Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Program, 72604-72606 [2021-27680]
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72604
Federal Register / Vol. 86, No. 243 / Wednesday, December 22, 2021 / Notices
methods used to support regulatory
submissions for finished tobacco
products including substantial
equivalence (SE) applications,
premarket tobacco product applications
(PMTA), and modified risk tobacco
product applications (MRTPA). These
recommendations include analytical
testing of tobacco product constituents,
ingredients, and additives, as well as
stability testing of finished tobacco
products. The principles in this
guidance may also be used for finished
tobacco product testing and reporting of
harmful and potentially harmful
constituents (HPHCs) in tobacco
products and tobacco smoke.
The FD&C Act requires, among other
things, premarket review for new
tobacco products and modified risk
tobacco products (see sections 910 and
911 (21 U.S.C. 387j and 21 U.S.C. 387k)
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act)), and also reporting of
HPHCs under section 904 of the FD&C
Act (21 U.S.C. 387d). Information about
constituents, for example, might be
required by law or otherwise support
the findings for premarket
authorization. Regulatory submissions
often contain data from analytical
testing, such as data about ingredients,
constituents, and additives. In standard
practice, analytical testing is done
through validation of the analytical
method. In these cases, the applicant
will want to use analytical methods that
are sufficiently precise, accurate,
selective, and sensitive. Validation
involves documenting, through the use
of specific laboratory investigations, that
the performance characteristics of the
method are suitable and reliable for the
intended analytical applications, in
terms of precision, accuracy, selectivity,
and sensitivity. When finalized, this
guidance is intended to help industry
produce more consistent and reliable
analytical data used to support
regulatory submissions for finished
tobacco products, such as SE
applications, PMTAs, MRTPAs, and for
finished tobacco product testing and
reporting of HPHCs in tobacco products
and tobacco smoke.
FDA is issuing this draft guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Validation and Verification of
Analytical Testing Methods used for
Tobacco Products.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
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II. Paperwork Reduction Act of 1995
We believe that the information
collection provisions in the draft
guidance do not create a new burden for
respondents. We believe the
recordkeeping provisions are part of
usual and customary business practice.
Tobacco manufacturers would have inhouse analysts or contractual
agreements with outside analytical
laboratories and suppliers, as applicable
for the type of tobacco product, to
address all these information collection
provisions.
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The collections of information in
section 910(c)(1)(A)(i) of the FD&C Act
have been approved under OMB control
number 0910–0768; the collections of
information in section 905(j) of the
FD&C Act (21 U.S.C. 387e(j)) have been
approved under OMB control number
0910–0673; and the collections of
information in 21 CFR part 1107 have
been approved under OMB control
number 0910–0684, the collections of
information in section 904(a)(3) of the
FD&C Act have been approved under
OMB control number 0910–0732.
III. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
draft guidance at https://www.fda.gov/
tobacco-products/products-guidanceregulations/rules-regulations-andguidance, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–27719 Filed 12–21–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1967]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Biosimilars User
Fee Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00031
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by January 21,
2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
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. The OMB
control number for this information
collection is 0910–0719. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Biosimilars User Fee Program
OMB Control Number 0910–0718—
Revision
This information collection supports
FDA’s Biosimilars User Fee Program.
The Biologics Price Competition and
Innovation Act of 2009 (BPCI Act)
amended the Public Health Service Act
(PHS Act) to create an abbreviated
approval pathway for biological
products shown to be biosimilar to or
interchangeable with an FDA-licensed
reference biological product. Section
351(k) of the PHS Act (42 U.S.C. 262(k)),
added by the BPCI Act, allows a
company to apply for licensure of a
biosimilar or interchangeable biological
product (351(k) application). The BPCI
Act also amended section 735 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379g) to include 351(k)
applications as a type of application
under ‘‘human drug application’’ for the
purposes of the prescription drug user
fee provisions.
