1195 
related to detecting, diagnosing, preventing, and 
treating COVID–19 and report any suspected price 
gouging of such materials to the Federal Trade 
Commission and appropriate law enforcement offi-
cials. 
SEC. 512. INFORMATION TO BE INCLUDED IN LIST OF DE-
VICES DETERMINED TO BE IN SHORTAGE. 
Section 506J(g)(2)(A) of the Federal Food, Drug, 
and Cosmetic Act, as added by section 3121 of the 
CARES Act (Public Law 116–136), is amended by insert-
ing ‘‘, including the device identifier or national product 
code for such device, if applicable’’ before the period at 
the end. 
SEC. 513. EXTENDED SHELF LIFE DATES FOR ESSENTIAL 
DEVICES. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 506J 
(21 U.S.C. 356j) the following: 
‘‘SEC. 506K. EXTENDED SHELF LIFE DATES FOR ESSENTIAL 
DEVICES. 
‘‘(a) IN GENERAL.—A manufacturer of a device sub-
ject to notification requirements under section 506J (in 
this section referred to as an ‘essential device’) shall— 
‘‘(1) submit to the Secretary data and informa-
tion as required by subsection (b)(1); 
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‘‘(2) conduct and submit the results of any 
studies required under subsection (b)(3); and 
‘‘(3) make any labeling change described in 
subsection (c) by the date specified by the Secretary 
pursuant to such subsection. 
‘‘(b) NOTIFICATION.— 
‘‘(1) IN GENERAL.—The Secretary may issue 
an order requiring the manufacturer of any essential 
device to submit, in such manner as the Secretary 
may prescribe, data and information from any stage 
of development of the device (including pilot, inves-
tigational, and final product validation) that are 
adequate to assess the shelf life of the device to de-
termine the longest supported expiration date. 
‘‘(2) UNAVAILABLE
OR
INSUFFICIENT
DATA 
AND INFORMATION.—If the data and information re-
ferred to in paragraph (1) are not available or are 
insufficient, the Secretary may require the manufac-
turer of the device to— 
‘‘(A) conduct studies adequate to provide 
the data and information; and 
‘‘(B) submit to the Secretary the results, 
data, and information generated by such studies 
when available. 
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‘‘(c) LABELING.—The Secretary may issue an order 
requiring the manufacturer of an essential device to make 
by a specified date any labeling change regarding the expi-
ration period that the Secretary determines to be appro-
priate based on the data and information required to be 
submitted under this section or any other data and infor-
mation available to the Secretary. 
‘‘(d) CONFIDENTIALITY.—Nothing in this section 
shall be construed as authorizing the Secretary to disclose 
any information that is a trade secret or confidential infor-
mation subject to section 552(b)(4) of title 5, United 
States Code, or section 1905 of title 18, United States 
Code.’’. 
(b) CIVIL MONETARY PENALTY.—Section 303(f) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333(f)) is amended by adding at the end the following: 
‘‘(10) CIVIL MONETARY PENALTY WITH RESPECT 
TO EXTENDED SHELF LIFE DATES FOR ESSENTIAL DE-
VICES.—If the manufacturer of a device subject to notifi-
cation requirements under section 506J violates section 
506K by failing to submit data and information as re-
quired under section 506K(b)(1), failing to conduct or 
submit the results of studies as required under section 
506K(b)(3), or failing to make a labeling change as re-
quired under section 506K(c), such manufacturer shall be 
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liable to the United States for a civil penalty in an amount 
not to exceed $10,000 for each such violation.’’. 
(c) EMERGENCY USE ELIGIBLE PRODUCTS.—Sub-
paragraph (A) of section 564A(a)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a(a)(1)) is 
amended to read as follows: 
‘‘(A) is approved or cleared under this 
chapter, otherwise listed as a device pursuant to 
section 510(j), conditionally approved under 
section 571, or licensed under section 351 of 
the Public Health Service Act;’’. 
SEC. 514. AUTHORITY TO DESTROY COUNTERFEIT DEVICES. 
(a) IN GENERAL.—Section 801(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is 
amended— 
(1) in the fourth sentence, by inserting ‘‘or 
counterfeit device’’ after ‘‘counterfeit drug’’; and 
(2) by striking ‘‘The Secretary of the Treasury 
shall cause the destruction of’’ and all that follows 
through ‘‘liable for costs pursuant to subsection 
(c).’’ and inserting the following: ‘‘The Secretary of 
the Treasury shall cause the destruction of any such 
article refused admission unless such article is ex-
ported, under regulations prescribed by the Sec-
retary of the Treasury, within 90 days of the date 
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of notice of such refusal or within such additional 
time as may be permitted pursuant to such regula-
tions, except that the Secretary of Health and 
Human Services may destroy, without the oppor-
tunity for export, any drug or device refused admis-
sion under this section, if such drug or device is val-
ued at an amount that is $2,500 or less (or such 
higher amount as the Secretary of the Treasury may 
set by regulation pursuant to section 498(a)(1) of 
the Tariff Act of 1930 (19 U.S.C. 1498(a)(1))) and 
was not brought into compliance as described under 
subsection (b). The Secretary of Health and Human 
Services shall issue regulations providing for notice 
and an opportunity to appear before the Secretary 
of Health and Human Services and introduce testi-
mony, as described in the first sentence of this sub-
section, on destruction of a drug or device under the 
seventh sentence of this subsection. The regulations 
shall provide that prior to destruction, appropriate 
due process is available to the owner or consignee 
seeking to challenge the decision to destroy the drug 
or device. Where the Secretary of Health and 
Human Services provides notice and an opportunity 
to appear and introduce testimony on the destruc-
tion of a drug or device, the Secretary of Health and 
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Human Services shall store and, as applicable, dis-
pose of the drug or device after the issuance of the 
notice, except that the owner and consignee shall re-
main liable for costs pursuant to subsection (c).’’. 
(b) DEFINITION.—Section 201(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) is 
amended— 
(1) by redesignating subparagraphs (1), (2), 
and (3) as clauses (A), (B), and (C), respectively; 
and 
(2) after making such redesignations— 
(A) by striking ‘‘(h) The term’’ and insert-
ing ‘‘(h)(1) The term’’; and 
(B) by adding at the end the following: 
‘‘(2) The term ‘counterfeit device’ means a device 
which, or the container, packaging, or labeling of which, 
without authorization, bears a trademark, trade name, or 
other identifying mark, imprint, or symbol, or any likeness 
thereof, or is manufactured using a design, of a device 
manufacturer, packer, or distributor other than the person 
or persons who in fact manufactured, packed, or distrib-
uted such device and which thereby falsely purports or is 
represented to be the product of, or to have been packed 
or distributed by, such other device manufacturer, packer, 
or distributor. 
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‘‘(3) For purposes of subparagraph (2)— 
‘‘(A) the term ‘manufactured’ refers to any of 
the following activities: manufacture, preparation, 
propagation, compounding, assembly, or processing; 
and 
‘‘(B) the term ‘manufacturer’ means a person 
who is engaged in any of the activities listed in 
clause (A).’’. 
SEC. 515. REPORTING REQUIREMENT FOR DRUG MANUFAC-
TURERS. 
(a) ESTABLISHMENTS IN A FOREIGN COUNTRY.— 
Section 510(i) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360(i)) is amended by inserting at the end 
the following new paragraph: 
‘‘(5) The requirements of paragraphs (1) and (2) 
shall apply to establishments within a foreign country en-
gaged in the manufacture, preparation, propagation, 
compounding, or processing of any drug, including the ac-
tive pharmaceutical ingredient, that is required to be listed 
pursuant to subsection (j). Such requirements shall apply 
regardless of whether the drug or active pharmaceutical 
ingredient undergoes further manufacture, preparation, 
propagation, compounding, or processing at a separate es-
tablishment or establishments outside the United States 
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prior to being imported or offered for import into the 
United States.’’. 
(b) LISTING OF DRUGS.—Section 510(j)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360(j)(1)) is amended— 
(1) in subparagraph (D), by striking ‘‘and’’ at 
the end; 
(2) in subparagraph (E), by striking the period 
at the end and inserting ‘‘; and’’; and 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(F) in the case of a drug contained in the ap-
plicable list, a certification that the registrant has— 
‘‘(i) identified every other establishment 
where manufacturing is performed for the drug; 
and 
‘‘(ii) notified each known foreign establish-
ment engaged in the manufacture, preparation, 
propagation, compounding, or processing of the 
drug, including the active pharmaceutical ingre-
dient, of the inclusion of the drug in the list 
and the obligation to register.’’. 
(c) QUARTERLY REPORTING ON AMOUNT OF DRUGS 
MANUFACTURED.—Section 510(j)(3)(A) of the Federal 
Food, Drug, and Cosmetic Act (as added by section 3112 
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of the CARES Act (Public Law 116–136)) is amended 
by striking ‘‘annually’’ and inserting ‘‘once during the 
month of March of each year, once during the month of 
June of each year, once during the month of September 
of each year, and once during the month of December of 
each year’’. 
SEC. 516. RECOMMENDATIONS TO ENCOURAGE DOMESTIC 
MANUFACTURING OF CRITICAL DRUGS. 
(a) IN GENERAL.—Not later than 14 days after the 
date of enactment of this Act, the Secretary shall enter 
into an agreement with the National Academies of 
Sciences, Engineering, and Medicine (referred to in this 
section as the ‘‘National Academies’’) under which, not 
later than 90 days after the date of entering into the 
agreement, the National Academies will— 
(1) establish a committee of experts who are 
knowledgeable about drug and device supply issues, 
including— 
(A) sourcing and production of critical 
drugs and devices; 
(B) sourcing and production of active 
pharmaceutical ingredients in critical drugs; 
(C) the raw materials and other compo-
nents for critical drugs and devices; and 
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(D) the public health and national security 
implications of the current supply chain for 
critical drugs and devices; 
(2) convene a public symposium to— 
(A) analyze the impact of United States 
dependence on the foreign manufacturing of 
critical drugs and devices on patient access and 
care, including in hospitals and intensive care 
units; and 
(B) recommend strategies to end United 
States dependence on foreign manufacturing to 
ensure the United States has a diverse and vital 
supply chain for critical drugs and devices to 
protect the Nation from natural or hostile oc-
currences; and 
(3) submit a report on the symposium’s pro-
ceedings to the Congress and publish a summary of 
such proceedings on the public website of the Na-
tional Academies. 
