226 
(I) The Director of the Centers for Disease 
Control and Prevention. 
(J) The Director of the National Institutes 
of Health and the Directors of such national re-
search institutes of the National Institutes of 
Health as the Secretary determines appropriate. 
(K) The Administrator of the Centers for 
Medicare & Medicaid Services. 
(L) The Director of National Drug Control 
Policy. 
(M) Representatives of other Federal agen-
cies that serve individuals with substance use 
disorder. 
(2) NON-FEDERAL MEMBERS.—The Committee 
shall include a minimum of 17 non-Federal members 
appointed by the Secretary, of which— 
(A) at least two such members shall be an 
individual who has received treatment for a di-
agnosis of an opioid use disorder; 
(B) at least two such members shall be an 
individual who has received treatment for a di-
agnosis of a substance use disorder other than 
an opioid use disorder; 
(C) at least two such members shall be a 
State Alcohol and Substance Abuse Director;
227 
(D) at least two such members shall be a 
representative of a leading research, advocacy, 
or service organization for adults with sub-
stance use disorder; 
(E) at least two such members shall— 
(i) be a physician, licensed mental 
health professional, advance practice reg-
istered nurse, or physician assistant; and 
(ii) have experience in treating indi-
viduals with opioid use disorder or other 
substance use disorders; 
(F) at least one such member shall be a 
substance use disorder treatment professional 
who is employed with an opioid treatment pro-
gram; 
(G) at least one such member shall be a 
substance use disorder treatment professional 
who has research or clinical experience in work-
ing with racial and ethnic minority populations; 
(H) at least one such member shall be a 
substance use disorder treatment professional 
who has research or clinical mental health expe-
rience in working with medically underserved 
populations;
228 
(I) at least one such member shall be a 
State-certified substance use disorder peer sup-
port specialist; 
(J) at least one such member shall be a 
drug court judge or a judge with experience in 
adjudicating cases related to substance use dis-
order; 
(K) at least one such member shall be a 
law enforcement officer or correctional officer 
with extensive experience in interacting with 
adults with a substance use disorder; and 
(L) at least one such member shall be an 
individual with experience providing services for 
homeless individuals and working with adults 
with a substance use disorder. 
(c) TERMS.— 
(1) IN GENERAL.—A member of the Committee 
appointed under subsection (b)(2) shall be appointed 
for a term of 3 years and may be reappointed for 
one or more 3-year terms. 
(2) VACANCIES.—A vacancy on the Committee 
shall be filled in the same manner in which the origi-
nal appointment was made. Any individual appointed 
to fill a vacancy for an unexpired term shall be ap-
pointed for the remainder of such term and may
229 
serve after the expiration of such term until a suc-
cessor has been appointed. 
(d) MEETINGS.—The Committee shall meet not fewer 
than two times each year. 
(e) DUTIES.—The Committee shall— 
(1) monitor opioid use disorder and other sub-
stance use disorder research, services, and support 
and prevention activities across all relevant Federal 
agencies, including coordination of Federal activities 
with respect to opioid use disorder and other sub-
stance use disorders; 
(2) identify and provide to the Secretary rec-
ommendations for improving Federal grants and 
programs for the prevention and treatment of, and 
recovery from, opioid use disorder and other sub-
stance use disorders; 
(3) review substance use disorder prevention 
and treatment strategies in different regions and 
populations in the United States and evaluate the 
extent to which Federal substance use disorder pre-
vention and treatment strategies are aligned with 
State and local substance use disorder prevention 
and treatment strategies; 
(4) make recommendations to the Secretary re-
garding any appropriate changes with respect to the
230 
activities and strategies described in paragraphs (1) 
through (3); 
(5) make recommendations to the Secretary re-
garding public participation in decisions relating to 
opioid use disorder and other substance use dis-
orders and the process by which public feedback can 
be better integrated into such decisions; and 
(6) make recommendations to ensure that 
opioid use disorder and other substance use disorder 
research, services, and support and prevention activi-
ties of the Department of Health and Human Serv-
ices and other Federal agencies are not unneces-
sarily duplicative. 
(f) ANNUAL REPORT.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of this Act, and annually 
thereafter for the life of the Committee, the Com-
mittee shall publish on the public information dash-
board established under section 7022(a) a report 
summarizing the activities carried out by the Com-
mittee pursuant to subsection (e), including any 
findings resulting from such activities. 
(2) RECOMMENDATION
FOR
COMMITTEE
EX-
TENSION.—After the publication of the second re-
port of the Committee under paragraph (1), the Sec-
232 
SEC. 7032. NATIONAL RECOVERY HOUSING BEST PRAC-
TICES. 
Part P of title III of the Public Health Service Act 
is amended by adding at the end the following new section: 
‘‘SEC. 399V–7. NATIONAL RECOVERY HOUSING BEST PRAC-
TICES. 
‘‘(a) BEST PRACTICES.—The Secretary of Health 
and Human Services, in consultation with the Secretary 
for Housing and Urban Development, patients with a his-
tory of opioid use disorder, and other stakeholders, which 
may include State accrediting entities and reputable pro-
viders, analysts, and stakeholders of recovery housing 
services, such as the National Alliance for Recovery Resi-
dences, shall identify or facilitate the development of best 
practices, which may include model laws for implementing 
suggested minimum standards, for operating recovery 
housing. 
‘‘(b) DISSEMINATION.—The Secretary shall dissemi-
nate the best practices identified or developed under sub-
section (a) to— 
‘‘(1) State agencies, which may include the pro-
vision of technical assistance to State agencies seek-
ing to adopt or implement such best practices; 
‘‘(2) recovery housing entities; and 
‘‘(3) the public, as appropriate. 
‘‘(c) DEFINITIONS.—In this section:
233 
‘‘(1) The term ‘recovery housing’ means a 
shared living environment free from alcohol and il-
licit drug use and centered on peer support and con-
nection to services, including medication-assisted 
treatment services, that promote sustained recovery 
from substance use disorders. 
‘‘(2) The term ‘State’ includes any of the sev-
eral States, the District of Columbia, each Indian 
tribe or tribal organization (as those terms are de-
fined in section 4 of the Indian Self-Determination 
and Education Assistance Act), and any territory or 
possession of the United States. 
‘‘(d) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $3,000,000 for the period of fiscal years 2019 
through 2021.’’. 
Subtitle E—Advancing Cutting 
Edge Research 
SEC. 7041. SHORT TITLE. 
This subtitle may be cited as the ‘‘Advancing Cutting 
Edge Research Act’’ or the ‘‘ACE Research Act’’. 
SEC. 7042. UNIQUE RESEARCH INITIATIVES. 
Section 402(n)(1) of the Public Health Service Act 
(42 U.S.C. 282(n)(1)) is amended— 
(1) in subparagraph (A), by striking ‘‘or’’;
234 
(2) in subparagraph (B), by striking the period 
and inserting ‘‘; or’’; and 
(3) by adding at the end the following: 
‘‘(C) high impact cutting-edge research 
that fosters scientific creativity and increases 
fundamental biological understanding leading to 
the prevention, diagnosis, or treatment of dis-
eases and disorders, or research urgently re-
quired to respond to a public health threat.’’. 
Subtitle F—Jessie’s Law 
SEC. 7051. SHORT TITLE. 
This subtitle may be cited as ‘‘Jessie’s Law’’. 
SEC. 7052. INCLUSION OF OPIOID ADDICTION HISTORY IN 
PATIENT RECORDS. 
(a) BEST PRACTICES.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary of 
Health and Human Services, in consultation with 
appropriate stakeholders, including a patient with a 
history of opioid use disorder, an expert in electronic 
health records, an expert in the confidentiality of pa-
tient health information and records, and a health 
care provider, shall identify or facilitate the develop-
ment of best practices regarding—
235 
(A) the circumstances under which infor-
mation that a patient has provided to a health 
care provider regarding such patient’s history of 
opioid use disorder should, only at the patient’s 
request, be prominently displayed in the med-
ical records (including electronic health records) 
of such patient; 
(B) what constitutes the patient’s request 
for the purpose described in subparagraph (A); 
and 
(C) the process and methods by which the 
information should be so displayed. 
(2) DISSEMINATION.—The Secretary shall dis-
seminate the best practices developed under para-
graph (1) to health care providers and State agen-
cies. 
(b) REQUIREMENTS.—In identifying or facilitating 
the development of best practices under subsection (a), as 
applicable, the Secretary, in consultation with appropriate 
stakeholders, shall consider the following: 
(1) The potential for addiction relapse or over-
dose, including overdose death, when opioid medica-
tions are prescribed to a patient recovering from 
opioid use disorder.
236 
(2) The benefits of displaying information 
about a patient’s opioid use disorder history in a 
manner similar to other potentially lethal medical 
concerns, including drug allergies and contraindica-
tions. 
(3) The importance of prominently displaying 
information about a patient’s opioid use disorder 
when a physician or medical professional is pre-
scribing medication, including methods for avoiding 
alert fatigue in providers. 
(4) The importance of a variety of appropriate 
medical professionals, including physicians, nurses, 
and pharmacists, to have access to information de-
scribed in this section when prescribing or dis-
pensing opioid medication, consistent with Federal 
and State laws and regulations. 
(5) The importance of protecting patient pri-
vacy, including the requirements related to consent 
for disclosure of substance use disorder information 
under all applicable laws and regulations. 
(6) All applicable Federal and State laws and 
regulations.
237 
SEC. 7053. COMMUNICATION WITH FAMILIES DURING 
EMERGENCIES. 
(a) PROMOTING AWARENESS OF AUTHORIZED DIS-
CLOSURES DURING EMERGENCIES.—The Secretary of 
Health and Human Services, acting through the Adminis-
trator of the Centers for Medicare & Medicaid Services 
and the Administrator of the Health Resources and Serv-
ices Administration, shall annually develop and dissemi-
nate written materials (electronically or by other means) 
to health care providers regarding permitted disclosures 
under Federal health care privacy law during emergencies, 
including overdoses, of certain health information to fami-
lies, caregivers, and health care providers. 
(b) USE OF MATERIAL.—For the purposes of car-
rying out subsection (a), the Secretary of Health and 
Human Services may use material produced under section 
11004 of the 21st Century Cures Act (42 U.S.C. 1320d– 
2 note). 
Subtitle G—Safe Disposal of 
Unused Medication 
SEC. 7061. SHORT TITLE. 
This subtitle may be cited as the ‘‘Safe Disposal of 
Unused Medication Act’’.
238 
SEC. 7062. DISPOSAL OF CONTROLLED SUBSTANCES OF A 
DECEASED HOSPICE PATIENT BY EMPLOY-
EES OF A QUALIFIED HOSPICE PROGRAM. 
