H. R. 2617—1346 
‘‘(5) The requirements of paragraphs (1) and (2) shall apply 
regardless of whether the drug or device undergoes further manu-
facture, preparation, propagation, compounding, or processing at 
a separate establishment outside the United States prior to being 
imported or offered for import into the United States.’’. 
(b) UPDATING REGULATIONS.—Not later than 2 years after the 
date of enactment of this Act, the Secretary of Health and Human 
Services shall update regulations, as appropriate, to implement 
the amendment made by subsection (a). 
SEC. 2512. EXTENDING EXPIRATION DATES FOR CERTAIN DRUGS. 
(a) IN GENERAL.—Not later than 1 year after the date of enact-
ment of this Act, the Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’) shall issue draft 
guidance, or revise existing guidance, to address recommendations 
for sponsors of applications submitted 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) regarding— 
(1) the submission of stability testing data in such applica-
tions, including considerations for data requirements that could 
be streamlined or reduced to facilitate faster review of longer 
proposed expiration dates; 
(2) establishing in the labeling of drugs the longest feasible 
expiration date scientifically supported by such data, taking 
into consideration how extended expiration dates may— 
(A) help prevent or mitigate drug shortages; and 
(B) affect product quality; and 
(3) the use of innovative approaches for drug and combina-
tion product stability modeling to support initial product expira-
tion dates and expiration date extensions. 
(b) REPORT.—Not later than 2 years after the date of enactment 
of this Act, and again 2 years thereafter, the Secretary shall submit 
to the Committee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Commerce of the 
House of Representatives a report that includes— 
(1) the number of drugs for which the Secretary has 
requested the manufacturer make a labeling change regarding 
the expiration date; and 
(2) for each drug for which the Secretary has requested 
a labeling change with respect to the expiration date, informa-
tion regarding the circumstances of such request, including— 
(A) the name and dose of such drug; 
(B) the rationale for the request; 
(C) whether the drug, at the time of the request, was 
listed on the drug shortage list under section 506E of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e), 
or was at risk of shortage; 
(D) whether the request was made in connection with 
a public health emergency declared under section 319 of 
the Public Health Service Act (42 U.S.C. 247d); and 
(E) whether the manufacturer made the requested 
change by the requested date, and for instances where 
the manufacturer does not make the requested change, 
the manufacturer’s justification for not making the change, 
if the manufacturer agrees to provide such justification 
for inclusion in the report.
H. R. 2617—1347 
SEC. 2513. COMBATING COUNTERFEIT DEVICES. 
(a) PROHIBITED ACTS.—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)(1) Forging, counterfeiting, simulating, or falsely rep-
resenting, or without proper authority using any mark, stamp, 
tag, label, or other identification upon any device or container, 
packaging, or labeling thereof so as to render such device a counter-
feit device. 
‘‘(2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, stone, or 
other thing designed to print, imprint, or reproduce the trademark, 
trade name, or other identifying mark or imprint of another or 
any likeness of any of the foregoing upon any device or container, 
packaging, or labeling thereof so as to render such device a counter-
feit device. 
‘‘(3) The doing of any act which causes a device to be a counter-
feit device, or the sale or dispensing, or the holding for sale or 
dispensing, of a counterfeit device.’’. 
(b) PENALTIES.—Section 303 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333) is amended— 
(1) in subsection (b)(8), by inserting ‘‘, or who violates 
section 301(fff)(3) by knowingly making, selling or dispensing, 
or holding for sale or dispensing, a counterfeit device,’’ after 
‘‘a counterfeit drug’’; and 
(2) in subsection (c), by inserting ‘‘; or (6) for having violated 
section 301(fff)(2) if such person acted in good faith and had 
no reason to believe that use of the punch, die, plate, stone, 
or other thing involved would result in a device being a counter-
feit device, or for having violated section 301(fff)(3) if the person 
doing the act or causing it to be done acted in good faith 
and had no reason to believe that the device was a counterfeit 
device’’ before the period. 
