[House Report 116-518]
[From the U.S. Government Publishing Office]


116th Congress     }                                    {      Report 
                        HOUSE OF REPRESENTATIVES
 2d Session        }                                    {      116-518

======================================================================



 
    STRENGTHENING AMERICA'S STRATEGIC NATIONAL STOCKPILE ACT OF 2020

                                _______
                                

 September 18, 2020.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 7574]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 7574) to amend the Public Health Service Act 
with respect to the Strategic National Stockpile, and for other 
purposes, having considered the same, reports favorably thereon 
with an amendment and recommends that the bill as amended do 
pass.

                                CONTENTS

  I. Purpose and Summary..............................................5
 II. Background and Need for the Legislation..........................6
III. Committee Hearings..............................................10
 IV. Committee Consideration.........................................10
  V. Committee Votes.................................................11
 VI. Oversight Findings..............................................11
VII. New Budget Authority, Entitlement Authority, and Tax Expenditure11
VIII.Federal Mandates Statement......................................11

 IX. Statement of General Performance Goals and Objectives...........11
  X. Duplication of Federal Programs.................................11
 XI. Committee Cost Estimate.........................................12
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits.....12
XIII.Advisory Committee Statement....................................12

XIV. Applicability to Legislative Branch.............................12
 XV. Section-by-Section Analysis of the Legislation..................12
XVI. Changes in Existing Law Made by the Bill, as Reported...........14

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

  (a) Short Title.--This Act may be cited as the ``Strengthening 
America's Strategic National Stockpile Act of 2020''.
  (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Reimbursable transfers.
Sec. 3. Equipment maintenance.
Sec. 4. Supply chain flexibility manufacturing pilot.
Sec. 5. GAO study on the feasibility and benefits of a user fee 
agreement.
Sec. 6. Grants for State strategic stockpiles.
Sec. 7. Action reporting.
Sec. 8. Improved, transparent processes.
Sec. 9. Authorization of appropriations.

SEC. 2. REIMBURSABLE TRANSFERS.

  Section 319F-2(a) of the Public Health Service Act (42 U.S.C. 247d-
6b(a)) is amended by adding at the end the following:
          ``(6) Transfers and reimbursements.--
                  ``(A) In general.--Without regard to chapter 5 of 
                title 40, United States Code, the Secretary may 
                transfer to any Federal department or agency, on a 
                reimbursable basis, any drugs, vaccines and other 
                biological products, medical devices, and other 
                supplies in the stockpile if--
                          ``(i) the transferred supplies are less than 
                        one year from expiry;
                          ``(ii) the stockpile is able to replenish the 
                        supplies, as appropriate; and
                          ``(iii) the Secretary decides the transfer is 
                        in the best interest of the United States 
                        Government.
                  ``(B) Use of reimbursement.--Reimbursement derived 
                from the transfer of supplies pursuant to subparagraph 
                (A) may be used by the Secretary, without further 
                appropriation and without fiscal year limitation, to 
                carry out this section.
                  ``(C) Rule of construction.--This paragraph shall not 
                be construed to preclude transfers of products in the 
                stockpile under other authorities.
                  ``(D) Report.--Not later than September 30, 2022, the 
                Secretary shall submit to the Committee on Energy and 
                Commerce of the House of Representatives and the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate a report on each transfer made under this 
                paragraph and the amount received by the Secretary in 
                exchange for that transfer.
                  ``(E) Sunset.--The authority to make transfers under 
                this paragraph shall cease to be effective on September 
                30, 2023.''.

SEC. 3. EQUIPMENT MAINTENANCE.

  Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) 
is amended--
          (1) in subsection (a)(3)--
                  (A) in subparagraph (I), by striking ``; and'' and 
                inserting a semicolon;
                  (B) in subparagraph (J), by striking the period at 
                the end and inserting a semicolon; and
                  (C) by inserting the following new subparagraph at 
                the end:
                  ``(K) ensure contents of the stockpile remain in good 
                working order and, as appropriate, conduct maintenance 
                services on contents of the stockpile; and''; and
          (2) in subsection (c)(7)(B), by adding at the end the 
        following new clause:
                          ``(ix) Equipment maintenance service.--In 
                        carrying out this section, the Secretary may 
                        enter into contracts for the procurement of 
                        equipment maintenance services.''.

SEC. 4. SUPPLY CHAIN FLEXIBILITY MANUFACTURING PILOT.

  (a) In General.--Section 319F-2(a)(3) of the Public Health Service 
Act (42 U.S.C. 247d-6b(a)(3)), as amended by section 3, is further 
amended by adding at the end the following new subparagraph:
                  ``(L) enhance medical supply chain elasticity and 
                establish and maintain domestic reserves of critical 
                medical supplies (including personal protective 
                equipment, ancillary medical supplies, and other 
                applicable supplies required for the administration of 
                drugs, vaccines and other biological products, and 
                other medical devices (including diagnostic tests)) 
                by--
                          ``(i) increasing emergency stock of critical 
                        medical supplies;
                          ``(ii) geographically diversifying domestic 
                        production of such medical supplies, as 
                        appropriate;
                          ``(iii) entering into cooperative agreements 
                        or partnerships with respect to manufacturing 
                        lines, facilities, and equipment for the 
                        domestic production of such medical supplies; 
                        and
                          ``(iv) managing, either directly or through 
                        cooperative agreements with manufacturers and 
                        distributors, domestic reserves established 
                        under this subparagraph by refreshing and 
                        replenishing stock of such medical supplies.''.
  (b) Reporting; Sunset.--Section 319F-2(a) of the Public Health 
Service Act (42 U.S.C. 247d-6b(a)), as amended by section 2, is further 
amended by adding at the end the following:
          ``(7) Reporting.--Not later than September 30, 2022, the 
        Secretary shall submit to the Committee on Energy and Commerce 
        of the House of Representatives and the Committee on Health, 
        Education, Labor and Pensions of the Senate a report on the 
        details of each cooperative agreement or partnership entered 
        into under paragraph (3)(L), including the amount expended by 
        the Secretary on each such cooperative agreement or 
        partnership.
          ``(8) Sunset.--The authority to enter into cooperative 
        agreements or partnerships pursuant to paragraph (3)(L) shall 
        cease to be effective on September 30, 2023.''.
  (c) Funding.--Section 319F-2(f) of the Public Health Service Act (42 
U.S.C. 247d-6b(f)) is amended by adding at the end the following:
          ``(3) Supply chain elasticity.--
                  ``(A) In general.--For the purpose of carrying out 
                subsection (a)(3)(L), there is authorized to be 
                appropriated $500,000,000 for each of fiscal years 2020 
                through 2023, to remain available until expended.
                  ``(B) Relation to other amounts.--The amount 
                authorized to be appropriated by subparagraph (A) for 
                the purpose of carrying out subsection (a)(3)(L) is in 
                addition to any other amounts available for such 
                purpose.''.

SEC. 5. GAO STUDY ON THE FEASIBILITY AND BENEFITS OF A USER FEE 
                    AGREEMENT.

  (a) In General.--The Comptroller General of the United States shall 
conduct a study to investigate the feasibility of establishing user 
fees to offset certain Federal costs attributable to the procurement of 
single-source materials for the Strategic National Stockpile under 
section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) and 
distributions of such materials from the Stockpile. In conducting this 
study, the Comptroller General shall consider, to the extent 
information is available--
          (1) whether entities receiving such distributions generate 
        profits from those distributions;
          (2) any Federal costs attributable to such distributions;
          (3) whether such user fees would provide the Secretary with 
        funding to potentially offset procurement costs of such 
        materials for the Strategic National Stockpile; and
          (4) any other issues the Comptroller General identifies as 
        relevant.
  (b) Report.--Not later than February 1, 2023, the Comptroller General 
of the United States shall submit to the Congress a report on the 
findings and conclusions of the study under subsection (a).

SEC. 6. GRANTS FOR STATE STRATEGIC STOCKPILES.

  Title III of the Public Health Service Act is amended by inserting 
after section 319F-4 of such Act (42 U.S.C. 247d-6e) the following new 
section:

``SEC. 319F-5. GRANTS FOR STATE STRATEGIC STOCKPILES.

  ``(a) In General.--The Secretary may establish a pilot program 
consisting of awarding grants to States to expand or maintain a 
strategic stockpile of commercially available drugs, medical equipment, 
personal protective equipment, and other products deemed by the State 
to be essential in the event of a public health emergency.
  ``(b) Allowable Use of Funds.--
          ``(1) Uses.--A State receiving a grant under this section may 
        use the grant funds to--
                  ``(A) acquire commercially available products listed 
                pursuant to paragraph (2) for inclusion in the State's 
                strategic stockpile;
                  ``(B) store, maintain, and distribute products in 
                such stockpile; and
                  ``(C) conduct planning in connection with such 
                activities.
          ``(2) List.--The Secretary shall develop and publish a list 
        of the products that are eligible, as described in subsection 
        (a), for inclusion in a State's strategic stockpile using funds 
        received under this section.
          ``(3) Consultation.--In developing the list under paragraph 
        (2) and otherwise determining the allowable uses of grant funds 
        under this section, the Secretary shall consult with States and 
        relevant stakeholders, including public health organizations.
  ``(c) Funding Requirement.--The Secretary may not obligate or expend 
any funds to award grants or fund any previously awarded grants under 
this section for a fiscal year unless the total amount made available 
to carry out section 319F-2 for such fiscal year is equal to or greater 
than the total amount of funds made available to carry out section 
319F-2 for fiscal year 2020.
  ``(d) Matching Funds.--
          ``(1) In general.--With respect to the costs of expanding and 
        maintaining a strategic stockpile through a grant under this 
        section, as a condition on receipt of the grant, a State shall 
        make available (directly) non-Federal contributions in cash 
        toward such costs in an amount that is equal to not less than 
        the amount of Federal funds provided through the grant.
          ``(2) Waiver.--The Secretary may waive the requirement of 
        paragraph (1) with respect to a State for the first two years 
        of the State receiving a grant under this section if the 
        Secretary determines that such waiver is needed for the State 
        to establish a strategic stockpile described in subsection (a).
  ``(e) Technical Assistance.--The Secretary shall provide technical 
assistance to States in establishing, expanding, and maintaining a 
stockpile described in subsection (a).
  ``(f) Definition.--In this section, the term `drug' has the meaning 
given to that term in section 201 of the Federal Food, Drug, and 
Cosmetic Act.
  ``(g) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $3,500,000,000 for each of 
fiscal years 2020 through 2023, to remain available until expended.
  ``(h) Sunset.--The authority vested by this section terminates at the 
end of fiscal year 2023.''.

SEC. 7. ACTION REPORTING.

