Notice2026-03353
Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Minor Use and Minor Species
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Published
February 20, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with designation of new animal drugs for minor use and minor species and indexing of new animal drugs for minor species.
Full Text
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<title>Federal Register, Volume 91 Issue 34 (Friday, February 20, 2026)</title>
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[Federal Register Volume 91, Number 34 (Friday, February 20, 2026)]
[Notices]
[Pages 8253-8255]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03353]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-1305]
Agency Information Collection Activities; Proposed Collection;
Comment Request; New Animal Drugs for Minor Use and Minor Species
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection associated with
designation of new animal drugs for minor use and minor species and
indexing of new animal drugs for minor species.
DATES: Either electronic or written comments on the collection of
information must be submitted by April 21, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 21, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
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-2026-N-1305 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; New Animal Drugs for Minor Use
and Minor Species.'' Received comments, those filed in a timely manner
(see ADDRESSES), 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
[[Page 8254]]
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Kelly Covington, Center for Veterinary
Medicine, Food and Drug Administration, 5001 Campus Drive, College
Park, MD 20740, 240-402-5661, <a href="/cdn-cgi/l/email-protection#c090928193b4a1a6a680a6a4a1eea8a8b3eea7afb6"><span class="__cf_email__" data-cfemail="eabab8abb99e8b8c8caa8c8e8bc4828299c48d859c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
New Animal Drugs for Minor Use and Minor Species--21 CFR Part 516
OMB Control Number 0910-0605--Extension
This information collection supports implementation of sections 572
and 573 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21
U.SC. 360ccc-1 and 21 U.S.C. 360ccc-2) which establish requirements for
the Designation of a Minor Use or Minor Species New Animal Drug and
Index of Legally Marketed Unapproved New Animal Drugs for Minor
Species, respectively. Agency regulations are codified in 21 CFR part
516 and include recordkeeping and reporting requirements. The general
provisions in 21 CFR 516 subpart A set forth its purpose, scope, and
applicable definitions (21 CFR part 516 subpart A).
Regulations in 21 CFR part 516 subpart B provide for designation
status for Minor Use and Minor Species (MUMS) drugs prior to their
approval or conditional approval. MUMS-drug designation makes the
sponsor eligible for incentives to support the approval or conditional
approval of the designated use and is completely optional for drug
sponsors. The regulations describe how to apply for designation, what
needs to be submitted and other information pertaining to this option.
Sponsors of designated new animal drugs are required to demonstrate
``due diligence'' toward approval or conditional approval through
submission of annual reports documenting their progress for each
designated use. The FDA uses this information to allow for determining
eligibility for designation and the associated incentives and benefits
described in section 573 of the act, including a 7-year period of
exclusive marketing rights. It enables FDA to process requests for
MUMS-drug designation, requests to amend MUMS-drug designation, changes
in sponsorship, termination of MUMS-drug designation, requirements for
annual reports from sponsors, and provisions for insufficient
quantities of MUMS-designated drugs. Sponsors use FDA's ``eSubmitter''
system to fill out a series of system generated screens to submit their
request and annual report electronically. To access the ``eSubmitter''
system, sponsors will use a previously established account.
Regulations in 21 CFR 516 subpart C are intended to make more
medications legally available to veterinarians and animal owners for
the treatment of minor animal species (21 U.S.C. 360ccc). The purpose
of these regulations is to encourage the development of these new
animal drugs, while still ensuring appropriate safeguards for animal
and human health. In some cases, a minor species drug is intended for
use in species that are too rare or too varied to be the subject of
adequate and well-controlled studies in support of a drug approval. In
such cases, FDA may add the drug to the Index of Legally Marketed
Unapproved New Animal Drugs for Minor Species as provided for by
Section 572 of the FD&C Act (21 U.S.C. 360ccc-2). Within limitations
established by the statute, such indexing provides a basis for legally
marketing an unapproved new animal drug intended for use in a minor
species. FDA regulations in 21 CFR part 516 Subpart C specify, among
other things, the criteria and procedures for requesting eligibility
for indexing and for requesting addition to the Index, as well as the
annual reporting requirements for index holders. The administrative
procedures and criteria for indexing a new animal drug for use in a
minor species, as well as modifications and removal of a drug from the
index are also set forth. FDA uses the information for the activities
described above. Requestors can either mail paper submissions to the
FDA or use FDA's ``eSubmitter'' system to fill out a series of system
generated screens to submit their request electronically. To access the
``eSubmitter'' system, sponsors will use a previously established
account.
Description of Respondents: The respondents to this information
collection are pharmaceutical companies that sponsor new animal drugs
for designation or requesters wishing to add a new animal drug to the
Index.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average
21 CFR section; activity Number of responses per annual burden per Total
respondents respondent responses response hours
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Designated New Animal Drugs for Minor Use and Minor Species, Subpart B
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516.20; content and format of MUMS-drug 5 2 10 16 160
designation request............................
516.26; requirements for amending MUMS-drug 3 1 3 2 6
designation....................................
516.27; change in sponsorship of MUMS-drug 1 1 1 1 1
designation....................................
[[Page 8255]]
516.29; termination of MUMS-drug designation.... 2 1 2 1 2
516.30; requirements of annual reports from 26 2 52 2 104
sponsor(s) of MUMS-designated drugs............
516.36; consequences for insufficient quantities 1 1 1 3 3
of MUMS-designated drugs.......................
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Subtotal.................................... ........... .............. .......... ........... 276
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Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Subpart C
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516.119; requires a foreign drug company to 10 1 10 1 10
submit and update the name and address of a
permanent U.S. resident agent..................
516.121; written request for a meeting with FDA 15 2 30 4 120
to discuss the requirements for indexing a new
animal drug....................................
516.123; written request for an informal 3 1 3 8 24
conference and a requestor's written response
to an FDA initial decision denying a request...
516.125; correspondence and information 2 3 6 20 120
associated with investigational use of new
animal drugs intended for indexing.............
516.129; content and format of a request for 20 2 40 20 800
determination of eligibility for indexing......
516.141; information to be submitted to FDA by a 20 1 20 16 320
requestor seeking to establish a qualified
expert panel...................................
516.143; content and format of the written 20 1 20 120 2,400
report of the qualified expert panel...........
516.145; content and format of a request for 10 1 10 20 200
addition to the Index..........................
516.161; content and format of a request for 10 1 10 4 40
modification of an indexed drug................
516.163; information to be contained in a 1 1 1 2 2
request to FDA to transfer ownership of a
drug's index file to another person............
516.165; requires drug experience reports and 25 10 250 5 1,250
distributor statements to be submitted to FDA..
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Subtotal.................................... ........... .............. .......... ........... 5,286
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Total................................... ........... .............. .......... ........... 5,562
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Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Total
21 CFR section, activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
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Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Subpart C
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516.141, requires the qualified 30 2 60 0.5 (30 min.)........... 30
expert panel leader to maintain
a copy of the written report
and all notes or minutes
relating to panel deliberations
that are submitted to the
requestor for 2 years after the
report is submitted.
516.165, requires the holder of 25 2 50 1....................... 50
an indexed drug to maintain
records of all information
pertinent to the safety or
effectiveness of the indexed
drug, from foreign and domestic
sources.
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Total....................... ............... .............. ......... ........................ 80
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated reporting and recordkeeping burden for the
information collection reflects an overall increase of 60 hours and a
corresponding increase of 120 responses and records. We attribute this
adjustment to an increase in the number of submissions we received over
the last few years.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03353 Filed 2-19-26; 8:45 am]
BILLING CODE 4164-01-P
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