Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
| Published date | 22 September 2021 |
| Citation | 86 FR 52685 |
| Record Number | 2021-20432 |
| Section | Notices |
| Court | Food And Drug Administration |
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Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices
4027, Attn: August 30, 2021 ACIP
Meeting.
Instructions: All submissions received
must include the Agency name and
Docket Number. All relevant comments
received in conformance with the
https://www.regulations.gov suitability
policy will be posted without change to
https://www.regulations.gov, including
any personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
In accordance with 41 CFR 102–
3.150(b), less than 15 calendar days’
notice is being given for this meeting
due to the exceptional circumstances of
the COVID–19 pandemic and rapidly
evolving COVID–19 vaccine
development and regulatory processes.
The Secretary of Health and Human
Services has determined that COVID–19
is a Public Health Emergency.
FOR FURTHER INFORMATION CONTACT
:
Stephanie Thomas, ACIP Committee
Management Specialist, Centers for
Disease Control and Prevention,
National Center for Immunization and
Respiratory Diseases, 1600 Clifton Road
NE, MS–H24–8, Atlanta, GA 30329–
4027; Telephone: 404–639–8367; Email:
ACIP@cdc.gov.
Public Participation
Written Public Comment: The docket
will close on August 30, 2021. Written
comments must be received on or before
August 30, 2021.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–20478 Filed 9–21–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0921]
B. Braun Medical, Inc.; Withdrawal of
Approval of Abbreviated New Drug
Application of Hydroxyethyl Starch
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of abbreviated
new drug application (ANDA)
BA110013/0032 for 6 Percent
Hydroxyethyl Starch 130/0.4 in 0.9
Percent Sodium Chloride Injection in
EXCEL
®
Plastic Container, held by B.
Braun Medical, Inc. B. Braun Medical,
Inc., requested in writing that the
Agency’s approval of the application be
withdrawn because the drug is no
longer being marketed and has waived
its opportunity for a hearing.
DATES
: Approval is withdrawn as of
October 22, 2021.
FOR FURTHER INFORMATION CONTACT
:
Myrna Hanna, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240
402–7911.
SUPPLEMENTARY INFORMATION
: B. Braun
Medical Inc., 901 Marcon Blvd.,
Allentown, PA 18109, has requested
that FDA withdraw approval of ANDA
BA110013/0032, pursuant to
§ 314.150(c) (21 CFR 314.150(c)),
because the drug is no longer being
marketed. By its request, B. Braun
Medical Inc. has also waived its
opportunity for a hearing. Withdrawal
of approval of an application under
§ 314.150(c) is without prejudice to
refiling.
Application No. Proprietary name
ANDA BA 110013/0032 ..... 6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection in EXCEL
®
Plastic Container.
Therefore, approval of the application
listed in the table, and all amendments
and supplements thereto, is hereby
withdrawn as of October 22, 2021.
Introduction or delivery for introduction
into interstate commerce for products
without an approved new drug
application or ANDA violates section
301(a) and (d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331(a) and
(d)). The drug product that is listed in
the table above that is in inventory on
October 22, 2021 may continue to be
dispensed until the inventory has been
depleted or the drug product has
reached its expiration date or otherwise
becomes violative, whichever occurs
first.
Dated: September 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–20511 Filed 9–21–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3326]
Reauthorization of the Biosimilar User
Fee Act; Public Meeting; Request for
Comments
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice of public meeting;
request for comments.
SUMMARY
: The Food and Drug
Administration (FDA or Agency) is
hosting a virtual public meeting to
discuss proposed recommendations for
the reauthorization of the Biosimilar
User Fee Act (BsUFA) for fiscal years
(FYs) 2023 through 2027. The BsUFA
authorizes FDA to collect user fees to
support the process for the review of
biosimilar biological product
applications. The current legislative
authority for BsUFA expires in
September 2022. At that time, new
legislation will be required for FDA to
continue collecting user fees in future
fiscal years. Following discussions with
the regulated industry and consultations
with public stakeholders, the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) directs FDA to publish the
recommendations for the reauthorized
program in the Federal Register, hold a
meeting at which the public may
present its views on such
recommendations, and provide for a
period of 30 days for the public to
provide written comments on such
recommendations. FDA will then
consider such public views and
comments and revise such
recommendations, as necessary.
DATES
: The public meeting will be held
on November 2, 2021, from 9 a.m. to 12
p.m. Eastern Time, and will be held by
webcast only. Submit either electronic
or written comments on this public
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meeting by December 2, 2021. See
SUPPLEMENTARY INFORMATION
for
registration date and information.