(c) SEIZURE.—Section 304(a)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 334(a)(2)) is amended— 
(1) by striking ‘‘, and (E)’’ and inserting ‘‘, (E)’’; and 
(2) by inserting ‘‘, (F) Any device that is a counterfeit 
device, (G) Any container, packaging, or labeling of a counterfeit 
device, and (H) Any punch, die, plate, stone, labeling, container, 
or other thing used or designed for use in making a counterfeit 
device or devices’’ before the period. 
SEC. 2514. PREVENTING MEDICAL DEVICE SHORTAGES. 
(a) NOTIFICATIONS.—Section 506J of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356j) is amended— 
(1) in subsection (f), by inserting ‘‘or (h)’’ after ‘‘subsection 
(a)’’; 
(2) by redesignating subsections (h) and (i) as subsections 
(i) and (j), respectively; and 
(3) by inserting after subsection (g) the following: 
‘‘(h) ADDITIONAL NOTIFICATIONS.—The Secretary may receive 
voluntary notifications from a manufacturer of a device that is 
life-supporting, life-sustaining, or intended for use in emergency 
medical care or during surgery, or any other device the Secretary 
determines to be critical to the public health, pertaining to a perma-
nent discontinuance in the manufacture of the device (except for 
any discontinuance as a result of an approved modification of the
H. R. 2617—1348 
device) or an interruption of the manufacture of the device that 
is likely to lead to a meaningful disruption in the supply of that 
device in the United States, and the reasons for such discontinuance 
or interruption.’’. 
(b) GUIDANCE ON VOLUNTARY NOTIFICATIONS OF DISCONTINU-
ANCE OR INTERRUPTION OF DEVICE MANUFACTURE.—Not later than 
1 year after the date of enactment of this Act, the Secretary shall 
issue draft guidance to facilitate voluntary notifications under sub-
section (h) of section 506J of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356j), as added by subsection (a). Such guidance 
shall include a description of circumstances in which a voluntary 
notification under such subsection (h) may be appropriate, rec-
ommended timeframes for such a notification, the process for 
receiving such a notification, and actions the Secretary may take 
to mitigate or prevent a shortage resulting from a discontinuance 
or interruption in the manufacture of a device for which such 
notification is received. The Secretary shall issue final guidance 
not later than 1 year after the close of the comment period for 
the draft guidance. 
(c) GUIDANCE ON DEVICE SHORTAGE NOTIFICATION REQUIRE-
MENT.—Not later than 1 year after the date of enactment of this 
Act, the Secretary shall issue or revise draft guidance regarding 
requirements under section 506J of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356j). Such guidance shall include a list 
of each device product code for which a manufacturer of such 
device is required to notify the Secretary in accordance with section 
506J. 
SEC. 2515. TECHNICAL CORRECTIONS. 
(a) TECHNICAL CORRECTIONS TO THE CARES ACT.—Division 
A of the CARES Act (Public Law 116–136) is amended— 
(1) in section 3111(1), by striking ‘‘in paragraph (1)’’ and 
inserting ‘‘in the matter preceding paragraph (1)’’; 
(2) in section 3112(d)(1), by striking ‘‘and subparagraphs 
(A) and (B)’’ and inserting ‘‘as subparagraphs (A) and (B)’’; 
and 
(3) in section 3112(e), by striking ‘‘Federal Food, Drug, 
Cosmetic Act’’ and inserting ‘‘Federal Food, Drug, and Cosmetic 
Act’’. 
(b) TECHNICAL CORRECTIONS TO THE FEDERAL FOOD, DRUG, 
AND COSMETIC ACT RELATED TO THE CARES ACT.— 
(1) SECTION 506C.—Section 506C(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356c(a)) is amended, in 
the flush text at the end, by striking the second comma after 
‘‘in the United States’’. 
(2) EFFECTIVE DATE.—The amendment made by paragraph 
(1) shall take effect as if included in section 3112 of division 
A of the CARES Act (Public Law 116–136). 
(c) OTHER TECHNICAL CORRECTION
TO
THE FEDERAL FOOD, 
DRUG, AND COSMETIC ACT.—Section 505B(f)(6)(I) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(f)(6)(I)) is amended 
by striking ‘‘subsection (a)(3)(B)’’ and inserting ‘‘subsection 
(a)(4)(C)’’.
