[Federal Register Volume 86, Number 98 (Monday, May 24, 2021)]
[Notices]
[Pages 27894-27895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10874]


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DEPARTMENT OF JUSTICE

Antitrust Division


Notice Pursuant to the Defense Production Act of 1950; Review of 
Plans of Action

AGENCY: Antitrust Division, U.S. Department of Justice.

ACTION: Notice of review.

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SUMMARY: Notice is hereby given pursuant to section 708 of the Defense 
Production Act of 1950 (``DPA'') for the Plan of Action to Establish a 
National Strategy for the Manufacture, Allocation, and Distribution of 
Medical Devices to Respond to COVID-19 (``Medical Devices Plan of 
Action''), the Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Medical Gases to Respond 
to COVID-19 (``Medical Gases Plan of Action''), the Plan of Action to 
Establish a National Strategy for the Manufacture, Allocation and 
Distribution of Diagnostic Test Kits and other Testing Components to 
Respond to COVID-19 (``Diagnostic Test Kits Plan of Action''), and the 
Plan of Action to Establish a National Strategy for the Manufacture, 
Allocation, and Distribution of Drug Products, Drug Substances, and 
Associated Medical Devices to Respond to COVID-19 (``Drug Products Plan 
of Action'') proposed by the Federal Emergency Management Agency 
(``FEMA''), that the Acting Assistant Attorney General finds for each 
that the purposes of section 708(c)(1) of the DPA may not reasonably be 
achieved through a plan of action having less anticompetitive effects 
or without any plan of action. Given these findings, the Medical 
Devices Plan of Action, the Medical Gases Plan of Action, the 
Diagnostic Test Kits Plan of Action, and the Drug Products Plan of 
Action may become effective following the publication of this notice. 
Given these findings, the Medical Devices Plan of Action, the Medical 
Gases Plan of Action, the Diagnostic Test Kits Plan of Action, and the 
Drug Products Plan of Action may become effective following the 
publication of this notice.

SUPPLEMENTARY INFORMATION: Under the DPA, FEMA may enter into plans 
with representatives of private industry for the purpose of improving 
the efficiency with which private firms contribute to the national 
defense when conditions exist that may pose a direct threat to the 
national defense or its preparedness. Such arrangements are generally 
known as ``voluntary agreements.'' Participants in an existing 
voluntary agreement may adopt documented methods, known as

[[Page 27895]]

