Notice2022-19955
Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment
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Published
September 15, 2022
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 its most recent periodic reassessment of the definition of "small number of animals" for minor use in major species (contained in our existing regulation for new animal drugs for minor use and minor species). We also are announcing that the small number of animals upper limit thresholds (small numbers) for horses and the food-producing major species (cattle, pigs, turkeys, and chickens) will remain the same. We are separately issuing a direct final rule and a companion proposed rule to revise (i.e., increase) the small numbers for dogs and cats.
Full Text
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<title>Federal Register, Volume 87 Issue 178 (Thursday, September 15, 2022)</title>
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[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56681-56682]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19955]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0176]
Defining Small Number of Animals for Minor Use Determination;
Periodic Reassessment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of its most recent periodic reassessment of
the definition of ``small number of animals'' for minor use in major
species (contained in our existing regulation for new animal drugs for
minor use and minor species). We also are announcing that the small
number of animals upper limit thresholds (small numbers) for horses and
the food-producing major species (cattle, pigs, turkeys, and chickens)
will remain the same. We are separately issuing a direct final rule and
a companion proposed rule to revise (i.e., increase) the small numbers
for dogs and cats.
DATES: Submit either electronic or written comments on the notice at
any time.
ADDRESSES: You may submit comments 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-2008-N-0176 for ``Defining Small Numbers of Animals for Minor Use
Determination; Periodic Reassessment.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
[[Page 56682]]
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.
FOR FURTHER INFORMATION CONTACT: Margaret Oeller, Center for Veterinary
Medicine (HVF-50), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0566, email: <a href="/cdn-cgi/l/email-protection#3954584b5e584b5c4d17565c55555c4b795f5d581751514a175e564f"><span class="__cf_email__" data-cfemail="2d404c5f4a4c5f48590342484141485f6d4b494c0345455e034a425b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The Minor Use and Minor Species Animal Health Act of 2004 (Pub. L.
108-282) (the MUMS Act) amended the Federal Food, Drug, and Cosmetic
Act (FD&C Act) to provide incentives for the development of new animal
drugs for use in minor animal species and for minor uses in major
animal species. The MUMS Act defines ``minor use'' as the intended use
of a drug in a major species for an indication that occurs infrequently
and in only a small number of animals or in limited geographical areas
and in only a small number of animals annually (see section 201(pp) of
the FD&C Act (21 U.S.C. 321(pp)).
In the Federal Register of August 26, 2009 (74 FR 43043), we issued
a final rule to define the term ``small number of animals'' by
establishing for each major species of animal (horses, dogs, cats,
cattle, pigs, turkeys, and chickens) an upper limit threshold (i.e.,
small number) to provide a means of determining whether any particular
intended use of a new animal drug in one of these species would qualify
as a minor use under the MUMS Act. The small numbers for the seven
major species of animals as established in the ``small number of
animals'' definition at 21 CFR 516.3(b) are 50,000 horses, 70,000 dogs,
120,000 cats, 310,000 cattle, 1,450,000 pigs, 14,000,000 turkeys, and
72,000,000 chickens.
In our final rule, in response to comments, we agreed that periodic
reassessment of the small numbers is appropriate and that such
reassessments should occur approximately every 5 years. We conducted
our first reassessment in 2013 and published the results in the Federal
Register on May 19, 2014 (79 FR 28736). We concluded, based on that
reassessment, that no changes to the definition of ``small number of
animals'' were needed.
II. Current Reassessment
We conducted our second reassessment of the ``small number of
animals'' definition in 2018-2019 (current reassessment), and the
results of that reassessment are summarized in our memorandum ``2018-
2019 Reassessment of Small Numbers of Animals for Minor Use
Determination'' (Ref. 1). FDA developed different processes for
establishing small numbers for the major species of companion animals
and the major species of food-producing animals, and we continue to use
those processes for our periodic reassessments of the small numbers.
Both processes are described in detail in the preamble to the proposed
rule that published in the Federal Register on March 18, 2008 (73 FR
14411) and in our memorandum for the current reassessment (Ref. 1).
Based on our current reassessment, there is not an adequate basis
to propose revisions to the currently published small numbers for
horses and the food-producing major species. The small numbers for
horses and the four food-producing major species as established in the
current ``small number of animals'' definition in Sec. 516.3(b) are
listed in table 1.
Table 1--Current Small Numbers for Horses and the Food-Producing Major
Species
[21 CFR 516.3(b)]
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Species Small No.
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Horses..................................................... 50,000
Cattle..................................................... 310,000
Pigs....................................................... 1,450,000
Turkeys.................................................... 14,000,000
Chickens................................................... 72,000,000
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In separate documents published elsewhere in this issue of the
Federal Register, we are publishing a direct final rule to revise
(i.e., increase) the ``small numbers'' for dogs and cats, and a
proposed rule as a companion to the direct final rule under FDA's usual
procedures for notice and comment.
III. Paperwork Reduction Act of 1995
While this notice of reassessment of the small numbers 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 notice. The
previously approved collections of information are subject to review by
OMB under the PRA. The collections of information in 21 CFR 516.20 have
been approved under OMB control number 0910-0605.
IV. References
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
1. FDA Memorandum, ``2018-2019 Reassessment of Small Numbers of
Animals for Minor Use Determination,'' 2021.
Dated: September 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19955 Filed 9-14-22; 8:45 am]
BILLING CODE 4164-01-P
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