(b) IMPROVING INFORMATION SHARING AND AVAIL-
ABILITY OF PUBLIC HEALTH DATA.—Section 310B of the 
Public Health Service Act (42 U.S.C. 242u) is amended 
to read as follows: 
‘‘SEC. 310B. IMPROVING INFORMATION SHARING AND 
AVAILABILITY OF PUBLIC HEALTH DATA. 
‘‘(a) IN GENERAL.—The Secretary acting through 
the Director of the Centers for Disease Control and Pre-
vention (in this section referred to as the ‘Secretary’) may 
require the reporting of public health and health care data 
and information to the Centers for Disease Control and 
Prevention by— 
‘‘(1) health care providers and facilities, includ-
ing pharmacies; 
‘‘(2) public health, clinical, and other labora-
tories and diagnostic testing entities; 
‘‘(3) State, local, and Tribal health depart-
ments; and 
‘‘(4) other entities, as determined appropriate 
by the Secretary. 
‘‘(b) 
CONTENT, 
FORM, 
MANNER, 
AND
FRE-
QUENCY.— 
‘‘(1) COLLABORATION.—The Secretary shall 
collaborate with representatives of State, local, and 
Tribal health departments and other entities on de-
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00029
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
termining the content, form, manner, and frequency 
of the reporting of public health and health care 
data and information required pursuant to sub-
section (a). 
‘‘(2) SIMULTANEOUS
REPORTING.—In deter-
mining the content, form, manner, and frequency of 
the reporting of public health and health care data 
and information pursuant to subsection (a), where a 
disease, condition, or related event is reportable 
under applicable State or local law, the Secretary 
shall require the data and information to be reported 
first or simultaneously to the appropriate State or 
local jurisdiction. 
‘‘(3) ALIGNMENT
WITH
STANDARDS
AND
IM-
PLEMENTATION
SPECIFICATIONS.—The 
content, 
form, manner, and frequency requirements required 
pursuant to this section shall align with the stand-
ards and implementation specifications adopted by 
the Secretary under section 3004, where applicable. 
‘‘(4) REASONABLE EFFORTS TO LIMIT REPORT-
ING.—The Secretary shall make reasonable efforts 
to limit the public health and health care data and 
information required to be reported under this sec-
tion to the minimum necessary to accomplish the in-
tended public health purpose. 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00030
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
‘‘(5) IMPLEMENTATION
AND
REGULATIONS.— 
The Secretary— 
‘‘(A) may promulgate by regulation the 
content, form, manner, and frequency in which 
public health and health care data and informa-
tion is required to be reported under this sec-
tion; and 
‘‘(B) in the event of a public health emer-
gency declared under section 319, or where the 
Secretary determines there is a significant po-
tential for such an emergency to exist, may 
issue such requirements— 
‘‘(i) by guidance in accordance with 
this section; and 
‘‘(ii) without regard to the procedures 
otherwise required by section 553 of title 
5, United States Code. 
‘‘(c) ENSURING THAT DATA IS ACCESSIBLE IN A 
TIMELY
MANNER
TO
STATE, LOCAL, AND
TRIBAL 
HEALTH AUTHORITIES.— 
‘‘(1) COLLABORATION.—The Secretary shall 
collaborate with representatives of State, local, and 
Tribal health departments, and entities representing 
such departments, to ensure that data and informa-
tion that is collected by the Centers for Disease Con-
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00031
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
trol and Prevention pursuant to this section are ac-
cessible, as appropriate, in a timely manner, to 
State, local, and Tribal health authorities. 
‘‘(2) RULES
OF
CONSTRUCTION.—Nothing in 
this section shall be construed— 
‘‘(A) to prevent any Federal agency, State, 
local, or Tribal health department, or other en-
tity from collecting data or information under 
other applicable law; or 
‘‘(B) to limit the authority of the Centers 
for Disease Control and Prevention to share 
public health surveillance data with State, local, 
or Tribal health authorities. 
