[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28234-28236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12968]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 formal meetings between FDA and biosimilar 
biological product sponsors or applicants.

DATES: Submit either electronic or written comments on the collection 
of information by August 17, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time

[[Page 28235]]

at the end of August 17, 2018. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if 
they are postmarked or the delivery service acceptance receipt is on or 
before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your 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-2013-D-0286 for ``Guidance for Industry: Formal Meetings Between 
Between the FDA and Biosimilar Biological Product Sponsors or 
Applicants.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
    <bullet> 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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, 
<a href="/cdn-cgi/l/email-protection#055557445671646363456361642b6d6d762b626a73"><span class="__cf_email__" data-cfemail="124240534166737474527476733c7a7a613c757d64">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the 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 these topics: (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.

Guidance for Industry: Formal Meetings Between the FDA and Biosimilar 
Biological Product Sponsors or Applicants

OMB Control Number 0910-0802--Extension

    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 
Food and Drug Administration Reauthorization Act of 2017, authorizes 
user fees for biosimilar biological products. FDA has committed to 
meeting certain performance goals in connection with the reauthorized 
biosimilar user fee program. FDA developed a guidance for industry 
entitled ``Formal Meetings Between FDA and Biosimilar Biological 
Products Sponsors or Applicants'' 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. The guidance describes FDA's current

[[Page 28236]]

thinking on how the Agency intends 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 includes two 
types of information collections: (1) The submission of a meeting 
request containing certain information and (2) the submission of the 
information package(s) that accompany the meeting request. This 
information collection supports this Agency guidance document.

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. However, a sponsor or applicant should only 
submit such a request 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, 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),
    3. 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 and, as 
applicable, 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 is be used by FDA to facilitate formal meetings 
with biosimilar biological product sponsors.

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 of the listed questions, 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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  Guidance for Industry: 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
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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
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 the 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 of 
CDER meeting requests upward by six respondents. We attribute this 
change to an increase in biosimilar product development.

    Dated: June 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12968 Filed 6-15-18; 8:45 am]
 BILLING CODE 4164-01-P


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