Subsection (g) of section 302 of the Controlled Sub-
stances Act (21 U.S.C. 822) is amended by adding at the 
end the following: 
‘‘(5)(A) In the case of a person receiving hospice care, 
an employee of a qualified hospice program, acting within 
the scope of employment, may handle, without being reg-
istered under this section, any controlled substance that 
was lawfully dispensed to the person receiving hospice 
care, for the purpose of disposal of the controlled sub-
stance after the death of such person, so long as such dis-
posal occurs onsite in accordance with all applicable Fed-
eral, State, Tribal, and local law. 
‘‘(B) For the purposes of this paragraph: 
‘‘(i) The terms ‘hospice care’ and ‘hospice pro-
gram’ have the meanings given to those terms in 
section 1861(dd) of the Social Security Act. 
‘‘(ii) The term ‘employee of a qualified hospice 
program’ means a physician, nurse, or other person 
who— 
‘‘(I) is employed by, or pursuant to ar-
rangements made by, a qualified hospice pro-
gram;
239 
‘‘(II)(aa) is licensed to perform medical or 
nursing services by the jurisdiction in which the 
person receiving hospice care was located; and 
‘‘(bb) is acting within the scope of such 
employment in accordance with applicable State 
law; and 
‘‘(III) has completed training through the 
qualified hospice program regarding the dis-
posal of controlled substances in a secure and 
responsible manner so as to discourage abuse, 
misuse, or diversion. 
‘‘(iii) The term ‘qualified hospice program’ 
means a hospice program that— 
‘‘(I) has written policies and procedures for 
assisting in the disposal of the controlled sub-
stances of a person receiving hospice care after 
the person’s death; 
‘‘(II) at the time when the controlled sub-
stances are first ordered— 
‘‘(aa) provides a copy of the written 
policies and procedures to the patient or 
patient representative and family; 
‘‘(bb) discusses the policies and proce-
dures with the patient or representative 
and the family in a language and manner
240 
that they understand to ensure that these 
parties are educated regarding the safe 
disposal of controlled substances; and 
‘‘(cc) documents in the patient’s clin-
ical record that the written policies and 
procedures were provided and discussed; 
and 
‘‘(III) at the time following the disposal of 
the controlled substances— 
‘‘(aa) documents in the patient’s clin-
ical record the type of controlled sub-
stance, dosage, route of administration, 
and quantity so disposed; and 
‘‘(bb) the time, date, and manner in 
which that disposal occurred.’’. 
Subtitle 
H—Substance 
Use 
Dis-
order Workforce Loan Repay-
ment 
SEC. 7071. SHORT TITLE. 
This subtitle may be cited as the ‘‘Substance Use 
Disorder Workforce Loan Repayment Act of 2018’’. 
SEC. 7072. LOAN REPAYMENT PROGRAM FOR SUBSTANCE 
USE DISORDER TREATMENT EMPLOYEES. 
Title VII of the Public Health Service Act is amend-
ed—
241 
(1) by redesignating part F as part G; and 
(2) by inserting after part E (42 U.S.C. 294n 
et seq.) the following: 
‘‘PART F—SUBSTANCE USE DISORDER 
TREATMENT EMPLOYEES 
‘‘SEC. 781. LOAN REPAYMENT PROGRAM FOR SUBSTANCE 
USE DISORDER TREATMENT EMPLOYEES. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Administrator of the Health Resources and Services 
Administration, shall carry out a program under which— 
‘‘(1) the Secretary enters into agreements with 
individuals to make payments in accordance with 
subsection (b) on the principal of and interest on 
any eligible loan; and 
‘‘(2) the individuals each agree to complete a 
period of service in a substance use disorder treat-
ment job, as described in subsection (d). 
‘‘(b) PAYMENTS.—For each year of obligated service 
by an individual pursuant to an agreement under sub-
section (a), the Secretary shall make a payment to such 
individual as follows: 
‘‘(1) SERVICE IN A SHORTAGE AREA.—The Sec-
retary shall pay— 
‘‘(A) for each year of obligated service by 
an individual pursuant to an agreement under
242 
subsection (a), 1⁄6 of the principal of and inter-
est on each eligible loan of the individual which 
is outstanding on the date the individual began 
service pursuant to the agreement; and 
‘‘(B) for completion of the sixth and final 
year of such service, the remainder of such 
principal and interest. 
‘‘(2) MAXIMUM AMOUNT.—The total amount of 
payments under this section to any individual shall 
not exceed $250,000. 
‘‘(c) ELIGIBLE LOANS.—The loans eligible for repay-
ment under this section are each of the following: 
‘‘(1) Any loan for education or training for a 
substance use disorder treatment job. 
‘‘(2) Any loan under part E of title VIII (relat-
ing to nursing student loans). 
‘‘(3) Any Federal Direct Stafford Loan, Fed-
eral Direct PLUS Loan, or Federal Direct Unsub-
sidized Stafford Loan, or Federal Direct Consolida-
tion Loan (as such terms are used in section 455 of 
the Higher Education Act of 1965). 
‘‘(4) Any Federal Perkins Loan under part E 
of title I of the Higher Education Act of 1965. 
‘‘(5) Any other Federal loan as determined ap-
propriate by the Secretary.
243 
‘‘(d) PERIOD OF SERVICE.—The period of service re-
quired by an agreement under subsection (a) shall consist 
of up to 6 years of full-time employment, with no more 
than 1 year passing between any 2 years of covered em-
ployment, in a substance use disorder treatment job in the 
United States in— 
‘‘(1) a Mental Health Professional Shortage 
Area, as designated under section 332; or 
‘‘(2) a county (or a municipality, if not con-
tained within any county) where the mean drug 
overdose death rate per 100,000 people over the past 
3 years for which official data is available from the 
State, is higher than the most recent available na-
tional average overdose death rate per 100,000 peo-
ple, as reported by the Centers for Disease Control 
and Prevention. 
‘‘(e) INELIGIBILITY FOR DOUBLE BENEFITS.—No 
borrower may, for the same service, receive a reduction 
of loan obligations or a loan repayment under both— 
‘‘(1) this subsection; and 
‘‘(2) any Federally supported loan forgiveness 
program, including under section 338B, 338I, or 
846 of this Act, or section 428J, 428L, 455(m), or 
460 of the Higher Education Act of 1965. 
‘‘(f) BREACH.—
244 
‘‘(1) LIQUIDATED
DAMAGES
FORMULA.—The 
Secretary may establish a liquidated damages for-
mula to be used in the event of a breach of an 
agreement entered into under subsection (a). 
‘‘(2) LIMITATION.—The failure by an individual 
to complete the full period of service obligated pur-
suant to such an agreement, taken alone, shall not 
constitute a breach of the agreement, so long as the 
individual completed in good faith the years of serv-
ice for which payments were made to the individual 
under this section. 
‘‘(g) ADDITIONAL CRITERIA.—The Secretary— 
‘‘(1) may establish such criteria and rules to 
carry out this section as the Secretary determines 
are needed and in addition to the criteria and rules 
specified in this section; and 
‘‘(2) shall give notice to the committees speci-
fied in subsection (h) of any criteria and rules so es-
tablished. 
‘‘(h) REPORT TO CONGRESS.—Not later than 5 years 
after the date of enactment of the Substance Use Disorder 
Workforce Loan Repayment Act of 2018, and every other 
year thereafter, the Secretary shall prepare and submit 
to the Committee on Energy and Commerce of the House
245 
of Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report on— 
‘‘(1) the number and location of borrowers who 
have qualified for loan repayments under this sec-
tion; and 
‘‘(2) the impact of this section on the avail-
ability of substance use disorder treatment employ-
ees nationally and in shortage areas and counties de-
scribed in subsection (d). 
‘‘(i) DEFINITION.—In this section: 
‘‘(1) The term ‘municipality’ means a city, 
town, or other public body created by or pursuant to 
State law, or an Indian Tribe. 
‘‘(2) The term ‘substance use disorder treat-
ment job’ means a full-time job (including a fellow-
ship)— 
‘‘(A) where the primary intent and func-
tion of the job is the direct treatment or recov-
ery support of patients with or in recovery from 
a substance use disorder, such as a physician, 
physician assistant, registered nurse, nurse 
practitioner, advanced practice registered nurse, 
social worker, recovery coach, mental health 
counselor, addictions counselor, psychologist or 
other behavioral health professional, or any
246 
other relevant professional as determine by the 
Secretary; and 
‘‘(B) which is located at a substance use 
disorder treatment program, private physician 
practice, hospital or health system-affiliated in-
patient treatment center or outpatient clinic 
(including an academic medical center-affiliated 
treatment program), correctional facility or pro-
gram, youth detention center or program, inpa-
tient psychiatric facility, crisis stabilization 
unit, community health center, community men-
tal health or other specialty community behav-
ioral health center, recovery center, school, com-
munity-based organization, telehealth platform, 
migrant health center, health program or facil-
ity operated by a tribe or tribal organization, 
Federal medical facility, or any other facility as 
determined appropriate for purposes of this sec-
tion by the Secretary. 
‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$25,000,000 for each of fiscal years 2019 through 2028.’’.
247 
Subtitle I—Preventing Overdoses 
While in Emergency Rooms 
SEC. 7081. SHORT TITLE. 
This subtitle may be cited as the ‘‘Preventing 
Overdoses While in Emergency Rooms Act of 2018’’. 
SEC. 7082. PROGRAM TO SUPPORT EMERGENCY ROOM DIS-
CHARGE AND CARE COORDINATION FOR 
DRUG OVERDOSE PATIENTS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall establish a program (in this subtitle 
referred to as the ‘‘Program’’) to develop protocols for dis-
charging patients who have presented with a drug over-
dose and enhance the integration and coordination of care 
and treatment options for individuals with substance use 
disorder after discharge. 
(b) GRANT ESTABLISHMENT AND PARTICIPATION.— 
(1) IN
GENERAL.—In carrying out the Pro-
gram, the Secretary shall award grants on a com-
petitive basis to not more than 20 eligible entities 
described in paragraph (2). 
(2) ELIGIBILITY.— 
(A) IN
GENERAL.—To be eligible for a 
grant under this subsection, an entity shall 
be—
248 
(i) a health care site described in sub-
paragraph (B); or 
(ii) a health care site coordinator de-
scribed in subparagraph (C). 
