H. R. 2617—1361 
manufacturing practices may be incorporated into the 
review of medical product applications; and 
‘‘(D) a summary of relevant feedback related to 
improving advanced and continuous pharmaceutical manu-
facturing solicited from the public, which may include other 
institutions of higher education, nonprofit organizations, 
and large and small pharmaceutical manufacturers, 
including generic and nonprescription manufacturers, and 
contract manufacturers, and other relevant entities. 
‘‘(h) DEFINITIONS.—In this section: 
‘‘(1) ADVANCED AND CONTINUOUS PHARMACEUTICAL MANU-
FACTURING.—The term ‘advanced and continuous pharma-
ceutical manufacturing’ refers to a method of pharmaceutical 
manufacturing, or a combination of pharmaceutical manufac-
turing methods— 
‘‘(A) that incorporates a novel technology, or uses an 
established technique or technology in a new or innovative 
way, that enhances drug quality or improves the manufac-
turing process for a drug, including processes that may 
apply to advanced therapies and the production of biological 
products, such as cell and gene therapies; or 
‘‘(B) for which the input materials are continuously 
fed into and transformed within the process, and the output 
materials are continuously removed from the system, uti-
lizing an integrated manufacturing process that consists 
of a series of 2 or more simultaneous unit operations. 
‘‘(2) BIOLOGICAL PRODUCT.—The term ‘biological product’ 
has the meaning given such term in section 351(i) of the Public 
Health Service Act (42 U.S.C. 262(i)). 
‘‘(3) DRUG.—The term ‘drug’ has the meaning given such 
term in section 201(g) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321(g)). 
‘‘(4) INSTITUTION OF HIGHER EDUCATION.—The term ‘institu-
tion 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)). 
‘‘(5) SECRETARY.—The term ‘Secretary’ means the Secretary 
of Health and Human Services. 
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) IN GENERAL.—There is authorized to be appropriated 
to carry out this section $100,000,000 for the period of fiscal 
years 2023 through 2027. 
‘‘(2) FEDERAL ADMINISTRATIVE EXPENSES.—Of the amounts 
made available to carry out this section for a fiscal year, the 
Secretary shall not use more than 8 percent for Federal 
administrative expenses, including training, technical assist-
ance, reporting, and evaluation.’’. 
(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.
H. R. 2617—1362 
(c) CLERICAL AMENDMENT.—The item relating to section 3016 
in the table of contents in section 1(b) of the 21st Century Cures 
Act (Public Law 114–255) is amended to read as follows: 
‘‘Sec. 3016. National Centers of Excellence in Advanced and Continuous Pharma-
ceutical Manufacturing.’’. 
SEC. 3205. PUBLIC WORKSHOP ON CELL THERAPIES. 
Not later than 3 years after the date of the enactment of 
this Act, the Secretary, acting through the Commissioner of Food 
and Drugs, shall convene a public workshop with relevant stake-
holders to discuss best practices on generating scientific data nec-
essary to further facilitate the development of certain human cell- 
, tissue-, and cellular-based medical products (and the latest sci-
entific information about such products) that are regulated as drugs 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.) and biological products under section 351 of the Public 
Health Service Act (42 U.S.C. 262), namely, stem cell and other 
cellular therapies. 
SEC. 3206. CLARIFICATIONS TO EXCLUSIVITY PROVISIONS FOR FIRST 
INTERCHANGEABLE 
BIOSIMILAR 
BIOLOGICAL 
PROD-
UCTS. 
Section 351(k)(6) of the Public Health Service Act (42 U.S.C. 
262(k)(6)) is amended— 
(1) in the matter preceding subparagraph (A)— 
(A) by striking ‘‘Upon review of’’ and inserting ‘‘The 
Secretary shall not make approval as an interchangeable 
biological product effective with respect to’’; 
(B) by striking ‘‘relying on’’ and inserting ‘‘that relies 
on’’; and 
(C) by striking ‘‘the Secretary shall not make a deter-
mination under paragraph (4) that the second or subse-
quent biological product is interchangeable for any condi-
tion of use’’; and 
(2) in the flush text that follows subparagraph (C)(ii), by 
striking ‘‘taken.’’ and inserting ‘‘taken, and the term ‘first inter-
changeable biosimilar biological product’ means any inter-
changeable biosimilar biological product that is approved on 
the first day on which such a product is approved as inter-
changeable with the reference product.’’. 
