Section 403(b) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, referred to in subsec. (a)(6)(A)(ix), is section 403(b) of Pub. L. 116–22, title IV,
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (c)(1)(B)(i)(III)(aa), is act June 25, 1938, ch. 675, 52 Stat. 1040. Chapter V of the Act is classified generally to subchapter V (§ 351 et seq.) of chapter 9 of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.
The Project BioShield Act of 2004, referred to in subsec. (c)(7)(B)(iii)(IV), is Pub. L. 108–276,
In subsec. (c)(7)(B)(ii)(VII), “section 3304(a)(1) of title 41” substituted for “section 303(c)(1) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(1))” on authority of Pub. L. 111–350, § 6(c),
In subsec. (c)(7)(B)(iii)(I), “section 134 of title 41” substituted for “section 4(11) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(11))” and “section 3101(b)(1)(A) of title 41” substituted for “section 302A(a) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 252a(a))” on authority of Pub. L. 111–350, § 6(c),
In subsec. (c)(7)(B)(iii)(I)(aa), “section 3305(a)(1) of title 41” substituted for “section 303(g)(1)(A) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A))” on authority of Pub. L. 111–350, § 6(c),
In subsec. (c)(7)(B)(iii)(I)(bb), “section 3101(b)(1)(B) of title 41” substituted for “section 302A(b) of such Act (41 U.S.C. 252a(b))” on authority of Pub. L. 111–350, § 6(c),
In subsec. (c)(7)(B)(iii)(II)(bb), “Section 8703(a) of title 41” substituted for “Subsections (a) and (b) of section 7 of the Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and (b))” on authority of Pub. L. 111–350, § 6(c),
In subsec. (c)(7)(B)(iii)(II)(cc), “Section 4706 of title 41” substituted for “Section 304C of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254d)” on authority of Pub. L. 111–350, § 6(c),
In subsec. (c)(7)(B)(iii)(II)(ee), “Section 3901 of title 41” substituted for “Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254(a))” on authority of Pub. L. 111–350, § 6(c),
In subsec. (c)(7)(B)(iv)(I), “section 3304(a)(1) of title 41” substituted for “section 303(c)(1) of title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(1))” and “such section 3304(a)(1)” substituted for “such section 303(c)(1)” on authority of Pub. L. 111–350, § 6(c),
In subsec. (c)(7)(B)(iv)(III), “such section 3304(a)(1)” substituted for “such section 303(c)(1)” on authority of Pub. L. 111–350, § 6(c),
In subsec. (c)(7)(B)(vii), “section 3306(a)(1)(B) of title 41” substituted for “section 303A(a)(1)(B) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253a(a)(1)(B))” on authority of Pub. L. 111–350, § 6(c),
Section was formerly classified to section 300hh–12 of this title prior to renumbering by Pub. L. 108–276.
2022—Subsec. (a)(2)(B)(i)(II). Pub. L. 117–328, § 2402, amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: “planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications (without disclosing proprietary information), including consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies in the health care system;”.
Subsec. (a)(3)(B). Pub. L. 117–328, § 2403(1), inserted “, regularly reviewed, and updated” after “followed”.
Subsec. (a)(3)(C). Pub. L. 117–328, § 2408(a)(1), substituted “local, and Tribal” for “and local”.
Subsec. (a)(3)(D). Pub. L. 117–328, § 2403(2), amended subpar. (D) generally. Prior to amendment, subpar. (D) read as follows: “review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that emerging threats, advanced technologies, and new countermeasures are adequately considered and that the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including through necessary replenishment;”.
Subsec. (a)(3)(F). Pub. L. 117–328, § 2405(a)(1)(A), substituted “at the discretion of the Secretary, in consultation with, or at the request of, the Secretary of Homeland Security,” for “as required by the Secretary of Homeland Security”.
Subsec. (a)(3)(J). Pub. L. 117–328, § 2408(a)(2), substituted “local, and Tribal” for “and local”.
Subsec. (a)(3)(K). Pub. L. 117–328, § 2404(b), added subpar. (K).
