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BILLING CODE 3410-34-P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 2, 3, and 4
[Docket No. APHIS-2019-0001]
RIN 0579-AE54
AWA Research Facility Registration Updates, Reviews, and Reports
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
SUMMARY: We are amending the Animal Welfare Act (AWA) regulations governing facilities
that conduct research, experimentation, teaching, and testing by removing duplicative and
unnecessary reviews and requests for information. We are removing the requirement that
registered research facilities update their registration information every 3 years because the
information is already collected by other means. We are also removing a redundant requirement
for the Institutional Animal Care and Use Committee at each facility to conduct a continuing
review of research activities involving animals and instead requiring a complete resubmission
and review of such activities at least every 3 years. We will also no longer require that research
facilities request an inactive status if they no longer use, handle, or transport AWA covered
animals. In addition, we are clarifying the duration of a registration and conditions for its
cancellation and will no longer require that the Institutional Official or Chief Executive Officer
sign the annual report. We are also making miscellaneous changes to improve readability.
These changes will reduce duplicative requirements and administrative burden on facilities while
continuing to ensure the integrity and credibility of research findings and the protection of
research animals.

DATES: This rule is effective [Insert date 30 days after date of publication in the Federal
Register].
FOR FURTHER INFORMATION CONTACT: Dr. Lance H. Bassage, VMD, Director,
National Policy Staff, Animal Care, APHIS, 4700 River Road Unit 84, Riverdale, MD 20737;
lance.h.bassage@usda.gov.
SUPPLEMENTARY INFORMATION:
Background
Under the Animal Welfare Act (AWA or the Act, 7 U.S.C. 2131 et seq.), the Secretary
of Agriculture is authorized to promulgate standards and other requirements governing the
humane handling, care, treatment, and transportation of certain animals by dealers, exhibitors,
operators of auction sales, research facilities, and carriers and intermediate handlers.
The Secretary has delegated responsibility for administering the AWA to the
Administrator of the U.S. Department of Agriculture’s (USDA’s) Animal and Plant Health
Inspection Service (APHIS). Within APHIS, the responsibility for administering the AWA has
been delegated to the Deputy Administrator for Animal Care. Definitions, regulations, and
standards established under the AWA are contained in 9 CFR parts 1, 2, and 3 (referred to below
as the regulations).
Part 1 contains definitions for terms used in parts 2 and 3. Part 2 provides administrative
regulations and sets forth institutional responsibilities for regulated parties. Part 3 provides
standards for the humane handling, care, treatment, and transportation of covered animals. Part 4
addresses rules of practice governing proceedings under the AWA.
On September 17, 2020, APHIS announced in the Federal Register (85 FR 57998-58002,
APHIS-2019-0001)1 proposed changes to 9 CFR part 2 in order to address reforms called for in
Title II, Section 2034(d) of the 21st Century Cures Act (21CCA). The 21CCA tasked the

https://www.federalregister.gov/documents/2020/09/17/2020-20512/awa-research-facilityregistration-updates-reviews-and-reports.

National Institutes of Health (NIH), the USDA, and the U.S. Food and Drug Administration
(FDA) to identify inconsistent, overlapping, and unnecessarily duplicative regulations and
policies associated with research using laboratory animals and to consider modifying,
streamlining, or repealing those that are unnecessary or impose administrative burdens or
excessive costs on regulated entities.2 These changes will reduce or remove redundant
registration, reporting, and review requirements of activities involving animals at
AWA-registered research facilities while ensuring that research animals continue to receive
humane care.
We solicited comments concerning our proposal for 60 days ending November 16,
2020. We received 61 comments by that date.3 They were from animal welfare organizations;
public and private universities, hospitals, and biomedical and other research institutions; a
veterinary association; and members of the public. They are discussed below by topic.
Registration of Research Facilities
Section 2.30(a)(1) currently requires that each research facility other than a Federal
research facility register with the Secretary by completing and filing an initial registration form.4
Facilities are also required to update their registration every 3 years by filing a registration
update form5 with the registrant's name, address, and contact information; USDA registration

Found at https://www.congress.gov/bill/114th-congress/house-bill/34/. An August 2019 report
issued jointly by the NIH, the USDA, and the FDA, titled “Reducing Administrative Burden for
Researchers: Animal Care and Use in Research,” is available at
https://olaw.nih.gov/sites/default/files/21CCA_final_report.pdf. The report identifies ways in
which Agencies can reduce regulatory and administrative burden consistent with requirements
under the AWA.
3 To view the proposal, supporting documents, and the comments we received, go to
www.regulations.gov. Enter APHIS-2019-0001 in the Search field.
4 APHIS Form 7011A: Application for Registration, New Registration.
5 APHIS Form 7011: Application for Registration, Registration Update.

