[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Notices]
[Pages 19492-19495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07445]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0286]


Draft Guidance for Industry on Formal Meetings Between FDA and 
Biosimilar Biological Product Sponsors or Applicants; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Formal 
Meetings Between the FDA and Biosimilar Biological Product Sponsors or 
Applicants.'' This draft guidance provides recommendations to industry 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 a meeting request 
and the associated meeting package to FDA for biosimilar biological 
products.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 31, 2013. Submit either electronic or written comments 
concerning the proposed collection of information by May 31, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or 
Office of Communication, Outreach, and Development (HFM-40), Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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 (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Formal Meetings Between the FDA and Biosimilar Biological 
Product Sponsors or Applicants.'' This draft 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 draft guidance, ``formal meeting'' includes any meeting that is 
requested by a sponsor or applicant following the request procedures 
provided in this draft guidance and includes meetings conducted in any 
format (i.e., face-to-face meeting, teleconference, or 
videoconference).
    The Biologics Price Competition and Innovation Act of 2009 amended 
the Public Health Service (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 draft 
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.
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    \1\ See http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM281991.pdf.
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    This draft 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 draft 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 (BLAs) under section 351(a) of the PHS Act.
    FDA expects that review staff will participate in many meetings 
with biosimilar biological product sponsors

[[Page 19493]]

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 draft 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 draft 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.
    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 Agency's current thinking on formal 
meetings between FDA and sponsors or applicants regarding biosimilar 
biological products. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501-
3520, Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information, including each proposed extension of an 
existing collection of information, before submitting the collection to 
OMB for approval. To comply with this requirement, FDA is publishing 
notice of the proposed collection of information set forth in this 
document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    The draft guidance on the procedures for formal meetings between 
FDA and biosimilar biological product sponsors or applicants describes 
procedures for requesting, scheduling, conducting, and documenting such 
formal meetings.
    The draft guidance describes two types of collections of 
information: (1) The submission of a meeting request containing certain 
information and (2) the submission of an information package that 
accompanies the meeting request. The draft guidance also refers to 
previously approved collections of information found in FDA 
regulations. The collections of information for 21 CFR 312.48 have been 
approved under OMB control number 0910-0014.

A. Request for a Meeting

    Under the draft guidance, a sponsor or applicant interested in 
meeting with CDER or CBER should submit a meeting request to the 
sponsor's or applicant's application (e.g., investigational new drug 
application, BLA) through the controlled document system. If there is 
no application, the request should be submitted to either the 
appropriate CDER division director with a copy sent to the division's 
chief of project management staff or to the division director of the 
appropriate product office within CBER. Before submitting any meeting 
request by fax or email when there is no application, the sponsor or 
applicant should contact the appropriate review division or the 
Biosimilars Program staff, CDER, Office of New Drugs, to determine to 
whom the request should be directed, how the request should be 
submitted, and the appropriate format for the request, and to arrange 
for confirmation of receipt of the request.
    FDA recommends that a request be submitted in this manner to 
prevent the possibility of faxed or emailed requests being overlooked 
because of the volume of emails received daily by FDA staff. Faxed or 
emailed requests should be sent during official business hours (8 a.m. 
to 4:30 p.m. EST/EDT) Monday through Friday (except Federal government 
holidays). Processing and receipt may be delayed for requests where 
confirmation of receipt has not been prearranged.
    Under the draft guidance, FDA requests that sponsors and applicants 
include in meeting requests certain information about the proposed 
meeting. This information includes:
    1. Product Name.
    2. Application Number (if applicable).
    3. Proposed Proper Name (or proper name if post-licensure).
    4. Structure (if applicable).
    5. Reference Product Name.
    6. Proposed Indication(s) or Context of Product Development.
    7. Meeting Type Being Requested (i.e., Biosimilar Initial Advisory 
meeting, BPD Type 1, 2, 3, or 4 meeting). The rationale for requesting 
the meeting type should be included.
    8. A Brief Statement of the Purpose of the Meeting. This statement 
should include a brief background of the issues underlying the agenda. 
It also can include a brief summary of completed or planned studies and 
clinical trials or data that the sponsor or applicant intends to 
discuss at the meeting, the general nature of the critical questions to 
be asked, and where the meeting fits in overall development plans. 
Although the statement need not provide detailed documentation of trial 
designs or completed studies and clinical trials, it should provide 
enough information to facilitate understanding of the issues, such as a 
small table that summarizes major results.
    9. A List of the Specific Objectives/Outcomes the Requester Expects 
from the Meeting.
    10. A Proposed Agenda, Including Estimated Times Needed for Each 
Agenda Item.
    11. A List of Questions, Grouped by Discipline. For each question 
there should be a brief explanation of the context and purpose of the 
question.
    12. A List of Ill Individuals with Their Titles and Affiliations 
Who Will Attend the Requested Meeting from the