Subsec. (a)(5). Pub. L. 117–328, § 2405(a)(1)(C), added par. (5). Former par. (5) redesignated (6).
Subsec. (a)(6). Pub. L. 117–328, § 2405(a)(1)(B), redesignated par. (5) as (6). Former par. (6) redesignated (7).
Subsec. (a)(6)(A)(x). Pub. L. 117–328, § 2405(a)(1)(D), added cl. (x).
Subsec. (a)(7). Pub. L. 117–328, § 2406, amended par. (7) generally. Prior to amendment, text read as follows: “The Secretary, in coordination with the Secretary of Homeland Security, may sell drugs, vaccines and other biological products, medical devices, or other supplies maintained in the stockpile under paragraph (1) to a Federal agency or private, nonprofit, State, local, tribal, or territorial entity for immediate use and distribution, provided that any such items being sold are—
“(A) within 1 year of their expiration date; or
“(B) determined by the Secretary to no longer be needed in the stockpile due to advances in medical or technical capabilities.”
Pub. L. 117–328, § 2405(a)(1)(B), redesignated par. (6) as (7).
Subsec. (c)(2)(C). Pub. L. 117–328, § 2405(a)(2), substituted “not later than March 15 of each year” for “on an annual basis”.
Subsec. (f)(1). Pub. L. 117–328, § 2405(b), substituted “$610,000,000 for each of fiscal years 2019 through 2021, and $750,000,000 for each of fiscal years 2022 and 2023” for “$610,000,000 for each of fiscal years 2019 through 2023”.
Subsec. (i). Pub. L. 117–328, § 2409(a), added subsec. (i).
2021—Subsec. (a)(6). Pub. L. 117–58 added par. (6).
2020—Subsec. (a)(1). Pub. L. 116–136 inserted “(including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests in the stockpile)” after “other supplies”.
2019—Subsec. (a)(1). Pub. L. 116–22, § 403(a)(2), inserted “the Assistant Secretary for Preparedness and Response and” after “collaboration with”, “and optimize” after “provide for” and “and, as informed by existing recommendations of, or consultations with, the Public Health Emergency Medical Countermeasure Enterprise established under section 300hh–10a of this title, make necessary additions or modifications to the contents of such stockpile or stockpiles based on the review conducted under paragraph (2)” after “public health emergency”, and struck out at end “The Secretary shall conduct an annual review (taking into account at-risk individuals) of the contents of the stockpile, including non-pharmaceutical supplies, and make necessary additions or modifications to the contents based on such review and shall submit such review annually to the appropriate congressional committees of jurisdiction to the extent that disclosure of such information does not compromise national security.”
Subsec. (a)(2). Pub. L. 116–22, § 403(a)(3), added par. (2). Former par. (2) redesignated (3).
Subsec. (a)(3). Pub. L. 116–22, § 403(a)(1), redesignated par. (2) as (3). Former par. (3) redesignated (4).
Subsec. (a)(3)(A). Pub. L. 116–22, § 403(a)(4)(A), inserted before semicolon at end “and the Public Health Emergency Medical Countermeasures Enterprise established under section 300hh–10a of this title”.
Subsec. (a)(3)(C). Pub. L. 116–22, § 403(a)(4)(B), inserted before semicolon at end “, and the availability, deployment, dispensing, and administration of countermeasures”.
Subsec. (a)(3)(E). Pub. L. 116–22, § 403(a)(4)(C), amended subpar. (E) generally. Prior to amendment, subpar. (E) read as follows: “devise plans for the effective and timely supply-chain management of the stockpile, in consultation with appropriate Federal, State and local agencies, and the public and private health care infrastructure;”.
Subsec. (a)(3)(I), (J). Pub. L. 116–22, § 403(a)(4)(D)–(F), added subpars. (I) and (J).
Subsec. (a)(4). Pub. L. 116–22, § 403(a)(1), redesignated par. (3) as (4).
Subsec. (a)(5). Pub. L. 116–22, § 403(a)(5), added par. (5).
