47316 Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices 

requested to make their presentation on 

or before September 15, 2021. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

September 16, 2021. 

Closed Committee Deliberations: On 

September 30, 2021, from 10:45 a.m. to 

11:45 a.m., the meeting will be closed to 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The recommendations of the 

advisory committee regarding the 

progress of the individual investigator’s 

research programs along with other 

information, will be discussed during 

this session. We believe that public 

discussion of these recommendations on 

individual scientists would constitute 

an unwarranted invasion of personal 

privacy. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Kathleen 

Hayes (CBERVRBPAC@fda.hhs.gov) at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at: 

https://www.fda.gov/advisorycommittees/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: August 18, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18107 Filed 8–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0891] 

Reauthorization of the Prescription 

Drug User Fee Act; Public Meeting; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is hosting a virtual public meeting 

entitled ‘‘Reauthorization of the 

Prescription Drug User Fee Act.’’ The 

purpose of the public meeting is to 

discuss proposed recommendations for 

the reauthorization of the Prescription 

Drug User Fee Act (PDUFA) for fiscal 

years (FYs) 2023 through 2027. PDUFA 

authorizes FDA to collect user fees to 

support the process for the review of 

human drug applications. The current 

legislative authority for PDUFA expires 

in September 2022. At that time, new 

legislation will be required for FDA to 

continue collecting prescription drug 

user fees in future fiscal years. 

Following discussions with the 

regulated 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, hold a meeting at which the 

public may present its views on such 

recommendations, and provide for a 

period of 30 days for the public to 

provide written comments 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 

on September 28, 2021, from 9 a.m. to 

2 p.m. Eastern Time, and will be held 

by webcast only. Submit either 

electronic or written comments on this 

public meeting by October 28, 2021. 

ADDRESSES: Registration to attend the 

virtual meeting and other information 

can be found at https://pdufaviireauthorization.eventbrite.com. 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 October 28, 2021. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of October 28, 2021. 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– 

2021–N–0891 for ‘‘Reauthorization of 

the Prescription Drug User Fee Act; 

Public Meeting; Request for Comments.’’ 

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 


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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. 

Transcripts of the meeting will be 

available on FDA’s website at https://

www.fda.gov/industry/prescriptiondrug-user-fee-amendments/pdufa-viifiscal-years-2023-2027 approximately 30 

days after the meeting. 

FOR FURTHER INFORMATION CONTACT: 

Patrick Zhou, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1148, 

Silver Spring, MD 20993–0002, 301– 

348–1817, Patrick.Zhou@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

FDA is announcing a virtual public 

meeting to discuss proposed 

recommendations for the 

reauthorization of PDUFA, the 

legislation that authorizes FDA to 

collect user fees to support the process 

for the review of human drug 

applications. The current authorization 

of the program (PDUFA VI) expires in 

September 2022. Without new 

legislation, FDA will no longer be able 

to collect user fees for future fiscal years 

to fund the process for the review of 

human drug applications. Section 

736B(f)(4) of the FD&C Act (21 U.S.C. 

379h–2(f)(4)) requires that after FDA 

holds negotiations with regulated 

industry and periodic consultations 

with stakeholders, we do the following: 

(1) Present recommendations to the 

relevant Congressional committees, (2) 

publish recommendations in the 

Federal Register, (3) provide a period of 

30 days for the public to provide written 

comments on the recommendations, (4) 

hold a meeting at which the public may 

present its views, 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 some of these requirements. After 

the public meeting, we will revise the 

recommendations as necessary and 

present our proposed recommendations 

to the Congressional committees. The 

purpose of the meeting is to hear the 

public’s views on the proposed 

recommendations for the reauthorized 

program (PDUFA VII). The following 

information is provided to help 

potential meeting participants better 

understand the history and evolution of 

the PDUFA program and the status of 

the proposed PDUFA VII 

recommendations. 

II. What is PDUFA and what does it do? 

The following information is provided 

to help potential meeting participants 

better understand the history and 

evolution of PDUFA and its status. 

PDUFA is a law that authorizes FDA to 

collect fees from drug companies that 

submit marketing applications for 

certain human drug and biological 

products. PDUFA was originally 

enacted in 1992 as the Prescription Drug 

User Fee Act (Pub. L. 102–571) for a 

period of 5 years. In 1997, Congress 

passed the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA, Pub. L. 105–115), which 

renewed the program (PDUFA II) for an 

additional 5 years. Congress then 

extended PDUFA again for another 5 

years (PDUFA III), through FY 2007, in 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (Pub. L. 107–188). 

