[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64529-64531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25328]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0129]


Agency Information Collection Activities; Proposed Additional 
Collection; Comment Request; General Licensing Provisions; Section 
351(k) Biosimilar Applications; Formal Meetings Between the Food and 
Drug Administration and Sponsors or Applicants

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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/revision of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on ``General Licensing 
Provisions; Section 351(k) Biosimilar Applications; Formal Meetings 
Between the FDA and Sponsors or Applicants.''

DATES: Submit either electronic or written comments on the collection 
of information by January 21, 2020.

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 January 21, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 21, 2020. 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:
     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.
     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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     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

[[Page 64530]]

identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2012-N-0129 for ``General Licensing Provisions; Section 351(k) 
Biosimilar Applications; Formal Meetings Between the FDA and 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.
     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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 additional 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.

General Licensing Provisions; Section 351(k) Biosimilar Applications; 
Formal Meetings Between the FDA and Sponsors or Applicants

OMB Control Number 0910-0719--Revision

    The Biologics Price Competition and Innovation Act of 2009 (BPCI 
Act) amended the Public Health Service Act (PHS Act) and other statutes 
to create an abbreviated licensure pathway for biological products 
shown to be biosimilar to, or interchangeable with an FDA-licensed 
reference product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)), 
added by the BPCI Act, sets forth the requirements for an application 
for a proposed biosimilar product and an application or a supplement 
for a proposed interchangeable product. In addition to the submission 
requirements associated with a 351(k) application for a proposed 
biosimilar or interchangeable biological product, FDA is committed to 
meeting certain performance goals in connection with the FDA 
Reauthorization Act of 2017 (FDARA) and its Biosimilar User Fee (BsUFA) 
program. These performance goals are found in the commitment letter 
entitled, ``Biosimilar Biological Product Reauthorization Performance 
Goals and Procedures Fiscal Years 2018 Through 2022'' available from 
our website at: https://www.fda.gov/media/100573/download. Included in 
the performance goals is information collection associated with 
meetings and other communications with FDA, and we are therefore 
revising the information collection to cover these provisions. Also 
consistent with the commitment letter, we have developed the associated 
guidance document entitled ``Formal Meetings Between the FDA and 
Sponsors or Applicants of BsUFA Products.'' The guidance document 
discusses the BsUFA meeting management goal provisions set forth in the 
commitment letter and provides instruction and recommendations to 
respondents 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). The 
guidance is intended to assist sponsors or applicants in generating and 
submitting meeting requests and associated meeting packages to FDA for 
biosimilar biological products. A formal meeting includes any meeting 
that is requested by a sponsor or applicant following the procedures 
provided in the guidance and includes meetings conducted in any format 
(i.e., face to face, teleconference/videoconference, written response 
only (WRO)). The guidance, available from our website at https://www.fda.gov/media/113913/download, includes the following 
recommendations pertaining to BsUFA meeting requests and information 
packages:

A. Request for a Meeting

    We recommend that a sponsor or applicant interested in meeting with 
CDER or CBER submit a meeting request electronically 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

[[Page 64531]]

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. 
We recommend the following information be included in the meeting 
request:
    1. Application number (if previously assigned),
    2. development-phase code name of the product (if prelicensure),
    3. proper name (if post licensure),
    4. structure (if applicable),
    5. proper and proprietary names of the reference product,
    6. proposed indication(s) or context of product development,
    7. pediatric study plans, if applicable,
    8. human factors engineering plan, if applicable,
    9. combination product information (e.g., constituent parts, 
including details of the device constituent part, intended packaging, 
planned human factors studies), if applicable,
    10. meeting type being requested (the rationale for requesting the 
meeting type should be included),
    11. proposed format of the meeting (face to face, tele-conference/
video-conference/WRO),
    12. 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.
    13. a list of specific objectives/outcomes expected from the 
meeting,
    14. a proposed agenda, including times required for each agenda 
item,
    15. a list of questions grouped by discipline and a brief 
explanation of the context and purpose of each question,
    16. a list of all individuals with their titles and affiliations 
who will attend the requested meeting from the requestor's organization 
and any consultants and interpreters,
    17. a list of FDA staff, if known, or disciplines asked to 
participate in the requested meeting, and
    18. suggested dates and times for the meeting.

We use the information 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

    We recommend that a sponsor or applicant submit a meeting package 
to the appropriate review division with the meeting request and that 
the following information be included in the package:
    1. Application number (if previously assigned),
    2. development-phase code name of product (if pre-licensure) or 
proper name (if post-licensure),
    3. structure (if applicable),
    4. proprietary and proper names of the reference product,
    5. proposed indication(s) or context of product development,
    6. dosage form, route of administration, dosing regimen (frequency 
and duration), and presentation(s),
    7. pediatric study plans, if applicable,
    8. human factors engineering plan, if applicable,
    9. combination product information, if applicable,
    10. a list of all individuals with their titles and affiliations 
who will attend the requested meeting from the requestor's organization 
and any consultants and interpreters,
    11. 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),
    12. a brief statement summarizing the purpose of the meeting,
    13. the proposed agenda, and
    14. 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 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.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
  BsUFA information collection       Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
CDER Meeting Requests...........              36             2.5              89              15           1,335
CDER Information Packages.......              29             2.2              64              30           1,920
CBER Meeting Requests...........               2               1               2              15              30
CBER Information Packages.......               2               2               4              30             120
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           3,405
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Since last OMB review of the information collection we have 
increased our burden estimate by 95 annual responses and 1,965 annual 
hours. This adjustment corresponds with an increase in submissions 
received by the Agency over the past 3 years.

    Dated: November 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25328 Filed 11-21-19; 8:45 am]
BILLING CODE 4164-01-P