Subsec. (c)(2)(C). Pub. L. 116–22, § 502(a), substituted “The Secretary and the Secretary of Homeland Security shall send to Congress, on an annual basis, all current material threat determinations and shall promptly notify the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives” for “The Secretary and the Homeland Security Secretary shall promptly notify the appropriate committees of Congress”.
Subsec. (c)(7)(B)(ii)(III). Pub. L. 116–22, § 502(b), inserted at end “The Secretary shall notify the vendor within 90 days of a determination by the Secretary to renew, extend, or terminate such contract.”
Subsec. (d). Pub. L. 116–22, § 702, amended subsec. (d) generally. Prior to amendment, text read as follows: “No Federal agency shall disclose under section 552 of title 5 any information identifying the location at which materials in the stockpile under subsection (a) are stored.”
Subsec. (f)(1). Pub. L. 116–22, § 403(c), substituted “$610,000,000 for each of fiscal years 2019 through 2023, to remain available until expended” for “$533,800,000 for each of fiscal years 2014 through 2018”.
Subsec. (g)(1). Pub. L. 116–22, § 504(a), substituted “$7,100,000,000 for the period of fiscal years 2019 through 2028, to remain available until expended” for “$2,800,000,000 for the period of fiscal years 2014 through 2018” and struck out at end “Amounts appropriated pursuant to the preceding sentence are authorized to remain available until
2016—Subsec. (a)(3). Pub. L. 114–255, § 3081(1), added par. (3).
Subsec. (c)(4)(A)(ii). Pub. L. 114–255, § 3085(1), substituted “and subject to the availability of appropriations, make available the special reserve fund as defined in subsection (h) for procurement of such countermeasure, as applicable” for “make a recommendation under paragraph (6) that the special reserve fund as defined in subsection (h) be made available for the procurement of such countermeasure”.
Subsec. (c)(6). Pub. L. 114–255, § 3085(2)(D), substituted “Recommendations for procurement” for “Recommendation for President’s approval” in heading.
Subsec. (c)(6)(A). Pub. L. 114–255, § 3085(2)(C), amended subpar. (A) generally. Prior to amendment, text read as follows: “The Secretary and the Homeland Security Secretary shall notify the appropriate congressional committees of each decision of the President to approve a recommendation under subparagraph (A). Such notice shall include an explanation of the decision to make available the special reserve fund as defined in subsection (h) for procurement of such a countermeasure, including, where available, the number of, nature of, and other information concerning potential suppliers of such countermeasure, and whether other potential suppliers of the same or similar countermeasures were considered and rejected for procurement under this section and the reasons therefor.”
Pub. L. 114–255, § 3085(2)(A), (B), redesignated subpar. (C) as (A) and struck out former subpar. (A). Text of former subpar. (A) read as follows: “In the case of a security countermeasure that the Secretary has, in accordance with paragraphs (3) and (5), determined to be appropriate for procurement under this subsection, the Homeland Security Secretary and the Secretary shall jointly submit to the President, in coordination with the Director of the Office of Management and Budget, a recommendation that the special reserve fund as defined in subsection (h) be made available for the procurement of such countermeasure.”
Subsec. (c)(6)(B). Pub. L. 114–255, § 3085(2)(A), (B), redesignated subpar. (D) as (B) and struck out former subpar. (B). Text of former subpar. (B) read as follows: “The special reserve fund as defined in subsection (h) is available for a procurement of a security countermeasure only if the President has approved a recommendation under subparagraph (A) regarding the countermeasure.”
Subsec. (c)(6)(C), (D). Pub. L. 114–255, § 3085(2)(B), redesignated subpars. (C) and (D) as (A) and (B), respectively.
Subsec. (c)(6)(E). Pub. L. 114–255, § 3085(2)(A), struck out subpar. (E). Text read as follows: “Recommendations and approvals under this paragraph apply solely to determinations that the special reserve fund as defined in subsection (h) will be made available for a procurement of a security countermeasure, and not to the substance of contracts for such procurement or other matters relating to awards of such contracts.”
