The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry; Availability; Request for Comments on Preliminary List of Affected Applications, 63894-63896 [2018-26855]
Download as PDF
63894
Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: December 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26900 Filed 12–11–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4750]
The ‘‘Deemed to be a License’’
Provision of the BPCI Act: Questions
and Answers; Draft Guidance for
Industry; Availability; Request for
Comments on Preliminary List of
Affected Applications
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; request
for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘The
‘Deemed to be a License’ Provision of
the BPCI Act: Questions and Answers.’’
This draft guidance is intended to
provide answers to common questions
about FDA’s interpretation of the
statutory provision under which an
application for a biological product
approved under the Federal Food, Drug,
and Cosmetic Act (FD&C Act) as of
March 23, 2020, will be deemed to be
a license for the biological product
under the Public Health Service Act
(PHS Act) on March 23, 2020. This
guidance also describes FDA’s
compliance policy for the labeling of
biological products that will be the
subject of deemed biologics license
applications (BLAs). This guidance is
intended to facilitate planning for the
March 23, 2020, transition date and
provide further clarity regarding the
Agency’s interpretation of this statutory
provision. FDA also invites comment on
the preliminary list of approved new
drug applications (NDAs) for biological
products under the FD&C Act that will
be deemed to be BLAs on the transition
date.
DATES: Submit either electronic or
written comments on the draft guidance
by February 11, 2019 to ensure that the
Agency considers your comment on this
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
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draft guidance before it begins work on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–
2015–D–4750 for ‘‘The ‘Deemed to be a
License’ Provision of the BPCI Act:
Questions and Answers; Draft Guidance
for Industry.’’ 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.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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 to 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:
Janice Weiner, Center for Drug
Evaluation and Research, Food and
E:\FR\FM\12DEN1.SGM
12DEN1
Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6270,
Silver Spring, MD 20993–0002, 301–
796–3475, Janice.Weiner@fda.hhs.gov;
or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7268,
Silver Spring, MD 20993–0002, 240–
402–7911, Stephen.Ripley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
amozie on DSK3GDR082PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘The ‘Deemed to be a License’ Provision
of the BPCI Act: Questions and
Answers.’’ This draft guidance is
intended to provide answers to common
questions about FDA’s interpretation of
the ‘‘transition’’ provision of the
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) under
which an application for a biological
product approved under section 505 of
the FD&C Act (21 U.S.C. 355) as of
March 23, 2020, will be deemed to be
a license for the biological product
under section 351 of the PHS Act (42
U.S.C. 262) on March 23, 2020 (‘‘the
transition date’’). This guidance also
describes FDA’s compliance policy for
the labeling of biological products that
will be the subject of deemed BLAs.
This guidance is intended to facilitate
planning for the transition date and
provide further clarity regarding the
Agency’s interpretation of this statutory
provision.
Although the majority of therapeutic
biological products have been licensed
under section 351 of the PHS Act, some
protein products historically have been
approved under section 505 of the FD&C
Act. On March 23, 2010, the BPCI Act
was enacted as part of the Patient
Protection and Affordable Care Act
(Pub. L. 111–148). The BPCI Act
clarified the statutory authority under
which certain protein products will be
regulated by amending the definition of
a ‘‘biological product’’ in section 351(i)
of the PHS Act to include a ‘‘protein
(except any chemically synthesized
polypeptide),’’ and describing
procedures for submission of a
marketing application for certain
‘‘biological products.’’ FDA has
previously stated its interpretation of
the statutory terms ‘‘protein’’ and
‘‘chemically synthesized polypeptide’’
in the amended definition of ‘‘biological
product’’ (see FDA’s draft guidance for
industry entitled ‘‘New and Revised
Draft Q&As on Biosimilar Development
and the BPCI Act (Revision 2),’’
available on FDA’s website at https://
www.fda.gov/Drugs/Guidance
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18:39 Dec 11, 2018
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ComplianceRegulatoryInformation/
Guidances/default.htm. Elsewhere in
this issue of the Federal Register, FDA
also has issued a proposed rule to
amend its regulation that defines
‘‘biological product’’ to incorporate
changes made by the BPCI Act, and to
provide its interpretation of the
statutory terms ‘‘protein’’ and
‘‘chemically synthesized polypeptide.’’
When final, this regulation will codify
FDA’s interpretation of these terms.