H. R. 2617—1349 
TITLE III—FOOD AND DRUG 
ADMINISTRATION 
SEC. 3001. SHORT TITLE. 
This title may be cited as the ‘‘Food and Drug Omnibus Reform 
Act of 2022’’. 
SEC. 3002. DEFINITION. 
In this title, except as otherwise specified, the term ‘‘Secretary’’ 
means the Secretary of Health and Human Services. 
Subtitle A—Reauthorizations 
SEC. 3101. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRI-
VATE PARTNERSHIP. 
Section 566(f) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb–5(f)) is amended by striking ‘‘$1,265,753 for 
the period beginning on October 1, 2022 and ending on December 
23, 2022’’ and inserting ‘‘$6,000,000 for each of fiscal years 2023 
through 2027’’. 
SEC. 3102. REAUTHORIZATION OF THE BEST PHARMACEUTICALS FOR 
CHILDREN PROGRAM. 
Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 
284m(d)(1)) is amended by striking ‘‘$5,273,973 for the period begin-
ning on October 1, 2022 and ending on December 23, 2022’’ and 
inserting ‘‘$25,000,000 for each of fiscal years 2023 through 2027’’. 
SEC. 3103. REAUTHORIZATION OF THE HUMANITARIAN DEVICE EXEMP-
TION INCENTIVE. 
Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking 
‘‘December 24, 2022’’ and inserting ‘‘October 1, 2027’’. 
SEC. 3104. REAUTHORIZATION OF THE PEDIATRIC DEVICE CONSORTIA 
PROGRAM. 
Section 305(e) of the Food and Drug Administration Amend-
ments Act of 2007 (Public Law 110–85; 42 U.S.C. 282 note) is 
amended by striking ‘‘$1,107,534 for the period beginning on 
October 1, 2022, and ending on December 23, 2022’’ and inserting 
‘‘$7,000,000 for each of fiscal years 2023 through 2027’’. 
SEC. 3105. REAUTHORIZATION OF PROVISION PERTAINING TO DRUGS 
CONTAINING SINGLE ENANTIOMERS. 
Section 505(u) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(u)) is amended— 
(1) in paragraph (1)(A)(ii)(II), by adding ‘‘(other than bio-
availability studies)’’ after ‘‘any clinical investigations’’; and 
(2) in paragraph (4), by striking ‘‘December 24, 2022’’ and 
inserting ‘‘October 1, 2027’’. 
SEC. 3106. REAUTHORIZATION OF CERTAIN DEVICE INSPECTIONS. 
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374(g)(11)) is amended by striking ‘‘December 24, 
2022’’ and inserting ‘‘October 1, 2027’’.
H. R. 2617—1350 
SEC. 3107. REAUTHORIZATION OF ORPHAN DRUG GRANTS. 
Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is 
amended— 
(1) in subsection (a)— 
(A) by striking ‘‘and (3)’’ and inserting ‘‘(3)’’; and 
(B) by inserting before the period at the end the fol-
lowing: ‘‘, and (4) developing regulatory science pertaining 
to the chemistry, manufacturing, and controls of individual-
ized medical products to treat individuals with rare dis-
eases or conditions’’; and 
(2) in subsection (c), by striking ‘‘$6,328,767 for the period 
beginning on October 1, 2022, and ending on December 23, 
2022’’ and inserting ‘‘$30,000,000 for each of fiscal years 2023 
through 2027’’. 
SEC. 
3108. 
REAUTHORIZATION 
OF 
REPORTING 
REQUIREMENTS 
RELATED TO PENDING GENERIC DRUG APPLICATIONS 
AND PRIORITY REVIEW APPLICATIONS. 
Section 807 of the FDA Reauthorization Act of 2017 (Public 
Law 115–52) is amended, in the matter preceding paragraph (1), 
by striking ‘‘December 23, 2022’’ and inserting ‘‘October 1, 2027’’. 
SEC. 3109. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM. 
