Notice2022-22816
Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Guidance for Industry; Availability
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Published
October 20, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 202 (Thursday, October 20, 2022)</title>
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[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63784-63785]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments.
[[Page 63785]]
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-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 <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 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, <a href="/cdn-cgi/l/email-protection#307c495e5e551e725f485542705654511e5858431e575f46"><span class="__cf_email__" data-cfemail="c488bdaaaaa1ea86abbca1b684a2a0a5eaacacb7eaa3abb2">[email protected]</span></a>.
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
<a href="https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm">https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm</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: 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
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