116 
in manufacturing drugs in the same context of use for 
which the designation was granted. 
‘‘(e) IMPLEMENTATION
AND
EVALUATION
OF
AD-
VANCED MANUFACTURING TECHNOLOGIES PILOT.— 
‘‘(1) PUBLIC
MEETING.—The Secretary shall 
publish in the Federal Register a notice of a public 
meeting, to be held not later than 180 days after the 
date of enactment of this section, to discuss and ob-
tain input and recommendations from relevant stake-
holders regarding— 
‘‘(A) the goals and scope of the pilot pro-
gram, and a suitable framework, procedures, and 
requirements for such program; and 
‘‘(B) ways in which the Food and Drug Ad-
ministration will support the use of advanced 
manufacturing technologies and other innovative 
manufacturing approaches for drugs. 
‘‘(2) PILOT PROGRAM GUIDANCE.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) not later than 180 days after the 
public meeting under paragraph (1), issue 
draft guidance regarding the goals and im-
plementation of the pilot program under 
this section; and 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00116
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
117 
‘‘(ii) not later than 2 years after the 
date of enactment of this section, issue final 
guidance regarding the implementation of 
such program. 
‘‘(B) CONTENT.—The guidance described in 
subparagraph (A) shall address— 
‘‘(i) the process by which a person may 
request a designation under subsection (b); 
‘‘(ii) the data and information that a 
person requesting such a designation is re-
quired to submit under subsection (c), and 
how the Secretary intends to evaluate such 
submissions; 
‘‘(iii) the process to expedite the devel-
opment and review of applications under 
subsection (d); and 
‘‘(iv) the criteria described in sub-
section (b) for eligibility for such a designa-
tion. 
‘‘(3) REPORT.—Not later than 3 years after the 
date of enactment of this section and annually there-
after, the Secretary shall publish on the website of the 
Food and Drug Administration and submit to the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate and the Committee on Energy and 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00117
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
118 
Commerce of the House of Representatives a report 
containing a description and evaluation of the pilot 
program being conducted under this section, includ-
ing the types of innovative manufacturing approaches 
supported under the program. Such report shall in-
clude the following: 
‘‘(A) The number of persons that have re-
quested designations and that have been granted 
designations. 
‘‘(B) The number of methods of manufac-
turing that have been the subject of designation 
requests and that have been granted designations. 
‘‘(C) The average number of calendar days 
for completion of evaluations under subsection 
(c)(2). 
‘‘(D) An analysis of the factors in data sub-
missions that are relevant to determinations to 
designate and not to designate after evaluation 
under subsection (c)(2). 
‘‘(E) The number of applications received 
under section 505 of this Act or section 351 of 
the Public Health Service Act, including supple-
mental applications, that have included an ad-
vanced manufacturing technology designated 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00118
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
119 
under this section, and the number of such appli-
cations approved. 
‘‘(f) SUNSET.—The Secretary— 
‘‘(1) may not consider any requests for designa-
tion submitted under subsection (c) after October 1, 
2029; and 
‘‘(2) may continue all activities under this sec-
tion with respect to advanced manufacturing tech-
nologies that were designated pursuant to subsection 
(d) prior to such date, if the Secretary determines 
such activities are in the interest of the public 
health.’’. 
SEC. 707. PUBLIC WORKSHOP ON CELL THERAPIES. 
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 
convene a public workshop with relevant stakeholders to dis-
cuss best practices on generating scientific data necessary 
to further facilitate the development of certain human cell- 
, tissue-, and cellular-based medical products (and the latest 
scientific information about such products) that are regu-
lated 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. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00119
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
120 
SEC. 708. REAUTHORIZATION OF BEST PHARMACEUTICALS 
FOR CHILDREN. 
Section 409I(d)(1) of the Public Health Service Act 
(42 U.S.C. 284m(d)(1)) is amended by striking ‘‘2018 
through 2022’’ and inserting ‘‘2023 through 2027’’. 
SEC. 709. REAUTHORIZATION FOR HUMANITARIAN DEVICE 
EXEMPTION AND DEMONSTRATION GRANTS 
FOR IMPROVING PEDIATRIC AVAILABILITY. 
(a) HUMANITARIAN
DEVICE
EXEMPTION.—Section 
520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking 
‘‘2022’’ and inserting ‘‘2027’’. 
(b) PEDIATRIC MEDICAL DEVICE SAFETY AND IM-
PROVEMENT ACT.—Section 305(e) of the Pediatric Medical 
Device Safety and Improvement Act of 2007 (Public Law 
110–85) is amended by striking ‘‘2018 through 2022’’ and 
inserting ‘‘2023 through 2027’’. 
SEC. 710. REAUTHORIZATION OF PROVISION RELATED TO 
EXCLUSIVITY 
OF 
CERTAIN 
DRUGS 
CON-
TAINING SINGLE ENANTIOMERS. 
Section 505(u)(4) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(u)(4)) is amended by striking 
‘‘2022’’ and inserting ‘‘2027’’. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00120
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
121 
SEC. 711. REAUTHORIZATION OF THE CRITICAL PATH PUB-
LIC-PRIVATE PARTNERSHIP PROGRAM. 
Section 566(f) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb–5(f)) is amended by striking 
‘‘$6,000,000 for each of fiscal years 2018 through 2022’’ and 
inserting ‘‘$10,000,000 for each of fiscal years 2023 through 
2027’’. 
SEC. 712. 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 following: ‘‘, and (4) developing regulatory 
science pertaining to the chemistry, manufac-
turing, and controls of individualized medical 
products to treat individuals with rare diseases 
or conditions’’; and 
(2) in subsection (c), by striking ‘‘2018 through 
2022’’ and inserting ‘‘2023 through 2027’’. 
SEC. 713. RESEARCH INTO PEDIATRIC USES OF DRUGS; AD-
DITIONAL AUTHORITIES OF FOOD AND DRUG 
ADMINISTRATION 
REGARDING 
MOLECU-
LARLY TARGETED CANCER DRUGS. 
(a) IN GENERAL.— 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00121
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
122 
(1) ADDITIONAL ACTIVE INGREDIENT FOR APPLI-
CATION
DRUG; LIMITATION
REGARDING
NOVEL-COM-
BINATION APPLICATION DRUG.—Section 505B(a)(3) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c(a)(3)) is amended— 
(A) by redesignating subparagraphs (B) 
and (C) as subparagraphs (C) and (D), respec-
tively; and 
(B) by striking subparagraph (A) and in-
serting the following: 
‘‘(A) IN GENERAL.—For purposes of para-
graph (1)(B), the investigation described in this 
paragraph is (as determined by the Secretary) a 
molecularly targeted pediatric cancer investiga-
tion of— 
‘‘(i) the drug or biological product for 
which the application referred to in such 
paragraph is submitted; or 
‘‘(ii) such drug or biological product in 
combination with— 
‘‘(I) an active ingredient of a 
drug or biological product— 
‘‘(aa) for which an approved 
application under section 505(j) 
under this Act or under section 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00122
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
123 
351(k) of the Public Health Serv-
ice Act is in effect; and 
‘‘(bb) that is determined by 
the Secretary to be the standard of 
care for treating a pediatric can-
cer; or 
‘‘(II) an active ingredient of a 
drug or biological product— 
‘‘(aa) for which an approved 
application under section 505(b) 
of this Act or section 351(a) of the 
Public Health Service Act to treat 
an adult cancer is in effect and is 
held by the same person submit-
ting the application under para-
graph (1)(B); and 
‘‘(bb) that is directed at a 
molecular target that the Sec-
retary determines to be substan-
tially relevant to the growth or 
progression of a pediatric cancer. 
‘‘(B) ADDITIONAL REQUIREMENTS.— 
‘‘(i) DESIGN
OF
INVESTIGATION.—A 
molecularly targeted pediatric cancer inves-
tigation referred to in subparagraph (A) 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00123
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
124 
shall be designed to yield clinically mean-
ingful pediatric study data that is gathered 
using appropriate formulations for each age 
group for which the study is required, re-
garding dosing, safety, and preliminary ef-
ficacy to inform potential pediatric label-
ing. 
‘‘(ii) LIMITATION.—An investigation 
described in subparagraph (A)(ii) may be 
required only if the drug or biological prod-
uct for which the application referred to in 
paragraph (1)(B) contains either— 
‘‘(I) a single new active ingre-
dient; or 
‘‘(II) more than one active ingre-
dient, if an application for the com-
bination of active ingredients has not 
previously been approved but each ac-
tive ingredient has been previously ap-
proved to treat an adult cancer. 
‘‘(iii) 
RESULTS
OF
ALREADY-COM-
PLETED PRECLINICAL STUDIES OF APPLICA-
TION
DRUG.—The Secretary may require 
that reports on an investigation required 
pursuant to paragraph (1)(B) include the 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00124
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
125 
results of all preclinical studies on which 
the decision to conduct such investigation 
was based. 
‘‘(iv) RULE
OF
CONSTRUCTION
RE-
GARDING INACTIVE INGREDIENTS.—With re-
spect to a combination of active ingredients 
referred to in subparagraph (A)(ii), such 
subparagraph shall not be construed as ad-
dressing the use of inactive ingredients with 
such combination.’’. 
