Editorial Notes
References in Text
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, June 24, 2019, 133 Stat. 947, which is not classified to the Code.
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, July 21, 2004, 118 Stat. 835. For complete classification of this Act to the Code, see Short Title of 2004 Amendments note set out under section 201 of this title and Tables.
Codification
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), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
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), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
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), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
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), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
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), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
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), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
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), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
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), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
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), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
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), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
Section was formerly classified to section 300hh–12 of this title prior to renumbering by Pub. L. 108–276.
Amendments
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 September 30, 2019.”
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.
Statutory Notes and Related Subsidiaries
Effective Date of 2002 Amendment
Pub. L. 107–296, title XVII, § 1705(b), Nov. 25, 2002, 116 Stat. 2316, provided that:
“The amendments made by this section [amending this section] shall take effect on the date of transfer of the Strategic National
Stockpile of the
Department of Health and Human Services to the Department [of Homeland Security].”
Improving Transparency and Predictability of Processes of the Strategic National Stockpile
Pub. L. 117–328, div. FF, title II, § 2404(a), Dec. 29, 2022, 136 Stat. 5785, provided that:
“Not later than 60 days after the date of enactment of this Act [
Dec. 29, 2022], the
Secretary of Health and Human
Services (referred to in this section as the
‘Secretary’) shall issue guidance describing the processes by which the
Secretary deploys the contents of the Strategic National
Stockpile under section 319F–2(a) of the
Public Health Service Act (
42 U.S.C. 247d–6b(a)), or otherwise distributes medical countermeasures, as applicable, to States, territories, Indian Tribes and Tribal organizations (as such terms are defined under section 4 of the
Indian Self-Determination and Education Assistance Act [
25 U.S.C. 5304]), and other applicable entities. Such guidance shall include information related to processes by which to request access to the contents of the Strategic National
Stockpile, factors considered by the
Secretary when making deployment or distribution decisions, and processes and points of contact through which entities may contact the
Secretary to address any issues related to products requested or received by such entity from the
stockpile, and on other relevant topics.”
Increased Manufacturing Capacity for Certain Critical Antibiotic Drugs
Pub. L. 117–328, div. FF, title II, § 2411, Dec. 29, 2022, 136 Stat. 5793, provided that:
“(a) Program.—
“(1) In general.—
The
Secretary, in consultation with the Assistant
Secretary for Preparedness and Response and Commissioner of Food and Drugs, may award contracts to increase the domestic manufacturing capacity of certain antibiotic drugs with identified supply chain vulnerabilities, or the active pharmaceutical ingredient or key starting material of such antibiotic drugs.
“(2) Eligible entities.—To be eligible to receive an award under this subsection, an entity shall—
“(B) prepare and submit to the Secretary an application at such time, and in such manner, and containing such information as the Secretary may require, including—
“(i)
a description of proposed activities to be supported by an award under this subsection to increase manufacturing capacity for such antibiotic drug or drugs;
“(ii)
the antibiotic drug or drugs, or related active pharmaceutical ingredients or key starting materials for such drug or drugs, that such entity intends to manufacture with any increased manufacturing capacity supported by an award under this subsection;
“(iii)
any additional products such increased manufacturing capacity could be used to manufacture;
“(iv)
a description of the current supply chain for such antibiotic drugs, including any existing and applicable manufacturing facilities, known vulnerabilities in the supply chain, known or potential supply limitations, such as foreign export restrictions, or subsidies from foreign governments, as applicable;
“(v)
a description of how such entity may use advanced or flexible manufacturing in carrying out the terms of an award under this subsection; and
“(vi)
a strategic plan regarding the maintenance, operation, and sustainment of such increased manufacturing capacity following the expiration of a contract under this subsection.
“(3) Use of funds.—
A recipient of an award under this subsection shall use such funds to build, expand, upgrade, modify, or recommission a facility located in the United States, which may include the purchase or upgrade of equipment, as applicable, to support increased manufacturing capacity of certain antibiotic drugs for which supply chain vulnerabilities exist, or the active pharmaceutical ingredient or key starting material of such antibiotic drugs.
