Document ID: FDA-2008-N-0176-0021
Agency: fda
Document Type: Notice
Title: Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment
Posted Date: 2022-09-15T04:00Z

[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56681-56682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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: [email protected].

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 https://www.regulations.gov.

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]
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