Proposed Rule2022-19956
Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment
Primary source
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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 proposing to revise 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 proposing certain revisions to the definition of "small number of animals" based on our most recent reassessment of the small numbers, which we conducted from 2018 to 2019.
Full Text
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[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Proposed Rules]
[Pages 56604-56610]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19956]
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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, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to revise 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
proposing certain revisions to 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: Either electronic or written comments on this proposed rule or
its companion direct final rule must be submitted by November 14, 2022.
Submit written comments (including recommendations) on the collection
of information under the Paperwork Reduction Act of 1995 by November
14, 2022. If FDA receives any timely significant adverse comments on
the direct final rule with which this proposed rule is associated, the
Agency will publish a document withdrawing the direct final rule within
30 days after the comment period ends. FDA will apply any significant
adverse comments received on the direct final rule to the proposed rule
in developing the final rule. FDA will then proceed to respond to
comments under this proposed rule using the usual notice and comment
procedures.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of
[[Page 56605]]
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:
<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-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 <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.
Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 to the Office of Management and Budget
(OMB) at <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this
particular information collection by selecting ``Currently under
Review--Open for Public Comments'' or by using the search function. The
title of this proposed collection is ``Designated New Animal Drugs for
Minor Use and Minor Species.''
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#264b475441475443520849434a4a435466404247084e4e5508414950"><span class="__cf_email__" data-cfemail="4c212d3e2b2d3e29386223292020293e0c2a282d6224243f622b233a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose and Coverage of the Proposed Rule
B. Summary of the Major Provisions of the Proposed 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 Proposed Regulatory Action
IV. Legal Authority
V. Description of the Proposed Rule
A. Proposed Revisions to the ``Small Number of Animals''
Definition in Sec. 516.3
B. Reassessment of the Small Numbers for Dogs and Cats
VI. Companion Document to Direct Final Rulemaking
VII. Preliminary 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 Proposed Rule
The proposed rule would amend 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 proposed rule is the result of our 2018-2019 reassessment of the
``small numbers of animals.''
[[Page 56606]]
B. Summary of the Major Provisions of the Proposed Rule
Based on our 2018-2019 reassessment, we are proposing to revise 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 proposed 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 that would be made by the proposed
rule, if finalized, would 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 costs
to prepare and submit additional minor use determination requests and
annual designation reports to FDA. In addition, FDA would 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 would 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 would 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.
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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 proposing to revise (i.e., increase) 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 proposing to revise 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
[[Page 56607]]
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 Proposed 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
proposing to increase the small numbers for dogs and cats only.
IV. Legal Authority
We are issuing this proposed 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 Proposed Rule
A. Proposed 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 proposing to revise 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 proposing revisions to 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. Companion Document to 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: <a href="https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm">https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm</a>.
This proposed rule is a companion to the direct final rule
published elsewhere in this issue of the Federal Register. We propose
to revise the ``small number of animals'' definition for dogs and cats
in Sec. 516.3(b). This proposed 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
direct final rule. The companion direct final rule and this companion
proposed rule are substantively identical. This 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 proposed rule
runs concurrently with the comment period for the companion direct
final rule. Any comments received in response to the companion direct
final rule will also be considered as comments regarding this proposed
rule.
We are providing a comment period for the proposed rule of 60 days
after the date of publication in the Federal Register. If we receive a
significant adverse comment, we intend to withdraw the direct final
rule before its effective date by publishing a notice 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 this proposed rule would not be considered a significant
adverse comment unless the comment states why the proposed
[[Page 56608]]
rule would be ineffective without the additional change. In addition,
if a significant adverse comment applies to a part of this proposed
rule and that part can be severed from the remainder of the proposed
rule, we may adopt as final those provisions of the proposed 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 the direct final
rule, a notice of significant adverse comment and withdraw the direct
final rule. If we withdraw the direct final rule, any comments received
will be applied to this 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 the
direct final rule during the comment period, no further action will be
taken related to this proposed rule. Instead, 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. Preliminary Economic Analysis of Impacts
We have examined the impacts of the proposed 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 proposed 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 proposed rule are less than 0.32
percent of average annual revenues for the smallest firms in the
industry, we propose to certify that the proposed 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 proposing ``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 proposed 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 proposed rule, if finalized, 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 proposed rule, if finalized. The proposed
rule, if finalized, 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 proposed rule, if finalized, 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 would 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 would also
incur a one-time cost to read and understand the rule.
We additionally estimate potential within-industry transfers from
sponsors receiving user fee waivers as a result of the proposed rule,
if finalized, 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 proposed rule
in table 1. We estimate that the annualized benefits over 20 years
would 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 would 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
$16,264.
Table 1--Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized ($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
[[Page 56609]]
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 Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 4) and at <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
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 proposed 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.
FDA invites comments on these topics: (1) whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Designated New Animal Drugs for Minor Use and Minor Species;
OMB control number 0910-0605--Revision.
Description: The proposed rule would revise 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 would be 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 Total
Activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
Reading and Understanding 474 1 474 0.683 (41 minutes)...... 323
the Rule.
----------------------------------------------------------------------------------------------------------------
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 that would be affected by this rule. We
estimate two recordkeepers per sponsor.
We expect that new animal drug sponsors would 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
[[Page 56610]]
requests and annual designation reports to FDA.
To ensure that comments on the information collections are
received, OMB recommends that written comments be submitted through
<a href="http://www.reginfo.gov">www.reginfo.gov</a> (see ADDRESSES). All comments should be identified with
the title of the information collection.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the information collection provisions of
this proposed rule to OMB for review. These information collection
requirements will not be effective until FDA publishes a final rule,
OMB approves the information collection requirements, and the rule goes
into effect. FDA will announce OMB approval of these requirements in
the Federal Register.
X. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed 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 proposed 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 proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the proposed 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. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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. <a href="https://www.avma.org/news/press-releases/avma-releases-latest-stats-pet-ownership-and-veterinary-care">https://www.avma.org/news/press-releases/avma-releases-latest-stats-pet-ownership-and-veterinary-care</a> and <a href="https://www.avma.org/sites/default/files/resources/AVMA-Pet-Demographics-Executive-Summary.pdf">https://www.avma.org/sites/default/files/resources/AVMA-Pet-Demographics-Executive-Summary.pdf</a>.
*4. FDA, ``Preliminary Regulatory Impact Analysis, Initial
Regulatory Flexibility Analysis, Unfunded Mandates Reform Act
Analysis,'' 2021.
List of Subjects in 21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
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, it is
proposed that 21 CFR part 516 be 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. 2022-19956 Filed 9-14-22; 8:45 am]
BILLING CODE 4164-01-P
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