[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Biologics Price Competition and Innovation Act of 2009; Draft Guidance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the availability of a draft guidance for industry entitled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 This draft
guidance describes FDA's approach to implementation of the statutory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 Specifically, this draft guidance describes FDA's interpretation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 This draft guidance also provides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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 13, 2016.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]
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