(2) DETERMINATION OF APPLICABLE REQUIRE-
MENTS.—Section 505B(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is 
amended by adding at the end the following: ‘‘The 
Secretary shall determine whether subparagraph (A) 
or (B) of subsection (a)(1) shall apply with respect to 
an application before the date on which the applicant 
is required to submit the initial pediatric study plan 
under paragraph (2)(A).’’. 
(3) 
CLARIFYING
APPLICABILITY.—Section 
505B(a)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c(a)(1)) is amended by adding at 
the end the following: 
‘‘(C) RULE OF CONSTRUCTION.—No appli-
cation that is subject to the requirements of sub-
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00125
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
126 
paragraph (B) shall be subject to the require-
ments of subparagraph (A), and no application 
(or supplement to an application) that is subject 
to the requirements of subparagraph (A) shall be 
subject to the requirements of subparagraph 
(B).’’. 
(4) 
CONFORMING
AMENDMENTS.—Section 
505B(a) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355c(a)) is amended— 
(A) in paragraph (3)(C), as redesignated by 
paragraph (1)(A) of this subsection, by striking 
‘‘investigations described in this paragraph’’ and 
inserting ‘‘investigations referred to in subpara-
graph (A)’’; and 
(B) in paragraph (3)(D), as redesignated 
by paragraph (1)(A) of this subsection, by strik-
ing ‘‘the assessments under paragraph (2)(B)’’ 
and inserting ‘‘the assessments required under 
paragraph (1)(A)’’. 
(b) GUIDANCE.—The Secretary shall— 
(1) not later than 6 months after the date of en-
actment of this Act, issue draft guidance on the im-
plementation of the requirements in subsection (a); 
and 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00126
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
127 
(2) not later than 12 months after closing the 
comment period on such draft guidance, finalize such 
guidance. 
(c) APPLICABILITY.—The amendments made by this 
section apply with respect to any application under section 
505(i) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(i)) and any application under section 351(a) 
of the Public Health Service Act (42 U.S.C. 262), that is 
submitted on or after the date that is 3 years after the date 
of enactment of this Act. 
(d) REPORTS TO CONGRESS.— 
(1) SECRETARY OF HEALTH AND HUMAN SERV-
ICES.—Not later than 2 years after the date of enact-
ment of this Act, the Secretary of Health and Human 
Services 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 on the Secretary’s ef-
forts, in coordination with industry, to ensure imple-
mentation of the amendments made by subsection (a). 
(2) GAO STUDY AND REPORT.— 
(A) STUDY.—Not later than 2 years after 
the date of enactment of this Act, the Comptroller 
General of the United States shall conduct a 
study of the effectiveness of requiring assessments 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00127
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
128 
and investigations described in section 505B of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C.355c), as amended by subsection (a), in 
the development of drugs and biological products 
for pediatric cancer indications. 
(B) FINDINGS.—Not later than 4 years 
after the date of enactment of this Act, the 
Comptroller General shall submit to the Com-
mittee on Energy and Commerce of the House of 
Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a 
report containing the findings of the study con-
ducted under subparagraph (A). 
Subtitle B—Inspections 
SEC. 721. FACTORY INSPECTION. 
(a) IN GENERAL.—Section 704(a)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is 
amended by striking ‘‘restricted devices’’ each place it ap-
pears and inserting ‘‘devices’’. 
(b) RECORDS OR OTHER INFORMATION.— 
(1) ESTABLISHMENTS.—Section 704(a)(4)(A) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
374(a)(4)(A)) is amended— 
(A) by striking ‘‘an establishment that is 
engaged in the manufacture, preparation, propa-
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00128
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
129 
gation, compounding, or processing of a drug’’ 
and inserting ‘‘an establishment that is engaged 
in the manufacture, preparation, propagation, 
compounding, or processing of a drug or device, 
or that is subject to inspection under paragraph 
(5)(C),’’; and 
(B) by inserting after ‘‘a sufficient descrip-
tion of the records requested’’ the following: ‘‘and 
a rationale for requesting such records or other 
information in advance of, or in lieu of, an in-
spection’’. 
(2) GUIDANCE.— 
(A) IN GENERAL.—The Secretary of Health 
and Human Services shall issue or update guid-
ance describing— 
(i) circumstances in which the Sec-
retary intends to issue requests for records 
or other information in advance of, or in 
lieu 
of, 
an 
inspection 
under 
section 
704(a)(4) of the Federal Food, Drug, and 
Cosmetic Act, as amended by paragraph 
(1); 
(ii) processes for responding to such re-
quests electronically or in physical form; 
and 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00129
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
130 
(iii) factors the Secretary intends to 
consider in evaluating whether such records 
and other information are provided within 
a reasonable timeframe, within reasonable 
limits, and in a reasonable manner, ac-
counting for resource and other limitations 
that may exist, including for small busi-
nesses. 
(B) TIMING.—The Secretary of Health and 
Human Services shall— 
(i) not later than 1 year after the date 
of enactment of this Act, issue draft guid-
ance under subparagraph (A); and 
(ii) not later than 1 year after the close 
of the comment period for such draft guid-
ance, issue final guidance under subpara-
graph (A). 
(c) BIORESEARCH MONITORING INSPECTIONS.— 
(1) IN GENERAL.—Section 704(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is 
amended by adding at the end the following: 
‘‘(5) BIORESEARCH MONITORING INSPECTIONS.— 
‘‘(A) IN GENERAL.—The Secretary may, to 
ensure the accuracy and reliability of studies 
and records or other information described in 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00130
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
131 
subparagraph (B) and to assess compliance with 
applicable requirements under this Act or the 
Public Health Service Act, enter sites and facili-
ties specified in subparagraph (C) in order to in-
spect such records or other information. 
‘‘(B) INFORMATION
SUBJECT
TO
INSPEC-
TION.—An inspection under this paragraph shall 
extend to all records and other information re-
lated to the studies and submissions described in 
subparagraph (E), including records and infor-
mation related to the conduct, results, and anal-
yses of, and the protection of human and animal 
trial participants participating in, such studies. 
‘‘(C) SITES AND FACILITIES SUBJECT TO IN-
SPECTION.— 
‘‘(i) 
SITES
AND
FACILITIES
DE-
SCRIBED.—The sites and facilities subject to 
inspection by the Secretary under this 
paragraph are those owned or operated by 
a person described in clause (ii) and which 
are (or were) utilized by such person in 
connection with— 
‘‘(I) developing an application or 
other submission to the Secretary 
under this Act or the Public Health 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00131
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
132 
Service Act related to marketing au-
thorization for a product described in 
paragraph (1); 
‘‘(II) preparing, conducting, or 
analyzing the results of a study de-
scribed in subparagraph (E); or 
‘‘(III) holding any records or 
other information described in sub-
paragraph (B). 
‘‘(ii) PERSONS DESCRIBED.—A person 
described in this clause is— 
‘‘(I) the sponsor of an application 
or submission specified in subpara-
graph (E); 
‘‘(II) a person engaged in any ac-
tivity described in clause (i) on behalf 
of such a sponsor, through a contract, 
grant, or other business arrangement 
with such sponsor; 
‘‘(III) an institutional review 
board, or other individual or entity, 
engaged by contract, grant, or other 
business arrangement with a non-
sponsor in preparing, collecting, or 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00132
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
133 
analyzing records or other information 
described in subparagraph (B); or 
‘‘(IV) any person not otherwise 
described in this clause that conducts, 
or has conducted, a study described in 
subparagraph (E) yielding records or 
other information described in sub-
paragraph (B). 
‘‘(D) CONDITIONS OF INSPECTION.— 
‘‘(i) ACCESS TO INFORMATION SUBJECT 
TO INSPECTION.—Subject to clause (ii), an 
entity that owns or operates any site or fa-
cility subject to inspection under this para-
graph shall provide the Secretary with ac-
cess to records and other information de-
scribed in subparagraph (B) that is held by 
or under the control of such entity, includ-
ing— 
‘‘(I) permitting the Secretary to 
record or copy such information for 
purposes of this paragraph; 
‘‘(II) providing the Secretary with 
access to any electronic information 
system utilized by such entity to hold, 
process, 
analyze, 
or 
transfer 
any 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00133
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
134 
records or other information described 
in subparagraph (B); and 
‘‘(III) permitting the Secretary to 
inspect the facilities, equipment, writ-
ten procedures, processes, and condi-
tions through which records or other 
information described in subparagraph 
(B) is or was generated, held, proc-
essed, analyzed, or transferred. 
‘‘(ii) NO EFFECT ON APPLICABILITY OF 
PROVISIONS FOR PROTECTION OF PROPRI-
ETARY INFORMATION OR TRADE SECRETS.— 
Nothing in clause (i) shall negate, super-
sede, or otherwise affect the applicability of 
provisions, under this or any other Act, pre-
venting or limiting the disclosure of con-
fidential commercial information or other 
information considered proprietary or trade 
secret. 
