Pandemic Response Voluntary Agreement Under Section 708 of the Defense Production Act; Plans of Action To Respond to COVID-19, 28851-28884 [2021-11278]

Download as PDF Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices Dated: May 24, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2021–11384 Filed 5–27–21; 8:45 am] National Eye Institute; Notice of Closed Meeting BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel; NEI Clinical Trials and Clinical Applications I. Date: June 24, 2021. Time: 11:00 a.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Eye Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 3400, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jennifer C Schiltz, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, National Eye Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 3400, Bethesda, MD 20817, 240–276–5864, jennifer.schiltz@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: May 24, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–11294 Filed 5–27–21; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel; NEI Clinical Trials and Clinical Applications II. Date: June 28, 2021. Time: 10:00 a.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Eye Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 3400, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jennifer C. Schiltz, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, National Eye Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 3400, Bethesda, MD 20817, 240–276–5864, jennifer.schiltz@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: May 24, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–11293 Filed 5–27–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA–2020–0016] Pandemic Response Voluntary Agreement Under Section 708 of the Defense Production Act; Plans of Action To Respond to COVID–19 Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. AGENCY: VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 PO 00000 Frm 00105 Fmt 4703 Sfmt 4703 28851 The Federal Emergency Management Agency (FEMA) announces the formation of four Plans of Action under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic: 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; 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; Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices to Respond to COVID–19; and Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases to Respond to COVID–19. This notice contains the text of all four Plans of Action. SUMMARY: FOR FURTHER INFORMATION CONTACT: Robert Glenn, Office of Business, Industry, Infrastructure Integration, via email at OB3I@fema.dhs.gov or via phone at (202) 212–1666. SUPPLEMENTARY INFORMATION: Background and Legal Authority The Defense Production Act (DPA), 50 U.S.C. 4501 et seq., authorizes the making of ‘‘voluntary agreements and plans of action’’ with, among others, representatives of industry and business to help provide for the national defense.1 The President’s authority to facilitate voluntary agreements was delegated to the Secretary of Homeland Security with respect to responding to the spread of COVID–19 within the United States in Executive Order 13911.2 The Secretary of Homeland Security has further delegated this authority to the FEMA Administrator.3 On August 17, 2020, after the appropriate consultations with the Attorney General and the Chairman of the Federal Trade Commission and after requesting and considering public comments, FEMA completed and published in the Federal Register a ‘‘Voluntary Agreement, Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a 1 50 U.S.C. 4558(c)(1). FR 18403 (Apr. 1, 2020). 3 DHS Delegation 09052, Rev. 00.1 (Apr. 1, 2020); DHS Delegation Number 09052 Rev. 00 (Jan. 3, 2017). 2 85 E:\FR\FM\28MYN1.SGM 28MYN1 28852 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices Pandemic’’ (Voluntary Agreement).4 Unless terminated earlier, the Voluntary Agreement is effective until August 17, 2025, and may be extended subject to additional approval by the Attorney General after consultation with the Chairman of the Federal Trade Commission. The Voluntary Agreement may be used to prepare for or respond to any pandemic, including COVID–19, during that time. FEMA is now activating four Plans of Action under the Voluntary Agreement: (1) 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. The primary goal of the Plan is to create 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. (2) 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. The primary goal of the Plan is to create 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. (3) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices to Respond to COVID–19. The primary goal of the Plan is to create 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. (4) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases to Respond to COVID–19. The primary purpose of this Plan is to create 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. Appropriate members of the private sector will be invited to join each Plan of Action as Sub-Committee Participants. Provided that a SubCommittee Participant acts in accordance with the terms of a Plan, the DPA affords the Participant a defense to civil and criminal action brought under the antitrust laws (or any similar law of any state) for actions taken to carry out the Plan. The Plans are designed to foster a close working relationship among FEMA, HHS, and Sub-Committee Participants to address national defense needs through cooperative action under the direction and active supervision of FEMA. The Attorney General, in consultation with the Chairman of the Federal Trade Commission, has made the required finding for each Plan of Action that the purposes of section 708(c)(1) of the DPA cannot reasonably be achieved without each Plan of Action, or by Plans of Action having less anticompetitive effects than the proposed Plans of Action. Pursuant to section 708(f)(1)(B) of the DPA, the Department of Justice separately published the findings for these Plans of Action in the Federal Register. The FEMA Administrator has certified in writing that each Plan of Action is necessary to help provide for the national defense. 4 Voluntary Agreement Under Section 708 of the Defense Production Act; Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic, 85 FR 50035, 50035 (Aug. 17, 2020). The Attorney General, in consultation with the Chairman of the Federal Trade Commission, made the required finding that the purpose of the Voluntary Agreement may not reasonably be achieved through an agreement having less anticompetitive effects or without any voluntary agreement and published the finding in the Federal Register on the same day. 85 FR 50049 (Aug. 17, 2020). VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 Text of 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 Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a Pandemic 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 Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a Pandemic Preface Pursuant to section 708 of the Defense Production Act of 1950 (DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management Agency (FEMA) Administrator (Administrator), after consultation with the Secretary of the Department of Health and Human Services (HHS), the Attorney General of the United States (Attorney General), and the Chair of the Federal Trade Commission (FTC), developed a Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic (Voluntary Agreement), 85 FR 50035 (August 17, 2020). The Voluntary Agreement, which operates through a series of Plans of Action, maximizes the manufacture and efficient distribution of Critical Healthcare Resources nationwide to respond to a pandemic by establishing unity of effort between Participants and the Federal Government for integrated coordination, planning, information sharing with FEMA, as authorized by FEMA, and allocation and distribution of Critical Healthcare Resources. This document establishes a Plan of Action (Plan) to Establish a National Strategy for the Manufacture, Allocation and Distribution of Diagnostic Test Kits and other Testing Components to Respond to COVID–19. This Plan will be implemented under the Voluntary Agreement by several Sub-Committees. (1) Sub-Committee to Define Requirements for COVID–19 Diagnostic Test Kits and other Testing Components, (2) Sub-Committee for Lab-Based Testing, (3) Sub-Committee for Point-of-Care Testing, (4) Sub-Committee for At-Home Testing, E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices (5) Sub-Committee for Swabs (Nasal & Throat), and (6) Sub-Committee for Transfer Media and Pipette Tips. The Sub-Committee to Define Requirements for COVID–19 Diagnostic Test Kits and other Testing Components will be formed first. FEMA may establish additional Sub-Committees under this Plan, so long as: (1) The Sub-Committee addresses one specific and well-defined category of item needed for COVID–19 testing; and (2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for COVID–19 Diagnostic Test Kits and other Testing Components. The purpose of the Plan is to maximize the manufacture and efficient distribution of Diagnostic Test Kits and other Testing Components and create a prioritization protocol for End-Users based upon their demonstrated or projected requirements including geographic and regional circumstances. The primary goal of the Plan is to create 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. When the requirements of the Plan are met, it affords Sub-Committee Participants defenses to civil and criminal actions brought under the antitrust laws (or any similar law of any state) for actions taken within the scope of the Plan. The Plan is designed to foster a close working relationship among FEMA, HHS, and Sub-Committee Participants to address national defense needs through cooperative action under the direction and active supervision of FEMA. Table of Contents I. Purpose .......................................................................................................................................................................................................................................... II. Authorities ................................................................................................................................................................................................................................... III. General Provisions ..................................................................................................................................................................................................................... A. Definitions ............................................................................................................................................................................................................................ B. Plan of Action Participation ................................................................................................................................................................................................ C. Effective Date and Duration of Participation ...................................................................................................................................................................... D. Withdrawal ........................................................................................................................................................................................................................... E. Plan of Action Activation and Deactivation ....................................................................................................................................................................... F. Rules and Regulations .......................................................................................................................................................................................................... G. Modification and Amendment ............................................................................................................................................................................................ H. Expenses ............................................................................................................................................................................................................................... I. Record Keeping ...................................................................................................................................................................................................................... IV. Antitrust Defense ....................................................................................................................................................................................................................... V. Terms and Conditions ................................................................................................................................................................................................................. A. Plan of Action Execution .................................................................................................................................................................................................... B. Information Management and Responsibilities .................................................................................................................................................................. C. Oversight ............................................................................................................................................................................................................................... VI. Establishment of the Sub-Committees ...................................................................................................................................................................................... VII. Application and Agreement ..................................................................................................................................................................................................... VIII. Assignment ............................................................................................................................................................................................................................... I. Purpose A pandemic may present conditions that pose a direct threat to the national defense of the United States or its preparedness programs such that, pursuant to DPA section 708(c)(1), an agreement to collectively coordinate, plan, and collaborate for the manufacture and distribution of Diagnostic Test Kits and other Testing Components is necessary for the national defense. This 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 is established under the Voluntary Agreement and establishes six Sub-Committees to oversee and implement the Plan. The Plan and SubCommittees will optimize the manufacture and the efficient distribution of selected types of Diagnostic Test Kits and other Testing Components and create a prioritization protocol for End-Users based upon their demonstrated or projected requirements. II. Authorities Section 708, Defense Production Act (50 U.S.C. 4558); sections 402(2) & 501(b), Robert T. Stafford Disaster Relief VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 and Emergency Assistance Act (42 U.S.C. 5121–5207); sections 503(b)(2)(B) & 504(a)(10) & (16) of the Homeland Security Act of 2002 (6 U.S.C. 313(b)(2)(B), 314(a)(10) & (16)); sections 201, 301, National Emergencies Act (50 U.S.C. 1601 et seq.); section 319, Public Health Service Act (42 U.S.C. 247d); Executive Order (E.O.) 13911, 85 FR 18403 (March 27, 2020); Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 85 FR 20195 (April 10, 2020). Pursuant to DPA section 708(f)(1)(A), the Administrator certifies that this Plan is necessary for the national defense. III. General Provisions A. Definitions Administrator The FEMA Administrator is the Sponsor of the Voluntary Agreement. Pursuant to a delegation or redelegation of the functions given to the President by DPA section 708, the Administrator proposes and provides for the development and carrying out of the Voluntary Agreement, including through the development and implementation of Plans of Action. The Administrator is responsible for PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 28853 421 421 421 421 425 426 426 427 427 428 428 428 429 429 429 431 435 436 437 438 carrying out all duties and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and for appointing one or more Chairpersons to manage and administer the Committee and all Sub-Committees formed to carry out the Voluntary Agreement. Agreement The Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic (Voluntary Agreement). Allocation The process of determining and directing the relative distribution among one or more competing requests from End-Users for the same Diagnostic Test Kits and other Testing Components. Through the Allocation process, FEMA—with participation from SubCommittee Participants—will assess the actual needs of End-Users and determine how to divide the available and projected supply of Diagnostic Test Kits and other Testing Components to minimize impacts to life, safety, and economic disruption associated with shortages of Diagnostic Test Kits and other Testing Components. Allocation will take place only under Exigent E:\FR\FM\28MYN1.SGM 28MYN1 28854 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices Circumstances. FEMA retains decisionmaking authority for all Allocation under this Plan. Attendees Subject matter experts, invited by the Chairperson or a Sub-Committee Chairperson to attend meetings authorized under the Voluntary Agreement or this Plan, to provide technical advice or to represent other government agencies or interested parties. Invitations to attendees will be extended as required for Committee or Sub-Committee meetings and deliberations. Chairperson FEMA senior executive(s), appointed by the Administrator, to chair the Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic (Committee). The Chairperson shall be responsible for the overall management and administration of the Committee, the Voluntary Agreement, and Plans of Action developed under the Voluntary Agreement while remaining under the supervision of the Administrator; shall initiate, or approve in advance, each meeting held to discuss problems, determine policies, recommend actions, and make decisions necessary to carry out the Voluntary Agreement; appoint one or more co-Chairpersons to chair the Committee, and otherwise shall carry out all duties and responsibilities assigned to him. With the approval of the Administrator, the Chairperson may create one or more Sub-Committees, and may appoint one or more SubCommittee Chairpersons to chair the Sub-Committees, as appropriate. Committee Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic established under the Voluntary Agreement. Competitively Sensitive Information Competitively Sensitive Information that is shared pursuant to this Plan may include any Document or other tangible thing or oral transmission that contains financial, business, commercial, scientific, technical, economic, or engineering information or data, including, but not limited to • financial statements and data, • customer and supplier lists, • price and other terms of sale to customers, • sales records, projections and forecasts, • inventory levels, • capacity and capacity utilization, • cost information, VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 • sourcing and procurement information, • manufacturing and production information, • delivery and shipping information, • systems and data designs, and • methods, techniques, processes, procedures, programs, codes, or similar information, whether tangible or intangible, and regardless of the method of storage, compilation, or recordation, if the owner thereof has taken reasonable measures to protect the information from disclosure to the public or competitors. These measures may be evidenced by marking or labeling the items as ‘‘competitively sensitive information’’ during submission to FEMA or in the Participant’s customary and existing treatment of such information (regardless of labeling). All Competitively Sensitive Information provided by a SubCommittee Participant as described herein is deemed Competitively Sensitive Information, except for Information that: a. Is published or has been made publicly available at the time of disclosure by the Sub-Committee Participant; b. was in the possession of, or was lawfully and readily available to, FEMA from another source at the time of disclosure without breaching any obligation of confidentiality applicable to the other source; or c. was independently developed or acquired without reference to or reliance upon the Sub-Committee Participant’s Competitively Sensitive Information; Where information deemed Competitively Sensitive Information is required to be disclosed by law, regulation, or court order, the ‘‘Competitively Sensitive’’ (or substantially similar) label will continue to attach to all information and portion(s) of documents that are not made public through the required disclosure. Diagnostic Test Kit Defined as any ‘‘drug’’ or ‘‘device’’ under the United States Food, Drug, and Cosmetic Act, 21 U.S.C. 321(g) or (h), respectively, used for detection or identification of the novel coronavirus in any individual. Document Any information, on paper or in electronic/audio/visual format, including written, recorded, and graphic materials of every kind, in the possession, custody, or control of the Participant and used or shared in the PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 course of participation in the Voluntary Agreement or a subsequent Plan of Action. End-User This includes all direct and ancillary medical support including, but not limited to, hospitals, independent healthcare providers, nursing homes, medical laboratories, independent physician offices, first responders, alternate care facilities and the general public that reasonably represents the totality of the nation’s response to COVID–19. Exigent Circumstances As determined by the Chairperson, the actual or forecasted shortage of a particular type of Diagnostic Test Kit or other Testing Component which likely cannot be fulfilled via usual market mechanisms for an acute, critical time period, and where immediate and substantial harm is projected to occur from lack of intervention. Pandemic A Pandemic is defined as an epidemic that has spread to human populations across a large geographic area that is subject to one or more declarations under the National Emergencies Act, the Public Health Service Act, or the Robert T. Stafford Disaster Relief and Emergency Assistance Act, or if the Administrator determines that one or more declarations is likely to occur and the epidemic poses a direct threat to the national defense or its preparedness programs. For example, Coronavirus Disease 2019 (COVID–19). Participant An individual, partnership, corporation, association, or private organization, other than a federal agency, that has substantive capabilities, resources or expertise to carry out the purpose of the Voluntary Agreement, that has been specifically invited to participate in the Voluntary Agreement by the Chairperson, and that has applied and agreed to the terms of the Voluntary Agreement. ‘‘Participant’’ includes a corporate or non-corporate entity entering into the Voluntary Agreement and all subsidiaries and affiliates of that entity in which that entity has 50 percent or more control either by stock ownership, board majority, or otherwise. The Administrator may invite Participants to join the Voluntary Agreement at any time during its effective period. Plan of Action (Plan) This document. A documented method, pursuant to 50 U.S.C. E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 4558(b)(2), proposed by FEMA to implement a particular set of activities under the Voluntary Agreement, through a Sub-Committee focused on a particular Critical Healthcare Resource, or pandemic response workstream or functional area necessary for the national defense. Plan of Action Agreement A separate commitment made by Participants upon invitation and agreement to participate in a Plan of Action as part of one or more SubCommittees. Completing the Plan of Action Agreement confers responsibilities on the Participant consistent with those articulated in the Plan and affords Participants a defense against antitrust claims under section 708 for actions taken to develop or carry out the Plan and the appropriate SubCommittee(s), as described in Section IV below. Representatives The representatives the Administrator identifies and invites to the Committee from FEMA, HHS, and other federal agencies with equities in this Plan, and empowered to speak on behalf of their agencies’ interests. The Attorney General and the Chair of the FTC, or their delegates, may also attend any meeting as a Representative. Sub-Committee A body formed by the Administrator from select Participants to implement a Plan of Action. Sub-Committee Chairperson FEMA executive, appointed by the Chairperson, to chair a Sub-Committee to implement a Plan of Action. The SubCommittee Chairperson shall be responsible for the overall management and administration of the SubCommittee in furtherance of this Plan while remaining under the supervision of the Administrator and the Chairperson. Sub-Committee Members Collectively the Sub-Committee Chairperson(s), Representatives, and Sub-Committee Participants. Jointly responsible developing and executing this Plan. Sub-Committee Participant A subset of Participants of the Committee, that have been specifically invited to participate in a SubCommittee by the Sub-Committee Chairperson, and that have applied and agreed to the terms of this Plan and signed the Plan of Action Agreement. The Sub-Committee Chairperson may VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 28855 invite Participants in the Committee to join a Sub-Committee as a SubCommittee Participant at any time during the Plan’s effective period. Committee meetings. The naming of these Sub-Committees does not commit the Administrator to creating them unless and until circumstances dictate. Testing Components Defined as any article needed to support the transportation, storage, distribution, or administration of a Diagnostic Test Kit or subsequent result. Common Testing Components include collection swabs, transport media and pipette tips, but other associated materials may be included, if and as appropriate. C. Effective Date and Duration of Participation This Plan is effective immediately upon satisfaction of the requirements of DPA section 708(f)(1). This Plan shall remain in effect until terminated in accordance with 44 CFR 332.4. It shall be effective for no more than five (5) years from August 17, 2020, when the requirements of DPA section 708(f)(1) were satisfied for the Voluntary Agreement, unless otherwise terminated pursuant to DPA section 708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 708(f)(2). No action may take place under this Plan until it is activated, as described in Section III(E), below. B. Plan of Action Participation This Plan will be implemented under the Voluntary Agreement by one or more Sub-Committees. (1) Sub-Committee to Define Requirements for COVID–19 Diagnostic Test Kits and other Testing Components, (2) Sub-Committee for Lab-Based Testing, (3) Sub-Committee for Point-of-Care Testing, (4) Sub-Committee for At-Home Testing, (5) Sub-Committee for Swabs (Nasal & Throat), and (6) Sub-Committee for Transfer Media and Pipette Tips. The Sub-Committee to Define Requirements for COVID–19 Diagnostic Test Kits and other Testing Components will be formed first. FEMA may establish additional Sub-Committees under this Plan, so long as: (1) The Sub-Committee addresses one specific and well-defined category of item needed for COVID–19 testing; and (2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for COVID–19 Diagnostic Test Kits and other Testing Components. Each Sub-Committee will consist of the (1) Sub-Committee Chairperson(s), (2) Representatives from FEMA, HHS, the Department of Justice (DOJ), and other federal agencies with equities in this Plan, and (3) Sub-Committee Participants that have substantive capabilities, resources or expertise to carry out the purpose of this Plan and have signed the Plan of Action Agreement. The Chairperson shall invite Sub-Committee Participants who, in his or her determination, are reasonably representative of the appropriate industry or segment of such industry. Other Attendees—invited by the SubCommittee Chairperson as subject matter experts to provide technical advice or to represent the interests of other government agencies or interested parties—may also participate in Sub- PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 D. Withdrawal Participation in the Plan is voluntary, as is the acceptance of most obligations under the Plan. Sub-Committee Participants may withdraw from this Plan or from an individual SubCommittee at any point, subject to the fulfillment of obligations previously agreed upon by the Participant prior to the date of withdrawal. Note that the obligations outlined in V.B regarding information management and associated responsibilities apply once a party has shared or received information through a Sub-Committee and remain in place after the party’s withdrawal from the Sub-Committee or Plan. If a SubCommittee Participant indicates an intent to withdraw from the Plan due to a modification or amendment of the Plan (described below), the SubCommittee Participant will not be required to perform actions directed by that modification or amendment. Withdrawal from the Plan will automatically trigger withdrawal from all Sub-Committees; however, a Participant may withdraw from a SubCommittee without also withdrawing from the Plan or other Sub-Committees. To withdraw from the Plan or from an individual Sub-Committee, a Participant must provide written notice to the Administrator at least fifteen (15) calendar days prior to the effective date of that Sub-Committee Participant’s withdrawal specifying the scope of withdrawal. Following receipt of such notice, the Administrator will inform the other Sub-Committee Participants of the date and the scope of the withdrawal. Upon the effective date of the withdrawal from the Plan, the SubCommittee Participant must cease all E:\FR\FM\28MYN1.SGM 28MYN1 28856 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices activities under the Plan. Upon the effective date of the withdrawal from one or more Sub-Committee(s), the SubCommittee Participant must cease all activities under the Plan that pertain to the withdrawn Sub-Committee(s). E. Plan of Action Activation and Deactivation The Administrator, in consultation with the Chairperson and SubCommittee Chairperson, will invite a select group of Participants in the Voluntary Agreement to form the following Sub-Committees, beginning with the Sub-Committee to Define Requirements for COVID–19 Diagnostic Test Kits and other Testing Components, which will be responsible for implementing this Plan. (1) Sub-Committee to Define Requirements for COVID–19 Diagnostic Test Kits and other Testing Components, (2) Sub-Committee for Lab-Based Testing, (3) Sub-Committee for Point-of-Care Testing, (4) Sub-Committee for At-Home Testing, (5) Sub-Committee for Swabs (Nasal & Throat), and (6) Sub-Committee for Transfer Media and Pipette Tips. The Sub-Committee to Define Requirements for COVID–19 Diagnostic Test Kits and other Testing Components will be formed first. FEMA may establish additional Sub-Committees under this Plan, so long as: (1) The Sub-Committee addresses one specific and well-defined category of item needed for COVID–19 testing; and (2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for COVID–19 Diagnostic Test Kits and other Testing Components. This Plan will be activated for each invited Participant when the Participant executes a Plan of Action Agreement, and a Participant may not participate in a Sub-Committee until the Plan of Action Agreement is executed. Participants will be invited to join this Plan at the discretion of the Chairperson or the Sponsor to the Voluntary Agreement. Participants will be further invited to attend specific meetings of one or more Sub-Committees at the discretion of the Chairperson. F. Rules and Regulations Sub-Committee Participants acknowledge and agree to comply with all provisions of DPA section 708, as amended, and regulations related thereto which are promulgated by FEMA, the Department of Homeland VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 Security, HHS, the Attorney General, and the FTC. FEMA has promulgated standards and procedures pertaining to voluntary agreements in 44 CFR part 332. The Administrator shall inform Participants of new rules and regulations as they are issued. G. Modification and Amendment The Administrator, after consultation with the Attorney General and the Chair of the FTC, may terminate or modify, in writing, this Plan at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may terminate or modify, in writing, this Plan at any time. Sub-Committee Participants may propose modifications or amendments to the Plan or to the Sub-Committees at any time. Where possible, material modifications to the Plan or a SubCommittee will be subject to a 30calendar day delayed implementation and opportunity for notice and comment by Sub-Committee Participants to the Chairperson. This delayed implementation period may be shortened or eliminated if the Administrator deems it necessary. The Administrator shall inform SubCommittee Participants of modifications or amendments to the Plan or to the Sub-Committees as they are proposed and issued. The Administrator, after consultation with the Attorney General and the Chair of the FTC, may remove Sub-Committee Participants from the Plan or from a Sub-Committee at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may remove SubCommittee Participants from this Plan or from a Sub-Committee at any time. If a Participant is removed from the Plan or from a Sub-Committee, the Participant may request written notice of the reasons for removal from the Chairperson, who shall provide such notice in a reasonable time period. H. Expenses Participation in this Plan or in a SubCommittee does not confer funds to Sub-Committee Participants, nor does it limit or prohibit any pre-existing source of funds. Unless otherwise specified, all expenses, administrative or otherwise, incurred by Sub-Committee Participants associated with participation in this Plan or a Sub-Committee shall be borne exclusively by the Sub-Committee Participants. I. Record Keeping Each Sub-Committee Chairperson shall have primary responsibility for PO 00000 Frm 00110 Fmt 4703 Sfmt 4703 maintaining records in accordance with 44 CFR part 332 and shall be the official custodian of records related to carrying out this Plan. Each Sub-Committee Participant shall maintain for five years all minutes of meetings, transcripts, records, documents, and other data, including any communications with other Sub-Committee Participants or with any other member of the SubCommittee, including drafts, related to the carrying out of this Plan or incorporating data or information received in the course of carrying out this Plan. Each Sub-Committee Participant agrees to produce to the Administrator, the Attorney General, and the Chair of the FTC upon request any item that this section requires the Participant to maintain. Any record maintained in accordance with 44 CFR part 332 shall be available for public inspection and copying, unless exempted on the grounds specified in 5 U.S.C. 552(b)(1), (3) or (4) or identified as privileged and confidential information in accordance with DPA section 705(d), and 44 CFR 332.5. IV. Antitrust Defense Under the provisions of DPA subsection 708(j), each Sub-Committee Participant in this Plan shall have available as a defense to any civil or criminal action brought for violation of the antitrust laws (or any similar law of any State) with respect to any action to develop or carry out this Plan, that such action was taken by the Sub-Committee Participant in the course of developing or carrying out this Plan, that the SubCommittee Participant complied with the provisions of DPA section 708 and the rules promulgated thereunder, and that the Sub-Committee Participant acted in accordance with the terms of the Voluntary Agreement and this Plan. Except in the case of actions taken to develop this Plan, this defense shall be available only to the extent the SubCommittee Participant asserting the defense demonstrates that the action was specified in, or was within the scope of, this Plan and within the scope of the appropriate Sub-Committee(s), including being taken at the direction and under the active supervision of FEMA. This defense shall not apply to any actions taken after the termination of this Plan. Immediately upon modification of this Plan, no defense to antitrust claims under Section 708 shall be available to any subsequent action that is beyond the scope of the modified Plan. The Sub-Committee Participant asserting the defense bears the burden of proof to establish the elements of the defense. The defense shall not be E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices available if the person against whom the defense is asserted shows that the action was taken for the purpose of violating the antitrust laws. V. Terms and Conditions As the sponsoring agency, FEMA will maintain oversight over Sub-Committee activities and direct and supervise actions taken to carry out this Plan, including by retaining decision-making authority over actions taken pursuant to the Plan to ensure such actions are necessary to address a direct threat to the national defense. The Attorney General and the Chair of the FTC will monitor activities of the SubCommittees to ensure they execute their responsibilities in a manner consistent with this Plan and their actions have the least anticompetitive effects possible. A. Plan of Action Execution This Plan will be used to support the following objectives to respond to a Pandemic by maximizing the manufacture and efficient distribution of selected types of Diagnostic Test Kits and other Testing Components and creating a prioritization protocol for End-Users based upon their demonstrated or projected requirements. Each Sub-Committee will undertake the following Objectives for the Diagnostic Test Kits and other Testing Components within its area of jurisdiction. 1. Objectives (1) Optimize the timely production of sufficient quantities of Diagnostic Test Kits and other Testing Components, as part of the overall national strategy, to reduce transmission of COVID–19 and mitigate the impacts caused by it. (2) Identify and encourage the development of Diagnostic Test Kits and Testing Components that can identify more than one illness (e.g., flu, strep throat or other bacterial infections, common cold, seasonal allergies, and COVID–19). (3) Identify and encourage the development of Diagnostic Test Kits and Testing Components that can mitigate supply chain constraints, by leveraging new technologies and different components. (4) Ensure Diagnostic Test Kits and other Testing Components are distributed effectively and equitably across the whole community nationally based on necessity and risk. (5) Balance restoration and maintenance of the nation’s stockpile of Diagnostic Test Kits and other Testing Components with near-term requirements. VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 (6) Establish a process for FEMA Allocation of Diagnostic Test Kits and other Testing Components nationwide. (7) Evaluate supply chain components to determine national vulnerabilities and propose corrective actions to improve resiliency in the manufacture and distribution of Diagnostic Test Kits and other Testing Components. (8) Ensure ongoing competition in the manufacture and distribution of Diagnostic Test Kits and other Testing Components to the greatest extent possible under the DPA. 2. Actions Sub-Committee Participants may be asked to support these objectives by taking the following specific actions: (1) Assist the Chairperson in identifying which types of Diagnostic Test Kits and other Testing Components should be included within each SubCommittee. Identification will be based upon each item’s importance to the national response to COVID–19 and whether it can be reasonably inferred, based upon the best evidence available, that the current and projected supply measured against current and projected demand may not adequately meet the requirements of all identified End-Users or regional or geographic areas of the country. (2) Provide input to the Chairperson in creating a prioritized list of End Users of Diagnostic Test Kits and other Testing Components, by category of End User, for each type of Diagnostic Test Kits and other Testing Components identified by each Sub-Committee, and ascertaining the relative demand and supply of Diagnostic Test Kits and other Testing Components among and within those End User categories. Prioritization shall be decided by the Chairperson, based upon each item’s importance, reflecting the consensus views of the SubCommittee Members that it represents the most effective way to save lives in responding to the COVID–19 pandemic. This list may be updated throughout the life of the Plan based upon either short term or long-term demands. These categories should be considered holistically in terms of the Whole-ofNation response to COVID–19. (3) Evaluate the domestic supply of Diagnostic Test Kits and other Testing Components and identify when the expansion of the domestic manufacture of Diagnostic Test Kits and other Testing Components may be necessary, as directed and decided by the Chairperson. (4) Provide information, assist, and validate, as necessary as decided by the Chairperson, demand projections for PO 00000 Frm 00111 Fmt 4703 Sfmt 4703 28857 Diagnostic Test Kits and other Testing Components. (5) Create a process for and collaborate in the evaluation of competing claims for Diagnostic Test Kits and/or other Testing Components from End-Users. (6) Prepare a general strategy to accomplish the activities listed in V(A)(2)(7) below regarding activities in Exigent Circumstances consistent with the decisions made by the Chairperson. (7) In Exigent Circumstances, with review and concurrence in all possible instances by DOJ in consultation with FTC: • Facilitate maximum availability of Diagnostic Test Kits and other Testing Components to the nation by deconflicting overlapping demands from the collective Participants’ customer base, as directed and decided by the Chairperson. • Facilitate maximum availability of Diagnostic Test Kits and other Testing Components to the nation by deconflicting overlapping supply chain demands placed upon Members, as directed and decided by the Chairperson. • Facilitate the efficient distribution of Diagnostic Test Kits and other Testing Components by deconflicting overlapping distribution chain activities of Members, as directed and decided by the Chairperson. • Create a process for and collaborate in the Allocation of Diagnostic Test Kits and other Testing Components nationwide consistent with the decisions made by the Chairperson. (8) Provide data and information necessary to validate the efforts of the Sub-Committee including the actual and planned amounts of Diagnostic Test Kits and other Testing Components to be distributed throughout the Nation, as determined by the Chairperson. (9) Provide feedback to the SubCommittee on the outcomes of the collective efforts of the Sub-Committee Members and any impediments or bottlenecks. (10) Advise the Chairperson whether additional Participants or Attendees should be invited to join this Plan and Sub-Committee. (11) Carry out other activities regarding Diagnostic Test Kits and other Testing Components as identified by Sub-Committees under this Plan as determined and directed by the Chairperson necessary to address the COVID–19 virus’ direct threat to the national defense, where such activities have been reviewed and approved by DOJ and FTC and received concurrence from Sub-Committee members. E:\FR\FM\28MYN1.SGM 28MYN1 28858 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices B. Information Management and Responsibilities FEMA will request only that data and information from Sub-Committee Participants that is necessary to meet the objectives of the Plan and consistent with the scope of the relevant SubCommittees. Upon signing a Plan of Action Agreement for this Plan, FEMA requests that Participants endeavor to cooperate with diligence and speed, and to the extent permissible under this Plan, and share with FEMA data and information necessary to meet the objectives of this Plan. Sub-Committee Participants agree to share with FEMA the following data with diligence and speed, to the extent permissible under this Plan, and abide by the following guidelines, where feasible and consistent with the data that is owned by each Sub-Committee Participant: (1) In general, Participants will not be asked to share Competitively Sensitive Information directly with other Participants. (2) FEMA will only request direct sharing of Competitively Sensitive Information among Participants during Exigent Circumstances where there is a mission critical need or timeline such that sharing only through FEMA is impractical or threatens the outcome of the Plan or Sub-Committee action. Such requests, if made, will be only among Participants whose participation is necessary to meet the objectives of the Plan, will be limited in scope to the greatest extent possible, and will be shared only pursuant to safeguards subject to prior review and audit by DOJ and FTC. Direct sharing of Competitively Sensitive Information with other Participants will be limited in scope and circumstances to the greatest extent possible. Participants may not share Competitively Sensitive Information directly with other Participants unless specifically requested by FEMA, in consultation with DOJ and FTC. All Competitively Sensitive Information delivered to FEMA or to another Sub-Committee Participant shall be delivered by secure means, for example, password-protected or encrypted electronic files or drives with the password/key delivered by separate communication or method or via upload to an appropriately secure web portal as directed by FEMA. All data delivered to the web portal designated by FEMA is deemed to be Competitively Sensitive Information. (3) To allow FEMA to identify and appropriately protect documents containing Competitively Sensitive Information by the Sub-Committee VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 Participant providing the documents, the Sub-Committee Participant will make good faith efforts to designate any Competitively Sensitive Information by placing restrictive markings on documents and things considered to be competitively sensitive, the restrictive markings being sufficiently clear in wording and visibility to indicate the restricted nature of the data. The SubCommittee Participant will identify Competitively Sensitive Information that is disclosed verbally by oral warning. Information designated as competitively sensitive will, to the extent allowed by law, be presumed to constitute confidential or privileged commercial or financial information, and be provided by the Sub-Committee Participant to FEMA with the expectation that it will be kept confidential by both parties, as such terms are understood in accordance with 5 U.S.C. 552(b)(4) of the Freedom of Information Act and federal judicial interpretations of this statute. FEMA agrees that to the extent any information designated as competitively sensitive by a Sub-Committee Participant is responsive to a request for disclosure under the Freedom of Information Act, FEMA will consult with the SubCommittee Participant and afford the Participant ten (10) working days to object to any disclosure by FEMA. (4) FEMA will make good faith efforts to appropriately recognize unmarked Documents containing Competitively Sensitive Information as Competitively Sensitive Information. However, FEMA cannot guarantee that all unmarked Documents will be recognized as being Competitively Sensitive Information and protected from disclosure to third parties. If the unmarked Documents have not been disclosed without restriction outside of FEMA, the SubCommittee Participant may retroactively request to have appropriate designations placed on the Documents. If the unmarked Documents have been disclosed without restriction outside of FEMA, FEMA will, to the extent practicable, remove any requested information from public forums controlled by FEMA and will work promptly to request that a receiving party return or destroy disclosed unmarked Documents if requested by the Sub-Committee Participant. (5) Competitively Sensitive Information may be used by FEMA, alone or in combination with additional information, including Documents and Competitively Sensitive Information received from third parties, to support FEMA’s implementation of this Plan as determined by the Chairperson. In all situations, FEMA will aggregate and PO 00000 Frm 00112 Fmt 4703 Sfmt 4703 anonymize Competitively Sensitive Information to the greatest extent possible to protect the interests retained by the owners of the data while still allowing the objectives of the Plan and Sub-Committee to be achieved. To the greatest extent possible, such aggregation will render the competitively sensitive nature of the Competitively Sensitive Information of the Sub-Committee Participant no longer recognizable in a commercially sensitive manner, and without sufficient information to enable, by inference or otherwise, attribution to Sub-Committee Participant or its affiliates (as clearly identified and disclosed to FEMA). Any disclosure of Competitively Sensitive Information by FEMA, within or outside a Sub-Committee, will be subject to review and approval by DOJ and FTC. (6) Except as otherwise expressly permitted by applicable federal law, FEMA shall not disclose any Competitively Sensitive Information or use any Competitively Sensitive Information for any purpose other than in connection with the purposes of this Plan, and FEMA will not sell any Competitively Sensitive Information of any Sub-Committee Participant. (7) Except as described below, FEMA may disclose Competitively Sensitive Information only to its employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors). Any individual with access to Competitively Sensitive Information will be expected to comply with the terms of this Plan. a. Information Sharing within the Sub-Committee: FEMA may share Competitively Sensitive Information with Sub-Committee Participants and Federal Representatives of the Plan, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) where there is a need to know and where disclosure is reasonably necessary in furtherance of implementing the Plan. FEMA will aggregate and anonymize data prior to sharing with the Sub-Committee Participants to the greatest extent possible while still allowing the objectives of the Plan to be achieved, and will not share data—particularly to competitors of the submitter—prior to consultation with and approval by the DOJ and FTC. i. Sub-Committee Participants, when providing Competitively Sensitive Information to FEMA, may request that this Information not be shared with other Sub-Committee Participants. Where these requests are made in good E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices faith and are reasonable in nature, FEMA will respect these requests to the greatest extent possible and will consult the owner of the data prior to any release made to Sub-Committee Participants. b. Restricted Reports. FEMA may communicate Competitively Sensitive Information to appropriate government officials through Restricted Reports. The information contained in Restricted Reports shall be aggregated and anonymized to the greatest extent possible, while recognizing that these officials may need a certain amount of granularity and specificity of information to appropriately respond to COVID–19. FEMA will aim to aggregate data to the County level, and will not share Restricted Reports prior to consultation and approval from the DOJ and FTC. FEMA may disclose Restricted Reports to relevant White House and Administration officials and State Governors, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) who have a need to know and to whom such disclosure is reasonably necessary solely in furtherance of the implementation of this Plan. FEMA shall take appropriate action (by instructions, agreement, or otherwise) to ensure that receiving parties comply with all data-sharing confidentiality and obligations under this Plan as if such persons or entities had been parties to this Plan. c. Public Reports. FEMA may share information with the public through Public Reports. Data contained in Public Reports shall be fully aggregated and anonymized. Public Reports shall be aggregated to at least a state level and may be publicly disclosed after consultation and approval from the DOJ and FTC. (8) Where possible and not obviated by Exigent Circumstances, FEMA will notify Sub-Committee Participants prior to the release of any Competitively Sensitive Information that has not been fully aggregated and anonymized. In consultation with DOJ and FTC, FEMA will consider any good-faith requests made by Sub-Committee members to hold the release of data or requests for further aggregation or anonymization. In general, FEMA will not provide notification prior to the release of Public Reports, under the presumption that the data in these reports has already been fully anonymized and de-identified. (9) Any party receiving Competitively Sensitive Information through this Plan shall use such information solely for the purposes outlined in the Plan and take VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 steps, such as imposing previously approved firewalls or tracking usage, to prevent misuse of the information. Disclosure and use of Competitively Sensitive Information will be limited to the greatest extent possible, and any party receiving Competitively Sensitive Information shall follow the procedures outlined in paragraph 7 above. (10) At the conclusion of a Participant’s involvement in a Plan— due to the deactivation of the Plan or due to the Participant’s withdrawal or removal—each Participant will be requested to sequester any and all Competitively Sensitive Information received through participation in the Plan. This sequestration shall include the deletion of all Competitively Sensitive Information unless required to be kept pursuant to the Record Keeping requirements as described supra, Section I, 44 CFR part 332, or any other provision of law. C. Oversight Each Sub-Committee Chairperson is responsible for ensuring that the Attorney General, or suitable delegate(s) from the DOJ, and the FTC Chair, or suitable delegate(s) from the FTC, have awareness of activities under this Plan, including activation, deactivation, and scheduling of meetings. The Attorney General, the FTC Chair, or their delegates may attend Sub-Committee meetings and request to be apprised of any activities taken in accordance with activities under this Plan. DOJ or FTC Representatives may request and review any proposed action by the SubCommittee or Sub-Committee Participants undertaken pursuant to this Plan, including the provision of data. If any DOJ or FTC Representative believes any actions proposed or taken are not consistent with relevant antitrust protections provided by the DPA, he or she shall provide warning and guidance to the Sub-Committee as soon as the potential issue is identified. If questions arise about the antitrust protections applicable to any particular action, FEMA may request DOJ, in consultation with the FTC, provide an opinion on the legality of the action under relevant DPA antitrust protections. VI. Establishment of the SubCommittees This Plan establishes Sub-Committees to implement the Plan to Establish a National Strategy for the Manufacture, Allocation and Distribution of Diagnostic Test Kits and other Testing Components to Respond to COVID–19 to provide the Federal Government and the Participants a forum to maximize the manufacture and efficient PO 00000 Frm 00113 Fmt 4703 Sfmt 4703 28859 distribution of selected types of Diagnostic Test Kits and other Testing Components and to create a prioritization protocol based upon identified types of Diagnostic Test Kits and other Testing Components EndUsers and their demonstrated or projected requirements, and demonstrated or projected geographic and regional areas of need. The outcome should include a framework to expeditiously meet any Diagnostic Test Kits and other Testing Components needs in Exigent Circumstances anywhere in the Nation, and to ensure that actions to support the stockpiling of Diagnostic Test Kits and other Testing Components do not interfere with immediate requirements that would result in an unacceptable risk to healthcare providers or other potential Diagnostic Test Kits and other Testing Components recipients. A SubCommittee Chairperson designated by the Chairperson will convene and preside over each Sub-Committee. SubCommittees will not be used for contract negotiations or contract discussions between the Participants and the Federal Government; such negotiations or discussions will be in accordance with applicable federal contracting policies and procedures. However, this shall not limit any discussion within a Sub-Committee about the operational utilization of existing and potential contracts between the Participants and Representatives when seeking to align their use with overall manufacturing and distribution efforts consistent with this Plan. Each Sub-Committee will consist of designated Representatives from FEMA, HHS, other federal agencies with equities in this Plan, and each SubCommittee Participant. The Attorney General and Chair of the FTC, or their delegates, may also join each SubCommittee and attend meetings at their discretion. Attendees may also be invited at the discretion of a SubCommittee Chairperson as subject matter experts, to provide technical advice, or to represent other government agencies, but will not be considered part of the Sub-Committee. To the extent necessary to respond to the Pandemic, only at the explicit direction of a Sub-Committee Chairperson, and subject to the provisions of Section V(B), SubCommittee Members may be asked to provide technical advice, share information, help identify and validate places and resources of the greatest need, help project future manufacturing and distribution demands, assist in identifying and resolving the allocation of scarce resources amongst all E:\FR\FM\28MYN1.SGM 28MYN1 28860 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices necessary public and private sector domestic needs under Exigent Circumstances, and take any other necessary actions to maximize the timely allocation and distribution of Diagnostic Test Kits and other Testing Components as determined necessary by FEMA to respond to the Pandemic. A Sub-Committee Chairperson or his or her designee, at the Sub-Committee Chairperson’s sole discretion, will make decisions on these issues in order to ensure the maximum efficiency and effectiveness in the use of SubCommittee Member’s resources. All Sub-Committee Participants will be invited to open Sub-Committee meetings. For selected Sub-Committee meetings, attendance may be limited to designated Sub-Committee Participants to meet specific operational requirements, as determined by FEMA. Each Sub-Committee Chairperson shall notify the Attorney General, the Chair of the FTC, Representatives, and Participants of the time, place, and nature of each meeting and of the proposed agenda of each meeting to be held to carry out this Plan. Additionally, each Sub-Committee Chairperson shall provide for publication in the Federal Register of a notice of the time, place, and nature of each meeting. If a meeting is open, a Federal Register notice will be published reasonably in advance of the meeting. A Sub-Committee Chairman may restrict attendance at meetings only on the grounds outlined by 44 CFR 332.5(c)(1)–(3). If a meeting is closed, a Federal Register notice will be published within ten (10) days of the meeting and will include the reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2). The Sub-Committee Chairperson shall establish the agenda for each meeting, be responsible for adherence to the agenda, and provide for a written summary or other record of each meeting and provide copies of transcripts or other records to FEMA, the Attorney General, the Chair of the FTC, and all Sub-Committee Participants. The Chairperson shall take necessary actions to protect from public disclosure any data discussed with or obtained from Sub-Committee Participants which a Sub-Committee Participant has identified as a trade secret or as privileged and confidential in accordance with DPA sections 708(h)(3) and 705(d), or which qualifies for withholding under 44 CFR 332.5. Establish a National Strategy for the Manufacture, Allocation and Distribution of Diagnostic Test Kits and other Testing Components under the Voluntary Agreement for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a Pandemic and to become a Participant in one or more SubCommittees established by this Plan. This Plan will be published in the Federal Register. This Plan is authorized under section 708 of the Defense Production Act of 1950, as amended. Regulations governing the Voluntary Agreement for the Manufacture and Distribution for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a Pandemic and all subsequent Plans of Action at 44 CFR part 332. The applicant, as a SubCommittee Participant, agrees to comply with the provisions of section 708 of the Defense Production Act of 1950, as amended, the regulations at 44 CFR part 332, and the terms of this Plan. VIII. Assignment No Sub-Committee Participant may assign or transfer this Plan, in whole or in part, or any protections, rights or obligations hereunder without the prior written consent of the Sub-Committee Chairperson. When requested, the SubCommittee Chairperson will respond to written requests for consent within 10 (ten) business days of receipt. lllllllllllllllllllll (Company name) lllllllllllllllllllll (Name of authorized representative) lllllllllllllllllllll (Signature of authorized representative) lllllllllllllllllllll (Date) lllllllllllllllllllll Administrator (Sponsor) lllllllllllllllllllll (Date) VII. Application and Agreement The Sub-Committee Participant identified below hereby agrees to join in the Federal Emergency Management Agency sponsored Plan of Action to VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 PO 00000 Frm 00114 Fmt 4703 Sfmt 4703 Text of 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 Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a Pandemic 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 Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a Pandemic Preface Pursuant to section 708 of the Defense Production Act of 1950 (DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management Agency (FEMA) Administrator (Administrator), after consultation with the Secretary of the Department of Health and Human Services (HHS), the Attorney General of the United States (Attorney General), and the Chair of the Federal Trade Commission (FTC), developed a Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic (Voluntary Agreement), 85 FR 50035 (August 17, 2020). The Voluntary Agreement, which operates through a series of Plans of Action, maximizes the manufacture and efficient distribution of Critical Healthcare Resources nationwide to respond to a pandemic by establishing unity of effort between Participants and the Federal Government for integrated coordination, planning, information sharing with FEMA, as authorized by FEMA, and allocation and distribution of Critical Healthcare Resources. This document establishes a Plan of Action (Plan) 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. This Plan will be implemented under the Voluntary Agreement by several Sub-Committees, beginning with a Sub-Committee to Define Requirements for COVID–19 Drug Products, Drug Substances, and Associated Medical Devices: (1) Sub-Committee to Define Requirements for COVID–19 Drug Products, Drug Substances, and Associated Medical Devices E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices (2) Sub-Committee for Monoclonal Antibodies, (3) Sub-Committee for Drug Products, Drug Substances, and Associated Medical Devices Related to the Treatment of Respiratory Illness, (4) Sub-Committee for Drug Products, Drug Substances, and Associated Medical Devices Related to Acute and Intensive Care, (5) Sub-Committee to Accelerate Coronavirus Treatment, (6) Sub-Committee for Strategic Investment Towards On-Shoring of Pharmaceutical Manufacturing and FillFinish, and (7) Sub-Committee for Emergency Use Authorizations. FEMA may establish additional SubCommittees under this Plan, so long as: (1) The Sub-Committee addresses one specific and well-defined category of Drug Products, Drug Substances, or Associated Medical Devices; and (2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for COVID–19 Drug Products, Drug Substances, and Associated Medical Devices. The purpose of the Plan and the SubCommittees is to maximize the manufacture and efficient distribution of selected types of Drug Products, Drug Substances, and Associated Medical Devices, and create a prioritization protocol for End-Users based upon their demonstrated or projected requirements including geographic and regional circumstances. The primary goal of the Plan is to create 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. When the requirements of the Plan are met, it affords Sub-Committee Participants defenses to civil and criminal actions brought under the antitrust laws (or any similar law of any state) for actions taken within the scope of the Plan. The Plan is designed to foster a close working relationship among FEMA, HHS, and Sub-Committee Participants to address national defense needs through cooperative action under the direction and active supervision of FEMA. Table of Contents I. Purpose .......................................................................................................................................................................................................................................... II. Authorities ................................................................................................................................................................................................................................... III. General Provisions ..................................................................................................................................................................................................................... A. Definitions ............................................................................................................................................................................................................................ B. Plan of Action Participation ................................................................................................................................................................................................ C. Effective Date and Duration of Participation ...................................................................................................................................................................... D. Withdrawal ........................................................................................................................................................................................................................... E. Plan of Action Activation and Deactivation ....................................................................................................................................................................... F. Rules and Regulations .......................................................................................................................................................................................................... G. Modification and Amendment ............................................................................................................................................................................................ H. Expenses ............................................................................................................................................................................................................................... I. Record Keeping ...................................................................................................................................................................................................................... IV. Antitrust Defense ....................................................................................................................................................................................................................... V. Terms and Conditions ................................................................................................................................................................................................................. A. Plan of Action Execution .................................................................................................................................................................................................... B. Information Management and Responsibilities .................................................................................................................................................................. C. Oversight ............................................................................................................................................................................................................................... VI. Establishment of the Sub-Committees ...................................................................................................................................................................................... VII. Application and Agreement ..................................................................................................................................................................................................... VIII. Assignment ............................................................................................................................................................................................................................... IX. Purpose A pandemic may present conditions that pose a direct threat to the national defense of the United States or its preparedness programs such that, pursuant to DPA section 708(c)(1), an agreement to collectively coordinate, plan, and collaborate for the manufacture, allocation and distribution of Drug Products, Drug Substances, and Associated Medical Devices is necessary for the national defense. This 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 is established under the Voluntary Agreement and establishes seven SubCommittees to oversee and implement the Plan. The Plan and Sub-Committees will optimize the manufacture and the efficient distribution of selected types of Drug Products, Drug Substances, and Associated Medical Devices and create a prioritization protocol for End-Users VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 28861 380 380 381 381 385 386 386 387 387 387 388 388 389 389 389 392 396 396 398 398 based upon their demonstrated or projected requirements. XI. General Provisions X. Authorities Administrator The FEMA Administrator is the Sponsor of the Voluntary Agreement. Pursuant to a delegation or redelegation of the functions given to the President by DPA section 708, the Administrator proposes and provides for the development and carrying out of the Voluntary Agreement, including through the development and implementation of Plans of Action. The Administrator is responsible for carrying out all duties and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and for appointing one or more Chairpersons to manage and administer the Committee and all Sub-Committees formed to carry out the Voluntary Agreement. Section 708, Defense Production Act (50 U.S.C. 4558); sections 402(2) & 501(b), Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121–5207); sections 503(b)(2)(B) & 504(a)(10) & (16) of the Homeland Security Act of 2002 (6 U.S.C. 313(b)(2)(B), 314(a)(10) & (16)); sections 201, 301, National Emergencies Act (50 U.S.C. 1601 et seq.); section 319, Public Health Service Act (42 U.S.C. 247d); Executive Order (E.O.) 13911, 85 FR 18403 (March 27, 2020); Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 85 FR 20195 (April 10, 2020). Pursuant to DPA section 708(f)(1)(A), the Administrator certifies that this Plan is necessary for the national defense. PO 00000 Frm 00115 Fmt 4703 Sfmt 4703 J. Definitions Agreement The Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to E:\FR\FM\28MYN1.SGM 28MYN1 28862 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices Respond to a Pandemic (Voluntary Agreement). Allocation The process of determining and directing the relative distribution among one or more competing requests from End-Users for the same Drug Products, Drug Substances, or Associated Medical Devices. Through the Allocation process, FEMA—with participation from Sub-Committee Participants—will assess the actual needs of End-Users and determine how to divide the available and projected supply of Drug Products, Drug Substances, and Associated Medical Devices to minimize impacts to life, safety, and economic disruption associated with shortages of Drug Products, Drug Substances, and Associated Medical Devices. Allocation will take place only under Exigent Circumstances. Although FEMA retains decision making authority for all Allocation under this Plan, other federal agency partners retain decision-making authority for all assets under their control. Associated Medical Devices A device, as defined under the United States Food, Drug, and Cosmetic Act, 21 U.S.C. 321(h), that is used to manufacture, transport, distribute, deliver, sanitize, dispose of, or in any other way facilitate the use of, any drug product or drug substance needed to cure, mitigate or treat COVID–19. Attendees Subject matter experts, invited by the Chairperson or a Sub-Committee Chairperson to attend meetings authorized under the Voluntary Agreement or this Plan, to provide technical advice or to represent other government agencies or interested parties. Invitations to attendees will be extended as required for Committee or Sub-Committee meetings and deliberations. Chairperson FEMA senior executive(s), appointed by the Administrator, to chair the Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic (Committee). The Chairperson shall be responsible for the overall management and administration of the Committee, the Voluntary Agreement, and Plans of Action developed under the Voluntary Agreement while remaining under the supervision of the Administrator; shall initiate, or approve in advance, each meeting held to discuss problems, determine policies, recommend actions, and make decisions necessary to carry VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 out the Voluntary Agreement; appoint one or more co-Chairpersons to chair the Committee, and otherwise shall carry out all duties and responsibilities assigned to them. With the approval of the Administrator, the Chairperson may create one or more Sub-Committees, and may appoint one or more SubCommittee Chairpersons to chair the Sub-Committees, as appropriate. Committee Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic established under the Voluntary Agreement. Competitively Sensitive Information Competitively Sensitive Information that is shared pursuant to this Plan may include any Document or other tangible thing or oral transmission that contains financial, business, commercial, scientific, technical, economic, or engineering information or data, including, but not limited to • financial statements and data, • customer and supplier lists, • price and other terms of sale to customers, • sales records, projections and forecasts, • inventory levels, • capacity and capacity utilization, • cost information, • sourcing and procurement information, • manufacturing and production information, • delivery and shipping information, • systems and data designs, and • methods, techniques, processes, procedures, programs, codes, or similar information, whether tangible or intangible, and regardless of the method of storage, compilation, or recordation, if the owner thereof has taken reasonable measures to protect the information from disclosure to the public or competitors. These measures may be evidenced by marking or labeling the items as ‘‘competitively sensitive information’’ during submission to FEMA or in the Participant’s customary and existing treatment of such information (regardless of labeling). All Competitively Sensitive Information provided by a SubCommittee Participant as described herein is deemed Competitively Sensitive Information, except for Information that: a. Is published or has been made publicly available at the time of disclosure by the Sub-Committee Participant; b. was in the possession of, or was lawfully and readily available