certificate numbers; and names of partners, officers, and the Institutional Official (IO) as
applicable.
We proposed to eliminate the requirement in § 2.30(a)(1) to update the research facility
registration every 3 years after the facility’s initial registration. We proposed this change
because § 2.30(c)(1) already requires such a facility to notify APHIS within 10 days of any
change in the name, address, ownership, or any other change in operations affecting its status as
a research facility. We also considered the registration update to be unnecessary because name,
address, contact information, and registration certificate numbers are included in the annual
report6 that facilities are required to submit to APHIS in accordance with § 2.36 of the
regulations. Eliminating the registration update requirement reduces administrative burden on
institutions, removes needless duplicative procedures for providing information, and is consistent
with the reforms mandated in the 21CCA.
A commenter disagreed with eliminating the registration update and asked that we
provide data to help them assess the basis for this proposed change, particularly how it addresses
USDA’s claim of needless duplication. The commenter also questioned whether research
facilities were complying with the requirement to report changes in operations to APHIS within
10 days and suggested that rather than being a redundant requirement, the registration update is
an opportunity for research facilities to make up for changes that they had not otherwise reported
to APHIS.
The registration update is duplicative and therefore unnecessary because a facility is
already required under § 2.30(c)(1) to provide this information whenever there is a change in the
name, address, or ownership, or other change in operations affecting its status as a research
facility. Regarding the question of whether facilities are complying with reporting requirements,
our records indicate consistent and substantial compliance with the requirement to report changes
to facility operations within 10 days of the changes. We disagree with the commenter’s

APHIS Form 7023: Annual Report of Research Facility.

implication that research facilities use the registration update to report changes to operations, as
the update form does not include fields for such data and APHIS would consider any such
changes to be improperly submitted.
Notification of Change of Operation
As noted above, the current requirement in § 2.30(c)(1) for research facilities to notify the
APHIS Animal Care Deputy Administrator in writing7 of any change in the name, address, or
ownership, or other change in operations affecting its status as a research facility within 10 days
after making such a change would remain in the regulations. We proposed to add language to
the requirement stating that a new Notification of Change form (APHIS Form 7033)8 may be
used to provide that information. In addition, we proposed to add a new provision to § 2.30 that
clarifies the duration of a research facility’s registration and conditions for its cancellation.
One commenter stated that eliminating the 3-year facility registration update form
(APHIS Form 7011) and instead relying on the proposed APHIS Form 7033 risks losing certain
information not required by the latter form, such as the checklist for the types of animals used at
a facility. Other commenters stated that even though facilities are already required to notify
APHIS within 10 days of any change in the name, address, or ownership, or any change in
operations affecting its status as a research facility, facilities are not specifically required to let
APHIS know of changes to types of animals used.
We disagree with the commenters. Neither the current registration update form nor the
new change notification form is intended to capture changes to types of animals used. APHIS
will continue to obtain detailed information about the types of animals used at facilities from the
semiannual reviews and annual report, and through inspections of facilities during business
hours.

Send changes to USDA/APHIS/AC, 4700 River Road Unit 84, Riverdale, MD 20737-1234, or
email animalcare@usda.gov.
8 While APHIS recommends use of Form 7033 for licensees and registrants, locally developed
formats may also be used for submitting a notification of change if desired.

Two commenters asked that APHIS clarify what constitutes a “change of operations” as
the term appears in § 2.30(c)(1). One commenter added that it is unclear that any facility
changes will compel the facility to complete APHIS Form 7033 or otherwise submit the required
information without having more detail about what a change of operations means.
A change of operations includes any change affecting a facility’s status as a research
facility, including but not limited to whether the facility is conducting teaching, testing, or
research activities using regulated species. Regarding the commenter’s concern about research
facilities completing proposed APHIS Form 7033, we note that under § 2.30(c)(1) they are
already required to report changes in operations that affect their status as a research facility. The
new form is intended to make it easier for facilities to provide the required information.
Duration of Registration and Conditions for Cancellation of a Registration
We noted in the proposed rule that a small number of research facilities become inactive
each year. We determined that requiring inactive facilities to request inactive status and continue
filing annual reports in accordance with § 2.30(c)(2) constitutes an unnecessary burden because
these facilities are no longer using animals covered under the AWA or otherwise functioning as a
research facility as the term is defined in § 1.1. For this reason, we proposed to remove the
provisions requiring such facilities to request inactive status and file an annual report. Under the
proposed change, facilities would no longer be identified as active or inactive, but instead be
registered or unregistered. Accordingly, under proposed § 2.30(d)(1), a research facility that
goes out of business or otherwise ceases to function as a research facility can request to have its
registration canceled by writing to the Deputy Administrator.
Some commenters suggested that we revise the heading of proposed § 2.30(d) to read,
“Cancellation and Resumption of a Registration” instead of “Duration of a Registration and
Conditions for Cancellation of a Registration” to reflect more accurately the content of the
paragraph.