(b) SYMPOSIUM.—In carrying out the agreement 
under subsection (a), the National Academies shall consult 
with— 
(1) the Department of Health and Human 
Services, the Department of Homeland Security, the 
Department of Defense, the Department of Com-
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merce, the Department of State, the Department of 
Veterans Affairs, the Department of Justice, and 
any other Federal agencies as appropriate; and 
(2) relevant stakeholders, including drug and 
device manufacturers, health care providers, medical 
professional societies, State-based societies, public 
health experts, State and local public health depart-
ments, State medical boards, patient groups, health 
care distributors, wholesalers and group purchasing 
organizations, pharmacists, and other entities with 
experience in health care and public health, as ap-
propriate. 
(c) DEFINITIONS.—For the purposes of this section: 
(1) The term ‘‘critical’’— 
(A) with respect to a device, refers to a de-
vice classified by the Food and Drug Adminis-
tration as implantable, life-saving, and life-sus-
taining; or 
(B) with respect to a drug, refers to a 
drug that is described in subsection (a) of sec-
tion 506C of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 356c) (relating to notifi-
cation of any discontinuance or interruption in 
the production of life-saving drugs). 
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(2) The terms ‘‘device’’ and ‘‘drug’’ have the 
meanings given to those terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321). 
SEC. 517. FAILURE TO NOTIFY OF A PERMANENT DIS-
CONTINUANCE OR AN INTERRUPTION. 
Section 301 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 331) is amended by adding at the end the 
following: 
‘‘(fff) The failure of a manufacturer of a drug de-
scribed in section 506C(a) or an active pharmaceutical in-
gredient of such a drug, without a reasonable basis as de-
termined by the Secretary, to notify the Secretary of a 
permanent discontinuance or an interruption, and the rea-
sons for such discontinuance or interruption, as required 
by section 506C.’’. 
SEC. 518. FAILURE TO DEVELOP RISK MANAGEMENT PLAN. 
Section 301 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 331), as amended by section 517, is fur-
ther amended by adding at the end the following: 
‘‘(ggg) The failure to develop, maintain, and imple-
ment a risk management plan, as required by section 
506C(j).’’. 
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SEC. 519. NATIONAL CENTERS OF EXCELLENCE IN CONTIN-
UOUS PHARMACEUTICAL MANUFACTURING. 
(a) IN GENERAL.—Section 3016 of the 21st Century 
Cures Act (21 U.S.C. 399h) is amended to read as follows: 
‘‘SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN CON-
TINUOUS 
PHARMACEUTICAL 
MANUFAC-
TURING. 
‘‘(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs— 
‘‘(1) shall solicit and, beginning not later than 
1 year after the date of enactment of the Investing 
in America’s Health Care During the COVID–19 
Pandemic Act receive requests from institutions of 
higher education to be designated as a National 
Center of Excellence in Continuous Pharmaceutical 
Manufacturing (in this section referred to as a ‘Na-
tional Center of Excellence’) to support the advance-
ment and development of continuous manufacturing; 
and 
‘‘(2) shall so designate any institution of higher 
education that— 
‘‘(A) requests such designation; and 
‘‘(B) meets the criteria specified in sub-
section (c). 
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‘‘(b) REQUEST FOR DESIGNATION.—A request for 
designation under subsection (a) shall be made to the Sec-
retary at such time, in such manner, and containing such 
information as the Secretary may require. Any such re-
quest shall include a description of how the institution of 
higher education meets or plans to meet each of the cri-
teria specified in subsection (c). 
‘‘(c) CRITERIA FOR DESIGNATION DESCRIBED.—The 
criteria specified in this subsection with respect to an in-
stitution of higher education are that the institution has, 
as of the date of the submission of a request under sub-
section (a) by such institution— 
‘‘(1) physical and technical capacity for re-
search and development of continuous manufac-
turing; 
‘‘(2) manufacturing knowledge-sharing net-
works with other institutions of higher education, 
large and small pharmaceutical manufacturers, ge-
neric and nonprescription manufacturers, contract 
manufacturers, and other entities; 
‘‘(3) proven capacity to design and demonstrate 
new, highly effective technology for use in contin-
uous manufacturing; 
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‘‘(4) a track record for creating and transfer-
ring knowledge with respect to continuous manufac-
turing; 
‘‘(5) the potential to train a future workforce 
for research on and implementation of advanced 
manufacturing and continuous manufacturing; and 
‘‘(6) experience in participating in and leading 
a continuous manufacturing technology partnership 
with other institutions of higher education, large and 
small pharmaceutical manufacturers (including ge-
neric and nonprescription drug manufacturers), con-
tract manufacturers, and other entities— 
‘‘(A) to support companies with continuous 
manufacturing in the United States; 
‘‘(B) to support Federal agencies with 
technical assistance, which may include regu-
latory and quality metric guidance as applica-
ble, for advanced manufacturing and continuous 
manufacturing; 
‘‘(C) with respect to continuous manufac-
turing, to organize and conduct research and 
development activities needed to create new and 
more effective technology, capture and dissemi-
nate expertise, create intellectual property, and 
maintain technological leadership; 
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‘‘(D) to develop best practices for design-
ing continuous manufacturing; and 
‘‘(E) to assess and respond to the work-
force needs for continuous manufacturing, in-
cluding the development of training programs if 
needed. 
‘‘(d) TERMINATION
OF DESIGNATION.—The Sec-
retary may terminate the designation of any National Cen-
ter of Excellence designated under this section if the Sec-
retary determines such National Center of Excellence no 
longer meets the criteria specified in subsection (c). Not 
later than 60 days before the effective date of such a ter-
mination, the Secretary shall provide written notice to the 
National Center of Excellence, including the rationale for 
such termination. 
‘‘(e) CONDITIONS FOR DESIGNATION.—As a condi-
tion of designation as a National Center of Excellence 
under this section, the Secretary shall require that an in-
stitution of higher education enter into an agreement with 
the Secretary under which the institution agrees— 
‘‘(1) to collaborate directly with the Food and 
Drug Administration to publish the reports required 
by subsection (g); 
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‘‘(2) to share data with the Food and Drug Ad-
ministration regarding best practices and research 
generated through the funding under subsection (f); 
‘‘(3) to develop, along with industry partners 
(which may include large and small biopharma-
ceutical manufacturers, generic and nonprescription 
manufacturers, and contract manufacturers) and an-
other institution or institutions designated under 
this section, if any, a roadmap for developing a con-
tinuous manufacturing workforce; 
‘‘(4) to develop, along with industry partners 
and other institutions designated under this section, 
a roadmap for strengthening existing, and devel-
oping new, relationships with other institutions; and 
‘‘(5) to provide an annual report to the Food 
and Drug Administration regarding the institution’s 
activities under this section, including a description 
of how the institution continues to meet and make 
progress on the criteria listed in subsection (c). 
‘‘(f) FUNDING.— 
‘‘(1) IN GENERAL.—The Secretary shall award 
funding, through grants, contracts, or cooperative 
agreements, to the National Centers of Excellence 
designated under this section for the purpose of 
studying and recommending improvements to contin-
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uous manufacturing, including such improvements 
as may enable the Centers— 
‘‘(A) to continue to meet the conditions 
specified in subsection (e); and 
‘‘(B) to expand capacity for research on, 
and development of, continuing manufacturing. 
‘‘(2) CONSISTENCY WITH FDA MISSION.—As a 
condition on receipt of funding under this sub-
section, a National Center of Excellence shall agree 
to consider any input from the Secretary regarding 
the use of funding that would— 
‘‘(A) help to further the advancement of 
continuous manufacturing through the National 
Center of Excellence; and 
‘‘(B) be relevant to the mission of the 
Food and Drug Administration. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this subsection $100,000,000, to remain available 
until expended. 
‘‘(4) RULE
OF
CONSTRUCTION.—Nothing in 
this section shall be construed as precluding a Na-
tional Center for Excellence designated under this 
section from receiving funds under any other provi-
sion of this Act or any other Federal law. 
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‘‘(g) ANNUAL REVIEW AND REPORTS.— 
‘‘(1) ANNUAL
REPORT.—Beginning not later 
than 1 year after the date on which the first des-
ignation is made under subsection (a), and annually 
thereafter, the Secretary shall— 
‘‘(A) submit to Congress a report describ-
ing the activities, partnerships and collabora-
tions, Federal policy recommendations, previous 
and continuing funding, and findings of, and 
any other applicable information from, the Na-
tional Centers of Excellence designated under 
this section; and 
‘‘(B) make such report available to the 
public in an easily accessible electronic format 
on the website of the Food and Drug Adminis-
tration. 
‘‘(2) REVIEW OF NATIONAL CENTERS OF EX-
CELLENCE AND POTENTIAL DESIGNEES.—The Sec-
retary shall periodically review the National Centers 
of Excellence designated under this section to ensure 
that such National Centers of Excellence continue to 
meet the criteria for designation under this section. 
‘‘(3) REPORT ON LONG-TERM VISION OF FDA 
ROLE.—Not later than 2 years after the date on 
which the first designation is made under subsection 
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(a), the Secretary, in consultation with the National 
Centers of Excellence designated under this section, 
shall submit a report to the Congress on the long- 
term vision of the Department of Health and 
Human Services on the role of the Food and Drug 
Administration in supporting continuous manufac-
turing, including— 
‘‘(A) a national framework of principles re-
lated to the implementation and regulation of 
continuous manufacturing; 
‘‘(B) a plan for the development of Federal 
regulations and guidance for how advanced 
manufacturing and continuous manufacturing 
can be incorporated into the development of 
pharmaceuticals and regulatory responsibilities 
of the Food and Drug Administration; and 
‘‘(C) appropriate feedback solicited from 
the public, which may include other institutions, 
large and small biopharmaceutical manufactur-
ers, generic and nonprescription manufacturers, 
and contract manufacturers. 
