[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1144-1145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31530]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-4778]
Heritable Intentional Genomic Alterations in Animals of Food-
Producing Species for Use as Models of Disease; Draft Guidance for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announcing the availability of a draft guidance for industry (GFI) #251
entitled ``Heritable Intentional Genomic Alterations in Animals of
Food-Producing Species for Use as Models of Disease.'' This draft
guidance, when finalized, will set forth FDA's policy regarding
heritable intentional genomic alterations (IGAs) in animals of food-
producing species, such as swine and rabbits, that are intended to be
marketed for use as models of human or animal disease in biomedical
research under contained and controlled conditions. The draft guidance
describes the conditions under which we generally may not expect
developers of IGAs in animal models of disease to submit an application
to FDA's Center for Veterinary Medicine (CVM) or to get our approval
before marketing their animals following CVM's prior review of risk
factor data.
DATES: Submit either electronic or written comments on the draft
guidance by March 10, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-4778 for ``Heritable Intentional Genomic Alterations in
Animals of Food-Producing Species for Use as Models of Disease.''
Received comments will be placed in the docket and, except
[[Page 1145]]
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: Adam Moyer, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 301-796-2319, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
#251 entitled ``Heritable Intentional Genomic Alterations in Animals of
Food-Producing Species for Use as Models of Disease.'' This guidance,
when finalized, will set forth FDA's policy regarding IGAs in animals
of food-producing species, such as swine and rabbits, that are intended
to be marketed for use as models of human or animal disease in
biomedical research under contained and controlled conditions (IGAs in
animal models of disease). This research may be basic research of
general applicability (e.g., understanding the underlying
pathophysiology of a disease or disease processes) or it may be
research or pre-clinical testing for a particular medical product that
may support an application for product approval (e.g., preclinical
trials of safety or effectiveness in altered animal models closely
resembling human disease).
In the Federal Register of May 2, 2024 (89 FR 35834), we announced
the availability of final GFI #187A entitled ``Heritable Intentional
Genomic Alterations in Animals: Risk-Based Approach.'' GFI #187A
clarifies that heritable IGAs in animals are subject to FDA oversight
and are regulated according to our risk-based regulatory approach. GFI
#187A indicates that while, in general, FDA approval of IGAs in animals
is required, under certain conditions we do not expect developers of
IGAs in animals to submit an application or get our approval before
marketing their product following our prior review of risk factor data.
Among these IGAs are those that GFI #187A describes as Category 2, for
which we may not expect developers to submit an application for
approval if, after analyzing data submitted about a product's risks, we
find we understand the product's risks for the specified intended use;
any identified risks, including their potential severity and likelihood
of occurring, are appropriately mitigated; and we have no further
questions for which we would need to see additional data.
In this draft GFI #251, we address those circumstances under which
we may not expect developers to submit an application for approval of
an IGA in an animal model of disease if, after looking at data
submitted about that product's risk, we determine that it appropriately
fits in Category 2. FDA believes that IGAs in animal models of disease
are likely to fit in Category 2 in part because the animals are
unlikely to enter the food supply or to escape and establish themselves
in the environment. For these reasons, based on case-by-case evaluation
of data and information as described in draft GFI #251, we may
determine that IGAs in an animal model of disease fits in Category 2,
and we do not expect developers of these IGAs to submit an application
for approval to us prior to marketing.
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
``Heritable Intentional Genomic Alterations in Animals of Food-
Producing Species for Use as Models of Disease.'' 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 514 have been approved under OMB control number 0910-
0032; the collections of information in 21 CFR part 511 have been
approved under OMB control number 0910-0117; and the collections of
information in 21 CFR part 58 have been approved under OMB control
number 0910-0119.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at 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: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31530 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P