[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Rules and Regulations]
[Pages 56583-56589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19954]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 516

[Docket No. FDA-2022-N-1128]
RIN 0910-AI46


Defining Small Number of Animals for Minor Use Determination; 
Periodic Reassessment

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
revising the ``small number of animals'' definition for dogs and cats 
in our existing regulation for new animal drugs for minor use or minor 
species. The Minor Use and Minor Species Animal Health Act of 2004 
(MUMS Act) provides incentives to encourage animal drug sponsors to 
develop and seek FDA approval of drugs intended for use in minor animal 
species or for minor uses in major animal species. Congress provided a 
statutory definition of ``minor use'' that relies on the phrase ``small 
number of animals'' to characterize such use. We are revising the 
definition of ``small number of animals'' based on our most recent 
reassessment of the small numbers, which we conducted from 2018 to 
2019.

DATES: This rule is effective December 14, 2022. Either electronic or 
written comments on this direct final rule or its companion proposed 
rule must be submitted by November 14, 2022. If FDA receives no 
significant adverse comments within the specified comment period, the 
Agency intends to publish a document confirming the effective date of 
the final rule in the Federal Register within 30 days after the comment 
period on this direct final rule ends. If timely significant adverse 
comments are received, the Agency will publish a document in the 
Federal Register withdrawing this direct final rule within 30 days 
after the comment period on this direct final rule ends.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 14, 2022. 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:
     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.

[[Page 56584]]

     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-2022-N-1128 for ``Defining Small Number of Animals for Minor Use 
Determination; Periodic Reassessment.'' Received comments, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' will be 
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: 

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Direct Final Rule
    B. Summary of the Major Provisions of the Direct Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations and Commonly Used Acronyms in This 
Document
III. Background
    A. Introduction
    B. History of Defining Small Numbers for Dogs and Cats
    C. Need for the Regulatory Action
IV. Legal Authority
V. Description of the Direct Final Rule
    A. Revisions to the ``Small Number of Animals'' Definition in 
Sec.  516.3
    B. Reassessment of the Small Numbers for Dogs and Cats
VI. Direct Final Rulemaking
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose and Coverage of the Direct Final Rule

    This direct final rule amends the definition of ``small number of 
animals'' as it relates to dogs and cats in our regulation implementing 
the MUMS Act. The term ``minor use'' is 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 occurs in limited geographical areas and in 
only a small number of animals annually. The ``small number of 
animals'' definition is used for purposes of determining whether a 
particular intended use of a drug in one of the seven major species of 
animals (horses, dogs, cats, cattle, pigs, turkeys, and chickens) 
qualifies as a minor use. In March 2008, FDA issued a proposed rule to 
establish the meaning of ``small number of animals'' as that term is 
used in the definition of minor use included in the Federal Food, Drug, 
and Cosmetic Act (FD&C Act). FDA finalized the rule in August 2009. The 
definition for the phrase ``small number of animals'' includes a 
specific upper limit number (i.e., small number) for each of the seven 
major species of animals.
    In response to comments submitted to FDA regarding the 2008 
proposed rule, we stated in the final rule that we would periodically 
reevaluate the small numbers and update the definition if necessary. 
This direct final rule is the result of our 2018-2019 reassessment of 
the ``small numbers of animals.''

B. Summary of the Major Provisions of the Direct Final Rule

    Based on our 2018-2019 reassessment, we are revising the small 
number for dogs included in the ``small number of animals'' definition 
from 70,000 to 80,000 and the small number for cats from 120,000 to 
150,000.

C. Legal Authority

    The legal authority for this direct final rule is the MUMS Act, 
which amended the FD&C Act. Additional authority comes from the 
``Regulations and Hearings'' section of the FD&C Act, which authorizes 
FDA to issue regulations for the efficient enforcement of the FD&C Act.

D. Costs and Benefits

    Sponsors that apply for and receive conditional approval for a new 
animal drug intended for a ``minor use'' in dogs or cats as a result of 
the changes to the small numbers made by the direct final rule will be 
able to market their drug earlier, which in turn could benefit pet 
owners by improving the health of dogs and cats with uncommon diseases 
or conditions. Both FDA and those sponsors receiving conditional 
approval could receive cost savings from deferring costs associated 
with providing FDA with substantial evidence that a new animal drug is 
effective until later in the drug development process. ``Substantial 
evidence'' is the effectiveness standard that must be met before a 
sponsor can receive full approval for its new animal drug under the 
FD&C Act. Conditional approval does not require the drug sponsor to 
demonstrate effectiveness by ``substantial evidence.'' Instead, the 
sponsor has to show that there is a ``reasonable expectation'' of 
effectiveness. Sponsors could incur

