[Federal Register Volume 86, Number 207 (Friday, October 29, 2021)]
[Notices]
[Pages 60049-60053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23499]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1459]


Generic Drug User Fee Amendments; 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) is announcing a virtual 
public meeting to discuss proposed recommendations for the 
reauthorization of the Generic Drug User Fee Amendments (GDUFA) for 
fiscal years (FYs) 2023 through 2027. GDUFA amended the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) to authorize FDA to assess and 
collect fees to support human generic drug activities. The current 
legislative authority for GDUFA expires at the end of September 2022. 
At that time, new legislation will be required for FDA to continue to 
assess and collect generic drug user fees for future fiscal years. The 
FD&C Act directs FDA, following negotiations with the regulated 
industry and periodic consultations with other stakeholders, to present 
recommendations for reauthorization of the GDUFA program to the 
relevant Congressional committees, publish the recommendations in the 
Federal Register, provide for a period of 30 days for the public to 
provide written comments on such recommendations, and hold a meeting at 
which the public may present its views on such recommendations. FDA 
will then consider such public views and comments and revise such 
recommendations as necessary.

DATES: The public meeting will be held on November 16, 2021, from 9 
a.m. to 2 p.m. Eastern Time and will be held virtually. Submit either 
electronic or written comments on this public meeting by December 12, 
2021. See the SUPPLEMENTARY INFORMATION section for registration date 
and information.

[[Page 60050]]


ADDRESSES: Registration to attend the virtual meeting and other 
information can be found at https://www.eventbrite.com/o/fda-34063199905. 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 December 12, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 12, 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-2020-N-1459 for ``Generic Drug User Fee Amendments; 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, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 3334, Silver Spring, MD 20993, 240-402-8926, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a virtual public meeting to discuss proposed 
recommendations for the reauthorization of GDUFA, which authorizes FDA 
to assess and collect user fees to support human generic drug 
activities, which are defined under the FD&C Act \1\ to include the 
activities necessary for the review (also called ``assessment'') of 
generic human drug applications and Type II active pharmaceutical 
ingredient (API) drug master files (DMFs),\2\ and for conducting 
inspections related to generic drugs, and to engage in other related 
activities. The current authorization of the program (GDUFA II) expires 
at the end of September 2022. Without new legislation, FDA will no 
longer be able to assess and collect user fees to help fund human 
generic drug activities for future fiscal years.
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    \1\ See section 744A(9) of the FD&C Act (21 U.S.C. 379j-41(9)).
    \2\ Type II active pharmaceutical ingredient drug master file 
means a submission of information to the Secretary by a person that 
intends to authorize FDA to reference the information to support 
approval of a generic drug submission without the submitter having 
to disclose the information to the generic drug submission 
applicant. Section 744A(13) of the FD&C Act.
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    Section 744C(f)(4) of the FD&C Act (21 U.S.C. 379j-43(f)(4)) 
requires that after FDA negotiates with the regulated industry,\3\ we 
do the following: (1) Present recommendations for reauthorization of 
the GDUFA program to the relevant Congressional committees, (2) publish 
such recommendations in the Federal Register, (3) provide for a period 
of 30 days for the public to provide written comments on such 
recommendations, (4) hold a meeting at which the public may present its 
views on such recommendations, and (5) after consideration of such 
public views and comments, revise such recommendations as necessary.
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    \3\ Section 744C(f)(3) of the FD&C Act requires periodic 
consultation with representatives of patient and consumer advocacy 
groups during negotiations with the generic drug industry.
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    This notice, the 30-day comment period, and the public meeting 
described in this notice will satisfy certain of these statutory 
requirements. After the public meeting, we will revise the 
recommendations as necessary and present the proposed recommendations

[[Page 60051]]

to the appropriate Congressional committees.
    The purpose of the public meeting announced in this Federal 
Register notice is to obtain the public's views on the proposed 
recommendations for the reauthorized program (GDUFA III). The following 
information is provided to help potential meeting participants better 
understand the history and evolution of the GDUFA program and the 
proposed GDUFA III recommendations.

