311 
metic Act (21 U.S.C. 381), as amended, is further 
amended by adding at the end the following: 
‘‘(u) ARTICLE OF CONCERN DEFINED.—For pur-
poses of subsection (a), the term ‘article of concern’ means 
an article that is or contains a drug or other substance— 
‘‘(1) for which, during the 24-month period 
prior to the article being imported or offered for im-
port, the Secretary of Health and Human Services— 
‘‘(A) has requested that, based on a deter-
mination that the drug or other substance ap-
pears to meet the requirements for temporary 
or permanent scheduling pursuant to section 
201 of the Controlled Substances Act, the At-
torney General initiate the process to control 
the drug or other substance in accordance with 
such Act; or 
‘‘(B) has, following the publication by the 
Attorney General of a notice in the Federal 
Register of the intention to issue an order tem-
porarily scheduling such drug or substance in 
schedule I of section 202 of the Controlled Sub-
stances Act pursuant to section 201(h) of such 
Act, made a determination that such article 
presents an imminent hazard to public safety; 
and
312 
‘‘(2) with respect to which the Attorney General 
has not— 
‘‘(A) scheduled the drug or other substance 
under such Act; or 
‘‘(B) notified the Secretary of Health and 
Human Services that the Attorney General has 
made a determination not to schedule the drug 
or other substance under such Act.’’. 
SEC. 7193. SEIZURE. 
Section 304(b) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 334(b)) is amended by striking the 
first sentence and inserting the following: ‘‘The article, 
equipment, or other thing proceeded against shall be liable 
to seizure by process pursuant to the libel, and the proce-
dure in cases under this section shall conform, as nearly 
as may be, to the procedure in admiralty rather than the 
procedure used for civil asset forfeiture proceedings set 
forth in section 983 of title 18, United States Code. On 
demand of either party any issue of fact joined in any such 
a case brought under this section shall be tried by jury. 
A seizure brought under this section is not governed by 
Rule G of the Supplemental Rules of Admiralty or Mari-
time Claims and Asset Forfeiture Actions. Exigent cir-
cumstances shall be deemed to exist for all seizures 
brought under this section, and in such cases, the sum-
313 
mons and arrest warrant shall be issued by the clerk of 
the court without court review.’’. 
SEC. 7194. DEBARRING VIOLATIVE INDIVIDUALS OR COM-
PANIES. 
(a) PROHIBITED ACT.—Section 301(cc) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) 
is amended— 
(1) by inserting after ‘‘an article of food’’ the 
following: ‘‘or a drug’’; and 
(2) by inserting after ‘‘a person debarred’’ the 
following: ‘‘from such activity’’. 
(b) DEBARMENT.—Section 306(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is 
amended— 
(1) in paragraph (1)— 
(A) in the matter preceding subparagraph 
(A), by striking ‘‘paragraph (2)’’ and inserting 
‘‘paragraph (2) or (3)’’; 
(B) in subparagraph (B), by striking ‘‘or’’ 
at the end; 
(C) in subparagraph (C), by striking the 
period at the end and inserting ‘‘, or’’; and 
(D) by adding at the end the following: 
‘‘(D) a person from importing or offering 
to import into the United States—
314 
‘‘(i) a controlled substance as defined 
in section 102(6) of the Controlled Sub-
stances Act; or 
‘‘(ii) any drug, if such drug is de-
clared to be valued at an amount that is 
$2,500 or less (or such higher amount as 
the Secretary of the Treasury may set by 
regulation pursuant to section 498(a)(1) of 
the Tariff Act of 1930), or if such drug is 
entering the United States by mail.’’; and 
(2) in paragraph (3)— 
(A) in the paragraph heading after 
‘‘FOOD’’ by inserting ‘‘OR DRUG’’; 
(B) by redesignating subparagraphs (A) 
and (B) as clauses (i) and (ii), respectively, and 
moving the indentation of each such clause 2 
ems to the right; 
(C) after making the amendments required 
by subparagraph (B), by striking ‘‘A person is 
subject’’ and inserting the following: 
‘‘(A) FOOD.—A person is subject’’; and 
(D) by adding at the end the following: 
‘‘(B) IMPORTATION OF DRUGS.—A person 
is subject to debarment under paragraph (1)(D) 
if—
315 
‘‘(i) the person has been convicted of 
a felony for conduct relating to the impor-
tation into the United States of any drug 
or controlled substance (as defined in sec-
tion 102 of the Controlled Substances 
Act); or 
‘‘(ii) the person has engaged in a pat-
tern of importing or offering for import ar-
ticles of drug that are— 
‘‘(I)(aa) adulterated, misbranded, 
or in violation of section 505; and 
‘‘(bb) present a threat of serious 
adverse health consequences or death 
to humans or animals; or 
‘‘(II) controlled substances whose 
importation is prohibited pursuant to 
section 401(m) of the Tariff Act of 
1930. 
‘‘(C) DEFINITION.—For purposes of sub-
paragraph (B), the term ‘pattern of importing 
or offering for import articles of drug’ means 
importing or offering for import articles of drug 
described in subclause (I) or (II) of subpara-
graph (B)(ii) in an amount, frequency, or dos-
316 
age that is inconsistent with personal or house-
hold use by the importer.’’. 
Subtitle U—Creating Opportunities 
That Necessitate New and En-
hanced Connections That Im-
prove Opioid Navigation Strate-
gies 
SEC. 7201. SHORT TITLE. 
This subtitle may be cited as the ‘‘Creating Opportu-
nities that Necessitate New and Enhanced Connections 
That Improve Opioid Navigation Strategies Act of 2018’’ 
or the ‘‘CONNECTIONS Act’’. 
SEC. 7202. PREVENTING OVERDOSES OF CONTROLLED SUB-
STANCES. 
Part P of title III of the Public Health Service Act 
(42 U.S.C. 280g et seq.) is amended by adding at the end 
the following new section: 
‘‘SEC. 399V–7. PREVENTING OVERDOSES OF CONTROLLED 
SUBSTANCES. 
‘‘(a) EVIDENCE-BASED PREVENTION GRANTS.— 
‘‘(1) IN GENERAL.—The Director of the Cen-
ters for Disease Control and Prevention may— 
‘‘(A) to the extent practicable, carry out 
any evidence-based prevention activity described 
in paragraph (2);
317 
‘‘(B) provide training and technical assist-
ance to States, localities, and Indian tribes for 
purposes of carrying out any such activity; and 
‘‘(C) award grants to States, localities, and 
Indian tribes for purposes of carrying out any 
such activity. 
‘‘(2) EVIDENCE-BASED
PREVENTION
ACTIVI-
TIES.—An evidence-based prevention activity de-
scribed in this paragraph is any of the following ac-
tivities: 
‘‘(A) With respect to a State, improving 
the efficiency and use of the State prescription 
drug monitoring program by— 
‘‘(i) encouraging all authorized users 
(as specified by the State) to register with 
and use the program and making the pro-
gram easier to use; 
‘‘(ii) enabling such users to access any 
updates to information collected by the 
program in as close to real-time as pos-
sible; 
‘‘(iii) providing for a mechanism for 
the program to automatically flag any po-
tential misuse or abuse of controlled sub-
stances and any detection of inappropriate
318 
prescribing practices relating to such sub-
stances; 
‘‘(iv) enhancing interoperability be-
tween the program and any electronic 
health records system, including by inte-
grating the use of electronic health records 
into the program for purposes of improving 
clinical decisionmaking; 
‘‘(v) continually updating program ca-
pabilities to respond to technological inno-
vation for purposes of appropriately ad-
dressing a controlled substance overdose 
epidemic as such epidemic may occur and 
evolve; 
‘‘(vi) facilitating data sharing between 
the program and the prescription drug 
monitoring 
programs 
of 
neighboring 
States; and 
‘‘(vii) meeting the purpose of the pro-
gram established under section 399O, as 
described in section 399O(a). 
‘‘(B) Achieving community or health sys-
tem interventions through activities such as—
319 
‘‘(i) establishing or improving con-
trolled substances prescribing interventions 
for insurers and health systems; 
‘‘(ii) enhancing the use of evidence- 
based controlled substances prescribing 
guidelines across sectors and health care 
settings; and 
‘‘(iii) implementing strategies to align 
the prescription of controlled substances 
with the guidelines described in clause (ii). 
‘‘(C) Evaluating interventions to better un-
derstand what works to prevent overdoses, in-
cluding those involving prescription and illicit 
controlled substances. 
‘‘(D) Implementing projects to advance an 
innovative prevention approach with respect to 
new and emerging public health crises and op-
portunities to address such crises, such as en-
hancing public education and awareness on the 
risks associated with opioids. 
‘‘(b) ENHANCED SURVEILLANCE OF CONTROLLED 
SUBSTANCE OVERDOSE GRANTS.— 
‘‘(1) IN GENERAL.—The Director of the Cen-
ters for Disease Control and Prevention may—
320 
‘‘(A) to the extent practicable, carry out 
any controlled substance overdose surveillance 
activity described in paragraph (2); 
‘‘(B) provide training and technical assist-
ance to States for purposes of carrying out any 
such activity; 
‘‘(C) award grants to States for purposes 
of carrying out any such activity; and 
‘‘(D) coordinate with the Assistant Sec-
retary for Mental Health and Substance Use to 
collect data pursuant to section 505(d)(1)(A) 
(relating to the number of individuals admitted 
to the emergency rooms of hospitals as a result 
of the abuse of alcohol or other drugs). 
‘‘(2) CONTROLLED SUBSTANCE OVERDOSE SUR-
VEILLANCE
ACTIVITIES.—A controlled substance 
overdose surveillance activity described in this para-
graph is any of the following activities: 
‘‘(A) Enhancing the timeliness of reporting 
data to the public, including data on fatal and 
nonfatal overdoses of controlled substances. 
‘‘(B) Enhancing comprehensiveness of data 
on controlled substances overdoses by collecting 
information on such overdoses from appropriate 
sources such as toxicology reports, autopsy re-
321 
ports, death scene investigations, and other risk 
factors. 
‘‘(C) Using data to help identify risk fac-
tors associated with controlled substances 
overdoses. 
‘‘(D) With respect to a State, supporting 
entities involved in providing information to in-
form efforts within the State, such as by coro-
ners and medical examiners, to improve accu-
rate testing and reporting of causes and con-
tributing 
factors 
to 
controlled 
substances 
overdoses. 
‘‘(E) Working to enable information shar-
ing regarding controlled substances overdoses 
among data sources. 
‘‘(c) DEFINITIONS.—In this section: 
‘‘(1) CONTROLLED
SUBSTANCE.—The term 
‘controlled substance’ has the meaning given that 
term in section 102 of the Controlled Substances 
Act. 
‘‘(2) INDIAN TRIBE.—The term ‘Indian tribe’ 
has the meaning given that term in section 4 of the 
Indian Self-Determination and Education Assistance 
Act.
322 
‘‘(d) AUTHORIZATION
OF
APPROPRIATIONS.—For 
purposes of carrying out this section and section 399O, 
there is authorized to be appropriated $486,000,000 for 
each of fiscal years 2019 through 2023.’’. 
SEC. 7203. PRESCRIPTION DRUG MONITORING PROGRAM. 
Section 399O of the Public Health Service Act (42 
U.S.C. 280g–3) is amended to read as follows: 
‘‘SEC. 399O. PRESCRIPTION DRUG MONITORING PROGRAM. 
‘‘(a) PROGRAM.— 
‘‘(1) IN GENERAL.—Each fiscal year, the Sec-
retary, in consultation with the Director of National 
Drug Control Policy, acting through the Director of 
the Centers for Disease Control and Prevention, the 
Assistant Secretary for Mental Health and Sub-
stance Use, and the National Coordinator for Health 
Information Technology, shall support States for the 
purpose of improving the efficiency and use of 
PDMPs, including— 
‘‘(A) establishment and implementation of 
a PDMP; 
‘‘(B) maintenance of a PDMP; 
‘‘(C) improvements to a PDMP by— 
‘‘(i) enhancing functional components 
to work toward—
323 
‘‘(I) universal use of PDMPs 
among providers and their delegates, 
to the extent that State laws allow, 
within a State; 
‘‘(II) more timely inclusion of 
data within a PDMP; 
‘‘(III) active management of the 
PDMP, in part by sending proactive 
or unsolicited reports to providers to 
inform prescribing; and 
‘‘(IV) ensuring the highest level 
of ease in use and access of PDMPs 
by providers and their delegates, to 
the extent that State laws allow; 
‘‘(ii) improving the intrastate inter-
operability of PDMPs by— 
‘‘(I) making PDMPs more ac-
tionable by integrating PDMPs within 
electronic health records and health 
information technology infrastructure; 
and 
‘‘(II) linking PDMP data to 
other data systems within the State, 
including—
324 
‘‘(aa) the data of pharmacy 
benefit managers, medical exam-
iners and coroners, and the 
State’s Medicaid program; 
‘‘(bb) worker’s compensation 
data; and 
‘‘(cc) prescribing data of 
providers of the Department of 
Veterans Affairs and the Indian 
Health Service within the State; 
‘‘(iii) improving the interstate inter-
operability of PDMPs through— 
‘‘(I) sharing of dispensing data in 
near-real time across State lines; and 
‘‘(II) integration of automated 
queries for multistate PDMP data 
and analytics into clinical workflow to 
improve the use of such data and ana-
lytics by practitioners and dispensers; 
or 
‘‘(iv) improving the ability to include 
treatment availability resources and refer-
ral capabilities within the PDMP. 
‘‘(2) STATE LEGISLATION.—As a condition on 
the receipt of support under this section, the Sec-
325 
retary shall require a State to demonstrate that the 
State has enacted legislation or regulations— 
‘‘(A) to provide for the implementation of 
the PDMP; and 
‘‘(B) to permit the imposition of appro-
priate penalties for the unauthorized use and 
disclosure of information maintained by the 
PDMP. 
‘‘(b) PDMP STRATEGIES.—The Secretary shall en-
courage a State, in establishing, improving, or maintaining 
a PDMP, to implement strategies that improve— 
‘‘(1) the reporting of dispensing in the State of 
a controlled substance to an ultimate user so the re-
porting occurs not later than 24 hours after the dis-
pensing event; 
‘‘(2) the consultation of the PDMP by each pre-
scribing practitioner, or their designee, in the State 
before initiating treatment with a controlled sub-
stance, or any substance as required by the State to 
be reported to the PDMP, and over the course of 
ongoing treatment for each prescribing event; 
‘‘(3) the consultation of the PDMP before dis-
pensing a controlled substance, or any substance as 
required by the State to be reported to the PDMP;
326 
‘‘(4) the proactive notification to a practitioner 
when patterns indicative of controlled substance mis-
use by a patient, including opioid misuse, are de-
tected; 
‘‘(5) the availability of data in the PDMP to 
other States, as allowable under State law; and 
‘‘(6) the availability of nonidentifiable informa-
tion to the Centers for Disease Control and Preven-
tion for surveillance, epidemiology, statistical re-
search, or educational purposes. 
‘‘(c) DRUG MISUSE AND ABUSE.—In consultation 
with practitioners, dispensers, and other relevant and in-
terested stakeholders, a State receiving support under this 
section— 
‘‘(1) shall establish a program to notify practi-
tioners and dispensers of information that will help 
to identify and prevent the unlawful diversion or 
misuse of controlled substances; and 
‘‘(2) may, to the extent permitted under State 
law, notify the appropriate authorities responsible 
for carrying out drug diversion investigations if the 
State determines that information in the PDMP 
maintained by the State indicates an unlawful diver-
sion or abuse of a controlled substance.
327 
‘‘(d) EVALUATION AND REPORTING.—As a condition 
on receipt of support under this section, the State shall 
report on interoperability with PDMPs of other States and 
Federal agencies, where appropriate, intrastate interoper-
ability with health information technology systems such as 
electronic health records, health information exchanges, 
and e-prescribing, where appropriate, and whether or not 
the State provides automatic, up-to-date, or daily informa-
tion about a patient when a practitioner (or the designee 
of a practitioner, where permitted) requests information 
about such patient. 
‘‘(e) EVALUATION AND REPORTING.—A State receiv-
ing support under this section shall provide the Secretary 
with aggregate nonidentifiable information, as permitted 
by State law, to enable the Secretary— 
‘‘(1) to evaluate the success of the State’s pro-
gram in achieving the purpose described in sub-
section (a); or 
‘‘(2) to prepare and submit to the Congress the 
report required by subsection (i)(2). 
‘‘(f) EDUCATION AND ACCESS TO THE MONITORING 
SYSTEM.—A State receiving support under this section 
shall take steps to—
328 
‘‘(1) facilitate prescribers and dispensers, and 
their delegates, as permitted by State law, to use the 
PDMP, to the extent practicable; and 
‘‘(2) educate prescribers and dispensers, and 
their delegates on the benefits of the use of PDMPs. 
‘‘(g) ELECTRONIC FORMAT.—The Secretary may 
issue guidelines specifying a uniform electronic format for 
the reporting, sharing, and disclosure of information pur-
suant to PDMPs. 
‘‘(h) RULES OF CONSTRUCTION.— 
‘‘(1) FUNCTIONS OTHERWISE AUTHORIZED BY 
LAW.—Nothing in this section shall be construed to 
restrict the ability of any authority, including any 
local, State, or Federal law enforcement, narcotics 
control, licensure, disciplinary, or program authority, 
to perform functions otherwise authorized by law. 
‘‘(2) ADDITIONAL
PRIVACY
PROTECTIONS.— 
Nothing in this section shall be construed as pre-
empting any State from imposing any additional pri-
vacy protections. 
‘‘(3) FEDERAL
PRIVACY
REQUIREMENTS.— 
Nothing in this section shall be construed to super-
sede any Federal privacy or confidentiality require-
ment, including the regulations promulgated under 
section 264(c) of the Health Insurance Portability
329 
and Accountability Act of 1996 (Public Law 104– 
191; 110 Stat. 2033) and section 543 of this Act. 
‘‘(4) NO
FEDERAL
PRIVATE
CAUSE
OF
AC-
TION.—Nothing in this section shall be construed to 
create a Federal private cause of action. 