[[Page 19494]]

Sponsor's or Applicant's Organization and Consultants.
    13. A List of FDA Staff, if Known, or Disciplines, Asked to 
Participate in the Requested Meeting.
    14. Suggested Dates and Times (e.g., morning or afternoon) for the 
Meeting Which are Within or Beyond the Appropriate Time Frame of the 
Meeting Type Being Requested.
    15. The Proposed Format of the Meeting (i.e., face-to-face meeting, 
teleconference, or videoconference).
    This information will be used by FDA to determine the utility of 
the meeting, to identify FDA staff necessary to discuss proposed agenda 
items, and to schedule the meeting.

B. Information Package

    FDA requests that a sponsor or applicant submit a meeting package 
to the appropriate review division with the meeting request. FDA 
recommends that information packages generally include:
    1. Product Name and Application Number (if applicable).
    2. Proposed Proper Name (or proper name if postlicensure).
    3. Structure (if applicable).
    4. Reference Product Name.
    5. Proposed Indication(s) or Context of Product Development.
    6. Dosage Form, Route of Administration, Dosing Regimen (frequency 
and duration), and Presentation(s).
    7. A List of Sponsor or Applicant Attendees, Affiliations, and 
Titles.
    8. A Background Section that Includes the Following:
    a. A brief history of the development program.
    b. The status of product development (e.g., chemistry, 
manufacturing, and controls; nonclinical; and clinical, including any 
development outside the United States, as applicable).
    9. A Brief Statement Summarizing the Purpose of the Meeting.
    10. A Proposed Agenda.
    11. A List of Questions for Discussion Grouped by Discipline and 
with a Brief Summary for Each Question to Explain the Need or Context 
for the Question.
    12. Data to Support Discussion Organized by Discipline and 
Question. The level of detail of the data should be appropriate to the 
meeting type requested and the product development stage.
    The purpose of the information package is to provide FDA staff the 
opportunity to adequately prepare for the meeting, including the review 
of relevant data concerning the product.
    Description of Respondents: A sponsor or applicant for a biosimilar 
biological product who requests a formal meeting with FDA regarding the 
development and review of a biosimilar biological product.
    Burden Estimate: Provided below is an estimate of the annual 
reporting burden for the submission of meeting requests and information 
packages under the draft guidance.
    The estimated number of respondents submitting meeting requests and 
information packages is based on the current workload and development 
expectations for biosimilar biological products. The burden hour 
estimate includes any time that may be needed by sponsors or applicants 
for rescheduling and canceling meetings, for premeetings and other 
communications with FDA about the meetings, and for resolution of 
disputes about meeting minutes.
    Based on the current workload and development expectations, FDA 
estimates that approximately 15 sponsors and applicants (respondents) 
may request approximately a total of 30 formal meetings, and submit 
approximately 30 information packages, with CDER annually, and 
approximately 1 respondent may request approximately 2 formal meetings, 
and submit approximately 2 information packages, with CBER annually.
    For a meeting request, the hours per response, which is the 
estimated number of hours that a respondent would spend preparing the 
information to be submitted with a meeting request in accordance with 
the draft guidance, is estimated to be approximately 15 hours. Based on 
FDA's experience, we expect it will take respondents this amount of 
time to gather and copy brief statements about the product and a 
description of the purpose and details of the meeting.
    For an information package, the hours per response, which is the 
estimated number of hours that a respondent would spend preparing the 
information package in accordance with the draft guidance, is estimated 
to be approximately 30 hours. Based on FDA's experience, we expect it 
will take respondents this amount of time to gather and copy brief 
statements about the product, a description of the details for the 
anticipated meeting, and data and information that generally would 
already have been compiled for submission to FDA. In total, we expect 
sponsors to spend 480 hours preparing meeting requests and 960 hours 
preparing information packages each year.

                                 Table 1--Estimated Annual Reporting Burden \1\
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 Draft guidance for industry on                                                       Average
 formal meetings between FDA and     Number of       Number of     Total annual     burden per
  biosimilar biological product     respondents    responses per     responses       response       Total hours
     sponsors or  applicants                        respondent                        (hours)
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Meeting Requests:
    CDER........................              15               2              30              15             450
    CBER........................               1               2               2              15              30
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    Total.......................  ..............  ..............  ..............  ..............             480
Information Packages:
    CDER........................              15               2              30              30             900
    CBER........................               1               2               2              30              60
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    Total.......................  ..............  ..............  ..............  ..............             960
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        Total...................  ..............  ..............  ..............  ..............           1,440
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 19495]]

IV. 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 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-07445 Filed 3-29-13; 8:45 am]
BILLING CODE 4160-01-P