to, FEMA PO 00000 Frm 00116 Fmt 4703 Sfmt 4703 from another source at the time of disclosure without breaching any obligation of confidentiality applicable to the other source; or c. was independently developed or acquired without reference to or reliance upon the Sub-Committee Participant’s Competitively Sensitive Information; Where information deemed Competitively Sensitive Information is required to be disclosed by law, regulation, or court order, the ‘‘Competitively Sensitive’’ (or substantially similar) label will continue to attach to all information and portion(s) of documents that are not made public through the required disclosure. Document Any information, on paper or in electronic/audio/visual format, including written, recorded, and graphic materials of every kind, in the possession, custody, or control of the Participant and used or shared in the course of participation in the Voluntary Agreement or a subsequent Plan of Action. Drug Product Is a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. Drug Substance Is an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient. End-User This includes all direct and ancillary medical support including, but not limited to, hospitals, independent healthcare providers, nursing homes, medical laboratories, dental care providers, independent physician offices, first responders, alternate care facilities and the general public that reasonably represents the totality of the nation’s response to COVID–19. ‘‘EndUser’’ may also include essential workers necessary to maintain or restore critical infrastructure operations, including but not limited to law enforcement, education, food and agriculture, energy, water and wastewater, and public works personnel. E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices Exigent Circumstances As determined by the Chairperson, the actual or forecasted shortage of a particular type or types of Drug Products, Drug Substances, and Associated Medical Devices which likely cannot be fulfilled via usual market mechanisms for an acute, critical time period, and where immediate and substantial harm is projected to occur from lack of intervention. Fill-Finish Fill-finish is the final manufacturing step in the overall drug manufacturing process. This process transfers a sterile drug from a filling needle to a sterile container. On-Shoring Building domestic capacity that is otherwise available in other Countries. Pandemic A Pandemic is defined as an epidemic that has spread to human populations across a large geographic area that is subject to one or more declarations under the National Emergencies Act, the Public Health Service Act, or the Robert T. Stafford Disaster Relief and Emergency Assistance Act, or if the Administrator determines that one or more declarations is likely to occur and the epidemic poses a direct threat to the national defense or its preparedness programs. For example, Coronavirus Disease 2019 (COVID–19). particular Critical Healthcare Resource, or pandemic response workstream or functional area necessary for the national defense. Plan of Action Agreement A separate commitment made by Participants upon invitation and agreement to participate in a Plan of Action as part of one or more SubCommittees. Completing the Plan of Action Agreement confers responsibilities on the Participant consistent with those articulated in the Plan and affords Participants a defense against antitrust claims under section 708 for actions taken to develop or carry out the Plan and the appropriate SubCommittee(s), as described in Section IV below. Representatives The representatives the Administrator identifies and invites to the Committee from FEMA, HHS, and other federal agencies with equities in this Plan, and empowered to speak on behalf of their agencies’ interests. The Attorney General and the Chair of the FTC, or their delegates, may also attend any meeting as a Representative. Strategic Investment Targeted investments for on-shoring of drug product and drug substance manufacturing, including fill-finish capacities. Sub-Committee Participant An individual, partnership, corporation, association, or private organization, other than a federal agency, that has substantive capabilities, resources or expertise to carry out the purpose of the Voluntary Agreement, that has been specifically invited to participate in the Voluntary Agreement by the Chairperson, and that has applied and agreed to the terms of the Voluntary Agreement. ‘‘Participant’’ includes a corporate or non-corporate entity entering into the Voluntary Agreement and all subsidiaries and affiliates of that entity in which that entity has 50 percent or more control either by stock ownership, board majority, or otherwise. The Administrator may invite Participants to join the Voluntary Agreement at any time during its effective period. A body formed by the Administrator from select Participants to implement a Plan of Action. Plan of Action (Plan) This document. A documented method, pursuant to 50 U.S.C. 4558(b)(2), proposed by FEMA to implement a particular set of activities under the Voluntary Agreement, through a Sub-Committee focused on a Sub-Committee Participant VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 Sub-Committee Chairperson FEMA official, appointed by the Chairperson, to chair a Sub-Committee to implement a Plan of Action. The SubCommittee Chairperson shall be responsible for the overall management and administration of the SubCommittee in furtherance of this Plan while remaining under the supervision of the Administrator and the Chairperson. Sub-Committee Members Collectively the Sub-Committee Chairperson(s), Representatives, and Sub-Committee Participants. Jointly responsible developing and executing this Plan. A subset of Participants of the Committee, that have been specifically invited to participate in a SubCommittee by the Sub-Committee Chairperson, and that have applied and agreed to the terms of this Plan and PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 28863 signed the Plan of Action Agreement. The Sub-Committee Chairperson may invite Participants in the Committee to join a Sub-Committee as a SubCommittee Participant at any time during the Plan’s effective period. K. Plan of Action Participation This Plan will be carried out by a subset of the Participants in the Voluntary Agreement through several Sub-Committees: (1) Sub-Committee to Define Requirements for COVID–19 Drug Products, Drug Substances, and Associated Medical Devices, (2) Sub-Committee for Monoclonal Antibodies, (3) Sub-Committee for Drug Products, Drug Substances, and Associated Medical Devices Related to the Treatment of Respiratory Illness, (4) Sub-Committee for Drug Products, Drug Substances, and Associated Medical Devices Related to Acute and Intensive Care, (5) Sub-Committee to Accelerate Coronavirus Treatment, (6) Sub-Committee for Strategic Investment Towards On-Shoring of Pharmaceutical Manufacturing and FillFinish, and (7) Sub-Committee for Emergency Use Authorizations. FEMA may establish additional SubCommittees under this Plan, so long as: (1) The Sub-Committee addresses one specific and well-defined category of Drug Products, Drug Substances, and Associated Medical Devices; and (2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for COVID–19 Drug Products, Drug Substances, and Associated Medical Devices. Each Sub-Committee will consist of the (1) Sub-Committee Chairperson(s), (2) Representatives from FEMA, HHS, the Department of Justice (DOJ), and other federal agencies with equities in this Plan, and (3) Sub-Committee Participants that have substantive capabilities, resources or expertise to carry out the purpose of this Plan and have signed the Plan of Action Agreement. The Chairperson shall invite Sub-Committee Participants who, in his or her determination, are reasonably representative of the appropriate industry or segment of such industry. Other Attendees—invited by the SubCommittee Chairperson as subject matter experts to provide technical advice or to represent the interests of other government agencies or interested parties—may also participate in SubCommittee meetings. The naming of these Sub-Committees does not commit E:\FR\FM\28MYN1.SGM 28MYN1 28864 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices the Administrator to creating them unless and until circumstances dictate. L. Effective Date and Duration of Participation This Plan is effective immediately upon satisfaction of the requirements of DPA section 708(f)(1). This Plan shall remain in effect until terminated in accordance with 44 CFR 332.4. It shall be effective for no more than five (5) years from August 17, 2020, when the requirements of DPA section 708(f)(1) were satisfied for the Voluntary Agreement, unless otherwise terminated pursuant to DPA section 708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 708(f)(2). No action may take place under this Plan until it is activated, as described in Section III(E), below. M. Withdrawal Participation in the Plan is voluntary, as is the acceptance of most obligations under the Plan. Sub-Committee Participants may withdraw from this Plan or from an individual SubCommittee at any point, subject to the fulfillment of obligations previously agreed upon by the Participant prior to the date of withdrawal. Note that the obligations outlined in V.B regarding information management and associated responsibilities apply once a party has shared or received information through a Sub-Committee, and remain in place after the party’s withdrawal from the Sub-Committee or Plan. If a SubCommittee Participant indicates an intent to withdraw from the Plan due to a modification or amendment of the Plan (described below), the SubCommittee Participant will not be required to perform actions directed by that modification or amendment. Withdrawal from the Plan will automatically trigger withdrawal from all Sub-Committees; however, a Participant may withdraw from a SubCommittee without also withdrawing from the Plan or other Sub-Committees. To withdraw from the Plan or from an individual Sub-Committee, a Participant must provide written notice to the Administrator at least fifteen (15) calendar days prior to the effective date of that Sub-Committee Participant’s withdrawal specifying the scope of withdrawal. Following receipt of such notice, the Administrator will inform the other Sub-Committee Participants of the date and the scope of the withdrawal. Upon the effective date of the withdrawal from the Plan, the SubCommittee Participant must cease all activities under the Plan. Upon the effective date of the withdrawal from VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 one or more Sub-Committee(s), the SubCommittee Participant must cease all activities under the Plan that pertain to the withdrawn Sub-Committee(s). N. Plan of Action Activation and Deactivation The Administrator, in consultation with the Chairperson and SubCommittee Chairperson, will invite a select group of Participants in the Voluntary Agreement to form the following Sub-Committees, beginning with the Sub-Committee to Define Requirements for COVID–19 Drug Products, Drug Substances, and Associated Medical Devices, which will be responsible for implementing this Plan. (1) Sub-Committee to Define Requirements for COVID–19 Drug Products, Drug Substances, and Associated Medical Devices, (2) Sub-Committee for Monoclonal Antibodies, (3) Sub-Committee for Drug Products, Drug Substances, and Associated Medical Devices Related to the Treatment of Respiratory Illness, (4) Sub-Committee for Drug Products, Drug Substances, and Associated Medical Devices Related to Acute and Intensive Care, (5) Sub-Committee to Accelerate Coronavirus Treatment, (6) Sub-Committee for Strategic Investment Towards On-Shoring of Pharmaceutical Manufacturing and FillFinish, and (7) Sub-Committee for Emergency Use Authorizations. FEMA may establish additional SubCommittees under this Plan, so long as: (1) The Sub-Committee addresses one specific and well-defined category of Drug Products, Drug Substances, and Associated Medical Devices; and (2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for COVID–19 Drug Products, Drug Substances, and Associated Medical Devices. This Plan will be activated for each invited Participant when the Participant executes a Plan of Action Agreement, and a Participant may not participate in a Sub-Committee until the Plan of Action Agreement is executed. Participants will be invited to join this Plan at the discretion of the Chairperson or the Sponsor to the Voluntary Agreement. Participants will be further invited to attend specific meetings of one or more Sub-Committees at the discretion of the Chairperson. O. Rules and Regulations Sub-Committee Participants acknowledge and agree to comply with PO 00000 Frm 00118 Fmt 4703 Sfmt 4703 all provisions of DPA section 708, as amended, and regulations related thereto which are promulgated by FEMA, the Department of Homeland Security, HHS, the Attorney General, and the FTC. FEMA has promulgated standards and procedures pertaining to voluntary agreements in 44 CFR part 332. The Administrator shall inform Participants of new rules and regulations as they are issued. P. Modification and Amendment The Administrator, after consultation with the Attorney General and the Chair of the FTC, may terminate or modify, in writing, this Plan at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may terminate or modify, in writing, this Plan at any time. Sub-Committee Participants may propose modifications or amendments to the Plan or to the Sub-Committees at any time. Where possible, material modifications to the Plan or a SubCommittee will be subject to a 30 calendar day delayed implementation and opportunity for notice and comment by Sub-Committee Participants to the Chairperson. This delayed implementation period may be shortened or eliminated if the Administrator deems it necessary. The Administrator shall inform SubCommittee Participants of modifications or amendments to the Plan or to the Sub-Committees as they are proposed and issued. The Administrator, after consultation with the Attorney General and the Chair of the FTC, may remove Sub-Committee Participants from the Plan or from a Sub-Committee at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may remove SubCommittee Participants from this Plan or from a Sub-Committee at any time. If a Participant is removed from the Plan or from a Sub-Committee, the Participant may request written notice of the reasons for removal from the Chairperson, who shall provide such notice in a reasonable time-period. Q. Expenses Participation in this Plan or in a SubCommittee does not confer funds to Sub-Committee Participants, nor does it limit or prohibit any pre-existing source of funds. Unless otherwise specified, all expenses, administrative or otherwise, incurred by Sub-Committee Participants associated with participation in this Plan or a Sub-Committee shall be borne exclusively by the Sub-Committee Participants. E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices R. Record Keeping Each Sub-Committee Chairperson shall have primary responsibility for maintaining records in accordance with 44 CFR part 332 and shall be the official custodian of records related to carrying out this Plan. Each Sub-Committee Participant shall maintain for five years all minutes of meetings, transcripts, records, documents, and other data, including any communications with other Sub-Committee Participants or with any other member of the SubCommittee, including drafts, related to the carrying out of this Plan or incorporating data or information received in the course of carrying out this Plan. Each Sub-Committee Participant agrees to produce to the Administrator, the Attorney General, and the Chair of the FTC upon request any item that this section requires the Participant to maintain. Any record maintained in accordance with 44 CFR part 332 shall be available for public inspection and copying, unless exempted on the grounds specified in 5 U.S.C. 552(b)(1), (3) or (4) or identified as privileged and confidential information in accordance with DPA section 705(d), and 44 CFR 332.5. XII. Antitrust Defense Under the provisions of DPA subsection 708(j), each Sub-Committee Participant in this Plan shall have available as a defense to any civil or criminal action brought for violation of the antitrust laws (or any similar law of any State) with respect to any action to develop or carry out this Plan, that such action was taken by the Sub-Committee Participant in the course of developing or carrying out this Plan, that the SubCommittee Participant complied with the provisions of DPA section 708 and the rules promulgated thereunder, and that the Sub-Committee Participant acted in accordance with the terms of the Voluntary Agreement and this Plan. Except in the case of actions taken to develop this Plan, this defense shall be available only to the extent the SubCommittee Participant asserting the defense demonstrates that the action was specified in, or was within the scope of, this Plan and within the scope of the appropriate Sub-Committee(s), including being taken at the direction and under the active supervision of FEMA. This defense shall not apply to any actions taken after the termination of this Plan. Immediately upon modification of this Plan, no defense to antitrust claims under Section 708 shall be available to any subsequent action that is beyond the scope of the modified VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 Plan. The Sub-Committee Participant asserting the defense bears the burden of proof to establish the elements of the defense. The defense shall not be available if the person against whom the defense is asserted shows that the action was taken for the purpose of violating the antitrust laws. XIII. Terms and Conditions As the sponsoring agency, FEMA will maintain oversight over Sub-Committee activities and direct and supervise actions taken to carry out this Plan, including by retaining decision-making authority over actions taken pursuant to the Plan to ensure such actions are necessary to address a direct threat to the national defense. The Attorney General and the Chair of the FTC will monitor activities of the SubCommittees to ensure they execute their responsibilities in a manner consistent with this Plan and their actions have the least anticompetitive effects possible. A. Plan of Action Execution This Plan will be used to support the following objectives to respond to a Pandemic by maximizing the manufacture and efficient distribution of selected types of Drug Products, Drug Substances, and Associated Medical Devices and creating a prioritization protocol for End-Users based upon their demonstrated or projected requirements and taking into account geographic and regional circumstances. Each SubCommittee will undertake the following Objectives for the Drug Products, Drug Substances, and Associated Medical Devices within its area of jurisdiction. 1. Objectives (1) Optimize the timely production of sufficient quantities of Drug Products, Drug Substances, and Associated Medical Devices to reduce loss of life and transmission of the COVID–19 virus. (2) Expand domestic manufacturing of Drug Products, Drug Substances, and Associated Medical Devices, including fill-finish capacities. (3) Ensure Drug Products, Drug Substances, and Associated Medical Devices are distributed effectively across the whole community nationally based on risk. (4) Balance restoration and maintenance of the nation’s stockpile of Drug Products, Drug Substances, and Associated Medical Devices with nearterm requirements. (5) Establish a process for FEMA Allocation of Drug Products, Drug Substances, and Associated Medical Devices nationwide. PO 00000 Frm 00119 Fmt 4703 Sfmt 4703 28865 (6) Ensure ongoing competition in the manufacture and distribution of Drug Products, Drug Substances, and Associated Medical Devices to the greatest extent possible under the DPA. 2. Actions Sub-Committee Participants may be asked to support these objectives by taking the following specific actions: (1) Assist the Chairperson in identifying which types of Drug Products, Drug Substances, and Associated Medical Devices should be included within each Sub-Committee. Identification will be based upon each item’s importance to the national response to COVID–19 and whether it can be reasonably inferred, based upon the best evidence available, that the current and projected supply measured against current and projected demand may not adequately meet the Drug Product, Drug Substance, and Associated Medical Device requirements to all identified End-Users or regional or geographic areas of the country as result of measures taken to respond to COVID–19. (2) Provide input to the Chairperson in creating a prioritized list of Drug Product, Drug Substance, and Associated Medical Device End-Users by categories for each type of Drug Product, Drug Substance, and Associated Medical Device identified by each Sub-Committee, and ascertaining the relative demand and supply of Drug Products, Drug Substances, and Associated Medical Devices among and within those End-User categories. Prioritization shall be decided by the Chairperson, based upon each item’s importance, reflecting the consensus views of the Sub-Committee Members that it represents the most effective way to save lives and prevent the transmission of the COVID–19 virus. This list may be updated throughout the life of the Plan based upon either short term or long-term demands. These categories should be considered holistically in terms of the Whole-ofNation response to COVID–19. (3) Evaluate the domestic supply of Drug Products, Drug Substances, and Associated Medical Devices and identify when the expansion of the domestic manufacture of Drug Products, Drug Substances, and Associated Medical Devices may be necessary, as directed and decided by the Chairperson. (4) Provide information, assist, and validate, as necessary as decided by the Chairperson, demand projections for Drug Products, Drug Substances, and Associated Medical Devices. E:\FR\FM\28MYN1.SGM 28MYN1 28866 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices (5) Create a process for and collaborate in the evaluation of competing claims for Drug Products, Drug Substances, and Associated Medical Devices from End-Users. (6) Prepare a general strategy to accomplish the activities listed in V(A)(2)(7) below regarding activities in Exigent Circumstances consistent with the decisions made by the Chairperson. (7) In Exigent Circumstances, with review and concurrence in all possible instances by DOJ in consultation with FTC: • Facilitate maximum availability of Drug Products, Drug Substances, and Associated Medical Devices to the nation or particular geographies by deconflicting overlapping demands from the collective Participants’ customer base, as directed and decided by the Chairperson. • Facilitate maximum availability of Drug Products, Drug Substances, and Associated Medical Devices to the nation or particular geographies by deconflicting overlapping supply chain demands placed upon Members, as directed and decided by the Chairperson. • Facilitate the efficient distribution of Drug Products, Drug Substances, and Associated Medical Devices by deconflicting overlapping distribution chain activities of Members, as directed and decided by the Chairperson. • Create a process for and collaborate in the Allocation of Drug Products, Drug Substances, and Associated Medical Devices nationwide or in particular geographies consistent with the decisions made by the Chairperson. • Create a process for and collaborate in meeting any other exigent requirements throughout the nation or particular geographies consistent with the overall strategy prepared by this Sub-Committee. • Create a process for and collaborate in establishing expanded domestic Drug Product, Drug Substance, and Associated Medical Device manufacturing and fill-finish capacities. (8) Provide data and information necessary to validate the efforts of the Sub-Committee including the actual and planned amounts of Drug Products, Drug Substances, and Associated Medical Devices to be distributed throughout the Nation, as determined by the Chairperson. (9) Provide feedback to the SubCommittee on the outcomes of the collective efforts of the Sub-Committee Members and any impediments or bottlenecks. (10) Advise the Chairperson whether additional Participants or Attendees VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 should be invited to join this Plan and Sub-Committee. (11) Carry out other activities regarding Drug Products, Drug Substances, and Associated Medical Devices as identified by SubCommittees under this Plan as determined and directed by the Chairperson necessary to address the COVID–19 virus’ direct threat to the national defense, where such activities have been reviewed and approved by DOJ and FTC and received concurrence from Sub-Committee members. D. Information Management and Responsibilities FEMA will request only that data and information from Sub-Committee Participants that is necessary to meet the objectives of the Plan and consistent with the scope of the relevant SubCommittees. Upon signing a Plan of Action Agreement for this Plan, FEMA requests that Participants endeavor to cooperate with diligence and speed, and to the extent permissible under this Plan, and share with FEMA data and information necessary to meet the objectives of this Plan. Sub-Committee Participants agree to share with FEMA the following data with diligence and speed, to the extent permissible under this Plan, and abide by the following guidelines, where feasible and consistent with the data that is owned by each Sub-Committee Participant: (1) In general, Participants will not be asked to share Competitively Sensitive Information directly with other Participants. (2) FEMA will only request direct sharing of Competitively Sensitive Information among Participants during Exigent Circumstances where there is a mission critical need or timeline such that sharing only through FEMA is impractical or threatens the outcome of the Plan or Sub-Committee action. Such requests, if made, will be only among Participants whose participation is necessary to meet the objectives of the Plan, will be limited in scope to the greatest extent possible, and will be shared only pursuant to safeguards subject to prior review and audit by DOJ and FTC. Direct sharing of Competitively Sensitive Information with other Participants will be limited in scope and circumstances to the greatest extent possible. Participants may not share Competitively Sensitive Information directly with other Participants unless specifically requested by FEMA, in consultation with DOJ and FTC. All Competitively Sensitive Information delivered to FEMA or to another Sub-Committee PO 00000 Frm 00120 Fmt 4703 Sfmt 4703 Participant shall be delivered by secure means, for example, password-protected or encrypted electronic files or drives with the password/key delivered by separate communication or method or via upload to an appropriately secure web portal as directed by FEMA. All data delivered to the web portal designated by FEMA is deemed to be Competitively Sensitive Information. (3) To allow FEMA to identify and appropriately protect documents containing Competitively Sensitive Information by the Sub-Committee Participant providing the documents, the Sub-Committee Participant will make good faith efforts to designate any Competitively Sensitive Information by placing restrictive markings on documents and things considered to be competitively sensitive, the restrictive markings being sufficiently clear in wording and visibility to indicate the restricted nature of the data. The SubCommittee Participant will identify Competitively Sensitive Information that is disclosed verbally by oral warning. Information designated as competitively sensitive will, to the extent allowed by law, be presumed to constitute confidential or privileged commercial or financial information, and be provided by the Sub-Committee Participant to FEMA with the expectation that it will be kept confidential by both parties, as such terms are understood in accordance with 5 U.S.C. 552(b)(4) of the Freedom of Information Act and federal judicial interpretations of this statute. FEMA agrees that to the extent any information designated as competitively sensitive by a Sub-Committee Participant is responsive to a request for disclosure under the Freedom of Information Act, FEMA will consult with the SubCommittee Participant and afford the Participant ten (10) working days to object to any disclosure by FEMA. (4) FEMA will make good faith efforts to appropriately recognize unmarked Documents containing Competitively Sensitive Information as Competitively Sensitive Information. However, FEMA cannot guarantee that all unmarked Documents will be recognized as being Competitively Sensitive Information and protected from disclosure to third parties. If the unmarked Documents have not been disclosed without restriction outside of FEMA, the SubCommittee Participant may retroactively request to have appropriate designations placed on the Documents. If the unmarked Documents have been disclosed without restriction outside of FEMA, FEMA will, to the extent practicable, remove any requested information from public forums E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices controlled by FEMA and will work promptly to request that a receiving party return or destroy disclosed unmarked Documents if requested by the Sub-Committee Participant. (5) Competitively Sensitive Information may be used by FEMA, alone or in combination with additional information, including Documents and Competitively Sensitive Information received from third parties, to support FEMA’s implementation of this Plan as determined by the Chairperson. In all situations, FEMA will aggregate and anonymize Competitively Sensitive Information to the greatest extent possible to protect the interests retained by the owners of the data while still allowing the objectives of the Plan and Sub-Committee to be achieved. To the greatest extent possible, such aggregation will render the competitively sensitive nature of the Competitively Sensitive Information of the Sub-Committee Participant no longer recognizable in a commercially sensitive manner, and without sufficient information to enable, by inference or otherwise, attribution to Sub-Committee Participant or its affiliates (as clearly identified and disclosed to FEMA). Any disclosure of Competitively Sensitive Information by FEMA, within or outside a Sub-Committee, will be subject to review and approval by DOJ and FTC. (6) Except as otherwise expressly permitted by applicable federal law, FEMA shall not disclose any Competitively Sensitive Information or use any Competitively Sensitive Information for any purpose other than in connection with the purposes of this Plan, and FEMA will not sell any Competitively Sensitive Information of any Sub-Committee Participant. (7) Except as described below, FEMA may disclose Competitively Sensitive Information only to its employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors). Any individual with access to Competitively Sensitive Information will be expected to comply with the terms of this Plan. a. Information Sharing within the Sub-Committee: FEMA may share Competitively Sensitive Information with Sub-Committee Participants and Federal Representatives of the Plan, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) where there is a need to know and where disclosure is reasonably necessary in furtherance of implementing the Plan. FEMA will aggregate and anonymize data prior to VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 sharing with the Sub-Committee Participants to the greatest extent possible while still allowing the objectives of the Plan to be achieved, and will not share data—particularly to competitors of the submitter—prior to consultation with and approval by the DOJ and FTC. i. Sub-Committee Participants, when providing Competitively Sensitive Information to FEMA, may request that this Information not be shared with other Sub-Committee Participants. Where these requests are made in good faith and are reasonable in nature, FEMA will respect these requests to the greatest extent possible and will consult the owner of the data prior to any release made to Sub-Committee Participants. b. Restricted Reports. FEMA may communicate Competitively Sensitive Information to appropriate government officials through Restricted Reports. The information contained in Restricted Reports shall be aggregated and anonymized to the greatest extent possible, while recognizing that these officials may need a certain amount of granularity and specificity of information to appropriately respond to COVID–19. FEMA will aim to aggregate data to the County level, and will not share Restricted Reports prior to consultation and approval from the DOJ and FTC. FEMA may disclose Restricted Reports to relevant White House and Administration officials and State Governors, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) who have a need to know and to whom such disclosure is reasonably necessary solely in furtherance of the implementation of this Plan. FEMA shall take appropriate action (by instructions, agreement, or otherwise) to ensure that receiving parties comply with all data-sharing confidentiality and obligations under this Plan as if such persons or entities had been parties to this Plan. c. Public Reports. FEMA may share information with the public through Public Reports. Data contained in Public Reports shall be fully aggregated and anonymized. Public Reports shall be aggregated to at least a state level and may be publicly disclosed after consultation and approval from the DOJ and FTC. (8) Where possible and not obviated by Exigent Circumstances, FEMA will notify Sub-Committee Participants prior to the release of any Competitively Sensitive Information that has not been fully aggregated and anonymized. In PO 00000 Frm 00121 Fmt 4703 Sfmt 4703 28867 consultation with DOJ and FTC, FEMA will consider any good-faith requests made by Sub-Committee members to hold the release of data or requests for further aggregation or anonymization. In general, FEMA will not provide notification prior to the release of Public Reports, under the presumption that the data in these reports has already been fully anonymized and de-identified. (9) Any party receiving Competitively Sensitive Information through this Plan shall use such information solely for the purposes outlined in the Plan and take steps, such as imposing previously approved firewalls or tracking usage, to prevent misuse of the information. Disclosure and use of Competitively Sensitive Information will be limited to the greatest extent possible, and any party receiving Competitively Sensitive Information shall follow the procedures outlined in paragraph 7 above. (10) At the conclusion of a Participant’s involvement in a Plan— due to the deactivation of the Plan or due to the Participant’s withdrawal or removal—each Participant will be requested to sequester any and all Competitively Sensitive Information received through participation in the Plan. This sequestration shall include the deletion of all Competitively Sensitive Information unless required to be kept pursuant to the Record Keeping requirements as described supra, Section I, 44 CFR part 332, or any other provision of law. E. Oversight Each Sub-Committee Chairperson is responsible for ensuring that the Attorney General, or suitable delegate(s) from the DOJ, and the FTC Chair, or suitable delegate(s) from the FTC, have awareness of activities under this Plan, including activation, deactivation, and scheduling of meetings. The Attorney General, the FTC Chair, or their delegates may attend Sub-Committee meetings and request to be apprised of any activities taken in accordance with activities under this Plan. DOJ or FTC Representatives may request and review any proposed action by the SubCommittee or Sub-Committee Participants undertaken pursuant to this Plan, including the provision of data. If any DOJ or FTC Representative believes any actions proposed or taken are not consistent with relevant antitrust protections provided by the DPA, he or she shall provide warning and guidance to the Sub-Committee as soon as the potential issue is identified. If questions arise about the antitrust protections applicable to any particular action, FEMA may request DOJ, in consultation with the FTC, provide an opinion on the E:\FR\FM\28MYN1.SGM 28MYN1 28868 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices legality of the action under relevant DPA antitrust protections. XIV. Establishment of the SubCommittees This Plan establishes Sub-Committees to implement the Plan 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 to provide the Federal Government and the Participants a forum to maximize the manufacture and efficient distribution of selected types of Drug Products, Drug Substances, and Associated Medical Devices and to create a prioritization protocol based upon identified types of Drug Product, Drug Substance, and Associated Medical Device End-Users and their demonstrated or projected requirements, and demonstrated or projected geographic and regional areas of need. The outcome should include a framework to expeditiously meet any Drug Product, Drug Substance, and Associated Medical Device needs in Exigent Circumstances anywhere in the Nation, and to ensure that actions to support Drug Product, Drug Substance, and Associated Medical Device stockpiling and reserves do not interfere with immediate requirements that would result in an unacceptable risk to healthcare providers or other potential Drug Product, Drug Substance, and Associated Medical Device recipients. A Sub-Committee Chairperson designated by the Chairperson will convene and preside over each Sub-Committee. SubCommittees will not be used for contract negotiations or contract discussions between the Participants and the Federal Government; such negotiations or discussions will be in accordance with applicable federal contracting policies and procedures. However, this shall not limit any discussion within a Sub-Committee about the operational utilization of existing and potential contracts between the Participants and Representatives when seeking to align their use with overall manufacturing and distribution efforts consistent with this Plan. Each Sub-Committee will consist of designated Representatives from FEMA, HHS, other federal agencies with equities in this Plan, and each SubCommittee Participant. The Attorney General and Chair of the FTC, or their delegates, may also join each SubCommittee and attend meetings at their discretion. Attendees may also be invited at the discretion of a SubCommittee Chairperson as subject matter experts, to provide technical advice, or to represent other government VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 agencies, but will not be considered part of the Sub-Committee. To the extent necessary to respond to the Pandemic, only at the explicit direction of a Sub-Committee Chairperson, and subject to the provisions of Section V(B), SubCommittee Members may be asked to provide technical advice, share information, help identify and validate places and resources of the greatest need, help project future manufacturing and distribution demands, assist in identifying and resolving the allocation of scarce resources amongst all necessary public and private sector domestic needs under Exigent Circumstances, and take any other necessary actions to maximize the timely manufacture and distribution of Drug Products, Drug Substances, and Associated Medical Devices as determined necessary by FEMA to respond to the Pandemic. A SubCommittee Chairperson or his or her designee, at the Sub-Committee Chairperson’s sole discretion, will make decisions on these issues in order to ensure the maximum efficiency and effectiveness in the use of SubCommittee Member’s resources. All Sub-Committee Participants will be invited to open Sub-Committee meetings. For selected Sub-Committee meetings, attendance may be limited to designated Sub-Committee Participants to meet specific operational requirements, as determined by FEMA. Each Sub-Committee Chairperson shall notify the Attorney General, the Chair of the FTC, Representatives, and Participants of the time, place, and nature of each meeting and of the proposed agenda of each meeting to be held to carry out this Plan. Additionally, each Sub-Committee Chairperson shall provide for publication in the Federal Register of a notice of the time, place, and nature of each meeting. If a meeting is open, a Federal Register notice will be published reasonably in advance of the meeting. A Sub-Committee Chairman may restrict attendance at meetings only on the grounds outlined by 44 CFR 332.5(c)(1)–(3). If a meeting is closed, a Federal Register notice will be published within ten (10) days of the meeting and will include the reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2). The Sub-Committee Chairperson shall establish the agenda for each meeting, be responsible for adherence to the agenda, and provide for a written summary or other record of each meeting and provide copies of transcripts or other records to FEMA, the Attorney General, the Chair of the FTC, and all Sub-Committee PO 00000 Frm 00122 Fmt 4703 Sfmt 4703 Participants. The Chairperson shall take necessary actions to protect from public disclosure any data discussed with or obtained from Sub-Committee Participants which a Sub-Committee Participant has identified as a trade secret or as privileged and confidential in accordance with DPA sections 708(h)(3) and 705(d), or which qualifies for withholding under 44 CFR 332.5. XV. Application and Agreement The Sub-Committee Participant identified below hereby agrees to join in the Federal Emergency Management Agency sponsored Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Drug Products, Drug Substances, and Associated Medical Devices under the Voluntary Agreement for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a Pandemic and to become a Participant in one or more SubCommittees established by this Plan. This Plan will be published in the Federal Register. This Plan is authorized under section 708 of the Defense Production Act of 1950, as amended. Regulations governing the Voluntary Agreement for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a Pandemic and all subsequent Plans of Action at 44 CFR part 332. The applicant, as a SubCommittee Participant, agrees to comply with the provisions of section 708 of the Defense Production Act of 1950, as amended, the regulations at 44 CFR part 332, and the terms of this Plan. XVI. Assignment No Sub-Committee Participant may assign or transfer this Plan, in whole or in part, or any protections, rights or obligations hereunder without the prior written consent of the Sub-Committee Chairperson. When requested, the SubCommittee Chairperson will respond to written requests for consent within 10 (ten) business days of receipt. lllllllllllllllllllll (Company name) lllllllllllllllllllll (Name of authorized representative) lllllllllllllllllllll (Signature of authorized representative) lllllllllllllllllllll (Date) lllllllllllllllllllll Administrator (Sponsor) lllllllllllllllllllll (Date) E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices Text of the Plan of Action To Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices To Respond to COVID–19 Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a Pandemic Plan of Action To Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices To Respond to COVID–19 Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a Pandemic Preface Pursuant to section 708 of the Defense Production Act of 1950 (DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management Agency (FEMA) Administrator (Administrator), after consultation with the Secretary of the Department of Health and Human Services (HHS), the Attorney General of the United States (Attorney General), and the Chair of the Federal Trade Commission (FTC), developed a Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic (Voluntary Agreement), 85 FR 50035 (August 17, 2020). The Voluntary Agreement, which operates through a series of Plans of Action, maximizes the manufacture and efficient distribution of Critical Healthcare Resources nationwide to respond to a pandemic by establishing unity of effort between Participants and the Federal Government for integrated coordination, planning, information sharing with FEMA, as authorized by FEMA, and allocation and distribution of Critical Healthcare Resources. This document establishes a Plan of Action (Plan) to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices to Respond to COVID–19. This Plan will be implemented under the Voluntary Agreement by several SubCommittees. (1) Sub-Committee to Define COVID– 19 Medical Device Requirements, (2) Sub-Committee for General Hospital Devices, (3) Sub-Committee for Immunology Devices, (4) Sub-Committee for Microbiology Devices, (5) Sub-Committee for Pathology Devices, and (6) Sub-Committee for Toxicology Devices. The Sub-Committee to Define COVID– 19 Medical Device Requirements will be formed first. FEMA may establish additional SubCommittees under this Plan, so long as: (1) The Sub-Committee addresses one specific and well-defined category of Medical Device; and 28869 (2) The Sub-Committee is recommended by the Sub-Committee to Define COVID–19 Medical Device Requirements. The purpose of the Plan and the SubCommittees is to maximize the manufacture and efficient distribution of selected types of Medical Devices and create a prioritization protocol for EndUsers based upon their demonstrated or projected requirements including geographic and regional circumstances. The primary goal of the Plan is to create 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. When the requirements of the Plan are met, it affords Sub-Committee Participants defenses to civil and criminal actions brought under the antitrust laws (or any similar law of any state) for actions taken within the scope of the Plan. The Plan is designed to foster a close working relationship among FEMA, HHS, and Sub-Committee Participants to address national defense needs through cooperative action under the direction and active supervision of FEMA. Table of Contents I. Purpose .......................................................................................................................................................................................................................................... II. Authorities ................................................................................................................................................................................................................................... III. General Provisions ..................................................................................................................................................................................................................... A. Definitions ............................................................................................................................................................................................................................ B. Plan of Action Participation ................................................................................................................................................................................................ C. Effective Date and Duration of Participation ...................................................................................................................................................................... D. Withdrawal ........................................................................................................................................................................................................................... E. Plan of Action Activation and Deactivation ....................................................................................................................................................................... F. Rules and Regulations .......................................................................................................................................................................................................... G. Modification and Amendment ............................................................................................................................................................................................ H. Expenses ............................................................................................................................................................................................................................... I. Record Keeping ...................................................................................................................................................................................................................... IV. Antitrust Defense ....................................................................................................................................................................................................................... V. Terms and Conditions ................................................................................................................................................................................................................. A. Plan of Action Execution .................................................................................................................................................................................................... B. Information Management and Responsibilities .................................................................................................................................................................. C. Oversight ............................................................................................................................................................................................................................... VI. Establishment of the Sub-Committees ...................................................................................................................................................................................... VII. Application and Agreement ..................................................................................................................................................................................................... VIII. Assignment ............................................................................................................................................................................................................................... XVII. Purpose A pandemic may present conditions that pose a direct threat to the national defense of the United States or its preparedness programs such that, pursuant to DPA section 708(c)(1), an agreement to collectively coordinate, plan, and collaborate for the manufacture and distribution of Medical Devices is necessary for the national defense. This Plan of Action to Establish VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices to Respond to COVID–19 is established under the Voluntary Agreement and establishes six SubCommittees to oversee and implement the Plan. The Plan and Sub-Committees will optimize the manufacture and the efficient distribution of selected types of Medical Devices and create a prioritization protocol for End-Users PO 00000 Frm 00123 Fmt 4703 Sfmt 4703 421 421 421 421 425 426 426 427 427 428 428 428 429 429 429 431 435 436 437 438 based upon their demonstrated or projected requirements. XVIII. Authorities Section 708, Defense Production Act (50 U.S.C. 4558); sections 402(2) & 501(b), Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121–5207); sections 503(b)(2)(B) & 504(a)(10) & (16) of the Homeland Security Act of 2002 (6 U.S.C. 313(b)(2)(B), 314(a)(10) & (16)); sections E:\FR\FM\28MYN1.SGM 28MYN1 28870 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 201, 301, National Emergencies Act (50 U.S.C. 1601 et seq.); section 319, Public Health Service Act (42 U.S.C. 247d); Executive Order (E.O.) 13911, 85 FR 18403 (March 27, 2020); Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 85 FR 20195 (April 10, 2020). Pursuant to DPA section 708(f)(1)(A), the Administrator certifies that this Plan is necessary for the national defense. XIX. General Provisions S. Definitions Administrator The FEMA Administrator is the Sponsor of the Voluntary Agreement. Pursuant to a delegation or redelegation of the functions given to the President by DPA section 708, the Administrator proposes and provides for the development and carrying out of the Voluntary Agreement, including through the development and implementation of Plans of Action. The Administrator is responsible for carrying out all duties and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and for appointing one or more Chairpersons to manage and administer the Committee and all Sub-Committees formed to carry out the Voluntary Agreement. Agreement The Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic (Voluntary Agreement). Allocation The process of determining and directing the relative distribution among one or more competing requests from End-Users for the same Medical Devices. Through the Allocation process, FEMA—with participation from Sub-Committee Participants—will assess the actual needs of End-Users and determine how to divide the available and projected supply of Medical Devices to minimize impacts to life, safety, and economic disruption associated with shortages of Medical Devices. Allocation will take place only under Exigent Circumstances. FEMA retains decision-making authority for all Allocation under this Plan. Attendees Subject matter experts, invited by the Chairperson or a Sub-Committee Chairperson to attend meetings authorized under the Voluntary Agreement or this Plan, to provide technical advice or to represent other VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 government agencies or interested parties. Invitations to attendees will be extended as required for Committee or Sub-Committee meetings and deliberations. Chairperson FEMA senior executive(s), appointed by the Administrator, to chair the Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic (Committee). The Chairperson shall be responsible for the overall management and administration of the Committee, the Voluntary Agreement, and Plans of Action developed under the Voluntary Agreement while remaining under the supervision of the Administrator; shall initiate, or approve in advance, each meeting held to discuss problems, determine policies, recommend actions, and make decisions necessary to carry out the Voluntary Agreement; appoint one or more co-Chairpersons to chair the Committee, and otherwise shall carry out all duties and responsibilities assigned to him. With the approval of the Administrator, the Chairperson may create one or more Sub-Committees, and may appoint one or more SubCommittee Chairpersons to chair the Sub-Committees, as appropriate. Committee Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic established under the Voluntary Agreement. Competitively Sensitive Information Competitively Sensitive Information that is shared pursuant to this Plan may include any Document or other tangible thing or oral transmission that contains financial, business, commercial, scientific, technical, economic, or engineering information or data, including, but not limited to • financial statements and data, • customer and supplier lists, • price and other terms of sale to customers, • sales records, projections and forecasts, • inventory levels, • capacity and capacity utilization, • cost information, • sourcing and procurement information, • manufacturing and production information, • delivery and shipping information, • systems and data designs, and • methods, techniques, processes, procedures, programs, codes, or similar information, whether tangible or intangible, and regardless of the method of storage, PO 00000 Frm 00124 Fmt 4703 Sfmt 4703 compilation, or recordation, if the owner thereof has taken reasonable measures to protect the information from disclosure to the public or competitors. These measures may be evidenced by marking or labeling the items as ‘‘competitively sensitive information’’ during submission to FEMA or in the Participant’s customary and existing treatment of such information (regardless of labeling). All Competitively Sensitive Information provided by a SubCommittee Participant as described herein is deemed Competitively Sensitive Information, except for Information that: a. Is published or has been made publicly available at the time of disclosure by the Sub-Committee Participant; b. was in the possession of, or was lawfully and readily available to, FEMA from another source at the time of disclosure without breaching any obligation of confidentiality applicable to the other source; or c. was independently developed or acquired without reference to or reliance upon the Sub-Committee Participant’s Competitively Sensitive Information; Where information deemed Competitively Sensitive Information is required to be disclosed by law, regulation, or court order, the ‘‘Competitively Sensitive’’ (or substantially similar) label will continue to attach to all information and portion(s) of documents that are not made public through the required disclosure. Document Any information, on paper or in electronic/audio/visual format, including written, recorded, and graphic materials of every kind, in the possession, custody, or control of the Participant and used or shared in the course of participation in the Voluntary Agreement or a subsequent Plan of Action. End-User This includes all direct and ancillary medical support including, but not limited to, hospitals, independent healthcare providers, nursing homes, medical laboratories, dental care providers, independent physician offices, first responders, alternate care facilities and the general public that reasonably represents the totality of the nation’s response to COVID–19. ‘‘EndUser’’ may also include essential workers necessary to maintain or restore critical infrastructure operations, including but not limited to law E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices enforcement, education, food and agriculture, energy, water and wastewater, and public works personnel. Exigent Circumstances As determined by the Chairperson, the actual or forecasted shortage of a particular type or types of Medical Devices which likely cannot be fulfilled via usual market mechanisms for an acute, critical time period, and where immediate and substantial harm is projected to occur from lack of intervention. General Hospital Devices Refers to general hospital and personal use devices intended for human use that are in commercial distribution, as classified and described in 21 CFR 880. Immunology Devices Refers to immunology devices intended for human use that are in commercial distribution, as classified and described in 21 CFR 866. Medical Device Defined under Section 201(h) of the Food, Drug and Cosmetic Act (21 U.S.C. 321) as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1. Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term ‘‘device’’ does not include software functions excluded pursuant to section 520(o) of the Food, Drug and Cosmetic Act. Microbiology Devices Refers to microbiology devices intended for human use that are in commercial distribution, as classified and described in 21 CFR 866. VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 Pandemic A Pandemic is defined as an epidemic that has spread to human populations across a large geographic area that is subject to one or more declarations under the National Emergencies Act, the Public Health Service Act, or the Robert T. Stafford Disaster Relief and Emergency Assistance Act, or if the Administrator determines that one or more declarations is likely to occur and the epidemic poses a direct threat to the national defense or its preparedness programs. For example, Coronavirus Disease 2019 (COVID–19). Participant An individual, partnership, corporation, association, or private organization, other than a federal agency, that has substantive capabilities, resources or expertise to carry out the purpose of the Voluntary Agreement, that has been specifically invited to participate in the Voluntary Agreement by the Chairperson, and that has applied and agreed to the terms of the Voluntary Agreement. ‘‘Participant’’ includes a corporate or non-corporate entity entering into the Voluntary Agreement and all subsidiaries and affiliates of that entity in which that entity has 50 percent or more control either by stock ownership, board majority, or otherwise. The Administrator may invite Participants to join the Voluntary Agreement at any time during its effective period. Pathology Devices Refers to pathology devices intended for human use that are in commercial distribution, as classified and described in 21 CFR 864. Plan of Action (Plan) This document. A documented method, pursuant to 50 U.S.C. 4558(b)(2), proposed by FEMA to implement a particular set of activities under the Voluntary Agreement, through a Sub-Committee focused on a particular Critical Healthcare Resource, or pandemic response workstream or functional area necessary for the national defense. Plan of Action Agreement A separate commitment made by Participants upon invitation and agreement to participate in a Plan of Action as part of one or more SubCommittees. Completing the Plan of Action Agreement confers responsibilities on the Participant consistent with those articulated in the Plan of Action and affords Participants a defense against antitrust claims under section 708 for actions taken to develop PO 00000 Frm 00125 Fmt 4703 Sfmt 4703 28871 or carry out the Plan and the appropriate Sub-Committee(s), as described in Section IV below. Representatives The representatives the Administrator identifies and invites to the Committee from FEMA, HHS, and other federal agencies with equities in this Plan, and empowered to speak on behalf of their agencies’ interests. The Attorney General and the Chair of the FTC, or their delegates, may also attend any meeting as a Representative. Sub-Committee A body formed by the Administrator from select Participants to implement a Plan of Action. Sub-Committee Chairperson FEMA executive, appointed by the Chairperson, to chair a Sub-Committee to implement a Plan of Action. The SubCommittee Chairperson shall be responsible for the overall management and administration of the SubCommittee in furtherance of this Plan while remaining under the supervision of the Administrator and the Chairperson. Sub-Committee Members Collectively the Sub-Committee Chairperson(s), Representatives, and Sub-Committee Participants. Jointly responsible developing and executing this Plan. Sub-Committee Participant A subset of Participants of the Committee, that have been specifically invited to participate in a SubCommittee by the Sub-Committee Chairperson, and that have applied and agreed to the terms of this Plan and signed the Plan of Action Agreement. The Sub-Committee Chairperson may invite Participants in the Committee to join a Sub-Committee as a SubCommittee Participant at any time during the Plan’s effective period. Toxicology Devices Refers to clinical toxicology devices intended for human use that are in commercial distribution, as classified and described in 21 CFR 862. T. Plan of Action Participation This Plan will be carried out by a subset of Participants in the Voluntary Agreement through several SubCommittees: (1) Sub-Committee to Define COVID– 19 Medical Device Requirements, (2) Sub-Committee for General Hospital Devices, (3) Sub-Committee for Immunology Devices, E:\FR\FM\28MYN1.SGM 28MYN1 28872 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices (4) Sub-Committee for Microbiology Devices, (5) Sub-Committee for Pathology Devices, and (6) Sub-Committee for Toxicology Devices The Sub-Committee to Define COVID– 19 Medical Device Requirements will be formed first. FEMA may establish additional SubCommittees under this Plan, so long as: (1) The Sub-Committee addresses one specific and well-defined category of Medical Device; and (2) The Sub-Committee is recommended by the Sub-Committee to Define COVID–19 Medical Device Requirements. Each Sub-Committee will consist of the (1) Sub-Committee Chairperson(s), (2) Representatives from FEMA, HHS, the Department of Justice (DOJ), and other federal agencies with equities in this Plan, and (3) Sub-Committee Participants that have substantive capabilities, resources or expertise to carry out the purpose of this Plan and have signed the Plan of Action Agreement. The Chairperson shall invite Sub-Committee Participants who, in his or her determination, are reasonably representative of the appropriate industry or segment of such industry. Other Attendees—invited by the SubCommittee Chairperson as subject matter experts to provide technical advice or to represent the interests of other government agencies or interested parties—may also participate in SubCommittee meetings. The naming of these Sub-Committees does not commit the Administrator to creating them unless and until circumstances dictate. U. Effective Date and Duration of Participation This Plan is effective immediately upon satisfaction of the requirements of DPA section 708(f)(1). This Plan shall remain in effect until terminated in accordance with 44 CFR 332.4. It shall be effective for no more than five (5) years from August 17, 2020, when the requirements of DPA section 708(f)(1) were satisfied for the Voluntary Agreement, unless otherwise terminated pursuant to DPA section 708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 708(f)(2). No action may take place under this Plan until it is activated, as described in Section III(E), below. V. Withdrawal Participation in the Plan is voluntary, as is the acceptance of most obligations under the Plan. Sub-Committee Participants may withdraw from this Plan or from an individual Sub- VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 Committee at any point, subject to the fulfillment of obligations previously agreed upon by the Participant prior to the date of withdrawal. Note that the obligations outlined in V.B regarding information management and associated responsibilities apply once a party has shared or received information through a Sub-Committee, and remain in place after the party’s withdrawal from the Sub-Committee or Plan. If a SubCommittee Participant indicates an intent to withdraw from the Plan due to a modification or amendment of the Plan (described below), the SubCommittee Participant will not be required to perform actions directed by that modification or amendment. Withdrawal from the Plan will automatically trigger withdrawal from all Sub-Committees; however, a Participant may withdraw from a SubCommittee without also withdrawing from the Plan or other Sub-Committees. To withdraw from the Plan or from an individual Sub-Committee, a Participant must provide written notice to the Administrator at least fifteen (15) calendar days prior to the effective date of that Sub-Committee Participant’s withdrawal specifying the scope of withdrawal. Following receipt of such notice, the Administrator will inform the other Sub-Committee Participants of the date and the scope of the withdrawal. Upon the effective date of the withdrawal from the Plan, the SubCommittee Participant must cease all activities under the Plan. Upon the effective date of the withdrawal from one or more Sub-Committee(s), the SubCommittee Participant must cease all activities under the Plan that pertain to the withdrawn Sub-Committee(s). W. Plan of Action Activation and Deactivation The Administrator, in consultation with the Chairperson and SubCommittee Chairperson, will invite a select group of Participants in the Voluntary Agreement to form the following Sub-Committees, beginning with the Sub-Committee to Define COVID–19 Medical Device Requirements, which will be responsible for implementing this Plan. (1) Sub-Committee to Define COVID– 19 Medical Device Requirements, (2) Sub-Committee for General Hospital Devices, (3) Sub-Committee for Immunology Devices, (4) Sub-Committee for Microbiology Devices, (5) Sub-Committee for Pathology Devices, and PO 00000 Frm 00126 Fmt 4703 Sfmt 4703 (6) Sub-Committee for Toxicology Devices FEMA may establish additional SubCommittees under this Plan, so long as: (1) The Sub-Committee addresses one specific and well-defined category of Medical Device; and (2) The Sub-Committee is recommended by the Sub-Committee to Define COVID–19 Medical Device Requirements. This Plan will be activated for each invited Participant when the Participant executes a Plan of Action Agreement, and a Participant may not participate in a Sub-Committee until the Plan of Action Agreement is executed. Participants will be invited to join this Plan at the discretion of the Chairperson or the Sponsor to the Voluntary Agreement. Participants will be further invited to attend specific meetings of one or more Sub-Committees at the discretion of the Chairperson. X. Rules and Regulations Sub-Committee Participants acknowledge and agree to comply with all provisions of DPA section 708, as amended, and regulations related thereto which are promulgated by FEMA, the Department of Homeland Security, HHS, the Attorney General, and the FTC. FEMA has promulgated standards and procedures pertaining to voluntary agreements in 44 CFR part 332. The Administrator shall inform Participants of new rules and regulations as they are issued. Y. Modification and Amendment The Administrator, after consultation with the Attorney General and the Chair of the FTC, may terminate or modify, in writing, this Plan at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may terminate or modify, in writing, this Plan at any time. Sub-Committee Participants may propose modifications or amendments to the Plan or to the Sub-Committees at any time. Where possible, material modifications to the Plan or a SubCommittee will be subject to a 30 calendar day delayed implementation and opportunity for notice and comment by Sub-Committee Participants to the Chairperson. This delayed implementation period may be shortened or eliminated if the Administrator deems it necessary. The Administrator shall inform SubCommittee Participants of modifications or amendments to the Plan or to the Sub-Committees as they are proposed and issued. E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices The Administrator, after consultation with the Attorney General and the Chair of the FTC, may remove Sub-Committee Participants from the Plan or from a Sub-Committee at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may remove SubCommittee Participants from this Plan or from a Sub-Committee at any time. If a Participant is removed from the Plan or from a Sub-Committee, the Participant may request written notice of the reasons for removal from the Chairperson, who shall provide such notice in a reasonable time period. Z. Expenses Participation in this Plan or in a SubCommittee does not confer funds to Sub-Committee Participants, nor does it limit or prohibit any pre-existing source of funds. Unless otherwise specified, all expenses, administrative or otherwise, incurred by Sub-Committee Participants associated with participation in this Plan or a Sub-Committee shall be borne exclusively by the Sub-Committee Participants. AA. Record Keeping Each Sub-Committee Chairperson shall have primary responsibility for maintaining records in accordance with 44 CFR part 332 and shall be the official custodian of records related to carrying out this Plan. Each Sub-Committee Participant shall maintain for five years all minutes of meetings, transcripts, records, documents, and other data, including any communications with other Sub-Committee Participants or with any other member of the SubCommittee, including drafts, related to the carrying out of this Plan or incorporating data or information received in the course of carrying out this Plan. Each Sub-Committee Participant agrees to produce to the Administrator, the Attorney General, and the Chair of the FTC upon request any item that this section requires the Participant to maintain. Any record maintained in accordance with 44 CFR part 332 shall be available for public inspection and copying, unless exempted on the grounds specified in 5 U.S.C. 552(b)(1), (3) or (4) or identified as privileged and confidential information in accordance with DPA section 705(d), and 44 CFR 332.5. XX. Antitrust Defense Under the provisions of DPA subsection 708(j), each Sub-Committee Participant in this Plan shall have available as a defense to any civil or criminal action brought for violation of the antitrust laws (or any similar law of VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 any State) with respect to any action to develop or carry out this Plan, that such action was taken by the Sub-Committee Participant in the course of developing or carrying out this Plan, that the SubCommittee Participant complied with the provisions of DPA section 708 and the rules promulgated thereunder, and that the Sub-Committee Participant acted in accordance with the terms of the Voluntary Agreement and this Plan. Except in the case of actions taken to develop this Plan, this defense shall be available only to the extent the SubCommittee Participant asserting the defense demonstrates that the action was specified in, or was within the scope of, this Plan and within the scope of the appropriate Sub-Committee(s), including being taken at the direction and under the active supervision of FEMA. This defense shall not apply to any actions taken after the termination of this Plan. Immediately upon modification of this Plan, no defense to antitrust claims under Section 708 shall be available to any subsequent action that is beyond the scope of the modified Plan. The Sub-Committee Participant asserting the defense bears the burden of proof to establish the elements of the defense. The defense shall not be available if the person against whom the defense is asserted shows that the action was taken for the purpose of violating the antitrust laws. XXI. Terms and Conditions As the sponsoring agency, FEMA will maintain oversight over Sub-Committee activities and direct and supervise actions taken to carry out this Plan, including by retaining decision-making authority over actions taken pursuant to the Plan to ensure such actions are necessary to address a direct threat to the national defense. The Attorney General and the Chair of the FTC will monitor activities of the SubCommittees to ensure they execute their responsibilities in a manner consistent with this Plan and their actions have the least anticompetitive effects possible. A. Plan of Action Execution This Plan will be used to support the following objectives to respond to a Pandemic by maximizing the manufacture and efficient distribution of selected types of Medical Devices and creating a prioritization protocol for End-Users based upon their demonstrated or projected requirements and taking into account geographic and regional circumstances. Each SubCommittee will undertake the following Objectives for the Medical Devices within its area of jurisdiction. PO 00000 Frm 00127 Fmt 4703 Sfmt 4703 28873 1. Objectives (1) Optimize the timely production of sufficient quantities of Medical Devices to reduce loss of life and transmission of the COVID–19 virus. (2) Ensure Medical Devices are distributed effectively across the whole community nationally based on risk. (3) Balance restoration and maintenance of the nation’s stockpile of Medical Devices with near-term requirements. (4) Establish a process for FEMA Allocation of Medical Devices nationwide. (5) Ensure ongoing competition in the manufacture and distribution of Medical Devices to the greatest extent possible under the DPA. 2. Actions Sub-Committee Participants may be asked to support these objectives by taking the following specific actions: (1) Assist the Chairperson in identifying which types of Medical Devices should be included within each Sub-Committee. Identification will be based upon each item’s importance to the national response to COVID–19 and whether it can be reasonably inferred, based upon the best evidence available, that that current and projected supply measured against current and projected demand may not adequately meet the Medical Device requirements to all identified End-Users or regional or geographic areas of the country as result of measures taken to respond to COVID– 19. (2) Provide input to the Chairperson in creating a prioritized list of Medical Device End-Users by categories for each type of Medical Device identified by each Sub-Committee and ascertaining the relative demand and supply of Medical Devices among and within those End-User categories. Prioritization shall be decided by the Chairperson, based upon each item’s importance, reflecting the consensus views of the Sub-Committee Members that it represents the most effective way to save lives and prevent the transmission of the COVID–19 virus. This list may be updated throughout the life of the Plan based upon either short term or longterm demands. These categories should be considered holistically in terms of the Whole-of-Nation response to COVID–19. (3) Evaluate the domestic supply of Medical Devices and identify when the expansion of the domestic manufacture of Medical Devices may be necessary, as directed and decided by the Chairperson. (4) Provide information, assist, and validate, as necessary as decided by the