[Senate Report 116-279]
[From the U.S. Government Publishing Office]


                                                  Calendar No. 573

116th Congress}                                           { Report
                                 SENATE
  2d Session  }                                           { 116-279

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

                FEDERAL EMERGENCY PANDEMIC RESPONSE ACT

                               __________

                              R E P O R T

                                 of the

                   COMMITTEE ON HOMELAND SECURITY AND

                          GOVERNMENTAL AFFAIRS

                          UNITED STATES SENATE

                              to accompany

                                S. 4204

           TO ESTABLISH AN INTERAGENCY TASK FORCE TO ANALYZE
      PREPAREDNESS FOR NATIONAL PANDEMICS, AND FOR OTHER PURPOSES




                October 19, 2020.--Ordered to be printed
                
                               __________
               
               
                    U.S. GOVERNMENT PUBLISHING OFFICE                    
                           WASHINGTON : 2020                     
          
-----------------------------------------------------------------------------------                 
                 
                
        COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS

                    RON JOHNSON, Wisconsin, Chairman
ROB PORTMAN, Ohio                    GARY C. PETERS, Michigan
RAND PAUL, Kentucky                  THOMAS R. CARPER, Delaware
JAMES LANKFORD, Oklahoma             MAGGIE HASSAN, New Hampshire
MITT ROMNEY, Utah                    KAMALA D. HARRIS, California
RICK SCOTT, Florida                  KYRSTEN SINEMA, Arizona
MICHAEL B. ENZI, Wyoming             JACKY ROSEN, Nevada
JOSH HAWLEY, Missouri

                Gabrielle D'Adamo Singer, Staff Director
                   Joseph C. Folio III, Chief Counsel
            Michelle D. Woods, Director of Homeland Security
             Barrett F. Percival, Professional Staff Member
               David M. Weinberg, Minority Staff Director
               Zachary I. Schram, Minority Chief Counsel
         Alexa E. Noruk, Minority Director of Homeland Security
 Christopher J. Mulkins, Minority Deputy Director of Homeland Security
                     Laura W. Kilbride, Chief Clerk
                     
                     
                                                  Calendar No. 573

116th Congress}                                           { Report
                                 SENATE
  2d Session  }                                           { 116-279

======================================================================
 
                FEDERAL EMERGENCY PANDEMIC RESPONSE ACT

                                _______
                                

                October 19, 2020.--Ordered to be printed

                                _______
                                

 Mr. Johnson, from the Committee on Homeland Security and Governmental 
                    Affairs, submitted the following

                              R E P O R T

                         [To accompany S. 4204]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Homeland Security and Governmental 
Affairs, to which was referred the bill (S. 4204) to establish 
an Interagency Task Force to analyze preparedness for national 
pandemics, and for other purposes, having considered the same, 
reports favorably thereon with an amendment (in the nature of a 
substitute) and recommends that the bill, as amended, do pass.

                                CONTENTS

                                                                   Page
  I. Purpose and Summary..............................................1
 II. Background and Need for the Legislation..........................2
III. Legislative History..............................................4
 IV. Section-by-Section Analysis......................................5
  V. Evaluation of Regulatory Impact..................................6
 VI. Congressional Budget Office Cost Estimate........................7
VII. Changes in Existing Law Made by the Bill, as Reported............8

                         i. purpose and summary

    The purpose of S. 4204, the Federal Emergency Pandemic 
Response Act, is to help ensure that the Federal Government is 
more prepared for future pandemics by convening relevant agency 
heads to examine preparedness, strengthening Federal and State 
coordination during a pandemic, and providing authorities to 
share personal protective equipment.