[[Page 56585]]

costs to prepare and submit additional minor use determination requests 
and annual designation reports to FDA. In addition, FDA will bear costs 
to review any additional minor use determination requests and annual 
designation reports it receives from sponsors. FDA estimates that the 
annualized benefits over 20 years will range from $0 to $6.06 million 
at a 7 percent discount rate, with a primary estimate of $3.03 million, 
and from $0 to $7.43 million at a 3 percent discount rate, with a 
primary estimate of $3.72 million. Annualized costs will range from 
$3,033 to $31,741 at a 7 percent discount rate, with a primary estimate 
of $17,387, and from $2,244 to $30,285 at a 3 percent discount rate, 
with a primary estimate of $16,264.

II. Table of Abbreviations and Commonly Used Acronyms in This Document

------------------------------------------------------------------------
     Abbreviation/acronym                    What it means
------------------------------------------------------------------------
2013 reassessment............  Reassessment of small numbers conducted
                                by FDA in 2013, the results of which
                                were published in May 2014 (79 FR
                                28736).
AVMA.........................  American Veterinary Medical Association.
21 CFR.......................  Title 21 of the Code of Federal
                                Regulations.
Current reassessment.........  Reassessment of small numbers conducted
                                by FDA in 2018-2019.
FDA..........................  U.S. Food and Drug Administration.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
MUMS.........................  Minor Use and Minor Species.
MUMS Act.....................  Minor Use and Minor Species Animal Health
                                Act of 2004.
OMB..........................  Office of Management and Budget.
Pub. L.......................  Public Law.
------------------------------------------------------------------------

III. Background

A. Introduction

    The MUMS Act (Pub. L. 108-282) amended the 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)). Congress charged FDA to further define the term ``small 
number of animals'' for minor use purposes (see Senate Report 108-226 
at 8, February 18, 2004). In the Federal Register of March 18, 2008 (73 
FR 14411), we issued a proposed 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 of animals'' definition was formally 
established by the final rule that was published on August 26, 2009 (74 
FR 43043). In that final rule, we addressed comments from the public 
regarding the 2008 proposed rule, including comments suggesting that 
the Agency reevaluate the small numbers on a periodic basis. We agreed 
that periodic reassessment of the small numbers is appropriate and that 
such reassessments should occur approximately every 5 years.
    We conducted our initial reassessment of the small numbers in 2013 
and published the results of that reassessment on May 19, 2014 (79 FR 
28736) (the 2013 reassessment). At that time, we did not change the 
small numbers for any of the major species.
    From 2018 to 2019, we conducted our second reassessment (current 
reassessment) of the small numbers (Ref. 1). Based on the current 
reassessment, we are revising (i.e., increasing) the small numbers for 
dogs and cats only. Elsewhere in this issue of the Federal Register, we 
are publishing a notice to announce that we are not revising the small 
numbers in the ``small number of animals'' definition for the other 
major species (i.e., horses, cattle, pigs, turkeys, and chickens). 
Because we are only revising the ``small number of animals'' definition 
as it relates to dogs and cats, the remainder of this document will 
focus on those two species.

B. History of Defining Small Numbers for Dogs and Cats

    The term ``small number of animals'' is defined in Sec.  516.3(b) 
(21 CFR 516.3(b)) of our regulation on new animal drugs for minor use 
and minor species. For each of the seven major species of animals, the 
definition specifies the greatest number of animals of that species 
that could be treated annually with a new animal drug for a particular 
indication and still qualify as a minor use. For dogs and cats, a 
``small number of animals'' is defined as equal to or less than 70,000 
dogs, or equal to or less than 120,000 cats.
    The process FDA used to establish the small numbers for the 
companion animal major species (dogs, cats and horses) is outlined in 
detail in the 2008 proposed rule. That process involved estimating the 
development cost for an animal drug intended for each of the three 
major companion animal species, estimating the amount that companion 
animal owners were willing to pay for a drug to treat each of those 
species, estimating the average percentage of companion animals that 
would likely be treated, and estimating the uncertainty associated with 
estimates of the rate of occurrence of various uncommon conditions in 
companion animals. Assessment of these various factors resulted in the 
formula, published in the proposed rule (73 FR 14411 at 14414), that we 
use to determine the small numbers for companion animals.

