diversity action plan submitted for such applica-
tions; 
(B) the reasons provided for why enrollment 
goals from submitted diversity action plans were 
not met; and 
(C) any postmarket studies of a drug or de-
vice in a demographic subgroup or subgroups re-
quired or recommended by the Secretary based 
on inadequate premarket clinical study diversity 
or based on other reasons where a premarket 
study lacked adequate diversity, including the 
status and completion date of any such study. 
(b) CONFIDENTIALITY.—Nothing in this section shall 
be construed as authorizing the Secretary of Health and 
Human Services to disclose any information that is a trade 
secret or confidential information subject to section 
552(b)(4) of title 5, United States Code, or section 1905 
of title 18, United States Code. 
SEC. 505. PUBLIC MEETING ON CLINICAL STUDY FLEXIBILI-
TIES INITIATED IN RESPONSE TO COVID–19 
PANDEMIC. 
(a) IN GENERAL.—Not later than 180 days after the 
date on which the COVID–19 emergency period ends, the 
Secretary of Health and Human Services shall convene a 
public meeting to discuss the recommendations provided by 
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the Food and Drug Administration during the COVID–19 
emergency period to mitigate disruption of clinical studies, 
including recommendations detailed in the guidance enti-
tled ‘‘Conduct of Clinical Trials of Medical Products Dur-
ing the COVID–19 Public Health Emergency, Guidance for 
Industry, Investigators, and Institutional Review Boards’’, 
as updated on August 8, 2021, and by any subsequent up-
dates to such guidance. The Secretary of Health and 
Human Services shall invite to such meeting representatives 
from the pharmaceutical and medical device industries who 
sponsored clinical studies during the COVID–19 emergency 
period and organizations representing patients. 
(b) TOPICS.—Not later than 90 days after the date on 
which the public meeting under subsection (a) is convened, 
the Secretary of Health and Human Services shall make 
available on the public website of the Food and Drug Ad-
ministration a report on the topics discussed at such meet-
ing. Such topics shall include discussion of— 
(1) the actions drug sponsors took to utilize such 
recommendations and the frequency at which such 
recommendations were employed; 
(2) the characteristics of the sponsors, studies, 
and patient populations impacted by such rec-
ommendations; 
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(3) a consideration of how recommendations in-
tended to mitigate disruption of clinical studies dur-
ing the COVID–19 emergency period, including any 
recommendations to consider decentralized clinical 
studies when appropriate, may have affected access to 
clinical studies for certain patient populations, espe-
cially unrepresented racial and ethnic minorities; and 
(4) recommendations for incorporating certain 
clinical study disruption mitigation recommendations 
into current or additional guidance to improve clin-
ical study access and enrollment of diverse patient 
populations. 
(c) COVID–19 EMERGENCY PERIOD DEFINED.—In 
this section, the term ‘‘COVID–19 emergency period’’ has 
the meaning given the term ‘‘emergency period’’ in section 
1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b– 
5(g)(1)(B)). 
SEC. 506. DECENTRALIZED CLINICAL STUDIES. 
(a) GUIDANCE.—The Secretary of Health and Human 
Services shall— 
(1) not later than 12 months after the date of en-
actment of this Act, issue draft guidance that address-
es considerations for decentralized clinical studies, in-
cluding considerations regarding the engagement, en-
rollment, and retention of a meaningfully diverse 
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clinical population, with respect to race, ethnicity, 
age, sex, and geographic location, when appropriate; 
and 
(2) not later than 1 year after closing the com-
ment period on such draft guidance, finalize such 
guidance. 
(b) CONTENT OF GUIDANCE.—The guidance under sub-
section (a) shall address the following: 
(1) Recommendations for how digital health 
technology or other remote assessment options, such as 
telehealth, could support decentralized clinical studies, 
including guidance on considerations for selecting 
technological platforms and mediums, data collection 
and use, data integrity and security, and commu-
nication to study participants through digital tech-
nology. 
