Program To Hire Special Assistant United States Attorneys in Targeted Federal Judicial Districts Utilizing Diversion Control Fee Account Funds, 14490-14494 [2017-05396]
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Federal Register / Vol. 82, No. 53 / Tuesday, March 21, 2017 / Proposed Rules
Operating Handbook and the Airplane Flight
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[FR Doc. 2017–05160 Filed 3–20–17; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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21 CFR Parts 1301 and 1311
[Docket No. DEA–445N]
Program To Hire Special Assistant
United States Attorneys in Targeted
Federal Judicial Districts Utilizing
Diversion Control Fee Account Funds
Drug Enforcement
Administration, Department of Justice.
AGENCY:
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ACTION:
Notice of proposed rulemaking.
The Drug Enforcement
Administration (DEA) is proposing a
rule that would expand and enhance the
enforcement component of the
Diversion Control Program (DCP) as
previously outlined in the December 30,
1996, Federal Register document
‘‘Registration and Reregistration
Application Fees,’’ hereinafter referred
to as the 1996 Rule. The 1996 Rule
specified six types of investigations
involving the diversion of controlled
substances, which could be pursued by
the DCP utilizing funding from the
Diversion Control Fee Account (DCFA).
Those investigations included the theft
or robbery of pharmaceutical controlled
substances, the acquisition of
pharmaceutical controlled substances
through fraud or deceit, and other illegal
diversion activities. The 1996 Rule also
authorized the continued use and
expansion by the DCP of Tactical
Diversion Squads (TDSs), defined as,
‘‘enforcement teams consisting of
Federal, state, and local law
enforcement personnel fully dedicated
to the investigation and prosecution of
persons involved in the diversion of
controlled substances.’’
DATES: Electronic comments must be
submitted, and written comments must
be postmarked, on or before April 20,
2017. Commenters should be aware that
the electronic Federal Docket
Management System will not accept
comments after 11:59 p.m. Eastern Time
on the last day of the comment period.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–445N’’ on all correspondence,
including any attachments.
The Drug Enforcement
Administration encourages that all
comments be submitted through the
Federal eRulemaking Portal, which
provides the ability to type short
comments directly into the comment
field on the Web page or to attach a file
for lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon completion
of your submission you will receive a
Comment Tracking Number for your
comment. Please be aware that
submitted comments are not
instantaneously available for public
view on Regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
submitted and there is no need to
resubmit the same comment. Paper
comments that duplicate an electronic
submission are not necessary and are
discouraged. Should you wish to mail a
paper comment in lieu of an electronic
SUMMARY:
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comment, it should be sent via regular
or express mail to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
FOR FURTHER INFORMATION CONTACT:
Michael J. Lewis, Diversion Control
Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION: This
proposed rule would expand on the
already-recognized investigative
activities funded by the DCFA and
allow for the hiring of attorneys in
support of these activities. The
attorneys, hired by DEA and paid with
funds from the DCFA, will be detailed
to the Department of Justice (DOJ) as
Special Assistant United States
Attorneys (SAUSAs), and will assist in
the investigation and prosecution of
those diversion crimes outlined in the
1996 Rule, and related civil actions.
DCFA-funded SAUSAs in the program
would be exclusively engaged in duties
which provide investigative and
prosecutorial support to federal criminal
and related civil diversion
investigations conducted by the DEA
and its partnering law enforcement
agencies. The investigations, and the
companion support provided by the
attorneys detailed as SAUSAs in this
program, will adhere to the guidelines
for the use of DCFA funding found in
Title 21, United States Code, 821, 822,
and 886a; the 1996 Rule, 76 FR 39318,
July 6, 2011; and 77 FR 15234, March
15, 2012.
In addition, the proposed rule would
authorize the SAUSAs hired by DEA
and detailed to DOJ to prosecute crimes
that are derivative or ancillary criminal
violations to the diversion crimes
outlined in the 1996 Rule. Examples of
these ancillary or derivative crimes
would include money laundering or
other financial crimes involving the
proceeds of diversion activity; firearms
and crimes of violence related to or
caused by diversion activity; use of a
communication facility to commit
diversion crimes; and the forfeiture of
assets which facilitate or are derived
from diversion activity.
In addition to protecting the public,
the proposed rule will enhance the
protections provided to the DEA
registrant community by the DCP by
ensuring that those engaged in criminal
and related civil violations affecting the
DEA registrant population are
apprehended, and, equally as important,
prosecuted. The proposed rule will
ensure that illegal activities that
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endanger the safety of registrants and
their employees (burglary and robbery
of registered locations); threatens the
credibility and financial stability of
registrants and their employees
(prescription forgery, fraud, and theft);
and damages the public perception and
reputation of the registrant community
(prescribing or dispensing outside the
course of medical practice and other
offenses committed by registrants) will
be fully addressed through robust
investigation and prosecution.
The proposed rule is a continuation of
the concepts outlined in ‘‘Controlled
Substances and List 1 Chemical
Registration and Reregistration Fees,’’
77 FR 15234 (Mar. 15, 2012), hereinafter
referred to as the 2012 Rule. The 2012
Rule provides that ‘‘it is essential to
utilize a diverse skilled workforce and
constantly review and modify all
aspects of the DCP to help successfully
execute the drug trafficking disruption
goals of the National Drug Control
Strategy and effectively prevent, detect,
and eliminate the diversion of
controlled substances and listed
chemicals into the illicit market while
ensuring a sufficient supply of these
substances for legitimate medical
purposes.’’ It is in furtherance of that
constant review—and modification
when necessary—that this rule is
proposed.
This proposed rule does not request
an increase in Registration and
Reregistration Fees.
Posting of Public Comments
Please note that all comments
received in response to this docket are
considered part of the public record.
They will, unless reasonable cause is
given, be made available by the Drug
Enforcement Administration for public
inspection online at https://
www.regulations.gov. Such information
includes personal identifying
information (such as your name,
address, etc.) voluntarily submitted by
the commenter. The Freedom of
Information Act (FOIA) applies to all
comments received. If you want to
submit personal identifying information
(such as your name, address, etc.) as
part of your comment, but do not want
it to be made publicly available, you
must include the phrase ‘‘PERSONAL
IDENTIFYING INFORMATION’’ in the
first paragraph of your comment. You
must also place the personal identifying
information you do not want to be made
publicly available in the first paragraph
of your comment and identify what
information you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be made
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publicly available, you must include the
phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify confidential
business information to be redacted
within the comment.
Comments containing personal
identifying information and confidential
business information identified as
directed above will generally be made
publicly available in redacted form. If a
comment has so much confidential
business information or personal
identifying information that it cannot be
effectively redacted, all or part of that
comment may not be made publicly
available. Comments posted to https://
www.regulations.gov may include any
personal identifying information (such
as name, address, and phone number) or
confidential business information
included in the text of your electronic
submission that is not identified as
directed above as confidential.