C. Need for the Regulatory Action

    In the preamble to the 2009 final rule in which we first 
established the definition of ``small number of animals,'' we agreed in 
response to comments that we should periodically reevaluate the small 
numbers and update the definition as necessary. We also agreed that 
such a reevaluation should take into account the potential for changes 
in the development cost of new animal drugs, changes in the amount that 
animal owners are willing to pay to treat affected animals, and changes 
in other factors involved in establishing a ``small number,'' such as 
the total population of major animal species (74 FR 43043 at 43044).
    In a memorandum containing the results of our current reassessment, 
we describe the processes that we used to reevaluate the small number 
of animals (Ref. 1). Based on the current reassessment, we are 
increasing the small numbers for dogs and cats only.

[[Page 56586]]

IV. Legal Authority

    We are issuing this direct final rule under the same legal 
authorities described in the proposed and final rules we issued to 
establish the ``small number of animals'' definition in 21 CFR part 516 
(see 73 FR 14411 at 14415 and 74 FR 43043 at 43049). These authorities 
include sections 571, 573, and 701 of the FD&C Act (21 U.S.C. 360ccc, 
360ccc-2, and 371). Sections 571 and 573 of the FD&C Act were 
established by the MUMS Act. Section 701(a) authorizes the Agency to 
issue regulations for the efficient enforcement of the FD&C Act.

V. Description of the Direct Final Rule

A. Revisions to the ``Small Number of Animals'' Definition in Sec.  
516.3

    As discussed in section III. C, when we published the final rule 
defining ``small number of animals'' for minor use designation in 2009, 
we agreed we should periodically reevaluate the small number of animals 
to account for changes in drug development costs, changes in the amount 
that animal owners are willing to pay to treat affected animals, and 
other relevant factors (74 FR 43043 at 43044). Based on our current 
reassessment (Ref. 1), we are revising the definition of ``small number 
of animals'' in Sec.  516.3(b) to increase the small number for dogs 
from 70,000 to 80,000, and to increase the small number for cats from 
120,000 to 150,000.

B. Reassessment of the Small Numbers for Dogs and Cats

    For our current reassessment of the small numbers, our primary 
source of information regarding costs related to dogs and cats is a 
2018 report prepared by Brakke Consulting Inc., (BCI) containing 
population estimates, disease incidence rates, and information about 
drug development costs and treatment costs for companion animals (Ref. 
2). The 2018 report is the latest update of the BCI report. We used 
previous versions of the BCI report for the 2008 proposed rule and the 
2013 reassessment. Our primary source of information regarding 
healthcare costs for dogs and cats is the 2017-2018 edition of the 
American Veterinary Medical Association (AVMA) U.S. Pet Ownership and 
Demographics Sourcebook, which contains surveys of pet ownership (Ref. 
3). This is an updated version of the same source we used for our 2008 
proposed rule and the 2013 reassessment.
    After evaluating the relevant data from these sources and using 
that information to reassess the small numbers for dogs and cats, we 
determined that the small numbers for dogs and cats should be 
increased. Therefore, we are revising the definition of ``small numbers 
of animals'' for these two species. For a full discussion of our 
current reassessment of the small numbers, see our current reassessment 
memorandum (Ref. 1).

VI. Direct Final Rulemaking

    In the document entitled ``Guidance for FDA and Industry: Direct 
Final Rule Procedures,'' announced in the Federal Register of November 
21, 1997 (62 FR 62466), FDA describes its procedures on when and how 
the Agency will employ direct final rulemaking. The guidance may be 
accessed at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
    We have determined that the subject of this rulemaking is suitable 
for a direct final rule. We are revising the ``small number of 
animals'' definition for dogs and cats in Sec.  516.3(b) to increase 
the small numbers for these two species. This rule is intended to make 
noncontroversial changes to an existing regulation. We do not 
anticipate that there will be any significant adverse comments.
    Consistent with our procedures on direct final rulemaking, we are 
publishing elsewhere in this issue of the Federal Register a companion 
proposed rule. The companion proposed rule and this direct final rule 
are substantively identical. The companion proposed rule provides the 
procedural framework within which the rule may be finalized in the 
event the direct final rule is withdrawn because of a significant 
adverse comment. The comment period for this direct final rule runs 
concurrently with the comment period for the companion proposed rule. 
Any comments received in response to the companion proposed rule will 
also be considered as comments regarding this direct final rule.
    We are providing a comment period for the direct final rule of 60 
days after the date of publication in the Federal Register. If we 
receive a significant adverse comment, we intend to withdraw this 
direct final rule before its effective date by publishing a 
notification in the Federal Register within 30 days after the comment 
period ends. A significant adverse comment explains why the rule would 
be inappropriate, including challenges to the rule's underlying premise 
or approach, or would be ineffective or unacceptable without a change. 
In determining whether an adverse comment is significant and warrants 
withdrawing a direct final rule, we will consider whether the comment 
raises an issue serious enough to warrant a substantive response in a 
notice-and-comment process in accordance with section 553 of the 
Administrative Procedure Act (5 U.S.C. 553).
    Comments that are frivolous, insubstantial, or outside the scope of 
the rule will not be considered significant or adverse under this 
procedure. A comment recommending a regulation change in addition to 
those in the direct final rule would not be considered a significant 
adverse comment unless the comment states why the rule would be 
ineffective without the additional change. In addition, if a 
significant adverse comment applies to a part of this rule and that 
part can be severed from the remainder of the rule, we may adopt as 
final those provisions of the rule that are not the subject of the 
significant adverse comment.
    If any significant adverse comment is received during the comment 
period, we will publish, before the effective date of this direct final 
rule, a notification of significant adverse comment and withdraw the 
direct final rule. If we withdraw the direct final rule, any comments 
received will be applied to the proposed rule and will be considered in 
developing a final rule using the usual notice-and-comment procedure. 
If we do not receive any significant adverse comment in response to 
this direct final rule during the comment period, we will publish a 
document in the Federal Register confirming the effective date of the 
final rule within 30 days after the comment period ends.