‘‘(3) REASONABLE EFFORTS TO REDUCE RE-
PORTING
BURDENS
AND
POTENTIAL
DUPLICA-
TION.—The Secretary shall make reasonable efforts 
to collaborate with representatives of Federal agen-
cies and State, local, and Tribal health departments 
to reduce reporting burdens and potential duplica-
tion of reporting requirements. Such efforts may in-
clude ensuring simultaneous sharing of data and in-
formation described in subsection (b) with State, 
local, and Tribal public health authorities. 
‘‘(d) 
CONFIDENTIALITY
AND
PROTECTION
OF 
DATA.—Any identifiable, sensitive information reported to 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00032
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
the Centers for Disease Control and Prevention pursuant 
to this section shall not be further disclosed or provided 
to any other individual or party, including any party in-
volved in civil, criminal, or administrative litigation, ex-
cept— 
‘‘(1) as necessary for public health purposes, in-
cluding with relevant Federal, State, local, or tribal 
public health authorities; 
‘‘(2) as required under section 552a(d)(1) of 
title 5, United States Code; 
‘‘(3) as required by applicable Federal laws, ex-
cluding instances of disclosure in any Federal, State, 
or local civil, criminal, administrative, legislative, or 
other proceeding; or 
‘‘(4) with the consent of each individual to 
whom the information pertains. 
‘‘(e) EXEMPTION
OF CERTAIN PUBLIC HEALTH 
DATA FROM DISCLOSURE.—The Secretary may exempt 
from disclosure under section 552(b)(3) of title 5, United 
States Code, public health and health care data and infor-
mation collected by the Centers for Disease Control and 
Prevention pursuant to this section or any other authority 
under which the Centers collects public health or health 
care data and information if— 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00033
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
‘‘(1) an individual is identified through such 
data or information; or 
‘‘(2) there is at least a very small risk, as deter-
mined by current scientific practices or statistical 
methods, that some combination of the data or in-
formation, the request for disclosure under such sec-
tion 552(b)(3), and other available data sources or 
the application of technology could be used to de-
duce the identity of the individuals to which such 
data or information pertains.’’. 
(c) PUBLIC HEALTH INFORMATION SHARING AND 
AVAILABILITY ADVISORY COMMITTEE.—Part A of title III 
of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by adding at the end the following: 
‘‘SEC. 310C. PUBLIC HEALTH INFORMATION SHARING AND 
AVAILABILITY ADVISORY COMMITTEE. 
‘‘(a) 
ESTABLISHMENT.—The 
Secretary, 
acting 
through the Director of the Centers for Disease Control 
and Prevention, shall establish an advisory committee, to 
be known as the Public Health Information Sharing and 
Availability Advisory Committee, to advise, and make rec-
ommendations to, the Director with respect to the imple-
mentation of public health and health care data and infor-
mation reporting and sharing under section 310B. 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00034
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
‘‘(b) MEMBERSHIP.—The membership of the advisory 
committee established pursuant to this section shall in-
clude— 
‘‘(1) individuals with subject matter expertise 
or experience in the following areas of public health 
and health care data and information, including— 
‘‘(A) State, territorial, local, and Tribal 
health department data systems or practices; 
and 
‘‘(B) health care data; 
‘‘(2) ex officio members, including from relevant 
Federal agencies such as the Office of the National 
Coordinator for Health Information Technology, the 
Centers for Medicare & Medicaid Services, the Cen-
ters for Disease Control and Prevention, and the Of-
fice of the Assistant Secretary for Health; 
‘‘(3) representatives of national organizations, 
including the Council of State and Territorial Epi-
demiologists, the Association of Public Health Lab-
oratories, the Association of State and Territorial 
Health Officials, the National Association of County 
and City Health Officials, and the Big Cities Health 
Coalition; and 
‘‘(4) such additional members as the Secretary 
determines appropriate. 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00035
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
‘‘(c) FACA APPLICABILITY.—The advisory com-
mittee established pursuant to this section is deemed to 
be an advisory committee subject to the Federal Advisory 
Committee Act.’’. 
(d) IMPROVING PUBLIC HEALTH DATA COLLEC-
TION.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this subsection as 
the ‘‘Secretary’’) shall award grants, contracts, or 
cooperative agreements to eligible entities for pur-
poses of identifying, developing, or disseminating 
best practices in the collection of electronic health 
information and the use of designated data stand-
ards and implementation specifications— 
(A) to improve the quality and complete-
ness of data, including demographic data, col-
lected, accessed, or used for public health pur-
poses; and 
(B) to address health disparities and re-
lated health outcomes. 