II. What is GDUFA and what does it do?

    GDUFA amended the FD&C Act to authorize FDA to assess and collect 
fees from drug companies that submit marketing applications for human 
generic drug applications, as well as from certain DMFs holders and 
from manufacturing facilities referenced in generic drug applications. 
GDUFA was originally enacted in 2012 as part of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144) and was 
authorized for a period of 5 years.
    In 2017, the GDUFA user fee program was reauthorized under the FDA 
Reauthorization Act of 2017 (Pub. L. 115-52, Title III), for FYs 2018 
through 2022 (GDUFA II). GDUFA II was designed to finance critical and 
measurable generic drug program enhancements intended to help speed 
public access to safe, effective, and high-quality generic drugs. As 
described in the GDUFA II Commitment Letter, FDA committed to achieve 
certain performance goals, provide enhanced communication intended to 
streamline abbreviated new drug application (ANDA) development and 
assessment, and take other steps to increase the efficiency of the 
assessment process. GDUFA II's Commitment Letter also established a 
pre-ANDA program to make transparent FDA's regulatory expectations for 
complex generic product developers early in product development and 
during application assessment.
    Additional information concerning GDUFA, including the text of the 
law, the GDUFA II Commitment Letter, key Federal Register documents, 
and GDUFA-related guidances, performance reports, and financial reports 
may be found on the FDA website at https://www.fda.gov/gdufa.

III. Proposed GDUFA III Recommendations

    In preparing the proposed recommendations to Congress for GDUFA 
reauthorization for GDUFA III, FDA conducted discussions with the 
regulated industry and consulted with patient and consumer advocacy 
groups, as required by the law, among other stakeholders. FDA began the 
GDUFA reauthorization process by publishing a notice in the Federal 
Register requesting public input on the reauthorization and announcing 
a public meeting, which was held on July 21, 2020 (85 FR 38378, June 
26, 2020). The meeting included presentations by FDA and different 
stakeholder groups, including patient and consumer advocacy groups, 
regulated industry, health professionals, and academic researchers. The 
materials from the meeting, including the agenda, presentations, and 
transcript can be found at https://www.fda.gov/drugs/public-meeting-reauthorization-generic-drug-user-fee-amendments-gdufa-07212020-07212020. The stakeholders were asked to respond to the following 
questions:
     What is your assessment of the overall performance of the 
GDUFA program to date?
     What aspects of GDUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?
     What new features should FDA consider adding to the 
program to enhance efficiency and effectiveness of the generic drug 
review process?
    Following the July 2020 public meeting, FDA conducted negotiations 
with the regulated industry and continued monthly consultations with 
other stakeholders from September 2020 through August 2021. As directed 
by Congress, FDA posted minutes of these meetings on its website: 
https://www.fda.gov/drugs/development-approval-process-drugs/gdufa-iii. 
The proposed enhancements for GDUFA III address many of the top 
priorities identified by FDA, the regulated industry, and other 
stakeholders. These include proposed program enhancements to advance 
approvals in fewer review cycles, proposals to enhance regulatory 
science and expedite complex generic drug development, and financial 
proposals to support the generic drug program as it evolves. The full 
descriptions of these proposed recommendations can be found in the 
proposed GDUFA III Commitment Letter (Proposed Commitment Letter), 
which will be posted prior to the public meeting on FDA's website at 
www.fda.gov/gdufa.
    The enhancements are described below with references to the section 
of the Proposed Commitment Letter where more detailed information can 
be found.

A. Advancing Approvals

    The enhancements made in GDUFA II were successful in increasing the 
number of generic drug approvals throughout its implementation. The 
proposed GDUFA III commitments are intended to build on this success to 
reduce the number of review cycles needed for approval by maximizing 
the value of each cycle and increasing the number of first-cycle 
approvals.
    ANDA Assessment Efficiencies--FDA proposes several changes to the 
assessment process to increase communication and efficiency. For 
example, FDA proposes to work with industry to resolve minor issues 
during the review cycle, even when this may require goal date 
extensions, and to minimize complete response letters (CRLs) in which 
the only deficiency is labeling. In addition, FDA proposes to expand 
opportunities for timely regulatory advice through the expansion of the 
definition of controlled correspondence used in the Commitment Letter 
and, for certain applications, the opportunity for a post-CRL 
scientific meeting. FDA also proposes to utilize ``imminent actions'' 
when it may be possible to approve an application within 60 days after 
the goal date in certain circumstances. More examples can be found in 
the Proposed Commitment Letter, section II.
    Drug Master Files (DMFs)--FDA proposes several enhancements related 
to the review of DMFs, including the opportunity for holders of certain 
DMFs to submit a request for assessment of the DMF 6 months prior to 
the planned submission date for certain original ANDAs, amendments 
containing a response to a CRL, and amendments seeking approval of an 
ANDA that previously received a tentative approval. In addition, FDA 
proposes to implement procedures to enhance the efficiency of the 
review of DMF amendments related to original ANDAs and prior approval 
supplements. Details of these enhancements can be found in the Proposed 
Commitment Letter, section VI.
    Pre-Submission Facility Correspondence (PFC)--The PFC process was 
established for GDUFA II to reduce the review goal date to 8 months for 
ANDA submissions that qualify for priority review per MAPP 5240.3, 
Prioritization of the Review of Original ANDAs, Amendments, and 
Supplements.\4\ For GDUFA III, FDA proposes to refine the description 
of the manufacturing information to be submitted in a PFC to focus on 
the