  (a) In General.--The Assistant Secretary for Preparedness and 
Response (in this section referred to as the ``Assistant Secretary''), 
in coordination with the Administrator of the Federal Emergency 
Management Agency, shall--
          (1) not later than 30 days after the date of enactment of 
        this Act, issue a report to the Committee on Energy and 
        Commerce of the House of Representatives and the Committee on 
        Health, Education, Labor, and Pensions of the Senate regarding 
        all State, local, Tribal, and territorial requests for supplies 
        from the Strategic National Stockpile related to COVID-19; and
          (2) not less than every 30 days thereafter through the end of 
        the emergency period (as such term is defined in section 
        1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b-
        5(g)(1)(B))), submit to such committees an updated version of 
        such report.
  (b) Reporting Period.--
          (1) Initial report.--The initial report under subsection (a) 
        shall address all requests described in such subsection made 
        during the period--
                  (A) beginning on January 31, 2020; and
                  (B) ending on the date that is 30 days before the 
                date of submission of the report.
          (2) Updates.--Each update to the report under subsection (a) 
        shall address all requests described in such subsection made 
        during the period--
                  (A) beginning at the end of the previous reporting 
                period under this section; and
                  (B) ending on the date that is 30 days before the 
                date of submission of the updated report.
  (c) Contents of Report.--The report under subsection (a) (and updates 
thereto) shall include--
          (1) the details of each request described in such subsection, 
        including--
                  (A) the specific medical countermeasures, devices, 
                personal protective equipment, and other materials 
                requested; and
                  (B) the amount of such materials requested; and
          (2) the outcomes of each request described in subsection (a), 
        including--
                  (A) whether the request was wholly fulfilled, 
                partially fulfilled, or denied;
                  (B) if the request was wholly or partially fulfilled, 
                the fulfillment amount; and
                  (C) if the request was partially fulfilled or denied, 
                a rationale for such outcome.

SEC. 8. IMPROVED, TRANSPARENT PROCESSES.

  (a) In General.--Not later than January 1, 2021, the Secretary of 
Health and Human Services, in collaboration with the Assistant 
Secretary for Preparedness and Response and the Director of the Centers 
for Disease Control and Prevention, shall develop and implement 
improved, transparent processes for the use and distribution of drugs, 
vaccines and other biological products, medical devices, and 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 Strategic National Stockpile under section 
319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) (in this 
section referred to as the ``Stockpile'').
  (b) Processes.--The processes developed under subsection (a) shall 
include--
          (1) the form and manner in which States, localities, Tribes, 
        and territories are required to submit requests for supplies 
        from the Stockpile;
          (2) the criteria used by the Secretary of Health and Human 
        Services in responding to such requests, including the reasons 
        for fulfilling or denying such requests;
          (3) what circumstances result in prioritization of 
        distribution of supplies from the Stockpile to States, 
        localities, Tribes, or territories;
          (4) clear plans for future, urgent communication between the 
        Secretary and States, localities, Tribes, and territories 
        regarding the outcome of such requests; and
          (5) any differences in the processes developed under 
        subsection (a) for geographically related emergencies, such as 
        weather events, and national emergencies, such as pandemics.
  (c) Classification.--The processes developed under subsection (a) 
shall be unclassified to the greatest extent possible consistent with 
national security. The Secretary of Health and Human Services may 
classify portions of such processes as necessary to protect national 
security.
  (d) Report to Congress.--Not later than January 1, 2021, the 
Secretary of Health and Human Services shall--
          (1) submit a report to the Committee on Energy and Commerce 
        of the House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate regarding the 
        improved, transparent processes developed under this section;
          (2) include in such report recommendations for opportunities 
        for communication (by telebriefing, phone calls, or in-person 
        meetings) between the Secretary and States, localities, Tribes, 
        and territories regarding such improved, transparent processes; 
        and
          (3) submit such report in unclassified form to the greatest 
        extent possible, except that the Secretary may include a 
        classified appendix if necessary to protect national security.

SEC. 9. AUTHORIZATION OF APPROPRIATIONS.

  Section 319F-2(f)(1) of the Public Health Service Act (42 U.S.C. 
247d-6b(f)(1)) is amended by striking ``$610,000,000 for each of fiscal 
years 2019 through 2023'' and inserting ``$705,000,000 for each of 
fiscal years 2020 through 2023''.

                         I. Purpose and Summary

    H.R. 7574, the ``Strengthening America's Strategic National 
Stockpile Act of 2020'', was introduced on July 13, 2020, by 
Representatives Elissa Slotkin (D-MI), Susan Brooks (R-IN), 
Anna G. Eshoo (D-CA), Earl ``Buddy'' L. Carter (R-GA), Debbie 
Dingell (D-MI), Jackie Walorski (R-IN), Diana DeGette (D-CO), 
David McKinley (R-WV), G.K. Butterfield (D-NC), Jeff Van Drew 
(R-NJ), Darren Soto (D-FL), Fred Upton (R-MI), Tom Malinowski 
(D-NJ), Richard Hudson (R-NC), Kim Schrier (D-CA), Greg 
Gianforte (R-MT), Gil Cisneros (D-CA), Joe Neguse (D-CO), and 
Michael C. Burgess (R-TX).
    H.R. 7574 amends the Public Health Service Act to enhance 
the capabilities of the Strategic National Stockpile (SNS) in 
order to ensure the Federal Government can sufficiently respond 
to the ongoing coronavirus disease of 2019 (COVID-19) pandemic 
and prepare for future public health emergencies that require 
distributions of drugs, devices, vaccines, or other ancillary 
medical supplies from the SNS.
    In order to ensure all supplies within the SNS are 
operational and to prevent expired items from remaining in the 
stockpile, the legislation authorizes the SNS to transfer to 
other Federal agencies for reimbursement supplies within the 
stockpile that are less than one year from expiry and requires 
that the SNS ensure the contents of the stockpile remain in 
good working order. Additionally, H.R. 7574 establishes a 
supply chain manufacturing pilot to enhance supply chain 
elasticity and build up the domestic reserves of critical 
medical supplies. This pilot would be intended to ensure 
manufacturing supply chains of critical supplies could be 
expanded when needed to meet demand, and then appropriately 
reduced once demand has been fulfilled.
    The bill also requires the Government Accountability Office 
(GAO) to study the feasibility of user fees for certain 
supplies within the SNS and authorizes grants to States to 
expand or maintain State strategic stockpiles of commercially 
available medical supplies and countermeasures for use in the 
event of a public health emergency. H.R. 7574 increases 
transparency of SNS medical countermeasure (MCM) allocation by 
requiring ongoing action reporting in response to the COVID-19 
pandemic, as well as the development of improved, transparent 
processes for the use and distribution of MCMs moving forward. 
Finally, the legislation increases the annual authorization of 
appropriations for the SNS to $705 million for each of the 
fiscal years 2020 through 2023.
    Based on lessons learned from the ongoing COVID-19 
pandemic, H.R. 7574 provides the SNS with the necessary tools 
and transparent processes that will ultimately strengthen its 
ability to better prepare for and respond to future public 
health emergencies.

