[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Rules and Regulations]
[Pages 54271-54273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17090]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 9

[Docket Number NIH-2019-0001]
RIN: 0925-AA66


Standards of Care for Chimpanzees Held in the Federally Supported 
Sanctuary System

AGENCY: National Institutes of Health, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: This document contains technical amendments to the Health and 
Human Services (HHS) regulation regarding the Standards of Care for 
Chimpanzees Held in the Federally Supported Sanctuary System. The 
regulatory content is being amended to correct references that are made 
throughout the regulation regarding delegated authorities and 
activities of the National Center for Research Resources (NCRR) of the 
National Institutes of Health (NIH). With the abolishment of NCRR in 
2011, the Director, NIH, delegated these authorities to the Office of 
Research Infrastructure Programs (ORIP) within the Division of Program 
Coordination, Planning, and Strategic Initiatives (DPCPSI), NIH. The 
ORIP/DPCPSI now has the lead responsibility for coordinating all 
efforts on behalf of HHS concerning the sanctuary system for surplus 
chimpanzees from both federal and non-federal sources. The references 
to NCRR throughout the regulation are corrected to reflect ORIP/DPCPSI, 
the definition of National Primate Research Center is corrected to 
reflect the correct number of currently existing centers, and the 
office address provided for ORIP/DPCPSI in the regulation is corrected.

DATES: Effective on September 1, 2020.

FOR FURTHER INFORMATION CONTACT: Daniel Hernandez, Acting NIH 
Regulations Officer, Office of Management Assessment, Division of 
Management Support, 6011 Executive Boulevard, Suite 601, Rockville, 
Maryland 20852-7669, telephone 301-435-3343, email 
[email protected].

SUPPLEMENTARY INFORMATION: On December 20, 2000, the United States 
Congress enacted the Chimpanzee Health Improvement, Maintenance, and 
Protection Act of 2000 (Pub. L. 106-551, ``CHIMP Act''). Section 1 of 
this law amended the Public Health Service Act by adding section 481C 
(42 U.S.C. 287a-3a). Section 481C requires the Secretary, HHS, to 
provide for the establishment and operation of a sanctuary system to 
provide for the lifetime care of chimpanzees that have been used, or 
were bred or purchased for use, in research conducted or supported by 
NIH, the Food and Drug Administration (FDA), or other agencies of the 
Federal Government, and with respect to which it has been determined by 
the Secretary, HHS, that the chimpanzees are not needed for such 
research (i.e., surplus chimpanzees).
    Section 481C(d) directs the Secretary, HHS, to establish, by 
regulation, standards of care for operating the sanctuary system to 
provide for the permanent retirement of surplus chimpanzees. On April 
5, 2001, the Secretary, HHS, delegated to the Director, NIH, 
authorities to establish and operate the sanctuary system. 
Subsequently, the Director, NIH, delegated the authorities to NCRR. On 
October 10, 2008, HHS issued a final rule that established the 
regulation at 42 CFR part 9 which sets forth the standards of care for 
chimpanzees held in the federally supported chimpanzee sanctuary 
system. References are made

[[Page 54272]]

throughout that regulation regarding delegated authorities and 
activities of NCRR, NIH.
    On September 9, 2011, the Secretary, HHS, approved an 
organizational change at NIH that included the abolishment of NCRR and 
the creation of the Office of Research Infrastructure Programs (ORIP) 
within the Division of Program Coordination, Planning, and Strategic 
Initiatives (DPCPSI). The DPCPSI had been established on May 6, 2008, 
as a result of provisions of the NIH Reform Act of 2006, Public Law 
109-482. The Director, NIH, delegated authorities to establish and 
operate the sanctuary system to ORIP within DPCPSI, NIH. The ORIP/
DPCPSI now has the lead responsibility for coordinating all efforts on 
behalf of HHS concerning the sanctuary system for surplus chimpanzees 
from both federal and non-federal sources.
    Recently, ORIP officials, in collaboration with NIH Regulations 
Program (NIHRP) officials, completed a review of the regulation 
codified at 42 CFR part 9, as part of NIH's efforts to comply with the 
requirements of the President's Regulatory Reform agenda, as set forth 
in Executive Order 13777, Enforcing the Regulatory Reform Agenda. One 
of the outcomes of the review was the determination that the regulation 
needed to be updated to correct its references regarding the delegated 
authorities and activities of NCRR and to indicate that ORIP/DPCPSI now 
has the lead responsibility for coordinating all efforts on behalf of 
HHS concerning the sanctuary system for surplus chimpanzees.
    Since the regulation was issued in 2008, the number of existing 
National Primate Research Centers has been reduced from eight to seven, 
as of 2015. This change needs to be made in the definition of National 
Primate Research Center provided in section 9.2 of the regulation.
    Additionally, the office address provided in section 9.4 of the 
regulation, 1 Democracy Plaza, is corrected to read One Democracy 
Plaza.