‘‘(h) DEFINITIONS.—In this section: 
‘‘(1) ADVANCED MANUFACTURING.—The term 
‘advanced manufacturing’ means an approach for 
the manufacturing of pharmaceuticals that incor-
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porates novel technology, or uses an established 
technique or technology in a new or innovative way 
(such as continuous manufacturing where the input 
materials are continuously transformed within the 
process by two or more unit operations) that en-
hances drug quality or improves the manufacturing 
process. 
‘‘(2) 
CONTINUOUS
MANUFACTURING.—The 
term ‘continuous manufacturing’— 
‘‘(A) means a process where the input ma-
terials are continuously fed into and trans-
formed within the process, and the processed 
output materials are continuously removed from 
the system; and 
‘‘(B) consists of an integrated process that 
consists of a series of two or more unit oper-
ations. 
‘‘(3) INSTITUTION OF HIGHER EDUCATION.— 
The term ‘institution of higher education’ has the 
meaning given such term in section 101(a) of the 
Higher Education Act of 1965 (20 U.S.C. 1001(a)). 
‘‘(4) SECRETARY.—The term ‘Secretary’ means 
the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs.’’. 
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(b) TRANSITION RULE.—Section 3016 of the 21st 
Century Cures Act (21 U.S.C. 399h), as in effect on the 
day before the date of the enactment of this section, shall 
apply with respect to grants awarded under such section 
before such date of enactment. 
Subtitle B—Strategic National 
Stockpile Improvements 
SEC. 531. 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 the contents of the stockpile 
remain in good working order and, as appro-
priate, conduct maintenance services on such 
contents; and’’; and 
(2) in subsection (c)(7)(B), by adding at the 
end the following new clause: 
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‘‘(ix) 
EQUIPMENT
MAINTENANCE 
SERVICE.—In carrying out this section, the 
Secretary may enter into contracts for the 
procurement of equipment maintenance 
services.’’. 
SEC. 532. 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 531, 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 pro-
duction of such medical supplies; 
‘‘(iii) purchasing, leasing, or entering 
into joint ventures with respect to facilities 
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and equipment for the production of such 
medical supplies; and 
‘‘(iv) working with distributors of 
such medical supplies to manage the do-
mestic reserves established under this sub-
paragraph 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)) is 
amended by adding at the end the following: 
‘‘(6) REPORTING.—Not later than September 
30, 2022, 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 purchase, lease, or joint ven-
ture entered into under paragraph (3)(L), including 
the amount expended by the Secretary on each such 
purchase, lease, or joint venture. 
‘‘(7) SUNSET.—The authority to make pur-
chases, leases, or joint ventures pursuant to para-
graph (3)(L) shall cease to be effective on Sep-
tember 30, 2023.’’. 
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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 2020 through 2023, 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. 533. REIMBURSABLE TRANSFERS FROM STRATEGIC 
NATIONAL STOCKPILE. 
Section 319F–2(a) of the Public Health Service Act 
(42 U.S.C. 247d–6b(a)), as amended, is further amended 
by adding at the end the following: 
‘‘(8) 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, 
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medical devices, and other supplies in the stock-
pile if— 
‘‘(i) the transferred supplies are less 
than 6 months from expiry; 
‘‘(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 be used by 
the Secretary, without further appropriation 
and without fiscal year limitation, to carry out 
this section. 
‘‘(C) REPORT.—Not later than September 
30, 2022, the Secretary shall submit to the 
Committee on Energy and Commerce of the 
House of Representatives and the Committee 
on Health, Education, Labor and Pensions of 
the Senate a report on each transfer made 
under this paragraph and the amount received 
by the Secretary in exchange for that transfer. 
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‘‘(D) SUNSET.—The authority to make 
transfers under this paragraph shall cease to be 
effective on September 30, 2023.’’. 
SEC. 534. STRATEGIC NATIONAL STOCKPILE ACTION RE-
PORTING. 
(a) IN GENERAL.—The Assistant Secretary for Pre-
paredness and Response (in this section referred to as the 
‘‘Assistant Secretary’’), in coordination with the Adminis-
trator 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. 
(b) REPORTING PERIOD.— 
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(1) INITIAL REPORT.—The initial report under 
subsection (a) shall address all requests described in 
such subsection made during the period— 
(A) beginning on January 31, 2020; and 
(B) ending on the date that is 30 days 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, 
including devices such as personal protective 
equipment, and other materials requested; and 
(B) the amount of such materials re-
quested; and 
(2) the outcomes of each request described in 
subsection (a), including— 
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(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. 535. IMPROVED, TRANSPARENT PROCESSES FOR THE 
STRATEGIC NATIONAL STOCKPILE. 
(a) IN GENERAL.—Not later than January 1, 2021, 
the Secretary, in collaboration with the Assistant Sec-
retary for Preparedness and Response and the Director 
of the Centers for Disease Control and Prevention, shall 
develop and implement improved, transparent processes 
for the use and distribution of drugs, vaccines and other 
biological products, medical devices, and other supplies 
(including personal protective equipment, ancillary med-
ical supplies, and other applicable supplies required for the 
administration of drugs, vaccines and other biological 
products, diagnostic tests, and other medical devices ) 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— 
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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 in re-
sponding 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) REPORT TO CONGRESS.—Not later than January 
1, 2021, the Secretary shall— 
(1) submit a report to the Committee 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; 
and 
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(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. 
SEC. 536. GAO STUDY ON THE FEASIBILITY AND BENEFITS 
OF A STRATEGIC NATIONAL STOCKPILE 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— 
(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 
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(4) any other issues the Comptroller General 
identifies as relevant. 
(b) REPORT.—Not later than February 1, 2023, the 
Comptroller General of the United States shall submit to 
the Congress a report on the findings and conclusions of 
the study under subsection (a). 
Subtitle C—Testing and Testing 
Infrastructure Improvements 
SEC. 541. COVID–19 TESTING STRATEGY. 
(a) STRATEGY.—Not later than 30 days after the 
date of the enactment of this Act, the Secretary shall up-
date the COVID–19 strategic testing plan under the head-
ing ‘‘Department of Health and Human Services—Office 
of the Secretary—Public Health and Social Service Emer-
gency Fund’’ in title I of division B of the Paycheck Pro-
tection Program and Health Care Enhancement Act (Pub-
lic Law 116–139, 134 Stat. 620, 626–627) and submit 
to the appropriate congressional committees such updated 
national plan identifying— 
(1) what level of, types of, and approaches to 
testing (including predicted numbers of tests, popu-
lations to be tested, and frequency of testing and the 
appropriate setting whether a health care setting 
(such as hospital-based, high-complexity laboratory, 
point-of-care, mobile testing units, pharmacies or 
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community health centers) or non-health care setting 
(such as workplaces, schools, or child care centers)) 
are necessary— 
(A) to sufficiently monitor and contribute 
to the control of the transmission of SARS– 
CoV–2 in the United States; 
(B) to ensure that any reduction in social 
distancing efforts, when determined appropriate 
by public health officials, can be undertaken in 
a manner that optimizes the health and safety 
of the people of the United States, and reduces 
disparities (including disparities related to race, 
ethnicity, sex, age, disability status, socio-
economic status, and geographic location) in the 
prevalence of, incidence of, and health outcomes 
with respect to, COVID–19; and 
(C) to provide for ongoing surveillance suf-
ficient to support contact tracing, case identi-
fication, quarantine, and isolation to prevent fu-
ture outbreaks of COVID–19; 
(2) specific plans and benchmarks, each with 
clear timelines, to ensure— 
(A) such level of, types of, and approaches 
to testing as are described in paragraph (1), 
with respect to optimizing health and safety; 
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(B) sufficient availability of all necessary 
testing materials and supplies, including extrac-
tion and testing kits, reagents, transport media, 
swabs, instruments, analysis equipment, per-
sonal protective equipment if necessary for test-
ing (including point-of-care testing), and other 
equipment; 
(C) allocation of testing materials and sup-
plies in a manner that optimizes public health, 
including by considering the variable impact of 
SARS–CoV–2 on specific States, territories, In-
dian Tribes, Tribal organizations, urban Indian 
organizations, communities, industries, and pro-
fessions; 
(D) sufficient evidence of validation for 
tests that are deployed as a part of such strat-
egy; 
(E) sufficient laboratory and analytical ca-
pacity, including target turnaround time for 
test results; 
(F) sufficient personnel, including per-
sonnel to collect testing samples, conduct and 
analyze results, and conduct testing follow-up, 
including contact tracing, as appropriate; and 
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(G) enforcement of the Families First 
Coronavirus Response Act (Public Law 116– 
127) to ensure patients who are tested are not 
subject to cost sharing; 
(3) specific plans to ensure adequate testing in 
rural areas, frontier areas, health professional short-
age areas, and medically underserved areas (as de-
fined in section 330I(a) of the Public Health Service 
Act (42 U.S.C. 254c–14(a))), and for underserved 
populations, Native Americans (including Indian 
Tribes, Tribal organizations, and urban Indian orga-
nizations), and populations at increased risk related 
to COVID–19; 
(4) specific plans to ensure accessibility of test-
ing to people with disabilities, older individuals, and 
individuals with underlying health conditions or 
weakened immune systems; and 
(5) specific plans for broadly developing and 
implementing testing for potential immunity in the 
United States, as appropriate, in a manner suffi-
cient— 
(A) to monitor and contribute to the con-
trol of SARS–CoV–2 in the United States; 
(B) to ensure that any reduction in social 
distancing efforts, when determined appropriate 
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by public health officials, can be undertaken in 
a manner that optimizes the health and safety 
of the people of the United States; and 
(C) to reduce disparities (including dispari-
ties related to race, ethnicity, sex, age, dis-
ability status, socioeconomic status, and geo-
graphic location) in the prevalence of, incidence 
of, and health outcomes with respect to, 
COVID–19. 