                II. Background and Need for Legislation

    Established in 1998 as the National Pharmaceutical 
Stockpile, Congress appropriated funds to the Department of 
Health and Human Services (HHS) to create a national stockpile 
of pharmaceuticals and other medical supplies that may be 
needed for rapid deployment in response to an emergency.\1\ In 
2002, the stockpile was renamed and first authorized as the 
Strategic National Stockpile (SNS) in the Public Health 
Security and Bioterrorism Preparedness Act of 2002.\2\ 
Historically, the SNS has largely contained materials relevant 
to chemical, biological, radiological, and nuclear (CBRN) 
events, including antibiotics, ancillary medical supplies, 
equipment, antidotes, antitoxins, antivirals, vaccines, and 
other medical countermeasures (MCMs) that are strategically 
located throughout the United States that can be distributed 
quickly after State and local authorities request such assets 
from the stockpile.\3\ The SNS also has limited quantities of 
personal protective equipment (PPE), including N95 respirators, 
face masks, face shields, gowns, coveralls, and gloves. With 
respect to what are typically widely-available supplies such as 
PPE, the SNS was designed to serve as a source of medical 
supplies and medicines for use during domestic public health 
emergencies in which adequate amounts of State and local 
supplies may be depleted and not immediately available.\4\ 
Since the initial authorization of the SNS, the stockpile has 
been continually reauthorized, most recently as part of the 
Pandemic All-Hazards Preparedness and Advancing Innovation Act 
of 2019.\5\
---------------------------------------------------------------------------
    \1\Strategic National Stockpile, Overview, Association of State and 
Territorial Health Officials, available at https://astho.org/Programs/
Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-
Toolkit/Strategic-National-Stockpile-Fact-Sheet/. See also Strategic 
National Stockpile: Origin, Policy Foundations, and Federal Context, 
available at https://www.ncbi.nlm.nih.gov/books/NBK396378/; Strategic 
National Stockpile (SNS) Radiation Emergency Medical Management, U.S. 
Dep't of Health & Human Services, available at https://
www.remm.nlm.gov/sns.htm.
    \2\ Id.
    \3\About the Strategic National Stockpile, Office of the Assistant 
Secretary for Preparedness and Response, available at https://
www.phe.gov/about/sns/Pages/about.aspx. See also National Stockpiles: 
Background and Issues for Congress, Congressional Research Service, 
available at https://www.crs.gov/Reports/
IF11574?source=search&guid9b97faf5767f4cb6bf0f65c69216cfae& index=0.
    \4\U.S. Department of Health and Human Services, Public Health 
Emergency, Inventory Management and Tracking System (IMATS), Sustaining 
the Stockpile (Mar. 12, 2020), available at https://www.phe.gov/about/
sns/Pages/imats.aspx.
    \5\P.L.116-22.
---------------------------------------------------------------------------
    Since the emergence of the novel coronavirus, known as 
SARS-CoV-2, the SNS has been utilized throughout the country to 
provide PPE, medical devices such as ventilators, and other 
medical supplies to health care workers and other first 
responders in order to meet the needed demand to respond to 
COVID-19. On January 31, 2020, HHS Secretary Alex Azar declared 
a public health emergency in response to the emergence of 
COVID-19\6\ and six weeks later, on March 13, 2020, President 
Trump issued a proclamation declaring a national emergency 
concerning the COVID-19 outbreak.\7\ The proclamation noted 
that the spread of COVID-19 within the United States 
``threatens to strain our Nation's healthcare system''\8\ and 
in the weeks and months following the national emergency 
declarations, this strain on the Nation's healthcare system 
continues. This was the first time the President had declared a 
nationwide Stafford Act emergency in response to a public 
health emergency.\9\
---------------------------------------------------------------------------
    \6\Secretary Azar Declares Public Health Emergency for United 
States for 2019 Novel Coronavirus, Jan. 31, 2020, available at https://
www.hhs.gov/about/news/2020/01/31/secretary-
azar-declares-public-health-emergency-us-2019-novel-
coronavirus.html#::text=Health%20and% 
20Human%20Services%20Secretary%20Alex%20M.%20Azar,healthcare%20community
%20in% 20responding%20to%202019%20novel%20coronavirus.
    \7\Proclamation on Declaring a National Emergency Concerning the 
Novel Coronavirus Disease (COVID-19) Outbreak, March 13, 2020, 
available at https://www.whitehouse.gov/presidential-actions/
proclamation-declaring-national-emergency-concerning-novel-coronavirus-
disease-covid-19-outbreak/.
    \8\Id.
    \9\Congressional Research Service, Presidential Declarations of 
Emergency for COVID-19: NEA and Stafford Act, INSIGHT IN11264 (Mar. 19, 
2020), available at https://crsreports.congress.gov/product/pdf/IN/
IN11264.
---------------------------------------------------------------------------
    In response to COVID-19, the SNS has deployed PPE, 
including N95 respirators, surgical and face masks, face 
shields, gloves, and disposable gowns to help prevent COVID-19 
transmission in all 50 States, the Nation's four largest 
cities, as well as in U.S. territories.\10\ The SNS has also 
deployed ventilators to areas in need.\11\ However, COVID-19 
``presented an unusual set of circumstances involving nearly 
simultaneous requests from all 56 [State, local, Tribal, and 
territorial] SLTT authorities.''\12\ As the pandemic has 
continued, the stockpile's supplies have been exhausted as a 
result of the simultaneous, widespread, and ongoing demand from 
across the country and around the world.\13\ The COVID-19 
pandemic has been an unprecedented experience for the SNS as 
compared with previous public health emergencies in which the 
SNS and relevant supplies in inventory were utilized for more 
targeted purposes.\14\
---------------------------------------------------------------------------
    \10\HHS/ASPR Strategic National Stockpile, Response to the COVID-19 
Pandemic, Office of the Assistant Secretary for Preparedness and 
Response, available at https://www.phe.gov/emergency/events/COVID19/
SNS/Pages/default.aspx.
    \11\ Id.
    \12\The Strategic National Stockpile and COVID-19, Testimony of 
Daniel M. Gerstein, The RAND Corporation, June 24, 2020, available at 
https://www.rand.org/content/dam/rand/pubs/testimonies/CTA500/CTA530-1/
RAND_CTA530-1.pdf.
    \13\See Protective gear in national stockpile is nearly depleted, 
DHS officials say, April 1, 2020, Washington Post, available at https:/
/www.washingtonpost.com/national/coronavirus-protective-gear-stockpile-
depleted/2020/04/01/44d6592a-741f-11ea-ae50-7148009252e3_story.html.
    \14\COVID-19: Opportunities to Improve Federal Response and 
Recovery Efforts, Report to the Congress, Government Accountability 
Office, June 25, 2020, available at https://www.gao.gov/reports/GAO-20-
625/.
---------------------------------------------------------------------------
    Additionally, some supplies within the SNS, including 
ventilators, were found to be inoperative when deployed based 
on lack of previous use and maintenance.\15\ Other supplies, 
such as respirators and face masks, were deployed from the 
stockpile despite having surpassed their manufacturer-
designated expiration for use.\16\ Some States and cities 
reported receiving masks and respirators with dry rot and 
faulty elastics.\17\ In one case discovered by the HHS Office 
of the Inspector General, certain masks distributed to a health 
system from the Federal and State governments were designed for 
children and therefore unusable for adult medical 
providers.\18\ In a statement, the CDC acknowledged that some 
items had indeed exceeded their manufacturer-designated shelf 
life, but were nevertheless sent to hospitals ``due to the 
potential urgent demand caused by the COVID-19 public health 
emergency.''\19\ The urgent demand also strained State-based 
stockpiled resources, which in some cases also contained 
expired supplies, compounding broader medical supply access 
throughout the country. For example, Missouri had a left-over 
supply of 663,920 N95 respirator masks, 253,800 surgical masks, 
154,000 gloves, 17,424 face shields, and 14,048 gowns provided 
by CDC after the 2009 H1N1 influenza pandemic.\20\ Stockpiles 
in California, Colorado, Connecticut, Illinois, Michigan, 
Nevada, New Hampshire, New Mexico, Ohio, Pennsylvania, 
Virginia, Vermont, Washington, and West Virginia all included 
at least some leftovers from the H1N1 pandemic as well.\21\
---------------------------------------------------------------------------
    \15\See A ventilator Stockpile, With One Hitch: Thousands Do Not 
Work, April 1, 2020, New York Times, available at https://
www.nytimes.com/2020/04/01/us/politics/coronavirus-ventilators.html.
    \16\Health care workers using expired gear during pandemic and 
`hoping for the best' March 30, 2020, NC Policy Watch, available at 
http://www.ncpolicywatch.com/2020/03/30/health-care-workers-using-
expired-gear-during-pandemic-and-hoping-for-the-best/.
    \17\Some states receive masks with dry rot, broken ventilators, 
April 4, 2020, AP News, available at https://apnews.com/
f43781b64bacd6aa094d9404f4ab91a4.
    \18\See Protective gear in national stockpile is nearly depleted, 
DHS officials say, April 1, 2020, Washington Post, available at https:/
/www.washingtonpost.com/national/coronavirus-protective-gear-stockpile-
depleted/2020/04/01/44d6592a-741f-11ea-ae50-7148009252e3_story.html. 
See also, Hospital Experiences Responding to the COVID-19 Pandemic: 
Results of a National Pulse Survey March 23-27, 2020, Dep't of Health 
and Human Services, Office of Inspector General, available at https://
oig.hhs.gov/oei/reports/oei-06-20-00300.pdf
    \19\Supra n. 17.
    \20\David Lieb, Cuneyt Dil, AP Review: State supply stocks sparse 
and dated before virus, THE ASSOCIATED PRESS (Apr. 23, 2020), available 
at https://apnews.com/1f123d323b4089a6f7b242abcceb6d08.
    \21\Id.
---------------------------------------------------------------------------
    The background of the supply shortfall would be incomplete 
without mention of how supply needs were compounded by failings 
of global medical supply chains, which were completely 
disrupted by the pandemic.\22\ Long standing declines in public 
health funding at the Federal and State levels and the growth 
of ``just in time'' inventory models, also contributed to 
nationwide shortages of critical supplies.\23\
---------------------------------------------------------------------------
    \22\We Need a Stress Test for Critical Supply Chains, David Simchi-
Levi and Edith Simchi-Levi, Harvard Business Review, April 28, 2020, 
available at https://hbr.org/2020/04/we-need-a-stress-test-for-
critical-supply-chains?ab=hero-subleft-1
    \23\State Public Health Resources and Capacity, Association of 
State and Territorial Health Officials, March 23, 2020, available at 
https://www.astho.org/Research/Data-and-Analysis/Data-Brief-on-State-
Public-Health-Resources-and-Capacity/. See also Why don't hospitals 
have enough masks? Because coronavirus broke the market. May 21, 2020, 
Washington Post, available at https://www.washingtonpost.com/outlook/
2020/05/21/why-dont-hospitals-have-enough-masks-because-coronavirus-
broke-market/.
---------------------------------------------------------------------------
    H.R. 7574 authorizes several important initiatives to 
address the challenges experienced during the COVID-19 pandemic 
by providing the SNS with new tools and flexibilities that will 
help address domestic supply chain shortfalls, ultimately 
strengthening the ability of the SNS to prepare for and respond 
to major public health emergencies in the future. Section 2 of 
H.R. 7574 allows the SNS to pilot the reimbursable transfer of 
supplies within the stockpile that are near expiration to other 
Federal agencies for more immediate usage, which will permit 
the SNS to use the reimbursement towards the purchase of new 
supplies for the stockpile that will be readily available for 
deployment and will not be at risk of imminent expiration. 
Additionally, section 3 of the legislation requires that items 
within the stockpile be maintained in ``good working order'' to 
prevent deployment of any devices or equipment that would not 
be operational as a result of lack of use or lack of 
maintenance. Further, this section clarifies that the Secretary 
may enter into contracts for purposes of equipment maintenance 
services.
    Section 4 of the bill is intended to increase the domestic 
reserves of critical medical supplies, including PPE, ancillary 
medical supplies, medical devices including diagnostic tests, 
and other supplies required for the administration of vaccines 
or treatments, which have been in significant shortage and 
extremely high demand since the emergence of COVID-19. This 
manufacturing pilot would support increasing emergency stock of 
medical supplies, diversification of medical supply production, 
and entering into cooperative agreements or partnerships for 
domestic production of medical supplies. This pilot will be in 
effect until September 30, 2023. Section 5 of H.R. 7574 directs 
the Comptroller General to conduct a study to investigate the 
feasibility of establishing user fees to offset Federal costs 
associated with the procurement of certain materials for the 
SNS. The study should examine whether the user fees would 
augment Congressional appropriations to the SNS for purposes of 
procurement.
    Section 6 authorizes the creation of a pilot grant program 
for the enhancement and maintenance of independent State-
managed medical stockpiles to help States and localities 
maintain reserve supplies. These State-managed reserves would 
be intended to supplement supplies deployed from the SNS, 
ultimately contributing additional resources in the event of an 
emergency and helping States be better prepared to manage 
critical shortages of medical resources in the future. Grants 
under this program can only be funded if the SNS's fiscal year 
funding is maintained at fiscal year 2020 funding levels or 
greater.
    In order to increase transparency with regards to SNS 
operations, section 7 of H.R. 7574 requires the Secretary, in 
consultation with the Administrator of the Federal Emergency 
Management Agency (FEMA), to submit monthly reports to Congress 
regarding all requests made by States, localities, Tribes and 
territories for supplies from the SNS during the COVID-19 
public health emergency. This action reporting is intended to 
better inform Congress about the needs and nature of requests 
of State and local health officials responding to COVID-19, and 
the allocations deployed from the SNS to fulfill those needs 
and requests. Additionally, section 8 of H.R. 7574 requires the 
Secretary to develop and implement an improved, transparent 
process for the use and distribution of supplies from the SNS 
in the future. Given the critical and vast needs identified 
during the COVID-19 public health emergency, a more transparent 
process by which States, localities, Tribes, and territories 
can request supplies from the SNS will help enhance the 
stockpile's response capabilities, potentially shorten 
deployment timeframes, and improve the allocation of resources.
    Finally, to ensure resource limitations do not contribute 
to shortages or delays for maintaining and deploying supplies 
from the SNS, H.R. 7574 also strengthens the stockpile's 
financial security by increasing the annual authorization of 
appropriations from $610 million to $705 million for each of 
the fiscal years 2020 through 2023. This reflects the enacted 
funding level for the SNS for fiscal year 2020.
    Together, the provisions of H.R. 7574 will strengthen the 
capabilities of the SNS to better prepare for and respond to 
public health emergencies in the future that require the 
deployment of critical medical supplies throughout the country. 
The legislation will also ensure the SNS has the ability to 
build better domestic manufacturing supply capacity as the 
Nation continues to respond to the COVID-19 pandemic.