[[Page 60052]]

information that is needed to inform FDA's decision regarding the need 
for a preapproval inspection. In addition, FDA proposes to reduce the 
information regarding bioequivalence and clinical studies needed in a 
PFC to focus on the key information needed by FDA to determine the need 
for a preapproval inspection and to better align with the timing of 
development programs. Details of the PFC enhancements can be found in 
the Proposed Commitment Letter, section II.F.
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    \4\ Available at: https://www.fda.gov/media/89061/download.
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    Facility Assessments--Although GDUFA II has generally been 
successful, facility assessments continue to be an area of opportunity 
for program improvement. For example, FDA recognizes that a 
manufacturing facility's violative compliance status may be resolved 
between the issuance of a CRL that included facility inspection-related 
deficiencies and the time of the applicant's CRL response. Where the 
resolution of the compliance status also resolves the facility-related 
deficiencies identified in a CRL, FDA proposes that applicants have the 
opportunity to request reclassification of facility-based Major CRL 
amendments to Minor amendments, thereby expediting the assessment of 
the submitted amendment. Details of the reclassification enhancement 
can be found in the Proposed Commitment Letter, section II.C.7.
    To help resolve facility inspection deficiencies, FDA proposes to 
establish Post-Warning-Letter Meetings for eligible facilities to 
obtain preliminary feedback from FDA on the adequacy and completeness 
of the facility's corrective action plans. FDA further proposes to 
improve clarity regarding the generic drug manufacturing facility 
reinspection process with goal dates and metrics. Details of these 
facility enhancements and more can be found in the Proposed Commitment 
Letter, section VII.

B. Pre-ANDA Program

    The goals of the pre-ANDA program are to establish transparent 
regulatory expectations for prospective applicants early in product 
development, assist applicants in developing complete submissions, 
promote a more efficient and effective ANDA assessment process, and 
reduce the number of assessment cycles required to obtain ANDA 
approval. The pre-ANDA program has been especially useful and 
successful in fulfilling these goals for complex generic products, and 
the proposals for GDUFA III are intended to expand on this success. 
Full details of the pre-ANDA program can be found in the Proposed 
Commitment Letter, section III.
    Suitability Petitions--FDA proposes to work to enhance the Agency's 
processes for the review of new and pending suitability petitions. 
Under the proposal, beginning in FY 2024, suitability petitions would 
be assigned goal dates and prioritized based on parameters, such as 
public health emergency, mitigating possible pharmaceutical waste, or 
for products under the President's Emergency Plan for AIDS Relief. 
Details of the proposed suitability petition enhancements can be found 
in the Proposed Commitment Letter, section III.B.
    Product-Specific Guidance (PSG)--Under GDUFA II, FDA established 
goals around PSGs for new chemical entities in order to facilitate 
generic competition. In GDUFA III, FDA proposes new goals around PSGs 
for complex products to further aid in the development of generic 
versions of complex drug products. FDA proposes to provide on its 
website information related to upcoming new and revised PSGs. FDA would 
make the prioritization of PSG development publicly available and allow 
for industry and public input on prioritization.
    In addition, recognizing that regulatory science continually 
evolves, FDA proposes that qualified ANDA applicants or potential 
applicants may request a PSG Teleconference to obtain Agency feedback 
on the potential impact of new recommendation(s) on ongoing 
bioequivalence studies. Details of the proposed PSG program 
enhancements can be found in the Proposed Commitment Letter, section 
III.C.

C. ANDA Assessment Meeting Program

    The goal of the ANDA Assessment Meeting Program is to provide 
targeted, robust advice to ANDA applicants as they work to meet the 
requirements for ANDA approval. FDA proposes two significant 
enhancements starting with the Enhanced Mid-Cycle Review Meeting, which 
would allow applicants to inquire about new data or information to 
address any possible deficiencies identified in a Discipline Review 
Letter. FDA also proposes the addition of a post-CRL Scientific Meeting 
in which the Agency may provide a qualified applicant scientific advice 
on possible alternative approaches to address deficiencies identified 
in a CRL related to establishing sameness. Details on the proposed ANDA 
Assessment Meeting Program enhancements can be found in the Proposed 
Commitment Letter, section IV.

