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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2024-D-5376]

# 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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #260 entitled “Type VII Veterinary Master File for Research and Development and Risk Reviews.” This draft guidance, when finalized, will describe FDA's current thinking regarding the use of Type VII Veterinary Master Files (Type VII VMFs). Type VII VMFs are appropriate for research and development of animal cells, tissues, and cell- and tissue-based products (ACTPs), gene therapies, and heritable intentional genomic alterations (IGAs) in animals.

# 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Submit either electronic or written comments on the draft guidance by March 10, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-5376 for “Type VII Veterinary Master File for Research and Development and Risk Reviews.” 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 (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:

                        Lynne Boxer, Center for Veterinary Medicine, Food and Drug                               ( print page 1144)                            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/​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. 2024-31531 Filed 1-6-25; 8:45 am]

BILLING CODE 4164-01-P