‘‘(iii) REASONABLENESS
OF
INSPEC-
TIONS.—An inspection under this para-
graph shall be conducted at reasonable 
times and within reasonable limits and in 
a reasonable manner. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00134
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
135 
‘‘(E) 
STUDIES
AND
SUBMISSIONS
DE-
SCRIBED.—The studies and submissions de-
scribed in this subparagraph are each of the fol-
lowing: 
‘‘(i) Clinical and nonclinical studies 
submitted to the Secretary in support of, or 
otherwise related to, applications and other 
submissions to the Secretary under this Act 
or the Public Health Service Act for mar-
keting authorization of a product described 
in paragraph (1). 
‘‘(ii) Postmarket safety activities con-
ducted under this Act or the Public Health 
Service Act. 
‘‘(iii) Any other clinical investigation 
of— 
‘‘(I) a drug subject to section 505 
or 512 of this Act or section 351 of the 
Public Health Service Act; or 
‘‘(II) a device subject to section 
520(g). 
‘‘(iv) Any other submissions made 
under this Act or the Public Health Service 
Act with respect to which the Secretary de-
termines an inspection under this para-
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00135
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
136 
graph is warranted in the interest of public 
health. 
‘‘(F) 
CLARIFICATION.—This 
paragraph 
clarifies the authority of the Secretary to conduct 
inspections of the type described in this para-
graph and shall not be construed as a basis for 
inferring that, prior to the date of enactment of 
this paragraph, the Secretary lacked the author-
ity to conduct such inspections, including under 
this Act or the Public Health Service Act.’’. 
(2) REVIEW
OF
PROCESSES
AND
PRACTICES; 
GUIDANCE FOR INDUSTRY.— 
(A) IN GENERAL.—The Secretary of Health 
and Human Services shall— 
(i) review processes and practices in ef-
fect as of the date of enactment of this Act 
applicable to inspections of foreign and do-
mestic sites and facilities described in sub-
paragraph (C)(i) of section 704(a)(5) of the 
Federal Food, Drug, and Cosmetic Act, as 
added by paragraph (1); and 
(ii) evaluate whether any updates are 
needed to facilitate the consistency of such 
processes and practices. 
(B) GUIDANCE.— 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00136
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
137 
(i) IN
GENERAL.—The Secretary of 
Health and Human Services shall issue 
guidance describing the processes and prac-
tices applicable to inspections of sites and 
facilities described in subparagraph (C)(i) 
of section 704(a)(5) of the Federal Food, 
Drug, and Cosmetic Act, as added by para-
graph (1), including with respect to the 
types of records and information required to 
be provided, best practices for communica-
tion between the Food and Drug Adminis-
tration and industry in advance of or dur-
ing an inspection or request for records or 
other information, and other inspections-re-
lated conduct, to the extent not specified in 
existing publicly available Food and Drug 
Administration guides and manuals for 
such inspections. 
(ii) TIMING.—The Secretary of Health 
and Human Services shall— 
(I) not later than 18 months after 
the date of enactment of this Act, issue 
draft guidance under clause (i); and 
(II) not later than 1 year after 
the close of the public comment period 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00137
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
138 
for such draft guidance, issue final 
guidance under clause (i). 
SEC. 722. USES OF CERTAIN EVIDENCE. 
Section 703 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 373) is amended by adding at the end the 
following: 
‘‘(c) APPLICABILITY.—The limitations on the Sec-
retary’s use of evidence obtained under this section, or any 
evidence which is directly or indirectly derived from such 
evidence, in a criminal prosecution of the person from 
whom such evidence was obtained shall not apply to evi-
dence, including records or other information, obtained 
under authorities other than this section, unless such limi-
tations are specifically incorporated by reference in such 
other authorities.’’. 
SEC. 723. IMPROVING FDA INSPECTIONS. 
(a) RISK FACTORS FOR ESTABLISHMENTS.—Section 
510(h)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(h)(4)) is amended— 
(1) by redesignating subparagraph (F) as sub-
paragraph (G); and 
(2) by inserting after subparagraph (E) the fol-
lowing: 
‘‘(F) The compliance history of establish-
ments in the country or region in which the es-
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00138
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
139 
tablishment is located that are subject to regula-
tion under this Act, including the history of vio-
lations related to products exported from such 
country or region that are subject to such regula-
tion.’’. 
(b) USE OF RECORDS.—Section 704(a)(4) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)) 
is amended— 
(1) by redesignating subparagraph (C) as sub-
paragraph (D); and 
(2) by inserting after subparagraph (B) the fol-
lowing: 
‘‘(C) The Secretary may rely on any records or other 
information that the Secretary may inspect under this sec-
tion to satisfy requirements that may pertain to a 
preapproval or risk-based surveillance inspection, or to re-
solve deficiencies identified during such inspections, if ap-
plicable and appropriate.’’. 
(c) RECOGNITION OF FOREIGN GOVERNMENT INSPEC-
TIONS.—Section 809 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 384e) is amended— 
(1) 
in 
subsection 
(a)(1), 
by 
inserting 
‘‘preapproval or’’ before ‘‘risk-based inspections’’; and 
(2) by adding at the end the following: 
‘‘(c) PERIODIC REVIEW.— 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00139
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
140 
‘‘(1) IN GENERAL.—Beginning not later than 1 
year after the date of the enactment of the Food and 
Drug Amendments of 2022, the Secretary shall peri-
odically assess whether additional arrangements and 
agreements with a foreign government or an agency 
of a foreign government, as allowed under this sec-
tion, are appropriate. 
‘‘(2) REPORTS
TO
CONGRESS.—Beginning not 
later than 4 years after the date of the enactment of 
the Food and Drug Amendments of 2022, and every 
4 years thereafter, the Secretary shall submit to the 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report de-
scribing the findings and conclusions of each review 
conducted under paragraph (1).’’. 
SEC. 724. GAO REPORT ON INSPECTIONS OF FOREIGN ES-
TABLISHMENTS MANUFACTURING DRUGS. 
(a) IN GENERAL.—Not later than 18 months after the 
date of the enactment of this Act, the Comptroller General 
of the United States shall submit to the Committee on En-
ergy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and Pensions 
of the Senate a report on inspections conducted by— 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00140
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
141 
(1) the Secretary of Health and Human Services 
(in this section referred to as the ‘‘Secretary’’) of for-
eign establishments pursuant to subsections (h) and 
(i) of section 510 and section 704 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360; 374); or 
(2) a foreign government or an agency of a for-
eign government pursuant to section 809 of such Act 
(21 U.S.C. 384e). 
(b) CONTENTS.—The report conducted under sub-
section (a) shall include— 
(1) what alternative tools, including remote in-
spections or remote evaluations, other countries are 
utilizing to facilitate inspections of foreign establish-
ments; 
(2) how frequently trusted foreign regulators con-
duct inspections of foreign facilities that could be use-
ful to the Food and Drug Administration to review 
in lieu of its own inspections; 
(3) how frequently and under what cir-
cumstances, including for what types of inspections, 
the Secretary utilizes existing agreements or arrange-
ments under section 809 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 384e) and whether the 
use of such agreements could be appropriately ex-
panded; 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00141
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
142 
(4) whether the Secretary has accepted reports of 
inspections of facilities in China and India conducted 
by entities with which they have entered into such an 
agreement or arrangement; 
(5) what additional foreign governments or agen-
cies of foreign governments the Secretary has consid-
ered entering into a mutual recognition agreement 
with and, if applicable, reasons why the Secretary de-
clined to enter into a mutual recognition agreement 
with such foreign governments or agencies; 
(6) what tools, if any, the Secretary used to fa-
cilitate inspections of domestic facilities that could 
also be effectively utilized to appropriately inspect 
foreign facilities; 
(7) what steps the Secretary has taken to iden-
tify and evaluate tools and strategies the Secretary 
may use to continue oversight with respect to inspec-
tions when in-person inspections are disrupted; 
(8) how the Secretary is considering incor-
porating alternative tools into the inspection activi-
ties conducted pursuant to the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.); and 
(9) what steps the Secretary has taken to iden-
tify and evaluate how the Secretary may use alter-
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00142
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
143 
native tools to address workforce shortages to carry 
out such inspection activities. 
SEC. 725. UNANNOUNCED FOREIGN FACILITY INSPECTIONS 
PILOT PROGRAM. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall conduct a pilot program under which the Sec-
retary increases the conduct of unannounced surveillance 
inspections of foreign human drug establishments and eval-
uates the differences between such inspections of domestic 
and foreign human drug establishments, including the im-
pact of announcing inspections to persons who own or oper-
ate foreign human drug establishments in advance of an 
inspection. Such pilot program shall evaluate— 
(1) differences in the number and type of viola-
tions of section 501(a)(2)(B) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) 
identified as a result of unannounced and announced 
inspections of foreign human drug establishments and 
any other significant differences between each type of 
inspection; 
(2) costs and benefits associated with conducting 
announced and unannounced inspections of foreign 
human drug establishments; 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00143
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
144 
(3) barriers to conducting unannounced inspec-
tions of foreign human drug establishments and any 
challenges to achieving parity between domestic and 
foreign human drug establishment inspections; and 
(4) approaches for mitigating any negative ef-
fects of conducting announced inspections of foreign 
human drug establishments. 