We are making no changes in response to the commenters. The heading of paragraph (d)
appropriately emphasizes the main point of the paragraph with respect to conditions of
registration. We added the new paragraph to clarify the duration of a research facility’s
registration and conditions for its cancellation.
We proposed to add a provision in § 2.30(d)(2) stating that the Deputy Administrator
may cancel a registration without a written request from the research facility, if he or she has
reason to believe that a research facility has ceased to function as a research facility.
A commenter expressed concern about the provision that the Deputy Administrator may
initiate a cancellation of a research facility’s registration. The commenter noted that various
reasons exist why a facility may choose to remain in active status without having animals, such
as an inactive academic institution that has used non-covered species at one time and anticipates
using covered species again. The commenter asked that we include language in the regulations
explaining how a facility would provide this information if they chose to remain active.
We are making no changes in response to the commenter. Facilities would no longer be
identified as having active or inactive status, but instead be either registered or unregistered.
While facilities may have their reasons for wishing to remain in active status, one that ceases to
function as a research facility, or has changed its method of operation so that it no longer uses,
handles, or transports animals, does not need to be registered for regulatory purposes. Whenever
it plans to resume activities as a research facility, the facility can submit a registration form in
accordance with § 2.30(c)(3) at least 10 days prior to using, handling, or transporting animals
again. We intend to provide for such a facility to be able to retain its previous registration
number upon registering.
One commenter recommended that APHIS define the term “evidence of business
activity” in greater detail.
We assume the commenter is referring to the phrase “evidence of business inactivity” we
used in the preamble to the proposed rule when discussing duration of registration and conditions

for cancellation. We noted in the preamble that such evidence of inactivity could include but not
be limited to multiple unsuccessful attempts to contact the facility by phone or mail, or no
activity apparent at the physical address listed in the registration.
A few commenters indicated that it is unclear how the USDA would formally notify the
facility that their registration was under consideration to be cancelled or was actually cancelled.
Another commenter suggested that APHIS should attempt to notify the facility with a letter
stating that the registration will be canceled within a certain timeframe if there is no response
challenging the cancellation. One commenter proposed that APHIS make at least four
documented attempts to contact the facility, with the fourth being by certified mail, and allow
four months for a response.
APHIS will make multiple attempts in writing and by phone during business hours to
establish contact with a research facility before considering canceling its registration due to
evidence of inactivity. Once we have determined that a facility is no longer functioning as a
research facility as the term is defined in § 1.1, there is no regulatory need for the facility to
remain registered.
Two commenters requested that the USDA provide a more tangible standard for
cancelling a registration than “has reason to believe.” One commenter recommended that a
potential standard could be when the Deputy Administrator “has developed credible evidence
that demonstrates a research facility has ceased to function as a research facility.”
In the preamble of the proposed rule, we explained that the Deputy Administrator may
cancel a registration if sufficient evidence exists that a facility has ceased to function as a
research facility. However, in the regulatory text of proposed § 2.30(d)(2), we used the words
“reason to believe.” We agree with the commenter’s suggestion that the language should be
more tangible and will amend paragraph (d)(2) accordingly by replacing “reason to believe” with
“sufficient evidence showing”.

The same commenter asked that we include a provision by which a facility can contest or
appeal the cancellation of a registration that it believes has been made in error.
We are making no changes in response to the commenter. APHIS will cancel a
registration if the research facility requests it, or if we have sufficient evidence showing that a
facility has ceased to function as a research facility. This evidence includes but is not limited to
failure to submit an annual report or respond to multiple contact attempts. We note above that
we will make several attempts in writing and by phone during business hours to establish contact
with a facility before deciding to cancel its registration based on sufficient evidence of inactivity,
so accordingly we see no need to include a provision to contest a cancellation. If a facility has
questions about cancellations, they are encouraged to contact APHIS Animal Care.9
We included in proposed paragraph (d)(3) the provision that if a research facility
registration has been canceled but the facility wishes to resume operations or otherwise conduct
regulated activities in the future, it is responsible for submitting an application to reregister at
least 10 days prior to it using, handling, or transporting animals. No fees would be associated
with reregistration.
A commenter requested that the USDA streamline the registration process so that it may
be consistently completed within 10 business days of receipt in order to ensure that reregistration
does not jeopardize funding or research plans.
We acknowledge the commenter’s request but are making no changes to the process.
APHIS typically completes the process of registering a facility within 10 business days of
receiving the application for registration and intends to continue doing so.
The commenter also asked that we outline the steps we will take to provide flexible
options for electronic registration and other measures to ensure timely processing and
notification of registration status.

USDA/APHIS/AC, 4700 River Road Unit 84, Riverdale, MD 20737-1234, or email
animalcare@usda.gov.

We are currently developing an electronic registration option that will provide greater
flexibility and efficiency for stakeholders. We will inform the regulated community when
electronic registration is available and where to access it.
A commenter recommended that APHIS place limitations on reregistration by requiring
that research facilities pay the costs of their reregistration. The commenter suggested that
without such a fee, research facilities unable to comply consistently with the AWA could use the
cancellation and reregistration processes to avoid being cited for noncompliance.
We are making no changes in response to the commenter’s recommendation. The AWA
is silent on authorizing the Secretary to charge a fee for registration. Regarding the commenter’s
concern, if a facility is out of compliance with the regulations or otherwise has pending citations,
canceling its registration will neither cancel the citations nor eliminate the possibility of APHIS
taking enforcement action, as enforcement is a process distinct from registration.
Proposed § 2.30(d)(3) includes registration requirements for formerly registered facilities
wishing to resume regulated activity. A few commenters recommended revising § 2.30(d)(3) to
read “If a research facility plans to resume activity,” presumably to replace “If a research facility
resumes operation or otherwise wishes to conduct regulated activities in the future…”.
We did not intend to imply that formerly registered facilities could resume operation of
regulated activities prior to registering again, so we agree with the language suggested by the
commenters and will replace the proposed wording with “plans to resume regulated activity” in
§ 2.30(d)(3). We emphasize that unregistered facilities wishing to engage in regulated activities
must submit APHIS Form 7011A at least 10 days prior to using, handling, or transporting
animals. We intend to allow formerly registered facilities to retain their original registration
number if they are registering again.
IACUC Facility Reviews
We noted in the proposed rule that § 2.31 requires the Institutional Animal Care and Use
Committee (IACUC) for each registered research facility to assess the facility's animal program,