(2) Recommendations for subject recruitment 
and retention, including considerations for sponsors 
to minimize or reduce burdens for clinical study par-
ticipants through the use of digital health technology, 
telehealth, local health care providers and labora-
tories, or other means. 
(3) Recommendations with respect to the evalua-
tion of data collected within a decentralized clinical 
study setting. 
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(c) DEFINITION.—In this section, the term ‘‘decentral-
ized clinical study’’ means a clinical study in which some 
or all of the study-related activities occur at a location sepa-
rate from the investigator’s location. 
TITLE VI—GENERIC DRUG 
COMPETITION 
SEC. 601. INCREASING TRANSPARENCY IN GENERIC DRUG 
APPLICATIONS. 
(a) IN GENERAL.—Section 505(j)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 
amended by adding at the end the following: 
‘‘(H)(i) Upon request (in controlled correspondence or 
otherwise) by a person that has submitted or intends to sub-
mit an abbreviated application for a new drug under this 
subsection for which the Secretary has specified in regula-
tion, including under section 314.94(a)(9), title 21, Code 
of Federal Regulations (or a successor regulation), or rec-
ommended in applicable guidance, certain qualitative or 
quantitative criteria with respect to an inactive ingredient, 
or on the Secretary’s own initiative during the review of 
such abbreviated application, the Secretary shall inform the 
person whether such new drug is qualitatively and quan-
titatively the same as the listed drug. 
‘‘(ii) Notwithstanding section 301(j), if the Secretary 
determines that such new drug is not qualitatively or quan-
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titatively the same as the listed drug, the Secretary shall 
identify and disclose to the person— 
‘‘(I) the ingredient or ingredients that cause the 
new drug not to be qualitatively or quantitatively the 
same as the listed drug; and 
‘‘(II) for any ingredient for which there is an 
identified quantitative deviation, the amount of such 
deviation. 
‘‘(iii) If the Secretary determines that such new drug 
is qualitatively and quantitatively the same as the listed 
drug, the Secretary shall not change or rescind such deter-
mination after the submission of an abbreviated application 
for such new drug under this subsection unless— 
‘‘(I) the formulation of the listed drug has been 
changed and the Secretary has determined that the 
prior listed drug formulation was withdrawn for rea-
sons of safety or effectiveness; or 
‘‘(II) the Secretary makes a written determina-
tion that the prior determination must be changed be-
cause an error has been identified. 
‘‘(iv) If the Secretary makes a written determination 
described in clause (iii)(II), the Secretary shall provide no-
tice and a copy of the written determination to the person 
making the request under clause (i). 
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‘‘(v) The disclosures required by this subparagraph are 
disclosures authorized by law including for purposes of sec-
tion 1905 of title 18, United States Code.’’. 
(b) GUIDANCE.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall issue draft guid-
ance, or update guidance, describing how the Sec-
retary will determine whether a new drug is quali-
tatively and quantitatively the same as the listed 
drug (as such terms are used in section 505(j)(3)(H) 
of the Federal Food, Drug, and Cosmetic Act, as 
added by subsection (a)), including with respect to as-
sessing pH adjusters. 
(2) PROCESS.—In issuing guidance as required 
by paragraph (1), the Secretary of Health and 
Human Services shall— 
(A) publish draft guidance; 
(B) provide a period of at least 60 days for 
comment on the draft guidance; and 
(C) after considering any comments re-
ceived, and not later than one year after the close 
of the comment period on the draft guidance, 
publish final guidance. 
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(c) APPLICABILITY.—Section 505(j)(3)(H) of the Fed-
eral Food, Drug, and Cosmetic Act, as added by subsection 
(a), applies beginning on the date of enactment of this Act, 
irrespective of the date on which the guidance required by 
subsection (b) is finalized. 
SEC. 602. ENHANCING ACCESS TO AFFORDABLE MEDICINES. 