``plans of action,'' to implement that voluntary agreement. A defense 
to actions brought under the antitrust laws is available to each 
participant acting within the scope of a voluntary agreement and plan 
of action that has come into force under the DPA.
    The DPA requires that each proposed plan of action be reviewed by 
the Attorney General prior to becoming effective. If, after consulting 
with the Chair of the Federal Trade Commission, the Attorney General 
finds that the purposes of the DPA's plans of action provision ``may 
not reasonably be achieved through a . . . plan of action having less 
anticompetitive effects or without any . . . plan of action,'' the plan 
of action may become effective. 50 U.S.C. 4558(f)(1)(B). All functions 
which the Attorney General is required or authorized to perform by 
section 708 of the DPA have been delegated to the Assistant Attorney 
General, Antitrust Division. 28 CFR. 0.40(l).
    On August 17, 2020, the Voluntary Agreement for the Manufacture and 
Distribution of Critical Healthcare Resources Necessary to Respond to a 
Pandemic (``Voluntary Agreement'') became effective. The proposed 
Medical Devices Plan of Action, the proposed Medical Gases Plan of 
Action, the proposed Diagnostic Test Kits Plan of Action, and the 
proposed Drug Products Plan of Action contain documented methods to 
implement the Voluntary Agreement as summarized below:
    1. The Medical Devices Plan of Action creates a mechanism to 
immediately meet exigent Medical Device requests anywhere in the Nation 
and to ensure that actions to support Medical Device stockpiling and 
reserves do not interfere with immediate requirements that would result 
in an unacceptable risk to healthcare providers or other potential 
Medical Device recipients. This mechanism involves the establishment 
several Sub-Committees organized by medical device type, which are 
designed to foster a close working relationship among FEMA, the 
Department of Health and Human Services (``HHS''), and participants in 
the Sub-Committees to address national defense needs through 
cooperative action under the direction and active supervision of FEMA. 
The proposed Medical Devices Plan of Action includes terms, conditions, 
and procedures under which participants agree voluntarily to 
participate in the Sub-Committees.
    2. The Medical Gases Plan of Action creates a mechanism to 
immediately meet exigent Medical Gas requests anywhere in the Nation 
and to ensure that actions to support Medical Gas stockpiling and 
reserves do not interfere with immediate requirements that would result 
in an unacceptable risk to healthcare providers or other potential 
Medical Gas recipients. This mechanism involves the establishment 
several Sub-Committees organized by medical gas type, which are 
designed to foster a close working relationship among FEMA, HHS, and 
participants in the Sub-Committees to address national defense needs 
through cooperative action under the direction and active supervision 
of FEMA. The proposed Medical Gases Plan of Action includes terms, 
conditions, and procedures under which participants agree voluntarily 
to participate in the Sub-Committees.
    3. The Diagnostic Test Kits Plan of Action creates a mechanism to 
immediately meet exigent requests for Diagnostic Test Kits and other 
Testing Components anywhere in the Nation and to ensure that actions to 
support stockpiling of Diagnostic Test Kits and other Testing 
Components do not interfere with immediate requirements. This mechanism 
involves the establishment several Sub-Committees organized by testing 
kit methodology, testing kit supplies, and testing kit components, 
which are designed to foster a close working relationship among FEMA, 
HHS, and participants in the Sub-Committees to address national defense 
needs through cooperative action under the direction and active 
supervision of FEMA. The proposed Diagnostic Test Kits Plan of Action 
includes terms, conditions, and procedures under which participants 
agree voluntarily to participate in the Sub-Committees.
    4. The Drug Products Plan of Action creates a mechanism to 
immediately meet exigent requests for Drug Products, Drug Substances, 
and Associated Medical Devices anywhere in the Nation and to ensure 
that actions to support Drug Products, Drug Substances, and Associated 
Medical Devices stockpiling and reserves do not interfere with 
immediate requirements that would result in an unacceptable risk to 
healthcare providers or other potential recipients of Drug Products, 
Drug Substances, and Associated Medical Devices. This mechanism 
involves the establishment several Sub-Committees organized by drug 
products and drug substances, development of new treatments, as well as 
domestic industrial base expansion, which are designed to foster a 
close working relationship among FEMA, HHS, and participants in the 
Sub-Committees to address national defense needs through cooperative 
action under the direction and active supervision of FEMA. The proposed 
Drug Products Plan of Action includes terms, conditions, and procedures 
under which participants agree voluntarily to participate in the Sub-
Committees.
    FEMA has certified that the proposed Medical Devices Plan of 
Action, the proposed Medical Gases Plan of Action, the proposed 
Diagnostic Test Kits Plan of Action, and the proposed Drug Products 
Plan of Action are each necessary to provide for the national defense 
in the event of a pandemic.
    FEMA requested that the Acting Assistant Attorney General, 
Antitrust Division, issue a finding that the proposed Medical Devices 
Plan of Action, the proposed Medical Gases Plan of Action, the proposed 
Diagnostic Test Kits Plan of Action, and the proposed Drug Products 
Plan of Action each satisfies the statutory criteria set forth in 50 
U.S.C. 4558(f)(1)(B). The Acting Assistant Attorney General, Antitrust 
Division, reviewed the proposed Medical Devices Plan of Action, the 
proposed Medical Gases Plan of Action, the proposed Diagnostic Test 
Kits Plan of Action, and the proposed Drug Products Plan of Action and 
consulted on them with the Acting Chairwoman of the Federal Trade 
Commission. On May 7, 2021, by letter to Deanne Criswell, FEMA 
Administrator, Richard Powers, Acting Assistant Attorney General, 
Antitrust Division, issued findings, pursuant to 50 U.S.C. 
4558(f)(1)(B), that the purposes of the DPA's plan of action provision 
``may not reasonably be achieved through a . . . plan of action having 
less anticompetitive effects or without any . . . plan of action'' for 
the following plans of action:
    1. Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Medical Devices to Respond 
to COVID-19;
    2. Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Medical Gases to Respond 
to COVID-19;
    3. Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation and Distribution of Diagnostic Test Kits and 
other Testing Components to Respond to COVID-19; and
    4. Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Drug Products, Drug 
Substances, and Associated Medical Devices to Respond to COVID-19.

David G.B. Lawrence,
Chief, Competition Policy & Advocacy Section.
[FR Doc. 2021-10874 Filed 5-21-21; 8:45 am]
BILLING CODE 4410-11-P