              ii. background and need for the legislation

    In 1998, Congress enacted the Omnibus Consolidated and 
Emergency Supplemental Appropriations Act, which required the 
Centers for Disease Control and Prevention (CDC) to acquire a 
pharmaceutical and vaccine stockpile.\1\ This program would 
become the National Pharmaceutical Stockpile (NPS), intended to 
``counter potential biological and chemical threats and threats 
from widespread diseases that could affect large numbers of 
persons in civilian population.''\2\ On March 1, 2003, the NPS 
was renamed the Strategic National Stockpile (SNS).\3\
---------------------------------------------------------------------------
    \1\Omnibus Consolidated and Emergency Supplemental Appropriations 
Act, 1999, Pub. L. No. 105-277, Title II, 112 Stat. 2681, 2681-358 
(1998), https://www.congress.gov/bill/105th-congress/house-bill/4328.
    \2\Strategic National Stockpile (SNS), Chemical Hazards Emergency 
Med. Mgmt., https://chemm.nlm.nih.gov/sns.htm (last updated Apr. 17, 
2020).
    \3\Id.
---------------------------------------------------------------------------
    The SNS serves as ``the nation's supply of life-saving 
pharmaceuticals and medical supplies, managed by [HHS] for use 
in a public health emergency.''\4\ SNS pharmaceuticals, medical 
supplies, medical devices, and other supplies are designed to 
supplement and re-supply state and local public health agencies 
in the event of an emergency.\5\
---------------------------------------------------------------------------
    \4\Strategic National Stockpile Response to COVID-19 Frequently 
Asked Questions, Off. of the Assistant Secretary for Preparedness & 
Response, https://www.phe.gov/emergency/events/COVID19/SNS/Pages/
FAQ.aspx (last updated Apr. 17, 2020) [hereinafter SNS FAQs].
    \5\ftp://ftp.cdc.gov/pub/MCMTraining/
Course%20Presentations_SNS%20Course_Jun_2017/2%20-
%20Introduction%20to%20Strategic%20National%20Stockpile%20Operations%20-
%20FINAL2a.pptx
---------------------------------------------------------------------------
    An example of the SNS's effectiveness and efficiency can be 
seen in the Federal response to the 2009 H1N1 Pandemic. 
According the HHS, ``the SNS demonstrated its ability to deploy 
antiviral drugs and personal protective equipment nationwide 
for an influenza emergency. The SNS shipped 25 percent of its 
total supply of influenza antiviral medications to 62 areas in 
just 7 days.''\6\ The Association of State and Territorial 
Health Officials stated that, ``[d]uring the H1N1 response, 
antivirals from the SNS were released in the largest quantities 
ever deployed from the SNS and in an accelerated 
timeframe.''\7\ In March 2020, the Washington Post reported 
that the stockpile distributed 85 million N95 respirators in 
response to the H1N1 pandemic using billions of dollars in 
additional funding.\8\ The problem was that the funding did not 
become permanent, and resources following the 2009 pandemic 
were depleted.
---------------------------------------------------------------------------
    \6\Greg Burel, The Evolution of the Strategic National Stockpile, 
Off. of the Assistant Secretary for Preparedness & Response (Aug. 21, 
2019), https://www.phe.gov/ASPRBlog/Pages/
BlogArticlePage.aspx?PostID=356.
    \7\Strategic National Stockpile, Ass'n of St. & Territorial Health 
Officials, https://www.astho.org/Programs/Preparedness/Public-Health-
Emergency-Law/Emergency-Use-Authorization-Toolkit/Strategic-National-
Stockpile-Fact-Sheet/ (last visited Aug. 4, 2020).
    \8\Beth Reinhard & Emma Brown, Face Masks in National Stockpile 
Have Not Been Substantially Replenished Since 2009, Wash. Post (Mar. 
10, 2020, 4:57 PM), https://www.washingtonpost.com/investigations/face-
masks-in-national-stockpile-have-not-been-substantially-replenished-
since-2009/2020/03/10/57e57316-60c9-11ea-8baf-519cedb6ccd9_story.html.
---------------------------------------------------------------------------
    On January 30, 2020, HHS activated the SNS Operations 
Center to provide ongoing coordination in support of the COVID-
19 response.\9\ On January 31, 2020, Alex Azar, Secretary of 
Human and Human Services, declared a public health emergency 
for the entire United States to aid the American healthcare 
community in response to COVID-19.\10\ In declaring the public 
health emergency, the announcement cited that, ``HHS divisions 
are also collaborating with industry to identify and move 
forward with development of potential diagnostics, vaccines, 
and therapeutics to detect, prevent, and treat [COVID-19] 
infections.''\11\ On March 21, 2020, as demand outpaced supply, 
HHS ``awarded contracts to incrementally purchase approximately 
600 million N95 respirators over the next 18 months.''\12\
---------------------------------------------------------------------------
    \9\SNS FAQs, supra note 4.
    \10\Press Release, U.S. Dep't of Health & Hum. Servs., Secretary 
Azar Declares Public Health Emergency for United States for 2019 Novel 
Coronavirus (Jan. 31, 2020), https://www.hhs.gov/about/news/2020/01/31/
secretary-azar-declares-public-health-emergency-us-2019-novel-
coronavirus.html.
    \11\Id.
    \12\SNS FAQs, supra note 4.