(b) PILOT PROGRAM SCOPE.—The inspections evalu-
ated under the pilot program under this section shall be 
routine surveillance inspections and shall not include in-
spections conducted as part of the Secretary’s evaluation 
of a request for approval to market a drug submitted under 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.) or the Public Health Service Act (42 U.S.C. 201 
et seq.). 
(c) PILOT PROGRAM INITIATION.—The Secretary shall 
initiate the pilot program under this section not later than 
180 days after the date of enactment of this Act. 
(d) REPORT.—The Secretary shall, not later than 180 
days following the completion of the pilot program under 
this section, make available on the website of the Food and 
Drug Administration a final report on the pilot program 
under this section, including— 
(1) findings and any associated recommenda-
tions with respect to the evaluation under subsection 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00144
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
145 
(a), including any recommendations to address iden-
tified barriers to conducting unannounced inspections 
of foreign human drug establishments; 
(2) findings and any associated recommenda-
tions regarding how the Secretary may achieve parity 
between domestic and foreign human drug inspec-
tions; and 
(3) the number of unannounced inspections dur-
ing the pilot program that would not be unannounced 
under existing practices. 
SEC. 726. REAUTHORIZATION OF INSPECTION PROGRAM. 
Section 704(g)(11) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 374(g)(11)) is amended by striking 
‘‘2022’’ and inserting ‘‘2027’’. 
SEC. 727. ENHANCING INTRA-AGENCY COORDINATION AND 
PUBLIC HEALTH ASSESSMENT WITH REGARD 
TO COMPLIANCE ACTIVITIES. 
(a) COORDINATION.—Section 506D of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356d) is amended 
by adding at the end the following: 
‘‘(g) COORDINATION.—The Secretary shall ensure 
timely and effective internal coordination and alignment 
among the field investigators of the Food and Drug Admin-
istration and the staff of the Center for Drug Evaluation 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00145
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
146 
and Research’s Office of Compliance and Drug Shortage 
Program regarding— 
‘‘(1) the reviews of reports shared pursuant to 
section 704(b)(2); and 
‘‘(2) any feedback or corrective or preventive ac-
tions in response to such reports.’’. 
(b) REPORTING.— 
(1) IN GENERAL.—Section 506C–1(a)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356c–1(a)(2)) is amended to read as follows: 
‘‘(2)(A) describes the communication between the 
field investigators of the Food and Drug Administra-
tion and the staff of the Center for Drug Evaluation 
and Research’s Office of Compliance and Drug Short-
age Program, including the Food and Drug Adminis-
tration’s procedures for enabling and ensuring such 
communication; 
‘‘(B) provides the number of reports described in 
section 704(b)(2) that were required to be sent to the 
appropriate offices of the Food and Drug Administra-
tion and the number of such reports that were sent; 
and 
‘‘(C) describes the coordination and alignment 
activities undertaken pursuant to section 506D(g);’’. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00146
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
147 
(2) APPLICABILITY.—The amendment made by 
paragraph (1) shall apply with respect to reports sub-
mitted on or after March 31, 2023. 
SEC. 728. REPORTING OF MUTUAL RECOGNITION AGREE-
MENTS FOR INSPECTIONS AND REVIEW AC-
TIVITIES. 
(a) IN GENERAL.—Not later than December 31, 2022, 
and annually thereafter, the Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall publish a report on the public website of the 
Food and Drug Administration on the utilization of agree-
ments entered into pursuant to section 809 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 384e) or other-
wise entered into by the Secretary in the previous fiscal 
year to recognize inspections between drug regulatory au-
thorities across countries and international regions with 
analogous review criteria to the Food and Drug Adminis-
tration, such as the Pharmaceutical Inspection Co-Oper-
ation Scheme, the Mutual Recognition Agreement with the 
European Union, and the Australia-Canada-Singapore- 
Switzerland-United Kingdom Consortium. 
(b) CONTENT.—The report under subsection (a) shall 
include each of the following: 
(1) The total number of establishments that are 
registered under section 510(i) of the Federal Food, 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00147
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
148 
Drug, and Cosmetic Act (21 U.S.C. 360(i)), and the 
number of such establishments in each region of inter-
est. 
(2) The total number of inspections conducted at 
establishments 
described 
in 
paragraph 
(1), 
disaggregated by inspections conducted— 
(A) pursuant to an agreement or other rec-
ognition described in subsection (a); and 
(B) by employees or contractors of the Food 
and Drug Administration. 
(3) Of the inspections described in paragraph 
(2), the total number of inspections in each region of 
interest. 
(4) Of the inspections in each region of interest 
reported pursuant to paragraph (3), the number of 
inspections in each FDA inspection category. 
(5) Of the number of inspections reported under 
each of paragraphs (3) and (4)— 
(A) the number of inspections which have 
been conducted pursuant to an agreement or 
other recognition described in subsection (a); and 
(B) the number of inspections which have 
been conducted by employees or contractors of the 
Food and Drug Administration. 
(c) DEFINITIONS.—In this section: 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00148
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
149 
(1) FDA INSPECTION
CATEGORY.—The term 
‘‘FDA inspection category’’ means the following in-
spection categories: 
(A) Inspections to support approvals of 
changes to the manufacturing process of drugs 
approved 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 
U.S.C. 262). 
(B) Surveillance inspections. 
(C) For-cause inspections. 
(2) REGION OF INTEREST.—The term ‘‘region of 
interest’’ means China, India, the European Union, 
and any other geographic region as the Secretary de-
termines appropriate. 
SEC. 729. ENHANCING TRANSPARENCY OF DRUG FACILITY 
INSPECTION TIMELINES. 
Section 902 of the FDA Reauthorization Act of 2017 
(21 U.S.C. 355 note) is amended to read as follows: 
‘‘SEC. 902. ANNUAL REPORT ON INSPECTIONS. 
‘‘Not later than 120 days after the end of each fiscal 
year, the Secretary of Health and Human Services shall 
post on the public website of the Food and Drug Adminis-
tration information related to inspections of facilities nec-
essary for approval of a drug under subsection (c) or (j) 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00149
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
150 
of section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355), approval of a device under section 515 
of such Act (21 U.S.C. 360e), or clearance of a device under 
section 510(k) of such Act (21 U.S.C. 360(k)) that were con-
ducted during the previous fiscal year. Such information 
shall include the following: 
‘‘(1) The median time following a request from 
staff of the Food and Drug Administration reviewing 
an application or report to the beginning of the in-
spection, including— 
‘‘(A) the median time for drugs described in 
section 505(j)(11)(A)(i) of the Federal Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
355(j)(11)(A)(i)); 
‘‘(B) the median time for drugs described in 
section 506C(a) of such Act (21 U.S.C. 356c(a)) 
only; and 
‘‘(C) the median time for drugs on the drug 
shortage list in effect under section 506E of such 
Act (21 U.S.C. 356e). 
‘‘(2) The median time from the issuance of a re-
port pursuant to section 704(b) of such Act (21 
U.S.C. 374(b)) to the sending of a warning letter, 
issuance of an import alert, or holding of a regulatory 
meeting for inspections for which the Secretary con-
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00150
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
151 
cluded that regulatory or enforcement action was in-
dicated, including the median time for each category 
of drugs listed in subparagraphs (A) through (C) of 
paragraph (1). 
‘‘(3) The median time from the sending of a 
warning letter, issuance of an import alert, or hold-
ing of a regulatory meeting to resolution of the ac-
tions indicated to address the conditions or practices 
observed during an inspection. 
‘‘(4) The number of facilities that failed to im-
plement adequate corrective or preventive actions fol-
lowing a report pursuant to such section 704(b), re-
sulting in a withhold recommendation, including the 
number of such times for each category of drugs listed 
in subparagraphs (A) through (C) of paragraph (1).’’. 
TITLE 
VIII—TRANSPARENCY, 
PROGRAM 
INTEGRITY, 
AND 
REGULATORY 
IMPROVE-
MENTS 
SEC. 801. PROMPT REPORTS OF MARKETING STATUS BY 
HOLDERS OF APPROVED APPLICATIONS FOR 
BIOLOGICAL PRODUCTS. 
(a) IN GENERAL.—Section 506I of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356i) is amended— 
(1) in subsection (a)— 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00151
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
152 
(A) in the matter preceding paragraph (1), 
by striking ‘‘The holder of an application ap-
proved under subsection (c) or (j) of section 505’’ 
and inserting ‘‘The holder of an application ap-
proved 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 ‘‘estab-
lished name’’ and inserting ‘‘established name 
(for biological products, by proper name)’’; and 
(C) in paragraph (3), by striking ‘‘or abbre-
viated application number’’ and inserting ‘‘, ab-
breviated application 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 ap-
proved 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’’; 
(B) in paragraph (1), by striking ‘‘estab-
lished name’’ and inserting ‘‘established name 
(for biological products, by proper name)’’; and 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00152
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
153 
(C) in paragraph (2), by striking ‘‘or abbre-
viated application number’’ and inserting ‘‘, ab-
breviated application number, or biologics license 
application number’’. 