VII. Economic Analysis of Impacts

    We have examined the impacts of the direct final rule under 
Executive Order 12866, Executive Order 13563, the Regulatory 
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform 
Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us 
to assess all costs and benefits of available regulatory alternatives 
and, when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). We believe that this direct final rule is not a 
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because net costs of the direct final rule are less than 0.32 
percent of average annual revenues for the smallest firms

[[Page 56587]]

in the industry, we certify that the direct final rule will not have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $165 
million, using the most current (2021) Implicit Price Deflator for the 
Gross Domestic Product. This direct final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    By expanding incentives for new animal drug development under the 
MUMS Act as a result of increasing the small numbers for dogs and cats, 
the direct final rule could benefit pet owners by improving the health 
of dogs and cats with uncommon diseases or conditions. These health 
improvements could result from the earlier marketing of new animal 
drugs by sponsors that apply for and receive conditional approval as a 
result of the direct final rule. The direct final rule also could 
result in cost savings to new animal drug sponsors and FDA. Sponsors 
that receive conditional approval have the ability to market their new 
animal drug for up to 5 years, subject to annual renewals, before 
providing substantial evidence that it is effective, as required for 
full approval. This would defer costs to sponsors and FDA associated 
with a demonstration of substantial evidence of effectiveness until 
later in the development process.
    Because the direct final rule could increase the number of uncommon 
diseases or conditions in dogs and cats that qualify for minor use drug 
development incentives, including user fee waivers, exclusive marketing 
rights, grants, and eligibility for conditional approval, sponsors 
could incur costs to prepare and submit additional minor use 
determination requests and, for those sponsors that pursue designation 
for their new animal drug, annual designation reports to FDA. FDA will 
bear costs to review any additional minor use determination requests 
and annual designation reports. Potential sponsors of new animal drugs 
for minor uses in dogs or cats will also incur a one-time cost to read 
and understand the direct final rule.
    We additionally estimate potential within-industry transfers from 
sponsors receiving user fee waivers as a result of the direct final 
rule to fee-paying sponsors, and transfers from government to industry 
in the form of grants to support safety and effectiveness testing.
    We summarize the annualized benefits and costs of the rule in table 
1. We estimate that the annualized benefits over 20 years will range 
from $0 to $6.06 million at a 7 percent discount rate, with a primary 
estimate of $3.03 million, and from $0 to $7.43 million at a 3 percent 
discount rate, with a primary estimate of $3.72 million. Annualized 
costs will range from $3,033 to $31,741 at a 7 percent discount rate, 
with a primary estimate of $17,387, and from $2,244 to $30,285 at a 3 
percent discount rate, with a primary estimate of $16,264.

                                       Table 1--Summary of Benefits, Costs, and Distributional Effects of the Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized ($m/year)....       $3.03       $0.00       $6.06        2021           7          20  These include benefits to pet owners and
                                              3.72        0.00        7.43        2021           3          20   cost savings to industry and FDA.
                                       ------------------------------------------------------------------------
    Annualized Quantified.............
 
    Qualitative.
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized ($m/year)....       0.017       0.003       0.032        2021           7          20
                                             0.016       0.002       0.030        2021           3          20
                                       ------------------------------------------------------------------------
    Annualized Quantified.............
 