In 2007, Title I of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA, Pub. L. 110–85) 

reauthorized PDUFA through FY 2012 

(PDUFA IV, Pub. L. 112–144) and in 

2012 the Food and Drug Administration 

Safety and Innovation Act (FDASIA) 

reauthorized the law through FY 2017 

(PDUFA V). PDUFA was most recently 

renewed in 2017 under Title I of the 

FDA Reauthorization Act of 2017 

(FDARA) which lasts through FY 2022 

(PDUFA VI). 

PDUFA’s intent is to provide 

additional revenues so that FDA can 

hire more staff, improve systems, and 

establish a better managed human drug 

review process to make important 

therapies available to patients sooner 

without compromising review quality or 

FDA’s high standards for safety, 

efficacy, and quality. As part of FDA’s 

negotiated agreement with industry 

during each reauthorization, the Agency 

agrees to certain performance and 

procedural goals and other 

commitments that apply to aspects of 

the human drug review program. These 

goals apply, for example, to the process 

for the review of original new human 

drug and biological product 

applications, postmarket safety 

activities, and new data standards and 

technology enhancements. 

During the first few years of PDUFA 

I, the additional funding enabled FDA to 

eliminate backlogs of original 

applications and supplements. Phased 

in over the 5 years of PDUFA I, the goals 

were to review and act on 90 percent of 

priority new drug applications (NDAs), 

biologics license applications (BLAs), 

and efficacy supplements within 6 

months of submission of a complete 

application; to review and act on 90 

percent of standard original NDAs, 

BLAs, and efficacy supplements within 

12 months, and to review and act on 

resubmissions and manufacturing 

supplements within 6 months. Over the 

course of PDUFA I, FDA exceeded all 

these performance goals and 

significantly reduced median review 

times of both priority and standard 

NDAs and BLAs. 

Under PDUFA II, the review 

performance goals were shortened, and 

new procedural goals were added to 

improve FDA’s interactions with 

industry sponsors and to help facilitate 

the drug development process. The 

procedural goals, for example, 

articulated time frames for scheduling 

sponsor-requested meetings intended to 

address issues or questions regarding 

specific drug development programs, as 

well as time frames for the timely 

response to industry-submitted 

questions on special study protocols. 

FDA met or exceeded all the review and 


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1When final, this guidance will represent the 

FDA’s current thinking on this topic. For the most 

recent version of a guidance, check the FDA 

guidance web page at https://www.fda.gov/ 

regulatory-information/search-fda-guidancedocuments. 

2See ‘‘Reauthorization of the Prescription Drug 

User Fee Act; Public Meeting; Request for 

Comments,’’ 85 FR 35096, June 8, 2020. 

procedural goals under PDUFA II. 

However, concerns grew that 

overworked review teams often had to 

return applications as ‘‘approvable’’ 

because they did not have the resources 

and sufficient staff time to work with 

the sponsors to resolve issues so that 

applications could be approved in the 

first review cycle. 

A sound financial footing and support 

for limited postmarket risk management 

were key themes of PDUFA III. Base 

user fee resources were significantly 

increased and a mechanism to account 

for changes in human drug review 

workload was adopted. PDUFA III also 

expanded the scope of user fee activities 

to include postmarket surveillance of 

new therapies for up to 3 years after 

marketing approval. FDA committed to 

the development of guidance for 

industry on risk assessment, risk 

management, and pharmacovigilance, as 

well as guidance to review staff and 

industry on review management 

principles. The draft guidance for 

industry entitled ‘‘Good Review 

Management Principles and Practices 

for New Drug Applications and 

Biologics License Applications’’ 

(GRMPs) was originally published in 

April 2005 and was subsequently 

revised and republished in September 

2018 (available at https://www.fda.gov/ 

media/72259/download (83 FR 48435, 

September 25, 2018)).1 Initiatives to 

improve application submission and 

Agency-sponsor interactions during the 

drug development and application 

review processes were also adopted. 

With PDUFA’s reauthorization under 

FDAAA Title I (PDUFA IV), FDA 

obtained a significant increase in base 

fee funding and committed to full 

implementation of GRMPs, which 

included providing a planned review 

timeline for premarket review, 

development of new guidance for 

industry on innovative clinical trials, 

modernization of postmarket safety, and 

elimination of the 3-year limitation on 

fee support for postmarket surveillance. 