(b) COORDINATION.—The Secretary shall carry out 
this section— 
(1) in coordination with the Administrator of 
the Federal Emergency Management Agency; 
(2) in collaboration with other agencies and de-
partments, as appropriate; and 
(3) taking into consideration the State plans for 
COVID–19 testing prepared as required under the 
heading ‘‘Department of Health and Human Serv-
ices—Office of the Secretary—Public Health and 
Social Service Emergency Fund’’ in title I of divi-
sion B of the Paycheck Protection Program and 
Health Care Enhancement Act (Public Law 116– 
139; 134 Stat. 620, 624). 
(c) UPDATES.— 
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(1) FREQUENCY.—The updated national plan 
under subsection (a) shall be updated every 30 days 
until the end of the public health emergency first de-
clared by the Secretary under section 319 of the 
Public Health Service Act (42 U.S.C. 247d) on Jan-
uary 31, 2020, with respect to COVID–19. 
(2) RELATION TO OTHER LAW.—Paragraph (1) 
applies in lieu of the requirement (for updates every 
90 days until funds are expended) in the second to 
last proviso under the heading ‘‘Department of 
Health and Human Services—Office of the Sec-
retary—Public Health and Social Service Emergency 
Fund’’ in title I of division B of the Paycheck Pro-
tection Program and Health Care Enhancement Act 
(Public Law 116–139; 134 Stat. 620, 627). 
(d) APPROPRIATE CONGRESSIONAL COMMITTEES.— 
In this section, the term ‘‘appropriate congressional com-
mittees’’ means— 
(1) the Committee on Appropriations and the 
Committee on Energy and Commerce of the House 
of Representatives; and 
(2) the Committee on Appropriations and the 
Committee on Health, Education, Labor and Pen-
sions and of the Senate. 
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SEC. 542. CENTRALIZED TESTING INFORMATION WEBSITE. 
The Secretary shall establish and maintain a public, 
searchable webpage, to be updated and corrected as nec-
essary through a process established by the Secretary, on 
the website of the Department of Health and Human 
Services that— 
(1) identifies all in vitro diagnostic and sero-
logical tests used in the United States to analyze 
clinical specimens for detection of SARS–CoV–2 or 
antibodies specific to SARS–CoV–2, including— 
(A) those tests— 
(i) that are approved, cleared, or au-
thorized under section 510(k), 513, 515, or 
564 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360(k), 360c, 360e, 
360bbb–3); 
(ii) that have been validated by the 
test’s developers for use on clinical speci-
mens and for which the developer has noti-
fied the Food and Drug Administration of 
the developer’s intent to market the test 
consistent with applicable guidance issued 
by the Secretary; or 
(iii) that have been developed and au-
thorized by a State that has notified the 
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Secretary of the State’s intention to review 
tests intended to diagnose COVID–19; and 
(B) other SARS–CoV–2-related tests that 
the Secretary determines appropriate in guid-
ance, which may include tests related to the 
monitoring of COVID–19 patient status; 
(2) provides relevant information, as deter-
mined by the Secretary, on each test identified pur-
suant to paragraph (1), which may include— 
(A) the name and contact information of 
the developer of the test; 
(B) the date of receipt of notification by 
the Food and Drug Administration of the devel-
oper’s intent to market the test; 
(C) the date of authorization for use of the 
test on clinical specimens, where applicable; 
(D) the letter of authorization for use of 
the test on clinical specimens, where applicable; 
(E) any fact sheets, manufacturer instruc-
tions, and package inserts for the test, includ-
ing information on intended use; 
(F) sensitivity and specificity of the test; 
and 
(G) in the case of tests distributed by com-
mercial manufacturers, the number of tests dis-
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tributed and, if available, the number of labora-
tories in the United States with the required 
platforms installed to perform the test; and 
(3) includes— 
(A) a list of laboratories certified under 
section 353 of the Public Health Service Act 
(42 U.S.C. 263a; commonly referred to as 
‘‘CLIA’’) that— 
(i) meet the regulatory requirements 
under such section to perform high- or 
moderate-complexity testing; and 
(ii) are authorized to perform SARS– 
CoV–2 diagnostic or serological tests on 
clinical specimens; and 
(B) information on each laboratory identi-
fied pursuant to subparagraph (A), including— 
(i) the name and address of the lab-
oratory; 
(ii) the CLIA certificate number; 
(iii) the laboratory type; 
(iv) the certificate type; and 
(v) the complexity level. 
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SEC. 543. MANUFACTURER REPORTING OF TEST DISTRIBU-
TION. 
(a) IN GENERAL.—A commercial manufacturer of an 
in vitro diagnostic or serological COVID–19 test shall, on 
a weekly basis, submit a notification to the Secretary re-
garding distribution of each such test, which notifica-
tion— 
(1) shall include the number of tests distributed 
and the entities to which the tests are distributed; 
and 
(2) may include the quantity of such tests dis-
tributed by the manufacturer. 
(b) CONFIDENTIALITY.—Nothing in this section shall 
be construed as authorizing the Secretary to disclose any 
information that is a trade secret or confidential informa-
tion subject to section 552(b)(4) of title 5, United States 
Code, or section 1905 of title 18, United States Code. 
(c) FAILURE TO MEET REQUIREMENTS.—If a manu-
facturer fails to submit a notification as required under 
subsection (a), the following applies: 
(1) The Secretary shall issue a letter to such 
manufacturer informing such manufacturer of such 
failure. 
(2) Not later than 7 calendar days after the 
issuance of a letter under paragraph (1), the manu-
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facturer to whom such letter is issued shall submit 
to the Secretary a written response to such letter— 
(A) setting forth the basis for noncompli-
ance; and 
(B) providing information as required 
under subsection (a). 
(3) Not later than 14 calendar days after the 
issuance of a letter under paragraph (1), the Sec-
retary shall make such letter and any response to 
such letter under paragraph (2) available to the pub-
lic on the internet website of the Food and Drug Ad-
ministration, with appropriate redactions made to 
protect information described in subsection (b). The 
preceding sentence shall not apply if the Secretary 
determines that— 
(A) the letter under paragraph (1) was 
issued in error; or 
(B) after review of such response, the 
manufacturer had a reasonable basis for not 
notifying as required under subsection (a). 
SEC. 544. STATE TESTING REPORT. 
For any State that authorizes (or intends to author-
ize) one or more laboratories in the State to develop and 
perform in vitro diagnostic COVID–19 tests, the head of 
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the department or agency of such State with primary re-
sponsibility for health shall— 
(1) notify the Secretary of such authorization 
(or intention to authorize); and 
(2) provide the Secretary with a weekly re-
port— 
(A) identifying all laboratories authorized 
(or intended to be authorized) by the State to 
develop 
and 
perform 
in 
vitro 
diagnostic 
COVID–19 tests; 
(B) including relevant information on all 
laboratories identified pursuant to subpara-
graph (A), which may include information on 
laboratory testing capacity; 
(C) identifying all in vitro diagnostic 
COVID–19 tests developed and approved for 
clinical use in laboratories identified pursuant 
to subparagraph (A); and 
(D) including relevant information on all 
tests identified pursuant to subparagraph (C), 
which may include— 
(i) the name and contact information 
of the developer of any such test; 
(ii) any fact sheets, manufacturer in-
structions, and package inserts for any 
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such test, including information on in-
tended use; and 
(iii) the sensitivity and specificity of 
any such test. 
SEC. 545. STATE LISTING OF TESTING SITES. 
Not later than 14 days after the date of enactment 
of this Act, any State receiving funding or assistance 
under this Act, as a condition on such receipt, shall estab-
lish and maintain a public, searchable webpage on the offi-
cial website of the State that— 
(1) identifies all sites located in the State that 
provide diagnostic or serological testing for SARS– 
CoV–2; and 
(2) provides appropriate contact information for 
SARS–CoV–2 testing sites pursuant to paragraph 
(1). 
SEC. 546. REPORTING OF COVID–19 TESTING RESULTS. 
(a) IN GENERAL.—Every laboratory that performs or 
analyzes a test that is intended to detect SARS–CoV–2 
or to diagnose a possible case of COVID–19 shall report 
daily the number of tests performed and the results from 
each such test to the Secretary of Health and Human 
Services and to the Secretary of Homeland Security, in 
such form and manner as such Secretaries may prescribe. 
Such information shall be made available to the public in 
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a searchable, electronic format as soon as is practicable, 
and in no case later than one week after such information 
is received. 
(b) ADDITIONAL REPORTING REQUIREMENTS.—The 
Secretaries specified in subsection (a)— 
(1) may specify additional reporting require-
ments under this section by regulation, including by 
interim final rule, or by guidance; and 
(2) may issue such regulations or guidance 
without regard to the procedures otherwise required 
by section 553 of title 5, United States Code. 
SEC. 547. GAO REPORT ON DIAGNOSTIC TESTS. 
(a) GAO STUDY.—Not later than 18 months after 
the date of enactment of this Act, the Comptroller General 
of the United States shall submit to the Committee on 
Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor and Pen-
sions of the Senate a report describing the response of 
entities described in subsection (b) to the COVID–19 pan-
demic with respect to the development, regulatory evalua-
tion, and deployment of diagnostic tests. 
(b) ENTITIES DESCRIBED.—Entities described in 
this subsection include— 
(1) laboratories, including public health, aca-
demic, clinical, and commercial laboratories; 
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(2) diagnostic test manufacturers; 
(3) State, local, Tribal, and territorial govern-
ments; and 
(4) the Food and Drug Administration, the 
Centers for Disease Control and Prevention, the 
Centers for Medicare & Medicaid Services, the Na-
tional Institutes of Health, and other relevant Fed-
eral agencies, as appropriate. 
