[Federal Register Volume 86, Number 182 (Thursday, September 23, 2021)]
[Notices]
[Pages 52912-52914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20517]


-----------------------------------------------------------------------

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Tissue-Based Products; Draft Guidance for Industry; Availability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.

-----------------------------------------------------------------------

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announcing the availability of a draft guidance for industry #254 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DATES: Submit either electronic or written comments on the draft 
guidance by November 22, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 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) #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 https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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