[Federal Register Volume 61, Number 251 (Monday, December 30, 1996)]
[Rules and Regulations]
[Pages 68624-68632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32953]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR PARTS 1301 and 1311
[DEA Number 140R]
RIN NUMBER 1117-AA34
Registration and Reregistration Application Fees
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule; remanded for further notice and comment.
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SUMMARY: On October 6, 1992, Congress passed the Departments of
Commerce, Justice, and State, the Judiciary, and Related Agencies
Appropriations Act of 1993, Pub. L. No. 102-395, 106 Stat. 1828 (1992)
(codified at 21 U.S.C. 886a) (Act). In section 886a(3) of this Act,
Congress directed that ``fees charged by the DEA under its Diversion
Control Program (DCP) shall be set at a level that ensures the recovery
of the full costs of operating the various aspects of the (diversion
control) program.'' On December 18, 1992, DEA published its proposal to
adjust the existing registration fee schedule. 57 FR 60,148. After
notice and comment, DEA published a Final Rule on March 22, 1993,
setting the new registration fees. 58 FR 15,272.
Following publication of the final rule, a complaint was filed by
the American Medical Association (AMA) and others in the United States
District Court for the District of Columbia. On July 5, 1994, the
district court issued its final order granting the government's motion
for summary judgment, and thus disposed of all claims with respect to
all parties. American Medical Association v. Reno, 857 F. Supp. 80
(D.D.C. 1994). The AMA appealed. On June 27, 1995, the United States
Court of Appeals for the District of Columbia Circuit issued its
decision holding that DEA's rulemaking was inadequate and that the rule
must be remanded, without being vacated, to the DEA for further
proceedings in which DEA provides both an opportunity for meaningful
notice and comment on, and an explanation of, the components of the
diversion control program. 57 F.3d 1129 (D.C. Cir. 1995) On August 29,
1995, the United States Court of Appeals for the District of Columbia
Circuit remanded this action to the district court with instructions.
On November 22, 1995, the District Court remanded the matter to DEA for
proceedings consistent with the opinion of the United States Court of
Appeals for the District of Columbia Circuit. This document responds to
that requirement and provides a description of the components of the
fee-funded diversion control program.
DATES: Comments and objections must be submitted on or before March 31,
1997.
FOR FURTHER INFORMATION CONTACT:
Mr. G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of
Diversion Control, Drug Enforcement Administration, Washington, DC
20537, Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION: The Departments of Commerce, Justice, and
State, the Judiciary, and Related Agencies Appropriations Act of 1993
(Pub. L. 102-395) required that DEA recover the costs associated with
the DCP through fees charged by DEA under that program. Therefore, DEA
published a notice of proposed rulemaking (NPRM) in the Federal
Register on December 18, 1992 (57 FR 60148) proposing to amend the fees
set forth in Title 21, Code of Federal Regulations (21 CFR),
Secs. 1301.11 and 1311.11. On March 22, 1993, following notice and
comment, DEA published a final rule in the Federal Register amending
the fees.
DEA's rulemaking was challenged in court, in part on the grounds
that it failed to provide adequate notice or explanation of the costs
and scope of the DCP to be funded through the fees. While the United
States District Court upheld the rule, on appeal, the United States
Court of Appeals, District of Columbia Circuit decided on August 29,
1995, that the rulemaking was to be remanded, without being vacated, to
DEA in order to identify the components of the fee-funded DCP and
provide a brief explanation of why DEA deemed each component to be part
of that program. Such description was to provide the opportunity for
meaningful notice and comment regarding the established fee. AMA, et
al. v. Janet Reno, Attorney General, et al., 57 F.3d 1129 (D.C. Cir.
1995). In response to the decision of the court, the following
explanation of the various components of the DCP is provided. Since the
court did not vacate the final rule, DEA is not republishing either the
original NPRM or final rule. Persons seeking further information
regarding those notices should see the December 18, 1992 issue of the
Federal Register (57 FR 60148) for the NPRM and the March 22, 1993
issue of the Federal Register (58 FR 15272) for the final rule.