---------------------------------------------------------------------------
    The COVID-19 pandemic placed greater demands on the SNS 
than ever before. On top of this historic demand, many public 
health experts warned that the stockpile was still 
significantly depleted following its distribution to respond to 
H1N1 in 2009.\13\ On March 5, 2020, the Assistant Secretary for 
Preparedness and Response (ASPR) at HHS told the U.S. Senate 
Committee on Health, Education, Labor, and Pensions in a public 
hearing that the stockpile held 35 million N95s.\14\ Senator 
Mitt Romney pointed out, ``[i]t strikes me we should have 
substantially more.''\15\ In fact, public health officials have 
stated that the actual amount was only one-third that many.\16\
---------------------------------------------------------------------------
    \13\Reinhard & Brown, supra note 8.
    \14\An Emerging Disease Threat: How the U.S. Is Responding to 
COVID-19, the Novel Coronavirus, Hearing Before the S. Comm. on Health, 
Education, Labor. & Pensions, 116th Cong. (2020) (statement of Dr. 
Robert Kadlec, Assistant Secretary for Preparedness and Response), 
https://www.help.senate.gov/hearings/an-emerging-disease-threat-how-
the-us-is-responding-to-covid-19-the-novel-coronavirus.
    \15\Id. (statement of Sen. Mitt Romney).
    \16\Reinhard & Brown, supra note 8.
---------------------------------------------------------------------------
    In responding to COVID-19, HHS was forced to make 
prioritization decisions in regards to the allocation of their 
resources. As HHS stated, ``[u]nder the joint direction of [the 
Federal Emergency Management Agency] and HHS in support of the 
COVID-19 response, the [SNS] has deployed all remaining 
personal protective equipment. A small percentage (10 percent) 
will be retained for critical needs of frontline healthcare 
workers serving in federal response efforts.''\17\
---------------------------------------------------------------------------
    \17\SNS FAQs, supra note 4.
---------------------------------------------------------------------------
    The shortcomings in the SNS's response to COVID-19 raised 
questions about the mission of the stockpile. Not only have 
prior events depleted its stock, but many healthcare experts 
have observed that the SNS was not given the necessary 
resources and funding to be a nationwide resource for large-
scale pandemic events. Former SNS Director Greg Burel stated, 
``[t]he SNS was never envisioned to be the first stop in 
response to pandemics and emerging infectious disease. Instead, 
its primary purpose was to prepare for potential chemical, 
biological, radiological, and nuclear events.''\18\
---------------------------------------------------------------------------
    \18\Greg Burel, The Rapidly Expanding Mission of the Strategic 
National Stockpile, Hill (Apr. 18, 2020, 1:00 PM), https://thehill.com/
opinion/white-house/493459-the-rapid-mission-of-the-strategic-national-
stockpile.
---------------------------------------------------------------------------
    Through hearings and oversight efforts, Chairman Johnson 
noted ``a lack of clarity and understanding of exactly what the 
SNS's role is, and what it should be.''\19\ Furthermore, he 
stated, ``[w]e are paying the price for this lack of 
articulation and clarity during the current pandemic.''\20\ 
Senator Rick Scott added, ``I agree with you. I think it starts 
with coming up exactly what our mission is. And if you have the 
right mission, and you have the right funding, then you 
probably get a good result.''\21\
---------------------------------------------------------------------------
    \19\The Role of the Strategic National Stockpile in Pandemic 
Response: Hearing Before the S. Comm. on Homeland Sec. & Governmental 
Affairs, 116th Cong. (2020) (statement of Sen. Ron Johnson, Chairman), 
https://www.hsgac.senate.gov/the-role-of-the-strategic-national-
stockpile-in-pandemic-response.
    \20\Id.
    \21\Id. (statement of Sen. Rick Scott).
---------------------------------------------------------------------------
    The Federal Emergency Pandemic Response Act would convene 
an interagency task force led by the Office of Management and 
Budget (OMB), without arriving at any predetermined 
conclusions, to determine what the mission of the SNS should 
be, and whether the current name aligns with the determined 
mission. The task force must also assess the current inventory, 
inventory practices, and whether or not that inventory meets 
the level necessary to respond to an event. This legislation 
also requires the task force to evaluate where the stocks 
should be held, whether centralized or decentralized, for 
security purposes and to ensure expediency in its distribution.
    This bill also requires the NRCC to share information with 
states (and requests states to voluntarily share information 
with the NRCC) about the available inventory of necessary 
medical supplies during a public health emergency. Finally, the 
bill authorizes the Department of Homeland Security (DHS) to 
share excess personal protective equipment (PPE) with HHS on 
reimbursable basis if the Secretary of DHS determines they have 
excess equipment beyond what is required to provide to their 
workforce.

