19391 Federal Register / Vol. 85, No. 67 / Tuesday, April 7, 2020 / Rules and Regulations 
6Office 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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1Due 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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