Notice2024-13655
Human User Safety in New and Abbreviated New Animal Drug Applications; Guidance for Industry; Availability
Primary source
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Published
June 21, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 89 Issue 120 (Friday, June 21, 2024)</title>
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[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52053-52054]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13655]
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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.
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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 June 21, 2024].
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
[[Page 52054]]
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#2b404a594e4505585e5858464a456b4d4f4a05434358054c445d"><span class="__cf_email__" data-cfemail="472c2635222969343234342a262907212326692f2f3469202831">[email protected]</span></a>.
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
<a href="https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm">https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13655 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P
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