                        III. LEGISLATIVE HISTORY

    Chairman Ron Johnson (R-WI) introduced S. 4204, the Federal 
Emergency Pandemic Response Act, on July 2, 2020. The bill was 
referred to the Committee on Homeland Security and Governmental 
Affairs. Senator Rick Scott (R-FL) later joined as a cosponsor.
    The Committee considered S. 4204 at a business meeting on 
July 22, 2020. Senator Johnson offered a substitute amendment, 
as modified, that replaced DHS with OMB to convene the 
interagency task force to lead the review of the SNS, and added 
more relevant federal stakeholders to the task force. The 
amendment was adopted by unanimous consent with Senators 
Johnson, Portman, Paul, Lankford, Romney, Scott, Enzi, Hawley, 
Peters, Carper, Hassan, Harris, and Rosen present.
    Ranking Member Gary Peters (D-MI) offered an amendment to 
strike the section codifying FEMA's Supply Chain Stabilization 
Task Force, and instead have the interagency task force 
identify and assess weaknesses in the supply chain and have the 
Federal Government develop a plan to address and preserve the 
supply of, as well as accelerate the production of, PPE in the 
U.S. The amendment was adopted by voice vote en bloc with 
Senators Johnson, Portman, Paul, Lankford, Romney, Scott, Enzi, 
Hawley, Peters, Carper, Hassan, Harris, and Rosen present.
    Senator Maggie Hassan (D-NH) offered an amendment, as 
modified, that would require the interagency task force to 
propose best practices on the procurement, distribution, and 
replenishment of supplies within the SNS, as well as evaluate 
databases the Federal Government manages that hold information 
on the inventory and location of the SNS. The amendment was 
adopted by voice vote en bloc with Senators Johnson, Portman, 
Paul, Lankford, Romney, Scott, Enzi, Hawley, Peters, Carper, 
Hassan, Harris, and Rosen present.
    Senator Kamala Harris (D-CA) offered an amendment, as 
modified, that would add the Director of Minority Health and 
the Director of Indian Health Services to the interagency task 
force, and require the task force to participate in a review of 
identifying communities that lack adequate resources to combat 
COVID-19, as well as produce routine reports to Congress on 
this review with recommendations on how to best allocate 
critical resource to at-risk communities. The amendment was 
adopted by voice vote en bloc with Senators Johnson, Portman, 
Paul, Lankford, Romney, Scott, Enzi, Hawley, Peters, Carper, 
Hassan, Harris, and Rosen present.
    Senator Jacky Rosen (D-NV) offered an amendment that would 
have the interagency task force provide recommendations on 
whether or not the SNS should inventory equipment and supplies 
for small scale and customizable manufacturing capabilities, 
such as 3D printing. The amendment was adopted by voice vote en 
bloc with Senators Johnson, Portman, Paul, Lankford, Romney, 
Scott, Enzi, Hawley, Peters, Carper, Hassan, Harris, and Rosen 
present.
    The Committee ordered the bill, as amended, reported 
favorably by voice vote. Senators present for the vote were: 
Johnson, Portman, Paul, Lankford, Romney, Scott, Enzi, Hawley, 
Peters, Carper, Hassan, Harris, and Rosen.

        IV. SECTION-BY-SECTION ANALYSIS OF THE BILL, AS REPORTED

Section 1. Short title

    This section establishes that the bill may be cited as the 
``Federal Emergency Pandemic Response Act.''

Section 2. Interagency Task Force to analyze preparedness for national 
        pandemic

    Subsection (a) instructs the Director of OMB, or another 
agency head selected by the Director of OMB, to convene an 
interagency Task Force to analyze U.S. pandemic preparedness.
    Subsection (b) lays out the officials who are required to 
participate in the Task Force. Those participants are: the 
Secretary of Homeland Security; the Director of the Office of 
Minority Health at HHS; the Director of Indian Health Service 
at HHS; the Under Secretary for Management of DHS; the 
Administrator of FEMA at DHS; the Administrator of the 
Transportation Security Administration at DHS; the Assistant 
Secretary of the Office of Countering Weapons of Mass 
Destruction at DHS; the Chief Medical Officer at DHS; the 
Secretary of HHS; the ASPR at HHS; the Director for CDC; the 
Secretary of Defense; the Director of OMB; any other head of a 
Federal agency that the Director of OMB deems necessary; and 
any other representative from state, local, Tribal, or 
territorial public health offices or representatives from 
private and nonprofit sector healthcare organizations that the 
Director of OMB deems necessary.
    Subsection (c) sets forward the responsibilities of the 
Task Force. This subsection requires the Task Force to define 
the mission of the SNS and assess if the title, ``Strategic 
National Stockpile'', is appropriate. The Task Force is also 
required to assess the current inventory of the stockpile and 
to determine future stockpile needs. To do so, the Task Force 
must list all supplies and make a determination of proper 
inventory levels through communication with other stakeholders, 
such as State, local, Tribal, territorial governments. 
Additionally, the Task Force is required under this subsection 
to make determinations regarding the sourcing of the stockpile, 
the required funding to satisfy the necessary levels, and 
location(s) where stocks should be held. The Task Force must 
develop plans for inventory maintenance, interagency 
coordination, and perform a supply chain analysis.
    This subsection also requires the Task Force to submit to 
Congress and FEMA reports every other month with information on 
communities in need of resources, communities with racial and 
ethnic disparities as it relates to COVID-19, and 
recommendations on where to allocate resources. Lastly, this 
subsection requires a comprehensive report be submitted to 
Congress detailing the Task Force's recommendations within 1 
year of enactment.
    Subsection (d) requires the Task Force to consult with 
experts in addressing racial and ethnic disparities before 
reporting to Congress.

