1144 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0611, 

lynne.boxer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry #260 

entitled ‘‘Type VII Veterinary Master 

File for Research and Development and 

Risk Reviews.’’ A Type VII VMF is a file 

that can receive submissions to FDA’s 

Center for Veterinary Medicine (CVM) 

that may contain confidential data and 

information related to unique regulatory 

considerations such as research and 

development of an ACTP, an IGA in an 

animal, gene therapy, or a risk review 

for an ACTP or IGA in an animal, where 

the information submitted is generally 

not intended to support product 

approval. The benefits of a Type VII 

VMF include: (1) confidential exchange 

of information with FDA that is not 

subject to user fees, (2) an opportunity 

for increased communication with FDA 

during early stages of product 

development, and (3) a process for 

reporting research studies outside of an 

investigational file. 

The scope of this draft guidance is 

limited to the use of Type VII VMFs for 

research and development and risk 

review requests. There are other uses of 

Type VII VMFs, but they are not 

addressed in this draft guidance. 

The use of a Type VII VMF is 

appropriate for research and 

development of ACTPs, gene therapies, 

and IGAs in animals, and for risk review 

of ACTPs and IGAs in animals because, 

for these types of novel products and 

rapidly evolving technologies, there 

may be unique regulatory 

considerations, concerning different 

types of issues, that may call for a 

developer’s interactions with CVM at an 

earlier stage than would normally take 

place with traditional products that 

CVM regulates. As described in the draft 

guidance, developers should open a 

Type VII VMF to cover these 

interactions with CVM. 

This level 1 draft guidance is being 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 The draft guidance, when 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 Type VII Veterinary 

Master File for Research and 

Development and Risk Reviews. 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. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. 

Dated: December 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31531 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–4778] 

Heritable Intentional Genomic 

Alterations in Animals of FoodProducing Species for Use as Models 

of Disease; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

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 FoodProducing 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 foodproducing 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 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 selfaddressed 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, 

Adam.Moyer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry #251 

entitled ‘‘Heritable Intentional Genomic 

Alterations in Animals of FoodProducing Species for Use as Models of 

Disease.’’ This guidance, when 

finalized, will set forth FDA’s policy 

regarding IGAs in animals of foodproducing 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 preclinical 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/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. 2024–31530 Filed 1–6–25; 8:45 am] 

BILLING CODE 4164–01–P 


ddrumheller on DSK120RN23PROD with NOTICES1