Additional provisions in FDAAA (Titles 

IV, V, and IX) gave FDA additional 

statutory authority that increased the 

pre- and postmarket review process 

requirements, added new deadlines, and 

effectively increased review workload. 

Specifically, the new provisions 

expanded FDA’s drug safety authorities, 

such as the authority to require risk 

evaluation mitigation strategies (REMS), 

order safety labeling changes, and 

require postmarket studies. 

Under Title I of FDASIA, the fourth 

renewal of PDUFA, FDA implemented a 

new review program (the Program) to 

promote greater transparency and 

increase communication between FDA’s 

review team and the applicant on the 

most innovative products reviewed by 

the Agency. The Program applied to all 

new molecular entity (NME) NDAs and 

original BLAs received by the Agency 

from October 1, 2012, through 

September 30, 2017. The Program added 

new opportunities for communication 

between the FDA review team and the 

applicant during review of a marketing 

application, including mid-cycle 

communications and late-cycle 

meetings, while adding 60 days to the 

review clock to provide for this 

increased interaction and to address 

review issues for these complex 

applications. PDUFA V also required an 

assessment of the impact of the 

Program. The independent assessment 

of the Program entitled ‘‘Assessment of 

the Program for Enhanced Review 

Transparency and Communication for 

NME NDAs and Original BLAs in 

PDUFA V,’’ is available at https://

www.fda.gov/media/101907/download. 

In August 2017, FDARA was enacted, 

which renewed the prescription drug 

user fee program for a fifth time. This 

iteration of the program continued and 

built upon the successes of PDUFA V. 

In PDUFA VI, FDA and industry 

members agreed to continue the 

Program model developed in PDUFA V 

to continue to promote the efficiency 

and effectiveness of the first cycle 

review process. PDUFA VI includes 

commitments to enhance regulatory 

science and expedite drug development 

by focusing on enhancing 

communication between FDA and 

sponsors during drug development, 

early consultation on the use of new 

surrogate endpoints, and exploring the 

use of real-world evidence for use in 

regulatory decision making, among 

other enhancements. This 

reauthorization also included 

commitments to enhance the use of 

regulatory tools to support drug 

development and review through 

incorporation of the patient’s voice in 

drug development, expanded use of a 

benefit-risk framework in drug reviews, 

and advancing the use of complex 

innovative trial designs and model 

informed drug development. More 

information on these commitments can 

be found in the PDUFA VI commitment 

letter at https://www.fda.gov/media/ 

99140/download. 

As part of the current authorization, 

FDA also modernized the user fee 

structure to improve program funding 

predictability, stability, and 

administrative efficiency. The new 

structure eliminated the supplement 

fees, replaced the establishment and 

product fees with a program fee, and 

shifted a greater proportion of the target 

revenue to the new more predictable 

and stable annual program fee. The 

agreement also included commitments 

to enhance management of user fee 

resources through the development of a 

resource capacity planning capability 

and third-party evaluation of program 

resource management, along with the 

publication and annual update of a 

5-year financial plan. 

Recognizing the challenges with 

hiring in PDUFA V, the current 

authorization also includes several 

commitments to improve the hiring and 

retention of critical review staff through 

modernization of FDA’s hiring system, 

augmentation of hiring staff capacity 

and capabilities, creation of a dedicated 

function focused on staffing the 

program, reporting on hiring metrics, 

and a comprehensive and continuous 

assessment of hiring and retention. 

Annual performance reports for the 

PDUFA program can be found through 

FDA’s web page ‘‘PDUFA Performance 

Reports,’’ available at https://

www.fda.gov/about-fda/user-feeperformance-reports/pdufaperformance-reports. Additionally, a list 

of some public-facing deliverables 

developed to meet PDUFA VI 

commitments is available on FDA’s web 

page ‘‘Completed PDUFA VI 

Deliverables,’’ available at https://

www.fda.gov/industry/prescriptiondrug-user-fee-amendments/completedpdufa-vi-deliverables. 

