Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants; Guidance for Industry; Availability, 72069-72071 [2015-29455]
Download as PDF
<![CDATA[
72069
Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices
qualified tropical disease may be
eligible for a voucher that can be used
to obtain a priority review for any
application submitted under section
505(b)(1) of the FD&C Act (21 U.S.C.
355(b)(1)) or section 351 of the Public
Health Service Act (the PHS Act). The
guidance explains to internal and
external stakeholders how FDA intends
to implement the provisions of section
524, and provides information on using
the priority review vouchers and on
transferring priority review vouchers to
other sponsors.
Under the guidance, sponsors of
certain tropical disease drug product
applications submitted under section
505(b)(1) of the FD&C Act and section
351 of the PHS Act may request a
priority review voucher. Based on
inquiries and discussions with industry
about section 524, we estimate that we
will receive annually approximately five
requests from five sponsors, and that
each request will take approximately 8
hours to prepare and submit to FDA.
The guidance also states that sponsors
should notify FDA of their intent to use
a priority review voucher, including the
date on which the sponsor intends to
submit the application, at least 90 days
before use. We estimate that we will
receive annually approximately five
notifications of intent to use a voucher
from five sponsors, and that each
notification will take approximately 8
hours to prepare and submit to FDA.
The guidance also permits the transfer
of a priority review voucher from one
sponsor to another, and states that each
transfer should be documented with a
letter of transfer. We estimate that we
will receive approximately two letters
indicating the transfer of a voucher from
two application holders, and two letters
from two new voucher owners
acknowledging the transfer, and that it
will take approximately 8 hours to
prepare and submit each letter to FDA.
In the Federal Register of October 20,
2008 (73 FR 62298), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. The comments we received
did not pertain to the information
collection that would result from the
guidance (that is, the four types of
submissions estimated in table 1).
FDA estimates the burden of this
collection of information as follows:
Description of Respondents: Sponsors
submitting applications under section
505(b)(1) of the FD&C Act or section 351
of the PHS Act.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Guidance for Industry on Tropical Disease Priority Review
Vouchers
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
Priority Review Voucher Request ........................................
Notifications of Intent To Use a Voucher ............................
Letters Indicating the Transfer of a Voucher Letter ............
Acknowledging the Receipt of a Transferred Voucher ........
5
5
2
2
1
1
1
1
5
5
2
2
8
8
8
8
40
40
16
16
Total ..............................................................................
........................
........................
........................
........................
112
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–29406 Filed 11–17–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0286]
Formal Meetings Between the Food
and Drug Administration and
Biosimilar Biological Product
Sponsors or Applicants; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled ‘‘Formal
Meetings Between the FDA and
Biosimilar Biological Product Sponsors
or Applicants.’’ This guidance provides
recommendations to industry on formal
meetings between FDA and sponsors or
SUMMARY:
VerDate Sep<11>2014
18:50 Nov 17, 2015
Jkt 238001
applicants relating to the development
and review of biosimilar biological
products regulated by the Center for
Drug Evaluation and Research (CDER)
and the Center for Biologics Evaluation
and Research (CBER). The guidance
assists sponsors and applicants in
generating and submitting meeting
requests and the associated meeting
packages to FDA for biosimilar
biological products. This guidance
finalizes the draft guidance issued on
April 1, 2013.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
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’’).
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
Written/Paper Submissions
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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,
E:\FR\FM\18NON1.SGM
18NON1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
72070
Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. [FDA–
2013–D–0286] for Formal Meetings
Between the FDA and Biosimilar
Biological Product Sponsors or
Applicants; 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
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
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 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: https://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 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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
VerDate Sep<11>2014
18:50 Nov 17, 2015
Jkt 238001
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002 or 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: Neel
Patel, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6483, Silver Spring,
MD 20993–0002, 301–796–0970; 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 ‘‘Formal
Meetings Between the FDA and
Biosimilar Biological Product Sponsors
or Applicants.’’ This guidance provides
recommendations to industry on formal
meetings between FDA and sponsors or
applicants relating to the development
and review of biosimilar biological
products regulated by CDER and CBER.
For the purposes of this guidance,
‘‘formal meeting’’ includes any meeting
that is requested by a sponsor or
applicant following the request
procedures provided in this guidance
and includes meetings conducted in any
format (i.e., face to face, teleconference,
or videoconference).