Legal Authority/Diversion Control Fee
Account
Through the enactment of the
Comprehensive Drug Abuse Prevention
and Control Act of 1970, as amended
(CSA), Congress has established a closed
system of distribution making it
unlawful to handle any controlled
substance or listed chemical except in a
manner authorized by the CSA. In order
to maintain this closed system of
distribution, the CSA imposes
registration requirements on some
handlers of controlled substances and
list I chemicals.1 21 U.S.C. 822 and 957;
21 CFR 1301.13 and 1309.25. Under the
CSA, the DEA is authorized to charge
reasonable fees relating to the
registration and control of the
manufacture, distribution, dispensing,
import, and export of controlled
substances and listed chemicals.2 21
U.S.C. 821 and 958(f). However, the
DEA must set fees at a level that ensures
the recovery of the full costs of
operating the various aspects of its
diversion control program as outlined in
21 U.S.C. 886a. This is known as the
Diversion Control Fee Account (DCFA).
The diversion control program consists
of the controlled substance and
chemical diversion control activities of
1 Pursuant to the CSA, certain entities are
exempted from registration, from paying the
registration fee entirely, or are exempted from the
requirement of a separate registration for activities
performed as a coincident activity under a
registered business activity.
2 The Attorney General delegated authorities
under the CSA (found in titles II and III of the Act)
to the Administrator of the DEA, who in turn
redelegated many of these authorities to the
Assistant Administrator of the DEA Diversion
Control Division. 28 CFR 0.100 et seq.
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the DEA which are related to the
registration and control of the
manufacture, distribution, dispensing,
importation, and exportation of
controlled substances and listed
chemicals.3 21 U.S.C. 886a(2). The
DCFA is then utilized by the DEA in
strict compliance with 21 U.S.C. 821,
822, and 886a; the 1996 Rule; 76 FR
39318, July 6, 2011; the 2012 Rule; as
well as all applicable laws, regulations,
and DEA policy to establish and
implement the DEA registration process;
to provide regulatory oversight of DEA
registrants; and to prevent, detect, and
investigate diversion from the legal
channels prescribed by law into illegal
channels that violate the CSA.
The Tactical Diversion Squad Program
As part of the DCP, and pursuant to
21 U.S.C. 821 and 886a, and the 1996
Rule, DEA has created Tactical
Diversion Squad (TDS) units staffed by
DEA Special Agents, Diversion
Investigators, Task Force Officers
(TFOs) 4 and Intelligence Analysts to
work collaboratively to investigate the
criminal and related civil aspects of the
illegal diversion of controlled
substances. These illegal practices are
outlined in the 1996 Rule and include
prescribing or dispensing of controlled
substances outside the course of
practice, the theft of controlled
substances, pharmacy burglary and
robbery, prescription forgery and fraud,
distribution of diverted controlled
substances, and other violations of
Federal law related to the diversion of
3 The Diversion Control Division is the strategic
focus area within the Administration that carries
out the mandates of the CSA to ensure that
adequate supplies of controlled substances and
listed chemicals are available to meet legitimate
domestic medical, scientific, industrial, and export
needs. The Diversion Control Division carries out
the mission of the DEA to prevent, detect, and
eliminate the diversion of these substances into the
illicit drug market. Activities in support of the
Diversion Control Division and its mission include:
Determination of program priorities; field
management oversight; coordination of major
investigations; drafting and promulgating
regulations; the design and proposal of national
legislation; advice and leadership on State
legislation/regulatory initiatives; oversight of the
importation and exportation of tableting and
encapsulating machines, controlled substances, and
listed chemicals; establishment of national drug
production quotas; activities related to drug
scheduling and compliance with international
treaty obligations; the design and execution of
diplomatic missions; computerized monitoring and
tracking of the distribution of certain controlled
substances; planning and allocation of program
resources; and liaison efforts with industry and
their representative associations as well as to the
DEA’s regulatory and law enforcement counterparts
at the federal, State, tribal, and local levels.
4 A TFO is a sworn officer of a state or local law
enforcement agency seconded to DEA and
credentialed by DEA as a Federal law enforcement
officer.
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controlled substances. In response to
growing drug-related threats,
particularly the threats posed by opioid
abuse, the DEA has continued to grow
the TDS program. Currently, the DEA
has staffed 79 TDS groups across the
United States to attack the illegal
diversion and trafficking of
pharmaceuticals.
Of particular note, state and local law
enforcement agencies have invested 283
of their officers to work as TFOs with
the TDS Squads across the United
States. These TFOs represent the
growing understanding in the law
enforcement community of the threat
posed by the diversion of
pharmaceutical drugs into our society.
The TFOs represent a tremendous
return on investment for the DCFA as
the salaries for these officers are borne
by their respective departments, with
the DCFA reimbursing the departments
for overtime expenses and providing the
TFOs with vehicle expenses, travel
expenses, and investigative expenses.
These groups have been extremely
effective in attacking the prescription
drug diversion and abuse problem when
allied with our critical prosecution
partners within the various United
States Attorney’s Offices. As the TDS
program continues to grow, it is critical
that more resources, such as SAUSAs,
are available to prosecute these cases
when necessary.
The DEA’s Special Assistant United
States Attorney Pilot Program
The United States is currently in the
midst of an epidemic of opioid abuse
and overdose death. Drug overdose has
overtaken deaths from firearms and
automobile accidents as the leading
cause of accidental or unintentional
injury death in the United States.5 In
2014, according to the Centers for
Disease Control, opioid overdoses killed
28,000 people in the United States, with
more than half of those deaths caused
by prescription opioids. Drug overdose
death increased by 11.4% from 2014 to
2015 alone (52,404 deaths to 47,055
deaths).6 Since 1999, the amount of
opioid pain medicine prescribed in the
United States has quadrupled, with a
corresponding rise in the number of
deaths from prescription opioids. In
addition to the direct harm caused by
the abuse of opioid drugs diverted from
legitimate use, it is clear that the use
and abuse of prescription opioids is a
gateway to the use of other illegal
substances. For example, more than
5 Centers for Disease Control 2014 Deaths, Final
Data Report.
6 Centers for Disease Control, Increases in Drug
and Opioid-Involved Overdose Deaths—United
States, 2010–2015.
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80% of heroin users in the United States
used prescription drugs as a gateway to
their eventual use of heroin.