Section 505(j)(10)(A) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(10)(A)) is amended by 
striking clauses (i) through (iii) and inserting the following: 
‘‘(i) a revision to the labeling of the listed drug 
has been approved by the Secretary within 90 days 
of when the application is otherwise eligible for ap-
proval under this subsection; 
‘‘(ii) the sponsor of the application agrees to sub-
mit revised labeling for the drug that is the subject of 
the application not later than 60 days after approval 
under this subsection of the application; 
‘‘(iii) the labeling revision described under clause 
(i) does not include a change to the ‘Warnings’ sec-
tion of the labeling; and’’. 
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TITLE 
VII—RESEARCH, 
DEVEL-
OPMENT, AND SUPPLY CHAIN 
IMPROVEMENTS 
Subtitle A—In General 
SEC. 701. ANIMAL TESTING ALTERNATIVES. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended— 
(1) in subsection (b)(5)(B)(i)(II), by striking 
‘‘animal’’ and inserting ‘‘nonclinical tests’’; 
(2) in subsection (i)— 
(A) in paragraph (1)(A), by striking ‘‘pre-
clinical tests (including tests on animals)’’ and 
inserting ‘‘nonclinical tests’’; and 
(B) in paragraph (2)(B), by striking ‘‘ani-
mal’’ and inserting ‘‘nonclinical tests’’; and 
(3) after subsection (y), by inserting the fol-
lowing: 
‘‘(z) NONCLINICAL TEST DEFINED.—For purposes of 
this section, the term ‘nonclinical test’ means a test con-
ducted in vitro, in silico, or in chemico, or a nonhuman 
in vivo test, that occurs before or during the clinical trial 
phase of the investigation of the safety and effectiveness of 
a drug. Such test may include the following: 
‘‘(1) Cell-based assays. 
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‘‘(2) Organ chips and microphysiological sys-
tems. 
‘‘(3) Computer modeling. 
‘‘(4) Other nonhuman or human biology-based 
test methods. 
‘‘(5) Animal tests.’’. 
SEC. 702. EMERGING TECHNOLOGY PROGRAM. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 201 et seq.) is amended by inserting after 
section 566 of such Act (21 U.S.C. 360bbb–5) the following: 
‘‘SEC. 566A. EMERGING TECHNOLOGY PROGRAM. 
‘‘(a) PROGRAM ESTABLISHMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall establish 
a program to support the adoption of, and improve 
the development of, innovative approaches to drug 
product design and manufacturing. 
‘‘(2) ACTIONS.—In carrying out the program 
under paragraph (1), the Secretary may— 
‘‘(A) facilitate and increase communication 
between public and private entities, consortia, 
and individuals with respect to innovative drug 
product design and manufacturing; 
‘‘(B) solicit information regarding, and 
conduct or support research on, innovative ap-
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proaches to drug product design and manufac-
turing; 
‘‘(C) convene meetings with representatives 
of industry, academia, other Federal agencies, 
international agencies, and other interested per-
sons, as appropriate; 
‘‘(D) convene working groups to support 
drug product design and manufacturing research 
and development; 
‘‘(E) support education and training for 
regulatory staff and scientists related to innova-
tive approaches to drug product design and 
manufacturing; 
‘‘(F) advance regulatory science related to 
the development and review of innovative ap-
proaches to drug product design and manufac-
turing; 
‘‘(G) convene or participate in working 
groups to support the harmonization of inter-
national regulatory requirements related to inno-
vative approaches to drug product design and 
manufacturing; and 
‘‘(H) award grants or contracts to carry out 
or support the program under paragraph (1). 
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‘‘(3) GRANTS AND CONTRACTS.—To seek a grant 
or contract under this section, an entity shall submit 
an application— 
‘‘(A) in such form and manner as the Sec-
retary may require; and 
‘‘(B) containing such information as the 
Secretary may require, including a description 
of— 
‘‘(i) how the entity will conduct the ac-
tivities to be supported through the grant or 
contract; and 
‘‘(ii) how such activities will further 
research and development related to, or 
adoption of, innovative approaches to drug 
product design and manufacturing. 
