[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13373-13375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05626]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4750]


Implementation of the ``Deemed To Be a License'' Provision of the 
Biologics Price Competition and Innovation Act of 2009; Draft Guidance 
for Industry; Availability and Request for Comments

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the availability of a draft guidance for industry entitled 
``Implementation of the `Deemed to be a License' Provision of the 
Biologics Price Competition and Innovation Act of 2009.'' This draft 
guidance describes FDA's approach to implementation of the statutory 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) on or before 
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 Specifically, this draft guidance describes FDA's interpretation 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 have been or will be approved under the FD&C Act on or 
before March 23, 2020. This draft guidance also provides 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 the transition 
provisions of the BPCI Act.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 13, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``Implementation of the `Deemed to be a License' 
Provision of the Biologics Price Competition and Innovation Act of 
2009; Draft Guidance for Industry; Availability and Request for 
Comments.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
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

[[Page 13374]]

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 http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the 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 Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6268, Silver Spring, MD 20993-0002, 301-
796-3601; 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 draft guidance for industry 
entitled ``Implementation of the `Deemed to be a License' Provision of 
the Biologics Price Competition and Innovation Act of 2009.'' This 
draft guidance describes FDA's approach to implementation of the 
provision of the BPCI Act under which an application for a biological 
product approved under section 505 of the FD&C Act (21 U.S.C. 355) on 
or before 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 draft 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 have been or will 
be approved under section 505 of the FD&C Act on or before March 23, 
2020. This draft 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 
changed 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).'' FDA has interpreted 
the statutory terms ``protein'' and ``chemically synthesized 
polypeptide'' to implement the amended definition of ``biological 
product'' (see FDA's guidance for industry entitled ``Biosimilars: 
Questions and Answers Regarding Implementation of the Biologics Price 
Competition and Innovation Act of 2009,'' available on FDA's Web site 
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm).
    The BPCI Act requires that a marketing application for a 
``biological product'' 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, because the BPCI Act provides only 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 ``on'' March 23, 2020, even though section 
7002(e)(2) of the BPCI Act expressly permits submission of an 
application under section 505 of the FD&C Act ``not later than'' March 
23, 2020, if certain criteria are met. Such an application may, for 
example, be withdrawn and resubmitted under section 351(a) or 351(k) of 
the PHS Act, as appropriate. FDA recognizes that this interpretation 
could have a significant impact on development programs for any 
proposed protein products intended for submission under section 505 of 
the FD&C Act that are not able to receive final approval by March 23, 
2020, and provides recommendations to sponsors in the draft guidance.
    We invite comment on the Agency's approach to implementation of the 
``deemed to be a license'' provision of the BPCI Act, as described in 
the draft guidance.
    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 implementation 
of the ``deemed to be a license'' provision of 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 that are subject to review by

[[Page 13375]]

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 0910-0014; the collection of 
information in 21 CFR part 314 has been approved under 0910-0001; the 
collection of information in 21 CFR part 601 has been approved under 
0910-0338; and the collection of information for applications submitted 
under section 351(k) of the PHS Act has been approved under 0910-0719. 
In accordance with the PRA, before publication of the final guidance 
document, FDA intends to solicit public comment and obtain OMB approval 
for any information collections recommended in this guidance that are 
new or that would represent material modifications to previously 
approved collections of information found in FDA regulations or 
guidances.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.

    Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05626 Filed 3-11-16; 8:45 am]
BILLING CODE 4164-01-P