Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments, 34736-34739 [2020-12317]
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Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Notices
Public: Business or other for-profit, Notfor-profit institutions, and Federal
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996,042; Total Annual Responses:
996,042; Total Annual Hours: 169,327.
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Dated: June 2, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–12285 Filed 6–5–20; 8:45 am]
BILLING CODE 4120–01–P
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.
Notice of public meeting;
request for comments.
ACTION:
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://pdufaviipublicmeeting.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
SUMMARY:
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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.
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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
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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-201509-18/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, Patrick.Zhou@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a virtual public
meeting to begin the reauthorization
process of PDUFA, the legislation that
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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.
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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
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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/regulatoryinformation/search-fda-guidancedocuments/good-review-managementprinciples-and-practices-new-drugapplications-and-biologics-license, was
published.1 Initiatives to improve
application submission and Agencysponsor 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
1 When finalized this will represent FDA’s
current thinking on this issue.
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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,
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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 5year 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.
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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
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34739
focus on process enhancements and
funding issues, and not focus on policy
issues.
Dated: June 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
B. Participating in the Public Meeting
[FR Doc. 2020–12317 Filed 6–5–20; 8:45 am]
Registration: Persons interested in
attending this virtual public meeting
should register online by 11:59 p.m.
Eastern Time on June 23, 2020, at https://
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.
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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; Information
Collection Request Title: Maternal
Health Portfolio Evaluation Design,
OMB No. 0906–xxxx—NEW
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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 August 7, 2020.
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
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Maternal Health Portfolio Evaluation
Design OMB No. 0906–xxxx—NEW.
Abstract: HRSA programs provide
health care to people who are
geographically isolated, economically,
or medically vulnerable. HRSA
programs help those in need of high
quality primary health care, such as
pregnant women and mothers.
Improving maternal health outcomes
and access to quality maternity care
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Notices]
[Pages 34736-34739]
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 34737]]
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 34738]]
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 34739]]
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 https://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
