[House Report 116-583]
[From the U.S. Government Publishing Office]
116th Congress } { Rept. 116-583
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
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BLOCK, REPORT, AND SUSPEND SUSPICIOUS SHIPMENTS ACT OF 2020
_______
November 16, 2020.--Ordered to be printed
_______
Mr. Pallone, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 3878]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 3878) to amend the Controlled Substances Act to
clarify the process for registrants to exercise due diligence
upon discovering a suspicious order, and for other purposes,
having considered the same, reports favorably thereon with an
amendment and recommends that the bill as amended do pass.
CONTENTS
Page
I. Purpose and Summary.............................................2
II. Background and Need for the Legislation.........................2
III. Committee Hearings..............................................3
IV. Committee Consideration.........................................3
V. Committee Votes.................................................4
VI. Oversight Findings..............................................4
VII. New Budget Authority, Entitlement Authority, and Tax Expenditure4
VIII. Congressional Budget Office Estimate............................5
IX. Federal Mandates Statement......................................6
X. Statement of General Performance Goals and Objectives...........6
XI. Duplication of Federal Programs.................................6
XII. Committee Cost Estimate.........................................6
XIII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits.....6
XIV. Advisory Committee Statement....................................6
XV. Applicability to Legislative Branch.............................6
XVI. Section-by-Section Analysis of the Legislation..................7
XVII. Changes in Existing Law Made by the Bill, as Reported...........7
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Block, Report, And Suspend Suspicious
Shipments Act of 2020''.
SEC. 2. CLARIFICATION OF PROCESS FOR REGISTRANTS TO EXERCISE DUE
DILIGENCE UPON DISCOVERING A SUSPICIOUS ORDER.
(a) In General.--Paragraph (3) of section 312(a) of the Controlled
Substances Act (21 U.S.C. 832(a)) is amended to read as follows:
``(3) upon discovering a suspicious order or series of
orders--
``(A) exercise due diligence;
``(B) establish and maintain (for not less than a
period to be determined by the Administrator of the
Drug Enforcement Administration) a record of the due
diligence that was performed;
``(C) decline to fill the order or series of orders
if the due diligence fails to resolve all of the
indicators that gave rise to the suspicion that filling
the order or series of orders would cause a violation
of this title by the registrant or the prospective
purchaser; and
``(D) notify the Administrator of the Drug
Enforcement Administration and the Special Agent in
Charge of the Division Office of the Drug Enforcement
Administration for the area in which the registrant is
located or conducts business of--
``(i) each suspicious order or series of
orders discovered by the registrant; and
``(ii) the indicators giving rise to the
suspicion that filling the order or series of
orders would cause a violation of this title by
the registrant or the prospective purchaser.''.
(b) Applicability.--Section 312(a)(3) of the Controlled Substances
Act, as amended by subsection (a), shall apply beginning on the day
that is 6 months after the date of enactment of this Act. Until such
day, section 312(a)(3) of the Controlled Substances Act shall apply as
such section 312(a)(3) was in effect on the day before the date of
enactment of this Act.
I. Purpose and Summary
H.R. 3878, the ``Block, Report, And Suspend Suspicious
Shipments Act of 2020'', was introduced by Representatives
David B. McKinley (R-WV) and Debbie Dingell (D-MI). This bill
would create additional requirements for drug manufacturers and
distributors who discover a suspicious order for controlled
substances. In addition to reporting the suspicious order to
the Drug Enforcement Administration (DEA), a manufacturer or
distributor must also exercise due diligence, decline to fill
the order or series of orders, notify the DEA of each
suspicious order or series of orders, and provide information
on the indicators that led to the belief that filling such
orders would be a violation. These requirements would become
effective six months following enactment of the bill.
II. Background and Need for Legislation
In 2018, 67,367 Americans died of a drug overdose, and of
those deaths, nearly 70 percent involved an opioid.\1\ Those
opioids include prescription pain relievers, heroin, and other
synthetic opioids such as fentanyl.\2\ The DEA requires
entities that manufacture or distribute controlled substances
to register with a system that tracks the manufacture,
distribution, and dispensing of such substances in order to
prevent diversion. The DEA also has established the Suspicious
Orders Reporting System (SORS) to identify and receive reports
of suspicious orders, which are orders of a controlled
substance of unusual size, orders of controlled substances
deviating substantially from normal patterns, and orders of
controlled substances of unusual frequency.\3\
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\1\Centers for Disease Control and Prevention, Opioid Overdose,
Understanding the Epidemic (https://www.cdc.gov/drugoverdose/epidemic/
index.html) (accessed September 19, 2020).
\2\Centers for Disease Control and Prevention, Opioid Overdose,
Data Analysis and Resources (https://www.cdc.gov/drugoverdose/data/
analysis.html) (accessed September 19, 2020).
\3\21 U.S.C. 802.
