Notice2021-20517
Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Draft Guidance for Industry; Availability
Primary source
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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The Food and Drug Administration (FDA or Agency or we) is announcing the availability of a draft guidance for industry #254 entitled "Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products." FDA's Center for Veterinary Medicine (CVM) is issuing this guidance for sponsors, firms, individuals, and establishments that participate in the manufacture of, or perform any aspect of, the donor eligibility determination for animal cells, tissues, and cell- and tissue-based products (ACTPs), which meet the definition of new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Donor eligibility is a critical component of current good manufacturing practices (CGMPs) when manufacturing ACTPs. A donor should be considered eligible to donate ACTPs only if screening of the donor shows that the donor is free from risk factors for, and clinical evidence of, infection with relevant disease agents and diseases, and the donor (and product/source material) test results for relevant disease agents are negative or nonreactive.
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 52912-52914]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20517]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0401]
Donor Eligibility 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Tissue-Based Products; Draft Guidance for Industry; Availability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 or Agency or we) is
announcing the availability of a draft guidance for industry #254
entitled ``Donor Eligibility for Animal Cells, Tissues, and Cell- and
Tissue-Based Products.'' FDA's Center for Veterinary Medicine (CVM) is
issuing this guidance
[[Page 52913]]
for sponsors, firms, individuals, and establishments that participate
in the manufacture of, or perform any aspect of, the donor eligibility
determination for animal cells, tissues, and cell- and tissue-based
products (ACTPs), which meet the definition of new animal drugs under
the Federal Food, Drug, and Cosmetic Act (FD&C Act). Donor eligibility
is a critical component of current good manufacturing practices (CGMPs)
when manufacturing ACTPs. A donor should be considered eligible to
donate ACTPs only if screening of the donor shows that the donor is
free from risk factors for, and clinical evidence of, infection with
relevant disease agents and diseases, and the donor (and product/source
material) test results for relevant disease agents are negative or
nonreactive.
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-0401 for ``Donor Eligibility 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 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#337f4a5d5d561d715c4b5641735557521d5b5b401d545c45"><span class="__cf_email__" data-cfemail="14586d7a7a713a567b6c7166547270753a7c7c673a737b62">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
(GFI) #254 entitled ``Donor Eligibility for Animal Cells, Tissues, and
Cell- and Tissue-Based Products.'' This draft guidance is for sponsors,
firms, individuals, and establishments that participate in the
manufacture of, or perform any aspect of, the donor eligibility
determination for ACTPs, which meet the definition of new animal drugs
under section 201(v) of the FD&C Act (21 U.S.C. 321(v)). ACTPs that are
intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease or are intended to affect the structure or
function of the animal generally meet the definition of a new animal
drug. 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. Advances in the field of veterinary
regenerative medicine have resulted in increasing research into
veterinary applications for ACTPs, and many of these products are
intended for use as new animal drugs.
Donor eligibility is a critical component of CGMPs when
manufacturing ACTPs. Selecting appropriate donors is critical to
product quality and compliance with ACTP CGMPs. Establishments
performing any function related to donor eligibility should comply with
the ACTP CGMPs related to that function. A donor should be considered
eligible to donate ACTPs only if screening of the donor shows that the
donor is free from risk factors for, and clinical evidence of,
infection with relevant disease agents and
[[Page 52914]]
diseases, and the donor (and product/source material) test results for
relevant disease agents are negative or nonreactive. To prevent
transmission of disease when manufacturing ACTPs, it is necessary to
determine that donors are healthy and free from relevant disease
agents. Transmission of relevant disease agents by an ACTP may be the
result of the presence of relevant disease agents in the donated cells/
tissues (either within the cells/tissues, within other accompanying
cells/tissues, or in the extracellular components of the product).
The CGMP requirements for new animal drugs are found in Title 21
parts 210 and 211 of the Code of Federal Regulations (21 CFR parts 210
and 211). These regulations are broad in scope, and FDA recognizes that
they do not specifically or fully address some aspects of the
manufacture of ACTPs, including donor eligibility determinations. This
guidance offers FDA's recommendations for determining that a donor is
free from relevant disease agents and is an eligible source of cells,
tissues, or both, used in the manufacture of allogeneic or xenogeneic
ACTPs. We encourage sponsors and manufacturers of ACTPs to contact CVM
early in the product development process to discuss considerations
specific to approval of a new animal drug product.
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 donor
eligibility 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/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</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: September 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20517 Filed 9-22-21; 8:45 am]
BILLING CODE 4164-01-P
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