Subsec. (c)(7)(A). Pub. L. 114–255, § 3085(3)(A), added subpar. (A) and struck out former subpar. (A). Text of former subpar. (A) read as follows: “For purposes of a procurement under this subsection that is approved by the President under paragraph (6), the Homeland Security Secretary and the Secretary shall have responsibilities in accordance with subparagraphs (B) and (C).”
Subsec. (c)(7)(B), (C). Pub. L. 114–255, § 3085(3), redesignated subpar. (C) as (B) and struck out former subpar. (B). Text of former subpar. (B) read as follows: “The Homeland Security Secretary shall enter into an agreement with the Secretary for procurement of a security countermeasure in accordance with the provisions of this paragraph. The special reserve fund as defined in subsection (h) shall be available for payments made by the Secretary to a vendor for such procurement.”
Subsec. (g)(4). Pub. L. 114–255, § 3081(2), amended par. (4) generally. Prior to amendment, text read as follows: “Not later than 30 days after any date on which the Secretary determines that the amount of funds in the special reserve fund available for procurement is less than $1,500,000,000, the Secretary shall submit to the appropriate committees of Congress a report detailing the amount of such funds available for procurement and the impact such reduction in funding will have—
“(A) in meeting the security countermeasure needs identified under this section; and
“(B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan (pursuant to section 300hh–10(d) of this title).”
Subsec. (g)(5). Pub. L. 114–255, § 3082(a), added par. (5).
2013—Subsec. (a)(1). Pub. L. 113–5, § 403(1)(A), inserted “consistent with section 300hh–10 of this title” after “amounts as are determined” and “and shall submit such review annually to the appropriate congressional committees of jurisdiction to the extent that disclosure of such information does not compromise national security” after “based on such review”.
Subsec. (a)(2)(D). Pub. L. 113–5, § 403(1)(B), inserted “and that the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including through necessary replenishment” before semicolon at end.
Subsec. (c). Pub. L. 113–5, § 401(b)(1)(A), substituted “special reserve fund as defined in subsection (h)” for “special reserve fund under paragraph (10)” wherever appearing.
Subsec. (c)(1)(B)(i)(III)(bb). Pub. L. 113–5, § 401(a)(1), substituted “10 years” for “eight years”.
Subsec. (c)(2)(C). Pub. L. 113–5, § 401(a)(2), substituted “the appropriate committees of Congress” for “the designated congressional committees (as defined in paragraph (10))”.
Subsec. (c)(5)(B)(ii). Pub. L. 113–5, § 401(a)(3), substituted “10 years” for “eight years”.
Subsec. (c)(6)(C). Pub. L. 113–5, § 401(a)(4), substituted “appropriate congressional committees” for “designated congressional committees” in heading and in text.
Subsec. (c)(7)(C)(i)(I). Pub. L. 113–5, § 401(a)(5)(A), inserted “including advanced research and development,” after “as may reasonably be required,”.
Subsec. (c)(7)(C)(ii)(III). Pub. L. 113–5, § 401(a)(5)(B)(i), substituted “10 years” for “eight years”.
Subsec. (c)(7)(C)(ii)(IX). Pub. L. 113–5, § 401(a)(5)(B)(ii), added subcl. (IX) and struck out former subcl. (IX). Prior to amendment, text read as follows: “The Secretary, in any contract for procurement under this section, may specify—
“(aa) the dosing and administration requirements for countermeasures to be developed and procured;
“(bb) the amount of funding that will be dedicated by the Secretary for development and acquisition of the countermeasure; and
“(cc) the specifications the countermeasure must meet to qualify for procurement under a contract under this section.”
Subsec. (c)(7)(C)(viii). Pub. L. 113–5, § 401(a)(5)(C), added cl. (viii).
Subsec. (c)(9), (10). Pub. L. 113–5, § 401(b)(1)(B), struck out pars. (9) and (10) which described restrictions on the use of funds and defined “special reserve fund” and “designated congressional committees”.
Subsec. (f)(1). Pub. L. 113–5, § 403(2), substituted “$533,800,000 for each of fiscal years 2014 through 2018. Such authorization is in addition to amounts in the special reserve fund referred to in subsection (h).” for “$640,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006. Such authorization is in addition to amounts in the special reserve fund referred to in subsection (c)(10)(A) of this section.”