(b) ADDITIONAL ONE-TIME REPORT.—Subsection (c) 
of section 506I of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356i) is amended to read as follows: 
‘‘(c) ADDITIONAL ONE-TIME REPORT.—Within 180 
days of the date of enactment of the Food and Drug Amend-
ments of 2022, all holders of applications approved under 
subsection (a) or (k) of section 351 of the Public Health 
Service Act shall review the information in the list pub-
lished under section 351(k)(9)(A) and shall submit a writ-
ten notice to the Secretary— 
‘‘(1) stating that all of the application holder’s 
biological products in the list published under section 
351(k)(9)(A) that are not listed as discontinued are 
available for sale; or 
‘‘(2) including the information required pursu-
ant to subsection (a) or (b), as applicable, for each of 
the application holder’s biological products that are 
in the list published under section 351(k)(9)(A) and 
not listed as discontinued, but have been discontinued 
from sale or never have been available for sale.’’. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00153
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
154 
(c) PURPLE BOOK.—Section 506I of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356i) is amended— 
(1) by striking subsection (d) and inserting the 
following: 
‘‘(d) FAILURE TO MEET REQUIREMENTS.—If a holder 
of an approved application fails to submit the information 
required under subsection (a), (b), or (c), the Secretary 
may— 
‘‘(1) move the application holder’s drugs from 
the active section of the list published under section 
505(j)(7)(A) to the discontinued section of the list, ex-
cept that the Secretary shall remove from the list in 
accordance with section 505(j)(7)(C) drugs the Sec-
retary determines have been withdrawn from sale for 
reasons of safety or effectiveness; and 
‘‘(2) identify the application holder’s biological 
products as discontinued in the list published under 
section 351(k)(9)(A) of the Public Health Service Act, 
except that the Secretary shall remove from the list in 
accordance with section 351(k)(9)(B) of such Act bio-
logical products for which the license has been revoked 
or suspended for reasons of safety, purity, or po-
tency.’’; and 
(2) in subsection (e)— 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00154
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
155 
(A) by inserting after the first sentence the 
following: ‘‘The Secretary shall update the list 
published under section 351(k)(9)(A) of the Pub-
lic Health Service Act based on information pro-
vided under subsections (a), (b), and (c) by iden-
tifying as discontinued biological products that 
are not available for sale, except that biological 
products for which the license has been revoked 
or suspended for safety, purity, or potency rea-
sons shall be removed from the list in accordance 
with section 351(k)(9)(B) of the Public Health 
Service Act.’’; 
(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 in-
serting ‘‘section 505(j)(7)(A)’’; and 
(2) by striking ‘‘subsection 505(j)(7)(C)’’ and in-
serting ‘‘section 505(j)(7)(C)’’. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00155
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
156 
SEC. 802. ENCOURAGING BLOOD DONATION. 
(a) STREAMLINING PATIENT
AND BLOOD DONOR 
INPUT.—Section 3003 of the 21st Century Cures Act (21 
U.S.C. 360bbb–8c note) is amended to read as follows: 
‘‘SEC. 3003. STREAMLINING PATIENT AND BLOOD DONOR 
INPUT. 
‘‘Chapter 35 of title 44, United States Code, shall not 
apply to the collection of information to which a response 
is voluntary, to solicit— 
‘‘(1) the views and perspectives of patients under 
section 569C of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–8c) (as amended by section 
3001) or section 3002; or 
‘‘(2) information from blood donors or potential 
blood donors to support the development of rec-
ommendations by the Secretary of Health and 
Human Services acting through the Commissioner of 
Food and Drugs concerning blood donation.’’. 
(b) CLERICAL AMENDMENT.—The table of contents in 
section 1(b) of the 21st Century Cures Act is amended by 
striking the item relating to section 3003 and inserting the 
following: 
‘‘Sec. 3003. Streamlining patient and blood donor input.’’. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00156
Fmt 6652
Sfmt 6213
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
157 
SEC. 803. REGULATION OF CERTAIN PRODUCTS AS DRUGS. 
Section 503 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 353) is amended by adding at the end the 
following: 
‘‘(h)(1) Any contrast agent, radioactive drug, or OTC 
monograph drug shall be deemed to be a drug under section 
201(g) and not a device under section 201(h). 
‘‘(2) For purposes of this subsection: 
‘‘(A) The term ‘contrast agent’ means an article 
that is intended for use in conjunction with a medical 
imaging device, and— 
‘‘(i) is a diagnostic radiopharmaceutical, as 
defined in sections 315.2 and 601.31 of title 21, 
Code of Federal Regulations (or any successor 
regulations); or 
‘‘(ii) is a diagnostic agent that improves the 
visualization of structure or function within the 
body by increasing the relative difference in sig-
nal intensity within the target tissue, structure, 
or fluid. 
‘‘(B) The term ‘radioactive drug’ has the mean-
ing given such term in section 310.3(n) of title 21, 
Code of Federal Regulations (or any successor regula-
tions), except that such term does not include— 
‘‘(i) an implant or article similar to an im-
plant; 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00157
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
158 
‘‘(ii) an article that applies radiation from 
outside of the body; or 
‘‘(iii) the radiation source of an article de-
scribed in clause (i) or (ii). 
‘‘(C) The term ‘OTC monograph drug’ has the 
meaning given such term in section 744L. 
‘‘(3) Nothing in this subsection shall be construed as 
allowing for the classification of a product as a drug (as 
defined in section 201(g)) if such product— 
‘‘(A) is not described in paragraph (1); and 
‘‘(B) meets the definition of a device under sec-
tion 201(h), 
unless another provision of this Act otherwise indicates a 
different classification.’’. 
SEC. 804. POSTAPPROVAL STUDIES AND PROGRAM INTEG-
RITY FOR ACCELERATED APPROVAL DRUGS. 
(a) IN GENERAL.—Section 506(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356(c)) is amended— 
(1) by striking paragraph (2) and inserting the 
following: 
‘‘(2) LIMITATION.— 
‘‘(A) IN GENERAL.—Approval of a product 
under this subsection may be subject to 1 or both 
of the following requirements: 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00158
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
159 
‘‘(i) That the sponsor conduct an ap-
propriate postapproval study or studies 
(which may be augmented or supported by 
real world evidence) to verify and describe 
the predicted effect on irreversible morbidity 
or mortality or other clinical benefit. 
‘‘(ii) That the sponsor submit copies of 
all promotional materials related to the 
product during the preapproval review pe-
riod and, following approval and for such 
period thereafter as the Secretary deter-
mines to be appropriate, at least 30 days 
prior to dissemination of the materials. 
‘‘(B) STUDIES NOT REQUIRED.—If the Sec-
retary does not require that the sponsor of a 
product approved under accelerated approval 
conduct a postapproval study under this para-
graph, the Secretary shall publish on the website 
of the Food and Drug Administration the ration-
ale for why such study is not appropriate or nec-
essary. 
‘‘(C) POSTAPPROVAL STUDY CONDITIONS.— 
Not later than the time of approval of a product 
under accelerated approval, the Secretary shall 
specify the conditions for a postapproval study 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00159
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
160 
or studies required to be conducted under this 
paragraph with respect to such product, which 
may include enrollment targets, the study pro-
tocol, and milestones, including the target date of 
study completion. 
‘‘(D) STUDIES BEGUN BEFORE APPROVAL.— 
The Secretary may require such study or studies 
to be underway prior to approval.’’; and 
(2) by striking paragraph (3) and inserting the 
following: 
‘‘(3) EXPEDITED WITHDRAWAL OF APPROVAL.— 
‘‘(A) IN
GENERAL.—The Secretary may 
withdraw approval of a product approved under 
accelerated approval using expedited procedures 
described in subparagraph (B), if— 
‘‘(i) the sponsor fails to conduct any 
required postapproval study of the product 
with due diligence, including with respect to 
conditions specified by the Secretary under 
paragraph (2)(C); 
‘‘(ii) a study required to verify and de-
scribe the predicted effect on irreversible 
morbidity or mortality or other clinical 
benefit of the product fails to verify and de-
scribe such effect or benefit; 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00160
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
161 
‘‘(iii) other evidence demonstrates that 
the product is not shown to be safe or effec-
tive under the conditions of use; or 
‘‘(iv) the sponsor disseminates false or 
misleading promotional materials with re-
spect to the product. 
‘‘(B) 
EXPEDITED
PROCEDURES
DE-
SCRIBED.—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 pro-
posed withdrawal; 
‘‘(III) an opportunity for a meet-
ing with the Commissioner of Food 
and Drugs or the Commissioner’s des-
ignee; and 
‘‘(IV) an opportunity for written 
appeal to— 
‘‘(aa) the Commissioner of 
Food and Drugs; or 
‘‘(bb) a designee of the Com-
missioner who has not partici-
pated in the proposed withdrawal 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00161
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
162 
of approval (other than a meeting 
pursuant to subclause (III)) and 
is not a subordinate of an indi-
vidual (other than the Commis-
sioner) who participated in such 
proposed withdrawal; 
‘‘(ii) providing an opportunity for 
public comment on the notice proposing to 
withdraw approval; 
‘‘(iii) the publication of a summary of 
the public comments received, and the Sec-
retary’s response to such comments, on the 
website of the Food and Drug Administra-
tion; and 
‘‘(iv) convening and consulting an ad-
visory committee 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. 