                        III. Committee Hearings

    For the purposes of section 103(i) of H. Res. 6 of the 
116th Congress, the following hearing was used to develop or 
consider H.R. 7574:
    The Committee on Energy and Commerce held a hearing on June 
23, 2020, entitled, ``Oversight of the Trump Administration's 
Response to the COVID-19 Pandemic.'' The full Committee 
received testimony from the following witnesses:
           Anthony Fauci, M.D., Director, National 
        Institute of Allergy and Infectious Diseases, National 
        Institutes of Health
           Adm. Brett P. Giroir, M.D., Assistant 
        Secretary for Health, U.S. Department of Health and 
        Human Services
           Stephen M. Hahn, M.D., Commissioner, U.S. 
        Food and Drug Administration
           Robert R. Redfield, M.D., Director, Centers 
        for Disease Control and Prevention

                      IV. Committee Consideration

    H.R. 7574, the ``Strengthening America's Strategic National 
Stockpile Act of 2020'', was introduced by Representatives 
Slotkin (D-MI) and other members on July 13, 2020, and referred 
to the Committee on Energy and Commerce. The bill was then 
referred to the Subcommittee on July 14, 2020, to the 
Subcommittee on Health. The bill was discharged from the 
subcommittee on July 15, 2020, when it was called up for 
consideration and markup by the full Committee. During 
committee consideration, a manager's amendment was offered by 
Mrs. Dingell of Michigan, on behalf of herself and Mrs. Brooks 
of Indiana. The Dingell/Brooks amendment to H.R. 7574 was 
agreed to by a voice vote. Consideration of the bill having 
concluded, the full Committee agreed to a motion on final 
passage by Mr. Pallone, Chairman of the committee, to order 
H.R. 7574 reported favorably to the House, amended, by a voice 
vote, a quorum being present.

                           V. Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. The 
Committee advises that there were no record votes taken on H.R. 
7574, including the motion for final passage of the bill.

                         VI. Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) 
of rule X of the Rules of the House of Representatives, the 
oversight findings and recommendations of the Committee are 
reflected in the descriptive portion of the report.

 VII. New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.
    The Committee has requested but not received from the 
Director of the Congressional Budget Office a statement as to 
whether this bill contains any new budget authority, spending 
authority, credit authority, or an increase or decrease in 
revenues or tax expenditures.

                    VIII. Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

       IX. Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to 
strengthen the Strategic National Stockpile for preparation in 
the event of future public health emergencies and for the 
continued response to the COVID-19 pandemic.

                   X. Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 7574 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                      XI. Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

    XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 7574 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                   XIII. Advisory Committee Statement

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                XIV. Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

           XV. Section-by-Section Analysis of the Legislation


Section 1. Short title; table of contents

    Section 1 designates that the short title may be cited as 
the ``Strengthening America's Strategic National Stockpile Act 
of 2020'' and provides the table of contents for the 
legislation.

Sec. 2. Reimbursable transfers

    Section 2 amends section 319F-2(a) of the Public Health 
Service Act to permit the Strategic National Stockpile to 
transfer to any Federal department or agency, on a reimbursable 
basis, any drugs, vaccines or other biological products, 
medical devices, and other supplies in the stockpile if the 
supplies are less than one year from expiry; the stockpile is 
able to replenish the supplies, as appropriate; and the 
Secretary decides the transfer is in the best interest of the 
United States Government. A report shall be submitted to the 
House Committee on Energy and Commerce and the Senate Committee 
on Health, Education, Labor and Pensions on each transfer made 
and the amount received in exchange for that transfer no later 
than September 30, 2022. The authority to make transfers under 
this section shall cease to be effective on September 30, 2023.

Sec. 3. Equipment maintenance

    Section 3 further amends Section 319F-2 of the Public 
Health Service Act to require that the contents of the 
stockpile remain in good working order and, as appropriate, 
have maintenance services conducted on the contents of the 
stockpile. Section 3 also permits the Secretary to enter into 
contracts for the procurement of equipment maintenance 
services.

Sec. 4. Supply chain flexibility manufacturing pilot

    Section 4 amends Section 319F-2(a)(3) of the Public Health 
Service Act to establish a supply chain flexibility 
manufacturing pilot in order to enhance medical supply chain 
elasticity and maintain domestic reserves of critical medical 
supplies. Such supplies include PPE, ancillary medical 
supplies, and other supplies required for the administration of 
drugs, vaccines, and other biological products, and other 
medical devices, including diagnostic tests. Such enhancements 
to domestic medical supply capacity may be done by increasing 
emergency stock of critical medical supplies diversifying 
domestic production of medical supplies, entering into 
cooperative agreements or partnerships with respect to 
manufacturing lines, facilities, and equipment for domestic 
production of medical supplies, and managing domestic reserves 
by refreshing and replenishing stock of such medical supplies. 
A report shall be submitted to the Committee on Energy and 
Commerce and the Committee on Health, Education, Labor and 
Pensions of the Senate on each cooperative agreement or 
partnership entered into under the manufacturing pilot and the 
amount expended by the Secretary on each cooperative agreement 
or partnership transfer no later than September 30, 2022. The 
authority to enter into cooperative agreements or partnerships 
under this section shall cease to be effective on September 30, 
2023. To carry out this manufacturing pilot, section 4 
authorizes $500,000,000 for each of fiscal years 2020 through 
2023.

Sec. 5. GAO study on the feasibility and benefits of a user fee 
        agreement

    Section 5 requires the Comptroller General of the United 
States to conduct a study to investigate the feasibility of 
establishing user fees to offset certain Federal costs 
attributable to the procurement of single-source materials for 
the SNS and distributions of such materials from the stockpile. 
In conducting this study, the Comptroller General shall 
consider, to the extent information is available: whether 
entities receiving such distributions generate profits from 
those distributions; any Federal costs attributable to such 
distributions; whether such user fees would provide the 
Secretary with funding to potentially offset procurement costs 
of such materials for the Strategic National Stockpile; and any 
other issues the Comptroller General identifies as relevant. 
The report shall be submitted to Congress not later than 
February 1, 2023.

Sec. 6. Grants for state strategic stockpiles

    Section 6 adds a new section 319F-5 to the Public Health 
Service Act to establish a pilot program that awards grants to 
States to expand or maintain a strategic stockpile of 
commercially available drugs, medical equipment, personal 
protective equipment, and other products deemed by the State to 
be essential in the event of a public health emergency. The 
Secretary shall develop and publish a list of products that are 
eligible for inclusion in a State's strategic stockpile using 
funds received through this pilot program. The Secretary may 
not obligate or expend any funds to award grants or fund any 
previously awarded grants under this section unless the total 
amount made available for the SNS under section 319F-2 is equal 
to or greater than the total amount of funds made available in 
fiscal year 2020. States shall make available non-Federal 
contributions in cash toward such costs in an amount that is 
equal to and not less than the amount of Federal funds provided 
under this pilot program. However, the Secretary may waive this 
matching fund requirement for the first two years of a State 
receiving a grant if the Secretary determines that such waiver 
is needed for a State to establish a strategic stockpile. To 
carry out this section, there is $3,500,000,000 authorized to 
be appropriated for each of the fiscal years 2020 through 2023. 
The authority vested by this section terminates at the end of 
fiscal year 2023.

Sec. 7. Action reporting

    Section 7 requires the Secretary, in consultation with the 
FEMA Administrator, to issue a report to the House Committee on 
Energy and Commerce and the Senate Committee on Health, 
Education, Labor and Pensions regarding all State, local, 
Tribal, and territorial requests for supplies from the SNS 
related to COVID-19. This report is required to be issued not 
later than 30 days after the date of enactment of H.R. 7574 and 
shall be updated every 30 days thereafter for the duration of 
the emergency period. Section 7 requires that the report 
include the specific medical countermeasures, devices, personal 
protective equipment, and other materials requested and the 
amount of such materials requested, as well as the outcomes of 
each request.

Sec. 8. Improved, transparent processes

    Section 8 requires the Secretary to develop and implement 
improved, transparent processes for the use and distribution of 
drugs, vaccines and other biological products, medical devices, 
and other supplies in the SNS. The processes developed shall 
include: the form and manner in which States, localities, 
Tribes, and territories are required to submit requests for 
supplies from the Stockpile; the criteria used by the Secretary 
in responding to such requests; the circumstances that result 
in prioritization of distribution to States, localities, 
Tribes, and territories; clear plans for future, urgent 
communication between the Secretary and States, localities, 
Tribes, and territories regarding the outcome of such requests; 
and any differences in the processes developed for 
geographically related emergencies and national emergencies.
    The processes developed shall be unclassified to the 
greatest extent possible consistent with national security. 
This report shall be submitted to the House Committee on Energy 
and Commerce and the Senate Committee on Health, Education, 
Labor and Pensions no later than January 1, 2021.

Sec. 9. Authorization of appropriations

    Section 9 amends section 319F-2(f)(1) of the Public Health 
Service Act to increase the annual authorization of 
appropriations from $610,000,000 to $705,000,000 for each of 
the fiscal years 2020 through 2023.

       XVI. Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT




           *       *       *       *       *       *       *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *



Part B--Federal-State Cooperation

           *       *       *       *       *       *       *



SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE AND SECURITY COUNTERMEASURE 
                    PROCUREMENTS.