The Biosimilar User Fee Act of 2012
(BsUFA) authorizes FDA to assess and
collect user fees for certain activities in
connection with biosimilar biological
E:\FR\FM\22DEN1.SGM
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72605
Federal Register / Vol. 86, No. 243 / Wednesday, December 22, 2021 / Notices
product development (BPD). BsUFA
was reauthorized for an additional 5
years in August 2017 (BsUFA II). We
developed the guidance entitled
‘‘Assessing User Fees Under the
Biosimilar User Fee Amendments of
2017’’ to assist industry in
understanding when fees are incurred
and the process by which applicants can
submit payments. The guidance also
explains how respondents can request
discontinuation from the BPD program
as well as how respondents can request
to move products to the discontinued
section of the biosimilar list. Finally, the
guidance provides information on the
consequences of failing to pay BsUFA II
fees as well as processes for submitting
reconsideration and appeal requests.
The guidance is available on the FDA
website at: https://www.fda.gov/media/
134567/download. The guidance was
issued consistent with our good
guidance practice regulations in
§ 10.115 (21 CFR 10.115), which provide
for public comment at any time.
We also developed Form FDA 3792,
the Biosimilars User Fee Cover Sheet,
which is submitted by each new BPD
entrant (identified via a new meeting
request or investigational new drug
(IND) submission) and for new biologics
license applications (BLAs). Form FDA
3792 requests the minimum necessary
information to identify the request, to
determine the amount of the fee to be
assessed, and to account for and track
user fees. The form provides a crossreference of the fees submitted for an
activity with the actual submission or
activity by using a unique number
tracking system. The information
collected is used by FDA’s Center for
Drug Evaluation and Research and
Center for Biologics Evaluation and
Research to initiate the administrative
screening of biosimilar biological
product INDs and BLAs and to account
for and track user fees associated with
BPD meetings.
In addition to Form FDA 3792, the
information collection includes an
annual survey of all BsUFA II
participants designed to provide
information to FDA of anticipated
BsUFA II activity in the upcoming fiscal
year. This information helps FDA set
appropriate annual BsUFA II fees.
For efficiency of Agency operations,
we are consolidating related information
collection currently approved in OMB
control number 0910–0719. Specifically
we are including our current
commitment goals as set forth in the
document ‘‘BsUFA Reauthorization
Performance Goals and Procedures
Fiscal Years 2018 Through 2022,’’
which represents the product of FDA
discussions with regulated industry and
public stakeholders, as mandated by
Congress. The document, referred to as
the ‘‘BsUFA II letter,’’ is available on
our website at: https://www.fda.gov/
downloads/ForIndustry/UserFees/
BiosimilarUserFeeActBsUFA/
UCM521121.pdf. The performance and
procedural goals specified in the BsUFA
II letter apply to aspects of the
biosimilar biological product review
program that are important for
facilitating timely access to safe and
effective biosimilar medicines for
patients. Among those considerations is
providing feedback to requests from
regulated industry. Each year, FDA
review staff participate in many
meetings with requesters who seek
advice relating to the development and
review of a biosimilar or
interchangeable product. Because these
meetings often represent critical points
in the regulatory and development
process, it is important that there are
clear procedures for the timely and
effective conduct of such meeting.
Accordingly, we issued draft guidance,
‘‘Formal Meetings Between the FDA and
Sponsors or Applicants of BsUFA
Products,’’ available on our website at:
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/formal-meetings-betweenfda-and-sponsors-or-applicants-bsufaproducts-guidance-industry. The
guidance was issued consistent with
Section I, Part 6 of the BsUFA II letter
(see p. 25), and with our good guidance
practice regulations in § 10.115, which
provide for public comment at any time.
The guidance provides procedural
instruction helpful to respondents and
helps us reach what we believe is a
more accurate burden estimate for the
information collection.
Also available from our website is our
Biosimilars Action Plan (BAP), which
discusses key actions the Agency is
taking to encourage innovation and
competition among biologics and the
development of biosimilars. The BAP
builds on progress in implementing the
approval pathway for biosimilar and
interchangeable products, and provides
interested persons with updates and
resource material.
In the Federal Register of September
17, 2021 (86 FR 51900), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
FDA form; survey
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Biosimilar User Fee Cover Sheet (Form FDA 3792) ..
Annual Survey .............................................................
Request for discontinuation from BPD program .........