Section 523(c) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360m(c)) is amended by striking ‘‘December 24, 2022’’ 
and inserting ‘‘on October 1, 2027’’ . 
Subtitle B—Drugs and Biologics 
CHAPTER 1—RESEARCH, DEVELOPMENT, AND 
COMPETITION IMPROVEMENTS 
SEC. 3201. PROMPT REPORTS OF MARKETING STATUS BY HOLDERS 
OF APPROVED APPLICATIONS FOR BIOLOGICAL PROD-
UCTS. 
(a) IN GENERAL.—Section 506I of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356i) is amended— 
(1) in subsection (a)— 
(A) in the matter preceding paragraph (1), by striking 
‘‘The holder of an application approved under subsection 
(c) or (j) of section 505’’ and inserting ‘‘The holder of an 
application approved 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’’; 
(B) in paragraph (2), by striking ‘‘established name’’ 
and inserting ‘‘established name (or, in the case of a 
biological product, the proper name)’’; and 
(C) in paragraph (3), by striking ‘‘or abbreviated 
application number’’ and inserting ‘‘, abbreviated applica-
tion number, or biologics license application number’’; and 
(2) in subsection (b)— 
(A) in the matter preceding paragraph (1), by striking 
‘‘The holder of an application approved under subsection 
(c) or (j)’’ and inserting ‘‘The holder of an application 
approved 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’’;
H. R. 2617—1352 
(B) by striking ‘‘monthly updates to the list’’ and 
inserting ‘‘monthly updates to the lists referred to in the 
preceding sentences’’; and 
(C) by striking ‘‘and shall update the list based on’’ 
and inserting ‘‘and shall update such lists based on’’. 
(d) TECHNICAL CORRECTIONS.—Section 506I(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356i(e)) is amended— 
(1) by striking ‘‘subsection 505(j)(7)(A)’’ and inserting ‘‘sec-
tion 505(j)(7)(A)’’; and 
(2) by striking ‘‘subsection 505(j)(7)(C)’’ and inserting ‘‘sec-
tion 505(j)(7)(C)’’. 
SEC. 3202. 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 Com-
merce of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate a 
report summarizing the activities of the Food and Drug 
Administration, with respect to the period of fiscal years 2023 
through fiscal year 2025, 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 approving 
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), including— 
(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 section 351 of the Public Health Service 
Act (42 U.S.C. 262) received by the Food and Drug Adminis-
tration, the number of such applications accepted and 
rejected for filing, and the numbers of such applications 
pending, approved, and for which a complete response letter 
has been issued by the Food and Drug Administration; 
(B) the number of applications for which the sponsor 
requested written recommendations pursuant to section 
525 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360aa) and the number of such applications for which 
the sponsor received such written recommendations; 
(C) a description of trends in drug approvals for rare 
diseases and conditions across review divisions at the Food 
and Drug Administration; 
(D) the extent to which the Food and Drug Administra-
tion is consulting with external experts pursuant to section 
569(a)(2) of the Federal 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; 
(E) the number of applications for which the Secretary 
allowed the sponsor to rely upon data and information 
pursuant to section 529A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360ff–1); and 
(F) a description of the Food and Drug Administration’s 
efforts to promote best practices in the development of 
novel 
treatments 
for 
rare 
diseases 
or 
conditions, 
including—
H. R. 2617—1353 
(i) reviewer training on policies, methods, and tools 
related to rare diseases and conditions; and 
(ii) new regulatory science and coordinated support 
for patient and stakeholder engagement. 
(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 disclosure of information 
that is prohibited from disclosure under section 301(j) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)) or 
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 referred to as the ‘‘Freedom 
of Information Act’’). 
(b) GUIDANCE.—Not later than 9 months after the date of 
enactment of this Act, the Secretary shall publish final guidance 
related to the draft guidance titled, ‘‘Rare Diseases: Common Issues 
in Drug Development’’, issued on February 1, 2019. 