E:\FR\FM\28MYN1.SGM 28MYN1 28874 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices Chairperson, demand projections for Medical Devices. (5) Create a process for and collaborate in the evaluation of competing claims for Medical Devices from End-Users. (6) Prepare a general strategy to accomplish the activities listed in V(A)(2)(7) below regarding activities in Exigent Circumstances consistent with the decisions made by the Chairperson. (7) In Exigent Circumstances, with review and concurrence in all possible instances by DOJ in consultation with FTC: • Facilitate maximum availability of Medical Devices to the nation or particular geographies by deconflicting overlapping demands from the collective Participants’ customer base, as directed and decided by the Chairperson. • Facilitate maximum availability of Medical Devices to the nation or particular geographies by deconflicting overlapping supply chain demands placed upon Members, as directed and decided by the Chairperson. • Facilitate the efficient distribution of Medical Devices by deconflicting overlapping distribution chain activities of Members, as directed and decided by the Chairperson. • Create a process for and collaborate in the Allocation of Medical Devices nationwide or in particular geographies consistent with the decisions made by the Chairperson. • Create a process for and collaborate in meeting any other exigent requirements throughout the nation or particular geographies consistent with the overall strategy prepared by this Sub-Committee. (8) Provide data and information necessary to validate the efforts of the Sub-Committee including the actual and planned amounts of Medical Devices to be distributed throughout the Nation, as determined by the Chairperson. (9) Provide feedback to the SubCommittee on the outcomes of the collective efforts of the Sub-Committee Members and any impediments or bottlenecks. (10) Advise the Chairperson whether additional Participants or Attendees should be invited to join this Plan and Sub-Committee. (11) Carry out other activities regarding Medical Devices as identified by Sub-Committees under this Plan as determined and directed by the Chairperson necessary to address the COVID–19 virus’ direct threat to the national defense, where such activities have been reviewed and approved by DOJ and FTC and received concurrence from Sub-Committee members. VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 F. Information Management and Responsibilities FEMA will request only that data and information from Sub-Committee Participants that is necessary to meet the objectives of the Plan and consistent with the scope of the relevant SubCommittees. Upon signing a Plan of Action Agreement for this Plan, FEMA requests that Participants endeavor to cooperate with diligence and speed, and to the extent permissible under this Plan, and share with FEMA data and information necessary to meet the objectives of this Plan. Sub-Committee Participants agree to share with FEMA the following data with diligence and speed, to the extent permissible under this Plan, and abide by the following guidelines, where feasible and consistent with the data that is owned by each Sub-Committee Participant: (1) In general, Participants will not be asked to share Competitively Sensitive Information directly with other Participants. (2) FEMA will only request direct sharing of Competitively Sensitive Information among Participants during Exigent Circumstances where there is a mission critical need or timeline such that sharing only through FEMA is impractical or threatens the outcome of the Plan or Sub-Committee action. Such requests, if made, will be only among Participants whose participation is necessary to meet the objectives of the Plan, will be limited in scope to the greatest extent possible, and will be shared only pursuant to safeguards subject to prior review and audit by DOJ and FTC. Direct sharing of Competitively Sensitive Information with other Participants will be limited in scope and circumstances to the greatest extent possible. Participants may not share Competitively Sensitive Information directly with other Participants unless specifically requested by FEMA, in consultation with DOJ and FTC. All Competitively Sensitive Information delivered to FEMA or to another Sub-Committee Participant shall be delivered by secure means, for example, password-protected or encrypted electronic files or drives with the password/key delivered by separate communication or method or via upload to an appropriately secure web portal as directed by FEMA. All data delivered to the web portal designated by FEMA is deemed to be Competitively Sensitive Information. (3) To allow FEMA to identify and appropriately protect documents containing Competitively Sensitive Information by the Sub-Committee PO 00000 Frm 00128 Fmt 4703 Sfmt 4703 Participant providing the documents, the Sub-Committee Participant will make good faith efforts to designate any Competitively Sensitive Information by placing restrictive markings on documents and things considered to be competitively sensitive, the restrictive markings being sufficiently clear in wording and visibility to indicate the restricted nature of the data. The SubCommittee Participant will identify Competitively Sensitive Information that is disclosed verbally by oral warning. Information designated as competitively sensitive will, to the extent allowed by law, be presumed to constitute confidential or privileged commercial or financial information, and be provided by the Sub-Committee Participant to FEMA with the expectation that it will be kept confidential by both parties, as such terms are understood in accordance with 5 U.S.C. 552(b)(4) of the Freedom of Information Act and federal judicial interpretations of this statute. FEMA agrees that to the extent any information designated as competitively sensitive by a Sub-Committee Participant is responsive to a request for disclosure under the Freedom of Information Act, FEMA will consult with the SubCommittee Participant and afford the Participant ten (10) working days to object to any disclosure by FEMA. (4) FEMA will make good faith efforts to appropriately recognize unmarked Documents containing Competitively Sensitive Information as Competitively Sensitive Information. However, FEMA cannot guarantee that all unmarked Documents will be recognized as being Competitively Sensitive Information and protected from disclosure to third parties. If the unmarked Documents have not been disclosed without restriction outside of FEMA, the SubCommittee Participant may retroactively request to have appropriate designations placed on the Documents. If the unmarked Documents have been disclosed without restriction outside of FEMA, FEMA will, to the extent practicable, remove any requested information from public forums controlled by FEMA and will work promptly to request that a receiving party return or destroy disclosed unmarked Documents if requested by the Sub-Committee Participant. (5) Competitively Sensitive Information may be used by FEMA, alone or in combination with additional information, including Documents and Competitively Sensitive Information received from third parties, to support FEMA’s implementation of this Plan as determined by the Chairperson. In all situations, FEMA will aggregate and E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices anonymize Competitively Sensitive Information to the greatest extent possible to protect the interests retained by the owners of the data while still allowing the objectives of the Plan and Sub-Committee to be achieved. To the greatest extent possible, such aggregation will render the competitively sensitive nature of the Competitively Sensitive Information of the Sub-Committee Participant no longer recognizable in a commercially sensitive manner, and without sufficient information to enable, by inference or otherwise, attribution to Sub-Committee Participant or its affiliates (as clearly identified and disclosed to FEMA). Any disclosure of Competitively Sensitive Information by FEMA, within or outside a Sub-Committee, will be subject to review and approval by DOJ and FTC. (6) Except as otherwise expressly permitted by applicable federal law, FEMA shall not disclose any Competitively Sensitive Information or use any Competitively Sensitive Information for any purpose other than in connection with the purposes of this Plan, and FEMA will not sell any Competitively Sensitive Information of any Sub-Committee Participant. (7) Except as described below, FEMA may disclose Competitively Sensitive Information only to its employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors). Any individual with access to Competitively Sensitive Information will be expected to comply with the terms of this Plan. a. Information Sharing within the Sub-Committee: FEMA may share Competitively Sensitive Information with Sub-Committee Participants and Federal Representatives of the Plan, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) where there is a need to know and where disclosure is reasonably necessary in furtherance of implementing the Plan. FEMA will aggregate and anonymize data prior to sharing with the Sub-Committee Participants to the greatest extent possible while still allowing the objectives of the Plan to be achieved, and will not share data—particularly to competitors of the submitter—prior to consultation with and approval by the DOJ and FTC. i. Sub-Committee Participants, when providing Competitively Sensitive Information to FEMA, may request that this Information not be shared with other Sub-Committee Participants. Where these requests are made in good VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 faith and are reasonable in nature, FEMA will respect these requests to the greatest extent possible and will consult the owner of the data prior to any release made to Sub-Committee Participants. b. Restricted Reports. FEMA may communicate Competitively Sensitive Information to appropriate government officials through Restricted Reports. The information contained in Restricted Reports shall be aggregated and anonymized to the greatest extent possible, while recognizing that these officials may need a certain amount of granularity and specificity of information to appropriately respond to COVID–19. FEMA will aim to aggregate data to the County level, and will not share Restricted Reports prior to consultation and approval from the DOJ and FTC. FEMA may disclose Restricted Reports to relevant White House and Administration officials and State Governors, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) who have a need to know and to whom such disclosure is reasonably necessary solely in furtherance of the implementation of this Plan. FEMA shall take appropriate action (by instructions, agreement, or otherwise) to ensure that receiving parties comply with all data-sharing confidentiality and obligations under this Plan as if such persons or entities had been parties to this Plan. c. Public Reports. FEMA may share information with the public through Public Reports. Data contained in Public Reports shall be fully aggregated and anonymized. Public Reports shall be aggregated to at least a state level and may be publicly disclosed after consultation and approval from the DOJ and FTC. (8) Where possible and not obviated by Exigent Circumstances, FEMA will notify Sub-Committee Participants prior to the release of any Competitively Sensitive Information that has not been fully aggregated and anonymized. In consultation with DOJ and FTC, FEMA will consider any good-faith requests made by Sub-Committee members to hold the release of data or requests for further aggregation or anonymization. In general, FEMA will not provide notification prior to the release of Public Reports, under the presumption that the data in these reports has already been fully anonymized and de-identified. (9) Any party receiving Competitively Sensitive Information through this Plan shall use such information solely for the purposes outlined in the Plan and take PO 00000 Frm 00129 Fmt 4703 Sfmt 4703 28875 steps, such as imposing previously approved firewalls or tracking usage, to prevent misuse of the information. Disclosure and use of Competitively Sensitive Information will be limited to the greatest extent possible, and any party receiving Competitively Sensitive Information shall follow the procedures outlined in paragraph 7 above. (10) At the conclusion of a Participant’s involvement in a Plan— due to the deactivation of the Plan or due to the Participant’s withdrawal or removal—each Participant will be requested to sequester any and all Competitively Sensitive Information received through participation in the Plan. This sequestration shall include the deletion of all Competitively Sensitive Information unless required to be kept pursuant to the Record Keeping requirements as described supra, Section I, 44 CFR part 332, or any other provision of law. G. Oversight Each Sub-Committee Chairperson is responsible for ensuring that the Attorney General, or suitable delegate(s) from the DOJ, and the FTC Chair, or suitable delegate(s) from the FTC, have awareness of activities under this Plan, including activation, deactivation, and scheduling of meetings. The Attorney General, the FTC Chair, or their delegates may attend Sub-Committee meetings and request to be apprised of any activities taken in accordance with activities under this Plan. DOJ or FTC Representatives may request and review any proposed action by the SubCommittee or Sub-Committee Participants undertaken pursuant to this Plan, including the provision of data. If any DOJ or FTC Representative believes any actions proposed or taken are not consistent with relevant antitrust protections provided by the DPA, he or she shall provide warning and guidance to the Sub-Committee as soon as the potential issue is identified. If questions arise about the antitrust protections applicable to any particular action, FEMA may request DOJ, in consultation with the FTC, provide an opinion on the legality of the action under relevant DPA antitrust protections. XXII. Establishment of the SubCommittees This Plan establishes Sub-Committees to implement the Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices Critical to COVID–19 Response to provide the Federal Government and the Participants a forum to maximize the manufacture and efficient distribution E:\FR\FM\28MYN1.SGM 28MYN1 28876 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices of selected types of Medical Devices and to create a prioritization protocol based upon identified types of Medical Device End-Users and their demonstrated or projected requirements, and demonstrated or projected geographic and regional areas of need. The outcome should include a framework to expeditiously meet any Medical Device needs in Exigent Circumstances 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. A SubCommittee Chairperson designated by the Chairperson will convene and preside over each Sub-Committee. SubCommittees will not be used for contract negotiations or contract discussions between the Participants and the Federal Government; such negotiations or discussions will be in accordance with applicable federal contracting policies and procedures. However, this shall not limit any discussion within a Sub-Committee about the operational utilization of existing and potential contracts between the Participants and Representatives when seeking to align their use with overall manufacturing and distribution efforts consistent with this Plan. Each Sub-Committee will consist of designated Representatives from FEMA, HHS, other federal agencies with equities in this Plan, and each SubCommittee Participant. The Attorney General and Chair of the FTC, or their delegates, may also join each SubCommittee and attend meetings at their discretion. Attendees may also be invited at the discretion of a SubCommittee Chairperson as subject matter experts, to provide technical advice, or to represent other government agencies, but will not be considered part of the Sub-Committee. To the extent necessary to respond to the Pandemic, only at the explicit direction of a Sub-Committee Chairperson, and subject to the provisions of Section V(B), SubCommittee Members may be asked to provide technical advice, share information, help identify and validate places and resources of the greatest need, help project future manufacturing and distribution demands, assist in identifying and resolving the allocation of scarce resources amongst all necessary public and private sector domestic needs under Exigent Circumstances, and take any other necessary actions to maximize the timely manufacture and distribution of Medical Devices as determined VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 necessary by FEMA to respond to the Pandemic. A Sub-Committee Chairperson or his or her designee, at the Sub-Committee Chairperson’s sole discretion, will make decisions on these issues in order to ensure the maximum efficiency and effectiveness in the use of Sub-Committee Member’s resources. All Sub-Committee Participants will be invited to open Sub-Committee meetings. For selected Sub-Committee meetings, attendance may be limited to designated Sub-Committee Participants to meet specific operational requirements, as determined by FEMA. Each Sub-Committee Chairperson shall notify the Attorney General, the Chair of the FTC, Representatives, and Participants of the time, place, and nature of each meeting and of the proposed agenda of each meeting to be held to carry out this Plan. Additionally, each Sub-Committee Chairperson shall provide for publication in the Federal Register of a notice of the time, place, and nature of each meeting. If a meeting is open, a Federal Register notice will be published reasonably in advance of the meeting. A Sub-Committee Chairman may restrict attendance at meetings only on the grounds outlined by 44 CFR 332.5(c)(1)–(3). If a meeting is closed, a Federal Register notice will be published within ten (10) days of the meeting and will include the reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2). The Sub-Committee Chairperson shall establish the agenda for each meeting, be responsible for adherence to the agenda, and provide for a written summary or other record of each meeting and provide copies of transcripts or other records to FEMA, the Attorney General, the Chair of the FTC, and all Sub-Committee Participants. The Chairperson shall take necessary actions to protect from public disclosure any data discussed with or obtained from Sub-Committee Participants which a Sub-Committee Participant has identified as a trade secret or as privileged and confidential in accordance with DPA sections 708(h)(3) and 705(d), or which qualifies for withholding under 44 CFR 332.5. XXIII. Application and Agreement The Sub-Committee Participant identified below hereby agrees to join in the Federal Emergency Management Agency sponsored Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices to Respond to COVID–19 under the Voluntary Agreement for the Manufacture and Distribution of Healthcare Resources Necessary to PO 00000 Frm 00130 Fmt 4703 Sfmt 4703 Respond to a Pandemic and to become a Participant in one or more SubCommittees established by this Plan. This Plan will be published in the Federal Register. This Plan is authorized under section 708 of the Defense Production Act of 1950, as amended. Regulations governing the Voluntary Agreement for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a Pandemic and all subsequent Plans of Action at 44 CFR part 332. The applicant, as a SubCommittee Participant, agrees to comply with the provisions of section 708 of the Defense Production Act of 1950, as amended, the regulations at 44 CFR part 332, and the terms of this Plan. XXIV. Assignment No Sub-Committee Participant may assign or transfer this Plan, in whole or in part, or any protections, rights or obligations hereunder without the prior written consent of the Sub-Committee Chairperson. When requested, the SubCommittee Chairperson will respond to written requests for consent within 10 (ten) business days of receipt. lllllllllllllllllllll (Company name) lllllllllllllllllllll (Name of authorized representative) lllllllllllllllllllll (Signature of authorized representative) lllllllllllllllllllll (Date) lllllllllllllllllllll Administrator (Sponsor) lllllllllllllllllllll (Date) Text of the Plan of Action To Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases To Respond to COVID–19 Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a Pandemic Plan of Action To Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases To Respond to COVID–19 Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a Pandemic Preface Pursuant to section 708 of the Defense Production Act of 1950 (DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management Agency (FEMA) Administrator (Administrator), after consultation with the Secretary of E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices the Department of Health and Human Services (HHS), the Attorney General of the United States (Attorney General), and the Chair of the Federal Trade Commission (FTC), developed a Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic (Voluntary Agreement), 85 FR 50035 (August 17, 2020). The Voluntary Agreement, which operates through a series of Plans of Action, maximizes the manufacture and efficient distribution of Critical Healthcare Resources nationwide to respond to a pandemic by establishing unity of effort between Participants and the Federal Government for integrated coordination, planning, information sharing with FEMA, as authorized by FEMA, and allocation and distribution of Critical Healthcare Resources. This document establishes a Plan of Action (Plan) to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases to Respond to COVID–19. This Plan will be implemented under the Voluntary Agreement by several SubCommittees. (1) Sub-Committee to Define COVID– 19 Medical Gas Requirements, (2) Sub-Committee for Oxygen, (3) Sub-Committee for Nitrous Oxide, (4) Sub-Committee for Carbon Dioxide, (5) Sub-Committee for Heliox, (6) Sub-Committee for Nitrogen (Medical Liquid Nitrogen), and (7) Sub-Committee for Medical Air. The Sub-Committee to Define COVID– 19 Medical Gas Requirements will be formed first. FEMA may establish additional SubCommittees under this Plan, so long as: (1) The Sub-Committee addresses one specific and well-defined category of Medical Gases; and (2) The Sub-Committee is recommended by the Sub-Committee to Define COVID–19 Medical Gas Requirements. The purpose of the Plan and the SubCommittees is to maximize the manufacture and efficient distribution of selected types of Medical Gases and create a prioritization protocol for EndUsers based upon their demonstrated or projected requirements including geographic and regional circumstances. The primary goal of the Plan is to create 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. When the requirements of the Plan are met, it affords SubCommittee Participants defenses to civil and criminal actions brought under the antitrust laws (or any similar law of any state) for actions taken within the scope of the Plan. The Plan is designed to foster a close working relationship among FEMA, HHS, and Sub-Committee Participants to address national defense needs through cooperative action under the direction and active supervision of FEMA. Table of Contents I. Purpose .......................................................................................................................................................................................................................................... II. Authorities ................................................................................................................................................................................................................................... III. General Provisions ..................................................................................................................................................................................................................... A. Definitions ............................................................................................................................................................................................................................ B. Plan of Action Participation ................................................................................................................................................................................................ C. Effective Date and Duration of Participation ...................................................................................................................................................................... D. Withdrawal ........................................................................................................................................................................................................................... E. Plan of Action Activation and Deactivation ....................................................................................................................................................................... F. Rules and Regulations .......................................................................................................................................................................................................... G. Modification and Amendment ............................................................................................................................................................................................ H. Expenses ............................................................................................................................................................................................................................... I. Record Keeping ...................................................................................................................................................................................................................... IV. Antitrust Defense ....................................................................................................................................................................................................................... V. Terms and Conditions ................................................................................................................................................................................................................. A. Plan of Action Execution .................................................................................................................................................................................................... B. Information Management and Responsibilities .................................................................................................................................................................. C. Oversight ............................................................................................................................................................................................................................... VI. Establishment of the Sub-Committees ...................................................................................................................................................................................... VII. Application and Agreement ..................................................................................................................................................................................................... VIII. Assignment ............................................................................................................................................................................................................................... XXV. Purpose A pandemic may present conditions that pose a direct threat to the national defense of the United States or its preparedness programs such that, pursuant to DPA section 708(c)(1), an agreement to collectively coordinate, plan, and collaborate for the manufacture and distribution of Medical Gases is necessary for the national defense. This Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases to Respond to COVID–19 is established under the Voluntary Agreement and establishes seven SubCommittees to oversee and implement the Plan. The Plan and Sub-Committees will optimize the manufacture and the efficient distribution of selected types of Medical Gases and create a VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 28877 421 421 421 421 425 426 426 427 427 428 428 428 429 429 429 431 435 436 437 438 prioritization protocol for End-Users based upon their demonstrated or projected requirements. section 708(f)(1)(A), the Administrator certifies that this Plan is necessary for the national defense. XXVI. Authorities Section 708, Defense Production Act (50 U.S.C. 4558); sections 402(2) & 501(b), Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121–5207); sections 503(b)(2)(B) & 504(a)(10) & (16) of the Homeland Security Act of 2002 (6 U.S.C. 313(b)(2)(B), 314(a)(10) & (16)); sections 201, 301, National Emergencies Act (50 U.S.C. 1601 et seq.); section 319, Public Health Service Act (42 U.S.C. 247d); Executive Order (E.O.) 13911, 85 FR 18403 (March 27, 2020); Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 85 FR 20195 (April 10, 2020). Pursuant to DPA XXVII. General Provisions PO 00000 Frm 00131 Fmt 4703 Sfmt 4703 BB. Definitions Administrator The FEMA Administrator is the Sponsor of the Voluntary Agreement. Pursuant to a delegation or redelegation of the functions given to the President by DPA section 708, the Administrator proposes and provides for the development and carrying out of the Voluntary Agreement, including through the development and implementation of Plans of Action. The Administrator is responsible for carrying out all duties and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and for E:\FR\FM\28MYN1.SGM 28MYN1 28878 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices appointing one or more Chairpersons to manage and administer the Committee and all Sub-Committees formed to carry out the Voluntary Agreement. Agreement The Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic (Voluntary Agreement). Allocation The process of determining and directing the relative distribution among one or more competing requests from End-Users for the same Medical Gases. Through the Allocation process, FEMA—with participation from SubCommittee Participants—will assess the actual needs of End-Users and determine how to divide the available and projected supply of Medical Gases to minimize impacts to life, safety, and economic disruption associated with shortages of Medical Gases. Allocation will take place only under Exigent Circumstances. FEMA retains decisionmaking authority for all Allocation under this Plan. Attendees Subject matter experts, invited by the Chairperson or a Sub-Committee Chairperson to attend meetings authorized under the Voluntary Agreement or this Plan, to provide technical advice or to represent other government agencies or interested parties. Invitations to attendees will be extended as required for Committee or Sub-Committee meetings and deliberations. Chairperson FEMA senior executive(s), appointed by the Administrator, to chair the Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic (Committee). The Chairperson shall be responsible for the overall management and administration of the Committee, the Voluntary Agreement, and Plans of Action developed under the Voluntary Agreement while remaining under the supervision of the Administrator; shall initiate, or approve in advance, each meeting held to discuss problems, determine policies, recommend actions, and make decisions necessary to carry out the Voluntary Agreement; appoint one or more co-Chairpersons to chair the Committee, and otherwise shall carry out all duties and responsibilities assigned to him. With the approval of the Administrator, the Chairperson may create one or more Sub-Committees, and may appoint one or more Sub- VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 Committee Chairpersons to chair the Sub-Committees, as appropriate. Committee Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic established under the Voluntary Agreement. Competitively Sensitive Information Competitively Sensitive Information that is shared pursuant to this Plan may include any Document or other tangible thing or oral transmission that contains financial, business, commercial, scientific, technical, economic, or engineering information or data, including, but not limited to • financial statements and data, • customer and supplier lists, • price and other terms of sale to customers, • sales records, projections and forecasts, • inventory levels, • capacity and capacity utilization, • cost information, • sourcing and procurement information, • manufacturing and production information, • delivery and shipping information, • systems and data designs, and • methods, techniques, processes, procedures, programs, codes, or similar information, whether tangible or intangible, and regardless of the method of storage, compilation, or recordation, if the owner thereof has taken reasonable measures to protect the information from disclosure to the public or competitors. These measures may be evidenced by marking or labeling the items as ‘‘competitively sensitive information’’ during submission to FEMA or in the Participant’s customary and existing treatment of such information (regardless of labeling). All Competitively Sensitive Information provided by a SubCommittee Participant as described herein is deemed Competitively Sensitive Information, except for Information that: a. Is published or has been made publicly available at the time of disclosure by the Sub-Committee Participant; b. was in the possession of, or was lawfully and readily available to, FEMA from another source at the time of disclosure without breaching any obligation of confidentiality applicable to the other source; or c. was independently developed or acquired without reference to or reliance upon the Sub-Committee PO 00000 Frm 00132 Fmt 4703 Sfmt 4703 Participant’s Competitively Sensitive Information; Where information deemed Competitively Sensitive Information is required to be disclosed by law, regulation, or court order, the ‘‘Competitively Sensitive’’ (or substantially similar) label will continue to attach to all information and portion(s) of documents that are not made public through the required disclosure. Document Any information, on paper or in electronic/audio/visual format, including written, recorded, and graphic materials of every kind, in the possession, custody, or control of the Participant and used or shared in the course of participation in the Voluntary Agreement or a subsequent Plan of Action. End-User This includes all direct and ancillary medical support including, but not limited to, hospitals, independent healthcare providers, nursing homes, medical laboratories, dental care providers, independent physician offices, first responders, alternate care facilities and the general public that reasonably represents the totality of the nation’s response to COVID–19. Exigent Circumstances As determined by the Chairperson, the actual or forecasted shortage of a particular type or types of Medical Gases which likely cannot be fulfilled via usual market mechanisms for an acute, critical time period, and where immediate and substantial harm is projected to occur from lack of intervention. Medical Gases Defined under Section 360ddd of the Food, Drug and Cosmetic Act (21 U.S.C. 360ddd) as a drug that is manufactured or stored in a liquefied, nonliquified, or cryogenic state, and administered as a gas. Medical Gases include, but are not limited to, Oxygen, Nitrogen, Nitrous oxide, Carbon dioxide, Helium, Carbon monoxide, and Medical air, so long as such gases meet the Standards established by the United States Pharmacopeia and the National Formulary (USP–NF). Pandemic A Pandemic is defined as an epidemic that has spread to human populations across a large geographic area that is subject to one or more declarations under the National Emergencies Act, the Public Health Service Act, or the Robert E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices T. Stafford Disaster Relief and Emergency Assistance Act, or if the Administrator determines that one or more declarations is likely to occur and the epidemic poses a direct threat to the national defense or its preparedness programs. For example, Coronavirus Disease 2019 (COVID–19). Participant An individual, partnership, corporation, association, or private organization, other than a federal agency, that has substantive capabilities, resources or expertise to carry out the purpose of the Voluntary Agreement, that has been specifically invited to participate in the Voluntary Agreement by the Chairperson, and that has applied and agreed to the terms of the Voluntary Agreement. ‘‘Participant’’ includes a corporate or non-corporate entity entering into the Voluntary Agreement and all subsidiaries and affiliates of that entity in which that entity has 50 percent or more control either by stock ownership, board majority, or otherwise. The Administrator may invite Participants to join the Voluntary Agreement at any time during its effective period. Plan of Action (Plan) This document. A documented method, pursuant to 50 U.S.C. 4558(b)(2), proposed by FEMA to implement a particular set of activities under the Voluntary Agreement, through a Sub-Committee focused on a particular Critical Healthcare Resource, or pandemic response workstream or functional area necessary for the national defense. Plan of Action Agreement A separate commitment made by Participants upon invitation and agreement to participate in a Plan of Action as part of one or more SubCommittees. Completing the Plan of Action Agreement confers responsibilities on the Participant consistent with those articulated in the Plan of Action and affords Participants a defense against antitrust claims under section 708 for actions taken to develop or carry out the Plan of Action and the appropriate Sub-Committee(s), as described in Section IV below. Representatives The representatives the Administrator identifies and invites to the Committee from FEMA, HHS, and other federal agencies with equities in this Plan, and empowered to speak on behalf of their agencies’ interests. The Attorney General and the Chair of the FTC, or VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 their delegates, may also attend any meeting as a Representative. Sub-Committee A body formed by the Administrator from select Participants to implement a Plan of Action. Sub-Committee Chairperson FEMA executive, appointed by the Chairperson, to chair a Sub-Committee to implement a Plan of Action. The SubCommittee Chairperson shall be responsible for the overall management and administration of the SubCommittee in furtherance of this Plan while remaining under the supervision of the Administrator and the Chairperson. Sub-Committee Members Collectively the Sub-Committee Chairperson(s), Representatives, and Sub-Committee Participants. Jointly responsible developing and executing this Plan. Sub-Committee Participant A subset of Participants of the Committee, that have been specifically invited to participate in a SubCommittee by the Sub-Committee Chairperson, and that have applied and agreed to the terms of this Plan and signed the Plan of Action Agreement. The Sub-Committee Chairperson may invite Participants in the Committee to join a Sub-Committee as a SubCommittee Participant at any time during the Plan’s effective period. CC. Plan of Action Participation This Plan will be carried out by a subset of Participants in the Voluntary Agreement through several SubCommittees: (1) Sub-Committee to Define COVID– 19 Medical Gas Requirements, (2) Sub-Committee for Oxygen, (3) Sub-Committee for Nitrous Oxide, (4) Sub-Committee for Carbon Dioxide, (5) Sub-Committee for Heliox, (6) Sub-Committee for Nitrogen (Medical Liquid Nitrogen), and (7) Sub-Committee for Medical Air. The Sub-Committee to Define COVID– 19 Medical Gas Requirements will be formed first. FEMA may establish additional Sub-Committees under this Plan, so long as: (1) The Sub-Committee addresses one specific and well-defined category of Medical Gases; and (2) The Sub-Committee is recommended by the Sub-Committee to Define COVID–19 Medical Gas Requirements. Each Sub-Committee will consist of the (1) Sub-Committee Chairperson(s), PO 00000 Frm 00133 Fmt 4703 Sfmt 4703 28879 (2) Representatives from FEMA, HHS, the Department of Justice (DOJ), and other federal agencies with equities in this Plan, and (3) Sub-Committee Participants that have substantive capabilities, resources or expertise to carry out the purpose of this Plan and have signed the Plan of Action Agreement. The Chairperson shall invite Sub-Committee Participants who, in his or her determination, are reasonably representative of the appropriate industry or segment of such industry. Other Attendees—invited by the SubCommittee Chairperson as subject matter experts to provide technical advice or to represent the interests of other government agencies or interested parties—may also participate in SubCommittee meetings. The naming of these Sub-Committees does not commit the Administrator to creating them unless and until circumstances dictate. DD. Effective Date and Duration of Participation This Plan is effective immediately upon satisfaction of the requirements of DPA section 708(f)(1). This Plan shall remain in effect until terminated in accordance with 44 CFR 332.4. It shall be effective for no more than five (5) years from August 17, 2020, when the requirements of DPA section 708(f)(1) were satisfied for the Voluntary Agreement, unless otherwise terminated pursuant to DPA section 708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 708(f)(2). No action may take place under this Plan until it is activated, as described in Section III(E), below. EE. Withdrawal Participation in the Plan is voluntary, as is the acceptance of most obligations under the Plan. Sub-Committee Participants may withdraw from this Plan or from an individual SubCommittee at any point, subject to the fulfillment of obligations previously agreed upon by the Participant prior to the date of withdrawal. Note that the obligations outlined in V.B regarding information management and associated responsibilities apply once a party has shared or received information through a Sub-Committee, and remain in place after the party’s withdrawal from the Sub-Committee or Plan. If a SubCommittee Participant indicates an intent to withdraw from the Plan due to a modification or amendment of the Plan (described below), the SubCommittee Participant will not be required to perform actions directed by that modification or amendment. Withdrawal from the Plan will automatically trigger withdrawal from E:\FR\FM\28MYN1.SGM 28MYN1 28880 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices all Sub-Committees; however, a Participant may withdraw from a SubCommittee without also withdrawing from the Plan or other Sub-Committees. To withdraw from the Plan or from an individual Sub-Committee, a Participant must provide written notice to the Administrator at least fifteen (15) calendar days prior to the effective date of that Sub-Committee Participant’s withdrawal specifying the scope of withdrawal. Following receipt of such notice, the Administrator will inform the other Sub-Committee Participants of the date and the scope of the withdrawal. Upon the effective date of the withdrawal from the Plan, the SubCommittee Participant must cease all activities under the Plan. Upon the effective date of the withdrawal from one or more Sub-Committee(s), the SubCommittee Participant must cease all activities under the Plan that pertain to the withdrawn Sub-Committee(s). FF. Plan of Action Activation and Deactivation The Administrator, in consultation with the Chairperson and SubCommittee Chairperson, will invite a select group of Participants in the Voluntary Agreement to form the following Sub-Committees, beginning with the Sub-Committee to Define COVID–19 Medical Gas Requirements, which will be responsible for implementing this Plan. (1) Sub-Committee to Define COVID– 19 Medical Gas Requirements, (2) Sub-Committee for Oxygen, (3) Sub-Committee for Nitrous Oxide, (4) Sub-Committee for Carbon Dioxide, (5) Sub-Committee for Heliox, (6) Sub-Committee for Nitrogen (Medical Liquid Nitrogen), and (7) Sub-Committee for Medical Air. FEMA may establish additional SubCommittees under this Plan, so long as: (1) The Sub-Committee addresses one specific and well-defined category of Medical Gases; and (2) The Sub-Committee is recommended by the Sub-Committee to Define COVID–19 Medical Gas Requirements. This Plan will be activated for each invited Participant when the Participant executes a Plan of Action Agreement, and a Participant may not participate in a Sub-Committee until the Plan of Action Agreement is executed. Participants will be invited to join this Plan at the discretion of the Chairperson or the Sponsor to the Voluntary Agreement. Participants will be further invited to attend specific meetings of VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 one or more Sub-Committees at the discretion of the Chairperson. GG. Rules and Regulations Sub-Committee Participants acknowledge and agree to comply with all provisions of DPA section 708, as amended, and regulations related thereto which are promulgated by FEMA, the Department of Homeland Security, HHS, the Attorney General, and the FTC. FEMA has promulgated standards and procedures pertaining to voluntary agreements in 44 CFR part 332. The Administrator shall inform Participants of new rules and regulations as they are issued. HH. Modification and Amendment The Administrator, after consultation with the Attorney General and the Chair of the FTC, may terminate or modify, in writing, this Plan at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may terminate or modify, in writing, this Plan at any time. Sub-Committee Participants may propose modifications or amendments to the Plan or to the Sub-Committees at any time. Where possible, material modifications to the Plan or a SubCommittee will be subject to a 30 calendar day delayed implementation and opportunity for notice and comment by Sub-Committee Participants to the Chairperson. This delayed implementation period may be shortened or eliminated if the Administrator deems it necessary. The Administrator shall inform SubCommittee Participants of modifications or amendments to the Plan or to the Sub-Committees as they are proposed and issued. The Administrator, after consultation with the Attorney General and the Chair of the FTC, may remove Sub-Committee Participants from the Plan or from a Sub-Committee at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may remove SubCommittee Participants from this Plan or from a Sub-Committee at any time. If a Participant is removed from the Plan or from a Sub-Committee, the Participant may request written notice of the reasons for removal from the Chairperson, who shall provide such notice in a reasonable time period. II. Expenses Participation in this Plan or in a SubCommittee does not confer funds to Sub-Committee Participants, nor does it limit or prohibit any pre-existing source of funds. Unless otherwise specified, all PO 00000 Frm 00134 Fmt 4703 Sfmt 4703 expenses, administrative or otherwise, incurred by Sub-Committee Participants associated with participation in this Plan or a Sub-Committee shall be borne exclusively by the Sub-Committee Participants. JJ. Record Keeping Each Sub-Committee Chairperson shall have primary responsibility for maintaining records in accordance with 44 CFR part 332 and shall be the official custodian of records related to carrying out this Plan. Each Sub-Committee Participant shall maintain for five years all minutes of meetings, transcripts, records, documents, and other data, including any communications with other Sub-Committee Participants or with any other member of the SubCommittee, including drafts, related to the carrying out of this Plan or incorporating data or information received in the course of carrying out this Plan. Each Sub-Committee Participant agrees to produce to the Administrator, the Attorney General, and the Chair of the FTC upon request any item that this section requires the Participant to maintain. Any record maintained in accordance with 44 CFR part 332 shall be available for public inspection and copying, unless exempted on the grounds specified in 5 U.S.C. 552(b)(1), (3) or (4) or identified as privileged and confidential information in accordance with DPA section 705(d), and 44 CFR 332.5. XXVIII. Antitrust Defense Under the provisions of DPA subsection 708(j), each Sub-Committee Participant in this Plan shall have available as a defense to any civil or criminal action brought for violation of the antitrust laws (or any similar law of any State) with respect to any action to develop or carry out this Plan, that such action was taken by the Sub-Committee Participant in the course of developing or carrying out this Plan, that the SubCommittee Participant complied with the provisions of DPA section 708 and the rules promulgated thereunder, and that the Sub-Committee Participant acted in accordance with the terms of the Voluntary Agreement and this Plan. Except in the case of actions taken to develop this Plan, this defense shall be available only to the extent the SubCommittee Participant asserting the defense demonstrates that the action was specified in, or was within the scope of, this Plan and within the scope of the appropriate Sub-Committee(s), including being taken at the direction and under the active supervision of FEMA. E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices This defense shall not apply to any actions taken after the termination of this Plan. Immediately upon modification of this Plan, no defense to antitrust claims under Section 708 shall be available to any subsequent action that is beyond the scope of the modified Plan. The Sub-Committee Participant asserting the defense bears the burden of proof to establish the elements of the defense. The defense shall not be available if the person against whom the defense is asserted shows that the action was taken for the purpose of violating the antitrust laws. XXIX. Terms and Conditions As the sponsoring agency, FEMA will maintain oversight over Sub-Committee activities and direct and supervise actions taken to carry out this Plan, including by retaining decision-making authority over actions taken pursuant to the Plan to ensure such actions are necessary to address a direct threat to the national defense. The Attorney General and the Chair of the FTC will monitor activities of the SubCommittees to ensure they execute their responsibilities in a manner consistent with this Plan and their actions have the least anticompetitive effects possible. A. Plan of Action Execution This Plan will be used to support the following objectives to respond to a Pandemic by maximizing the manufacture and efficient distribution of selected types of Medical Gases and creating a prioritization protocol for End-Users based upon their demonstrated or projected requirements and taking into account geographic and regional circumstances. Each SubCommittee will undertake the following Objectives for the Medical Gases within its area of jurisdiction. 1. Objectives (1) Optimize the timely production of sufficient quantities of Medical Gases to reduce loss of life from the COVID–19 virus. (2) Ensure Medical Gases are distributed effectively across the whole community nationally based on risk. (3) Balance restoration and maintenance of the nation’s stockpile of Medical Gases with near-term requirements. (4) Establish a process for FEMA Allocation of Medical Gases nationwide. (5) Ensure ongoing competition in the manufacture and distribution of Medical Gases to the greatest extent possible under the DPA. VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 2. Actions Sub-Committee Participants may be asked to support these objectives by taking the following specific actions: (1) Assist the Chairperson in scoping each Sub-Committee and prioritizing among Sub-Committees based on each Medical Gas’ importance to the national response to COVID–19 and whether it can be reasonably inferred, based upon the best evidence available, that the current and projected supply measured against current and projected demand may not adequately meet the Medical Gas requirements to all identified EndUsers or regional or geographic areas of the country as result of measures taken to respond to COVID–19. (2) Provide input to the Chairperson in creating a prioritized list of Medical Gas End-Users by categories for each type of Medical Gases identified by each Sub-Committee and ascertaining the relative demand and supply of Medical Gases among and within those End User categories. Prioritization shall be decided by the Chairperson, based upon each item’s importance, reflecting the consensus views of the Sub-Committee Members that it represents the most effective way to save lives in responding to the COVID–19 pandemic. This list may be updated throughout the life of the Plan based upon either short term or long-term demands. These categories should be considered holistically in terms of the Whole-of-Nation response to COVID–19. (3) Evaluate the domestic supply of Medical Gases and identify when the expansion of the domestic manufacture of Medical Gases may be necessary, as directed and decided by the Chairperson. (4) Provide information, assist, and validate, as necessary as decided by the Chairperson, demand projections for Medical Gases. (5) Create a process for and collaborate in the evaluation of competing claims for Medical Gases from End-Users. (6) Prepare a general strategy to accomplish the activities listed in V(A)(2)(7) below regarding activities in Exigent Circumstances consistent with the decisions made by the Chairperson. (7) In Exigent Circumstances, with review and concurrence in all possible instances by DOJ in consultation with FTC: • Facilitate maximum availability of Medical Gases to the nation or particular geographies by deconflicting overlapping demands from the collective Participants’ customer base, as directed and decided by the Chairperson. PO 00000 Frm 00135 Fmt 4703 Sfmt 4703 28881 • Facilitate maximum availability of Medical Gases to the nation or particular geographies by deconflicting overlapping supply chain demands placed upon Members, as directed and decided by the Chairperson. • Facilitate the efficient distribution of Medical Gases by deconflicting overlapping distribution chain activities of Members, as directed and decided by the Chairperson. • Create a process for and collaborate in the Allocation of Medical Gases nationwide or in particular geographies consistent with the decisions made by the Chairperson. • Create a process for and collaborate in meeting any other exigent requirements throughout the nation or particular geographies consistent with the overall strategy prepared by this Sub-Committee. (8) Provide data and information necessary to validate the efforts of the Sub-Committee including the actual and planned amounts of Medical Gases to be distributed throughout the Nation, as determined by the Chairperson. (9) Provide feedback to the SubCommittee on the outcomes of the collective efforts of the Sub-Committee Members and any impediments or bottlenecks. (10) Advise the Chairperson whether additional Participants or Attendees should be invited to join this Plan and Sub-Committee. (11) Carry out other activities regarding Medical Gases as identified by Sub-Committees under this Plan as determined and directed by the Chairperson necessary to address the COVID–19 virus’ direct threat to the national defense, where such activities have been reviewed and approved by DOJ and FTC and received concurrence from Sub-Committee members. H. Information Management and Responsibilities FEMA will request only that data and information from Sub-Committee Participants that is necessary to meet the objectives of the Plan and consistent with the scope of the relevant SubCommittees. Upon signing a Plan of Action Agreement for this Plan, FEMA requests that Participants endeavor to cooperate with diligence and speed, and to the extent permissible under this Plan, and share with FEMA data and information necessary to meet the objectives of this Plan. Sub-Committee Participants agree to share with FEMA the following data with diligence and speed, to the extent permissible under this Plan, and abide by the following guidelines, where feasible and consistent with the data E:\FR\FM\28MYN1.SGM 28MYN1 28882 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices that is owned by each Sub-Committee Participant: (1) In general, Participants will not be asked to share Competitively Sensitive Information directly with other Participants. (2) FEMA will only request direct sharing of Competitively Sensitive Information among Participants during Exigent Circumstances where there is a mission critical need or timeline such that sharing only through FEMA is impractical or threatens the outcome of the Plan or Sub-Committee action. Such requests, if made, will be only among Participants whose participation is necessary to meet the objectives of the Plan, will be limited in scope to the greatest extent possible, and will be shared only pursuant to safeguards subject to prior review and audit by DOJ and FTC. Direct sharing of Competitively Sensitive Information with other Participants will be limited in scope and circumstances to the greatest extent possible. Participants may not share Competitively Sensitive Information directly with other Participants unless specifically requested by FEMA, in consultation with DOJ and FTC. All Competitively Sensitive Information delivered to FEMA or to another Sub-Committee Participant shall be delivered by secure means, for example, password-protected or encrypted electronic files or drives with the password/key delivered by separate communication or method or via upload to an appropriately secure web portal as directed by FEMA. All data delivered to the web portal designated by FEMA is deemed to be Competitively Sensitive Information. (3) To allow FEMA to identify and appropriately protect documents containing Competitively Sensitive Information by the Sub-Committee Participant providing the documents, the Sub-Committee Participant will make good faith efforts to designate any Competitively Sensitive Information by placing restrictive markings on documents and things considered to be competitively sensitive, the restrictive markings being sufficiently clear in wording and visibility to indicate the restricted nature of the data. The SubCommittee Participant will identify Competitively Sensitive Information that is disclosed verbally by oral warning. Information designated as competitively sensitive will, to the extent allowed by law, be presumed to constitute confidential or privileged commercial or financial information, and be provided by the Sub-Committee Participant to FEMA with the expectation that it will be kept confidential by both parties, as such VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 terms are understood in accordance with 5 U.S.C. 552(b)(4) of the Freedom of Information Act and federal judicial interpretations of this statute. FEMA agrees that to the extent any information designated as competitively sensitive by a Sub-Committee Participant is responsive to a request for disclosure under the Freedom of Information Act, FEMA will consult with the SubCommittee Participant and afford the Participant ten (10) working days to object to any disclosure by FEMA. (4) FEMA will make good faith efforts to appropriately recognize unmarked Documents containing Competitively Sensitive Information as Competitively Sensitive Information. However, FEMA cannot guarantee that all unmarked Documents will be recognized as being Competitively Sensitive Information and protected from disclosure to third parties. If the unmarked Documents have not been disclosed without restriction outside of FEMA, the SubCommittee Participant may retroactively request to have appropriate designations placed on the Documents. If the unmarked Documents have been disclosed without restriction outside of FEMA, FEMA will, to the extent practicable, remove any requested information from public forums controlled by FEMA and will work promptly to request that a receiving party return or destroy disclosed unmarked Documents if requested by the Sub-Committee Participant. (5) Competitively Sensitive Information may be used by FEMA, alone or in combination with additional information, including Documents and Competitively Sensitive Information received from third parties, to support FEMA’s implementation of this Plan as determined by the Chairperson. In all situations, FEMA will aggregate and anonymize Competitively Sensitive Information to the greatest extent possible to protect the interests retained by the owners of the data while still allowing the objectives of the Plan and Sub-Committee to be achieved. To the greatest extent possible, such aggregation will render the competitively sensitive nature of the Competitively Sensitive Information of the Sub-Committee Participant no longer recognizable in a commercially sensitive manner, and without sufficient information to enable, by inference or otherwise, attribution to Sub-Committee Participant or its affiliates (as clearly identified and disclosed to FEMA). Any disclosure of Competitively Sensitive Information by FEMA, within or outside a Sub-Committee, will be subject to review and approval by DOJ and FTC. PO 00000 Frm 00136 Fmt 4703 Sfmt 4703 (6) Except as otherwise expressly permitted by applicable federal law, FEMA shall not disclose any Competitively Sensitive Information or use any Competitively Sensitive Information for any purpose other than in connection with the purposes of this Plan, and FEMA will not sell any Competitively Sensitive Information of any Sub-Committee Participant. (7) Except as described below, FEMA may disclose Competitively Sensitive Information only to its employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors). Any individual with access to Competitively Sensitive Information will be expected to comply with the terms of this Plan. a. Information Sharing within the Sub-Committee: FEMA may share Competitively Sensitive Information with Sub-Committee Participants and Federal Representatives of the Plan, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) where there is a need to know and where disclosure is reasonably necessary in furtherance of implementing the Plan. FEMA will aggregate and anonymize data prior to sharing with the Sub-Committee Participants to the greatest extent possible while still allowing the objectives of the Plan to be achieved, and will not share data—particularly to competitors of the submitter—prior to consultation with and approval by the DOJ and FTC. i. Sub-Committee Participants, when providing Competitively Sensitive Information to FEMA, may request that this Information not be shared with other Sub-Committee Participants. Where these requests are made in good faith and are reasonable in nature, FEMA will respect these requests to the greatest extent possible and will consult the owner of the data prior to any release made to Sub-Committee Participants. b. Restricted Reports. FEMA may communicate Competitively Sensitive Information to appropriate government officials through Restricted Reports. The information contained in Restricted Reports shall be aggregated and anonymized to the greatest extent possible, while recognizing that these officials may need a certain amount of granularity and specificity of information to appropriately respond to COVID–19. FEMA will aim to aggregate data to the County level, and will not share Restricted Reports prior to consultation and approval from the DOJ E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices and FTC. FEMA may disclose Restricted Reports to relevant White House and Administration officials and State Governors, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) who have a need to know and to whom such disclosure is reasonably necessary solely in furtherance of the implementation of this Plan. FEMA shall take appropriate action (by instructions, agreement, or otherwise) to ensure that receiving parties comply with all data-sharing confidentiality and obligations under this Plan as if such persons or entities had been parties to this Plan. c. Public Reports. FEMA may share information with the public through Public Reports. Data contained in Public Reports shall be fully aggregated and anonymized. Public Reports shall be aggregated to at least a state level and may be publicly disclosed after consultation and approval from the DOJ and FTC. (8) Where possible and not obviated by Exigent Circumstances, FEMA will notify Sub-Committee Participants prior to the release of any Competitively Sensitive Information that has not been fully aggregated and anonymized. In consultation with DOJ and FTC, FEMA will consider any good-faith requests made by Sub-Committee members to hold the release of data or requests for further aggregation or anonymization. In general, FEMA will not provide notification prior to the release of Public Reports, under the presumption that the data in these reports has already been fully anonymized and de-identified. (9) Any party receiving Competitively Sensitive Information through this Plan shall use such information solely for the purposes outlined in the Plan and take steps, such as imposing previously approved firewalls or tracking usage, to prevent misuse of the information. Disclosure and use of Competitively Sensitive Information will be limited to the greatest extent possible, and any party receiving Competitively Sensitive Information shall follow the procedures outlined in paragraph 7 above. (10) At the conclusion of a Participant’s involvement in a Plan— due to the deactivation of the Plan or due to the Participant’s withdrawal or removal—each Participant will be requested to sequester any and all Competitively Sensitive Information received through participation in the Plan. This sequestration shall include the deletion of all Competitively Sensitive Information unless required to be kept pursuant to the Record Keeping VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 requirements as described supra, Section I, 44 CFR part 332, or any other provision of law. I. Oversight Each Sub-Committee Chairperson is responsible for ensuring that the Attorney General, or suitable delegate(s) from the DOJ, and the FTC Chair, or suitable delegate(s) from the FTC, have awareness of activities under this Plan, including activation, deactivation, and scheduling of meetings. The Attorney General, the FTC Chair, or their delegates may attend Sub-Committee meetings and request to be apprised of any activities taken in accordance with activities under this Plan. DOJ or FTC Representatives may request and review any proposed action by the SubCommittee or Sub-Committee Participants undertaken pursuant to this Plan, including the provision of data. If any DOJ or FTC Representative believes any actions proposed or taken are not consistent with relevant antitrust protections provided by the DPA, he or she shall provide warning and guidance to the Sub-Committee as soon as the potential issue is identified. If questions arise about the antitrust protections applicable to any particular action, FEMA may request DOJ, in consultation with the FTC, provide an opinion on the legality of the action under relevant DPA antitrust protections. XXX. Establishment of the SubCommittees This Plan establishes Sub-Committees to implement the Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases to Respond to COVID–19 to provide the Federal Government and the Participants a forum to maximize the manufacture and efficient distribution of selected types of Medical Gases and to create a prioritization protocol based upon identified types of Medical Gas End-Users and their demonstrated or projected requirements, and demonstrated or projected geographic and regional areas of need. The outcome should include a framework to expeditiously meet any Medical Gas needs in Exigent Circumstances 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. A SubCommittee Chairperson designated by the Chairperson will convene and preside over each Sub-Committee. SubCommittees will not be used for contract PO 00000 Frm 00137 Fmt 4703 Sfmt 4703 28883 negotiations or contract discussions between the Participants and the Federal Government; such negotiations or discussions will be in accordance with applicable federal contracting policies and procedures. However, this shall not limit any discussion within a Sub-Committee about the operational utilization of existing and potential contracts between the Participants and Representatives when seeking to align their use with overall manufacturing and distribution efforts consistent with this Plan. Each Sub-Committee will consist of designated Representatives from FEMA, HHS, other federal agencies with equities in this Plan, and each SubCommittee Participant. The Attorney General and Chair of the FTC, or their delegates, may also join each SubCommittee and attend meetings at their discretion. Attendees may also be invited at the discretion of a SubCommittee Chairperson as subject matter experts, to provide technical advice, or to represent other government agencies, but will not be considered part of the Sub-Committee. To the extent necessary to respond to the Pandemic, only at the explicit direction of a Sub-Committee Chairperson, and subject to the provisions of Section V(B), SubCommittee Members may be asked to provide technical advice, share information, help identify and validate places and resources of the greatest need, help project future manufacturing and distribution demands, assist in identifying and resolving the allocation of scarce resources amongst all necessary public and private sector domestic needs under Exigent Circumstances, and take any other necessary actions to maximize the timely manufacture and distribution of Medical Gases as determined necessary by FEMA to respond to the Pandemic. A Sub-Committee Chairperson or his or her designee, at the Sub-Committee Chairperson’s sole discretion, will make decisions on these issues in order to ensure the maximum efficiency and effectiveness in the use of SubCommittee Member’s resources. All Sub-Committee Participants will be invited to open Sub-Committee meetings. For selected Sub-Committee meetings, attendance may be limited to designated Sub-Committee Participants to meet specific operational requirements, as determined by FEMA. Each Sub-Committee Chairperson shall notify the Attorney General, the Chair of the FTC, Representatives, and Participants of the time, place, and nature of each meeting and of the proposed agenda of each meeting to be E:\FR\FM\28MYN1.SGM 28MYN1 28884 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices held to carry out this Plan. Additionally, each Sub-Committee Chairperson shall provide for publication in the Federal Register of a notice of the time, place, and nature of each meeting. If a meeting is open, a Federal Register notice will be published reasonably in advance of the meeting. A Sub-Committee Chairman may restrict attendance at meetings only on the grounds outlined by 44 CFR 332.5(c)(1)–(3). If a meeting is closed, a Federal Register notice will be published within ten (10) days of the meeting and will include the reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2). The Sub-Committee Chairperson shall establish the agenda for each meeting, be responsible for adherence to the agenda, and provide for a written summary or other record of each meeting and provide copies of transcripts or other records to FEMA, the Attorney General, the Chair of the FTC, and all Sub-Committee Participants. The Chairperson shall take necessary actions to protect from public disclosure any data discussed with or obtained from Sub-Committee Participants which a Sub-Committee Participant has identified as a trade secret or as privileged and confidential in accordance with DPA sections 708(h)(3) and 705(d), or which qualifies for withholding under 44 CFR 332.5. XXXI. Application and Agreement The Sub-Committee Participant identified below hereby agrees to join in the Federal Emergency Management Agency sponsored Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases to Respond to COVID–19 under the Voluntary Agreement for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a Pandemic and to become a Participant in one or more SubCommittees established by this Plan. This Plan will be published in the Federal Register. This Plan is authorized under section 708 of the Defense Production Act of 1950, as amended. Regulations governing the Voluntary Agreement for the Manufacture and Distribution for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a Pandemic and all subsequent Plans of Action at 44 CFR part 332. The applicant, as a SubCommittee Participant, agrees to comply with the provisions of section 708 of the Defense Production Act of 1950, as amended, the regulations at 44 CFR part 332, and the terms of this Plan. VerDate Sep<11>2014 17:28 May 27, 2021 Jkt 253001 XXXII. Assignment No Sub-Committee Participant may assign or transfer this Plan, in whole or in part, or any protections, rights or obligations hereunder without the prior written consent of the Sub-Committee Chairperson. When requested, the SubCommittee Chairperson will respond to written requests for consent within 10 (ten) business days of receipt. lllllllllllllllllllll (Company name) lllllllllllllllllllll (Name of authorized representative) lllllllllllllllllllll (Signature of authorized representative) lllllllllllllllllllll (Date) lllllllllllllllllllll Administrator (Sponsor) lllllllllllllllllllll (Date) Deanne Criswell, Administrator, Federal Emergency Management Agency. [FR Doc. 2021–11278 Filed 5–27–21; 8:45 am] BILLING CODE 9111–19–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [Docket No. FWS–R2–ES–2020–0119; FXES11130200000–212–FF02ENEH00] Endangered and Threatened Wildlife and Plants; Draft Revised Recovery Plan for Houston Toad Fish and Wildlife Service, Interior. ACTION: Notice of availability; request for comment. AGENCY: We, the U.S. Fish and Wildlife Service, announce the availability of our draft revised recovery plan for the Houston toad, listed as endangered under the Endangered Species Act. The Houston toad is a semi-aquatic species endemic to pine and oak forests within Austin, Bastrop, Burleson, Colorado, Lavaca, Lee, Leon, Milam, and Robinson Counties, Texas. We provide this notice to seek comments from the public and Federal, Tribal, State, and local governments. DATES: We must receive written comments on or before July 27, 2021. ADDRESSES: Reviewing documents: You may obtain a copy of the draft revised recovery plan in Docket No. FWS–R2– ES–2020–0119 at http:// www.regulations.gov. Submitting Comments: You may submit comments by one of the following methods: SUMMARY: PO 00000 Frm 00138 Fmt 4703 Sfmt 4703 • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments on Docket No. FWS–R2–ES–2020–0119. • U.S. mail: Public Comments Processing; Attn: Docket No. FWS–R2– ES–2020–0119; U.S. Fish and Wildlife Service Headquarters, MS: PRB/3W; 5275 Leesburg Pike, Falls Church, VA 22041–3803. For additional information about submitting comments, see Request for Public Comments and Public Availability of Comments under SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Adam Zerrenner, Field Supervisor, Austin Ecological Services Field Office, by phone at 512–490–0057, by email at adam_zerrenner@fws.gov, or via the Federal Relay Service at 800–877–8339 for TTY service. SUPPLEMENTARY INFORMATION: We, the U.S. Fish and Wildlife Service (Service), announce the availability of our draft revised recovery plan for the Houston toad (Anaxyrus houstonensis; formerly Bufo houstonensis), listed as endangered under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.). Houston toads are endemic to aquatic and terrestrial habitats within pine and oak forests in Austin, Bastrop, Burleson, Colorado, Lavaca, Lee, Leon, Milam, and Robinson Counties, Texas. The draft revised recovery plan includes site-specific management actions and objective, measurable criteria that, when met, will enable us to remove the Houston toad from the list of endangered and threatened wildlife. We request review and comment on this plan from local, State, and Federal agencies; Tribes; and the public. We will also accept any new information on the status of the Houston toad throughout its range to assist in finalizing the recovery plan. Background Recovery of endangered or threatened animals and plants to the point where they are again secure, self-sustaining members of their ecosystems is a primary goal of our endangered species program and the ESA. Recovery means improvement of the status of listed species to the point at which listing is no longer appropriate under the criteria set out in section 4(a)(1) of the ESA. The ESA requires the development of recovery plans for listed species, unless such a plan would not promote the conservation of a particular species. The Service approved the original recovery plan for the Houston toad on September 17, 1984 (Service 1984). This draft recovery plan represents the first E:\FR\FM\28MYN1.SGM 28MYN1