ADDRESSES
: Registration to attend the
meeting and other information can be
found at https://bsufaiii-
finalpublicmeeting.eventbrite.com.
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 2, 2021. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of December 2, 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–
2015–N–3326 for ‘‘Reauthorization of
the Biosimilar 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, 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
:
Emily Ewing, Center for Drug
Evaluation and Research, Food and
Drug Administration, 240–402–0196,
Emily.Ewing@fda.hhs.gov.
SUPPLEMENTARY INFORMATION
:
I. Introduction
FDA is announcing a virtual public
meeting to discuss proposed
recommendations for the
reauthorization of BsUFA, the
legislation that authorizes FDA to
collect user fees to support the process
for the review of biosimilar biological
product applications. The current
authorization of the program (BsUFA II)
expires in September 2022. Without
new legislation, FDA will no longer be
able to collect user fees for future FYs
to fund the process for the review of
biosimilar biological product
applications. Section 744I(f)(2) of the
FD&C Act (21 U.S.C. 379j–53(f)(2))
requires the Agency perform the
following actions after holding
negotiations with regulated industry
members: (1) Present recommendations
to the relevant Congressional
committees; (2) publish
recommendations in the Federal
Register, (3) provide a period of 30 days
for the public to provide written
comments on the recommendations; (4)
hold a meeting at which the public may
present its views; and (5) after
consideration of public views and
comments, revise the recommendations
as necessary.
This notice, the 30-day comment
period, and the public meeting will
satisfy some of these requirements. After
the public meeting, we will revise the
recommendations as necessary and
present our proposed recommendations
to the Congressional committees.
The purpose of the meeting is to hear
the public’s views on the proposed
recommendations for the reauthorized
program (BsUFA III). The following
information is provided to help
potential meeting participants better
understand the history and evolution of
the BsUFA program and the status of the
proposed BsUFA III recommendations.
II. What is BsUFA and what does it do?
BsUFA is a law that authorizes FDA
to assess and collect fees from drug
companies that submit marketing
applications for certain biosimilar
biological products. BsUFA was
originally enacted in 2012 as the
Biosimilar User Fee Act under the Food
and Drug Administration Safety and
Innovation Act (FDASIA, Pub. L. 112–
144) for a period of 5 years. In 2017,
BsUFA was renewed for 5 more years
under the FDA Reauthorization Act of
2017 (FDARA, Pub. L. 115–52).
BsUFA is intended to provide
additional revenues so that FDA can
hire staff, improve systems, and
continue a well-managed biosimilar
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biological product review process to
make biosimilar biological product
therapies available to patients sooner
without compromising review quality or
FDA’s high standards for safety,
efficacy, and quality. As part of FDA’s
agreements with industry during prior
BsUFA authorizations, the Agency
agreed to certain performance and
procedural goals and other
commitments. These goals apply to the
process for the review of biosimilar
biological product applications,
including biosimilar biological product
development meetings, review of
applications and supplements, and
other review activities. FDA’s web page
‘‘Biosimilar User Fee Amendments’’
provides more information about
BsUFA, including the statutory text of
FDARA, the BsUFA commitment letter,
‘‘Biosimilar Authorization Performance
Goals and Procedures Fiscal Years 2013
through 2017’’ (BsUFA Commitment
Letter), key Federal Register documents,
BsUFA-related guidances, BsUFA user
fee rates, performance reports, and
financial reports. The Agency’s
‘‘Biosimilar User Fee Amendments’’
web page is available at https://
www.fda.gov/industry/fda-user-fee-
programs/biosimilar-user-fee-
amendments.
With the current authorization of
BsUFA II under FDARA, FDA
implemented a review program (‘‘the
Program’’) to promote the efficiency and
effectiveness of the first cycle review
process. The Program allows for
additional communication between the
FDA review team and applicants of
biosimilar biological products,
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. BsUFA II also
includes commitments to advance
development of biosimilar biological
products through further clarification of
the regulatory pathway that permits a
biosimilar biological product to be
licensed under section 351(k) of the
Public Health Service Act, and to
enhance capacity for biosimilar
guidance development, reviewer
training, and timely communication.
More information on these
commitments can be found in the
BsUFA II Commitment Letter at https://
www.fda.gov/media/100573/download.
As part of the current authorization,
FDA established an independent fee
structure and fee amounts to improve
program funding predictability,
stability, and administrative efficiency.
