 Presubmission 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: 

• 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. 

• 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 PreSubmissions in FYs 2025, 2026, and 

2027. 

• 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): 

• $15,396,600 for FY 2025 

• $44,135,700 for FY 2026 

• $56,244,000 for FY 2027 

E. Deficiency Letters 

To support improved communication 

in FDA letters requesting additional 


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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-fdaguidance-documents/breakthroughdevices-program) and Safer 

Technologies Program devices (https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/safertechnologies-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 ASCAaccredited 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 


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Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 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/medicaldevices/workshops-conferencesmedical-devices/public-meetingmedical-device-user-fee-amendmentsfiscal-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-medicaldevices/public-meeting-medical-deviceuser-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 

Susan.Monahan@fda.hhs.gov 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-amendmentsmdufa/medical-device-user-feeamendments-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/workshopsconferences-medical-devices/publicmeeting-medical-device-user-feeamendments-fiscal-years-2023-through2027-04192022. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; COVID–19 Provider 

Relief Fund (PRF) and American 

Rescue Plan (ARP) Rural Payment 

Reporting Activities, OMB No. 0906– 

0068—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than June 6, 2022. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 


khammond on DSKJM1Z7X2PROD with NOTICES