Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments

CourtFood And Drug Administration
Citation85 FR 68886
Published date30 October 2020
SectionNotices
Record Number2020-24028
68886
Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices
A
NNUAL
B
URDEN
E
STIMATES
—Continued
Instrument
Total
number of
respondents
annually
Total number
of annual
responses per
respondent
Average
annual burden
hours per
response
Total/annual
burden hours
Insurance Match File: Daily, Reporting Electronically ..................................... 2 251 0.083 41.67
Match File: Daily, Reporting Manually ............................................................. 108 251 0.1 2,710.80
Estimated Total Annual Burden
Hours: 2,817.21.
Authority: 42 U.S.C. 652(a)(9), which
requires OCSE to operate the FPLS
established by 42 U.S.C. 653(a)(1) and 42
U.S.C. 652(m), which authorizes OCSE,
through the FPLS, to compare information
concerning individuals owing past-due
support with information maintained by
insurers (or their agents) concerning
insurance claims, settlements, awards, and
payments, and to furnish information
resulting from the data matches to the state
child support agencies responsible for
collecting child support from the individuals.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–24141 Filed 10–29–20; 8:45 am]
BILLING CODE 4184–41–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 on the
reauthorization of the Biosimilar User
Fee Act (BsUFA) for fiscal years (FYs)
2023 through 2027. BsUFA authorizes
FDA to collect user fees to support the
process for the review of biosimilar
biological products. 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. FDA begins the BsUFA
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 for FYs 2023
through 2027. These comments will be
published and available on FDA’s
website.
DATES
: The public meeting will be held
on November 19, 2020, from 9 a.m. to
12:30 p.m., and will be held by webcast
only. Registration to attend the meeting
and other information can be found at
https://bsufaiii-
publicmeeting.eventbrite.com. Submit
either electronic or written comments
on this public meeting by December 19,
2020. See the
SUPPLEMENTARY
INFORMATION
section for registration date
and information.
ADDRESSES
: 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 19,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 19, 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,
240–402–7500.
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.
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
VerDate Sep<11>2014 21:10 Oct 29, 2020 Jkt 253001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1
jbell on DSKJLSW7X2PROD with NOTICES
68887
Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices
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.gpo.gov/
fdsys/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/industry/biosimilar-user-
fee-amendments/public-meeting-
reauthorization-biosimilar-user-fee-act-
bsufa-11192020-11192020
approximately 30 days after the
meeting.
FOR FURTHER INFORMATION CONTACT
:
Emily Ewing, Center for Drug
Evaluation and Research, 240–402–
0196, Emily.Ewing@fda.hhs.gov.
SUPPLEMENTARY INFORMATION
:
I. Background
FDA is announcing a virtual public
meeting to begin the process for the
reauthorization of the Biosimilar User
Fee Act (BsUFA). The authority to
collect user fees under BsUFA expires
in September 2022. Without new
legislation, FDA would no longer be
able to collect user fees for future fiscal
years to fund the biosimilar biological
product review process. Before FDA
begins negotiations with the regulated
industry on BsUFA reauthorization, the
Agency is holding the public meeting
announced in this notice, at which
stakeholders, including all members of
the public, may present their views on
reauthorization, including any
suggestions for changes to the
performance goals referred to in the
‘‘Biosimilar Biological Product
Reauthorization Performance Goals and
Procedures Fiscal Years 2018 through
2022’’ (the BsUFA II Commitment
Letter). In addition, FDA will provide a
period of 30 days after the public
meeting for the public to submit written
comments. The purpose of this public
meeting is to hear stakeholder views on
BsUFA as we consider elements to
propose, update, or discontinue in the
next BsUFA. In addition to any other
relevant information the public would
like to share, the FDA is interested in
responses to the following three general
questions:
What is your assessment of the
overall performance of the BsUFA
program to date?
What current elements should be
retained, changed, or discontinued to
further strengthen and improve the
program?
What new elements should FDA
consider adding to the program to
enhance the efficiency and effectiveness
of the biosimilar biologic review
process?
II. What is BsUFA? What does it do?
FDA provides the following
information to help potential meeting
participants better understand the
history and evolution of BsUFA and its
status. BsUFA is a law that authorizes
FDA to assess and collect fees from drug
companies that submit marketing
applications for 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 five more years under the
FDA Reauthorization Act of 2017
(FDARA, Pub. L. 115–52). BsUFA’s
intent is to provide additional revenues
so that FDA can hire staff, improve
systems, and continue a well-managed
biosimilar biological product review
process to make biosimilar biological
product therapies available to patients
sooner. As part of FDA’s agreements
with industry during prior BsUFA
authorizations, the Agency agreed to
certain performance and procedural
goals and other commitments, which are
documented on FDA’s website. The
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 website provides more
information about BsUFA, including the
statutory text of the FDA
Reauthorization Act of 2017 (FDARA,
Pub. L. 115–52), the BsUFA II
Commitment Letter, ‘‘Biosimilar
Authorization Performance Goals and
Procedures Fiscal Years 2013 through
2017’’ (the BsUFA Commitment Letter),
key Federal Register documents,
BsUFA-related guidances, BsUFA user
fee rates, performance reports, and
financial reports: 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 and minimize the number of
review cycles necessary for approval.
