AWA Research Facility Registration Updates, Reviews, and Reports, 66919-66926 [2021-25614]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Rules and Regulations]
[Pages 66919-66926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25614]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

========================================================================


Federal Register / Vol. 86, No. 224 / Wednesday, November 24, 2021 / 
Rules and Regulations

[[Page 66919]]


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

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 December 27, 2021.

FOR FURTHER INFORMATION CONTACT: Dr. Lance H. Bassage, VMD, Director, 
National Policy Staff, Animal Care, APHIS, 4700 River Road, Unit 84, 
Riverdale, MD 20737; [email protected].

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 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.
---------------------------------------------------------------------------

    \1\ https://www.federalregister.gov/documents/2020/09/17/2020-20512/awa-research-facility-registration-updates-reviews-and-reports.
    \2\ 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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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 form \5\ with the registrant's name, address, and 
contact information; USDA registration certificate numbers; and names 
of partners, officers, and the Institutional Official (IO) as 
applicable.
---------------------------------------------------------------------------

    \4\ APHIS Form 7011A: Application for Registration, New 
Registration.
    \5\ APHIS Form 7011: Application for Registration, Registration 
Update.
---------------------------------------------------------------------------

    We proposed to eliminate the requirement in Sec.  2.30(a)(1) to 
update the research facility registration every 3 years after the 
facility's initial registration. We proposed this change because Sec.  
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

[[Page 66920]]

because name, address, contact information, and registration 
certificate numbers are included in the annual report \6\ that 
facilities are required to submit to APHIS in accordance with Sec.  
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.
---------------------------------------------------------------------------

    \6\ APHIS Form 7023: Annual Report of Research Facility.
---------------------------------------------------------------------------

    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 Sec.  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 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 Sec.  2.30(c)(1) for 
research facilities to notify the APHIS Animal Care Deputy 
Administrator in writing \7\ 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 Sec.  2.30 that clarifies the 
duration of a research facility's registration and conditions for its 
cancellation.
---------------------------------------------------------------------------

    \7\ Send changes to USDA/APHIS/AC, 4700 River Road, Unit 84, 
Riverdale, MD 20737-1234, or email [email protected].
    \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.
---------------------------------------------------------------------------

    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.
    Two commenters asked that APHIS clarify what constitutes a ``change 
of operations'' as the term appears in Sec.  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 
Sec.  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 Sec.  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 Sec.  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 Sec.  
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 
Sec.  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 Sec.  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

[[Page 66921]]

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 Sec.  
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 Sec.  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 Sec.  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\
---------------------------------------------------------------------------

    \9\ USDA/APHIS/AC, 4700 River Road, Unit 84, Riverdale, MD 
20737-1234, or email [email protected].
---------------------------------------------------------------------------

    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.
    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 Sec.  2.30(d)(3) includes registration requirements for 
formerly registered facilities wishing to resume regulated activity. A 
few commenters recommended revising Sec.  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 Sec.  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 Sec.  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

[[Page 66922]]

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 Sec.  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 Sec.  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 Sec.  2.31(c)(3). 
In addition, the IACUC's functions under Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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 3-year 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 Sec.  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 Sec.  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 Sec.  
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 Sec.  
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 
Service \10\ can continue

[[Page 66923]]

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.
---------------------------------------------------------------------------

    \10\ 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.
---------------------------------------------------------------------------

    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 Sec.  
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 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 Sec.  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 Sec.  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

[[Page 66924]]

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 
Sec.  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 Sec.  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 
Sec.  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 Sec.  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 Sec.  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 Sec.  
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 Sec.  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

[[Page 66925]]

semiannually, the research facility's program for humane care and use 
of animals, conducting reviews as determined necessary, and 
investigating public complaints as warranted.
---------------------------------------------------------------------------

    \11\ 5 U.S.C. 302--Delegation of authority.
---------------------------------------------------------------------------

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 Sec.  3.111, we are 
removing extraneous punctuation and wording. In Sec. Sec.  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 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

     Paragraph (a)(1): Eliminate the requirement for research 
facility registration updates at 3-year intervals;
     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;
     Paragraph (d): Clarify the duration of a registration and 
conditions for cancellation of a registration;

Section 2.31--IACUC

     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

     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 Sec.  2.30(a)(1) and 
approximately $11,000 from the change in Sec.  2.36(a). APHIS also 
expects that the changes to Sec.  2.30(c)(2) and (3) will reduce 
administrative burden of certain inactive research facilities. APHIS 
expects that the change in Sec.  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

0
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.


0
2. Section 2.30 is amended as follows:
0
a. By revising paragraphs (a)(1) and (c);
0
b. By redesignating paragraph (d) as paragraph (e);
0
c. By adding a new paragraph (d); and
0
d. By adding a heading for newly redesignated paragraph (e).
    The revisions and addition read as follows:


Sec.  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

[[Page 66926]]

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. * * *

0
3. In Sec.  2.31, paragraph (d)(5) is revised to read as follows:


Sec.  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.
* * * * *

0
4. In Sec.  2.36, paragraph (a) is revised to read as follows:


Sec.  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

0
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.


Sec.  3.111   [Amended]

0
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

0
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.


Sec.  4.10   [Amended]

0
8. In Sec.  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.


Sec.  4.11  [Amended]

0
9. In Sec.  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 11-23-21; 8:45 am]
BILLING CODE 3410-34-P