Notice2021-20514
Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Draft Guidance for Industry; Availability
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Published
September 23, 2021
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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry #253 entitled "Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products."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.
Full Text
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<title>Federal Register, Volume 86 Issue 182 (Thursday, September 23, 2021)</title>
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[Federal Register Volume 86, Number 182 (Thursday, September 23, 2021)]
[Notices]
[Pages 52911-52912]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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and Tissue-Based Products; Draft Guidance for Industry; Availability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announcing the availability of a draft guidance for industry #253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:
<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-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 <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 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, <a href="/cdn-cgi/l/email-protection#014d786f6f642f436e796473416765602f6969722f666e77"><span class="__cf_email__" data-cfemail="cc80b5a2a2a9e28ea3b4a9be8caaa8ade2a4a4bfe2aba3ba">[email protected]</span></a>.
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 <a href="https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm">https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm</a>, <a href="http://inside.fda.gov:9003/PolicyProcedures/GuidanceRegulations/FederalRegister/default.htm">http://inside.fda.gov:9003/PolicyProcedures/GuidanceRegulations/FederalRegister/default.htm</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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