1156 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

Dated: December 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31543 Filed 1–6–25; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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 selfaddressed 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, 

Adam.Moyer@fda.hhs.gov. 

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: RiskBased 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 writein campaigns. Those campaigns 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 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/guidanceindustry, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–4689] 

Considerations for the Use of Artificial 

Intelligence To Support Regulatory 

Decision-Making for Drug and 

Biological Products; Draft Guidance 

for Industry; Availability; Comment 

Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Considerations for the Use of Artificial 

Intelligence To Support Regulatory 

Decision-Making for Drug and 

Biological Products.’’ In accordance 

with its mission of protecting, 

promoting, and advancing public 

health, FDA’s Center for Drug 

Evaluation and Research (CDER), in 

collaboration with the Center for 

Biologics Evaluation and Research 

(CBER), the Center for Devices and 

Radiological Health (CDRH), the Center 

for Veterinary Medicine (CVM), the 

Oncology Center of Excellence (OCE), 

the Office of Combination Products 

(OCP), and the Office of Inspections and 

Investigations (OII), is issuing this draft 

guidance to provide recommendations 

to industry on the use of artificial 

intelligence (AI) to produce information 

or data intended to support regulatory 

decision-making regarding the safety, 

effectiveness, or quality for drug and 

biological products. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 7, 2025 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit electronic or written comments 

on the proposed collection of 

information in the draft guidance by 

April 7, 2025. 

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. 


ddrumheller on DSK120RN23PROD with NOTICES1