[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Notices]
[Pages 35096-35099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12317]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0128]


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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is hosting a 
virtual public meeting 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. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that 
FDA begin the PDUFA reauthorization process by publishing a notice in 
the Federal Register requesting public input and holding a public 
meeting where the public may present its views on the reauthorization. 
FDA invites public comment as the Agency begins the process to 
reauthorize the program in FYs 2023 through 2027. These comments will 
be published and available on FDA's website.

DATES: The public meeting will be held on July 23, 2020, from 9 a.m. to 
2 p.m., and will take place virtually and will be held by webcast only. 
Submit either electronic or written comments on this public meeting by 
August 23, 2020.

ADDRESSES: Registration to attend the meeting and other information can 
be found at https://pdufavii-publicmeeting.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 August 23, 2020. The

[[Page 35097]]

https://www.regulations.gov electronic filing system will accept 
comments until 11:59 p.m. Eastern Time at the end of August 23, 2020. 
Comments received by mail/hand delivery/courier (for written/paper 
submissions) will be considered timely if they are postmarked or the 
delivery service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0128 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 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500. Transcripts of the meeting 
will be available on the FDA website at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee 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, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a virtual public meeting to begin the 
reauthorization process of PDUFA, the legislation that authorizes FDA 
to collect user fees to support the process for the review of human 
drugs, including various components in FDA including the Center for 
Drug Evaluation and Research (CDER), the Center for Biologics 
Evaluation and Research (CBER), the Office of the Commissioner (OC), 
and the Office of Regulatory Affairs (ORA). 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 human drug review process. Section 736B(f)(2) 
of the FD&C Act (21 U.S.C. 379h-2(f)(2)) requires that before FDA 
begins negotiations with the regulated industry on PDUFA 
reauthorization, the Agency performs the following: (1) Publish a 
notice in the Federal Register requesting public input on the 
reauthorization; (2) hold a public meeting where the public may present 
its views on the reauthorization; (3) provide a period of 30 days after 
the public meeting to obtain written comments from the public; and (4) 
publish the comments at https://www.fda.gov. This notice, the public 
meeting, the 30-day comment period after the meeting, and the posting 
of the comments on the FDA website will satisfy these requirements. The 
purpose of the meeting is to hear stakeholder views on PDUFA as we 
consider the features to propose, update, and discontinue in the next 
PDUFA. FDA is interested in responses to the following three questions 
and welcomes any other pertinent information stakeholders would like to 
share:
     What is your assessment of the overall performance of 
PDUFA VI thus far?
     What current features of PDUFA should be reduced or 
discontinued to ensure the continued efficiency and effectiveness of 
the human drug review process?
     What new features should FDA consider adding to the 
program to enhance the efficiency and effectiveness of the human drug 
review process?

II. What is PDUFA? 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. The Prescription Drug User Fee Act (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.

[[Page 35098]]

    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 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 again 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 
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. In September 2018 the 
draft guidance, ``Good Review Management Principles and Practices for 
New Drug Applications and Biologics License Applications'' (GRMPs), 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-review-management-principles-and-practices-new-drug-applications-and-biologics-license, was published.\1\ Initiatives 
to improve application submission and Agency-sponsor interactions 
during the drug development and application review processes were also 
adopted.
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    \1\ When finalized this will represent FDA's current thinking on 
this issue.
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    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 the FDA 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 addition to continued commitment to a significant set of review, 
processing, and procedural goals, PDUFA V also included commitments 
related to enhancing regulatory science and expediting drug 
development, enhancing benefit-risk assessment in regulatory decision-
making, modernizing the FDA drug safety system, and improving the 
efficiency of human drug review by requiring electronic submissions and 
standardization of electronic drug application data.
    In August 2017, FDARA was enacted, which renewed the prescription 
drug user fee program for a sixth 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,

[[Page 35099]]

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 iteration includes 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. A list of the deliverables 
developed to meet PDUFA VI commitments is available on the FDA web page 
at: https://www.fda.gov/industry/prescription-drug-user-fee-amendments/completed-pdufa-vi-deliverables.

III. Public Meeting Information

A. Purpose and Scope of the Meeting

    In general, the meeting format will include presentations by FDA 
and a series of panels representing different stakeholder groups. We 
will also provide an opportunity for other stakeholders to provide 
public comment at the meeting. FDA policy issues are beyond the scope 
of these reauthorization discussions. Accordingly, the presentations 
should focus on process enhancements and funding issues, and not focus 
on policy issues.

B. Participating in the Public Meeting

    Registration: Persons interested in attending this virtual public 
meeting should register online by 11:59 p.m. Eastern Time on June 23, 
2020, at http://pdufavii-publicmeeting.eventbrite.com. Please provide 
complete contact information for each attendee, including name, title, 
affiliation, email, and telephone.
    Opportunity for Public Comment: Those who register online by June 
23, 2020, will receive a notification about an opportunity to 
participate in the public comment session of the meeting. If you wish 
to speak during the public comment session, follow the instructions in 
the notification 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 July 9, 2020, 11:59 p.m. Eastern Time. 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 July 16, 2020. 
No commercial or promotional material will be permitted to be presented 
at the public meeting.
    Streaming Webcast of the Public Meeting: The webcast for this 
public meeting is available at https://collaboration.fda.gov/pdufajuly2020/.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: 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 transcript will also be available on the 
internet at https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments.

    Dated: June 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-12317 Filed 6-5-20; 8:45 am]
BILLING CODE 4164-01-P