Electronic Detonators
| Published date | 07 April 2020 |
| Citation | 85 FR 19391 |
| Record Number | 2020-06649 |
| Section | Rules and Regulations |
| Court | Mine Safety And Health Administration |
19391
Federal Register / Vol. 85, No. 67 / Tuesday, April 7, 2020 / Rules and Regulations
6
Office of Mgmt. & Budget, Exec. Office of The
President, Interim Guidance Implementing Section
2 of the Executive Order of January 30, 2017 Titled
‘‘Reducing Regulation and Controlling Regulatory
Costs’’ (Feb. 2, 2017).
for rulemakings. However, 21 U.S.C.
811(j) provides that in cases where a
certain new drug is: (1) Approved by
HHS, under section 505(c) of the FDCA,
and (2) HHS recommends control in
CSA schedule II–V, DEA shall issue an
interim final rule scheduling the drug
within 90 days. As stated in the legal
authority section, the 90-day time frame
is the later of: (1) The date DEA receives
HHS’s scientific and medical
evaluation/scheduling recommendation,
or (2) the date DEA receives notice of
the NDA approval by HHS.
Additionally, the law specifies that the
rulemaking shall become immediately
effective as an interim final rule without
requiring DEA to demonstrate good
cause.
Executive Orders 12866, 13563, and
13771, Regulatory Planning and Review,
Improving Regulation and Regulatory
Review, and Reducing Regulation and
Controlling Regulatory Costs
In accordance with 21 U.S.C. 811(a)
and (j), this scheduling action is subject
to formal rulemaking procedures
performed ‘‘on the record after
opportunity for a hearing,’’ which are
conducted pursuant to the provisions of
5 U.S.C. 556 and 557. The CSA sets
forth the procedures and criteria for
scheduling a drug or other substance.
Such actions are exempt from review by
the Office of Management and Budget
(OMB) pursuant to section 3(d)(1) of
Executive Order 12866 and the
principles reaffirmed in Executive Order
13563.
This interim final rule is not an
Executive Order 13771 regulatory action
pursuant to Executive Order 12866 and
OMB guidance.
6
Executive Order 12988, Civil Justice
Reform
This regulation meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of Executive Order 12988 to
eliminate drafting errors and ambiguity,
minimize litigation, provide a clear legal
standard for affected conduct, and
promote simplification and burden
reduction.
Executive Order 13132, Federalism
This rulemaking does not have
federalism implications warranting the
application of Executive Order 13132.
The rule does not have substantial
direct effects on the States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
Executive Order 13175, Consultation
and Coordination With Indian Tribal
Governments
This rule does not have tribal
implications warranting the application
of Executive Order 13175. It does not
have substantial direct effects on one or
more Indian tribes, on the relationship
between the Federal government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal government and Indian tribes.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
(5 U.S.C. 601–612) applies to rules that
are subject to notice and comment
under section 553(b) of the APA. Under
21 U.S.C. 811(j), DEA is not required to
publish a general notice of proposed
rulemaking. Consequently, the RFA
does not apply to this interim final rule.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded
Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has
determined that this action would not
result in any Federal mandate that may
result ‘‘in the expenditure by State,
local, and tribal governments, in the
aggregate, or by the private sector, of
$100,000,000 or more (adjusted
annually for inflation) in any 1 year.’’
Therefore, neither a Small Government
Agency Plan nor any other action is
required under UMRA of 1995.
Paperwork Reduction Act of 1995
This action does not impose a new
collection of information requirement
under the Paperwork Reduction Act of
1995. 44 U.S.C. 3501–3521. This action
would not impose recordkeeping or
reporting requirements on State or local
governments, individuals, businesses, or
organizations. An agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
Congressional Review Act
This rule is not a major rule as
defined by the Congressional Review
Act (CRA), 5 U.S.C. 804. This rule will
not result in: An annual effect on the
economy of $100 million or more; a
major increase in costs or prices for
consumers, individual industries,
Federal, State, or local government
agencies, or geographic regions; or
significant adverse effects on
competition, employment, investment,
productivity, innovation, or on the
ability of United States-based
companies to compete with foreign-
based companies in domestic and
export markets. However, pursuant to
the CRA, DEA has submitted a copy of
this interim final rule to both Houses of
Congress and to the Comptroller
General.
