
[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]


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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 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Questions and Answers; Draft Guidance for Industry; Availability; 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.

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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the availability of a draft guidance for industry entitled ``The 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 This draft guidance is intended to provide answers to common 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DATES: Submit either electronic or written comments on the draft 
guidance by February 11, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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, 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:

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]
 BILLING CODE 4164-01-P