Additionally, in a 2012 study by the
Substance Abuse and Mental Health
Services Administration (SAMHSA) of
emergency room visits for drug related
overdose in young adults aged 18 to 25,
more than 11% were admitted for
misuse/abuse of benzodiazepines; more
than were admitted for use of heroin
(9.9%), cocaine (8.8%), or
methamphetamine (5.6%).7
As indicated above, to answer this
drug abuse epidemic, DEA has
dedicated increasing resources to the
DCP through the expansion of the TDS
program, which has resulted in dramatic
program growth over the past decade. In
2006, DEA had five TDS groups in
operation with only 70 Special Agents
dedicated to diversion investigations
and funded by the DCFA. By 2016, the
number of TDS groups had grown to 79,
with 340 Special Agents dedicated to
diversion investigations.
The prosecution of those responsible
for, and engaged in, criminal and related
civil diversion activity is integral to
public safety. As the number of
personnel dedicated to diversion
investigations has increased, the arrests
and potential defendants identified for
prosecution have also increased. Should
prosecutions not keep pace with these
increased activities, the reduction of the
diversion of controlled substances
cannot be accomplished. To help ensure
that the increased investment of DCFA
resources into the investigation of
diversion activity outlined in the 1996
Rule are fully realized with prosecution
efforts, the DEA, in cooperation with the
Executive Office for United States
Attorneys (EOUSA) 8 and the United
States Attorneys’ Offices, proposes to
institute a program to hire attorneys
with the requisite experience and
education to serve as Special Assistant
United States Attorneys (SAUSAs) in
targeted federal judicial districts.
Pursuant to 21 U.S.C. 821 and 886a, the
1996 Rule, and the 2012 Rule, the
hiring, training, and activities of these
attorneys will be funded by the DCFA.
Once hired, these attorneys will be
provided with additional specialized
training under this program for
prosecuting crimes resulting from
DCFA-funded investigations. The
criteria utilized in determining the
7 Substance Abuse and Mental Health Services
Administration December 2012 Report entitled
Admissions Reporting Benzodiazepine and Narcotic
Pain Reliever Abuse at Treatment Entry.
8 The Executive Office for United States Attorneys
(EOUSA) is the Department of Justice component
that provides administrative and policy oversight to
the 94 Offices of the United States Attorney.
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appropriate geographic placement of
detailed SAUSAs will be based on an
examination of several factors in each
district, including prescription drug
abuse rates; drug overdose death rates;
an analysis of opioid prescribing and
ordering; input from other Federal,
state, and local officials; the number of
DCFA-funded DEA personnel in the
district; and the input from the United
States Attorney, the Diversion Control
Division, and the DEA Special Agent in
Charge for each judicial district.
DEA proposes that the attorneys hired
as a part of this program will be directly
employed by DEA, and funded through
the DCFA. Once hired, they would be
detailed to DOJ and receive
authorization to serve as SAUSAs from
EOUSA, the United States Attorney, and
the U.S. District Court in the district of
hire to serve in the capacity of a
SAUSA. In this role, the SAUSAs would
be permitted to represent the United
States in criminal and civil proceedings
before the courts and apply for various
legal orders. All of the anticipated
activities will relate to, and result from,
those investigations conducted pursuant
to the 1996 Rule.
While the use of DEA attorneys
detailed as SAUSAs and funded through
the DCFA is a new concept, the use of
attorneys detailed as SAUSAs to
complement the capabilities of the
United States Attorneys’ Offices is not.
Applicable Department of Justice policy
states the following regarding SAUSAs
employed by other agencies:
Attorneys employed in other departments
or agencies of the federal government may be
appointed as Special Assistants to United
States Attorneys, without compensation
other than that paid by their own agency, to
assist in the trial or presentation of cases
when their services and assistance are
needed. Such appointments, and
appointments of Assistant United States
Attorneys from one United States Attorney’s
office to another, may be made by the United
States Attorney requiring their services.9
In many areas, SAUSAs have been
designated from state and local
prosecutors’ offices to allow a greater
volume of specific types of cases
(firearms cases primarily) to be
presented in federal court than would
otherwise be possible with the resources
allocated to the United States Attorneys’
Office. Likewise, funds from the Federal
High Intensity Drug Trafficking Area
(HIDTA) grant program have been
utilized to hire attorneys to serve as
SAUSAs that specifically provide
prosecutorial and legal services to
9 U.S. Dep’t of Justice, United States Attorneys’
Manual, § 3–2.300 (1998), available at https://
www.justice.gov/usam/usam-3-2000-united-statesattorneys-ausas-special-assistants-and-agac.
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narcotics task forces funded by the
HIDTA program. Both of these programs
have been highly effective and serve as
good models for the proposed use of
DCFA-funded SAUSAs to prosecute
diversion-related offenses.
The goal of this proposed effort is to
ensure the effective and efficient use of
DCFA resources dedicated to the TDS
program by providing resources to help
ensure that criminal and related civil
cases with sufficient evidence are
prosecuted in a timely manner. All
DCFA-funded SAUSAs in the program
would be utilized exclusively to support
DCFA-funded investigations conducted
by the DEA and its partnering law
enforcement agencies. The types of
investigations in which the SAUSAs
will assist, and the crimes they will
prosecute will stem from the types of
investigations identified in the 1996
Rule, which states: ‘‘The targets and
types of investigations conducted by the
DCP pursuant to 21 U.S.C. 821 are
identified below.
(1) Registrants and their agents or
employees suspected of diverting
controlled substances from legitimate
channels;
(2) Persons who engage in the
smuggling, theft, robbery and/or
trafficking of pharmaceutical controlled
substances, including, where
appropriate, identifying and
immobilizing their sources of supply,
whether domestic or foreign, through
enforcement of the controls relating to
the manufacture, distribution, import,
export, and dispensing of controlled
substances;
(3) Persons, both registered and
nonregistered, who conduct controlled
substances activities for which they do
not have the required DOA or state
authorization;
(4) Persons who obtain
pharmaceutical controlled substances
from registrants through fraud, deceit, or
circumvention of the controls on
manufacturing, distribution, or
dispensing, i.e. fraudulent use of
another person’s DEA registration
number to obtain controlled substances,
doctor shoppers, prescription forgers,
etc.;
(5) The trafficking by non-registrants
in controlled substances which are
fraudulently promoted as legitimate
therapies (such as ‘‘herbal remedies’’
sold ‘‘under the counter’’ which actually
contain a controlled substance);
(6) Persons who use their DEA
registrations to assist in the diversion or
misuse of controlled substances for
other than medical purposes, such as
health care fraud, self-abuse, trading
controlled substances for non-medical
purposes, etc.’’ 61 FR 68629.