III. Proposed PDUFA VII 

Recommendations 

In preparing the proposed 

recommendations to Congress for 

PDUFA reauthorization, FDA conducted 

discussions with the regulated industry 

and consulted with stakeholders, as 

required by the law. We began the 

PDUFA 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 July 23, 

2020.2 The meeting included 

presentations by FDA and a series of 

panels with representatives of different 

stakeholder groups, including patient 

advocates, consumer groups, regulated 

industry, health professionals, and 

academic researchers. The materials 


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from the meeting, including a transcript 

and webcast recording, can be found at 

https://www.fda.gov/drugs/news-eventshuman-drugs/public-meetingreauthorization-prescription-drug-userfee-act-pdufa-07232020-07232020. 

Following the July 2020 public 

meeting, FDA conducted negotiations 

with the regulated industry and held 

monthly consultations with 

stakeholders from September 2020 

through February 2021. As directed by 

Congress, FDA posted minutes of these 

meetings on its web page ‘‘PDUFA VII: 

Fiscal Years 2023–2027,’’ available at 

https://www.fda.gov/industry/ 

prescription-drug-user-fee-amendments/ 

pdufa-vii-fiscal-years-2023-2027. 

The proposed enhancements for 

PDUFA VII address many of the top 

priorities identified by public 

stakeholders, the regulated industry, 

and FDA. While some of the proposed 

enhancements are new, many either 

build on successful enhancements or 

refine elements from the existing 

program. The enhancements are 

proposed in the following areas: Center 

for Biologics Evaluation and Research 

(CBER) product review support, 

premarket review, regulatory decision 

tools, postmarketing evaluation, digital 

health and informatics, chemistry, 

manufacturing, and controls (CMC), and 

financial management. The full text of 

the proposed PDUFA VII commitment 

letter can be found on the Agency’s web 

page ‘‘PDUFA VII: Fiscal Years 2023– 

2027,’’ available at https://www.fda.gov/ 

industry/prescription-drug-user-feeamendments/pdufa-vii-fiscal-years2023-2027. Each significant new or 

modified enhancement is described 

briefly below: 

A. NME Milestones and Postmarketing 

Requirements (PMRs) 

To ensure the timely availability of 

information on the safety and efficacy of 

therapies, FDA proposes to establish 

new timelines, performance goals, and a 

new process for pre-approval review of 

PMRs. Sponsors would also have the 

opportunity to request a review of 

existing PMRs for release. Any adopted 

changes and adjustments will be 

updated in relevant manuals of policies 

and procedures, standard operating 

procedures, and guidances. This 

enhancement is described in section I.C 

of the proposed PDUFA VII 

commitment letter. 

B. Split Real Time Application Review 

Pilot Program 

To allow earlier patient access to 

therapies that address an unmet medical 

need, FDA proposes establishing a pilot 

program for efficacy supplements that 

meet specific criteria. Applications that 

are accepted into the pilot program will 

be submitted in a ‘‘split’’ fashion, 

specifically in two parts with each 

component submitted approximately 2 

months apart. The goal is to shorten the 

time from the date of complete 

submission of the application to the 

action date. This enhancement is 

described in section I.D of the proposed 

PDUFA VII commitment letter. 

C. Meeting Management Goals 

To improve overall meeting 

management, FDA proposes creating 

two new meeting types to better define 

the purpose of certain meeting requests: 

Type D and INTERACT. The Type D 

meeting allows for quicker discussion 

on a narrow set of issues (no more than 

two focused topics) between FDA and a 

sponsor, such as a followup question 

that raises a new issue after a formal 

meeting. The INTERACT meeting 

facilitates Investigational New Drug 

Application (IND) enabling efforts 

where a sponsor is facing a novel, 

challenging issue that might otherwise 

delay progress of the product towards 

entry into the clinic in the absence of 

this early FDA input. There would also 

be a new followup opportunity to pose 

clarifying questions after meetings or a 

written-response-only communication. 

These enhancements are described in 

section I.J of the proposed PDUFA VII 

commitment letter. 

D. Enhancing Regulatory Science and 

Expediting Drug Development 

The extension and continuation of 

FDA’s efforts to enhance regulatory 

science and expedite drug development 

will encompass further evaluation and 

enhancement of FDA-sponsor 

communications, ensuring the sustained 

success of the breakthrough therapy 

program, continuing early consultations 

between FDA and sponsors on the use 

of new surrogate endpoints as the 

primary basis for product approval, 

advancing rare disease drug 

development, advancing the 

development of combination products, 

and exploring the use of real world 

evidence for use in regulatory decision 

making. These enhancements are 

described in section I.K of the proposed 

PDUFA VII commitment letter. 

