Notice2024-09278
Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach; Guidance for Industry; Availability
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Published
May 2, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #187A entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach." This guidance is intended to clarify FDA's requirements and recommendations with respect to heritable intentional genomic alterations (IGAs) in animals. The guidance is being issued as one of two companion documents. This guidance, entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach," describes FDA's risk-based regulatory approach to the oversight of heritable IGAs in animals. This means that for people or companies developing certain types of IGAs in animals, FDA may not expect them to submit an application or get approval before marketing their product. For other types of IGAs in animals that do go through the approval process, the companion draft guidance document, GFI #187B entitled "Heritable Intentional Genomic Alterations in Animals: The Approval Process" describes how the approval process applies to heritable IGAs in animals.
Full Text
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<title>Federal Register, Volume 89 Issue 86 (Thursday, May 2, 2024)</title>
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[Federal Register Volume 89, Number 86 (Thursday, May 2, 2024)]
[Notices]
[Pages 35832-35834]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09278]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0394]
Heritable Intentional Genomic Alterations in Animals: Risk-Based
Approach; 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 final guidance for industry (GFI)
#187A entitled ``Heritable Intentional Genomic Alterations in Animals:
Risk-Based Approach.'' This guidance is intended to clarify FDA's
requirements and recommendations with respect to heritable intentional
genomic alterations (IGAs) in animals. The guidance is being issued as
one of two companion documents. This guidance, entitled ``Heritable
Intentional Genomic Alterations in Animals: Risk-Based Approach,''
describes FDA's risk-based regulatory approach to the oversight of
heritable IGAs in animals. This means that for people or companies
developing certain types of IGAs in animals, FDA may not expect them to
submit an application or get approval before marketing their product.
For other types of IGAs in animals that do go through the approval
process, the companion draft guidance document, GFI #187B entitled
``Heritable Intentional Genomic Alterations in Animals: The Approval
Process'' describes how the approval process applies to heritable IGAs
in animals.
DATES: The announcement of the guidance is published in the Federal
Register on May 2, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
[[Page 35833]]
<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-2008-D-0394 for ``Heritable Intentional Genomic Alterations in
Animals: Risk-Based Approach.'' 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Adam Moyer, Center for Veterinary
Medicine (HFV-108), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-796-2319, <a href="/cdn-cgi/l/email-protection#acedc8cdc182e1c3d5c9deeccac8cd82c4c4df82cbc3da"><span class="__cf_email__" data-cfemail="f5b4919498dbb89a8c9087b5939194db9d9d86db929a83">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 19, 2017 (82 FR 6561), FDA
published the notice of availability for a draft GFI #187 entitled
``Regulation of Intentionally Altered Genomic DNA in Animals'' giving
interested persons until April 19, 2017, to comment on the draft
guidance. On April 13, 2017, we published a notice announcing the
extension of the comment period to June 19, 2017 (82 FR 17844). FDA
received numerous comments on the draft guidance and those comments
were considered as the guidance was finalized. As noted, this guidance
is intended to clarify our risk-based regulatory approach for
developers of heritable IGAs in animals.
The guidance is being issued as one of two companion documents. GFI
#187A, ``Heritable Intentional Genomic Alterations in Animals: Risk-
Based Approach,'' describes FDA's risk-based approach to the oversight
of IGAs in animals. This means that, for people or companies developing
certain types of IGAs in animals, FDA may not expect them to submit an
application or get FDA approval before marketing their product. These
are IGAs in animals and animal products for which FDA finds that we
understand the product's risks for the specified intended use, any
identified risks are appropriately mitigated, and we have no further
questions for which we would need to see additional data to address.
The guidance explains that FDA's approach is risk-based and ranges
from:
<bullet> Category 1 products for which we do not expect developers
to consult with us prior to marketing an animal containing an IGA where
the risk is best understood and mitigated; to
<bullet> Category 2 products for which we may not expect developers
to submit an application for approval of the IGA if, after looking at
data submitted about that product's risk, we find that we understand
the product's risks for the specified intended use, any identified
risks are appropriately mitigated, and we have no further questions for
which we would need to see additional data to address; to
<bullet> Category 3 products for which FDA will review and, where
the data supports it, approve a product using data requirements that
are proportionate to the risk associated with the particular product.