Matters of Regulatory Procedure

Administrative Procedure Act

    Pursuant to 5 U.S.C. 553(b) and (d), the Secretary, HHS, has found 
good cause exists for waiving the general notice of proposed 
rulemaking, opportunity for public comment and 30-day delay in 
effectiveness as to these technical updates and correction. The notice, 
comment and delayed effective date provisions are being waived in part 
because these minor amendments concern matters of agency organization, 
practice and procedure. Further, it is in the public interest that 
correct and up-to-date information be contained in the affected 
sections of the regulation at 42 CFR part 9 as soon as possible.
Executive Orders 12866 and 13563
    Executive Orders 12866, ''Regulatory Planning and Review,'' and 
13563, ``Improving Regulation and Regulatory Review,'' direct agencies 
to assess all costs and benefits of available regulatory alternatives 
and, if regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety effects, distributive impacts, and equity). 
Section 3(f) of Executive Order 12866 defines a ``significant 
regulatory action'' as an action that is likely to result in a rule: 
(1) Having an annual effect on the economy of $100 million or more in 1 
year, or adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlements, grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order. A regulatory impact 
analysis (RIA) is required for significant and, economically 
significant rules with economically significant effects ($100 million 
or more in any 1 year). It has been determined that this amendatory 
rulemaking is not significant.
Executive Order 13771
    Executive Order 13771, ``Reducing Regulation and Controlling 
Regulatory Costs,'' directs agencies to issue two deregulatory actions 
for each new significant regulatory action that imposes costs. The 
incremental costs of a new regulation should be offset by the costs 
eliminated by the prior regulations. The Secretary, HHS, has determined 
this amending rulemaking action is not significant and thus is neither 
regulatory nor deregulatory for the purposes of Executive Order 13771.
Executive Order 13132
    Executive Order 13132, ``Federalism,'' requires that federal 
agencies consult with state and local government officials in the 
development of regulatory policies with federalism implications. The 
Secretary, HHS, has reviewed this final rule as required under the 
Executive Order and determined that it will not have federalism 
implications. The Secretary, HHS, certifies that the final rule will 
not have effect on the States or on the distribution of power and 
responsibilities among various levels of government.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. chapter 6) requires 
agencies to analyze regulatory options that would minimize the 
significant economic impact of a rule on small entities. The Secretary 
has determined that this rulemaking will not have a significant 
economic impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
agencies to prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandates that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually to 
inflation) in any one year. The current threshold after adjustment for 
inflation is $154 million, using the most current (2018) Implicit Price 
Deflator for the Gross Domestic Product. The Secretary, HHS, has 
determined that this final amendatory rulemaking will not result in an 
expenditure in any year that meets or exceeds that amount.

Paperwork Reduction Act

    The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply, 
because this amendatory rulemaking does not contain information 
collection requirements that require the approval of the Office of 
Management and Budget.

Congressional Review Act

    The Secretary, HHS, has determined that this amendatory rulemaking 
is a non-major rule under the Congressional Review Act (5 U.S.C. 
chapter 8) and has provided a report thereon to the Senate, House of 
Representatives and General Accounting Office in accordance with that 
law.

List of Subjects

    Animal welfare, humane care and treatment of chimpanzees.
    Accordingly, under the authority of 42 U.S.C. 216, the Department 
of Health and Human Services amends 42 CFR

[[Page 54273]]

part 9 by making the following correcting amendments:

Title 42--Public Health

PART 9--STANDARDS OF CARE FOR CHIMPANZEES HELD IN THE FEDERALLY 
SUPPORTED SANCTUARY SYSTEM

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 42 U.S.C. 216, 287a-3a.