“(4) Reports.—
An entity in receipt of an award under this subsection shall submit to the
Secretary such reports as the
Secretary may require related to increasing domestic manufacturing capacity of antibiotic drugs pursuant to a contract under this subsection, including actions taken to implement the strategic plan required under paragraph (2)(B)(vi).
“(5) Contract terms.—The following shall apply to a contract to support increased domestic manufacturing capacity under this subsection:
“(A) Milestone-based payments.—
The
Secretary may provide payment, including advance payment or partial payment for significant milestones, if the
Secretary makes a determination that such payment is necessary and appropriate.
“(B) Repayment.—
The contract shall provide that such payment is required to be repaid if there is a failure to perform by the manufacturer under the contract; if the specified milestones are reached, an advance or partial payment shall not be required to be repaid.
“(C) Contract duration.—
“(i) In general.—
Each contract shall be for a period not to exceed 5 years.
“(ii) Non-renewability.—
A contract shall not be renewable.
“(iii) Notifications of extensions and terminations.—
If the
Secretary decides to terminate a contract prior to its expiration, the
Secretary shall notify the manufacturer within 90 days of such determination.
“(D) Additional terms.—The Secretary, in any contract under this subsection—
“(i) may specify—
“(I)
the amount of funding that will be dedicated by the
Secretary for supporting increased manufacturing capacity under such contract; and
“(II)
the amount of manufacturing capacity that such eligible entity must meet; and
“(ii)
shall provide a clear statement of defined Federal Government purpose limited to uses related to increasing domestic manufacturing capacity for antibiotic drugs to address identified supply chain vulnerabilities and challenges to establishing and maintaining domestic manufacturing capacity.
“(E) Sustainment.—
Each contract shall provide for the eligible entity to update the strategic plan required under paragraph (2)(B)(vi) throughout the duration of such contract, as required by the
Secretary.
“(b) Report.—Not later than 2 years after the date of enactment of this Act [Dec. 29, 2022] and every year thereafter until the termination or expiration of all such contracts, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on any activities supported under subsection (a), including—
“(1)
the antibiotic drugs for which the
Secretary prioritized awards under subsection (a), including a description of how the
Secretary consulted with stakeholders to inform such prioritization;
“(2) information regarding each contract awarded pursuant to subsection (a), including—
“(A)
the recipient of each such contract, including any recipients of a subaward;
“(B)
the milestone and performance requirements pursuant to each such contract;
“(C)
the duration of each such contract;
“(D)
the amount of funding provided by the
Secretary pursuant to each such contract, including any advanced or partial payments;
“(E)
the antibiotic drugs supported through each such contract, including a description of the medical necessity of each such antibiotic drug and any supply chain vulnerabilities, limitations, and related characteristics identified pursuant to subsection (a)(2)(B)(iv) for each such antibiotic drug; and
“(F)
the amount of increased manufacturing capacity for such antibiotic drug that each such contract supports; and
“(3)
a description of how such contracts address supply chain vulnerabilities, including increasing manufacturing capacity of antibiotic drugs in the United States; and
“(4)
a description of the strategic plan submitted pursuant to subsection (a)(2)(B)(vi) by each recipient of an award under subsection (a).
“(c) Rule of Construction.—Nothing in this section shall be construed—
“(1)
to limit, directly or indirectly, or otherwise impact the private distribution, purchase, or sale of antibiotic drugs or active pharmaceutical ingredients or key starting materials; or
“(d) Definitions.—For purposes of this section:
“(2) Antibiotic drug.—
The term ‘antibiotic drug’ means an antibacterial or antifungal drug approved by the
Food and Drug Administration under section 505(j) of the
Federal Food, Drug, and Cosmetic Act (
21 U.S.C. 355(j)) that is of significant priority to providing health care and is medically necessary to have available at all times in an amount adequate to serve patient needs.