Request to move products to discontinued section of
the Biosimilar List.
Biosimilar product applications (351(k)(2)(A)) .............
Interchangeable product applications (351(k)(2)(B)) ...
Patent infringement notifications .................................
Formal Meetings Guidance for Industry Recommendations.
60
60
10
5
1
1
1
1
60
60
10
5
0.5 (30 minutes) .....
1 .............................
1 .............................
0.5 (30 minutes) .....
30
60
10
2.5
4
2
4
69
2.25
1
2.25
2.30
9
2
9
159
860 .........................
860 .........................
2 .............................
21.42 ......................
7,740
1,720
18
3,405
Total ......................................................................
........................
........................
314
................................
12,985.5
In anticipation of increased
participation in the BPD program, we
have adjusted our estimate to reflect an
increase in the number of respondents
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17:55 Dec 21, 2021
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since last OMB review. We have also
made adjustments to reflect information
collection consolidated from OMB
control number 0910–0719. We invite
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Sfmt 4703
comment on our estimates and
assumptions.
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72606
Federal Register / Vol. 86, No. 243 / Wednesday, December 22, 2021 / Notices
Dated: December 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–27680 Filed 12–21–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–P–0375]
Determination That Alcohol and
Dextrose Injection, 5 Milliliters/100
Milliliters, 5 Grams/100 Milliliters; and
10 Milliliters/100 Milliliters, 5 Grams/
100 Milliliters, Were Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that Alcohol and
Dextrose Injection, 5 milliliters (mL)/
100 mL, 5 gram (g)/100 mL; and Alcohol
and Dextrose Injection, 10 mL/100 mL,
5 g/100 mL, were withdrawn from sale
for reasons of safety or effectiveness.
The Agency will not accept or approve
abbreviated new drug applications
(ANDAs) for Alcohol and Dextrose
Injection, 5 mL/100 mL, 5 g/100 mL;
and 10 mL/100 mL, 5 g/100 mL.
FOR FURTHER INFORMATION CONTACT:
Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6272,
Silver Spring, MD 20993–0002, 240–
825–9944, Kaetochi.Okemgbo@
fda.hhs.gov.
SUMMARY:
Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) Has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and, with certain exceptions,
labeling as the listed drug, which is a
version of the drug that was previously
approved; and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
khammond on DSKJM1Z7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:55 Dec 21, 2021
Jkt 256001
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
Between 1938 and 1968, FDA
evaluated NDAs solely on the basis of
safety information. In 1962, the
Kefauver-Harris Drug Amendments
(Pub. L. 87–781) amended the FD&C Act
to require that new drug products also
be shown to be effective in order to
obtain approval of an NDA. After the
enactment of the Kefauver-Harris Drug
Amendments, FDA initiated the Drug
Efficacy Study Implementation (DESI) to
evaluate the effectiveness of drug
products that had been approved
between 1938 and 1962 solely on the
basis of safety.
FDA introduced the concept of an
‘‘abbreviated new drug application’’ in
1968 as a vehicle for approval of certain
drugs affected by the DESI review.
When a drug product subject to the
DESI review was determined to be
effective for one or more indications,
FDA would issue a Federal Register
notice for that drug product describing
the DESI review findings and stating
whether abbreviated new drug
applications that met specified criteria
could be submitted to FDA (see
generally 35 FR 11273 (July 14, 1970);
35 FR 6574 (April 24, 1970)) for
products that had not been marketed
under an NDA. Such a finding allowed
manufacturers to submit an abbreviated
new drug application in lieu of an NDA.
For approval of these applications,
which were submitted before the Drug
Price Competition and Patent Term
Restoration Act of 1984 (Hatch-Waxman
Amendments) (Pub. L. 98–417) created
the current ANDA pathway, FDA relied
on the evidence of effectiveness that had
been provided, reviewed, and accepted
during the DESI process and evaluated
the safety of these drug products on the
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
basis of information included in NDAs
submitted prior to 1962, as well as the
subsequent marketing experience with
the drugs. These applications are
referred to as pre-Hatch-Waxman
abbreviated new drug applications or
‘‘PANDAs’’.1 PANDAs were submitted
under section 505(b) of the FD&C Act
and approved for safety and
effectiveness under section 505(c) of the
FD&C Act (see 86 FR 44731 at 44732
(August 13, 2021)).