(2) ELIGIBLE ENTITIES.—To be eligible to re-
ceive an award under this subsection an entity 
shall— 
(A) be a health care provider, academic 
medical center, community-based organization, 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00036
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
State, local governmental entity, Indian Tribe 
or Tribal organization (as such terms are de-
fined in section 4 of the Indian Self Determina-
tion and Education Assistance Act (25 U.S.C. 
5304)), Urban Indian organization (as defined 
in section 4 of the Indian Health Care Improve-
ment Act (25 U.S.C. 1603)), or other appro-
priate public or private nonprofit entity, or a 
consortia of any such entities; and 
(B) submit an application to the Secretary 
at such time, in such manner, and containing 
such information as the Secretary may require. 
(3) ACTIVITIES.—Entities receiving awards 
under this subsection shall use such award to de-
velop and test best practices for training health care 
providers to use standards and implementation spec-
ifications that assist in the capture, access, ex-
change, and use of electronic health information, in-
cluding demographic information, disability status, 
veteran status, housing status, functional status, 
and other data elements. Such activities shall, at a 
minimum, include— 
(A) improving, understanding, and using 
data standards and implementation specifica-
tions; 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00037
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
(B) developing or identifying methods to 
improve communication with patients in a cul-
turally and linguistically appropriate manner, 
including to better capture information related 
to demographics of such individuals; 
(C) developing methods for accurately cat-
egorizing and recording patient responses using 
available data standards; 
(D) educating providers regarding the util-
ity of such information for public health pur-
poses and the importance of accurate collection 
and recording of such data; and 
(E) other activities, as the Secretary deter-
mines appropriate. 
(4) REPORTING.— 
(A) REPORTING BY AWARD RECIPIENTS.— 
Each recipient of an award under this sub-
section shall submit to the Secretary a report 
on the results of best practices identified, devel-
oped, or disseminated through such award. 
(B) REPORT
TO
CONGRESS.—Not later 
than 1 year after the completion of the program 
under this subsection, the Secretary shall sub-
mit a report to Congress on the success of the 
best practices developed under such program, 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00038
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
opportunities for further dissemination of such 
best practices, and recommendations for im-
proving the capture, access, exchange, and use 
of information to improve public health and re-
duce health disparities. 
(5) NONDUPLICATION OF EFFORTS.—The Sec-
retary shall ensure that the activities and programs 
carried out under this subsection are free of unnec-
essary duplication of effort. 
(6) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated $10,000,000 
for each of fiscal years 2024 through 2026 to carry 
out this subsection. 
(e) INFORMATION COLLECTION.—Section 319D(a) of 
the Public Health Service Act (42 U.S.C. 247d–4(a)) is 
amended by adding at the end the following: 
‘‘(5) INFORMATION
COLLECTION.—Subchapter 
I of chapter 35 of title 44, United States Code, shall 
not apply to information collection by the Centers 
for Disease Control and Prevention, including the 
Agency for Toxic Substances and Disease Registry, 
that are part of investigations, research, surveil-
lance, or evaluations undertaken for public health 
purposes under any available authority.’’. 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00039
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
TITLE 
IV—ENSURING 
WORK-
FORCE TO PREPARE FOR AND 
RESPOND TO PUBLIC HEALTH 
SECURITY THREATS 
SEC. 401. TEMPORARY REASSIGNMENT OF STATE AND 
LOCAL 
PERSONNEL 
DURING 
A 
PUBLIC 
HEALTH EMERGENCY. 
(a) REPORT TO CONGRESS.—Section 319(e)(6) of the 
Public Health Service Act (42 U.S.C. 247d(e)(6)) is 
amended by striking ‘‘Not later than 4 years after the date 
of enactment of the Pandemic and All-Hazards Prepared-
ness Reauthorization Act of 2013, the Comptroller Gen-
eral of the United States shall’’ and inserting ‘‘Not later 
than 4 years after the date of enactment of the Protecting 
PAHPA Act of 2023, the Comptroller General of the 
United States shall’’. 