(c) CONTENTS.—The report under subsection (a) 
shall include— 
(1) a description of actions taken by entities de-
scribed in subsection (b) to develop, evaluate, and 
deploy diagnostic tests; 
(2) an assessment of the coordination of Fed-
eral agencies in the development, regulatory evalua-
tion, and deployment of diagnostic tests; 
(3) an assessment of the standards used by the 
Food and Drug Administration to evaluate diag-
nostic tests; 
(4) an assessment of the clarity of Federal 
agency guidance related to testing, including the 
ability for individuals without medical training to 
understand which diagnostic tests had been evalu-
ated by the Food and Drug Administration; 
(5) a description of— 
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(A) actions taken and clinical processes 
employed by States and territories that have 
authorized laboratories to develop and perform 
diagnostic tests not authorized, approved, or 
cleared by the Food and Drug Administration, 
including actions of such States and territories 
to evaluate the accuracy and sensitivity of such 
tests; and 
(B) the standards used by States and ter-
ritories when deciding when to authorize labora-
tories to develop or perform diagnostic tests; 
(6) an assessment of the steps taken by labora-
tories and diagnostic test manufacturers to validate 
diagnostic tests, as well as the evidence collected by 
such entities to support validation; and 
(7) based on available reports, an assessment of 
the accuracy and sensitivity of a representative sam-
ple of available diagnostic tests. 
(d) DEFINITION.—In this section, the term ‘‘diag-
nostic test’’ means an in vitro diagnostic product (as de-
fined in section 809.3(a) of title 21, Code of Federal Regu-
lations) for— 
(1) the detection of SARS–CoV–2; 
(2) the diagnosis of the virus that causes 
COVID–19; or 
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(3) the detection of antibodies specific to 
SARS–CoV–2, such as a serological test. 
SEC. 
548. 
PUBLIC 
HEALTH 
DATA 
SYSTEM 
TRANS-
FORMATION. 
Subtitle C of title XXVIII of the Public Health Serv-
ice Act (42 U.S.C. 300hh–31 et seq.) is amended by add-
ing at the end the following: 
‘‘SEC. 
2823. 
PUBLIC 
HEALTH 
DATA 
SYSTEM 
TRANS-
FORMATION. 
‘‘(a) EXPANDING CDC AND PUBLIC HEALTH DE-
PARTMENT CAPABILITIES.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, shall— 
‘‘(A) conduct activities to expand, enhance, 
and improve applicable public health data sys-
tems used by the Centers for Disease Control 
and Prevention, related to the interoperability 
and improvement of such systems (including as 
it relates to preparedness for, prevention and 
detection of, and response to public health 
emergencies); and 
‘‘(B) award grants or cooperative agree-
ments to State, local, Tribal, or territorial pub-
lic health departments for the expansion and 
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modernization of public health data systems, to 
assist public health departments in— 
‘‘(i) assessing current data infrastruc-
ture capabilities and gaps to improve and 
increase consistency in data collection, 
storage, and analysis and, as appropriate, 
to improve dissemination of public health- 
related information; 
‘‘(ii) improving secure public health 
data collection, transmission, exchange, 
maintenance, and analysis; 
‘‘(iii) improving the secure exchange 
of data between the Centers for Disease 
Control and Prevention, State, local, Trib-
al, and territorial public health depart-
ments, public health organizations, and 
health care providers, including by public 
health officials in multiple jurisdictions 
within such State, as appropriate, and by 
simplifying and supporting reporting by 
health care providers, as applicable, pursu-
ant to State law, including through the use 
of health information technology; 
‘‘(iv) enhancing the interoperability of 
public health data systems (including sys-
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tems created or accessed by public health 
departments) with health information tech-
nology, including with health information 
technology 
certified 
under 
section 
3001(c)(5); 
‘‘(v) supporting and training data sys-
tems, data science, and informatics per-
sonnel; 
‘‘(vi) supporting earlier disease and 
health condition detection, such as through 
near real-time data monitoring, to support 
rapid public health responses; 
‘‘(vii) supporting activities within the 
applicable jurisdiction related to the expan-
sion and modernization of electronic case 
reporting; and 
‘‘(viii) developing and disseminating 
information related to the use and impor-
tance of public health data. 
‘‘(2) DATA STANDARDS.—In carrying out para-
graph (1), the Secretary, acting through the Direc-
tor of the Centers for Disease Control and Preven-
tion, shall, as appropriate and in consultation with 
the Office of the National Coordinator for Health 
Information Technology, designate data and tech-
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nology standards (including standards for interoper-
ability) for public health data systems, with def-
erence given to standards published by consensus- 
based standards development organizations with 
public input and voluntary consensus-based stand-
ards bodies. 
‘‘(3) 
PUBLIC-PRIVATE
PARTNERSHIPS.—The 
Secretary may develop and utilize public-private 
partnerships for technical assistance, training, and 
related implementation support for State, local, 
Tribal, and territorial public health departments, 
and the Centers for Disease Control and Prevention, 
on the expansion and modernization of electronic 
case reporting and public health data systems, as 
applicable. 
‘‘(b) REQUIREMENTS.— 
‘‘(1) 
HEALTH
INFORMATION
TECHNOLOGY 
STANDARDS.—The Secretary may not award a grant 
or cooperative agreement under subsection (a)(1)(B) 
unless the applicant uses or agrees to use standards 
endorsed by the National Coordinator for Health In-
formation 
Technology 
pursuant 
to 
section 
3001(c)(1) or adopted by the Secretary under sec-
tion 3004. 
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‘‘(2) WAIVER.—The Secretary may waive the 
requirement under paragraph (1) with respect to an 
applicant if the Secretary determines that the activi-
ties under subsection (a)(1)(B) cannot otherwise be 
carried out within the applicable jurisdiction. 
‘‘(3) APPLICATION.—A State, local, Tribal, or 
territorial health department applying for a grant or 
cooperative agreement under this section shall sub-
mit an application to the Secretary at such time and 
in such manner as the Secretary may require. Such 
application shall include information describing— 
‘‘(A) the activities that will be supported 
by the grant or cooperative agreement; and 
‘‘(B) how the modernization of the public 
health data systems involved will support or im-
pact the public health infrastructure of the 
health department, including a description of 
remaining gaps, if any, and the actions needed 
to address such gaps. 
‘‘(c) STRATEGY AND IMPLEMENTATION PLAN.—Not 
later than 180 days after the date of enactment of this 
section, the Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall submit 
to the Committee on Health, Education, Labor and Pen-
sions of the Senate and the Committee on Energy and 
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Commerce of the House of Representatives a coordinated 
strategy and an accompanying implementation plan that 
identifies and demonstrates the measures the Secretary 
will utilize to— 
‘‘(1) update and improve applicable public 
health data systems used by the Centers for Disease 
Control and Prevention; and 
‘‘(2) carry out the activities described in this 
section to support the improvement of State, local, 
Tribal, and territorial public health data systems. 
‘‘(d) 
CONSULTATION.—The 
Secretary, 
acting 
through the Director of the Centers for Disease Control 
and Prevention, shall consult with State, local, Tribal, and 
territorial health departments, professional medical and 
public health associations, associations representing hos-
pitals or other health care entities, health information 
technology experts, and other appropriate public or private 
entities regarding the plan and grant program to mod-
ernize public health data systems pursuant to this section. 
Activities under this subsection may include the provision 
of technical assistance and training related to the ex-
change of information by such public health data systems 
used by relevant health care and public health entities at 
the local, State, Federal, Tribal, and territorial levels, and 
the development and utilization of public-private partner-
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ships for implementation support applicable to this sec-
tion. 
‘‘(e) REPORT TO CONGRESS.—Not later than 1 year 
after the date of enactment of this section, the Secretary 
shall submit a report to the Committee on Health, Edu-
cation, Labor and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives that includes— 
‘‘(1) a description of any barriers to— 
‘‘(A) public health authorities imple-
menting interoperable public health data sys-
tems and electronic case reporting; 
‘‘(B) the exchange of information pursuant 
to electronic case reporting; or 
‘‘(C) reporting by health care providers 
using such public health data systems, as ap-
propriate, and pursuant to State law; 
‘‘(2) an assessment of the potential public 
health impact of implementing electronic case re-
porting and interoperable public health data sys-
tems; and 
‘‘(3) a description of the activities carried out 
pursuant to this section. 
‘‘(f) ELECTRONIC CASE REPORTING.—In this sec-
tion, the term ‘electronic case reporting’ means the auto-
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mated identification, generation, and bilateral exchange of 
reports of health events among electronic health record or 
health information technology systems and public health 
authorities. 
‘‘(g) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated $450,000,000 to remain available until ex-
pended.’’. 
SEC. 549. PILOT PROGRAM TO IMPROVE LABORATORY IN-
FRASTRUCTURE. 
(a) IN GENERAL.—The Secretary shall award grants 
to States and political subdivisions of States to support 
the improvement, renovation, or modernization of infra-
structure at clinical laboratories (as defined in section 353 
of the Public Health Service Act (42 U.S.C. 263a)) that 
will help to improve SARS–CoV–2 and COVID–19 testing 
and response activities, including the expansion and en-
hancement of testing capacity at such laboratories. 
(b) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$1,000,000,000 to remain available until expended. 
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SEC. 550. CORE PUBLIC HEALTH INFRASTRUCTURE FOR 
STATE, LOCAL, TRIBAL, AND TERRITORIAL 
HEALTH DEPARTMENTS. 
(a) PROGRAM.—The Secretary, acting through the 
Director of the Centers for Disease Control and Preven-
tion, shall establish a core public health infrastructure 
program consisting of awarding grants under subsection 
(b). 
(b) GRANTS.— 
(1) AWARD.—For the purpose of addressing 
core public health infrastructure needs, the Sec-
retary— 
(A) shall award a grant to each State 
health department; and 
(B) may award grants on a competitive 
basis to State, local, Tribal, or territorial health 
departments. 
(2) ALLOCATION.—Of the total amount of 
funds awarded as grants under this subsection for a 
fiscal year— 
(A) not less than 50 percent shall be for 
grants to State health departments under para-
graph (1)(A); and 
(B) not less than 30 percent shall be for 
grants to State, local, Tribal, or territorial 
health departments under paragraph (1)(B). 
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(c) USE OF FUNDS.—A State, local, Tribal, or terri-
torial health department receiving a grant under sub-
section (b) shall use the grant funds to address core public 
health infrastructure needs, including those identified in 
the accreditation process under subsection (g). 