‘‘(i) PROGRESS REPORT.—Not later than 3 years 
after the date of enactment of the CONNECTIONS Act, 
the Secretary shall— 
‘‘(1) complete a study that— 
‘‘(A) determines the progress of States in 
establishing and implementing PDMPs con-
sistent with this section; 
‘‘(B) provides an analysis of the extent to 
which the operation of PDMPs has— 
‘‘(i) reduced inappropriate use, abuse, 
diversion of, and overdose with, controlled 
substances; 
‘‘(ii) established or strengthened ini-
tiatives to ensure linkages to substance use 
disorder treatment services; or 
‘‘(iii) affected patient access to appro-
priate care in States operating PDMPs; 
‘‘(C) determine the progress of States in 
achieving interstate interoperability and intra-
state interoperability of PDMPs, including an
330 
assessment of technical, legal, and financial 
barriers to such progress and recommendations 
for addressing these barriers; 
‘‘(D) determines the progress of States in 
implementing near real-time electronic PDMPs; 
‘‘(E) provides an analysis of the privacy 
protections in place for the information re-
ported to the PDMP in each State receiving 
support under this section and any rec-
ommendations of the Secretary for additional 
Federal or State requirements for protection of 
this information; 
‘‘(F) determines the progress of States in 
implementing technological alternatives to cen-
tralized data storage, such as peer-to-peer file 
sharing or data pointer systems, in PDMPs and 
the potential for such alternatives to enhance 
the privacy and security of individually identifi-
able data; and 
‘‘(G) evaluates the penalties that States 
have enacted for the unauthorized use and dis-
closure of information maintained in PDMPs, 
and the criteria used by the Secretary to deter-
mine whether such penalties qualify as appro-
priate for purposes of subsection (a)(2); and
331 
‘‘(2) submit a report to the Congress on the re-
sults of the study. 
‘‘(j) ADVISORY COUNCIL.— 
‘‘(1) ESTABLISHMENT.—A State may establish 
an advisory council to assist in the establishment, 
improvement, or maintenance of a PDMP consistent 
with this section. 
‘‘(2) LIMITATION.—A State may not use Fed-
eral funds for the operations of an advisory council 
to assist in the establishment, improvement, or 
maintenance of a PDMP. 
‘‘(3) SENSE OF CONGRESS.—It is the sense of 
the Congress that, in establishing an advisory coun-
cil to assist in the establishment, improvement, or 
maintenance of a PDMP, a State should consult 
with appropriate professional boards and other inter-
ested parties. 
‘‘(k) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘controlled substance’ means a 
controlled substance (as defined in section 102 of 
the Controlled Substances Act) in schedule II, III, 
or IV of section 202 of such Act. 
‘‘(2) The term ‘dispense’ means to deliver a 
controlled substance to an ultimate user by, or pur-
suant to the lawful order of, a practitioner, irrespec-
332 
tive of whether the dispenser uses the internet or 
other means to effect such delivery. 
‘‘(3) The term ‘dispenser’ means a physician, 
pharmacist, or other person that dispenses a con-
trolled substance to an ultimate user. 
‘‘(4) The term ‘interstate interoperability’ with 
respect to a PDMP means the ability of the PDMP 
to electronically share reported information with an-
other State if the information concerns either the 
dispensing of a controlled substance to an ultimate 
user who resides in such other State, or the dis-
pensing of a controlled substance prescribed by a 
practitioner whose principal place of business is lo-
cated in such other State. 
‘‘(5) The term ‘intrastate interoperability’ with 
respect to a PDMP means the integration of PDMP 
data within electronic health records and health in-
formation technology infrastructure or linking of a 
PDMP to other data systems within the State, in-
cluding the State’s Medicaid program, workers’ com-
pensation programs, and medical examiners or coro-
ners. 
‘‘(6) The term ‘nonidentifiable information’ 
means information that does not identify a practi-
tioner, dispenser, or an ultimate user and with re-
333 
spect to which there is no reasonable basis to believe 
that the information can be used to identify a practi-
tioner, dispenser, or an ultimate user. 
‘‘(7) The term ‘PDMP’ means a prescription 
drug monitoring program that is State-controlled. 
‘‘(8) The term ‘practitioner’ means a physician, 
dentist, veterinarian, scientific investigator, phar-
macy, hospital, or other person licensed, registered, 
or otherwise permitted, by the United States or the 
jurisdiction in which the individual practices or does 
research, to distribute, dispense, conduct research 
with respect to, administer, or use in teaching or 
chemical analysis, a controlled substance in the 
course of professional practice or research. 
‘‘(9) The term ‘State’ means each of the 50 
States, the District of Columbia, and any common-
wealth or territory of the United States. 
‘‘(10) The term ‘ultimate user’ means a person 
who has obtained from a dispenser, and who pos-
sesses, a controlled substance for the person’s own 
use, for the use of a member of the person’s house-
hold, or for the use of an animal owned by the per-
son or by a member of the person’s household. 
‘‘(11) The term ‘clinical workflow’ means the 
integration of automated queries for prescription
334 
drug monitoring programs data and analytics into 
health information technologies such as electronic 
health record systems, health information exchanges, 
and/or pharmacy dispensing software systems, thus 
streamlining provider access through automated que-
ries.’’. 
Subtitle V—Securing Opioids and 
Unused Narcotics With Delib-
erate Disposal and Packaging 
SEC. 7211. SHORT TITLE. 
This subtitle may be cited as the ‘‘Securing Opioids 
and Unused Narcotics with Deliberate Disposal and Pack-
aging Act of 2018’’ or the ‘‘SOUND Disposal and Pack-
aging Act’’. 
SEC. 7212. IMPROVED TECHNOLOGIES, CONTROLS, OR 
MEASURES WITH RESPECT TO THE PACK-
AGING OR DISPOSAL OF CERTAIN DRUGS. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 505–1 (21 U.S.C. 355–1) the following new section: 
‘‘SEC. 505–2. SAFETY-ENHANCING PACKAGING AND DIS-
POSAL FEATURES. 
‘‘(a) ORDERS.— 
‘‘(1) IN GENERAL.—The Secretary may issue 
an order requiring the holder of a covered applica-
335 
tion to implement or modify one or more tech-
nologies, controls, or measures with respect to the 
packaging or disposal of one or more drugs identi-
fied in the covered application, if the Secretary de-
termines such technologies, controls, or measures to 
be appropriate to help mitigate the risk of abuse or 
misuse of such drug or drugs, which may include by 
reducing the availability of unused drugs. 
‘‘(2) PRIOR
CONSULTATION.—The Secretary 
may not issue an order under paragraph (1) unless 
the Secretary has consulted with relevant stake-
holders, through a public meeting, workshop, or oth-
erwise, about matters that are relevant to the sub-
ject of the order. 
‘‘(3) ASSURING ACCESS AND MINIMIZING BUR-
DEN.—Technologies, controls, or measures required 
under paragraph (1) shall— 
‘‘(A) be commensurate with the specific 
risk of abuse or misuse of the drug listed in the 
covered application; 
‘‘(B) considering such risk, not be unduly 
burdensome on patient access to the drug, con-
sidering in particular any available evidence re-
garding the expected or demonstrated public
336 
health impact of such technologies, controls, or 
measures; and 
‘‘(C) reduce the risk of abuse or misuse of 
such drug. 
‘‘(4) ORDER
CONTENTS.—An order issued 
under paragraph (1) may— 
‘‘(A) provide for a range of options for im-
plementing or modifying the technologies, con-
trols, or measures required to be implemented 
by such order; and 
‘‘(B) incorporate by reference standards 
regarding packaging or disposal set forth in an 
official compendium, established by a nationally 
or internationally recognized standard develop-
ment organization, or described on the public 
website of the Food and Drug Administration, 
so long as the order includes the rationale for 
incorporation of such standard. 
‘‘(5) ORDERS APPLICABLE TO DRUG CLASS.— 
When a concern about the risk of abuse or misuse 
of a drug relates to a pharmacological class, the Sec-
retary may, after consultation with relevant stake-
holders, issue an order under paragraph (1) which 
applies to the pharmacological class.
337 
‘‘(b) COMPLIANCE.—The holder of a covered applica-
tion shall— 
‘‘(1) submit a supplement containing proposed 
changes to the covered application to comply with an 
order issued under subsection (a) not later than— 
‘‘(A) 180 calendar days after the date on 
which the order is issued; or 
‘‘(B)(i) such longer time period as speci-
fied by the Secretary in such order; or 
‘‘(ii) if a request for an alternative date is 
submitted by the holder of such application not 
later than 60 calendar days after the date on 
which such order is issued— 
‘‘(I) such requested alternative date if 
agreed to by the Secretary; or 
‘‘(II) another date as specified by the 
Secretary; and 
‘‘(2) implement the changes approved pursuant 
to such supplement not later than the later of— 
‘‘(A) 90 calendar days after the date on 
which the supplement is approved; or 
‘‘(B) the end of such longer period as is— 
‘‘(i) determined to be appropriate by 
the Secretary; or
338 
‘‘(ii) approved by the Secretary pursu-
ant to a request by the holder of the cov-
ered application that explains why such 
longer period is needed, including to satisfy 
any other applicable Federal statutory or 
regulatory requirements. 
‘‘(c) ALTERNATIVE MEASURES.—The holder of the 
covered application may propose, and the Secretary shall 
approve, technologies, controls, or measures regarding 
packaging, storage, or disposal other than those specified 
in the applicable order issued under subsection (a), if such 
technologies, controls, or measures are supported by data 
and information demonstrating that such alternative tech-
nologies, controls, or measures can be expected to mitigate 
the risk of abuse or misuse of the drug or drugs involved, 
including by reducing the availability of unused drugs, to 
at least the same extent as the technologies, controls, or 
measures specified in such order. 
‘‘(d) DISPUTE RESOLUTION.—If a dispute arises in 
connection with a supplement submitted under subsection 
(b), the holder of the covered application may appeal a 
determination made with respect to such supplement using 
applicable dispute resolution procedures specified by the 
Secretary in regulations or guidance. 
‘‘(e) DEFINITIONS.—In this section—
339 
‘‘(1) the term ‘covered application’ means an 
application submitted under subsection (b) or (j) of 
section 505 for approval under such section or an 
application submitted under section 351 of Public 
Health Service Act for approval under such section, 
with respect to a drug that is or contains an opioid 
for which a listing in schedule II or III (on a tem-
porary or permanent basis) is in effect under section 
202 of the Controlled Substances Act; and 
‘‘(2) the term ‘relevant stakeholders’ may in-
clude scientific experts within the drug manufac-
turing industry; brand and generic drug manufactur-
ers; standard development organizations; wholesalers 
and distributors; payers; health care providers; phar-
macists; pharmacies; manufacturers; poison centers; 
and representatives of the National Institute on 
Drug Abuse, the National Institutes of Health, the 
Centers for Disease Control and Prevention, the 
Centers for Medicare & Medicaid Services, the Drug 
Enforcement Agency, the Consumer Product Safety 
Commission, individuals who specialize in treating 
addiction, and patient and caregiver groups.’’. 
(b) PROHIBITED ACTS.—Section 501 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend-
ed by inserting after paragraph (j) the following:
340 
‘‘(k) If it is a drug approved under a covered applica-
tion (as defined in section 505–2(e)), the holder of which 
does not meet the requirements of paragraphs (1) and (2) 
of subsection (b) of such section.’’. 
(c) REQUIRED CONTENT OF AN ABBREVIATED NEW 
DRUG APPLICATION.—Section 505(j)(2)(A) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(2)(A)) is amended— 
(1) in clause (vii)(IV), by striking ‘‘and’’ at the 
end; 
(2) in clause (viii), by striking the period at the 
end and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(ix) if the drug is or contains an opioid for 
which a listing in schedule II or III (on a temporary 
or permanent basis) is in effect under section 202 of 
the Controlled Substances Act, information to show 
that the applicant has proposed technologies, con-
trols, or measures related to the packaging or dis-
posal of the drug that provide protections com-
parable to those provided by the technologies, con-
trols, or measures required for the applicable listed 
drug under section 505–2, if applicable.’’. 
(d) GROUNDS FOR REFUSING TO APPROVE AN AB-
BREVIATED NEW DRUG APPLICATION.—Section 505(j)(4)
341 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(4)), is amended— 
(1) in subparagraph (J), by striking ‘‘or’’ at the 
end; 
(2) in subparagraph (K), by striking the period 
at the end and inserting ‘‘; or’’; and 
(3) by adding at the end the following: 
‘‘(L) if the drug is a drug described in 
paragraph (2)(A)(ix) and the applicant has not 
proposed technologies, controls, or measures re-
lated to the packaging or disposal of such drug 
that the Secretary determines provide protec-
tions comparable to those provided by the tech-
nologies, controls, or measures required for the 
applicable listed drug under section 505–2.’’. 
(e) RULES OF CONSTRUCTION.— 
(1) Any labeling describing technologies, con-
trols, or measures related to packaging or disposal 
intended to mitigate the risk of abuse or misuse of 
a drug product that is subject to an abbreviated new 
drug application, including labeling describing dif-
ferences from the reference listed drug resulting 
from the application of section 505–2 of the Federal 
Food, Drug, and Cosmetic Act, as added by sub-
section (a), shall not be construed—
342 
(A) as changes to labeling not permissible 
under clause (v) of section 505(j)(2)(A) of such 
Act (21 U.S.C. 355(j)(2)(A)), or a change in 
the conditions of use prescribed, recommended, 
or suggested in the labeling proposed for the 
new drug under clause (i) of such section; or 
(B) to preclude approval of an abbreviated 
new drug application under subparagraph (B) 
or (G) of section 505(j)(4) of such Act (21 
U.S.C. 355(j)(4)). 
(2) For a covered application that is an applica-
tion submitted under subsection (j) of section 505 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355), subsection (j)(2)(A) of such section 
505 shall not be construed to limit the type of data 
or information the Secretary of Health and Human 
Services may request or consider in connection with 
making any determination under section 505–2. 
(f) GAO REPORT.—Not later than 12 months after 
the date of enactment of this Act, the Comptroller General 
of the United States shall prepare and submit to the Con-
gress a report containing— 
(1) a description of available evidence, if any, 
on the effectiveness of site-of-use, in-home controlled
343 
substance disposal products and packaging tech-
nologies; 
(2) identification of ways in which such disposal 
products intended for use by patients, consumers, 
and other end users that are not registrants under 
the Controlled Substances Act, are made available to 
the public and barriers to the use of such disposal 
products; 
(3) identification of ways in which packaging 
technologies are made available to the public and 
barriers to the use of such technologies; 
(4) a description of Federal oversight, if any, of 
site-of-use, in-home controlled substance disposal 
products, including— 
(A) identification of the Federal agencies 
that oversee such products; 
(B) identification of the methods of dis-
posal of controlled substances recommended by 
these agencies for site-of-use, in-home disposal; 
and 
(C) a description of the effectiveness of 
such recommendations at preventing the diver-
sion of legally prescribed controlled substances;
344 
(5) a description of Federal oversight, if any, of 
controlled substance packaging technologies, includ-
ing— 
(A) identification of the Federal agencies 
that oversee such technologies; 
(B) identification of the technologies rec-
ommended by these agencies, including unit 
dose packaging, packaging that provides a set 
duration, or other packaging systems that may 
mitigate abuse or misuse; and 
(C) a description of the effectiveness of 
such recommendations at preventing the diver-
sion of legally prescribed controlled substances; 
and 
(6) recommendations on— 
(A) whether site-of-use, in-home controlled 
substance disposal products and packaging 
technologies require Federal oversight and, if 
so, which agencies should be responsible for 
such oversight and, as applicable, approval of 
such products or technologies; and 
(B) the potential role of the Federal Gov-
ernment in evaluating such products to ensure 
product efficacy.
345 
Subtitle W—Postapproval Study 
Requirements 
SEC. 7221. POSTAPPROVAL STUDY REQUIREMENTS. 
(a) PURPOSES OF STUDY.—Section 505(o)(3)(B) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(o)(3)(B)) is amended by adding at the end the fol-
lowing: 
‘‘(iv) To assess a potential reduction 
in effectiveness of the drug for the condi-
tions of use prescribed, recommended, or 
suggested in the labeling thereof if— 
‘‘(I) the drug involved— 
‘‘(aa) is or contains a sub-
stance for which a listing in any 
schedule is in effect (on a tem-
porary or permanent basis) under 
section 201 of the Controlled 
Substances Act; or 
‘‘(bb) is a drug that has not 
been approved under this section 
or licensed under section 351 of 
the Public Health Service Act, 
for which an application for such 
approval or licensure is pending 
or anticipated, and for which the
346 
Secretary provides notice to the 
sponsor that the Secretary in-
tends to issue a scientific and 
medical 
evaluation 
and 
rec-
ommend controls under the Con-
trolled Substances Act; and 
‘‘(II) the potential reduction in 
effectiveness could result in the bene-
fits of the drug no longer outweighing 
the risks.’’. 
(b) ESTABLISHMENT
OF REQUIREMENT.—Section 
505(o)(3)(C) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(o)(3)(C)) is amended by striking 
‘‘such requirement’’ and all that follows through ‘‘safety 
information.’’ and inserting the following: ‘‘such require-
ment— 
‘‘(i) in the case of a purpose described 
in clause (i), (ii), or (iii) of subparagraph 
(B), only if the Secretary becomes aware of 
new safety information; and 
‘‘(ii) in the case of a purpose de-
scribed in clause (iv) of such subpara-
graph, if the Secretary determines that 
new effectiveness information exists.’’.
347 
(c) APPLICABILITY.—Section 505(o)(3) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)) 
is amended by adding at the end the following new sub-
paragraph: 
‘‘(G) APPLICABILITY.—The conduct of a 
study or clinical trial required pursuant to this 
paragraph for the purpose specified in subpara-
graph (B)(iv) shall not be considered a new 
clinical investigation for the purpose of a period 
of exclusivity under clause (iii) or (iv) of sub-
section (c)(3)(E) or clause (iii) or (iv) of sub-
section (j)(5)(F).’’. 
(d) 
NEW
EFFECTIVENESS
INFORMATION
DE-
FINED.—Section 505(o)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(o)(2)) is amended by 
adding at the end the following new subparagraph: 
‘‘(D) 
NEW
EFFECTIVENESS
INFORMA-
TION.—The term ‘new effectiveness informa-
tion’, with respect to a drug that is or contains 
a controlled substance for which a listing in any 
schedule is in effect (on a temporary or perma-
nent basis) under section 201 of the Controlled 
Substances Act, means new information about 
the effectiveness of the drug, including a new 
analysis of existing information, derived from—
348 
‘‘(i) a clinical trial; an adverse event 
report; a postapproval study or clinical 
trial (including a study or clinical trial 
under paragraph (3)); 
‘‘(ii) 
peer-reviewed 
biomedical 
lit-
erature; 
‘‘(iii) 
data 
derived 
from 
the 
postmarket risk identification and analysis 
system under subsection (k); or 
‘‘(iv) other scientific data determined 
to be appropriate by the Secretary.’’. 
(e) CONFORMING AMENDMENTS WITH RESPECT TO 
LABELING CHANGES.—Section 505(o)(4) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(4)) is 
amended— 
(1) in subparagraph (A)— 
(A) in the heading, by inserting ‘‘OR NEW 
EFFECTIVENESS’’ after ‘‘SAFETY’’; 
(B) by striking ‘‘safety information’’ and 
inserting ‘‘new safety information or new effec-
tiveness information such’’; and 
(C) by striking ‘‘believes should be’’ and 
inserting ‘‘believes changes should be made to’’; 
(2) in subparagraph (B)(i)—
349 
(A) by striking ‘‘new safety information’’ 
and by inserting ‘‘new safety information or 
new effectiveness information’’; and 
(B) 
by 
inserting 
‘‘indications,’’ 
after 
‘‘boxed warnings,’’; 
(3) in subparagraph (C), by inserting ‘‘or new 
effectiveness information’’ after ‘‘safety informa-
tion’’; and 
(4) in subparagraph (E), by inserting ‘‘or new 
effectiveness information’’ after ‘‘safety informa-
tion’’. 