Agencies

[Federal Register Volume 86, Number 102 (Friday, May 28, 2021)]
[Notices]
[Pages 28851-28884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11278]


=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0016]


Pandemic Response Voluntary Agreement Under Section 708 of the 
Defense Production Act; Plans of Action To Respond to COVID-19

AGENCY: Federal Emergency Management Agency, Department of Homeland 
Security.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Federal Emergency Management Agency (FEMA) announces the 
formation of four Plans of Action under the Voluntary Agreement for the 
Manufacture and Distribution of Critical Healthcare Resources Necessary 
to Respond to a Pandemic: 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; 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; Plan 
of Action to Establish a National Strategy for the Manufacture, 
Allocation, and Distribution of Medical Devices to Respond to COVID-19; 
and Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Medical Gases to Respond 
to COVID-19. This notice contains the text of all four Plans of Action.

FOR FURTHER INFORMATION CONTACT: Robert Glenn, Office of Business, 
Industry, Infrastructure Integration, via email at [email protected] or 
via phone at (202) 212-1666.

SUPPLEMENTARY INFORMATION:

Background and Legal Authority

    The Defense Production Act (DPA), 50 U.S.C. 4501 et seq., 
authorizes the making of ``voluntary agreements and plans of action'' 
with, among others, representatives of industry and business to help 
provide for the national defense.\1\ The President's authority to 
facilitate voluntary agreements was delegated to the Secretary of 
Homeland Security with respect to responding to the spread of COVID-19 
within the United States in Executive Order 13911.\2\ The Secretary of 
Homeland Security has further delegated this authority to the FEMA 
Administrator.\3\
---------------------------------------------------------------------------

    \1\ 50 U.S.C. 4558(c)(1).
    \2\ 85 FR 18403 (Apr. 1, 2020).
    \3\ DHS Delegation 09052, Rev. 00.1 (Apr. 1, 2020); DHS 
Delegation Number 09052 Rev. 00 (Jan. 3, 2017).
---------------------------------------------------------------------------

    On August 17, 2020, after the appropriate consultations with the 
Attorney General and the Chairman of the Federal Trade Commission and 
after requesting and considering public comments, FEMA completed and 
published in the Federal Register a ``Voluntary Agreement, Manufacture 
and Distribution of Critical Healthcare Resources Necessary to Respond 
to a

[[Page 28852]]

Pandemic'' (Voluntary Agreement).\4\ Unless terminated earlier, the 
Voluntary Agreement is effective until August 17, 2025, and may be 
extended subject to additional approval by the Attorney General after 
consultation with the Chairman of the Federal Trade Commission. The 
Voluntary Agreement may be used to prepare for or respond to any 
pandemic, including COVID-19, during that time.
---------------------------------------------------------------------------

    \4\ Voluntary Agreement Under Section 708 of the Defense 
Production Act; Manufacture and Distribution of Critical Healthcare 
Resources Necessary to Respond to a Pandemic, 85 FR 50035, 50035 
(Aug. 17, 2020). The Attorney General, in consultation with the 
Chairman of the Federal Trade Commission, made the required finding 
that the purpose of the Voluntary Agreement may not reasonably be 
achieved through an agreement having less anticompetitive effects or 
without any voluntary agreement and published the finding in the 
Federal Register on the same day. 85 FR 50049 (Aug. 17, 2020).
---------------------------------------------------------------------------

    FEMA is now activating four Plans of Action under the Voluntary 
Agreement:
    (1) 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. The primary goal of 
the Plan is to create 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.
    (2) 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. The 
primary goal of the Plan is to create 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.
    (3) Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Medical Devices to Respond 
to COVID-19. The primary goal of the Plan is to create 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.
    (4) Plan of Action to Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Medical Gases to Respond 
to COVID-19. The primary purpose of this Plan is to create 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.
    Appropriate members of the private sector will be invited to join 
each Plan of Action as Sub-Committee Participants. Provided that a Sub-
Committee Participant acts in accordance with the terms of a Plan, the 
DPA affords the Participant a defense to civil and criminal action 
brought under the antitrust laws (or any similar law of any state) for 
actions taken to carry out the Plan. The Plans are designed to foster a 
close working relationship among FEMA, HHS, and Sub-Committee 
Participants to address national defense needs through cooperative 
action under the direction and active supervision of FEMA.
    The Attorney General, in consultation with the Chairman of the 
Federal Trade Commission, has made the required finding for each Plan 
of Action that the purposes of section 708(c)(1) of the DPA cannot 
reasonably be achieved without each Plan of Action, or by Plans of 
Action having less anticompetitive effects than the proposed Plans of 
Action. Pursuant to section 708(f)(1)(B) of the DPA, the Department of 
Justice separately published the findings for these Plans of Action in 
the Federal Register. The FEMA Administrator has certified in writing 
that each Plan of Action is necessary to help provide for the national 
defense.

