[Federal Register Volume 89, Number 84 (Tuesday, April 30, 2024)]
[Notices]
[Pages 34253-34254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09286]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-1244]


Considerations for the Use of Human-and Animal-Derived Materials 
and Components in the Manufacture of Cell and Gene Therapy and Tissue-
Engineered Medical Products; Draft Guidance for Industry; Availability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) is announcing 
the availability of a draft document entitled ``Considerations for the 
Use of Human- and Animal-Derived Materials and Components in the 
Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical 
Products; Draft Guidance for Industry.'' The draft guidance document 
provides manufacturers of cellular and gene therapy (CGT) and tissue-
engineered medical products (TEMPs) with recommendations regarding 
assuring the safety, quality, and identity of materials of human and 
animal origin used in the manufacture of these products. In addition, 
recommendations are provided regarding the chemistry, manufacturing, 
and control (CMC) information submitted in an investigational new drug 
application (IND) relating to the use of human- and animal-derived 
materials.

DATES: Submit either electronic or written comments on the draft 
guidance by July 29, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2024-D-1244 for ``Considerations for the Use of Human- and Animal-
Derived Materials and Components in the Manufacture of Cell and Gene 
Therapy and Tissue-Engineered Medical Products; Draft Guidance for 
Industry.'' 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 draft guidance to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in 
processing your requests. The draft guidance may also be obtained by 
mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301,

[[Page 34254]]

Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft document entitled 
``Considerations for the Use of Human-and Animal-Derived Materials and 
Components in the Manufacture of Cell and Gene Therapy and Tissue-
Engineered Medical Products; Draft Guidance for Industry.'' The use of 
human- and animal-derived materials to manufacture CGT products and 
TEMPs raises several key issues to consider, including transmission of 
adventitious agents, material lot-to-lot consistency, and material 
identity, as well as general material qualification considerations. The 
draft guidance document provides manufacturers of CGT products and 
TEMPs with recommendations regarding assuring the safety, quality, and 
identity of materials of human and animal origin used in the 
manufacture of these products. In addition, recommendations are 
provided regarding the CMC information submitted in an IND relating to 
the use of human- and animal-derived materials.
    Human- and animal-derived materials may be used directly during 
manufacturing of a drug substance and a drug product. In addition, 
human- and animal-derived materials may be used in the manufacture of 
reagents or substrates used in manufacturing, such as cell banks, viral 
stocks, antibodies, and other proteins. Some common examples of human- 
and animal-derived materials include human or animal blood, antibodies 
produced in sera from animal hybridoma cells, and cytokines produced in 
insect cell lines.
    Use of human- and animal-derived materials during product 
manufacturing may increase risks of infectious disease transmission, 
and raises potential safety concerns, such as the possible introduction 
of adventitious agents or other impurities into CGT products and TEMPs. 
Human- and animal-derived materials can also contribute to product 
variability by affecting the reproducibility of the manufacturing 
process or the quality of the final product.
    The draft guidance, when finalized, is intended to supplement the 
following two final guidances: ``Chemistry, Manufacturing, and Control 
(CMC) Information for Human Gene Therapy Investigational New Drug 
Applications (INDs); Guidance for Industry'' dated January 2020, and 
``Guidance for FDA Reviewers and Sponsors: Content and Review of 
Chemistry, Manufacturing, and Control (CMC) Information for Human 
Somatic Cell Therapy Investigational New Drug Applications (INDs)'' 
dated April 2008.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of another human gene therapy final guidance document 
entitled ``Safety Testing of Human Allogeneic Cells Expanded for Use in 
Cell-Based Medical Products; Draft Guidance for Industry.''
    This 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 
``Considerations for the Use of Human- and Animal-Derived Materials and 
Components in the Manufacture of Cell and Gene Therapy and Tissue-
Engineered Medical 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. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR part 312 pertaining to the submission of investigational new 
drug applications have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 211 pertaining to 
current good manufacturing practice for finished pharmaceuticals have 
been approved under OMB control number 0910-0139. The collections of 
information in 21 CFR part 601 pertaining to biologics license 
applications have been approved under OMB control number 0910-0338. The 
collections of information in 21 CFR parts 610, 630, and 640 pertaining 
to current good manufacturing practice for blood and blood components 
have been approved under OMB control number 0910-0116. The collections 
of information in 21 CFR part 1271 pertaining to human cells, tissues, 
and cellular and tissue-based products have been approved under OMB 
control number 0910-0543. The collections of information in FDA's 
guidance entitled ``Formal Meetings Between the FDA and Sponsors or 
Applicants'' have been approved under OMB control number 0910-0001. The 
collections of information in FDA's guidance entitled, ``PHS Guideline 
on Infectious Disease Issues in Xenotransplantation'' have been 
approved under OMB control number 0910-0456.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    Dated: April 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09286 Filed 4-29-24; 8:45 am]
BILLING CODE 4164-01-P