‘‘(b) GUIDANCE.—The Secretary shall— 
‘‘(1) issue or update guidance to help facilitate 
the adoption of, and advance the development of, in-
novative approaches to drug product design and man-
ufacturing; and 
‘‘(2) include in such guidance descriptions of— 
‘‘(A) any regulatory requirements related to 
the development or review of technologies related 
to innovative approaches to drug product design 
and manufacturing, including updates and im-
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100 
provements to such technologies after product ap-
proval; and 
‘‘(B) data that can be used to demonstrate 
the identity, safety, purity, and potency of drugs 
manufactured using such technologies. 
‘‘(c) REPORT TO CONGRESS.—Not later than 4 years 
after the date of enactment of this section, 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 containing— 
‘‘(1) an annual accounting of the allocation of 
funds made available to carry out this section; 
‘‘(2) a description of how Food and Drug Ad-
ministration staff were utilized to carry out this sec-
tion and, as applicable, any challenges or limitations 
related to staffing; 
‘‘(3) the number of public meetings held or par-
ticipated in by the Food and Drug Administration 
pursuant to this section, including meetings convened 
as part of a working group described in subparagraph 
(D) or (G) of subsection (a)(2), and the topics of each 
such meeting; and 
‘‘(4) the number of drug products approved or li-
censed, after the date of enactment of this section, 
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101 
using an innovative approach to drug product design 
and manufacturing. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$20,000,000 for each fiscal year 2023 through 2027.’’. 
SEC. 703. IMPROVING THE TREATMENT OF RARE DISEASES 
AND CONDITIONS. 
(a) REPORT ON ORPHAN DRUG PROGRAM.— 
(1) IN GENERAL.—Not later than September 30, 
2026, the Secretary shall submit to the Committee on 
Energy and Commerce of the House of Representa-
tives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report summa-
rizing the activities of the Food and Drug Adminis-
tration related to designating drugs under section 526 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bb) for a rare disease or condition and ap-
proving such drugs under section 505 of such Act (21 
U.S.C. 355) or licensing such drugs under section 351 
of the Public Health Service Act (42 U.S.C. 262), in-
cluding— 
(A) the number of applications for such 
drugs under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) or sec-
tion 351 of the Public Health Service Act (42 
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102 
U.S.C. 262) received by the Food and Drug Ad-
ministration, the number of such applications 
accepted and rejected for filing, and the number 
of such applications pending, approved, and dis-
approved by the Food and Drug Administration; 
(B) a description of trends in drug approv-
als for rare diseases and conditions across review 
divisions at the Food and Drug Administration; 
(C) the extent to which the Food and Drug 
Administration is consulting with external ex-
perts pursuant to section 569(a)(2) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb–8(a)(2)) on topics pertaining to drugs 
for a rare disease or condition, including how 
and when any such consultation is occurring; 
and 
(D) the Food and Drug Administration’s ef-
forts to promote best practices in the development 
of novel treatments for rare diseases, including— 
(i) reviewer training on rare disease- 
related policies, methods, and tools; and 
(ii) new regulatory science and coordi-
nated support for patient and stakeholder 
engagement. 
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103 
(2) PUBLIC AVAILABILITY.—The Secretary shall 
make the report under paragraph (1) available to the 
public, including by posting the report on the website 
of the Food and Drug Administration. 
(3) INFORMATION DISCLOSURE.—Nothing in this 
subsection shall be construed to authorize the disclo-
sure of information that is prohibited from disclosure 
under section 1905 of title 18, United States Code, or 
subject to withholding under paragraph (4) of section 
552(b) of title 5, United States Code (commonly re-
ferred to as the ‘‘Freedom of Information Act’’). 
