tents of a benefit/risk framework described in section 
704(b)(2) of the Federal Food, Drug, and Cosmetic Act, 
as amended by subsection (a), that supports a safe, stable, 
redundant drug supply chain. 
(c) GUIDANCE.—The Secretary of Health and 
Human Services shall— 
(1) not later than one year after the date of en-
actment of this Act, issue draft guidance regarding 
the goals and implementation of a benefit/risk 
framework described in subsection (b); and 
(2) not later than two years after such date of 
enactment, issue final guidance with respect to the 
implementation of such a framework. 
SEC. 
103. 
ENCOURAGING 
INTERNATIONAL 
HARMONI-
ZATION. 
(a) GAO STUDY.—Not later than one year after the 
date of enactment of this Act, the Comptroller General 
of the United States shall issue a report evaluating— 
(1) the consistency with which the International 
Conference on Harmonisation (in this section re-
ferred to as ‘‘ICH’’) guidelines on good manufac-
turing practices, including ICH Guidelines Q8–11, 
are being implemented by drug regulatory authori-
ties across countries and international regions; 
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(2) whether domestic active pharmaceutical in-
gredient manufacturers (including any such contract 
manufacturers) are provided sufficient opportunity 
to participate with regulatory authorities in the de-
velopment of guidelines prior to implementation; 
(3) whether divergence from ICH guidelines or 
differing regulatory standards or requirements by 
drug regulatory authorities across countries and 
international regions creates— 
(A) inefficiencies in drug manufacturing; 
(B) incompatible requirements that can 
contribute to or exacerbate drug shortages; and 
(C) the most common areas of divergence 
between ICH guidelines and regulatory stand-
ards and requirements by drug regulatory au-
thorities across countries and international re-
gions that, if rectified, may reduce the ineffi-
ciencies and incompatibilities identified pursu-
ant to subparagraphs (A) and (B). 
(b) INTERNATIONAL TRAINING PROGRAM.—Not later 
than two years after the date of enactment of this Act, 
informed by the needs identified in the report issued pur-
suant to subsection (a), the Secretary of Health and 
Human Services, in conjunction with drug regulatory au-
thorities across countries and international regions and 
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the ICH, shall develop and implement a training program 
for drug regulatory authorities across countries and inter-
national regions to promote consistent application of and 
reduce divergence from ICH guidelines on good manufac-
turing practices. 
SEC. 104. MUTUAL RECOGNITION AGREEMENTS FOR IN-
SPECTIONS AND REVIEW ACTIVITIES. 
(a) MUTUAL RECOGNITION OF INSPECTIONS.—Pur-
suant to section 809 of the Federal Food, Drug and Cos-
metics Act (21 U.S.C. 384e), the Secretary of Health and 
Human Services (in this section referred to as the ‘‘Sec-
retary’’) shall establish or expand initiatives for mutual 
sharing of review and inspection criteria between drug reg-
ulatory authorities across countries and international re-
gions, such as through the Pharmaceutical Cooperation 
Inspection Scheme, the Mutual Recognition Agreement 
with the European Union, and the Australia-Canada- 
Singapore-Switzerland Consortium, to— 
(1) reduce the potential for duplicative regu-
latory evaluation of medical products regulated by 
the Food and Drug Administration; and 
(2) more constructively allocate appropriations 
to the Food and Drug Administration, including 
those attributable to user fees, to harmonized regu-
latory processes. 
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(b) ADDITIONAL COUNTRIES, REGIONS, AND EVAL-
UATION.—In carrying out subsection (a), the Secretary 
may expand the initiatives to include— 
(1) additional countries and geographic regions 
with established and competent regulatory frame-
works; and 
(2) additional types of regulatory evaluation, in-
cluding with respect to— 
(A) good manufacturing practice inspec-
tions; and 
(B) approval of changes to the manufac-
turing of drugs for which an approval or licen-
sure is in effect under section 505 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355) or section 351 of the Public Health Serv-
ice Act (42 U.S.C. 262). 
(c) IMPLEMENTATION FRAMEWORK.— 
(1) PUBLICATION.—Not later than one year 
after the date of enactment of this Act, the Sec-
retary shall publish an implementation framework 
for the agreements to share review and inspection 
criteria under subsection (a) on the public website of 
the Food and Drug Administration. 