(d) FORMULA GRANTS TO STATE HEALTH DEPART-
MENTS.—In making grants under subsection (b)(1)(A), 
the Secretary shall award funds to each State health de-
partment in accordance with— 
(1) a formula based on population size; burden 
of preventable disease and disability; and core public 
health infrastructure gaps, including those identified 
in the accreditation process under subsection (g); 
and 
(2) application requirements established by the 
Secretary, including a requirement that the State 
health department submit a plan that demonstrates 
to the satisfaction of the Secretary that the State’s 
health department will— 
(A) address its highest priority core public 
health infrastructure needs; and 
(B) as appropriate, allocate funds to local 
health departments within the State. 
(e) COMPETITIVE GRANTS TO STATE, LOCAL, TRIB-
AL, AND
TERRITORIAL
HEALTH
DEPARTMENTS.—In 
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making grants under subsection (b)(1)(B), the Secretary 
shall give priority to applicants demonstrating core public 
health infrastructure needs identified in the accreditation 
process under subsection (g). 
(f) MAINTENANCE OF EFFORT.—The Secretary may 
award a grant to an entity under subsection (b) only if 
the entity demonstrates to the satisfaction of the Sec-
retary that— 
(1) funds received through the grant will be ex-
pended only to supplement, and not supplant, non- 
Federal and Federal funds otherwise available to the 
entity for the purpose of addressing core public 
health infrastructure needs; and 
(2) with respect to activities for which the grant 
is awarded, the entity will maintain expenditures of 
non-Federal amounts for such activities at a level 
not less than the level of such expenditures main-
tained by the entity for the fiscal year preceding the 
fiscal year for which the entity receives the grant. 
(g) ESTABLISHMENT OF A PUBLIC HEALTH ACCRED-
ITATION PROGRAM.— 
(1) IN GENERAL.—The Secretary shall— 
(A) develop, and periodically review and 
update, standards for voluntary accreditation of 
State, local, Tribal, and territorial health de-
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partments and public health laboratories for the 
purpose of advancing the quality and perform-
ance of such departments and laboratories; and 
(B) implement a program to accredit such 
health departments and laboratories in accord-
ance with such standards. 
(2) COOPERATIVE AGREEMENT.—The Secretary 
may enter into a cooperative agreement with a pri-
vate nonprofit entity to carry out paragraph (1). 
(h) REPORT.—The Secretary shall submit to the Con-
gress an annual report on progress being made to accredit 
entities under subsection (g), including— 
(1) a strategy, including goals and objectives, 
for accrediting entities under subsection (g) and 
achieving the purpose described in subsection 
(g)(1)(A); 
(2) identification of gaps in research related to 
core public health infrastructure; and 
(3) recommendations of priority areas for such 
research. 
(i) DEFINITION.—In this section, the term ‘‘core pub-
lic health infrastructure’’ includes— 
(1) workforce capacity and competency; 
(2) laboratory systems; 
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(3) testing capacity, including test platforms, 
mobile testing units, and personnel; 
(4) health information, health information sys-
tems, and health information analysis; 
(5) disease surveillance; 
(6) contact tracing; 
(7) communications; 
(8) financing; 
(9) other relevant components of organizational 
capacity; and 
(10) other related activities. 
(j) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
$6,000,000,000, to remain available until expended. 
SEC. 551. CORE PUBLIC HEALTH INFRASTRUCTURE AND 
ACTIVITIES FOR CDC. 
(a) IN GENERAL.—The Secretary, acting through the 
Director of the Centers for Disease Control and Preven-
tion, shall expand and improve the core public health in-
frastructure and activities of the Centers for Disease Con-
trol and Prevention to address unmet and emerging public 
health needs. 
(b) REPORT.—The Secretary shall submit to the Con-
gress an annual report on the activities funded through 
this section. 
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(c) DEFINITION.—In this section, the term ‘‘core 
public health infrastructure’’ has the meaning given to 
such term in section 550. 
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$1,000,000,000, to remain available until expended. 
Subtitle 
D—COVID–19 
National 
Testing and Contact Tracing 
Initiative 
SEC. 561. NATIONAL SYSTEM FOR COVID–19 TESTING, CON-
TACT TRACING, SURVEILLANCE, CONTAIN-
MENT, AND MITIGATION. 
(a) IN GENERAL.—The Secretary, acting through the 
Director of the Centers for Disease Control and Preven-
tion, and in coordination with State, local, Tribal, and ter-
ritorial health departments, shall establish and implement 
a nationwide evidence-based system for— 
(1) testing, contact tracing, surveillance, con-
tainment, and mitigation with respect to COVID–19; 
(2) offering guidance on voluntary isolation and 
quarantine of individuals infected with, or exposed to 
individuals infected with, the virus that causes 
COVID–19; and 
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(3) public reporting on testing, contact tracing, 
surveillance, and voluntary isolation and quarantine 
activities with respect to COVID–19. 
(b) COORDINATION; TECHNICAL ASSISTANCE.—In 
carrying out the national system under this section, the 
Secretary shall— 
(1) coordinate State, local, Tribal, and terri-
torial activities related to testing, contact tracing, 
surveillance, containment, and mitigation with re-
spect to COVID–19, as appropriate; and 
(2) provide technical assistance for such activi-
ties, as appropriate. 
(c) CONSIDERATION.—In establishing and imple-
menting the national system under this section, the Sec-
retary shall take into consideration— 
(1) the State plans referred to in the heading 
‘‘Public Health and Social Services Emergency 
Fund’’ in title I of division B of the Paycheck Pro-
tection Program and Health Care Enhancement Act 
(Public Law 116–139); and 
(2) the testing strategy submitted under section 
541. 
(d) REPORTING.—The Secretary shall— 
(1) not later than one month after the date of 
the enactment of this Act, submit to the Committee 
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on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Edu-
cation, Labor and Pensions a preliminary report on 
the effectiveness of the activities carried out pursu-
ant to this subtitle; and 
(2) not later than three months after the end 
of the public health emergency declared pursuant to 
section 319 of the Public Health Service Act (42 
U.S.C. 247d) with respect to COVID–19, submit to 
such committees a final report on such effectiveness. 
SEC. 562. GRANTS. 
(a) IN GENERAL.—To implement the national system 
under section 561, the Secretary, acting through the Di-
rector of the Centers for Disease Control and Prevention, 
shall, subject to the availability of appropriations, award 
grants to State, local, Tribal, and territorial health depart-
ments that seek grants under this section to carry out co-
ordinated testing, contact tracing, surveillance, contain-
ment, and mitigation with respect to COVID–19, includ-
ing— 
(1) diagnostic and surveillance testing and re-
porting; 
(2) community-based contact tracing efforts; 
and 
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(3) policies related to voluntary isolation and 
quarantine of individuals infected with, or exposed to 
individuals infected with, the virus that causes 
COVID–19. 
(b) FLEXIBILITY.—The Secretary shall ensure that— 
(1) the grants under subsection (a) provide 
flexibility for State, local, Tribal, and territorial 
health departments to modify, establish, or maintain 
evidence-based systems; and 
(2) local health departments receive funding 
from State health departments or directly from the 
Centers for Disease Control and Prevention to con-
tribute to such systems, as appropriate. 
(c) ALLOCATIONS.— 
(1) FORMULA.—The Secretary, acting through 
the Director of the Centers for Disease Control and 
Prevention, shall allocate amounts made available 
pursuant to subsection (a) in accordance with a for-
mula to be established by the Secretary that pro-
vides a minimum level of funding to each State, 
local, Tribal, and territorial health department that 
seeks a grant under this section and allocates addi-
tional funding based on the following prioritization: 
(A) The Secretary shall give highest pri-
ority to applicants proposing to serve popu-
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lations in one or more geographic regions with 
a high burden of COVID–19 based on data pro-
vided by the Centers for Disease Control and 
Prevention, or other sources as determined by 
the Secretary. 
(B) The Secretary shall give second high-
est priority to applicants preparing for, or cur-
rently working to mitigate, a COVID–19 surge 
in a geographic region that does not yet have 
a high number of reported cases of COVID–19 
based on data provided by the Centers for Dis-
ease Control and Prevention, or other sources 
as determined by the Secretary. 
(C) The Secretary shall give third highest 
priority to applicants proposing to serve high 
numbers of low-income and uninsured popu-
lations, including medically underserved popu-
lations (as defined in section 330(b)(3) of the 
Public 
Health 
Service 
Act 
(42 
U.S.C. 
254b(b)(3))), health professional shortage areas 
(as defined under section 332(a) of the Public 
Health Service Act (42 U.S.C. 254e(a))), racial 
and ethnic minorities, or geographically diverse 
areas, as determined by the Secretary. 
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(2) NOTIFICATION.—Not later than the date 
that is one week before first awarding grants under 
this section, 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 notifica-
tion detailing the formula established under para-
graph (1) for allocating amounts made available pur-
suant to subsection (a). 