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During the course of the
investigations described in paragraphs 1
through 6 of the 1996 Rule, additional
criminal activity may be uncovered. To
the extent this additional criminal
activity is committed by an individual
or group of individuals whose primary
criminal activity is described in
paragraphs 1 through 6 of the 1996 Rule,
and the additional criminal activity is
derivative of, or ancillary to, the illegal
activity described in those paragraphs,
the investigations have included this
additional criminal activity, and these
crimes will be prosecuted by the
SAUSAs described in this proposed
rule. Examples of this type of additional
criminal activity would include
weapons offenses or crimes of violence
in support of diversion offenses; money
laundering, structuring or other
financial violation to support diversion
offenses, or utilizing monies derived
from diversion offenses; the use of a
telecommunication device in support of
diversion offenses; and the forfeiture of
assets derived from, or facilitating,
diversion offenses.
Cost of the SAUSA Program
The DEA proposes to initially hire 20
attorneys utilizing funding from the
DCFA to implement the program. The
initial 20 attorneys would be selected to
serve in a minimum of 12 and
maximum of 20 federal judicial districts
at an estimated annual cost of $3.8
million.10 With an annual,
Congressionally-approved budget of
more than $371,000,000.00 (Fiscal Year
2016), the expenditures related to the
SAUSA program would comprise only
1% of the annual DCFA budget. As a
result of the low cost in comparison to
the overall DCFA budget, as well as the
reprioritization of other DCFA
expenditures, this project is not
expected to result in an increase to the
registration fee schedule. If finalized,
this program would be continually
evaluated by the DEA to ensure that
DCFA funding is spent in accordance
with guidelines for the use of DCFA
funding found in 21 U.S.C. 821, 822,
and 886a; the 1996 Rule; 76 FR 39318,
July 6, 2011; and the 2012 Rule. DEA
would also continuously evaluate the
program to ensure that the project is
successful in securing the criminal and
civil prosecutions necessary to justify
10 The
cost estimate for the 20 positions is based
on the U.S. Office of Personnel Management 2016
General Schedule (GS) Locality Pay Table for
‘‘Washington-Baltimore-Arlington, DC–MD–VA–
WV–PA’’ at the GS–15 Step 5 level of $145,162. The
‘‘Washington-Baltimore-Arlington, DC–MD–VA–
WV–PA’’ is used to be conservative. Including an
estimated 30% for benefits, the estimated cost per
position is $188,711 per year, or $3,774,212 ($3.8
million) per year for all 20 positions.
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the continued expenditure of DCFA
funding.
Regulatory Analyses
Executive Orders 12866 and 13563
This proposed rule was developed in
accordance with the principles of
Executive Orders 12866 and 13563. As
described previously, the estimated
annual cost of $3.8 million is less than
1% of the annual DCFA budget and
sufficient funding exists in the DCFA
budget to allow for this program due to
the reprioritization of other budgetary
items within the DCP. This program will
result in a net zero economic effect and
no impact on registration fees.
Therefore, the DEA does not anticipate
that this rulemaking will have an annual
effect on the economy of $100 million
or more or adversely affect in a material
way the economy, a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or state, local, or tribal
governments or communities.
This proposed rule is not a
‘‘significant regulatory action’’ under
Executive Order 12866 Section 3(f).
Executive Order 12988
This proposed rule meets the
applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive
Order 12988, Civil Justice Reform to
eliminate ambiguity, minimize
litigation, establish clear legal
standards, and reduce burden.
Executive Order 13132
This rulemaking does not have
federalism implications warranting the
application of Executive Order 13132.
The rule does not have substantial
direct effects on the States, on the
relationship between the national
government and the States, or the
distribution of power and
responsibilities among the various
levels of government.
Executive Order 13175
This proposed rule does not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or the
distribution of power and
responsibilities between the Federal
Government and Indian tribes.
Unfunded Mandates Reform Act
This proposed rule will not result in
the expenditure by state, local, and
tribal governments, in the aggregate, or
by the private sector, of $100,000,000 or
more (adjusted for inflation) in any one
year, and will not significantly or
uniquely affect small governments.
Therefore, no actions were deemed
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21MRP1
14494
Federal Register / Vol. 82, No. 53 / Tuesday, March 21, 2017 / Proposed Rules
necessary under the provisions of the
Unfunded Mandates Reform Act of
1995, 2 U.S.C. 1532.
Regulatory Flexibility Act
The Administrator, in accordance
with the Regulatory Flexibility Act (5
U.S.C. 601–612) (RFA), has reviewed
this proposed rule and by approving it
certifies that the rule will not, if
promulgated, have a significant
economic impact on a substantial
number of small entities. There are
nearly 1.7 million DEA registrations, of
which, a large majority either are held
by small entities or are those employed
by small entities. As discussed above,
the DEA estimates the estimated annual
cost of $3.8 million is offset by
reprioritization of other DCFA
expenditures, resulting in a net zero
economic effect and no impact on
registration fees for any registrants.
Therefore, the DEA estimates that the
rule will not, if promulgated, have a
significant effect on a substantial
number of these small entities.
Paperwork Reduction Act of 1995
This action does not impose a new
collection of information requirement
under the Paperwork Reduction Act of
1995. 44 U.S.C. 3501–3521
Dated: March 11, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017–05396 Filed 3–20–17; 8:45 am]
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket Number USCG–2017–0168]
RIN 1625–AA08
Special Local Regulation; Corsica
River, Queen Anne’s County, MD
Coast Guard, DHS.
Notice of proposed rulemaking.
AGENCY:
The Coast Guard proposes to
establish special local regulations for
certain waters of the Corsica River. This
action is necessary to provide for the
safety of life on the navigable waters
located in Queen Anne’s County, MD
during a rowing event on April 22,
2017. If necessary, due to inclement
weather, the event will be rescheduled
to April 23, 2017. This proposed
rulemaking would prohibit persons and
vessels from entering the regulated area
unless authorized by the Captain of the
mstockstill on DSK3G9T082PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
15:59 Mar 20, 2017
Jkt 241001
If
you have questions about this proposed
rulemaking, call or email Mr. Ronald
Houck, U.S. Coast Guard Sector
Maryland-National Capital Region;
telephone 410–576–2674, email
Ronald.L.Houck@uscg.mil.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Table of Abbreviations
CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
E.O. Executive order
FR Federal Register
NPRM Notice of proposed rulemaking
Pub. L. Public Law
§ Section
U.S.C. United States Code
II. Background, Purpose, and Legal
Basis
BILLING CODE 4410–09–P
ACTION:
Port Maryland-National Capital Region
or the Coast Guard Patrol Commander.
We invite your comments on this
proposed rulemaking.
DATES: Comments and related material
must be received by the Coast Guard on
or before April 20, 2017.
