Notice2025-19565
Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication; Guidance for Industry; Availability
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Published
October 16, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry (GFI) #299 entitled "Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication." This guidance is intended to inform new animal drug sponsors that dual labeling of a new animal drug product may include an intended use that is fully approved under section 512(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and an intended use that is conditionally approved under section 571 of the FD&C Act where the claim to be added to the existing product labeling is intended to treat or prevent New World screwworm myiasis.
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<title>Federal Register, Volume 90 Issue 198 (Thursday, October 16, 2025)</title>
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[Federal Register Volume 90, Number 198 (Thursday, October 16, 2025)]
[Notices]
[Pages 48313-48314]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19565]
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Federal Register / Vol. 90, No. 198 / Thursday, October 16, 2025 /
Notices
[[Page 48313]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-4500]
Dual Labeling for Fully Approved and Conditionally Approved New
Animal Drugs With a New World Screwworm-Related Indication; 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, the Agency, or we) is
announcing the availability of a final guidance for industry (GFI) #299
entitled ``Dual Labeling for Fully Approved and Conditionally Approved
New Animal Drugs With a New World Screwworm-Related Indication.'' This
guidance is intended to inform new animal drug sponsors that dual
labeling of a new animal drug product may include an intended use that
is fully approved under section 512(b) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) and an intended use that is conditionally
approved under section 571 of the FD&C Act where the claim to be added
to the existing product labeling is intended to treat or prevent New
World screwworm myiasis.
DATES: The announcement of the guidance is published in the Federal
Register on October 16, 2025.
ADDRESSES: You may submit either electronic or written/paper 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-2025-D-4500 for ``Dual Labeling for Fully Approved and
Conditionally Approved New Animal Drugs With a New World Screwworm-
Related Indication.'' 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, Center for Veterinary Medicine, 5100
Campus Drive, College Park, MD 20740-3840. Send two self-addressed
adhesive labels to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: <a href="/cdn-cgi/l/email-protection#4c0d1f070f1a010c2a282d6224243f622b233a"><span class="__cf_email__" data-cfemail="e2a3b1a9a1b4afa2848683cc8a8a91cc858d94">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of guidance for industry #299
entitled ``Dual Labeling for Fully Approved and Conditionally Approved
New Animal Drugs With a New World Screwworm-Related Indication.'' We
are issuing this
[[Page 48314]]
guidance consistent with our good guidance practices (GGP) regulation
(Sec. 10.115 (21 CFR 10.115)). We are implementing this guidance
without initially seeking prior public comment because we have
determined that prior public participation is not feasible or
appropriate (see Sec. 10.115(g)(2)). We made this determination in
light of the significant potential for a public health emergency
associated with New World Screwworm, Cochliomyia hominivorax, (NWS).
NWS is a parasitic fly that lays eggs in and on open wounds and
mucous membranes of warm-blooded animals. NWS can infest livestock,
pets, wildlife, occasionally birds, and in rare cases, people. Although
eradicated from North America and Central America decades ago, NWS has
progressed north since 2022 and is approaching the U.S. border with
Mexico. This parasite poses an emerging threat to livestock and food
security, with potential impacts on both national security and animal
health. In order to respond effectively and efficiently to this threat,
FDA must act expeditiously to review and, where appropriate, approve or
authorize animal drugs for NWS myiasis.\1\ Such approvals may include
conditional approvals under section 571 of the FD&C Act for new
indications for products that are currently approved for a different
indication(s) under section 512 of the FD&C Act.
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\1\ We note that this guidance document is relevant to new
animal drugs with approved and conditionally approved claims.
Emergency Use Authorizations under section 564 of the FD&C Act are
outside the scope of this guidance.
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Section 571(f)(2) of the FD&C Act permits the agency, through
regulation or guidance, to determine under what conditions an intended
use that is the subject of a conditional approval may be included in
the same product label with any intended use approved under section 512
of the FD&C Act, i.e., a full approval. The guidance document refers to
this practice as ``dual labeling.'' While FDA intends to issue guidance
in the future to more broadly address conditions under which it would
consider dual labeling appropriate, FDA is issuing this guidance
concerning products with indications for NWS at this time due to the
particular need to act quickly and efficiently to address the imminent
health threat of NWS.
Although this guidance document is immediately in effect, it
remains subject to comment in accordance with FDA's GGP regulation.
The guidance represents the current thinking of FDA on ``Dual
Labeling for Fully Approved and Conditionally Approved New Animal Drugs
With a New World Screwworm-Related Indication.'' 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 new 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 sections 512 and 571 of the FD&C Act (21 U.S.C. 360b) have been
approved under 0910-0032. The collections of information in 21 CFR
514.80 have been approved under 0910-0284.
III. Electronic Access
Persons with access to the internet may obtain the document at
<a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, or <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>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-19565 Filed 10-15-25; 8:45 am]
BILLING CODE 4164-01-P
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