Highlights from those sections are 

included below. 

1. Advancing Development of Drugs for 

Rare Diseases 

The lack of regulatory precedent, 

small trial populations, and/or limited 

understanding of natural history 

associated with rare diseases creates 

unique challenges when determining 

the appropriate efficacy endpoint(s) for 

clinical trials intended to evaluate the 

effectiveness of rare disease therapies. 

Though difficult to establish, welldeveloped efficacy endpoints, especially 

those that could apply to other rare 

diseases with similar manifestations, 

drive the general advancement of rare 

disease drug development. In addition 

to challenges associated with 

developing endpoints that appropriately 

capture key signs and symptoms of a 

rare disease and directly measure how 

patients feel, function, or survive, 

surrogate endpoint development is also 

challenging in diseases with slow 

progression, small patient populations, 

or other challenges commonly 

associated with drug development in 

rare diseases. 

To support the advancement of rare 

disease treatments, FDA proposes a 

pilot program for supporting efficacy 

endpoint development for drugs that 

treat rare diseases by offering additional 

engagement opportunities with the 

Agency to sponsors of development 

programs that meet specific criteria. 

2. Advancing Development of DrugDevice and Biologic DeviceCombination Products Regulated by 

CBER and the Center for Drug 

Evaluation and Research (CDER) 

Sponsors employ Use-Related Risk 

Analyses (URRA) studies to identify the 

need for risk mitigation strategies and to 

design a human factors (HF) validation 

study. Based on a URRA, a sponsor may 

propose that an HF validation study 

submission is not required to support 

the safe and effective use of a drugdevice or biologic-device combination 

product. FDA proposes establishing new 

procedures for the review of URRAs 

along with performance goals. 

HF validation studies are conducted 

to evaluate the user interface of a drugdevice or biologic-device combination 

product to eliminate or mitigate userelated hazards that may affect the safe 

and effective use of the combination 

product. Over the past decade, more 

combination products have been 

developed to deliver therapeutics via 

different routes of administration (e.g., 

parenteral, inhalation) with complex 

engineering designs. HF validation 

protocols are reviewed during the IND 

stage with the goal towards developing 

a final finished combination product 

that supports the marketing application. 

To achieve this objective, FDA proposes 

updating the procedures for HF 

validation study protocols along with a 

new performance goal. 


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3. Advancing Real-World Evidence for 

Use in Regulatory Decision Making 

In accordance with Section 3022 of 

the 21st Century Cures Act, and by 

providing earlier and increased Agency 

advice, FDA proposes a new pilot 

program around real-world evidence 

(RWE) to improve the quality and 

acceptability of RWE-based approaches 

in support of new intended labeling 

claims, including approval of new 

indications of approved medical 

products or to satisfy post-approval 

study requirements. 

E. Enhancing Regulatory Decision Tools 

To Support Drug Development and 

Review 

Building on the success of PDUFA VI, 

the enhancements under this section 

focus on enhancing regulatory decision 

tools to support drug development and 

review in the areas of patient focused 

drug development, benefit-risk 

assessment in regulatory decision 

making, drug development tools for 

qualification pathway for biomarkers, 

model-informed drug development, and 

complex innovative clinical trial 

designs. The details of these 

enhancements can be found in section 

I.L of the proposed PDUFA VII 

commitment letter. 

F. Enhancement and Modernization of 

the FDA Drug Safety System 

FDA will continue to utilize user fees 

to enhance the drug safety system, 

including adopting new scientific 

approaches, improving the utility of 

existing tools for the detection, 

evaluation, prevention, and mitigation 

of adverse events, modernizing REMS 

assessments, and coordinating 

regulatory activity in the premarket and 

postmarket settings. Enhancements to 

the drug safety system will improve 

public health by increasing patient 

protection while continuing to enable 

access to needed medical products. 

Specifically, PDUFA VII user fees will 

provide support for modernization and 

improvement of REMS assessments and 

optimization of the Sentinel Initiative 

(https://www.fda.gov/safety/fdassentinel-initiative) through: (1) 

Maintenance of Sentinel Initiative 

capabilities and continued integration 

into FDA drug safety activities and (2) 

enhancement of the analytic capabilities 

of the Sentinel Initiative to address 

questions of product safety and advance 

the understanding of how RWE can be 

used for studying effectiveness. These 

enhancements are described in section 

I.M of the proposed PDUFA VII 

commitment letter. 