(B) HEALTH CARE SITES.—To be eligible 
for a grant under this section, a health care site 
shall— 
(i) submit an application to the Sec-
retary at such time, in such manner, and 
containing such information as specified by 
the Secretary; 
(ii) have an emergency department; 
(iii)(I) have a licensed health care pro-
fessional onsite who has a waiver under 
section 303(g) of the Controlled Sub-
stances Act (21 U.S.C. 823(g)) to dispense 
or prescribe covered drugs; or 
(II) have a demonstrable plan to hire 
a sufficient number of full-time licensed 
health care professionals who have waivers 
described in subclause (I) to administer 
such treatment onsite; 
(iv) have in place an agreement with 
a sufficient number and range of entities 
certified under applicable State and Fed-
249 
eral law, such as pursuant to registration 
or a waiver under section 303(g) of the 
Controlled Substances Act (21 U.S.C. 
823(g)) or certification as described in sec-
tion 8.2 of title 42 of the Code of Federal 
Regulations, to provide treatment for sub-
stance use disorder such that the entity or 
the resulting network of entities with an 
agreement with the hospital cumulatively 
are capable of providing all evidence-based 
services for the treatment of substance use 
disorder, as medically appropriate for the 
individual involved, including— 
(I) 
medication-assisted 
treat-
ment; 
(II) withdrawal and detoxifica-
tion services that include patient eval-
uation, stabilization, and readiness for 
and entry into treatment; and 
(III) counseling; 
(v) deploy onsite peer recovery special-
ists to help connect patients with treat-
ment and recovery support services; and
250 
(vi) include the provision of overdose 
reversal medication in discharge protocols 
for opioid overdose patients. 
(C) HEALTH CARE SITE COORDINATORS.— 
To be eligible for a grant under this section, a 
health care site coordinator shall— 
(i) be an organization described in 
section 501(c)(3) of the Internal Revenue 
Code of 1986 (and exempt from tax under 
section 501(a) of such Code) or a State, 
local, or Tribal government; 
(ii) submit an application to the Sec-
retary at such time, in such manner, and 
containing such information as specified by 
the Secretary; and 
(iii) have an agreement with multiple 
eligible health care sites described in sub-
paragraph (B). 
(3) PREFERENCE.—In awarding grants under 
this section, the Secretary may give preference to eli-
gible entities described in paragraph (2) that meet 
either or both of the following criteria: 
(A) The eligible health care site is, or the 
eligible health care site coordinator has an 
agreement described in paragraph (2)(C)(iii)
251 
with a site that is, a critical access hospital (as 
defined in section 1861(mm)(1) of the Social 
Security Act (42 U.S.C. 1395x(mm)(1))), a 
low-volume hospital (as defined in section 
1886(d)(12)(C)(i) of such Act (42 U.S.C. 
1395ww(d)(12)(C)(i))), or a sole community 
hospital 
(as 
defined 
in 
section 
1886(d)(5)(D)(iii) of such Act (42 U.S.C. 
1395ww(d)(5)(D)(iii))). 
(B) The eligible health care site or the eli-
gible health care site coordinator is located in 
a geographic area with a drug overdose rate 
that is higher than the national rate, or in a ge-
ographic area with a rate of emergency depart-
ment visits for overdoses that is higher than the 
national rate, as determined by the Secretary 
based on the most recent data from the Centers 
for Disease Control and Prevention. 
(4) MEDICATION-ASSISTED
TREATMENT
DE-
FINED.—For purposes of this section, the term 
‘‘medication-assisted treatment’’ means the use of a 
drug approved under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
a biological product licensed under section 351 of 
the Public Health Service Act (42 U.S.C. 262), in
252 
combination with behavioral health services, to pro-
vide an individualized approach to the treatment of 
substance use disorders, including opioid use dis-
orders. 
(c) PERIOD OF GRANT.—A grant awarded to an eligi-
ble entity under this section shall be for a period of at 
least 2 years. 
(d) GRANT USES.— 
(1) REQUIRED USES.—A grant awarded under 
this section to an eligible entity shall be used for 
both of the following purposes: 
(A) To establish policies and procedures 
that address the provision of overdose reversal 
medication, prescription and dispensing of 
medication-assisted treatment to an emergency 
department patient who has had a non-fatal 
overdose or who is at risk of a drug overdose, 
and the subsequent referral to evidence-based 
treatment upon discharge for patients who have 
experienced a non-fatal drug overdose or who 
are at risk of a drug overdose. 
(B) To develop best practices for treating 
non-fatal drug overdoses, including with respect 
to care coordination and integrated care models 
for long term treatment and recovery options
253 
for individuals who have experienced a non-fatal 
drug overdose. 
(2) ADDITIONAL PERMISSIBLE USES.—A grant 
awarded under this section to an eligible entity may 
be used for any of the following purposes: 
(A) To hire emergency department peer re-
covery specialists; counselors; therapists; social 
workers; or other licensed medical professionals 
specializing in the treatment of substance use 
disorder. 
(B) To establish integrated models of care 
for individuals who have experienced a non-fatal 
drug overdose which may include patient as-
sessment, follow up, and transportation to 
treatment facilities. 
(C) To provide for options for increasing 
the availability and access of medication-as-
sisted treatment and other evidence-based treat-
ment for individuals with substance use dis-
orders. 
(D) To offer consultation with and referral 
to other supportive services that help in treat-
ment and recovery. 
(e) REPORTING REQUIREMENTS.—
254 
(1) REPORTS BY GRANTEES.—Each eligible en-
tity awarded a grant under this section shall submit 
to the Secretary an annual report for each year for 
which the entity has received such grant that in-
cludes information on— 
(A) the number of individuals treated at 
the site (or, in the case of an eligible health 
care site coordinator, at sites covered by the 
agreement 
referred 
to 
in 
subsection 
(b)(2)(C)(iii)) for non-fatal overdoses in the 
emergency department; 
(B) the number of individuals administered 
each medication-assisted treatment at such site 
or sites in the emergency department; 
(C) the number of individuals referred by 
such site or sites to other treatment facilities 
after a non-fatal overdose, the types of such 
other facilities, and the number of such individ-
uals admitted to such other facilities pursuant 
to such referrals; 
(D) the frequency and number of patient 
readmissions for non-fatal overdoses and sub-
stance use disorder; 
(E) for what the grant funding was used; 
and
255 
(F) the effectiveness of, and any other rel-
evant additional data regarding, having an on-
site health care professional to administer and 
begin medication-assisted treatment for sub-
stance use disorders. 
(2) REPORT BY SECRETARY.—Not less than 1 
year after the conclusion of the Program, the Sec-
retary shall submit to Congress a report that in-
cludes— 
(A) findings of the Program; 
(B) overall patient outcomes under the 
Program, such as with respect to hospital read-
mission; 
(C) what percentage of patients treated by 
a site funded through a grant under this section 
were readmitted to a hospital for non-fatal or 
fatal overdose; 
(D) an evaluation determining the effec-
tiveness of having a practitioner onsite to ad-
minister and begin medication-assisted treat-
ment for substance use disorder; and 
(E) a compilation of voluntary guidelines 
and best practices from the reports submitted 
under paragraph (1).
256 
(f) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated to carry out this subtitle 
$50,000,000 for the period of fiscal years 2019 through 
2023. 
Subtitle J—Alternatives to Opioids 
in the Emergency Department 
SEC. 7091. SHORT TITLE. 
This subtitle may be cited as the ‘‘Alternatives to 
Opioids in the Emergency Department Act’’ or the 
‘‘ALTO Act’’. 
SEC. 7092. EMERGENCY DEPARTMENT ALTERNATIVES TO 
OPIOIDS DEMONSTRATION PROGRAM. 
(a) DEMONSTRATION PROGRAM GRANTS.—The Sec-
retary of Health and Human Services (in this section re-
ferred to as the ‘‘Secretary’’) shall carry out a demonstra-
tion program under which the Secretary shall award 
grants to hospitals and emergency departments, including 
freestanding emergency departments, to develop, imple-
ment, enhance, or study alternative pain management pro-
tocols and treatments that limit the use and prescription 
of opioids in emergency departments. 
(b) ELIGIBILITY.—To be eligible to receive a grant 
under subsection (a), a hospital or emergency department 
shall submit an application to the Secretary at such time,
257 
in such manner, and containing such information as the 
Secretary may require. 
(c) GEOGRAPHIC DIVERSITY.—In awarding grants 
under this section, the Secretary shall seek to ensure geo-
graphical diversity among grant recipients. 
(d) USE OF FUNDS.—Grants under subsection (a) 
shall be used to— 
(1) target common painful conditions, such as 
renal colic, sciatica, headaches, musculoskeletal pain, 
and extremity fractures; 
(2) train providers and other hospital personnel 
on protocols and the use of treatments that limit the 
use and prescription of opioids in the emergency de-
partment; and 
(3) provide alternatives to opioids to patients 
with painful conditions, not including patients who 
present with pain related to cancer, end-of-life symp-
tom palliation, or complex multisystem trauma. 
(e) CONSULTATION.—The Secretary shall implement 
a process for recipients of grants under subsection (a) to 
consult (in a manner that allows for sharing of evidence- 
based best practices) with each other and with persons 
having robust knowledge, including emergency depart-
ments and physicians that have successfully deployed al-
ternative pain management protocols, such as non-drug
258 
approaches studied through the National Center for Com-
plimentary and Integrative Health including acupuncture 
that limit the use of opioids. The Secretary shall offer to 
each recipient of a grant under subsection (a) technical 
support as necessary. 
(f) REPORT TO THE SECRETARY.—Each recipient of 
a grant under this section shall submit to the Secretary 
(during the period of such grant) annual reports on the 
progress of the program funded through the grant. These 
reports shall include, in accordance with State and Fed-
eral statutes and regulations regarding disclosure of pa-
tient information— 
(1) a description of and specific information 
about the alternative pain management protocols 
employed; 
(2) data on the alternative pain management 
protocols and treatments employed, including— 
(A) during a baseline period before the 
program began, as defined by the Secretary; 
(B) at various stages of the program, as 
determined by the Secretary; and 
(C) the conditions for which the alternative 
pain management protocols and treatments 
were employed;
259 
(3) the success of each specific alternative pain 
management protocol; 
(4) data on the opioid prescriptions written, in-
cluding— 
(A) during a baseline period before the 
program began, as defined by the Secretary; 
(B) at various stages of the program, as 
determined by the Secretary; and 
(C) the conditions for which the opioids 
were prescribed; 
(5) the demographic characteristics of patients 
who were treated with an alternative pain manage-
ment protocol, including age, sex, race, ethnicity, 
and insurance status and type; 
(6) data on patients who were eventually pre-
scribed opioids after alternative pain management 
protocols and treatments were employed; and 
(7) any other information the Secretary deems 
necessary. 
