4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-0592]
Human User Safety in New and Abbreviated New Animal Drug Applications; 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 (GFI) #278 entitled “Human User Safety in New and
Abbreviated New Animal Drug Applications.” This guidance is intended for sponsors interested
in pursuing the approval, or conditional approval, of new animal drugs (including new generic
animal drugs). This guidance addresses general principles of human user safety (HUS)
assessment for new animal drugs, sources of data, mitigation strategies for proposed new animal
drugs, potential recommendations to address HUS concerns, and how HUS information should
be submitted to the Center of Veterinary Medicine (CVM).
DATES: The announcement of the guidance is published in the Federal Register on [INSERT
DATE OF PUBLICATION IN THE FEDERAL REGISTER].
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-2023-D-0592

for “Human User Safety in New and Abbreviated New Animal Drug Applications.” 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Karen Sussman, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., Rockville MD 20855,
240-402-0876, karen.sussman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 5, 2023 (88 FR 20170), FDA published the notice of
availability for a draft guidance entitled “Human User Safety in New and Abbreviated New
Animal Drug Applications” giving interested persons until June 5, 2023, to comment on the draft
guidance. FDA received one comment submission on the draft guidance, and the comments in
that submission were considered as the guidance was finalized. The final guidance was revised
to clarify recommendations regarding the use of non-animal based or other alternative methods
to demonstrate user safety, use of labeling language to address risks to the human user, and
elements of drug handling prior to administration. Other editorial changes were also made to
improve clarity. The guidance announced in this notice finalizes the draft guidance dated April
2023.
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 “Human
User Safety in New and Abbreviated New Animal Drug Applications.” 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 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 0910-0032; and
the collections of information in 512(n)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b(n)(1)) have been approved under OMB control number 0910-0669.

III. Electronic Access
Persons with access to the internet may obtain the 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: June 17, 2024.

Lauren K. Roth,
Associate Commissioner for Policy.

[FR Doc. 2024-13655 Filed: 6/20/2024 8:45 am; Publication Date: 6/21/2024]