  (a) Strategic National Stockpile.--
          (1) In general.--The Secretary, in collaboration with 
        the Assistant Secretary for Preparedness and Response 
        and the Director of the Centers for Disease Control and 
        Prevention, and in coordination with the Secretary of 
        Homeland Security (referred to in this section as the 
        ``Homeland Security Secretary''), shall maintain a 
        stockpile or stockpiles of drugs, vaccines and other 
        biological products, medical devices, and 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) in such 
        numbers, types, and amounts as are determined 
        consistent with section 2811 by the Secretary to be 
        appropriate and practicable, taking into account other 
        available sources, to provide for and optimize the 
        emergency health security of the United States, 
        including the emergency health security of children and 
        other vulnerable populations, in the event of a 
        bioterrorist attack or other public health emergency 
        and, as informed by existing recommendations of, or 
        consultations with, the Public Health Emergency Medical 
        Countermeasure Enterprise established under section 
        2811-1, make necessary additions or modifications to 
        the contents of such stockpile or stockpiles based on 
        the review conducted under paragraph (2).
          (2) Threat-based review.--
                  (A) In general.--The Secretary shall conduct 
                an annual threat-based review (taking into 
                account at-risk individuals) of the contents of 
                the stockpile under paragraph (1), including 
                non-pharmaceutical supplies, and, in 
                consultation with the Public Health Emergency 
                Medical Countermeasures Enterprise established 
                under section 2811-1, review contents within 
                the stockpile and assess whether such contents 
                are consistent with the recommendations made 
                pursuant to section 2811-1(c)(1)(A). Such 
                review shall be submitted on June 15, 2019, and 
                on March 15 of each year thereafter, to the 
                Committee on Health, Education, Labor, and 
                Pensions and the Committee on Appropriations of 
                the Senate and the Committee on Energy and 
                Commerce and the Committee on Appropriations of 
                the House of Representatives, in a manner that 
                does not compromise national security.
                  (B) Additions, modifications, and 
                replenishments.--Each annual threat-based 
                review under subparagraph (A) shall, for each 
                new or modified countermeasure procurement or 
                replenishment, provide--
                          (i) information regarding--
                                  (I) the quantities of the 
                                additional or modified 
                                countermeasure procured for, or 
                                contracted to be procured for, 
                                the stockpile;
                                  (II) 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;
                                  (III) the presence or lack of 
                                a commercial market for the 
                                countermeasure at the time of 
                                procurement;
                                  (IV) the emergency health 
                                security threat or threats such 
                                countermeasure procurement is 
                                intended to address, including 
                                whether such procurement is 
                                consistent with meeting 
                                emergency health security needs 
                                associated with such threat or 
                                threats;
                                  (V) an assessment of whether 
                                the emergency health security 
                                threat or threats described in 
                                subclause (IV) could be 
                                addressed in a manner that 
                                better utilizes the resources 
                                of the stockpile and permits 
                                the greatest possible increase 
                                in the level of emergency 
                                preparedness to address such 
                                threats;
                                  (VI) whether such 
                                countermeasure is replenishing 
                                an expiring or expired 
                                countermeasure, is a different 
                                countermeasure with the same 
                                indication that is replacing an 
                                expiring or expired 
                                countermeasure, or is a new 
                                addition to the stockpile;
                                  (VII) a description of how 
                                such additions or modifications 
                                align with projected 
                                investments under previous 
                                countermeasures budget plans 
                                under section 2811(b)(7), 
                                including expected life-cycle 
                                costs, expenditures related to 
                                countermeasure procurement to 
                                address the threat or threats 
                                described in subclause (IV), 
                                replenishment dates (including 
                                the ability to extend the 
                                maximum shelf life of a 
                                countermeasure), and the 
                                manufacturing capacity required 
                                to replenish such 
                                countermeasure; and
                                  (VIII) appropriate protocols 
                                and processes for the 
                                deployment, distribution, or 
                                dispensing of the 
                                countermeasure at the State and 
                                local level, including plans 
                                for relevant capabilities of 
                                State and local entities to 
                                dispense, distribute, and 
                                administer the countermeasure; 
                                and
                          (ii) an assurance, which need not be 
                        provided in advance of procurement, 
                        that for each countermeasure procured 
                        or replenished under this subsection, 
                        the Secretary completed a review 
                        addressing each item listed under this 
                        subsection in advance of such 
                        procurement or replenishment.
          (3) Procedures.--The Secretary, in managing the 
        stockpile under paragraph (1), shall--
                  (A) consult with the working group under 
                section 319F(a) and the Public Health Emergency 
                Medical Countermeasures Enterprise established 
                under section 2811-1;
                  (B) ensure that adequate procedures are 
                followed with respect to such stockpile for 
                inventory management and accounting, and for 
                the physical security of the stockpile;
                  (C) in consultation with Federal, State, and 
                local officials, take into consideration the 
                timing and location of special events, and the 
                availability, deployment, dispensing, and 
                administration of countermeasures;
                  (D) 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;
                  (E) devise plans for effective and timely 
                supply-chain management of the stockpile, in 
                consultation with the Director of the Centers 
                for Disease Control and Prevention, the 
                Assistant Secretary for Preparedness and 
                Response, the Secretary of Transportation, the 
                Secretary of Homeland Security, the Secretary 
                of Veterans Affairs, and the heads of other 
                appropriate Federal agencies; State, local, 
                Tribal, and territorial agencies; and the 
                public and private health care infrastructure, 
                as applicable, taking into account the 
                manufacturing capacity and other available 
                sources of products and appropriate 
                alternatives to supplies in the stockpile;
                  (F) deploy the stockpile as required by the 
                Secretary of Homeland Security to respond to an 
                actual or potential emergency;
                  (G) deploy the stockpile at the discretion of 
                the Secretary to respond to an actual or 
                potential public health emergency or other 
                situation in which deployment is necessary to 
                protect the public health or safety;
                  (H) ensure the adequate physical security of 
                the stockpile;
                  (I) ensure that each countermeasure or 
                product under consideration for procurement 
                pursuant to this subsection receives the same 
                consideration regardless of whether such 
                countermeasure or product receives or had 
                received funding under section 319L, including 
                with respect to whether the countermeasure or 
                product is most appropriate to meet the 
                emergency health security needs of the United 
                States[; and];
                  (J) provide assistance, including technical 
                assistance, to maintain and improve State and 
                local public health preparedness capabilities 
                to distribute and dispense medical 
                countermeasures and products from the 
                stockpile, as appropriate[.];
                  (K) ensure contents of the stockpile remain 
                in good working order and, as appropriate, 
                conduct maintenance services on contents of the 
                stockpile; and
                  (L) enhance medical supply chain elasticity 
                and establish and maintain domestic reserves of 
                critical medical supplies (including personal 
                protective equipment, ancillary medical 
                supplies, and other applicable supplies 
                required for the administration of drugs, 
                vaccines and other biological products, and 
                other medical devices (including diagnostic 
                tests)) by--
                          (i) increasing emergency stock of 
                        critical medical supplies;
                          (ii) geographically diversifying 
                        domestic production of such medical 
                        supplies, as appropriate;
                          (iii) entering into cooperative 
                        agreements or partnerships with respect 
                        to manufacturing lines, facilities, and 
                        equipment for the domestic production 
                        of such medical supplies; and
                          (iv) managing, either directly or 
                        through cooperative agreements with 
                        manufacturers and distributors, 
                        domestic reserves established under 
                        this subparagraph by refreshing and 
                        replenishing stock of such medical 
                        supplies.
          (4) Utilization guidelines.--The Secretary shall 
        ensure timely and accurate recommended utilization 
        guidelines for qualified countermeasures (as defined in 
        section 319F-1), qualified pandemic and epidemic 
        products (as defined in section 319F-3), and security 
        countermeasures (as defined in subsection (c)), 
        including for such products in the stockpile.
          (5) GAO report.--
                  (A) In general.--Not later than 3 years after 
                the date of enactment of the Pandemic and All-
                Hazards Preparedness and Advancing Innovation 
                Act of 2019, and every 5 years thereafter, the 
                Comptroller General of the United States shall 
                conduct a review of any changes to the contents 
                or management of the stockpile since January 1, 
                2015. Such review shall include--
                          (i) an assessment of the 
                        comprehensiveness and completeness of 
                        each annual threat-based review under 
                        paragraph (2), including whether all 
                        newly procured or replenished 
                        countermeasures within the stockpile 
                        were described in each annual review, 
                        and whether, consistent with paragraph 
                        (2)(B), the Secretary conducted the 
                        necessary internal review in advance of 
                        such procurement or replenishment;
                          (ii) an assessment of whether the 
                        Secretary established health security 
                        and science-based justifications, and a 
                        description of such justifications for 
                        procurement decisions related to health 
                        security needs with respect to the 
                        identified threat, for additions or 
                        modifications to the stockpile based on 
                        the information provided in such 
                        reviews under paragraph (2)(B), 
                        including whether such review was 
                        conducted prior to procurement, 
                        modification, or replenishment;
                          (iii) an assessment of the plans 
                        developed by the Secretary for the 
                        deployment, distribution, and 
                        dispensing of countermeasures procured, 
                        modified, or replenished under 
                        paragraph (1), including whether such 
                        plans were developed prior to 
                        procurement, modification, or 
                        replenishment;
                          (iv) an accounting of countermeasures 
                        procured, modified, or replenished 
                        under paragraph (1) that received 
                        advanced research and development 
                        funding from the Biomedical Advanced 
                        Research and Development Authority;
                          (v) an analysis of how such 
                        procurement decisions made progress 
                        toward meeting emergency health 
                        security needs related to the 
                        identified threats for countermeasures 
                        added, modified, or replenished under 
                        paragraph (1);
                          (vi) a description of the resources 
                        expended related to the procurement of 
                        countermeasures (including additions, 
                        modifications, and replenishments) in 
                        the stockpile, and how such 
                        expenditures relate to the ability of 
                        the stockpile to meet emergency health 
                        security needs;
                          (vii) an assessment of the extent to 
                        which additions, modifications, and 
                        replenishments reviewed under paragraph 
                        (2) align with previous relevant 
                        reports or reviews by the Secretary or 
                        the Comptroller General;
                          (viii) with respect to any change in 
                        the Federal organizational management 
                        of the stockpile, an assessment and 
                        comparison of the processes affected by 
                        such change, including planning for 
                        potential countermeasure deployment, 
                        distribution, or dispensing 
                        capabilities and processes related to 
                        procurement decisions, use of 
                        stockpiled countermeasures, and use of 
                        resources for such activities; and
                          (ix) an assessment of whether the 
                        processes and procedures described by 
                        the Secretary pursuant to section 
                        403(b) of the Pandemic and All-Hazards 
                        Preparedness and Advancing Innovation 
                        Act of 2019 are sufficient to ensure 
                        countermeasures and products under 
                        consideration for procurement pursuant 
                        to subsection (a) receive the same 
                        consideration regardless of whether 
                        such countermeasures and products 
                        receive or had received funding under 
                        section 319L, including with respect to 
                        whether such countermeasures and 
                        products are most appropriate to meet 
                        the emergency health security needs of 
                        the United States.
                  (B) Submission.--Not later than 6 months 
                after completing a classified version of the 
                review under subparagraph (A), the Comptroller 
                General shall submit an unclassified version of 
                the review to the congressional committees of 
                jurisdiction.
          (6) Transfers and reimbursements.--
                  (A) In general.--Without regard to chapter 5 
                of title 40, United States Code, the Secretary 
                may transfer to any Federal department or 
                agency, on a reimbursable basis, any drugs, 
                vaccines and other biological products, medical 
                devices, and other supplies in the stockpile 
                if--
                          (i) the transferred supplies are less 
                        than one year from expiry;
                          (ii) the stockpile is able to 
                        replenish the supplies, as appropriate; 
                        and
                          (iii) the Secretary decides the 
                        transfer is in the best interest of the 
                        United States Government.
                  (B) Use of reimbursement.--Reimbursement 
                derived from the transfer of supplies pursuant 
                to subparagraph (A) may be used by the 
                Secretary, without further appropriation and 
                without fiscal year limitation, to carry out 
                this section.
                  (C) Rule of construction.--This paragraph 
                shall not be construed to preclude transfers of 
                products in the stockpile under other 
                authorities.
                  (D) Report.--Not later than September 30, 
                2022, the Secretary shall submit to the 
                Committee on Energy and Commerce of the House 
                of Representatives and the Committee on Health, 
                Education, Labor, and Pensions of the Senate a 
                report on each transfer made under this 
                paragraph and the amount received by the 
                Secretary in exchange for that transfer.
                  (E) Sunset.--The authority to make transfers 
                under this paragraph shall cease to be 
                effective on September 30, 2023.
          (7) Reporting.--Not later than September 30, 2022, 
        the Secretary shall submit to the Committee on Energy 
        and Commerce of the House of Representatives and the 
        Committee on Health, Education, Labor and Pensions of 
        the Senate a report on the details of each cooperative 
        agreement or partnership entered into under paragraph 
        (3)(L), including the amount expended by the Secretary 
        on each such cooperative agreement or partnership.
          (8) Sunset.--The authority to enter into cooperative 
        agreements or partnerships pursuant to paragraph (3)(L) 
        shall cease to be effective on September 30, 2023.
  (b) Smallpox Vaccine Development.--
          (1) In general.--The Secretary shall award contracts, 
        enter into cooperative agreements, or carry out such 
        other activities as may reasonably be required in order 
        to ensure that the stockpile under subsection (a) 
        includes an amount of vaccine against smallpox as 
        determined by such Secretary to be sufficient to meet 
        the health security needs of the United States.
          (2) Rule of construction.--Nothing in this section 
        shall be construed to limit the private distribution, 
        purchase, or sale of vaccines from sources other than 
        the stockpile described in subsection (a).
  (c) Additional Authority Regarding Procurement of Certain 
Countermeasures; Availability of Special Reserve Fund.--
          (1) In general.--
                  (A) Use of fund.--A security countermeasure 
                may, in accordance with this subsection, be 
                procured with amounts in the special reserve 
                fund as defined in subsection (h).
                  (B) Security countermeasure.--For purposes of 
                this subsection, the term ``security 
                countermeasure'' means a drug (as that term is 
                defined by section 201(g)(1) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 
                321(g)(1))), biological product (as that term 
                is defined by section 351(i) of this Act (42 
                U.S.C. 262(i))), or device (as that term is 
                defined by section 201(h) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 321(h))) 
                that--
                          (i)(I) the Secretary determines to be 
                        a priority (consistent with sections 
