446 
‘‘(9) CONTINUATION COVERAGE PREMIUM AS-
SISTANCE.—In the case of an assistance eligible in-
dividual who receives premium assistance for con-
tinuation coverage under section 30312(a)(1) of the 
Worker Health Coverage Protection Act for any 
month during the taxable year, such individual shall 
not be treated as an eligible individual, a certified 
individual, or a qualifying family member for pur-
poses of this section or section 7527 with respect to 
such month.’’. 
(B) EFFECTIVE
DATE.—The amendment 
made by subparagraph (A) shall apply to tax-
able years ending after the date of the enact-
ment of this Act. 
(17) EXCLUSION OF CONTINUATION COVERAGE 
PREMIUM ASSISTANCE FROM GROSS INCOME.— 
(A) IN GENERAL.—Part III of subchapter 
B of chapter 1 of the Internal Revenue Code of 
1986 is amended by inserting after section 
139H the following new section: 
‘‘SEC. 139I. CONTINUATION COVERAGE PREMIUM ASSIST-
ANCE. 
‘‘In the case of an assistance eligible individual (as 
defined in subsection (a)(3) of section 30312 of the Work-
er Health Coverage Protection Act), gross income does not 
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447 
include any premium assistance provided under subsection 
(a)(1) of such section.’’. 
(B) CLERICAL AMENDMENT.—The table of 
sections for part III of subchapter B of chapter 
1 of such Code is amended by inserting after 
the item relating to section 139H the following 
new item: 
‘‘Sec. 139I. Continuation coverage premium assistance.’’. 
(C) EFFECTIVE DATE.—The amendments 
made by this paragraph shall apply to taxable 
years ending after the date of the enactment of 
this Act. 
(18) DEADLINES
WITH
RESPECT
TO
NO-
TICES.—Notwithstanding section 518 of the Em-
ployee Retirement Income Security Act of 1974 and 
section 7508A of the Internal Revenue Code of 
1986, the Secretary of Labor and the Secretary of 
the Treasury, respectively, may not waive or extend 
any deadline with respect to the provision of notices 
described in paragraphs (7), (8), and (9). 
(b) RULE OF CONSTRUCTION.—In all matters of in-
terpretation, rules, and operational procedures, the lan-
guage of this section shall be interpreted broadly for the 
benefit of workers and their families. 
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TITLE IV—APPLICATION TO OTHER HEALTH 
PROGRAMS 
PROHIBITION ON COPAYMENTS AND COST SHARING FOR 
TRICARE
BENEFICIARIES
RECEIVING
COVID–19 
TREATMENT 
SEC. 30401. 
(a) IN GENERAL.—Section 6006(a) of the Families 
First Coronavirus Response Act (Public Law 116–127; 38 
U.S.C. 1074 note) is amended by striking ‘‘or visits de-
scribed in paragraph (2) of such section’’ and inserting 
‘‘, visits described in paragraph (2) of such section, or 
medical care to treat COVID–19’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply with respect to medical care fur-
nished on or after the date of the enactment of this Act. 
PROHIBITION ON COPAYMENTS AND COST SHARING FOR 
VETERANS RECEIVING COVID–19 TREATMENT FUR-
NISHED BY DEPARTMENT OF VETERANS AFFAIRS 
SEC. 30402. 
(a) IN GENERAL.—Section 6006(b) of the Families 
First Coronavirus Response Act (Public Law 116–127; 38 
U.S.C. 1701 note) is amended by striking ‘‘or visits de-
scribed in paragraph (2) of such section’’ and inserting 
‘‘, visits described in paragraph (2) of such section, or hos-
pital care or medical services to treat COVID–19’’. 
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449 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply with respect to hospital care and 
medical services furnished on or after the date of the en-
actment of this Act. 
PROHIBITION ON COPAYMENTS AND COST SHARING FOR 
FEDERAL CIVILIAN EMPLOYEES RECEIVING COVID–19 
TREATMENT 
SEC. 30403. 
(a) IN GENERAL.—Section 6006(c) of the Families 
First Coronavirus Response Act (Public Law 116–127; 5 
U.S.C. 8904 note) is amended by striking ‘‘or visits de-
scribed in paragraph (2) of such section’’ and inserting 
‘‘, visits described in paragraph (2) of such section, or hos-
pital care or medical services to treat COVID–19’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply with respect to hospital care and 
medical services furnished on or after the date of the en-
actment of this Act. 
TITLE V—PUBLIC HEALTH POLICIES 
DEFINITIONS 
SEC. 30501. 
In this title: 
(1) Except as inconsistent with the provisions 
of this title, the term ‘‘Secretary’’ means the Sec-
retary of Health and Human Services. 
