[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Notices]
[Pages 45942-45944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19674]


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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: Formal Meetings Between the Food and Drug Administration and 
Biosimilar Biological Product Sponsors or Applicants

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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.

DATES: Fax written comments on the collection of information by October 
11, 2018.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0802. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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: Formal Meetings between the Food and Drug 
Administration and Biosimilar Biological Product Sponsors or 
Applicants.
    OMB Control No. 0910-0802--Extension.

[[Page 45943]]

    This information collection supports the above captioned Agency 
guidance. The Biologics Price Competition and Innovation Act of 2009, 
the Biosimilar User Fee Act of 2012, and the recent passage of the 
Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the 
FDA Reauthorization Act of 2017, authorize user fees for biosimilar 
biological products. FDA has committed to meeting certain performance 
goals in connection with the reauthorized biosimilar user fee program. 
To provide 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) or the Center for Biologics Evaluation 
and Research (CBER) and assist sponsors and applicants in generating 
and submitting meeting requests and the associated meeting packages to 
FDA for biosimilar biological products, we developed guidance for 
industry entitled ``Formal Meetings Between FDA and Biosimilar 
Biological Products Sponsors or Applicants.'' The guidance describes 
our current thinking on how we intend to interpret and apply certain 
provisions of BsUFA II and provides information on specific performance 
goals for the management of meetings associated with the development 
and review of biosimilar biological products. The guidance document 
includes two types of information collection: (1) The submission of a 
meeting request containing certain information and (2) the submission 
of the information package(s) that accompany the meeting request.

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 (i.e., investigational new drug application, 
biologics license application). If there is no application, a sponsor 
or applicant should submit the request 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, but only after first contacting the 
appropriate review division or the Biosimilars Program staff, CDER, 
Office of New Drugs to determine to whom the request should be 
directed, how it should be submitted, and the appropriate format for 
the request and to arrange for confirmation of receipt of the request. 
Under the guidance, FDA requests that sponsors and applicants 
incorporate certain information in the meeting request, including:
    1. Product name,
    2. application number (if applicable), proposed proper name or 
proper name (post licensure),
    4. structure,
    5. reference product name,
    6. proposed indication(s) or context of product development,
    7. meeting type being requested (the rationale for requesting the 
meeting type should be included),
    8. a brief statement of the purpose of the meeting, including a 
brief background of the issues underlying the agenda. It can also 
include a brief summary of completed or planned studies and clinical 
trials or data 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 the overall development plans.
    9. a list of specific objectives/outcomes expected from the 
meeting,
    10. a proposed agenda, including times required for each agenda 
item,
    11. a list of questions grouped by discipline and a brief 
explanation of the context and purpose of each question,
    12. a list of all individuals with their titles and affiliations 
who will attend the requested meeting from the requestor'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 for the meeting, and
    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 the information packages generally include:
    1. Product name and application number (if applicable),
    2. proposed proper name or proper name (post licensure),
    3. structure,
    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 all sponsor's or applicant's attendees and consultants 
with their titles and affiliations who will attend the requested 
meeting,
    8. background that includes a brief history of the development 
program and 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. the 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, and
    12. data to support discussion organized by discipline and 
question.
    The purpose of the meeting 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.
    In the Federal Register of June 18, 2018 (83 FR 28234), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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GFI: Formal meetings between FDA                     Number of
    and biosimilar biological        Number of     responses per   Total annual   Average burden    Total hours
 product sponsors or applicants     respondents     respondent       responses     per response
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CDER Meeting Requests...........              36             2.5              89              15           1,335
CBER Meeting Requests...........               2               1               2              15              30
CDER Information Packages.......              29             2.2              64              30           1,920

[[Page 45944]]

 
CBER Information Packages.......               2               2               4              30             120
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    Total.......................  ..............  ..............  ..............  ..............           3,405
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Since last OMB approval, there has been an increase in meeting 
requests with CDER and a corresponding increase in the number of 
information packages. Accordingly, we have adjusted our estimate upward 
by six respondents to CDER meeting requests. We attribute this change 
to an increase in biosimilar product development.

    Dated: September 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19674 Filed 9-10-18; 8:45 am]
 BILLING CODE 4164-01-P