(f) RULE
OF
CONSTRUCTION.—Nothing in the 
amendments made by this section shall be construed to 
alter, in any manner, the meaning or application of the 
provisions of paragraph (3) of section 505(o) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)) 
with respect to the authority of the Secretary of Health 
and Human Services to require a postapproval study or 
clinical trial for a purpose specified in clauses (i) through 
(iii) of subparagraph (B) of such paragraph (3) or para-
graph (4) of such section 505(o) with respect to the Sec-
retary’s authority to require safety labeling changes.
350 
TITLE VIII—MISCELLANEOUS 
Subtitle A—Synthetics Trafficking 
and Overdose Prevention 
SEC. 8001. SHORT TITLE; TABLE OF CONTENTS. 
This subtitle may be cited as the ‘‘Synthetics Traf-
ficking and Overdose Prevention Act of 2018’’ or ‘‘STOP 
Act of 2018’’. 
SEC. 8002. CUSTOMS FEES. 
(a) IN GENERAL.—Section 13031(b)(9) of the Con-
solidated Omnibus Budget Reconciliation Act of 1985 (19 
U.S.C. 58c(b)(9)) is amended by adding at the end the 
following: 
‘‘(D)(i) With respect to the processing of items 
that are sent to the United States through the inter-
national postal network by ‘Inbound Express Mail 
service’ or ‘Inbound EMS’ (as that service is de-
scribed in the mail classification schedule referred to 
in section 3631 of title 39, United States Code), the 
following payments are required: 
‘‘(I) $1 per Inbound EMS item. 
‘‘(II) If an Inbound EMS item is formally 
entered, the fee provided for under subsection 
(a)(9), if applicable. 
‘‘(ii) Notwithstanding section 451 of the Tariff 
Act of 1930 (19 U.S.C. 1451), the payments re-
351 
quired by clause (i), as allocated pursuant to clause 
(iii)(I), shall be the only payments required for reim-
bursement of U.S. Customs and Border Protection 
for customs services provided in connection with the 
processing of an Inbound EMS item. 
‘‘(iii)(I) The payments required by clause (i)(I) 
shall be allocated as follows: 
‘‘(aa) 50 percent of the amount of the pay-
ments shall be paid on a quarterly basis by the 
United States Postal Service to the Commis-
sioner of U.S. Customs and Border Protection 
in accordance with regulations prescribed by the 
Secretary of the Treasury to reimburse U.S. 
Customs and Border Protection for customs 
services provided in connection with the proc-
essing of Inbound EMS items. 
‘‘(bb) 50 percent of the amount of the pay-
ments shall be retained by the Postal Service to 
reimburse the Postal Service for services pro-
vided in connection with the customs processing 
of Inbound EMS items. 
‘‘(II) Payments received by U.S. Customs and 
Border Protection under subclause (I)(aa) shall, in 
accordance with section 524 of the Tariff Act of 
1930 (19 U.S.C. 1524), be deposited in the Customs
352 
User Fee Account and used to directly reimburse 
each appropriation for the amount paid out of that 
appropriation for the costs incurred in providing 
services to international mail facilities. Amounts de-
posited in accordance with the preceding sentence 
shall be available until expended for the provision of 
such services. 
‘‘(III) Payments retained by the Postal Service 
under subclause (I)(bb) shall be used to directly re-
imburse the Postal Service for the costs incurred in 
providing services in connection with the customs 
processing of Inbound EMS items. 
‘‘(iv) Beginning in fiscal year 2021, the Sec-
retary, in consultation with the Postmaster General, 
may adjust, not more frequently than once each fis-
cal year, the amount described in clause (i)(I) to an 
amount commensurate with the costs of services pro-
vided in connection with the customs processing of 
Inbound EMS items, consistent with the obligations 
of the United States under international agree-
ments.’’. 
(b) CONFORMING AMENDMENTS.—Section 13031(a) 
of the Consolidated Omnibus Budget Reconciliation Act 
of 1985 (19 U.S.C. 58c(a)) is amended—
353 
(1) in paragraph (6), by inserting ‘‘(other than 
an item subject to a fee under subsection 
(b)(9)(D))’’ after ‘‘customs officer’’; and 
(2) in paragraph (10)— 
(A) in subparagraph (C), in the matter 
preceding clause (i), by inserting ‘‘(other than 
Inbound EMS items described in subsection 
(b)(9)(D))’’ after ‘‘release’’; and 
(B) in the flush at the end, by inserting 
‘‘or of Inbound EMS items described in sub-
section (b)(9)(D),’’ after ‘‘(C),’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on January 1, 2020. 
SEC. 8003. MANDATORY ADVANCE ELECTRONIC INFORMA-
TION FOR POSTAL SHIPMENTS. 
(a) MANDATORY ADVANCE ELECTRONIC INFORMA-
TION.— 
(1) IN GENERAL.—Section 343(a)(3)(K) of the 
Trade Act of 2002 (Public Law 107–210; 19 U.S.C. 
2071 note) is amended to read as follows: 
‘‘(K)(i) The Secretary shall prescribe regu-
lations requiring the United States Postal Serv-
ice to transmit the information described in 
paragraphs (1) and (2) to the Commissioner of 
U.S. Customs and Border Protection for inter-
354 
national mail shipments by the Postal Service 
(including shipments to the Postal Service from 
foreign postal operators that are transported by 
private carrier) consistent with the require-
ments of this subparagraph. 
‘‘(ii) In prescribing regulations under 
clause (i), the Secretary shall impose require-
ments for the transmission to the Commissioner 
of information described in paragraphs (1) and 
(2) for mail shipments described in clause (i) 
that are comparable to the requirements for the 
transmission of such information imposed on 
similar non-mail shipments of cargo, taking into 
account the parameters set forth in subpara-
graphs (A) through (J). 
‘‘(iii) The regulations prescribed under 
clause (i) shall require the transmission of the 
information described in paragraphs (1) and (2) 
with respect to a shipment as soon as prac-
ticable in relation to the transportation of the 
shipment, consistent with subparagraph (H). 
‘‘(iv) Regulations prescribed under clause 
(i) shall allow for the requirements for the 
transmission to the Commissioner of informa-
tion described in paragraphs (1) and (2) for
355 
mail shipments described in clause (i) to be im-
plemented in phases, as appropriate, by— 
‘‘(I) setting incremental targets for in-
creasing the percentage of such shipments 
for which information is required to be 
transmitted to the Commissioner; and 
‘‘(II) taking into consideration— 
‘‘(aa) the risk posed by such 
shipments; 
‘‘(bb) the volume of mail shipped 
to the United States by or through a 
particular country; and 
‘‘(cc) the capacities of foreign 
postal operators to provide that infor-
mation to the Postal Service. 
‘‘(v)(I) Notwithstanding clause (iv), the 
Postal Service shall, not later than December 
31, 2018, arrange for the transmission to the 
Commissioner of the information described in 
paragraphs (1) and (2) for not less than 70 
percent of the aggregate number of mail ship-
ments, including 100 percent of mail shipments 
from the People’s Republic of China, described 
in clause (i).
356 
‘‘(II) If the requirements of subclause (I) 
are not met, the Comptroller General of the 
United States shall submit to the appropriate 
congressional committees, not later than June 
30, 2019, a report— 
‘‘(aa) assessing the reasons for the 
failure to meet those requirements; and 
‘‘(bb) identifying recommendations to 
improve the collection by the Postal Serv-
ice of the information described in para-
graphs (1) and (2). 
‘‘(vi)(I) Notwithstanding clause (iv), the 
Postal Service shall, not later than December 
31, 2020, arrange for the transmission to the 
Commissioner of the information described in 
paragraphs (1) and (2) for 100 percent of the 
aggregate number of mail shipments described 
in clause (i). 
‘‘(II) The Commissioner, in consultation 
with the Postmaster General, may determine to 
exclude a country from the requirement de-
scribed in subclause (I) to transmit information 
for mail shipments described in clause (i) from 
the country if the Commissioner determines 
that the country—
357 
‘‘(aa) does not have the capacity to 
collect and transmit such information; 
‘‘(bb) represents a low risk for mail 
shipments that violate relevant United 
States laws and regulations; and 
‘‘(cc) accounts for low volumes of mail 
shipments that can be effectively screened 
for compliance with relevant United States 
laws and regulations through an alternate 
means. 
‘‘(III) The Commissioner shall, at a min-
imum on an annual basis, re-evaluate any de-
termination made under subclause (II) to ex-
clude a country from the requirement described 
in subclause (I). If, at any time, the Commis-
sioner determines that a country no longer 
meets the requirements under subclause (II), 
the Commissioner may not further exclude the 
country from the requirement described in sub-
clause (I). 
‘‘(IV) The Commissioner shall, on an an-
nual basis, submit to the appropriate congres-
sional committees— 
‘‘(aa) a list of countries with respect 
to which the Commissioner has made a de-
358 
termination under subclause (II) to exclude 
the countries from the requirement de-
scribed in subclause (I); and 
‘‘(bb) information used to support 
such determination with respect to such 
countries. 
‘‘(vii)(I) The Postmaster General shall, in 
consultation with the Commissioner, refuse any 
shipments received after December 31, 2020, 
for which the information described in para-
graphs (1) and (2) is not transmitted as re-
quired under this subparagraph, except as pro-
vided in subclause (II). 
‘‘(II) If remedial action is warranted in 
lieu of refusal of shipments pursuant to sub-
clause (I), the Postmaster General and the 
Commissioner shall take remedial action with 
respect to the shipments, including destruction, 
seizure, controlled delivery or other law enforce-
ment initiatives, or correction of the failure to 
provide the information described in paragraphs 
(1) and (2) with respect to the shipments. 
‘‘(viii) Nothing in this subparagraph shall 
be construed to limit the authority of the Sec-
retary to obtain information relating to inter-
359 
national mail shipments from private carriers or 
other appropriate parties. 
‘‘(ix) In this subparagraph, the term ‘ap-
propriate congressional committees’ means— 
‘‘(I) the Committee on Finance and 
the Committee on Homeland Security and 
Governmental Affairs of the Senate; and 
‘‘(II) the Committee on Ways and 
Means, the Committee on Oversight and 
Government Reform, and the Committee 
on Homeland Security of the House of 
Representatives.’’. 
(2) JOINT
STRATEGIC
PLAN
ON
MANDATORY 
ADVANCE INFORMATION.—Not later than 60 days 
after the date of the enactment of this Act, the Sec-
retary of Homeland Security and the Postmaster 
General shall develop and submit to the appropriate 
congressional committees a joint strategic plan de-
tailing specific performance measures for achiev-
ing— 
(A) the transmission of information as re-
quired by section 343(a)(3)(K) of the Trade 
Act of 2002, as amended by paragraph (1); and 
(B) the presentation by the Postal Service 
to U.S. Customs and Border Protection of all
360 
mail targeted by U.S. Customs and Border Pro-
tection for inspection. 
(b) CAPACITY BUILDING.— 
(1) IN GENERAL.—Section 343(a) of the Trade 
Act of 2002 (Public Law 107–210; 19 U.S.C. 2071 
note) is amended by adding at the end the following: 
‘‘(5) CAPACITY BUILDING.— 
‘‘(A) IN GENERAL.—The Secretary, with 
the concurrence of the Secretary of State, and 
in coordination with the Postmaster General 
and the heads of other Federal agencies, as ap-
propriate, may provide technical assistance, 
equipment, technology, and training to enhance 
the capacity of foreign postal operators— 
‘‘(i) to gather and provide the infor-
mation required by paragraph (3)(K); and 
‘‘(ii) to otherwise gather and provide 
postal shipment information related to— 
‘‘(I) terrorism; 
‘‘(II) items the importation or in-
troduction of which into the United 
States is prohibited or restricted, in-
cluding controlled substances; and 
‘‘(III) such other concerns as the 
Secretary determines appropriate.
361 
‘‘(B) PROVISION
OF
EQUIPMENT
AND 
TECHNOLOGY.—With respect to the provision of 
equipment and technology under subparagraph 
(A), the Secretary may lease, loan, provide, or 
otherwise assist in the deployment of such 
equipment and technology under such terms 
and conditions as the Secretary may prescribe, 
including nonreimbursable loans or the transfer 
of ownership of equipment and technology.’’. 
(2) JOINT
STRATEGIC
PLAN
ON
CAPACITY 
BUILDING.—Not later than 1 year after the date of 
the enactment of this Act, the Secretary of Home-
land Security and the Postmaster General shall, in 
consultation with the Secretary of State, jointly de-
velop and submit to the appropriate congressional 
committees a joint strategic plan— 
(A) detailing the extent to which U.S. Cus-
toms and Border Protection and the United 
States Postal Service are engaged in capacity 
building efforts under section 343(a)(5) of the 
Trade Act of 2002, as added by paragraph (1); 
(B) describing plans for future capacity 
building efforts; and 
(C) assessing how capacity building has in-
creased the ability of U.S. Customs and Border
362 
Protection and the Postal Service to advance 
the goals of this subtitle and the amendments 
made by this subtitle. 
(c) REPORT AND CONSULTATIONS BY SECRETARY OF 
HOMELAND SECURITY AND POSTMASTER GENERAL.— 
(1) REPORT.—Not later than 180 days after 
the date of the enactment of this Act, and annually 
thereafter until 3 years after the Postmaster Gen-
eral has met the requirement under clause (vi) of 
subparagraph (K) of section 343(a)(3) of the Trade 
Act of 2002, as amended by subsection (a)(1), the 
Secretary of Homeland Security and the Postmaster 
General shall, in consultation with the Secretary of 
State, jointly submit to the appropriate congres-
sional committees a report on compliance with that 
subparagraph that includes the following: 
(A) An assessment of the status of the reg-
ulations required to be promulgated under that 
subparagraph. 
(B) An update regarding new and existing 
agreements reached with foreign postal opera-
tors for the transmission of the information re-
quired by that subparagraph. 
(C) A summary of deliberations between 
the United States Postal Service and foreign
363 
postal operators with respect to issues relating 
to the transmission of that information. 
(D) A summary of the progress made in 
achieving the transmission of that information 
for the percentage of shipments required by 
that subparagraph. 
(E) An assessment of the quality of that 
information being received by foreign postal op-
erators, as determined by the Secretary of 
Homeland Security, and actions taken to im-
prove the quality of that information. 
(F) A summary of policies established by 
the Universal Postal Union that may affect the 
ability of the Postmaster General to obtain the 
transmission of that information. 
(G) A summary of the use of technology to 
detect illicit synthetic opioids and other illegal 
substances in international mail parcels and 
planned acquisitions and advancements in such 
technology. 
(H) Such other information as the Sec-
retary of Homeland Security and the Post-
master General consider appropriate with re-
spect to obtaining the transmission of informa-
tion required by that subparagraph.
364 
(2) CONSULTATIONS.—Not later than 180 days 
after the date of the enactment of this Act, and 
every 180 days thereafter until the Postmaster Gen-
eral has met the requirement under clause (vi) of 
section 343(a)(3)(K) of the Trade Act of 2002, as 
amended by subsection (a)(1), to arrange for the 
transmission of information with respect to 100 per-
cent of the aggregate number of mail shipments de-
scribed in clause (i) of that section, the Secretary of 
Homeland Security and the Postmaster General 
shall provide briefings to the appropriate congres-
sional committees on the progress made in achieving 
the transmission of that information for that per-
centage of shipments. 
(d) GOVERNMENT ACCOUNTABILITY OFFICE RE-
PORT.—Not later than June 30, 2019, the Comptroller 
General of the United States shall submit to the appro-
priate congressional committees a report— 
(1) assessing the progress of the United States 
Postal Service in achieving the transmission of the 
information required by subparagraph (K) of section 
343(a)(3) of the Trade Act of 2002, as amended by 
subsection (a)(1), for the percentage of shipments 
required by that subparagraph;
365 
(2) assessing the quality of the information re-
ceived from foreign postal operators for targeting 
purposes; 
(3) assessing the specific percentage of targeted 
mail presented by the Postal Service to U.S. Cus-
toms and Border Protection for inspection; 
(4) describing the costs of collecting the infor-
mation required by such subparagraph (K) from for-
eign postal operators and the costs of implementing 
the use of that information; 
(5) assessing the benefits of receiving that in-
formation with respect to international mail ship-
ments; 
(6) assessing the feasibility of assessing a cus-
toms fee under section 13031(b)(9) of the Consoli-
dated Omnibus Budget Reconciliation Act of 1985, 
as amended by section 8002, on international mail 
shipments other than Inbound Express Mail service 
in a manner consistent with the obligations of the 
United States under international agreements; and 
(7) identifying recommendations, including rec-
ommendations for legislation, to improve the compli-
ance of the Postal Service with such subparagraph 
(K), including an assessment of whether the detec-
366 
tion of illicit synthetic opioids in the international 
mail would be improved by— 
(A) requiring the Postal Service to serve as 
the consignee for international mail shipments 
containing goods; or 
(B) designating a customs broker to act as 
an importer of record for international mail 
shipments containing goods. 
(e) TECHNICAL CORRECTION.—Section 343 of the 
Trade Act of 2002 (Public Law 107–210; 19 U.S.C. 2071 
note) is amended in the section heading by striking ‘‘AD-
VANCED’’ and inserting ‘‘ADVANCE’’. 
(f) APPROPRIATE CONGRESSIONAL COMMITTEES DE-
FINED.—In this section, the term ‘‘appropriate congres-
sional committees’’ means— 
(1) the Committee on Finance and the Com-
mittee on Homeland Security and Governmental Af-
fairs of the Senate; and 
(2) the Committee on Ways and Means, the 
Committee on Oversight and Government Reform, 
and the Committee on Homeland Security of the 
House of Representatives. 
SEC. 8004. INTERNATIONAL POSTAL AGREEMENTS. 
(a) EXISTING AGREEMENTS.—
367 
(1) IN GENERAL.—In the event that any provi-
sion of this subtitle, or any amendment made by this 
Act, is determined to be in violation of obligations 
of the United States under any postal treaty, con-
vention, or other international agreement related to 
international postal services, or any amendment to 
such an agreement, the Secretary of State should 
negotiate to amend the relevant provisions of the 
agreement so that the United States is no longer in 
violation of the agreement. 
(2) RULE OF CONSTRUCTION.—Nothing in this 
subsection shall be construed to permit delay in the 
implementation of this subtitle or any amendment 
made by this subtitle. 