ADDRESSES: You may submit comments
identified by docket number USCG–
2017–0168 using the Federal
eRulemaking Portal at https://
www.regulations.gov. See the ‘‘Public
Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
On February 16, 2017, The Gunston
School of Centreville, MD notified the
Coast Guard that it will be conducting
a rowing regatta from 8 a.m. until 2 p.m.
on April 22, 2017, and if necessary, due
to inclement weather, from 8 a.m. until
2 p.m. on April 23, 2017. The high
school rowing event consists of
approximately 30 participants
competing on a designated 1500-meter
distance course in the Corsica River that
starts at Rocky Point and finishes at
Jacobs Nose near Centreville, MD.
Hazards from the rowing competition
include participants operating within
and adjacent to the designated
navigation channel and interfering with
vessels intending to operate within that
channel, as well as rowing within
approaches to local public and private
marinas and boat facilities. The COTP
Maryland-National Capital Region has
determined that potential hazards
associated with the rowing event would
be a safety concern for anyone intending
to participate in this event or for vessels
that operate within specified waters of
the Corsica River in Queen Anne’s
County, MD.
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
The purpose of this rulemaking is to
protect event participants, spectators
and transiting vessels on specified
waters of the Corsica River before,
during, and after the scheduled event.
The Coast Guard proposes this
rulemaking under authority in 33 U.S.C.
1233, which authorize the Coast Guard
to establish and define special local
regulations.
III. Discussion of Proposed Rule
The COTP Maryland-National Capital
Region proposes to establish special
local regulations from 7:30 a.m. until
2:30 p.m. on April 22, 2017, and if
necessary, due to inclement weather,
from 7:30 a.m. until 2:30 p.m. on April
23, 2017. The regulated area would
include all navigable waters of the
Corsica River, from shoreline to
shoreline, within an area bounded on
the east by a line drawn from latitude
39°04′32″ N., longitude 076°05′20″ W.,
thence south to latitude 39°04′07″ N.,
longitude 076°05′20″ W., and bounded
on the west by a line drawn from
latitude 39°04′59″ N., longitude
076°06′30″ W., thence south to latitude
39°04′44″ N., longitude 076°06′30″ W.,
located near Centreville, MD. The
duration of the regulated area is
intended to ensure the safety of event
participants and vessels within the
specified navigable waters before,
during, and after the scheduled 8 a.m.
until 2 p.m. rowing competition. Except
for The Gunston Invitational
participants, no vessel or person would
be permitted to enter the regulated area
without obtaining permission from the
COTP Maryland-National Capital
Region or the Coast Guard Patrol
Commander. The regulatory text we are
proposing appears at the end of this
document.
IV. Regulatory Analyses
We developed this proposed rule after
considering numerous statutes and
Executive orders (E.O.s) related to
rulemaking. Below we summarize our
analyses based on a number of these
statutes and E.O.s, and we discuss First
Amendment rights of protestors.
A. Regulatory Planning and Review
E.O.s 12866 and 13563 direct agencies
to assess the costs and benefits of
available regulatory alternatives and, if
regulation is necessary, to select
regulatory approaches that maximize
net benefits. E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. This NPRM has not been
designated a ‘‘significant regulatory
action,’’ under E.O. 12866. Accordingly,
E:\FR\FM\21MRP1.SGM
21MRP1
Agencies
[Federal Register Volume 82, Number 53 (Tuesday, March 21, 2017)]
[Proposed Rules]
[Pages 14490-14494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05396]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1301 and 1311
[Docket No. DEA-445N]
Program To Hire Special Assistant United States Attorneys in
Targeted Federal Judicial Districts Utilizing Diversion Control Fee
Account Funds
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration (DEA) is proposing a rule
that would expand and enhance the enforcement component of the
Diversion Control Program (DCP) as previously outlined in the December
30, 1996, Federal Register document ``Registration and Reregistration
Application Fees,'' hereinafter referred to as the 1996 Rule. The 1996
Rule specified six types of investigations involving the diversion of
controlled substances, which could be pursued by the DCP utilizing
funding from the Diversion Control Fee Account (DCFA). Those
investigations included the theft or robbery of pharmaceutical
controlled substances, the acquisition of pharmaceutical controlled
substances through fraud or deceit, and other illegal diversion
activities. The 1996 Rule also authorized the continued use and
expansion by the DCP of Tactical Diversion Squads (TDSs), defined as,
``enforcement teams consisting of Federal, state, and local law
enforcement personnel fully dedicated to the investigation and
prosecution of persons involved in the diversion of controlled
substances.''
DATES: Electronic comments must be submitted, and written comments must
be postmarked, on or before April 20, 2017. Commenters should be aware
that the electronic Federal Docket Management System will not accept
comments after 11:59 p.m. Eastern Time on the last day of the comment
period.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-445N'' on all correspondence, including any
attachments.
The Drug Enforcement Administration encourages that all comments be
submitted through the Federal eRulemaking Portal, which provides the
ability to type short comments directly into the comment field on the
Web page or to attach a file for lengthier comments. Please go to
https://www.regulations.gov and follow the online instructions at that
site for submitting comments. Upon completion of your submission you
will receive a Comment Tracking Number for your comment. Please be
aware that submitted comments are not instantaneously available for
public view on Regulations.gov. If you have received a Comment Tracking
Number, your comment has been successfully submitted and there is no
need to resubmit the same comment. Paper comments that duplicate an
electronic submission are not necessary and are discouraged. Should you
wish to mail a paper comment in lieu of an electronic comment, it
should be sent via regular or express mail to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION: This proposed rule would expand on the
already-recognized investigative activities funded by the DCFA and
allow for the hiring of attorneys in support of these activities. The
attorneys, hired by DEA and paid with funds from the DCFA, will be
detailed to the Department of Justice (DOJ) as Special Assistant United
States Attorneys (SAUSAs), and will assist in the investigation and
prosecution of those diversion crimes outlined in the 1996 Rule, and
related civil actions. DCFA-funded SAUSAs in the program would be
exclusively engaged in duties which provide investigative and
prosecutorial support to federal criminal and related civil diversion
investigations conducted by the DEA and its partnering law enforcement
agencies. The investigations, and the companion support provided by the
attorneys detailed as SAUSAs in this program, will adhere to the
guidelines for the use of DCFA funding found in Title 21, United States
Code, 821, 822, and 886a; the 1996 Rule, 76 FR 39318, July 6, 2011; and
77 FR 15234, March 15, 2012.
In addition, the proposed rule would authorize the SAUSAs hired by
DEA and detailed to DOJ to prosecute crimes that are derivative or
ancillary criminal violations to the diversion crimes outlined in the
1996 Rule. Examples of these ancillary or derivative crimes would
include money laundering or other financial crimes involving the
proceeds of diversion activity; firearms and crimes of violence related
to or caused by diversion activity; use of a communication facility to
commit diversion crimes; and the forfeiture of assets which facilitate
or are derived from diversion activity.
