[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4368 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  2d Session
                                S. 4368

    To prepare the Strategic National Stockpile for a public health 
 emergency and require the maintenance of a domestic supply chain for 
       countermeasures in the stockpile, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 29, 2020

   Mr. Brown introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
    To prepare the Strategic National Stockpile for a public health 
 emergency and require the maintenance of a domestic supply chain for 
       countermeasures in the stockpile, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protecting American Heroes Act of 
2020''.

SEC. 2. STRATEGIC NATIONAL STOCKPILE.

    (a) Additional Provisions To Prepare the Strategic National 
Stockpile for Public Health Emergencies.--
            (1) In general.--Section 319F-2 of the Public Health 
        Service Act (42 U.S.C. 247d-6b) is amended--
                    (A) by redesignating subsection (h) as subsection 
                (i); and
                    (B) by inserting after subsection (g) the 
                following:
    ``(h) Additional Provisions To Prepare the Strategic National 
Stockpile for Public Health Emergencies.--
            ``(1) Preparing for emergencies affecting all states.--
                    ``(A) In general.--The Public Health Emergency 
                Medical Countermeasures Enterprise established under 
                section 2811-1 shall develop a model to enable the 
                stockpile under subsection (a)(1) to be prepared to 
                effectively respond to a public health emergency, 
                including one that simultaneously affects all States.
                    ``(B) Model.--The model under subparagraph (A) 
                shall include--
                            ``(i)(I) requirements with respect to the 
                        number, types, and amounts of countermeasures 
                        that are necessary to prepare the stockpile 
                        under subsection (a)(1) to respond to a public 
                        health emergency described in subparagraph (A); 
                        and
                            ``(II) the cost necessary to meet such 
                        requirements;
                            ``(ii) an assessment of the domestic supply 
                        chain for all countermeasures that are needed 
                        for the stockpile to be prepared for a public 
                        health emergency described in subparagraph (A), 
                        including--
                                    ``(I) an identification of any 
                                known domestic suppliers of such 
                                countermeasures;
                                    ``(II) an identification of any 
                                gaps in the domestic supply chain for 
                                such countermeasures;
                                    ``(III) steps needed to address the 
                                gaps in the domestic supply chain for 
                                such countermeasures;
                                    ``(IV) an identification of any 
                                countermeasure in the stockpile that 
                                only has one source, domestic or 
                                foreign, for procurement; and
                                    ``(V) steps needed to diversify 
                                sources for any countermeasure in the 
                                stockpile that has only one source, 
                                domestic or foreign, for procurement.
                    ``(C) Submission to congress.--Not later than 120 
                days after the date of enactment of the Protecting 
                American Heroes Act of 2020, the Public Health 
                Emergency Medical Countermeasures Enterprise 
                established under section 2811-1 shall submit the 
                assessment required under subparagraph (B)(ii) to each 
                Committee described in subsection (a)(2)(A).
            ``(2) Requirement to identify and maintain domestic supply 
        chain.--
                    ``(A) In general.--The Executive Deputy Assistant 
                Secretary of the Strategic National Stockpile appointed 
                under paragraph (3) (referred to in this paragraph as 
                the `Executive Deputy Assistant Secretary') shall, in 
                accordance with this paragraph, identify and maintain a 
                domestic source (which may be multiple sources) for all 
                countermeasures in the stockpile under subsection 
                (a)(1).
                    ``(B) Requirement for items in stockpile.--
                            ``(i) In general.--Except as provided under 
                        clause (ii), the Executive Deputy Assistant 
                        Secretary shall require all countermeasures in 
                        the stockpile under subsection (a)(1), and any 
                        component part of such countermeasures, to be 
                        grown, reprocessed, reused, or produced in the 
                        United States.
                            ``(ii) Waivers.--The Executive Deputy 
                        Assistant Secretary may, on a case-by-case 
                        basis, waive the requirement under clause (i) 
                        in the case of a contract for a countermeasure 
                        in the stockpile under subsection (a)(1)--
                                    ``(I) for which the Executive 
                                Deputy Assistant Secretary determines 
                                that a satisfactory quality and 
                                sufficient quantity of such 
                                countermeasure that is grown, 
                                reprocessed, reused, or produced in the 
                                United States cannot be procured as and 
                                when needed at United States market 
                                prices; or
                                    ``(II) that is, or includes, any 
                                material determined to be a 
                                nonavailable article under section 
                                25.104 of the Federal Acquisition 
                                Regulation for purposes of subpart I of 
                                part 25 of the Federal Acquisition 
                                Regulation.