As explained above, the current
ANDA pathway is described in section
505(j) of the FD&C Act. Because of
substantive differences in the
application approval pathway for
PANDAs, which were approved for
safety and effectiveness under section
505(c) of the FD&C Act, compared to
ANDAs approved under section 505(j)
of the FD&C Act, FDA has determined
that PANDA products can serve as
reference listed drugs for 505(j) ANDA
applicants seeking to make generic
versions of these products and that there
is a finding of safety and effectiveness
that may be relied upon for approval by
applicants of 505(b)(2) applications.
Alcohol and Dextrose Injection, 5 mL/
100 mL, 5 g/100 mL; and 10 mL/100
mL, 5 g/100 mL, is the subject of NDA
004589, held by B. Braun Medical Inc.
The initial application, which included
Alcohol and Dextrose Injection, 5 mL/
100 mL, 5 g/100 mL, was allowed to
take effect on February 21, 1942.
Alcohol and Dextrose Injection, 10 mL/
100 mL, 5 g/100 mL, was allowed to
take effect in a supplemental
application on January 17, 1946. On July
28, 1972, FDA published a Federal
Register notice regarding the DESI
review of NDA 004589 (see 37 FR
15184). Under the DESI review, FDA
concluded that there was substantial
evidence of efficacy for two
formulations of 5 percent Alcohol and 5
percent Dextrose for the indication ‘‘for
increasing caloric intake.’’ Based on the
Federal Register notice, FDA approved
Alcohol and Dextrose Injection, 5 mL/
100 mL, 5 g/100 mL in three PANDAs:
ANDA 083263, held by Hospira, Inc.
and initially approved on February 26,
1974; ANDA 083483, held by Miles
Laboratories Inc. and originally
approved on November 22, 1974; and
1 See ‘‘Drug Products Approved in Abbreviated
New Drug Applications Before the Enactment of the
Hatch-Waxman Amendments; Establishment of a
Public Docket; Request for Comments,’’ 86 FR
44731 (August 13, 2021). Note that the scope of the
referenced notice is limited to drug products
approved in PANDAs under section 505 of the
FD&C Act prior to the Hatch-Waxman
Amendments; the notice does not cover
applications for antibiotic drug products that were
originally submitted under section 507 of the FD&C
Act (21 U.S.C. 357).
E:\FR\FM\22DEN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Notices]
[Pages 72604-72606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27680]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1967]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Biosimilars User Fee
Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 21, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://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. The OMB control number for
this information collection is 0910-0719. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Biosimilars User Fee Program
OMB Control Number 0910-0718--Revision
This information collection supports FDA's Biosimilars User Fee
Program. The Biologics Price Competition and Innovation Act of 2009
(BPCI Act) amended the Public Health Service Act (PHS Act) to create an
abbreviated approval pathway for biological products shown to be
biosimilar to or interchangeable with an FDA-licensed reference
biological product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)),
added by the BPCI Act, allows a company to apply for licensure of a
biosimilar or interchangeable biological product (351(k) application).
The BPCI Act also amended section 735 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications as a type
of application under ``human drug application'' for the purposes of the
prescription drug user fee provisions.
The Biosimilar User Fee Act of 2012 (BsUFA) authorizes FDA to
assess and collect user fees for certain activities in connection with
biosimilar biological
[[Page 72605]]
product development (BPD). BsUFA was reauthorized for an additional 5
years in August 2017 (BsUFA II). We developed the guidance entitled
``Assessing User Fees Under the Biosimilar User Fee Amendments of
2017'' to assist industry in understanding when fees are incurred and
the process by which applicants can submit payments. The guidance also
explains how respondents can request discontinuation from the BPD
program as well as how respondents can request to move products to the
discontinued section of the biosimilar list. Finally, the guidance
provides information on the consequences of failing to pay BsUFA II
fees as well as processes for submitting reconsideration and appeal
requests. The guidance is available on the FDA website at: https://www.fda.gov/media/134567/download. The guidance was issued consistent
with our good guidance practice regulations in Sec. 10.115 (21 CFR
10.115), which provide for public comment at any time.