SEC. 3207. GAO REPORT ON NONPROFIT PHARMACEUTICAL ORGANIZA-
TIONS. 
(a) GAO REVIEW.—The Comptroller General of the United 
States (referred to in this section as the ‘‘Comptroller General’’) 
shall prepare a report on— 
(1) what is known about nonprofit pharmaceutical manufac-
turing organizations, including the impact of such organizations 
on the development, availability, and cost of prescription drugs 
in the United States, which may include information with 
respect to the capacity and capability to help prevent or miti-
gate shortages of such drugs, and any challenges to manufac-
turing or other operations; and 
(2) recommendations to address such challenges. 
(b) REPORT.—Not later than 2 years after the date of enactment 
of this Act, the Comptroller General shall submit the report 
described in subsection (a) to the Committee on Health, Education,
H. R. 2617—1363 
Labor, and Pensions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives. 
SEC. 3208. RARE DISEASE ENDPOINT ADVANCEMENT PILOT PROGRAM. 
(a) IN GENERAL.—The Secretary shall establish a pilot program 
under which the Secretary establishes procedures to provide 
increased interaction with sponsors of rare disease drug develop-
ment programs for purposes of advancing the development of effi-
cacy endpoints, including surrogate and intermediate endpoints, 
for drugs intended to treat rare diseases, including through— 
(1) determining eligibility of participants for such program; 
and 
(2) developing and implementing a process for applying 
to, and participating in, such a program. 
(b) PUBLIC WORKSHOPS.—The Secretary shall conduct up to 
3 public workshops, which shall be completed not later than Sep-
tember 30, 2026, to discuss topics relevant to the development 
of endpoints for rare diseases, which may include discussions 
about— 
(1) novel endpoints developed through the pilot program 
established under this section; and 
(2) as appropriate, the use of real world evidence and 
real world data to support the validation of efficacy endpoints, 
including surrogate and intermediate endpoints, for rare dis-
eases. 
(c) REPORTS.— 
(1) INTERIM REPORT.—Not later than September 30, 2026, 
the Secretary shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives 
a report describing the completed and ongoing activities in 
the pilot program established under this section and public 
workshops described in subsection (b). 
(2) FINAL REPORT.—Not later than September 30, 2027, 
the Secretary shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives 
a report describing the outcomes of the pilot program estab-
lished under this section. 
(d) GUIDANCE.—Not later than September 30, 2027, the Sec-
retary shall issue guidance describing best practices and strategies 
for development of efficacy endpoints, including surrogate and inter-
mediate endpoints, for rare diseases. 
(e) SUNSET.—The Secretary may not accept any new application 
or request to participate in the program established by this section 
on or after October 1, 2027. 
SEC. 3209. ANIMAL TESTING ALTERNATIVES. 
(a) IN GENERAL.—Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended— 
(1) in subsection (i)— 
(A) in paragraph (1)(A), by striking ‘‘preclinical tests 
(including tests on animals)’’ and inserting ‘‘nonclinical 
tests’’; and 
(B) in paragraph (2)(B), by striking ‘‘animal’’ and 
inserting ‘‘nonclinical tests’’; and 
(2) by inserting after subsection (y) the following:
H. R. 2617—1364 
‘‘(z) NONCLINICAL TEST DEFINED.—For purposes of this section, 
the term ‘nonclinical test’ means a test conducted 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. 
‘‘(2) Organ chips and microphysiological systems. 
‘‘(3) Computer modeling. 
‘‘(4) Other nonhuman or human biology-based test methods, 
such as bioprinting. 
‘‘(5) Animal tests.’’. 
(b) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATIONS.—Item (bb) 
of section 351(k)(2)(A)(i)(I) of the Public Health Service Act (42 
U.S.C. 262(k)(2)(A)(i)(I)) is amended to read as follows: 
‘‘(bb) an assessment of toxicity (which may 
rely on, or consist of, a study or studies 
described in item (aa) or (cc)); and’’. 
SEC. 3210. MODERNIZING ACCELERATED APPROVAL. 