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Recent reviews of the DEA's suspicious orders work,
however, found flaws and inefficiencies. A Department of
Justice Inspector General report found that the SORS did not
include all suspicious reports provided to the DEA, ``thereby
significantly impacting its usefulness.''\4\ This bill would
clarify existing efforts put forward by the DEA and ensure that
registrants and the agency would comply with the suspicious
order requirements established by regulations and the
Controlled Substances Act.
---------------------------------------------------------------------------
\4\U.S. Department of Justice Office of the Inspector General,
Review of the Drug Enforcement Administration's Regulatory and
Enforcement Efforts to Control the Diversion of Opioids (September
2019).
---------------------------------------------------------------------------
III. Committee Hearings
For the purposes of section 103(i) of H. Res. 6 of the
116th Congress, the following hearing was used to develop or
consider H.R. 3878:
The Subcommittee on Health held a legislative hearing on
Tuesday, March 3, 2020, entitled, ``Combatting an Epidemic:
Legislation to Help Patients with Substance Use Disorders.''
The Subcommittee received testimony from the following
witnesses:
Panel I:
ADM Brett P. Giroir, M.D., Assistant
Secretary for Health and Senior Adviser to the
Secretary on Opioid Policy, Department of Health and
Human Services
Kimberly Brandt, Principal Deputy
Administrator for Policy & Operations, Centers for
Medicare & Medicaid Services
Thomas W. Prevoznik, Deputy Assistant
Administrator, Diversion Control Division, Drug
Enforcement Administration
Panel II:
Michael P. Botticelli, Executive Director,
Grayken Center for Addiction, Boston Medical Center
Smita Das, M.D., Ph.D., M.P.H., Addiction
Psychiatrist, Dual Diagnosis Clinic, Clinical Assistant
Professor, Psychiatry and Behavioral Sciences, Stanford
University School of Medicine
Patty McCarthy, Chief Executive Officer,
Faces & Voices of Recovery
Robert I.L. Morrison, Executive Director/
Director of Legislative Affairs, National Association
of State Alcohol and Drug Abuse Directors
Margaret B. Rizzo, Executive Director, JSAS
HealthCare, Inc.
Shawn A. Ryan, M.D., M.B.A., Chair,
Legislative Advocacy Committee, American Society of
Addiction Medicine
IV. Committee Consideration
Representatives McKinley and Dingell introduced H.R. 3878
on July 23, 2019, and the bill was referred to the Committee on
Energy and Commerce. H.R. 3878 was then referred to the
Subcommittee on Health on July 24, 2019. A legislative hearing
was held on the bill on March 3, 2020.
On September 9, 2020, H.R. 3878 was discharged from further
consideration by the Subcommittee on Health as the bill was
called up for consideration by the full Committee on Energy and
Commerce. The full Committee met in virtual open markup session
on September 9, 2020, pursuant to notice, to consider H.R.
3878. During consideration of the bill, an amendment offered by
Mr. McKinley was agreed to by a voice vote. Upon conclusion of
consideration of the bill, the full Committee agreed to a
motion on final passage offered by Mr. Pallone, Chairman of the
committee, to order H.R. 3878 reported favorably to the House,
amended, by a voice vote, a quorum being present.
V. Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. The
Committee advises that there were no record votes taken on H.R.
3878, including the motion for final passage of the bill.
VI. Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1)
of rule X of the Rules of the House of Representatives, the
oversight findings and recommendations of the Committee are
reflected in the descriptive portion of the report.
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to 3(c)(2) of rule XIII of the Rules of the House
of Representatives, the Committee adopts as its own the
estimate of new budget authority, entitlement authority, or tax
expenditures or revenues contained in the cost estimate
prepared by the Director of the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974.
VIII. Congressional Budget Office Estimate
On September 9, 2020, the House Committee on the Judiciary
ordered reported the following pieces of legislation that would
make changes to the Drug Enforcement Administration's (DEA)
Diversion Control Program:
H.R. 3878, the Block, Report, and Suspend
Suspicious Shipments Act of 2019, would require
registrants who manufacture, distribute, or dispense
controlled substances to take additional steps in
reporting suspicious orders, including maintaining a
record of due diligence, declining to fill the order,
and notifying DEA.
H.R. 4806, the DEBAR Act of 2019, would
allow the Attorney General to issue an order
prohibiting applicants from registering as a
manufacturer, distributor, or dispenser of controlled
substances if they meet certain criteria.
H.R. 4812, the Ensuring Compliance Against
Drug Diversion Act of 2019, would terminate authority
to manufacture, distribute, or dispense controlled
substances when a registrant dies, ceases legal
existence, or discontinues business.
The Diversion Control Program is funded by registration
fees, which are treated in the budget as reductions in direct
spending; DEA is authorized to spend those fees without further
appropriation. Each bill would either codify existing
regulations or clarify procedures already in place. On that
basis, and using information from the agency, CBO estimates
that under the bill the increase in spending of those fees
above current levels would not be significant.