                        302(2) and 304(a) of the Homeland 
                        Security Act of 2002) to diagnose, 
                        mitigate, prevent, or treat harm from 
                        any biological, chemical, radiological, 
                        or nuclear agent identified as a 
                        material threat under paragraph 
                        (2)(A)(ii), or to diagnose, mitigate, 
                        prevent, or treat harm from a condition 
                        that may result in adverse health 
                        consequences or death and may be caused 
                        by administering a drug, biological 
                        product, or device against such an 
                        agent;
                          (II) the Secretary determines under 
                        paragraph (2)(B)(ii) to be a necessary 
                        countermeasure; and
                          (III)(aa) is approved or cleared 
                        under chapter V of the Federal Food, 
                        Drug, and Cosmetic Act or licensed 
                        under section 351 of this Act; or
                          (bb) is a countermeasure for which 
                        the Secretary determines that 
                        sufficient and satisfactory clinical 
                        experience or research data (including 
                        data, if available, from pre-clinical 
                        and clinical trials) support a 
                        reasonable conclusion that the 
                        countermeasure will qualify for 
                        approval or licensing within 10 years 
                        after the date of a determination under 
                        paragraph (5); or
                          (ii) is authorized for emergency use 
                        under section 564 of the Federal Food, 
                        Drug, and Cosmetic Act.
          (2) Determination of material threats.--
                  (A) Material threat.--The Homeland Security 
                Secretary, in consultation with the Secretary 
                and the heads of other agencies as appropriate, 
                shall on an ongoing basis--
                          (i) assess current and emerging 
                        threats of chemical, biological, 
                        radiological, and nuclear agents; and
                          (ii) determine which of such agents 
                        present a material threat against the 
                        United States population sufficient to 
                        affect national security.
                  (B) Public health impact; necessary 
                countermeasures.--The Secretary shall on an 
                ongoing basis--
                          (i) assess the potential public 
                        health consequences for the United 
                        States population of exposure to agents 
                        identified under subparagraph (A)(ii); 
                        and
                          (ii) determine, on the basis of such 
                        assessment, the agents identified under 
                        subparagraph (A)(ii) for which 
                        countermeasures are necessary to 
                        protect the public health.
                  (C) Notice to congress.--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 that a determination has been 
                made pursuant to subparagraph (A) or (B).
                  (D) Assuring access to threat information.--
                In making the assessment and determination 
                required under subparagraph (A), the Homeland 
                Security Secretary shall use all relevant 
                information to which such Secretary is entitled 
                under section 202 of the Homeland Security Act 
                of 2002, including but not limited to 
                information, regardless of its level of 
                classification, relating to current and 
                emerging threats of chemical, biological, 
                radiological, and nuclear agents.
          (3) Assessment of availability and appropriateness of 
        countermeasures.--
                  (A) In general.--The Secretary, in 
                consultation with the Homeland Security 
                Secretary, shall assess on an ongoing basis the 
                availability and appropriateness of specific 
                countermeasures to address specific threats 
                identified under paragraph (2).
                  (B) Information.--The Secretary shall 
                institute a process for making publicly 
                available the results of assessments under 
                subparagraph (A) while withholding such 
                information as--
                          (i) would, in the judgment of the 
                        Secretary, tend to reveal public health 
                        vulnerabilities; or
                          (ii) would otherwise be exempt from 
                        disclosure under section 552 of title 
                        5, United States Code.
          (4) Call for development of countermeasures; 
        commitment for recommendation for procurement.--
                  (A) Proposal to the president.--If, pursuant 
                to an assessment under paragraph (3), the 
                Homeland Security Secretary and the Secretary 
                make a determination that a countermeasure 
                would be appropriate but is either
                currently not developed or unavailable for 
                procurement as a security countermeasure or is 
                approved, licensed, or cleared only for 
                alternative uses, such Secretaries may jointly 
                submit to the President a proposal to--
                          (i) issue a call for the development 
                        of such countermeasure; and
                          (ii) make a commitment that, upon the 
                        first development of such 
                        countermeasure that meets the 
                        conditions for procurement under 
                        paragraph (5), the Secretaries will, 
                        based in part on information obtained 
                        pursuant to such call, 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.
                  (B) Countermeasure specifications.--The 
                Homeland Security Secretary and the Secretary 
                shall, to the extent practicable, include in 
                the proposal under subparagraph (A)--
                          (i) estimated quantity of purchase 
                        (in the form of number of doses or 
                        number of effective courses of 
                        treatments regardless of dosage form);
                          (ii) necessary measures of minimum 
                        safety and effectiveness;
                          (iii) estimated price for each dose 
                        or effective course of treatment 
                        regardless of dosage form; and
                          (iv) other information that may be 
                        necessary to encourage and facilitate 
                        research, development, and manufacture 
                        of the countermeasure or to provide 
                        specifications for the countermeasure.
                  (C) Presidential approval.--If the President 
                approves a proposal under subparagraph (A), the 
                Homeland Security Secretary and the Secretary 
                shall make known to persons who may respond to 
                a call for the countermeasure involved--
                          (i) the call for the countermeasure;
                          (ii) specifications for the 
                        countermeasure under subparagraph (B); 
                        and
                          (iii) the commitment described in 
                        subparagraph (A)(ii).
          (5) Secretary's determination of countermeasures 
        appropriate for funding from special reserve fund.--
                  (A) In general.--The Secretary, in accordance 
                with the provisions of this paragraph, shall 
                identify specific security countermeasures that 
                the Secretary determines, in consultation with 
                the Homeland Security Secretary, to be 
                appropriate for inclusion in the stockpile 
                under subsection (a) pursuant to procurements 
                made with amounts in the special reserve fund 
                as defined in subsection (h) (referred to in 
                this subsection individually as a ``procurement 
                under this subsection'').
                  (B) Requirements.--In making a determination 
                under subparagraph (A) with respect to a 
                security countermeasure, the Secretary shall 
                determine and consider the following:
                          (i) The quantities of the product 
                        that will be needed to meet the 
                        stockpile needs.
                          (ii) The feasibility of production 
                        and delivery within 10 years of 
                        sufficient quantities of the product.
                          (iii) Whether there is a lack of a 
                        significant commercial market for the 
                        product at the time of procurement, 
                        other than as a security 
                        countermeasure.
          (6) Recommendations for procurement.--
                  (A) Notice to appropriate congressional 
                committees.--The Secretary shall notify the 
                Committee on Appropriations and the Committee 
                on Health, Education, Labor, and Pensions of 
                the Senate and the Committee on Appropriations 
                and the Committee on Energy and Commerce of the 
                House of Representatives of each decision to 
                make available the special reserve fund as 
                defined in subsection (h) for procurement of a 
                security countermeasure, including, where 
                available, the number of, the 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 for each such rejection.
                  (B) Subsequent specific countermeasures.--
                Procurement under this subsection of a security 
                countermeasure for a particular purpose does 
                not preclude the subsequent procurement under 
                this subsection of any other security 
                countermeasure for such purpose if the 
                Secretary has determined under paragraph (5)(A) 
                that such countermeasure is appropriate for 
                inclusion in the stockpile and if, as 
                determined by the Secretary, such 
                countermeasure provides improved safety or 
                effectiveness, or for other reasons enhances 
                preparedness to respond to threats of use of a 
                biological, chemical, radiological, or nuclear 
                agent. Such a determination by the Secretary is 
                committed to agency discretion.
          (7) Procurement.--
                  (A) Payments from special reserve fund.--The 
                special reserve fund as defined in subsection 
                (h) shall be available for payments made by the 
                Secretary to a vendor for procurement of a 
                security countermeasure in accordance with the 
                provisions of this paragraph.
                  (B) Procurement.--
                          (i) In general.--The Secretary shall 
                        be responsible for--
                                  (I) arranging for procurement 
                                of a security countermeasure, 
                                including negotiating terms 
                                (including quantity, production 
                                schedule, and price) of, and 
                                entering into, contracts and 
                                cooperative agreements, and for 
                                carrying out such other 
                                activities as may reasonably be 
                                required, including advanced 
                                research and development, in 
                                accordance with the provisions 
                                of this subparagraph; and
                                  (II) promulgating such 
                                regulations as the Secretary 
                                determines necessary to 
                                implement the provisions of 
                                this subsection.
                          (ii) Contract terms.--A contract for 
                        procurements under this subsection 
                        shall (or, as specified below, may) 
                        include the following terms:
                                  (I) Payment conditioned on 
                                delivery.--The contract shall 
                                provide that no payment may be 
                                made until delivery 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, partial 
                                payment for significant 
                                milestones, or payment to 
                                increase manufacturing capacity 
                                is necessary to ensure success 
                                of a project, the Secretary 
                                shall pay an amount, not to 
                                exceed 10 percent of the 
                                contract amount, in advance of 
                                delivery. The Secretary shall, 
                                to the extent practicable, make 
                                the determination of advance 
                                payment at the same time as the 
                                issuance of a solicitation. 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. The 
                                contract may also provide for 
                                additional advance payments of 
                                5 percent each for meeting the 
                                milestones specified in such 
                                contract, except that such 
                                payments shall not exceed 50 
                                percent of the total contract 
                                amount. If the specified 
                                milestones are reached, the 
                                advanced payments of 5 percent 
                                shall not be required to be 
                                repaid. Nothing in this 
                                subclause shall be construed as 
                                affecting the rights of vendors 
                                under provisions of law or 
                                regulation (including the 
                                Federal Acquisition Regulation) 
                                relating to the termination of 
                                contracts for the convenience 
                                of the Government.
                                  (II) Discounted payment.--The 
                                contract may provide for a 
                                discounted price per unit of a 
                                product that is not licensed, 
                                cleared, or approved as 
                                described in paragraph 
                                (1)(B)(i)(III)(aa) at the time 
                                of delivery, and may provide 
                                for payment of an additional 
                                amount per unit if the product 
                                becomes so licensed, cleared, 
                                or approved before the 
                                expiration date of the contract 
                                (including an additional amount 
                                per unit of product delivered 
                                before the effective date of 
                                such licensing, clearance, or 
                                approval).
                                  (III) Contract duration.--The 
                                contract shall be for a period 
                                not to exceed five years, 
                                except that, in first awarding 
                                the contract, the Secretary may 
                                provide for a longer duration, 
                                not exceeding 10 years, if the 
                                Secretary determines that 
                                complexities or other 
                                difficulties in performance 
                                under the contract justify such 
                                a period. The contract shall be 
                                renewable for additional 
                                periods, none of which shall 
                                exceed five years. The 
                                Secretary shall notify the 
                                vendor within 90 days of a 
                                determination by the Secretary 
                                to renew, extend, or terminate 
                                such contract.
                                  (IV) Storage by vendor.--The 
                                contract may provide that the 
                                vendor will provide storage for 
                                stocks of a product delivered 
                                to the ownership of the Federal 
                                Government under the contract, 
                                for such period and under such 
                                terms and conditions as the 
                                Secretary may specify, and in 
                                such case amounts from the 
                                special reserve fund as defined 
                                in subsection (h) shall be 
                                available for costs of 
                                shipping, handling, storage, 
                                and related costs for such 
                                product.
                                  (V) Product approval.--The 
                                contract shall provide that the 
                                vendor seek approval, 
                                clearance, or licensing of the 
                                product from the Secretary; for 
                                a timetable for the development 
                                of data and other information 
                                to support such approval, 
                                clearance, or licensing; and 
                                that the Secretary may waive 
                                part or all of this contract 
                                term on request of the vendor 
                                or on the initiative of the 
                                Secretary.
                                  (VI) Non-stockpile transfers 
                                of security countermeasures.--
                                The contract shall provide that 
                                the vendor will comply with all 
                                applicable export-related 
                                controls with respect to such 
                                countermeasure.
                                  (VII) Sales exclusivity.--The 
                                contract may provide that the 
                                vendor is the exclusive 
                                supplier of the product to the 
                                Federal Government for a 
                                specified period of time, not 
                                to exceed the term of the 
                                contract, on the condition that 
                                the vendor is able to satisfy 
                                the needs of the Government. 
                                During the agreed period of 
                                sales exclusivity, the vendor 
                                shall not assign its rights of 
                                sales exclusivity to another 
                                entity or entities without 
                                approval by the Secretary. Such 
                                a sales exclusivity provision 
                                in such a contract shall 
                                constitute a valid basis for a 
                                sole source procurement under 
                                section 303(c)(1) of the 
                                Federal Property and 
                                Administrative Services Act of 
                                1949 (41 U.S.C. 253(c)(1)).
                                  (VIII) Warm based surge 
                                capacity.--The contract may 
                                provide that the vendor 
                                establish domestic 
                                manufacturing capacity of the 
                                product to ensure that 
                                additional production of the 
                                product is available in the 
                                event that the Secretary 
                                determines that there is a need 
                                to quickly purchase additional 
                                quantities of the product. Such 
                                contract may provide a fee to 
                                the vendor for establishing and 
                                maintaining such capacity in 
                                excess of the initial 
                                requirement for the purchase of 
                                the product. Additionally, the 
                                cost of maintaining the 
                                domestic manufacturing capacity 
                                shall be an allowable and 
                                allocable direct cost of the 
                                contract.
                                  (IX) Contract terms.--The 
                                Secretary, in any contract for 
                                procurement under this 
                                section--
                                          (aa) may specify--
                                                  (AA) the 