The new structure established a BsUFA
target revenue based on BsUFA program
costs and updated the overall fee
structure and related financial
mechanisms. 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, management of the
carryover balance, along with the
publication and annual update of a 5-
year financial plan.
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 BsUFA II commitments is
available on the FDA web page https://
www.fda.gov/industry/biosimilar-user-
fee-amendments/completed-bsufa-ii-
deliverables.
III. Proposed BsUFA III
Recommendations
In preparing the proposed
recommendations to Congress for
BsUFA reauthorization, FDA conducted
discussions with regulated industry
members, as required by the law. We
began the BsUFA reauthorization
process by publishing a notice in the
Federal Register requesting public input
on the reauthorization and announcing
a public meeting that was held on
November 19, 2020. The meeting
included presentations by FDA and a
series of panels with representatives of
different stakeholder groups, including
patient advocates, consumer groups,
regulated industry members, health
professionals, and academic researchers.
The materials from the meeting,
including a transcript and webcast
recording, can be found at https://
www.fda.gov/industry/biosimilar-user-
fee-amendments/public-meeting-
reauthorization-biosimilar-user-fee-act-
bsufa-11192020-11192020.
Following the November 2020 public
meeting, FDA conducted negotiations
with regulated industry from March
2021 through June 2021. As directed by
Congress, FDA posted minutes of these
meetings on its web page at https://
www.fda.gov/industry/biosimilar-user-
fee-amendments/bsufa-iii-fiscal-years-
2023-2027.
The proposed enhancements for
BsUFA III address many of the top
priorities identified by public
stakeholders, regulated industry, and
FDA. While some of the proposed
enhancements are new, many either
build on successful enhancements or
refine elements from the existing
program. The enhancements are
proposed in the following areas:
Supplemental applications, meeting
management, best practices in
communication between FDA and
sponsors, inspections and alternative
tools, interchangeable biosimilar
biological product development,
regulatory science, finance, hiring and
retention, and information technology.
The full text of the proposed BsUFA III
Commitment Letter can be found on the
Agency’s web page ‘‘BsUFA III: Fiscal
Years 2023—2027,’’ available at https://
www.fda.gov/industry/biosimilar-user-
fee-amendments/bsufa-iii-fiscal-years-
2023-2027. Each significant new or
modified enhancement is described
briefly below:
A. Original and Resubmitted
Supplemental Biosimilar Biological
Product Applications
To expedite the review of
supplemental biosimilar biological
product applications, FDA proposes to
establish new supplement categories,
timelines, and performance goals. New
review timelines range from 3 to 10
months, depending on the content and
category of the supplement submission.
Certain supplements for safety labeling
updates and labeling updates to add or
remove an indication that do not
contain efficacy data sets would have
shorter review timelines than
supplements in other categories. These
enhancements are described in section
I.A.2 of the proposed BsUFA III
Commitment Letter.
B. Meeting Management Goals
To improve overall meeting
management, FDA proposes to modify
the Biosimilar Initial Advisory (BIA)
meeting, create a new Type 2a meeting,
and modify the timing of Type 4
meeting background packages. FDA
would not require the submission of
preliminary comparative analytical data
for a BIA meeting. The new Type 2a
meeting would allow for quicker
discussion on a narrow set of issues
(e.g., often one but no more than two
issues) involving no more than three
review disciplines or divisions.
Traditional Type 2 meetings under
BsUFA II would be renamed to Type 2b
meetings in BsUFA III. Under this
proposal, the Type 4 meeting
background package may be submitted
up to 14 calendar days after FDA
receives the meeting request. There
would also be a new followup
opportunity to pose clarifying questions
after meetings or a written-response-
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only communication. These
enhancements are described in section
I.H of the proposed BsUFA III
Commitment Letter.
C. Promoting Best Practices in
Communication Between FDA and
Sponsors During Application Review
To enhance communication with
sponsors during biosimilar biologic
product application review, FDA
proposes to update relevant guidances,
our Manual of Policies and Procedures,
and our Standard Operating Procedures
and Policies regarding best practices in
communication. FDA would utilize
lessons learned from BsUFA II to update
the relevant documents, as appropriate.
The details of this enhancement are
found in section II.A of the proposed
BsUFA III Commitment Letter.
D. Enhancing Inspection
Communication and Alternative Tools
To facilitate the timely development
of biosimilar biological products and
their availability to patients, FDA
proposes to notify sponsors of certain
pre-license inspections and to issue
guidance on FDA’s thinking on the use
of alternative tools to assess
manufacturing facilities beyond the
COVID–19 pandemic. These
enhancements are described in section
II.B of the proposed BsUFA III
Commitment Letter.