                            ``(iii) Notification of waivers.--In the 
                        case of any contract for the procurement of a 
                        countermeasure in the stockpile under 
                        subsection (a)(1), if the Executive Deputy 
                        Assistant Secretary applies a waiver under 
                        clause (ii) with respect to that contract, the 
                        Executive Deputy Assistant Secretary shall, not 
                        later than 7 days after the award of the 
                        contract, submit to each Committee described in 
                        subsection (a)(2)(A) a notification that the 
                        waiver has been applied.
                    ``(C) Notice of discontinuance or interruption in 
                domestic supply chain.--
                            ``(i) Timing.--The Executive Deputy 
                        Assistant Secretary shall require any 
                        manufacturer of a countermeasure in the 
                        stockpile under subsection (a)(1) (other than a 
                        countermeasure to which a waiver has been 
                        applied under subparagraph (B)(ii)) to provide 
                        notice to the Executive Deputy Assistant 
                        Secretary of any discontinuance or interruption 
                        in the manufacture of such countermeasure. Such 
                        notice shall be submitted to the Executive 
                        Deputy Assistant Secretary--
                                    ``(I) at least 6 months prior to 
                                the date of the discontinuance or 
                                interruption; or
                                    ``(II) if compliance with subclause 
                                (I) is not possible, as soon as 
                                practicable.
                            ``(ii) Contents.--The notice required under 
                        clause (i) shall include disclosure of--
                                    ``(I) reasons for the 
                                discontinuation or interruption of the 
                                countermeasure;
                                    ``(II) if applicable, and without 
                                disclosing proprietary information, if 
                                an active pharmaceutical ingredient is 
                                a reason for, or risk factor in, such 
                                discontinuation or interruption, the 
                                source of the active pharmaceutical 
                                ingredient, and any alternative sources 
                                for the active pharmaceutical 
                                ingredient known by the manufacturer;
                                    ``(III) if applicable, whether any 
                                associated device used for preparation 
                                or administration included in the 
                                countermeasure is a reason for, or a 
                                risk factor in, such discontinuation or 
                                interruption;
                                    ``(IV) if applicable, the expected 
                                duration of the interruption; and
                                    ``(V) any such other information as 
                                the Executive Deputy Assistant 
                                Secretary may require.
            ``(3) Executive deputy assistant secretary of the strategic 
        national stockpile.--
                    ``(A) In general.--The Assistant Secretary for 
                Preparedness and Response shall appoint an Executive 
                Deputy Assistant Secretary of the Strategic National 
                Stockpile (referred to in this paragraph as the 
                `Executive Deputy Assistant Secretary'), who shall 
                report directly to the Assistant Secretary for 
                Preparedness and Response and serve in a career 
                reserved position, as defined in section 3132(a) of 
                title 5, United States Code.
                    ``(B) Qualifications.--Any individual appointed as 
                the Executive Deputy Assistant Secretary under 
                subparagraph (A) shall be selected from individuals 
                who, on the day before the date of enactment of the 
                Protecting American Heroes Act of 2020--
                            ``(i) are career appointees, as defined in 
                        section 3132(a) of title 5, United States Code; 
                        or
                            ``(ii) are former such career appointees 
                        and are eligible for reinstatement as such 
                        career appointees.
                    ``(C) Functions.--The Executive Deputy Assistant 
                Secretary appointed under subparagraph (A) shall--
                            ``(i) notwithstanding the functions of the 
                        Assistant Secretary for Preparedness and 
                        Response under section 2811-1, have authority 
                        to make decisions with respect to the stockpile 
                        under subsection (a)(1);
                            ``(ii) establish and maintain a domestic 
                        supply chain for countermeasures in such 
                        stockpile to the greatest extent possible;
                            ``(iii) consult with States and relevant 
                        stakeholders, including public health 
                        organizations, about the procurement and 
                        distribution of countermeasures in the 
                        stockpile; and
                            ``(iv) carry out all other duties of any 
                        individual serving as the Director of the 
                        Strategic National Stockpile prior to the date 
                        of enactment of the Protecting American Heroes 
                        Act of 2020.