(b) SUNSET.—Section 319(e)(8) of the Public Health 
Service Act (42 U.S.C. 247d(e)(8)) is amended by striking 
‘‘2023’’ and inserting ‘‘2028’’. 
SEC. 402. EPIDEMIC INTELLIGENCE SERVICE. 
Section 317F(c)(2) of the Public Health Service Act 
(42 U.S.C. 247b–7(c)(2)) is amended by striking ‘‘2019 
through 2023’’ and inserting ‘‘2024 through 2028’’. 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00040
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
drug to submit, in such manner as the Secretary 
may prescribe, data and information from any stage 
of development of the drug that are adequate to as-
sess the stability of the drug to determine the long-
est supported expiration date. 
‘‘(2) LACK OF DATA AND INFORMATION.—If the 
data and information required pursuant to an order 
issued under paragraph (1) are not available or are 
insufficient, as determined by the Secretary, the Sec-
retary may issue an order requiring the manufac-
turer of the drug— 
‘‘(A) to conduct studies, which may be a 
continuation of ongoing studies, to provide data 
and information adequate to assess the stability 
of the drug and to determine the longest sup-
ported expiration date; and 
‘‘(B) to submit such data and information 
to the Secretary in such manner as the Sec-
retary may prescribe in the order. 
‘‘(c) LABELING.—The Secretary may issue an order 
requiring the manufacturer of a life-saving drug, by a date 
determined by the Secretary in consultation with the spon-
sor of the drug, to make any labeling change regarding 
the expiration date or storage and handling of the drug 
that the Secretary determines to be appropriate based on 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00042
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
the data and information required to be submitted under 
this section or any other data and information available 
to the Secretary. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) LIFE-SAVING DRUG.—The term ‘life-saving 
drug’ means a drug, that is— 
‘‘(A)(i) a medical countermeasure; or 
‘‘(ii) on the drug shortage list under sec-
tion 506E or determined by the Secretary to be 
at risk of shortage; and 
‘‘(B)(i) life-supporting; 
‘‘(ii) life-sustaining; or 
‘‘(iii) intended for use in the prevention or 
treatment of a debilitating disease or condition 
in humans or animals, including any such drug 
used in emergency medical care or during sur-
gery or any such drug that is critical to the 
public health during a public health emergency 
declared by the Secretary under section 319 of 
the Public Health Service Act. 
‘‘(2) MEDICAL COUNTERMEASURE.—The term 
‘medical countermeasure’ means a countermeasure 
as defined in section 565(a). 
‘‘(e) CONFIDENTIALITY.—Nothing in this section 
shall be construed as authorizing the Secretary to disclose 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00043
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
any information that is a trade secret or confidential infor-
mation subject to section 552(b)(4) of title 5, United 
States Code, or section 1905 of title 18, United States 
Code.’’. 
(b) PROHIBITED ACT.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331), as 
amended by section 3503(a)(1)(A) of division FF of Pub-
lic Law 117–328, is amended by inserting at the end the 
following new subsection: 
‘‘(jjj) The failure to comply with any order issued 
under section 506M.’’. 
(c) PENALTIES.—Subsection (b) of section 303 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) 
is amended by inserting at the end the following: 
‘‘(9) If a manufacturer of a life-saving drug fails to 
submit data and information as required under section 
506M(b)(1), fails to conduct or submit the data and infor-
mation generated by studies as required under section 
506M(b)(2), or fails to make a labeling change as required 
under section 506M(c), such manufacturer shall be subject 
to a civil penalty of not more than $10,000 for the first 
day on which the violation occurs and not more than 
$10,000 for each subsequent day on which the violation 
is not corrected.’’. 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00044
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
Subtitle B—Drug Origin 
Transparency 
SEC. 511. ENHANCED DRUG MANUFACTURING AMOUNT IN-
FORMATION REPORTING. 
