Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability, 74345-74346 [2020-25606]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices
Estimated Total Annual Burden
Hours: 6,272.
Authority: 42 U.S.C. 1397 through 1397e.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–25639 Filed 11–19–20; 8:45 am]
BILLING CODE 4184–24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0611]
Biosimilarity and Interchangeability:
Additional Draft Q&As on Biosimilar
Development and the Biologics Price
Competition and Innovation Act of
2009; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Biosimilarity and Interchangeability:
Additional Draft Q&As on Biosimilar
Development and the BPCI Act.’’ The
question and answer (Q&A) format is
intended to inform prospective
applicants and facilitate the
development of proposed biosimilars
and proposed interchangeable
biosimilars, as well as to describe FDA’s
interpretation of certain statutory
requirements added by the Biologics
Price Competition and Innovation Act of
2009 (BPCI Act). This draft guidance
document provides new Q&As. It does
not replace the draft guidance document
entitled ‘‘New and Revised Draft Q&As
on Biosimilar Development and the
BPCI Act (Revision 2),’’ issued
December 12, 2018.
DATES: Submit either electronic or
written comments on the draft guidance
by January 19, 2021 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
17:08 Nov 19, 2020
Jkt 253001
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–
2011–D–0611 for ‘‘Biosimilarity and
Interchangeability: Additional Draft
Q&As on Biosimilar Development and
the BPCI Act.’’ Received comments 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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
74345
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Sandra Benton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1132,
Silver Spring, MD 20993, 301–796–
1042, sandra.benton@fda.hhs.gov, or
Stephen Ripley, 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, stephen.ripley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Biosimilarity and Interchangeability:
E:\FR\FM\20NON1.SGM
20NON1
khammond on DSKJM1Z7X2PROD with NOTICES
74346
Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices
Additional Draft Q&As on Biosimilar
Development and the BPCI Act.’’ The
Q&A format is intended to inform
prospective applicants and facilitate the
development of proposed biosimilars
and proposed interchangeable
biosimilars, as well as to describe FDA’s
interpretation of certain statutory
requirements added by the BPCI Act.
The BPCI Act created an abbreviated
licensure pathway in section 351(k) of
the PHS Act (42 U.S.C. 262(k)) for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product (see sections 7001 through 7003
of the Patient Protection and Affordable
Care Act (Pub. L. 111–148)). FDA
believes that guidance for industry that
provides answers to commonly asked
questions regarding FDA’s
interpretation of the BPCI Act will
enhance transparency and facilitate the
development and approval of biosimilar
and interchangeable products.
FDA has been using the format of
Q&A guidance to describe the Agency’s
thinking on and update certain
information and recommendations
relevant to the development of
biosimilar and interchangeable
products. This draft guidance document
contains only Q&As that are in draft
form. After FDA has considered any
comments on the Q&As contained in
this draft guidance received during the
relevant comment period and, as
appropriate, incorporated suggested
changes to the Q&A, individual Q&As
will be finalized and moved to the final
guidance document ‘‘Questions and
Answers on Biosimilar Development
and the BPCI Act,’’ which is updated as
appropriate. The final guidance contains
Q&As that have been through the public
comment process and reflects FDA’s
current thinking on the topics
described. A Q&A may be withdrawn
and removed from the Q&A guidance
documents if, for instance, the issue
addressed in the Q&A has been
addressed in another FDA guidance
document. No such changes to currently
issued draft or final guidance
documents are being made in
connection with the issuance of this
draft guidance.
FDA has maintained the original
numbering of the Q&As used in the
December 2018 final guidance
‘‘Questions and Answers on Biosimilar
Development and the BPCI Act’’ and the
December 2018 draft guidance ‘‘New
and Revised Draft Q&As on Biosimilar
Development and the BPCI Act
(Revision 2).’’ This draft guidance
document provides new Q&As. It does
not replace the draft guidance document
entitled ‘‘New and Revised Draft Q&As
VerDate Sep<11>2014
17:08 Nov 19, 2020
Jkt 253001
on Biosimilar Development and the
BPCI Act (Revision 2),’’ issued
December 12, 2018.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The Q&As in this draft guidance, when
finalized, will appear in the final
guidance, and the final guidance will
represent the current thinking of FDA
on the Q&As posed in the ‘‘Biosimilarity
and Interchangeability: Additional Draft
Q&As on Biosimilar Development and
the BPCI Act.’’ 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.
II. Paperwork Reduction Act of 1995
This draft 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 21 CFR part 312 for
submission of an investigational new
drug application have been approved
under OMB control number 0910–0014.
The collections of information in 21
CFR 314.50 for submission of a new
drug application have been approved
under OMB control number 0910–0001.
The collections of information in
section 351(a) of the PHS Act and 21
CFR part 601 for submission of a
biologics license application (BLA) have
been approved under OMB control
number 0910–0338. The collections of
information in section 351(k) of the PHS
Act and 21 CFR part 601 for submission
of a BLA have been approved under
OMB control number 0910–0719.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://
www.regulations.gov.