(d) USE OF FUNDS.—A State, local, Tribal, and ter-
ritorial health department receiving a grant under this 
section shall, to the extent possible, use the grant funds 
for the following activities, or other activities deemed ap-
propriate by the Director of the Centers for Disease Con-
trol and Prevention: 
(1) TESTING.—To implement a coordinated 
testing system that— 
(A) leverages or modernizes existing test-
ing infrastructure and capacity; 
(B) is consistent with the updated testing 
strategy required under section 541; 
(C) is coordinated with the State plan for 
COVID–19 testing prepared as required under 
the heading ‘‘Department of Health and 
Human Services—Office of the Secretary— 
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Public Health and Social Service Emergency 
Fund’’ in title I of division B of the Paycheck 
Protection Program and Health Care Enhance-
ment Act (Public Law 116–139; 134 Stat. 620, 
624); 
(D) is informed by contact tracing and 
surveillance activities under this subtitle; 
(E) is informed by guidelines established 
by the Centers for Disease Control and Preven-
tion for which populations should be tested; 
(F) identifies how diagnostic and sero-
logical tests in such system shall be validated 
prior to use; 
(G) identifies how diagnostic and sero-
logical tests and testing supplies will be distrib-
uted to implement such system; 
(H) identifies specific strategies for ensur-
ing testing capabilities and accessibility in ra-
cial and ethnic minority populations; 
(I) identifies specific strategies for ensur-
ing testing capabilities and accessibility in 
medically underserved populations (as defined 
in section 330(b)(3) of the Public Health Serv-
ice Act (42 U.S.C. 254b(b)(3))), health profes-
sional shortage areas (as defined under section 
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332(a) of the Public Health Service Act (42 
U.S.C. 254e(a))), and geographically diverse 
areas, as determined by the Secretary; 
(J) identifies how testing may be used, and 
results may be reported, in both health care set-
tings (such as hospitals, laboratories for mod-
erate or high-complexity testing, pharmacies, 
mobile testing units, and community health cen-
ters) and non-health care settings (such as 
workplaces, schools, childcare centers, or drive- 
throughs); 
(K) allows for testing in sentinel surveil-
lance programs, as appropriate; and 
(L) supports the procurement and distribu-
tion of diagnostic and serological tests and test-
ing supplies to meet the goals of the system. 
(2) CONTACT TRACING.—To implement a co-
ordinated contact tracing system that— 
(A) leverages or modernizes existing con-
tact tracing systems and capabilities, including 
community health workers, health departments, 
and Federally qualified health centers; 
(B) is able to investigate cases of COVID– 
19, and help to identify other potential cases of 
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COVID–19, through tracing contacts of individ-
uals with positive diagnoses; 
(C) establishes culturally competent and 
multilingual strategies for contact tracing, ad-
dressing the specific needs of racial and ethnic 
minority populations, which may include con-
sultation with and support from faith-based, 
nonprofit, cultural or civic organizations with 
established ties to the community; 
(D) establishes culturally competent and 
multilingual strategies for contact tracing, ad-
dressing the specific needs of medically under-
served populations (as defined in section 
330(b)(3) of the Public Health Service Act (42 
U.S.C. 254b(b)(3))), health professional short-
age areas (as defined under section 332(a) of 
the Public Health Service Act(42 U.S.C. 2324 
254e(a))); 
(E) provides individuals identified under 
the contact tracing program with information 
and support for containment or mitigation; 
(F) enables State, local, Tribal, and terri-
torial health departments to work with a non-
governmental, community partner or partners 
and State and local workforce development sys-
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tems (as defined in section 3(67) of Workforce 
Innovation and Opportunity Act (29 U.S.C. 
3102(67))) receiving grants under section 
566(b) of this Act to hire and compensate a lo-
cally-sourced contact tracing workforce, if nec-
essary, to supplement the public health work-
force, to— 
(i) identify the number of contact 
tracers needed for the respective State, lo-
cality, territorial, or Tribal health depart-
ment to identify all cases of COVID–19 
currently in the jurisdiction and those an-
ticipated to emerge over the next 18 
months in such jurisdiction; 
(ii) outline qualifications necessary for 
contact tracers; 
(iii) train the existing and newly hired 
public health workforce on best practices 
related to tracing close contacts of individ-
uals diagnosed with COVID–19, including 
the protection of individual privacy and cy-
bersecurity protection; and 
(iv) equip the public health workforce 
with tools and resources to enable a rapid 
response to new cases; 
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(G) identifies the level of contact tracing 
needed within the State, locality, territory, or 
Tribal area to contain and mitigate the trans-
mission of COVID–19; and 
(H) establishes statewide mechanisms to 
integrate regular evaluation to the Centers for 
Disease Control and Prevention regarding con-
tact tracing efforts, makes such evaluation pub-
licly available, and to the extent possible pro-
vides for such evaluation at the county level. 
(3) SURVEILLANCE.—To strengthen the exist-
ing public health surveillance system that— 
(A) leverages or modernizes existing sur-
veillance systems within the respective State, 
local, Tribal, or territorial health department 
and national surveillance systems; 
(B) detects and identifies trends in 
COVID–19 at the county level; 
(C) evaluates State, local, Tribal, and ter-
ritorial health departments in achieving surveil-
lance capabilities with respect to COVID–19; 
(D) integrates and improves disease sur-
veillance and immunization tracking; 
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(E) identifies specific strategies for ensur-
ing disease surveillance in racial and ethnic mi-
nority populations; and 
(F) identifies specific strategies for ensur-
ing disease surveillance in medically under-
served populations (as defined in section 
330(b)(3) of the Public Health Service Act (42 
U.S.C. 254b(b)(3))), health professional short-
age areas (as defined under section 332(a) of 
the Public Health Service Act (42 U.S.C. 
254e(a))), and geographically diverse areas, as 
determined by the Secretary. 
(4) CONTAINMENT AND MITIGATION.—To im-
plement a coordinated containment and mitigation 
system that— 
(A) leverages or modernizes existing con-
tainment and mitigation strategies within the 
respective State, local, Tribal, or territorial gov-
ernments and national containment and mitiga-
tion strategies; 
(B) may provide for, connect to, and lever-
age existing social services and support for indi-
viduals who have been infected with or exposed 
to COVID–19 and who are isolated or quar-
antined in their homes, such as through— 
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(i) food assistance programs; 
(ii) guidance for household infection 
control; 
(iii) information and assistance with 
childcare services; and 
(iv) information and assistance per-
taining to support available under the 
CARES Act (Public Law 116–136) and 
this Act; 
(C) provides guidance on the establishment 
of safe, high-quality, facilities for the voluntary 
isolation of individuals infected with, or quar-
antine of the contacts of individuals exposed to 
COVID–19, where hospitalization is not re-
quired, which facilities should— 
(i) be prohibited from making inquir-
ies relating to the citizenship status of an 
individual isolated or quarantined; and 
(ii) be operated by a non-Federal, 
community partner or partners that— 
(I) have previously established re-
lationships in localities; 
(II) work with local places of 
worship, community centers, medical 
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facilities, and schools to recruit local 
staff for such facilities; and 
(III) are fully integrated into 
State, local, Tribal, or territorial con-
tainment and mitigation efforts; 
(D) identifies specific strategies for ensur-
ing containment and mitigation activities in ra-
cial and ethnic minority populations; and 
(E) identifies specific strategies for ensur-
ing containment and mitigation activities in 
medically underserved populations (as defined 
in section 330(b)(3) of the Public Health Serv-
ice Act (42 U.S.C. 254b(b)(3))), health profes-
sional shortage areas (as defined under section 
332(a) of the Public Health Service Act (42 
U.S.C. 254e(a))), and geographically diverse 
areas, as determined by the Secretary. 
(e) REPORTING.—The Secretary shall facilitate 
mechanisms for timely, standardized reporting by grantees 
under this section regarding implementation of the sys-
tems established under this section and coordinated proc-
esses with the reporting as required and under the heading 
‘‘Department of Health and Human Services—Office of 
the Secretary—Public Health and Social Service Emer-
gency Fund’’ in title I of division B of the Paycheck Pro-
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tection Program and Health Care Enhancement Act (Pub-
lic Law 116–139, 134 Stat. 620), including— 
(1) a summary of county or local health depart-
ment level information from the States receiving 
funding, and information from directly funded local-
ities, territories, and Tribal entities, about the activi-
ties that will be undertaken using funding awarded 
under this section, including subgrants; 
(2) any anticipated shortages of required mate-
rials for testing for COVID–19 under subsection (a); 
and 
(3) other barriers in the prevention, mitigation, 
or treatment of COVID–19 under this section. 
(f) PUBLIC LISTING OF AWARDS.—The Secretary 
shall— 
(1) not later than 7 days after first awarding 
grants under this section, post in a searchable, elec-
tronic format a list of all awards made by the Sec-
retary under this section, including the recipients 
and amounts of such awards; and 
(2) update such list not less than every 7 days 
until all funds made available to carry out this sec-
tion are expended. 
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SEC. 563. GUIDANCE, TECHNICAL ASSISTANCE, INFORMA-
TION, AND COMMUNICATION. 
(a) IN GENERAL.— Not later than 14 days after the 
date of the enactment of this Act, the Secretary, in coordi-
nation with other Federal agencies, as appropriate, shall 
issue guidance, provide technical assistance, and provide 
information to States, localities, Tribes, and territories, 
with respect to the following: 
(1) The diagnostic and serological testing of in-
dividuals identified through contact tracing for 
COVID–19, including information with respect to 
the reduction of duplication related to programmatic 
activities, reporting, and billing. 
(2) Best practices regarding contact tracing, in-
cluding the collection of data with respect to such 
contact tracing and requirements related to the 
standardization of demographic and syndromic infor-
mation collected as part of contact tracing efforts. 
(3) Best practices regarding COVID–19 disease 
surveillance, including best practices to reduce dupli-
cation in surveillance activities, identifying gaps in 
surveillance and surveillance systems, and ways in 
which the Secretary plans to effectively support 
State, local, Tribal and territorial health depart-
ments in addressing such gaps. 
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(4) Information on ways for State, local, Tribal, 
and territorial health departments to establish and 
maintain the testing, contact tracing, and surveil-
lance activities described in paragraphs (1) through 
(3). 
(5) The protection of any personally identifiable 
health information collected pursuant to this sub-
title. 
(6) Best practices regarding privacy and cyber-
security protection related to contact tracing, con-
tainment, and mitigation efforts. 
(7) Best practices related to improving public 
compliance for isolation and containment measures 
and reaching medically underserved communities. 
