[Federal Register Volume 86, Number 182 (Thursday, September 23, 2021)]
[Notices]
[Pages 52911-52912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20514]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Good Manufacturing Practices for Animal Cells, Tissues, and Cell- 
and Tissue-Based Products; Draft Guidance for Industry; Availability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, Agency, or we) is 
announcing the availability of a draft guidance for industry #253 
entitled ``Good Manufacturing Practices 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) meeting the definition of new animal drugs with recommendations 
for meeting requirements for current good manufacturing practices 
(CGMPs). All new animal drugs, including ACTPs, are required to be 
manufactured in accordance with CGMPS 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DATES: Submit either electronic or written comments on the draft 
guidance by November 22, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2021-D-0399 for ``Good Manufacturing Practices for Animal Cells, 
Tissues, and Cell- and Tissue-Based Products.''

[[Page 52912]]

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 draft 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

    FDA is announcing the availability of a draft guidance for industry 
(GFI) #253 entitled ``Good Manufacturing Practices for Animal Cells, 
Tissues, and Cell- and Tissue-Based Products.'' CVM is issuing this 
guidance to provide establishments that manufacture ACTPs with 
recommendations for meeting CGMP requirements. All new animal drugs, 
including ACTPs, are required to be manufactured in accordance with 
CGMPS to ensure that such drugs meet the requirements of the FD&C Act 
as to safety and have the identity, strength, quality, and purity 
characteristics that they purport to or are represented to possess. The 
CGMP requirements for new animal drugs are found in Title 21 parts 210 
and 211 of the Code of Federal Regulations (parts 210 and 211 (21 CFR 
parts 210 and 211)). The CGMP regulations in parts 210 and 211 are 
broad in scope, and we recognize that these regulations do not 
specifically or fully address all aspects of the manufacture of ACTPs, 
including early stages of the manufacturing process. This guidance 
provides our recommendations for complying with section 501(a)(2)(B) of 
the FD&C Act (21 U.S.C. 351(a)(2)(B)) for those aspects of 
manufacturing specific to ACTPs.
    ACTPs that meet the definition of a new animal drug are subject to 
the same statutory and regulatory requirements found under the FD&C Act 
and Title 21 of the CFR. Sponsors are responsible for ensuring that 
their products are manufactured in accordance with Federal law, 
including parts 210 and 211 and section 501(a)(2)(B) of the FD&C Act. 
New animal drugs not manufactured in conformity with CGMPs are 
adulterated under the relevant provisions of the FD&C Act.
    This guidance specifically addresses the methods, facilities, and 
controls used for manufacturing ACTPs, including steps in recovery, 
processing, storage, labeling, packaging, and distribution. We refer to 
our recommendations for meeting CGMPs in the manufacture of ACTPs as 
ACTP CGMPs. These ACTP CGMPs should be applied to consistently produce 
quality and to ensure that ACTPs are not contaminated and do not become 
contaminated during manufacturing.
    This level 1 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 good 
manufacturing practices 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 draft guidance 
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, http://inside.fda.gov:9003/PolicyProcedures/GuidanceRegulations/FederalRegister/default.htm, or https://www.regulations.gov.

    Dated: September 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20514 Filed 9-22-21; 8:45 am]
BILLING CODE 4164-01-P