(c) STUDY ON EUROPEAN UNION SAFETY AND EFFICACY REVIEWS 
OF DRUGS FOR RARE DISEASES AND CONDITIONS.— 
(1) IN GENERAL.—The Secretary shall enter into a contract 
with the National Academies of Sciences, Engineering, and 
Medicine (referred to in this section as the ‘‘National Acad-
emies’’) 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; 
(B) the consideration and use of supplemental data 
submitted during review processes in the United States 
and the European Union, including data associated with 
open label extension studies and expanded access programs 
specific to rare diseases or conditions; 
(C) an assessment of collaborative efforts between 
United States and European Union regulators related to— 
(i) product development programs under review; 
(ii) policies under development and those recently 
issued; and 
(iii) scientific information related to product 
development or regulation; and 
(D) recommendations for how Congress can support 
collaborative efforts described in subparagraph (C). 
(2) CONSULTATION.—The contract under paragraph (1) shall 
provide for consultation with relevant stakeholders, including— 
(A) representatives from the Food and Drug Adminis-
tration and the European Medicines Agency; 
(B) patients with rare diseases or conditions; and 
(C) patient groups that— 
(i) represent patients with rare diseases or condi-
tions; and 
(ii) have international patient outreach. 
(3) REPORT.—The contract under paragraph (1) shall pro-
vide for, not later than 2 years after the date of entering 
into such contract—
H. R. 2617—1354 
(A) the completion of the study under paragraph (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 National Academies to make the report 
under paragraph (3) available to the public, including by posting 
the report on the website of the National Academies. 
(d) PUBLIC MEETING.— 
(1) IN GENERAL.—Not later than December 31, 2023, the 
Secretary, acting through the Commissioner of Food and Drugs, 
shall convene one or more public meetings to solicit input 
from stakeholders regarding the approaches described in para-
graph (2). 
(2) APPROACHES.—The public meeting or meetings under 
paragraph (1) shall address approaches to increasing and 
improving engagement with rare disease or condition patients, 
groups representing such patients, rare disease or condition 
experts, and experts 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 understanding 
the risks of side effects relative to the health status of 
the patient and the progression of the disease or condition. 
(3) PUBLIC DOCKET.—The Secretary shall establish a public 
docket to receive written comments related to the approaches 
addressed during each public meeting under paragraph (1). 
Such public docket shall remain open for 60 days following 
the date of each such public meeting. 
(4) REPORTS.—Not later than 180 days after each public 
meeting under paragraph (1), the Commissioner of Food and 
Drugs shall develop and publish on the website of the Food 
and Drug Administration a report on— 
(A) the approaches discussed at the public meeting; 
and 
(B) any related recommendations. 
(e) CONSULTATION
ON
THE SCIENCE
OF SMALL POPULATION 
STUDIES.—Section 569(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–8(b)) is amended— 
(1) in paragraph (6), by striking ‘‘; and’’ and inserting 
a semicolon; 
(2) in paragraph (7), by striking the period and inserting 
‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(8) the science of small population studies.’’. 
(f) GAO REPORT.— 
(1) IN GENERAL.—Not later than 18 months after the date 
of enactment of this Act, the Comptroller General of the United 
States shall submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives, a report 
assessing the policies, practices, and programs of the Food
H. R. 2617—1355 
and Drug Administration with respect to the review of applica-
tions for approval of drugs under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) and licensing 
of biological products under section 351 of the Public Health 
Service Act (42 U.S.C. 262) intended to treat rare diseases 
and conditions. 