In addition to protecting the public, the proposed rule will
enhance the protections provided to the DEA registrant community by the
DCP by ensuring that those engaged in criminal and related civil
violations affecting the DEA registrant population are apprehended,
and, equally as important, prosecuted. The proposed rule will ensure
that illegal activities that
[[Page 14491]]
endanger the safety of registrants and their employees (burglary and
robbery of registered locations); threatens the credibility and
financial stability of registrants and their employees (prescription
forgery, fraud, and theft); and damages the public perception and
reputation of the registrant community (prescribing or dispensing
outside the course of medical practice and other offenses committed by
registrants) will be fully addressed through robust investigation and
prosecution.
The proposed rule is a continuation of the concepts outlined in
``Controlled Substances and List 1 Chemical Registration and
Reregistration Fees,'' 77 FR 15234 (Mar. 15, 2012), hereinafter
referred to as the 2012 Rule. The 2012 Rule provides that ``it is
essential to utilize a diverse skilled workforce and constantly review
and modify all aspects of the DCP to help successfully execute the drug
trafficking disruption goals of the National Drug Control Strategy and
effectively prevent, detect, and eliminate the diversion of controlled
substances and listed chemicals into the illicit market while ensuring
a sufficient supply of these substances for legitimate medical
purposes.'' It is in furtherance of that constant review--and
modification when necessary--that this rule is proposed.
This proposed rule does not request an increase in Registration and
Reregistration Fees.
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. They will, unless reasonable
cause is given, be made available by the Drug Enforcement
Administration for public inspection online at https://www.regulations.gov. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter. The Freedom of Information Act (FOIA) applies to all
comments received. If you want to submit personal identifying
information (such as your name, address, etc.) as part of your comment,
but do not want it to be made publicly available, you must include the
phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of
your comment. You must also place the personal identifying information
you do not want to be made publicly available in the first paragraph of
your comment and identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify
confidential business information to be redacted within the comment.
Comments containing personal identifying information and
confidential business information identified as directed above will
generally be made publicly available in redacted form. If a comment has
so much confidential business information or personal identifying
information that it cannot be effectively redacted, all or part of that
comment may not be made publicly available. Comments posted to https://www.regulations.gov may include any personal identifying information
(such as name, address, and phone number) or confidential business
information included in the text of your electronic submission that is
not identified as directed above as confidential.
Legal Authority/Diversion Control Fee Account
Through the enactment of the Comprehensive Drug Abuse Prevention
and Control Act of 1970, as amended (CSA), Congress has established a
closed system of distribution making it unlawful to handle any
controlled substance or listed chemical except in a manner authorized
by the CSA. In order to maintain this closed system of distribution,
the CSA imposes registration requirements on some handlers of
controlled substances and list I chemicals.\1\ 21 U.S.C. 822 and 957;
21 CFR 1301.13 and 1309.25. Under the CSA, the DEA is authorized to
charge reasonable fees relating to the registration and control of the
manufacture, distribution, dispensing, import, and export of controlled
substances and listed chemicals.\2\ 21 U.S.C. 821 and 958(f). However,
the DEA must set fees at a level that ensures the recovery of the full
costs of operating the various aspects of its diversion control program
as outlined in 21 U.S.C. 886a. This is known as the Diversion Control
Fee Account (DCFA). The diversion control program consists of the
controlled substance and chemical diversion control activities of the
DEA which are related to the registration and control of the
manufacture, distribution, dispensing, importation, and exportation of
controlled substances and listed chemicals.\3\ 21 U.S.C. 886a(2). The
DCFA is then utilized by the DEA in strict compliance with 21 U.S.C.
821, 822, and 886a; the 1996 Rule; 76 FR 39318, July 6, 2011; the 2012
Rule; as well as all applicable laws, regulations, and DEA policy to
establish and implement the DEA registration process; to provide
regulatory oversight of DEA registrants; and to prevent, detect, and
investigate diversion from the legal channels prescribed by law into
illegal channels that violate the CSA.
---------------------------------------------------------------------------
\1\ Pursuant to the CSA, certain entities are exempted from
registration, from paying the registration fee entirely, or are
exempted from the requirement of a separate registration for
activities performed as a coincident activity under a registered
business activity.
\2\ The Attorney General delegated authorities under the CSA
(found in titles II and III of the Act) to the Administrator of the
DEA, who in turn redelegated many of these authorities to the
Assistant Administrator of the DEA Diversion Control Division. 28
CFR 0.100 et seq.
\3\ The Diversion Control Division is the strategic focus area
within the Administration that carries out the mandates of the CSA
to ensure that adequate supplies of controlled substances and listed
chemicals are available to meet legitimate domestic medical,
scientific, industrial, and export needs. The Diversion Control
Division carries out the mission of the DEA to prevent, detect, and
eliminate the diversion of these substances into the illicit drug
market. Activities in support of the Diversion Control Division and
its mission include: Determination of program priorities; field
management oversight; coordination of major investigations; drafting
and promulgating regulations; the design and proposal of national
legislation; advice and leadership on State legislation/regulatory
initiatives; oversight of the importation and exportation of
tableting and encapsulating machines, controlled substances, and
listed chemicals; establishment of national drug production quotas;
activities related to drug scheduling and compliance with
international treaty obligations; the design and execution of
diplomatic missions; computerized monitoring and tracking of the
distribution of certain controlled substances; planning and
allocation of program resources; and liaison efforts with industry
and their representative associations as well as to the DEA's
regulatory and law enforcement counterparts at the federal, State,
tribal, and local levels.
---------------------------------------------------------------------------
The Tactical Diversion Squad Program
As part of the DCP, and pursuant to 21 U.S.C. 821 and 886a, and the
1996 Rule, DEA has created Tactical Diversion Squad (TDS) units staffed
by DEA Special Agents, Diversion Investigators, Task Force Officers
(TFOs) \4\ and Intelligence Analysts to work collaboratively to
investigate the criminal and related civil aspects of the illegal
diversion of controlled substances. These illegal practices are
outlined in the 1996 Rule and include prescribing or dispensing of
controlled substances outside the course of practice, the theft of
controlled substances, pharmacy burglary and robbery, prescription
forgery and fraud, distribution of diverted controlled substances, and
other violations of Federal law related to the diversion of
[[Page 14492]]
controlled substances. In response to growing drug-related threats,
particularly the threats posed by opioid abuse, the DEA has continued
to grow the TDS program. Currently, the DEA has staffed 79 TDS groups
across the United States to attack the illegal diversion and
trafficking of pharmaceuticals.
---------------------------------------------------------------------------
\4\ A TFO is a sworn officer of a state or local law enforcement
agency seconded to DEA and credentialed by DEA as a Federal law
enforcement officer.