(2) CONTENTS.—The implementation frame-
work under this subsection shall— 
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(A) include the timeline for establishing or 
expanding initiatives described in subsection 
(a); 
(B) describe additional types of regulatory 
processes that will become subject to such ini-
tiatives; 
(C) specify the countries and geographic 
regions where such initiatives will be established 
or expanded; and 
(D) identify additional opportunities and 
challenges for expanding mutual recognition 
agreements in drug and biologic regulation. 
(d) ANNUAL REPORTING.— 
(1) IN GENERAL.—Not later than the end of 
calendar year 2020 and annually thereafter, the Sec-
retary shall publish a report on the public website of 
the Food and Drug Administration on the utilization 
of agreements described in subsection (c)(1) in the 
previous fiscal year. 
(2) CONTENTS.—The report under paragraph 
(1) shall include each of the following: 
(A) The total number of establishments 
that are registered under section 510(i) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360) and located outside of the United 
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States, and of these establishments, the number 
in each region of interest. 
(B) The total number of inspections con-
ducted at establishments described in subpara-
graph (A). 
(C) Of the inspections described in sub-
paragraph (B), the total number of inspections 
in each of region of interest. 
(D) Of the inspections in each region of in-
terest reported pursuant to subparagraph (C), 
the number of inspections in each FDA inspec-
tion category. 
(E) Of the number of inspections reported 
under each of subparagraphs (B), (C), and 
(D)— 
(i) the number of inspections which 
have been conducted pursuant to an agree-
ment described in subsection (c)(1); and 
(ii) the number of inspections which 
have been conducted by employees or other 
agents of the Food and Drug Administra-
tion. 
(3) DEFINITIONS.—In this subsection: 
(A) The term ‘‘region of interest’’ refers to 
China, India, the European Union, and any 
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other geographic region as determined appro-
priate by the Secretary. 
(B) The term ‘‘FDA inspection category’’ 
means refers to the following inspection cat-
egories: 
(i) Inspections to support an approval 
of a drug under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355) or section 351 of the Public Health 
Service Act (42 U.S.C. 262). 
(ii) Good manufacturing practice in-
spections. 
(iii) For-cause inspections. 
SEC. 105. ENHANCING TRANSPARENCY OF DRUG FACILITY 
INSPECTION TIMELINES. 
Section 902 of the FDA Reauthorization Act of 2017 
(21 U.S.C. 355 note) is amended to read as follows: 
‘‘SEC. 902. ANNUAL REPORT ON INSPECTIONS. 
‘‘Not later than March 1 of each year, the Secretary 
of Health and Human Services shall post on the public 
website of the Food and Drug Administration information 
related to inspections of facilities necessary for approval 
of a drug under subsection (c) or (j) of section 505 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355), approval of a device under section 515 of such Act 
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(21 U.S.C. 360e), or clearance of a device under section 
510(k) of such Act (21 U.S.C. 360(k)) that were con-
ducted during the previous calendar year. Such informa-
tion shall include the following: 
‘‘(1) The median time following a request from 
staff of the Food and Drug Administration review-
ing an application or report to the beginning of the 
inspection, and the median time from the beginning 
of an inspection to the issuance of a report pursuant 
to section 704(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374(b)), including— 
‘‘(A) the median time for drugs described 
in 505(j)(11)(A)(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i)); 
‘‘(B) the median time for drugs described 
in section 506C(a) of such Act (21 U.S.C. 
356c(a)) only; and 
‘‘(C) the median time for drugs on the 
drug shortage list in effect under section 506E 
of such Act (21 U.S.C. 356f). 
‘‘(2) The median time from the issuance of a 
report pursuant to such section 704(b) to the send-
ing of a warning letter, issuance of an import alert, 
or holding of a regulatory meeting for inspections 
for which the Secretary concluded that regulatory or 
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enforcement action was indicated, including the me-
dian time for each category of drugs listed in sub-
paragraphs (A) through (C) of paragraph (1). 
‘‘(3) The median time from the sending of a 
warning letter, issuance of an import alert, or hold-
ing of a regulatory meeting to resolution of the regu-
latory or enforcement action indicated for inspec-
tions for which the Secretary concluded that such 
action was indicated. 
‘‘(4) The number of times that a facility was 
issued a report pursuant to such section 704(b) and 
approval of an application was delayed due to the 
issuance of a withhold recommendation, including 
the number of such times for each category of drugs 
listed in subparagraphs (A) through (C) of para-
graph (1).’’. 