G. Enhancements Related to Product 

Quality Reviews, Chemistry, 

Manufacturing, and Controls 

Approaches, and Advancing the 

Utilization of Innovative Manufacturing 

Technologies 

To ensure new and innovative 

products are developed and available to 

patients in a timely manner, FDA 

proposes several enhancements related 

to communication between FDA and 

sponsors during product quality 

reviews, CMC approaches, and 

advancing use of innovative 

manufacturing technologies. 

For product quality reviews, these 

enhancements would include promoting 

the use of structured information 

requests, a third-party assessment on 

current practices related to information 

requests, and a goal to notify sponsors 

of certain pre-approval inspections. 

Given the accelerated development of 

certain human drug products, FDA also 

proposes a new pilot program to 

facilitate the expedited CMC 

development of products under an IND 

based upon the anticipated clinical 

benefit of earlier patient access to 

products. Additionally, FDA proposes 

holding a public workshop to help 

advance utilization and implementation 

of innovative manufacturing by 

facilitating and discussing best 

practices, barriers, and overall 

strategies. These enhancements are 

described in section I.N of the proposed 

PDUFA VII commitment letter. 

H. Enhancing CBER’s Capacity To 

Support Development, Review, and 

Approval of Cell and Gene Therapy 

Products 

To ensure that new and innovative 

cell and gene therapy products are 

developed and available to patients in a 

timely manner, FDA proposes to build 

on the success of the Cell and Gene 

Therapy Program (CGTP) in CBER to 

further support and advance a balanced 

approach to product development and 

regulation. To this end, FDA will 

strengthen staff capacity and capability 

to meet the increasing challenges and 

demands in this growing field. 

Increasing staff capacity will overcome 

existing resource limitations, allowing 

staff to spend additional time on 

meetings and submission reviews 

including those with breakthrough or 

regenerative medicine advanced therapy 

designations, expand stakeholder 

outreach, invest in new policy and 

guidance, and facilitate development 

and use of regulatory tools and scientific 

technologies. These enhancements are 

described in section I.O of the proposed 

PDUFA VII commitment letter. 

I. Supporting Review of New Allergenic 

Extract Products 

FDA proposes to incorporate and 

include new allergenic extract products 

into the PDUFA program. Allergenic 

extract products licensed after October 

1, 2022, would generally be included in 

user fees. Allergenic extract products 

licensed before October 1, 2022, and 

standardized allergenic extract products 

submitted pursuant to a notification to 

the applicant from the Secretary of 

Health and Human Services regarding 

the existence of a potency test that 

measures the allergenic activity of an 

allergenic extract product licensed by 

the applicant before October 1, 2022, 

would remain excluded from PDUFA. 

All performance goals, procedures, and 

commitments in this letter apply to the 

allergenic products included in the 

PDUFA program under PDUFA VII. 

These enhancements are described in 

section I.P of the proposed PDUFA VII 

commitment letter. 

J. Continued Enhancement of User Fee 

Resource Management 

FDA is committed to ensuring the 

sustainability of PDUFA program 

resources and to enhancing the 

operational agility of the PDUFA 

program. FDA will build on the 

financial enhancements included in 

PDUFA VI and continue activities in 

PDUFA VII to ensure optimal use of 

user fee resources and the alignment of 

staff to workload through the continued 

maturation and assessment of the 

Agency’s resource capacity planning 

capability. This would also include an 

independent assessment of the resource 

capacity planning capability. FDA will 

also continue activities to promote 

transparency of the use of financial 

resources in support of the PDUFA 

program through annual public 

meetings, publishing a 5-year financial 

plan (along with annual updates), and 

additional reporting in the annual 

PDUFA Financial Report. These 

enhancements are described in section 

II of the proposed PDUFA VII 

commitment letter. 

K. Enhancing Transparency and 

Leveraging Modern Technology 

FDA is committed to enhancing the 

transparency of its information 

technology (IT) activities and 

modernization plans and will continue 

maintaining catalogs, standards, and 

plan updates that are published 

regularly to FDA’s website in addition 

to the publication of a Data and 

Technology Modernization Strategy 

document and sharing regular updates 

on CBER IT modernization progress. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices 47321 

FDA will continue regular meetings 

between FDA and industry IT 

leadership to discuss challenges, 

emerging needs, and progress on IT 

initiatives relevant to PDUFA VII. 