---------------------------------------------------------------------------
Of particular note, state and local law enforcement agencies have
invested 283 of their officers to work as TFOs with the TDS Squads
across the United States. These TFOs represent the growing
understanding in the law enforcement community of the threat posed by
the diversion of pharmaceutical drugs into our society. The TFOs
represent a tremendous return on investment for the DCFA as the
salaries for these officers are borne by their respective departments,
with the DCFA reimbursing the departments for overtime expenses and
providing the TFOs with vehicle expenses, travel expenses, and
investigative expenses. These groups have been extremely effective in
attacking the prescription drug diversion and abuse problem when allied
with our critical prosecution partners within the various United States
Attorney's Offices. As the TDS program continues to grow, it is
critical that more resources, such as SAUSAs, are available to
prosecute these cases when necessary.
The DEA's Special Assistant United States Attorney Pilot Program
The United States is currently in the midst of an epidemic of
opioid abuse and overdose death. Drug overdose has overtaken deaths
from firearms and automobile accidents as the leading cause of
accidental or unintentional injury death in the United States.\5\ In
2014, according to the Centers for Disease Control, opioid overdoses
killed 28,000 people in the United States, with more than half of those
deaths caused by prescription opioids. Drug overdose death increased by
11.4% from 2014 to 2015 alone (52,404 deaths to 47,055 deaths).\6\
Since 1999, the amount of opioid pain medicine prescribed in the United
States has quadrupled, with a corresponding rise in the number of
deaths from prescription opioids. In addition to the direct harm caused
by the abuse of opioid drugs diverted from legitimate use, it is clear
that the use and abuse of prescription opioids is a gateway to the use
of other illegal substances. For example, more than 80% of heroin users
in the United States used prescription drugs as a gateway to their
eventual use of heroin.
---------------------------------------------------------------------------
\5\ Centers for Disease Control 2014 Deaths, Final Data Report.
\6\ Centers for Disease Control, Increases in Drug and Opioid-
Involved Overdose Deaths--United States, 2010-2015.
---------------------------------------------------------------------------
Additionally, in a 2012 study by the Substance Abuse and Mental
Health Services Administration (SAMHSA) of emergency room visits for
drug related overdose in young adults aged 18 to 25, more than 11% were
admitted for misuse/abuse of benzodiazepines; more than were admitted
for use of heroin (9.9%), cocaine (8.8%), or methamphetamine (5.6%).\7\
---------------------------------------------------------------------------
\7\ Substance Abuse and Mental Health Services Administration
December 2012 Report entitled Admissions Reporting Benzodiazepine
and Narcotic Pain Reliever Abuse at Treatment Entry.
---------------------------------------------------------------------------
As indicated above, to answer this drug abuse epidemic, DEA has
dedicated increasing resources to the DCP through the expansion of the
TDS program, which has resulted in dramatic program growth over the
past decade. In 2006, DEA had five TDS groups in operation with only 70
Special Agents dedicated to diversion investigations and funded by the
DCFA. By 2016, the number of TDS groups had grown to 79, with 340
Special Agents dedicated to diversion investigations.
The prosecution of those responsible for, and engaged in, criminal
and related civil diversion activity is integral to public safety. As
the number of personnel dedicated to diversion investigations has
increased, the arrests and potential defendants identified for
prosecution have also increased. Should prosecutions not keep pace with
these increased activities, the reduction of the diversion of
controlled substances cannot be accomplished. To help ensure that the
increased investment of DCFA resources into the investigation of
diversion activity outlined in the 1996 Rule are fully realized with
prosecution efforts, the DEA, in cooperation with the Executive Office
for United States Attorneys (EOUSA) \8\ and the United States
Attorneys' Offices, proposes to institute a program to hire attorneys
with the requisite experience and education to serve as Special
Assistant United States Attorneys (SAUSAs) in targeted federal judicial
districts. Pursuant to 21 U.S.C. 821 and 886a, the 1996 Rule, and the
2012 Rule, the hiring, training, and activities of these attorneys will
be funded by the DCFA. Once hired, these attorneys will be provided
with additional specialized training under this program for prosecuting
crimes resulting from DCFA-funded investigations. The criteria utilized
in determining the appropriate geographic placement of detailed SAUSAs
will be based on an examination of several factors in each district,
including prescription drug abuse rates; drug overdose death rates; an
analysis of opioid prescribing and ordering; input from other Federal,
state, and local officials; the number of DCFA-funded DEA personnel in
the district; and the input from the United States Attorney, the
Diversion Control Division, and the DEA Special Agent in Charge for
each judicial district.
---------------------------------------------------------------------------
\8\ The Executive Office for United States Attorneys (EOUSA) is
the Department of Justice component that provides administrative and
policy oversight to the 94 Offices of the United States Attorney.
---------------------------------------------------------------------------
DEA proposes that the attorneys hired as a part of this program
will be directly employed by DEA, and funded through the DCFA. Once
hired, they would be detailed to DOJ and receive authorization to serve
as SAUSAs from EOUSA, the United States Attorney, and the U.S. District
Court in the district of hire to serve in the capacity of a SAUSA. In
this role, the SAUSAs would be permitted to represent the United States
in criminal and civil proceedings before the courts and apply for
various legal orders. All of the anticipated activities will relate to,
and result from, those investigations conducted pursuant to the 1996
Rule.
While the use of DEA attorneys detailed as SAUSAs and funded
through the DCFA is a new concept, the use of attorneys detailed as
SAUSAs to complement the capabilities of the United States Attorneys'
Offices is not. Applicable Department of Justice policy states the
following regarding SAUSAs employed by other agencies:
Attorneys employed in other departments or agencies of the
federal government may be appointed as Special Assistants to United
States Attorneys, without compensation other than that paid by their
own agency, to assist in the trial or presentation of cases when
their services and assistance are needed. Such appointments, and
appointments of Assistant United States Attorneys from one United
States Attorney's office to another, may be made by the United
States Attorney requiring their services.\9\
---------------------------------------------------------------------------
\9\ U.S. Dep't of Justice, United States Attorneys' Manual,
Sec. 3-2.300 (1998), available at https://www.justice.gov/usam/usam-3-2000-united-states-attorneys-ausas-special-assistants-and-agac.
In many areas, SAUSAs have been designated from state and local
prosecutors' offices to allow a greater volume of specific types of
cases (firearms cases primarily) to be presented in federal court than
would otherwise be possible with the resources allocated to the United
States Attorneys' Office. Likewise, funds from the Federal High
Intensity Drug Trafficking Area (HIDTA) grant program have been
utilized to hire attorneys to serve as SAUSAs that specifically provide
prosecutorial and legal services to
[[Page 14493]]
narcotics task forces funded by the HIDTA program. Both of these
programs have been highly effective and serve as good models for the
proposed use of DCFA-funded SAUSAs to prosecute diversion-related
offenses.