(2) CONTENT OF REPORT.—The report under paragraph (1) 
shall— 
(A) describe the activities of the Food and Drug 
Administration dedicated to the development and review 
of drugs and biological products intended to treat rare 
diseases and conditions under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) and section 
351 of the Public Health Service Act (42 U.S.C. 262); 
(B) describe challenges with developing and obtaining 
approval or licensure of drugs and biological products 
intended to treat rare diseases and conditions, such as 
challenges related to designing and conducting clinical 
trials, clinical trial subject recruitment and enrollment, 
study endpoints, and ensuring data quality, assessing the 
benefit-risk profile of drugs and biological products 
intended to treat rare diseases and conditions, and meeting 
requirements for approval or licensure; 
(C) assess the effectiveness of policies and practices 
of the Food and Drug Administration related to the review 
of applications for drugs and biological products intended 
to treat rare diseases and conditions, including— 
(i) initiatives to support the development and 
review of drugs and biological products intended to 
treat rare diseases and conditions, including initiatives 
related to regulatory science, clinical trial design, 
statistical analysis, and other relevant topics; 
(ii) consideration of relevant patient-focused drug 
development data and information, including patient 
experience data and the views of patients, pursuant 
to section 569C of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb–8c); 
(iii) training and other efforts to ensure the exper-
tise of personnel of the Food and Drug Administration 
regarding the review of applications for drugs and 
biological products intended to treat rare diseases and 
conditions; and 
(iv) consultations and engagement with stake-
holders and external experts pursuant to section 569 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb–8); 
(D) assess the extent to which the Food and Drug 
Administration is applying the policies and practices 
described in subparagraph (C) consistently across review 
divisions, and the factors that influence the extent to which 
such application is consistent; and 
(E) include recommendations to address challenges and 
deficiencies 
identified, 
including 
recommendations 
to 
improve the effectiveness, consistency, and coordination of 
policies, practices, and programs of the Food and Drug 
Administration related to the review of applications for
H. R. 2617—1356 
drugs and biological products intended to treat rare dis-
eases and conditions. 
(g) DEFINITION.—In this section, the terms ‘‘rare disease or 
condition’’, ‘‘rare diseases or conditions’’, and ‘‘rare diseases and 
conditions’’ have the meaning given the term ‘‘rare disease or condi-
tion’’ in section 526(a)(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb(a)(2)). 
SEC. 3203. 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 design and manufacturing. 
‘‘(2) ACTIONS.—In carrying out the program under para-
graph (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 manufac-
turing; 
‘‘(B) solicit information regarding, and conduct or sup-
port research on, innovative approaches to drug product 
design and manufacturing; 
‘‘(C) convene meetings with representatives of industry, 
academia, other Federal agencies, international agencies, 
and other interested persons, 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 innovative approaches to drug 
product design and manufacturing; 
‘‘(F) advance regulatory science related to the develop-
ment and review of innovative approaches to drug product 
design and manufacturing; 
‘‘(G) convene or participate in working groups to sup-
port the harmonization of international regulatory require-
ments related to innovative approaches to drug product 
design and manufacturing; and 
‘‘(H) award grants or contracts to carry out or support 
the program under paragraph (1). 
‘‘(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 Secretary may 
require; and 
‘‘(B) containing such information as the Secretary may 
require, including a description of— 
‘‘(i) how the entity will conduct the activities 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—
H. R. 2617—1357 
‘‘(1) issue or update guidance to help facilitate the adoption 
of, and advance the development of, innovative approaches 
to drug product design and manufacturing; 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 improvements to such technologies 
after product approval; 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 Represent-
atives and the Committee on Health, Education, Labor, and Pen-
sions 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 Administration 
staff were utilized to carry out this section and, as applicable, 
any challenges or limitations related to staffing; 
‘‘(3) the number of public meetings held or participated 
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 licensed, 
after the date of enactment of this section, using an innovative 
approach to drug product design and manufacturing.’’. 
SEC. 3204. NATIONAL CENTERS OF EXCELLENCE IN ADVANCED AND 
CONTINUOUS PHARMACEUTICAL MANUFACTURING. 
(a) IN GENERAL.—Section 3016 of the 21st Century Cures Act 
(21 U.S.C. 399h) is amended to read as follows: 
‘‘SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN ADVANCED AND 
CONTINUOUS PHARMACEUTICAL MANUFACTURING. 