SEC. 106. ADVANCED MANUFACTURING TECHNOLOGIES 
PROGRAM. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 524B. ADVANCED MANUFACTURING TECHNOLOGIES 
PROGRAM. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of the Manufacturing API, Drugs, and 
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Excipients in America Act of 2020, the Secretary shall 
continue in effect the program to evaluate new drug manu-
facturing technologies that are included in an application, 
or supplement to an application, for a drug under sub-
section (b) or (j) of section 505 of this Act or for a biologi-
cal product submitted under subsection (a) or (k) of sec-
tion 351 of the Public Health Service Act. 
‘‘(b) DESIGNATION.—The Secretary shall designate a 
method of manufacturing a drug as an advanced manufac-
turing technology under this section if the drug manufac-
turer demonstrates that such technology is likely to— 
‘‘(1) prevent or resolve a drug shortage; 
‘‘(2) maintain an adequate supply of critical 
medications for national emergencies; or 
‘‘(3) promote the adoption of innovative ap-
proaches to drug product design and manufacturing. 
‘‘(c) CONSULTATION.—If the Secretary designates a 
method of manufacturing as an advanced manufacturing 
technology under this section, the Secretary shall take ac-
tions to expedite the development and implementation of 
such method of manufacture for purposes of approval of 
the application under subsection (c) or (j) of section 505 
of this Act or subsection (a) or (k) of section 351 of the 
Public Health Service Act, which may include, as appro-
priate— 
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‘‘(1) holding meetings between the sponsor of 
the application and appropriate Food and Drug Ad-
ministration staff throughout the development of the 
technology; 
‘‘(2) providing timely advice to, and interactive 
communication with, the sponsor regarding the de-
velopment of the technology; and 
‘‘(3) involving senior managers and experienced 
staff of the Food and Drug Administration, as ap-
propriate, in a collaborative, cross-disciplinary review 
of the method of manufacturing. 
‘‘(d) EVALUATION
OF
AN ADVANCED MANUFAC-
TURING TECHNOLOGY.— 
‘‘(1) PACKAGE.—A sponsor who receives des-
ignation of an advanced manufacturing technology 
under this section shall provide the Secretary with a 
package of scientific evidence supporting the imple-
mentation of the advanced manufacturing technology 
in a particular context-of-use. 
‘‘(2) EVALUATION.—Within 90 days of receiv-
ing the package, the Secretary shall determine 
whether a designated advanced manufacturing tech-
nology is validated for the proposed context of use 
based on the scientific merit the supporting evidence 
provided by the sponsor. 
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‘‘(3) EFFECT OF APPROVAL.—Upon approval, 
the same sponsor may rely upon the advanced man-
ufacturing technology for use across multiple manu-
facturing product lines within the same context-of- 
use without having to re-submit data to the Sec-
retary validating the underlying technology. 
‘‘(e) IMPLEMENTATION AND REPORTING.— 
‘‘(1) PUBLIC
MEETING.—The Secretary shall 
publish in the Federal Register a notice of a public 
meeting to be held no later than 1 year after the 
date of enactment of the Manufacturing API, 
Drugs, and Excipients in America Act of 2020 to 
discuss and obtain input and recommendations from 
stakeholders regarding the goals and scope of, and 
a suitable framework and procedures and require-
ments for, the program under this section. 
‘‘(2) 
PROGRAM
GUIDANCE.—The 
Secretary 
shall— 
‘‘(A) not later than 1 year after the date 
of enactment of the Manufacturing API, Drugs, 
and Excipients in America Act of 2020, issue 
draft guidance regarding the goals and imple-
mentation of the program under this section; 
and 
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‘‘(B) not later than 2 years after the date 
of enactment of the Manufacturing API, Drugs, 
and Excipients in America Act of 2020, issue 
final guidance with respect to the implementa-
tion of such program. 
‘‘(3) REPORT.—The Secretary shall make avail-
able on the public website of the Food and Drug Ad-
ministration an annual report on the progress of the 
program under this section.’’. 
TITLE II—TAX INCENTIVES TO 
INCREASE DOMESTIC PHAR-
MACEUTICAL AND MEDICAL 
DEVICE PRODUCTION 
SEC. 201. CREDIT FOR PHARMACEUTICAL AND MEDICAL 
DEVICE PRODUCTION ACTIVITIES IN DIS-
TRESSED ZONES. 
(a) IN GENERAL.—Subpart D of part IV of sub-
chapter A of chapter 1 of the Internal Revenue Code of 
1986 is amended by adding at the end the following new 
section: 
‘‘SEC. 45U. DISTRESSED ZONE PHARMACEUTICAL AND MED-
ICAL DEVICE PRODUCTION CREDIT. 