(a) IN GENERAL.—Section 510(j)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(j)(3)) is 
amended— 
(1) in subparagraph (A), by adding ‘‘or (2)’’ 
after ‘‘paragraph (1)’’; and 
(2) by adding at the end the following: 
‘‘(C) Each report submitted pursuant to sub-
paragraph (A) with respect to a drug shall— 
‘‘(i) include additional information as may 
be specified by the Secretary in regulation or 
guidance regarding the supply chain for such 
drug, such as— 
‘‘(I) the identity of the respective sup-
pliers of each active pharmaceutical ingre-
dient, active pharmaceutical ingredient in-
termediate, and in-process material used in 
such manufacture, preparation, propaga-
tion, compounding, or processing of the 
drug; and 
‘‘(II) the respective amounts of such 
drug that were manufactured, prepared, 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00045
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
propagated, compounded, or processed 
using an active pharmaceutical ingredient, 
active pharmaceutical ingredient inter-
mediate, and in-process material from each 
such identified supplier; and 
‘‘(ii) be submitted more frequently than 
annually, in accordance with a reporting sched-
ule as may be specified by the Secretary in such 
regulation or guidance, but not more frequently 
than 4 times per year. 
‘‘(D) Any additional information specified in 
regulation or guidance pursuant to subparagraph 
(C) shall be a required element of reports under this 
paragraph not earlier than 6 months after the date 
on which such regulation or guidance is issued in 
final form (and in no event shall the absence of any 
regulation or guidance issued under subparagraph 
(C) affect the requirement to report as described in 
subparagraph (A)).’’. 
(b) 
CONFORMING
AMENDMENT.—Section 
510(j)(3)(B) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 510(j)(3)(B)) is amended by striking ‘‘sub-
paragraph (A)’’ and inserting ‘‘this paragraph’’. 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00046
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
SEC. 512. REQUIRE DRUG LABELING TO INCLUDE ORIGI-
NAL MANUFACTURER AND SUPPLY CHAIN IN-
FORMATION. 
Section 502 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) is amended— 
(1) in paragraph (b)— 
(A) by striking ‘‘(b) If in a package’’ and 
inserting ‘‘(b)(1) If in a package’’; 
(B) by striking ‘‘a label containing (1) the 
name and place’’ and inserting ‘‘a label con-
taining— 
‘‘(A) the name and place’’; 
(C) by striking ‘‘or distributor; and (2) an 
accurate statement’’ and inserting ‘‘or dis-
tributor; and 
‘‘(B) an accurate statement’’; 
(D) by striking ‘‘under clause (2) of this 
paragraph’’ and inserting ‘‘under this clause’’; 
and 
(E) by inserting at the end the following: 
‘‘(2)(A) Subject to clause (C), if it is a drug, 
including an active pharmaceutical ingredient, unless 
it bears a label containing the name and place of 
business, and unique facility identifier of the original 
manufacturer of such drug or active pharmaceutical 
ingredient, except that the Secretary may provide, 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00047
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
labeling requirements specified in subparagraph (1), in-
cluding by electronic means.’’. 
Subtitle C—Medical Device 
Shortage Reduction 
SEC. 521. CLARIFYING DEVICE SHORTAGE NOTIFICATIONS. 
Section 506J(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 356j(a)) is amended— 
(1) in paragraph (2), by striking ‘‘during, or in 
advance of, a public health emergency’’; and 
(2) in the matter following paragraph (2), by 
striking ‘‘, during, or in advance of, a public health 
emergency declared by the Secretary under section 
319 of the Public Health Service Act,’’. 
SEC. 522. SUPPLY CHAIN RISK MANAGEMENT. 
(a) Section 506J of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356j) is amended by striking 
subsection (h) and inserting the following: 
‘‘(h) RISK MANAGEMENT PLANS.—Each manufac-
turer of a device described in subsection (a) shall develop, 
maintain, and, as appropriate, implement a risk manage-
ment plan that identifies and evaluates risks to the supply 
of the device, as applicable, for each establishment in 
which such device is manufactured. Such risk management 
plan— 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00049
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
‘‘(1) may identify and evaluate risks to the sup-
ply of more than 1 device, or device category, manu-
factured at the same establishment; and 
‘‘(2) shall be subject to inspection and copying 
by the Secretary pursuant to section 704 or at the 
request of the Secretary.’’. 
(b) CONFORMING AMENDMENT.—Section 506J(f) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356j(f)) is amended by striking ‘‘or (h)’’ after ‘‘subsection 
(a)’’. 