facilities, and procedures and evaluate proposed research activities or significant changes in
ongoing activities related to the care, treatment, housing, and use of research animals. In
accordance with this section, the IACUC reviews the research facility's programs and facilities to
determine compliance with AWA and institutional requirements. The IACUC also reviews
proposed animal research activities or significant changes to ongoing activities and notifies the
principal investigator (PI) and the research facility of its decision to approve or withhold
approval.
Section § 2.31(c)(1) requires the IACUC of each research facility to review, at least once
every 6 months, the research facility's program for humane care and use of animals using the
AWA regulations as a basis for evaluation. Under § 2.31(c)(2), the IACUC is also required to
inspect all of the research facility's animal facilities, including animal study areas, again using
the AWA regulations as a basis for evaluation. The IACUC reports the outcome of these
semiannual evaluations to the Institutional Official of the research facility in accordance with
requirements in § 2.31(c)(3). In addition, the IACUC’s functions under § 2.31(c)(4) include
reviewing and investigating reports of noncompliance received from facility personnel, as well
as public complaints, involving the care and use of animals at the research facility. If
noncompliance with the AWA is found during these reviews and inspections, the IACUC is
authorized to require modifications or suspend an activity involving animals in accordance with
the specifications set forth in § 2.31(d)(6).
In order to approve newly proposed research activities or proposed significant changes in
ongoing activities, the IACUC is also required to conduct a review of components of the
proposed activities or significant changes related to the care and use of animals and determine
that they meet the requirements listed in § 2.31(d)(1). Once a research activity or a significant
change to an ongoing activity has been approved, paragraph (d)(5) of this section requires the
IACUC to conduct continuing reviews of activities covered under the regulations at 9 CFR 1.1,
et seq., at appropriate intervals as determined by the IACUC, but not less than annually.

We proposed to amend § 2.31(d)(5) by removing the continuing review requirement and
adding the requirement for a complete review of activities at appropriate intervals as determined
by the IACUC, but not less than every 3 years. As we noted in the proposed rule, we made this
change in order to harmonize the USDA AWA regulations with the NIH requirement for a
complete review of IACUC-approved activities at 3-year intervals.
Several commenters disagreed with our proposal to remove the continuing review
requirement in § 2.31(d)(5) and add the requirement for a complete review. One commenter
stated that an annual review of research activities and protocols is crucial to maintain
transparency and accountability in animal research, and many expressed the view that these
changes create too long of an interval between reviews to ensure animal welfare oversight.
Another commenter stated that allowing IACUCs to conduct complete reviews “at appropriate
intervals” no less than every 3 years would give IACUCs far too much leeway in reviewing
activities and animal welfare oversight, and one stated that we provided no data to support a 3year complete review, noting that it is unclear how the expanded review period comports with
annual and semiannual inspections. One commenter stated that APHIS does not elucidate how it
will ensure that the AWA standards of treatment will be adhered to with a relaxed review
standard.
We acknowledge the concerns expressed by these commenters over whether IACUC
reviews at research facilities are sufficiently frequent and thorough to ensure animal welfare.
However, we emphasize that the two review types have different objectives, and that removing
the continuing review and adding a complete review, as we have proposed, will actually enhance
the thoroughness of review of animal activities with no effect on frequency and oversight—we
explain this point below.
The purpose of the continuing review required in paragraph (d)(5) of the current
regulations is not specified. In practice, however, it has consisted of the IACUC determining
whether significant changes impacting animal welfare have occurred in a research activity since

the time it was originally approved or last reviewed. We consider the continuing review to be
redundant because, under § 2.31(c) and (d), any significant changes to an ongoing activity are
already required to be reviewed by the IACUC. Further, the semiannual review of a research
facility's program for humane care and use of animals covers animal use in all facility research
activities to ensure that the approved activity continues to comply with regulatory and
institutional requirements, and under paragraph (c)(3) any departures from the regulations found
by the IACUC are required to be reported and addressed appropriately. In addition, under
§ 2.31(c)(4), the IACUC is required to review, and, if warranted, investigate complaints by the
public or facility personnel involving the care and use of animals at the research facility at any
time. Finally, removing the continuing review requirement has no effect on the IACUC approval
process for new activities and significant changes to animal activities.
The complete review required by NIH at federally funded facilities involves a full
evaluation of each new animal research activity—including all elements pertaining to animal
welfare listed under § 2.31(d) and (e)—with resubmission and complete review of that activity
every 3 years thereafter as if it were a new activity. The NIH requires the complete review of the
entire activity protocol even if no significant changes have been made to it in that 3-year period,
the rationale being that regulations or scientific developments germane to the activity may have
changed during the period between reviews. The complete review does not affect the IACUC's
authority under § 2.31(c)(3) to determine the best means of conducting the evaluations required
by paragraphs (c)(1) and (2) of the facility’s programs and facilities. A facility’s programs
include the animal activities, and the IACUC’s evaluations required by paragraphs (c)(1) and (2)
include monitoring after approval.
Based on the results of the complete review, the IACUC grants or withholds approval, or
requires modifications to the activity. The purpose of the complete review is to ensure that all
elements of animal use in a research activity, or changes to an ongoing activity, are humane and

