
[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63896-63898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26854]


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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.

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 
``Interpretation of the `Deemed To Be a License' Provision of the 
Biologics Price Competition and Innovation Act of 2009.'' This guidance 
describes 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. 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:
     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/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

[[Page 63897]]

``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; 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 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; 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a 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 interpretation of the provision of 
the BPCI Act under which an application for a biological product 
approved under section 505 of the Federal Food, Drug, and Cosmetic Act 
(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. Specifically, this guidance describes 
FDA's interpretation of the ``deemed to be a license'' provision in 
section 7002(e) of the BPCI Act for biological products that are 
approved under section 505 of the FD&C Act as of March 23, 2020 (the 
transition date). This guidance also provides recommendations to 
sponsors of proposed protein products intended for submission in an 
application that may not receive final approval under section 505 of 
the FD&C Act on or before March 23, 2020, to facilitate alignment of 
product development plans with FDA's interpretation of section 7002(e) 
of the BPCI Act.
    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 a ``biological 
product.'' FDA 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)-(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). Among other things, while section 7002(e)(4) of the BPCI Act 
explicitly provides that an approved application under section 505 of 
the FD&C Act shall be deemed to be a license on March 23, 2020, the 
statute does not provide a means for deeming an approved new drug 
application (NDA) to be an approved biologics license application (BLA) 
prior to, or after, the transition date. Therefore, FDA interprets 
section 7002(e) of the BPCI Act to plainly mean that, on March 23, 
2020, only approved NDAs will be deemed to be BLAs. After March 23, 
2020, the Agency will not approve any application submitted under 
section 505 of the FD&C Act for a biological product subject to the 
transition provision that is pending or tentatively approved. Such an 
application may, for example, be withdrawn and submitted under section 
351(a) or 351(k) of the PHS Act, as appropriate. In the final guidance, 
FDA provides recommendations to minimize the impact on development 
programs for any proposed biological 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.
    In the Federal Register of March 14, 2016 (81 FR 13373), FDA 
announced the availability of the draft of this guidance. FDA received 
several comments on the draft guidance, and those comments were 
considered as the guidance was finalized. This final guidance explains 
that FDA interprets section 7002(e) of the BPCI Act and section 351 of 
the PHS Act to mean that an approved NDA for a biological product that 
will be deemed to be ``licensed'' under section 351(a) of the PHS Act 
on March 23, 2020, can be a reference product for a proposed biosimilar 
product or a proposed interchangeable product (see section 351(i)(4) of 
the PHS Act). However, a biological product that was first approved in 
an NDA under section 505 of the FD&C Act and deemed ``licensed'' under 
section 351(a) of the PHS Act on March 23, 2020, will not have been 
``first licensed under subsection (a)'' for purposes of section 
351(k)(7) of the PHS Act. Thus, such a biological product will not be 
eligible for exclusivity under section 351(k)(7)(A) and (B) of the PHS 
Act. Moreover, FDA interprets the limitations on eligibility for 
reference product exclusivity in section 351(k)(7)(C) of the PHS Act to 
apply to any reference product. The guidance also clarifies the 
Agency's approach to supplements submitted to an approved NDA for a 
biological product before March 23, 2020, that are pending on the 
transition date.
    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 ``Interpretation of the `Deemed To Be a 
License' Provision of the Biologics Price Competition and Innovation 
Act of 2009.'' It does not

[[Page 63898]]

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. This guidance 
is not subject to Executive Order 12866.

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. 3501-3520). The 
collection of information in 21 CFR part 312 has been approved under 
OMB control number 0910-0014; 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 part 601 has been approved under 
OMB control number 0910-0338; and the collection of information for 
applications submitted under section 351(k) of the PHS Act has been 
approved under OMB control number 0910-0719; the collection of 
information in FDA's guidance for industry entitled ``Formal Meetings 
Between the FDA and Biosimilar Biological Product Sponsors or 
Applicants'' has been approved under OMB control number 0910-0802; and 
the collection of information in FDA's guidance for industry entitled 
``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA 
Products'' has been approved under OMB control number 0910-0429.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: December 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26854 Filed 12-11-18; 8:45 am]
BILLING CODE 4164-01-P