The Biologics Price Competition and
Innovation Act of 2009 amended the
Public Health Service Act (PHS Act) and
other statutes to create an abbreviated
licensure pathway in section 351(k) of
the PHS Act (42 U.S.C. 262(k)) for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological product (see
sections 7001 through 7003 of the
Patient Protection and Affordable Care
Act (Pub. L. 111–148)). The Biosimilar
User Fee Act of 2012 (BsUFA), enacted
as part of the Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–144), amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to authorize a new user
fee program for biosimilar biological
products. FDA has committed to
meeting certain performance goals in
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
connection with the new user fee
program. The performance goals, which
are set forth in a letter from the
Secretary of Health and Human Services
to the Chairman of the Committee on
Health, Education, Labor, and Pensions
of the Senate and the Chairman of the
Committee on Energy and Commerce of
the House of Representatives,1 include
meeting management goals for formal
meetings that occur between FDA and
sponsors or applicants during the
development phase of a biosimilar
biological product. This guidance
describes the Agency’s current thinking
on how it intends to interpret and apply
certain provisions of BsUFA, and also
provides information on specific
performance goals for the management
of meetings associated with the
development and review of biosimilar
biological products.
This guidance reflects a unified
approach to all formal meetings between
sponsors or applicants and FDA for
biosimilar biological product
development (BPD) programs. It is
intended to assist sponsors and
applicants in generating and submitting
a meeting request and the associated
meeting package to FDA for biosimilar
biological products. This guidance does
not apply to new drug or abbreviated
new drug applications under section
505 of the FD&C Act or to biologics
license applications under section
351(a) of the PHS Act.
FDA expects that review staff will
participate in many meetings with
biosimilar biological product sponsors
or applicants who seek guidance
relating to the development and review
of biosimilar biological products.
Because these meetings often will
represent critical points in the
regulatory process, it is important that
there are efficient, consistent procedures
for the timely and effective conduct of
such meetings. The good meeting
management practices in this guidance
are intended to provide consistent
procedures that will promote wellmanaged meetings and to ensure that
such meetings are scheduled within a
reasonable time, conducted efficiently,
and documented appropriately. The
following five meeting types that occur
between sponsors or applicants and
FDA staff during the biosimilar BPD
phase are described in the guidance: (1)
Biosimilar Initial Advisory meeting; (2)
BPD Type 1 meeting; (3) BPD Type 2
meeting; (4) BPD Type 3 meeting; and
(5) BPD Type 4 meeting.
1 See https://www.fda.gov/downloads/Drugs/
DevelopmentApprovalProcess/HowDrugsare
DevelopedandApproved/ApprovalApplications/
TherapeuticBiologicApplications/Biosimilars/
UCM281991.pdf.
E:\FR\FM\18NON1.SGM
18NON1
Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices
On April 1, 2013 (78 FR 19492), FDA
announced the availability of a draft
version of this guidance. All comments
received during the comment period for
the draft guidance have been reviewed
and, where appropriate, incorporated
into this guidance. As a result of the
public comments, information has been
added to provide clarity on the process
for requesting meetings, including
identifying the appropriate meeting
type, and the data expectations to
support the appropriate meeting type.
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 formal meetings
between FDA and biosimilar biological
product sponsors or applicants. 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.
Electronic Submissions
II. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that 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
this guidance was approved under OMB
control number 0910–0802.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: November 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–29455 Filed 11–17–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adverse Event
Reporting; Electronic Submissions
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
18:50 Nov 17, 2015
Jkt 238001
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
[Docket No. FDA–2012–N–0921]
AGENCY:
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the use of the FDA Electronic
Submission Gateway (ESG) and the
Safety Reporting Portal (SRP) to collect
adverse event reports and other safety
information for FDA-regulated products.
DATES: Submit either electronic or
written comments on the collection of
information by January 19, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
72071
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–
2012–N–0921 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Electronic Submission of Food and Drug
Administration Adverse Event Reports
and Other Safety Information Using the
Electronic Submission Gateway and the
Safety Reporting Portal.’’ 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 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
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 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: https://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 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 Division of Dockets
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Notices]
[Pages 72069-72071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29455]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0286]
Formal Meetings Between the Food and Drug Administration and
Biosimilar Biological Product Sponsors or Applicants; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Formal Meetings
Between the FDA and Biosimilar Biological Product Sponsors or
Applicants.'' This guidance provides recommendations to industry on
formal meetings between FDA and sponsors or applicants relating to the
development and review of biosimilar biological products regulated by
the Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER). The guidance assists sponsors
and applicants in generating and submitting meeting requests and the
associated meeting packages to FDA for biosimilar biological products.