“(3) Key starting material.—
The term ‘key starting material’ means any component of a drug that the
Secretary determines to be necessary to the safety and effectiveness of the drug.
“(e) Sunset.—
The authority to enter into new contracts under this section shall cease to be effective 3 years after the date of enactment of this Act [Dec. 29, 2022], and, beginning on the date that is 8 years after the date of enactment of this Act, this section shall have no force or effect.”
First Responder Anthrax Preparedness
Pub. L. 114–268, Dec. 14, 2016, 130 Stat. 1387, provided that:
“SECTION 1. SHORT TITLE.
“This Act may be cited as the ‘First Responder Anthrax Preparedness Act’.
“SEC. 2. VOLUNTARY PRE-EVENT ANTHRAX VACCINATION PILOT PROGRAM FOR EMERGENCY RESPONSE PROVIDERS.
“(a) Pilot Program.—
“(1) Establishment.—
The
Secretary of Homeland Security, in coordination with the
Secretary of Health and Human
Services, shall carry out a pilot program to provide eligible anthrax vaccines from the Strategic National
Stockpile under section 319F–2(a) of the
Public Health Service Act (
42 U.S.C. 247d–6b(a)) that will be nearing the end of their labeled dates of use at the time such vaccines are made available to States for administration to emergency response providers who would be at high risk of exposure to anthrax if such an attack should occur and who voluntarily consent to such administration.
“(2) Determination.—The Secretary of Health and Human Services shall determine whether an anthrax vaccine is eligible to be provided to the Secretary of Homeland Security for the pilot program described in paragraph (1) based on—
“(A)
a determination that the vaccine is not otherwise allotted for other purposes;
“(B)
a determination that the provision of the vaccine will not reduce, or otherwise adversely affect, the capability to meet projected requirements for this product during a public health emergency, including a significant reduction of available quantities of vaccine in the Strategic National
Stockpile; and
“(C)
such other considerations as determined appropriate by the
Secretary of Health and Human
Services.
“(3) Preliminary requirements.—Before implementing the pilot program required under this subsection, the Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, shall—
“(A)
establish a communication platform for the pilot program;
“(B)
develop and deliver education and training for the pilot program;
“(C)
conduct economic analysis of the pilot program, including a preliminary estimate of total costs and expected benefits;
“(D)
create a logistical platform for the anthrax vaccine request process under the pilot program;
“(E)
establish goals and desired outcomes for the pilot program; and
“(F) establish a mechanism to reimburse the Secretary of Health and Human Services for—
“(i)
the costs of shipment and transportation of such vaccines provided to the
Secretary of Homeland Security from the Strategic National
Stockpile under such pilot program, including staff time directly supporting such shipment and transportation; and
“(ii)
the amount, if any, by which the warehousing costs of the Strategic National
Stockpile are increased in order to operate such pilot program.
“(4) Location.—
“(A) In general.—
In carrying out the pilot program required under this subsection, the Secretary of Homeland Security shall select not fewer than 2 nor more than 5 States for voluntary participation in the pilot program.
“(B) Requirement.—
Each State that participates in the pilot program under this subsection shall ensure that such participation is consistent with the All-Hazards Public Health Emergency Preparedness and Response Plan of the State developed under section 319C–1 of the
Public Health Service Act (
42 U.S.C. 247d–3a).
“(5) Guidance for selection.—
To ensure that participation in the pilot program under this subsection strategically increases State and local response readiness in the event of an anthrax release, the
Secretary of Homeland Security, in coordination with the
Secretary of Health and Human
Services, shall provide guidance to participating States and units of local government on identifying emergency response providers who are at high risk of exposure to anthrax.