                                                dosing and 
                                                administration 
                                                requirements 
                                                for the 
                                                countermeasure 
                                                to be developed 
                                                and procured;
                                                  (BB) the 
                                                amount of 
                                                funding that 
                                                will be 
                                                dedicated by 
                                                the Secretary 
                                                for advanced 
                                                research, 
                                                development, 
                                                and procurement 
                                                of the 
                                                countermeasure; 
                                                and
                                                  (CC) the 
                                                specifications 
                                                the 
                                                countermeasure 
                                                must meet to 
                                                qualify for 
                                                procurement 
                                                under a 
                                                contract under 
                                                this section; 
                                                and
                                          (bb) shall provide a 
                                        clear statement of 
                                        defined Government 
                                        purpose limited to uses 
                                        related to a security 
                                        countermeasure, as 
                                        defined in paragraph 
                                        (1)(B).
                          (iii) Availability of simplified 
                        acquisition procedures.--
                                  (I) In general.--If the 
                                Secretary determines that there 
                                is a pressing need for a 
                                procurement of a specific 
                                countermeasure, the amount of 
                                the procurement under this 
                                subsection shall be deemed to 
                                be below the threshold amount 
                                specified in section 4(11) of 
                                the Office of Federal 
                                Procurement Policy Act (41 
                                U.S.C. 403(11)), for purposes 
                                of application to such 
                                procurement, pursuant to 
                                section 302A(a) of the Federal 
                                Property and Administrative 
                                Services Act of 1949 (41 U.S.C. 
                                252a(a)), of--
                                          (aa) section 
                                        303(g)(1)(A) of the 
                                        Federal Property and 
                                        Administrative Services 
                                        Act of 1949 (41 U.S.C. 
                                        253(g)(1)(A)) and its 
                                        implementing 
                                        regulations; and
                                          (bb) section 302A(b) 
                                        of such Act (41 U.S.C. 
                                        252a(b)) and its 
                                        implementing 
                                        regulations.
                                  (II) Application of certain 
                                provisions.--Notwithstanding 
                                subclause (I) and the provision 
                                of law and regulations referred 
                                to in such clause, each of the 
                                following provisions shall 
                                apply to procurements described 
                                in this clause to the same 
                                extent that such provisions 
                                would apply to such 
                                procurements in the absence of 
                                subclause (I):
                                          (aa) Chapter 37 of 
                                        title 40, United States 
                                        Code (relating to 
                                        contract work hours and 
                                        safety standards).
                                          (bb) Subsections (a) 
                                        and (b) of section 7 of 
                                        the Anti-Kickback Act 
                                        of 1986 (41 U.S.C. 
                                        57(a) and (b)).
                                          (cc) Section 304C of 
                                        the Federal Property 
                                        and Administrative 
                                        Services Act of 1949 
                                        (41 U.S.C. 254d) 
                                        (relating to the 
                                        examination of 
                                        contractor records).
                                          (dd) Section 3131 of 
                                        title 40, United States 
                                        Code (relating to bonds 
                                        of contractors of 
                                        public buildings or 
                                        works).
                                          (ee) Subsection (a) 
                                        of section 304 of the 
                                        Federal Property and 
                                        Administrative Services 
                                        Act of 1949 (41 U.S.C. 
                                        254(a)) (relating to 
                                        contingent fees to 
                                        middlemen).
                                          (ff) Section 6002 of 
                                        the Solid Waste 
                                        Disposal Act (42 U.S.C. 
                                        6962).
                                          (gg) Section 1354 of 
                                        title 31, United States 
                                        Code (relating to the 
                                        limitation on the use 
                                        of appropriated funds 
                                        for contracts with 
                                        entities not meeting 
                                        veterans employment 
                                        reporting 
                                        requirements).
                                  (III) Internal controls to be 
                                established.--The Secretary 
                                shall establish appropriate 
                                internal controls for 
                                procurements made under this 
                                clause, including requirements 
                                with respect to documentation 
                                of the justification for the 
                                use of the authority provided 
                                under this paragraph with 
                                respect to the procurement 
                                involved.
                                  (IV) Authority to limit 
                                competition.--In conducting a 
                                procurement under this 
                                subparagraph, the Secretary may 
                                not use the authority provided 
                                for under subclause (I) to 
                                conduct a procurement on a 
                                basis other than full and open 
                                competition unless the 
                                Secretary determines that the 
                                mission of the BioShield 
                                Program under the Project 
                                BioShield Act of 2004 would be 
                                seriously impaired without such 
                                a limitation.
                          (iv) Procedures other than full and 
                        open competition.--
                                  (I) In general.--In using the 
                                authority provided in section 
                                303(c)(1) of title III of the 
                                Federal Property and 
                                Administrative Services Act of 
                                1949 (41 U.S.C. 253(c)(1)) to 
                                use procedures other than 
                                competitive procedures in the 
                                case of a procurement under 
                                this subsection, the phrase 
                                ``available from only one 
                                responsible source'' in such 
                                section 303(c)(1) shall be 
                                deemed to mean ``available from 
                                only one responsible source or 
                                only from a limited number of 
                                responsible sources''.
                                  (II) Relation to other 
                                authorities.--The authority 
                                under subclause (I) is in 
                                addition to any other authority 
                                to use procedures other than 
                                competitive procedures.
                                  (III) Applicable government-
                                wide regulations.--The 
                                Secretary shall implement this 
                                clause in accordance with 
                                government-wide regulations 
                                implementing such section 
                                303(c)(1) (including 
                                requirements that offers be 
                                solicited from as many 
                                potential sources as is 
                                practicable under the 
                                circumstances, that required 
                                notices be published, and that 
                                submitted offers be 
                                considered), as such 
                                regulations apply to 
                                procurements for which an 
                                agency has authority to use 
                                procedures other than 
                                competitive procedures when the 
                                property or services needed by 
                                the agency are available from 
                                only one responsible source or 
                                only from a limited number of 
                                responsible sources and no 
                                other type of property or 
                                services will satisfy the needs 
                                of the agency.
                          (v) Premium provision in multiple 
                        award contracts.--
                                  (I) In general.--If, under 
                                this subsection, the Secretary 
                                enters into contracts with more 
                                than one vendor to procure a 
                                security countermeasure, such 
                                Secretary may, notwithstanding 
                                any other provision of law, 
                                include in each of such 
                                contracts a provision that--
                                          (aa) identifies an 
                                        increment of the total 
                                        quantity of security 
                                        countermeasure 
                                        required, whether by 
                                        percentage or by 
                                        numbers of units; and
                                          (bb) promises to pay 
                                        one or more specified 
                                        premiums based on the 
                                        priority of such 
                                        vendors' production and 
                                        delivery of the 
                                        increment identified 
                                        under item (aa), in 
                                        accordance with the 
                                        terms and conditions of 
                                        the contract.
                                  (II) Determination of 
                                government's requirement not 
                                reviewable.--If the Secretary 
                                includes in each of a set of 
                                contracts a provision as 
                                described in subclause (I), 
                                such Secretary's determination 
                                of the total quantity of 
                                security countermeasure 
                                required, and any amendment of 
                                such determination, is 
                                committed to agency discretion.
                          (vi) Extension of closing date for 
                        receipt of proposals not reviewable.--A 
                        decision by the Secretary to extend the 
                        closing date for receipt of proposals 
                        for a procurement under this subsection 
                        is committed to agency discretion.
                          (vii) Limiting competition to sources 
                        responding to request for 
                        information.--In conducting a 
                        procurement under this subsection, the 
                        Secretary may exclude a source that has 
                        not responded to a request for 
                        information under section 303A(a)(1)(B) 
                        of the Federal Property and 
                        Administrative Services Act of 1949 (41 
                        U.S.C. 253a(a)(1)(B)) if such request 
                        has given notice that the Secretary may 
                        so exclude such a source.
                          (viii) Flexibility.--In carrying out 
                        this section, the Secretary may, 
                        consistent with the applicable 
                        provisions of this section, enter into 
                        contracts and other agreements that are 
                        in the best interest of the Government 
                        in meeting identified security 
                        countermeasure needs, including with 
                        respect to reimbursement of the cost of 
                        advanced research and development as a 
                        reasonable, allowable, and allocable 
                        direct cost of the contract involved.
                          (ix) Equipment maintenance service.--
                        In carrying out this section, the 
                        Secretary may enter into contracts for 
                        the procurement of equipment 
                        maintenance services.
          (8) Interagency cooperation.--
                  (A) In general.--In carrying out activities 
                under this section, the Homeland Security 
                Secretary and the Secretary are authorized, 
                subject to subparagraph (B), to enter into 
                interagency agreements and other collaborative 
                undertakings with other agencies of the United 
                States Government. 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, United 
                States Code, except that all such orders shall 
                be processed under the terms established under 
                this subsection for the procurement of 
                countermeasures.
                  (B) Limitation.--An agreement or undertaking 
                under this paragraph shall not authorize 
                another agency to exercise the authorities 
                provided by this section to the Homeland 
                Security Secretary or to the Secretary.
  (d) Disclosures.--No Federal agency may disclose under 
section 552 of title 5, United States Code any information 
identifying the location at which materials in the stockpile 
described in subsection (a) are stored, or other information 
regarding the contents or deployment capability of the 
stockpile that could compromise national security.
  (e) Definition.--For purposes of subsection (a), the term 
``stockpile'' includes--
          (1) a physical accumulation (at one or more 
        locations) of the supplies described in subsection (a); 
        or
          (2) a contractual agreement between the Secretary and 
        a vendor or vendors under which such vendor or vendors 
        agree to provide to such Secretary supplies described 
        in subsection (a).
  (f) Authorization of Appropriations.--
          (1) Strategic national stockpile.--For the purpose of 
        carrying out subsection (a), there are authorized to be 
        appropriated [$610,000,000 for each of fiscal years 
        2019 through 2023] $705,000,000 for each of fiscal 
        years 2020 through 2023, to remain available until 
        expended. Such authorization is in addition to amounts 
        in the special reserve fund referred to in subsection 
        (h).
          (2) Smallpox vaccine development.--For the purpose of 
        carrying out subsection (b), there are authorized to be 
        appropriated $509,000,000 for fiscal year 2002, and 
        such sums as may be necessary for each of fiscal years 
        2003 through 2006.
          (3) Supply chain elasticity.--
                  (A) In general.--For the purpose of carrying 
                out subsection (a)(3)(L), there is authorized 
                to be appropriated $500,000,000 for each of 
                fiscal years 2020 through 2023, to remain 
                available until expended.
                  (B) Relation to other amounts.--The amount 
                authorized to be appropriated by subparagraph 
                (A) for the purpose of carrying out subsection 
                (a)(3)(L) is in addition to any other amounts 
                available for such purpose.
  (g) Special Reserve Fund.--
          (1) Authorization of appropriations.--In addition to 
        amounts appropriated to the special reserve fund prior 
        to the date of the enactment of this subsection, there 
        is authorized to be appropriated, for the procurement 
        of security countermeasures under subsection (c) and 
        for carrying out section 319L (relating to the 
        Biomedical Advanced Research and Development 
        Authority), $7,100,000,000 for the period of fiscal 
        years 2019 through 2028, to remain available until 
        expended.
          (2) Use of special reserve fund for advanced research 
        and development.--The Secretary may utilize not more 
        than 50 percent of the amounts authorized to be 
        appropriated under paragraph (1) to carry out section 
        319L (related to the Biomedical Advanced Research and 
        Development Authority). Amounts authorized to be 
        appropriated under this subsection to carry out section 
        319L are in addition to amounts otherwise authorized to 
        be appropriated to carry out such section.
          (3) Restrictions on use of funds.--Amounts in the 
        special reserve fund shall not be used to pay costs 
        other than payments made by the Secretary to a vendor 
        for advanced development (under section 319L) or for 
        procurement of a security countermeasure under 
        subsection (c)(7).
          (4) Report on security countermeasure procurement.--
        Not later than March 1 of each year in which the 
        Secretary determines that the amount of funds available 
        for procurement of security countermeasures is less 
        than $1,500,000,000, the Secretary shall submit to the 
        Committee on Appropriations and the Committee on 
        Health, Education, Labor, and Pensions of the Senate 
        and the Committee on Appropriations and the Committee 
        on Energy and Commerce of the House of Representatives 
        a report detailing the amount of such funds available 
        for procurement and the impact such amount of 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 
                2811(d)).
          (5) Clarification on contracting authority.--The 
        Secretary, acting through the Director of the 
        Biomedical Advanced Research and Development Authority, 
        shall carry out the programs funded by the special 
        reserve fund (for the procurement of security 
        countermeasures under subsection (c) and for carrying 
        out section 319L), including the execution of 
        procurement contracts, grants, and cooperative 
        agreements pursuant to this section and section 319L.
  (h) Definitions.--In this section:
          (1) The term ``advanced research and development'' 
        has the meaning given such term in section 319L(a).
          (2) The term ``special reserve fund'' means the 
        ``Biodefense Countermeasures'' appropriations account, 
        any appropriation made available pursuant to section 
        521(a) of the Homeland Security Act of 2002, and any 
        appropriation made available pursuant to subsection 
        (g)(1).