Text of 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 Implemented Under the 
Voluntary Agreement for the Manufacture and Distribution of Critical 
Healthcare Resources Necessary To Respond to a Pandemic

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 Implemented Under the Voluntary 
Agreement for the Manufacture and Distribution of Critical Healthcare 
Resources Necessary To Respond to a Pandemic

Preface

    Pursuant to section 708 of the Defense Production Act of 1950 
(DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management 
Agency (FEMA) Administrator (Administrator), after consultation with 
the Secretary of the Department of Health and Human Services (HHS), the 
Attorney General of the United States (Attorney General), and the Chair 
of the Federal Trade Commission (FTC), developed a Voluntary Agreement 
for the Manufacture and Distribution of Critical Healthcare Resources 
Necessary to Respond to a Pandemic (Voluntary Agreement), 85 FR 50035 
(August 17, 2020). The Voluntary Agreement, which operates through a 
series of Plans of Action, maximizes the manufacture and efficient 
distribution of Critical Healthcare Resources nationwide to respond to 
a pandemic by establishing unity of effort between Participants and the 
Federal Government for integrated coordination, planning, information 
sharing with FEMA, as authorized by FEMA, and allocation and 
distribution of Critical Healthcare Resources.
    This document establishes a Plan of Action (Plan) to Establish a 
National Strategy for the Manufacture, Allocation and Distribution of 
Diagnostic Test Kits and other Testing Components to Respond to COVID-
19. This Plan will be implemented under the Voluntary Agreement by 
several Sub-Committees.
    (1) Sub-Committee to Define Requirements for COVID-19 Diagnostic 
Test Kits and other Testing Components,
    (2) Sub-Committee for Lab-Based Testing,
    (3) Sub-Committee for Point-of-Care Testing,
    (4) Sub-Committee for At-Home Testing,

[[Page 28853]]

    (5) Sub-Committee for Swabs (Nasal & Throat), and
    (6) Sub-Committee for Transfer Media and Pipette Tips.
    The Sub-Committee to Define Requirements for COVID-19 Diagnostic 
Test Kits and other Testing Components will be formed first. FEMA may 
establish additional Sub-Committees under this Plan, so long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of item needed for COVID-19 testing; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
Requirements for COVID-19 Diagnostic Test Kits and other Testing 
Components.
    The purpose of the Plan is to maximize the manufacture and 
efficient distribution of Diagnostic Test Kits and other Testing 
Components and create a prioritization protocol for End-Users based 
upon their demonstrated or projected requirements including geographic 
and regional circumstances. The primary goal of the Plan is to create 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. When 
the requirements of the Plan are met, it affords Sub-Committee 
Participants defenses to civil and criminal actions brought under the 
antitrust laws (or any similar law of any state) for actions taken 
within the scope of the Plan. The Plan is designed to foster a close 
working relationship among FEMA, HHS, and Sub-Committee Participants to 
address national defense needs through cooperative action under the 
direction and active supervision of FEMA.

Table of Contents

I. Purpose.....................................................      421
II. Authorities................................................      421
III. General Provisions........................................      421
    A. Definitions.............................................      421
    B. Plan of Action Participation............................      425
    C. Effective Date and Duration of Participation............      426
    D. Withdrawal..............................................      426
    E. Plan of Action Activation and Deactivation..............      427
    F. Rules and Regulations...................................      427
    G. Modification and Amendment..............................      428
    H. Expenses................................................      428
    I. Record Keeping..........................................      428
IV. Antitrust Defense..........................................      429
V. Terms and Conditions........................................      429
    A. Plan of Action Execution................................      429
    B. Information Management and Responsibilities.............      431
    C. Oversight...............................................      435
VI. Establishment of the Sub-Committees........................      436
VII. Application and Agreement.................................      437
VIII. Assignment...............................................      438
 

I. Purpose

    A pandemic may present conditions that pose a direct threat to the 
national defense of the United States or its preparedness programs such 
that, pursuant to DPA section 708(c)(1), an agreement to collectively 
coordinate, plan, and collaborate for the manufacture and distribution 
of Diagnostic Test Kits and other Testing Components is necessary for 
the national defense. This 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 is 
established under the Voluntary Agreement and establishes six Sub-
Committees to oversee and implement the Plan. The Plan and Sub-
Committees will optimize the manufacture and the efficient distribution 
of selected types of Diagnostic Test Kits and other Testing Components 
and create a prioritization protocol for End-Users based upon their 
demonstrated or projected requirements.

II. Authorities

    Section 708, Defense Production Act (50 U.S.C. 4558); sections 
402(2) & 501(b), Robert T. Stafford Disaster Relief and Emergency 
Assistance Act (42 U.S.C. 5121-5207); sections 503(b)(2)(B) & 
504(a)(10) & (16) of the Homeland Security Act of 2002 (6 U.S.C. 
313(b)(2)(B), 314(a)(10) & (16)); sections 201, 301, National 
Emergencies Act (50 U.S.C. 1601 et seq.); section 319, Public Health 
Service Act (42 U.S.C. 247d); Executive Order (E.O.) 13911, 85 FR 18403 
(March 27, 2020); Prioritization and Allocation of Certain Scarce or 
Threatened Health and Medical Resources for Domestic Use, 85 FR 20195 
(April 10, 2020). Pursuant to DPA section 708(f)(1)(A), the 
Administrator certifies that this Plan is necessary for the national 
defense.

III. General Provisions

A. Definitions

Administrator
    The FEMA Administrator is the Sponsor of the Voluntary Agreement. 
Pursuant to a delegation or redelegation of the functions given to the 
President by DPA section 708, the Administrator proposes and provides 
for the development and carrying out of the Voluntary Agreement, 
including through the development and implementation of Plans of 
Action. The Administrator is responsible for carrying out all duties 
and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and 
for appointing one or more Chairpersons to manage and administer the 
Committee and all Sub-Committees formed to carry out the Voluntary 
Agreement.
Agreement
    The Voluntary Agreement for the Manufacture and Distribution of 
Critical Healthcare Resources Necessary to Respond to a Pandemic 
(Voluntary Agreement).
Allocation
    The process of determining and directing the relative distribution 
among one or more competing requests from End-Users for the same 
Diagnostic Test Kits and other Testing Components. Through the 
Allocation process, FEMA--with participation from Sub-Committee 
Participants--will assess the actual needs of End-Users and determine 
how to divide the available and projected supply of Diagnostic Test 
Kits and other Testing Components to minimize impacts to life, safety, 
and economic disruption associated with shortages of Diagnostic Test 
Kits and other Testing Components. Allocation will take place only 
under Exigent

[[Page 28854]]

Circumstances. FEMA retains decision-making authority for all 
Allocation under this Plan.
Attendees
    Subject matter experts, invited by the Chairperson or a Sub-
Committee Chairperson to attend meetings authorized under the Voluntary 
Agreement or this Plan, to provide technical advice or to represent 
other government agencies or interested parties. Invitations to 
attendees will be extended as required for Committee or Sub-Committee 
meetings and deliberations.
Chairperson
    FEMA senior executive(s), appointed by the Administrator, to chair 
the Committee for the Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic (Committee). The Chairperson shall be responsible 
for the overall management and administration of the Committee, the 
Voluntary Agreement, and Plans of Action developed under the Voluntary 
Agreement while remaining under the supervision of the Administrator; 
shall initiate, or approve in advance, each meeting held to discuss 
problems, determine policies, recommend actions, and make decisions 
necessary to carry out the Voluntary Agreement; appoint one or more co-
Chairpersons to chair the Committee, and otherwise shall carry out all 
duties and responsibilities assigned to him. With the approval of the 
Administrator, the Chairperson may create one or more Sub-Committees, 
and may appoint one or more Sub-Committee Chairpersons to chair the 
Sub-Committees, as appropriate.
Committee
    Committee for the Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic established under the Voluntary Agreement.
Competitively Sensitive Information
    Competitively Sensitive Information that is shared pursuant to this 
Plan may include any Document or other tangible thing or oral 
transmission that contains financial, business, commercial, scientific, 
technical, economic, or engineering information or data, including, but 
not limited to

 financial statements and data,
 customer and supplier lists,
 price and other terms of sale to customers,
 sales records, projections and forecasts,
 inventory levels,
 capacity and capacity utilization,
 cost information,
 sourcing and procurement information,
 manufacturing and production information,
 delivery and shipping information,
 systems and data designs, and
 methods, techniques, processes, procedures, programs, codes, 
or similar information,

whether tangible or intangible, and regardless of the method of 
storage, compilation, or recordation, if the owner thereof has taken 
reasonable measures to protect the information from disclosure to the 
public or competitors. These measures may be evidenced by marking or 
labeling the items as ``competitively sensitive information'' during 
submission to FEMA or in the Participant's customary and existing 
treatment of such information (regardless of labeling).
    All Competitively Sensitive Information provided by a Sub-Committee 
Participant as described herein is deemed Competitively Sensitive 
Information, except for Information that:
    a. Is published or has been made publicly available at the time of 
disclosure by the Sub-Committee Participant;
    b. was in the possession of, or was lawfully and readily available 
to, FEMA from another source at the time of disclosure without 
breaching any obligation of confidentiality applicable to the other 
source; or
    c. was independently developed or acquired without reference to or 
reliance upon the Sub-Committee Participant's Competitively Sensitive 
Information;
    Where information deemed Competitively Sensitive Information is 
required to be disclosed by law, regulation, or court order, the 
``Competitively Sensitive'' (or substantially similar) label will 
continue to attach to all information and portion(s) of documents that 
are not made public through the required disclosure.
Diagnostic Test Kit
    Defined as any ``drug'' or ``device'' under the United States Food, 
Drug, and Cosmetic Act, 21 U.S.C. 321(g) or (h), respectively, used for 
detection or identification of the novel coronavirus in any individual.
Document
    Any information, on paper or in electronic/audio/visual format, 
including written, recorded, and graphic materials of every kind, in 
the possession, custody, or control of the Participant and used or 
shared in the course of participation in the Voluntary Agreement or a 
subsequent Plan of Action.
End-User
    This includes all direct and ancillary medical support including, 
but not limited to, hospitals, independent healthcare providers, 
nursing homes, medical laboratories, independent physician offices, 
first responders, alternate care facilities and the general public that 
reasonably represents the totality of the nation's response to COVID-
19.
Exigent Circumstances
    As determined by the Chairperson, the actual or forecasted shortage 
of a particular type of Diagnostic Test Kit or other Testing Component 
which likely cannot be fulfilled via usual market mechanisms for an 
acute, critical time period, and where immediate and substantial harm 
is projected to occur from lack of intervention.
Pandemic
    A Pandemic is defined as an epidemic that has spread to human 
populations across a large geographic area that is subject to one or 
more declarations under the National Emergencies Act, the Public Health 
Service Act, or the Robert T. Stafford Disaster Relief and Emergency 
Assistance Act, or if the Administrator determines that one or more 
declarations is likely to occur and the epidemic poses a direct threat 
to the national defense or its preparedness programs. For example, 
Coronavirus Disease 2019 (COVID-19).
Participant
    An individual, partnership, corporation, association, or private 
organization, other than a federal agency, that has substantive 
capabilities, resources or expertise to carry out the purpose of the 
Voluntary Agreement, that has been specifically invited to participate 
in the Voluntary Agreement by the Chairperson, and that has applied and 
agreed to the terms of the Voluntary Agreement. ``Participant'' 
includes a corporate or non-corporate entity entering into the 
Voluntary Agreement and all subsidiaries and affiliates of that entity 
in which that entity has 50 percent or more control either by stock 
ownership, board majority, or otherwise. The Administrator may invite 
Participants to join the Voluntary Agreement at any time during its 
effective period.
Plan of Action (Plan)
    This document. A documented method, pursuant to 50 U.S.C.

[[Page 28855]]

4558(b)(2), proposed by FEMA to implement a particular set of 
activities under the Voluntary Agreement, through a Sub-Committee 
focused on a particular Critical Healthcare Resource, or pandemic 
response workstream or functional area necessary for the national 
defense.
Plan of Action Agreement
    A separate commitment made by Participants upon invitation and 
agreement to participate in a Plan of Action as part of one or more 
Sub-Committees. Completing the Plan of Action Agreement confers 
responsibilities on the Participant consistent with those articulated 
in the Plan and affords Participants a defense against antitrust claims 
under section 708 for actions taken to develop or carry out the Plan 
and the appropriate Sub-Committee(s), as described in Section IV below.
Representatives
    The representatives the Administrator identifies and invites to the 
Committee from FEMA, HHS, and other federal agencies with equities in 
this Plan, and empowered to speak on behalf of their agencies' 
interests. The Attorney General and the Chair of the FTC, or their 
delegates, may also attend any meeting as a Representative.
Sub-Committee
    A body formed by the Administrator from select Participants to 
implement a Plan of Action.
Sub-Committee Chairperson
    FEMA executive, appointed by the Chairperson, to chair a Sub-
Committee to implement a Plan of Action. The Sub-Committee Chairperson 
shall be responsible for the overall management and administration of 
the Sub-Committee in furtherance of this Plan while remaining under the 
supervision of the Administrator and the Chairperson.
Sub-Committee Members
    Collectively the Sub-Committee Chairperson(s), Representatives, and 
Sub-Committee Participants. Jointly responsible developing and 
executing this Plan.
Sub-Committee Participant
    A subset of Participants of the Committee, that have been 
specifically invited to participate in a Sub-Committee by the Sub-
Committee Chairperson, and that have applied and agreed to the terms of 
this Plan and signed the Plan of Action Agreement. The Sub-Committee 
Chairperson may invite Participants in the Committee to join a Sub-
Committee as a Sub-Committee Participant at any time during the Plan's 
effective period.
Testing Components
    Defined as any article needed to support the transportation, 
storage, distribution, or administration of a Diagnostic Test Kit or 
subsequent result. Common Testing Components include collection swabs, 
transport media and pipette tips, but other associated materials may be 
included, if and as appropriate.

B. Plan of Action Participation

    This Plan will be implemented under the Voluntary Agreement by one 
or more Sub-Committees.
    (1) Sub-Committee to Define Requirements for COVID-19 Diagnostic 
Test Kits and other Testing Components,
    (2) Sub-Committee for Lab-Based Testing,
    (3) Sub-Committee for Point-of-Care Testing,
    (4) Sub-Committee for At-Home Testing,
    (5) Sub-Committee for Swabs (Nasal & Throat), and
    (6) Sub-Committee for Transfer Media and Pipette Tips.
    The Sub-Committee to Define Requirements for COVID-19 Diagnostic 
Test Kits and other Testing Components will be formed first. FEMA may 
establish additional Sub-Committees under this Plan, so long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of item needed for COVID-19 testing; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
Requirements for COVID-19 Diagnostic Test Kits and other Testing 
Components.
    Each Sub-Committee will consist of the (1) Sub-Committee 
Chairperson(s), (2) Representatives from FEMA, HHS, the Department of 
Justice (DOJ), and other federal agencies with equities in this Plan, 
and (3) Sub-Committee Participants that have substantive capabilities, 
resources or expertise to carry out the purpose of this Plan and have 
signed the Plan of Action Agreement. The Chairperson shall invite Sub-
Committee Participants who, in his or her determination, are reasonably 
representative of the appropriate industry or segment of such industry. 
Other Attendees--invited by the Sub-Committee Chairperson as subject 
matter experts to provide technical advice or to represent the 
interests of other government agencies or interested parties--may also 
participate in Sub-Committee meetings. The naming of these Sub-
Committees does not commit the Administrator to creating them unless 
and until circumstances dictate.

C. Effective Date and Duration of Participation

    This Plan is effective immediately upon satisfaction of the 
requirements of DPA section 708(f)(1). This Plan shall remain in effect 
until terminated in accordance with 44 CFR 332.4. It shall be effective 
for no more than five (5) years from August 17, 2020, when the 
requirements of DPA section 708(f)(1) were satisfied for the Voluntary 
Agreement, unless otherwise terminated pursuant to DPA section 
708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 
708(f)(2). No action may take place under this Plan until it is 
activated, as described in Section III(E), below.

D. Withdrawal

    Participation in the Plan is voluntary, as is the acceptance of 
most obligations under the Plan. Sub-Committee Participants may 
withdraw from this Plan or from an individual Sub-Committee at any 
point, subject to the fulfillment of obligations previously agreed upon 
by the Participant prior to the date of withdrawal. Note that the 
obligations outlined in V.B regarding information management and 
associated responsibilities apply once a party has shared or received 
information through a Sub-Committee and remain in place after the 
party's withdrawal from the Sub-Committee or Plan. If a Sub-Committee 
Participant indicates an intent to withdraw from the Plan due to a 
modification or amendment of the Plan (described below), the Sub-
Committee Participant will not be required to perform actions directed 
by that modification or amendment. Withdrawal from the Plan will 
automatically trigger withdrawal from all Sub-Committees; however, a 
Participant may withdraw from a Sub-Committee without also withdrawing 
from the Plan or other Sub-Committees. To withdraw from the Plan or 
from an individual Sub-Committee, a Participant must provide written 
notice to the Administrator at least fifteen (15) calendar days prior 
to the effective date of that Sub-Committee Participant's withdrawal 
specifying the scope of withdrawal. Following receipt of such notice, 
the Administrator will inform the other Sub-Committee Participants of 
the date and the scope of the withdrawal.
    Upon the effective date of the withdrawal from the Plan, the Sub-
Committee Participant must cease all

[[Page 28856]]

activities under the Plan. Upon the effective date of the withdrawal 
from one or more Sub-Committee(s), the Sub-Committee Participant must 
cease all activities under the Plan that pertain to the withdrawn Sub-
Committee(s).

E. Plan of Action Activation and Deactivation

    The Administrator, in consultation with the Chairperson and Sub-
Committee Chairperson, will invite a select group of Participants in 
the Voluntary Agreement to form the following Sub-Committees, beginning 
with the Sub-Committee to Define Requirements for COVID-19 Diagnostic 
Test Kits and other Testing Components, which will be responsible for 
implementing this Plan.
    (1) Sub-Committee to Define Requirements for COVID-19 Diagnostic 
Test Kits and other Testing Components,
    (2) Sub-Committee for Lab-Based Testing,
    (3) Sub-Committee for Point-of-Care Testing,
    (4) Sub-Committee for At-Home Testing,
    (5) Sub-Committee for Swabs (Nasal & Throat), and
    (6) Sub-Committee for Transfer Media and Pipette Tips.
    The Sub-Committee to Define Requirements for COVID-19 Diagnostic 
Test Kits and other Testing Components will be formed first. FEMA may 
establish additional Sub-Committees under this Plan, so long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of item needed for COVID-19 testing; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
Requirements for COVID-19 Diagnostic Test Kits and other Testing 
Components.
    This Plan will be activated for each invited Participant when the 
Participant executes a Plan of Action Agreement, and a Participant may 
not participate in a Sub-Committee until the Plan of Action Agreement 
is executed. Participants will be invited to join this Plan at the 
discretion of the Chairperson or the Sponsor to the Voluntary 
Agreement. Participants will be further invited to attend specific 
meetings of one or more Sub-Committees at the discretion of the 
Chairperson.

F. Rules and Regulations

    Sub-Committee Participants acknowledge and agree to comply with all 
provisions of DPA section 708, as amended, and regulations related 
thereto which are promulgated by FEMA, the Department of Homeland 
Security, HHS, the Attorney General, and the FTC. FEMA has promulgated 
standards and procedures pertaining to voluntary agreements in 44 CFR 
part 332. The Administrator shall inform Participants of new rules and 
regulations as they are issued.

G. Modification and Amendment

    The Administrator, after consultation with the Attorney General and 
the Chair of the FTC, may terminate or modify, in writing, this Plan at 
any time. The Attorney General, after consultation with the Chair of 
the FTC and the Administrator, may terminate or modify, in writing, 
this Plan at any time. Sub-Committee Participants may propose 
modifications or amendments to the Plan or to the Sub-Committees at any 
time.
    Where possible, material modifications to the Plan or a Sub-
Committee will be subject to a 30-calendar day delayed implementation 
and opportunity for notice and comment by Sub-Committee Participants to 
the Chairperson. This delayed implementation period may be shortened or 
eliminated if the Administrator deems it necessary. The Administrator 
shall inform Sub-Committee Participants of modifications or amendments 
to the Plan or to the Sub-Committees as they are proposed and issued.
    The Administrator, after consultation with the Attorney General and 
the Chair of the FTC, may remove Sub-Committee Participants from the 
Plan or from a Sub-Committee at any time. The Attorney General, after 
consultation with the Chair of the FTC and the Administrator, may 
remove Sub-Committee Participants from this Plan or from a Sub-
Committee at any time. If a Participant is removed from the Plan or 
from a Sub-Committee, the Participant may request written notice of the 
reasons for removal from the Chairperson, who shall provide such notice 
in a reasonable time period.

H. Expenses

    Participation in this Plan or in a Sub-Committee does not confer 
funds to Sub-Committee Participants, nor does it limit or prohibit any 
pre-existing source of funds. Unless otherwise specified, all expenses, 
administrative or otherwise, incurred by Sub-Committee Participants 
associated with participation in this Plan or a Sub-Committee shall be 
borne exclusively by the Sub-Committee Participants.

I. Record Keeping

    Each Sub-Committee Chairperson shall have primary responsibility 
for maintaining records in accordance with 44 CFR part 332 and shall be 
the official custodian of records related to carrying out this Plan. 
Each Sub-Committee Participant shall maintain for five years all 
minutes of meetings, transcripts, records, documents, and other data, 
including any communications with other Sub-Committee Participants or 
with any other member of the Sub-Committee, including drafts, related 
to the carrying out of this Plan or incorporating data or information 
received in the course of carrying out this Plan. Each Sub-Committee 
Participant agrees to produce to the Administrator, the Attorney 
General, and the Chair of the FTC upon request any item that this 
section requires the Participant to maintain. Any record maintained in 
accordance with 44 CFR part 332 shall be available for public 
inspection and copying, unless exempted on the grounds specified in 5 
U.S.C. 552(b)(1), (3) or (4) or identified as privileged and 
confidential information in accordance with DPA section 705(d), and 44 
CFR 332.5.

IV. Antitrust Defense

    Under the provisions of DPA subsection 708(j), each Sub-Committee 
Participant in this Plan shall have available as a defense to any civil 
or criminal action brought for violation of the antitrust laws (or any 
similar law of any State) with respect to any action to develop or 
carry out this Plan, that such action was taken by the Sub-Committee 
Participant in the course of developing or carrying out this Plan, that 
the Sub-Committee Participant complied with the provisions of DPA 
section 708 and the rules promulgated thereunder, and that the Sub-
Committee Participant acted in accordance with the terms of the 
Voluntary Agreement and this Plan. Except in the case of actions taken 
to develop this Plan, this defense shall be available only to the 
extent the Sub-Committee Participant asserting the defense demonstrates 
that the action was specified in, or was within the scope of, this Plan 
and within the scope of the appropriate Sub-Committee(s), including 
being taken at the direction and under the active supervision of FEMA.
    This defense shall not apply to any actions taken after the 
termination of this Plan. Immediately upon modification of this Plan, 
no defense to antitrust claims under Section 708 shall be available to 
any subsequent action that is beyond the scope of the modified Plan. 
The Sub-Committee Participant asserting the defense bears the burden of 
proof to establish the elements of the defense. The defense shall not 
be

[[Page 28857]]

available if the person against whom the defense is asserted shows that 
the action was taken for the purpose of violating the antitrust laws.

V. Terms and Conditions

    As the sponsoring agency, FEMA will maintain oversight over Sub-
Committee activities and direct and supervise actions taken to carry 
out this Plan, including by retaining decision-making authority over 
actions taken pursuant to the Plan to ensure such actions are necessary 
to address a direct threat to the national defense. The Attorney 
General and the Chair of the FTC will monitor activities of the Sub-
Committees to ensure they execute their responsibilities in a manner 
consistent with this Plan and their actions have the least 
anticompetitive effects possible.

A. Plan of Action Execution

    This Plan will be used to support the following objectives to 
respond to a Pandemic by maximizing the manufacture and efficient 
distribution of selected types of Diagnostic Test Kits and other 
Testing Components and creating a prioritization protocol for End-Users 
based upon their demonstrated or projected requirements. Each Sub-
Committee will undertake the following Objectives for the Diagnostic 
Test Kits and other Testing Components within its area of jurisdiction.
1. Objectives
    (1) Optimize the timely production of sufficient quantities of 
Diagnostic Test Kits and other Testing Components, as part of the 
overall national strategy, to reduce transmission of COVID-19 and 
mitigate the impacts caused by it.
    (2) Identify and encourage the development of Diagnostic Test Kits 
and Testing Components that can identify more than one illness (e.g., 
flu, strep throat or other bacterial infections, common cold, seasonal 
allergies, and COVID-19).
    (3) Identify and encourage the development of Diagnostic Test Kits 
and Testing Components that can mitigate supply chain constraints, by 
leveraging new technologies and different components.
    (4) Ensure Diagnostic Test Kits and other Testing Components are 
distributed effectively and equitably across the whole community 
nationally based on necessity and risk.
    (5) Balance restoration and maintenance of the nation's stockpile 
of Diagnostic Test Kits and other Testing Components with near-term 
requirements.
    (6) Establish a process for FEMA Allocation of Diagnostic Test Kits 
and other Testing Components nationwide.
    (7) Evaluate supply chain components to determine national 
vulnerabilities and propose corrective actions to improve resiliency in 
the manufacture and distribution of Diagnostic Test Kits and other 
Testing Components.
    (8) Ensure ongoing competition in the manufacture and distribution 
of Diagnostic Test Kits and other Testing Components to the greatest 
extent possible under the DPA.
2. Actions
    Sub-Committee Participants may be asked to support these objectives 
by taking the following specific actions:
    (1) Assist the Chairperson in identifying which types of Diagnostic 
Test Kits and other Testing Components should be included within each 
Sub-Committee. Identification will be based upon each item's importance 
to the national response to COVID-19 and whether it can be reasonably 
inferred, based upon the best evidence available, that the current and 
projected supply measured against current and projected demand may not 
adequately meet the requirements of all identified End-Users or 
regional or geographic areas of the country.
    (2) Provide input to the Chairperson in creating a prioritized list 
of End Users of Diagnostic Test Kits and other Testing Components, by 
category of End User, for each type of Diagnostic Test Kits and other 
Testing Components identified by each Sub-Committee, and ascertaining 
the relative demand and supply of Diagnostic Test Kits and other 
Testing Components among and within those End User categories. 
Prioritization shall be decided by the Chairperson, based upon each 
item's importance, reflecting the consensus views of the Sub-Committee 
Members that it represents the most effective way to save lives in 
responding to the COVID-19 pandemic. This list may be updated 
throughout the life of the Plan based upon either short term or long-
term demands. These categories should be considered holistically in 
terms of the Whole-of-Nation response to COVID-19.
    (3) Evaluate the domestic supply of Diagnostic Test Kits and other 
Testing Components and identify when the expansion of the domestic 
manufacture of Diagnostic Test Kits and other Testing Components may be 
necessary, as directed and decided by the Chairperson.
    (4) Provide information, assist, and validate, as necessary as 
decided by the Chairperson, demand projections for Diagnostic Test Kits 
and other Testing Components.
    (5) Create a process for and collaborate in the evaluation of 
competing claims for Diagnostic Test Kits and/or other Testing 
Components from End-Users.
    (6) Prepare a general strategy to accomplish the activities listed 
in V(A)(2)(7) below regarding activities in Exigent Circumstances 
consistent with the decisions made by the Chairperson.
    (7) In Exigent Circumstances, with review and concurrence in all 
possible instances by DOJ in consultation with FTC:
     Facilitate maximum availability of Diagnostic Test Kits 
and other Testing Components to the nation by deconflicting overlapping 
demands from the collective Participants' customer base, as directed 
and decided by the Chairperson.
     Facilitate maximum availability of Diagnostic Test Kits 
and other Testing Components to the nation by deconflicting overlapping 
supply chain demands placed upon Members, as directed and decided by 
the Chairperson.
     Facilitate the efficient distribution of Diagnostic Test 
Kits and other Testing Components by deconflicting overlapping 
distribution chain activities of Members, as directed and decided by 
the Chairperson.
     Create a process for and collaborate in the Allocation of 
Diagnostic Test Kits and other Testing Components nationwide consistent 
with the decisions made by the Chairperson.
    (8) Provide data and information necessary to validate the efforts 
of the Sub-Committee including the actual and planned amounts of 
Diagnostic Test Kits and other Testing Components to be distributed 
throughout the Nation, as determined by the Chairperson.
    (9) Provide feedback to the Sub-Committee on the outcomes of the 
collective efforts of the Sub-Committee Members and any impediments or 
bottlenecks.
    (10) Advise the Chairperson whether additional Participants or 
Attendees should be invited to join this Plan and Sub-Committee.
    (11) Carry out other activities regarding Diagnostic Test Kits and 
other Testing Components as identified by Sub-Committees under this 
Plan as determined and directed by the Chairperson necessary to address 
the COVID-19 virus' direct threat to the national defense, where such 
activities have been reviewed and approved by DOJ and FTC and received 
concurrence from Sub-Committee members.

[[Page 28858]]

B. Information Management and Responsibilities

    FEMA will request only that data and information from Sub-Committee 
Participants that is necessary to meet the objectives of the Plan and 
consistent with the scope of the relevant Sub-Committees. Upon signing 
a Plan of Action Agreement for this Plan, FEMA requests that 
Participants endeavor to cooperate with diligence and speed, and to the 
extent permissible under this Plan, and share with FEMA data and 
information necessary to meet the objectives of this Plan.
    Sub-Committee Participants agree to share with FEMA the following 
data with diligence and speed, to the extent permissible under this 
Plan, and abide by the following guidelines, where feasible and 
consistent with the data that is owned by each Sub-Committee 
Participant:
    (1) In general, Participants will not be asked to share 
Competitively Sensitive Information directly with other Participants.
    (2) FEMA will only request direct sharing of Competitively 
Sensitive Information among Participants during Exigent Circumstances 
where there is a mission critical need or timeline such that sharing 
only through FEMA is impractical or threatens the outcome of the Plan 
or Sub-Committee action. Such requests, if made, will be only among 
Participants whose participation is necessary to meet the objectives of 
the Plan, will be limited in scope to the greatest extent possible, and 
will be shared only pursuant to safeguards subject to prior review and 
audit by DOJ and FTC. Direct sharing of Competitively Sensitive 
Information with other Participants will be limited in scope and 
circumstances to the greatest extent possible. Participants may not 
share Competitively Sensitive Information directly with other 
Participants unless specifically requested by FEMA, in consultation 
with DOJ and FTC. All Competitively Sensitive Information delivered to 
FEMA or to another Sub-Committee Participant shall be delivered by 
secure means, for example, password-protected or encrypted electronic 
files or drives with the password/key delivered by separate 
communication or method or via upload to an appropriately secure web 
portal as directed by FEMA. All data delivered to the web portal 
designated by FEMA is deemed to be Competitively Sensitive Information.
    (3) To allow FEMA to identify and appropriately protect documents 
containing Competitively Sensitive Information by the Sub-Committee 
Participant providing the documents, the Sub-Committee Participant will 
make good faith efforts to designate any Competitively Sensitive 
Information by placing restrictive markings on documents and things 
considered to be competitively sensitive, the restrictive markings 
being sufficiently clear in wording and visibility to indicate the 
restricted nature of the data. The Sub-Committee Participant will 
identify Competitively Sensitive Information that is disclosed verbally 
by oral warning. Information designated as competitively sensitive 
will, to the extent allowed by law, be presumed to constitute 
confidential or privileged commercial or financial information, and be 
provided by the Sub-Committee Participant to FEMA with the expectation 
that it will be kept confidential by both parties, as such terms are 
understood in accordance with 5 U.S.C. 552(b)(4) of the Freedom of 
Information Act and federal judicial interpretations of this statute. 
FEMA agrees that to the extent any information designated as 
competitively sensitive by a Sub-Committee Participant is responsive to 
a request for disclosure under the Freedom of Information Act, FEMA 
will consult with the Sub-Committee Participant and afford the 
Participant ten (10) working days to object to any disclosure by FEMA.
    (4) FEMA will make good faith efforts to appropriately recognize 
unmarked Documents containing Competitively Sensitive Information as 
Competitively Sensitive Information. However, FEMA cannot guarantee 
that all unmarked Documents will be recognized as being Competitively 
Sensitive Information and protected from disclosure to third parties. 
If the unmarked Documents have not been disclosed without restriction 
outside of FEMA, the Sub-Committee Participant may retroactively 
request to have appropriate designations placed on the Documents. If 
the unmarked Documents have been disclosed without restriction outside 
of FEMA, FEMA will, to the extent practicable, remove any requested 
information from public forums controlled by FEMA and will work 
promptly to request that a receiving party return or destroy disclosed 
unmarked Documents if requested by the Sub-Committee Participant.
    (5) Competitively Sensitive Information may be used by FEMA, alone 
or in combination with additional information, including Documents and 
Competitively Sensitive Information received from third parties, to 
support FEMA's implementation of this Plan as determined by the 
Chairperson. In all situations, FEMA will aggregate and anonymize 
Competitively Sensitive Information to the greatest extent possible to 
protect the interests retained by the owners of the data while still 
allowing the objectives of the Plan and Sub-Committee to be achieved. 
To the greatest extent possible, such aggregation will render the 
competitively sensitive nature of the Competitively Sensitive 
Information of the Sub-Committee Participant no longer recognizable in 
a commercially sensitive manner, and without sufficient information to 
enable, by inference or otherwise, attribution to Sub-Committee 
Participant or its affiliates (as clearly identified and disclosed to 
FEMA). Any disclosure of Competitively Sensitive Information by FEMA, 
within or outside a Sub-Committee, will be subject to review and 
approval by DOJ and FTC.
    (6) Except as otherwise expressly permitted by applicable federal 
law, FEMA shall not disclose any Competitively Sensitive Information or 
use any Competitively Sensitive Information for any purpose other than 
in connection with the purposes of this Plan, and FEMA will not sell 
any Competitively Sensitive Information of any Sub-Committee 
Participant.
    (7) Except as described below, FEMA may disclose Competitively 
Sensitive Information only to its employees, officers, directors, 
contractors, agents, and advisors (including attorneys, accountants, 
consultants, and financial advisors). Any individual with access to 
Competitively Sensitive Information will be expected to comply with the 
terms of this Plan.
    a. Information Sharing within the Sub-Committee: FEMA may share 
Competitively Sensitive Information with Sub-Committee Participants and 
Federal Representatives of the Plan, and their respective employees, 
officers, directors, contractors, agents, and advisors (including 
attorneys, accountants, consultants, and financial advisors) where 
there is a need to know and where disclosure is reasonably necessary in 
furtherance of implementing the Plan. FEMA will aggregate and anonymize 
data prior to sharing with the Sub-Committee Participants to the 
greatest extent possible while still allowing the objectives of the 
Plan to be achieved, and will not share data--particularly to 
competitors of the submitter--prior to consultation with and approval 
by the DOJ and FTC.
    i. Sub-Committee Participants, when providing Competitively 
Sensitive Information to FEMA, may request that this Information not be 
shared with other Sub-Committee Participants. Where these requests are 
made in good

[[Page 28859]]

faith and are reasonable in nature, FEMA will respect these requests to 
the greatest extent possible and will consult the owner of the data 
prior to any release made to Sub-Committee Participants.
    b. Restricted Reports. FEMA may communicate Competitively Sensitive 
Information to appropriate government officials through Restricted 
Reports. The information contained in Restricted Reports shall be 
aggregated and anonymized to the greatest extent possible, while 
recognizing that these officials may need a certain amount of 
granularity and specificity of information to appropriately respond to 
COVID-19. FEMA will aim to aggregate data to the County level, and will 
not share Restricted Reports prior to consultation and approval from 
the DOJ and FTC. FEMA may disclose Restricted Reports to relevant White 
House and Administration officials and State Governors, and their 
respective employees, officers, directors, contractors, agents, and 
advisors (including attorneys, accountants, consultants, and financial 
advisors) who have a need to know and to whom such disclosure is 
reasonably necessary solely in furtherance of the implementation of 
this Plan. FEMA shall take appropriate action (by instructions, 
agreement, or otherwise) to ensure that receiving parties comply with 
all data-sharing confidentiality and obligations under this Plan as if 
such persons or entities had been parties to this Plan.
    c. Public Reports. FEMA may share information with the public 
through Public Reports. Data contained in Public Reports shall be fully 
aggregated and anonymized. Public Reports shall be aggregated to at 
least a state level and may be publicly disclosed after consultation 
and approval from the DOJ and FTC.
    (8) Where possible and not obviated by Exigent Circumstances, FEMA 
will notify Sub-Committee Participants prior to the release of any 
Competitively Sensitive Information that has not been fully aggregated 
and anonymized. In consultation with DOJ and FTC, FEMA will consider 
any good-faith requests made by Sub-Committee members to hold the 
release of data or requests for further aggregation or anonymization. 
In general, FEMA will not provide notification prior to the release of 
Public Reports, under the presumption that the data in these reports 
has already been fully anonymized and de-identified.
    (9) Any party receiving Competitively Sensitive Information through 
this Plan shall use such information solely for the purposes outlined 
in the Plan and take steps, such as imposing previously approved 
firewalls or tracking usage, to prevent misuse of the information. 
Disclosure and use of Competitively Sensitive Information will be 
limited to the greatest extent possible, and any party receiving 
Competitively Sensitive Information shall follow the procedures 
outlined in paragraph 7 above.
    (10) At the conclusion of a Participant's involvement in a Plan--
due to the deactivation of the Plan or due to the Participant's 
withdrawal or removal--each Participant will be requested to sequester 
any and all Competitively Sensitive Information received through 
participation in the Plan. This sequestration shall include the 
deletion of all Competitively Sensitive Information unless required to 
be kept pursuant to the Record Keeping requirements as described supra, 
Section I, 44 CFR part 332, or any other provision of law.

C. Oversight

    Each Sub-Committee Chairperson is responsible for ensuring that the 
Attorney General, or suitable delegate(s) from the DOJ, and the FTC 
Chair, or suitable delegate(s) from the FTC, have awareness of 
activities under this Plan, including activation, deactivation, and 
scheduling of meetings. The Attorney General, the FTC Chair, or their 
delegates may attend Sub-Committee meetings and request to be apprised 
of any activities taken in accordance with activities under this Plan. 
DOJ or FTC Representatives may request and review any proposed action 
by the Sub-Committee or Sub-Committee Participants undertaken pursuant 
to this Plan, including the provision of data. If any DOJ or FTC 
Representative believes any actions proposed or taken are not 
consistent with relevant antitrust protections provided by the DPA, he 
or she shall provide warning and guidance to the Sub-Committee as soon 
as the potential issue is identified. If questions arise about the 
antitrust protections applicable to any particular action, FEMA may 
request DOJ, in consultation with the FTC, provide an opinion on the 
legality of the action under relevant DPA antitrust protections.

VI. Establishment of the Sub-Committees

    This Plan establishes Sub-Committees to implement the Plan to 
Establish a National Strategy for the Manufacture, Allocation and 
Distribution of Diagnostic Test Kits and other Testing Components to 
Respond to COVID-19 to provide the Federal Government and the 
Participants a forum to maximize the manufacture and efficient 
distribution of selected types of Diagnostic Test Kits and other 
Testing Components and to create a prioritization protocol based upon 
identified types of Diagnostic Test Kits and other Testing Components 
End-Users and their demonstrated or projected requirements, and 
demonstrated or projected geographic and regional areas of need. The 
outcome should include a framework to expeditiously meet any Diagnostic 
Test Kits and other Testing Components needs in Exigent Circumstances 
anywhere in the Nation, and to ensure that actions to support the 
stockpiling of Diagnostic Test Kits and other Testing Components do not 
interfere with immediate requirements that would result in an 
unacceptable risk to healthcare providers or other potential Diagnostic 
Test Kits and other Testing Components recipients. A Sub-Committee 
Chairperson designated by the Chairperson will convene and preside over 
each Sub-Committee. Sub-Committees will not be used for contract 
negotiations or contract discussions between the Participants and the 
Federal Government; such negotiations or discussions will be in 
accordance with applicable federal contracting policies and procedures. 
However, this shall not limit any discussion within a Sub-Committee 
about the operational utilization of existing and potential contracts 
between the Participants and Representatives when seeking to align 
their use with overall manufacturing and distribution efforts 
consistent with this Plan.
    Each Sub-Committee will consist of designated Representatives from 
FEMA, HHS, other federal agencies with equities in this Plan, and each 
Sub-Committee Participant. The Attorney General and Chair of the FTC, 
or their delegates, may also join each Sub-Committee and attend 
meetings at their discretion. Attendees may also be invited at the 
discretion of a Sub-Committee Chairperson as subject matter experts, to 
provide technical advice, or to represent other government agencies, 
but will not be considered part of the Sub-Committee.
    To the extent necessary to respond to the Pandemic, only at the 
explicit direction of a Sub-Committee Chairperson, and subject to the 
provisions of Section V(B), Sub-Committee Members may be asked to 
provide technical advice, share information, help identify and validate 
places and resources of the greatest need, help project future 
manufacturing and distribution demands, assist in identifying and 
resolving the allocation of scarce resources amongst all

[[Page 28860]]

necessary public and private sector domestic needs under Exigent 
Circumstances, and take any other necessary actions to maximize the 
timely allocation and distribution of Diagnostic Test Kits and other 
Testing Components as determined necessary by FEMA to respond to the 
Pandemic. A Sub-Committee Chairperson or his or her designee, at the 
Sub-Committee Chairperson's sole discretion, will make decisions on 
these issues in order to ensure the maximum efficiency and 
effectiveness in the use of Sub-Committee Member's resources. All Sub-
Committee Participants will be invited to open Sub-Committee meetings. 
For selected Sub-Committee meetings, attendance may be limited to 
designated Sub-Committee Participants to meet specific operational 
requirements, as determined by FEMA.
    Each Sub-Committee Chairperson shall notify the Attorney General, 
the Chair of the FTC, Representatives, and Participants of the time, 
place, and nature of each meeting and of the proposed agenda of each 
meeting to be held to carry out this Plan. Additionally, each Sub-
Committee Chairperson shall provide for publication in the Federal 
Register of a notice of the time, place, and nature of each meeting. If 
a meeting is open, a Federal Register notice will be published 
reasonably in advance of the meeting. A Sub-Committee Chairman may 
restrict attendance at meetings only on the grounds outlined by 44 CFR 
332.5(c)(1)-(3). If a meeting is closed, a Federal Register notice will 
be published within ten (10) days of the meeting and will include the 
reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2).
    The Sub-Committee Chairperson shall establish the agenda for each 
meeting, be responsible for adherence to the agenda, and provide for a 
written summary or other record of each meeting and provide copies of 
transcripts or other records to FEMA, the Attorney General, the Chair 
of the FTC, and all Sub-Committee Participants. The Chairperson shall 
take necessary actions to protect from public disclosure any data 
discussed with or obtained from Sub-Committee Participants which a Sub-
Committee Participant has identified as a trade secret or as privileged 
and confidential in accordance with DPA sections 708(h)(3) and 705(d), 
or which qualifies for withholding under 44 CFR 332.5.

VII. Application and Agreement

    The Sub-Committee Participant identified below hereby agrees to 
join in the Federal Emergency Management Agency sponsored Plan of 
Action to Establish a National Strategy for the Manufacture, Allocation 
and Distribution of Diagnostic Test Kits and other Testing Components 
under the Voluntary Agreement for the Manufacture and Distribution of 
Healthcare Resources Necessary to Respond to a Pandemic and to become a 
Participant in one or more Sub-Committees established by this Plan. 
This Plan will be published in the Federal Register. This Plan is 
authorized under section 708 of the Defense Production Act of 1950, as 
amended. Regulations governing the Voluntary Agreement for the 
Manufacture and Distribution for the Manufacture and Distribution of 
Healthcare Resources Necessary to Respond to a Pandemic and all 
subsequent Plans of Action at 44 CFR part 332. The applicant, as a Sub-
Committee Participant, agrees to comply with the provisions of section 
708 of the Defense Production Act of 1950, as amended, the regulations 
at 44 CFR part 332, and the terms of this Plan.

VIII. Assignment

    No Sub-Committee Participant may assign or transfer this Plan, in 
whole or in part, or any protections, rights or obligations hereunder 
without the prior written consent of the Sub-Committee Chairperson. 
When requested, the Sub-Committee Chairperson will respond to written 
requests for consent within 10 (ten) business days of receipt.

