[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]