(g) REPORT TO CONGRESS.—Not later than 1 year 
after completion of the demonstration program under this 
section, the Secretary shall submit a report to the Con-
gress on the results of the demonstration program and in-
clude in the report—
260 
(1) the number of applications received and the 
number funded; 
(2) a summary of the reports described in sub-
section (f), including standardized data; and 
(3) recommendations for broader implementa-
tion of pain management protocols that limit the use 
and prescription of opioids in emergency depart-
ments or other areas of the health care delivery sys-
tem. 
(h) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$10,000,000 for each of fiscal years 2019 through 2021. 
Subtitle K—Stop Counterfeit Drugs 
by Regulating and Enhancing 
Enforcement Now 
SEC. 7101. SHORT TITLE. 
This subtitle may be cited as the ‘‘Stop Counterfeit 
Drugs by Regulating and Enhancing Enforcement Now 
Act’’ or the ‘‘SCREEN Act’’. 
SEC. 7102. DETENTION, REFUSAL, AND DESTRUCTION OF 
DRUGS OFFERED FOR IMPORTATION. 
(a) INCREASING THE MAXIMUM DOLLAR AMOUNT OF 
DRUGS SUBJECT TO DESTRUCTION.—The sixth sentence 
in section 801(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381(a)) is amended by striking ‘‘ex-
261 
cept that the Secretary’’ and all that follows through the 
two periods at the end and inserting ‘‘except that the Sec-
retary of Health and Human Services may destroy, with-
out the opportunity for export, any drug refused admission 
under this section, if such drug is declared 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 regu-
lation pursuant to section 498(a)(1) of the Tariff Act of 
1930 or such higher amount as the Commissioner of Food 
and Drugs may set based on a finding by the Commis-
sioner that the higher amount is in the interest of public 
health), or if such drug is entering the United States by 
mail, and was not brought into compliance as described 
under subsection (b).’’. 
(b) DESTRUCTION OF ARTICLES OF CONCERN.—The 
sixth sentence of section 801(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(a)), as amended 
by subsection (a), is further amended by inserting before 
the period at the end the following: ‘‘; and the Secretary 
of Health and Human Services may destroy, without the 
opportunity for export, any article refused admission 
under clause (6) of the third sentence of this subsection’’. 
(c) TECHNICAL AMENDMENTS.—The seventh, eighth, 
and ninth sentences of section 801(a) of the Federal Food,
262 
Drug, and Cosmetic Act (21 U.S.C. 381(a)) are amend-
ed— 
(1) by striking ‘‘a drug’’ each place it appears 
and inserting ‘‘an article’’; and 
(2) by striking ‘‘the drug’’ each place it appears 
and inserting ‘‘the article’’. 
(d) RULE OF CONSTRUCTION.—The last sentence in 
section 801(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 381(a)) is amended to read as follows: 
‘‘Clauses (2), (5), and (6) of the third sentence of this 
subsection shall not be construed to prohibit the admission 
of narcotic or nonnarcotic drugs or other substances, the 
importation of which is permitted under the Controlled 
Substances Import and Export Act.’’. 
SEC. 7103. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED DRUG 
PRODUCTS. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(eee) The failure to comply with any order issued 
under section 569D.’’. 
(b) NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED DRUGS.—Subchapter 
E of chapter V of the Federal Food, Drug, and Cosmetic
263 
Act (21 U.S.C. 360bbb et seq.) is amended by adding at 
the end the following: 
‘‘SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RE-
CALL OF ADULTERATED OR MISBRANDED 
DRUGS. 
‘‘(a) ORDER TO CEASE DISTRIBUTION
AND RE-
CALL.— 
‘‘(1) IN GENERAL.—Upon a determination that 
the use or consumption of, or exposure to, a drug 
may present an imminent or substantial hazard to 
the public health, the Secretary shall issue an order 
requiring any person who distributes the drug to im-
mediately cease distribution of the drug. 
‘‘(2) HEARING.—An order under paragraph (1) 
shall provide the person subject to the order with an 
opportunity for an informal hearing, to be held not 
later than 10 days after the date of issuance of the 
order, on— 
‘‘(A) the actions required by the order; and 
‘‘(B) whether the order should be amended 
to require a recall of the drug. 
‘‘(3) INADEQUATE
GROUNDS.—If, after pro-
viding an opportunity for a hearing under paragraph 
(2), the Secretary determines that inadequate
264 
grounds exist to support the actions required by the 
order, the Secretary shall vacate the order. 
‘‘(4) AMENDMENT TO ORDER TO REQUIRE RE-
CALL.—If, after providing an opportunity for an in-
formal hearing under paragraph (2), the Secretary 
determines that the order should be amended to in-
clude a recall of the drug with respect to which the 
order was issued, the Secretary shall— 
‘‘(A) amend the order to require a recall; 
and 
‘‘(B) after consultation with the drug 
sponsor, specify a timetable in which the recall 
will occur. 
‘‘(5) NOTICE
TO
PERSONS
AFFECTED.—An 
order under this subsection shall require any person 
who distributes the drug to provide for notice, in-
cluding to individuals as appropriate, to persons who 
may be affected by the order to cease distribution of 
or recall the drug, as applicable. 
‘‘(6) ACTION FOLLOWING ORDER.—Any person 
who is subject to an order under paragraph (1) or 
(4) shall immediately cease distribution of or recall, 
as applicable, the drug and provide notification as 
required by such order.
265 
‘‘(b) NOTICE TO CONSUMERS AND HEALTH OFFI-
CIALS.—The Secretary shall, as the Secretary determines 
to be necessary, provide notice of a recall order under this 
section to— 
‘‘(1) consumers to whom the drug was, or may 
have been, distributed; and 
‘‘(2) appropriate State and local health officials. 
‘‘(c) ORDER TO RECALL.— 
‘‘(1) CONTENTS.—An order to recall a drug 
under subsection (a) shall— 
‘‘(A) require periodic reports to the Sec-
retary describing the progress of the recall; and 
‘‘(B) provide for notice, including to indi-
viduals as appropriate, to persons who may be 
affected by the recall. 
‘‘(2) ASSISTANCE ALLOWED.—In providing for 
notice under paragraph (1)(B), the Secretary may 
allow for the assistance of health professionals, State 
or local officials, or other individuals designated by 
the Secretary. 
‘‘(3) NONDELEGATION.—An order under this 
section shall be ordered by the Secretary or an offi-
cial designated by the Secretary. An official may not 
be so designated under this section unless the offi-
cial is the Director of the Center for Drug Evalua-
266 
tion and Research, is an official senior to such Di-
rector, or is so designated by such Director. 
‘‘(d) SAVINGS CLAUSE.—Nothing contained in this 
section shall be construed as limiting— 
‘‘(1) the authority of the Secretary to issue an 
order to cease distribution of, or to recall, an drug 
under any other provision of this Act or the Public 
Health Service Act; or 
‘‘(2) the ability of the Secretary to request any 
person to perform a voluntary activity related to any 
drug subject to this Act or the Public Health Service 
Act.’’. 
(c) DRUGS SUBJECT TO REFUSAL.—The third sen-
tence of subsection (a) of section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381) is amended by 
inserting ‘‘or (5) in the case of a drug, such drug is sub-
ject to an order under section 568 to cease distribution 
of or recall the drug,’’ before ‘‘then such article shall be 
refused admission’’. 
(d) APPLICATION.—Sections 301(eee) and 569D of 
the Federal Food, Drug, and Cosmetic Act, as added by 
subsections (a) and (b), shall apply with respect to a drug 
as of such date, not later than 1 year after the date of 
the enactment of this Act, as the Secretary of Health and 
Human Services shall specify.
267 
SEC. 7104. SINGLE SOURCE PATTERN OF SHIPMENTS OF 
ADULTERATED OR MISBRANDED DRUGS. 
Section 801 of the Federal Food, Drug, and Cosmetic 
Act is amended by adding at the end the following: 
‘‘(t) SINGLE SOURCE PATTERN OF SHIPMENTS OF 
ADULTERATED
OR MISBRANDED DRUGS.—If the Sec-
retary identifies a pattern of adulterated or misbranded 
drugs being offered for import from the same manufac-
turer, distributor, or importer, the Secretary may by order 
choose to treat all drugs being offered for import from 
such manufacturer, distributor, or importer as adulterated 
or misbranded unless otherwise demonstrated.’’. 
SEC. 7105. FUND TO STRENGTHEN EFFORTS OF FDA TO 
COMBAT THE OPIOID AND SUBSTANCE USE 
EPIDEMIC. 
Chapter X of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 1015. FUND TO STRENGTHEN EFFORTS OF FDA TO 
COMBAT THE OPIOID AND SUBSTANCE USE 
EPIDEMIC. 
‘‘(a) IN GENERAL.—The Commissioner of Food and 
Drugs shall use any funds appropriated pursuant to the 
authorization of appropriations under subsection (c) to 
carry out the programs and activities described in sub-
section (d) to strengthen and facilitate the Food and Drug
268 
Administration’s efforts to address the opioid and sub-
stance use epidemic. Such funds shall be in addition to 
any funds which are otherwise available to carry out such 
programs and activities. 
‘‘(b) FDA OPIOID AND SUBSTANCE USE EPIDEMIC 
RESPONSE FUND.— 
‘‘(1) ESTABLISHMENT OF FUND.—There is es-
tablished in the Treasury a fund, to be known as the 
FDA Opioid and Substance Use Epidemic Response 
Fund (referred to in this subsection as the ‘Fund’), 
for purposes of funding the programs and activities 
described in subsection (d). 
‘‘(2) TRANSFER.—For the period of fiscal years 
2019 through 2023, $110,000,000 shall be trans-
ferred to the Fund from the general fund of the 
Treasury. 
‘‘(3) AMOUNTS
DEPOSITED.—Any amounts 
transferred under paragraph (2) shall remain un-
available in the Fund until such amounts are appro-
priated pursuant to subsection (c). 
‘‘(c) APPROPRIATIONS.— 
‘‘(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
For the period of fiscal years 2019 through 2023, 
there is authorized to be appropriated from the 
Fund to the Food and Drug Administration, for the
269 
purpose of carrying out the programs and activities 
described in subsection (d), an amount not to exceed 
the total amount transferred to the Fund under sub-
section (b)(2). Notwithstanding subsection (g), such 
funds shall remain available until expended. 
‘‘(2) OFFSETTING FUTURE APPROPRIATIONS.— 
For any of fiscal years 2019 through 2023, for any 
discretionary appropriation out of the Fund to the 
Food and Drug Administration pursuant to the au-
thorization of appropriations under paragraph (1) 
for the purpose of carrying out the programs and 
activities described in subsection (d), the total 
amount of such appropriations for the applicable fis-
cal year (not to exceed the total amount remaining 
in the Fund) shall be subtracted from the estimate 
of discretionary budget authority and the resulting 
outlays for any estimate under the Congressional 
Budget and Impoundment Control Act of 1974 or 
the Balanced Budget and Emergency Deficit Control 
Act of 1985, and the amount transferred to the 
Fund shall be reduced by the same amount. 