                    ``(D) Quarterly report.--Not later than 180 days 
                after the date of enactment of the Protecting American 
                Heroes Act of 2020, and each calendar quarter 
                thereafter, the Executive Deputy Assistant Secretary 
                shall submit to the Assistant Secretary for 
                Preparedness and Response and each Committee described 
                in subsection (a)(2)(A) a report that includes--
                            ``(i) the number, types, and amounts of 
                        countermeasures in the stockpile under 
                        subsection (a)(1);
                            ``(ii) whether such number, types, and 
                        amounts are sufficient to meet a public health 
                        emergency that simultaneously affects all 
                        States;
                            ``(iii) whether any countermeasures in the 
                        stockpile have expired or failed to receive 
                        necessary maintenance in a timely fashion;
                            ``(iv) the status of the domestic supply 
                        chain with respect to countermeasures in such 
                        stockpile, including--
                                    ``(I) whether there are gaps in the 
                                supply chain, including the domestic 
                                supply chain, for such countermeasures; 
                                and
                                    ``(II) any instance in which the 
                                Executive Deputy Assistant Secretary 
                                applies a waiver under paragraph 
                                (2)(B)(ii) to a countermeasure;
                            ``(v) recommended steps necessary to 
                        address any gap described in clause (iv)(I); 
                        and
                            ``(vi)(I) whether any countermeasures in 
                        such stockpile are obtained from a sole source; 
                        and
                            ``(II) whether any steps should be taken to 
                        diversify sourcing of such countermeasures.
                    ``(E) First appointment.--With respect to the first 
                individual to serve as the Executive Deputy Assistant 
                Secretary after the date of enactment of the Protecting 
                American Heroes Act of 2020, the Assistant Secretary 
                for Preparedness and Response shall appoint such 
                individual under subparagraph (A) not later than 90 
                days after such date of enactment.
            ``(4) Definition of countermeasure.--In this subsection, 
        the term `countermeasure' includes a drug, vaccine or other 
        biological product, medical device, or other supplies 
        (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) described in subsection (a)(1).''.
            (2) Appropriations.--Section 319F-2(f) of the Public Health 
        Service Act (42 U.S.C. 247d-6b(f)) is amended--
                    (A) in the subsection heading, by striking 
                ``Authorization of Appropriations'' and inserting 
                ``Appropriations; Authorization of Appropriations''; 
                and
                    (B) by amending paragraph (1) to read as follows:
            ``(1) Strategic national stockpile.--There are 
        appropriated, out of any money in the Treasury not otherwise 
        appropriated, such sums as necessary, to remain available until 
        expended, to carry out subsections (a) and (h). Such amounts 
        are in addition to any amounts in the special reserve fund 
        under subsection (g).''.
            (3) Conforming amendments.--
                    (A) Section 319F-2 of the Public Health Service Act 
                (42 U.S.C. 247d-6b) is amended--
                            (i) in subsection (c), by striking ``as 
                        defined in subsection (h)'' each place it 
                        appears; and
                            (ii) in subsection (f), by striking as 
                        ``referred to in subsection (h)''.
                    (B) Section 2811(d)(2)(G) of the Public Health 
                Service Act (42 U.S.C. 300hh-10(d)(2)(G)) is amended by 
                striking ``as defined in section 319F-2(h)'' and 
                inserting ``as defined in section 319F-2(i)''.
    (b) Domestic Supply Chain Evaluations in Threat Assessment and GAO 
Report; Functions of Secretary.--Section 319F-2(a) of the Public Health 
Service Act (42 U.S.C. 247d-6b(a)) is amended--
            (1) in paragraph (2)--
                    (A) in subparagraph (A), by inserting ``, including 
                the domestic supply chain for such contents,'' after 
                ``within the stockpile''; and
                    (B) in subparagraph (B)(i)(II), by inserting ``, 
                including domestic manufacturing capacity,'' after 
                ``appropriate manufacturing capacity'';
            (2) in paragraph (3)--
                    (A) by redesignating subparagraphs (E) through (J) 
                as subparagraphs (F) through (K), respectively;
                    (B) by inserting after subparagraph (D) the 
                following:
                    ``(E) acting through the Executive Deputy Assistant 
                Secretary of the Strategic National Stockpile appointed 
                under subsection (h)(3), in accordance with subsection 
                (h)(2), establish, maintain, and (when necessary) 
                expand a supply chain based in the United States for 
                countermeasures (as defined in subsection (h)(4)) in 
                the stockpile;''; and
                    (C) in subparagraph (F), as so redesignated, by 
                inserting ``to ensure a robust supply chain for the 
                production in the United States of countermeasures (as 
                defined in subsection (h)(4)),'' before ``in 
                consultation with''; and
            (3) in paragraph (5)(A)--
                    (A) by redesignating clauses (iii) through (ix) as 
                clauses (iv) through (x), respectively; and
                    (B) by inserting after clause (ii) the following:
                            ``(iii) an assessment of the plans 
                        developed by the Executive Deputy Assistant 
                        Secretary of the Strategic National Stockpile 
                        appointed under subsection (h)(3) to, in 
                        accordance with subsection (h)(2), establish, 
                        maintain, and (when necessary) expand a supply 
                        chain based in the United States for 
                        countermeasures (as defined in subsection 
                        (h)(4)) procured for the stockpile;''.
