[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This guidance finalizes the draft guidance issued on April 1, 2013.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: 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,

[[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 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 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 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 http://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 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://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