‘‘(d) FOOD AND DRUG ADMINISTRATION.—The en-
tirety of the funds made available pursuant to subsection 
(c)(1) shall be for the Commissioner of Food and Drugs, 
pursuant to applicable authorities in the Public Health
270 
Service Act (42 U.S.C. 201 et seq.) or this Act and other 
applicable Federal law, to support widespread innovation 
in non-opioid and non-addictive medical products for pain 
treatment, access to opioid addiction treatments, appro-
priate use of approved opioids, and efforts to reduce illicit 
importation of opioids. Such support may include the fol-
lowing programs and activities: 
‘‘(1) Obligating contract funds beginning in fis-
cal year 2019 for an educational campaign that 
will— 
‘‘(A) educate patients and their families to 
differentiate opioid medications; 
‘‘(B) raise awareness about preferred stor-
age and disposal methods; and 
‘‘(C) inform patients, families, and commu-
nities about medication-assisted treatment op-
tions. 
‘‘(2) Building the Food and Drug Administra-
tion’s presence in international mail facilities, includ-
ing through— 
‘‘(A) improvements in equipment and in-
formation technology enhancements to identify 
unapproved, counterfeit, or other unlawful 
pharmaceuticals for destruction; 
‘‘(B) increased and improved surveillance;
271 
‘‘(C) renovations at international mail fa-
cility locations; and 
‘‘(D) the purchase of laboratory equip-
ment. 
‘‘(3) Enhancing the identification and targeting 
of entities offering products and products being of-
fered by such entities for import into the United 
States through review and analysis of Internet 
websites, import data, and other sources of intel-
ligence for purposes of making the best use of the 
Food and Drug Administration’s inspection and ana-
lytical resources. 
‘‘(4) Increasing the number of staff of the Food 
and Drug Administration to increase the number of 
packages being examined, ensuring the safety of the 
staff undertaking such examinations, and ensuring 
that packages identified as illegal, counterfeit, mis-
branded, or adulterated are removed from commerce 
through available authorities, including administra-
tive destruction. 
‘‘(5) Enhancing the Food and Drug Adminis-
tration’s criminal investigations resources (including 
full-time equivalent employees and equipment), im-
ports surveillance, and international work.
272 
‘‘(6) Obtaining for the Food and Drug Admin-
istration equipment and full-time equivalent employ-
ees needed to efficiently screen and analyze products 
offered for import, including by building data librar-
ies of new substances and analogues to facilitate 
identification and evaluation of pharmaceutical- 
based agents and by purchasing screening tech-
nologies for use at international mail facilities. 
‘‘(7) Operating the Food and Drug Administra-
tion’s forensic laboratory facility to ensure adequate 
laboratory space and functionality for additional 
work and full-time equivalent employees. 
‘‘(e) ACCOUNTABILITY AND OVERSIGHT.— 
‘‘(1) WORK PLAN.— 
‘‘(A) IN
GENERAL.—Not later than 180 
days after the date of enactment of this Act, 
the Commissioner of Food and Drugs shall sub-
mit to the Committee on Health, Education, 
Labor and Pensions of the Senate and the 
Committee on Energy and Commerce of the 
House of Representatives, a work plan includ-
ing the proposed allocation of funds appro-
priated pursuant to the authorization of appro-
priations under subsection (c) for each of fiscal
273 
years 2019 through 2023 and the contents de-
scribed in subparagraph (B). 
‘‘(B) CONTENTS.—The work plan sub-
mitted under subparagraph (A) shall include— 
‘‘(i) the amount of money to be obli-
gated or expended out of the Fund in each 
fiscal year for each program and activity 
described in subsection (d); and 
‘‘(ii) a description and justification of 
each such program and activity. 
‘‘(2) REPORTS.— 
‘‘(A) ANNUAL REPORTS.—Not later than 
October 1 of each of fiscal years 2020 through 
2024, the Secretary of Health and Human 
Services shall submit to the Committee on 
Health, Education, Labor and Pensions of the 
Senate and the Committee on Energy and Com-
merce of the House of Representatives a report 
that includes— 
‘‘(i) the amount of money obligated or 
expended out of the Fund in the prior fis-
cal year for each program and activity de-
scribed in subsection (d); 
‘‘(ii) a description of all programs and 
activities using funds provided pursuant to
274 
the authorization of appropriations under 
subsection (c); and 
‘‘(iii) how the programs and activities 
are advancing public health. 
‘‘(B) ADDITIONAL REPORTS.—At the re-
quest of the Committee on Health, Education, 
Labor and Pensions of the Senate or the Com-
mittee on Energy and Commerce of the House 
of Representatives, the Commissioner shall pro-
vide an update in the form of testimony and 
any additional reports to the respective congres-
sional committee regarding the allocation of 
funding under this section or the description of 
the programs and activities undertaken with 
such funding. 
‘‘(f) LIMITATIONS.—Notwithstanding any transfer 
authority authorized by this section or any appropriations 
Act, any funds made available pursuant to the authoriza-
tion of appropriations under subsection (c) may not be 
used for any purpose other than the programs and activi-
ties described in subsection (d) to strengthen and facilitate 
the Food and Drug Administration’s efforts to address the 
opioid and substance use epidemic. 
‘‘(g) SUNSET.—This section shall expire on Sep-
tember 30, 2022, except that—
275 
‘‘(1) this subsection does not apply to reporting 
under subsection (e)(2); and 
‘‘(2) this section shall remain in effect until 
such time, and to such extent, as may be necessary 
for the funds transferred by subsection (b)(2) to be 
fully expended.’’. 
SEC. 7106. CONSIDERATION OF POTENTIAL FOR MISUSE 
AND 
ABUSE 
REQUIRED 
FOR 
DRUG 
AP-
PROVAL. 
(a) IN GENERAL.—Section 505(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) is 
amended— 
(1) in the first sentence— 
(A) by striking ‘‘or (7)’’ and inserting 
‘‘(7)’’; and 
(B) by inserting ‘‘or (8) if the drug is or 
contains a controlled substance for which a list-
ing in any schedule is in effect under the Con-
trolled Substances Act or that is permanently 
scheduled pursuant to section 201 of such Act, 
on the basis of information submitted to him as 
part of the application, or upon the basis of any 
other information before him with respect to 
such drug, the drug is unsafe for use due to the 
risks of abuse or misuse or there is insufficient
276 
information to show that the drug is safe for 
use considering such risks;’’ before ‘‘he shall 
issue an order refusing to approve the applica-
tion’’; and 
(2) in the second sentence, by striking ‘‘(6)’’ 
and inserting ‘‘(8)’’. 
(b) WITHDRAWAL AUTHORITY.—Section 505(e) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(e)) is amended in the first sentence— 
(1) by striking ‘‘or (5)’’ and inserting ‘‘(5)’’; 
and 
(2) by inserting the following: ‘‘; or (6) that, in 
the case of a drug that is or contains a controlled 
substance for which a listing in any schedule is in 
effect under the Controlled Substances Act or that 
is permanently scheduled pursuant to section 201 of 
such Act, on the basis of new information before him 
with respect to such drug, evaluated together with 
the information available to him when the applica-
tion was approved, that the drug is unsafe for use 
due to the risks of abuse or misuse’’ after ‘‘of a ma-
terial fact’’. 
(c) RULE
OF
CONSTRUCTION.—Nothing in the 
amendments made by this section shall be construed to 
limit or narrow, in any manner, the meaning or applica-
277 
tion of the provisions of paragraphs (1), (2), (3), (4), (5), 
and (7) of section 505(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(d)) or paragraphs (1) and 
(2) of section 505(e) of such Act (21 U.S.C. 355(e)). 
Subtitle L—Treatment, Education, 
and Community Help to Combat 
Addiction 
SEC. 7111. SHORT TITLE. 
This subtitle may be cited as the ‘‘Treatment, Edu-
cation, and Community Help to Combat Addiction Act of 
2018’’ or the ‘‘TEACH to Combat Addiction Act of 
2018’’. 
SEC. 7112. ESTABLISHMENT OF REGIONAL CENTERS OF EX-
CELLENCE IN SUBSTANCE USE DISORDER 
EDUCATION. 
Part D of title V of the Public Health Service Act 
is amended by inserting after section 549 (42 U.S.C. 
290ee–4) the following new section: 
‘‘SEC. 550. REGIONAL CENTERS OF EXCELLENCE IN SUB-
STANCE USE DISORDER EDUCATION. 
‘‘(a) IN GENERAL.—The Secretary, in consultation 
with such other agencies as are appropriate, shall, subject 
to the availability of appropriations, establish a solicitation 
process and award cooperative agreements to eligible enti-
ties for the designation of such entities as Regional Cen-
278 
ters of Excellence in Substance Use Disorder Education 
and support of such regional centers of excellence to en-
hance and improve how health professionals are educated 
in substance use disorder prevention, treatment, and re-
covery through development, evaluation, and distribution 
of evidence-based curricula for health profession schools. 
An eligible entity designated by the Secretary as a Re-
gional Center of Excellence in Substance Use Disorder 
Education shall carry out the activities described in sub-
section (b). 
‘‘(b) SELECTION OF CENTERS OF EXCELLENCE.— 
‘‘(1) ELIGIBLE ENTITIES.—To be eligible to re-
ceive a cooperative agreement under subsection (a), 
an entity shall— 
‘‘(A) be an entity specified by the Sec-
retary that offers education to students in var-
ious health professions, which may include— 
‘‘(i) a health system; 
‘‘(ii) a teaching hospital; 
‘‘(iii) a medical school; 
‘‘(iv) a certified behavioral health clin-
ic; or 
‘‘(v) any other health profession 
school, school of public health, or Coopera-
tive Extension Program at institutions of
279 
higher education engaged in an aspect of 
the prevention, treatment, or recovery of 
substance use disorders; 
‘‘(B) be accredited by the appropriate edu-
cational accreditation body; 
‘‘(C) demonstrate an existing strategy, and 
have in place a plan for continuing such strat-
egy, or a proposed strategy to implement a cur-
riculum based on best practices for substance 
use disorder prevention, treatment, and recov-
ery; 
‘‘(D) demonstrate community engagement 
and participation through community partners, 
including other health profession schools, men-
tal health counselors, social workers, peer recov-
ery specialists, substance use treatment pro-
grams, community health centers, physicians’ 
offices, certified behavioral health clinics, law 
enforcement, and the business community; and 
‘‘(E) provide to the Secretary such infor-
mation, at such time, and in such manner, as 
the Secretary may require. 