(b) FUTURE AGREEMENTS.— 
(1) CONSULTATIONS.—Before entering into, on 
or after the date of the enactment of this Act, any 
postal treaty, convention, or other international 
agreement related to international postal services, or 
any amendment to such an agreement, that is re-
lated to the ability of the United States to secure 
the provision of advance electronic information by 
foreign postal operators, the Secretary of State 
should consult with the appropriate congressional 
committees (as defined in section 8003(f)).
368 
(2) EXPEDITED NEGOTIATION OF NEW AGREE-
MENT.—To the extent that any new postal treaty, 
convention, or other international agreement related 
to international postal services would improve the 
ability of the United States to secure the provision 
of advance electronic information by foreign postal 
operators as required by regulations prescribed 
under section 343(a)(3)(K) of the Trade Act of 
2002, as amended by section 8003(a)(1), the Sec-
retary of State should expeditiously conclude such 
an agreement. 
SEC. 8005. COST RECOUPMENT. 
(a) IN GENERAL.—The United States Postal Service 
shall, to the extent practicable and otherwise recoverable 
by law, ensure that all costs associated with complying 
with this subtitle and amendments made by this subtitle 
are charged directly to foreign shippers or foreign postal 
operators. 
(b) COSTS NOT CONSIDERED REVENUE.—The recov-
ery of costs under subsection (a) shall not be deemed rev-
enue for purposes of subchapter I and II of chapter 36 
of title 39, United States Code, or regulations prescribed 
under that chapter.
369 
SEC. 8006. DEVELOPMENT OF TECHNOLOGY TO DETECT IL-
LICIT NARCOTICS. 
(a) IN GENERAL.—The Postmaster General and the 
Commissioner of U.S. Customs and Border Protection, in 
coordination with the heads of other agencies as appro-
priate, shall collaborate to identify and develop technology 
for the detection of illicit fentanyl, other synthetic opioids, 
and other narcotics and psychoactive substances entering 
the United States by mail. 
(b) OUTREACH
TO PRIVATE SECTOR.—The Post-
master General and the Commissioner shall conduct out-
reach to private sector entities to gather information re-
garding the current state of technology to identify areas 
for innovation relating to the detection of illicit fentanyl, 
other synthetic opioids, and other narcotics and 
psychoactive substances entering the United States. 
SEC. 8007. CIVIL PENALTIES FOR POSTAL SHIPMENTS. 
Section 436 of the Tariff Act of 1930 (19 U.S.C. 
1436) is amended by adding at the end the following new 
subsection: 
‘‘(e) CIVIL PENALTIES FOR POSTAL SHIPMENTS.— 
‘‘(1) CIVIL PENALTY.—A civil penalty shall be 
imposed against the United States Postal Service if 
the Postal Service accepts a shipment in violation of 
section 343(a)(3)(K)(vii)(I) of the Trade Act of 
2002.
370 
‘‘(2) MODIFICATION OF CIVIL PENALTY.— 
‘‘(A) IN
GENERAL.—U.S. Customs and 
Border Protection shall reduce or dismiss a civil 
penalty imposed pursuant to paragraph (1) if 
U.S. Customs and Border Protection deter-
mines that the United States Postal Service— 
‘‘(i) has a low error rate in compliance 
with section 343(a)(3)(K) of the Trade Act 
of 2002; 
‘‘(ii) is cooperating with U.S. Customs 
and Border Protection with respect to the 
violation of section 343(a)(3)(K)(vii)(I) of 
the Trade Act of 2002; or 
‘‘(iii) has taken remedial action to 
prevent 
future 
violations 
of 
section 
343(a)(3)(K)(vii)(I) of the Trade Act of 
2002. 
‘‘(B) WRITTEN NOTIFICATION.—U.S. Cus-
toms and Border Protection shall issue a writ-
ten notification to the Postal Service with re-
spect to each exercise of the authority of sub-
paragraph (A) to reduce or dismiss a civil pen-
alty imposed pursuant to paragraph (1).
371 
‘‘(3) ONGOING LACK OF COMPLIANCE.—If U.S. 
Customs and Border Protection determines that the 
United States Postal Service— 
‘‘(A) has repeatedly committed violations 
of section 343(a)(3)(K)(vii)(I) of the Trade Act 
of 2002, 
‘‘(B) has failed to cooperate with U.S. 
Customs and Border Protection with respect to 
violations of section 343(a)(3)(K)(vii)(I) of the 
Trade Act of 2002, and 
‘‘(C) has an increasing error rate in com-
pliance with section 343(a)(3)(K) of the Trade 
Act of 2002, 
civil penalties may be imposed against the United 
States Postal Service until corrective action, satis-
factory to U.S. Customs and Border Protection, is 
taken.’’. 
SEC. 8008. REPORT ON VIOLATIONS OF ARRIVAL, REPORT-
ING, 
ENTRY, 
AND 
CLEARANCE 
REQUIRE-
MENTS AND FALSITY OR LACK OF MANIFEST. 
(a) IN GENERAL.—The Commissioner of U.S. Cus-
toms and Border Protection shall submit to the appro-
priate congressional committees an annual report that 
contains the information described in subsection (b) with 
respect to each violation of section 436 of the Tariff Act
372 
of 1930 (19 U.S.C. 1436), as amended by section 8007, 
and section 584 of such Act (19 U.S.C. 1584) that oc-
curred during the previous year. 
(b) INFORMATION DESCRIBED.—The information de-
scribed in this subsection is the following: 
(1) The name and address of the violator. 
(2) The specific violation that was committed. 
(3) The location or port of entry through which 
the items were transported. 
(4) An inventory of the items seized, including 
a description of the items and the quantity seized. 
(5) The location from which the items origi-
nated. 
(6) The entity responsible for the apprehension 
or seizure, organized by location or port of entry. 
(7) The amount of penalties assessed by U.S. 
Customs and Border Protection, organized by name 
of the violator and location or port of entry. 
(8) The amount of penalties that U.S. Customs 
and Border Protection could have levied, organized 
by name of the violator and location or port of entry. 
(9) The rationale for negotiating lower pen-
alties, organized by name of the violator and location 
or port of entry.
373 
(c) APPROPRIATE CONGRESSIONAL COMMITTEES DE-
FINED.—In this section, the term ‘‘appropriate congres-
sional committees’’ means— 
(1) the Committee on Finance and the Com-
mittee on Homeland Security and Governmental Af-
fairs of the Senate; and 
(2) the Committee on Ways and Means, the 
Committee on Oversight and Government Reform, 
and the Committee on Homeland Security of the 
House of Representatives. 
SEC. 8009. EFFECTIVE DATE; REGULATIONS. 
(a) EFFECTIVE DATE.—This subtitle and the amend-
ments made by this subtitle (other than the amendments 
made by section 8002) shall take effect on the date of the 
enactment of this Act. 
(b) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this Act, such regulations as are 
necessary to carry out this subtitle and the amendments 
made by this subtitle shall be prescribed.
374 
Subtitle 
B—Recognizing 
Early 
Childhood Trauma Related to 
Substance Abuse 
SEC. 8011. SHORT TITLE. 
This subtitle may be cited as the ‘‘Recognizing Early 
Childhood Trauma Related to Substance Abuse Act of 
2018’’. 
SEC. 8012. RECOGNIZING EARLY CHILDHOOD TRAUMA RE-
LATED TO SUBSTANCE ABUSE. 
(a) DISSEMINATION
OF INFORMATION.—The Sec-
retary of Health and Human Services shall disseminate 
information, resources, and, if requested, technical assist-
ance to early childhood care and education providers and 
professionals working with young children on— 
(1) ways to properly recognize children who 
may be impacted by trauma related to substance 
abuse by a family member or other adult; and 
(2) how to respond appropriately in order to 
provide for the safety and well-being of young chil-
dren and their families. 
(b) GOALS.—The information, resources, and tech-
nical assistance provided under subsection (a) shall— 
(1) educate early childhood care and education 
providers and professionals working with young chil-
dren on understanding and identifying the early
375 
signs and risk factors of children who might be im-
pacted by trauma due to exposure to substance 
abuse; 
(2) suggest age-appropriate communication 
tools, procedures, and practices for trauma-informed 
care, including ways to prevent or mitigate the ef-
fects of trauma; 
(3) provide options for responding to children 
impacted by trauma due to exposure to substance 
abuse that consider the needs of the child and fam-
ily, including recommending resources and referrals 
for evidence-based services to support such family; 
and 
(4) 
promote 
whole-family 
and 
multi- 
generational approaches to prevent separation and 
support re-unification of families whenever possible 
and in the best interest of the child. 
(c) RULE OF CONSTRUCTION.—Such information, re-
sources, and if applicable, technical assistance, shall not 
be construed to amend the requirements under— 
(1) the Child Care and Development Block 
Grant Act of 1990 (42 U.S.C. 9858 et seq.); 
(2) the Head Start Act (42 U.S.C. 9831 et 
seq.); or
376 
(3) the Individuals with Disabilities Education 
Act (20 U.S.C. 1400 et seq.). 
Subtitle C—Assisting States’ Imple-
mentation of Plans of Safe Care 
SEC. 8021. SHORT TITLE. 
This subtitle may be cited as the ‘‘Assisting States’ 
Implementation of Plans of Safe Care Act’’. 
SEC. 8022. ASSISTING STATES WITH IMPLEMENTATION OF 
PLANS OF SAFE CARE. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall provide written guidance and, if ap-
propriate, technical assistance to support States in com-
plying with, and implementing, subsections (b)(2)(B)(iii) 
and (d)(18) of section 106 of the Child Abuse Prevention 
and Treatment Act (42 U.S.C. 5106a) in order to promote 
better protections for young children and family-centered 
responses. 
(b) REQUIREMENTS.—The guidance and technical as-
sistance shall— 
(1) enhance States’ understanding of require-
ments and flexibilities under the law, including clari-
fying key terms; 
(2) address State-identified challenges with de-
veloping, implementing, and monitoring plans of safe 
care;
377 
(3) disseminate best practices related to devel-
oping and implementing plans of safe care, including 
differential response, collaboration and coordination, 
and identification and delivery of services, while rec-
ognizing needs of different populations and varying 
community approaches across States; 
(4) support collaboration between health care 
providers, social service agencies, public health agen-
cies, and the child welfare system, to promote a fam-
ily-centered treatment approach; 
(5) prevent separation and support reunifica-
tion of families if in the best interests of the child; 
(6) recommend treatment approaches for serv-
ing infants, pregnant women, and postpartum 
women whose infants may be affected by substance 
use that are designed to keep infants with their 
mothers and families whenever appropriate, includ-
ing recommendations to encourage pregnant women 
to receive health and other support services during 
pregnancy; 
(7) support State efforts to develop technology 
systems to manage and monitor implementation of 
plans of safe care; and 
(8) help States improve the long-term safety 
and well-being of young children and their families.
378 
(c) CONSTRUCTION.—The guidance and technical as-
sistance shall not be construed to amend the requirements 
of the Child Abuse Prevention and Treatment Act (42 
U.S.C. 5101 et seq.). 
(d) DEFINITION.—For purposes of this section, the 
term ‘‘State’’ has the meaning given such term in section 
3 of the Child Abuse Prevention and Treatment Act (42 
U.S.C. 5101 note). 
Subtitle D—Improving the Federal 
Response to Families Impacted 
by Substance Use Disorder 
SEC. 8031. SHORT TITLE. 
This subtitle may be cited as the ‘‘Improving the Fed-
eral Response to Families Impacted by Substance Use 
Disorder Act’’. 
SEC. 8032. INTERAGENCY TASK FORCE TO IMPROVE THE 
FEDERAL RESPONSE TO FAMILIES IMPACTED 
BY SUBSTANCE USE DISORDERS. 
(a) ESTABLISHMENT.—There is established a task 
force, to be known as the ‘‘Interagency Task Force to Im-
prove the Federal Response to Families Impacted by Sub-
stance Use Disorders’’ (in this section referred to as 
‘‘Task Force’’). 
(b) RESPONSIBILITIES.—The Task Force—
379 
(1) shall identify, evaluate, and recommend 
ways in which Federal agencies can better coordi-
nate responses to substance use disorders and the 
opioid crisis; and 
(2) shall carry out the additional duties de-
scribed in subsection (d). 
(c) MEMBERSHIP.— 
(1) NUMBER
AND
APPOINTMENT.—The Task 
Force shall be composed of 12 Federal officials hav-
ing responsibility for, or administering programs re-
lated to, the duties of the Task Force. The Secretary 
of Health and Human Services, the Secretary of 
Education, the Secretary of Agriculture, and the 
Secretary of Labor shall each appoint two members 
to the Task Force from among the Federal officials 
employed by the Department of which they are the 
head. Additional Federal agency officials appointed 
by the Secretary of Health and Human Services 
shall fill the remaining positions of the Task Force. 
(2) CHAIRPERSON.—The Secretary of Health 
and Human Services shall designate a Federal offi-
cial employed by the Department of Health and 
Human Services to serve as the chairperson of the 
Task Force.
380 
(3) 
DEADLINE
FOR
APPOINTMENT.—Each 
member shall be appointed to the Task Force not 
later than 60 days after the date of the enactment 
of this Act. 
(4) ADDITIONAL
AGENCY
INPUT.—The Task 
Force may seek input from other Federal agencies 
and offices with experience, expertise, or information 
relevant in responding to the opioid crisis. 
(5) VACANCIES.—A vacancy in the Task Force 
shall be filled in the manner in which the original 
appointment was made. 
(6) PROHIBITION
OF
COMPENSATION.—Mem-
bers of the Task Force may not receive pay, allow-
ances, or benefits by reason of their service on the 
Task Force. 
(d) DUTIES.—The Task Force shall carry out the fol-
lowing duties: 
(1) Solicit input from stakeholders, including 
frontline service providers, medical professionals, 
educators, mental health professionals, researchers, 
experts in infant, child, and youth trauma, child wel-
fare professionals, and the public, in order to inform 
the activities of the Task Force. 
(2) Develop a strategy on how the Task Force 
and participating Federal agencies will collaborate,
381 
prioritize, and implement a coordinated Federal ap-
proach with regard to responding to substance use 
disorders, including opioid misuse, that shall in-
clude— 
(A) identifying options for the coordination 
of existing grants that support infants, chil-
dren, and youth, and their families as appro-
priate, who have experienced, or are at risk of 
experiencing, exposure to substance abuse dis-
orders, including opioid misuse; and 
(B) other ways to improve coordination, 
planning, and communication within and across 
Federal agencies, offices, and programs, to bet-
ter serve children and families impacted by sub-
stance use disorders, including opioid misuse. 
(3) Based off the strategy developed under 
paragraph (2), evaluate and recommend opportuni-
ties for local- and State-level partnerships, profes-
sional development, or best practices that— 
(A) are designed to quickly identify and 
refer children and families, as appropriate, who 
have experienced or are at risk of experiencing 
exposure to substance abuse; 
(B) utilize and develop partnerships with 
early childhood education programs, local social
382 
services organizations, and health care services 
aimed at preventing or mitigating the effects of 
exposure to substance use disorders, including 
opioid misuse; 
(C) offer community-based prevention ac-
tivities, including educating families and chil-
dren on the effects of exposure to substance use 
disorders, including opioid misuse, and how to 
build resilience and coping skills to mitigate 
those effects; 
(D) in accordance with Federal privacy 
protections, utilize non-personally identifiable 
data from screenings, referrals, or the provision 
of services and supports to evaluate and im-
prove processes addressing exposure to sub-
stance use disorders, including opioid misuse; 
and 
(E) are designed to prevent separation and 
support reunification of families if in the best 
interest of the child. 
(4) In fulfilling the requirements of paragraphs 
(2) and (3), consider evidence-based, evidence-in-
formed, and promising best practices related to iden-
tifying, referring, and supporting children and fami-
lies at risk of experiencing exposure to substance
383 
abuse or experiencing substance use disorder, includ-
ing opioid misuse, including— 
(A) prevention strategies for those at risk 
of experiencing or being exposed to substance 
abuse, including misuse of opioids; 
(B) whole-family and multi-generational 
approaches; 
(C) community-based initiatives; 
(D) referral to, and implementation of, 
trauma-informed practices and supports; and 
(E) multi-generational practices that assist 
parents, foster parents, and kinship and other 
caregivers 
(e) FACA.—The Federal Advisory Committee Act (5 
U.S.C. App. 2) shall not apply to the Task Force. 
(f) ACTION PLAN; REPORTS.—The Task Force— 
(1) shall prepare a detailed action plan to be 
implemented by participating Federal agencies to 
create a collaborative, coordinated response to the 
opioid crisis, which shall include— 
(A) relevant information identified and col-
lected under subsection (d); 
(B) a proposed timeline for implementing 
recommendations and efforts identified under 
subsection (d); and
384 
(C) a description of how other Federal 
agencies and offices with experience, expertise, 
or information relevant in responding to the 
opioid crisis that have provided input under 
subsection (c)(4) will be participating in the co-
ordinated approach; 
(2) shall submit to the Congress a report de-
scribing the action plan prepared under paragraph 
(1), including, where applicable, identification of any 
recommendations included in such plan that require 
additional legislative authority to implement; and 
(3) shall submit a report to the Governors de-
scribing the opportunities for local- and State-level 
partnerships, professional development, or best prac-
tices recommended under subsection (d)(3). 
(g) DISSEMINATION.— 
(1) IN GENERAL.—The action plan and reports 
required under subsection (f) shall be— 
(A) disseminated widely, including among 
the participating Federal agencies and the Gov-
ernors; and 
(B) be made publicly available online in an 
accessible format. 
(2) DEADLINE.—The action plan and reports 
required under subsection (f) may be released on
385 
separate dates but shall be released not later than 
9 months after the date of the enactment of this 
Act. 
(h) TERMINATION.—The Task Force shall terminate 
30 days after the dissemination of the action plan and re-
ports under subsection (g). 
(i) FUNDING.—The administrative expenses of the 
Task Force shall be paid out of existing Department of 
Health and Human Services funds or appropriations. 
(j) DEFINITIONS.—For purposes of this section: 
(1) The term ‘‘Governor’’ means the chief exec-
utive officer of a State. 
(2) The term ‘‘participating Federal agencies’’ 
means all the Executive agencies (as defined in sec-
tion 105 of title 5, United States Code) whose offi-
cials have been appointed to the Task Force. 
(3) The term ‘‘State’’ means each of the several 
States, the District of Columbia, the Commonwealth 
of Puerto Rico, the Virgin Islands, Guam, American 
Samoa, and the Commonwealth of the Northern 
Mariana Islands.
386 
Subtitle E—Establishment of an 
Advisory Committee on Opioids 
and the Workplace 
SEC. 8041. ESTABLISHMENT OF AN ADVISORY COMMITTEE 
ON OPIOIDS AND THE WORKPLACE. 