We also developed Form FDA 3792, the Biosimilars User Fee Cover
Sheet, which is submitted by each new BPD entrant (identified via a new
meeting request or investigational new drug (IND) submission) and for
new biologics license applications (BLAs). Form FDA 3792 requests the
minimum necessary information to identify the request, to determine the
amount of the fee to be assessed, and to account for and track user
fees. The form provides a cross-reference of the fees submitted for an
activity with the actual submission or activity by using a unique
number tracking system. The information collected is used by FDA's
Center for Drug Evaluation and Research and Center for Biologics
Evaluation and Research to initiate the administrative screening of
biosimilar biological product INDs and BLAs and to account for and
track user fees associated with BPD meetings.
In addition to Form FDA 3792, the information collection includes
an annual survey of all BsUFA II participants designed to provide
information to FDA of anticipated BsUFA II activity in the upcoming
fiscal year. This information helps FDA set appropriate annual BsUFA II
fees.
For efficiency of Agency operations, we are consolidating related
information collection currently approved in OMB control number 0910-
0719. Specifically we are including our current commitment goals as set
forth in the document ``BsUFA Reauthorization Performance Goals and
Procedures Fiscal Years 2018 Through 2022,'' which represents the
product of FDA discussions with regulated industry and public
stakeholders, as mandated by Congress. The document, referred to as the
``BsUFA II letter,'' is available on our website at: https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf. The performance and procedural goals specified in the
BsUFA II letter apply to aspects of the biosimilar biological product
review program that are important for facilitating timely access to
safe and effective biosimilar medicines for patients. Among those
considerations is providing feedback to requests from regulated
industry. Each year, FDA review staff participate in many meetings with
requesters who seek advice relating to the development and review of a
biosimilar or interchangeable product. Because these meetings often
represent critical points in the regulatory and development process, it
is important that there are clear procedures for the timely and
effective conduct of such meeting. Accordingly, we issued draft
guidance, ``Formal Meetings Between the FDA and Sponsors or Applicants
of BsUFA Products,'' available on our website at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-bsufa-products-guidance-industry. The guidance was issued consistent with Section I, Part 6 of
the BsUFA II letter (see p. 25), and with our good guidance practice
regulations in Sec. 10.115, which provide for public comment at any
time. The guidance provides procedural instruction helpful to
respondents and helps us reach what we believe is a more accurate
burden estimate for the information collection.
Also available from our website is our Biosimilars Action Plan
(BAP), which discusses key actions the Agency is taking to encourage
innovation and competition among biologics and the development of
biosimilars. The BAP builds on progress in implementing the approval
pathway for biosimilar and interchangeable products, and provides
interested persons with updates and resource material.
In the Federal Register of September 17, 2021 (86 FR 51900), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA form; survey Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Biosimilar User Fee Cover Sheet (Form FDA 60 1 60 0.5 (30 minutes)......................... 30
3792).
Annual Survey................................ 60 1 60 1........................................ 60
Request for discontinuation from BPD program. 10 1 10 1........................................ 10
Request to move products to discontinued 5 1 5 0.5 (30 minutes)......................... 2.5
section of the Biosimilar List.
Biosimilar product applications 4 2.25 9 860...................................... 7,740
(351(k)(2)(A)).
Interchangeable product applications 2 1 2 860...................................... 1,720
(351(k)(2)(B)).
Patent infringement notifications............ 4 2.25 9 2........................................ 18
Formal Meetings Guidance for Industry 69 2.30 159 21.42.................................... 3,405
Recommendations.
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Total.................................... .............. .............. 314 ......................................... 12,985.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
In anticipation of increased participation in the BPD program, we
have adjusted our estimate to reflect an increase in the number of
respondents since last OMB review. We have also made adjustments to
reflect information collection consolidated from OMB control number
0910-0719. We invite comment on our estimates and assumptions.
[[Page 72606]]
Dated: December 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27680 Filed 12-21-21; 8:45 am]
BILLING CODE 4164-01-P