This guidance finalizes the draft guidance issued on April 1, 2013.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments 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): 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,
[[Page 72070]]
marked and identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All submissions received must include the Docket No.
[FDA-2013-D-0286] for Formal Meetings Between the FDA and Biosimilar
Biological Product Sponsors or Applicants; 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 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 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 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: https://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 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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 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: Neel Patel, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6483, Silver Spring, MD 20993-0002, 301-796-0970; 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 ``Formal Meetings Between the FDA and Biosimilar Biological
Product Sponsors or Applicants.'' This guidance provides
recommendations to industry on formal meetings between FDA and sponsors
or applicants relating to the development and review of biosimilar
biological products regulated by CDER and CBER. For the purposes of
this guidance, ``formal meeting'' includes any meeting that is
requested by a sponsor or applicant following the request procedures
provided in this guidance and includes meetings conducted in any format
(i.e., face to face, teleconference, or videoconference).
The Biologics Price Competition and Innovation Act of 2009 amended
the Public Health Service Act (PHS Act) and other statutes to create an
abbreviated licensure pathway in section 351(k) of the PHS Act (42
U.S.C. 262(k)) for biological products shown to be biosimilar to, or
interchangeable with, an FDA-licensed biological product (see sections
7001 through 7003 of the Patient Protection and Affordable Care Act
(Pub. L. 111-148)). The Biosimilar User Fee Act of 2012 (BsUFA),
enacted as part of the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144), amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to authorize a new user fee program for
biosimilar biological products. FDA has committed to meeting certain
performance goals in connection with the new user fee program. The
performance goals, which are set forth in a letter from the Secretary
of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives,\1\ include meeting management goals for formal
meetings that occur between FDA and sponsors or applicants during the
development phase of a biosimilar biological product. This guidance
describes the Agency's current thinking on how it intends to interpret
and apply certain provisions of BsUFA, and also provides information on
specific performance goals for the management of meetings associated
with the development and review of biosimilar biological products.
---------------------------------------------------------------------------
\1\ See https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM281991.pdf.
---------------------------------------------------------------------------
This guidance reflects a unified approach to all formal meetings
between sponsors or applicants and FDA for biosimilar biological
product development (BPD) programs. It is intended to assist sponsors
and applicants in generating and submitting a meeting request and the
associated meeting package to FDA for biosimilar biological products.
This guidance does not apply to new drug or abbreviated new drug
applications under section 505 of the FD&C Act or to biologics license
applications under section 351(a) of the PHS Act.
FDA expects that review staff will participate in many meetings
with biosimilar biological product sponsors or applicants who seek
guidance relating to the development and review of biosimilar
biological products. Because these meetings often will represent
critical points in the regulatory process, it is important that there
are efficient, consistent procedures for the timely and effective
conduct of such meetings. The good meeting management practices in this
guidance are intended to provide consistent procedures that will
promote well-managed meetings and to ensure that such meetings are
scheduled within a reasonable time, conducted efficiently, and
documented appropriately. The following five meeting types that occur
between sponsors or applicants and FDA staff during the biosimilar BPD
phase are described in the guidance: (1) Biosimilar Initial Advisory
meeting; (2) BPD Type 1 meeting; (3) BPD Type 2 meeting; (4) BPD Type 3
meeting; and (5) BPD Type 4 meeting.
[[Page 72071]]
On April 1, 2013 (78 FR 19492), FDA announced the availability of a
draft version of this guidance. All comments received during the
comment period for the draft guidance have been reviewed and, where
appropriate, incorporated into this guidance. As a result of the public
comments, information has been added to provide clarity on the process
for requesting meetings, including identifying the appropriate meeting
type, and the data expectations to support the appropriate meeting
type.
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 formal meetings between FDA and biosimilar
biological product sponsors or applicants. 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 contains information collection provisions that 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 this guidance was approved under OMB
control number 0910-0802.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
Dated: November 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29455 Filed 11-17-15; 8:45 am]
BILLING CODE 4164-01-P