(a) ESTABLISHMENT.—Not later than 90 days after 
enactment of this Act, the Secretary of Labor shall estab-
lish an Advisory Committee on Opioids and the Workplace 
(referred to in this subtitle as the ‘‘Advisory Committee’’) 
to advise the Secretary on actions the Department of 
Labor can take to provide informational resources and 
best practices on how to appropriately address the impact 
of opioid abuse on the workplace and support workers 
abusing opioids. 
(b) MEMBERSHIP.— 
(1) COMPOSITION.—The Secretary of Labor 
shall appoint as members of the Advisory Committee 
19 individuals with expertise in employment, work-
place health programs, human resources, substance 
use disorder, and other relevant fields. The Advisory 
Committee shall be composed as follows: 
(A) Four of the members shall be individ-
uals representative of employers or other orga-
nizations representing employers.
387 
(B) Four of the members shall be individ-
uals representative of workers or other organi-
zations representing workers, of which at least 
two must be representatives designated by labor 
organizations. 
(C) Three of the members shall be individ-
uals representative of health benefit plans, em-
ployee assistance plan providers, workers’ com-
pensation program administrators, and work-
place safety and health professionals. 
(D) Eight of the members shall be individ-
uals representative of substance abuse treat-
ment and recovery experts, including medical 
doctors, licensed addiction therapists, and sci-
entific and academic researchers, of which one 
individual may be a representative of a local or 
State government agency that oversees or co-
ordinates programs that address substance use 
disorder. 
(2) CHAIR.—From the members appointed 
under paragraph (1), the Secretary of Labor shall 
appoint a chairperson. 
(3) TERMS.—Each member of the Advisory 
Committee shall serve for a term of 3 years. A mem-
388 
ber appointed to fill a vacancy shall be appointed 
only for the remainder of such term. 
(4) QUORUM.—A majority of members of the 
Advisory Committee shall constitute a quorum and 
action shall be taken only by a majority vote of the 
members. 
(5) VOTING.—The Advisory Committee shall es-
tablish voting procedures. 
(6) NO COMPENSATION.—Members of the Advi-
sory Committee shall serve without compensation. 
(7) DISCLOSURE.—Every member of the Advi-
sory Committee must disclose the entity, if applica-
ble, that he or she is representing. 
(c) DUTIES.— 
(1) ADVISEMENT.— 
(A) IN
GENERAL.—The Advisory Com-
mittee established under subsection (a) shall 
advise the Secretary of Labor on actions the 
Department of Labor can take to provide infor-
mational resources and best practices on how to 
appropriately address the impact of opioid 
abuse on the workplace and support workers 
abusing opioids.
389 
(B) CONSIDERATIONS.—In providing such 
advice, the Advisory Committee shall take into 
account— 
(i) evidence-based and other employer 
substance abuse policies and best practices 
regarding opioid use or abuse, including 
benefits provided by employee assistance 
programs or other employer-provided bene-
fits, programs, or resources; 
(ii) the effect of opioid use or abuse 
on the safety of the workplace as well as 
policies and procedures addressing work-
place safety and health; 
(iii) the impact of opioid abuse on 
productivity and absenteeism, and assess-
ments of model human resources policies 
that support workers abusing opioids, such 
as policies that facilitate seeking and re-
ceiving treatment and returning to work; 
(iv) the extent to which alternative 
pain management treatments other than 
opioids are or should be covered by em-
ployer-sponsored health plans; 
(v) the legal requirements protecting 
employee privacy and health information in
390 
the workplace, as well as the legal require-
ments related to nondiscrimination; 
(vi) potential interactions of opioid 
abuse with other substance use disorders; 
(vii) any additional benefits or re-
sources available to an employee abusing 
opioids that promote retaining employment 
or reentering the workforce; 
(viii) evidence-based initiatives that 
engage employers, employees, and commu-
nity leaders to promote early identification 
of opioid abuse, intervention, treatment, 
and recovery; 
(ix) 
workplace 
policies 
regarding 
opioid abuse that reduce stigmatization 
among fellow employees and management; 
and 
(x) the legal requirements of the Men-
tal Health Parity and Addiction Equity 
Act and other laws related to health cov-
erage of substance abuse and mental 
health services and medications. 
(2) REPORT.—Prior to its termination as pro-
vided in subsection (j), the Advisory Committee shall 
issue a report to the Secretary of Labor and to the
391 
Committee on Education and the Workforce of the 
House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate, detailing successful programs and policies in-
volving workplace resources and benefits, including 
recommendations or examples of best practices for 
how employers can support and respond to employ-
ees impacted by opioid abuse. 
(d) MEETINGS.—The Advisory Committee shall meet 
at least twice a year at the call of the chairperson. 
(e) STAFF SUPPORT.—The Secretary of Labor shall 
make available staff necessary for the Advisory Committee 
to carry out its responsibilities. 
(f) FEDERAL
ADVISORY
COMMITTEE
ACT.—The 
Federal Advisory Committee Act shall apply to the Advi-
sory Committee established under this subtitle. 
(g) NO
APPROPRIATED
FUNDS.—No additional 
funds are authorized to be appropriated to carry out this 
subtitle. Expenses of the Advisory Committee shall be paid 
with funds otherwise appropriated to Departmental Man-
agement within the Department of Labor. 
(h) EX OFFICIO.—Three nonvoting representatives 
from agencies within the Department of Health and 
Human Services whose responsibilities include opioid pre-
scribing guidelines, workplace safety, and monitoring of
392 
substance abuse and prevention programs shall be ap-
pointed by the Secretary of Labor and designated as ex 
officio members. 
(i) AGENDA.—The Secretary of Labor or a represent-
ative of the Secretary shall consult with the Chair in es-
tablishing the agenda for Committee meetings. 
(j) TERMINATION.—The Advisory Committee estab-
lished under this subtitle shall terminate 3 years after the 
date of enactment of this Act. 
Subtitle F—Veterans Treatment 
Court Improvement 
SEC. 8051. SHORT TITLE. 
This subtitle may be cited as the ‘‘Veterans Treat-
ment Court Improvement Act of 2018’’. 
SEC. 8052. HIRING BY DEPARTMENT OF VETERANS AFFAIRS 
OF ADDITIONAL VETERANS JUSTICE OUT-
REACH SPECIALISTS. 
(a) HIRING
OF ADDITIONAL VETERANS JUSTICE 
OUTREACH SPECIALISTS.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of this Act, the Secretary 
of Veterans Affairs shall hire not fewer than 50 Vet-
erans Justice Outreach Specialists and place each 
such Veterans Justice Outreach Specialist at an eli-
393 
gible Department of Veterans Affairs medical center 
in accordance with this section. 
(2) REQUIREMENTS.—The Secretary shall en-
sure that each Veterans Justice Outreach Specialist 
employed under paragraph (1)— 
(A) serves, either exclusively or in addition 
to other duties, as part of a justice team in a 
veterans treatment court or other veteran-fo-
cused court; and 
(B) otherwise meets Department hiring 
guidelines for Veterans Justice Outreach Spe-
cialists. 
(b) ELIGIBLE DEPARTMENT OF VETERANS AFFAIRS 
MEDICAL CENTERS.—For purposes of this section, an eli-
gible Department of Veterans Affairs medical center is 
any Department of Veterans Affairs medical center that— 
(1) complies with all Department guidelines and 
regulations for placement of a Veterans Justice Out-
reach Specialist; 
(2) works within a local criminal justice system 
with justice-involved veterans; 
(3) maintains an affiliation with one or more 
veterans treatment courts or other veteran-focused 
courts; and 
(4) either—
394 
(A) routinely provides Veterans Justice 
Outreach Specialists to serve as part of a jus-
tice team in a veterans treatment court or other 
veteran-focused court; or 
(B) establishes a plan that is approved by 
the Secretary to provide Veterans Justice Out-
reach Specialists employed under subsection 
(a)(1) to serve as part of a justice team in a 
veterans treatment court or other veteran-fo-
cused court. 
(c) PLACEMENT PRIORITY.—The Secretary shall 
prioritize the placement of Veterans Justice Outreach Spe-
cialists employed under subsection (a)(1) at eligible De-
partment of Veterans Affairs medical centers that have 
or intend to establish an affiliation, for the purpose of car-
rying out the Veterans Justice Outreach Program, with 
a veterans treatment court, or other veteran-focused court, 
that— 
(1) was established on or after the date of the 
enactment of this Act; or 
(2)(A) was established before the date of the 
enactment of this Act; and 
(B) is not fully staffed with Veterans Justice 
Outreach Specialists. 
(d) REPORTS.—
395 
(1) REPORT BY SECRETARY OF VETERANS AF-
FAIRS.— 
(A) IN GENERAL.—Not later than 1 year 
after the date of the enactment of this Act, the 
Secretary of Veterans Affairs shall submit to 
Congress a report on the implementation of this 
section and its effect on the Veterans Justice 
Outreach Program. 
(B) CONTENTS.—The report submitted 
under paragraph (1) shall include the following: 
(i) The status of the efforts of the 
Secretary to hire Veterans Justice Out-
reach Specialists pursuant to subsection 
(a)(1), including the total number of Vet-
erans Justice Outreach Specialists hired by 
the Secretary pursuant to such subsection 
and the number that the Secretary expects 
to hire pursuant to such subsection. 
(ii) The total number of Veterans 
Justice Outreach Specialists assigned to 
each Department of Veterans Affairs med-
ical center that participates in the Vet-
erans Justice Outreach Program, including 
the number of Veterans Justice Outreach 
Specialists hired under subsection (a)(1)
396 
disaggregated by Department of Veterans 
Affairs medical center. 
(iii) The total number of eligible De-
partment of Veterans Affairs medical cen-
ters that sought placement of a Veterans 
Justice Outreach Specialist under sub-
section (a)(1), how many Veterans Justice 
Outreach Specialists each such center 
sought, and how many of such medical 
centers received no placement of a Vet-
erans Justice Outreach Specialist under 
subsection (a)(1). 
(iv) For each eligible Department of 
Veterans Affairs medical center— 
(I) the number of justice-involved 
veterans who were served or are ex-
pected to be served by a Veterans 
Justice 
Outreach 
Specialist 
hired 
under subsection (a)(1); and 
(II) the number of justice-in-
volved veterans who do not have ac-
cess to a Veterans Justice Outreach 
Specialist. 
(2) REPORT
BY
COMPTROLLER
GENERAL
OF 
THE UNITED STATES.—
397 
(A) IN GENERAL.—Not later than 3 years 
after the date of the enactment of this Act, the 
Comptroller General of the United States shall 
submit to Congress a report on the implementa-
tion of this section and the effectiveness of the 
Veterans Justice Outreach Program. 
(B) CONTENTS.—The report required by 
subparagraph (A) shall include the following: 
(i) An assessment of whether the Sec-
retary has fulfilled the Secretary’s obliga-
tions under this section. 
(ii) The number of veterans who are 
served by Veterans Justice Outreach Spe-
cialists hired under subsection (a)(1), 
disaggregated by demographics (including 
discharge status). 
(iii) An identification of any sub-
groups of veterans who underutilize serv-
ices provided under laws administered by 
the Secretary, including an assessment of 
whether these veterans have access to Vet-
erans Justice Outreach Specialists under 
the Veterans Justice Outreach Program. 
(iv) Such recommendations as the 
Comptroller General may have for the Sec-
398 
retary to improve the effectiveness of the 
Veterans Justice Outreach Program. 
(e) DEFINITIONS.—In this section: 
(1) JUSTICE TEAM.—The term ‘‘justice team’’ 
means the group of individuals, which may include 
a judge, court coordinator, prosecutor, public de-
fender, treatment provider, probation or other law 
enforcement officer, program mentor, and Veterans 
Justice Outreach Specialist, who assist justice-in-
volved veterans in a veterans treatment court or 
other veteran-focused court. 
(2) JUSTICE-INVOLVED
VETERAN.—The term 
‘‘justice-involved veteran’’ means a veteran with ac-
tive, ongoing, or recent contact with some compo-
nent of a local criminal justice system. 
(3) LOCAL
CRIMINAL
JUSTICE
SYSTEM.—The 
term ‘‘local criminal justice system’’ means law en-
forcement, jails, prisons, and Federal, State, and 
local courts. 
(4) 
VETERANS
JUSTICE
OUTREACH
PRO-
GRAM.—The term ‘‘Veterans Justice Outreach Pro-
gram’’ means the program through which the De-
partment of Veterans Affairs identifies justice-in-
volved veterans and provides such veterans with ac-
cess to Department services.
399 
(5) 
VETERANS
JUSTICE
OUTREACH
SPE-
CIALIST.—The term ‘‘Veterans Justice Outreach 
Specialist’’ means an employee of the Department of 
Veterans Affairs who serves as a liaison between the 
Department and the local criminal justice system on 
behalf of a justice-involved veteran. 
(6) VETERANS TREATMENT COURT.—The term 
‘‘veterans treatment court’’ means a State or local 
court that is participating in the veterans treatment 
court program (as defined in section 2991(i)(1) of 
the Omnibus Crime Control and Safe Streets Act of 
1968 (42 U.S.C. 3797aa(i)(1))). 
Subtitle G—Peer Support Coun-
seling Program for Women Vet-
erans 
SEC. 8061. PEER SUPPORT COUNSELING PROGRAM FOR 
WOMEN VETERANS. 
(a) IN GENERAL.—Section 1720F(j) of title 38, 
United States Code, is amended by adding at the end the 
following new paragraph: 
‘‘(4)(A) As part of the counseling program under this 
subsection, the Secretary shall emphasize appointing peer 
support counselors for women veterans. To the degree 
practicable, the Secretary shall seek to recruit women peer 
support counselors with expertise in—
400 
‘‘(i) female gender-specific issues and services; 
‘‘(ii) the provision of information about services 
and benefits provided under laws administered by 
the Secretary; or 
‘‘(iii) employment mentoring. 
‘‘(B) To the degree practicable, the Secretary shall 
emphasize facilitating peer support counseling for women 
veterans who are eligible for counseling and services under 
section 1720D of this title, have post-traumatic stress dis-
order or suffer from another mental health condition, are 
homeless or at risk of becoming homeless, or are otherwise 
at increased risk of suicide, as determined by the Sec-
retary. 
‘‘(C) The Secretary shall conduct outreach to inform 
women veterans about the program and the assistance 
available under this paragraph. 
‘‘(D) In carrying out this paragraph, the Secretary 
shall coordinate with such community organizations, State 
and local governments, institutions of higher education, 
chambers of commerce, local business organizations, orga-
nizations that provide legal assistance, and other organiza-
tions as the Secretary considers appropriate. 
‘‘(E) In carrying out this paragraph, the Secretary 
shall provide adequate training for peer support coun-
selors, including training carried out under the national
401 
program of training required by section 304(c) of the 
Caregivers and Veterans Omnibus Health Services Act of 
2010 (38 U.S.C. 1712A note).’’. 
(b) FUNDING.—The Secretary of Veterans Affairs 
shall carry out paragraph (4) of section 1720F(j) of title 
38, United States Code, as added by subsection (a), using 
funds otherwise made available to the Secretary. No addi-
tional funds are authorized to be appropriated by reason 
of such paragraph. 
(c) REPORT TO CONGRESS.—Not later than 2 years 
after the date of the enactment of this Act, the Secretary 
of Veterans Affairs shall submit to the Committees on 
Veterans’ Affairs of the Senate and House of Representa-
tives a report on the peer support counseling program 
under section 1720F(j) of title 38, United States Code, 
as amended by this section. Such report shall include— 
(1) the number of peer support counselors in 
the program; 
(2) an assessment of the effectiveness of the 
program; and 
(3) a description of the oversight of the pro-
gram.
402 
Subtitle H—Treating Barriers to 
Prosperity 
SEC. 8071. SHORT TITLE. 
This subtitle may be cited as the ‘‘Treating Barriers 
to Prosperity Act of 2018’’. 
SEC. 8072. DRUG ABUSE MITIGATION INITIATIVE. 
(a) IN GENERAL.—Chapter 145 of title 40, United 
States Code, is amended by inserting after section 14509 
the following: 
‘‘§ 14510. Drug abuse mitigation initiative 
‘‘(a) IN GENERAL.—The Appalachian Regional Com-
mission may provide technical assistance to, make grants 
to, enter into contracts with, or otherwise provide amounts 
to individuals or entities in the Appalachian region for 
projects and activities to address drug abuse, including 
opioid abuse, in the region, including projects and activi-
ties— 
‘‘(1) to facilitate the sharing of best practices 
among States, counties, and other experts in the re-
gion with respect to reducing such abuse; 
‘‘(2) to initiate or expand programs designed to 
eliminate or reduce the harm to the workforce and 
economic growth of the region that results from such 
abuse;
403 
‘‘(3) to attract and retain relevant health care 
services, businesses, and workers; and 
‘‘(4) to develop relevant infrastructure, includ-
ing broadband infrastructure that supports the use 
of telemedicine. 
‘‘(b) LIMITATION ON AVAILABLE AMOUNTS.—Of the 
cost of any activity eligible for a grant under this sec-
tion— 
‘‘(1) not more than 50 percent may be provided 
from amounts appropriated to carry out this section; 
and 
‘‘(2) notwithstanding paragraph (1)— 
‘‘(A) in the case of a project to be carried 
out in a county for which a distressed county 
designation is in effect under section 14526, 
not more than 80 percent may be provided from 
amounts appropriated to carry out this section; 
and 
‘‘(B) in the case of a project to be carried 
out in a county for which an at-risk designation 
is in effect under section 14526, not more than 
70 percent may be provided from amounts ap-
propriated to carry out this section. 
‘‘(c) SOURCES
OF ASSISTANCE.—Subject to sub-
section (b), a grant provided under this section may be
404 
provided from amounts made available to carry out this 
section in combination with amounts made available— 
‘‘(1) under any other Federal program (subject 
to the availability of subsequent appropriations); or 
‘‘(2) from any other source. 
‘‘(d) FEDERAL SHARE.—Notwithstanding any provi-
sion of law limiting the Federal share under any other 
Federal program, amounts made available to carry out 
this section may be used to increase that Federal share, 
as the Appalachian Regional Commission determines to be 
appropriate.’’. 
(b) CLERICAL AMENDMENT.—The analysis for chap-
ter 145 of title 40, United States Code, is amended by 
inserting after the item relating to section 14509 the fol-
lowing: 
‘‘14510. Drug abuse mitigation initiative.’’. 
Subtitle 
I—Supporting 
Grand-
parents Raising Grandchildren 
SEC. 8081. SHORT TITLE. 
This subtitle may be cited as the ‘‘Supporting Grand-
parents Raising Grandchildren Act’’. 
SEC. 8082. FINDINGS. 
Congress finds the following: 
(1) More than 2,500,000 grandparents in the 
United States are the primary caretaker of their
405 
grandchildren, and experts report that such numbers 
are increasing as the opioid epidemic expands. 
