Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States, 49929-49934 [2020-18012]

Agencies

• Executive Office of the President

[Federal Register Volume 85, Number 158 (Friday, August 14, 2020)]
[Presidential Documents]
[Pages 49929-49934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18012]



[[Page 49927]]

Vol. 85

Friday,

No. 158

August 14, 2020

Part VII





The President





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Executive Order 13944--Combating Public Health Emergencies and 
Strengthening National Security by Ensuring Essential Medicines, 
Medical Countermeasures, and Critical Inputs Are Made in the United 
States



Executive Order 13945--Fighting the Spread of COVID-19 by Providing 
Assistance to Renters and Homeowners



Notice of August 13, 2020--Continuation of the National Emergency With 
Respect to Export Control Regulations


                        Presidential Documents 



Federal Register / Vol. 85, No. 158 / Friday, August 14, 2020 / 
Presidential Documents

___________________________________________________________________

Title 3--
The President

[[Page 49929]]

                Executive Order 13944 of August 6, 2020

                
Combating Public Health Emergencies and 
                Strengthening National Security by Ensuring Essential 
                Medicines, Medical Countermeasures, and Critical Inputs 
                Are Made in the United States

                By the authority vested in me as President by the 
                Constitution and the laws of the United States of 
                America, it is hereby ordered as follows:

                Section 1. Policy. The United States must protect our 
                citizens, critical infrastructure, military forces, and 
                economy against outbreaks of emerging infectious 
                diseases and chemical, biological, radiological, and 
                nuclear (CBRN) threats. To achieve this, the United 
                States must have a strong Public Health Industrial Base 
                with resilient domestic supply chains for Essential 
                Medicines, Medical Countermeasures, and Critical Inputs 
                deemed necessary for the United States. These domestic 
                supply chains must be capable of meeting national 
                security requirements for responding to threats arising 
                from CBRN threats and public health emergencies, 
                including emerging infectious diseases such as COVID-
                19. It is critical that we reduce our dependence on 
                foreign manufacturers for Essential Medicines, Medical 
                Countermeasures, and Critical Inputs to ensure 
                sufficient and reliable long-term domestic production 
                of these products, to minimize potential shortages, and 
                to mobilize our Nation's Public Health Industrial Base 
                to respond to these threats. It is therefore the policy 
                of the United States to:

                    (a) accelerate the development of cost-effective 
                and efficient domestic production of Essential 
                Medicines and Medical Countermeasures and have adequate 
                redundancy built into the domestic supply chain for 
                Essential Medicines, Medical Countermeasures, and 
                Critical Inputs;
                    (b) ensure long-term demand for Essential 
                Medicines, Medical Countermeasures, and Critical Inputs 
                that are produced in the United States;
                    (c) create, maintain, and maximize domestic 
                production capabilities for Critical Inputs, Finished 
                Drug Products, and Finished Devices that are essential 
                to protect public safety and human health and to 
                provide for the national defense; and
                    (d) combat the trafficking of counterfeit Essential 
                Medicines, Medical Countermeasures, and Critical Inputs 
                over e-commerce platforms and from third-party online 
                sellers involved in the government procurement process.

                I am therefore directing each executive department and 
                agency involved in the procurement of Essential 
                Medicines, Medical Countermeasures, and Critical Inputs 
                (agency) to consider a variety of actions to increase 
                their domestic procurement of Essential Medicines, 
                Medical Countermeasures, and Critical Inputs, and to 
                identify vulnerabilities in our Nation's supply chains 
                for these products. Under this order, agencies will 
                have the necessary flexibility to increase their 
                domestic procurement in appropriate and responsible 
                ways, while protecting our Nation's service members, 
                veterans, and their families from increases in drug 
                prices and without interfering with our Nation's 
                ability to respond to the spread of COVID-19.