“(6) Distribution of information.—The Secretary of Homeland Security shall require that each State that participates in the pilot program under this subsection submit a written certification to the Secretary of Homeland Security stating that each emergency response provider within the State that participates in the pilot program is provided with disclosures and educational materials designated by the Secretary of Health and Human Services, which may include—
“(A)
materials regarding the associated benefits and risks of any vaccine provided under the pilot program, and of exposure to anthrax;
“(B)
additional material consistent with the Centers for Disease Control and Prevention’s clinical guidance; and
“(C)
notice that the Federal Government is not obligated to continue providing anthrax vaccine after the date on which the pilot program ends.
“(7) Memorandum of understanding.—Before implementing the pilot program under this subsection, the Secretary of Homeland Security shall enter into a memorandum of understanding with the Secretary of Health and Human Services to—
“(A)
define the roles and responsibilities of each Department for the pilot program; and
“(B)
establish other performance metrics and policies for the pilot program, as appropriate.
“(8) Report.—
“(A) In general.—Notwithstanding subsection (c), not later than 1 year after the date on which the initial vaccines are administered under this section, and annually thereafter until 1 year after the completion of the pilot program under this section, the Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, shall submit to the Committee on Homeland Security and the Committee on Energy and Commerce of the House of Representatives and the Committee on Homeland Security and Governmental Affairs and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the progress and results of the pilot program, including—
“(i) a detailed tabulation of the costs to administer the program, including—
“(I)
total costs for management and administration;
“(II)
total costs to ship vaccines;
“(III)
total number of full-time equivalents allocated to the program; and
“(IV)
total costs to the Strategic National
Stockpile;
“(ii)
the number and percentage of eligible emergency response providers, as determined by each pilot location, that volunteer to participate;
“(iii)
the degree to which participants complete the vaccine regimen;
“(iv)
the total number of doses of vaccine administered; and
“(v)
recommendations to improve initial and recurrent participation in the pilot program.
“(B) Final report.—The final report required under subparagraph (A) shall—
“(i)
consider whether the pilot program required under this subsection should continue after the date described in subsection (c); and
“(ii) include—
“(I)
an analysis of the costs and benefits of continuing the program to provide anthrax vaccines to emergency response providers;
“(II)
an explanation of the economic, health, and other risks and benefits of administering vaccines through the pilot program rather than post-event treatment; and
“(III)
in the case of a recommendation under clause (i) to continue the pilot program after the date described in subsection (c), a plan under which the pilot program could be continued.
“(b) Deadline for Implementation.—
Not later than 1 year after the date of enactment of this Act [Dec. 14, 2016], the Secretary of Homeland Security shall begin implementing the pilot program under this section.
“(c) Sunset.—
The authority to carry out the pilot program under this section shall expire on the date that is 5 years after the date of enactment of this Act [Dec. 14, 2016].”
Stockpile Functions Transferred
Pub. L. 108–276, § 3(c)(1), (2), July 21, 2004, 118 Stat. 853, provided that:
“(1) In general.—
Except as provided in paragraph (2), there shall be transferred to the
Secretary of Health and Human
Services the functions, personnel, assets, unexpended balances, and liabilities of the Strategic National
Stockpile, including the functions of the
Secretary of Homeland Security relating thereto.
“(2) Exceptions.—
“(A) Functions.—
The transfer of functions pursuant to paragraph (1) shall not include such functions as are explicitly assigned to the
Secretary of Homeland Security by this Act [see Short Title of 2004 Amendments note set out under
section 201 of this title] (including the amendments made by this Act).
Potassium Iodide
Pub. L. 107–188, title I, § 127, June 12, 2002, 116 Stat. 615, provided that:
“(a) In General.—
Through the national
stockpile under
section 121 [now section 319F–2 of act
July 1, 1944,
42 U.S.C. 247d–6b], the President, subject to subsections (b) and (c), shall make available to State and local governments potassium iodide tablets for stockpiling and for distribution as appropriate to public facilities, such as schools and hospitals, in quantities sufficient to provide adequate protection for the population within 20 miles of a nuclear power plant.
