[Federal Register Volume 85, Number 44 (Thursday, March 5, 2020)]
[Notices]
[Pages 12930-12932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04537]
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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 Biologics Price
Competition and Innovation Act: Questions and Answers; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``The
`Deemed To Be a License' Provision of the BPCI Act: Questions and
Answers.'' This guidance is intended to provide answers to common
questions about FDA's implementation 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 implementation of this statutory provision. This
guidance finalizes the draft guidance of the same title issued on
December 12, 2018.
DATES: The announcement of the guidance is published in the Federal
Register on March 5, 2020.
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:
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.'' 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
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``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.
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 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. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Janice Weiner, Center for Drug
Evaluation and Research, Food and 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 guidance for industry
entitled ``The `Deemed to be a License' Provision of the BPCI Act:
Questions and Answers.'' This guidance is intended to provide answers
to common questions about FDA's implementation 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
implementation 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.'' Section 605 of the Further Consolidated
Appropriations Act, 2020 (Pub. L. 116-94), further amended the
definition of a ``biological product'' in section 351(i) of the PHS Act
to remove the parenthetical ``(except any chemically synthesized
polypeptide)'' from the statutory category of ``protein.'' In the
Federal Register of February 21, 2020, FDA issued a final rule that
amends its regulation that defines ``biological product'' to
incorporate changes made by the BPCI Act and the Further Consolidated
Appropriations Act, 2020, and to provide its interpretation of the
statutory term ``protein'' (85 FR 10057). This rule is effective on
March 23, 2020. FDA also has previously stated its interpretation of
the statutory term ``protein'' 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)'' (December 2018), available on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs (``Biosimilar Q&A Draft Guidance'')).\1\
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\1\ FDA also described its interpretation of the statutory term
``chemically synthesized polypeptide'' in the Biosimilar Q&A Draft
Guidance and the proposed rule entitled ``Definition of the Term
`Biological Product' '' (83 FR 63817, December 12, 2018); however,
this interpretation is no longer necessary to our interpretation of
the statutory term ``biological product'' in light of the amendment
made by section 605 of the Further Consolidated Appropriations Act,
2020.
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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).\2\
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\2\ Section 607 of the Further Consolidated Appropriations Act,
2020, amended section 7002(e)(4) of the BPCI Act to provide that FDA
will continue to review an application for a biological product
under section 505 of the FD&C Act after March 23, 2020, so long as
that application was submitted under section 505 of the FD&C Act, is
filed not later than March 23, 2019, and is not approved as of March
23, 2020. If such an application is approved under section 505 of
the FD&C Act before October 1, 2022, it will be deemed to be a
license for the biological product under section 351 of the PHS Act
upon approval (see section 7002(e)(4)(B)(iii) and (vi) of the BPCI
Act).
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In the Federal Register of December 12, 2018 (83 FR 63894), FDA
invited comment on the preliminary list of approved applications for
biological products under the FD&C Act that will be affected by the
transition provision (``Preliminary List'') (available on FDA's website
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/deemed-be-license-provision-bpci-act). FDA explained that
if an application holder or other person believes that an approved new
drug application (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 guidance
and the list. FDA posted updates to the Preliminary List on September
23, 2019, and January 15, 2020.
In the Federal Register of December 12, 2018, FDA also invited
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. However, FDA did not receive any substantive comments on
this topic. The current Preliminary List includes a small number of
drug-biologic combination products and complex mixtures assigned to the
Center for Drug Evaluation and Research, which reflects the Agency's
current thinking that the approved NDAs for these products are
appropriately subject
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to the transition provision. FDA's evaluation of each of these approved
NDAs for drug-biologic combination products or complex mixtures was
informed by a general consideration of the factors used to determine
the appropriate marketing application type for antibody-drug conjugates
(see FDA's guidance for industry entitled ``Questions and Answers on
Biosimilar Development and the BPCI Act'' (December 2018), available on
FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs).
To ensure that the Agency considers any additional comments on the
list before the statutory transition date, the January 2020 update to
the Preliminary List recommended that application holders or other
interested persons submit either electronic or written comments no
later than February 19, 2020.
This guidance finalizes the draft guidance entitled ``The `Deemed
to be a License' Provision of the BPCI Act: Questions and Answers''
issued on December 12, 2018 (83 FR 63894). FDA considered comments
received on the draft guidance as the guidance was finalized. Changes
from the draft to the final guidance include: (1) Providing information
on updating the listing information for the biological product in FDA's
electronic Drug Registration and Listing System between March 23, 2020,
and June 30, 2020; (2) clarifying that, in the absence of other changes
made by the application holder that would require a new National Drug
Code (NDC) number, biological products approved under the FD&C Act will
retain their current NDC number after the NDA is deemed to be a BLA;
(3) providing information on establishment standards for ``non-
specified biological products'' that are the subject of deemed BLAs;
(4) clarifying the process for submitting followup reports on or after
March 23, 2020, for any initial field alert report submitted before
March 23, 2020; and (5) clarifying certain aspects of FDA's compliance
policy for the labeling of biological products that are the subject of
deemed BLAs. In addition, technical changes were made for consistency
with the revisions to the PHS Act and the BPCI Act enacted in sections
605 and 607 of the Further Consolidated Appropriations Act, 2020, and
editorial changes were made to improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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 and regulations.
II. Paperwork Reduction Act of 1995
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 21 CFR part 314 have been approved under
0910-0001; the collections of information in 21 CFR parts 601 and 610
have been approved under 0910-0338; the collections of information in
21 CFR 600.80 through 600.90 have been approved under 0910-0308; and
the collections of information in 21 CFR 201.56, 201.57, and 201.80
have been approved under 0910-0572. In addition, the collections of
information for applications submitted under section 351(k) of the PHS
Act have been approved under 0910-0719.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.
Dated: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04537 Filed 3-4-20; 8:45 am]
BILLING CODE 4164-01-P