(2) Between 2009 and 2016, the incidence of 
parental alcohol or other drug use as a contributing 
factor for children’s out-of-home placement rose 
from 25.4 to 37.4 percent. 
(3) When children cannot remain safely with 
their parents, placement with relatives is preferred 
over placement in foster care with nonrelatives be-
cause placement with relatives provides stability for 
children and helps them maintain family connec-
tions. 
(4) The number of foster children placed with 
a grandparent or other relative increased from 24 
percent in 2006 to 32 percent in 2016, according to 
data from the Department of Health and Human 
Services. 
(5) Grandparents’ lives are enhanced by caring 
for their grandchildren; the overwhelming majority 
of grandparents report experiencing significant bene-
fits in serving as their grandchildren’s primary care-
givers. 
(6) Providing full-time care to their grand-
children may decrease grandparents’ ability to ad-
406 
dress their own physical and mental health needs 
and personal well-being. 
(7) Grandparents would benefit from better co-
ordination and dissemination of information and re-
sources available to support them in their caregiving 
responsibilities. 
SEC. 8083. ADVISORY COUNCIL TO SUPPORT GRAND-
PARENTS RAISING GRANDCHILDREN. 
(a) ESTABLISHMENT.—There is established an Advi-
sory Council to Support Grandparents Raising Grand-
children. 
(b) MEMBERSHIP.— 
(1) IN GENERAL.—The Advisory Council shall 
be composed of the following members, or their des-
ignee: 
(A) The Secretary of Health and Human 
Services. 
(B) The Secretary of Education. 
(C) The Administrator of the Administra-
tion for Community Living. 
(D) The Director of the Centers for Dis-
ease Control and Prevention. 
(E) The Assistant Secretary for Mental 
Health and Substance Use.
407 
(F) The Assistant Secretary for the Ad-
ministration for Children and Families. 
(G) A grandparent raising a grandchild. 
(H) An older relative caregiver of children. 
(I) As appropriate, the head of other Fed-
eral departments, or agencies, identified by the 
Secretary of Health and Human Services as 
having responsibilities, or administering pro-
grams, relating to current issues affecting 
grandparents or other older relatives raising 
children. 
(2) LEAD AGENCY.—The Department of Health 
and Human Services shall be the lead agency for the 
Advisory Council. 
(c) DUTIES.— 
(1) IN GENERAL.— 
(A) INFORMATION.—The Advisory Council 
shall identify, promote, coordinate, and dissemi-
nate to the public information, resources, and 
the best practices available to help grand-
parents and other older relatives— 
(i) meet the health, educational, nutri-
tional, and other needs of the children in 
their care; and
408 
(ii) maintain their own physical and 
mental health and emotional well-being. 
(B) OPIOIDS.—In carrying out the duties 
described in subparagraph (A), the Advisory 
Council shall consider the needs of those af-
fected by the opioid crisis. 
(C) NATIVE AMERICANS.—In carrying out 
the duties described in subparagraph (A), the 
Advisory Council shall consider the needs of 
members of Native American tribes. 
(2) REPORT.— 
(A) IN
GENERAL.—Not later than 180 
days after the date of enactment of this Act, 
the Advisory Council shall submit a report to— 
(i) the appropriate committees; 
(ii) the State agencies that are re-
sponsible for carrying out family caregiver 
programs; and 
(iii) the public online in an accessible 
format. 
(B) REPORT
FORMAT.—The report shall 
include— 
(i) best practices, resources, and other 
useful information for grandparents and 
other older relatives raising children identi-
409 
fied under paragraph (1)(A) including, if 
applicable, any information related to the 
needs of children who have been impacted 
by the opioid epidemic; 
(ii) an identification of any gaps in 
items under clause (i); and 
(iii) where applicable, identification of 
any additional Federal legislative authority 
necessary to implement the activities de-
scribed in clause (i) and (ii). 
(3) FOLLOW-UP
REPORT.—Not later than 2 
years after the date on which the report required 
under paragraph (2)(A) is submitted, the Advisory 
Council shall submit a follow-up report that includes 
the information identified in paragraph (2)(B) to— 
(A) the appropriate committees; 
(B) the State agencies that are responsible 
for carrying out family caregiver programs; and 
(C) the public online in an accessible for-
mat. 
(4) PUBLIC INPUT.— 
(A) IN GENERAL.—The Advisory Council 
shall establish a process for public input to in-
form the development of, and provide updates 
to, the best practices, resources, and other in-
410 
formation described in paragraph (1) that shall 
include— 
(i) outreach to States, local entities, 
and organizations that provide information 
to, or support for, grandparents or other 
older relatives raising children; and 
(ii) outreach to grandparents and 
other older relatives with experience rais-
ing children. 
(B) NATURE
OF
OUTREACH.—Such out-
reach shall ask individuals to provide input 
on— 
(i) information, resources, and best 
practices available, including identification 
of any gaps and unmet needs; and 
(ii) recommendations that would help 
grandparents and other older relatives bet-
ter meet the health, educational, nutri-
tional, and other needs of the children in 
their care, as well as maintain their own 
physical and mental health and emotional 
well-being. 
(d) FACA.—The Advisory Council shall be exempt 
from the requirements of the Federal Advisory Committee 
Act (5 U.S.C. App.).
411 
(e) FUNDING.—No additional funds are authorized to 
be appropriated to carry out this subtitle. 
(f) SUNSET.—The Advisory Council shall terminate 
on the date that is 3 years after the date of enactment 
of this Act. 
SEC. 8084. DEFINITIONS. 
In this subtitle: 
(1) ADVISORY COUNCIL.—In this subtitle, the 
term ‘‘Advisory Council’’ means the Advisory Coun-
cil to Support Grandparents Raising Grandchildren 
that is established under section 8083. 
(2) APPROPRIATE COMMITTEES.—In this sub-
title, the term ‘‘appropriate committees’’ means the 
following: 
(A) The Special Committee on Aging of 
the Senate. 
(B) The Committee on Health, Education, 
Labor, and Pensions of the Senate. 
(C) The Committee on Education and the 
Workforce of the House of Representatives. 
(D) The Committee on Energy and Com-
merce of the House of Representatives.
412 
Subtitle J—Reauthorizing and Ex-
tending Grants for Recovery 
From Opioid Use Programs 
SEC. 8091. SHORT TITLE. 
This subtitle may be cited as the ‘‘Reauthorizing and 
Extending Grants for Recovery from Opioid Use Pro-
grams Act of 2018’’ or the ‘‘REGROUP Act of 2018’’. 
SEC. 8092. REAUTHORIZATION OF THE COMPREHENSIVE 
OPIOID ABUSE GRANT PROGRAM. 
Section 1001(a)(27) of the Omnibus Crime Control 
and Safe Streets Act of 1968 (34 U.S.C. 10261(a)(27)) 
is amended by striking ‘‘through 2021’’ and inserting 
‘‘and 2018, and $330,000,000 for each of fiscal years 
2019 through 2023’’. 
TITLE IX—SITSA ACT 
SEC. 9001. SHORT TITLE. 
This title may be cited as the ‘‘Stop the Importation 
and Trafficking of Synthetic Analogues Act of 2017’’ or 
the ‘‘SITSA Act’’. 
SEC. 9002. ESTABLISHMENT OF SCHEDULE A. 
Section 202 of the Controlled Substances Act (21 
U.S.C. 812) is amended— 
(1) in subsection (a), by striking ‘‘five schedules 
of controlled substances, to be known as schedules I, 
II, III, IV, and V’’ and inserting ‘‘six schedules of
413 
controlled substances, to be known as schedules I, 
II, III, IV, V, and A’’; 
(2) in subsection (b), by adding at the end the 
following: 
‘‘(6) SCHEDULE A.— 
‘‘(A) IN GENERAL.—The drug or substance— 
‘‘(i) has— 
‘‘(I) a chemical structure that is sub-
stantially similar to the chemical structure 
of a controlled substance in schedule I, II, 
III, IV, or V; and 
‘‘(II) an actual or predicted stimulant, 
depressant, or hallucinogenic effect on the 
central nervous system that is substantially 
similar to or greater than the stimulant, 
depressant, or hallucinogenic effect on the 
central nervous system of a controlled sub-
stance in schedule I, II, III, IV, or V; and 
‘‘(ii) is not— 
‘‘(I) listed or otherwise included in 
any other schedule in this section or by 
regulation of the Attorney General; and 
‘‘(II) with respect to a particular per-
son, subject to an exemption that is in ef-
fect for investigational use, for that person,
414 
under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) 
to the extent conduct with respect to such 
substance is pursuant to such exemption. 
‘‘(B) PREDICTED STIMULANT, DEPRESSANT, OR 
HALLUCINOGENIC
EFFECT.—For purpose of this 
paragraph, a predicted stimulant, depressant, or hal-
lucinogenic effect on the central nervous system may 
be based on— 
‘‘(i) the chemical structure and— 
‘‘(I) the structure activity relation-
ships; or 
‘‘(II) binding receptor assays and 
other relevant scientific information about 
the substance; 
‘‘(ii)(I) the current or relative potential for 
abuse of the substance; and 
‘‘(II) the clandestine importation, manu-
facture, or distribution, or diversion from legiti-
mate channels, of the substance; or 
‘‘(iii) the capacity of the substance to 
cause a state of dependence, including physical 
or psychological dependence that is similar to or 
greater than that of a controlled substance in 
schedule I, II, III, IV, or V.’’; and
415 
(3) in subsection (c), in the matter preceding 
schedule I, by striking ‘‘IV, and V’’ and inserting 
‘‘IV, V, and A’’. 
SEC. 9003. TEMPORARY AND PERMANENT SCHEDULING OF 
SCHEDULE A SUBSTANCES. 
Section 201 of the Controlled Substances Act (21 
U.S.C. 811) is amended by adding at the end the fol-
lowing: 
‘‘(k) TEMPORARY AND PERMANENT SCHEDULING OF 
SCHEDULE A SUBSTANCES.— 
‘‘(1) The Attorney General may issue a tem-
porary order adding a drug or substance to schedule 
A if the Attorney General finds that— 
‘‘(A) the drug or other substance satisfies 
the criteria for being considered a schedule A 
substance; and 
‘‘(B) adding such drug or substance to 
schedule A will assist in preventing abuse of the 
drug or other substance. 
‘‘(2) A temporary scheduling order issued under 
paragraph (1) shall not take effect until 30 days 
after the date of the publication by the Attorney 
General of a notice in the Federal Register of the in-
tention to issue such order and the grounds upon 
which such order is to be issued. The temporary
416 
scheduling order shall expire not later than 5 years 
after the date it becomes effective, except that the 
Attorney General may, during the pendency of pro-
ceedings under paragraph (5), extend the temporary 
scheduling order for up to 180 days. 
‘‘(3) A temporary scheduling order issued under 
paragraph (1) shall be vacated upon the issuance of 
a permanent order issued under paragraph (5) with 
regard to the same substance, or upon the subse-
quent issuance of any scheduling order under this 
section. 
‘‘(4) A temporary scheduling order issued under 
paragraph (1) shall not be subject to judicial review. 
‘‘(5)(A) Beginning no earlier than 3 years after 
issuing an order temporarily scheduling a drug or 
other substance under this subsection, the Attorney 
General may, by rule, issue a permanent order add-
ing a drug or other substance to schedule A if such 
drug or substance satisfies the criteria for being con-
sidered a controlled substance in schedule A under 
this subsection, except as provided in subparagraph 
(B). 
‘‘(B) If the Secretary has determined, based on 
relevant scientific studies and necessary data re-
quested by the Secretary and gathered by the Attor-
417 
ney General, that a drug or other substance that has 
been temporarily placed in schedule A does not have 
sufficient potential for abuse to warrant control in 
any schedule, and so advises the Attorney General in 
writing, the Attorney General may not issue a per-
manent scheduling order under subparagraph (A) 
and shall, within 30 days of receiving the Secretary’s 
advice issue an order immediately terminating the 
temporary scheduling order. 
‘‘(6) Before initiating proceedings under para-
graph (1), the Attorney General shall transmit no-
tice of a temporary order proposed to be issued to 
the Secretary of Health and Human Services. In 
issuing an order under paragraph (1), the Attorney 
General shall take into consideration any comments 
submitted by the Secretary of Health and Human 
Services in response to a notice transmitted pursu-
ant to this paragraph. 
‘‘(7) On the date of the publication of a notice 
in the Federal Register pursuant to paragraph (2), 
the Attorney General shall transmit the same notice 
to Congress. The temporary scheduling order shall 
take effect according to paragraph (2), except that 
the temporary scheduling order may be disapproved 
by an Act of Congress within 180 days from the
418 
date of publication of the notice in the Federal Reg-
ister.’’. 
SEC. 9004. PENALTIES. 
(a) CONTROLLED
SUBSTANCES
ACT.—The Con-
trolled Substances Act (21 U.S.C. 801 et seq.) is amend-
ed— 
(1) in section 401(b)(1) (21 U.S.C. 841(b)(1)), 
by adding at the end the following: 
‘‘(F)(i) In the case of any controlled substance in 
schedule A, such person shall be sentenced to a term of 
imprisonment of not more than 10 years and if death or 
serious bodily injury results from the use of such sub-
stance shall be sentenced to a term of imprisonment of 
not more than 15 years, a fine not to exceed the greater 
of that authorized in accordance with the provisions of 
title 18, United States Code, or $500,000 if the defendant 
is an individual or $2.5 million if the defendant is other 
than an individual, or both. 
‘‘(ii) If any person commits such a violation after a 
prior conviction for a felony drug offense has become final, 
such person shall be sentenced to a term of imprisonment 
of not more than 20 years and if death or serious bodily 
injury results from the use of such substance shall be sen-
tenced to a term of imprisonment of not more than 30 
years, a fine not to exceed the greater of twice that author-
419 
ized in accordance with the provisions of title 18, United 
States Code, or $1 million if the defendant is an individual 
or $5 million if the defendant is other than an individual, 
or both. 
‘‘(iii) Any sentence imposing a term of imprisonment 
under this subparagraph shall, in the absence of such a 
prior conviction, impose a term of supervised release of 
not less than 2 years in addition to such term of imprison-
ment and shall, if there was such a prior conviction, im-
pose a term of supervised release of not less than 4 years 
in addition to such term of imprisonment.’’; 
(2) in section 403(a) (21 U.S.C. 843(a))— 
(A) in paragraph (8), by striking ‘‘or’’ at 
the end; 
(B) in paragraph (9), by striking the pe-
riod at the end and inserting ‘‘; or’’; and 
(C) by inserting after paragraph (9) the 
following: 
‘‘(10) to export a substance in violation of the 
controlled substance laws of the country to which 
the substance is exported.’’; and 
(3) in section 404 (21 U.S.C. 844), by inserting 
after subsection (a) the following: 
‘‘(b) A person shall not be subject to a criminal or 
civil penalty under this title or under any other Federal
420 
law solely for possession of a schedule A controlled sub-
stance.’’. 
(b) CONTROLLED SUBSTANCES IMPORT AND EXPORT 
ACT.—Section 1010(b) of the Controlled Substances Im-
port and Export Act (21 U.S.C. 960(b)) is amended by 
adding at the end the following: 
‘‘(8) In the case of a violation under subsection (a) 
involving a controlled substance in schedule A, the person 
committing such violation shall be sentenced to a term of 
imprisonment of not more than 20 years and if death or 
serious bodily injury results from the use of such sub-
stance shall be sentenced to a term of imprisonment of 
not more than life, a fine not to exceed the greater of that 
authorized in accordance with the provisions of title 18, 
United States Code, or $1 million if the defendant is an 
individual or $5 million if the defendant is other than an 
individual, or both. If any person commits such a violation 
after a prior conviction for a felony drug offense has be-
come final, such person shall be sentenced to a term of 
imprisonment of not more than 30 years and if death or 
serious bodily injury results from the use of such sub-
stance shall be sentenced to not more than life imprison-
ment, a fine not to exceed the greater of twice that author-
ized in accordance with the provisions of title 18, United 
States Code, or $2 million if the defendant is an individual
421 
or $10 million if the defendant is other than an individual, 
or both. Notwithstanding section 3583 of title 18, United 
States Code, any sentence imposing a term of imprison-
ment under this paragraph shall, in the absence of such 
a prior conviction, impose a term of supervised release of 
not less than 3 years in addition to such term of imprison-
ment and shall, if there was such a prior conviction, im-
pose a term of supervised release of not less than 6 years 
in addition to such term of imprisonment. Notwith-
standing the prior sentence, and notwithstanding any 
other provision of law, the court shall not place on proba-
tion or suspend the sentence of any person sentenced 
under the provisions of this paragraph which provide for 
a mandatory term of imprisonment if death or serious 
bodily injury results.’’. 
SEC. 9005. FALSE LABELING OF SCHEDULE A CONTROLLED 
SUBSTANCES. 
(a) IN GENERAL.—Section 305 of the Controlled 
Substances Act (21 U.S.C. 825) is amended by adding at 
the end the following: 
‘‘(f) FALSE
LABELING
OF
SCHEDULE
A CON-
TROLLED SUBSTANCES.— 
‘‘(1) It shall be unlawful to import, export, 
manufacture, distribute, dispense, or possess with 
intent to manufacture, distribute, or dispense, a
422 
schedule A substance or product containing a sched-
ule A substance, unless the substance or product 
bears a label clearly identifying a schedule A sub-
stance or product containing a schedule A substance 
by the nomenclature used by the International 
Union of Pure and Applied Chemistry (IUPAC). 
‘‘(2)(A) A product described in subparagraph 
(B) is exempt from the International Union of Pure 
and Applied Chemistry nomenclature requirement of 
this subsection if such product is labeled in the man-
ner required under the Federal Food, Drug, and 
Cosmetic Act. 
‘‘(B) A product is described in this subpara-
graph if the product— 
‘‘(i) is the subject of an approved applica-
tion as described in section 505(b) or (j) of the 
Federal Food, Drug, and Cosmetic Act; or 
‘‘(ii) is exempt from the provisions of sec-
tion 505 of such Act relating to new drugs be-
cause— 
‘‘(I) it is intended solely for investiga-
tional use as described in section 505(i) of 
such Act; and 
‘‘(II) such product is being used ex-
clusively for purposes of a clinical trial
423 
that is the subject of an effective investiga-
tional new drug application.’’. 
(b) PENALTIES.—Section 402 of the Controlled Sub-
stances Act (21 U.S.C. 842) is amended— 
(1) in subsection (a)(16), by inserting ‘‘or sub-
section (f)’’ after ‘‘subsection (e)’’; and 
(2) in subsection (c)(1)(D), by inserting ‘‘or a 
schedule A substance’’ after ‘‘anabolic steroid’’. 
SEC. 9006. REGISTRATION REQUIREMENTS FOR HANDLERS 
OF SCHEDULE A SUBSTANCES. 