Subsecs. (g), (h). Pub. L. 113–5, § 401(b)(2), added subsecs. (g) and (h).
2006—Pub. L. 109–417, § 406(1), inserted “and security countermeasure procurements” after “Stockpile” in section catchline.
Subsec. (a)(1). Pub. L. 109–417, § 102(c), inserted “in collaboration with the Director of the Centers for Disease Control and Prevention, and” after “The Secretary,” and inserted at end “The Secretary shall conduct an annual review (taking into account at-risk individuals) of the contents of the stockpile, including non-pharmaceutical supplies, and make necessary additions or modifications to the contents based on such review.”
Subsec. (c). Pub. L. 109–417, § 406(2)(A), struck out “biomedical” before “countermeasures” in heading.
Subsec. (c)(1)(B)(i)(I). Pub. L. 109–417, § 403(b), which directed amendment of section 319F–2(c)(1)(B) by substituting “diagnose, mitigate, prevent, or treat” for “treat, identify, or prevent” wherever appearing, was executed by making the substitution in two places in subsec. (c)(1)(B)(i)(I) of this section, which is section 319F–2 of the Public Health Service Act, to reflect the probable intent of Congress.
Subsec. (c)(3). Pub. L. 109–417, § 406(2)(B), designated existing provisions as subpar. (A), inserted heading, and added subpar. (B).
Subsec. (c)(4)(A). Pub. L. 109–417, § 406(2)(C), inserted “not developed or” after “currently” in introductory provisions.
Subsec. (c)(5)(B)(i). Pub. L. 109–417, § 406(2)(D), substituted “to meet the stockpile needs” for “to meet the needs of the stockpile”.
Subsec. (c)(7)(B). Pub. L. 109–417, § 406(2)(E), substituted “cost” for “costs” in subpar. heading, struck out cl. (i) designation and heading before “The Homeland”, and struck out heading and text of cl. (ii). Text read as follows: “The actual costs to the Secretary under this section, other than the costs described in clause (i), shall be paid from the appropriation provided for under subsection (f)(1) of this section.”
Subsec. (c)(7)(C)(ii)(I). Pub. L. 109–417, § 406(2)(F)(i), amended heading and text of subcl. (I) generally. Prior to amendment, text read as follows: “The contract shall provide that no payment may be made until delivery has been made of a portion, acceptable to the Secretary, of the total number of units contracted for, except that, notwithstanding any other provision of law, the contract may provide that, if the Secretary determines (in the Secretary’s discretion) that an advance payment is necessary to ensure success of a project, the Secretary may pay an amount, not to exceed 10 percent of the contract amount, in advance of delivery. The contract shall provide that such advance payment is required to be repaid if there is a failure to perform by the vendor under the contract. Nothing in this subclause may be construed as affecting rights of vendors under provisions of law or regulation (including the Federal Acquisition Regulation) relating to termination of contracts for the convenience of the Government.”
Subsec. (c)(7)(C)(ii)(VII) to (IX). Pub. L. 109–417, § 406(2)(F)(ii), added subcls. (VII) to (IX).
Subsec. (c)(8)(A). Pub. L. 109–417, § 406(2)(G), inserted at end “Such agreements may allow other executive agencies to order qualified and security countermeasures under procurement contracts or other agreements established by the Secretary. Such ordering process (including transfers of appropriated funds between an agency and the Department of Health and Human Services as reimbursements for such orders for countermeasures) may be conducted under the authority of section 1535 of title 31, except that all such orders shall be processed under the terms established under this subsection for the procurement of countermeasures.”
2004—Pub. L. 108–276, § 3(a)(2), amended section generally. Prior to amendment, text related in subsec. (a) to Strategic National Stockpile, in subsec. (b) to smallpox vaccine development, in subsec. (c) to disclosures, in subsec. (d) to definition of “stockpile”, and in subsec. (e) to authorization of appropriations.