    Qualitative.
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers: \1\
    Federal Annualized Monetized ($m/         0.43        0.00        0.86        2021           7          20
     year).                                   0.48        0.00        0.97        2021           3          20
                                       -----------------------------------------------------------------------------------------------------------------
                                        From: Government
                                        To: Industry
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized ($m/           0.47        0.00        0.94        2021           7          20
     year).                                   0.57        0.00        1.14        2021           3          20
                                       -----------------------------------------------------------------------------------------------------------------
                                        From: Industry
                                        To: Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local, or Tribal Government: None............................................................................................................
    Small Business: Quantified effects of less than 0.32 percent of average annual revenues for the smallest firms......................................
    Wages: None.........................................................................................................................................
    Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Transfers are monetary payments between persons or groups that do not affect the total resources available to society.

    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the direct final rule. The full analysis of 
economic impacts is available in the docket for this direct final rule 
(Ref. 4) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

[[Page 56588]]

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This direct final rule contains information collection provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). A 
description of these provisions is given in the Description section of 
this document with an estimate of the annual recordkeeping burden. 
Included in the estimate is the time for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing each collection of information.
    Title: Designated New Animal Drugs for Minor Use and Minor Species; 
OMB control number 0910-0605--Revision.
    Description: The direct final rule revises the ``small number of 
animals'' definition for dogs and cats in our existing regulation at 
Sec.  516.3(b) for new animal drugs for minor use and minor species. 
The small numbers for dogs and cats are increased. The MUMS Act 
provides incentives to encourage animal drug sponsors to develop and 
seek FDA approval of drugs intended for use in minor species or for 
minor uses in major animal species. Congress provided a statutory 
definition of ``minor use'' that relies on the phrase ``small number of 
animals'' to characterize such use. The ``small number of animals'' 
definition is used for purposes of determining whether a particular 
intended use of a drug in one of the major species of animals qualifies 
as a minor use.
    Description of Respondents: Pharmaceutical companies that sponsor 
new animal drugs.
    We estimate the burden of this information collection as follows:

                                                    Table 2--Estimated One-time Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reading and Understanding the Rule...........             474               1             474  0.683 (41 minutes).......................             323
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Using the number of active sponsors of new animal drug applications 
and active sponsors of abbreviated new animal drug applications, we 
estimate there are 237 sponsors affected by this rule. We estimate two 
recordkeepers per sponsor.
    We expect that new animal drug sponsors will incur a one-time 
burden associated with reading and understanding the rule and a nominal 
increase in the overall annual burden associated with reporting 
requirements resulting from a potential increase in submissions of 
minor use determination requests and annual designation reports to FDA.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(d)), we have submitted the information collection provisions of 
this direct final rule to OMB for review. Before the effective date of 
this direct final rule, FDA will publish a notice in the Federal 
Register announcing OMB's decision to approve, modify, or disapprove of 
the information collections of this direct final rule.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number.

X. Federalism

    We have analyzed this direct final rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the direct final rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this direct final rule in accordance with the 
principles set forth in Executive Order 13175. We have determined that 
the direct final rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. Accordingly, we conclude that the direct 
final rule does not contain policies that have tribal implications as 
defined in the Executive order and, consequently, a tribal summary 
impact statement is not required.

XII. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

* 1. FDA Memorandum, ``2018-2019 Reassessment of Small Numbers of 
Animals for Minor Use Determination'', 2021.
* 2. Brakke Consulting, Inc., Update of Population Estimates, 
Disease Incidence Rates, Drug Development Costs and Treatment Costs 
for Companion Animals,'' October 22, 2018.
3. American Veterinary Medical Association, ``Pet Ownership and 
Demographics Sourcebook,'' 2017-2018 Edition, October 2018. Accessed 
November 09, 2021. https://www.avma.org/news/press-releases/avma-releases-latest-stats-pet-ownership-and-veterinary-care and https://www.avma.org/sites/default/files/resources/AVMA-Pet-Demographics-Executive-Summary.pdf.
* 4. FDA, ``Final Regulatory Impact Analysis, Final Regulatory 
Flexibility Analysis, Unfunded Mandates Reform Act Analysis'', 2021.

List of Subjects in 21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential

[[Page 56589]]

business information, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
516 is amended as follows:

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
1. The authority citation for part 516 continues to read as follows:

    Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.


0
2. Amend Sec.  516.3(b) by revising the definition for ``Small number 
of animals'' to read as follows:


Sec.  516.3  Definitions.

* * * * *
    (b) * * *
    Small number of animals means equal to or less than 50,000 horses; 
80,000 dogs; 150,000 cats; 310,000 cattle; 1,450,000 pigs; 14,000,000 
turkeys; and 72,000,000 chickens.
* * * * *

    Dated: August 31, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-19954 Filed 9-14-22; 8:45 am]
BILLING CODE 4164-01-P