(a) CONTROLLED SUBSTANCES ACT.—Section 303 of 
the Controlled Substances Act (21 U.S.C. 823) is amend-
ed by adding at the end the following: 
‘‘(k)(1) The Attorney General shall register an appli-
cant to manufacture schedule A substances if— 
‘‘(A) the applicant demonstrates that the sched-
ule A substances will be used for research, analyt-
ical, or industrial purposes approved by the Attorney 
General; and 
‘‘(B) the Attorney General determines that such 
registration is consistent with the public interest and 
with the United States obligations under inter-
national treaties, conventions, or protocols in effect 
on the date of enactment of this subsection.
424 
‘‘(2) In determining the public interest under para-
graph (1)(B), the Attorney General shall consider— 
‘‘(A) maintenance of effective controls against 
diversion of particular controlled substances and any 
controlled substance in schedule A compounded 
therefrom into other than legitimate medical, sci-
entific, research, or industrial channels, by limiting 
the importation and bulk manufacture of such con-
trolled substances to a number of establishments 
which can produce an adequate and uninterrupted 
supply of these substances under adequately com-
petitive conditions for legitimate medical, scientific, 
research, and industrial purposes; 
‘‘(B) compliance with applicable State and local 
law; 
‘‘(C) promotion of technical advances in the art 
of manufacturing substances described in subpara-
graph (A) and the development of new substances; 
‘‘(D) prior conviction record of applicant under 
Federal and State laws relating to the manufacture, 
distribution, or dispensing of substances described in 
paragraph (A); 
‘‘(E) past experience in the manufacture of con-
trolled substances, and the existence in the establish-
ment of effective control against diversion; and
425 
‘‘(F) such other factors as may be relevant to 
and consistent with the public health and safety. 
‘‘(3) If an applicant is registered to manufacture con-
trolled substances in schedule I or II under subsection (a), 
the applicant shall not be required to apply for a separate 
registration under this subsection. 
‘‘(l)(1) The Attorney General shall register an appli-
cant to distribute schedule A substances— 
‘‘(A) if the applicant demonstrates that the 
schedule A substances will be used for research, ana-
lytical, or industrial purposes approved by the Attor-
ney General; and 
‘‘(B) unless the Attorney General determines 
that the issuance of such registration is inconsistent 
with the public interest. 
‘‘(2) In determining the public interest under para-
graph (1)(B), the Attorney General shall consider— 
‘‘(A) maintenance of effective control against 
diversion of particular controlled substances into 
other than legitimate medical, scientific, and indus-
trial channels; 
‘‘(B) compliance with applicable State and local 
law; 
‘‘(C) prior conviction record of applicant under 
Federal or State laws relating to the manufacture,
426 
distribution, or dispensing of substances described in 
subparagraph (A); 
‘‘(D) past experience in the distribution of con-
trolled substances; and 
‘‘(E) such other factors as may be relevant to 
and consistent with the public health and safety. 
‘‘(3) If an applicant is registered to distribute a con-
trolled substance in schedule I or II under subsection (b), 
the applicant shall not be required to apply for a separate 
registration under this subsection. 
‘‘(m)(1)(A) Not later than 90 days after the date on 
which a substance is placed in schedule A, any practitioner 
who was engaged in research on the substance before the 
placement of the substance in schedule A and any manu-
facturer or distributor who was handling the substance be-
fore the placement of the substance in schedule A shall 
register with the Attorney General. 
‘‘(B)(i) If an applicant described in subparagraph (A) 
is registered pursuant to subsection (f) to conduct re-
search with a controlled substance in schedule I or II on 
the date on which another substance is placed in schedule 
A, the applicant may, subject to clause (iii), conduct re-
search with that other controlled substance in schedule A 
while the application for registration pursuant to subpara-
graph (A) is pending.
427 
‘‘(ii) If an applicant described in subparagraph (A) 
is registered pursuant to subsection (f) as described in 
clause (i) to conduct research with a controlled substance 
in schedule III, IV, or V on the date on which another 
substance is placed in schedule A, the applicant may, sub-
ject to clause (iii), conduct research with that other con-
trolled substance in schedule A while the application for 
registration pursuant to subparagraph (A) is pending, 
provided the substance for which the applicant is reg-
istered to conduct research is in the same schedule as, or 
a less-restricted schedule than, the controlled substance 
whose similarity in chemical structure and actual or pre-
dicted effect to the controlled substance in schedule A 
formed the basis for placement of the substance in sched-
ule A, as set forth in the order published in the Federal 
Register placing the substance in schedule A. 
‘‘(iii) The permission to conduct research pursuant 
to clause (i) or clause (ii) is conditional on the applicant’s 
complying with the registration and other requirements 
for controlled substances in schedule A. 
‘‘(iv) This subparagraph does not apply to applicants 
registered pursuant to subsection (f) whose authorization 
to conduct research with any controlled substances is lim-
ited to doing so as a coincident activity pursuant to appli-
cable regulations of the Attorney General.
428 
‘‘(2)(A) Not later than 60 days after the date on 
which the Attorney General receives an application for 
registration to conduct research on a schedule A sub-
stance, the Attorney General shall— 
‘‘(i) grant, or initiate proceedings under section 
304(c) to deny, the application; or 
‘‘(ii) request supplemental information from the 
applicant. 
‘‘(B) Not later than 30 days after the date on which 
the Attorney General receives supplemental information 
requested under subparagraph (A)(ii) in connection with 
an application described in subparagraph (A), the Attor-
ney General shall grant or deny the application. 
‘‘(n)(1) The Attorney General shall register a sci-
entific investigator or a qualified research institution to 
conduct research with controlled substances in schedule A 
in accordance with this subsection. In evaluating applica-
tions for such registration, the Attorney General shall 
apply the criteria set forth in subsection (f) of this section 
that apply to practitioners seeking a registration to con-
duct research with a schedule I controlled substance, ex-
cept that the applicant shall not be required to submit a 
research protocol. 
‘‘(2) If the applicant is not currently registered under 
subsection (f) to conduct research with a schedule I con-
429 
trolled substance, the Attorney General shall refer the ap-
plication to the Secretary, who shall determine whether 
the applicant will be engaged in bona fide research and 
is qualified to conduct such research. The 60-day period 
under subsection (m)(2)(A) shall be tolled during the pe-
riod beginning on the date on which the Attorney General 
refers an application to the Secretary under this para-
graph, and ending on the date on which the Secretary sub-
mits a determination related to such referral to the Attor-
ney General. 
‘‘(3) An applicant who meets the criteria under sub-
section (m)(1)(B) with respect to a particular schedule A 
controlled substance shall be considered qualified to con-
duct research with that substance. The Attorney General 
shall modify such applicant’s registration to include such 
schedule A controlled substance in accordance with this 
paragraph. The applicant shall notify the Attorney Gen-
eral of his intent to conduct research with a controlled 
substance in schedule A. Upon receiving such notification, 
the Attorney General shall modify the practitioner’s exist-
ing registration to authorize research with schedule A con-
trolled substances, unless the Attorney General determines 
that the registration modification would be inconsistent 
with the public interest based on the criteria of subsection 
(f).
430 
‘‘(4) Registrations issued under this subsection to a 
qualified research institution will apply to all agents and 
employees of that institution acting within the scope of 
their professional practice. 
‘‘(5) At least 30 days prior to conducting any re-
search with a controlled substance in schedule A, the reg-
istrant shall provide the Attorney General with written no-
tification of the following: 
‘‘(A) The name of and drug code for each sub-
stance. 
‘‘(B) The name of each individual with access 
to each substance. 
‘‘(C) The amount of each substance. 
‘‘(D) Other similar information the Attorney 
General may require. 
‘‘(6) The quantity of a schedule A controlled sub-
stance possessed by a person registered under this sub-
section shall be appropriate for the research being con-
ducted, subject to the additional limitations set forth in 
this paragraph. To reduce the risk of diversion, the Attor-
ney General may establish limitations on the quantity of 
schedule A controlled substances that may be manufac-
tured or possessed for purposes of research under this sub-
section and shall publish such limitations on the website 
of the Drug Enforcement Administration. A person reg-
431 
istered under this subsection may, based on legitimate re-
search needs, apply to the Attorney General to manufac-
ture or possess an amount greater than that so specified 
by the Attorney General. The Attorney General shall 
specify the manner in which such applications shall be 
submitted. The Attorney General shall act on an applica-
tion filed under this subparagraph within 30 days of re-
ceipt of such application. If the Attorney General fails to 
act within 30 days, the registrant shall be allowed to man-
ufacture and possess up to the amount requested. The At-
torney General shall have the authority to reverse the in-
crease for cause. 
‘‘(7) The Attorney General shall by regulation specify 
the manner in which applications for registration under 
this subsection shall be submitted. 
‘‘(8) Registrants authorized under this subsection 
may manufacture and possess schedule A controlled sub-
stances up to the approved amounts only for use in their 
own research setting or institution. Manufacturing for use 
in any other setting or institution shall require a manufac-
turer’s registration under section 303(a).’’. 
(b) CONTROLLED SUBSTANCES IMPORT AND EXPORT 
ACT.—Section 1008 of the Controlled Substances Import 
and Export Act (21 U.S.C. 958) is amended by adding 
at the end the following:
432 
‘‘(j)(1) The Attorney General shall register an appli-
cant to import or export a schedule A substance if— 
‘‘(A) the applicant demonstrates that the sched-
ule A substances will be used for research, analyt-
ical, or industrial purposes approved by the Attorney 
General; and 
‘‘(B) the Attorney General determines that such 
registration is consistent with the public interest and 
with the United States obligations under inter-
national treaties, conventions, or protocols in effect 
on the date of enactment of this subsection. 
‘‘(2) In determining the public interest under para-
graph (1)(B), the Attorney General shall consider the fac-
tors described in subparagraphs (A) through (F) of sec-
tion 303(k)(2). 
‘‘(3) If an applicant is registered to import or export 
a controlled substance in schedule I or II under subsection 
(a), the applicant shall not be required to apply for a sepa-
rate registration under this subsection.’’. 
SEC. 9007. ADDITIONAL CONFORMING AMENDMENTS. 
(a) CONTROLLED
SUBSTANCES
ACT.—The Con-
trolled Substances Act (21 U.S.C. 801 et seq.) is amend-
ed— 
(1) in section 303(c) (21 U.S.C. 823(c))—
433 
(A) by striking ‘‘subsections (a) and (b)’’ 
and inserting ‘‘subsection (a), (b), (k), or (l)’’; 
and 
(B) by striking ‘‘schedule I or II’’ and in-
serting ‘‘schedule I, II, or A’’; 
(2) in section 306 (21 U.S.C. 826)— 
(A) in subsection (a), in the first sentence, 
by striking ‘‘schedules I and II’’ and inserting 
‘‘schedules I, II, and A’’; 
(B) in subsection (b), in the second sen-
tence, by striking ‘‘schedule I or II’’ and insert-
ing ‘‘schedule I, II, or A’’; 
(C) in subsection (c), in the first sentence, 
by striking ‘‘schedules I and II’’ and inserting 
‘‘schedules I, II, and A’’; 
(D) in subsection (d), in the first sentence, 
by striking ‘‘schedule I or II’’ and inserting 
‘‘schedule I, II, or A’’; 
(E) in subsection (e), in the first sentence, 
by striking ‘‘schedule I or II’’ and inserting 
‘‘schedule I, II, or A’’; and 
(F) in subsection (f), in the first sentence, 
by striking ‘‘schedules I and II’’ and inserting 
‘‘schedules I, II, and A’’;
434 
(3) in section 308(a) (21 U.S.C. 828(a)), by 
striking ‘‘schedule I or II’’ and inserting ‘‘schedule 
I, II, or A’’; 
(4) in section 402(b) (21 U.S.C. 842(b)), in the 
matter preceding paragraph (1), by striking ‘‘sched-
ule I or II’’ and inserting ‘‘schedule I, II, or A’’; 
(5) in section 403(a)(1) (21 U.S.C. 843(a)(1)), 
by striking ‘‘schedule I or II’’ and inserting ‘‘sched-
ule I, II, or A’’; and 
(6) in section 511(f) (21 U.S.C. 881(f)), by 
striking ‘‘schedule I or II’’ each place it appears and 
inserting ‘‘schedule I, II, or A’’. 
(b) CONTROLLED SUBSTANCES IMPORT EXPORT 
ACT.—The Controlled Substances Import and Export Act 
(21 U.S.C. 951 et seq.) is amended— 
(1) in section 1002(a) (21 U.S.C. 952(a))— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘schedule I or II’’ and inserting 
‘‘schedule I, II, or A’’; and 
(B) in paragraph (2), by striking ‘‘sched-
ule I or II’’ and inserting ‘‘schedule I, II, or 
A’’; 
(2) in section 1003 (21 U.S.C. 953)—
435 
(A) in subsection (c), in the matter pre-
ceding paragraph (1), by striking ‘‘schedule I or 
II’’ and inserting ‘‘schedule I, II, or A’’; and 
(B) in subsection (d), by striking ‘‘schedule 
I or II’’ and inserting ‘‘schedule I, II, or A’’; 
(3) in section 1004(1) (21 U.S.C. 954(1)), by 
striking ‘‘schedule I’’ and inserting ‘‘schedule I or 
A’’; 
(4) in section 1005 (21 U.S.C. 955), by striking 
‘‘schedule I or II’’ and inserting ‘‘schedule I, II, or 
A’’; and 
(5) in section 1009(a) (21 U.S.C. 959(a)), by 
striking ‘‘schedule I or II’’ and inserting ‘‘schedule 
I, II, or A’’. 
SEC. 9008. CONTROLLED SUBSTANCE ANALOGUES. 
Section 102 of the Controlled Substances Act (21 
U.S.C. 802) is amended— 
(1) in paragraph (6), by striking ‘‘or V’’ and in-
serting ‘‘V, or A’’; 
(2) in paragraph (14)— 
(A) by striking ‘‘schedule I(c) and’’ and in-
serting ‘‘schedule I(c), schedule A, and’’; and 
(B) by striking ‘‘schedule I(c),’’ and insert-
ing ‘‘schedule I(c) and schedule A,’’; and
436 
(3) in paragraph (32)(A), by striking ‘‘(32)(A)’’ 
and all that follows through clause (iii) and inserting 
the following: 
‘‘(32)(A) Except as provided in subparagraph (C), 
the term ‘controlled substance analogue’ means a sub-
stance whose chemical structure is substantially similar to 
the chemical structure of a controlled substance in sched-
ule I or II— 
‘‘(i) which has a stimulant, depressant, or hal-
lucinogenic effect on the central nervous system that 
is substantially similar to or greater than the stimu-
lant, depressant, or hallucinogenic effect on the cen-
tral nervous system of a controlled substance in 
schedule I or II; or 
‘‘(ii) with respect to a particular person, which 
such person represents or intends to have a stimu-
lant, depressant, or hallucinogenic effect on the cen-
tral nervous system that is substantially similar to 
or greater than the stimulant, depressant, or hallu-
cinogenic effect on the central nervous system of a 
controlled substance in schedule I or II.’’. 
SEC. 9009. RULES OF CONSTRUCTION. 
Nothing in this title, or the amendments made by this 
title, may be construed to limit—
437 
(1) the prosecution of offenses involving con-
trolled substance analogues under the Controlled 
Substances Act (21 U.S.C. 801 et seq.); or 
(2) the authority of the Attorney General to 
temporarily or permanently schedule, reschedule, or 
decontrol controlled substances under provisions of 
section 201 of the Controlled Substances Act (21 
U.S.C. 811) that are in effect on the day before the 
date of enactment of this title. 
SEC. 9010. STUDY BY COMPTROLLER GENERAL. 
Not later than 2 years after the date of enactment 
of this title, the Comptroller General of the United States 
shall complete a study and submit a report to the Commit-
tees on the Judiciary of the House of Representatives and 
of the Senate regarding the costs associated with the 
amendments made by section 4, including— 
(1) the annual amounts expended by Federal 
agencies in carrying out the amendments; 
(2) the costs associated with arrests, trials, con-
victions, imprisonment, or imposition of other sanc-
tions in accordance with the amendments; and 
(3) the impact (including the fiscal impact) of 
the amendments on existing correctional facilities 
and the likelihood that those amendments will create 
a need for additional capacity for housing prisoners.
438 
SEC. 9011. REPORT ON CONTROLLED SUBSTANCE ANA-
LOGUES SOLD BY MEANS OF THE INTERNET. 
Not later than 1 year after the date of the enactment 
of this title, and annually thereafter, the Administrator 
of the Drug Enforcement Administration shall make pub-
licly available on the website of the Drug Enforcement Ad-
ministration a report on, for the previous year, the lawful 
and unlawful sale of controlled substance analogues (as 
defined in section 102 of the Controlled Substances Act 
(21 U.S.C. 802)) by means of the Internet, including the 
following information: 
(1) The types of controlled substance analogues 
that were sold, and the number of sales for each 
such substance. 
(2) The name of each person, entity, or Inter-
net site, whether in the United States or abroad, 
that knowingly or intentionally delivers, distributes, 
or dispenses, or offers or attempts to deliver, dis-
tribute, or dispense, a controlled substance analogue 
by means of the Internet, whether lawfully or unlaw-
fully. 
(3) An estimate of the total revenue for all of 
the vendors described in paragraph (2) for all of the 
sales described in paragraph (1).
439 
SEC. 9012. CONTROLLED SUBSTANCE ANALOGUES. 
Section 203 of the Controlled Substances Act (21 
U.S.C. 813) is amended— 
(1) by striking ‘‘A controlled’’ and inserting 
‘‘(a) IN GENERAL.—A controlled’’; and 
(2) by adding at the end the following: 
‘‘(b) DETERMINATION.—In determining whether a 
controlled substance analogue was intended for human 
consumption under subsection (a), the following factors 
may be considered, along with any other relevant factors: 
‘‘(1) The marketing, advertising, and labeling 
of the substance. 
‘‘(2) The known efficacy or usefulness of the 
substance for the marketed, advertised or labeled 
purpose. 
‘‘(3) The difference between the price at which 
the substance is sold and the price at which the sub-
stance it is purported to be or advertised as is nor-
mally sold. 
‘‘(4) The diversion of the substance from legiti-
mate channels and the clandestine importation, man-
ufacture, or distribution of the substance. 
‘‘(5) Whether the defendant knew or should 
have known the substance was intended to be con-
sumed by injection, inhalation, ingestion, or any 
other immediate means.
440 
‘‘(6) Any controlled substance analogue that is 
manufactured, formulated, sold, distributed, or mar-
keted with the intent to avoid the provisions of exist-
ing drug laws. 
‘‘(c) LIMITATION.—For purposes of this section, evi-
dence that a substance was not marketed, advertised, or 
labeled for human consumption, by itself, shall not be suf-
ficient to establish that the substance was not intended 
for human consumption.’’. 
TITLE X—THRIVE ACT 
SEC. 10001. SHORT TITLE. 
