Presidential Determination and Waiver Pursuant to Section 303 of the Defense Production Act of 1950, as Amended, on Essential Medicines, Medical Countermeasures, and Critical Inputs

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Published

January 2, 2024

Signed

December 27, 2023

Issuing agencies

Executive Office of the President

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<title>Federal Register, Volume 89 Issue 1 (Tuesday, January 2, 2024)</title>
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[Federal Register Volume 89, Number 1 (Tuesday, January 2, 2024)]
[Presidential Documents]
[Pages 3-4]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-28947]




                        Presidential Documents 



Federal Register / Vol. 89, No. 1 / Tuesday, January 2, 2024 / 
Presidential Documents

[[Page 3]]


                Presidential Determination No. 2024-03 of December 27, 
                2023

                
Presidential Determination and Waiver Pursuant to 
                Section 303 of the Defense Production Act of 1950, as 
                Amended, on Essential Medicines, Medical 
                Countermeasures, and Critical Inputs

                Memorandum for the Secretary of Health and Human 
                Services

                By the authority vested in me as President by the 
                Constitution and the laws of the United States of 
                America, including section 303 of the Defense 
                Production Act of 1950, as amended (the ``Act'') (50 
                U.S.C. 4533), it is hereby ordered as follows:

                Section 1. Determination. (a) I hereby determine, 
                pursuant to section 303(a)(5) of the Act, that:

(i) the essential medicines, medical countermeasures, and critical inputs 
referenced in subsection (b) of this section are industrial resources, 
materials, or critical technology items essential to the national defense;

(ii) without Presidential action under section 303 of the Act, United 
States industry cannot reasonably be expected to provide the capability for 
the needed industrial resources, materials, or critical technology items in 
a timely manner; and

(iii) purchases, purchase commitments, or other action pursuant to section 
303 of the Act are the most cost-effective, expedient, and practical 
alternative method for meeting the need.

                    (b) The scope of projects implemented pursuant to 
                section 303 of the Act under the determination in this 
                section is limited to drug and biologic essential 
                medicines, medical countermeasures, and critical inputs 
                identified, as of the date of this determination, 
                pursuant to section 3(c) of 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).

                Sec. 2. Waiver of Statutory Requirements. Pursuant to 
                section 303(a)(7)(B) of the Act, I find that action to 
                expand the domestic production capabilities for 
                essential medicines, medical countermeasures, and 
                critical inputs is necessary to avert an industrial 
                resource or critical technology item shortfall that 
                would severely impair national defense capability. 
                Therefore, I waive the requirements of section 
                303(a)(5)-(a)(6) of the Act for the purpose of 
                expanding the domestic production capabilities for 
                essential medicines, medical countermeasures, and 
                critical inputs needed for national defense.

                Sec. 3. General Provisions. (a) Nothing in this 
                determination 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 the Office of Management and Budget 
relating to budgetary, administrative, or legislative proposals.

                    (b) This determination shall be implemented 
                consistent with applicable law and subject to the 
                availability of appropriations.
                    (c) This determination is not intended to, and does 
                not, create any right or benefit, substantive or 
                procedural, enforceable at law or in equity by

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                any party against the United States, its departments, 
                agencies, or entities, its officers, employees, or 
                agents, or any other person.
                    (d) You are authorized and directed to publish this 
                determination in the Federal Register
                <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    Washington, December 27, 2023

[FR Doc. 2023-28947
Filed 12-29-23; 8:45 am]
Billing code 4150-42-P


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