designed to minimize animal distress, and that alternatives to painful and distressing procedures
have been considered and implemented to the extent possible.
We proposed harmonizing our review requirements with NIH by adding the complete
review requirement because it ensures that every component in a research activity that uses
animals is thoroughly evaluated. We note that under the current AWA regulations, no such
equivalent review requirement exists. In other words, once approved, an animal research activity
using AWA species that is not funded by the Public Health Service10 can continue indefinitely
without ever being fully revisited to ensure its underlying design or foundational assumptions are
in step with current science and regulatory policy relating to animal welfare. The continuous
review was never intended to serve this purpose, as it involves only periodic checks sufficiently
covered by other reviews discussed above.
For the complete review, the PI will provide the IACUC with a written description of all
current activities that involve the care and use of animals for review and approval. Changes such
as but not limited to personnel, species, study objectives, and frequency of sample collections
may be reviewed by the IACUC as frequently as necessary, but not less than every 3 years.
A commenter expressed concern that any violation of IACUC-approved protocols, such
as performing procedures on animals beyond what was initially approved or experiencing more
animal mortalities than was initially approved, would not necessarily be brought to the attention
of the IACUC until the 3-year review, by which time it could be too late to take appropriate
action.
We note the commenter’s concern but reiterate that, under § 2.31(c), the IACUC is
required to review the research facility's program for humane care and use of animals at least
once every 6 months, which includes animal use in all facility research activities, and under

The Public Health Service is a collection of agencies with the Department of Health and
Human Services that includes NIH. NIH requires that a complete IACUC review of research
protocols be conducted at least once every 3 years for facilities conducting research funded by
the Public Health Service.

paragraph (c)(3) any departures from the regulations found by the IACUC at any time are
required to be reported and addressed appropriately. The IACUC may approve, require
modifications, or withhold approval of such changes, using the AWA regulations as the basis for
its decision. Requirements for submitting a proposal to make significant changes to an ongoing
activity are listed in § 2.31(e). Furthermore, the IACUC may review animal use in an ongoing
activity at any time if there are indications that it deviates from initially approved procedures.
One commenter stated that an annual review is essential for ensuring that when new
alternatives in animal use become available, the IACUC and the PI can promptly consider them.
Similarly, several commenters noted that advances in scientific knowledge are emerging so
quickly that refinements for improving the humane treatment of animals in research activities
may go unused in the long period between reviews.
In the interim 3-year period before a complete review occurs, the semiannual review, and
the IACUC review and approval process for significant changes, remain in place for raising
concerns about changes in a scientific method or the existence of alternatives that reduce or
replace live animal use. In addition, the Animal Welfare Information Center remains a resource
for the PI to consult regarding the latest alternatives. The AWA regulations under § 2.32(c)(5)
require training of PIs and other facility staff in using this resource or that of the National
Library of Medicine. If the PI decides to implement an alternative in a research activity based on
new knowledge, then he or she can submit an amendment to the IACUC for review and approval
at any time.
Two commenters cited a 2014 audit report by the USDA Office of Inspector General
(OIG) that found a substantial number of research facilities reviewed in fiscal years 2009-2011
misreported animal use and that IACUCs did not approve, monitor, or report adequately on
experimental procedures on animals. Citing these issues in the OIG audit, the commenters
indicated that a full IACUC continuing review on at least an annual basis is needed to ensure
compliance and protect animals.

We acknowledge the conclusions of the audit report, in which USDA-OIG recommended
that APHIS provide research facilities with training or best practice guidelines for IACUC
protocol reviews and approvals regarding experimental procedures. As noted in the audit report,
APHIS agreed with the OIG recommendation and has since developed guidance for research
facilities on protocol review and approval, including updating the Animal Care Inspection Guide
with additional guidance on IACUC best practices. In addition, NIH and APHIS formed the
Interagency Collaborative Animal Research Education Project, which involves frequent trainings
to empower IACUCs and their institutions to improve animal welfare and increase compliance
with Federal standards.
We reiterate that eliminating the continuing review does not affect the frequency or depth
of reviews required to ensure the humane care and use of animals, and that addition of the
complete review further addresses the commenter’s concerns.
A few commenters indicated that reducing the frequency of protocol review will diminish
efforts to follow the “Three R’s”—reduction, refinement, replacement—thus undermining the
spirit and intent of the independent policing inherent to the current AWA enforcement structure
and limiting the IACUC’s role.
We are making no changes in response to the comment. The IACUC’s role is not limited
or diminished as the result of removing the continuous review requirement, and addition of the
complete review provides the committee with an additional strategy for ensuring animal welfare.
We add that the IACUC has the authority to review the humane care and use of animals and all
the research facility's animal facilities whenever deemed necessary to ensure compliance with the
AWA.
A commenter stated that the proposed changes in review hamstring Congressional review
and related agency reporting, as both reporting and funding may rely upon outdated data.
The annual continuing review is distinct from the annual report that facilities will still be
required to submit to APHIS. The annual report provides data about the animals used by species