“(b) State and Local Plans.—
“(1) In general.—Subsection (a) applies with respect to a State or local government, subject to paragraph (2), if the government involved meets the following conditions:
“(A)
Such government submits to the President a plan for the stockpiling of potassium iodide tablets, and for the distribution and utilization of potassium iodide tablets in the event of a nuclear incident.
“(B)
The plan is accompanied by certifications by such government that the government has not already received sufficient quantities of potassium iodide tablets from the Federal Government.
“(2) Local governments.—Subsection (a) applies with respect to a local government only if, in addition to the conditions described in paragraph (1), the following conditions are met:
“(A) The State in which the locality involved is located—
“(i)
does not have a plan described in paragraph (1)(A); or
“(ii)
has a plan described in such paragraph, but the plan does not address populations at a distance greater than 10 miles from the nuclear power plant involved.
“(B)
The local government has petitioned the State to modify the State plan to address such populations, not exceeding 20 miles from such plant, and 60 days have elapsed without the State modifying the State plan to address populations at the full distance sought by the local government through the petition.
“(C)
The local government has submitted its local plan under paragraph (1)(A) to the State, and the State has approved the plan and certified that the plan is not inconsistent with the State emergency plan.
“(c) Guidelines.—
Not later than one year after the date of the enactment of this Act [June 12, 2002], the President, in consultation with individuals representing appropriate Federal, State, and local agencies, shall establish guidelines for the stockpiling of potassium iodide tablets, and for the distribution and utilization of potassium iodide tablets in the event of a nuclear incident. Such tablets may not be made available under subsection (a) until such guidelines have been established.
“(d) Information.—
The President shall carry out activities to inform State and local governments of the program under this section.
“(e) Reports.—
“(1) President.—Not later than six months after the date on which the guidelines under subsection (c) are issued, the President shall submit to the Congress a report—
“(A)
on whether potassium iodide tablets have been made available under subsection (a) or other Federal, State, or local programs, and the extent to which State and local governments have established
stockpiles of such tablets; and
“(B)
the measures taken by the President to implement this section.
“(2) National academy of sciences.—
“(A) In general.—
The President shall request the National Academy of Sciences to enter into an agreement with the President under which the Academy conducts a study to determine what is the most effective and safe way to distribute and administer potassium iodide tablets on a mass scale. If the Academy declines to conduct the study, the President shall enter into an agreement with another appropriate public or nonprofit private entity to conduct the study.
“(B) Report.—
The President shall ensure that, not later than six months after the date of the enactment of this Act [June 12, 2002], the study required in subparagraph (A) is completed and a report describing the findings made in the study is submitted to the Congress.
“(f) Applicability.—
Subsections (a) and (d) cease to apply as requirements if the President determines that there is an alternative and more effective prophylaxis or preventive measures for adverse thyroid conditions that may result from the release of radionuclides from nuclear power plants.”
[Memorandum of President of the United States, July 3, 2007, 72 F.R. 37627, provided:
[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.]
Executive Documents
Ex. Ord. No. 13944. Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States
Ex. Ord. No. 13944, Aug. 6, 2020, 85 F.R. 49929, provided:
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 [now 10 U.S.C. 3204(a)]; section 3304(a) of title 41, 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 [Aug. 6, 2020], 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 [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.
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 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) [50 U.S.C. 4553 note], 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
(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.
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.
Ex. Ord. No. 13962. Ensuring Access to United States Government COVID–19 Vaccines
Ex. Ord. No. 13962, Dec. 8, 2020, 85 F.R. 79777, provided:
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. Purpose. Through unprecedented collaboration across the United States Government, industry, and international partners, the United States expects to soon have safe and effective COVID–19 vaccines available for the American people. To ensure the health and safety of our citizens, to strengthen our economy, and to enhance the security of our Nation, we must ensure that Americans have priority access to COVID–19 vaccines developed in the United States or procured by the United States Government (“United States Government COVID–19 Vaccines”).