The goal of this proposed effort is to ensure the effective and
efficient use of DCFA resources dedicated to the TDS program by
providing resources to help ensure that criminal and related civil
cases with sufficient evidence are prosecuted in a timely manner. All
DCFA-funded SAUSAs in the program would be utilized exclusively to
support DCFA-funded investigations conducted by the DEA and its
partnering law enforcement agencies. The types of investigations in
which the SAUSAs will assist, and the crimes they will prosecute will
stem from the types of investigations identified in the 1996 Rule,
which states: ``The targets and types of investigations conducted by
the DCP pursuant to 21 U.S.C. 821 are identified below.
(1) Registrants and their agents or employees suspected of
diverting controlled substances from legitimate channels;
(2) Persons who engage in the smuggling, theft, robbery and/or
trafficking of pharmaceutical controlled substances, including, where
appropriate, identifying and immobilizing their sources of supply,
whether domestic or foreign, through enforcement of the controls
relating to the manufacture, distribution, import, export, and
dispensing of controlled substances;
(3) Persons, both registered and nonregistered, who conduct
controlled substances activities for which they do not have the
required DOA or state authorization;
(4) Persons who obtain pharmaceutical controlled substances from
registrants through fraud, deceit, or circumvention of the controls on
manufacturing, distribution, or dispensing, i.e. fraudulent use of
another person's DEA registration number to obtain controlled
substances, doctor shoppers, prescription forgers, etc.;
(5) The trafficking by non-registrants in controlled substances
which are fraudulently promoted as legitimate therapies (such as
``herbal remedies'' sold ``under the counter'' which actually contain a
controlled substance);
(6) Persons who use their DEA registrations to assist in the
diversion or misuse of controlled substances for other than medical
purposes, such as health care fraud, self-abuse, trading controlled
substances for non-medical purposes, etc.'' 61 FR 68629.
During the course of the investigations described in paragraphs 1
through 6 of the 1996 Rule, additional criminal activity may be
uncovered. To the extent this additional criminal activity is committed
by an individual or group of individuals whose primary criminal
activity is described in paragraphs 1 through 6 of the 1996 Rule, and
the additional criminal activity is derivative of, or ancillary to, the
illegal activity described in those paragraphs, the investigations have
included this additional criminal activity, and these crimes will be
prosecuted by the SAUSAs described in this proposed rule. Examples of
this type of additional criminal activity would include weapons
offenses or crimes of violence in support of diversion offenses; money
laundering, structuring or other financial violation to support
diversion offenses, or utilizing monies derived from diversion
offenses; the use of a telecommunication device in support of diversion
offenses; and the forfeiture of assets derived from, or facilitating,
diversion offenses.
Cost of the SAUSA Program
The DEA proposes to initially hire 20 attorneys utilizing funding
from the DCFA to implement the program. The initial 20 attorneys would
be selected to serve in a minimum of 12 and maximum of 20 federal
judicial districts at an estimated annual cost of $3.8 million.\10\
With an annual, Congressionally-approved budget of more than
$371,000,000.00 (Fiscal Year 2016), the expenditures related to the
SAUSA program would comprise only 1% of the annual DCFA budget. As a
result of the low cost in comparison to the overall DCFA budget, as
well as the reprioritization of other DCFA expenditures, this project
is not expected to result in an increase to the registration fee
schedule. If finalized, this program would be continually evaluated by
the DEA to ensure that DCFA funding is spent in accordance with
guidelines for the use of DCFA funding found in 21 U.S.C. 821, 822, and
886a; the 1996 Rule; 76 FR 39318, July 6, 2011; and the 2012 Rule. DEA
would also continuously evaluate the program to ensure that the project
is successful in securing the criminal and civil prosecutions necessary
to justify the continued expenditure of DCFA funding.
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\10\ The cost estimate for the 20 positions is based on the U.S.
Office of Personnel Management 2016 General Schedule (GS) Locality
Pay Table for ``Washington-Baltimore-Arlington, DC-MD-VA-WV-PA'' at
the GS-15 Step 5 level of $145,162. The ``Washington-Baltimore-
Arlington, DC-MD-VA-WV-PA'' is used to be conservative. Including an
estimated 30% for benefits, the estimated cost per position is
$188,711 per year, or $3,774,212 ($3.8 million) per year for all 20
positions.
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Regulatory Analyses
Executive Orders 12866 and 13563
This proposed rule was developed in accordance with the principles
of Executive Orders 12866 and 13563. As described previously, the
estimated annual cost of $3.8 million is less than 1% of the annual
DCFA budget and sufficient funding exists in the DCFA budget to allow
for this program due to the reprioritization of other budgetary items
within the DCP. This program will result in a net zero economic effect
and no impact on registration fees. Therefore, the DEA does not
anticipate that this rulemaking will have an annual effect on the
economy of $100 million or more or adversely affect in a material way
the economy, a sector of the economy, productivity, competition, jobs,
the environment, public health or safety, or state, local, or tribal
governments or communities.
This proposed rule is not a ``significant regulatory action'' under
Executive Order 12866 Section 3(f).
Executive Order 12988
This proposed rule meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice
Reform to eliminate ambiguity, minimize litigation, establish clear
legal standards, and reduce burden.
Executive Order 13132
This rulemaking does not have federalism implications warranting
the application of Executive Order 13132. The rule does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or the distribution of power
and responsibilities among the various levels of government.
Executive Order 13175
This proposed rule does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or the distribution of power and responsibilities between the
Federal Government and Indian tribes.
Unfunded Mandates Reform Act
This proposed rule will not result in the expenditure by state,
local, and tribal governments, in the aggregate, or by the private
sector, of $100,000,000 or more (adjusted for inflation) in any one
year, and will not significantly or uniquely affect small governments.
Therefore, no actions were deemed
[[Page 14494]]
necessary under the provisions of the Unfunded Mandates Reform Act of
1995, 2 U.S.C. 1532.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act (5 U.S.C. 601-612) (RFA), has reviewed this proposed rule and by
approving it certifies that the rule will not, if promulgated, have a
significant economic impact on a substantial number of small entities.
There are nearly 1.7 million DEA registrations, of which, a large
majority either are held by small entities or are those employed by
small entities. As discussed above, the DEA estimates the estimated
annual cost of $3.8 million is offset by reprioritization of other DCFA
expenditures, resulting in a net zero economic effect and no impact on
registration fees for any registrants. Therefore, the DEA estimates
that the rule will not, if promulgated, have a significant effect on a
substantial number of these small entities.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521
Dated: March 11, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-05396 Filed 3-20-17; 8:45 am]
BILLING CODE 4410-09-P