Additionally, FDA will advance the use 

of cloud-based technology in the 

PDUFA program to modernize the 

Electronic Submission Gateway and 

promote innovation in drug 

development and the regulatory review 

process. These enhancements are 

described in section IV.A of the 

proposed PDUFA VII commitment 

letter. 

L. Expanding and Enhancing 

Bioinformatics Support 

Bioinformatics and computational 

biology are increasingly being used to 

assess product quality, safety, and 

efficacy, and facilitate the development, 

characterization, and manufacture of 

human drugs and biologics. Recognizing 

the substantial increase in the volume 

and diversity of bioinformatics and 

computational biology information and 

data in regulatory submissions, such as 

Next Generation Sequencing, FDA 

proposes numerous activities to meet 

this growing need. These activities will 

include developing additional expertise 

and staff capacity in both CDER and 

CBER to efficiently review and provide 

technical and timely feedback, assessing 

and strengthening the computational 

infrastructure to support and advance 

our informatics platforms, and 

continuing to develop data standards 

and to issue/revise guidances on these 

topics. These enhancements are 

described in section IV.B of the 

proposed PDUFA VII commitment 

letter. 

M. Enhancing Use of Digital Health 

Technologies (DHTs) To Support Drug 

Development and Review 

While the biomedical field has 

experienced rapid development and 

implementation of DHTs, FDA has 

limited experience evaluating novel 

DHT-based measurements in human 

drug development. FDA recognizes the 

potential for DHTs to provide scientific 

and practical advantages in supporting 

the assessment of patients by generating 

information outside of the traditional 

clinic visit. FDA also recognizes the 

need to build capacity and expertise to 

advise the biopharmaceutical industry 

in their development and 

implementation and to evaluate DHT 

outputs including the impact of 

regulatory initiatives (or regulatory 

science). To support new drug 

registration, label expansion, and safety 

monitoring, DHT-based data need to be 

fit for the intended purpose. Toward 

these ends, FDA proposes to undertake 

numerous activities, including the 

publication of a framework document to 

guide the use of DHT-derived data in 

regulatory decision making, the 

formation of a committee to provide 

support to DHT-related efforts, and a 

series of public meetings, demonstration 

projects, and new or updated guidances. 

These enhancements are described in 

section IV.C of the proposed PDUFA VII 

commitment letter. 

N. Enhancements to Fee Mechanisms 

for Increased Predictability, Stability, 

and Efficiency 

The PDUFA VII agreement continues 

to build on the resource capacity 

planning capability established in 

PDUFA VI and continues financial 

transparency initiatives. In addition, 

PDUFA VII enhances mechanism to 

manage financial risks by establishing a 

minimum amount of available operating 

reserves to be maintained each year. 

This minimum amount will start at an 

amount equivalent to 8 weeks of 

operations and increase to 10 weeks of 

operations by FY 2025. PDUFA VII also 

adds a strategic hiring and retention 

adjustment to ensure FDA has the 

funding necessary to provide for the 

costs of retaining and hiring highly 

qualified scientific and technical staff 

for the process for the review of human 

drug applications under PDUFA. This 

strategic hiring and retention 

adjustment will add $9 million to the 

base revenue amount in FY 2023 and $4 

million in each subsequent year. 

O. Impact of PDUFA VII Enhancements 

on User Fee Revenue 

To implement the proposed 

enhancements for PDUFA VII, funding 

for a cumulative total of 352 full-time 

equivalent staff is proposed to be 

phased in over the course of PDUFA VII. 

The new funding will be phased in as 

follows: 

• $65,773,693 for FY 2023 

• $25,097,671 for FY 2024 

• $14,154,169 for FY 2025 

• $4,864,860 for FY 2026 

• $1,314,620 for FY 2027 

In addition, to support the other 

additional direct costs associated with 

PDUFA VII enhancements, the 

following amounts will be added: 

• $44,386,150 for FY 2023 

• $60,967,993 for FY 2024 

• $35,799,314 for FY 2025 

• $35,799,314 for FY 2026 

• $35,799,314 for FY 2027 

IV. Public Meeting Information 

A. Purpose and Scope of the Meeting 

The meeting will include a 

presentation by FDA and a series of 

panels with FDA and Industry 

representatives to present and discuss 

the agreed-upon proposed 

enhancements. For members of the 

public who would like to make verbal 

comments on the proposed 

enhancements (see instructions below), 

there will be a public comment period 

at the end of the meeting. We will also 

provide an opportunity for individuals 

to submit written comments to the 

docket before and after the meeting. 