The Program allowed for additional
communication between the FDA
review team and applicants of
biosimilar biological products,
including pre-submission meetings,
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 to accommodate this
additional interaction. BsUFA II also
includes commitments to advance
development of biosimilar biological
products through further clarification of
the 351(k) regulatory pathway, and to
enhance capacity for biosimilar
regulations and 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.
BsUFA II established an independent
fee structure and fee amounts to ensure
stable and predictable user fee funding,
improve the predictability of FDA
funding and sponsor invoices, improve
efficiency by simplifying the
administration of user fees, and enhance
flexibility of financial mechanisms to
improve management of BsUFA
program funding. The structure also
established a BsUFA target revenue
based on BsUFA program costs and
updated the overall fee structure. 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 five-
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 at
https://www.fda.gov/industry/
biosimilar-user-fee-amendments/
completed-bsufa-ii-deliverables.
VerDate Sep<11>2014 21:10 Oct 29, 2020 Jkt 253001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1
jbell on DSKJLSW7X2PROD with NOTICES
68888
Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices
III. Public Meeting Information
A. Purpose and Scope of the Meeting
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
outside of the BsUFA program are
beyond the scope of these
reauthorization discussions.
Accordingly, the comments should
focus on process enhancements and
funding issues, and not 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 November 5, 2020, at
https://bsufaiii-
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 November
5, 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
November 5, 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 November 12, 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/bsufanov2020/.
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/biosimilar-user-fee-
amendments/public-meeting-
reauthorization-biosimilar-user-fee-act-
bsufa-11192020-11192020.
Dated: October 26, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–24028 Filed 10–29–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2088]
Sanofi-Aventis U.S. LLC, et.al.;
Withdrawal of Approval of 11
Abbreviated New Drug Applications
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 11 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
DATES
: Approval is withdrawn as of
November 30, 2020.
FOR FURTHER INFORMATION CONTACT
:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION
: The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
Application No. Drug Applicant
ANDA 061884 ...................... Rifamate (isoniazid and rifampin) Capsules, 150 milli-
grams (mg); 300 mg. Sanofi-Aventis U.S. LLC 55 Corporate Dr., Bridgewater,
NJ 08807.
ANDA 065196 ...................... Ceftazidime for Injection, 1 gram(g)/vial ......................... Morton Grove Pharmaceuticals Inc./Wockhardt USA
LLC., 6451 Main St., Morton Grove, IL 60053.
ANDA 065197 ...................... Cefotaxime for Injection, Equivalent to (EQ) 1 g base/
vial; EQ 2 g base/vial; EQ 500 mg base/vial. Do.
ANDA 078229 ...................... Terbinafine Hydrochloride (HCl) Tablets, EQ 250 mg
base. Do.
ANDA 081134 ...................... Niacin Tablets, 500 mg ................................................... Do.
ANDA 091659 ...................... Heparin Sodium Injection, 5,000 units/milliliter (mL) ...... CASI Pharmaceuticals, Inc., 9620 Medical Center Dr.,
Suite 300, Rockville, MD 20850.
ANDA 202647 ...................... Granisetron HCl Injection, EQ 0.1 mg base/mL (EQ 0.1
mg base/mL). Yung Shin Pharmaceutical Industrial Co., Ltd./Carlsbad
Technology, Inc., 5922 Farnsworth Ct., Carlsbad, CA
92008.
ANDA 202648 ...................... Granisetron HCl Injection, EQ 1 mg base/mL (EQ 1 mg
base/mL); EQ 4 mg base/4 mL (EQ 1 mg base/mL). Do.
ANDA 205173 ...................... Bosentan Tablets, 62.5 mg and 125 mg ........................ Mylan Pharmaceuticals Inc., 781 Chestnut Ridge Rd.,
P.O. Box 4310, Morgantown, WV 26504.
ANDA 207843 ...................... Telmisartan Tablets, 20 mg, 40 mg, and 80 mg ............ Hisun Pharmaceutical (Hangzhou) Co., Ltd./Hisun
Pharmaceuticals USA, Inc., 200 Crossing Blvd., 2nd
Floor, Bridgewater, NJ 08807.
VerDate Sep<11>2014 21:10 Oct 29, 2020 Jkt 253001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1
jbell on DSKJLSW7X2PROD with NOTICES

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT