[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]
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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.
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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
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Abbreviation/acronym What it means
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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.
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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 $16,264.
Table 1--Summary of Benefits, Costs, and Distributional Effects of the Rule
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Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized ($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