Sec. 2. Policy. It is the policy of the United States to ensure Americans have priority access to free, safe, and effective COVID–19 vaccines. After ensuring the ability to meet the vaccination needs of the American people, it is in the interest of the United States to facilitate international access to United States Government COVID–19 Vaccines.
Sec. 3. American Access to COVID–19 Vaccines. (a) The Secretary of Health and Human Services, through Operation Warp Speed and with the support of the Secretary of Defense, shall ensure safe and effective COVID–19 vaccines are available to the American people, coordinating with public and private entities—including State, territorial, and tribal governments, where appropriate—to enable the timely distribution of such vaccines.
(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.
Sec. 4. International Access to United States Government COVID–19 Vaccines. After determining that there exists a sufficient supply of COVID–19 vaccine doses for all Americans who choose to be vaccinated, as required by section 3(b) of this order, the Secretary of Health and Human Services and the Secretary of State, in coordination with the Administrator of the United States Agency for International Development, the Chief Executive Officer of the United States International Development Finance Corporation, the Chairman and President of the Export-Import Bank of the United States, and the heads of other agencies, shall facilitate international access to United States Government COVID–19 Vaccines for allies, partners, and others, as appropriate and consistent with applicable law.
Sec. 5. Coordination of International Access to United States Government COVID–19 Vaccines. Within 30 days of the date of this order [Dec. 8, 2020], the Assistant to the President for National Security Affairs shall coordinate development of an interagency strategy for the implementation of section 4 of this order.
Sec. 6. 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 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. A Sustainable Public Health Supply Chain
Ex. Ord. No. 14001, Jan. 21, 2021, 86 F.R. 7219, provided:
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:
Section 1. Purpose. The Federal Government must act urgently and effectively to combat the coronavirus disease 2019 (COVID–19) pandemic. To that end, this order directs immediate actions to secure supplies necessary for responding to the pandemic, so that those supplies are available, and remain available, to the Federal Government and State, local, Tribal, and territorial authorities, as well as to America’s health care workers, health systems, and patients. These supplies are vital to the Nation’s ability to reopen its schools and economy as soon and safely as possible.
Sec. 2. Immediate Inventory of Response Supplies and Identification of Emergency Needs. (a) The Secretary of State, the Secretary of Defense, the Secretary of Health and Human Services, the Secretary of Homeland Security, and the heads of appropriate executive departments and agencies (agencies), in coordination with the COVID–19 Response Coordinator, shall:
(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.
Sec. 3. Pricing. To take steps to address the pricing of 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 March 23, 2020 (Preventing Hoarding of Health and Medical Resources To Respond to the Spread of COVID–19) [50 U.S.C. 4512 note], with respect to scarce materials or materials the supply of which would be threatened by accumulation for the purpose of hoarding or price gouging.
(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.
Sec. 4. Pandemic Supply Chain Resilience Strategy. Within 180 days of the date of this order [Jan. 21, 2021], the Secretary of Defense, the Secretary of Health and Human Services, and the Secretary of Homeland Security, in coordination with the Assistant to the President for National Security Affairs (APNSA), the Assistant to the President for Domestic Policy, the COVID–19 Response Coordinator, and the heads of any agencies or entities selected by the APNSA and COVID–19 Response Coordinator, shall provide to the President a strategy to design, build, and sustain a long-term capability in the United States to manufacture supplies for future pandemics and biological threats. This strategy shall include:
(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.
Sec. 5. Access to Strategic National Stockpile. The Secretary of Health and Human Services shall consult with Tribal authorities and take steps, as appropriate and consistent with applicable law, to facilitate access to the Strategic National Stockpile for federally recognized Tribal governments, Indian Health Service healthcare providers, Tribal health authorities, and Urban Indian Organizations.
Sec. 6. 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 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.
Designation and Authorization To Perform Functions Under Section 319F–2 of the Public Health Service Act
Memorandum of President of the United States, Oct. 21, 2004, 69 F.R. 70349, provided:
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.