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Text of 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 
Implemented Under the Voluntary Agreement for the Manufacture and 
Distribution of Critical Healthcare Resources Necessary To Respond to a 
Pandemic

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 Implemented Under the 
Voluntary Agreement for the Manufacture and Distribution of Critical 
Healthcare Resources Necessary To Respond to a Pandemic

Preface

    Pursuant to section 708 of the Defense Production Act of 1950 
(DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management 
Agency (FEMA) Administrator (Administrator), after consultation with 
the Secretary of the Department of Health and Human Services (HHS), the 
Attorney General of the United States (Attorney General), and the Chair 
of the Federal Trade Commission (FTC), developed a Voluntary Agreement 
for the Manufacture and Distribution of Critical Healthcare Resources 
Necessary to Respond to a Pandemic (Voluntary Agreement), 85 FR 50035 
(August 17, 2020). The Voluntary Agreement, which operates through a 
series of Plans of Action, maximizes the manufacture and efficient 
distribution of Critical Healthcare Resources nationwide to respond to 
a pandemic by establishing unity of effort between Participants and the 
Federal Government for integrated coordination, planning, information 
sharing with FEMA, as authorized by FEMA, and allocation and 
distribution of Critical Healthcare Resources.
    This document establishes a Plan of Action (Plan) 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. This Plan will be implemented under the Voluntary 
Agreement by several Sub-Committees, beginning with a Sub-Committee to 
Define Requirements for COVID-19 Drug Products, Drug Substances, and 
Associated Medical Devices:
    (1) Sub-Committee to Define Requirements for COVID-19 Drug 
Products, Drug Substances, and Associated Medical Devices

[[Page 28861]]

    (2) Sub-Committee for Monoclonal Antibodies,
    (3) Sub-Committee for Drug Products, Drug Substances, and 
Associated Medical Devices Related to the Treatment of Respiratory 
Illness,
    (4) Sub-Committee for Drug Products, Drug Substances, and 
Associated Medical Devices Related to Acute and Intensive Care,
    (5) Sub-Committee to Accelerate Coronavirus Treatment,
    (6) Sub-Committee for Strategic Investment Towards On-Shoring of 
Pharmaceutical Manufacturing and Fill-Finish, and
    (7) Sub-Committee for Emergency Use Authorizations.
    FEMA may establish additional Sub-Committees under this Plan, so 
long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of Drug Products, Drug Substances, or Associated Medical 
Devices; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
Requirements for COVID-19 Drug Products, Drug Substances, and 
Associated Medical Devices.
    The purpose of the Plan and the Sub-Committees is to maximize the 
manufacture and efficient distribution of selected types of Drug 
Products, Drug Substances, and Associated Medical Devices, and create a 
prioritization protocol for End-Users based upon their demonstrated or 
projected requirements including geographic and regional circumstances. 
The primary goal of the Plan is to create 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. When the requirements 
of the Plan are met, it affords Sub-Committee Participants defenses to 
civil and criminal actions brought under the antitrust laws (or any 
similar law of any state) for actions taken within the scope of the 
Plan. The Plan is designed to foster a close working relationship among 
FEMA, HHS, and Sub-Committee Participants to address national defense 
needs through cooperative action under the direction and active 
supervision of FEMA.

Table of Contents

I. Purpose.....................................................      380
II. Authorities................................................      380
III. General Provisions........................................      381
    A. Definitions.............................................      381
    B. Plan of Action Participation............................      385
    C. Effective Date and Duration of Participation............      386
    D. Withdrawal..............................................      386
    E. Plan of Action Activation and Deactivation..............      387
    F. Rules and Regulations...................................      387
    G. Modification and Amendment..............................      387
    H. Expenses................................................      388
    I. Record Keeping..........................................      388
IV. Antitrust Defense..........................................      389
V. Terms and Conditions........................................      389
    A. Plan of Action Execution................................      389
    B. Information Management and Responsibilities.............      392
    C. Oversight...............................................      396
VI. Establishment of the Sub-Committees........................      396
VII. Application and Agreement.................................      398
VIII. Assignment...............................................      398
 

IX. Purpose

    A pandemic may present conditions that pose a direct threat to the 
national defense of the United States or its preparedness programs such 
that, pursuant to DPA section 708(c)(1), an agreement to collectively 
coordinate, plan, and collaborate for the manufacture, allocation and 
distribution of Drug Products, Drug Substances, and Associated Medical 
Devices is necessary for the national defense. This 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 is established under the Voluntary 
Agreement and establishes seven Sub-Committees to oversee and implement 
the Plan. The Plan and Sub-Committees will optimize the manufacture and 
the efficient distribution of selected types of Drug Products, Drug 
Substances, and Associated Medical Devices and create a prioritization 
protocol for End-Users based upon their demonstrated or projected 
requirements.

X. Authorities

    Section 708, Defense Production Act (50 U.S.C. 4558); sections 
402(2) & 501(b), Robert T. Stafford Disaster Relief and Emergency 
Assistance Act (42 U.S.C. 5121-5207); sections 503(b)(2)(B) & 
504(a)(10) & (16) of the Homeland Security Act of 2002 (6 U.S.C. 
313(b)(2)(B), 314(a)(10) & (16)); sections 201, 301, National 
Emergencies Act (50 U.S.C. 1601 et seq.); section 319, Public Health 
Service Act (42 U.S.C. 247d); Executive Order (E.O.) 13911, 85 FR 18403 
(March 27, 2020); Prioritization and Allocation of Certain Scarce or 
Threatened Health and Medical Resources for Domestic Use, 85 FR 20195 
(April 10, 2020). Pursuant to DPA section 708(f)(1)(A), the 
Administrator certifies that this Plan is necessary for the national 
defense.

XI. General Provisions

J. Definitions

Administrator
    The FEMA Administrator is the Sponsor of the Voluntary Agreement. 
Pursuant to a delegation or redelegation of the functions given to the 
President by DPA section 708, the Administrator proposes and provides 
for the development and carrying out of the Voluntary Agreement, 
including through the development and implementation of Plans of 
Action. The Administrator is responsible for carrying out all duties 
and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and 
for appointing one or more Chairpersons to manage and administer the 
Committee and all Sub-Committees formed to carry out the Voluntary 
Agreement.
Agreement
    The Voluntary Agreement for the Manufacture and Distribution of 
Critical Healthcare Resources Necessary to

[[Page 28862]]

Respond to a Pandemic (Voluntary Agreement).
Allocation
    The process of determining and directing the relative distribution 
among one or more competing requests from End-Users for the same Drug 
Products, Drug Substances, or Associated Medical Devices. Through the 
Allocation process, FEMA--with participation from Sub-Committee 
Participants--will assess the actual needs of End-Users and determine 
how to divide the available and projected supply of Drug Products, Drug 
Substances, and Associated Medical Devices to minimize impacts to life, 
safety, and economic disruption associated with shortages of Drug 
Products, Drug Substances, and Associated Medical Devices. Allocation 
will take place only under Exigent Circumstances. Although FEMA retains 
decision making authority for all Allocation under this Plan, other 
federal agency partners retain decision-making authority for all assets 
under their control.
Associated Medical Devices
    A device, as defined under the United States Food, Drug, and 
Cosmetic Act, 21 U.S.C. 321(h), that is used to manufacture, transport, 
distribute, deliver, sanitize, dispose of, or in any other way 
facilitate the use of, any drug product or drug substance needed to 
cure, mitigate or treat COVID-19.
Attendees
    Subject matter experts, invited by the Chairperson or a Sub-
Committee Chairperson to attend meetings authorized under the Voluntary 
Agreement or this Plan, to provide technical advice or to represent 
other government agencies or interested parties. Invitations to 
attendees will be extended as required for Committee or Sub-Committee 
meetings and deliberations.
Chairperson
    FEMA senior executive(s), appointed by the Administrator, to chair 
the Committee for the Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic (Committee). The Chairperson shall be responsible 
for the overall management and administration of the Committee, the 
Voluntary Agreement, and Plans of Action developed under the Voluntary 
Agreement while remaining under the supervision of the Administrator; 
shall initiate, or approve in advance, each meeting held to discuss 
problems, determine policies, recommend actions, and make decisions 
necessary to carry out the Voluntary Agreement; appoint one or more co-
Chairpersons to chair the Committee, and otherwise shall carry out all 
duties and responsibilities assigned to them. With the approval of the 
Administrator, the Chairperson may create one or more Sub-Committees, 
and may appoint one or more Sub-Committee Chairpersons to chair the 
Sub-Committees, as appropriate.
Committee
    Committee for the Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic established under the Voluntary Agreement.
Competitively Sensitive Information
    Competitively Sensitive Information that is shared pursuant to this 
Plan may include any Document or other tangible thing or oral 
transmission that contains financial, business, commercial, scientific, 
technical, economic, or engineering information or data, including, but 
not limited to

 financial statements and data,
 customer and supplier lists,
 price and other terms of sale to customers,
 sales records, projections and forecasts,
 inventory levels,
 capacity and capacity utilization,
 cost information,
 sourcing and procurement information,
 manufacturing and production information,
 delivery and shipping information,
 systems and data designs, and
 methods, techniques, processes, procedures, programs, codes, 
or similar information,

whether tangible or intangible, and regardless of the method of 
storage, compilation, or recordation, if the owner thereof has taken 
reasonable measures to protect the information from disclosure to the 
public or competitors. These measures may be evidenced by marking or 
labeling the items as ``competitively sensitive information'' during 
submission to FEMA or in the Participant's customary and existing 
treatment of such information (regardless of labeling).
    All Competitively Sensitive Information provided by a Sub-Committee 
Participant as described herein is deemed Competitively Sensitive 
Information, except for Information that:
    a. Is published or has been made publicly available at the time of 
disclosure by the Sub-Committee Participant;
    b. was in the possession of, or was lawfully and readily available 
to, FEMA from another source at the time of disclosure without 
breaching any obligation of confidentiality applicable to the other 
source; or
    c. was independently developed or acquired without reference to or 
reliance upon the Sub-Committee Participant's Competitively Sensitive 
Information;
    Where information deemed Competitively Sensitive Information is 
required to be disclosed by law, regulation, or court order, the 
``Competitively Sensitive'' (or substantially similar) label will 
continue to attach to all information and portion(s) of documents that 
are not made public through the required disclosure.
Document
    Any information, on paper or in electronic/audio/visual format, 
including written, recorded, and graphic materials of every kind, in 
the possession, custody, or control of the Participant and used or 
shared in the course of participation in the Voluntary Agreement or a 
subsequent Plan of Action.
Drug Product
    Is a finished dosage form, e.g., tablet, capsule, or solution, that 
contains a drug substance, generally, but not necessarily, in 
association with one or more other ingredients.
Drug Substance
    Is an active ingredient that is intended to furnish pharmacological 
activity or other direct effect in the diagnosis, cure, mitigation, 
treatment, or prevention of disease or to affect the structure or any 
function of the human body, but does not include intermediates used in 
the synthesis of such ingredient.
End-User
    This includes all direct and ancillary medical support including, 
but not limited to, hospitals, independent healthcare providers, 
nursing homes, medical laboratories, dental care providers, independent 
physician offices, first responders, alternate care facilities and the 
general public that reasonably represents the totality of the nation's 
response to COVID-19. ``End-User'' may also include essential workers 
necessary to maintain or restore critical infrastructure operations, 
including but not limited to law enforcement, education, food and 
agriculture, energy, water and wastewater, and public works personnel.

[[Page 28863]]

Exigent Circumstances
    As determined by the Chairperson, the actual or forecasted shortage 
of a particular type or types of Drug Products, Drug Substances, and 
Associated Medical Devices which likely cannot be fulfilled via usual 
market mechanisms for an acute, critical time period, and where 
immediate and substantial harm is projected to occur from lack of 
intervention.
Fill-Finish
    Fill-finish is the final manufacturing step in the overall drug 
manufacturing process. This process transfers a sterile drug from a 
filling needle to a sterile container.
On-Shoring
    Building domestic capacity that is otherwise available in other 
Countries.
Pandemic
    A Pandemic is defined as an epidemic that has spread to human 
populations across a large geographic area that is subject to one or 
more declarations under the National Emergencies Act, the Public Health 
Service Act, or the Robert T. Stafford Disaster Relief and Emergency 
Assistance Act, or if the Administrator determines that one or more 
declarations is likely to occur and the epidemic poses a direct threat 
to the national defense or its preparedness programs. For example, 
Coronavirus Disease 2019 (COVID-19).
Participant
    An individual, partnership, corporation, association, or private 
organization, other than a federal agency, that has substantive 
capabilities, resources or expertise to carry out the purpose of the 
Voluntary Agreement, that has been specifically invited to participate 
in the Voluntary Agreement by the Chairperson, and that has applied and 
agreed to the terms of the Voluntary Agreement. ``Participant'' 
includes a corporate or non-corporate entity entering into the 
Voluntary Agreement and all subsidiaries and affiliates of that entity 
in which that entity has 50 percent or more control either by stock 
ownership, board majority, or otherwise. The Administrator may invite 
Participants to join the Voluntary Agreement at any time during its 
effective period.
Plan of Action (Plan)
    This document. A documented method, pursuant to 50 U.S.C. 
4558(b)(2), proposed by FEMA to implement a particular set of 
activities under the Voluntary Agreement, through a Sub-Committee 
focused on a particular Critical Healthcare Resource, or pandemic 
response workstream or functional area necessary for the national 
defense.
Plan of Action Agreement
    A separate commitment made by Participants upon invitation and 
agreement to participate in a Plan of Action as part of one or more 
Sub-Committees. Completing the Plan of Action Agreement confers 
responsibilities on the Participant consistent with those articulated 
in the Plan and affords Participants a defense against antitrust claims 
under section 708 for actions taken to develop or carry out the Plan 
and the appropriate Sub-Committee(s), as described in Section IV below.
Representatives
    The representatives the Administrator identifies and invites to the 
Committee from FEMA, HHS, and other federal agencies with equities in 
this Plan, and empowered to speak on behalf of their agencies' 
interests. The Attorney General and the Chair of the FTC, or their 
delegates, may also attend any meeting as a Representative.
Strategic Investment
    Targeted investments for on-shoring of drug product and drug 
substance manufacturing, including fill-finish capacities.
Sub-Committee
    A body formed by the Administrator from select Participants to 
implement a Plan of Action.
Sub-Committee Chairperson
    FEMA official, appointed by the Chairperson, to chair a Sub-
Committee to implement a Plan of Action. The Sub-Committee Chairperson 
shall be responsible for the overall management and administration of 
the Sub-Committee in furtherance of this Plan while remaining under the 
supervision of the Administrator and the Chairperson.
Sub-Committee Members
    Collectively the Sub-Committee Chairperson(s), Representatives, and 
Sub-Committee Participants. Jointly responsible developing and 
executing this Plan.
Sub-Committee Participant
    A subset of Participants of the Committee, that have been 
specifically invited to participate in a Sub-Committee by the Sub-
Committee Chairperson, and that have applied and agreed to the terms of 
this Plan and signed the Plan of Action Agreement. The Sub-Committee 
Chairperson may invite Participants in the Committee to join a Sub-
Committee as a Sub-Committee Participant at any time during the Plan's 
effective period.

K. Plan of Action Participation

    This Plan will be carried out by a subset of the Participants in 
the Voluntary Agreement through several Sub-Committees:
    (1) Sub-Committee to Define Requirements for COVID-19 Drug 
Products, Drug Substances, and Associated Medical Devices,
    (2) Sub-Committee for Monoclonal Antibodies,
    (3) Sub-Committee for Drug Products, Drug Substances, and 
Associated Medical Devices Related to the Treatment of Respiratory 
Illness,
    (4) Sub-Committee for Drug Products, Drug Substances, and 
Associated Medical Devices Related to Acute and Intensive Care,
    (5) Sub-Committee to Accelerate Coronavirus Treatment,
    (6) Sub-Committee for Strategic Investment Towards On-Shoring of 
Pharmaceutical Manufacturing and Fill-Finish, and
    (7) Sub-Committee for Emergency Use Authorizations.
    FEMA may establish additional Sub-Committees under this Plan, so 
long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of Drug Products, Drug Substances, and Associated Medical 
Devices; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
Requirements for COVID-19 Drug Products, Drug Substances, and 
Associated Medical Devices.
    Each Sub-Committee will consist of the (1) Sub-Committee 
Chairperson(s), (2) Representatives from FEMA, HHS, the Department of 
Justice (DOJ), and other federal agencies with equities in this Plan, 
and (3) Sub-Committee Participants that have substantive capabilities, 
resources or expertise to carry out the purpose of this Plan and have 
signed the Plan of Action Agreement. The Chairperson shall invite Sub-
Committee Participants who, in his or her determination, are reasonably 
representative of the appropriate industry or segment of such industry. 
Other Attendees--invited by the Sub-Committee Chairperson as subject 
matter experts to provide technical advice or to represent the 
interests of other government agencies or interested parties--may also 
participate in Sub-Committee meetings. The naming of these Sub-
Committees does not commit

[[Page 28864]]

the Administrator to creating them unless and until circumstances 
dictate.

L. Effective Date and Duration of Participation

    This Plan is effective immediately upon satisfaction of the 
requirements of DPA section 708(f)(1). This Plan shall remain in effect 
until terminated in accordance with 44 CFR 332.4. It shall be effective 
for no more than five (5) years from August 17, 2020, when the 
requirements of DPA section 708(f)(1) were satisfied for the Voluntary 
Agreement, unless otherwise terminated pursuant to DPA section 
708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 
708(f)(2). No action may take place under this Plan until it is 
activated, as described in Section III(E), below.

M. Withdrawal

    Participation in the Plan is voluntary, as is the acceptance of 
most obligations under the Plan. Sub-Committee Participants may 
withdraw from this Plan or from an individual Sub-Committee at any 
point, subject to the fulfillment of obligations previously agreed upon 
by the Participant prior to the date of withdrawal. Note that the 
obligations outlined in V.B regarding information management and 
associated responsibilities apply once a party has shared or received 
information through a Sub-Committee, and remain in place after the 
party's withdrawal from the Sub-Committee or Plan. If a Sub-Committee 
Participant indicates an intent to withdraw from the Plan due to a 
modification or amendment of the Plan (described below), the Sub-
Committee Participant will not be required to perform actions directed 
by that modification or amendment. Withdrawal from the Plan will 
automatically trigger withdrawal from all Sub-Committees; however, a 
Participant may withdraw from a Sub-Committee without also withdrawing 
from the Plan or other Sub-Committees. To withdraw from the Plan or 
from an individual Sub-Committee, a Participant must provide written 
notice to the Administrator at least fifteen (15) calendar days prior 
to the effective date of that Sub-Committee Participant's withdrawal 
specifying the scope of withdrawal. Following receipt of such notice, 
the Administrator will inform the other Sub-Committee Participants of 
the date and the scope of the withdrawal.
    Upon the effective date of the withdrawal from the Plan, the Sub-
Committee Participant must cease all activities under the Plan. Upon 
the effective date of the withdrawal from one or more Sub-Committee(s), 
the Sub-Committee Participant must cease all activities under the Plan 
that pertain to the withdrawn Sub-Committee(s).

N. Plan of Action Activation and Deactivation

    The Administrator, in consultation with the Chairperson and Sub-
Committee Chairperson, will invite a select group of Participants in 
the Voluntary Agreement to form the following Sub-Committees, beginning 
with the Sub-Committee to Define Requirements for COVID-19 Drug 
Products, Drug Substances, and Associated Medical Devices, which will 
be responsible for implementing this Plan.
    (1) Sub-Committee to Define Requirements for COVID-19 Drug 
Products, Drug Substances, and Associated Medical Devices,
    (2) Sub-Committee for Monoclonal Antibodies,
    (3) Sub-Committee for Drug Products, Drug Substances, and 
Associated Medical Devices Related to the Treatment of Respiratory 
Illness,
    (4) Sub-Committee for Drug Products, Drug Substances, and 
Associated Medical Devices Related to Acute and Intensive Care,
    (5) Sub-Committee to Accelerate Coronavirus Treatment,
    (6) Sub-Committee for Strategic Investment Towards On-Shoring of 
Pharmaceutical Manufacturing and Fill-Finish, and
    (7) Sub-Committee for Emergency Use Authorizations.
    FEMA may establish additional Sub-Committees under this Plan, so 
long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of Drug Products, Drug Substances, and Associated Medical 
Devices; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
Requirements for COVID-19 Drug Products, Drug Substances, and 
Associated Medical Devices.
    This Plan will be activated for each invited Participant when the 
Participant executes a Plan of Action Agreement, and a Participant may 
not participate in a Sub-Committee until the Plan of Action Agreement 
is executed. Participants will be invited to join this Plan at the 
discretion of the Chairperson or the Sponsor to the Voluntary 
Agreement. Participants will be further invited to attend specific 
meetings of one or more Sub-Committees at the discretion of the 
Chairperson.

O. Rules and Regulations

    Sub-Committee Participants acknowledge and agree to comply with all 
provisions of DPA section 708, as amended, and regulations related 
thereto which are promulgated by FEMA, the Department of Homeland 
Security, HHS, the Attorney General, and the FTC. FEMA has promulgated 
standards and procedures pertaining to voluntary agreements in 44 CFR 
part 332. The Administrator shall inform Participants of new rules and 
regulations as they are issued.

P. Modification and Amendment

    The Administrator, after consultation with the Attorney General and 
the Chair of the FTC, may terminate or modify, in writing, this Plan at 
any time. The Attorney General, after consultation with the Chair of 
the FTC and the Administrator, may terminate or modify, in writing, 
this Plan at any time. Sub-Committee Participants may propose 
modifications or amendments to the Plan or to the Sub-Committees at any 
time.
    Where possible, material modifications to the Plan or a Sub-
Committee will be subject to a 30 calendar day delayed implementation 
and opportunity for notice and comment by Sub-Committee Participants to 
the Chairperson. This delayed implementation period may be shortened or 
eliminated if the Administrator deems it necessary. The Administrator 
shall inform Sub-Committee Participants of modifications or amendments 
to the Plan or to the Sub-Committees as they are proposed and issued.
    The Administrator, after consultation with the Attorney General and 
the Chair of the FTC, may remove Sub-Committee Participants from the 
Plan or from a Sub-Committee at any time. The Attorney General, after 
consultation with the Chair of the FTC and the Administrator, may 
remove Sub-Committee Participants from this Plan or from a Sub-
Committee at any time. If a Participant is removed from the Plan or 
from a Sub-Committee, the Participant may request written notice of the 
reasons for removal from the Chairperson, who shall provide such notice 
in a reasonable time-period.

Q. Expenses

    Participation in this Plan or in a Sub-Committee does not confer 
funds to Sub-Committee Participants, nor does it limit or prohibit any 
pre-existing source of funds. Unless otherwise specified, all expenses, 
administrative or otherwise, incurred by Sub-Committee Participants 
associated with participation in this Plan or a Sub-Committee shall be 
borne exclusively by the Sub-Committee Participants.

[[Page 28865]]

R. Record Keeping

    Each Sub-Committee Chairperson shall have primary responsibility 
for maintaining records in accordance with 44 CFR part 332 and shall be 
the official custodian of records related to carrying out this Plan. 
Each Sub-Committee Participant shall maintain for five years all 
minutes of meetings, transcripts, records, documents, and other data, 
including any communications with other Sub-Committee Participants or 
with any other member of the Sub-Committee, including drafts, related 
to the carrying out of this Plan or incorporating data or information 
received in the course of carrying out this Plan. Each Sub-Committee 
Participant agrees to produce to the Administrator, the Attorney 
General, and the Chair of the FTC upon request any item that this 
section requires the Participant to maintain. Any record maintained in 
accordance with 44 CFR part 332 shall be available for public 
inspection and copying, unless exempted on the grounds specified in 5 
U.S.C. 552(b)(1), (3) or (4) or identified as privileged and 
confidential information in accordance with DPA section 705(d), and 44 
CFR 332.5.

XII. Antitrust Defense

    Under the provisions of DPA subsection 708(j), each Sub-Committee 
Participant in this Plan shall have available as a defense to any civil 
or criminal action brought for violation of the antitrust laws (or any 
similar law of any State) with respect to any action to develop or 
carry out this Plan, that such action was taken by the Sub-Committee 
Participant in the course of developing or carrying out this Plan, that 
the Sub-Committee Participant complied with the provisions of DPA 
section 708 and the rules promulgated thereunder, and that the Sub-
Committee Participant acted in accordance with the terms of the 
Voluntary Agreement and this Plan. Except in the case of actions taken 
to develop this Plan, this defense shall be available only to the 
extent the Sub-Committee Participant asserting the defense demonstrates 
that the action was specified in, or was within the scope of, this Plan 
and within the scope of the appropriate Sub-Committee(s), including 
being taken at the direction and under the active supervision of FEMA.
    This defense shall not apply to any actions taken after the 
termination of this Plan. Immediately upon modification of this Plan, 
no defense to antitrust claims under Section 708 shall be available to 
any subsequent action that is beyond the scope of the modified Plan. 
The Sub-Committee Participant asserting the defense bears the burden of 
proof to establish the elements of the defense. The defense shall not 
be available if the person against whom the defense is asserted shows 
that the action was taken for the purpose of violating the antitrust 
laws.

XIII. Terms and Conditions

    As the sponsoring agency, FEMA will maintain oversight over Sub-
Committee activities and direct and supervise actions taken to carry 
out this Plan, including by retaining decision-making authority over 
actions taken pursuant to the Plan to ensure such actions are necessary 
to address a direct threat to the national defense. The Attorney 
General and the Chair of the FTC will monitor activities of the Sub-
Committees to ensure they execute their responsibilities in a manner 
consistent with this Plan and their actions have the least 
anticompetitive effects possible.

A. Plan of Action Execution

    This Plan will be used to support the following objectives to 
respond to a Pandemic by maximizing the manufacture and efficient 
distribution of selected types of Drug Products, Drug Substances, and 
Associated Medical Devices and creating a prioritization protocol for 
End-Users based upon their demonstrated or projected requirements and 
taking into account geographic and regional circumstances. Each Sub-
Committee will undertake the following Objectives for the Drug 
Products, Drug Substances, and Associated Medical Devices within its 
area of jurisdiction.
1. Objectives
    (1) Optimize the timely production of sufficient quantities of Drug 
Products, Drug Substances, and Associated Medical Devices to reduce 
loss of life and transmission of the COVID-19 virus.
    (2) Expand domestic manufacturing of Drug Products, Drug 
Substances, and Associated Medical Devices, including fill-finish 
capacities.
    (3) Ensure Drug Products, Drug Substances, and Associated Medical 
Devices are distributed effectively across the whole community 
nationally based on risk.
    (4) Balance restoration and maintenance of the nation's stockpile 
of Drug Products, Drug Substances, and Associated Medical Devices with 
near-term requirements.
    (5) Establish a process for FEMA Allocation of Drug Products, Drug 
Substances, and Associated Medical Devices nationwide.
    (6) Ensure ongoing competition in the manufacture and distribution 
of Drug Products, Drug Substances, and Associated Medical Devices to 
the greatest extent possible under the DPA.
2. Actions
    Sub-Committee Participants may be asked to support these objectives 
by taking the following specific actions:
    (1) Assist the Chairperson in identifying which types of Drug 
Products, Drug Substances, and Associated Medical Devices should be 
included within each Sub-Committee. Identification will be based upon 
each item's importance to the national response to COVID-19 and whether 
it can be reasonably inferred, based upon the best evidence available, 
that the current and projected supply measured against current and 
projected demand may not adequately meet the Drug Product, Drug 
Substance, and Associated Medical Device requirements to all identified 
End-Users or regional or geographic areas of the country as result of 
measures taken to respond to COVID-19.
    (2) Provide input to the Chairperson in creating a prioritized list 
of Drug Product, Drug Substance, and Associated Medical Device End-
Users by categories for each type of Drug Product, Drug Substance, and 
Associated Medical Device identified by each Sub-Committee, and 
ascertaining the relative demand and supply of Drug Products, Drug 
Substances, and Associated Medical Devices among and within those End-
User categories. Prioritization shall be decided by the Chairperson, 
based upon each item's importance, reflecting the consensus views of 
the Sub-Committee Members that it represents the most effective way to 
save lives and prevent the transmission of the COVID-19 virus. This 
list may be updated throughout the life of the Plan based upon either 
short term or long-term demands. These categories should be considered 
holistically in terms of the Whole-of-Nation response to COVID-19.
    (3) Evaluate the domestic supply of Drug Products, Drug Substances, 
and Associated Medical Devices and identify when the expansion of the 
domestic manufacture of Drug Products, Drug Substances, and Associated 
Medical Devices may be necessary, as directed and decided by the 
Chairperson.
    (4) Provide information, assist, and validate, as necessary as 
decided by the Chairperson, demand projections for Drug Products, Drug 
Substances, and Associated Medical Devices.

[[Page 28866]]

    (5) Create a process for and collaborate in the evaluation of 
competing claims for Drug Products, Drug Substances, and Associated 
Medical Devices from End-Users.
    (6) Prepare a general strategy to accomplish the activities listed 
in V(A)(2)(7) below regarding activities in Exigent Circumstances 
consistent with the decisions made by the Chairperson.
    (7) In Exigent Circumstances, with review and concurrence in all 
possible instances by DOJ in consultation with FTC:
     Facilitate maximum availability of Drug Products, Drug 
Substances, and Associated Medical Devices to the nation or particular 
geographies by deconflicting overlapping demands from the collective 
Participants' customer base, as directed and decided by the 
Chairperson.
     Facilitate maximum availability of Drug Products, Drug 
Substances, and Associated Medical Devices to the nation or particular 
geographies by deconflicting overlapping supply chain demands placed 
upon Members, as directed and decided by the Chairperson.
     Facilitate the efficient distribution of Drug Products, 
Drug Substances, and Associated Medical Devices by deconflicting 
overlapping distribution chain activities of Members, as directed and 
decided by the Chairperson.
     Create a process for and collaborate in the Allocation of 
Drug Products, Drug Substances, and Associated Medical Devices 
nationwide or in particular geographies consistent with the decisions 
made by the Chairperson.
     Create a process for and collaborate in meeting any other 
exigent requirements throughout the nation or particular geographies 
consistent with the overall strategy prepared by this Sub-Committee.
     Create a process for and collaborate in establishing 
expanded domestic Drug Product, Drug Substance, and Associated Medical 
Device manufacturing and fill-finish capacities.
    (8) Provide data and information necessary to validate the efforts 
of the Sub-Committee including the actual and planned amounts of Drug 
Products, Drug Substances, and Associated Medical Devices to be 
distributed throughout the Nation, as determined by the Chairperson.
    (9) Provide feedback to the Sub-Committee on the outcomes of the 
collective efforts of the Sub-Committee Members and any impediments or 
bottlenecks.
    (10) Advise the Chairperson whether additional Participants or 
Attendees should be invited to join this Plan and Sub-Committee.
    (11) Carry out other activities regarding Drug Products, Drug 
Substances, and Associated Medical Devices as identified by Sub-
Committees under this Plan as determined and directed by the 
Chairperson necessary to address the COVID-19 virus' direct threat to 
the national defense, where such activities have been reviewed and 
approved by DOJ and FTC and received concurrence from Sub-Committee 
members.

D. Information Management and Responsibilities

    FEMA will request only that data and information from Sub-Committee 
Participants that is necessary to meet the objectives of the Plan and 
consistent with the scope of the relevant Sub-Committees. Upon signing 
a Plan of Action Agreement for this Plan, FEMA requests that 
Participants endeavor to cooperate with diligence and speed, and to the 
extent permissible under this Plan, and share with FEMA data and 
information necessary to meet the objectives of this Plan.
    Sub-Committee Participants agree to share with FEMA the following 
data with diligence and speed, to the extent permissible under this 
Plan, and abide by the following guidelines, where feasible and 
consistent with the data that is owned by each Sub-Committee 
Participant:
    (1) In general, Participants will not be asked to share 
Competitively Sensitive Information directly with other Participants.
    (2) FEMA will only request direct sharing of Competitively 
Sensitive Information among Participants during Exigent Circumstances 
where there is a mission critical need or timeline such that sharing 
only through FEMA is impractical or threatens the outcome of the Plan 
or Sub-Committee action. Such requests, if made, will be only among 
Participants whose participation is necessary to meet the objectives of 
the Plan, will be limited in scope to the greatest extent possible, and 
will be shared only pursuant to safeguards subject to prior review and 
audit by DOJ and FTC. Direct sharing of Competitively Sensitive 
Information with other Participants will be limited in scope and 
circumstances to the greatest extent possible. Participants may not 
share Competitively Sensitive Information directly with other 
Participants unless specifically requested by FEMA, in consultation 
with DOJ and FTC. All Competitively Sensitive Information delivered to 
FEMA or to another Sub-Committee Participant shall be delivered by 
secure means, for example, password-protected or encrypted electronic 
files or drives with the password/key delivered by separate 
communication or method or via upload to an appropriately secure web 
portal as directed by FEMA. All data delivered to the web portal 
designated by FEMA is deemed to be Competitively Sensitive Information.
    (3) To allow FEMA to identify and appropriately protect documents 
containing Competitively Sensitive Information by the Sub-Committee 
Participant providing the documents, the Sub-Committee Participant will 
make good faith efforts to designate any Competitively Sensitive 
Information by placing restrictive markings on documents and things 
considered to be competitively sensitive, the restrictive markings 
being sufficiently clear in wording and visibility to indicate the 
restricted nature of the data. The Sub-Committee Participant will 
identify Competitively Sensitive Information that is disclosed verbally 
by oral warning. Information designated as competitively sensitive 
will, to the extent allowed by law, be presumed to constitute 
confidential or privileged commercial or financial information, and be 
provided by the Sub-Committee Participant to FEMA with the expectation 
that it will be kept confidential by both parties, as such terms are 
understood in accordance with 5 U.S.C. 552(b)(4) of the Freedom of 
Information Act and federal judicial interpretations of this statute. 
FEMA agrees that to the extent any information designated as 
competitively sensitive by a Sub-Committee Participant is responsive to 
a request for disclosure under the Freedom of Information Act, FEMA 
will consult with the Sub-Committee Participant and afford the 
Participant ten (10) working days to object to any disclosure by FEMA.
    (4) FEMA will make good faith efforts to appropriately recognize 
unmarked Documents containing Competitively Sensitive Information as 
Competitively Sensitive Information. However, FEMA cannot guarantee 
that all unmarked Documents will be recognized as being Competitively 
Sensitive Information and protected from disclosure to third parties. 
If the unmarked Documents have not been disclosed without restriction 
outside of FEMA, the Sub-Committee Participant may retroactively 
request to have appropriate designations placed on the Documents. If 
the unmarked Documents have been disclosed without restriction outside 
of FEMA, FEMA will, to the extent practicable, remove any requested 
information from public forums

[[Page 28867]]

controlled by FEMA and will work promptly to request that a receiving 
party return or destroy disclosed unmarked Documents if requested by 
the Sub-Committee Participant.
    (5) Competitively Sensitive Information may be used by FEMA, alone 
or in combination with additional information, including Documents and 
Competitively Sensitive Information received from third parties, to 
support FEMA's implementation of this Plan as determined by the 
Chairperson. In all situations, FEMA will aggregate and anonymize 
Competitively Sensitive Information to the greatest extent possible to 
protect the interests retained by the owners of the data while still 
allowing the objectives of the Plan and Sub-Committee to be achieved. 
To the greatest extent possible, such aggregation will render the 
competitively sensitive nature of the Competitively Sensitive 
Information of the Sub-Committee Participant no longer recognizable in 
a commercially sensitive manner, and without sufficient information to 
enable, by inference or otherwise, attribution to Sub-Committee 
Participant or its affiliates (as clearly identified and disclosed to 
FEMA). Any disclosure of Competitively Sensitive Information by FEMA, 
within or outside a Sub-Committee, will be subject to review and 
approval by DOJ and FTC.
    (6) Except as otherwise expressly permitted by applicable federal 
law, FEMA shall not disclose any Competitively Sensitive Information or 
use any Competitively Sensitive Information for any purpose other than 
in connection with the purposes of this Plan, and FEMA will not sell 
any Competitively Sensitive Information of any Sub-Committee 
Participant.
    (7) Except as described below, FEMA may disclose Competitively 
Sensitive Information only to its employees, officers, directors, 
contractors, agents, and advisors (including attorneys, accountants, 
consultants, and financial advisors). Any individual with access to 
Competitively Sensitive Information will be expected to comply with the 
terms of this Plan.
    a. Information Sharing within the Sub-Committee: FEMA may share 
Competitively Sensitive Information with Sub-Committee Participants and 
Federal Representatives of the Plan, and their respective employees, 
officers, directors, contractors, agents, and advisors (including 
attorneys, accountants, consultants, and financial advisors) where 
there is a need to know and where disclosure is reasonably necessary in 
furtherance of implementing the Plan. FEMA will aggregate and anonymize 
data prior to sharing with the Sub-Committee Participants to the 
greatest extent possible while still allowing the objectives of the 
Plan to be achieved, and will not share data--particularly to 
competitors of the submitter--prior to consultation with and approval 
by the DOJ and FTC.
    i. Sub-Committee Participants, when providing Competitively 
Sensitive Information to FEMA, may request that this Information not be 
shared with other Sub-Committee Participants. Where these requests are 
made in good faith and are reasonable in nature, FEMA will respect 
these requests to the greatest extent possible and will consult the 
owner of the data prior to any release made to Sub-Committee 
Participants.
    b. Restricted Reports. FEMA may communicate Competitively Sensitive 
Information to appropriate government officials through Restricted 
Reports. The information contained in Restricted Reports shall be 
aggregated and anonymized to the greatest extent possible, while 
recognizing that these officials may need a certain amount of 
granularity and specificity of information to appropriately respond to 
COVID-19. FEMA will aim to aggregate data to the County level, and will 
not share Restricted Reports prior to consultation and approval from 
the DOJ and FTC. FEMA may disclose Restricted Reports to relevant White 
House and Administration officials and State Governors, and their 
respective employees, officers, directors, contractors, agents, and 
advisors (including attorneys, accountants, consultants, and financial 
advisors) who have a need to know and to whom such disclosure is 
reasonably necessary solely in furtherance of the implementation of 
this Plan. FEMA shall take appropriate action (by instructions, 
agreement, or otherwise) to ensure that receiving parties comply with 
all data-sharing confidentiality and obligations under this Plan as if 
such persons or entities had been parties to this Plan.
    c. Public Reports. FEMA may share information with the public 
through Public Reports. Data contained in Public Reports shall be fully 
aggregated and anonymized. Public Reports shall be aggregated to at 
least a state level and may be publicly disclosed after consultation 
and approval from the DOJ and FTC.
    (8) Where possible and not obviated by Exigent Circumstances, FEMA 
will notify Sub-Committee Participants prior to the release of any 
Competitively Sensitive Information that has not been fully aggregated 
and anonymized. In consultation with DOJ and FTC, FEMA will consider 
any good-faith requests made by Sub-Committee members to hold the 
release of data or requests for further aggregation or anonymization. 
In general, FEMA will not provide notification prior to the release of 
Public Reports, under the presumption that the data in these reports 
has already been fully anonymized and de-identified.
    (9) Any party receiving Competitively Sensitive Information through 
this Plan shall use such information solely for the purposes outlined 
in the Plan and take steps, such as imposing previously approved 
firewalls or tracking usage, to prevent misuse of the information. 
Disclosure and use of Competitively Sensitive Information will be 
limited to the greatest extent possible, and any party receiving 
Competitively Sensitive Information shall follow the procedures 
outlined in paragraph 7 above.
    (10) At the conclusion of a Participant's involvement in a Plan--
due to the deactivation of the Plan or due to the Participant's 
withdrawal or removal--each Participant will be requested to sequester 
any and all Competitively Sensitive Information received through 
participation in the Plan. This sequestration shall include the 
deletion of all Competitively Sensitive Information unless required to 
be kept pursuant to the Record Keeping requirements as described supra, 
Section I, 44 CFR part 332, or any other provision of law.

E. Oversight

    Each Sub-Committee Chairperson is responsible for ensuring that the 
Attorney General, or suitable delegate(s) from the DOJ, and the FTC 
Chair, or suitable delegate(s) from the FTC, have awareness of 
activities under this Plan, including activation, deactivation, and 
scheduling of meetings. The Attorney General, the FTC Chair, or their 
delegates may attend Sub-Committee meetings and request to be apprised 
of any activities taken in accordance with activities under this Plan. 
DOJ or FTC Representatives may request and review any proposed action 
by the Sub-Committee or Sub-Committee Participants undertaken pursuant 
to this Plan, including the provision of data. If any DOJ or FTC 
Representative believes any actions proposed or taken are not 
consistent with relevant antitrust protections provided by the DPA, he 
or she shall provide warning and guidance to the Sub-Committee as soon 
as the potential issue is identified. If questions arise about the 
antitrust protections applicable to any particular action, FEMA may 
request DOJ, in consultation with the FTC, provide an opinion on the

[[Page 28868]]

legality of the action under relevant DPA antitrust protections.

XIV. Establishment of the Sub-Committees

    This Plan establishes Sub-Committees to implement the Plan 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 to provide the Federal Government and 
the Participants a forum to maximize the manufacture and efficient 
distribution of selected types of Drug Products, Drug Substances, and 
Associated Medical Devices and to create a prioritization protocol 
based upon identified types of Drug Product, Drug Substance, and 
Associated Medical Device End-Users and their demonstrated or projected 
requirements, and demonstrated or projected geographic and regional 
areas of need. The outcome should include a framework to expeditiously 
meet any Drug Product, Drug Substance, and Associated Medical Device 
needs in Exigent Circumstances anywhere in the Nation, and to ensure 
that actions to support Drug Product, Drug Substance, and Associated 
Medical Device stockpiling and reserves do not interfere with immediate 
requirements that would result in an unacceptable risk to healthcare 
providers or other potential Drug Product, Drug Substance, and 
Associated Medical Device recipients. A Sub-Committee Chairperson 
designated by the Chairperson will convene and preside over each Sub-
Committee. Sub-Committees will not be used for contract negotiations or 
contract discussions between the Participants and the Federal 
Government; such negotiations or discussions will be in accordance with 
applicable federal contracting policies and procedures. However, this 
shall not limit any discussion within a Sub-Committee about the 
operational utilization of existing and potential contracts between the 
Participants and Representatives when seeking to align their use with 
overall manufacturing and distribution efforts consistent with this 
Plan.
    Each Sub-Committee will consist of designated Representatives from 
FEMA, HHS, other federal agencies with equities in this Plan, and each 
Sub-Committee Participant. The Attorney General and Chair of the FTC, 
or their delegates, may also join each Sub-Committee and attend 
meetings at their discretion. Attendees may also be invited at the 
discretion of a Sub-Committee Chairperson as subject matter experts, to 
provide technical advice, or to represent other government agencies, 
but will not be considered part of the Sub-Committee.
    To the extent necessary to respond to the Pandemic, only at the 
explicit direction of a Sub-Committee Chairperson, and subject to the 
provisions of Section V(B), Sub-Committee Members may be asked to 
provide technical advice, share information, help identify and validate 
places and resources of the greatest need, help project future 
manufacturing and distribution demands, assist in identifying and 
resolving the allocation of scarce resources amongst all necessary 
public and private sector domestic needs under Exigent Circumstances, 
and take any other necessary actions to maximize the timely manufacture 
and distribution of Drug Products, Drug Substances, and Associated 
Medical Devices as determined necessary by FEMA to respond to the 
Pandemic. A Sub-Committee Chairperson or his or her designee, at the 
Sub-Committee Chairperson's sole discretion, will make decisions on 
these issues in order to ensure the maximum efficiency and 
effectiveness in the use of Sub-Committee Member's resources. All Sub-
Committee Participants will be invited to open Sub-Committee meetings. 
For selected Sub-Committee meetings, attendance may be limited to 
designated Sub-Committee Participants to meet specific operational 
requirements, as determined by FEMA.
    Each Sub-Committee Chairperson shall notify the Attorney General, 
the Chair of the FTC, Representatives, and Participants of the time, 
place, and nature of each meeting and of the proposed agenda of each 
meeting to be held to carry out this Plan. Additionally, each Sub-
Committee Chairperson shall provide for publication in the Federal 
Register of a notice of the time, place, and nature of each meeting. If 
a meeting is open, a Federal Register notice will be published 
reasonably in advance of the meeting. A Sub-Committee Chairman may 
restrict attendance at meetings only on the grounds outlined by 44 CFR 
332.5(c)(1)-(3). If a meeting is closed, a Federal Register notice will 
be published within ten (10) days of the meeting and will include the 
reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2).
    The Sub-Committee Chairperson shall establish the agenda for each 
meeting, be responsible for adherence to the agenda, and provide for a 
written summary or other record of each meeting and provide copies of 
transcripts or other records to FEMA, the Attorney General, the Chair 
of the FTC, and all Sub-Committee Participants. The Chairperson shall 
take necessary actions to protect from public disclosure any data 
discussed with or obtained from Sub-Committee Participants which a Sub-
Committee Participant has identified as a trade secret or as privileged 
and confidential in accordance with DPA sections 708(h)(3) and 705(d), 
or which qualifies for withholding under 44 CFR 332.5.