‘‘(a) IN GENERAL.—The Secretary of Health and Human Serv-
ices, acting through the Commissioner of Food and Drugs— 
‘‘(1) may, to support the advancement, development, and 
implementation of advanced and continuous pharmaceutical 
manufacturing— 
‘‘(A) solicit requests for designation as National Centers 
of Excellence in Advanced and Continuous Pharmaceutical 
Manufacturing (in this section referred to as a ‘National 
Center of Excellence’); 
‘‘(B) beginning not later than one year after the date 
of enactment of the Food and Drug Omnibus Reform Act 
of 2022, designate as National Centers of Excellence 
institutions of higher education or consortia of institutions 
of higher education that— 
‘‘(i) request such designation; and 
‘‘(ii) meet the eligibility criteria specified in sub-
section (c); and 
‘‘(C) award grants to such institutions or consortia 
of institutions; and
H. R. 2617—1358 
‘‘(2) shall so designate not more than 5 institutions of 
higher education or consortia of such institutions. 
‘‘(b) REQUEST
FOR DESIGNATION.—A request for designation 
under subsection (a) shall be made to the Secretary at such time, 
in such manner, and containing such information as the Secretary 
may require. 
‘‘(c) ELIGIBILITY CRITERIA
FOR DESIGNATION.—To be eligible 
to receive a designation under this section, an institution of higher 
education or consortium of institutions of higher education shall 
include in its request for designation a description of the institu-
tion’s or consortium’s— 
‘‘(1) physical capacity and technical capabilities to conduct 
advanced research on, and to develop and implement, advanced 
and continuous pharmaceutical manufacturing; 
‘‘(2) collaboration or partnerships with other institutions 
of higher education, nonprofit organizations, and large and 
small pharmaceutical manufacturers, including generic and 
nonprescription manufacturers, contract manufacturers, and 
other relevant entities; 
‘‘(3) proven capacity to design, develop, implement, and 
demonstrate new, highly effective technologies for use in 
advanced and continuous pharmaceutical manufacturing; 
‘‘(4) proven ability to facilitate training of a qualified 
workforce for advanced research on, and development and 
implementation of, advanced and continuous pharmaceutical 
manufacturing; and 
‘‘(5)(A) experience in participating in and leading advanced 
and continuous pharmaceutical manufacturing technology part-
nerships with other institutions of higher education, nonprofit 
organizations, and large and small pharmaceutical manufactur-
ers, including generic and nonprescription manufacturers, con-
tract manufacturers, and other relevant entities to— 
‘‘(i) support the implementation of advanced or contin-
uous pharmaceutical manufacturing for companies manu-
facturing or seeking to manufacture in the United States; 
‘‘(ii) support Federal agencies with technical assistance 
and workforce training, which may include regulatory and 
quality metric guidance as applicable, and hands-on 
training, for advanced and continuous pharmaceutical 
manufacturing; 
‘‘(iii) organize and conduct advanced research and 
development activities, with respect to advanced or contin-
uous pharmaceutical manufacturing, needed to develop new 
and more effective technology, and to develop and support 
technological leadership; 
‘‘(iv) develop best practices for designing, developing, 
and implementing advanced and continuous pharma-
ceutical manufacturing processes; and 
‘‘(v) identify and assess workforce needs for advanced 
and 
continuous 
pharmaceutical 
manufacturing, 
and 
address such workforce needs, which may include the 
development and implementing of training programs; or 
‘‘(B) a plan, to be implemented within 2 years, to establish 
partnerships described in subparagraph (A). 
‘‘(d) TERMINATION OF DESIGNATION.—The Secretary may termi-
nate the designation of any National Center of Excellence des-
ignated under this section if the Secretary determines such National
H. R. 2617—1359 
Center of Excellence no longer meets the criteria specified in sub-
section (c). Not later than 90 days before the effective date of 
such a termination, the Secretary shall provide written notice to 
the National Center of Excellence, including the rationale for such 
termination. 