(a) IN GENERAL.—Section 506(c) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356(c)) is amended— 
(1) in paragraph (2)— 
(A) by redesignating subparagraphs (A) and (B) as 
clauses (i) and (ii), respectively, and adjusting the margins 
accordingly; 
(B) by striking ‘‘Approval of a product’’ and inserting 
the following: 
‘‘(A) IN GENERAL.—Approval of a product’’; 
(C) in clause (i) of such subparagraph (A), as so redesig-
nated, by striking ‘‘appropriate postapproval studies’’ and 
inserting ‘‘an appropriate postapproval study or studies’’; 
and 
(D) by adding at the end the following: 
‘‘(B) STUDIES
NOT
REQUIRED.—If the Secretary does 
not require that the sponsor of a product approved under 
accelerated approval conduct a postapproval study under 
this paragraph, the Secretary shall publish on the website 
of the Food and Drug Administration the rationale for 
why such study is not appropriate or necessary. 
‘‘(C) POSTAPPROVAL STUDY CONDITIONS.—Not later than 
the date of approval of a product under accelerated 
approval, the Secretary shall specify the conditions for 
a postapproval study or studies required to be conducted 
under this paragraph with respect to such product, which 
may include enrollment targets, the study protocol, and 
milestones, including the target date of study completion. 
‘‘(D) STUDIES BEGUN BEFORE APPROVAL.—The Secretary 
may require, as appropriate, a study or studies to be under-
way prior to approval, or within a specified time period 
after the date of approval, of the applicable product.’’; and 
(2) in paragraph (3)— 
(A) in the matter preceding subparagraph (A), by 
striking ‘‘(as prescribed by the Secretary in regulations 
which shall include an opportunity for an informal 
hearing)’’ and inserting ‘‘described in subparagraph (B)’’;
H. R. 2617—1365 
(B) by redesignating subparagraphs (A) through (D) 
as clauses (i) through (iv), respectively and adjusting the 
margins accordingly; 
(C) by striking ‘‘The Secretary may’’ and inserting the 
following: 
‘‘(A) IN GENERAL.—The Secretary may’’; 
(D) in clause (i) of such subparagraph (A), as so redesig-
nated, by striking ‘‘drug with due diligence’’ and inserting 
‘‘product with due diligence, including with respect to condi-
tions specified by the Secretary under paragraph (2)(C)’’; 
(E) in clause (iii) of such subparagraph (A), as so 
redesignated, by inserting ‘‘shown to be’’ after ‘‘product 
is not’’; and 
(F) by adding at the end the following: 
‘‘(B) EXPEDITED
PROCEDURES
DESCRIBED.—Expedited 
procedures described in this subparagraph shall consist 
of, prior to the withdrawal of accelerated approval— 
‘‘(i) providing the sponsor with— 
‘‘(I) due notice; 
‘‘(II) an explanation for the proposed with-
drawal; 
‘‘(III) an opportunity for a meeting with the 
Commissioner or the Commissioner’s designee; and 
‘‘(IV) an opportunity for written appeal to— 
‘‘(aa) the Commissioner; or 
‘‘(bb) a designee of the Commissioner who 
has not participated in the proposed with-
drawal of approval (other than a meeting 
pursuant to subclause (III)) and is not subordi-
nate of an individual (other than the Commis-
sioner) who participated in such proposed 
withdrawal; 
‘‘(ii) providing an opportunity for public comment 
on the proposal to withdraw approval; 
‘‘(iii) the publication of a summary of the public 
comments received, and the Secretary’s response to 
such comments, on the website of the Food and Drug 
Administration; and 
‘‘(iv) convening and consulting an advisory com-
mittee on issues related to the proposed withdrawal, 
if requested by the sponsor and if no such advisory 
committee has previously advised the Secretary on 
such issues with respect to the withdrawal of the 
product prior to the sponsor’s request.’’. 
(b) REPORTS OF POSTMARKETING STUDIES.—Section 506B(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356b(a)) 
is amended— 
(1) by redesignating paragraph (2) as paragraph (3); and 
(2) by inserting after paragraph (1) the following: 
‘‘(2) ACCELERATED APPROVAL.—Notwithstanding paragraph 
(1), a sponsor of a drug approved pursuant to accelerated 
approval shall submit to the Secretary a report of the progress 
of any study required under section 506(c), including progress 
toward enrollment targets, milestones, and other information 
as required by the Secretary, not later than 180 days after 
the approval of such drug and not less frequently than every 
180 days thereafter, until the study is completed or terminated.