Draft GFI #187B, ``Heritable Intentional Genomic Alterations in
Animals: The Approval Process,'' whose notice of availability is
published elsewhere in this edition of the Federal Register, describes
how the FDA approval process applies to heritable IGAs in animals.
FDA received comments on the draft guidance that came from industry
(companies that produce IGAs and trade associations), individual
consumers, academics, non-governmental organizations (consumer,
environmental), other Federal and State government agencies, and
individual developers of IGAs in animals. In the Federal Register
notice announcing availability of the draft guidance, FDA posed
questions regarding whether there
[[Page 35834]]
are categories of IGAs in animals that pose less risk and, if so, what
data or information supports that contention. No commenters provided
data to address the Agency's questions other than scientific literature
references that were not directly applicable or conclusive.
In the notice announcing availability of the draft guidance, FDA
also asked for comment on the appropriate terminology for animals with
intentional genomic alterations. Commenters expressed different
preferences, but there was no general consensus on an appropriate term.
FDA has adopted ``intentional genomic alteration'' or ``IGA'' in
animals as the term it will use to refer to intentional genomic
alterations in animals regardless of whether they are developed with
genetic engineering, including genome editing, or some other modern
molecular technology. This term is simple and sufficiently broad to
encompass intentional genomic alterations achieved through means that
currently exist and those yet to be developed. Moreover, section
740(d)(4)(B) of the Federal Food, Drug, and Cosmetic Act uses this term
(21 U.S.C. 379j-12(d)(4)(B)). However, the scope of the guidance does
not include induction of polyploidy by heat, pressure, or chemical
treatment, or selective breeding or other assisted reproductive
technologies. Non-heritable intentional genomic alterations in animals
are also outside the scope of this guidance document.
Changes FDA has made in response to comments include:
<bullet> Reorganization and use of plain language to make FDA's
regulatory approach clearer to stakeholders;
<bullet> Expansion of IGAs for which FDA may decide it does not
expect submission of an application for approval following a review of
data and a determination that the IGA meets the Category 2 description
in the guidance. The new types of IGAs include:
[ssquf] IGAs that are equivalent to genomic sequences that are
found in animals of the same species with a history of safe use in
animal agriculture food production and
[ssquf] IGAs that are equivalent to what could be theoretically
achieved through conventional breeding under certain conditions,
including that the IGAs are not expected to result in changes to food
composition and their intended use does not include any effect on
disease or other health outcome;
<bullet> Clarification that if you are:
[ssquf] ;a farmer, grower, or other entity that just has animals
with IGAs that FDA has approved or determined are Category 2 on your
farm or other premises, including the offspring of those animals,
[ssquf] and you are not the developer of the IGA in the animal or
marketing the animals with any new claims,
then, as a general matter, you do not have to register or list with FDA
and you can engage in your ordinary activities (e.g., breeding,
growing, etc.) without contacting FDA; and
<bullet> Clarification that those who breed an animal containing an
IGA that FDA has approved or has determined is Category 2:
[ssquf] with another animal containing an IGA that FDA has approved
or also determined is Category 2 or
[ssquf] with an animal that does not contain an IGA
and make no new claims do not need to contact FDA and nothing further
is required.
The guidance announced in this notice finalizes the draft guidance
dated January 2017.
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on ``Heritable Intentional Genomic
Alterations in Animals: Risk-Based Approach.'' 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
regarding environmental analysis in 21 CFR part 25 have been approved
under OMB control number 0910-0322; the collections of information
regarding applications in 21 CFR part 514 have been approved under OMB
control number 0910-0284; and the collections of information regarding
investigational exemptions in 21 CFR part 511 have been approved under
OMB control number 0910-0117.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<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: April 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09278 Filed 5-1-24; 8:45 am]
BILLING CODE 4164-01-P
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