Notice2024-09279
Heritable Intentional Genomic Alterations in Animals: The Approval Process; Draft Guidance for Industry; Availability
Primary source
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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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #187B entitled "Heritable Intentional Genomic Alterations in Animals: The Approval Process." This draft guidance is intended to clarify FDA's requirements and recommendations for developers of intentional genomic alterations (IGA) in animals. The draft guidance is being issued as one of two companion documents. "Heritable Intentional Genomic Alterations in Animals: The Approval Process" describes how the FDA approval process applies to heritable IGAs in animals. FDA is issuing GFI #187B as a draft guidance to solicit comments that will enable the Agency to update, and make as efficient as possible, the approval process for IGAs in animals. In addition, FDA requests comments on questions that it intends to address in the final version of this guidance document. The companion final guidance, GFI #187A 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.
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 35834-35836]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09279]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-2648]
Heritable Intentional Genomic Alterations in Animals: The
Approval Process; Draft Guidance for Industry; Availability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)
#187B entitled ``Heritable Intentional Genomic Alterations in Animals:
The Approval Process.'' This draft guidance is intended to clarify
FDA's requirements and recommendations for developers of intentional
genomic alterations (IGA) in animals. The draft guidance is being
issued as one of two companion documents. ``Heritable Intentional
Genomic Alterations in Animals: The Approval Process'' describes how
the FDA approval process applies to heritable IGAs in animals. FDA is
issuing GFI #187B as a draft guidance to solicit comments that will
enable the Agency to update, and make as efficient as possible, the
approval process for IGAs in animals. In addition, FDA requests
comments on questions that it intends to address in the final version
of this guidance document. The companion final guidance, GFI #187A
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.
DATES: Submit either electronic or written comments on the draft
guidance by July 31, 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:
[[Page 35835]]
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-2019-D-2648 for ``Heritable Intentional Genomic Alterations in
Animals: The Approval Process.'' 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 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, <a href="/cdn-cgi/l/email-protection#c283a6a3afec8fadbba7b082a4a6a3ecaaaab1eca5adb4"><span class="__cf_email__" data-cfemail="6f2e0b0e02412200160a1d2f090b0e4107071c41080019">[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 GFI #187 and those
comments were considered as the guidance was revised. As noted, this
draft guidance, GFI #187B, is intended to explain how FDA's approval
process applies in the context of products related to heritable IGAs in
animals.
The draft guidance is being issued as one of two companion
documents. Draft GFI #187B, ``Heritable Intentional Genomic Alterations
in Animals: The Approval Process,'' describes how the FDA approval
process applies to heritable IGAs in animals. Final GFI #187A,
``Heritable Intentional Genomic Alterations in Animals: Risk-Based
Approach,'' whose notice of availability is published elsewhere in this
edition of the Federal Register, describes FDA's risk-based approach to
the oversight of IGAs in animals.
FDA received and reviewed 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. Among the changes made to
the draft guidance, we have:
<bullet> Indicated our willingness to consider multiple heritable
IGAs or a single IGA in multiple lines or breeds of animals of the same
species under a single application;
<bullet> Clarified that FDA's review of applications is subject to
specific timeframes;
<bullet> Acknowledged that it may not be feasible to gather data on
multiple generations and encourage developers of heritable IGAs in
animals to contact FDA to discuss alternative approaches of
demonstrating durability;
<bullet> Indicated that alternative disposition methods for
investigational animals may be acceptable if the sponsor contacts FDA's
Center for Veterinary Medicine;
<bullet> Further described post-market records and reports
requirements and clarified who they apply to; and
<bullet> Provided additional information on establishment
registration requirements, including explaining that, as a general
matter, pet stores, farms, or other animal production facilities do not
have to register or list with FDA and can engage in ordinary activities
(e.g., breeding, growing, etc.) without contacting FDA.
FDA is issuing this draft guidance to solicit public comment that
will further
[[Page 35836]]
improve it. To help inform our thinking as we begin the process of
further updating the guidance, we invite comment on the following
questions:
1. What are some alternative strategies for providing data that
would support approval of heritable IGAs in animals?
a. How can a developer demonstrate the durability of a heritable
IGA over time in situations where collection of data on multiple
generations of animals is difficult or not possible?
b. What are possible strategies a developer could utilize to
address the approval requirements for multiple heritable IGAs (e.g.,
multiple iterations of the same alteration resulting in the same
intended phenotype or multiple alterations resulting in more than one
intended phenotype) under a single approval?
2. What areas of current good manufacturing practices and good
laboratory practices specific to the production of heritable IGAs in
animals do you believe need clarification through the publication of
additional guidance?
3. Are there process improvements (e.g., combining steps of the
approval process) (see page 16, section IV.C. Recommended Process for
Completing Pre-approval Assessments for IGAs in Animals, of the
guidance) that you believe would make the approval process easier to
navigate?
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: The Approval
Process.'' 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 25 have been approved under OMB control number 0910-
0322; the collections of information in 21 CFR part 58 have been
approved under OMB control number 0910-0119; the collections of
information in 21 CFR part 207 have been approved under OMB control
number 0910-0045; the collections of information in 21 CFR part 211
have been approved under OMB control number 0910-0139; the collections
of information in 21 CFR part 511 have been approved under OMB control
number 0910-0117; the collections of information in 21 CFR part 514
have been approved under OMB control number 0910-0284; and the
collections of information in 21 CFR 558.6(a)(4) have been approved
under OMB control number 0910-0363.
III. Electronic Access
Persons with access to the internet may obtain the draft 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. 2024-09279 Filed 5-1-24; 8:45 am]
BILLING CODE 4164-01-P
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