This title may be cited as the ‘‘Transitional Housing 
for Recovery in Viable Environments Demonstration Pro-
gram Act’’ or the ‘‘THRIVE Act’’. 
SEC. 10002. DEMONSTRATION PROGRAM TO STUDY THE IM-
PACT OF USING RENTAL VOUCHERS FOR 
SUPPORTIVE HOUSING FOR INDIVIDUALS RE-
COVERING FROM OPIOID USE DISORDERS OR 
OTHER SUBSTANCE USE DISORDERS. 
Section 8(o) of the United States Housing Act of 
1937 (42 U.S.C. 1437f(o)) is amended by adding at the 
end the following new paragraph: 
‘‘(21) RENTAL VOUCHER DEMONSTRATION PRO-
GRAM FOR SUPPORTIVE HOUSING FOR INDIVIDUALS
441 
RECOVERING
FROM
OPIOID
USE
DISORDERS
OR 
OTHER SUBSTANCE USE DISORDERS.— 
‘‘(A) 
ESTABLISHMENT.—The 
Secretary 
shall establish a demonstration program under 
which the Secretary shall set aside, allocate, 
and distribute directly to eligible entities, from 
amounts made available for rental assistance 
under this subsection, the amounts specified in 
subparagraph (B) for an eligible entity to pro-
vide a voucher for such assistance to a covered 
individual through a supportive housing pro-
gram that provides treatment for opioid use dis-
orders or other substance use disorders (as ap-
plicable), coordination with workforce develop-
ment providers, and such assistance, as deter-
mined by the entity. 
‘‘(B) AMOUNT.—The amount specified in 
this subparagraph is, for fiscal year 2019, the 
amount necessary to provide the lesser of— 
‘‘(i) 0.5 percent of the total number of 
vouchers renewed under this subsection 
during the fiscal year ending immediately 
before the date of the enactment of this 
paragraph; or 
‘‘(ii) 10,000 vouchers.
442 
‘‘(C) CRITERIA FOR ELIGIBLE ENTITIES.— 
An eligible entity shall— 
‘‘(i) provide an evidence-based treat-
ment program and demonstrate the ability 
to coordinate with workforce development 
providers for individuals recovering from 
an opioid use disorder or other substance 
use disorder, as applicable, that meet 
standards established by the Secretary; 
and 
‘‘(ii) demonstrate prior experience ad-
ministering rental assistance vouchers, 
demonstrate prior experience administering 
supportive housing programs under the 
McKinney-Vento Homeless Act, or dem-
onstrate a partnership with a public hous-
ing agency or a housing program of a 
State, unit of local government, or Indian 
tribe (as such term is defined in section 4 
of the Native American Housing and Self- 
Determination Act of 1996 (25 U.S.C. 
4103)) that ensures effective administra-
tion of rental assistance vouchers. 
‘‘(D) APPLICATION.—To receive a rental 
assistance voucher under this paragraph, an eli-
443 
gible entity shall submit an application to the 
Secretary that shall include— 
‘‘(i) a description of the terms of 
treatment 
program, 
coordination 
with 
workforce development providers, and rent-
al assistance to be provided to a covered 
individual, and assurances that such de-
scription shall be communicated to covered 
individuals that receive vouchers pursuant 
to the demonstration program established 
under this paragraph; 
‘‘(ii) a transitional plan that begins on 
the date on which a covered individual 
completes the treatment program of the el-
igible entity that includes information on 
additional treatment, coordination with 
workforce development opportunities, and 
housing resources and services available to 
such covered individual; and 
‘‘(iii) evidence sufficient to dem-
onstrate that the local government having 
jurisdiction over the location of any sup-
portive housing facility to be used by the 
eligible entity in connection with the dem-
444 
onstration program under this paragraph 
permits such facilities in such location. 
‘‘(E) SELECTION.—In selecting eligible en-
tities to receive rental assistance vouchers 
under this paragraph, the Secretary shall— 
‘‘(i) ensure that such eligible enti-
ties— 
‘‘(I) are diverse; 
‘‘(II) represent an appropriate 
balance of eligible entities located in 
urban and rural areas, including trib-
al communities; 
‘‘(III) have adequate resources 
for treatment, recovery, and sup-
portive services; 
‘‘(IV) fully comply with the Fair 
Housing Act (42 U.S.C. 3601 et seq.) 
and the Civil Rights Act of 1964 (42 
U.S.C. 2000a et seq.); 
‘‘(V) appropriately reflect the im-
pact that opioids are having in tribal 
communities; and 
‘‘(VI) provide supportive and 
transitional housing programs in di-
verse geographic regions with high
445 
rates of mortality due to opioid use 
disorders or other substance use dis-
orders, as applicable, based on data of 
the Centers for Disease Control and 
Prevention; and 
‘‘(ii) consider, in consultation with the 
Secretary of Health and Human Services 
and the Secretary of Labor— 
‘‘(I) the success of each recipient 
eligible entity at helping individuals 
complete the treatment program of 
the eligible entity and refrain from il-
licit opioid or other substance usage, 
as applicable; 
‘‘(II) the coordination with work-
force development providers by the eli-
gible entity; 
‘‘(III) the percentage of partici-
pants in unsubsidized employment 
during the second and fourth calendar 
quarter after exit from the program; 
and 
‘‘(IV) the percentage of partici-
pants in the treatment program of the 
eligible entity that do not relapse into
446 
opioid or other substance usage, as 
applicable. 
‘‘(F) REISSUANCE
OF
VOUCHER.—Upon 
termination of the provision of rental assistance 
through a voucher to a covered individual, the 
eligible entity that initially offered such voucher 
may use such voucher to provide rental assist-
ance to another covered individual. 
‘‘(G) DURATION.—The Secretary shall not 
make rental assistance available under this 
paragraph after the expiration of the 5-year pe-
riod beginning on the date of the enactment of 
this paragraph. 
‘‘(H) 
WAIVERS.—The 
Secretary 
may, 
through publication of a notice in the Federal 
Register, waive or specify alternative require-
ments for any provision of statue or regulation 
governing the use of vouchers under this sub-
section (except for requirements relating to fair 
housing, nondiscrimination, labor standards, or 
the environment) upon a finding by the Sec-
retary that such waiver or alternative require-
ment is necessary for the purposes of this para-
graph. 
‘‘(I) REPORTS.—
447 
‘‘(i) BY THE ELIGIBLE ENTITY.—An 
eligible entity that receives a rental assist-
ance voucher under this paragraph shall 
submit to the Secretary— 
‘‘(I) annually, the transitional 
plan 
described 
in 
subparagraph 
(D)(ii) and information on each cov-
ered individual’s housing upon termi-
nation of the provision of rental as-
sistance through a voucher to such 
covered individual in a manner that 
protects the privacy of such covered 
individual; and 
‘‘(II) not later than 4 years after 
the date of the enactment of this 
paragraph, a plan describing the 
treatment and housing options for any 
covered individual assisted by such 
voucher who will not have completed 
the program before the day that is 5 
years after such date of enactment. 
‘‘(ii) BY THE SECRETARY.—The Sec-
retary shall submit to Congress a report 
that analyzes the impact of rental assist-
ance provided under this paragraph—
448 
‘‘(I) not later than 2 years after 
the date of the enactment of this 
paragraph; and 
‘‘(II) not later than 4 years after 
the date of the enactment of this 
paragraph. 
‘‘(J) DEFINITIONS.—In this paragraph: 
‘‘(i) ELIGIBLE ENTITY.—The term ‘el-
igible entity’ means a tribally designated 
housing entity (as such term is defined in 
section 4 of the Native American Housing 
and Self-Determination Act of 1996 (24 
U.S.C. 4103)), or a nonprofit organization, 
that meets the criteria described under 
subparagraph (C). 
‘‘(ii) 
COVERED
INDIVIDUAL.—The 
term ‘covered individual’ means an indi-
vidual recovering from an opioid use dis-
order or other substance use disorder.’’. 
SEC. 10003. REPEAL OF RENTAL VOUCHER DEMONSTRA-
TION PROGRAM. 
Effective the day that is 5 years after the date of 
the enactment of this title, paragraph (21) of section 8(o) 
of the United States Housing Act of 1937 (42 U.S.C. 
1437f(o)), as added by this title, is repealed.
449 
SEC. 10004. DEMONSTRATION CLOSE-OUT. 
An eligible entity that provided vouchers for rental 
assistance under paragraph (21) of section 8(o) of the 
United States Housing Act of 1937 (42 U.S.C. 1437f(o)), 
as added by this title, shall return any such vouchers to 
the Secretary of Housing and Urban Development not 
later than the day that is 5 years after the date of the 
enactment of this title for use only for renewals of expiring 
contracts for such assistance. 
SEC. 10005. NO ADDITIONAL FUNDS AUTHORIZED. 
No additional funds are authorized to be appro-
priated to carry out the requirements of this title and the 
amendments made by this title. Such requirements shall 
be carried out using amounts otherwise authorized to be 
appropriated. 
TITLE XI—IMD CARE ACT 
SEC. 11001. SHORT TITLE. 
This title may be cited as the ‘‘Individuals in Med-
icaid Deserve Care that is Appropriate and Responsible 
in its Execution Act’’ or the ‘‘IMD CARE Act’’.
450 
SEC. 11002. MEDICAID STATE PLAN OPTION TO PROVIDE 
SERVICES FOR CERTAIN INDIVIDUALS WITH 
TARGETED SUDS IN INSTITUTIONS FOR MEN-
TAL DISEASES. 
Section 1915 of the Social Security Act (42 U.S.C. 
1396n) is amended by adding at the end the following new 
subsection: 
‘‘(l) STATE PLAN OPTION TO PROVIDE SERVICES 
FOR CERTAIN INDIVIDUALS IN INSTITUTIONS FOR MEN-
TAL DISEASES.— 
‘‘(1) IN GENERAL.—With respect to calendar 
quarters beginning during the period beginning Jan-
uary 1, 2019, and ending December 31, 2023, a 
State may elect, through a State plan amendment, 
to, notwithstanding section 1905(a), provide medical 
assistance for services furnished in institutions for 
mental diseases and for other medically necessary 
services furnished to eligible individuals with tar-
geted SUDs, in accordance with the requirements of 
this subsection. 
‘‘(2) PAYMENTS.— 
‘‘(A) IN
GENERAL.—Amounts expended 
under a State plan amendment under para-
graph (1) for services described in such para-
graph furnished, with respect to a 12-month pe-
riod, to an eligible individual with a targeted
451 
SUD who is a patient in an institution for men-
tal diseases shall be treated as medical assist-
ance for which payment is made under section 
1903(a) but only to the extent that such serv-
ices are furnished for not more than a period 
of 30 days (whether or not consecutive) during 
such 12-month period. 
‘‘(B) 
CLARIFICATION.—Payment 
made 
under this paragraph for expenditures under a 
State plan amendment under this subsection 
with respect to services described in paragraph 
(1) furnished to an eligible individual with a 
targeted SUD shall not affect payment that 
would otherwise be made under section 1903(a) 
for expenditures under the State plan (or waiv-
er of such plan) for medical assistance for such 
individual. 
‘‘(3) INFORMATION REQUIRED IN STATE PLAN 
AMENDMENT.— 
‘‘(A) IN
GENERAL.—A State electing to 
provide medical assistance pursuant to this sub-
section shall include with the submission of the 
State plan amendment under paragraph (1) to 
the Secretary—
452 
‘‘(i) a plan on how the State will im-
prove access to outpatient care during the 
period of the State plan amendment, in-
cluding a description of— 
‘‘(I) the process by which eligible 
individuals with targeted SUDs will 
make the transition from receiving in-
patient services in an institution for 
mental diseases to appropriate out-
patient care; and 
‘‘(II) the process the State will 
undertake to ensure eligible individ-
uals with targeted SUDs are provided 
care in the most integrated setting ap-
propriate to the needs of the individ-
uals; and 
‘‘(ii) a description of how the State 
plan amendment ensures an appropriate 
clinical screening of eligible individuals 
with targeted SUDs, including assessments 
to determine level of care and length of 
stay recommendations based upon the 
multidimensional assessment criteria of the 
American Society of Addiction Medicine
453 
and to determine the appropriate setting 
for such care. 
‘‘(B) REPORT.—Not later than the sooner 
of December 31, 2024, or 1 year after the date 
of the termination of a State plan amendment 
under this subsection, the State shall submit to 
the Secretary a report that includes at least— 
‘‘(i) the number of eligible individuals 
with targeted SUDs who received services 
pursuant to such State plan amendment; 
‘‘(ii) the length of the stay of each 
such individual in an institution for mental 
diseases; 
‘‘(iii) the type of outpatient treatment, 
including medication-assisted treatment, 
each such individual received after being 
discharged from such institution; 
‘‘(iv) the number of eligible individ-
uals with any co-occuring disorders who re-
ceived services pursuant to such State plan 
amendment and the co-occuring disorders 
from which they suffer; and 
‘‘(v) information regarding the effects 
of a State plan amendment on access to 
community care for individuals suffering
454 
from a mental disease other than sub-
stance use disorder. 
‘‘(4) DEFINITIONS.—In this subsection: 
‘‘(A) ELIGIBLE INDIVIDUAL WITH A TAR-
GETED SUD.—The term ‘eligible individual with 
a targeted SUD’ means an individual who— 
‘‘(i) with respect to a State, is en-
rolled for medical assistance under the 
State plan (or a waiver of such plan); 
‘‘(ii) is at least 21 years of age; 
‘‘(iii) has not attained 65 years of 
age; and 
‘‘(iv) has been diagnosed with at least 
one targeted SUD. 
‘‘(B) INSTITUTION
FOR
MENTAL
DIS-
EASES.—The term ‘institution for mental dis-
eases’ has the meaning given such term in sec-
tion 1905(i). 
‘‘(C) OPIOID
PRESCRIPTION
PAIN
RE-
LIEVER.—The term ‘opioid prescription pain re-
liever’ 
includes 
hydrocodone 
products, 
oxycodone products, tramadol products, codeine 
products, morphine products, fentanyl products, 
buprenorphine products, oxymorphone products, 
meperidine products, hydromorphone products,
455 
methadone, and any other prescription pain re-
liever identified by the Assistant Secretary for 
Mental Health and Substance Use. 
‘‘(D) 
OTHER
MEDICALLY
NECESSARY 
SERVICES.—The term ‘other medically nec-
essary services’ means, with respect to an eligi-
ble individual with a targeted SUD who is a pa-
tient in an institution for mental diseases, items 
and services that are provided to such indi-
vidual outside of such institution to the extent 
that such items and services would be treated 
as medical assistance for such individual if such 
individual were not a patient in such institu-
tion. 
‘‘(E) TARGETED SUD.— 
‘‘(i) IN
GENERAL.—The term ‘tar-
geted SUD’ means an opioid use disorder 
or a cocaine use disorder. 
‘‘(ii) COCAINE
USE
DISORDER.—The 
term ‘cocaine use disorder’ means a dis-
order that meets the criteria of the Diag-
nostic and Statistical Manual of Mental 
Disorders, 4th Edition (or a successor edi-
tion), for either dependence or abuse for
456 
cocaine, including cocaine base (commonly 
referred to as ‘crack cocaine’). 
‘‘(iii) OPIOID
USE
DISORDER.—The 
term ‘opioid use disorder’ means a disorder 
that meets the criteria of the Diagnostic 
and Statistical Manual of Mental Dis-
orders, 4th Edition (or a successor edi-
tion), for heroin use disorder or pain re-
liever use disorder (including with respect 
to opioid prescription pain relievers).’’. 
SEC. 11003. PROMOTING VALUE IN MEDICAID MANAGED 
CARE. 
Section 1903(m) of the Social Security Act (42 
U.S.C. 1396b(m)) is amended by adding at the end the 
following new paragraph: 
‘‘(7)(A) With respect to expenditures described in 
subparagraph (B) that are incurred by a State for any 
fiscal year after fiscal year 2020 (and before fiscal year 
2024), in determining the pro rata share to which the 
United States is equitably entitled under subsection 
(d)(3), the Secretary shall substitute the Federal medical 
assistance percentage that applies for such fiscal year to 
the State under section 1905(b) (without regard to any 
adjustments to such percentage applicable under such sec-
457 
tion or any other provision of law) for the percentage that 
applies to such expenditures under section 1905(y). 
‘‘(B) Expenditures described in this subparagraph, 
with respect to a fiscal year to which subparagraph (A) 
applies, are expenditures incurred by a State for payment 
for medical assistance provided to individuals described in 
subclause (VIII) of section 1902(a)(10)(A)(i) by a man-
aged care entity, or other specified entity (as defined in 
subparagraph (D)(iii)), that are treated as remittances be-
cause the State— 
‘‘(i) has satisfied the requirement of section 
438.8 of title 42, Code of Federal Regulations (or 
any successor regulation), by electing— 
‘‘(I) in the case of a State described in 
subparagraph (C), to apply a minimum medical 
loss ratio (as defined in subparagraph (D)(ii)) 
that is at least 85 percent but not greater than 
the minimum medical loss ratio (as so defined) 
that such State applied as of May 31, 2018; or 
‘‘(II) in the case of a State not described 
in subparagraph (C), to apply a minimum med-
ical loss ratio that is equal to 85 percent; and 
‘‘(ii) recovered all or a portion of the expendi-
tures as a result of the entity’s failure to meet such 
ratio.
458 
‘‘(C) For purposes of subparagraph (B), a State de-
scribed in this subparagraph is a State that as of May 
31, 2018, applied a minimum medical loss ratio (as cal-
culated under subsection (d) of section 438.8 of title 42, 
Code of Federal Regulations (as in effect on June 1, 
2018)) for payment for services provided by entities de-
scribed in such subparagraph under the State plan under 
this title (or a waiver of the plan) that is equal to or great-
er than 85 percent. 
‘‘(D) For purposes of this paragraph: 
‘‘(i) The term ‘managed care entity’ means a 
medicaid managed care organization described in 
section 1932(a)(1)(B)(i). 
‘‘(ii) The term ‘minimum medical loss ratio’ 
means, with respect to a State, a minimum medical 
loss ratio (as calculated under subsection (d) of sec-
tion 438.8 of title 42, Code of Federal Regulations 
(as in effect on June 1, 2018)) for payment for serv-
ices provided by entities described in subparagraph 
(B) under the State plan under this title (or a waiv-
er of the plan). 
‘‘(iii) The term ‘other specified entity’ means— 
‘‘(I) a prepaid inpatient health plan, as de-
fined in section 438.2 of title 42, Code of Fed-
459 
eral Regulations (or any successor regulation); 
and 
‘‘(II) a prepaid ambulatory health plan, as 
defined in such section (or any successor regu-
lation).’’. 
Passed the House of Representatives June 22, 2018. 
Attest: 
Clerk.
115TH CONGRESS 
2D SESSION 
H. R. 6 
AN ACT 
To provide for opioid use disorder prevention, 
recovery, and treatment, and for other purposes.