(b) STUDY ON EUROPEAN UNION SAFETY AND EFFI-
CACY REVIEWS OF DRUGS FOR RARE DISEASES AND CON-
DITIONS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall enter into a contract with an 
appropriate entity to conduct a study on processes for 
evaluating the safety and efficacy of drugs for rare 
diseases or conditions in the United States and the 
European Union, including— 
(A) flexibilities, authorities, or mechanisms 
available to regulators in the United States and 
the European Union specific to rare diseases or 
conditions; 
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104 
(B) the consideration and use of supple-
mental data submitted during review processes 
in the United States and the European Union, 
including data associated with open label exten-
sion studies and expanded access programs spe-
cific to rare diseases or conditions; 
(C) an assessment of collaborative efforts be-
tween United States and European Union regu-
lators related to— 
(i) 
product 
development 
programs 
under review; 
(ii) policies under development recently 
issued; and 
(iii) scientific information related to 
product development or regulation; and 
(D) recommendations for how Congress can 
support collaborative efforts described in sub-
paragraph (C). 
(2) CONSULTATION.—The contract under para-
graph (1) shall provide for consultation with relevant 
stakeholders, including— 
(A) representatives from the Food and Drug 
Administration and the European Medicines 
Agency; 
(B) rare disease or condition patients; and 
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105 
(C) patient groups that— 
(i) represent rare disease or condition 
patients; and 
(ii) have international patient out-
reach. 
(3) REPORT.—The contract under paragraph (1) 
shall provide for, not later than 2 years after the date 
of entering into such contract— 
(A) the completion of the study under para-
graph (1); and 
(B) the submission of a report on the results 
of such study to the Committee on Energy and 
Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and 
Pensions of the Senate. 
(4) PUBLIC AVAILABILITY.—The contract under 
paragraph (1) shall provide for the appropriate entity 
referred to in paragraph (1) to make the report under 
paragraph (3) available to the public, including by 
posting the report on the website of the appropriate 
entity. 
(c) PUBLIC MEETING.— 
(1) IN GENERAL.—Not later than December 31, 
2023, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, 
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106 
shall convene one or more public meetings to solicit 
input from stakeholders regarding the approaches de-
scribed in paragraph (2). 
(2) APPROACHES.—The public meeting or meet-
ings under paragraph (1) shall address approaches to 
increasing and improving engagement with rare dis-
ease or condition patients, groups representing such 
patients, rare disease or condition experts, and ex-
perts on small population studies, in order to improve 
the understanding with respect to rare diseases or 
conditions of— 
(A) patient burden; 
(B) treatment options; and 
(C) side effects of treatments, including— 
(i) comparing the side effects of treat-
ments; and 
(ii) understanding the risks of side ef-
fects relative to the health status of the pa-
tient and the progression of the disease or 
condition. 
(3) PUBLIC DOCKET.—The Secretary of Health 
and Human Services shall establish a public docket to 
receive written comments related to the approaches 
addressed during each public meeting under para-
graph (1). Such public docket shall remain open for 
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107 
60 days following the date of each such public meet-
ing. 
(4) REPORTS.—Not later than 180 days after 
each public meeting under paragraph (1), the Com-
missioner of Food and Drugs shall develop and pub-
lish on the website of the Food and Drug Administra-
tion a report on— 
(A) the approaches discussed at the public 
meeting; and 
(B) any related recommendations. 
(d) CONSULTATION ON THE SCIENCE OF SMALL POPU-
LATION STUDIES.—Section 569(a)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–8(a)(2)) is 
amended by adding at the end the following: 
‘‘(C) SMALL
POPULATION
STUDIES.—The 
external experts on the list maintained pursuant 
to subparagraph (A) may include experts on the 
science of small population studies.’’. 
(e) STUDY ON SUFFICIENCY AND USE OF FDA MECHA-
NISMS FOR INCORPORATING THE PATIENT AND CLINICIAN 
PERSPECTIVE IN FDA PROCESSES RELATED TO APPLICA-
TIONS CONCERNING DRUGS FOR RARE DISEASES OR CON-
DITIONS.— 
(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study on the use of 
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108 
Food and Drug Administration mechanisms and tools 
to ensure that patient and physician perspectives are 
considered and incorporated throughout the processes 
of the Food and Drug Administration— 
(A) for approving or licensing under section 
505 of the Federal Food, Drug, or Cosmetic Act 
(21 U.S.C. 355) or section 351 of the Public 
Health Service Act (42 U.S.C. 262) a drug des-
ignated as a drug for a rare disease or condition 
under section 526 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bb); and 
(B) in making any determination related to 
such a drug’s approval, including assessment of 
the drug’s— 
(i) safety or effectiveness; or 
(ii) postapproval safety monitoring. 