                Sec. 2. Maximizing Domestic Production in Procurement. 
                (a) Agencies shall, as appropriate, to the maximum 
                extent permitted by applicable law, and in consultation 
                with the Commissioner of Food and Drugs (FDA 
                Commissioner) with respect to Critical Inputs, use 
                their respective authorities under section 2304(c) of 
                title 10, United States Code; section 3304(a) of title 
                41,

[[Page 49930]]

                United States Code; and subpart 6.3 of the Federal 
                Acquisition Regulation, title 48, Code of Federal 
                Regulations, to conduct the procurement of Essential 
                Medicines, Medical Countermeasures, and Critical Inputs 
                by:

(i) using procedures to limit competition to only those Essential 
Medicines, Medical Countermeasures, and Critical Inputs that are produced 
in the United States; and

(ii) dividing procurement requirements among two or more manufacturers 
located in the United States, as appropriate.

                    (b) Within 90 days of the date of this order, the 
                Director of the Office of Management and Budget (OMB), 
                in consultation with appropriate agency heads, shall:

(i) review the authority of each agency to limit the online procurement of 
Essential Medicines and Medical Countermeasures to e-commerce platforms 
that have:

  (A) adopted, and certified their compliance with, the applicable best 
practices published by the Department of Homeland Security in its Report to 
the President on ``Combating Trafficking in Counterfeit and Pirated 
Goods,'' dated January 24, 2020; and

  (B) agreed to permit the Department of Homeland Security's National 
Intellectual Property Rights Coordination Center to evaluate and confirm 
their compliance with such best practices; and

(ii) report its findings to the President.

                    (c) Within 90 days of the date of this order, the 
                head of each agency shall, in consultation with the FDA 
                Commissioner, develop and implement procurement 
                strategies, including long-term contracts, consistent 
                with law, to strengthen and mobilize the Public Health 
                Industrial Base in order to increase the manufacture of 
                Essential Medicines, Medical Countermeasures, and 
                Critical Inputs in the United States.
                    (d) No later than 30 days after the FDA 
                Commissioner has identified, pursuant to section 3(c) 
                of this order, the initial list of Essential Medicines, 
                Medical Countermeasures, and Critical Inputs, the 
                United States Trade Representative shall, to the extent 
                permitted by law, take all appropriate action to modify 
                United States Federal procurement product coverage 
                under all relevant Free Trade Agreements and the World 
                Trade Organization Agreement on Government Procurement 
                to exclude coverage of Essential Medicines, Medical 
                Countermeasures, and Critical Inputs. The United States 
                Trade Representative shall further modify United States 
                Federal procurement product coverage, as appropriate, 
                to reflect updates by the FDA Commissioner. After the 
                modifications to United States Federal procurement 
                coverage take effect, the United States Trade 
                Representative shall make any necessary, corresponding 
                modifications of existing waivers under section 301 of 
                the Trade Agreements Act of 1979. The United States 
                Trade Representative shall notify the President, 
                through the Director of OMB, once it has taken the 
                actions described in this subsection.
                    (e) No later than 60 days after the FDA 
                Commissioner has identified, pursuant to section 3(c) 
                of this order, the initial list of Essential Medicines, 
                Medical Countermeasures, and Critical Inputs, and 
                notwithstanding the public interest exception in 
                subsection (f)(i)(1) of this section, the Secretary of 
                Defense shall, to the maximum extent permitted by 
                applicable law, use his authority under section 
                225.872-1(c) of the Defense Federal Acquisition 
                Regulation Supplement to restrict the procurement of 
                Essential Medicines, Medical Countermeasures, and 
                Critical Inputs to domestic sources and to reject 
                otherwise acceptable offers of such products from 
                sources in Qualifying Countries in instances where 
                considered necessary for national defense reasons.
                    (f) Subsections (a), (d), and (e) of this section 
                shall not apply:

[[Page 49931]]

(i) where the head of the agency determines in writing, with respect to a 
specific contract or order, that (1) their application would be 
inconsistent with the public interest; (2) the relevant Essential 
Medicines, Medical Countermeasures, and Critical Inputs are not produced in 
the United States in sufficient and reasonably available commercial 
quantities and of a satisfactory quality; or (3) their application would 
cause the cost of the procurement to increase by more than 25 percent, 
unless applicable law requires a higher percentage, in which case such 
higher percentage shall apply;

(ii) with respect to the procurement of items that are necessary to respond 
to any public health emergency declared under section 319 of the Public 
Health Service Act (42 U.S.C. 247d), any major disaster or emergency 
declared under the Stafford Disaster Relief and Emergency Assistance Act 
(42 U.S.C. 5121 et seq.), or any national emergency declared under the 
National Emergencies Act (50 U.S.C. 1601 et seq.).