‘‘(2) 
DIVERSITY.—In 
awarding 
cooperative 
agreements under subsection (a), the Secretary shall 
take into account regional differences among eligible
280 
entities and shall make an effort to ensure geo-
graphic diversity. 
‘‘(c) DISSEMINATION OF INFORMATION.— 
‘‘(1) PUBLIC
POSTING.—The Secretary shall 
make information provided to the Secretary under 
subsection (b)(1)(E) publically available on the 
Internet website of the Department of Health and 
Human Services. 
‘‘(2) EVALUATION.—The Secretary shall evalu-
ate each project carried out by a Regional Center of 
Excellence in Substance Use Disorder Education 
under this section and shall disseminate the findings 
with respect to each such evaluation to appropriate 
public and private entities. 
‘‘(d) FUNDING.—There is authorized to be appro-
priated to carry out this section, $4,000,000 for each of 
fiscal years 2019 through 2023.’’. 
Subtitle M—Guidance From Na-
tional Mental Health and Sub-
stance Use Policy Laboratory 
SEC. 7121. GUIDANCE FROM NATIONAL MENTAL HEALTH 
AND SUBSTANCE USE POLICY LABORATORY. 
Section 501A(b) of the Public Health Service Act (42 
U.S.C. 290aa–0(b)) is amended—
281 
(1) in paragraph (5), by striking ‘‘and’’ at the 
end; 
(2) in paragraph (6), by striking the period at 
the end and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(7) issue and periodically update guidance for 
entities applying for grants from the Substance 
Abuse and Mental Health Services Administration in 
order to— 
‘‘(A) encourage the funding of evidence- 
based practices; 
‘‘(B) encourage the replication of prom-
ising or effective practices; and 
‘‘(C) inform applicants on how to best ar-
ticulate the rationale for the funding of a pro-
gram or activity.’’. 
Subtitle N—Comprehensive Opioid 
Recovery Centers 
SEC. 7131. SHORT TITLE. 
This subtitle may be cited as the ‘‘Comprehensive 
Opioid Recovery Centers Act of 2018’’. 
SEC. 7132. COMPREHENSIVE OPIOID RECOVERY CENTERS. 
(a) IN GENERAL.—Part D of title V of the Public 
Health Service Act is amended by adding at the end the 
following new section:
282 
‘‘SEC. 550. COMPREHENSIVE OPIOID RECOVERY CENTERS. 
‘‘(a) IN
GENERAL.—The Secretary shall award 
grants on a competitive basis to eligible entities to estab-
lish or operate a comprehensive opioid recovery center (re-
ferred to in this section as a ‘Center’). 
‘‘(b) GRANT PERIOD.— 
‘‘(1) IN
GENERAL.—A grant awarded under 
subsection (a) shall be for a period not less than 3 
years and not more than 5 years. 
‘‘(2) RENEWAL.—A grant awarded under sub-
section (a) may be renewed, on a competitive basis, 
for additional periods of time, as determined by the 
Secretary. In determining whether to renew a grant 
under this paragraph, the Secretary shall consider 
the data submitted under subsection (h). 
‘‘(c) MINIMUM NUMBER
OF CENTERS.—The Sec-
retary shall allocate the amounts made available under 
subsection (i) in such amounts that not fewer than 10 
Centers will be established across the United States. 
‘‘(d) APPLICATION.—In order to be eligible for a 
grant under subsection (a), an entity shall submit an ap-
plication to the Secretary at such time and in such manner 
as the Secretary may require. Such application shall in-
clude—
283 
‘‘(1) evidence that such entity carries out, or is 
capable of coordinating with other entities to carry 
out, the activities described in subsection (g); and 
‘‘(2) such other information as the Secretary 
may require. 
‘‘(e) PRIORITY.—In awarding grants under sub-
section (a), the Secretary shall give priority to eligible enti-
ties located in a State or Indian country (as defined in 
section 1151 of title 18, United States Code)— 
‘‘(1) with a high per capita drug overdose mor-
tality rate, as determined by the Director of the 
Centers for Disease Control and Prevention; or 
‘‘(2) based on any other criteria or need, as de-
termined by the Secretary. 
‘‘(f) USE
OF GRANT FUNDS.—An eligible entity 
awarded a grant under subsection (a) shall use the grant 
funds to establish or operate a Center to carry out the 
activities described in subsection (g). 
‘‘(g) CENTER ACTIVITIES
AND SERVICES.—Each 
Center shall, at a minimum, carry out the activities de-
scribed in this subsection. In the case of a Center that 
determines that a service described in paragraph (2) can-
not reasonably be carried out by the Center, such Center 
shall contract with such other entities as may be necessary
284 
to ensure that patients have access to the full range of 
services described in such paragraph. 
‘‘(1) COMMUNITY
OUTREACH.—Each Center 
shall carry out the following outreach activities: 
‘‘(A) Train and supervise outreach staff to 
work with schools, workplaces, faith-based orga-
nizations, State and local health departments, 
law enforcement, and first responders to ensure 
that such institutions are aware of the services 
of the Center. 
‘‘(B) Disseminate and make available on-
line evidence-based resources that educate pro-
fessionals and the public on opioid use disorder 
and other substance use disorders. 
‘‘(2) TREATMENT AND RECOVERY SERVICES.— 
Each Center shall provide the following treatment 
and recovery services: 
‘‘(A) Ensure that intake evaluations meet 
the clinical needs of patients. 
‘‘(B) Periodically conduct patient assess-
ments to ensure continued and meaningful re-
covery, as defined by the Assistant Secretary 
for Mental Health and Substance Use. 
‘‘(C) Provide the full continuum of treat-
ment services, including—
285 
‘‘(i) all drugs approved under section 
505 of the Federal Food, Drug, and Cos-
metic Act and all biological products li-
censed under section 351 of this Act, in-
cluding methadone, to treat substance use 
disorders, including opioid use disorder 
and alcohol use disorder; 
‘‘(ii) withdrawal management, which 
shall include medically supervised detoxi-
fication that includes patient evaluation, 
stabilization, and readiness for and entry 
into treatment; 
‘‘(iii) counseling and case manage-
ment, including counseling and recovery 
services for any possible co-occurring men-
tal illness; 
‘‘(iv) residential rehabilitation; 
‘‘(v) recovery housing; 
‘‘(vi) community-based and peer re-
covery support services; 
‘‘(vii) job training and placement as-
sistance to support reintegration into the 
workforce; and 
‘‘(viii) other best practices, as deter-
mined by the Secretary.
286 
‘‘(D) Administer an onsite pharmacy and 
provide toxicology services. 
‘‘(E) Establish and operate a secure and 
confidential electronic health information sys-
tem. 
‘‘(F) Offer family support services such as 
child care, family counseling, and parenting 
interventions to help stabilize families impacted 
by substance use disorder. 
‘‘(h) DATA
REPORTING
AND
PROGRAM
OVER-
SIGHT.—With respect to a grant awarded under sub-
section (a) to an eligible entity for a Center, not later than 
90 days after the end of the first year of the grant period, 
and annually thereafter for the duration of the grant pe-
riod (including the duration of any renewal period for such 
grant), the entity shall submit data, as appropriate, to the 
Secretary regarding— 
‘‘(1) the programs and activities funded by the 
grant; 
‘‘(2) health outcomes of individuals with a sub-
stance use disorder who received services from the 
Center; 
‘‘(3) the effectiveness of interventions designed, 
tested, and evaluated by the Center; and
287 
‘‘(4) any other information that the Secretary 
may require for the purpose of— 
‘‘(A) evaluating the effectiveness of the 
Center; and 
‘‘(B) ensuring that the Center is complying 
with all the requirements of the grant, including 
providing the full continuum of services de-
scribed in subsection (g)(2)(C) and providing 
drugs and devices for overdose reversal under 
such subsection. 
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated $10,000,000 for each of fis-
cal years 2019 through 2023 for purposes of carrying out 
this section.’’. 
(b) REPORTS TO CONGRESS.— 
(1) PRELIMINARY REPORT.—Not later than 3 
years after the date of the enactment of this Act, the 
Secretary of Health and Human Services shall sub-
mit to Congress a preliminary report that analyzes 
data submitted under section 550(h) of the Public 
Health Service Act, as added by subsection (a). 
(2) FINAL
REPORT.—Not later than 1 year 
after submitting the preliminary report required 
under paragraph (1), the Secretary of Health and
288 
Human Services shall submit to Congress a final re-
port that includes— 
(A) an evaluation of the effectiveness of 
comprehensive opioid recovery centers estab-
lished or operated pursuant to section 550 of 
the Public Health Service Act, as added by sub-
section (a); 
(B) recommendations on whether the grant 
program established under such section 550 
should be reauthorized and expanded; and 
(C) standards and best practices for the 
treatment of substance use disorders, as identi-
fied through such grant program. 
Subtitle O—Poison Center Network 
Enhancement 
SEC. 7141. SHORT TITLE. 
This subtitle may be cited as the ‘‘Poison Center Net-
work Enhancement Act of 2018’’. 
SEC. 7142. REAUTHORIZATION OF POISON CONTROL CEN-
TERS NATIONAL TOLL-FREE NUMBER. 
Section 1271 of the Public Health Service Act (42 
U.S.C. 300d–71) is amended to read as follows:
289 
‘‘SEC. 1271. ESTABLISHMENT AND MAINTENANCE OF THE 
NATIONAL 
TOLL-FREE 
NUMBER 
AND 
EN-
HANCED COMMUNICATIONS CAPABILITIES. 
‘‘(a) IN GENERAL.—The Secretary shall provide co-
ordination and assistance to poison control centers for— 
‘‘(1) the development, establishment, implemen-
tation, and maintenance of a nationwide toll-free 
phone number; and 
‘‘(2) the enhancement of communications capa-
bilities, which may include text capabilities. 
‘‘(b) CONSULTATION.—The Secretary may consult 
with nationally recognized professional organizations in 
the field of poison control to determine the best and most 
effective means of achieving the goals described in para-
graphs (1) and (2) of subsection (a). 
‘‘(c) RULE OF CONSTRUCTION.—In assisting with 
public health emergencies, responses, or preparedness, 
nothing in this section shall be construed to restrict the 
work of poison control centers or the use of their resources 
by the Secretary or other governmental agencies. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section 
$700,000 for each of fiscal years 2019 through 2023.’’.
290 
SEC. 7143. REAUTHORIZATION OF NATIONWIDE PUBLIC 
AWARENESS CAMPAIGN TO PROMOTE POI-
SON CONTROL CENTER UTILIZATION. 