and the level of pain and distress experienced during the annual reporting period. Furthermore,
agency funding is not dependent on the annual report of animal use by research facilities.
One commenter stated that revising the review requirements lies outside the scope of the
statutory source, explaining that APHIS does not explain whether the protection of animals
would be adversely affected by reducing administrative burden in accordance with 2034(d) of
the 21CCA.
We disagree with the commenter. The 21CCA tasked the NIH, in collaboration with the
USDA and the FDA, to review regulations and policies for the care and use of laboratory
animals and revise them appropriately to reduce administrative burden on investigators while
maintaining the integrity and credibility of research findings and protection of research animals.
The reduction in administrative burden will have no effect on animal welfare in research
facilities, as there will be no change in the degree of IACUC and APHIS oversight.
A few commenters stated that harmonizing the IACUC review requirement with NIH
requirements is insufficient to ensure animal welfare at research facilities, with one noting that
serious animal welfare violations have been documented at NIH facilities in the past few years.
Another commenter suggested that, instead of changing the USDA review, the NIH should
conform to USDA’s stronger annual review requirement. Another commenter stated that the
proposal to align with the NIH review timeframe is based purely on convenience and is an
inadequate reason to put animals in harm’s way.
We reiterate that APHIS’ addition of the complete review as a regulatory requirement
ensures a thorough evaluation of research activity design and development with respect to
maintaining animal welfare and is independent of NIH oversight activities. Together with
semiannual inspections, monitoring of animal activities at an interval deemed necessary for each
facility, and investigation of complaints as warranted, the level of animal welfare oversight at
facilities will not be diminished by this change.

Another commenter suggested changing the requirement to a 2-year or less review
interval, explaining that it would relieve burden while matching the NIH requirement of a
complete review of IACUC-approved activities.
We are making no changes in response to the commenter. In keeping with the reforms of
the 21CCA, our proposed changes eliminate the redundancy of the continuous review while
retaining the semiannual review. Regarding the complete review, we reiterate that the IACUC
may choose to review ongoing activities more frequently than 3 years as part of a program
review.

In the proposed rule, we noted that the complete review would result in approval of an
activity using animals for an interval approved by the IACUC, not to exceed 3 years after the
review, unless the IACUC suspends the activity for nonconformance with the description of that
activity as provided by the PI and approved by the IACUC under § 2.31(d)(6).
A commenter stated that in addition to a protocol expiring after 3 years or being
terminated, it is likely that research facilities have methods to terminate an approved IACUC
protocol other than those cited in the regulations. The commenter noted as one example a
voluntary termination by the PI or the IACUC for a reason other than that described in
§ 2.31(d)(6), or suspension by the IO.
We are making no changes in response to the comment. However, we acknowledge the
commenter’s point that a facility may choose to terminate a research activity voluntarily for
reasons not included in the regulations.
A commenter suggested we consider the way protocols are renewed on an annual basis in
Canada following a full review.
We are making no changes in response to the commenter. We note that under the
regulations, research facilities are currently required to submit an annual report and under the

proposed regulatory changes will undertake the 3-year complete review. Consistent with the
aims of the 21CCA, this change harmonizes our review requirements with NIH requirements for
Public Health Service-funded studies.
As a final note on our proposed addition of the complete review to § 2.31(d)(5), we are
amending the language we originally proposed to read “all activities” instead of “proposed
activities” pertaining to requirements for submitting written descriptions of activities to the
IACUC involving the care and use of animals. This change more accurately reflects what we
intended and reinforces commenter concerns that both proposed and ongoing activities involving
animal care and use fall under the review requirement.
Annual Report Signature
We proposed to amend § 2.36(a) to eliminate the requirement for Chief Executive Officer
(CEO) and IO signatures on a paper copy of the annual report. We noted that this guards against
identity theft and allows for the facility representative to electronically submit the annual report
on behalf of the CEO or IO while maintaining requirements for the facility annual report and
practices. We also proposed to modify § 2.36(a) to inform registered research facilities and
Federal research facilities that APHIS Forms 7023, 7023A, and 7023B may be used to submit
the annual report information required in § 2.36(b).
Several commenters indicated that requiring the CEO or IO to sign the annual report
makes them legally accountable and connected to the IACUC process and recommended against
eliminating the requirement. One such commenter advised against eliminating the requirement
for a signed paper copy of the report. Another commenter stated that, since the CEO or IO is
ultimately responsible for making modifications to a facility and for ensuring that research
protocols are modified as necessary for animal welfare purposes, his or her signature on the
report confirms the awareness that such modifications are needed. The commenter added that if
the annual report was submitted by the facility representative electronically, the CEO or IO may
not be aware that modifications are needed for the facility to conform with the AWA. The

