I 
116TH CONGRESS 
2D SESSION 
H. R. 6930 
To mitigate drug shortages and provide incentives for maintaining, expanding, 
and relocating the manufacturing of active pharmaceutical ingredients, 
excipients, medical diagnostic devices, pharmaceuticals, and personal pro-
tective equipment in the United States, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 19, 2020 
Mr. CARTER of Georgia (for himself, Mr. GRIFFITH, Mr. MCKINLEY, Mr. 
CRAWFORD, and Mr. SOTO) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce, and in addition to 
the Committee on Ways and Means, for a period to be subsequently de-
termined by the Speaker, in each case for consideration of such provisions 
as fall within the jurisdiction of the committee concerned 
A BILL 
To mitigate drug shortages and provide incentives for main-
taining, expanding, and relocating the manufacturing of 
active pharmaceutical ingredients, excipients, medical di-
agnostic devices, pharmaceuticals, and personal protec-
tive equipment in the United States, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Manufacturing API, 
Drugs, and Excipients in America Act of 2020’’ or the 
‘‘MADE in America Act of 2020’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—HEALTH PROVISIONS 
Sec. 101. Report to Congress on barriers to domestic manufacturing of medical 
products and supplies. 
Sec. 102. Enhance intraagency coordination and public health assessment with 
regard to compliance activities. 
Sec. 103. Encouraging international harmonization. 
Sec. 104. Mutual recognition agreements for inspections and review activities. 
Sec. 105. Enhancing transparency of drug facility inspection timelines. 
Sec. 106. Advanced manufacturing technologies program. 
TITLE II—TAX INCENTIVES TO INCREASE DOMESTIC 
PHARMACEUTICAL AND MEDICAL DEVICE PRODUCTION 
Sec. 201. Credit for pharmaceutical and medical device production activities in 
distressed zones. 
TITLE I—HEALTH PROVISIONS 
SEC. 101. REPORT TO CONGRESS ON BARRIERS TO DOMES-
TIC MANUFACTURING OF MEDICAL PROD-
UCTS AND SUPPLIES. 
(a) REPORT.—Not later than January 1, 2021, the 
Secretary of Health and Human Services (referred to in 
this section as the ‘‘Secretary’’) shall submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on barriers 
to domestic manufacturing of active pharmaceutical ingre-
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dients, drugs, and devices that are sourced or manufac-
tured outside of the United States. 
(b) CONTENTS.—Such report shall— 
(1) identify factors that limit or otherwise dis-
courage the domestic manufacturing of active phar-
maceutical ingredients, drugs, and devices that are 
currently sourced or manufactured outside of the 
United States, including any Federal, State, local, or 
Tribal laws and regulations that hinder domestic 
manufacturing opportunities; and 
(2) recommend specific strategies to overcome 
the challenges identified under paragraph (1), in-
cluding strategies— 
(A) to develop effective incentives for do-
mestic manufacturing; and 
(B) to make changes to laws or regulations 
that hinder domestic manufacturing opportuni-
ties. 
(c) CONSULTATION.—In carrying out the report 
under subsection (a), the Secretary shall consult with— 
(1) the Food and Drug Administration, the 
Centers for Medicare & Medicaid Services, the De-
partment of Defense, the Department of Commerce, 
the Department of State, the Department of Vet-
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erans Affairs, the Department of Justice, and any 
other Federal agencies as appropriate; and 
(2) relevant stakeholders, including drug, de-
vice, and active pharmaceutical ingredient manufac-
turers, and other entities, as appropriate. 
(d) DEFINITION.—In this section, the term ‘‘active 
pharmaceutical ingredient’’ has the meaning given to such 
term in section 207.1 of title 21, Code of Federal Regula-
tions (and any successor regulations). 
(e) PUBLICATION.—The Secretary shall make the re-
port under subsection (a) available on the public website 
of the Department of Health and Human Services. 
SEC. 102. ENHANCE INTRAAGENCY COORDINATION AND 
PUBLIC HEALTH ASSESSMENT WITH REGARD 
TO COMPLIANCE ACTIVITIES. 
(a) BENEFIT/RISK FRAMEWORK.— 
(1) IN
GENERAL.—Paragraph (2) of section 
704(b) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 374(b)) is amended by adding at the end 
the following: ‘‘The Secretary shall ensure timely 
and effective coordination among such offices re-
garding the reviews of such report and the align-
ment of any feedback regarding such report, and 
any corrective or preventive actions in response to 
such report, after consideration of the benefits and 
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risks to the public health, patient safety, the drug 
supply and drug supply chain, and timely patient ac-
cess to drugs.’’. 
(2) ANNUAL
REPORTING.—Subsection (b) of 
section 704 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 374) is amended by adding at 
the end the following new paragraph: 
‘‘(3) On an annual basis, the Secretary shall prepare 
a report on the utilization of the framework described in 
paragraph (2) and post such report on the public website 
of the Food and Drug Administration.’’. 
(3) APPLICABILITY.—The amendments made 
by paragraphs (1) and (2) shall take effect on the 
effective date described in section 3112 of the 
CARES Act (Public Law 116–136), after executing 
the amendments made by such section 3112, and 
shall apply beginning on the date that is 1 year after 
the date of enactment of this Act. 
(b) PUBLIC MEETING.—The Secretary of Health and 
Human Services shall publish in the Federal Register a 
notice of a public meeting to be held no later than six 
months after the date of enactment of this Act to discuss 
and obtain input and recommendations from public stake-
holders, including patient advocates, consumers, regulated 
industry, and health care providers, regarding the con-
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