‘‘(e) CONDITIONS FOR DESIGNATION.—As a condition of designa-
tion as a National Center of Excellence under this section, the 
Secretary shall require that an institution of higher education or 
consortium of institutions of higher education enter into an agree-
ment with the Secretary under which the institution or consortium 
agrees— 
‘‘(1) to collaborate directly with the Food and Drug Adminis-
tration to publish the reports required by subsection (g); 
‘‘(2) to share data with the Food and Drug Administration 
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 
pharmaceutical 
manufacturers, 
including generic and nonprescription manufacturers, and con-
tract research organizations or contract manufacturers that 
carry out drug development and manufacturing activities) and 
another institution or consortium designated under this section, 
if any, a strategic plan for developing an advanced and contin-
uous pharmaceutical manufacturing workforce; 
‘‘(4) to develop, along with industry partners and other 
institutions or consortia of such institutions designated under 
this section, a strategic plan for strengthening existing, and 
developing new, partnerships with other institutions of higher 
education or consortia thereof, or nonprofit organizations; and 
‘‘(5) to provide an annual report to the Food and Drug 
Administration regarding the designee’s activities under this 
section, including a description of how the designee continues 
to meet and make progress on the criteria specified in sub-
section (c). 
‘‘(f) FUNDING.— 
‘‘(1) IN
GENERAL.—The Secretary shall award funding, 
through grants, contracts, or cooperative agreements, to the 
entities designated as National Centers of Excellence under 
this section for the purposes of supporting the advanced 
research on, and development and implementation of, advanced 
and continuous pharmaceutical manufacturing, and recom-
mending improvements to advanced and continuous pharma-
ceutical manufacturing, including— 
‘‘(A) expanding capacity for advanced research on, and 
development of, advanced and continuous pharmaceutical 
manufacturing; and 
‘‘(B) implementing advanced research capacity and 
capabilities in advanced and continuous pharmaceutical 
manufacturing suitable for accelerating the development 
of drug products needed to respond to public health threats, 
mitigate or prevent drug shortages, address drug quality 
issues and supply chain disruptions, and other cir-
cumstances with respect to which the Secretary may deter-
mine the rapid development of new products or new manu-
facturing processes may be appropriate. 
‘‘(2) CONSISTENCY WITH FDA MISSION.—As a condition on 
receipt of funding under this subsection, a National Center
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of Excellence shall consider any input from the Secretary 
regarding the use of funding related to— 
‘‘(A) best practices to increase, and provide for the 
advancement of, advanced and continuous pharmaceutical 
manufacturing through the National Center of Excellence; 
and 
‘‘(B) the extent to which activities conducted by the 
National Center of Excellence are consistent with the mis-
sion of the Food and Drug Administration. 
‘‘(3) RULE OF CONSTRUCTION.—Nothing in this section shall 
be construed as precluding a National Center for Excellence 
designated under this section from receiving funds under any 
other provision of this Act or any other Federal law. 
‘‘(g) ANNUAL REVIEW AND REPORTS.— 
‘‘(1) ANNUAL REPORT TO CONGRESS.—Beginning not later 
than one year after the date on which the first designation 
is made under subsection (a), and annually thereafter, the 
Secretary shall— 
‘‘(A) submit to Congress a report describing the activi-
ties, partnerships and collaborations, Federal policy rec-
ommendations, previous and continuing funding, and 
findings of, and any other applicable information from, 
the National Centers of Excellence designated under this 
section; 
‘‘(B) include in such report an accounting of the Federal 
administrative expenses described in subsection (i)(2) over 
the reporting period; and 
‘‘(C) make such report available to the public in an 
easily accessible electronic format on the website of the 
Food and Drug Administration. 
‘‘(2) CENTER OF EXCELLENCE REPORT.—An entity receiving 
a grant under this section shall, not later than 1 year after 
receiving such grant, and annually thereafter for the duration 
of the grant period, submit to the Secretary a summary of 
programs and activities funded under the grant. 
‘‘(3) PERIODIC
REVIEW.—The Secretary 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. 
‘‘(4) ADDITIONAL REPORT TO CONGRESS.—Not later than 1 
year 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 role of the Food 
and Drug Administration in supporting advanced and contin-
uous pharmaceutical manufacturing, including— 
‘‘(A) a national framework of principles related to the 
implementation of advanced and continuous pharma-
ceutical manufacturing; 
‘‘(B) a plan for the development of Federal regulations 
and guidance to support and facilitate the incorporation 
of advanced or continuous manufacturing into the develop-
ment of pharmaceuticals; 
‘‘(C) a plan for development of Federal regulations 
or guidance related to the review of advanced and contin-
uous pharmaceutical manufacturing, including how such