‘‘(a) IN GENERAL.—For purposes of section 38, the 
distressed zone pharmaceutical and medical device produc-
tion credit for the taxable year shall be an amount equal 
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to 30 percent of the qualified production activity expendi-
tures of the taxpayer for the taxable year. 
‘‘(b) QUALIFIED PRODUCTION ACTIVITY EXPENDI-
TURES.—For purposes of this section— 
‘‘(1) IN GENERAL.—The term ‘qualified produc-
tion activity expenditures’ means— 
‘‘(A) wages paid or incurred to an em-
ployee of the taxpayer for services performed by 
such employee in the conduct of a qualified 
pharmaceutical or diagnostic medical device 
production business in a distressed zone (but 
only if the employee’s principal place of employ-
ment is in a distressed zone), or 
‘‘(B) amounts paid or incurred for any 
tangible personal property (whether or not oth-
erwise properly chargeable to capital account) 
used in the conduct of a qualified pharma-
ceutical or medical device production business 
in a distressed zone (but only if the primary use 
of such property is in a distressed zone). 
‘‘(2) QUALIFIED PHARMACEUTICAL OR MEDICAL 
DEVICE PRODUCTION BUSINESS.— 
‘‘(A) IN
GENERAL.—The term ‘qualified 
pharmaceutical or medical device production 
business’ means the trade or business of pro-
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ducing pharmaceuticals, excipients, active phar-
maceutical ingredients, medical diagnostic de-
vices, or personal protective equipment. 
‘‘(B) ACTIVE
PHARMACEUTICAL
INGRE-
DIENT.—The term ‘active pharmaceutical ingre-
dients’ has the meaning given to such term in 
section 207.1 of title 21, Code of Federal Regu-
lations (and any successor regulations). 
‘‘(C) EXCIPIENT.—The term ‘excipient’— 
‘‘(i) means any inactive ingredient 
that is intentionally added to a pharma-
ceutical that is not intended to exert thera-
peutic effects at the intended dosage, other 
than by acting to improve product delivery; 
and 
‘‘(ii) includes any such filler, extend-
ers, diluent, wetting agent, solvent, emulsi-
fier, 
preservative, 
flavor, 
absorption 
enhancer, sustained release matrix, and 
coloring agent. 
‘‘(D) MEDICAL DIAGNOSTIC DEVICE.—The 
term ‘medical diagnostic device’ means any de-
vice (as defined in section 201(h) of the Federal 
Food, Drug, and Cosmetic Act) intended for 
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use in the diagnosis of disease or other condi-
tions. 
‘‘(E) 
PERSONAL
PROTECTIVE
EQUIP-
MENT.—The term ‘personal protective equip-
ment’ means— 
‘‘(i) any device (as defined in section 
201(h) of the Federal Food, Drug, and 
Cosmetic Act) that is a face mask, filtering 
facepiece respirator, face shield, surgical 
mask, gown, other apparel, or glove that is 
intended for a medical purpose; and 
‘‘(ii) any particulate filtering air puri-
fying respiratory protective device that is 
approved by the National Institute for Oc-
cupational Safety and Health under part 
84 of title 42, Code of Federal Regulations 
(or successor regulations). 
‘‘(F) PHARMACEUTICAL.—The term ‘phar-
maceutical’— 
‘‘(i) means any drug (as defined in 
section 201 of the Federal Food, Drug, 
and Cosmetic Act); and 
‘‘(ii) includes a biological product (as 
defined in section 351 of the Public Health 
Service Act). 
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‘‘(3) CERTAIN HEALTH PLAN EXPENSES TREAT-
ED AS WAGES.— 
‘‘(A) IN GENERAL.—For purposes of para-
graph (1), the term ‘wages’ shall include so 
much of the eligible employer’s qualified health 
plan expenses as are properly allocable to such 
wages. 
‘‘(B) 
QUALIFIED
HEALTH
PLAN
EX-
PENSES.—For purposes of this paragraph, the 
term ‘qualified health plan expenses’ means 
amounts paid or incurred by the eligible em-
ployer to provide and maintain a group health 
plan (as defined in section 5000(b)(1)), but 
only to the extent that such amounts are ex-
cluded from the gross income of employees by 
reason of section 106(a) of such Code. 
‘‘(C) ALLOCATION RULES.—For purposes 
of this paragraph, qualified health plan ex-
penses shall be allocated to qualified wages in 
such manner as the Secretary may prescribe. 
