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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1156-1157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31532]

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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; 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 final guidance for industry #187B entitled 
``Heritable Intentional Genomic Alterations in Animals: The Approval 
Process.'' This guidance clarifies FDA's requirements and 
recommendations for developers of intentional genomic alterations 
(IGAs) in animals. The guidance is 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. 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.

DATES: The announcement of the guidance is published in the Federal 
Register on January 7, 2025.

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:
     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-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 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, 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, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 301-796-2319, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On May 2, 2024, FDA announced in the Federal Register the 
availability of two companion guidances to describe FDA's approach to 
regulating IGAs in animals. The notice of availability of the first of 
these two guidances, final GFI #187A, entitled ``Heritable Intentional 
Genomic Alterations in Animals: Risk-Based Approach'' (89 FR 35832), 
describes FDA's risk-based approach to the oversight of IGAs in 
animals.
    The second companion IGA guidance, draft GFI #187B entitled 
``Heritable Intentional Genomic Alterations in Animals: The Approval 
Process'' (89 FR 35834), describes how the FDA approval process applies 
to heritable IGAs in animals. Interested parties had until July 31, 
2024, to comment on the draft guidance.
    FDA received approximately 5,000 comments on draft GFI #187B, with 
4,982 of them resulting from two write-in campaigns. Those campaigns

[[Page 1157]]

criticized FDA regulation of IGAs in animals for neglecting animal 
welfare. The remaining comments came from industry (companies that 
produce IGAs and trade associations), individual developers of IGAs in 
animals, academics, non-governmental organizations (consumer, 
environmental), and individual consumers.
    FDA has made changes in the final GFI #187B that include additional 
explanation or clarification about: (1) how FDA's animal safety review 
includes animal health and well-being; (2) how compositional analysis 
relates to the food safety evaluation; (3) what FDA means by a 
``significant change'' with respect to durability; (4) what can be 
included in a single IGA-related application; (5) what methods, 
including methods other than whole genome sequencing, may be most 
appropriate for molecular characterization of the lineage of animals 
with the IGA; (6) further clarification regarding data expectations, 
including what data constitutes a ``full characterization'' of the site 
of alteration and potential unintended alterations; and (7) more 
detailed information on review timelines. In addition, editorial 
changes were made to improve clarity. The guidance announced in this 
notice finalizes the draft guidance dated May 2024.
    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: 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 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. 2024-31532 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
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