SEC. 523. CLARIFYING VOLUNTARY NOTIFICATIONS. 
Section 506J(i) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 356j(i)) is amended by adding at 
the end the following: ‘‘Nothing in this section shall be 
construed to limit the authority of the Secretary to request 
that a manufacturer (or other person involved in the de-
vice supply chain) provide, on a voluntary basis, informa-
tion to the Secretary or the authority of the Secretary to 
receive such information.’’. 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00050
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
Subtitle D—Drug Shortage 
Prevention 
SEC. 531. IMPROVING NOTIFICATION PROCEDURES IN 
CASE OF INCREASED DEMAND FOR CRITICAL 
ESSENTIAL MEDICINES. 
(a) IN GENERAL.—Section 506C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amend-
ed— 
(1) in the section heading, by striking ‘‘DIS-
CONTINUANCE OR INTERRUPTION IN THE PRO-
DUCTION OF LIFE-SAVING DRUGS’’ and inserting 
‘‘NOTIFICATION OF ISSUES AFFECTING DOMES-
TIC
SUPPLY
OF
CRITICAL
ESSENTIAL
MEDI-
CINES’’; 
(2) by striking subsections (a), (b), and (c), and 
inserting the following: 
‘‘(a) NOTIFICATION REQUIRED.— 
‘‘(1) IN GENERAL.—A manufacturer of a crit-
ical essential medicine shall notify the Secretary, in 
accordance with subsection (b), of— 
‘‘(A)(i) a permanent discontinuance in the 
manufacture of the drug or an interruption of 
the manufacture of the drug that is likely to 
lead to a meaningful disruption in the supply of 
such drug in the United States; 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00051
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
‘‘(ii) a permanent discontinuance in the 
manufacture of an active pharmaceutical ingre-
dient, an excipient, or any other input in the 
final dosage form of such drug or an interrup-
tion in the manufacture of the active pharma-
ceutical ingredient, an excipient, or any other 
input in the final dosage form of such drug of 
such drug that is likely to lead to a meaningful 
disruption in the supply of the active pharma-
ceutical ingredient of such drug; 
‘‘(iii) an increased demand (other than an 
anticipated seasonal surge) for such drug or an 
active pharmaceutical ingredient, an excipient, 
or any other input in the final dosage form of 
such drug that is likely to lead to a shortage of 
the drug or the active pharmaceutical ingre-
dient, an excipient, or any other input in the 
final dosage form of such drug; and 
‘‘(B) the reasons for such discontinuance, 
interruption, or increased demand. 
‘‘(2) CONTENTS.—Notification under this sub-
section with respect to a critical essential medicine 
shall include— 
‘‘(A) with respect to the reasons for the 
discontinuation, interruption, or increased de-
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00052
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
mand referred to in paragraph (1)(C), if an ac-
tive pharmaceutical ingredient, an excipient, or 
any other input in the final dosage form of such 
drug is a reason for, or risk factor in, such dis-
continuation, interruption, or increased de-
mand, the source of the active pharmaceutical 
ingredient, excipient, or other input and any al-
ternative sources for the an active pharma-
ceutical ingredient, an excipient, or any other 
input by the manufacturer; 
‘‘(B) whether any associated device used 
for preparation or administration included in 
the drug is a reason for, or a risk factor in, 
such discontinuation, interruption, or increased 
demand; 
‘‘(C) the expected duration of the interrup-
tion or increased demand; and 
‘‘(D) such other information as the Sec-
retary may require. 
‘‘(b) TIMING.— 
‘‘(1) IN
GENERAL.—A notice required under 
subsection (a) shall be submitted to the Secretary— 
‘‘(A) at least 6 months prior to the date of 
the discontinuance or interruption; 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00053
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
‘‘(B) in the case of such a notice with re-
spect to increased demand for a critical essen-
tial medicine, not later than 30 days after the 
submission of the initial notification under 
paragraph (2); or 
‘‘(C) if compliance with subparagraph (A) 
or (B) is not possible, as soon as practicable. 