Except as otherwise provided by the Secretary, 
such allocation shall be treated as properly 
made if made on the basis of being pro rata 
among employees and pro rata on the basis of 
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periods of coverage (relative to the periods to 
which such wages relate). 
‘‘(4) DISTRESSED ZONE.—The term ‘distressed 
zone’ means a population census tract— 
‘‘(A) which has been designated as a quali-
fied opportunity zone under section 1400Z–1, 
and 
‘‘(B) which has a poverty rate in excess of 
30 percent for the calendar year prior to the 
calendar year that includes the date of enact-
ment of this section. 
‘‘(c) SPECIAL RULES.— 
‘‘(1) REDUCTION IN BASIS.—If a credit is de-
termined under this section with respect to any 
property by reason of any qualified production activ-
ity expenditures described in subsection (b)(1)(B), 
the basis of such property shall be reduced by the 
amount of the credit so determined. 
‘‘(2) COORDINATION WITH OTHER CREDITS.— 
Any qualified production activity expenditures taken 
into account in determining the amount of the credit 
under subsection (a) shall not be taken into account 
in determining a credit under any other provision of 
this chapter. 
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‘‘(3) LIMITATION ON WAGES TAKEN INTO AC-
COUNT.—The amount of wages taken into account 
under subsection (a) with respect to any employee 
shall not exceed an amount equal to the contribution 
and benefit base in effect under section 230 of the 
Social Security Act for the calendar year in which 
the taxable year begins.’’. 
(b) CREDIT ALLOWED AGAINST ALTERNATIVE MIN-
IMUM TAX.—Section 38(c)(4)(B) of such Code is amended 
by redesignating clauses (x), (xi), and (xii) as clauses (xi), 
(xii), and (xiii), respectively and by inserting after clause 
(ix) the following new clause: 
‘‘(x) the credit determined under sec-
tion 45U,’’. 
(c) SPECIAL RULE FOR CONTROLLED FOREIGN COR-
PORATIONS.—Section 960(d) of such Code is amended by 
adding at the end the following new paragraph: 
‘‘(4) SPECIAL FOR CONTROLLED FOREIGN COR-
PORATIONS
WITH
DISTRESSED
ZONE
PHARMA-
CEUTICAL AND MEDICAL DEVICE EXPENDITURES.— 
The amount of foreign taxes deemed paid by a do-
mestic corporation under paragraph (1) (determined 
without regard to this paragraph) shall be increased 
by an amount equal to the lesser of— 
‘‘(A) the excess of— 
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‘‘(i) the amount calculated with re-
spect to such corporation under paragraph 
(1) (determined without regard to this 
paragraph and by substituting ‘100 per-
cent’ for ‘80 percent’), over 
‘‘(ii) the amount calculated with re-
spect to such corporation under paragraph 
(1) (determined without regard to this 
paragraph), or 
‘‘(B) an amount equal to 15 percent of the 
qualified production activity expenditures (as 
defined in section 45U(b)(1)) of the controlled 
foreign corporation for the taxable year of the 
foreign corporation ending in or with the tax-
able year of the domestic corporation.’’. 
(d) DENIAL OF DEDUCTION.—Section 280C of such 
Code is amended by adding at the end the following new 
subsection: 
‘‘(i) DISTRESSED
ZONE
PHARMACEUTICAL
AND 
MEDICAL DEVICE PRODUCTION CREDIT.—No deduction 
shall be allowed for that portion of the qualified produc-
tion activity expenditures (as defined in section 45U(b)) 
otherwise allowable as a deduction for the taxable year 
which is equal to the amount of the distressed zone phar-
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maceutical and medical device production credit deter-
mined for such taxable year under section 45U(a).’’. 
(e) PART OF GENERAL BUSINESS CREDIT.—Section 
38(b) of such Code is amended by striking ‘‘plus’’ at the 
end of paragraph (32), by striking the period at the end 
of paragraph (33) and inserting ‘‘, plus’’, and by adding 
at the end the following new paragraph: 
‘‘(34) the distressed zone pharmaceutical and 
medical device production credit determined under 
section 45U(a).’’. 
(f) CLERICAL AMENDMENT.—The table of sections 
for subpart D of part IV of subchapter A of chapter 1 
is amended by adding at the end the following new item: 
‘‘Sec. 45U. Distressed zone pharmaceutical and medical device production cred-
it.’’. 
(g) EFFECTIVE DATE.—The amendments made by 
this section shall apply to amounts paid or incurred after 
the date of the enactment of this Act. 
Æ 
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