List of Subjects in 21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
For the reasons set out above, DEA
amends 21 CFR part 1308 as follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
■1. The authority citation for 21 CFR
part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b),
956(b), unless otherwise noted.
■2. Amend § 1308.14 by:
■a. Redesignating paragraphs (c)(30)
through (c)(56) as (c)(31) through (c)(57);
and
■b. Adding new paragraph (c)(30).
The addition reads as follows:
§ 1308.14 Schedule IV.
* * * * *
(c) * * *
(30) Lemborexant ............................. 2245
* * * * *
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020–07089 Filed 4–6–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Mine Safety and Health Administration
30 CFR Parts 56 and 57
[Docket No. MSHA–2019–0007]
RIN 1219–AB88
Electronic Detonators
AGENCY
: Mine Safety and Health
Administration, Labor.
ACTION
: Direct final rule; confirmation of
effective date.
SUMMARY
: The Mine Safety and Health
Administration (MSHA) confirms the
effective date for the direct final rule,
Electronic Detonators, which was
published on January 14, 2020, to revise
certain safety standards for explosives at
metal and nonmetal mines.
DATES
: The effective date of the final
rule published in the Federal Register
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19392
Federal Register / Vol. 85, No. 67 / Tuesday, April 7, 2020 / Rules and Regulations
1
Due to the public health emergency posed by
COVID–19, the HHS Office for Civil Rights (OCR)
is exercising its enforcement discretion under the
conditions outlined herein. We believe that this
guidance is a statement of agency policy not subject
to the notice and comment requirements of the
Administrative Procedure Act (APA). 5 U.S.C.
553(b)(A). OCR additionally finds that, even if this
guidance were subject to the public participation
provisions of the APA, prior notice and comment
for this guidance is impracticable, and there is good
of January 14, 2020 (85 FR 2022) is
confirmed: March 16, 2020.
ADDRESSES
:
Federal Register Publications: Access
rulemaking documents electronically at
https://www.msha.gov/regulations/
rulemaking or http://
www.regulations.gov [Docket Number:
MSHA–2019–0007].
Email Notification: To subscribe to
receive email notification when MSHA
publishes rulemaking documents in the
Federal Register, go to https://
www.msha.gov/subscriptions.
FOR FURTHER INFORMATION CONTACT
:
Sheila A. McConnell, Director, Office of
Standards, Regulations, and Variances,
MSHA, at mcconnell.sheila.a@dol.gov
(email), 202–693–9440 (voice), or 202–
693–9441 (fax). These are not toll-free
numbers.
SUPPLEMENTARY INFORMATION
:
Effective Date
On January 14, 2020, MSHA
published in the Federal Register a
direct final rule to revise certain safety
standards for explosives at metal and
nonmetal mines (85 FR 2022). In the
same issue of the Federal Register,
MSHA published a companion
proposed rule (85 FR 2064) for notice
and comment rulemaking to provide a
procedural framework to finalize the
rule in the event that the Agency
received significant adverse comments
and had to withdraw the direct final
rule. After reviewing all the comments
received during the public comment
period, MSHA has determined that
these comments are not adverse to the
direct final rule. Therefore, the direct
final rule took effect on March 16, 2020.
Authority: 30 U.S.C. 811
David G. Zatezalo,
Assistant Secretary of Labor for Mine Safety
and Health Administration.