(2) TOPICS.—The study under paragraph (1) 
shall— 
(A) identify and compare the processes that 
the Food and Drug Administration has formally 
put in place and utilized to gather external ex-
pertise (including patients, patient groups, and 
physicians) related to applications for rare dis-
eases or conditions; 
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109 
(B) examine tools or mechanisms to im-
prove efforts and initiatives of the Food and 
Drug Administration to collect and consider such 
external expertise with respect to applications for 
rare diseases or conditions throughout the appli-
cation review and approval or licensure proc-
esses, including within internal benefit-risk as-
sessments, advisory committee processes, and 
postapproval safety monitoring; and 
(C) examine processes or alternatives to ad-
dress or resolve conflicts of interest that impede 
the Food and Drug Administration in gaining 
external expert input on rare diseases or condi-
tions with a limited set of clinical and research 
experts. 
(3) REPORT.—Not later than 2 years after the 
date of enactment of this Act, the Comptroller General 
of the United States shall— 
(A) complete the study under paragraph 
(1); 
(B) submit a report on the results of such 
study to the Congress; and 
(C) include in such report recommenda-
tions, if appropriate, for changes to the processes 
and authorities of the Food and Drug Adminis-
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tration to improve the collection and consider-
ation of external expert opinions of patients, pa-
tient groups, and physicians with expertise in 
rare diseases or conditions. 
(f) DEFINITION.—In this section, the term ‘‘rare dis-
ease or condition’’ has the meaning given such term in sec-
tion 526(a)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bb(a)(2)). 
SEC. 704. ANTIFUNGAL RESEARCH AND DEVELOPMENT. 
(a) DRAFT GUIDANCE.—Not later than 3 years after 
the date of the enactment of this Act, the Secretary of Health 
and Human Services, acting through the Commissioner of 
Food and Drugs, shall issue draft guidance for industry for 
the purposes of assisting entities seeking approval under 
section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) or licensure under section 351 of the Public 
Health Service Act (42 U.S.C. 262) of antifungal therapies 
designed to treat coccidioidomycosis (commonly known as 
Valley Fever). 
(b) FINAL GUIDANCE.—Not later than 18 months after 
the close of the public comment period on the draft guidance 
issued pursuant to subsection (a), the Secretary of Health 
and Human Services, acting through the Commissioner of 
Food and Drugs, shall finalize the draft guidance. 
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(c) WORKSHOP.—To assist entities developing preven-
tive vaccines for fungal infections and coccidioidomycosis, 
the Secretary of Health and Human Services shall hold a 
public workshop. 
SEC. 705. ADVANCING QUALIFIED INFECTIOUS DISEASE 
PRODUCT INNOVATION. 
(a) IN GENERAL.—Section 505E of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355f) is amended— 
(1) in subsection (c)— 
(A) in paragraph (2), by striking ‘‘or’’ at 
the end; 
(B) in paragraph (3), by striking the period 
at the end and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(4) an application pursuant to section 351(a) 
of the Public Health Service Act.’’; 
(2) in subsection (d)(1), by inserting ‘‘of this Act 
or section 351(a) of the Public Health Service Act’’ 
after ‘‘section 505(b)’’; and 
(3) by amending subsection (g) to read as fol-
lows: 
‘‘(g) QUALIFIED INFECTIOUS DISEASE PRODUCT.— 
The term ‘qualified infectious disease product’ means a 
drug, including an antibacterial or antifungal drug or a 
biological product, for human use that— 
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‘‘(1) acts directly on bacteria or fungi or on sub-
stances produced by such bacteria or fungi; and 
‘‘(2) is intended to treat a serious or life-threat-
ening infection, including such an infection caused 
by— 
‘‘(A) an antibacterial or antifungal resist-
ant pathogen, including novel or emerging infec-
tious pathogens; or 
‘‘(B) qualifying pathogens listed by the Sec-
retary under subsection (f).’’. 
