[Congressional Record Volume 167, Number 183 (Tuesday, October 19, 2021)]
[House]
[Pages H5651-H5654]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STRENGTHENING AMERICA'S STRATEGIC NATIONAL STOCKPILE ACT OF 2021
Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the
bill (H.R. 3635) to amend the Public Health Service Act with respect to
the Strategic National Stockpile, and for other purposes.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 3635
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
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
2021''.
(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.
[[Page H5652]]
``(B) Use of reimbursement.--Reimbursement derived from the
transfer of supplies pursuant to subparagraph (A) may, to the
extent and in the amounts made available in advance in
appropriations Acts, be used by the Secretary to carry out
this section. Funds made available pursuant to the preceding
sentence are in addition to any other funds that may be made
available for such purpose.
``(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, 2023, 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,
2024.''.
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, 2023, 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, 2024.''.
(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 2022 through 2024, 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, 2024, 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, devices, 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 2022.
``(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 2022 through 2024, to
remain available until expended.
``(h) Sunset.--The authority vested by this section
terminates at the end of fiscal year 2024.''.
SEC. 7. ACTION REPORTING.
(a) In General.--The Secretary of Health and Human Services
or the Assistant Secretary for Preparedness and Response, in
consultation 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, 2022; 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.
[[Page H5653]]
(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, 2022, the
Secretary of Health and Human Services 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, 2022,
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 2022 through 2024''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New
Jersey (Mr. Pallone) and the gentleman from Kentucky (Mr. Guthrie) each
will control 20 minutes.
The Chair recognizes the gentleman from New Jersey.
General Leave
Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material on H.R. 3635.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
Mr. PALLONE. Madam Speaker, I yield myself such time as I may
consume.
Madam Speaker, I rise today in support of H.R. 3635, the
Strengthening America's Strategic National Stockpile Act of 2021.
This bill makes long-overdue improvements to the Strategic National
Stockpile to ensure we have access to critical lifesaving medical
supplies during public health emergencies. Since the beginning of the
COVID-19 pandemic, there has been a lot of attention around the
Strategic National Stockpile and our preparedness for this pandemic.
The stockpile was not stocked as it should have been and this bill
makes important improvements to correct that for the future. The bill
will ensure that the Strategic National Stockpile, also known as SNS,
is operating at its highest potential moving forward in order to
continue to respond to COVID-19, and also to prepare for the next
public health emergency.
This bipartisan bill seeks to reduce America's dependence on foreign
sources of critical medical supplies, including personal protective
equipment. It does this by boosting domestic manufacturing to make
those supplies in the United States and promoting private-public
partnerships to ensure a coordinated response. The legislation also
makes needed improvements to the Strategic National Stockpile to ensure
it is fully equipped with medical supplies that are safe and in working
order.
Importantly, the bill also improves transparency around the readiness
of the Strategic National Stockpile and how requests from States and
Tribes are being managed. It also directs the Department of Health and
Human Services to develop and implement improved, transparent processes
for these types of requests moving forward. This will be critical for
ensuring adequate supplies within the Strategic National Stockpile, as
well as informing readiness efforts in the States and also at Tribal
levels.
As healthcare systems all across our Nation continue to be stretched
to the limit combating the COVID-19 Delta variant, we need to continue
to push solutions that support our public health and national security
response capability. The improvements to the Strategic National
Stockpile put forward in this bill are critical to protecting our
frontline workers and patients with the supplies that they need to stay
safe.
Madam Speaker, I commend the bipartisan leadership of Representatives
Slotkin and Hudson in preparing this bill. This bipartisan bill was
passed out of the Committee on Energy and Commerce and by this House
unanimously last Congress.
Madam Speaker, I encourage my colleagues to once again join me in
strong support of this important bill, and I reserve the balance of my
time.
Mr. GUTHRIE. Madam Speaker, I yield myself such time as I may
consume.
Madam Speaker, I rise in support of H.R. 3635, Strengthening
America's Strategic National Stockpile Act, which was spearheaded by
Representatives Hudson and Slotkin. This legislation includes several
critical initiatives that will improve the Strategic National
Stockpile, or SNS.
First, the bill allows the SNS to transfer products between federal
agencies and to ensure they are used before their expiration.
Second, the bill directs the Secretary of Health and Human Services
to examine user fee agreements, ensure the SNS products are in working
order, and allows agreements with domestic producers to improve the
supply chain to refresh and replenish existing stocks.
Third, the bill directs the Federal Emergency Management Agency and
the Centers for Disease Control and Prevention to report on
distributions from the SNS, as well as requests for supplies from
State, local, Tribal, and territorial agencies.
Finally, the bill authorizes a pilot program to establish State
stockpiles. We must ensure our country is prepared to combat the next
health crisis, no matter if it is from a disease, disaster, or
terrorism.
Madam Speaker, I urge my colleagues to support this bipartisan
legislation to improve and sustain the Strategic National Stockpile,
and I reserve the balance of my time.
Mr. PALLONE. Madam Speaker, I have no additional speakers, and I
reserve the balance of my time.
Mr. GUTHRIE. Madam Speaker, I yield 3 minutes to the gentleman from
North Carolina (Mr. Hudson), my colleague, and a primary sponsor of
this piece of legislation.
