
[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Pages 32157-32160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13695]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Formal Meetings Between the Food and Drug Administration and 
Biosimilar Biological Product Sponsors or Applicants

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by July 6, 
2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the title. Also include the FDA 
docket number found in brackets in the heading of this document.

[[Page 32158]]


FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry on Formal Meetings Between FDA and Biosimilar 
Biological Product Sponsors or Applicants OMB Control Number 0910--NEW

    In the Federal Register of April 1, 2013 (78 FR 19492), FDA 
announced the availability of a draft guidance for industry entitled 
``Formal Meetings Between FDA and Biosimilar Biological Product 
Sponsors or Applicants.'' The guidance provided 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). 
This guidance assists sponsors and applicants in generating and 
submitting a meeting request and the associated meeting package to FDA 
for biosimilar biological products.
    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. 11 2-144), 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, 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 
described 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.
    The 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. 
The 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 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.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance 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.
    The 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 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 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 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 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.

[[Page 32159]]

    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 All Individuals with Their Titles and Affiliations 
Who Will Attend the Requested Meeting from the 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 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 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 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.
    In the Federal Register of April 1, 2013 (78 FR 19492), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. None of the comments pertained to the 
information collection provisions in the draft guidance.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
 Guidance for industry on formal
    meetings between FDA and         Number of       Number of     Total annual   Average burden
  biosimilar biological product     respondents    responses per     responses     per response     Total hours
     sponsors or applicants                         respondent                        (hours)
----------------------------------------------------------------------------------------------------------------
Meeting Requests:
    CDER........................              15               2              30              15             450

[[Page 32160]]

 
    CBER........................               1               2               2              15              30
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............             480
----------------------------------------------------------------------------------------------------------------
Information Packages:
    CDER........................              15               2              30              30             900
    CBER........................               1               2               2              30              60
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............             960
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............           1,440
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

C. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and is 
available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address in this reference section, but we are not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)

    1. See http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM281991.pdf.

    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13695 Filed 6-4-15; 8:45 am]
 BILLING CODE 4164-01-P