B. Participating in the Public Meeting 

Registration: Registration is optional 

and not required to attend this virtual 

public meeting. However, registering 

will allow FDA to provide you with 

email updates if any meeting details 

change. If you wish to register, you can 

do so at https://pdufaviireauthorization.eventbrite.com. 

Opportunity for Verbal Public 

Comment: Those who register online 

will receive a confirmation email that 

includes a link to a request form to 

make a verbal public comment at the 

meeting. If you wish to speak during the 

public comment session, follow the 

instructions in that email and identify 

which topic(s) you wish to address. We 

will do our best to accommodate 

requests to make public comments. 

Individuals and organizations with 

common interests are urged to 

consolidate or coordinate their 

comments and request time jointly. All 

requests to make a public comment 

during the meeting must be received by 

September 14, 2021, 11:59 p.m. Eastern 

Time. Depending on the number of 

requests, we will determine the amount 

of time allotted to each commenter, the 

approximate time each comment is to 

begin, and will select and notify 

participants by September 21, 2021. No 

commercial or promotional material 

will be permitted to be presented at the 

public meeting. 

Streaming Webcast of the Public 

Meeting: The Zoom Webinar ID for this 

public meeting is 161 932 6064. The 

webcast link for this public meeting can 

be found here: https://

fda.zoomgov.com/j/1619326064?pwd=

WWZhZXhYRDNoYmg0W

FRvSVgvdE5BUT09. 

The link above should allow you to 

enter the webinar directly. If Zoom asks 

for a passcode, please use the casesensitive passcode below. 

Case-Sensitive Passcode for Zoom 

Webinar: PDUFa7! 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 


lotter on DSK11XQN23PROD with NOTICES1
47322 Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices 

transcript will also be available on the 

internet at https://www.fda.gov/ 

industry/prescription-drug-user-feeamendments/pdufa-vii-fiscal-years2023-2027. 

Dated: August 18, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18094 Filed 8–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Black Lung Clinics Program 

Performance Measures, OMB No. 

0915–0292—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with of the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30 day 

comment period for this Notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than September 23, 

2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Black Lung Clinics Program 

Performance Measures OMB No. 0915– 

0292 Revision. 

Abstract: HRSA’s Federal Office of 

Rural Health Policy conducts an annual 

data collection of user information for 

the Black Lung Clinics Program (BLCP), 

which has been ongoing with OMB 

approval since 2004. The BLCP is 

authorized by Sec. 427(a) of the Federal 

Mine Safety and Health Act of 1977, as 

amended (30 U.S.C. 937), and 

accompanying regulations at 42 CFR 

part 55a, to reduce the morbidity and 

mortality associated with 

occupationally-related coal mine dust 

lung disease through the screening, 

diagnosis, and treatment of active, 

inactive, retired, and/or disabled coal 

miners. Collecting this data provides 

HRSA with information on how well 

each grantee is meeting the needs of 

these miners in their communities. 

Need and Proposed Use of the 

Information: Data from the annual 

performance measures report provides 

quantitative information about the 

clinics, specifically: (a) The 

characteristics of the patients they serve 

(age, diagnoses, occupation type); (b) the 

characteristics of services provided 

(clinical services and benefits 

counseling); and (c) the number of 

patients served. This assessment enables 

HRSA to provide data required by 

Congress under the Government 

Performance and Results Act of 1993. It 

also ensures that funds are effectively 

used to provide services that meet the 

target population needs. 

The proposed changes of the BLCP 

measures are a result of the 

accumulation of grantee and stakeholder 

feedback, and information gathered 

from the previously approved BLCP 

measures. The proposed changes 

include revisions of current measures 

for better usability and additional 

questions about screening program 

participation, smoking, pulmonary 

function testing, referral for services, 

and COVID–19 vaccination. 

Likely Respondents: Respondents will 

likely be award recipients of the Black 

Lung Clinics Program. 

A 60-day Federal Register Notice was 

published in the Federal Register on 

May 13, 2021, vol. 86, No. 91, pp. 

26225–26226. There were no public 

comments. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Black Lung Clinics Program Measures ............................... 15 1 15 10 150 

Total .............................................................................. 15 ........................ 15 ........................ 150 

HRSA specifically requests comments 

on: (1) The necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 


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