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SEC. 319F-5. GRANTS FOR STATE STRATEGIC STOCKPILES.

  (a) In General.--The Secretary may establish a pilot program 
consisting of awarding grants to States to expand or maintain a 
strategic stockpile of commercially available drugs, medical 
equipment, personal protective equipment, and other products 
deemed by the State to be essential in the event of a public 
health emergency.
  (b) Allowable Use of Funds.--
          (1) Uses.--A State receiving a grant under this 
        section may use the grant funds to--
                  (A) acquire commercially available products 
                listed pursuant to paragraph (2) for inclusion 
                in the State's strategic stockpile;
                  (B) store, maintain, and distribute products 
                in such stockpile; and
                  (C) conduct planning in connection with such 
                activities.
          (2) List.--The Secretary shall develop and publish a 
        list of the products that are eligible, as described in 
        subsection (a), for inclusion in a State's strategic 
        stockpile using funds received under this section.
          (3) Consultation.--In developing the list under 
        paragraph (2) and otherwise determining the allowable 
        uses of grant funds under this section, the Secretary 
        shall consult with States and relevant stakeholders, 
        including public health organizations.
  (c) Funding Requirement.--The Secretary may not obligate or 
expend any funds to award grants or fund any previously awarded 
grants under this section for a fiscal year unless the total 
amount made available to carry out section 319F-2 for such 
fiscal year is equal to or greater than the total amount of 
funds made available to carry out section 319F-2 for fiscal 
year 2020.
  (d) Matching Funds.--
          (1) In general.--With respect to the costs of 
        expanding and maintaining a strategic stockpile through 
        a grant under this section, as a condition on receipt 
        of the grant, a State shall make available (directly) 
        non-Federal contributions in cash toward such costs in 
        an amount that is equal to not less than the amount of 
        Federal funds provided through the grant.
          (2) Waiver.--The Secretary may waive the requirement 
        of paragraph (1) with respect to a State for the first 
        two years of the State receiving a grant under this 
        section if the Secretary determines that such waiver is 
        needed for the State to establish a strategic stockpile 
        described in subsection (a).
  (e) Technical Assistance.--The Secretary shall provide 
technical assistance to States in establishing, expanding, and 
maintaining a stockpile described in subsection (a).
  (f) Definition.--In this section, the term ``drug'' has the 
meaning given to that term in section 201 of the Federal Food, 
Drug, and Cosmetic Act.
  (g) Authorization of Appropriations.--To carry out this 
section, there is authorized to be appropriated $3,500,000,000 
for each of fiscal years 2020 through 2023, to remain available 
until expended.
  (h) Sunset.--The authority vested by this section terminates 
at the end of fiscal year 2023.

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