commenter supported digital signature and electronic submission of the report but asked that we
require CEO or IO signature.
We note that under the definition in § 1.1, the IO is the individual at a research facility
who is authorized to legally commit on behalf of the research facility that the requirements of
9 CFR parts 1, 2, and 3 will be met. The IACUC is required to prepare a report of findings from
the semiannual inspections to be given to the IO. The CEO and IO of the facility are legally
responsible for facility and activity conformance with the AWA regardless of whether they
actually sign the annual report.
Another commenter stated that changing the signature requirement is arbitrary and
recommended against it, as APHIS does not consider its costs or alternatives to the revision.
We disagree that it is arbitrary because the change is consistent with the reforms called
for in the 21CCA to reduce administrative burden. The costs of this change to the regulations are
considered in the supporting economic analysis (see footnote 3 for a link to the analysis).
Other Comments
One commenter stated that IACUCs at taxpayer-funded State universities should open
their meetings to the public.
This comment is beyond the scope of the rulemaking as we proposed no changes to
IACUC meetings.
A commenter stated that we failed to show the cost savings to facilities of the proposed
changes.
Information about costs can be found in the economic analysis prepared for this
rulemaking.
Another commenter stated that cost savings and relief from regulatory burden would be
achieved by moving away from animal experiments toward human-relevant research.
The comment is beyond the scope of this rulemaking as we did not address the topic of
whether animal experimentation should be eliminated.

A commenter questioned whether the Secretary of Agriculture has the authority to
delegate administration of the AWA to the APHIS Administrator. The commenter also stated
that while the Administrative Procedure Act requires a “reasoned explanation” for finalizing
proposed changes, the proposed rule does not explain how reducing duplicative requirements and
administrative burden on research facilities, maintaining research integrity and oversight, and
ensuring that research animals continue to receive humane care would result from the proposed
provisions in the rule.
The delegation authority of the USDA Secretary is established by statute.11 As for the
relationship between reducing administrative burden while maintaining oversight and humane
animal care, we respond that the reduction in burden does not impede current processes in place
to ensure oversight, such as evaluating, at least semiannually, the research facility's program for
humane care and use of animals, conducting reviews as determined necessary, and investigating
public complaints as warranted.
Miscellaneous
In parts 2, 3, and 4 of the current regulations, we proposed and are making minor
corrections in punctuation and wording to improve readability. In paragraphs (f)(6) and (7) of
§ 3.111, we are removing extraneous punctuation and wording. In §§ 4.10 and 4.11, we are
adding pronouns that are more inclusive.
Therefore, for the reasons given in the proposed rule and in this document, we are
adopting the proposed rule as a final rule with the changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This final rule has been determined to be not significant for the purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.
In accordance with the Regulatory Flexibility Act, we have analyzed the potential
economic effects of this action on small entities. The analysis is summarized below. Copies of

U.S.C. 302-Delegation of authority.

the full analysis are available on the Regulations.gov website (see footnote 3 in this document for
a link to Regulations.gov) or by contacting the person listed under FOR FURTHER
INFORMATION CONTACT.
APHIS is amending five requirements in the following three sections of the Animal
Welfare Regulations. The five amendments in these three sections are summarized as follows:
Section 2.30-Registration
ï‚·

Paragraph (a)(1): Eliminate the requirement for research facility registration updates at
3-year intervals;

ï‚·

Paragraph (c): Eliminate the requirement for a research facility to request being placed
on inactive status if the facility has not used, handled, or transported animals for a
period of at least 2 years;

ï‚·

Paragraph (d): Clarify the duration of a registration and conditions for cancellation of a
registration;

Section 2.31-IACUC
ï‚·

Paragraph (d)(5): Replace continuing annual reviews of activities involving animals
approved by the IACUC with reviews and approval by the IACUC at intervals not
exceeding 3 years; and

Section 2.36-Annual Report
ï‚·

Paragraph (a): Eliminate the requirement for Chief Executive Officer and Institutional
Official signatures on the reporting facility annual report.

APHIS solicited public comments concerning these amendments for 60 days ending
November 16, 2020 and received 61 comments. Three commenters raised concerns that were
specific and relevant to the Initial Regulatory Flexibility Analysis (IRFA). The commenters
expressed concern that the changes could compromise humane animal care at research facilities.
Processes in place under the regulations by which IACUC monitors animal activities will not be

affected by the changes. These processes include semiannual inspections and the authority to
investigate any complaints where warranted under 9 CFR 2.31.
APHIS has quantified annual savings for facilities that total approximately $80,000 from
the changes in § 2.30(a)(1) and approximately $11,000 from the change in § 2.36(a). APHIS
also expects that the changes to § 2.30(c)(2) and (3) will reduce administrative burden of certain
inactive research facilities. APHIS expects that the change in § 2.31(d)(5) will be cost neutral;
no quantifiable public information is available to show expected net cost savings from the
change.
These changes are intended to reduce administrative burden on investigators, IACUC
members, attending veterinarians, and other related facility staff, and will not affect the Animal
Welfare regulations that ensure humane animal care during research, testing, experiments, or
teaching. Facilities covered by this final rule include small entities.
Based on our review of available information, the APHIS Administrator has determined
that this action will not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic Assistance under No.
10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation
with State and local officials. (See 2 CFR chapter IV.)
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not
intended to have retroactive effect. The Act provides administrative procedures which must be
exhausted prior to a judicial challenge to the provisions of this rule.
Paperwork Reduction Act
This rule contains no new information collection or recordkeeping requirements under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The information collection

