Notice2024-09286
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Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry; Availability
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Published
April 30, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry." The draft guidance document provides manufacturers of cellular and gene therapy (CGT) and tissue- engineered medical products (TEMPs) with recommendations regarding assuring the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.
Full Text
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<title>Federal Register, Volume 89 Issue 84 (Tuesday, April 30, 2024)</title>
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[Federal Register Volume 89, Number 84 (Tuesday, April 30, 2024)]
[Notices]
[Pages 34253-34254]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Engineered Medical Products; Draft Guidance for Industry; Availability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Products; Draft Guidance for Industry.'' The draft guidance document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:
<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-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 <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 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 <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</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: 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
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</html>Indexed from Federal Register on April 30, 2024.
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