XV. Application and Agreement

    The Sub-Committee Participant identified below hereby agrees to 
join in the Federal Emergency Management Agency sponsored Plan of 
Action to Establish a National Strategy for the Manufacture, 
Allocation, and Distribution of Drug Products, Drug Substances, and 
Associated Medical Devices under the Voluntary Agreement for the 
Manufacture and Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic and to become a Participant in one or more Sub-
Committees established by this Plan. This Plan will be published in the 
Federal Register. This Plan is authorized under section 708 of the 
Defense Production Act of 1950, as amended. Regulations governing the 
Voluntary Agreement for the Manufacture and Distribution of Healthcare 
Resources Necessary to Respond to a Pandemic and all subsequent Plans 
of Action at 44 CFR part 332. The applicant, as a Sub-Committee 
Participant, agrees to comply with the provisions of section 708 of the 
Defense Production Act of 1950, as amended, the regulations at 44 CFR 
part 332, and the terms of this Plan.

XVI. Assignment

    No Sub-Committee Participant may assign or transfer this Plan, in 
whole or in part, or any protections, rights or obligations hereunder 
without the prior written consent of the Sub-Committee Chairperson. 
When requested, the Sub-Committee Chairperson will respond to written 
requests for consent within 10 (ten) business days of receipt.

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[[Page 28869]]

Text of the Plan of Action To Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Medical Devices To Respond 
to COVID-19 Implemented Under the Voluntary Agreement for the 
Manufacture and Distribution of Critical Healthcare Resources Necessary 
To Respond to a Pandemic

Plan of Action To Establish a National Strategy for the Manufacture, 
Allocation, and Distribution of Medical Devices To Respond to COVID-19 
Implemented Under the Voluntary Agreement for the Manufacture and 
Distribution of Critical Healthcare Resources Necessary To Respond to a 
Pandemic

Preface

    Pursuant to section 708 of the Defense Production Act of 1950 
(DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management 
Agency (FEMA) Administrator (Administrator), after consultation with 
the Secretary of the Department of Health and Human Services (HHS), the 
Attorney General of the United States (Attorney General), and the Chair 
of the Federal Trade Commission (FTC), developed a Voluntary Agreement 
for the Manufacture and Distribution of Critical Healthcare Resources 
Necessary to Respond to a Pandemic (Voluntary Agreement), 85 FR 50035 
(August 17, 2020). The Voluntary Agreement, which operates through a 
series of Plans of Action, maximizes the manufacture and efficient 
distribution of Critical Healthcare Resources nationwide to respond to 
a pandemic by establishing unity of effort between Participants and the 
Federal Government for integrated coordination, planning, information 
sharing with FEMA, as authorized by FEMA, and allocation and 
distribution of Critical Healthcare Resources.
    This document establishes a Plan of Action (Plan) to Establish a 
National Strategy for the Manufacture, Allocation, and Distribution of 
Medical Devices to Respond to COVID-19. This Plan will be implemented 
under the Voluntary Agreement by several Sub-Committees.
    (1) Sub-Committee to Define COVID-19 Medical Device Requirements,
    (2) Sub-Committee for General Hospital Devices,
    (3) Sub-Committee for Immunology Devices,
    (4) Sub-Committee for Microbiology Devices,
    (5) Sub-Committee for Pathology Devices, and
    (6) Sub-Committee for Toxicology Devices.
    The Sub-Committee to Define COVID-19 Medical Device Requirements 
will be formed first.
    FEMA may establish additional Sub-Committees under this Plan, so 
long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of Medical Device; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
COVID-19 Medical Device Requirements.
    The purpose of the Plan and the Sub-Committees is to maximize the 
manufacture and efficient distribution of selected types of Medical 
Devices and create a prioritization protocol for End-Users based upon 
their demonstrated or projected requirements including geographic and 
regional circumstances. The primary goal of the Plan is to create 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. When the requirements of the 
Plan are met, it affords Sub-Committee Participants defenses to civil 
and criminal actions brought under the antitrust laws (or any similar 
law of any state) for actions taken within the scope of the Plan. The 
Plan is designed to foster a close working relationship among FEMA, 
HHS, and Sub-Committee Participants to address national defense needs 
through cooperative action under the direction and active supervision 
of FEMA.

Table of Contents

I. Purpose.....................................................      421
II. Authorities................................................      421
III. General Provisions........................................      421
    A. Definitions.............................................      421
    B. Plan of Action Participation............................      425
    C. Effective Date and Duration of Participation............      426
    D. Withdrawal..............................................      426
    E. Plan of Action Activation and Deactivation..............      427
    F. Rules and Regulations...................................      427
    G. Modification and Amendment..............................      428
    H. Expenses................................................      428
    I. Record Keeping..........................................      428
IV. Antitrust Defense..........................................      429
V. Terms and Conditions........................................      429
    A. Plan of Action Execution................................      429
    B. Information Management and Responsibilities.............      431
    C. Oversight...............................................      435
VI. Establishment of the Sub-Committees........................      436
VII. Application and Agreement.................................      437
VIII. Assignment...............................................      438
 

XVII. Purpose

    A pandemic may present conditions that pose a direct threat to the 
national defense of the United States or its preparedness programs such 
that, pursuant to DPA section 708(c)(1), an agreement to collectively 
coordinate, plan, and collaborate for the manufacture and distribution 
of Medical Devices is necessary for the national defense. This Plan of 
Action to Establish a National Strategy for the Manufacture, 
Allocation, and Distribution of Medical Devices to Respond to COVID-19 
is established under the Voluntary Agreement and establishes six Sub-
Committees to oversee and implement the Plan. The Plan and Sub-
Committees will optimize the manufacture and the efficient distribution 
of selected types of Medical Devices and create a prioritization 
protocol for End-Users based upon their demonstrated or projected 
requirements.

XVIII. Authorities

    Section 708, Defense Production Act (50 U.S.C. 4558); sections 
402(2) & 501(b), Robert T. Stafford Disaster Relief and Emergency 
Assistance Act (42 U.S.C. 5121-5207); sections 503(b)(2)(B) & 
504(a)(10) & (16) of the Homeland Security Act of 2002 (6 U.S.C. 
313(b)(2)(B), 314(a)(10) & (16)); sections

[[Page 28870]]

201, 301, National Emergencies Act (50 U.S.C. 1601 et seq.); section 
319, Public Health Service Act (42 U.S.C. 247d); Executive Order (E.O.) 
13911, 85 FR 18403 (March 27, 2020); Prioritization and Allocation of 
Certain Scarce or Threatened Health and Medical Resources for Domestic 
Use, 85 FR 20195 (April 10, 2020). Pursuant to DPA section 
708(f)(1)(A), the Administrator certifies that this Plan is necessary 
for the national defense.

XIX. General Provisions

S. Definitions

Administrator
    The FEMA Administrator is the Sponsor of the Voluntary Agreement. 
Pursuant to a delegation or redelegation of the functions given to the 
President by DPA section 708, the Administrator proposes and provides 
for the development and carrying out of the Voluntary Agreement, 
including through the development and implementation of Plans of 
Action. The Administrator is responsible for carrying out all duties 
and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and 
for appointing one or more Chairpersons to manage and administer the 
Committee and all Sub-Committees formed to carry out the Voluntary 
Agreement.
Agreement
    The Voluntary Agreement for the Manufacture and Distribution of 
Critical Healthcare Resources Necessary to Respond to a Pandemic 
(Voluntary Agreement).
Allocation
    The process of determining and directing the relative distribution 
among one or more competing requests from End-Users for the same 
Medical Devices. Through the Allocation process, FEMA--with 
participation from Sub-Committee Participants--will assess the actual 
needs of End-Users and determine how to divide the available and 
projected supply of Medical Devices to minimize impacts to life, 
safety, and economic disruption associated with shortages of Medical 
Devices. Allocation will take place only under Exigent Circumstances. 
FEMA retains decision-making authority for all Allocation under this 
Plan.
Attendees
    Subject matter experts, invited by the Chairperson or a Sub-
Committee Chairperson to attend meetings authorized under the Voluntary 
Agreement or this Plan, to provide technical advice or to represent 
other government agencies or interested parties. Invitations to 
attendees will be extended as required for Committee or Sub-Committee 
meetings and deliberations.
Chairperson
    FEMA senior executive(s), appointed by the Administrator, to chair 
the Committee for the Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic (Committee). The Chairperson shall be responsible 
for the overall management and administration of the Committee, the 
Voluntary Agreement, and Plans of Action developed under the Voluntary 
Agreement while remaining under the supervision of the Administrator; 
shall initiate, or approve in advance, each meeting held to discuss 
problems, determine policies, recommend actions, and make decisions 
necessary to carry out the Voluntary Agreement; appoint one or more co-
Chairpersons to chair the Committee, and otherwise shall carry out all 
duties and responsibilities assigned to him. With the approval of the 
Administrator, the Chairperson may create one or more Sub-Committees, 
and may appoint one or more Sub-Committee Chairpersons to chair the 
Sub-Committees, as appropriate.
Committee
    Committee for the Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic established under the Voluntary Agreement.
Competitively Sensitive Information
    Competitively Sensitive Information that is shared pursuant to this 
Plan may include any Document or other tangible thing or oral 
transmission that contains financial, business, commercial, scientific, 
technical, economic, or engineering information or data, including, but 
not limited to

 financial statements and data,
 customer and supplier lists,
 price and other terms of sale to customers,
 sales records, projections and forecasts,
 inventory levels,
 capacity and capacity utilization,
 cost information,
 sourcing and procurement information,
 manufacturing and production information,
 delivery and shipping information,
 systems and data designs, and
 methods, techniques, processes, procedures, programs, codes, 
or similar information,

whether tangible or intangible, and regardless of the method of 
storage, compilation, or recordation, if the owner thereof has taken 
reasonable measures to protect the information from disclosure to the 
public or competitors. These measures may be evidenced by marking or 
labeling the items as ``competitively sensitive information'' during 
submission to FEMA or in the Participant's customary and existing 
treatment of such information (regardless of labeling).
    All Competitively Sensitive Information provided by a Sub-Committee 
Participant as described herein is deemed Competitively Sensitive 
Information, except for Information that:
    a. Is published or has been made publicly available at the time of 
disclosure by the Sub-Committee Participant;
    b. was in the possession of, or was lawfully and readily available 
to, FEMA from another source at the time of disclosure without 
breaching any obligation of confidentiality applicable to the other 
source; or
    c. was independently developed or acquired without reference to or 
reliance upon the Sub-Committee Participant's Competitively Sensitive 
Information;

Where information deemed Competitively Sensitive Information is 
required to be disclosed by law, regulation, or court order, the 
``Competitively Sensitive'' (or substantially similar) label will 
continue to attach to all information and portion(s) of documents that 
are not made public through the required disclosure.
Document
    Any information, on paper or in electronic/audio/visual format, 
including written, recorded, and graphic materials of every kind, in 
the possession, custody, or control of the Participant and used or 
shared in the course of participation in the Voluntary Agreement or a 
subsequent Plan of Action.
End-User
    This includes all direct and ancillary medical support including, 
but not limited to, hospitals, independent healthcare providers, 
nursing homes, medical laboratories, dental care providers, independent 
physician offices, first responders, alternate care facilities and the 
general public that reasonably represents the totality of the nation's 
response to COVID-19. ``End-User'' may also include essential workers 
necessary to maintain or restore critical infrastructure operations, 
including but not limited to law

[[Page 28871]]

enforcement, education, food and agriculture, energy, water and 
wastewater, and public works personnel.
Exigent Circumstances
    As determined by the Chairperson, the actual or forecasted shortage 
of a particular type or types of Medical Devices which likely cannot be 
fulfilled via usual market mechanisms for an acute, critical time 
period, and where immediate and substantial harm is projected to occur 
from lack of intervention.
General Hospital Devices
    Refers to general hospital and personal use devices intended for 
human use that are in commercial distribution, as classified and 
described in 21 CFR 880.
Immunology Devices
    Refers to immunology devices intended for human use that are in 
commercial distribution, as classified and described in 21 CFR 866.
Medical Device
    Defined under Section 201(h) of the Food, Drug and Cosmetic Act (21 
U.S.C. 321) as an instrument, apparatus, implement, machine, 
contrivance, implant, in vitro reagent, or other similar or related 
article, including a component part, or accessory which is:
    1. Recognized in the official National Formulary, or the United 
States Pharmacopoeia, or any supplement to them,
    2. intended for use in the diagnosis of disease or other 
conditions, or in the cure, mitigation, treatment, or prevention of 
disease, in man or other animals, or
    3. intended to affect the structure or any function of the body of 
man or other animals, and which does not achieve its primary intended 
purposes through chemical action within or on the body of man or other 
animals and

which does not achieve its primary intended purposes through chemical 
action within or on the body of man or other animals and which is not 
dependent upon being metabolized for the achievement of its primary 
intended purposes. The term ``device'' does not include software 
functions excluded pursuant to section 520(o) of the Food, Drug and 
Cosmetic Act.
Microbiology Devices
    Refers to microbiology devices intended for human use that are in 
commercial distribution, as classified and described in 21 CFR 866.
Pandemic
    A Pandemic is defined as an epidemic that has spread to human 
populations across a large geographic area that is subject to one or 
more declarations under the National Emergencies Act, the Public Health 
Service Act, or the Robert T. Stafford Disaster Relief and Emergency 
Assistance Act, or if the Administrator determines that one or more 
declarations is likely to occur and the epidemic poses a direct threat 
to the national defense or its preparedness programs. For example, 
Coronavirus Disease 2019 (COVID-19).
Participant
    An individual, partnership, corporation, association, or private 
organization, other than a federal agency, that has substantive 
capabilities, resources or expertise to carry out the purpose of the 
Voluntary Agreement, that has been specifically invited to participate 
in the Voluntary Agreement by the Chairperson, and that has applied and 
agreed to the terms of the Voluntary Agreement. ``Participant'' 
includes a corporate or non-corporate entity entering into the 
Voluntary Agreement and all subsidiaries and affiliates of that entity 
in which that entity has 50 percent or more control either by stock 
ownership, board majority, or otherwise. The Administrator may invite 
Participants to join the Voluntary Agreement at any time during its 
effective period.
Pathology Devices
    Refers to pathology devices intended for human use that are in 
commercial distribution, as classified and described in 21 CFR 864.
Plan of Action (Plan)
    This document. A documented method, pursuant to 50 U.S.C. 
4558(b)(2), proposed by FEMA to implement a particular set of 
activities under the Voluntary Agreement, through a Sub-Committee 
focused on a particular Critical Healthcare Resource, or pandemic 
response workstream or functional area necessary for the national 
defense.
Plan of Action Agreement
    A separate commitment made by Participants upon invitation and 
agreement to participate in a Plan of Action as part of one or more 
Sub-Committees. Completing the Plan of Action Agreement confers 
responsibilities on the Participant consistent with those articulated 
in the Plan of Action and affords Participants a defense against 
antitrust claims under section 708 for actions taken to develop or 
carry out the Plan and the appropriate Sub-Committee(s), as described 
in Section IV below.
Representatives
    The representatives the Administrator identifies and invites to the 
Committee from FEMA, HHS, and other federal agencies with equities in 
this Plan, and empowered to speak on behalf of their agencies' 
interests. The Attorney General and the Chair of the FTC, or their 
delegates, may also attend any meeting as a Representative.
Sub-Committee
    A body formed by the Administrator from select Participants to 
implement a Plan of Action.
Sub-Committee Chairperson
    FEMA executive, appointed by the Chairperson, to chair a Sub-
Committee to implement a Plan of Action. The Sub-Committee Chairperson 
shall be responsible for the overall management and administration of 
the Sub-Committee in furtherance of this Plan while remaining under the 
supervision of the Administrator and the Chairperson.
Sub-Committee Members
    Collectively the Sub-Committee Chairperson(s), Representatives, and 
Sub-Committee Participants. Jointly responsible developing and 
executing this Plan.
Sub-Committee Participant
    A subset of Participants of the Committee, that have been 
specifically invited to participate in a Sub-Committee by the Sub-
Committee Chairperson, and that have applied and agreed to the terms of 
this Plan and signed the Plan of Action Agreement. The Sub-Committee 
Chairperson may invite Participants in the Committee to join a Sub-
Committee as a Sub-Committee Participant at any time during the Plan's 
effective period.
Toxicology Devices
    Refers to clinical toxicology devices intended for human use that 
are in commercial distribution, as classified and described in 21 CFR 
862.

T. Plan of Action Participation

    This Plan will be carried out by a subset of Participants in the 
Voluntary Agreement through several Sub-Committees:
    (1) Sub-Committee to Define COVID-19 Medical Device Requirements,
    (2) Sub-Committee for General Hospital Devices,
    (3) Sub-Committee for Immunology Devices,

[[Page 28872]]

    (4) Sub-Committee for Microbiology Devices,
    (5) Sub-Committee for Pathology Devices, and
    (6) Sub-Committee for Toxicology Devices
    The Sub-Committee to Define COVID-19 Medical Device Requirements 
will be formed first.
    FEMA may establish additional Sub-Committees under this Plan, so 
long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of Medical Device; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
COVID-19 Medical Device Requirements.
    Each Sub-Committee will consist of the (1) Sub-Committee 
Chairperson(s), (2) Representatives from FEMA, HHS, the Department of 
Justice (DOJ), and other federal agencies with equities in this Plan, 
and (3) Sub-Committee Participants that have substantive capabilities, 
resources or expertise to carry out the purpose of this Plan and have 
signed the Plan of Action Agreement. The Chairperson shall invite Sub-
Committee Participants who, in his or her determination, are reasonably 
representative of the appropriate industry or segment of such industry. 
Other Attendees--invited by the Sub-Committee Chairperson as subject 
matter experts to provide technical advice or to represent the 
interests of other government agencies or interested parties--may also 
participate in Sub-Committee meetings. The naming of these Sub-
Committees does not commit the Administrator to creating them unless 
and until circumstances dictate.

U. Effective Date and Duration of Participation

    This Plan is effective immediately upon satisfaction of the 
requirements of DPA section 708(f)(1). This Plan shall remain in effect 
until terminated in accordance with 44 CFR 332.4. It shall be effective 
for no more than five (5) years from August 17, 2020, when the 
requirements of DPA section 708(f)(1) were satisfied for the Voluntary 
Agreement, unless otherwise terminated pursuant to DPA section 
708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 
708(f)(2). No action may take place under this Plan until it is 
activated, as described in Section III(E), below.

V. Withdrawal

    Participation in the Plan is voluntary, as is the acceptance of 
most obligations under the Plan. Sub-Committee Participants may 
withdraw from this Plan or from an individual Sub-Committee at any 
point, subject to the fulfillment of obligations previously agreed upon 
by the Participant prior to the date of withdrawal. Note that the 
obligations outlined in V.B regarding information management and 
associated responsibilities apply once a party has shared or received 
information through a Sub-Committee, and remain in place after the 
party's withdrawal from the Sub-Committee or Plan. If a Sub-Committee 
Participant indicates an intent to withdraw from the Plan due to a 
modification or amendment of the Plan (described below), the Sub-
Committee Participant will not be required to perform actions directed 
by that modification or amendment. Withdrawal from the Plan will 
automatically trigger withdrawal from all Sub-Committees; however, a 
Participant may withdraw from a Sub-Committee without also withdrawing 
from the Plan or other Sub-Committees. To withdraw from the Plan or 
from an individual Sub-Committee, a Participant must provide written 
notice to the Administrator at least fifteen (15) calendar days prior 
to the effective date of that Sub-Committee Participant's withdrawal 
specifying the scope of withdrawal. Following receipt of such notice, 
the Administrator will inform the other Sub-Committee Participants of 
the date and the scope of the withdrawal.
    Upon the effective date of the withdrawal from the Plan, the Sub-
Committee Participant must cease all activities under the Plan. Upon 
the effective date of the withdrawal from one or more Sub-Committee(s), 
the Sub-Committee Participant must cease all activities under the Plan 
that pertain to the withdrawn Sub-Committee(s).

W. Plan of Action Activation and Deactivation

    The Administrator, in consultation with the Chairperson and Sub-
Committee Chairperson, will invite a select group of Participants in 
the Voluntary Agreement to form the following Sub-Committees, beginning 
with the Sub-Committee to Define COVID-19 Medical Device Requirements, 
which will be responsible for implementing this Plan.
    (1) Sub-Committee to Define COVID-19 Medical Device Requirements,
    (2) Sub-Committee for General Hospital Devices,
    (3) Sub-Committee for Immunology Devices,
    (4) Sub-Committee for Microbiology Devices,
    (5) Sub-Committee for Pathology Devices, and
    (6) Sub-Committee for Toxicology Devices

FEMA may establish additional Sub-Committees under this Plan, so long 
as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of Medical Device; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
COVID-19 Medical Device Requirements.
    This Plan will be activated for each invited Participant when the 
Participant executes a Plan of Action Agreement, and a Participant may 
not participate in a Sub-Committee until the Plan of Action Agreement 
is executed. Participants will be invited to join this Plan at the 
discretion of the Chairperson or the Sponsor to the Voluntary 
Agreement. Participants will be further invited to attend specific 
meetings of one or more Sub-Committees at the discretion of the 
Chairperson.

X. Rules and Regulations

    Sub-Committee Participants acknowledge and agree to comply with all 
provisions of DPA section 708, as amended, and regulations related 
thereto which are promulgated by FEMA, the Department of Homeland 
Security, HHS, the Attorney General, and the FTC. FEMA has promulgated 
standards and procedures pertaining to voluntary agreements in 44 CFR 
part 332. The Administrator shall inform Participants of new rules and 
regulations as they are issued.

Y. Modification and Amendment

    The Administrator, after consultation with the Attorney General and 
the Chair of the FTC, may terminate or modify, in writing, this Plan at 
any time. The Attorney General, after consultation with the Chair of 
the FTC and the Administrator, may terminate or modify, in writing, 
this Plan at any time. Sub-Committee Participants may propose 
modifications or amendments to the Plan or to the Sub-Committees at any 
time.
    Where possible, material modifications to the Plan or a Sub-
Committee will be subject to a 30 calendar day delayed implementation 
and opportunity for notice and comment by Sub-Committee Participants to 
the Chairperson. This delayed implementation period may be shortened or 
eliminated if the Administrator deems it necessary. The Administrator 
shall inform Sub-Committee Participants of modifications or amendments 
to the Plan or to the Sub-Committees as they are proposed and issued.

[[Page 28873]]

    The Administrator, after consultation with the Attorney General and 
the Chair of the FTC, may remove Sub-Committee Participants from the 
Plan or from a Sub-Committee at any time. The Attorney General, after 
consultation with the Chair of the FTC and the Administrator, may 
remove Sub-Committee Participants from this Plan or from a Sub-
Committee at any time. If a Participant is removed from the Plan or 
from a Sub-Committee, the Participant may request written notice of the 
reasons for removal from the Chairperson, who shall provide such notice 
in a reasonable time period.

Z. Expenses

    Participation in this Plan or in a Sub-Committee does not confer 
funds to Sub-Committee Participants, nor does it limit or prohibit any 
pre-existing source of funds. Unless otherwise specified, all expenses, 
administrative or otherwise, incurred by Sub-Committee Participants 
associated with participation in this Plan or a Sub-Committee shall be 
borne exclusively by the Sub-Committee Participants.

AA. Record Keeping

    Each Sub-Committee Chairperson shall have primary responsibility 
for maintaining records in accordance with 44 CFR part 332 and shall be 
the official custodian of records related to carrying out this Plan. 
Each Sub-Committee Participant shall maintain for five years all 
minutes of meetings, transcripts, records, documents, and other data, 
including any communications with other Sub-Committee Participants or 
with any other member of the Sub-Committee, including drafts, related 
to the carrying out of this Plan or incorporating data or information 
received in the course of carrying out this Plan. Each Sub-Committee 
Participant agrees to produce to the Administrator, the Attorney 
General, and the Chair of the FTC upon request any item that this 
section requires the Participant to maintain. Any record maintained in 
accordance with 44 CFR part 332 shall be available for public 
inspection and copying, unless exempted on the grounds specified in 5 
U.S.C. 552(b)(1), (3) or (4) or identified as privileged and 
confidential information in accordance with DPA section 705(d), and 44 
CFR 332.5.

XX. Antitrust Defense

    Under the provisions of DPA subsection 708(j), each Sub-Committee 
Participant in this Plan shall have available as a defense to any civil 
or criminal action brought for violation of the antitrust laws (or any 
similar law of any State) with respect to any action to develop or 
carry out this Plan, that such action was taken by the Sub-Committee 
Participant in the course of developing or carrying out this Plan, that 
the Sub-Committee Participant complied with the provisions of DPA 
section 708 and the rules promulgated thereunder, and that the Sub-
Committee Participant acted in accordance with the terms of the 
Voluntary Agreement and this Plan. Except in the case of actions taken 
to develop this Plan, this defense shall be available only to the 
extent the Sub-Committee Participant asserting the defense demonstrates 
that the action was specified in, or was within the scope of, this Plan 
and within the scope of the appropriate Sub-Committee(s), including 
being taken at the direction and under the active supervision of FEMA.
    This defense shall not apply to any actions taken after the 
termination of this Plan. Immediately upon modification of this Plan, 
no defense to antitrust claims under Section 708 shall be available to 
any subsequent action that is beyond the scope of the modified Plan. 
The Sub-Committee Participant asserting the defense bears the burden of 
proof to establish the elements of the defense. The defense shall not 
be available if the person against whom the defense is asserted shows 
that the action was taken for the purpose of violating the antitrust 
laws.

XXI. Terms and Conditions

    As the sponsoring agency, FEMA will maintain oversight over Sub-
Committee activities and direct and supervise actions taken to carry 
out this Plan, including by retaining decision-making authority over 
actions taken pursuant to the Plan to ensure such actions are necessary 
to address a direct threat to the national defense. The Attorney 
General and the Chair of the FTC will monitor activities of the Sub-
Committees to ensure they execute their responsibilities in a manner 
consistent with this Plan and their actions have the least 
anticompetitive effects possible.

A. Plan of Action Execution

    This Plan will be used to support the following objectives to 
respond to a Pandemic by maximizing the manufacture and efficient 
distribution of selected types of Medical Devices and creating a 
prioritization protocol for End-Users based upon their demonstrated or 
projected requirements and taking into account geographic and regional 
circumstances. Each Sub-Committee will undertake the following 
Objectives for the Medical Devices within its area of jurisdiction.
1. Objectives
    (1) Optimize the timely production of sufficient quantities of 
Medical Devices to reduce loss of life and transmission of the COVID-19 
virus.
    (2) Ensure Medical Devices are distributed effectively across the 
whole community nationally based on risk.
    (3) Balance restoration and maintenance of the nation's stockpile 
of Medical Devices with near-term requirements.
    (4) Establish a process for FEMA Allocation of Medical Devices 
nationwide.
    (5) Ensure ongoing competition in the manufacture and distribution 
of Medical Devices to the greatest extent possible under the DPA.
2. Actions
    Sub-Committee Participants may be asked to support these objectives 
by taking the following specific actions:
    (1) Assist the Chairperson in identifying which types of Medical 
Devices should be included within each Sub-Committee. Identification 
will be based upon each item's importance to the national response to 
COVID-19 and whether it can be reasonably inferred, based upon the best 
evidence available, that that current and projected supply measured 
against current and projected demand may not adequately meet the 
Medical Device requirements to all identified End-Users or regional or 
geographic areas of the country as result of measures taken to respond 
to COVID-19.
    (2) Provide input to the Chairperson in creating a prioritized list 
of Medical Device End-Users by categories for each type of Medical 
Device identified by each Sub-Committee and ascertaining the relative 
demand and supply of Medical Devices among and within those End-User 
categories. Prioritization shall be decided by the Chairperson, based 
upon each item's importance, reflecting the consensus views of the Sub-
Committee Members that it represents the most effective way to save 
lives and prevent the transmission of the COVID-19 virus. This list may 
be updated throughout the life of the Plan based upon either short term 
or long-term demands. These categories should be considered 
holistically in terms of the Whole-of-Nation response to COVID-19.
    (3) Evaluate the domestic supply of Medical Devices and identify 
when the expansion of the domestic manufacture of Medical Devices may 
be necessary, as directed and decided by the Chairperson.
    (4) Provide information, assist, and validate, as necessary as 
decided by the

[[Page 28874]]

Chairperson, demand projections for Medical Devices.
    (5) Create a process for and collaborate in the evaluation of 
competing claims for Medical Devices from End-Users.
    (6) Prepare a general strategy to accomplish the activities listed 
in V(A)(2)(7) below regarding activities in Exigent Circumstances 
consistent with the decisions made by the Chairperson.
    (7) In Exigent Circumstances, with review and concurrence in all 
possible instances by DOJ in consultation with FTC:
     Facilitate maximum availability of Medical Devices to the 
nation or particular geographies by deconflicting overlapping demands 
from the collective Participants' customer base, as directed and 
decided by the Chairperson.
     Facilitate maximum availability of Medical Devices to the 
nation or particular geographies by deconflicting overlapping supply 
chain demands placed upon Members, as directed and decided by the 
Chairperson.
     Facilitate the efficient distribution of Medical Devices 
by deconflicting overlapping distribution chain activities of Members, 
as directed and decided by the Chairperson.
     Create a process for and collaborate in the Allocation of 
Medical Devices nationwide or in particular geographies consistent with 
the decisions made by the Chairperson.
     Create a process for and collaborate in meeting any other 
exigent requirements throughout the nation or particular geographies 
consistent with the overall strategy prepared by this Sub-Committee.
    (8) Provide data and information necessary to validate the efforts 
of the Sub-Committee including the actual and planned amounts of 
Medical Devices to be distributed throughout the Nation, as determined 
by the Chairperson.
    (9) Provide feedback to the Sub-Committee on the outcomes of the 
collective efforts of the Sub-Committee Members and any impediments or 
bottlenecks.
    (10) Advise the Chairperson whether additional Participants or 
Attendees should be invited to join this Plan and Sub-Committee.
    (11) Carry out other activities regarding Medical Devices as 
identified by Sub-Committees under this Plan as determined and directed 
by the Chairperson necessary to address the COVID-19 virus' direct 
threat to the national defense, where such activities have been 
reviewed and approved by DOJ and FTC and received concurrence from Sub-
Committee members.

F. Information Management and Responsibilities

    FEMA will request only that data and information from Sub-Committee 
Participants that is necessary to meet the objectives of the Plan and 
consistent with the scope of the relevant Sub-Committees. Upon signing 
a Plan of Action Agreement for this Plan, FEMA requests that 
Participants endeavor to cooperate with diligence and speed, and to the 
extent permissible under this Plan, and share with FEMA data and 
information necessary to meet the objectives of this Plan.
    Sub-Committee Participants agree to share with FEMA the following 
data with diligence and speed, to the extent permissible under this 
Plan, and abide by the following guidelines, where feasible and 
consistent with the data that is owned by each Sub-Committee 
Participant:
    (1) In general, Participants will not be asked to share 
Competitively Sensitive Information directly with other Participants.
    (2) FEMA will only request direct sharing of Competitively 
Sensitive Information among Participants during Exigent Circumstances 
where there is a mission critical need or timeline such that sharing 
only through FEMA is impractical or threatens the outcome of the Plan 
or Sub-Committee action. Such requests, if made, will be only among 
Participants whose participation is necessary to meet the objectives of 
the Plan, will be limited in scope to the greatest extent possible, and 
will be shared only pursuant to safeguards subject to prior review and 
audit by DOJ and FTC. Direct sharing of Competitively Sensitive 
Information with other Participants will be limited in scope and 
circumstances to the greatest extent possible. Participants may not 
share Competitively Sensitive Information directly with other 
Participants unless specifically requested by FEMA, in consultation 
with DOJ and FTC. All Competitively Sensitive Information delivered to 
FEMA or to another Sub-Committee Participant shall be delivered by 
secure means, for example, password-protected or encrypted electronic 
files or drives with the password/key delivered by separate 
communication or method or via upload to an appropriately secure web 
portal as directed by FEMA. All data delivered to the web portal 
designated by FEMA is deemed to be Competitively Sensitive Information.
    (3) To allow FEMA to identify and appropriately protect documents 
containing Competitively Sensitive Information by the Sub-Committee 
Participant providing the documents, the Sub-Committee Participant will 
make good faith efforts to designate any Competitively Sensitive 
Information by placing restrictive markings on documents and things 
considered to be competitively sensitive, the restrictive markings 
being sufficiently clear in wording and visibility to indicate the 
restricted nature of the data. The Sub-Committee Participant will 
identify Competitively Sensitive Information that is disclosed verbally 
by oral warning. Information designated as competitively sensitive 
will, to the extent allowed by law, be presumed to constitute 
confidential or privileged commercial or financial information, and be 
provided by the Sub-Committee Participant to FEMA with the expectation 
that it will be kept confidential by both parties, as such terms are 
understood in accordance with 5 U.S.C. 552(b)(4) of the Freedom of 
Information Act and federal judicial interpretations of this statute. 
FEMA agrees that to the extent any information designated as 
competitively sensitive by a Sub-Committee Participant is responsive to 
a request for disclosure under the Freedom of Information Act, FEMA 
will consult with the Sub-Committee Participant and afford the 
Participant ten (10) working days to object to any disclosure by FEMA.
    (4) FEMA will make good faith efforts to appropriately recognize 
unmarked Documents containing Competitively Sensitive Information as 
Competitively Sensitive Information. However, FEMA cannot guarantee 
that all unmarked Documents will be recognized as being Competitively 
Sensitive Information and protected from disclosure to third parties. 
If the unmarked Documents have not been disclosed without restriction 
outside of FEMA, the Sub-Committee Participant may retroactively 
request to have appropriate designations placed on the Documents. If 
the unmarked Documents have been disclosed without restriction outside 
of FEMA, FEMA will, to the extent practicable, remove any requested 
information from public forums controlled by FEMA and will work 
promptly to request that a receiving party return or destroy disclosed 
unmarked Documents if requested by the Sub-Committee Participant.
    (5) Competitively Sensitive Information may be used by FEMA, alone 
or in combination with additional information, including Documents and 
Competitively Sensitive Information received from third parties, to 
support FEMA's implementation of this Plan as determined by the 
Chairperson. In all situations, FEMA will aggregate and

[[Page 28875]]

anonymize Competitively Sensitive Information to the greatest extent 
possible to protect the interests retained by the owners of the data 
while still allowing the objectives of the Plan and Sub-Committee to be 
achieved. To the greatest extent possible, such aggregation will render 
the competitively sensitive nature of the Competitively Sensitive 
Information of the Sub-Committee Participant no longer recognizable in 
a commercially sensitive manner, and without sufficient information to 
enable, by inference or otherwise, attribution to Sub-Committee 
Participant or its affiliates (as clearly identified and disclosed to 
FEMA). Any disclosure of Competitively Sensitive Information by FEMA, 
within or outside a Sub-Committee, will be subject to review and 
approval by DOJ and FTC.
    (6) Except as otherwise expressly permitted by applicable federal 
law, FEMA shall not disclose any Competitively Sensitive Information or 
use any Competitively Sensitive Information for any purpose other than 
in connection with the purposes of this Plan, and FEMA will not sell 
any Competitively Sensitive Information of any Sub-Committee 
Participant.
    (7) Except as described below, FEMA may disclose Competitively 
Sensitive Information only to its employees, officers, directors, 
contractors, agents, and advisors (including attorneys, accountants, 
consultants, and financial advisors). Any individual with access to 
Competitively Sensitive Information will be expected to comply with the 
terms of this Plan.
    a. Information Sharing within the Sub-Committee: FEMA may share 
Competitively Sensitive Information with Sub-Committee Participants and 
Federal Representatives of the Plan, and their respective employees, 
officers, directors, contractors, agents, and advisors (including 
attorneys, accountants, consultants, and financial advisors) where 
there is a need to know and where disclosure is reasonably necessary in 
furtherance of implementing the Plan. FEMA will aggregate and anonymize 
data prior to sharing with the Sub-Committee Participants to the 
greatest extent possible while still allowing the objectives of the 
Plan to be achieved, and will not share data--particularly to 
competitors of the submitter--prior to consultation with and approval 
by the DOJ and FTC.
    i. Sub-Committee Participants, when providing Competitively 
Sensitive Information to FEMA, may request that this Information not be 
shared with other Sub-Committee Participants. Where these requests are 
made in good faith and are reasonable in nature, FEMA will respect 
these requests to the greatest extent possible and will consult the 
owner of the data prior to any release made to Sub-Committee 
Participants.
    b. Restricted Reports. FEMA may communicate Competitively Sensitive 
Information to appropriate government officials through Restricted 
Reports. The information contained in Restricted Reports shall be 
aggregated and anonymized to the greatest extent possible, while 
recognizing that these officials may need a certain amount of 
granularity and specificity of information to appropriately respond to 
COVID-19. FEMA will aim to aggregate data to the County level, and will 
not share Restricted Reports prior to consultation and approval from 
the DOJ and FTC. FEMA may disclose Restricted Reports to relevant White 
House and Administration officials and State Governors, and their 
respective employees, officers, directors, contractors, agents, and 
advisors (including attorneys, accountants, consultants, and financial 
advisors) who have a need to know and to whom such disclosure is 
reasonably necessary solely in furtherance of the implementation of 
this Plan. FEMA shall take appropriate action (by instructions, 
agreement, or otherwise) to ensure that receiving parties comply with 
all data-sharing confidentiality and obligations under this Plan as if 
such persons or entities had been parties to this Plan.
    c. Public Reports. FEMA may share information with the public 
through Public Reports. Data contained in Public Reports shall be fully 
aggregated and anonymized. Public Reports shall be aggregated to at 
least a state level and may be publicly disclosed after consultation 
and approval from the DOJ and FTC.
    (8) Where possible and not obviated by Exigent Circumstances, FEMA 
will notify Sub-Committee Participants prior to the release of any 
Competitively Sensitive Information that has not been fully aggregated 
and anonymized. In consultation with DOJ and FTC, FEMA will consider 
any good-faith requests made by Sub-Committee members to hold the 
release of data or requests for further aggregation or anonymization. 
In general, FEMA will not provide notification prior to the release of 
Public Reports, under the presumption that the data in these reports 
has already been fully anonymized and de-identified.
    (9) Any party receiving Competitively Sensitive Information through 
this Plan shall use such information solely for the purposes outlined 
in the Plan and take steps, such as imposing previously approved 
firewalls or tracking usage, to prevent misuse of the information. 
Disclosure and use of Competitively Sensitive Information will be 
limited to the greatest extent possible, and any party receiving 
Competitively Sensitive Information shall follow the procedures 
outlined in paragraph 7 above.
    (10) At the conclusion of a Participant's involvement in a Plan--
due to the deactivation of the Plan or due to the Participant's 
withdrawal or removal--each Participant will be requested to sequester 
any and all Competitively Sensitive Information received through 
participation in the Plan. This sequestration shall include the 
deletion of all Competitively Sensitive Information unless required to 
be kept pursuant to the Record Keeping requirements as described supra, 
Section I, 44 CFR part 332, or any other provision of law.

G. Oversight

    Each Sub-Committee Chairperson is responsible for ensuring that the 
Attorney General, or suitable delegate(s) from the DOJ, and the FTC 
Chair, or suitable delegate(s) from the FTC, have awareness of 
activities under this Plan, including activation, deactivation, and 
scheduling of meetings. The Attorney General, the FTC Chair, or their 
delegates may attend Sub-Committee meetings and request to be apprised 
of any activities taken in accordance with activities under this Plan. 
DOJ or FTC Representatives may request and review any proposed action 
by the Sub-Committee or Sub-Committee Participants undertaken pursuant 
to this Plan, including the provision of data. If any DOJ or FTC 
Representative believes any actions proposed or taken are not 
consistent with relevant antitrust protections provided by the DPA, he 
or she shall provide warning and guidance to the Sub-Committee as soon 
as the potential issue is identified. If questions arise about the 
antitrust protections applicable to any particular action, FEMA may 
request DOJ, in consultation with the FTC, provide an opinion on the 
legality of the action under relevant DPA antitrust protections.

XXII. Establishment of the Sub-Committees

    This Plan establishes Sub-Committees to implement the Plan of 
Action to Establish a National Strategy for the Manufacture, 
Allocation, and Distribution of Medical Devices Critical to COVID-19 
Response to provide the Federal Government and the Participants a forum 
to maximize the manufacture and efficient distribution

[[Page 28876]]

of selected types of Medical Devices and to create a prioritization 
protocol based upon identified types of Medical Device End-Users and 
their demonstrated or projected requirements, and demonstrated or 
projected geographic and regional areas of need. The outcome should 
include a framework to expeditiously meet any Medical Device needs in 
Exigent Circumstances 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. A Sub-Committee Chairperson designated by the 
Chairperson will convene and preside over each Sub-Committee. Sub-
Committees will not be used for contract negotiations or contract 
discussions between the Participants and the Federal Government; such 
negotiations or discussions will be in accordance with applicable 
federal contracting policies and procedures. However, this shall not 
limit any discussion within a Sub-Committee about the operational 
utilization of existing and potential contracts between the 
Participants and Representatives when seeking to align their use with 
overall manufacturing and distribution efforts consistent with this 
Plan.
    Each Sub-Committee will consist of designated Representatives from 
FEMA, HHS, other federal agencies with equities in this Plan, and each 
Sub-Committee Participant. The Attorney General and Chair of the FTC, 
or their delegates, may also join each Sub-Committee and attend 
meetings at their discretion. Attendees may also be invited at the 
discretion of a Sub-Committee Chairperson as subject matter experts, to 
provide technical advice, or to represent other government agencies, 
but will not be considered part of the Sub-Committee.
    To the extent necessary to respond to the Pandemic, only at the 
explicit direction of a Sub-Committee Chairperson, and subject to the 
provisions of Section V(B), Sub-Committee Members may be asked to 
provide technical advice, share information, help identify and validate 
places and resources of the greatest need, help project future 
manufacturing and distribution demands, assist in identifying and 
resolving the allocation of scarce resources amongst all necessary 
public and private sector domestic needs under Exigent Circumstances, 
and take any other necessary actions to maximize the timely manufacture 
and distribution of Medical Devices as determined necessary by FEMA to 
respond to the Pandemic. A Sub-Committee Chairperson or his or her 
designee, at the Sub-Committee Chairperson's sole discretion, will make 
decisions on these issues in order to ensure the maximum efficiency and 
effectiveness in the use of Sub-Committee Member's resources. All Sub-
Committee Participants will be invited to open Sub-Committee meetings. 
For selected Sub-Committee meetings, attendance may be limited to 
designated Sub-Committee Participants to meet specific operational 
requirements, as determined by FEMA.
    Each Sub-Committee Chairperson shall notify the Attorney General, 
the Chair of the FTC, Representatives, and Participants of the time, 
place, and nature of each meeting and of the proposed agenda of each 
meeting to be held to carry out this Plan. Additionally, each Sub-
Committee Chairperson shall provide for publication in the Federal 
Register of a notice of the time, place, and nature of each meeting. If 
a meeting is open, a Federal Register notice will be published 
reasonably in advance of the meeting. A Sub-Committee Chairman may 
restrict attendance at meetings only on the grounds outlined by 44 CFR 
332.5(c)(1)-(3). If a meeting is closed, a Federal Register notice will 
be published within ten (10) days of the meeting and will include the 
reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2).
    The Sub-Committee Chairperson shall establish the agenda for each 
meeting, be responsible for adherence to the agenda, and provide for a 
written summary or other record of each meeting and provide copies of 
transcripts or other records to FEMA, the Attorney General, the Chair 
of the FTC, and all Sub-Committee Participants. The Chairperson shall 
take necessary actions to protect from public disclosure any data 
discussed with or obtained from Sub-Committee Participants which a Sub-
Committee Participant has identified as a trade secret or as privileged 
and confidential in accordance with DPA sections 708(h)(3) and 705(d), 
or which qualifies for withholding under 44 CFR 332.5.

XXIII. Application and Agreement

    The Sub-Committee Participant identified below hereby agrees to 
join in the Federal Emergency Management Agency sponsored Plan of 
Action to Establish a National Strategy for the Manufacture, 
Allocation, and Distribution of Medical Devices to Respond to COVID-19 
under the Voluntary Agreement for the Manufacture and Distribution of 
Healthcare Resources Necessary to Respond to a Pandemic and to become a 
Participant in one or more Sub-Committees established by this Plan. 
This Plan will be published in the Federal Register. This Plan is 
authorized under section 708 of the Defense Production Act of 1950, as 
amended. Regulations governing the Voluntary Agreement for the 
Manufacture and Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic and all subsequent Plans of Action at 44 CFR part 
332. The applicant, as a Sub-Committee Participant, agrees to comply 
with the provisions of section 708 of the Defense Production Act of 
1950, as amended, the regulations at 44 CFR part 332, and the terms of 
this Plan.