H. R. 2617—1366 
The Secretary shall promptly publish on the website of the 
Food and Drug Administration, in an easily searchable format, 
the information reported under this paragraph.’’. 
(c) ENFORCEMENT.—Section 301 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 331), as amended by title II, is further 
amended by adding at the end the following: 
‘‘(ggg) The failure of a sponsor of a product approved under 
accelerated approval pursuant to section 506(c)— 
‘‘(1) to conduct with due diligence any postapproval study 
required under section 506(c) with respect to such product; 
or 
‘‘(2) to submit timely reports with respect to such product 
in accordance with section 506B(a)(2).’’. 
(d) GUIDANCE.— 
(1) IN
GENERAL.—The Secretary shall issue guidance 
describing— 
(A) how sponsor questions related to the identification 
of novel surrogate or intermediate clinical endpoints may 
be addressed in early-stage development meetings with 
the Food and Drug Administration; 
(B) the use of novel clinical trial designs that may 
be used to conduct appropriate postapproval studies as 
may be required under section 506(c)(2)(A) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)(2)(A)), as 
amended by subsection (a); 
(C) the expedited procedures described in section 
506(c)(3)(B) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 356(c)(3)(B)); and 
(D) considerations related to the use of surrogate or 
intermediate clinical endpoints that may support the accel-
erated approval of an application under 506(c)(1)(A) of such 
Act (21 U.S.C. 356(c)(1)(A)), including considerations in 
evaluating the evidence related to any such endpoints. 
(2) FINAL GUIDANCE.—The Secretary shall issue— 
(A) draft guidance under paragraph (1) not later than 
18 months after the date of enactment of this Act; and 
(B) final guidance not later than 1 year after the close 
of the public comment period on such draft guidance. 
(e) ACCELERATED APPROVAL COUNCIL.— 
(1) IN
GENERAL.—Not later than 1 year after the date 
of enactment of this Act, the Secretary shall establish an intra- 
agency coordinating council (referred to in this subsection as 
the ‘‘Council’’) within the Food and Drug Administration to 
ensure the consistent and appropriate use of accelerated 
approval across the Food and Drug Administration, pursuant 
to section 506(c) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356(c)). 
(2) MEMBERSHIP.—The members of the Council shall consist 
of the following senior officials, or a designee of such official, 
from the Food and Drug Administration and relevant Centers: 
(A) The Director of the Center for Drug Evaluation 
and Research. 
(B) The Director of the Center for Biologics Evaluation 
and Research. 
(C) The Director of the Oncology Center of Excellence. 
(D) The Director of the Office of New Drugs.
H. R. 2617—1367 
(E) The Director of the Office of Orphan Products 
Development. 
(F) The Director of the Office of Tissues and Advanced 
Therapies. 
(G) The Director of the Office of Medical Policy. 
(H) At least 3 directors of review divisions or offices 
overseeing products approved under accelerated approval, 
including at least one director within the Office of Neuro-
science. 
(3) DUTIES OF THE COUNCIL.— 
(A) MEETINGS.—The Council shall convene not fewer 
than 3 times per calendar year to discuss issues related 
to accelerated approval, including any relevant cross-dis-
ciplinary approaches related to product review with respect 
to accelerated approval. 
(B) POLICY DEVELOPMENT.—The Council shall directly 
engage with product review teams to support the consistent 
and appropriate use of accelerated approval across the 
Food and Drug Administration. Such engagement may 
include— 
(i) developing guidance for Food and Drug 
Administration staff and best practices for, and across, 
product review teams, including with respect to 
communication between sponsors and the Food and 
Drug Administration and the review of products under 
accelerated approval; 
(ii) providing training for product review teams; 
and 
(iii) advising review divisions on best practices 
with respect to product-specific development, review, 
and 
withdrawal 
of 
products 
under 
accelerated 
approval. 
(4) PUBLICATION OF A REPORT.—Not later than 1 year after 
the date of enactment of this Act, and annually thereafter, 
the Council shall publish on the public website of the Food 
and Drug Administration a report on the activities of the 
Council. 
(f) RULE OF CONSTRUCTION.—Nothing in this section (including 
the amendments made by this section) shall be construed to affect 
ongoing withdrawal proceedings for products approved pursuant 
to section 506(c) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 356(c)) for which a notice of proposed withdrawal has 
been published in the Federal Register prior to the date of enact-
ment of this Act. Such proceedings may continue under procedures 
in effect prior to the date of enactment of this Act. 
