Notice2023-07064
Human User Safety in New and Abbreviated New Animal Drug Applications; Draft Guidance for Industry; Availability
Primary source
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Published
April 5, 2023
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #278 (GFI #278) entitled "Human User Safety in New and Abbreviated New Animal Drug Applications." Human User Safety (HUS) is an integral component of the overall safety evaluation of proposed new animal drugs. FDA is issuing this guidance to clarify the current approaches and recommendations of FDA's Center for Veterinary Medicine (CVM) for HUS assessment and submission of HUS information to support the overall safety of proposed new animal drugs prior to approval.
Full Text
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<title>Federal Register, Volume 88 Issue 65 (Wednesday, April 5, 2023)</title>
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[Federal Register Volume 88, Number 65 (Wednesday, April 5, 2023)]
[Notices]
[Pages 20170-20171]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-07064]
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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Applications; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry #278 (GFI #278)
entitled ``Human User Safety in New and Abbreviated New Animal Drug
Applications.'' Human User Safety (HUS) is an integral component of the
overall safety evaluation of proposed new animal drugs. FDA is issuing
this guidance to clarify the current approaches and recommendations of
FDA's Center for Veterinary Medicine (CVM) for HUS assessment and
submission of HUS information to support the overall safety of proposed
new animal drugs prior to approval.
DATES: Submit either electronic or written comments on the draft
guidance by June 5, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
<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 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 draft 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#abc0cad9cec585d8ded8d8c6cac5ebcdcfca85c3c3d885ccc4dd"><span class="__cf_email__" data-cfemail="8ee5effcebe0a0fdfbfdfde3efe0cee8eaefa0e6e6fda0e9e1f8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of draft GFI #278 entitled
``Human User Safety in New and Abbreviated New Animal Drug
Applications.'' This draft 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 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 CVM.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR
[[Page 20171]]
10.115). The draft guidance, when finalized, will represent 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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 511 have been approved under OMB control
number 0910-0117; in 21 CFR part 514 have been approved under OMB
control numbers 0910-0032 and 0910-0284; in 21 CFR part 516 have been
approved under OMB control numbers 0910-0605 and 0910-0620; and in
section 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 draft guidance
at <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</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: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07064 Filed 4-4-23; 8:45 am]
BILLING CODE 4164-01-P
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