E. Advancing Development of Biosimilar
Biological-Device Combination Products
Regulated by CDER and CBER
Sponsors employ Use-Related Risk
Analyses (URRA) studies to identify the
need for risk mitigation strategies and to
design a human factors (HF) validation
study. Based on a URRA, a sponsor may
propose that a HF validation study is
not needed to support the safe and
effective use of a biosimilar biologic-
device combination product. FDA
proposes establishing new procedures
for the review of URRAs along with
performance goals. Human factors
studies are conducted to evaluate the
user interface of a biosimilar biologic-
device combination product to
eliminate or mitigate use-related
hazards that may affect the safe and
effective use of the combination
product. Over the past decade, more
combination products have been
developed to deliver therapeutics via
different routes of administration (e.g.,
parenteral, inhalation) with complex
engineering designs. HF validation
protocols are reviewed during the
investigational new drug application
stage with the goal towards developing
a final finished combination product
that supports the marketing application.
To achieve this objective, FDA proposes
updating the procedures for HF
validation study protocols, along with a
new performance goal. These
enhancements are described in section
II.C of the proposed BsUFA III
Commitment Letter.
F. Advancing Development of
Interchangeable Biosimilar Biological
Products
FDA proposes a focused effort in
BsUFA III to further advance the
development of safe and effective
interchangeable biosimilar biological
products. This effort would address
current needs, prospectively identify
future needs, and incorporate the
following components: (1) Research
leveraging the BsUFA III Regulatory
Science Pilot Program; (2) foundational
guidance development; and (3)
stakeholder engagement involving a
scientific workshop on the development
of interchangeable biosimilar biological
products to help identify future needs.
Associated with this workshop, FDA
would issue draft and final strategy
documents outlining FDA’s actions to
facilitate the development of
interchangeable biosimilar biological
products. The details of this
enhancement are described in section
II.D of the proposed BsUFA III
Commitment Letter.
G. Regulatory Science
To enhance regulatory decision-
making and facilitate science-based
recommendations in areas foundational
to biosimilar biological product
development, FDA proposes to pilot a
regulatory science program broadly
applicable to biosimilar and
interchangeable biological product
development, with project goals not
specific to a product or product class.
The pilot program would focus on two
demonstration projects: (1) Advancing
the development of interchangeable
biosimilar biological products and (2)
improving the efficiency of biosimilar
biological product development. As part
of these demonstration projects, FDA
proposes to engage stakeholders in a
public meeting to review the progress of
the demonstration projects and to solicit
input of future priorities. An interim
report would be issued prior to the
public meeting, and a final summary
report of outcomes from the pilot
program would be posted on FDA’s
website. Within 12 months of
completing the demonstration projects,
FDA would publish a comprehensive
strategy document outlining actions
FDA will take to facilitate the
development of biosimilar and
interchangeable biological products.
These enhancements are described in
section II.E of the proposed BsUFA III
Commitment Letter.
H. Continued Enhancement of User Fee
Resource Management
FDA is committed to ensuring the
sustainability of BsUFA program
resources and to enhancing the
operational agility of the BsUFA
program. FDA proposes to build on the
financial enhancements included in
BsUFA II and continue activities in
BsUFA III to ensure optimal use of user
fee resources and the alignment of staff
to workload through the continued
maturation and assessment of the
Agency’s resource capacity planning
capability. This proposal would also
include an independent assessment of
the resource capacity planning
capability. FDA proposes to continue
activities to promote transparency of the
use of financial resources in support of
the BsUFA program through annual
public meetings, publishing a 5-year
financial plan along with annual
updates, and additional reporting in the
annual BsUFA Financial Report. These
enhancements are described in section
III of the proposed BsUFA III
Commitment Letter.
I. Information Technology
FDA proposes to establish and
progress a data and technology
modernization strategy that provides
FDA’s strategic direction for current and
future state data-driven regulatory
initiatives. Additionally, FDA would
advance the use of cloud-based
technology to modernize the Electronic
Submission Gateway to support greater
data submission bandwidth and storage
in the BsUFA program. These
enhancements are described in section
V of the proposed BsUFA III
Commitment Letter.
