Notice2024-13921
Priority Zoonotic Animal Drug Designation and Review Process; Guidance for Industry; Availability
Primary source
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Published
June 26, 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 #283 entitled "Priority Zoonotic Animal Drug Designation and Review Process." This guidance is intended to assist sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation for a new animal drug. This guidance is intended to provide the eligibility criteria for PZAD designation, the process for requesting PZAD designation, and enhancements in the FDA review process for PZADs.
Full Text
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<title>Federal Register, Volume 89 Issue 123 (Wednesday, June 26, 2024)</title>
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[Federal Register Volume 89, Number 123 (Wednesday, June 26, 2024)]
[Notices]
[Pages 53427-53428]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13921]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-3740]
Priority Zoonotic Animal Drug Designation and Review Process;
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 #283 entitled
``Priority Zoonotic Animal Drug Designation and Review Process.'' This
guidance is intended to assist sponsors pursuing Priority Zoonotic
Animal Drug (PZAD) designation for a new animal drug. This guidance is
intended to provide the eligibility criteria for PZAD designation, the
process for requesting PZAD designation, and enhancements in the FDA
review process for PZADs.
DATES: The announcement of the guidance is published in the Federal
Register on June 26, 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-3740 for ``Priority Zoonotic Animal Drug Designation and
Review Process.'' 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Evgenij Evdokimov, Center for
Veterinary Medicine (HFV-108), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0712,
<a href="/cdn-cgi/l/email-protection#f693809193989f9cd8938092999d9f9b9980b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="a1c4d7c6c4cfc8cb8fc4d7c5cecac8ccced7e1c7c5c08fc9c9d28fc6ced7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
[[Page 53428]]
I. Background
In the Federal Register of December 18, 2023 (88 FR 87433), FDA
published the notice of availability for a draft GFI #283 entitled
``Priority Zoonotic Animal Drug Designation and Review Process'' giving
interested persons until February 16, 2024, to comment on the draft
guidance. FDA received several comments on the draft guidance and those
comments were considered as the guidance was finalized. Changes to the
final guidance include the following: providing examples of preliminary
clinical evidence for the purposes of PZAD designation; confirming that
PZAD indications may appear on the same product labeling as non-PZAD
indications; and confirming that PZAD designation does not impact
potential qualification for other review incentive programs within or
outside of the Center for Veterinary Medicine. In addition, editorial
changes were made to improve clarity. The guidance announced in this
notice finalizes the draft guidance dated December 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 the Priority Zoonotic Animal Drug
Designation and Review Process. 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 511.1 have been approved
under OMB control number 0910-0117.
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. 2024-13921 Filed 6-25-24; 8:45 am]
BILLING CODE 4164-01-P
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