(b) PRIORITY REVIEW.—Section 524A(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360n–1(a)) 
is amended by inserting ‘‘of this Act or section 351(a) of 
the Public Health Service Act that requires clinical data 
(other than bioavailability studies) to demonstrate safety or 
effectiveness’’ before the period at the end. 
SEC. 706. ADVANCED MANUFACTURING TECHNOLOGIES 
DESIGNATION PILOT PROGRAM. 
Subchapter A of chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
inserting after section 506J (21 U.S.C. 356j) the following: 
‘‘SEC. 506K. ADVANCED MANUFACTURING TECHNOLOGIES 
DESIGNATION PILOT PROGRAM. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this section, the Secretary shall initiate 
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a pilot program under which persons may request designa-
tion of an advanced manufacturing technology as described 
in subsection (b). 
‘‘(b) DESIGNATION PROCESS.—The Secretary shall es-
tablish a process for the designation under this section of 
methods of manufacturing drugs, including biological prod-
ucts, and active pharmaceutical ingredients of such drugs, 
as advanced manufacturing technologies. A method of man-
ufacturing, or a combination of manufacturing methods, is 
eligible for designation as an advanced manufacturing tech-
nology if such method or combination of methods incor-
porates a novel technology, or uses an established technique 
or technology in a novel way, that will substantially im-
prove the manufacturing process for a drug and maintain 
equivalent or provide superior drug quality, including by— 
‘‘(1) reducing development time for a drug using 
the designated manufacturing method; or 
‘‘(2) increasing or maintaining the supply of— 
‘‘(A) a drug that is described in section 
506C(a) and is intended to treat a serious or 
life-threatening condition; or 
‘‘(B) a drug that is on the drug shortage list 
under section 506E. 
‘‘(c) EVALUATION AND DESIGNATION OF AN ADVANCED 
MANUFACTURING TECHNOLOGY.— 
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‘‘(1) SUBMISSION.—A person who requests des-
ignation of a method of manufacturing as an ad-
vanced manufacturing technology under this section 
shall submit to the Secretary data or information 
demonstrating that the method of manufacturing 
meets the criteria described in subsection (b) in a 
particular context of use. The Secretary may facili-
tate the development and review of such data or infor-
mation by— 
‘‘(A) providing timely advice to, and inter-
active communication with, such person regard-
ing the development of the method of manufac-
turing; and 
‘‘(B) involving senior managers and experi-
enced staff of the Food and Drug Administra-
tion, as appropriate, in a collaborative, cross- 
disciplinary review of the method of manufac-
turing, as applicable. 
‘‘(2) EVALUATION AND DESIGNATION.—Not later 
than 180 calendar days after the receipt of a request 
under paragraph (1), the Secretary shall determine 
whether to designate such method of manufacturing as 
an advanced manufacturing technology, in a par-
ticular context of use, based on the data and informa-
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tion submitted under paragraph (1) and the criteria 
described in subsection (b). 
‘‘(d) REVIEW OF ADVANCED MANUFACTURING TECH-
NOLOGIES.—If the Secretary designates a method of manu-
facturing as an advanced manufacturing technology, the 
Secretary shall— 
‘‘(1) expedite the development and review of an 
application submitted under section 505 of this Act or 
section 351 of the Public Health Service Act, includ-
ing supplemental applications, for drugs that are 
manufactured using a designated advanced manufac-
turing technology and could help mitigate or prevent 
a shortage or substantially improve manufacturing 
processes for a drug and maintain equivalent or pro-
vide superior drug quality, as described in subsection 
(b); and 
‘‘(2) allow the holder of an advanced technology 
designation, or a person authorized by the advanced 
manufacturing technology designation holder, to ref-
erence or rely upon, in an application submitted 
under section 505 of this Act or section 351 of the 
Public Health Service Act, including a supplemental 
application, data and information about the des-
ignated advanced manufacturing technology for use 
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