H.R. 3878 would impose a private-sector mandate on
manufacturers, distributors, and dispensers of controlled
substances by expanding reporting requirements and prohibiting
them from fulfilling unresolved suspicious orders. CBO is
uncertain how DEA would implement the new requirements and
cannot evaluate the potential costs for the mandated entities
to comply. In 2019, DEA received reports of 370,000 suspicious
orders; however, CBO cannot predict the number of orders that
would be precluded by the bill or the value of such orders. CBO
cannot estimate the potential foregone revenue and therefore
cannot determine whether the aggregate cost of the mandates
would exceed the annual threshold established in UMRA for
private-sector mandates ($168 million in 2020, adjusted
annually for inflation).
H.R. 4806 and H.R. 4812 do not contain private-sector
mandates as defined in UMRA.
None of the bills contain intergovernmental mandates as
defined in UMRA.
The CBO staff contacts for this estimate are Lindsay Wylie
(for federal costs) and Lilia Ledezma (for mandates). The
estimate was reviewed by H. Samuel Papenfuss, Deputy Director
of Budget Analysis.
IX. Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
X. Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to amend
the Controlled Substances Act to clarify the process for
registrants who discover a suspicious order for controlled
substances, including requiring such registrants to exercise
due diligence upon discovering a suspicious order or decline to
fill the order, and for other purposes.
XI. Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 3878 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
XII. Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
XIII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 3878 contains no earmarks, limited
tax benefits, or limited tariff benefits.
XIV. Advisory Committee Statement
No advisory committee within the meaning of section 5(b) of
the Federal Advisory Committee Act was created by this
legislation.
XV. Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
XVI. Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates that the short title may be cited as
the ``Block, Report, And Suspend Suspicious Shipments Act of
2020''.
Sec. 2. Clarification of process for registrants to exercise due
diligence upon discovering a suspicious order
Section 2 amends the Controlled Substances Act to add
registrant reporting requirements regarding suspicious orders.
Upon discovering a suspicious order or series of orders, the
registrant must exercise due diligence, keep record of the due
diligence that was performed, decline to fill the order or
orders, and notify the DEA Administrator and Special Agent in
Charge of the Divisions Office of the DEA where the registrant
is located of each suspicious order or series of orders and the
indicators that gave rise to the suspicion that filing the
order or orders would be in violation of the Act. This change
goes into effect six months after enactment of this Act.
XVII. Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, and existing law in which no
change is proposed is shown in roman):
CONTROLLED SUBSTANCES ACT
TITLE II--CONTROL AND ENFORCEMENT
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances; Piperidine Reporting
* * * * * * *
SEC. 312. SUSPICIOUS ORDERS.
(a) Reporting.--Each registrant shall--
(1) design and operate a system to identify
suspicious orders for the registrant;
(2) ensure that the system designed and operated
under paragraph (1) by the registrant complies with
applicable Federal and State privacy laws; and
[(3) upon discovering a suspicious order or series of
orders, notify the Administrator of the Drug
Enforcement Administration and the Special Agent in
Charge of the Division Office of the Drug Enforcement
Administration for the area in which the registrant is
located or conducts business.]
(3) upon discovering a suspicious order or series of
orders--
(A) exercise due diligence;
(B) establish and maintain (for not less than
a period to be determined by the Administrator
of the Drug Enforcement Administration) a
record of the due diligence that was performed;
(C) decline to fill the order or series of
orders if the due diligence fails to resolve
all of the indicators that gave rise to the
suspicion that filling the order or series of
orders would cause a violation of this title by
the registrant or the prospective purchaser;
and
(D) notify the Administrator of the Drug
Enforcement Administration and the Special
Agent in Charge of the Division Office of the
Drug Enforcement Administration for the area in
which the registrant is located or conducts
business of--
(i) each suspicious order or series
of orders discovered by the registrant;
and
(ii) the indicators giving rise to
the suspicion that filling the order or
series of orders would cause a
violation of this title by the
registrant or the prospective
purchaser.
(b) Suspicious Order Database.--
(1) In general.--Not later than 1 year after the date
of enactment of this section, the Attorney General
shall establish a centralized database for collecting
reports of suspicious orders.
(2) Satisfaction of reporting requirements.--If a
registrant reports a suspicious order to the
centralized database established under paragraph (1),
the registrant shall be considered to have complied
with the requirement under subsection (a)(3) to notify
the Administrator of the Drug Enforcement
Administration and the Special Agent in Charge of the
Division Office of the Drug Enforcement Administration
for the area in which the registrant is located or
conducts business.
(c) Sharing Information With the States.--
(1) In general.--The Attorney General shall prepare
and make available information regarding suspicious
orders in a State, including information in the
database established under subsection (b)(1), to the
point of contact for purposes of administrative, civil,
and criminal oversight relating to the diversion of
controlled substances for the State, as designated by
the Governor or chief executive officer of the State.
(2) Timing.--The Attorney General shall provide
information in accordance with paragraph (1) within a
reasonable period of time after obtaining the
information.
(3) Coordination.--In establishing the process for
the provision of information under this subsection, the
Attorney General shall coordinate with States to ensure
that the Attorney General has access to information, as
permitted under State law, possessed by the States
relating to prescriptions for controlled substances
that will assist in enforcing Federal law.
* * * * * * *