D. Continued Enhancement of User Fee Resource Management

    FDA is committed to ensuring the sustainability of GDUFA program 
resources and to enhancing the operational agility of the GDUFA program 
through maturation of the Resource Capacity Planning (RCP) capability 
and the proposed implementation of a Capacity Planning Adjustment 
(CPA). The CPA would allow for increases in inflation-adjusted target 
revenue for the upcoming fiscal year as a result of expected workload 
increases for certain human generic drug activities. Specifically, FDA 
proposes an amendment to the statute to add authority for the 
implementation of a CPA, which also would bring the GDUFA program in 
alignment in this respect with the Prescription Drug User Fee Act 
(PDUFA) and Biosimilar User Fee Amendments (BSUFA) programs. Under the 
proposed agreement, the CPA would be implemented starting in fiscal 
year 2024 and would include certain limits on its authorized increases. 
Continued maturation of RCP would include areas such as (1) continual 
improvement of time reporting to support enhanced management of GDUFA 
resources and (2) the integration of RCP analyses in the Agency's 
resource and operational decision-making processes.
    In addition, new statutory language is proposed for GDUFA III to 
provide a mechanism to manage financial risks by authorizing a minimum 
amount of available operating reserves to be maintained each year. As 
proposed for GDUFA III, the amount of operating reserves that can be 
added through additional fees would be no more than 8 weeks of 
operations in FY 2024, increasing to a maximum of 10 weeks of 
operations by FY 2026. In addition, if operating reserves are estimated 
to exceed 12 weeks, there would be a reduction in fees to maintain the 
operating reserve at no more than 12 weeks.
    FDA and industry also proposed the following changes to the 
allocation of total fee revenues among fee categories: (1) The 
proportion of fee revenues derived from API facility fees would 
decrease from 7 percent in GDUFA II to 6 percent in GDUFA III; (2) the 
fee revenues derived from generic drug facility fees (also referred to 
as finished dosage form or FDF fees) would remain at 20 percent, but 
the fee for contract manufacturing organizations would decrease from 
one-third of the annual FDF fee in GDUFA II to 24 percent of the annual 
FDF fee in GDUFA III; and (3) the proportion of fee revenues

[[Page 60053]]

derived from the generic drug applicant program fee would increase from 
35 percent in GDUFA II to 36 percent in GDUFA III.

E. Impact of GDUFA III Enhancements on User Fee Revenue

    To implement the proposed enhancements for GDUFA III, funding for a 
total of 128 new full-time equivalent staff is proposed for FY 2023.

IV. Public Meeting Information

A. Purpose and Scope of the Meeting

    The meeting will include presentations by FDA and panels 
representing different stakeholder groups identified in the statute 
(such as patient and consumer advocacy groups and regulated industry). 
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 to attend this virtual 
meeting. However, registering will allow FDA to provide you with email 
updates if any meeting details change. Persons interested in 
registering for this public meeting must register online by 11:59 p.m. 
Eastern Time on November 15, 2021, at https://www.eventbrite.com/o/fda-34063199905. Please provide complete contact information for each 
attendee, including name, title, affiliation, address, email, and 
telephone.
    Opportunity for Public Comment: If you wish to present during the 
public comment session, please submit your request to 
[email protected] by 11:59 p.m. Eastern Time on November 8, 
2021. Your email should contain which topic(s) you wish to address and 
include complete contact information, including name, title, 
affiliation, address, and email 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 presentations, and request time for a joint 
presentation. Following the close of registration, we will determine 
the amount of time allotted to each presenter and the approximate time 
each oral presentation is to begin, and will select and notify 
participants by November 9, 2021. If selected for presentation, any 
presentation materials must be emailed to [email protected] 
no later than November 11, 2021. No commercial or promotional material 
will be permitted to be presented or distributed during the virtual 
public meeting.
    Streaming Webcast of the Public Meeting: The Zoom Webinar ID for 
this public meeting is 160 003 0426. The webcast link for this public 
meeting, which should allow you to enter the webinar directly, can be 
found here: https://fda.zoomgov.com/j/1600030426?pwd=YThMd0sweXNQOVNOdVpYZHMrdVFSUT09. If Zoom asks for a 
passcode, please use the following case-sensitive passcode: GDUFa3!
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments and in this docket 
at https://www.regulations.gov. It may also be viewed at the Dockets 
Management Staff (see ADDRESSES).

    Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23499 Filed 10-28-21; 8:45 am]
BILLING CODE 4164-01-P