activities in this rule are approved under the Office of Management and Budget control number
0579-0036.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to compliance with the
E-Government Act to promote the use of the internet and other information technologies, to
provide increased opportunities for citizen access to Government information and services, and
for other purposes. For information pertinent to E-Government Act compliance related to this
rule, please contact Mr. Joseph Moxey, APHIS’ Paperwork Reduction Act Coordinator, at (301)
851-2483.
List of Subjects
9 CFR Part 2
Animal welfare, Pets, Reporting and recordkeeping requirements, Research.
9 CFR Part 3
Animal welfare, Marine mammals, Pets, Reporting and recordkeeping requirements,
Research, Transportation.
9 CFR Part 4
Administrative practice and procedure, Animal welfare.
Accordingly, we are amending 9 CFR parts 2, 3, and 4 as follows:
PART 2—REGULATIONS
1. The authority citation for part 2 continues to read as follows:
Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
2. Section 2.30 is amended as follows:
a. By revising paragraphs (a)(1) and (c);
b. By redesignating paragraph (d) as paragraph (e);
c. By adding a new paragraph (d); and
d. By adding a heading for newly redesignated paragraph (e).

The revisions and addition read as follows:
§ 2.30 Registration.
(a) *

*

*

(1) Each research facility, other than a Federal research facility, shall register with the
Secretary by completing and filing a properly executed form which will be furnished, upon
request, by the Deputy Administrator. The registration form shall be filed with the Deputy
Administrator. Except as provided in paragraph (a)(2) of this section, where a school or
department of a university or college uses or intends to use live animals for research, tests,
experiments, or teaching, the university or college rather than the school or department will be
considered the research facility and will be required to register with the Secretary. An official
who has the legal authority to bind the parent organization shall sign the registration form.
*

*

*

*

*

(c) Notification of change of operation. A research facility shall notify the Deputy
Administrator in writing of any change in the name, address, or ownership, or other change in
operations affecting its status as a research facility, within 10 days after making such change.
The Notification of Change form (APHIS Form 7033) may be used to provide the information.
(d) Duration of a registration and conditions for cancellation of a registration. (1) A
research facility that goes out of business or ceases to function as a research facility, or that
changes its method of operation so that it no longer uses, handles, or transports animals, and does
not plan to use, handle, or transport animals at any time in the future, may have its registration
canceled by making a written request to the Deputy Administrator.
(2) If the Deputy Administrator has sufficient evidence showing that a research facility
has ceased to function as a research facility, then the Deputy Administrator may cancel the
registration on its own, without a written request from the research facility.

(3) If a research facility plans to resume regulated activity, the facility is responsible for
submitting a form (APHIS Form 7011A) to reregister at least 10 days prior to it using, handling,
or transporting animals. There are no fees associated with such reregistration.
(e) Non-interference with APHIS officials. * * *
3. In § 2.31, paragraph (d)(5) is revised to read as follows:
§ 2.31 Institutional Animal Care and Use Committee (IACUC).
*

*

*

*

(d) *

*
*

*

(5) The IACUC shall conduct complete reviews of activities covered by this subchapter
at appropriate intervals as determined by the IACUC, but not less than every 3 years. The
complete review shall address all requirements related to the care and use of animals under
paragraphs (d) and (e) of this section. The IACUC shall be provided a written description of all
activities that involve the care and use of animals for review and approval at the end of the term.
*

*

*

*

*

4. In § 2.36, paragraph (a) is revised to read as follows:
§ 2.36 Annual report.
(a) The reporting facility shall be that segment of the research facility, or that department,
agency, or instrumentality of the United States that uses or intends to use live animals in
research, tests, experiments, or for teaching. Each reporting facility shall submit an annual report
to the Deputy Administrator on or before December 1 of each calendar year. The report shall
cover the previous Federal fiscal year. The Annual Report of Research Facility (APHIS Form
7023), Continuation Sheet for Annual Report of Research Facility (APHIS Form 7023A), and
Annual Report of Research Facility Column E Explanation (APHIS Form 7023B) are forms
which may be used to submit the information required by paragraph (b) of this section.
*

*

*

*

*

PART 3—STANDARDS

5. The authority citation for part 3 continues to read as follows:
Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
§ 3.111 [Amended]
6. Section 3.111 is amended in paragraphs (f)(6) and (7) by removing “, which”.
PART 4—RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER THE ANIMAL
WELFARE ACT
7. The authority citation for part 4 continues to read as follows:
Authority: 7 U.S.C. 2149 and 2151; 7 CFR 2.22, 2.80, and 371.7.
§ 4.10 [Amended]
8. In § 4.10, paragraph (a) is amended by removing the words “he” and “his” and adding
the words “he or she” and “his or her” in its places, respectively.
§ 4.11 [Amended]
9. In § 4.11, paragraph (a) introductory text is amended by removing the word “his” and
adding the words “his or her” in its place.

Done in Washington, DC, this 18th day of November 2021.

Mark Davidson
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2021-25614 Filed: 11/23/2021 8:45 am; Publication Date: 11/24/2021]