2002—Subsec. (a)(1). Pub. L. 107–296, § 1705(a)(1), substituted “The Secretary of Homeland Security” for “The Secretary of Health and Human Services” and inserted “the Secretary of Health and Human Services and” after “in coordination with” and “of Health and Human Services” after “as are determined by the Secretary”.
Subsecs. (a)(2), (b)(1). Pub. L. 107–296, § 1705(a)(2), inserted “of Health and Human Services” after “Secretary” wherever appearing.
Pub. L. 107–296, title XVII, § 1705(b),
Pub. L. 117–328, div. FF, title II, § 2404(a),
Pub. L. 117–328, div. FF, title II, § 2411,
Pub. L. 114–268, “This Act may be cited as the ‘First Responder Anthrax Preparedness Act’.
Pub. L. 108–276, § 3(c)(1), (2),
Pub. L. 107–188, title I, § 127,
[Memorandum of President of the United States,
[Memorandum for the Secretary of Health and Human Services[,] the Secretary of Energy[,] the Secretary of Homeland Security[,] the Chairman of the Nuclear Regulatory Commission[, and] the Director of the Office of Science and Technology Policy
[By the authority vested in me as President by the Constitution and the laws of the United States, including section 301 of title 3, United States Code, and section 204(b) of the National Science and Technology Policy, Organization, and Priorities Act of 1976, as amended (42 U.S.C. 6613(b)), the functions of the President under section 127 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107–188) (42 U.S.C. 247d–6b note) are assigned as follows:
[(1) the function of making a determination under subsection 127(f) of Public Law 107–188 is assigned to the Director of the Office of Science and Technology Policy; and
[(2) the functions of the President under section 127 of Public Law 107–188 other than that assigned under subsection 127(f) are assigned to the Chairman of the Nuclear Regulatory Commission.
[In the performance of such functions the Chairman and the Director should consult each other and the Secretaries of Health and Human Services, Energy, and Homeland Security, as appropriate.
[The Director is authorized and directed to publish this memorandum in the Federal Register.]
Ex. Ord. No. 13944,
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:
(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.
(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 [
(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
(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 [19 U.S.C. 2511]. 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:
(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.
(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 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.
(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
(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.
(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
(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.
(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.
(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.
Ex. Ord. No. 13962,
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:
(b) The Secretary of Health and Human Services, in consultation with the Secretary of Defense and the heads of other executive departments and agencies (agencies), as appropriate, shall ensure that Americans have priority access to United States Government COVID–19 Vaccines, and shall ensure that the most vulnerable United States populations have first access to such vaccines.
(c) The Secretary of Health and Human Services shall ensure that a sufficient supply of COVID–19 vaccine doses is available for all Americans who choose to be vaccinated in order to safeguard America from COVID–19.
(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 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.
Ex. Ord. No. 14001,
By the authority vested in me as President by the Constitution and the laws of the United States of America, including the Defense Production Act of 1950, as amended (50 U.S.C. 4501 et seq.), sections 319 and 361 of the Public Health Service Act (42 U.S.C. 247d and 264), sections 306 and 307 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5149 and 5150), and section 301 of title 3, United States Code, it is hereby ordered as follows:
(i) immediately review the availability of critical materials, treatments, and supplies needed to combat COVID–19 (pandemic response supplies), including personal protective equipment (PPE) and the resources necessary to effectively produce and distribute tests and vaccines at scale; and
(ii) assess, including by reviewing prior such assessments, whether United States industry can be reasonably expected to provide such supplies in a timely manner.
(b) Where a review and assessment described in section 2(a)(i) of this order identifies shortfalls in the provision of pandemic response supplies, the head of the relevant agency shall:
(i) promptly revise its operational assumptions and planning factors being used to determine the scope and prioritization, acquisition, and distribution of such supplies; and
(ii) take appropriate action using all available legal authorities, including the Defense Production Act, to fill those shortfalls as soon as practicable by acquiring additional stockpiles, improving distribution systems, building market capacity, or expanding the industrial base.