Dated: November 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25606 Filed 11–19–20; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1584]
Authorization of Emergency Use of
Certain Medical Devices During
COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance and reissuance of Emergency
Use Authorizations (EUAs) (the
Authorizations) for certain medical
devices related to the Coronavirus
Disease 2019 (COVID–19) public health
emergency. FDA has issued, and in
some cases reissued, the Authorizations
listed in this document under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act). These Authorizations
contain, among other things, conditions
on the emergency use of the authorized
products. The Authorizations follow the
February 4, 2020, determination by
Secretary of Health and Human Services
(HHS) that there is a public health
emergency that has a significant
potential to affect national security or
the health and security of U.S. citizens
living abroad, and that involves the
virus that causes COVID–19, and the
subsequent declarations on February 4,
2020, March 2, 2020, and March 24,
2020, that circumstances exist justifying
the authorization of emergency use of in
vitro diagnostics for detection and/or
diagnosis of the virus that causes
COVID–19, personal respiratory
protective devices, and medical devices,
including alternative products used as
medical devices, respectively, subject to
the terms of any authorization issued
under the FD&C Act. These
Authorizations, which include an
explanation of the reasons for issuance
and reissuance, are listed in this
document, and are available on FDA’s
website at the links indicated.
DATES: These Authorizations are
applicable on their date of issuance/
reissuance.
SUMMARY:
Submit written requests for
single copies of an EUA to the Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4338, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
request or include a fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
ADDRESSES:
E:\FR\FM\20NON1.SGM
20NON1
]]>Agencies
[Federal Register Volume 85, Number 225 (Friday, November 20, 2020)]
[Notices]
[Pages 74345-74346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25606]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0611]
Biosimilarity and Interchangeability: Additional Draft Q&As on
Biosimilar Development and the Biologics Price Competition and
Innovation Act of 2009; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Biosimilarity and Interchangeability: Additional Draft Q&As on
Biosimilar Development and the BPCI Act.'' The question and answer
(Q&A) format is intended to inform prospective applicants and
facilitate the development of proposed biosimilars and proposed
interchangeable biosimilars, as well as to describe FDA's
interpretation of certain statutory requirements added by the Biologics
Price Competition and Innovation Act of 2009 (BPCI Act). This draft
guidance document provides new Q&As. It does not replace the draft
guidance document entitled ``New and Revised Draft Q&As on Biosimilar
Development and the BPCI Act (Revision 2),'' issued December 12, 2018.
DATES: Submit either electronic or written comments on the draft
guidance by January 19, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-2011-D-0611 for ``Biosimilarity and Interchangeability: Additional
Draft Q&As on Biosimilar Development and the BPCI Act.'' Received
comments 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993, 301-796-
1042, [email protected], or Stephen Ripley, 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, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Biosimilarity and Interchangeability:
[[Page 74346]]
Additional Draft Q&As on Biosimilar Development and the BPCI Act.'' The
Q&A format is intended to inform prospective applicants and facilitate
the development of proposed biosimilars and proposed interchangeable
biosimilars, as well as to describe FDA's interpretation of certain
statutory requirements added by the BPCI Act.
The BPCI Act created an abbreviated licensure pathway in section
351(k) of the PHS Act (42 U.S.C. 262(k)) for biological products shown
to be biosimilar to, or interchangeable with, an FDA-licensed
biological reference product (see sections 7001 through 7003 of the
Patient Protection and Affordable Care Act (Pub. L. 111-148)). FDA
believes that guidance for industry that provides answers to commonly
asked questions regarding FDA's interpretation of the BPCI Act will
enhance transparency and facilitate the development and approval of
biosimilar and interchangeable products.
FDA has been using the format of Q&A guidance to describe the
Agency's thinking on and update certain information and recommendations
relevant to the development of biosimilar and interchangeable products.
This draft guidance document contains only Q&As that are in draft form.
After FDA has considered any comments on the Q&As contained in this
draft guidance received during the relevant comment period and, as
appropriate, incorporated suggested changes to the Q&A, individual Q&As
will be finalized and moved to the final guidance document ``Questions
and Answers on Biosimilar Development and the BPCI Act,'' which is
updated as appropriate. The final guidance contains Q&As that have been
through the public comment process and reflects FDA's current thinking
on the topics described. A Q&A may be withdrawn and removed from the
Q&A guidance documents if, for instance, the issue addressed in the Q&A
has been addressed in another FDA guidance document. No such changes to
currently issued draft or final guidance documents are being made in
connection with the issuance of this draft guidance.
FDA has maintained the original numbering of the Q&As used in the
December 2018 final guidance ``Questions and Answers on Biosimilar
Development and the BPCI Act'' and the December 2018 draft guidance
``New and Revised Draft Q&As on Biosimilar Development and the BPCI Act
(Revision 2).'' This draft guidance document provides new Q&As. It does
not replace the draft guidance document entitled ``New and Revised
Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),''
issued December 12, 2018.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The Q&As in this draft
guidance, when finalized, will appear in the final guidance, and the
final guidance will represent the current thinking of FDA on the Q&As
posed in the ``Biosimilarity and Interchangeability: Additional Draft
Q&As on Biosimilar Development and the BPCI Act.'' 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.
II. Paperwork Reduction Act of 1995
This draft 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 21 CFR part 312 for submission of an
investigational new drug application have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR
314.50 for submission of a new drug application have been approved
under OMB control number 0910-0001. The collections of information in
section 351(a) of the PHS Act and 21 CFR part 601 for submission of a
biologics license application (BLA) have been approved under OMB
control number 0910-0338. The collections of information in section
351(k) of the PHS Act and 21 CFR part 601 for submission of a BLA have
been approved under OMB control number 0910-0719.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.
Dated: November 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25606 Filed 11-19-20; 8:45 am]
BILLING CODE 4164-01-P
