Standards of Care for Chimpanzees Held in the Federally Supported Sanctuary System, 54271-54273 [2020-17090]
Download as PDF
Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Rules and Regulations
(ii) Provide classified or unclassified
notice of the exclusion or removal order
to the appropriate congressional
committees and leadership;
(iii) Provide the exclusion or removal
order to the ISA;
(iv) Notify the Interagency Suspension
and Debarment Committee about the
exclusion or removal order.
(2) May provide the exclusion order
or removal order to other persons,
including public disclosure, as the
official deems appropriate and to the
extent consistent with national security
and law enforcement interests.
(g) Delegation. The officials identified
in paragraph (a) of this section may not
delegate the authority to issue exclusion
and removal orders to an official below
the level one level below the Deputy
Secretary or Principal Deputy Director
level, except that the Secretary of
Defense may delegate authority for
removal orders to the Commander of
U.S. Cyber Command, who may not redelegate such authority to an official
below the level of the Deputy
Commander.
(h) Removal from Federal supply
contracts. If the officials identified in
paragraphs (b) through (d) of this
section, or their delegate, issue orders
collectively resulting in a governmentwide exclusion, the Administrator for
General Services and officials at other
executive agencies responsible for
management of the Federal Supply
Schedules, government-wide
acquisition contracts and multi-agency
contracts shall facilitate implementation
of such orders by removing the covered
articles or sources identified in the
orders from such contracts.
(i) Annual review of issued orders.
The officials identified in paragraphs (b)
through (d) of this section shall review
all issued exclusion and removal orders
not less frequently than annually
pursuant to procedures established by
the FASC.
(j) Modification or rescission of issued
orders. The officials identified in
paragraphs (b) through (d) of this
section may modify or rescind an issued
exclusion or removal order, provided
that a modified order shall not apply
more broadly than the order before the
modification.
jbell on DSKJLSW7X2PROD with RULES
§ 201.304 Executive agency compliance
with exclusion and removal orders.
(a) Agency compliance. Executive
agencies shall:
(1) Comply with exclusion and
removal orders issued pursuant to
§ 201.303 and applicable to their
agency, as required by 41 U.S.C. 1323(d)
and 44 U.S.C. 35554(a)(1)(B); and
VerDate Sep<11>2014
15:57 Aug 31, 2020
Jkt 250001
(2) Not make publicly-available any
exclusion order or removal order unless
otherwise approved by the FASC prior
to such release.
(b) Exceptions to issued exclusion and
removal orders. An executive agency
required to comply with an exclusion
order or a removal order may submit to
the official that issued the order a
request that an issued order not apply
to the agency, to specific actions of the
agency, to actions of the agency for a
period of time before compliance with
the order is practicable, and any other
request that the requesting agency seeks.
The request shall include all necessary
information for the issuing official to
review and evaluate the request,
including alternative mitigations to the
risks addressed by the order and the
ability of an agency to fulfill its mission
critical functions. Other circumstances
that may warrant an exception to an
issued order include other findings
related to the national interest,
including national security reviews,
national security investigations, or
national security agreements. The
request shall be submitted in writing.
The FASC may establish and update
additional procedures for requesting
waivers and criteria for approving or
disapproving such requests as
appropriate.
[FR Doc. 2020–18939 Filed 8–31–20; 8:45 am]
BILLING CODE 3110–05–P
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.
Final rule; technical
amendments.
ACTION:
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
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
54271
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 dhernandez@
od.nih.gov.
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
E:\FR\FM\01SER1.SGM
01SER1
54272
Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Rules and Regulations
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
jbell on DSKJLSW7X2PROD with RULES
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 30day 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,
VerDate Sep<11>2014
15:57 Aug 31, 2020
Jkt 250001
practice and procedure. Further, it is in
the public interest that correct and upto-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
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
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
E:\FR\FM\01SER1.SGM
01SER1
Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Rules and Regulations
part 9 by making the following
correcting amendments:
c. In paragraph (e) removing the
phrase ‘‘NCRR’’ and adding, in its place,
the phrase ‘‘ORIP/DPCPSI/NIH.’’
■
Title 42—Public Health
PART 9—STANDARDS OF CARE FOR
CHIMPANZEES HELD IN THE
FEDERALLY SUPPORTED
SANCTUARY SYSTEM
1. The authority citation for part 9
continues to read as follows:
■
[Amended]
2. Amend § 9.2 by:
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’’.
■ b. In the definition of ‘‘Sanctuary
Contractor’’ by removing the phrase
‘‘NCRR/NIH’’ and adding, in its place
the phrase ‘‘ORIP/DPCPSI/NIH.’’