                    (g) To the maximum extent permitted by law, any 
                public interest determination made pursuant to section 
                2(f)(i)(1) of this order shall be construed to maximize 
                the procurement and use of Essential Medicines and 
                Medical Countermeasures produced in the United States.
                    (h) The head of an agency who makes any 
                determination pursuant to section 2(f)(i) of this order 
                shall submit an annual report to the President, through 
                the Director of OMB and the Assistant to the President 
                for Trade and Manufacturing Policy, describing the 
                justification for each such determination.

                Sec. 3. Identifying Vulnerabilities in Supply Chains. 
                (a) Within 180 days of the date of this order, the 
                Secretary of Health and Human Services, through the FDA 
                Commissioner and in consultation with the Director of 
                OMB, shall take all necessary and appropriate action, 
                consistent with law, to identify vulnerabilities in the 
                supply chain for Essential Medicines, Medical 
                Countermeasures, and Critical Inputs and to mitigate 
                those vulnerabilities, including by:

(i) considering proposing regulations or revising guidance on the 
collection of the following information from manufacturers of Essential 
Medicines and Medical Countermeasures as part of the application and 
regulatory approval process:

  (A) the sources of Finished Drug Products, Finished Devices, and Critical 
Inputs;

  (B) the use of any scarce Critical Inputs; and

  (C) the date of the last FDA inspection of the manufacturer's regulated 
facilities and the results of such inspection;

(ii) entering into written agreements, pursuant to section 20.85 of title 
21, Code of Federal Regulations, with the National Security Council, 
Department of State, Department of Defense, Department of Veterans Affairs, 
and other interested agencies, as appropriate, to disclose records 
regarding the security and vulnerabilities of the supply chains for 
Essential Medicines, Medical Countermeasures, and Critical Inputs;

(iii) recommending to the President any changes in applicable law that may 
be necessary to accomplish the objectives of this subsection; and

(iv) reviewing FDA regulations to determine whether any of those 
regulations may be a barrier to domestic production of Essential Medicines, 
Medical Countermeasures, and Critical Inputs, and by advising the President 
whether such regulations should be repealed or amended.

                    (b) The Secretary of Health and Human Services, 
                through the FDA Commissioner, shall take all 
                appropriate action, consistent with applicable law, to:

(i) accelerate FDA approval or clearance, as appropriate, for domestic 
producers of Essential Medicines, Medical Countermeasures, and Critical

[[Page 49932]]

Inputs, including those needed for infectious disease and CBRN threat 
preparedness and response;

(ii) issue guidance with recommendations regarding the development of 
Advanced Manufacturing techniques;

(iii) negotiate with countries to increase site inspections and increase 
the number of unannounced inspections of regulated facilities manufacturing 
Essential Medicines, Medical Countermeasures, and Critical Inputs; and

(iv) refuse admission, as appropriate, to imports of Essential Medicines, 
Medical Countermeasures, and Critical Inputs if the facilities in which 
they are produced refuse or unreasonably delay an inspection.