Sec.  9.2  [Amended]

0
2. Amend Sec.  9.2 by:
0
a. In the definition of ``National Primate Research Center (NPRC)'' 
removing the phrase ``National Center for Research Resources'' and 
adding, in its place, the phrase ``Office of Research Infrastructure 
Programs (ORIP) within the Division of Program Coordination, Planning 
and Strategic Initiatives (DPCPSI),'' removing the date ``June 2007'' 
and adding, in its place, the date ``2015''; and removing the word 
``eight'' and adding, in its place, the word ``seven''.
0
b. In the definition of ``Sanctuary Contractor'' by removing the phrase 
``NCRR/NIH'' and adding, in its place the phrase ``ORIP/DPCPSI/NIH.''
0
c. In the definition of ``Sanctuary of federally supported chimpanzee 
system'' by removing the phrase ``NCRR/NIH/HHS'' and adding, in its 
place, the phrase ``ORIP/DPCPSI/NIH/HHS.''


Sec.  9.3   [Amended]

0
3. Amend Sec.  9.3 by:
0
a. In paragraph (a)(2)(ix) removing the phrase ``NCRR'' and adding, in 
its place, the phrase ``ORIP/DPCPSI.''
0
b. In paragraph (a)(8) removing the phrase ``NCRR/NIH'' and adding, in 
its place, the phrase ``ORIP/DPCPSI/NIH.''
0
c. In paragraph (b)(2) removing the phrase ``NCRR/NIH'' and adding, in 
its place, the phrase ORIP/DPCPSI/NIH.''


Sec.  9.4   [Amended]

0
4. In Sec.  9.4, amend paragraph (a) by removing the phrase ``NCRR'' 
and adding, in its place, the phrase ``ORIP/DPCPSI'', and removing the 
number ``1'' in the ``1 Democracy Plaza'' address and adding, in its 
place, the word ``One'' to read ``One Democracy Plaza''.


Sec.  9.5   [Amended]

0
5. Amend Sec.  9.5 by:
0
a. In paragraph (c)(4) removing the phrase ``NCRR/NIH'' and adding, in 
its place, the phrase ``ORIP/DPCPSI/NIH.''
0
b. In paragraph (d)(2) removing the phrase ``NCRR'' and adding, in its 
place, the phrase ORIP/DPCPSI/NIH.''
0
c. In paragraph (e) removing the phrase ``NCRR'' and adding, in its 
place, the phrase ``ORIP/DPCPSI/NIH.''


Sec.  9.6   [Amended]

0
6. In Sec.  9.6, amend paragraph (d)(2) by removing the phrase ``NCRR'' 
and adding, in its place, the phrase ``ORIP/DPCPSI.''


Sec.  9.9   [Amended]

0
7. In Sec.  9.9, amend paragraph (a) by removing the phrase ``NCRR/
NIH'' and adding, in its place, ``ORIP/DPCPSI/NIH.''


Sec.  9.12   [Amended]

0
8. Amend Sec.  9.12 by:
0
a. In paragraph (a) removing the phrase ``NCRR'' and adding, in its 
place, the phrase ``ORIP/DPCPSI''; removing the phrase ``NCRR/NIH/HHS'' 
and adding, in its place, the phrase ORIP/DPCPSI/NIH/HHS''; and 
removing the phrase ``NIH/NCRR Project Officer'' and adding, in its 
place, the phrase ``ORIP/DPCPSI/NIH Project Officer.''
0
b. In paragraph (b) removing the phrase ``NCRR/NIH/HHS'' and adding, in 
its place, ``ORIP/DPCPSI/NIH/HHS''; removing the phrase ``NCRR'' and 
adding, in its place, the phrase ``ORIP/DPCPSI''; and removing the 
phrase ``NCRR/NIH'' and adding, in its place, the phrase ``ORIP/DPCPSI/
NIH.''

    Dated: July 21, 2020.
Francis S. Collins,
Director, National Institutes of Health.
Alex M. Azar II,
Secretary, Health and Human Services.
[FR Doc. 2020-17090 Filed 8-31-20; 8:45 am]
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