[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54626-54627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17262]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1954]


Classification Categories for Certain Supplements Under the 
Biosimilar User Fee Amendments of 2022; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

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the availability of a draft guidance for industry entitled 
``Classification Categories for Certain Supplements Under BsUFA III.'' 
This draft guidance provides recommendations for applicants and FDA 
review staff on classification categories A, B, C, D, E, and F for 
original and resubmitted prior approval supplements submitted to 
approved applications under the Public Health Service Act (PHS Act). 
The commitment letter associated with the Biosimilar User Fee 
Amendments of 2022 (BsUFA III) sets forth these supplement 
classification categories and their associated review performance 
goals. This draft guidance is intended to help applicants identify the 
appropriate classification category and review goal date of the 
supplement being submitted.

DATES: Submit either electronic or written comments on the draft 
guidance by October 10, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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 identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-D-1954 for ``Classification Categories for Certain Supplements 
Under BsUFA III.'' Received comments 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, 240-402-7500.
     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.govinfo.gov/content/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, 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, 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 draft 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, [email protected]; 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 ``Classification Categories for Certain Supplements Under 
BsUFA III.'' This draft guidance provides recommendations for 
applicants and FDA review staff on classification categories A, B, C, 
D, E, and F for original and resubmitted prior approval supplements 
(hereafter ``supplements'') submitted to approved applications under 
section 351(k) of the PHS Act (42 U.S.C. 262(k)).
    These classification categories pertain to supplements for 
biosimilar and interchangeable biosimilar products seeking the 
following:


[[Page 54627]]


 To update prescribing information and, if applicable, FDA-
approved patient labeling (e.g., Patient Package Insert, Medication 
Guide, Instructions for Use) with safety information that has been 
updated in the reference product labeling and is applicable to one or 
more indications for which the biosimilar or interchangeable biosimilar 
product is licensed
 To receive licensure for an additional indication
 To remove an approved indication
 To receive an initial determination of interchangeability

    This draft guidance is intended to help applicants identify the 
appropriate classification category and review goal date of the 
supplement being submitted. Section I.A. of the commitment letter 
associated with the BsUFA III sets forth these supplement 
classification categories and their associated review performance 
goals. The full text of the proposed BsUFA III Commitment Letter can be 
found on the Agency's web page ``BsUFA III: Fiscal Years 2023-2027,'' 
available at https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027.
    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 
``Classification Categories for Certain Supplements Under BsUFA III.'' 
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 pertaining to the Biosimilar User Fee Program and for 
the submission of biologics license applications under section 351(k) 
of the PHS Act regarding biosimilar product applications, 
interchangeable biosimilar product applications, and supplemental 
applications have been approved under OMB control number 0910-0718. The 
collections of information in 21 CFR 201.56 and 201.57 for the 
submission of labeling have been approved under OMB control number 
0910-0572. The collections of information pertaining to Medication 
Guides for prescription human drug and biological products have been 
approved under OMB control number 0910-0393. The collections of 
information in 21 CFR part 601 for the submission of biologics license 
applications, supplemental applications, and Form FDA 356h have been 
approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17262 Filed 8-10-23; 8:45 am]
BILLING CODE 4164-01-P