■ 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.’’
[Amended]
3. Amend § 9.3 by:
a. In paragraph (a)(2)(ix) removing the
phrase ‘‘NCRR’’ and adding, in its place,
the phrase ‘‘ORIP/DPCPSI.’’
■ b. In paragraph (a)(8) removing the
phrase ‘‘NCRR/NIH’’ and adding, in its
place, the phrase ‘‘ORIP/DPCPSI/NIH.’’
■ c. In paragraph (b)(2) removing the
phrase ‘‘NCRR/NIH’’ and adding, in its
place, the phrase ORIP/DPCPSI/NIH.’’
■
■
§ 9.4
[Amended]
jbell on DSKJLSW7X2PROD with RULES
5. Amend § 9.5 by:
a. In paragraph (c)(4) removing the
phrase ‘‘NCRR/NIH’’ and adding, in its
place, the phrase ‘‘ORIP/DPCPSI/NIH.’’
■ b. In paragraph (d)(2) removing the
phrase ‘‘NCRR’’ and adding, in its place,
the phrase ORIP/DPCPSI/NIH.’’
■
■
15:57 Aug 31, 2020
7. In § 9.9, amend paragraph (a) by
removing the phrase ‘‘NCRR/NIH’’ and
adding, in its place, ‘‘ORIP/DPCPSI/
NIH.’’
§ 9.12
[Amended]
8. Amend § 9.12 by:
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.’’
■ 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]
BILLING CODE 4140–01–P
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Part 571
RIN 2127–AM26
Federal Motor Vehicle Safety
Standards; Minimum Sound
Requirements for Hybrid and Electric
Vehicles
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Interim final rule; request for
comments.
AGENCY:
[Amended]
VerDate Sep<11>2014
[Amended]
[Docket No. NHTSA–2020–0086]
4. In § 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’’.
■
§ 9.5
6. In § 9.6, amend paragraph (d)(2) by
removing the phrase ‘‘NCRR’’ and
adding, in its place, the phrase ‘‘ORIP/
DPCPSI.’’
■
■
■
■
§ 9.3
[Amended]
§ 9.9
Authority: 42 U.S.C. 216, 287a–3a.
§ 9.2
§ 9.6
Jkt 250001
SUMMARY: This interim final rule
responds to an ‘‘emergency petition’’
submitted by the Alliance of
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
54273
Automotive Innovation (Alliance)
regarding the phase-in and compliance
requirements of Federal Motor Vehicle
Safety Standard No. 141 (FMVSS 141),
‘‘Minimum sound for hybrid and
electric vehicles.’’ The petition details
the challenges manufacturers have
encountered in complying with FMVSS
141 due to disruptions in the supply
chain caused by the Coronavirus
Disease 2019 (COVID–19) public health
emergency. The petition requests three
changes to the phase-in and compliance
requirements of FMVSS 141. After
considering the concerns raised in the
petition, NHTSA has decided to grant
the petition, in part, by electing to defer
the phase-in and compliance dates by
six months. NHTSA is denying the
request for an alternative performance
option during the phase-in period.
DATES: Effective date: The amendments
made in this rule are effective August
28, 2020.
Comment date: You should submit
your comments early enough to ensure
that the docket receives them not later
than September 16, 2020.
ADDRESSES: You may submit comments
to the docket number identified in the
heading of this document by any of the
following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov. Follow the
online instructions for submitting
comments.
• Mail: Docket Management Facility:
U.S. Department of Transportation, 1200
New Jersey Avenue SE, West Building
Ground Floor, Room W12–140,
Washington, DC 20590–0001.
• Hand Delivery or Courier: 1200
New Jersey Avenue SE, West Building
Ground Floor, Room W12–140, between
9 a.m. and 5 p.m. ET, Monday through
Friday, except Federal holidays. To be
sure someone is there to help you,
please call (202) 366–9322 before
coming.
• Fax: 202–493–2251.
Regardless of how you submit your
comments, please be sure to mention
the docket number of this document.
Instructions: For detailed instructions
on submitting comments and additional
information on the rulemaking process,
see the Public Participation section of
this document. Note that all comments
received will be posted without change
to https://www.regulations.gov, including
any personal information provided.
Please see the Privacy Act heading
under Rulemaking Notices and Analyses
regarding documents submitted to the
Agency’s dockets.
Docket: For access to the docket to
read background documents or
comments received, go to https://
E:\FR\FM\01SER1.SGM
01SER1
Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4140-01-P