XXIV. Assignment

    No Sub-Committee Participant may assign or transfer this Plan, in 
whole or in part, or any protections, rights or obligations hereunder 
without the prior written consent of the Sub-Committee Chairperson. 
When requested, the Sub-Committee Chairperson will respond to written 
requests for consent within 10 (ten) business days of receipt.

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Text of the Plan of Action To Establish a National Strategy for the 
Manufacture, Allocation, and Distribution of Medical Gases To Respond 
to COVID-19 Implemented Under the Voluntary Agreement for the 
Manufacture and Distribution of Critical Healthcare Resources Necessary 
To Respond to a Pandemic

Plan of Action To Establish a National Strategy for the Manufacture, 
Allocation, and Distribution of Medical Gases To Respond to COVID-19 
Implemented Under the Voluntary Agreement for the Manufacture and 
Distribution of Critical Healthcare Resources Necessary To Respond to a 
Pandemic

Preface

    Pursuant to section 708 of the Defense Production Act of 1950 
(DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management 
Agency (FEMA) Administrator (Administrator), after consultation with 
the Secretary of

[[Page 28877]]

the Department of Health and Human Services (HHS), the Attorney General 
of the United States (Attorney General), and the Chair of the Federal 
Trade Commission (FTC), developed a Voluntary Agreement for the 
Manufacture and Distribution of Critical Healthcare Resources Necessary 
to Respond to a Pandemic (Voluntary Agreement), 85 FR 50035 (August 17, 
2020). The Voluntary Agreement, which operates through a series of 
Plans of Action, maximizes the manufacture and efficient distribution 
of Critical Healthcare Resources nationwide to respond to a pandemic by 
establishing unity of effort between Participants and the Federal 
Government for integrated coordination, planning, information sharing 
with FEMA, as authorized by FEMA, and allocation and distribution of 
Critical Healthcare Resources.
    This document establishes a Plan of Action (Plan) to Establish a 
National Strategy for the Manufacture, Allocation, and Distribution of 
Medical Gases to Respond to COVID-19. This Plan will be implemented 
under the Voluntary Agreement by several Sub-Committees.
    (1) Sub-Committee to Define COVID-19 Medical Gas Requirements,
    (2) Sub-Committee for Oxygen,
    (3) Sub-Committee for Nitrous Oxide,
    (4) Sub-Committee for Carbon Dioxide,
    (5) Sub-Committee for Heliox,
    (6) Sub-Committee for Nitrogen (Medical Liquid Nitrogen), and
    (7) Sub-Committee for Medical Air.
    The Sub-Committee to Define COVID-19 Medical Gas Requirements will 
be formed first.
    FEMA may establish additional Sub-Committees under this Plan, so 
long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of Medical Gases; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
COVID-19 Medical Gas Requirements.
    The purpose of the Plan and the Sub-Committees is to maximize the 
manufacture and efficient distribution of selected types of Medical 
Gases and create a prioritization protocol for End-Users based upon 
their demonstrated or projected requirements including geographic and 
regional circumstances. The primary goal of the Plan is to create 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. When the requirements of the 
Plan are met, it affords Sub-Committee Participants defenses to civil 
and criminal actions brought under the antitrust laws (or any similar 
law of any state) for actions taken within the scope of the Plan. The 
Plan is designed to foster a close working relationship among FEMA, 
HHS, and Sub-Committee Participants to address national defense needs 
through cooperative action under the direction and active supervision 
of FEMA.

Table of Contents

I. Purpose.....................................................      421
II. Authorities................................................      421
III. General Provisions........................................      421
    A. Definitions.............................................      421
    B. Plan of Action Participation............................      425
    C. Effective Date and Duration of Participation............      426
    D. Withdrawal..............................................      426
    E. Plan of Action Activation and Deactivation..............      427
    F. Rules and Regulations...................................      427
    G. Modification and Amendment..............................      428
    H. Expenses................................................      428
    I. Record Keeping..........................................      428
IV. Antitrust Defense..........................................      429
V. Terms and Conditions........................................      429
    A. Plan of Action Execution................................      429
    B. Information Management and Responsibilities.............      431
    C. Oversight...............................................      435
VI. Establishment of the Sub-Committees........................      436
VII. Application and Agreement.................................      437
VIII. Assignment...............................................      438
 

XXV. Purpose

    A pandemic may present conditions that pose a direct threat to the 
national defense of the United States or its preparedness programs such 
that, pursuant to DPA section 708(c)(1), an agreement to collectively 
coordinate, plan, and collaborate for the manufacture and distribution 
of Medical Gases is necessary for the national defense. This Plan of 
Action to Establish a National Strategy for the Manufacture, 
Allocation, and Distribution of Medical Gases to Respond to COVID-19 is 
established under the Voluntary Agreement and establishes seven Sub-
Committees to oversee and implement the Plan. The Plan and Sub-
Committees will optimize the manufacture and the efficient distribution 
of selected types of Medical Gases and create a prioritization protocol 
for End-Users based upon their demonstrated or projected requirements.

XXVI. Authorities

    Section 708, Defense Production Act (50 U.S.C. 4558); sections 
402(2) & 501(b), Robert T. Stafford Disaster Relief and Emergency 
Assistance Act (42 U.S.C. 5121-5207); sections 503(b)(2)(B) & 
504(a)(10) & (16) of the Homeland Security Act of 2002 (6 U.S.C. 
313(b)(2)(B), 314(a)(10) & (16)); sections 201, 301, National 
Emergencies Act (50 U.S.C. 1601 et seq.); section 319, Public Health 
Service Act (42 U.S.C. 247d); Executive Order (E.O.) 13911, 85 FR 18403 
(March 27, 2020); Prioritization and Allocation of Certain Scarce or 
Threatened Health and Medical Resources for Domestic Use, 85 FR 20195 
(April 10, 2020). Pursuant to DPA section 708(f)(1)(A), the 
Administrator certifies that this Plan is necessary for the national 
defense.

XXVII. General Provisions

BB. Definitions

Administrator
    The FEMA Administrator is the Sponsor of the Voluntary Agreement. 
Pursuant to a delegation or redelegation of the functions given to the 
President by DPA section 708, the Administrator proposes and provides 
for the development and carrying out of the Voluntary Agreement, 
including through the development and implementation of Plans of 
Action. The Administrator is responsible for carrying out all duties 
and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and 
for

[[Page 28878]]

appointing one or more Chairpersons to manage and administer the 
Committee and all Sub-Committees formed to carry out the Voluntary 
Agreement.
Agreement
    The Voluntary Agreement for the Manufacture and Distribution of 
Critical Healthcare Resources Necessary to Respond to a Pandemic 
(Voluntary Agreement).
Allocation
    The process of determining and directing the relative distribution 
among one or more competing requests from End-Users for the same 
Medical Gases. Through the Allocation process, FEMA--with participation 
from Sub-Committee Participants--will assess the actual needs of End-
Users and determine how to divide the available and projected supply of 
Medical Gases to minimize impacts to life, safety, and economic 
disruption associated with shortages of Medical Gases. Allocation will 
take place only under Exigent Circumstances. FEMA retains decision-
making authority for all Allocation under this Plan.
Attendees
    Subject matter experts, invited by the Chairperson or a Sub-
Committee Chairperson to attend meetings authorized under the Voluntary 
Agreement or this Plan, to provide technical advice or to represent 
other government agencies or interested parties. Invitations to 
attendees will be extended as required for Committee or Sub-Committee 
meetings and deliberations.
Chairperson
    FEMA senior executive(s), appointed by the Administrator, to chair 
the Committee for the Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic (Committee). The Chairperson shall be responsible 
for the overall management and administration of the Committee, the 
Voluntary Agreement, and Plans of Action developed under the Voluntary 
Agreement while remaining under the supervision of the Administrator; 
shall initiate, or approve in advance, each meeting held to discuss 
problems, determine policies, recommend actions, and make decisions 
necessary to carry out the Voluntary Agreement; appoint one or more co-
Chairpersons to chair the Committee, and otherwise shall carry out all 
duties and responsibilities assigned to him. With the approval of the 
Administrator, the Chairperson may create one or more Sub-Committees, 
and may appoint one or more Sub-Committee Chairpersons to chair the 
Sub-Committees, as appropriate.
Committee
    Committee for the Distribution of Healthcare Resources Necessary to 
Respond to a Pandemic established under the Voluntary Agreement.
Competitively Sensitive Information
    Competitively Sensitive Information that is shared pursuant to this 
Plan may include any Document or other tangible thing or oral 
transmission that contains financial, business, commercial, scientific, 
technical, economic, or engineering information or data, including, but 
not limited to

 financial statements and data,
 customer and supplier lists,
 price and other terms of sale to customers,
 sales records, projections and forecasts,
 inventory levels,
 capacity and capacity utilization,
 cost information,
 sourcing and procurement information,
 manufacturing and production information,
 delivery and shipping information,
 systems and data designs, and
 methods, techniques, processes, procedures, programs, codes, 
or similar information,

whether tangible or intangible, and regardless of the method of 
storage, compilation, or recordation, if the owner thereof has taken 
reasonable measures to protect the information from disclosure to the 
public or competitors. These measures may be evidenced by marking or 
labeling the items as ``competitively sensitive information'' during 
submission to FEMA or in the Participant's customary and existing 
treatment of such information (regardless of labeling).
    All Competitively Sensitive Information provided by a Sub-Committee 
Participant as described herein is deemed Competitively Sensitive 
Information, except for Information that:
    a. Is published or has been made publicly available at the time of 
disclosure by the Sub-Committee Participant;
    b. was in the possession of, or was lawfully and readily available 
to, FEMA from another source at the time of disclosure without 
breaching any obligation of confidentiality applicable to the other 
source; or
    c. was independently developed or acquired without reference to or 
reliance upon the Sub-Committee Participant's Competitively Sensitive 
Information;

Where information deemed Competitively Sensitive Information is 
required to be disclosed by law, regulation, or court order, the 
``Competitively Sensitive'' (or substantially similar) label will 
continue to attach to all information and portion(s) of documents that 
are not made public through the required disclosure.
Document
    Any information, on paper or in electronic/audio/visual format, 
including written, recorded, and graphic materials of every kind, in 
the possession, custody, or control of the Participant and used or 
shared in the course of participation in the Voluntary Agreement or a 
subsequent Plan of Action.
End-User
    This includes all direct and ancillary medical support including, 
but not limited to, hospitals, independent healthcare providers, 
nursing homes, medical laboratories, dental care providers, independent 
physician offices, first responders, alternate care facilities and the 
general public that reasonably represents the totality of the nation's 
response to COVID-19.
Exigent Circumstances
    As determined by the Chairperson, the actual or forecasted shortage 
of a particular type or types of Medical Gases which likely cannot be 
fulfilled via usual market mechanisms for an acute, critical time 
period, and where immediate and substantial harm is projected to occur 
from lack of intervention.
Medical Gases
    Defined under Section 360ddd of the Food, Drug and Cosmetic Act (21 
U.S.C. 360ddd) as a drug that is manufactured or stored in a liquefied, 
nonliquified, or cryogenic state, and administered as a gas. Medical 
Gases include, but are not limited to, Oxygen, Nitrogen, Nitrous oxide, 
Carbon dioxide, Helium, Carbon monoxide, and Medical air, so long as 
such gases meet the Standards established by the United States 
Pharmacopeia and the National Formulary (USP-NF).
Pandemic
    A Pandemic is defined as an epidemic that has spread to human 
populations across a large geographic area that is subject to one or 
more declarations under the National Emergencies Act, the Public Health 
Service Act, or the Robert

[[Page 28879]]

T. Stafford Disaster Relief and Emergency Assistance Act, or if the 
Administrator determines that one or more declarations is likely to 
occur and the epidemic poses a direct threat to the national defense or 
its preparedness programs. For example, Coronavirus Disease 2019 
(COVID-19).
Participant
    An individual, partnership, corporation, association, or private 
organization, other than a federal agency, that has substantive 
capabilities, resources or expertise to carry out the purpose of the 
Voluntary Agreement, that has been specifically invited to participate 
in the Voluntary Agreement by the Chairperson, and that has applied and 
agreed to the terms of the Voluntary Agreement. ``Participant'' 
includes a corporate or non-corporate entity entering into the 
Voluntary Agreement and all subsidiaries and affiliates of that entity 
in which that entity has 50 percent or more control either by stock 
ownership, board majority, or otherwise. The Administrator may invite 
Participants to join the Voluntary Agreement at any time during its 
effective period.
Plan of Action (Plan)
    This document. A documented method, pursuant to 50 U.S.C. 
4558(b)(2), proposed by FEMA to implement a particular set of 
activities under the Voluntary Agreement, through a Sub-Committee 
focused on a particular Critical Healthcare Resource, or pandemic 
response workstream or functional area necessary for the national 
defense.
Plan of Action Agreement
    A separate commitment made by Participants upon invitation and 
agreement to participate in a Plan of Action as part of one or more 
Sub-Committees. Completing the Plan of Action Agreement confers 
responsibilities on the Participant consistent with those articulated 
in the Plan of Action and affords Participants a defense against 
antitrust claims under section 708 for actions taken to develop or 
carry out the Plan of Action and the appropriate Sub-Committee(s), as 
described in Section IV below.
Representatives
    The representatives the Administrator identifies and invites to the 
Committee from FEMA, HHS, and other federal agencies with equities in 
this Plan, and empowered to speak on behalf of their agencies' 
interests. The Attorney General and the Chair of the FTC, or their 
delegates, may also attend any meeting as a Representative.
Sub-Committee
    A body formed by the Administrator from select Participants to 
implement a Plan of Action.
Sub-Committee Chairperson
    FEMA executive, appointed by the Chairperson, to chair a Sub-
Committee to implement a Plan of Action. The Sub-Committee Chairperson 
shall be responsible for the overall management and administration of 
the Sub-Committee in furtherance of this Plan while remaining under the 
supervision of the Administrator and the Chairperson.
Sub-Committee Members
    Collectively the Sub-Committee Chairperson(s), Representatives, and 
Sub-Committee Participants. Jointly responsible developing and 
executing this Plan.
Sub-Committee Participant
    A subset of Participants of the Committee, that have been 
specifically invited to participate in a Sub-Committee by the Sub-
Committee Chairperson, and that have applied and agreed to the terms of 
this Plan and signed the Plan of Action Agreement. The Sub-Committee 
Chairperson may invite Participants in the Committee to join a Sub-
Committee as a Sub-Committee Participant at any time during the Plan's 
effective period.

CC. Plan of Action Participation

    This Plan will be carried out by a subset of Participants in the 
Voluntary Agreement through several Sub-Committees:
    (1) Sub-Committee to Define COVID-19 Medical Gas Requirements,
    (2) Sub-Committee for Oxygen,
    (3) Sub-Committee for Nitrous Oxide,
    (4) Sub-Committee for Carbon Dioxide,
    (5) Sub-Committee for Heliox,
    (6) Sub-Committee for Nitrogen (Medical Liquid Nitrogen), and
    (7) Sub-Committee for Medical Air.
    The Sub-Committee to Define COVID-19 Medical Gas Requirements will 
be formed first. FEMA may establish additional Sub-Committees under 
this Plan, so long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of Medical Gases; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
COVID-19 Medical Gas Requirements.
    Each Sub-Committee will consist of the (1) Sub-Committee 
Chairperson(s), (2) Representatives from FEMA, HHS, the Department of 
Justice (DOJ), and other federal agencies with equities in this Plan, 
and (3) Sub-Committee Participants that have substantive capabilities, 
resources or expertise to carry out the purpose of this Plan and have 
signed the Plan of Action Agreement. The Chairperson shall invite Sub-
Committee Participants who, in his or her determination, are reasonably 
representative of the appropriate industry or segment of such industry. 
Other Attendees--invited by the Sub-Committee Chairperson as subject 
matter experts to provide technical advice or to represent the 
interests of other government agencies or interested parties--may also 
participate in Sub-Committee meetings. The naming of these Sub-
Committees does not commit the Administrator to creating them unless 
and until circumstances dictate.

DD. Effective Date and Duration of Participation

    This Plan is effective immediately upon satisfaction of the 
requirements of DPA section 708(f)(1). This Plan shall remain in effect 
until terminated in accordance with 44 CFR 332.4. It shall be effective 
for no more than five (5) years from August 17, 2020, when the 
requirements of DPA section 708(f)(1) were satisfied for the Voluntary 
Agreement, unless otherwise terminated pursuant to DPA section 
708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 
708(f)(2). No action may take place under this Plan until it is 
activated, as described in Section III(E), below.

EE. Withdrawal

    Participation in the Plan is voluntary, as is the acceptance of 
most obligations under the Plan. Sub-Committee Participants may 
withdraw from this Plan or from an individual Sub-Committee at any 
point, subject to the fulfillment of obligations previously agreed upon 
by the Participant prior to the date of withdrawal. Note that the 
obligations outlined in V.B regarding information management and 
associated responsibilities apply once a party has shared or received 
information through a Sub-Committee, and remain in place after the 
party's withdrawal from the Sub-Committee or Plan. If a Sub-Committee 
Participant indicates an intent to withdraw from the Plan due to a 
modification or amendment of the Plan (described below), the Sub-
Committee Participant will not be required to perform actions directed 
by that modification or amendment. Withdrawal from the Plan will 
automatically trigger withdrawal from

[[Page 28880]]

all Sub-Committees; however, a Participant may withdraw from a Sub-
Committee without also withdrawing from the Plan or other Sub-
Committees. To withdraw from the Plan or from an individual Sub-
Committee, a Participant must provide written notice to the 
Administrator at least fifteen (15) calendar days prior to the 
effective date of that Sub-Committee Participant's withdrawal 
specifying the scope of withdrawal. Following receipt of such notice, 
the Administrator will inform the other Sub-Committee Participants of 
the date and the scope of the withdrawal.
    Upon the effective date of the withdrawal from the Plan, the Sub-
Committee Participant must cease all activities under the Plan. Upon 
the effective date of the withdrawal from one or more Sub-Committee(s), 
the Sub-Committee Participant must cease all activities under the Plan 
that pertain to the withdrawn Sub-Committee(s).

FF. Plan of Action Activation and Deactivation

    The Administrator, in consultation with the Chairperson and Sub-
Committee Chairperson, will invite a select group of Participants in 
the Voluntary Agreement to form the following Sub-Committees, beginning 
with the Sub-Committee to Define COVID-19 Medical Gas Requirements, 
which will be responsible for implementing this Plan.
    (1) Sub-Committee to Define COVID-19 Medical Gas Requirements,
    (2) Sub-Committee for Oxygen,
    (3) Sub-Committee for Nitrous Oxide,
    (4) Sub-Committee for Carbon Dioxide,
    (5) Sub-Committee for Heliox,
    (6) Sub-Committee for Nitrogen (Medical Liquid Nitrogen), and
    (7) Sub-Committee for Medical Air.
    FEMA may establish additional Sub-Committees under this Plan, so 
long as:
    (1) The Sub-Committee addresses one specific and well-defined 
category of Medical Gases; and
    (2) The Sub-Committee is recommended by the Sub-Committee to Define 
COVID-19 Medical Gas Requirements.
    This Plan will be activated for each invited Participant when the 
Participant executes a Plan of Action Agreement, and a Participant may 
not participate in a Sub-Committee until the Plan of Action Agreement 
is executed. Participants will be invited to join this Plan at the 
discretion of the Chairperson or the Sponsor to the Voluntary 
Agreement. Participants will be further invited to attend specific 
meetings of one or more Sub-Committees at the discretion of the 
Chairperson.

GG. Rules and Regulations

    Sub-Committee Participants acknowledge and agree to comply with all 
provisions of DPA section 708, as amended, and regulations related 
thereto which are promulgated by FEMA, the Department of Homeland 
Security, HHS, the Attorney General, and the FTC. FEMA has promulgated 
standards and procedures pertaining to voluntary agreements in 44 CFR 
part 332. The Administrator shall inform Participants of new rules and 
regulations as they are issued.

HH. Modification and Amendment

    The Administrator, after consultation with the Attorney General and 
the Chair of the FTC, may terminate or modify, in writing, this Plan at 
any time. The Attorney General, after consultation with the Chair of 
the FTC and the Administrator, may terminate or modify, in writing, 
this Plan at any time. Sub-Committee Participants may propose 
modifications or amendments to the Plan or to the Sub-Committees at any 
time.
    Where possible, material modifications to the Plan or a Sub-
Committee will be subject to a 30 calendar day delayed implementation 
and opportunity for notice and comment by Sub-Committee Participants to 
the Chairperson. This delayed implementation period may be shortened or 
eliminated if the Administrator deems it necessary. The Administrator 
shall inform Sub-Committee Participants of modifications or amendments 
to the Plan or to the Sub-Committees as they are proposed and issued.
    The Administrator, after consultation with the Attorney General and 
the Chair of the FTC, may remove Sub-Committee Participants from the 
Plan or from a Sub-Committee at any time. The Attorney General, after 
consultation with the Chair of the FTC and the Administrator, may 
remove Sub-Committee Participants from this Plan or from a Sub-
Committee at any time. If a Participant is removed from the Plan or 
from a Sub-Committee, the Participant may request written notice of the 
reasons for removal from the Chairperson, who shall provide such notice 
in a reasonable time period.

II. Expenses

    Participation in this Plan or in a Sub-Committee does not confer 
funds to Sub-Committee Participants, nor does it limit or prohibit any 
pre-existing source of funds. Unless otherwise specified, all expenses, 
administrative or otherwise, incurred by Sub-Committee Participants 
associated with participation in this Plan or a Sub-Committee shall be 
borne exclusively by the Sub-Committee Participants.

JJ. Record Keeping

    Each Sub-Committee Chairperson shall have primary responsibility 
for maintaining records in accordance with 44 CFR part 332 and shall be 
the official custodian of records related to carrying out this Plan. 
Each Sub-Committee Participant shall maintain for five years all 
minutes of meetings, transcripts, records, documents, and other data, 
including any communications with other Sub-Committee Participants or 
with any other member of the Sub-Committee, including drafts, related 
to the carrying out of this Plan or incorporating data or information 
received in the course of carrying out this Plan. Each Sub-Committee 
Participant agrees to produce to the Administrator, the Attorney 
General, and the Chair of the FTC upon request any item that this 
section requires the Participant to maintain. Any record maintained in 
accordance with 44 CFR part 332 shall be available for public 
inspection and copying, unless exempted on the grounds specified in 5 
U.S.C. 552(b)(1), (3) or (4) or identified as privileged and 
confidential information in accordance with DPA section 705(d), and 44 
CFR 332.5.

XXVIII. Antitrust Defense

    Under the provisions of DPA subsection 708(j), each Sub-Committee 
Participant in this Plan shall have available as a defense to any civil 
or criminal action brought for violation of the antitrust laws (or any 
similar law of any State) with respect to any action to develop or 
carry out this Plan, that such action was taken by the Sub-Committee 
Participant in the course of developing or carrying out this Plan, that 
the Sub-Committee Participant complied with the provisions of DPA 
section 708 and the rules promulgated thereunder, and that the Sub-
Committee Participant acted in accordance with the terms of the 
Voluntary Agreement and this Plan. Except in the case of actions taken 
to develop this Plan, this defense shall be available only to the 
extent the Sub-Committee Participant asserting the defense demonstrates 
that the action was specified in, or was within the scope of, this Plan 
and within the scope of the appropriate Sub-Committee(s), including 
being taken at the direction and under the active supervision of FEMA.

[[Page 28881]]

    This defense shall not apply to any actions taken after the 
termination of this Plan. Immediately upon modification of this Plan, 
no defense to antitrust claims under Section 708 shall be available to 
any subsequent action that is beyond the scope of the modified Plan. 
The Sub-Committee Participant asserting the defense bears the burden of 
proof to establish the elements of the defense. The defense shall not 
be available if the person against whom the defense is asserted shows 
that the action was taken for the purpose of violating the antitrust 
laws.

XXIX. Terms and Conditions

    As the sponsoring agency, FEMA will maintain oversight over Sub-
Committee activities and direct and supervise actions taken to carry 
out this Plan, including by retaining decision-making authority over 
actions taken pursuant to the Plan to ensure such actions are necessary 
to address a direct threat to the national defense. The Attorney 
General and the Chair of the FTC will monitor activities of the Sub-
Committees to ensure they execute their responsibilities in a manner 
consistent with this Plan and their actions have the least 
anticompetitive effects possible.

A. Plan of Action Execution

    This Plan will be used to support the following objectives to 
respond to a Pandemic by maximizing the manufacture and efficient 
distribution of selected types of Medical Gases and creating a 
prioritization protocol for End-Users based upon their demonstrated or 
projected requirements and taking into account geographic and regional 
circumstances. Each Sub-Committee will undertake the following 
Objectives for the Medical Gases within its area of jurisdiction.
1. Objectives
    (1) Optimize the timely production of sufficient quantities of 
Medical Gases to reduce loss of life from the COVID-19 virus.
    (2) Ensure Medical Gases are distributed effectively across the 
whole community nationally based on risk.
    (3) Balance restoration and maintenance of the nation's stockpile 
of Medical Gases with near-term requirements.
    (4) Establish a process for FEMA Allocation of Medical Gases 
nationwide.
    (5) Ensure ongoing competition in the manufacture and distribution 
of Medical Gases to the greatest extent possible under the DPA.
2. Actions
    Sub-Committee Participants may be asked to support these objectives 
by taking the following specific actions:
    (1) Assist the Chairperson in scoping each Sub-Committee and 
prioritizing among Sub-Committees based on each Medical Gas' importance 
to the national response to COVID-19 and whether it can be reasonably 
inferred, based upon the best evidence available, that the current and 
projected supply measured against current and projected demand may not 
adequately meet the Medical Gas requirements to all identified End-
Users or regional or geographic areas of the country as result of 
measures taken to respond to COVID-19.
    (2) Provide input to the Chairperson in creating a prioritized list 
of Medical Gas End-Users by categories for each type of Medical Gases 
identified by each Sub-Committee and ascertaining the relative demand 
and supply of Medical Gases among and within those End User categories. 
Prioritization shall be decided by the Chairperson, based upon each 
item's importance, reflecting the consensus views of the Sub-Committee 
Members that it represents the most effective way to save lives in 
responding to the COVID-19 pandemic. This list may be updated 
throughout the life of the Plan based upon either short term or long-
term demands. These categories should be considered holistically in 
terms of the Whole-of-Nation response to COVID-19.
    (3) Evaluate the domestic supply of Medical Gases and identify when 
the expansion of the domestic manufacture of Medical Gases may be 
necessary, as directed and decided by the Chairperson.
    (4) Provide information, assist, and validate, as necessary as 
decided by the Chairperson, demand projections for Medical Gases.
    (5) Create a process for and collaborate in the evaluation of 
competing claims for Medical Gases from End-Users.
    (6) Prepare a general strategy to accomplish the activities listed 
in V(A)(2)(7) below regarding activities in Exigent Circumstances 
consistent with the decisions made by the Chairperson.
    (7) In Exigent Circumstances, with review and concurrence in all 
possible instances by DOJ in consultation with FTC:
     Facilitate maximum availability of Medical Gases to the 
nation or particular geographies by deconflicting overlapping demands 
from the collective Participants' customer base, as directed and 
decided by the Chairperson.
     Facilitate maximum availability of Medical Gases to the 
nation or particular geographies by deconflicting overlapping supply 
chain demands placed upon Members, as directed and decided by the 
Chairperson.
     Facilitate the efficient distribution of Medical Gases by 
deconflicting overlapping distribution chain activities of Members, as 
directed and decided by the Chairperson.
     Create a process for and collaborate in the Allocation of 
Medical Gases nationwide or in particular geographies consistent with 
the decisions made by the Chairperson.
     Create a process for and collaborate in meeting any other 
exigent requirements throughout the nation or particular geographies 
consistent with the overall strategy prepared by this Sub-Committee.
    (8) Provide data and information necessary to validate the efforts 
of the Sub-Committee including the actual and planned amounts of 
Medical Gases to be distributed throughout the Nation, as determined by 
the Chairperson.
    (9) Provide feedback to the Sub-Committee on the outcomes of the 
collective efforts of the Sub-Committee Members and any impediments or 
bottlenecks.
    (10) Advise the Chairperson whether additional Participants or 
Attendees should be invited to join this Plan and Sub-Committee.
    (11) Carry out other activities regarding Medical Gases as 
identified by Sub-Committees under this Plan as determined and directed 
by the Chairperson necessary to address the COVID-19 virus' direct 
threat to the national defense, where such activities have been 
reviewed and approved by DOJ and FTC and received concurrence from Sub-
Committee members.

H. Information Management and Responsibilities

    FEMA will request only that data and information from Sub-Committee 
Participants that is necessary to meet the objectives of the Plan and 
consistent with the scope of the relevant Sub-Committees. Upon signing 
a Plan of Action Agreement for this Plan, FEMA requests that 
Participants endeavor to cooperate with diligence and speed, and to the 
extent permissible under this Plan, and share with FEMA data and 
information necessary to meet the objectives of this Plan.
    Sub-Committee Participants agree to share with FEMA the following 
data with diligence and speed, to the extent permissible under this 
Plan, and abide by the following guidelines, where feasible and 
consistent with the data

[[Page 28882]]

that is owned by each Sub-Committee Participant:
    (1) In general, Participants will not be asked to share 
Competitively Sensitive Information directly with other Participants.
    (2) FEMA will only request direct sharing of Competitively 
Sensitive Information among Participants during Exigent Circumstances 
where there is a mission critical need or timeline such that sharing 
only through FEMA is impractical or threatens the outcome of the Plan 
or Sub-Committee action. Such requests, if made, will be only among 
Participants whose participation is necessary to meet the objectives of 
the Plan, will be limited in scope to the greatest extent possible, and 
will be shared only pursuant to safeguards subject to prior review and 
audit by DOJ and FTC. Direct sharing of Competitively Sensitive 
Information with other Participants will be limited in scope and 
circumstances to the greatest extent possible. Participants may not 
share Competitively Sensitive Information directly with other 
Participants unless specifically requested by FEMA, in consultation 
with DOJ and FTC. All Competitively Sensitive Information delivered to 
FEMA or to another Sub-Committee Participant shall be delivered by 
secure means, for example, password-protected or encrypted electronic 
files or drives with the password/key delivered by separate 
communication or method or via upload to an appropriately secure web 
portal as directed by FEMA. All data delivered to the web portal 
designated by FEMA is deemed to be Competitively Sensitive Information.
    (3) To allow FEMA to identify and appropriately protect documents 
containing Competitively Sensitive Information by the Sub-Committee 
Participant providing the documents, the Sub-Committee Participant will 
make good faith efforts to designate any Competitively Sensitive 
Information by placing restrictive markings on documents and things 
considered to be competitively sensitive, the restrictive markings 
being sufficiently clear in wording and visibility to indicate the 
restricted nature of the data. The Sub-Committee Participant will 
identify Competitively Sensitive Information that is disclosed verbally 
by oral warning. Information designated as competitively sensitive 
will, to the extent allowed by law, be presumed to constitute 
confidential or privileged commercial or financial information, and be 
provided by the Sub-Committee Participant to FEMA with the expectation 
that it will be kept confidential by both parties, as such terms are 
understood in accordance with 5 U.S.C. 552(b)(4) of the Freedom of 
Information Act and federal judicial interpretations of this statute. 
FEMA agrees that to the extent any information designated as 
competitively sensitive by a Sub-Committee Participant is responsive to 
a request for disclosure under the Freedom of Information Act, FEMA 
will consult with the Sub-Committee Participant and afford the 
Participant ten (10) working days to object to any disclosure by FEMA.
    (4) FEMA will make good faith efforts to appropriately recognize 
unmarked Documents containing Competitively Sensitive Information as 
Competitively Sensitive Information. However, FEMA cannot guarantee 
that all unmarked Documents will be recognized as being Competitively 
Sensitive Information and protected from disclosure to third parties. 
If the unmarked Documents have not been disclosed without restriction 
outside of FEMA, the Sub-Committee Participant may retroactively 
request to have appropriate designations placed on the Documents. If 
the unmarked Documents have been disclosed without restriction outside 
of FEMA, FEMA will, to the extent practicable, remove any requested 
information from public forums controlled by FEMA and will work 
promptly to request that a receiving party return or destroy disclosed 
unmarked Documents if requested by the Sub-Committee Participant.
    (5) Competitively Sensitive Information may be used by FEMA, alone 
or in combination with additional information, including Documents and 
Competitively Sensitive Information received from third parties, to 
support FEMA's implementation of this Plan as determined by the 
Chairperson. In all situations, FEMA will aggregate and anonymize 
Competitively Sensitive Information to the greatest extent possible to 
protect the interests retained by the owners of the data while still 
allowing the objectives of the Plan and Sub-Committee to be achieved. 
To the greatest extent possible, such aggregation will render the 
competitively sensitive nature of the Competitively Sensitive 
Information of the Sub-Committee Participant no longer recognizable in 
a commercially sensitive manner, and without sufficient information to 
enable, by inference or otherwise, attribution to Sub-Committee 
Participant or its affiliates (as clearly identified and disclosed to 
FEMA). Any disclosure of Competitively Sensitive Information by FEMA, 
within or outside a Sub-Committee, will be subject to review and 
approval by DOJ and FTC.
    (6) Except as otherwise expressly permitted by applicable federal 
law, FEMA shall not disclose any Competitively Sensitive Information or 
use any Competitively Sensitive Information for any purpose other than 
in connection with the purposes of this Plan, and FEMA will not sell 
any Competitively Sensitive Information of any Sub-Committee 
Participant.
    (7) Except as described below, FEMA may disclose Competitively 
Sensitive Information only to its employees, officers, directors, 
contractors, agents, and advisors (including attorneys, accountants, 
consultants, and financial advisors). Any individual with access to 
Competitively Sensitive Information will be expected to comply with the 
terms of this Plan.
    a. Information Sharing within the Sub-Committee: FEMA may share 
Competitively Sensitive Information with Sub-Committee Participants and 
Federal Representatives of the Plan, and their respective employees, 
officers, directors, contractors, agents, and advisors (including 
attorneys, accountants, consultants, and financial advisors) where 
there is a need to know and where disclosure is reasonably necessary in 
furtherance of implementing the Plan. FEMA will aggregate and anonymize 
data prior to sharing with the Sub-Committee Participants to the 
greatest extent possible while still allowing the objectives of the 
Plan to be achieved, and will not share data--particularly to 
competitors of the submitter--prior to consultation with and approval 
by the DOJ and FTC.
    i. Sub-Committee Participants, when providing Competitively 
Sensitive Information to FEMA, may request that this Information not be 
shared with other Sub-Committee Participants. Where these requests are 
made in good faith and are reasonable in nature, FEMA will respect 
these requests to the greatest extent possible and will consult the 
owner of the data prior to any release made to Sub-Committee 
Participants.
    b. Restricted Reports. FEMA may communicate Competitively Sensitive 
Information to appropriate government officials through Restricted 
Reports. The information contained in Restricted Reports shall be 
aggregated and anonymized to the greatest extent possible, while 
recognizing that these officials may need a certain amount of 
granularity and specificity of information to appropriately respond to 
COVID-19. FEMA will aim to aggregate data to the County level, and will 
not share Restricted Reports prior to consultation and approval from 
the DOJ

[[Page 28883]]

and FTC. FEMA may disclose Restricted Reports to relevant White House 
and Administration officials and State Governors, and their respective 
employees, officers, directors, contractors, agents, and advisors 
(including attorneys, accountants, consultants, and financial advisors) 
who have a need to know and to whom such disclosure is reasonably 
necessary solely in furtherance of the implementation of this Plan. 
FEMA shall take appropriate action (by instructions, agreement, or 
otherwise) to ensure that receiving parties comply with all data-
sharing confidentiality and obligations under this Plan as if such 
persons or entities had been parties to this Plan.
    c. Public Reports. FEMA may share information with the public 
through Public Reports. Data contained in Public Reports shall be fully 
aggregated and anonymized. Public Reports shall be aggregated to at 
least a state level and may be publicly disclosed after consultation 
and approval from the DOJ and FTC.
    (8) Where possible and not obviated by Exigent Circumstances, FEMA 
will notify Sub-Committee Participants prior to the release of any 
Competitively Sensitive Information that has not been fully aggregated 
and anonymized. In consultation with DOJ and FTC, FEMA will consider 
any good-faith requests made by Sub-Committee members to hold the 
release of data or requests for further aggregation or anonymization. 
In general, FEMA will not provide notification prior to the release of 
Public Reports, under the presumption that the data in these reports 
has already been fully anonymized and de-identified.
    (9) Any party receiving Competitively Sensitive Information through 
this Plan shall use such information solely for the purposes outlined 
in the Plan and take steps, such as imposing previously approved 
firewalls or tracking usage, to prevent misuse of the information. 
Disclosure and use of Competitively Sensitive Information will be 
limited to the greatest extent possible, and any party receiving 
Competitively Sensitive Information shall follow the procedures 
outlined in paragraph 7 above.
    (10) At the conclusion of a Participant's involvement in a Plan--
due to the deactivation of the Plan or due to the Participant's 
withdrawal or removal--each Participant will be requested to sequester 
any and all Competitively Sensitive Information received through 
participation in the Plan. This sequestration shall include the 
deletion of all Competitively Sensitive Information unless required to 
be kept pursuant to the Record Keeping requirements as described supra, 
Section I, 44 CFR part 332, or any other provision of law.

I. Oversight

    Each Sub-Committee Chairperson is responsible for ensuring that the 
Attorney General, or suitable delegate(s) from the DOJ, and the FTC 
Chair, or suitable delegate(s) from the FTC, have awareness of 
activities under this Plan, including activation, deactivation, and 
scheduling of meetings. The Attorney General, the FTC Chair, or their 
delegates may attend Sub-Committee meetings and request to be apprised 
of any activities taken in accordance with activities under this Plan. 
DOJ or FTC Representatives may request and review any proposed action 
by the Sub-Committee or Sub-Committee Participants undertaken pursuant 
to this Plan, including the provision of data. If any DOJ or FTC 
Representative believes any actions proposed or taken are not 
consistent with relevant antitrust protections provided by the DPA, he 
or she shall provide warning and guidance to the Sub-Committee as soon 
as the potential issue is identified. If questions arise about the 
antitrust protections applicable to any particular action, FEMA may 
request DOJ, in consultation with the FTC, provide an opinion on the 
legality of the action under relevant DPA antitrust protections.

XXX. Establishment of the Sub-Committees

    This Plan establishes Sub-Committees to implement the Plan of 
Action to Establish a National Strategy for the Manufacture, 
Allocation, and Distribution of Medical Gases to Respond to COVID-19 to 
provide the Federal Government and the Participants a forum to maximize 
the manufacture and efficient distribution of selected types of Medical 
Gases and to create a prioritization protocol based upon identified 
types of Medical Gas End-Users and their demonstrated or projected 
requirements, and demonstrated or projected geographic and regional 
areas of need. The outcome should include a framework to expeditiously 
meet any Medical Gas needs in Exigent Circumstances 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. A Sub-Committee Chairperson 
designated by the Chairperson will convene and preside over each Sub-
Committee. Sub-Committees will not be used for contract negotiations or 
contract discussions between the Participants and the Federal 
Government; such negotiations or discussions will be in accordance with 
applicable federal contracting policies and procedures. However, this 
shall not limit any discussion within a Sub-Committee about the 
operational utilization of existing and potential contracts between the 
Participants and Representatives when seeking to align their use with 
overall manufacturing and distribution efforts consistent with this 
Plan.
    Each Sub-Committee will consist of designated Representatives from 
FEMA, HHS, other federal agencies with equities in this Plan, and each 
Sub-Committee Participant. The Attorney General and Chair of the FTC, 
or their delegates, may also join each Sub-Committee and attend 
meetings at their discretion. Attendees may also be invited at the 
discretion of a Sub-Committee Chairperson as subject matter experts, to 
provide technical advice, or to represent other government agencies, 
but will not be considered part of the Sub-Committee.
    To the extent necessary to respond to the Pandemic, only at the 
explicit direction of a Sub-Committee Chairperson, and subject to the 
provisions of Section V(B), Sub-Committee Members may be asked to 
provide technical advice, share information, help identify and validate 
places and resources of the greatest need, help project future 
manufacturing and distribution demands, assist in identifying and 
resolving the allocation of scarce resources amongst all necessary 
public and private sector domestic needs under Exigent Circumstances, 
and take any other necessary actions to maximize the timely manufacture 
and distribution of Medical Gases as determined necessary by FEMA to 
respond to the Pandemic. A Sub-Committee Chairperson or his or her 
designee, at the Sub-Committee Chairperson's sole discretion, will make 
decisions on these issues in order to ensure the maximum efficiency and 
effectiveness in the use of Sub-Committee Member's resources. All Sub-
Committee Participants will be invited to open Sub-Committee meetings. 
For selected Sub-Committee meetings, attendance may be limited to 
designated Sub-Committee Participants to meet specific operational 
requirements, as determined by FEMA.
    Each Sub-Committee Chairperson shall notify the Attorney General, 
the Chair of the FTC, Representatives, and Participants of the time, 
place, and nature of each meeting and of the proposed agenda of each 
meeting to be

[[Page 28884]]

held to carry out this Plan. Additionally, each Sub-Committee 
Chairperson shall provide for publication in the Federal Register of a 
notice of the time, place, and nature of each meeting. If a meeting is 
open, a Federal Register notice will be published reasonably in advance 
of the meeting. A Sub-Committee Chairman may restrict attendance at 
meetings only on the grounds outlined by 44 CFR 332.5(c)(1)-(3). If a 
meeting is closed, a Federal Register notice will be published within 
ten (10) days of the meeting and will include the reasons why the 
meeting is closed pursuant to 44 CFR 332.3(c)(2).
    The Sub-Committee Chairperson shall establish the agenda for each 
meeting, be responsible for adherence to the agenda, and provide for a 
written summary or other record of each meeting and provide copies of 
transcripts or other records to FEMA, the Attorney General, the Chair 
of the FTC, and all Sub-Committee Participants. The Chairperson shall 
take necessary actions to protect from public disclosure any data 
discussed with or obtained from Sub-Committee Participants which a Sub-
Committee Participant has identified as a trade secret or as privileged 
and confidential in accordance with DPA sections 708(h)(3) and 705(d), 
or which qualifies for withholding under 44 CFR 332.5.

XXXI. Application and Agreement

    The Sub-Committee Participant identified below hereby agrees to 
join in the Federal Emergency Management Agency sponsored Plan of 
Action to Establish a National Strategy for the Manufacture, 
Allocation, and Distribution of Medical Gases to Respond to COVID-19 
under the Voluntary Agreement for the Manufacture and Distribution of 
Healthcare Resources Necessary to Respond to a Pandemic and to become a 
Participant in one or more Sub-Committees established by this Plan. 
This Plan will be published in the Federal Register. This Plan is 
authorized under section 708 of the Defense Production Act of 1950, as 
amended. Regulations governing the Voluntary Agreement for the 
Manufacture and Distribution for the Manufacture and Distribution of 
Healthcare Resources Necessary to Respond to a Pandemic and all 
subsequent Plans of Action at 44 CFR part 332. The applicant, as a Sub-
Committee Participant, agrees to comply with the provisions of section 
708 of the Defense Production Act of 1950, as amended, the regulations 
at 44 CFR part 332, and the terms of this Plan.

XXXII. Assignment

    No Sub-Committee Participant may assign or transfer this Plan, in 
whole or in part, or any protections, rights or obligations hereunder 
without the prior written consent of the Sub-Committee Chairperson. 
When requested, the Sub-Committee Chairperson will respond to written 
requests for consent within 10 (ten) business days of receipt.

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(Name of authorized representative)

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(Signature of authorized representative)

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Administrator (Sponsor)

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Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-11278 Filed 5-27-21; 8:45 am]
BILLING CODE 9111-19-P