‘‘(2) INITIAL NOTIFICATION WITH RESPECT TO 
INCREASED DEMAND.—In the case a notification re-
quired under subsection (a) with respect to increased 
demand for a critical essential medicine, the manu-
facturer of the drug involved shall submit to the 
Secretary an initial notification not later than 48 
hours after the date on which there has been in-
creased demand for the critical essential medicine 
for a period of at least 6 consecutive weeks. 
‘‘(c) DISTRIBUTION.—To the maximum extent prac-
ticable, the Secretary shall distribute, through such means 
as the Secretary deems appropriate, information on the 
discontinuance or interruption of the manufacture of, or 
the increased demand for, critical essential medicines to 
appropriate organizations, including physician, health pro-
vider, and patient organizations, as described in section 
506E.’’; 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00054
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
or condition, including any such drug used 
in emergency medical care or during sur-
gery or any such drug that is critical to 
the public health during a public health 
emergency declared by the Secretary under 
section 319 of the Public Health Service 
Act; and 
‘‘(B) is not a radio pharmaceutical drug 
product or any other product as designated by 
the Secretary;’’. 
(c) REGULATIONS.—Not later than 18 months after 
the date of the enactment of this Act, the Secretary of 
Health and Human Services shall issue final regulations 
to implement the amendments made by subsections (a) 
and (b). 
(d) GUIDANCE.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner 
of Food and Drugs, shall issue guidance on the re-
quirements for notifications required to be submitted 
under section 506C of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356c), as amended by sub-
sections (a) and (b), with respect to increased de-
mand for critical essential medicines (as defined in 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00056
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
such section 506C). Such guidance shall specifically 
address— 
(A) the ways in which manufacturers of 
critical essential medicines can improve demand 
predictability; 
(B) what information manufacturers of 
critical essential medicines should send to the 
Secretary; and 
(C) what communications from the manu-
facturer the Secretary would request with re-
spect to increases in demand following such no-
tifications. 
(2) CONSULTATION.—In developing such guid-
ance, the Secretary shall consult with relevant stake-
holders, including manufacturers of critical essential 
medicines and local, State, or Federal public health 
officials. 
(3) TIMING.—The Secretary of Health and 
Human Services, acting through the Commissioner 
of Food and Drugs, shall issue— 
(A) draft guidance under paragraph (1) 
not later than 120 days after the date of the 
enactment of this Act; and 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00057
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
(B) final guidance under such paragraph 
not later than 180 days after the date of the 
enactment of this Act. 
Subtitle E—Protecting Americans 
From Unsafe Drugs 
SEC. 541. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF DRUGS. 
(a) ORDER TO CEASE DISTRIBUTION
AND RE-
CALL.—Section 569D of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb–8d) is amended— 
(1) in the section heading, by striking ‘‘CON-
TROLLED SUBSTANCES’’ and inserting ‘‘DRUGS’’; 
(2) by striking ‘‘controlled substance’’ each 
place such term appears and inserting ‘‘drug’’; 
(3) in subsection (b)— 
(A) by striking ‘‘controlled substances’’ 
and inserting ‘‘drugs’’; and 
(B) by inserting ‘‘of subsection (a)’’ after 
‘‘an order pursuant to paragraph (1) or an 
amended order pursuant to subparagraph (B) 
or (C) of paragraph (3)’’; and 
(4) in subsection (c), by striking ‘‘or an official 
senior to such Director’’ and inserting ‘‘or the Direc-
tor of the Center for Biologics Evaluation and Re-
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00058
Fmt 6652
Sfmt 6201
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB
search (or an official senior to either such Direc-
tor)’’. 
(b) IMPORTS AND EXPORTS.—Section 801(a) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381(a)), as amended by section 3503(a)(4)(C) of division 
FF of Public Law 117–328, is amended by striking ‘‘is 
a controlled substance subject to an order under section 
569D’’ and inserting ‘‘is a drug subject to an order under 
section 569D’’. 
Æ 
VerDate Sep 11 2014 
04:51 Aug 09, 2023
Jkt 039200
PO 00000
Frm 00059
Fmt 6652
Sfmt 6301
E:\BILLS\H4697.IH
H4697
pbinns on DSKJLVW7X2PROD with $$_JOB