The BPCI Act requires that a
marketing application for a ‘‘biological
product’’ (that previously could have
been submitted under section 505 of the
FD&C Act) must be submitted under
section 351 of the PHS Act; this
requirement is subject to certain
exceptions during a 10-year transition
period ending on March 23, 2020 (see
section 7002(e)(1) to (3) and (e)(5) of the
BPCI Act). On March 23, 2020, an
approved application for a biological
product under section 505 of the FD&C
Act shall be deemed to be a license for
the biological product under section 351
of the PHS Act (see section 7002(e)(4) of
the BPCI Act).
In the Federal Register of March 14,
2016 (81 FR 13373), FDA announced the
availability of a draft guidance on
‘‘Implementation of the ‘Deemed to be a
License’ Provision of the Biologics Price
Competition and Innovation Act of
2009’’ (Transition Policy Draft
Guidance). In the Transition Policy
Draft Guidance, FDA explains that
because the BPCI Act expressly provides
that an application that is approved on
March 23, 2020, shall be deemed to be
a license, FDA interprets section 7002(e)
of the BPCI Act to mean that the Agency
will not approve any application under
section 505 of the FD&C Act for a
biological product subject to the
transition provisions that is pending or
tentatively approved after March 23,
2020. Such an application may, for
example, be withdrawn and submitted
under section 351(a) or 351(k) of the
PHS Act, as appropriate. FDA also
provides recommendations to minimize
the impact on development programs
for any proposed protein products
intended for submission under section
505 of the FD&C Act that may not be
able to receive final approval by March
23, 2020.
FDA received several comments on
the Transition Policy Draft Guidance,
including comments requesting that
FDA provide additional information on
administrative procedures and
regulatory issues that would facilitate
planning for the transition date. For
example, commenters requested
additional information on FDA
expectations with respect to certain
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63895
requirements for biological products
regulated under the PHS Act that differ
from requirements for drug products
regulated under the FD&C Act.
Commenters also requested information
on FDA’s approach to certain
procedural issues, such as: (1) The
transition of biological products from
FDA’s ‘‘Approved Drug Products with
Therapeutic Equivalence Evaluations’’
(the Orange Book) to FDA’s ‘‘Lists of
Licensed Biological Products with
Reference Product Exclusivity and
Biosimilarity or Interchangeability
Evaluations’’ (the Purple Book); (2)
whether an approved NDA will be
deemed to be a license under section
351(a) or 351(k) of the PHS Act; (3) how
BLA numbers will be assigned; and (4)
user fee issues. This Q&A draft guidance
is intended to address these comments
and provide additional information to
facilitate planning for the transition
date.
We invite comment on the Q&A draft
guidance, including additional topics
that may be helpful for the Agency to
address in connection with the
transition date. In particular, we invite
comment on the compliance policy for
the labeling of biological products that
are the subject of deemed BLAs and the
length of the compliance period. In
addition, we invite comment on the
factors that FDA should consider in
determining whether a combination
product composed of a biological
product constituent part and a drug
constituent part will be subject to the
transition provision.
We also invite comment on the
preliminary list of approved
applications for biological products
under the FD&C Act that will be affected
by the transition provision (available on
FDA’s website at https://www.fda.gov/
Drugs/GuidanceComplianceRegulatory
Information/default.htm). If an
application holder or other person
believes that an approved NDA should
be added to the list or should not be
included on the list, the application
holder or other person should submit a
comment to the public docket
established for this Q&A draft guidance
and the list.
This draft guidance is being issued
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 ‘‘The ‘Deemed to be a License’
Provision of the BPCI Act: Questions
and Answers.’’ 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
E:\FR\FM\12DEN1.SGM
12DEN1
63896
Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
and regulations. This guidance is not
subject to Executive Order 12866.
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. 3501–3520). The collection of
information in 21 CFR part 314 has been
approved under OMB control number
0910–0001; the collection of
information in 21 CFR parts 601 and
610 has been approved under OMB
control number 0910–0338; the
collection of information in 21 CFR
600.80 through 600.90 has been
approved under OMB control number
0910–0308; and the collection of
information in 21 CFR 201.56, 201.57,
and 201.80 has been approved under
OMB control number 0910–0572. In
addition, the collections of information
for applications submitted under section
351(k) of the PHS Act (42 U.S.C. 262(k))
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 or https://
www.regulations.gov.