                    (c) Within 90 days of the date of this order, and 
                periodically updated as appropriate, the FDA 
                Commissioner, in consultation with the Director of OMB, 
                the Assistant Secretary for Preparedness and Response 
                in the Department of Health and Human Services, the 
                Assistant to the President for Economic Policy, and the 
                Director of the Office of Trade and Manufacturing 
                Policy, shall identify the list of Essential Medicines, 
                Medical Countermeasures, and their Critical Inputs that 
                are medically necessary to have available at all times 
                in an amount adequate to serve patient needs and in the 
                appropriate dosage forms.
                    (d) Within 180 days of the date of this order, the 
                Secretary of Defense, in consultation with the Director 
                of OMB, shall take all necessary and appropriate 
                action, consistent with law, to identify 
                vulnerabilities in the supply chain for Essential 
                Medicines, Medical Countermeasures, and Critical Inputs 
                necessary to meet the unique needs of the United States 
                Armed Forces and to mitigate the vulnerabilities 
                identified in subsection (a) of this section. The 
                Secretary of Defense shall provide to the Secretary of 
                Health and Human Services, the FDA Commissioner, the 
                Director of OMB, and the Director of the Office of 
                Trade and Manufacturing Policy a list of defense-
                specific Essential Medicines, Medical Countermeasures, 
                and Critical Inputs that are medically necessary to 
                have available for defense use in adequate amounts and 
                in appropriate dosage forms. The Secretary of Defense 
                shall, as appropriate, periodically update this list.

                Sec. 4. Streamlining Regulatory Requirements. 
                Consistent with law, the Administrator of the 
                Environmental Protection Agency shall take all 
                appropriate action to identify relevant requirements 
                and guidance documents that can be streamlined to 
                provide for the development of Advanced Manufacturing 
                facilities and the expeditious domestic production of 
                Critical Inputs, including by accelerating siting and 
                permitting approvals.

                Sec. 5. Priorities and Allocation of Essential 
                Medicines, Medical Countermeasures, and Critical 
                Inputs. The Secretary of Health and Human Services 
                shall, as appropriate and in accordance with the 
                delegation of authority under Executive Order 13603 of 
                March 16, 2012 (National Defense Resources 
                Preparedness), use the authority under section 101 of 
                the Defense Production Act of 1950, as amended (50 
                U.S.C. 4511), to prioritize the performance of Federal 
                Government contracts or orders for Essential Medicines, 
                Medical Countermeasures, or Critical Inputs over 
                performance of any other contracts or orders, and to 
                allocate such materials, services, and facilities as 
                the Secretary deems necessary or appropriate to promote 
                the national defense.

                Sec. 6. Reporting. (a) No later than December 15, 2021, 
                and annually thereafter, the head of each agency shall 
                submit a report to the President, through the Director 
                of OMB and the Assistant to the President for Trade and 
                Manufacturing Policy, detailing, for the preceding 
                three fiscal years:

(i) the Essential Medicines, Medical Countermeasures, and Critical Inputs 
procured by the agency;

(ii) the agency's annual itemized and aggregated expenditures for all 
Essential Medicines, Medical Countermeasures, and Critical Inputs;

(iii) the sources of these products and inputs; and

[[Page 49933]]

(iv) the agency's plan to support domestic production of such products and 
inputs in the next fiscal year.

                    (b) Within 180 days of the date of this order, the 
                Secretary of Commerce shall submit a report to the 
                Director of OMB, the Assistant to the President for 
                National Security Affairs, the Director of the National 
                Economic Council, and the Director of the Office of 
                Trade and Manufacturing Policy, describing any change 
                in the status of the Public Health Industrial Base and 
                recommending initiatives to strengthen the Public 
                Health Industrial Base.
                    (c) To the maximum extent permitted by law, and 
                with the redaction of any information protected by law 
                from disclosure, each agency's report shall be 
                published in the Federal Register and on each agency's 
                official website.

                Sec. 7. Definitions. As used in this order:

                    (a) ``Active Pharmaceutical Ingredient'' has the 
                meaning set forth in section 207.1 of title 21, Code of 
                Federal Regulations.
                    (b) ``Advanced Manufacturing'' means any new 
                medical product manufacturing technology that can 
                improve drug quality, address shortages of medicines, 
                and speed time to market, including continuous 
                manufacturing and 3D printing.
                    (c) ``API Starting Material'' means a raw or 
                intermediate material that is used in the manufacturing 
                of an API, that is incorporated as a significant 
                structural fragment into the structure of the API, and 
                that is determined by the FDA Commissioner to be 
                relevant in assessing the safety and effectiveness of 
                Essential Medicines and Medical Countermeasures.
                    (d) ``Critical Inputs'' means API, API Starting 
                Material, and other ingredients of drugs and components 
                of medical devices that the FDA Commissioner determines 
                to be critical in assessing the safety and 
                effectiveness of Essential Medicines and Medical 
                Countermeasures.
                    (e) ``Essential Medicines'' are those Essential 
                Medicines deemed necessary for the United States 
                pursuant to section 3(c) of this order.
                    (f) ``Finished Device'' has the meaning set forth 
                in section 820.3(l) of title 21, Code of Federal 
                Regulations.
                    (g) ``Finished Drug Product'' has the meaning set 
                forth in section 207.1 of title 21, Code of Federal 
                Regulations.
                    (h) ``Healthcare and Public Health Sector'' means 
                the critical infrastructure sector identified in 
                Presidential Policy Directive 21 of February 12, 2013 
                (Critical Infrastructure Security and Resilience), and 
                the National Infrastructure Protection Plan of 2013.
                    (i) An Essential Medicine or Medical Countermeasure 
                is ``produced in the United States'' if the Critical 
                Inputs used to produce the Essential Medicine or 
                Medical Countermeasures are produced in the United 
                States and if the Finished Drug Product or Finished 
                Device, are manufactured, prepared, propagated, 
                compounded, or processed, as those terms are defined in 
                section 360(a)(1) of title 21, United States Code, in 
                the United States.
                    (j) ``Medical Countermeasures'' means items that 
                meet the definition of ``qualified countermeasure'' in 
                section 247d-6a(a)(2)(A) of title 42, United States 
                Code; ``qualified pandemic or epidemic product'' in 
                section 247d-6d(i)(7) of title 42, United States Code; 
                ``security countermeasure'' in section 247d-6b(c)(1)(B) 
                of title 42, United States Code; or personal protective 
                equipment described in part 1910 of title 29, Code of 
                Federal Regulations.
                    (k) ``Public Health Industrial Base'' means the 
                facilities and associated workforces within the United 
                States, including research and development facilities, 
                that help produce Essential Medicines, Medical 
                Countermeasures, and Critical Inputs for the Healthcare 
                and Public Health Sector.
                    (l) ``Qualifying Countries'' has the meaning set 
                forth in section 225.003, Defense Federal Acquisition 
                Regulation Supplement.

[[Page 49934]]

                Sec. 8. Rule of Construction. Nothing in this order 
                shall be construed to impair or otherwise affect:

                    (a) the ability of State, local, tribal, or 
                territorial governments to timely procure necessary 
                resources to respond to any public health emergency 
                declared under section 319 of the Public Health Service 
                Act (42 U.S.C. 247d), any major disaster or emergency 
                declared under the Stafford Act (42 U.S.C. 5121 et 
                seq.), or any national emergency declared under the 
                National Emergencies Act (50 U.S.C. 1601 et seq.);
                    (b) the ability or authority of any agency to 
                respond to the spread of COVID-19; or
                    (c) the authority of the Secretary of Veterans 
                Affairs to take all necessary steps, including those 
                necessary to implement the policy set forth in section 
                1 of this order, to ensure that service members, 
                veterans, and their families continue to have full 
                access to Essential Medicines at reasonable and 
                affordable prices.

                Sec. 9. Severability. If any provision of this order, 
                or the application of any provision to any person or 
                circumstance, is held to be invalid, the remainder of 
                this order and the application of any of its other 
                provisions to any other persons or circumstances shall 
                not be affected thereby.

                Sec. 10. General Provisions. (a) Nothing in this order 
                shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or 
the head thereof; or

(ii) the functions of the Director of OMB relating to budgetary, 
administrative, or legislative proposals.

                    (b) This order shall be implemented consistent with 
                applicable law and subject to the availability of 
                appropriations.
                    (c) This order is not intended to, and does not, 
                create any right or benefit, substantive or procedural, 
                enforceable at law or in equity by any party against 
                the United States, its departments, agencies, or 
                entities, its officers, employees, or agents, or any 
                other person.
                
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    August 6, 2020.

[FR Doc. 2020-18012
Filed 8-13-20; 11:15 am]
Billing code 3295-F0-P