    (c) Enhancing Threat-Based Reviews.--Section 319F-2(a) of the 
Public Health Service Act (42 U.S.C. 247d-6b(a)) is amended--
            (1) in paragraph (1), by striking ``based on the review 
        conducted under paragraph (2)'' and inserting ``based on any 
        review conducted under paragraph (2)''; and
            (2) in paragraph (2), by adding at the end the following:
                    ``(C) In-person or virtual briefings.--
                            ``(i) In general.--Not later than 30 days 
                        after submitting each annual threat-based 
                        review under subparagraph (A) to the Committees 
                        described in such subparagraph, the Executive 
                        Deputy Assistant Secretary of the Strategic 
                        National Stockpile, appointed under subsection 
                        (h)(3), shall provide an in-person, or virtual, 
                        briefing on such review to the members of such 
                        Committees.
                            ``(ii) Public health emergencies.--
                                    ``(I) Monthly reviews.--During the 
                                period of any public health emergency, 
                                the Executive Deputy Assistant 
                                Secretary of the Strategic National 
                                Stockpile, appointed under subsection 
                                (h)(3), shall, on a monthly basis, 
                                provide an in-person, or virtual, 
                                briefing to all members of Congress 
                                on--
                                            ``(aa) the countermeasures 
                                        (as defined in subsection 
                                        (h)4)) in the stockpile under 
                                        paragraph (1);
                                            ``(bb) the status of the 
                                        supply chain, including the 
                                        domestic supply chain, for such 
                                        countermeasures;
                                            ``(cc) how such 
                                        countermeasures are being 
                                        distributed; and
                                            ``(dd) communication with 
                                        State and local governments on 
                                        their needs with respect to 
                                        acquiring such countermeasures 
                                        in the stockpile and on the 
                                        status of countermeasures that 
                                        are available in the stockpile.
                                    ``(II) Baseline review.--Not later 
                                than 15 days after the date of 
                                enactment of the Protecting American 
                                Heroes Act of 2020, the Secretary shall 
                                conduct a baseline review of the 
                                stockpile under paragraph (1) and 
                                provide an in-person, or virtual, 
                                briefing to all members of Congress on 
                                each issue described in items (aa) 
                                through (dd) of subclause (I).
                    ``(D) Supplemental reviews.--In the event that the 
                Executive Deputy Assistant Secretary of the Strategic 
                National Stockpile, appointed under subsection (h)(3), 
                determines there is a significant depletion of any 
                countermeasure (as defined in subsection (h)(4)) in the 
                stockpile under paragraph (1), the Executive Deputy 
                Assistant Secretary of the Strategic National Stockpile 
                shall, not later than 30 days after making such 
                determination--
                            ``(i) conduct a supplemental threat-based 
                        review on each issue described in items (aa) 
                        through (dd) of subparagraph (C)(I); and
                            ``(ii) provide such review in writing to 
                        the Committees described in subparagraph 
                        (A).''.

SEC. 3. ENHANCEMENTS TO THE DEFENSE PRODUCTION ACT OF 1950.

     Section 107 of the Defense Production Act of 1950 (50 U.S.C. 4517) 
is amended by adding at the end the following:
    ``(c) Health Emergency Authority.--With respect to a public health 
emergency declared under section 319 of the Public Health Service Act 
(42 U.S.C. 247d), or preparations for such a public health emergency, 
the Secretary of Health and Human Services and the Administrator of the 
Federal Emergency Management Agency may carry out the authorities 
provided under this section to the same extent as the President.''.
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