Section 3. National Response Coordination Center role in improving 
        transparency

    Subsection (a) provides that FEMA and the NRCC are to 
request and share information with state, local, Tribal and 
territorial governments on the inventory and holdings of 
critical supplies during a public health emergency.
    Subsection (b) requires the NRCC to report annually to 
Congress on their activities.

Section 4. Other authorities

    This section amends the Homeland Security Act of 2002 to 
authorize the DHS Secretary to transfer excess supplies and 
equipment in DHS inventory upon receiving a formal request from 
the HHS Secretary. In addition, this section requires DHS to 
evaluate the availability of excess supplies and ensure the 
transfer of supplies will not affect the health of DHS 
personnel. The Secretaries of HHS and the DHS must inform 
Congress of any effort to transfer excess material. Lastly, 
this section provides that the HHS Secretary, in consultation 
with the DHS Secretary, may sell supplies from the SNS that are 
approaching their expiration date or deemed dispensable.

                   V. EVALUATION OF REGULATORY IMPACT

    Pursuant to the requirements of paragraph 11(b) of rule 
XXVI of the Standing Rules of the Senate, the Committee has 
considered the regulatory impact of this bill and determined 
that the bill will have no regulatory impact within the meaning 
of the rules. The Committee agrees with the Congressional 
Budget Office's statement that the bill contains no 
intergovernmental or private-sector mandates as defined in the 
Unfunded Mandates Reform Act (UMRA) and would impose no costs 
on state, local, or tribal governments.

             VI. CONGRESSIONAL BUDGET OFFICE COST ESTIMATE

                                     U.S. Congress,
                               Congressional Budget Office,
                                 Washington, DC, September 8, 2020.
Hon. Ron Johnson,
Chairman, Committee on Homeland Security and Governmental Affairs, U.S. 
        Senate, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for S. 4204, the Federal 
Emergency Pandemic Response Act.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Matthew 
Pickford.
            Sincerely,
                                         Phillip L. Swagel,
                                                          Director.
    Enclosure.

 [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    

    S. 4204 would establish a federal interagency task force to 
analyze the nation's preparedness for national pandemics. The 
bill would detail the task force's membership and 
responsibilities, which would include a review of the mission 
of the Strategic National Stockpile and an assessment of its 
current inventory and future needs. In addition, the bill 
would:
           Direct the National Response Coordination 
        Center (which is operated by the Federal Emergency 
        Management Agency) to request and share information 
        from state, local, and tribal governments regarding 
        their inventories of medical supplies during pandemic 
        and related health emergencies, and
           Permit the Department of Health and Human 
        Services (HHS) to sell medical supplies maintained in 
        the Strategic National Stockpile under certain 
        circumstances.
    Because federal agencies are currently coordinating 
activities similar to those required by S. 4204, CBO expects 
that implementing any new activities required under the bill 
would not require substantial resources. Therefore, CBO 
estimates that implementing the bill would not have a 
significant cost; any spending would be subject to the 
availability of appropriated funds.
    S. 4204 could affect direct spending by allowing HHS to 
sell some medical supplies in the Strategic National Stockpile 
to state, local, and tribal governments. CBO expects that those 
sales would be small and infrequent and would thus have no 
significant effect on direct spending over the 2021-2030 
period.
    The CBO staff contacts for this estimate are Matthew 
Pickford, Jon Sperl, and Lisa Ramirez-Branum. The estimate was 
reviewed by H. Samuel Papenfuss, Deputy Director of Budget 
Analysis.

       VII. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

    Because this legislation would not repeal or amend any 
provision of current law, it would not make changes in existing 
law within the meaning of clauses (a) and (b) of paragraph 12 
of rule XXVI of the Standing Rules of the Senate.

                                  [all]