IIB 
117TH CONGRESS 
1ST SESSION H. R. 3635 
IN THE SENATE OF THE UNITED STATES 
OCTOBER 21, 2021 
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
AN ACT 
To amend the Public Health Service Act with respect to 
the Strategic National Stockpile, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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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 depart-
ment or agency, on a reimbursable basis, any 
drugs, vaccines and other biological products, 
medical devices, and other supplies in the stock-
pile if— 
‘‘(i) the transferred supplies are less 
than one year from expiry; 
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‘‘(ii) the stockpile is able to replenish 
the supplies, as appropriate; and 
‘‘(iii) the Secretary decides the trans-
fer is in the best interest of the United 
States Government. 
‘‘(B) USE
OF
REIMBURSEMENT.—Reim-
bursement derived from the transfer of supplies 
pursuant to subparagraph (A) may, to the ex-
tent and in the amounts made available in ad-
vance 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 
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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 subpara-
graph at the end: 
‘‘(K) ensure contents of the stockpile re-
main in good working order and, as appro-
priate, conduct maintenance services on con-
tents 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 
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procurement of equipment maintenance 
services.’’. 
SEC. 4. SUPPLY CHAIN FLEXIBILITY MANUFACTURING 
PILOT. 
(a) IN GENERAL.—Section 319F–2(a)(3) of the Pub-
lic 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 elas-
ticity and establish and maintain domestic re-
serves 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 de-
vices (including diagnostic tests)) by— 
‘‘(i) increasing emergency stock of 
critical medical supplies; 
‘‘(ii) geographically diversifying do-
mestic production of such medical supplies, 
as appropriate; 
‘‘(iii) entering into cooperative agree-
ments or partnerships with respect to man-
ufacturing lines, facilities, and equipment 
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for the domestic production of such med-
ical supplies; and 
‘‘(iv) managing, either directly or 
through cooperative agreements with man-
ufacturers and distributors, domestic re-
serves 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 Com-
mittee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Edu-
cation, Labor and Pensions of the Senate a report 
on the details of each cooperative agreement or part-
nership entered into under paragraph (3)(L), includ-
ing the amount expended by the Secretary on each 
such cooperative agreement or partnership. 
‘‘(8) SUNSET.—The authority to enter into co-
operative agreements or partnerships pursuant to 
paragraph (3)(L) shall cease to be effective on Sep-
tember 30, 2024.’’. 
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(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 au-
thorized to be appropriated $500,000,000 for 
each of fiscal years 2022 through 2024, to re-
main 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 fea-
sibility of establishing user fees to offset certain Federal 
costs attributable to the procurement of single-source ma-
terials 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 Gen-
eral shall consider, to the extent information is available— 
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(1) whether entities receiving such distributions 
generate profits from those distributions; 
(2) any Federal costs attributable to such dis-
tributions; 
(3) whether such user fees would provide the 
Secretary with funding to potentially offset procure-
ment costs of such materials for the Strategic Na-
tional 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. 
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‘‘(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 prod-
ucts listed pursuant to paragraph (2) for inclu-
sion in the State’s strategic stockpile; 
‘‘(B) store, maintain, and distribute prod-
ucts 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 de-
scribed 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 fis-
cal year unless the total amount made available to carry 
out section 319F–2 for such fiscal year is equal to or 
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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 (di-
rectly) 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, ex-
panding, and maintaining a stockpile described in sub-
section (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. 
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‘‘(g) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $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 Prepared-
ness and Response, in consultation with the Administrator 
of the Federal Emergency Management Agency, shall— 
(1) not later than 30 days after the date of en-
actment of this Act, issue a report to the Committee 
on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate regarding 
all State, local, Tribal, and territorial requests for 
supplies from the Strategic National Stockpile re-
lated 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 So-
cial Security Act (42 U.S.C. 1320b–5(g)(1)(B))), 
submit to such committees an updated version of 
such report. 
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(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 be-
fore the date of submission of the report. 
(2) UPDATES.—Each update to the report 
under subsection (a) shall address all requests de-
scribed 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 be-
fore the date of submission of the updated re-
port. 
(c) CONTENTS OF REPORT.—The report under sub-
section (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 re-
quested; and 
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(2) the outcomes of each request described in 
subsection (a), including— 
(A) whether the request was wholly ful-
filled, 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 administra-
tion of drugs, vaccines and other biological products, med-
ical devices, and diagnostic tests) in the Strategic National 
Stockpile under section 319F–2 of the Public Health Serv-
ice 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— 
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(1) the form and manner in which States, local-
ities, 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 communica-
tion 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 emer-
gencies, such as weather events, and national emer-
gencies, 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. 
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(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 En-
ergy 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 Sec-
retary 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 Sec-
retary 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 
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