SEC. 3211. ANTIFUNGAL RESEARCH AND DEVELOPMENT. 
(a) DRAFT GUIDANCE.—Not later than 3 years after the date 
of enactment of this Act, the Secretary, acting through the Commis-
sioner 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 coccidioi-
domycosis (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
H. R. 2617—1368 
to subsection (a), the Secretary, acting through the Commissioner 
of Food and Drugs, shall finalize the draft guidance. 
(c) WORKSHOP.—To assist entities developing preventive vac-
cines for fungal infections and coccidioidomycosis, the Secretary 
shall hold a public workshop. 
SEC. 3212. 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’’ and inserting 
‘‘;’’; 
(B) in paragraph (3), by striking the period 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 follows: 
‘‘(g) QUALIFIED
INFECTIOUS
DISEASE
PRODUCT.—The term 
‘qualified infectious disease product’ means a drug (including a 
biological product), including an antibacterial or antifungal drug, 
for human use that— 
‘‘(1) acts on bacteria or fungi or on substances produced 
by such bacteria or fungi; and 
‘‘(2) is intended to treat a serious or life-threatening infec-
tion, including such an infection caused by— 
‘‘(A) an antibacterial or antifungal resistant pathogen, 
including novel or emerging infectious pathogens; or 
‘‘(B) qualifying pathogens listed by the Secretary under 
subsection (f).’’. 
(b) PRIORITY REVIEW.—Section 524A(a) of the Federal 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. 
SEC. 3213. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNA-
TION PROGRAM. 
Subchapter A of chapter V of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351 et seq.), as amended by title II, is 
further amended by inserting after section 506K the following: 
‘‘SEC. 506L. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNA-
TION PROGRAM. 
‘‘(a) IN GENERAL.—Not later than 1 year after the date of 
enactment of this section, the Secretary shall initiate a program 
under which persons may request designation of an advanced manu-
facturing technology as described in subsection (b).
H. R. 2617—1369 
‘‘(b) DESIGNATION PROCESS.—The Secretary shall establish a 
process for the designation under this section of methods of manu-
facturing drugs, including biological products, and active pharma-
ceutical ingredients of such drugs, as advanced manufacturing tech-
nologies. A method of manufacturing, or a combination of manufac-
turing methods, is eligible for designation as an advanced manufac-
turing technology 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 improve the 
manufacturing process for a drug while maintaining equivalent, 
or providing superior, drug quality, including by— 
‘‘(1) reducing development time for a drug using the des-
ignated manufacturing method; or 
‘‘(2) increasing or maintaining the supply of— 
‘‘(A) a drug that is life-supporting, life-sustaining, or 
of critical importance to providing health care; or 
‘‘(B) a drug that is on the drug shortage list under 
section 506E. 
‘‘(c) EVALUATION AND DESIGNATION OF AN ADVANCED MANUFAC-
TURING TECHNOLOGY.— 
‘‘(1) SUBMISSION.—A person who requests designation of 
a method of manufacturing as an advanced manufacturing 
technology under this section shall submit to the Secretary 
data or information demonstrating that the method of manufac-
turing meets the criteria described in subsection (b) in a par-
ticular context of use. The Secretary may facilitate the develop-
ment and review of such data or information by— 
‘‘(A) providing timely advice to, and interactive commu-
nication with, such person regarding the development of 
the method of manufacturing; and 
‘‘(B) involving senior managers and experienced staff 
of the Food and Drug Administration, as appropriate, in 
a collaborative, cross-disciplinary review of the method of 
manufacturing, 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 tech-
nology, in a particular context of use, based on the data and 
information submitted under paragraph (1) and the criteria 
described in subsection (b). 
‘‘(d) REVIEW OF ADVANCED MANUFACTURING TECHNOLOGIES.— 
If the Secretary designates a method of manufacturing 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, including supplemental applications, 
for drugs that are manufactured using a designated advanced 
manufacturing technology; and 
‘‘(2) allow the holder of an advanced technology designation, 
or a person authorized by the advanced manufacturing tech-
nology designation holder, to reference 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 designated 
advanced manufacturing technology for use in manufacturing