Section 1272 of the Public Health Service Act (42 
U.S.C. 300d–72) is amended to read as follows: 
‘‘SEC. 1272. NATIONWIDE PUBLIC AWARENESS CAMPAIGN 
TO PROMOTE POISON CONTROL CENTER UTI-
LIZATION AND THEIR PUBLIC HEALTH EMER-
GENCY RESPONSE CAPABILITIES. 
‘‘(a) IN GENERAL.—The Secretary shall— 
‘‘(1) carry out, and expand upon, a national 
public awareness campaign to educate the public and 
health care providers about— 
‘‘(A) poisoning, toxic exposure, and drug 
misuse prevention; and 
‘‘(B) the availability of poison control cen-
ter resources in local communities; and 
‘‘(2) as part of such campaign, highlight the 
nationwide toll-free number and enhanced commu-
nications capabilities supported under section 1271. 
‘‘(b) CONSULTATION.—In carrying out and expand-
ing upon the national campaign under subsection (a), the 
Secretary may consult with nationally recognized profes-
sional organizations in the field of poison control response 
for the purpose of determining the best and most effective 
methods for achieving public awareness.
291 
‘‘(c) CONTRACT WITH ENTITY.—The Secretary may 
carry out subsection (a) by entering into contracts with 
one or more public or private entities, including nationally 
recognized professional organizations in the field of poison 
control and national media firms, for the development and 
implementation of the awareness campaign under sub-
section (a), which may include— 
‘‘(1) the development and distribution of poi-
soning and toxic exposure prevention, poison control 
center, and public health emergency awareness and 
response materials; 
‘‘(2) television, radio, internet, and newspaper 
public service announcements; and 
‘‘(3) other means and activities to provide for 
public and professional awareness and education. 
‘‘(d) EVALUATION.—The Secretary shall— 
‘‘(1) establish baseline measures and bench-
marks to quantitatively evaluate the impact of the 
nationwide public awareness campaign carried out 
under this section; and 
‘‘(2) on a biennial basis, prepare and submit to 
the appropriate committees of Congress an evalua-
tion of the nationwide public awareness campaign.
292 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section, 
$800,000 for each of fiscal years 2019 through 2023.’’. 
SEC. 7144. REAUTHORIZATION OF THE POISON CONTROL 
CENTER GRANT PROGRAM. 
Section 1273 of the Public Health Service Act (42 
U.S.C. 300d–73) is amended to read as follows: 
‘‘SEC. 1273. MAINTENANCE OF THE POISON CONTROL CEN-
TER GRANT PROGRAM. 
‘‘(a) AUTHORIZATION OF PROGRAM.—The Secretary 
shall award grants to poison control centers accredited 
under subsection (c) (or granted a waiver under subsection 
(d)) and nationally recognized professional organizations 
in the field of poison control for the purposes of— 
‘‘(1) preventing, and providing treatment rec-
ommendations for, poisonings and toxic exposures 
including opioid and drug misuse; 
‘‘(2) assisting with public health emergencies, 
responses, and preparedness; and 
‘‘(3) complying with the operational require-
ments needed to sustain the accreditation of the cen-
ter under subsection (c). 
‘‘(b) ADDITIONAL USES OF FUNDS.—In addition to 
the purposes described in subsection (a), a poison center 
or professional organization awarded a grant under such
293 
subsection may also use amounts received under such 
grant— 
‘‘(1) to research, establish, implement, and 
evaluate best practices in the United States for poi-
soning prevention, poison control center outreach, 
opioid and drug misuse information and response, 
and public health emergency, response, and pre-
paredness programs; 
‘‘(2) to research, develop, implement, revise, 
and communicate standard patient management 
guidelines for commonly encountered toxic expo-
sures; 
‘‘(3) to improve national toxic exposure and 
opioid misuse surveillance by enhancing cooperative 
activities between poison control centers in the 
United States and the Centers for Disease Control 
and Prevention and other governmental agencies; 
‘‘(4) to research, improve, and enhance the 
communications and response capability and capac-
ity of the Nation’s network of poison control centers 
to facilitate increased access to the centers through 
the integration and modernization of the current 
poison control centers communications and data sys-
tem, including enhancing the network’s telephony, 
internet, data, and social networking technologies;
294 
‘‘(5) to develop, support, and enhance tech-
nology and capabilities of nationally recognized pro-
fessional organizations in the field of poison control 
to collect national poisoning, toxic occurrence, and 
related public health data; 
‘‘(6) to develop initiatives to foster the en-
hanced public health utilization of national poison 
data collected by such organizations; 
‘‘(7) to support and expand the toxicologic ex-
pertise within poison control centers; and 
‘‘(8) to improve the capacity of poison control 
centers to answer high volumes of contacts and 
internet communications, and to sustain and en-
hance the poison control center’s network capability 
to respond during times of national crisis or other 
public health emergencies. 
‘‘(c) ACCREDITATION.—Except as provided in sub-
section (d), the Secretary may award a grant to a poison 
control center under subsection (a) only if— 
‘‘(1) the center has been accredited by a nation-
ally recognized professional organization in the field 
of poison control, and the Secretary has approved 
the organization as having in effect standards for 
accreditation that reasonably provide for the protec-
295 
tion of the public health with respect to poisoning; 
or 
‘‘(2) the center has been accredited by a State 
government, and the Secretary has approved the 
State government as having in effect standards for 
accreditation that reasonably provide for the protec-
tion of the public health with respect to poisoning. 
‘‘(d) WAIVER OF ACCREDITATION REQUIREMENTS.— 
‘‘(1) IN GENERAL.—The Secretary may grant a 
waiver of the accreditation requirements of sub-
section (c) with respect to a nonaccredited poison 
control center that applies for a grant under this 
section if such center can reasonably demonstrate 
that the center will obtain such an accreditation 
within a reasonable period of time as determined ap-
propriate by the Secretary. 
‘‘(2) RENEWAL.—The Secretary may renew a 
waiver under paragraph (1). 
‘‘(3) LIMITATION.—The Secretary may not, 
after the date of enactment of the Poison Control 
Network Enhancement Act of 2018, grant to a poi-
son control center waivers or renewals that total 
more than 5 years. 
‘‘(e) SUPPLEMENT NOT SUPPLANT.—Amounts made 
available to a poison control center under this section shall
296 
be used to supplement and not supplant other Federal, 
State, or local funds provided for such center. 
‘‘(f) MAINTENANCE OF EFFORT.—A poison control 
center, in utilizing the proceeds of a grant under this sec-
tion, shall maintain the annual recurring expenditures of 
the center for its activities at a level that is not less than 
80 percent of the average level of such recurring expendi-
tures maintained by the center for the preceding 3 fiscal 
years for which a grant is received. 
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section, 
$28,600,000 for each of fiscal years 2019 through 2023. 
The Secretary may utilize an amount not to exceed 6 per-
cent of the amount appropriated pursuant to the pre-
ceding sentence for each fiscal year for coordination, dis-
semination, technical assistance, program evaluation, data 
activities, and other program administration functions, 
which are determined by the Secretary to be appropriate 
for carrying out the program under this section.’’. 
Subtitle P—Eliminating Opioid 
Related Infectious Diseases 
SEC. 7151. SHORT TITLE. 
This subtitle may be cited as the ‘‘Eliminating Opioid 
Related Infectious Diseases Act of 2018’’.
297 
SEC. 7152. REAUTHORIZATION AND EXPANSION OF PRO-
GRAM OF SURVEILLANCE AND EDUCATION 
REGARDING INFECTIONS ASSOCIATED WITH 
ILLICIT DRUG USE AND OTHER RISK FAC-
TORS. 
Section 317N of the Public Health Service Act (42 
U.S.C. 247b–15) is amended to read as follows: 
‘‘SEC. 317N. SURVEILLANCE AND EDUCATION REGARDING 
INFECTIONS 
ASSOCIATED 
WITH 
ILLICIT 
DRUG USE AND OTHER RISK FACTORS. 
‘‘(a) IN GENERAL.—The Secretary may (directly and 
through grants to public and nonprofit private entities) 
provide for programs for the following: 
‘‘(1) To cooperate with the States and Indian 
tribes in implementing or maintaining a surveillance 
system to determine the incidence of infections com-
monly associated with illicit drug use, including in-
fections commonly associated with injection drug use 
such as viral hepatitis, human immunodeficiency 
virus, and infective endocarditis, and to assist the 
States in determining the prevalence of such infec-
tions, which may include the reporting of cases of 
such infections. 
‘‘(2) To identify, counsel, and offer testing to 
individuals who are at risk of infections as a result
298 
of injection drug use, receiving blood transfusions 
prior to July 1992, or other risk factors. 
‘‘(3) To provide appropriate referrals for coun-
seling, testing, and medical treatment of individuals 
identified under paragraph (2) and to ensure, to the 
extent practicable, the provision of appropriate fol-
low-up services. 
‘‘(4) To develop and disseminate public infor-
mation and education programs for the detection 
and control of infections described in paragraph (1), 
with priority given to high-risk populations as deter-
mined by the Secretary. 
‘‘(5) To improve the education, training, and 
skills of health professionals in the detection and 
control of infections and the coordination of treat-
ment of addiction and infectious diseases described 
in paragraph (1), with priority given to substance 
use disorder treatment providers, pediatricians and 
other primary care providers, obstetrician-gyne-
cologists, infectious diseases clinicians, and HIV cli-
nicians. 
‘‘(b) LABORATORY
PROCEDURES.—The Secretary 
may (directly or through grants to public and nonprofit 
private entities) carry out programs to provide for im-
299 
provements in the quality of clinical-laboratory procedures 
regarding infections described in subsection (a)(1). 
‘‘(c) DEFINITIONS.—In this section: 
‘‘(1) The term ‘Indian tribe’ has the meaning 
given that term in section 4 of the Indian Self-De-
termination and Education Assistance Act. 
‘‘(2) The term ‘injection drug use’ means— 
‘‘(A) intravenous administration of a sub-
stance in schedule I under section 202 of the 
Controlled Substances Act; 
‘‘(B) intravenous administration of a sub-
stance in schedule II, III, IV, or V under sec-
tion 202 of the Controlled Substances Act that 
has not been approved for intravenous use 
under— 
‘‘(i) section 505 of the Federal Food, 
Drug and Cosmetic Act; or 
‘‘(ii) section 351 of the Public Health 
Service Act; or 
‘‘(C) intravenous administration of a sub-
stance in schedule II, III, IV, or V under sec-
tion 202 of the Controlled Substances Act that 
has not been prescribed to the person using the 
substance.
300 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated $40,000,000 for each of the fiscal years 
2019 through 2023.’’. 
Subtitle Q—Better Pain 
Management Through Better Data 
SEC. 7161. SHORT TITLE. 
This subtitle may be cited as the ‘‘Better Pain Man-
agement Through Better Data Act of 2018’’. 