‘‘(4) LABELING.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the labeling for a product approved 
under accelerated approval shall include— 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00162
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
163 
‘‘(i) a statement indicating that the 
product was approved under accelerated ap-
proval; 
‘‘(ii) a statement indicating that con-
tinued approval of the product is subject to 
postmarketing studies to verify clinical ben-
efit; 
‘‘(iii) identification of the surrogate or 
intermediate endpoint or endpoints that 
supported approval and any known limita-
tions of such surrogate or intermediate end-
point or endpoints in determining clinical 
benefit; and 
‘‘(iv) a succinct description of the 
product and any uncertainty about antici-
pated clinical benefit and a discussion of 
available evidence with respect to such clin-
ical benefit. 
‘‘(B) APPLICABILITY.—The labeling require-
ments of subparagraph (A) shall apply only to 
products approved under accelerated approval 
for which the predicted effect on irreversible mor-
bidity or mortality or other clinical benefit has 
not been verified. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00163
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
164 
‘‘(C) RULE
OF
CONSTRUCTION.—With re-
spect to any application pending before the Sec-
retary on the date of enactment of the Food and 
Drug Amendments of 2022, the Secretary shall 
allow any applicable changes to the product la-
beling required to comply with subparagraph (A) 
to be made by supplement after the approval of 
such application. 
‘‘(5) REPORTING.—Not later than September 30, 
2025, 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 describing 
circumstances in which the Secretary considered real 
world evidence submitted to support postapproval 
studies required under this subsection that were com-
pleted after the date of enactment of the Food and 
Drug Amendments of 2022.’’. 
(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 para-
graph (3); and 
(2) by inserting after paragraph (1) the fol-
lowing: 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00164
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
165 
‘‘(2) 
ACCELERATED
APPROVAL.—Notwith-
standing paragraph (1), a sponsor of a drug ap-
proved under accelerated approval shall submit to the 
Secretary a report of the progress of any study re-
quired under section 506(c), including progress to-
ward enrollment targets, milestones, and other infor-
mation 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.’’. 
(c) GUIDANCE.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services 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 post-
approval studies as may be required under sec-
tion 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); and 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00165
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
166 
(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)). 
(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. 
(d) 
RARE
DISEASE
ENDPOINT
ADVANCEMENT 
PILOT.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall establish a pilot program 
under which the Secretary will establish procedures to 
provide increased interaction with sponsors of rare 
disease drug development programs for purposes of 
advancing the development of efficacy endpoints, in-
cluding surrogate and intermediate endpoints, for 
drugs intended to treat rare diseases, including 
through— 
(A) determining eligibility of participants 
for such a program; and 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00166
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
167 
(B) developing and implementing a process 
for applying to, and participating in, such a 
program. 
(2) PUBLIC WORKSHOPS.—The Secretary shall 
conduct up to 3 public workshops, which shall be com-
pleted not later than September 30, 2026, to discuss 
topics relevant to the development of endpoints for 
rare diseases, which may include discussions about— 
(A) novel endpoints developed through the 
pilot program established under this subsection; 
and 
(B) as appropriate, the use of real world 
evidence and real world data to support the vali-
dation of efficacy endpoints, including surrogate 
and intermediate endpoints, for rare diseases. 
(3) REPORT.—Not later than September 30, 
2027, 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 describing 
the outcomes of the pilot program established under 
this subsection. 
(4) GUIDANCE.—Not later than September 30, 
2027, the Secretary shall issue guidance describing 
best practices and strategies for development of effi-
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00167
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
168 
cacy endpoints, including surrogate and intermediate 
endpoints, for rare diseases. 
(5) SUNSET.—The Secretary may not accept any 
new application or request to participate in the pro-
gram established by this subsection on or after Octo-
ber 1, 2027. 
SEC. 805. FACILITATING THE USE OF REAL WORLD EVI-
DENCE. 
(a) GUIDANCE.—Not later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall issue, or revise existing, guidance on 
considerations for the use of real world data and real world 
evidence to support regulatory decisionmaking, as follows: 
(1) With respect to drugs, such guidance shall 
address— 
(A) the use of such data and evidence to 
support the approval of a drug application 
under section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355) or a biological 
product application under section 351 of the 
Public Health Service Act (42 U.S.C. 262), or to 
support an investigational use exemption under 
section 505(i) of the Federal Food, Drug, and 
Cosmetic Act or section 351(a)(3) of the Public 
Health Service Act; and 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00168
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
169 
(B) the use of such data and evidence ob-
tained as a result of the use of drugs authorized 
for emergency use under section 564 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb–3) in such applications, submissions, or 
requests; and 
(C) standards and methodologies which may 
be used for collection and analysis of real world 
evidence included in such applications, submis-
sions, or requests, as appropriate. 
(2) With respect to devices, such guidance shall 
address— 
(A) the use of such data and evidence to 
support the approval, clearance, or classification 
of a device pursuant to an application or sub-
mission 
submitted 
under 
section 
510(k), 
513(f)(2), or 515 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(k), 360c(f)(2), 
360e), or to support an investigational use ex-
emption under section 520(g) of such Act (21 
U.S.C. 360j(g)); 
(B) the use of such data and evidence ob-
tained as a result of the use of devices authorized 
for emergency use under section 564 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00169
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
170 
360bbb–3), in such applications, submissions, or 
requests; and 
(C) standards and methodologies which may 
be used for collection and analysis of real world 
evidence included in such applications, submis-
sions, or requests, as appropriate. 
(b) REPORT TO CONGRESS.—Not later than 2 years 
after the termination of the public health emergency deter-
mination by the Secretary of Health and Human Services 
under section 564 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–3) on February 4, 2020, with respect 
to the Coronavirus Disease 2019 (COVID–19), the Secretary 
shall submit a report 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 
on— 
(1) the number of applications, submissions, or 
requests submitted for clearance or approval under 
section 505, 510(k), 513(f)(2), or 515 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355, 
360(k), 360c(f)(2), 360e) or section 351 of the Public 
Health Service Act, for which an authorization under 
section 564 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–3) was previously granted; 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00170
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
171 
(2) of the number of applications so submitted, 
the number of such applications— 
(A) for which real world evidence was sub-
mitted and used to support a regulatory deci-
sion; and 
(B) for which real world evidence was sub-
mitted and determined to be insufficient to sup-
port a regulatory decision; and 
(3) a summary explanation of why, in the case 
of applications described in paragraph (2)(B), real 
world evidence could not be used to support regu-
latory decisions. 
(c) INFORMATION DISCLOSURE.—Nothing in this sec-
tion shall be construed to authorize the disclosure of infor-
mation that is prohibited from disclosure under section 
1905 of title 18, United States Code, or subject to with-
holding under subsection (b)(4) of section 552 of title 5, 
United States Code (commonly referred to as the ‘‘Freedom 
of Information Act’’). 
SEC. 806. DUAL SUBMISSION FOR CERTAIN DEVICES. 
Section 513 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360c) is amended by adding at the end the 
following: 
‘‘(k) For a device authorized for emergency use under 
section 564 for which, in accordance with section 564(m), 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00171
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
172 
the Secretary has deemed a laboratory examination or pro-
cedure associated with such device to be in the category of 
examinations and procedures described in section 353(d)(3) 
of the Public Health Service Act, the sponsor of such device 
may, when submitting a request for classification under sec-
tion 513(f)(2), submit a single submission containing— 
‘‘(1) the information needed for such a request; 
and 
‘‘(2) sufficient information to enable the Sec-
retary to determine whether such laboratory examina-
tion or procedure satisfies the criteria to be cat-
egorized under section 353(d)(3) of the Public Health 
Service Act.’’. 
SEC. 807. MEDICAL DEVICES ADVISORY COMMITTEE MEET-
INGS. 
(a) IN GENERAL.—The Secretary shall convene one or 
more panels of the Medical Devices Advisory Committee not 
less than once per year for the purpose of providing advice 
to the Secretary on topics related to medical devices used 
in pandemic preparedness and response, including topics 
related to in vitro diagnostics. 
(b) REQUIRED PANEL MEMBER.—A panel convened 
under subsection (a) shall include at least 1 population 
health-specific representative. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00172
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
173 
(c) SUNSET.—This section shall cease to be effective on 
October 1, 2027. 
SEC. 808. ENSURING CYBERSECURITY OF MEDICAL DE-
VICES. 
(a) IN GENERAL.—Subchapter A of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 
seq.), as amended by section 501, is further amended by 
adding at the end the following: 
‘‘SEC. 524C. ENSURING CYBERSECURITY OF DEVICES. 