[FR Doc. 2020–06649 Filed 4–6–20; 8:45 am]
BILLING CODE 4520–43–P
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 172
[Docket ID: DOD–2018–OS–0044]
RIN 0790–AK30
Disposition of Proceeds From DoD
Sales of Surplus Personal Property
AGENCY
: Office of the Under Secretary of
Defense (Comptroller), DoD.
ACTION
: Final rule.
SUMMARY
: This final rule removes DoD’s
regulation that provides instructions to
DoD Components on the collection and
disposition of cash and cash equivalents
received for the sale of DoD surplus
personal property. Proceeds from the
sale of surplus personal property shall
be deposited by the collecting DoD
Component promptly to a U.S. Treasury
account. Process instructions are
conveyed directly to potential buyers
and bidders when invitation for bids are
distributed or published. Therefore, this
rule is unnecessary and can be removed
from the CFR.
DATES
: This rule is effective on April 7,
2020.
FOR FURTHER INFORMATION CONTACT
:
Kellie Allison at 703–614–0410.
SUPPLEMENTARY INFORMATION
: It has been
determined that publication of this CFR
part removal for public comment is
impracticable, unnecessary, and
contrary to public interest since it is
based on removing DoD guidance that is
not required to be codified and is
publicly available on the Department’s
website. DoD guidance will continue to
be published in DoD 7000.14–R,
Financial Management Regulation,
Volume 11A, Chapter 5, ‘‘Disposition of
Proceeds from DoD Sales of Surplus
Personal Property’’ available at http://
comptroller.defense.gov/Portals/45/
documents/fmr/current/11a/11a_05.pdf.
This rule is not significant under
Executive Order (E.O.) 12866,
‘‘Regulatory Planning and Review.’’
Therefore, E.O. 13771, ‘‘Reducing
Regulation and Controlling Regulatory
Costs,’’ does not apply.
List of Subjects in 32 CFR Part 172
Personal property, Recyclable
material, Surplus Government property.
PART 172—[REMOVED]
■Accordingly, by the authority of 5
U.S.C. 301, 32 CFR part 172 is removed.
Dated: March 27, 2020.
Aaron T. Siegel,
Federal Register Liaison Officer, Department
of Defense.
[FR Doc. 2020–06773 Filed 4–6–20; 8:45 am]
BILLING CODE 5001–06–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Parts 160 and 164
Enforcement Discretion Under HIPAA
To Allow Uses and Disclosures of
Protected Health Information by
Business Associates for Public Health
and Health Oversight Activities in
Response to COVID–19
AGENCY
: Office of the Secretary, HHS.
ACTION
: Notification of enforcement
discretion.
SUMMARY
: This notification is to inform
the public that the Department of Health
and Human Services (HHS) is exercising
its discretion in how it applies the
Privacy Rule under the Health Insurance
Portability and Accountability Act of
1996 (HIPAA). Current regulations
allow a HIPAA business associate to use
and disclose protected health
information for public health and health
oversight purposes only if expressly
permitted by its business associate
agreement with a HIPAA covered entity.
As a matter of enforcement discretion,
effective immediately, the HHS Office
for Civil Rights (OCR) will exercise its
enforcement discretion and will not
impose potential penalties for violations
of certain provisions of the HIPAA
Privacy Rule against covered health care
providers or their business associates for
uses and disclosures of protected health
information by business associates for
public health and health oversight
activities during the COVID–19
nationwide public health emergency.
DATES
: The Notification of Enforcement
Discretion will remain in effect until the
Secretary of HHS declares that the
public health emergency no longer
exists, or upon the expiration date of the
declared public health emergency (as
determined by 42 U.S.C. 247d),
whichever occurs first.
FOR FURTHER INFORMATION CONTACT
:
Rachel Seeger at (202) 619–0403 or (800)
537–7697 (TDD).
SUPPLEMENTARY INFORMATION
: HHS is
informing the public that it is exercising
its discretion in how it applies the
Privacy Rule under the Health Insurance
Portability and Accountability Act of
1996 (HIPAA).
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