Mr. HUDSON. Madam Speaker, I rise in support of H.R. 3635,
Strengthening America's Strategic National Stockpile Act of 2021, a
bill I am proud to have introduced along with Representative Slotkin.
The COVID-19 pandemic has exposed the dangers of relying on foreign
countries for needed medical supplies.
[[Page H5654]]
H.R. 3635 will reduce our dependence on foreign sources of supplies
like PPE by boosting domestic manufacturing to make these products here
in the United States. It would also make critical improvements to our
Strategic National Stockpile to ensure it is full and items are ready
to be deployed when needed.
Strengthening our stockpile of PPE and domestic manufacturing has
never been more important for our economy and our national security. I
urge my colleagues to support this legislation so we can be better
prepared for the next public health emergency.
Madam Speaker, additionally, I am proud to have introduced H.R. 4032,
the Open RAN Outreach Act, a bill that will also be considered by this
House today.
The Open RAN Outreach Act will strengthen our telecommunications
supply chains and help protect small and rural communications providers
from Chinese-backed companies. Protecting our supply chains and pushing
back against China are more critical than ever before, especially for
our vulnerable telecommunications networks. Providers backed by the
Chinese Communist Party have tried to undercut the market and expand
their outreach, particularly in our underserved rural communities.
By passing H.R. 4032, we can encourage a competitive market of
trusted vendors to expand network access across our country. Just like
H.R. 3635, this bill is also critical not just for our economy, but for
our national security.
Madam Speaker, I urge my colleagues to support it as well.
Mr. PALLONE. Madam Speaker, I reserve the balance of my time.
Mr. GUTHRIE. Madam Speaker, I yield 3 minutes to the gentlewoman from
Indiana (Mrs. Walorski), a member of the Committee on Ways and Means.
Mrs. WALORSKI. Madam Speaker, I rise today in support of H.R. 3635,
the Strengthening America's Strategic National Stockpile Act. A key
lesson from the pandemic has been the absolute need to end our
dependence on the Chinese Communist Party for the production of
medicines, personal protective equipment, and other critical medical
supplies.
Now more than ever, we know that secure and resilient supply chains
are vital to the safety and success of the American people. It is so
critical to focus on breaking our dependency on China and move domestic
manufacturing of PPE products back home to the U.S.
Early on in the pandemic, the Department of Homeland Security
concluded that China ``intentionally concealed the severity'' of this
virus so they could hoard PPE by blocking exports and buying it up
through its state-owned enterprises, a theory that has been confirmed
time and time again.
In March of 2020, the New York Times reported that factories in China
were not authorized to export masks, and all the while bought up much
of the world's supply first. In February of last year, Chinese
entrepreneurs and aid groups visited pharmacies in affluent countries
and emerging markets, buying masks in bulk to send to China.
Similarly, the Sydney Morning Herald reported that the Greenland
Group, a Chinese government-backed property giant, instructed its
employees worldwide--even accountants and receptionists and their HR
teams--to stop what they were doing and bulk buy as many medical
supplies as they could in January and February of 2020.
It is quite simple. We must not trust the Chinese Communist Party.
The bipartisan legislation before us today is a strong step in the
right direction toward strengthening American manufacturing of PPE in
Indiana and across the rest of the country.
Specifically, it includes the Medical Supplies for Pandemics Act I
led with Congresswoman Dingell, that would enhance medical supply chain
elasticity, improve the domestic production of PPE, and partner with
private industry to refresh and replenish existing stocks of medical
supplies.
Our legislation takes other important measures, such as supporting
State efforts to expand and maintain our own stockpiles, improving
maintenance of the national stockpile to ensure it is in good working
order and allow the transfer of stockpile items nearing their
expiration dates to other federal agencies.
To prepare for the next crisis and better protect frontline
healthcare workers, we need to boost U.S. manufacturing of PPE and
strengthen the Strategic National Stockpile.
Madam Speaker, I urge support, and I thank my colleagues.
Mr. GUTHRIE. Madam Speaker, I am prepared to close, and I yield
myself such time as I may consume.
Madam Speaker, I urge support of this piece of legislation.
Fortunately, the last big pandemic that came across the country was
in 1918, the flu pandemic, so over 100 years. What we learned, although
it was well-planned and all, the Strategic National Stockpile, until
you really face a pandemic like we have, you don't truly understand
exactly everything you need to do, although the Strategic National
Stockpile was there, it was drawn from, it was used. There were a lot
of lessons learned.
Madam Speaker, it is important that we apply these lessons. I
appreciate my colleagues for doing this, moving forward. Hopefully, it
will be another 100 years or more before we have to use the Strategic
National Stockpile, but it certainly is prudent that we are ready.
Madam Speaker, I urge the passage of this legislation, and I yield
back the balance of my time.
Mr. PALLONE. Madam Speaker, I agree with my colleague that what this
bill does is basically take the lessons that we learned from the
pandemic about what can be done to improve the Strategic National
Stockpile for the future.
Madam Speaker, I ask everyone to support the bill on a bipartisan
basis, and I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from New Jersey (Mr. Pallone) that the House suspend the
rules and pass the bill, H.R. 3635.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. GOOD of Virginia. Madam Speaker, on that I demand the yeas and
nays.
The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution
8, the yeas and nays are ordered.
Pursuant to clause 8 of rule XX, further proceedings on this motion
are postponed.
____________________