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450 
(2) The term ‘‘State’’ refers to each of the 50 
States and the District of Columbia. 
(3) The term ‘‘Tribal’’, with respect to a de-
partment of health (or health department), in-
cludes— 
(A) Indian Tribes that— 
(i) are operating one or more health 
facilities pursuant to an agreement under 
the Indian Self-Determination and Edu-
cation Assistance Act (25 U.S.C. 5301 et 
seq.); or 
(ii) receive services from a facility op-
erated by the Indian Health Services; and 
(B) Tribal organizations and Urban Indian 
organizations. 
Subtitle A—Supply Chain Improvements 
MEDICAL SUPPLIES RESPONSE COORDINATOR 
SEC. 30511. 
(a) IN GENERAL.—The President shall appoint a 
Medical Supplies Response Coordinator to coordinate the 
efforts of the Federal Government regarding the supply 
and distribution of critical medical supplies and equipment 
related to detecting, diagnosing, preventing, and treating 
COVID–19, including personal protective equipment, med-
ical devices, drugs, and vaccines. 
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(b) QUALIFICATIONS.—To qualify to be appointed as 
the Medical Supplies Response Coordinator, an individual 
shall be a senior government official with— 
(1) health care training, including training re-
lated to infectious diseases or hazardous exposures; 
and 
(2) a familiarity with medical supply chain lo-
gistics. 
(c) ACTIVITIES.—The Medical Supplies Response Co-
ordinator shall— 
(1) consult with State, local, territorial, and 
Tribal officials to ensure that health care facilities 
and health care workers have sufficient personal pro-
tective equipment and other medical supplies; 
(2) evaluate ongoing needs of States, localities, 
territories, Tribes, health care facilities, and health 
care workers to determine the need for critical med-
ical supplies and equipment; 
(3) serve as a point of contact for industry for 
procurement and distribution of critical medical sup-
plies and equipment, including personal protective 
equipment, medical devices, testing supplies, drugs, 
and vaccines; 
(4) procure and distribute critical medical sup-
plies and equipment, including personal protective 
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453 
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. 
INFORMATION TO BE INCLUDED IN LIST OF DEVICES 
DETERMINED TO BE IN SHORTAGE 
SEC. 30512. 
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. 
EXTENDED SHELF LIFE DATES FOR ESSENTIAL DEVICES 
SEC. 30513. 
(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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454 
‘‘(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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455 
‘‘(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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456 
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;’’. 
AUTHORITY TO DESTROY COUNTERFEIT DEVICES 
SEC. 30514. 
(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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457 
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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458 
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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459 
‘‘(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).’’. 
REPORTING REQUIREMENT FOR DRUG MANUFACTURERS 
SEC. 30515. 
(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 
prior to being imported or offered for import into the 
United States.’’. 
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460 
(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 
of the CARES Act (Public Law 116–136)) is amended 
by striking ‘‘annually’’ and inserting ‘‘once during the 
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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’’. 
RECOMMENDATIONS TO ENCOURAGE DOMESTIC 
MANUFACTURING OF CRITICAL DRUGS 
SEC. 30516. 
(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 
(D) the public health and national security 
implications of the current supply chain for 
critical drugs and devices; 
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462 
(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-
merce, the Department of State, the Department of 
Veterans Affairs, the Department of Justice, and 
any other Federal agencies as appropriate; and 
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463 
(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). 
(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). 
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FAILURE TO NOTIFY OF A PERMANENT DISCONTINUANCE 
OR AN INTERRUPTION 
SEC. 30517. 
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.’’. 
FAILURE TO DEVELOP RISK MANAGEMENT PLAN 
SEC. 30518. 
Section 301 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 331), as amended by section 30517, 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).’’. 
NATIONAL CENTERS OF EXCELLENCE IN CONTINUOUS 
PHARMACEUTICAL MANUFACTURING 
SEC. 30519. 
(a) IN GENERAL.—Section 3016 of the 21st Century 
Cures Act (21 U.S.C. 399h) is amended to read as follows: 
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465 
‘‘NATIONAL CENTERS OF EXCELLENCE IN CONTINUOUS 
PHARMACEUTICAL MANUFACTURING 
‘‘SEC. 3016. 
‘‘(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 National 
Centers of Excellence in Continuous Pharmaceutical 
Manufacturing Act of 2019, receive requests from 
institutions of higher education to be designated as 
a National Center of Excellence in Continuous Phar-
maceutical Manufacturing (in this section referred to 
as a ‘National Center of Excellence’) to support the 
advancement and development of continuous manu-
facturing; 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). 
