Notice2023-17261
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Draft Guidance for Industry; Availability
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Published
August 11, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products." This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biosimilar products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This draft guidance for industry revises and replaces the draft guidance of the same name issued in June 2018.
Full Text
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<title>Federal Register, Volume 88 Issue 154 (Friday, August 11, 2023)</title>
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[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54622-54624]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17261]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1922]
Formal Meetings Between the Food and Drug Administration and
Sponsors or Applicants of Biosimilar User Fee Act Products; Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 54623]]
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Formal
Meetings Between the FDA and Sponsors or Applicants of BsUFA
Products.'' This draft guidance provides recommendations to industry on
formal meetings between FDA and sponsors or applicants relating to the
development and review of biosimilar or interchangeable biosimilar
products regulated by the Center for Drug Evaluation and Research
(CDER) or the Center for Biologics Evaluation and Research (CBER). This
draft guidance for industry revises and replaces the draft guidance of
the same name issued in June 2018.
DATES: Submit either electronic or written comments on the draft
guidance by October 10, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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-2018-D-1922 for ``Formal Meetings Between the Food and Drug
Administration and Sponsors or Applicants of Biosimilar User Fee Act
Products.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993, 301-796-
1042, <a href="/cdn-cgi/l/email-protection#164577787264773854737862797856707277387e7e6538717960"><span class="__cf_email__" data-cfemail="eab98b848e988bc4a88f849e8584aa8c8e8bc4828299c48d859c">[email protected]</span></a>; or Anne Taylor, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants
of BsUFA Products.'' This draft guidance provides recommendations to
industry on formal meetings between FDA and sponsors or applicants
relating to the development and review of biosimilar or interchangeable
biosimilar products regulated by CDER or CBER. This draft guidance does
not apply to meetings associated with the development of products
intended for submission in, or review of, new drug applications or
abbreviated new drug applications under section 505 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355), biologics
license applications (BLAs) under section 351(a) of the Public Health
Service Act (PHS Act) (42 U.S.C. 262(a)), or submissions for devices
under the FD&C Act. For the purposes of this draft guidance, a formal
meeting includes any meeting that is requested by a sponsor or
applicant following the procedures provided in this draft guidance and
includes meetings conducted in any
[[Page 54624]]
format (i.e., in-person, virtual (video conference), teleconference, or
written response only). This guidance discusses the principles of good
meeting management practices and describes standardized procedures for
requesting, preparing, scheduling, conducting, and documenting such
formal meetings.
This draft guidance for industry revises and replaces the draft
guidance of the same name issued on June 5, 2018 (83 FR 26060). This
revision includes:
<bullet> Changes to the data expectations in Biosimilar Initial
Advisory meeting requests
<bullet> Addition of Biological Product Development (BPD) Type 2a
meeting
<bullet> Changes to when the meeting background package is submitted
for BPD Type 4 meeting
<bullet> Changes to the description of the available meeting formats
<bullet> Addition of an option for a request for clarification
FDA also made certain clarifying and editorial changes. Editorial
changes were made primarily for clarification.
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 current thinking of FDA on ``Formal
Meetings Between the FDA and Sponsors or Applicants of BsUFA
Products.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 regarding sponsor requests to FDA
related to the submission of an investigational new drug application
have been approved under OMB control number 0910-0014. The collections
of information in section 351(a) of the PHS Act and part 601 (21 CFR
part 601) relating to the submission of a BLA have been approved under
OMB control number 0910-0338. The collections of information in section
351(k) of the PHS Act and part 601 relating to the submission of
biosimilar applications and biosimilar user fee applications have been
approved under OMB control number 0910-0718.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17261 Filed 8-10-23; 8:45 am]
BILLING CODE 4164-01-P
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