‘‘(a) IN GENERAL.—For purposes of ensuring cyberse-
curity throughout the lifecycle of a cyber device, any person 
who submits a premarket submission for the cyber device 
shall include such information as the Secretary may require 
to ensure that the cyber device meets such cybersecurity re-
quirements as the Secretary determines to be appropriate 
to demonstrate a reasonable assurance of safety and effec-
tiveness, including at a minimum the cybersecurity require-
ments under subsection (b). 
‘‘(b) CYBERSECURITY REQUIREMENTS.—At a min-
imum, the manufacturer of a cyber device shall meet the 
following cybersecurity requirements: 
‘‘(1) The manufacturer shall have a plan to ap-
propriately monitor, identify, and address in a rea-
sonable time postmarket cybersecurity vulnerabilities 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00173
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
174 
and exploits, including coordinated vulnerability dis-
closure and procedures. 
‘‘(2) The manufacturer shall design, develop, and 
maintain processes and procedures to ensure the de-
vice and related systems are cybersecure, and shall 
make available updates and patches to the cyber de-
vice and related systems throughout the lifecycle of the 
cyber device to address— 
‘‘(A) on a reasonably justified regular cycle, 
known unacceptable vulnerabilities; and 
‘‘(B) as soon as possible out of cycle, critical 
vulnerabilities that could cause uncontrolled 
risks. 
‘‘(3) The manufacturer shall provide in the label-
ing of the cyber device a software bill of materials, in-
cluding commercial, open-source, and off-the-shelf 
software components. 
‘‘(4) The manufacturer shall comply with such 
other requirements as the Secretary may require to 
demonstrate reasonable assurance of the safety and ef-
fectiveness of the device for purposes of cybersecurity, 
which the Secretary may require by an order pub-
lished in the Federal Register. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00174
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
175 
‘‘(c) SUBSTANTIAL EQUIVALENCE.—In making a de-
termination of substantial equivalence under section 513(i) 
for a cyber device, the Secretary may— 
‘‘(1) find that cybersecurity information for the 
cyber device described in the relevant premarket sub-
mission in the cyber device’s use environment is inad-
equate; and 
‘‘(2) issue a nonsubstantial equivalence deter-
mination based on this finding. 
‘‘(d) DEFINITION.—In this section: 
‘‘(1) CYBER
DEVICE.—The term ‘cyber device’ 
means a device that— 
‘‘(A) includes software, including software 
as or in a device; 
‘‘(B) has the ability to connect to the inter-
net; or 
‘‘(C) contains any such technological char-
acteristics that could be vulnerable to cybersecu-
rity threats. 
‘‘(2) LIFECYCLE OF THE CYBER DEVICE.—The 
term ‘lifecycle of the cyber device’ includes the 
postmarket lifecycle of the cyber device. 
‘‘(3) PREMARKET SUBMISSION.—The term ‘pre-
market submission’ means any submission under sec-
tion 510(k), 513, 515(c), 515(f), or 520(m). 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00175
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
176 
‘‘(e) EXEMPTION.—The Secretary may identify devices 
or types of devices that are exempt from meeting the cyberse-
curity requirements established by this section and regula-
tions promulgated pursuant to this section. The Secretary 
shall publish in the Federal Register, and update, as appro-
priate, a list of the devices and types of devices so identified 
by the Secretary.’’. 
(b) PROHIBITED ACT.—Section 301(q) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)) is amend-
ed by adding at the end the following: 
‘‘(3) The failure to comply with any requirement 
under section 524C (relating to ensuring device cybersecu-
rity).’’. 
(c) ADULTERATION.—Section 501 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351) is amended by 
inserting after paragraph (j) the following: 
‘‘(k) If it is a device subject to the requirements set 
forth in section 524C (relating to ensuring device cybersecu-
rity) and fails to comply with any requirement under that 
section.’’. 
(d) MISBRANDING.—Section 502(t) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352(t)) is amend-
ed— 
(1) by striking ‘‘or (3)’’ and inserting ‘‘(3)’’; and 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00176
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
177 
(2) by inserting before the period at the end the 
following: ‘‘, or (4) to furnish a software bill of mate-
rials as required under section 524C (relating to en-
suring device cybersecurity)’’. 
SEC. 809. PUBLIC DOCKET ON PROPOSED CHANGES TO 
THIRD-PARTY VENDORS. 
(a) IN GENERAL.— 
(1) OPENING PUBLIC DOCKET.—Not later than 
90 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall open 
a single public docket to solicit comments on factors 
that generally should be considered by the Secretary 
when reviewing requests from sponsors of drugs sub-
ject to risk evaluation and mitigation strategies to 
change third-party vendors engaged by sponsors to 
aid in implementation and management of the strate-
gies. 
(2) FACTORS.—Such factors include the potential 
effects of changes in third-party vendors on— 
(A) patient access; and 
(B) prescribing and administration of the 
drugs by health care providers. 
(3) CLOSING PUBLIC DOCKET.—The Secretary of 
Health and Human Services may close such public 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00177
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
178 
docket not earlier than 90 days after such docket is 
opened. 
(4) NO DELAY.—Nothing in this section shall 
delay agency action on any modification to a risk 
evaluation and mitigation strategy. 
(b) GAO REPORT.—Not later than December 31, 2026, 
the Comptroller General of the United States shall submit 
to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report on— 
(1) the number of changes in third-party vendors 
(engaged by sponsors to aid implementation and 
management of risk evaluation and mitigation strate-
gies) for an approved risk evaluation and mitigation 
strategy the Secretary of Health and Human Services 
has approved under section 505–1(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(h)); 
(2) any issues affecting patient access to the 
drug that is subject to the strategy or considerations 
with respect to the administration or prescribing of 
such drug by health care providers that arose as a re-
sult of such modifications; and 
(3) how such issues were resolved, as applicable. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00178
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
179 
SEC. 810. FACILITATING EXCHANGE OF PRODUCT INFORMA-
TION PRIOR TO APPROVAL. 
(a) IN GENERAL.—Section 502 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352) is amended— 
(1) in paragraph (a)— 
(A) by striking ‘‘drugs for coverage’’ and in-
serting ‘‘drugs or devices for coverage’’; and 
(B) by striking ‘‘drug’’ each place it ap-
pears and inserting ‘‘drug or device’’, respec-
tively; 
(2) in paragraphs (a)(1) and (a)(2)(B), by strik-
ing ‘‘under section 505 or under section 351 of the 
Public Health Service Act’’ and inserting ‘‘under sec-
tion 505, 510(k), 513(f)(2), or 515 of this Act or sec-
tion 351 of the Public Health Service Act’’; 
(3) in paragraph (a)(1)— 
(A) by striking ‘‘under section 505 or under 
section 351(a) of the Public Health Service Act’’ 
and inserting ‘‘under section 505, 510(k), 
513(f)(2), or 515 of this Act or section 351 of the 
Public Health Service Act’’; and 
(B) by striking ‘‘in section 505(a) or in 
subsections (a) and (k) of section 351 of the Pub-
lic Health Service Act’’ and inserting ‘‘in section 
505, 510(k), 513(f)(2), or 515 of this Act or sec-
tion 351 of the Public Health Service Act’’; and 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00179
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
180 
(4) by adding at the end the following: 
‘‘(gg)(1) Unless its labeling bears adequate directions 
for use in accordance with paragraph (f), except that (in 
addition to drugs or devices that conform with exemptions 
pursuant to such paragraph) no drug or device shall be 
deemed to be misbranded under such paragraph through the 
provision of product information to a payor, formulary 
committee, or other similar entity with knowledge and ex-
pertise in the area of health care economic analysis car-
rying out its responsibilities for the selection of drugs or 
devices for coverage or reimbursement if the product infor-
mation relates to an investigational drug or device or inves-
tigational use of a drug or device that is approved, cleared, 
granted marketing authorization, or licensed under section 
505, 510(k), 513(f)(2), or 515 of this Act or section 351 
of the Public Health Service Act (as applicable), provided— 
‘‘(A) the product information includes— 
‘‘(i) a clear statement that the investiga-
tional drug or device or investigational use of a 
drug or device has not been approved, cleared, 
granted marketing authorization, or licensed 
under section 505, 510(k), 513(f)(2), or 515 of 
this Act or section 351 of the Public Health 
Service Act (as applicable) and that the safety 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00180
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
181 
and effectiveness of the drug or device or use has 
not been established; 
‘‘(ii) information related to the stage of de-
velopment of the drug or device involved, such 
as— 
‘‘(I) the status of any study or studies 
in which the investigational drug or device 
or investigational use is being investigated; 
‘‘(II) how the study or studies relate to 
the overall plan for the development of the 
drug or device; and 
‘‘(III) whether an application, pre-
market notification, or request for classi-
fication for the investigational drug or de-
vice or investigational use has been sub-
mitted to the Secretary and when such a 
submission is planned; 
‘‘(iii) in the case of information that in-
cludes factual presentations of results from stud-
ies, which shall not be selectively presented, a de-
scription of— 
‘‘(I) all material aspects of study de-
sign, methodology, and results; and 
‘‘(II) all material limitations related to 
the study design, methodology, and results; 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00181
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
182 
‘‘(iv) where applicable, a prominent state-
ment disclosing the indication or indications for 
which the Secretary has approved, granted mar-
keting authorization, cleared, or licensed the 
product 
pursuant 
to 
section 
505, 
510(k), 
513(f)(2), or 515 of this Act or section 351 of the 
Public Health Service Act, and a copy of the 
most current required labeling; and 
‘‘(v) updated information, if previously 
communicated information becomes materially 
outdated as a result of significant changes or as 
a result of new information regarding the prod-
uct or its review status; and 
‘‘(B) the product information does not include— 
‘‘(i) information that represents that an un-
approved product— 
‘‘(I) has been approved, cleared, grant-
ed marketing authorization, or licensed 
under section 505, 510(k), 513(f)(2), or 515 
of this Act or section 351 of the Public 
Health Service Act (as applicable); or 
‘‘(II) has otherwise been determined to 
be safe or effective for the purpose or pur-
poses for which the drug or device is being 
studied; or 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00182
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
183 
‘‘(ii) information that represents that an 
unapproved use of a drug or device that has been 
so approved, granted marketing authorization, 
cleared, or licensed— 
‘‘(I) is so approved, granted marketing 
authorization, cleared, or licensed; or 
‘‘(II) that the product is safe or effec-
tive for the use or uses for which the drug 
or device is being studied. 