J. Enhancements to Fee Mechanisms for
Increased Predictability, Stability, and
Efficiency
The proposed BsUFA III agreement
continues to build on the resource
capacity planning capability established
in BsUFA II and continues financial
transparency initiatives. In addition, to
manage financial risks in the program,
BsUFA III proposes to enhance the
operating reserve adjustment
mechanism to provide for a defined
minimum and maximum required
amount of operating reserves. The
proposed minimum amount is
equivalent to 10 weeks of operating
reserves and the maximum amount is
equivalent to 21 weeks of available
operating reserves to be maintained
each year. The annual maximum
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amount of available operating reserves
would be phased in over the first 3 years
of BsUFA III (33 weeks in fiscal year
2023, 27 weeks in fiscal year 2024, and
21 weeks in fiscal year 2025). BsUFA III
also proposes to add a strategic hiring
and retention adjustment to ensure FDA
has the funding necessary to provide for
the costs of retaining and hiring highly
qualified scientific and technical staff
for the process for the review of
biosimilar biological product
applications under BsUFA. This
strategic hiring and retention
adjustment would add $150,000 to the
base revenue amount each fiscal year
during BsUFA III.
K. Impact of BsUFA III Enhancements
on User Fee Revenue
To implement the proposed
enhancements for BsUFA III, funding
for a cumulative total of 15 FTE staff is
proposed to be phased in over the
course of BsUFA III. The new funding
would be phased in as follows:
•$4,428,886 for fiscal year 2023
•$320,569 for fiscal year 2024
IV. Public Meeting Information
A. Purpose and Scope of the Meeting
The virtual public meeting will
include a presentation by FDA and an
industry panel. For members of the
public who would like to make verbal
comments on the proposed
enhancements, there will be a public
comment period at the end of the
meeting (see instructions below). We
will also provide an opportunity for
individuals to submit written comments
to the docket before and after the
meeting.
B. Participating in the Public Meeting
Registration: Registration is optional
and not required to attend this virtual
public meeting. However, registering
will allow FDA to provide you with
email updates if any meeting details
change. If you wish to register, you can
do so at https://bsufaiii-finalpublic
meeting.eventbrite.com.
Opportunity for Verbal Public
Comment: Those who register online
will receive a confirmation email that
includes a link to a request form to
make a verbal public comment at the
meeting. If you wish to speak during the
public comment session, follow the
instructions in 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
October 19, 2021, 11:59 p.m. Eastern
Time. Depending on the number of
requests, we will determine the amount
of time allotted to each commenter, the
approximate time each comment is to
begin, and will select and notify
participants by October 26, 2021. No
commercial or promotional material
will be permitted to be presented at the
public meeting.
Streaming Webcast of the Public
Meeting: The Zoom Webinar ID for this
public meeting is 161 047 8285. The
webcast link for this public meeting can
be found here: https://fda.zoomgov.
com/j/1610478285?pwd=MG1lN2hr
YzBVTGhsd1F2eVhwZG1DQT09. The
link above should allow you to enter the
webinar directly. If Zoom asks for a
passcode, please use the case-sensitive
passcode below.
Case-Sensitive Passcode for Zoom
Webinar: S9d&fx
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
). Transcripts of the
meeting will be available on the FDA
web page https://www.fda.gov/industry/
biosimilar-user-fee-amendments/bsufa-
iii-fiscal-years-2023-2027 approximately
30 days after the meeting.
Dated: September 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–20432 Filed 9–21–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Bureau of Primary
Health Care—Program Management
Resource Compendium, 0906–XXXX,
New
AGENCY
: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION
: Notice.
SUMMARY
: In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
DATES
: Comments on this ICR should be
received no later than October 22, 2021.
ADDRESSES
: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT
: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
9094.
SUPPLEMENTARY INFORMATION
:
Information Collection Request Title:
Bureau of Primary Health Care—
Program Management Resource
Compendium, OMB No. 0906–XXXX,
New.
Abstract: The Program Management
Resource Compendium project will
encompass an historical analysis of
HRSA’s Bureau of Primary Health Care
(BPHC), as well as a historical analysis
of the Health Center Program, performed
by federal contractors. Dating from the
founding of the initial community
health centers in the mid-1960s up to
the present time, the analysis will
consider the evolution and critical
milestones of BPHC and the Health
Center Program based on documentary
research and interviews with
individuals with historical knowledge
of the Health Center Program and the
health center movement.
A 60-day notice published in the
Federal Register (86 FR 30962 (June 10,
2021). There were no public comments.
Need and Proposed Use of the
Information: The information gathered
through interviews will be combined
with information drawn from
documentary research to inform the
historical analysis. The results of the
analysis will be presented in
communication products for an internal
audience, as well as products for an
external audience. The goals of the
project are to increase awareness of the
Health Center Program management
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