WEMICATED 1
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INFORMATION
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S. 483

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of tilt
?Janina Stems nf gmzrics

AT THE SECOND SESSION

Begun and held at the City of Washington on Monday.
the fourth day ofIanum-y, two thousand and sixteen.

San ?it

To improve enforcement efforts related to prescription drug divoruion and abuse.
and for other purposes.

Be it enacted by the Senate and House of Representatives of
the United States ofAmericn in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ?Ensuring Patient Access and
E?'octivc Drug Enforcement Act of 2016".

SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED SUBSTANCES
ACT

Dartmomsrs? 
(1) FACTORS AS MAY BE RELEVANT TO AND CONSISTENT WITH

THE PUBLIC HEALTH AND warn?Section 303 of the Controlled

Substances Act (21 U.S.C. 823) is amended by adding at the

end the following:

In this section, the phrase ?factors as may be relevant
to an consistent with the public health and safest)? means factors
that are relevant to and consistent with the ?ndings contained
in section 101.?.

IWNT DANGER TO THE PUBLIC HEALTH OR 

Section 304(d) of the Controlled Substances Act (21 U.S.C.

824(d}) is amended?

by striking The Attorney General? and
inserting The Attorney General"; and
(B) adding at the end the following:

In this subsection, the phrase ?imminent danger to the
public health or safet means that, due to the failure of the reg-
istrant to maintain 0 active controls against diversion or otherwise
comply with the 0in ations of a registrant under this title or
title there is a s?astant'ial likelihood of an immediate threat
that death, serious bodily harm. or abuse of a controlled substance
will occur in the absence of an immediate suspension of the registra-
tion.?.

OPPORTUNITY To SUBMIT Connemara ACTION PLAN Felon
To REVOCATION 0R of section 304 of
the Controlled Substances Act (21 U.S.C. 824) is amended?

(1) by striking the last three sentences;
(2) by striking Before" and inserting Before";

and

(3) by adding at the end the following:
An order to show cause under parag'ra (1) shall?

?(Al contain a statement of the basis or the denial, revoca-
tion, or suspension, including speci?c citations to any laws

S. 483?2

or regulations alleged 'to be violated by the applicant or reg-

istrant;

"(Bl direct the applicant or registrant to appear before
the'Attorney General at a time and place stated in the order.
but not less than 30 days after the date of receipt of the
order; and 

notify the applicant or registrant of the opportunity
to submit a corrective action plan on or before the date of
a earsnce.

?dz Upon review of any corrective action plan submitted by
an applicant or registrant pursuant to aragraph (2), the Attorney
General shall determine ether deni . revocation, or suspension
proceedings should be discontinued. or deferred for the purposes
of modi?cation, amendment, or clari?cation to such plan.

Proceedings to deny, revoke, or suspend shall be conducted

ursuant to this section in accordance with subchapter ll of chapter
a of title 5, United States Code. Such proceedings shall be inde-
pendent of, and not in lieu of, criminal rosecutions or other pro-
ceedin :5 under this title or an other aw of the United States.

The requirements of ?s subsection shall not apply to
the issuance of an immediate suspension order under subsection


SEC. 3. REPORT TO CONGRESS.

(9.) IN later than 1 year after the date of onset-
ment of this Act, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, the Adminis-
trator of the Substance Abuse and Mental Health Services Adminis-
tration, the Director of the ency for Healthcare Research and
Quality, and the Director of Centers for Disease Control and
Prevention, in coordination with the Administrator of the Drug
Enforcement Administration and in consultation with the Secretary
of Defense and the Secretary of Veterans Affairs, shall submit
a report to the Committee on the Judiciary of the House of Rep-
resentatives, the Committee on Energy and Commerce of the House
of Re resentatives, the Committee on the Judiciary of the Senate,
and the Committee on Health, Education. Labor, and Pensions
of the Senate identiiying?

(1) obstacles to legitimate patient access to controlled sub-
stances; -

issues with diversion of controlled substances;

(3) how collaboration between Federal, State, local, and
tribal law enforcement agencies and the pharmaceutical
industry can bene?t patients and prevent diversion and abuse
of controlled substances;

the availability of medical education. training opportuni-
ties, and comprehensive clinical guidance for pain management
and 'oid prescribing, and any gags that should be addressed;

)bene?cial enhancements to tats prescription drug mon-
itoring programs, including enhancements to require com-
prehensive prescriber input and to expand access to the pro-
grams for appropriate authorized users; and

(6) steps to improve reporting requirements so that the
public and Congress have more information regarding prescrip?
tion 0 ioids, such as the volume and formulation of prescription
opioi prescribed annually, the dispensing of such prescription
opioids, and outliers and trends within large data sets.

S. 483?3

03) re ort under subsection shall incor-
porate feedback and recommen ations from the following:

(1) Patient groups.

(2) Pharmacies.

(3) Drug manufacturers.

(4) Common or contract carriers and werehousomen.

Hospitals, physicians, and other health care providers.

State attorneys general.

. (7) Federal, State, local, and tribal law enforcement agen-
c165. -

(8) Health insurance providers and entities that provide
pharmacy bene?t management services on behalf of 9. health
msuranee provider.

(9) Wholesale drug distributors.

[10) Veterinarians.

{11) Professional medical societies and boards.

(12) State and local public health authorities.

(13) Health services research organizations.

Speaker of the House of Representatives.

Vice President of the United States and
President of the Senate.