(b) GUIDANCE ON PAYMENT.—Not later than 14 
days after the date of the enactment of this Act, the Sec-
retary, in coordination with the Administrator of the Cen-
ters for Medicare & Medicaid Services, the Director of the 
Centers for Disease Control and Prevention, and in coordi-
nation with other Federal agencies, as appropriate, shall 
develop and issue to State, local, Tribal, and territorial 
health departments clear guidance and policies— 
(1) with respect to the coordination of claims 
submitted for payment out of the Public Health and 
Social Services Emergency Fund for services fur-
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nished 
in 
a 
facility 
referred 
to 
in 
section 
562(d)(4)(C); 
(2) identifying how an individual who is isolated 
or quarantined at home or in such a facility— 
(A) incurs no out-of-pocket costs for any 
services furnished to such individual while iso-
lated; and 
(B) may receive income support for lost 
earnings or payments for expenses such as child 
care or elder care while such individual is iso-
lated at home or in such a facility; 
(3) providing information and assistance per-
taining to support available under the CARES Act 
(Public Law 116–136) and this Act; and 
(4) identifying State, local, Tribal, and terri-
torial health departments or partner agencies that 
may provide social support services, such as gro-
ceries or meals, health education, internet access, 
and behavioral health services, to individuals who 
isolated or quarantined at home or in such a facility. 
(c) GUIDANCE ON TESTING.—Not later than 14 days 
after the date of the enactment of this Act, the Secretary, 
in coordination with the Commissioner of Food and 
Drugs, the Director of the National Institutes of Health, 
and the Director of the Centers for Disease Control and 
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Prevention, and in coordination with other Federal agen-
cies as appropriate, shall develop and issue to State, local, 
Tribal, and territorial health departments clear guidance 
and policies regarding— 
(1) objective standards to characterize the per-
formance of all diagnostic and serological tests for 
COVID–19 in order to independently evaluate tests 
continuously over time; 
(2) protocols for the evaluation of the perform-
ance of diagnostic and serological tests for COVID– 
19; and 
(3) a repository of characterized specimens to 
use to evaluate the performance of those tests that 
can be made available for appropriate entities to use 
to evaluate performance. 
(d) COMMUNICATION.—The Secretary shall identify 
and publicly announce the form and manner for commu-
nication with State, local, Tribal, and territorial health de-
partments for purposes of carrying out the activities ad-
dressed by guidance issued under subsections (a) and (b). 
(e) AVAILABILITY TO PROVIDERS.—Guidance issued 
under subsection (a)(1) shall be issued to health care pro-
viders. 
(f) ONGOING PROVISION OF GUIDANCE AND TECH-
NICAL ASSISTANCE.—Notwithstanding whether funds are 
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available specifically to carry out this subtitle, guidance 
and technical assistance shall continue to be provided 
under this section. 
SEC. 564. RESEARCH AND DEVELOPMENT. 
The Secretary, in coordination with the Director of 
the Centers for Disease Control and Prevention and in col-
laboration with the Director of the National Institutes of 
Health, the Director of the Agency for Healthcare Re-
search and Quality, the Commissioner of Food and Drugs, 
and the Administrator of the Centers for Medicare & Med-
icaid Services, shall support research and development on 
more efficient and effective strategies— 
(1) for the surveillance of SARS–CoV–2 and 
COVID–19; 
(2) for the testing and identification of individ-
uals infected with COVID–19; and 
(3) for the tracing of contacts of individuals in-
fected with COVID–19. 
SEC. 565. AWARENESS CAMPAIGNS. 
The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention and in coordi-
nation with other offices and agencies, as appropriate, 
shall award competitive grants or contracts to one or more 
public or private entities, including faith-based organiza-
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tions, to carry out multilingual and culturally appropriate 
awareness campaigns. Such campaigns shall— 
(1) be based on available scientific evidence; 
(2) increase awareness and knowledge of 
COVID–19, including countering stigma associated 
with COVID–19; 
(3) improve information on the availability of 
COVID–19 diagnostic testing; and 
(4) promote cooperation with contact tracing ef-
forts. 
SEC. 566. GRANTS TO STATE AND TRIBAL WORKFORCE 
AGENCIES. 
(a) DEFINITIONS.—In this section: 
(1) IN
GENERAL.—Except as otherwise pro-
vided, the terms in this section have the meanings 
given the terms in section 3 of the Workforce Inno-
vation and Opportunity Act (29 U.S.C. 3102). 
(2) APPRENTICESHIP; APPRENTICESHIP
PRO-
GRAM.—The term ‘‘apprenticeship’’ or ‘‘apprentice-
ship program’’ means an apprenticeship program 
registered under the Act of August 16, 1937 (com-
monly known as the ‘‘National Apprenticeship Act’’) 
(50 Stat. 664, chapter 663; 29 U.S.C. 50 et seq.), 
including any requirement, standard, or rule promul-
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gated under such Act, as such requirement, stand-
ard, or rule was in effect on December 30, 2019. 
(3) CONTACT
TRACING
AND
RELATED
POSI-
TIONS.—The term ‘‘contact tracing and related posi-
tions’’ means employment related to contact tracing, 
surveillance, containment, and mitigation activities 
as described in paragraphs (2), (3), and (4) of sec-
tion 562(d). 
(4) ELIGIBLE ENTITY.—The term ‘‘eligible enti-
ty’’ means— 
(A) a State or territory, including the Dis-
trict of Columbia and Puerto Rico; 
(B) an Indian Tribe, Tribal organization, 
Alaska Native entity, Indian-controlled organi-
zations serving Indians, or Native Hawaiian or-
ganizations; 
(C) an outlying area; or 
(D) a local board, if an eligible entity 
under subparagraphs (A) through (C) has not 
applied with respect to the area over which the 
local board has jurisdiction as of the date on 
which the local board submits an application 
under subsection (c). 
(5) ELIGIBLE
INDIVIDUAL.—Notwithstanding 
section 170(b)(2) of the Workforce Innovation and 
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Opportunity Act (29 U.S.C. 3225(b)(2)), the term 
‘‘eligible individual’’ means an individual seeking or 
securing employment in contact tracing and related 
positions and served by an eligible entity or commu-
nity-based organization receiving funding under this 
section. 
(6) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Labor. 
(b) GRANTS.— 
(1) IN GENERAL.—Subject to the availability of 
appropriations under subsection (g), the Secretary 
shall award national dislocated worker grants under 
section 170(b)(1)(B) of the Workforce Innovation 
and Opportunity Act (29 U.S.C. 3225(b)(1)(B)) to 
each eligible entity that seeks a grant to assist local 
boards and community-based organizations in car-
rying out activities under subsections (f) and (d), re-
spectively, for the following purposes: 
(A) To support the recruitment, place-
ment, and training, as applicable, of eligible in-
dividuals seeking employment in contact tracing 
and related positions in accordance with the na-
tional system for COVID–19 testing, contact 
tracing, surveillance, containment, and mitiga-
tion established under section 561. 
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(3) LOCAL
BOARD
USE
OF
FUNDS.—A local 
board, or an eligible entity that is a local board, 
shall use— 
(A) not less than 60 percent of the funds 
for recruitment and training for COVID–19 
testing, contact tracing, surveillance, contain-
ment, and mitigation established under section 
561; 
(B) not less than 30 of the funds to sup-
port the transition of individuals hired as con-
tact tracers and related positions into an edu-
cation or training program, or unsubsidized em-
ployment upon completion of such positions; 
and 
(C) not more than 10 percent of the funds 
for administrative costs. 
(f) ELIGIBLE ACTIVITIES.—The State or local boards 
shall use funds awarded under this section to support the 
recruitment and placement of eligible individuals, training 
and employment transition as related to contact tracing 
and related positions, and for the following activities: 
(1) Establishing or expanding partnerships 
with— 
(A) State, local, Tribal, and territorial 
public health departments; 
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(B) community-based health providers, in-
cluding community health centers and rural 
health clinics; 
(C) labor organizations or joint labor man-
agement organizations; 
(D) two-year and four-year institutions of 
higher education (as defined in section 101 of 
the Higher Education Act of 1965 (20 U.S.C. 
1001)), including institutions eligible to receive 
funds under section 371(a) of the Higher Edu-
cation Act of 1965 (20 U.S.C. 1067q(a)); and 
(E) community action agencies or other 
community-based organizations serving local 
areas in which there is a demand for contact 
tracing and related positions. 
(2) Providing training for contact tracing and 
related positions in coordination with State, local, 
Tribal, or territorial health departments that is con-
sistent with the State or territorial testing and con-
tact tracing strategy, and ensuring that eligible indi-
viduals receive compensation while participating in 
such training. 
(3) Providing eligible individuals with— 
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(A) adequate and safe equipment, environ-
ments, and facilities for training and super-
vision, as applicable; 
(B) information regarding the wages and 
benefits related to contact tracing and related 
positions, as compared to State, local, and na-
tional averages; 
(C) supplies and equipment needed by the 
eligible individuals to support placement of an 
individual in contact tracing and related posi-
tions, as applicable; 
(D) an individualized employment plan for 
each eligible individual, as applicable— 
(i) in coordination with the entity em-
ploying the eligible individual in a contact 
tracing and related positions; and 
(ii) which shall include providing a 
case manager to work with each eligible in-
dividual to develop the plan, which may in-
clude— 
(I) identifying employment and 
career goals, and setting appropriate 
achievement objectives to attain such 
goals; and 
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(5) for purposes of subsection (c)(3), attests to 
whether the amount determined under subsection (e) 
with respect to the lost revenue of an eligible health 
care provider for a calendar quarter exceeds an 
amount that equals 10 percent of the net patient 
revenue (as defined in such subsection) of the pro-
vider for the corresponding quarter in 2019; 
(6) includes projections of the eligible expenses 
and lost revenues of the health care provider, as de-
scribed in subsection (c), for the calendar quarter 
that immediately follows the calendar quarter for 
which reimbursement is sought; and 
(7) indicates the dollar amounts described in 
each of subparagraphs (A) and (B) of subsection 
(e)(1) and subparagraphs (A), (B), and (C) of sub-
section (e)(2) for the calendar quarter and any other 
information the Secretary determines necessary to 
determine expenses and lost revenue related to 
COVID–19. 
(h) LIMITATIONS.— 
(1) NO
DUPLICATIVE
REIMBURSEMENT.—The 
Secretary may not provide, and a health care pro-
vider may not accept, reimbursement under this sec-
tion for expenses or losses with respect to which— 
VerDate Sep 11 2014 
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