‘‘(2) For purposes of this paragraph, the term ‘product 
information’ includes— 
‘‘(A) information describing the drug or device 
(such as drug class, device description, and features); 
‘‘(B) information about the indication or indica-
tions being investigated; 
‘‘(C) the anticipated timeline for a possible ap-
proval, clearance, marketing authorization, or licen-
sure pursuant to section 505, 510(k), 513, or 515 of 
this Act or section 351 of the Public Health Service 
Act; 
‘‘(D) drug or device pricing information; 
‘‘(E) patient utilization projections; 
‘‘(F) product-related programs or services; and 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00183
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
184 
‘‘(G) factual presentations of results from studies 
that do not characterize or make conclusions regard-
ing safety or efficacy.’’. 
(b) GAO STUDY AND REPORT.—Beginning on the date 
that is 5 years and 6 months after the date of enactment 
of this Act, the Comptroller General of the United States 
shall conduct a study on the provision and use of informa-
tion pursuant to section 502(gg) of the Federal Food, Drug, 
and Cosmetic Act, as added by this subsection (a), between 
manufacturers of drugs and devices (as defined in section 
201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321)) and entities described in such section 502(gg). Such 
study shall include an analysis of the following: 
(1) The types of information communicated be-
tween such manufacturers and payors. 
(2) The manner of communication between such 
manufacturers and payors. 
(3)(A) Whether such manufacturers file an ap-
plication for approval, marketing authorization, 
clearance, or licensing of a new drug or device or the 
new use of a drug or device that is the subject of com-
munication between such manufacturers and payors 
under section 502(gg) of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a). 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00184
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
185 
(B) How frequently the Food and Drug Admin-
istration approves, grants marketing authorization, 
clears, or licenses the new drug or device or new use. 
(C) The timeframe between the initial commu-
nications permitted under section 502(gg) of the Fed-
eral Food, Drug, and Cosmetic Act, as added by sub-
section (a), regarding an investigational drug or de-
vice or investigational use, and the initial marketing 
of such drug or device. 
SEC. 811. BANS OF DEVICES FOR ONE OR MORE INTENDED 
USES. 
(a) IN GENERAL.—Section 516(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360f(a)) is amended— 
(1) in paragraph (1), by inserting ‘‘for one or 
more intended use’’ before the semicolon at the end; 
and 
(2) in the matter following paragraph (2), by in-
serting ‘‘for any such intended use or uses. A device 
that is banned for one or more intended uses is not 
a legally marketed device under section 1006 when in-
tended for such use or uses’’ after ‘‘banned device’’. 
(b) SPECIFIC DEVICES DEEMED BANNED.—Section 
516 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360f) is further amended by adding at the end the following: 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00185
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
186 
‘‘(c) SPECIFIC DEVICE BANNED.—Electrical stimula-
tion devices that apply a noxious electrical stimulus to a 
person’s skin intended to reduce or cease self-injurious be-
havior or aggressive behavior are deemed to be banned de-
vices, as described in subsection (a). 
‘‘(d) REVERSAL
BY REGULATION.—Devices banned 
under this section are banned devices unless or until the 
Secretary promulgates a regulation to make such devices 
or use of such devices no longer banned based on a finding 
that such devices or use of such devices does not present 
substantial deception or an unreasonable and substantial 
risk of illness or injury, or that such risk can be corrected 
or eliminated by labeling.’’. 
SEC. 812. CLARIFYING APPLICATION OF EXCLUSIVE AP-
PROVAL, CERTIFICATION, OR LICENSURE FOR 
DRUGS DESIGNATED FOR RARE DISEASES OR 
CONDITIONS. 
(a) APPLICATION OF EXCLUSIVE APPROVAL, CERTIFI-
CATION, OR LICENSURE
FOR DRUGS DESIGNATED
FOR 
RARE DISEASES OR CONDITIONS.—Section 527 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is 
amended— 
(1) in subsection (a), in the matter following 
paragraph (2), by striking ‘‘same disease or condi-
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00186
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
187 
tion’’ and inserting ‘‘same approved indication or use 
within such rare disease or condition’’; 
(2) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘same rare disease or condition’’ and 
inserting ‘‘same indication or use for which the 
Secretary has approved or licensed such drug’’; 
and 
(B) in paragraph (1), by striking ‘‘with the 
disease or condition for which the drug was des-
ignated’’ and inserting ‘‘for whom the drug is 
indicated’’; and 
(3) in subsection (c), by striking ‘‘same rare dis-
ease or condition’’ and inserting ‘‘same indication or 
use’’. 
(b) APPLICATION OF AMENDMENTS.—The amendments 
made by subsection (a) shall apply with respect to any drug 
designated under section 526 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bb), regardless of the date 
on which the drug was so designated, and regardless of the 
date on which the drug was approved under section 505 
of such Act (21 U.S.C. 355) or licensed under section 351 
of the Public Health Service Act (42 U.S.C. 262). 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00187
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
188 
SEC. 813. GAO REPORT ON THIRD-PARTY REVIEW. 
Not later than September 30, 2026, the Comptroller 
General of the United States shall submit to the Committee 
on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pen-
sions of the Senate a report on the third-party review pro-
gram described in section 523 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360m). Such report shall in-
clude— 
(1) a description of the financial and staffing re-
sources used to carry out such program; 
(2) a description of actions taken by the Sec-
retary pursuant section 523(b)(2)(C) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
360m(b)(2)(C)); and 
(3) the results of an audit of the performance of 
select persons accredited under such program. 
SEC. 814. REPORTING ON PENDING GENERIC DRUG APPLI-
CATIONS AND PRIORITY REVIEW APPLICA-
TIONS. 
Section 807 of the FDA Reauthorization Act of 2017 
(Public Law 115–52) is amended, in the matter preceding 
paragraph (1), by striking ‘‘2022’’ and inserting ‘‘2027’’. 
SEC. 815. FDA WORKFORCE IMPROVEMENTS. 
Section 714A of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379d–3a) is amended— 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00188
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
189 
(1) in subsection (a), by striking ‘‘medical prod-
ucts’’ and inserting ‘‘products regulated by the Food 
and Drug Administration’’; and 
(2) by striking subsection (d) and inserting the 
following: 
‘‘(d) AGENCY-WIDE STRATEGIC WORKFORCE PLAN.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of the Food and Drug Amend-
ments of 2022, the Commissioner of Food and Drugs 
shall develop and begin implementation of an agency- 
wide strategic workforce plan at the Food and Drug 
Administration, which shall include— 
‘‘(A) agency-wide human capital goals and 
strategies; 
‘‘(B) performance measures, benchmarks, or 
other elements to facilitate the monitoring and 
evaluation of the progress made toward such 
goals and the effectiveness of such strategies; and 
‘‘(C) a process for updating such plan based 
on timely and relevant information on an ongo-
ing basis. 
‘‘(2) REPORT TO CONGRESS.—Not later than 18 
months after the date of enactment of the Food and 
Drug Amendments of 2022, the Secretary shall submit 
to the Committee on Energy and Commerce of the 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00189
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
190 
House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate 
a report describing the plan under paragraph (1) and 
the status of its implementation.’’. 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00190
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00191
Fmt 6652
Sfmt 6203
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS
Union Calendar No. 262 
117TH CONGRESS 
2D SESSION 
H. R. 7667 
[Report No. 117–348] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic 
Act to revise and extend the user-fee programs 
for prescription drugs, medical devices, generic 
drugs, and biosimilar biological products, and for 
other purposes. 
JUNE 7, 2022 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
VerDate Sep 11 2014 
00:33 Jun 08, 2022
Jkt 029200
PO 00000
Frm 00192
Fmt 6651
Sfmt 6651
E:\BILLS\H7667.RH
H7667
kjohnson on DSK79L0C42PROD with BILLS