Dated: December 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26855 Filed 12–11–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4750]
Interpretation of the ‘‘Deemed To Be a
License’’ Provision of the Biologics
Price Competition and Innovation Act
of 2009; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
amozie on DSK3GDR082PROD with NOTICES1
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Interpretation of the ‘Deemed To Be a
License’ Provision of the Biologics Price
Competition and Innovation Act of
2009.’’ This guidance describes FDA’s
SUMMARY:
VerDate Sep<11>2014
18:39 Dec 11, 2018
Jkt 247001
interpretation of the statutory provision
under which an application for a
biological product approved under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) as of March 23, 2020, will
be deemed to be a license for the
biological product under the Public
Health Service Act (PHS Act) on March
23, 2020. Specifically, this guidance
describes FDA’s interpretation of the
‘‘deemed to be a license’’ provision of
the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) for
biological products that are approved
under the FD&C Act as of March 23,
2020. This guidance also provides
recommendations to sponsors of
proposed protein products intended for
submission in an application that may
not receive final approval under the
FD&C Act on or before March 23, 2020,
to facilitate alignment of product
development plans with FDA’s
interpretation of the transition provision
of the BPCI Act.
DATES: The announcement of the
guidance is published in the Federal
Register on December 12, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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:
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
• 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–D–4750 for ‘‘Interpretation of the
‘Deemed To Be a License’ Provision of
the Biologics Price Competition and
Innovation Act of 2009; Guidance for
Industry; Availability.’’ 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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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
E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63894-63896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26855]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-4750]
The ``Deemed to be a License'' Provision of the BPCI Act:
Questions and Answers; Draft Guidance for Industry; Availability;
Request for Comments on Preliminary List of Affected Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``The
`Deemed to be a License' Provision of the BPCI Act: Questions and
Answers.'' This draft guidance is intended to provide answers to common
questions about FDA's interpretation of the statutory provision under
which an application for a biological product approved under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020,
will be deemed to be a license for the biological product under the
Public Health Service Act (PHS Act) on March 23, 2020. This guidance
also describes FDA's compliance policy for the labeling of biological
products that will be the subject of deemed biologics license
applications (BLAs). This guidance is intended to facilitate planning
for the March 23, 2020, transition date and provide further clarity
regarding the Agency's interpretation of this statutory provision. FDA
also invites comment on the preliminary list of approved new drug
applications (NDAs) for biological products under the FD&C Act that
will be deemed to be BLAs on the transition date.
DATES: Submit either electronic or written comments on the draft
guidance by February 11, 2019 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-2015-D-4750 for ``The `Deemed to be a License' Provision of the
BPCI Act: Questions and Answers; Draft Guidance for Industry.''
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.
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.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.
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 to 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: Janice Weiner, Center for Drug
Evaluation and Research, Food and
[[Page 63895]]
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6270,
Silver Spring, MD 20993-0002, 301-796-3475, [email protected];
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268,
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 ``The `Deemed to be a License' Provision of the BPCI Act:
Questions and Answers.'' This draft guidance is intended to provide
answers to common questions about FDA's interpretation of the
``transition'' provision of the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) under which an application for a
biological product approved under section 505 of the FD&C Act (21
U.S.C. 355) as of March 23, 2020, will be deemed to be a license for
the biological product under section 351 of the PHS Act (42 U.S.C. 262)
on March 23, 2020 (``the transition date''). This guidance also
describes FDA's compliance policy for the labeling of biological
products that will be the subject of deemed BLAs. This guidance is
intended to facilitate planning for the transition date and provide
further clarity regarding the Agency's interpretation of this statutory
provision.
Although the majority of therapeutic biological products have been
licensed under section 351 of the PHS Act, some protein products
historically have been approved under section 505 of the FD&C Act. On
March 23, 2010, the BPCI Act was enacted as part of the Patient
Protection and Affordable Care Act (Pub. L. 111-148). The BPCI Act
clarified the statutory authority under which certain protein products
will be regulated by amending the definition of a ``biological
product'' in section 351(i) of the PHS Act to include a ``protein
(except any chemically synthesized polypeptide),'' and describing
procedures for submission of a marketing application for certain
``biological products.'' FDA has previously stated its interpretation
of the statutory terms ``protein'' and ``chemically synthesized
polypeptide'' in the amended definition of ``biological product'' (see
FDA's draft guidance for industry entitled ``New and Revised Draft Q&As
on Biosimilar Development and the BPCI Act (Revision 2),'' available on
FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
Elsewhere in this issue of the Federal Register, FDA also has issued a
proposed rule to amend its regulation that defines ``biological
product'' to incorporate changes made by the BPCI Act, and to provide
its interpretation of the statutory terms ``protein'' and ``chemically
synthesized polypeptide.'' When final, this regulation will codify
FDA's interpretation of these terms.