SEC. 7162. GUIDANCE ADDRESSING ALTERNATIVE AP-
PROACHES TO DATA COLLECTION AND LA-
BELING CLAIMS FOR OPIOID SPARING. 
(a) IN GENERAL.—For purposes of assisting spon-
sors in collecting and incorporating opioid-sparing data in 
product labeling, the Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’) 
shall conduct a public meeting and update or issue one 
or more guidances in accordance with subsection (b). 
(b) GUIDANCE.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner 
of Food and Drugs, shall update or issue one or 
more guidances addressing— 
(A) alternative methods for data collection 
on opioid sparing;
301 
(B) alternative methods for inclusion of 
such data in product labeling; and 
(C) investigations other than clinical trials, 
including partially controlled studies and objec-
tive trials without matched controls such as his-
torically controlled analyses, open-label studies, 
and meta-analyses, on opioid sparing for inclu-
sion in product labeling. 
(2) CONTENTS.—The guidances under para-
graph (1) shall address— 
(A) innovative clinical trial designs for 
ethically and efficiently collecting data on opioid 
sparing for inclusion in product labeling; 
(B) primary and secondary endpoints for 
the reduction of opioid use while maintaining 
adequate pain control; 
(C) use of real world evidence, including 
patient registries, and patient reported out-
comes to support inclusion of opioid-sparing 
data in product labeling; and 
(D) how sponsors may obtain feedback 
from the Secretary relating to such issues prior 
to— 
(i) commencement of such data collec-
tion; or
302 
(ii) the submission of resulting data to 
the Secretary. 
(3) PUBLIC
MEETING.—Prior to updating or 
issuing the guidances required by paragraph (1), the 
Secretary shall consult with stakeholders, including 
representatives of regulated industry, academia, pa-
tients, and provider organizations, through a public 
meeting to be held not later than 12 months after 
the date of enactment of this Act. 
(4) TIMING.—The Secretary shall— 
(A) not later than 12 months after the 
date of the public meeting required by para-
graph (3), update or issue the one or more 
draft guidances required by paragraph (1); and 
(B) not later than 12 months after the 
date on which the public comment period for 
such draft guidances closes, finalize such guid-
ances. 
(c) DEFINITION.—In this section: 
(1) The terms ‘‘opioid sparing’’ and ‘‘opioid- 
sparing’’ refer to the use of drugs or devices (as de-
fined in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321)) that reduce pain 
while enabling the reduction, replacement, or avoid-
ance of oral opioids.
303 
(2) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
Subtitle R—Special Registration 
for Telemedicine Clarification 
SEC. 7171. SHORT TITLE. 
This subtitle may be cited as the ‘‘Special Registra-
tion for Telemedicine Clarification Act of 2018’’. 
SEC. 7172. DEADLINE FOR INTERIM FINAL REGULATIONS 
FOR A SPECIAL REGISTRATION TO ENGAGE 
IN THE PRACTICE OF TELEMEDICINE. 
Section 311(h)(2) of the Controlled Substances Act 
(21 U.S.C. 831(h)(2)) is amended by striking ‘‘The Attor-
ney General shall, with the concurrence of the Secretary, 
promulgate regulations’’ and inserting ‘‘Not later than 1 
year after the date of enactment of the Special Registra-
tion for Telemedicine Clarification Act of 2018, the Attor-
ney General shall, with the concurrence of the Secretary, 
promulgate interim final regulations’’. 
Subtitle S—Peer Support 
Communities of Recovery 
SEC. 7181. SHORT TITLE. 
This subtitle may be cited as the ‘‘Peer Support Com-
munities of Recovery Act’’.
304 
SEC. 7182. BUILDING COMMUNITIES OF RECOVERY. 
Section 547 of the Public Health Service Act (42 
U.S.C. 290ee–2) is amended— 
(1) in subsection (a)— 
(A) in the heading, by striking ‘‘DEFINI-
TION’’ and inserting ‘‘DEFINITIONS’’; 
(B) in the matter preceding paragraph (1), 
by striking ‘‘In this section, the term ‘recovery 
community organization’ means an independent 
nonprofit organization that—’’ and inserting 
‘‘In this section:’’; 
(C) by redesignating paragraphs (1) and 
(2) as subparagraphs (A) and (B), respectively, 
and moving such subparagraphs (as so redesig-
nated) 2 ems to the right; 
(D) by inserting before subparagraph (A) 
(as so redesignated) the following: 
‘‘(1) RECOVERY COMMUNITY ORGANIZATION.— 
The term ‘recovery community organization’ means 
an independent nonprofit organization that—’’; and 
(E) by adding at the end the following: 
‘‘(2) ELIGIBLE ENTITY.—The term ‘eligible en-
tity’ means— 
‘‘(A) a national nonprofit entity focused on 
substance use disorder with a network of local
305 
affiliates and partners that are geographically 
and organizationally diverse; or 
‘‘(B) a nonprofit organization— 
‘‘(i) focused on substance use dis-
order; 
‘‘(ii) established by individuals in per-
sonal or family recovery; and 
‘‘(iii) serving prevention, treatment, 
recovery, payor, faith-based, and criminal 
justice stakeholders in the implementation 
of local addiction and recovery initiatives.’’; 
(2) in subsection (b)— 
(A) by striking ‘‘The Secretary shall award 
grants to recovery community organizations’’ 
and inserting ‘‘The Secretary— 
‘‘(1) shall award grants to recovery community 
organizations’’; 
(B) by striking ‘‘services.’’ and inserting 
‘‘services and allow such organizations to use 
such grant funds to carry out the activities de-
scribed in subparagraphs (A) through (C) of 
subsection (c)(2); and’’; and 
(C) by adding at the end the following:
306 
‘‘(2) may award grants to eligible entities for 
purposes of establishing regional technical assistance 
centers, in accordance with subsection (c)(2)(D).’’; 
(3) by striking subsection (c); 
(4) by redesignating subsections (d) and (e) as 
subsections (c) and (d), respectively; 
(5) in subsection (c) (as so redesignated)— 
(A) in paragraph (1), by striking ‘‘shall be 
used’’ and inserting ‘‘to a recovery community 
organization shall be used’’; 
(B) in paragraph (2)— 
(i) in subparagraph (A), in the matter 
preceding clause (i), by inserting before 
‘‘build’’ the following: ‘‘in the case of a 
grant awarded to a recovery community or-
ganization,’’; 
(ii) in subparagraph (B)— 
(I) by inserting before ‘‘reduce’’ 
the following: ‘‘in the case of a grant 
awarded to a recovery community or-
ganization,’’; and 
(II) by striking ‘‘and’’ at the end; 
(iii) in subparagraph (C)— 
(I) by inserting before ‘‘conduct’’ 
the following: ‘‘in the case of a grant
307 
awarded to a recovery community or-
ganization,’’; and 
(II) by striking the period at the 
end and inserting ‘‘; and’’; and 
(iv) by adding at the end the fol-
lowing: 
‘‘(D) in the case of a grant awarded to an 
eligible entity, provide for the establishment of 
regional technical assistance centers to provide 
regional technical assistance for the following: 
‘‘(i) Implementation of regionally driv-
en, peer-delivered addiction recovery sup-
port services before, during, after, or in 
conjunction with addiction treatment. 
‘‘(ii) Establishment of recovery com-
munity organizations. 
‘‘(iii) Establishment of recovery com-
munity centers.’’; and 
(6) in subsection (d) (as so redesignated), by 
inserting before the period the following: ‘‘, and 
$15,000,000 for each of fiscal years 2019 through 
2023’’.
308 
Subtitle T—Stop Illicit Drug 
Importation 
SEC. 7191. SHORT TITLE. 
This short title may be cited as the ‘‘Stop Illicit Drug 
Importation Act of 2018’’. 
SEC. 7192. DETENTION, REFUSAL, AND DESTRUCTION OF 
DRUGS OFFERED FOR IMPORTATION. 
(a) ARTICLES TREATED AS DRUGS FOR PURPOSES 
OF IMPORTATION.—Section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381) is amended by 
adding at the end the following: 
‘‘(t) ARTICLES TREATED AS DRUGS FOR PURPOSES 
OF THIS SECTION.— 
‘‘(1) LABELED ARTICLES.—An article shall not 
be treated as a drug pursuant to this subsection if— 
‘‘(A) an electronic import entry for such 
article is submitted using an authorized elec-
tronic data interchange system; and 
‘‘(B) such article is designated in such sys-
tem as a drug, device, dietary supplement, or 
other product that is regulated under this Act. 
‘‘(2) ARTICLES
COVERED.—Subject to para-
graph (1), for purposes of this section, an article de-
scribed in this paragraph may be treated by the Sec-
retary as a drug if it—
309 
‘‘(A) is or contains an ingredient that is an 
active ingredient that is contained within— 
‘‘(i) a drug that has been approved 
under section 505 of this Act; or 
‘‘(ii) a biological product that has 
been approved under section 351 of the 
Public Health Service Act; 
‘‘(B) is or contains an ingredient that is an 
active ingredient in a drug or biological product 
if— 
‘‘(i) an investigational use exemption 
has been authorized for such drug or bio-
logical product under section 505(i) of this 
Act or section 351(a) of the Public Health 
Service Act; 
‘‘(ii) substantial clinical investigation 
has been instituted for such drug or bio-
logical product; and 
‘‘(iii) the existence of such clinical in-
vestigation has been made public; or 
‘‘(C) is or contains a substance that has a 
chemical structure that is substantially similar 
to the chemical structure of an active ingredient 
in a drug or biological product described in sub-
paragraph (A) or (B).
310 
‘‘(3) EFFECT.—Except to the extent that an ar-
ticle may be treated as a drug pursuant to para-
graph (2), this subsection shall not be construed as 
bearing on or being relevant to the question of 
whether any article is a drug as defined in section 
201(g).’’. 
(b) ARTICLES OF CONCERN.— 
(1) DELIVERY
BY
TREASURY
TO
HHS.—The 
first sentence of section 801(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(a)) is 
amended by striking ‘‘and cosmetics’’ and inserting 
‘‘cosmetics, and potential articles of concern (as de-
fined in subsection (u))’’. 
(2) REFUSED ADMISSION.—The third sentence 
of section 801(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)) is amended by 
striking ‘‘then such article shall be refused admis-
sion’’ and inserting ‘‘or (5) such article is an article 
of concern (as defined in subsection (u)), or (6) such 
article is a drug that is being imported or offered for 
import in violation of section 301(cc), then such ar-
ticle shall be refused admission’’. 
(3) DEFINITION OF ARTICLE OF CONCERN.— 
Section 801 of the Federal Food, Drug, and Cos-