Document ID: FDA-2021-D-0399-0005
Agency: fda
Document Type: Notice
Title: Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell-and-Tissue-Based Products; Guidance for Industry; Availability - #253 - Final Guidance
Posted Date: 2022-10-20T04:00Z

[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63784-63785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22816]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0399]

Current Good Manufacturing Practice for Animal Cells, Tissues, 
and Cell- and Tissue-Based Products; 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, Agency, or we) is 
announcing the availability of a final guidance for industry #253 
entitled ``Current Good Manufacturing Practice for Animal Cells, 
Tissues, and Cell- and Tissue-Based Products.'' FDA's Center for 
Veterinary Medicine (CVM) is issuing this guidance to provide 
establishments that manufacture animal cells, tissues, and cell- and 
tissue-based products (ACTPs) with recommendations for meeting 
requirements for current good manufacturing practice (CGMP). All new 
animal drugs, including ACTPs, are required to be manufactured in 
accordance with CGMP to ensure that such drugs meet the requirements of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, and 
have the identity, strength, quality, and purity characteristics, which 
they purport to or are represented to possess. This guidance also 
provides FDA's recommendations for those aspects of manufacturing 
specific to ACTPs in accordance with existing CGMP regulations, as 
applicable, and with the FD&C Act. In this guidance, we specifically 
address the methods, facilities, and controls used for manufacturing 
ACTPs.

DATES: The announcement of the guidance is published in the Federal 
Register on October 20, 2022.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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.

[[Page 63785]]

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-2021-D-0399 for ``Current Good Manufacturing Practice for Animal 
Cells, Tissues, and Cell- and Tissue-Based Products.'' 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 guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 
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: Lynne Boxer, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0611, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 23, 2021 (86 FR 52911), FDA 
published the notice of availability for a draft guidance entitled 
``Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and 
Tissue-Based Products'' giving interested persons until November 22, 
2021, to comment on the draft guidance. FDA received two submissions 
that contained multiple comments on the draft guidance and those 
comments were considered as the guidance was finalized. Editorial 
changes were made to improve clarity, for example, by making clear that 
the final guidance is intended to apply to xenogeneic, allogeneic, and 
autologous ACTPs and that under certain circumstances, we may not 
expect an individual veterinarian or veterinary practice engaged solely 
in recovering cells or tissues for further ACTP processing by third 
parties to register with FDA. Other editorial changes clarify 
definitions of terms used in the final guidance, such as the definition 
of the term ``establishment.'' The guidance announced in this notice 
finalizes the draft guidance dated September 2021.
    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on ``Current Good Manufacturing Practice 
for Animal Cells, Tissues, and Cell- and Tissue-Based 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 514 have been approved under OMB control 
number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22816 Filed 10-19-22; 8:45 am]
BILLING CODE 4164-01-P