The BPCI Act requires that a marketing application for a
``biological product'' (that previously could have been submitted under
section 505 of the FD&C Act) must be submitted under section 351 of the
PHS Act; this requirement is subject to certain exceptions during a 10-
year transition period ending on March 23, 2020 (see section 7002(e)(1)
to (3) and (e)(5) of the BPCI Act). On March 23, 2020, an approved
application for a biological product under section 505 of the FD&C Act
shall be deemed to be a license for the biological product under
section 351 of the PHS Act (see section 7002(e)(4) of the BPCI Act).
In the Federal Register of March 14, 2016 (81 FR 13373), FDA
announced the availability of a draft guidance on ``Implementation of
the `Deemed to be a License' Provision of the Biologics Price
Competition and Innovation Act of 2009'' (Transition Policy Draft
Guidance). In the Transition Policy Draft Guidance, FDA explains that
because the BPCI Act expressly provides that an application that is
approved on March 23, 2020, shall be deemed to be a license, FDA
interprets section 7002(e) of the BPCI Act to mean that the Agency will
not approve any application under section 505 of the FD&C Act for a
biological product subject to the transition provisions that is pending
or tentatively approved after March 23, 2020. Such an application may,
for example, be withdrawn and submitted under section 351(a) or 351(k)
of the PHS Act, as appropriate. FDA also provides recommendations to
minimize the impact on development programs for any proposed protein
products intended for submission under section 505 of the FD&C Act that
may not be able to receive final approval by March 23, 2020.
FDA received several comments on the Transition Policy Draft
Guidance, including comments requesting that FDA provide additional
information on administrative procedures and regulatory issues that
would facilitate planning for the transition date. For example,
commenters requested additional information on FDA expectations with
respect to certain requirements for biological products regulated under
the PHS Act that differ from requirements for drug products regulated
under the FD&C Act. Commenters also requested information on FDA's
approach to certain procedural issues, such as: (1) The transition of
biological products from FDA's ``Approved Drug Products with
Therapeutic Equivalence Evaluations'' (the Orange Book) to FDA's
``Lists of Licensed Biological Products with Reference Product
Exclusivity and Biosimilarity or Interchangeability Evaluations'' (the
Purple Book); (2) whether an approved NDA will be deemed to be a
license under section 351(a) or 351(k) of the PHS Act; (3) how BLA
numbers will be assigned; and (4) user fee issues. This Q&A draft
guidance is intended to address these comments and provide additional
information to facilitate planning for the transition date.
We invite comment on the Q&A draft guidance, including additional
topics that may be helpful for the Agency to address in connection with
the transition date. In particular, we invite comment on the compliance
policy for the labeling of biological products that are the subject of
deemed BLAs and the length of the compliance period. In addition, we
invite comment on the factors that FDA should consider in determining
whether a combination product composed of a biological product
constituent part and a drug constituent part will be subject to the
transition provision.
We also invite comment on the preliminary list of approved
applications for biological products under the FD&C Act that will be
affected by the transition provision (available on FDA's website at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm). If an application holder or other person believes that an
approved NDA should be added to the list or should not be included on
the list, the application holder or other person should submit a
comment to the public docket established for this Q&A draft guidance
and the list.
This draft guidance is being issued 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 ``The `Deemed
to be a License' Provision of the BPCI Act: Questions and Answers.'' 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
[[Page 63896]]
and regulations. This guidance is not subject to Executive Order 12866.
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. 3501-3520). The
collection of information in 21 CFR part 314 has been approved under
OMB control number 0910-0001; the collection of information in 21 CFR
parts 601 and 610 has been approved under OMB control number 0910-0338;
the collection of information in 21 CFR 600.80 through 600.90 has been
approved under OMB control number 0910-0308; and the collection of
information in 21 CFR 201.56, 201.57, and 201.80 has been approved
under OMB control number 0910-0572. In addition, the collections of
information for applications submitted under section 351(k) of the PHS
Act (42 U.S.C. 262(k)) 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 or
https://www.regulations.gov.
Dated: December 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26855 Filed 12-11-18; 8:45 am]
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