‘‘(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-
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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; 
‘‘(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 
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‘‘(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; 
‘‘(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. 
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468 
‘‘(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); 
‘‘(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 
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469 
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-
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-
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470 
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. 
‘‘(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 
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471 
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 
(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— 
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472 
‘‘(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-
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. 
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473 
‘‘(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.’’. 
(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. 
VACCINE MANUFACTURING AND ADMINISTRATION 
CAPACITY 
SEC. 30520. 
(a) ENHANCING MANUFACTURING CAPACITY.— 
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474 
(1) 
IN
GENERAL.—The 
Secretary, 
acting 
through the Director of the Biomedical Advanced 
Research and Development Authority, shall, as ap-
propriate, award contracts, grants, and cooperative 
agreements, and enter into other transactions, to ex-
pand and enhance manufacturing capacity of vac-
cines and vaccine candidates to prevent the spread 
of SARS–CoV–2 and COVID–19. 
(2) AUTHORIZATION OF APPROPRIATIONS.—To 
carry out this subsection, there are authorized to be 
appropriated such sums as may be necessary for fis-
cal years 2020 through 2024, to remain available 
until expended. 
(b) REPORT ON VACCINE MANUFACTURING AND AD-
MINISTRATION CAPACITY.— 
(1) IN GENERAL.—Not later than December 31, 
2020, the Secretary shall submit 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 a report 
detailing— 
(A) an assessment of the estimated supply 
of vaccines and ancillary medical products re-
lated to vaccine administration necessary to 
control and stop the spread of SARS–CoV–2 
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475 
and COVID–19, domestically and internation-
ally; 
(B) an assessment of current and future 
domestic manufacturing capacity for vaccines or 
vaccine candidates to control or stop the spread 
of SARS–CoV–2 and COVID–19, vaccine can-
didates, and ancillary products related to the 
administration of such vaccines, including iden-
tification of any gaps in manufacturing capac-
ity; 
(C) activities conducted to expand and en-
hance manufacturing capacity for vaccines, vac-
cine candidates, and ancillary medical products 
to levels sufficient to control and stop the 
spread of SARS–CoV–2 and COVID–19, do-
mestically and internationally, including a list 
and explanation of all contracts, grants, and co-
operative agreements awarded, and other trans-
actions entered into, for purposes of such ex-
pansion and enhancement and how such activi-
ties will help to meet future domestic manufac-
turing capacity needs; 
(D) a plan for the ongoing support of en-
hanced manufacturing capacity for vaccines, 
vaccine candidates, and ancillary medical prod-
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476 
ucts sufficient to control and stop the spread of 
SARS–CoV–2 and COVID–19, domestically 
and internationally; and 
(E) a plan to support the administration of 
vaccines approved or authorized by the Food 
and Drug Administration to control and stop 
the spread of SARS–CoV–2 and COVID–19, 
domestically and internationally, including Fed-
eral workforce enhancements necessary to ad-
minister such vaccines. 
(2) ANCILLARY MEDICAL PRODUCTS.—For pur-
poses of this subsection, ‘‘ancillary medical prod-
ucts’’ includes— 
(A) vials; 
(B) bandages; 
(C) alcohol swabs; 
(D) syringes; 
(E) needles; 
(F) gloves and other personal protective 
equipment; and 
(G) other medical products the Secretary 
determines necessary for the administration of 
vaccines. 
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477 
Subtitle B—Strategic National Stockpile Improvements 
EQUIPMENT MAINTENANCE 
SEC. 30531. 
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: 
‘‘(ix) 
EQUIPMENT
MAINTENANCE 
SERVICE.—In carrying out this section, the 
Secretary may enter into contracts for the 
procurement of equipment maintenance 
services.’’. 
SUPPLY CHAIN FLEXIBILITY MANUFACTURING PILOT 
SEC. 30532. 
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478 
(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 30531, 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 
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.’’. 
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479 
(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.’’. 
(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. 
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480 
‘‘(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.’’. 
REIMBURSABLE TRANSFERS FROM STRATEGIC NATIONAL 
STOCKPILE 
SEC. 30533. 
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, 
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. 
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481 
‘‘(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. 
‘‘(D) SUNSET.—The authority to make 
transfers under this paragraph shall cease to be 
effective on September 30, 2023.’’. 
STRATEGIC NATIONAL STOCKPILE ACTION REPORTING 
SEC. 30534. 
(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 
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482 
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.— 
(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 
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483 
(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— 
(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. 
IMPROVED, TRANSPARENT PROCESSES FOR THE 
STRATEGIC NATIONAL STOCKPILE 
SEC. 30535. 
(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 
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484 
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— 
(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, 
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496 
(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-
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 
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