(c) Upon completing the review and assessment described in section 2(a)(i) of this order, the Secretary of Health and Human Services shall provide to the President, through the COVID–19 Response Coordinator, a report on the status and inventory of the Strategic National Stockpile.
(d) The Secretary of State, the Secretary of Defense, the Secretary of Health and Human Services, the Secretary of Homeland Security, and the heads of any other agencies relevant to inventorying pandemic response supplies shall, as soon as practicable, provide to the President, through the COVID–19 Response Coordinator, a report consisting of:
(i) an assessment of the need for, and an inventory of current supplies of, key pandemic response supplies;
(ii) an analysis of their agency’s capacity to produce, provide, and distribute pandemic response supplies;
(iii) an assessment of their agency’s procurement of pandemic response supplies on the availability of such supplies on the open market;
(iv) an account of all existing or ongoing agency actions, contracts, and investment agreements regarding pandemic response supplies;
(v) a list of any gaps between the needs identified in section 2(a)(i) of this order and supply chain delivery, and recommendations on how to close such gaps; and
(vi) a compilation and summary of their agency’s existing distribution and prioritization plans for pandemic response supplies, which shall include any assumptions or planning factors used to determine such needs and any recommendations for changes to such assumptions or factors.
(e) The COVID–19 Response Coordinator, in coordination with the heads of appropriate agencies, shall review the report described in section 2(d) of this order and submit recommendations to the President that address:
(i) whether additional use of the Defense Production Act, by the President or agencies exercising delegated authority under the Act, would be helpful; and
(ii) the extent to which liability risk, regulatory requirements, or other factors impede the development, production, and procurement of pandemic response supplies, and any actions that can be taken, consistent with law, to remove those impediments.
(f) The heads of agencies responsible for completing the requirements of this section, as appropriate and in coordination with the COVID–19 Response Coordinator, shall consult with State, local, Tribal, and territorial authorities, as well as with other entities critical to assessing the availability of and need for pandemic response supplies.
(a) The Secretary of Health and Human Services shall promptly recommend to the President, through the COVID–19 Response Coordinator, whether any changes should be made to the authorities delegated to the Secretary by Executive Order 13910 of
(b) The Secretary of Defense, the Secretary of Health and Human Services, and the Secretary of Homeland Security shall promptly review and provide to the President, through the COVID–19 Response Coordinator, recommendations for how to address the pricing of pandemic response supplies, including whether and how to direct the use of reasonable pricing clauses in Federal contracts and investment agreements, or other related vehicles, and whether to use General Services Administration Schedules to facilitate State, local, Tribal, and territorial government buyers and compacts in purchasing pandemic response supplies using Federal supply schedules.
(a) mechanisms to respond to emergency supply needs of State, local, Tribal, and territorial authorities, which should include standards and processes to prioritize requests and delivery and to ensure equitable distribution based on public health criteria;
(b) an analysis of the role of foreign supply chains in America’s pandemic supply chain, America’s role in the international public health supply chain, and options for strengthening and better coordinating global supply chain systems in future pandemics;
(c) mechanisms to address points of failure in the supply chains and to ensure necessary redundancies;
(d) the roles of the Strategic National Stockpile and other Federal and military stockpiles in providing pandemic supplies on an ongoing or emergency basis, including their roles in allocating supplies across States, localities, tribes, and territories, sustaining supplies during a pandemic, and in contingency planning to ensure adequate preparedness for future pandemics and public health emergencies;
(e) approaches to assess and maximize the value and efficacy of public/private partnerships and the value of Federal investments in latent manufacturing capacity; and
(f) an approach to develop a multi-year implementation plan for domestic production of pandemic supplies.
(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 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.
Memorandum of President of the United States,
Memorandum for the Director of the Office of Management and Budget
By the authority vested in me by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, I hereby direct you to perform the functions vested in the President under section 319F–2(c)(6) of the Public Health Service Act, 42 U.S.C. 247d–6b(c)(6).
Any reference in this memorandum to the provision of any Act shall be deemed to include references to any hereafter-enacted provision of law that is the same or substantially the same as such provision.
You are authorized and directed to publish this memorandum in the Federal Register.