Background of The Budget Item ``Diversion Control Program''
The Comprehensive Drug Abuse Prevention and Control Act of 1970
(Pub. L. 91-513, commonly known as the Controlled Substances Act and
the Controlled Substances Import and Export Act (CSA)), established the
current Federal authority and programs to control the manufacture,
distribution, importation, exportation and dispensing of ``controlled
substances'' and to prevent the diversion of such substances from
legitimate medical, scientific, research, and industrial channels into
the illicit traffic. The CSA established a system of scheduling of
substances, registration of legitimate handlers, production quotas,
dispensing and distribution controls, record-keeping and reporting,
import/export provisions, and penalties for violations of the CSA. It
also mandated administrative and enforcement provisions, and
cooperative efforts with state and local authorities. Additionally, as
discussed in the later section regarding international activities, the
United States has obligations under the United Nations Single
Convention on Narcotic Drugs, 1961 (1961 Convention), and the
Convention on Psychotropic Substances, 1971 (1971 Convention) (referred
to collectively as the international treaties), to which it is a party,
with respect to international control and cooperation to prevent the
diversion of controlled substances. The CSA programs relating to the
registration and control of the manufacture, distribution, and
dispensing of controlled substances are the domestic mechanism for
implementing these treaty provisions. Over the past 25 years, the CSA
has
[[Page 68625]]
been amended to include various enhancements and refinements needed to
achieve the goals of the CSA and fulfill the U.S.'s obligations under
international treaties in an ever changing milieu of diversion, abuse
and illicit trafficking of drugs. These modifications include, among
others, the Narcotic Addict Treatment Act of 1974 (Pub. L. 93-281), The
Psychotropic Substance Act of 1978 (Pub. L. 95-633), the Diversion
Control Amendments of 1984 (Pub. L. 98-473), the Anti-Drug Abuse Act of
1986 (Pub. L. 99-570), and the Anabolic Steroids Control Act of 1990
(Pub. L. 101-647).
In executing the CSA mandates and international treaty obligations
related to the registration and control of the manufacture,
distribution, dispensing, importation and exportation of controlled
substances, Congress and the DEA (and its predecessor agency the Bureau
of Narcotics and Dangerous Drugs, BNDD) established an identified work
force and programs generally known as the DCP. Within DEA, the
programmatic authority and responsibility for this effort is exercised
by the Office of Diversion Control (OD) using the Congressionally
authorized resources identified in the budget category DCP which are
committed to those responsibilities and programs.
Historically, for the purposes of budget formulation and
appropriation, only resources, along with their individual ``modular''
or overhead costs, devoted to diversion control efforts, were
administratively identified as the DCP within the annual budget request
to Congress. Other resources which support a broad range of DEA
activities, including ``Diversion Control'', were carried for
administrative purposes in the budget formulation and appropriation
process under other budget categories, such as legal support. For
example, DEA's Office of Chief Counsel, which is carried as part of the
DEA Budget Category ``Management and Administration,'' exists primarily
to provide legal support to the entire agency. Although that office has
a full section devoted to ``Diversion Control'' support, such as legal
interpretation, DEA registration revocation actions, and quota
hearings, no resources of the Office of Chief Counsel are included in
the ``DCP'' category of DEA's annual budget submission, since the
overall Chief Counsel function is not primarily devoted to Diversion
Control and is carried elsewhere in the DEA budget.
Since 1970, the CSA has provided that the Attorney General ``is
authorized to promulgate rules and regulations and to charge reasonable
fees'' relating to the registration and control of the manufacture,
distribution, dispensing, import, and export of controlled substances.
See 21 U.S.C. 821 and 958. Prior to 1993, the fees collected solely for
registration to handle controlled substances were deposited into the
general fund of the United States Treasury; they did not accrue to DEA.
In October 1992, during the annual Congressional appropriation
process, Congress established the ``Diversion Control Fee Account.''
This was an amendment to the Department of Justice and Related Agencies
Appropriations Act, and did not purport to realign or curtail any DEA
programs, activities, or priorities; the amendment established
legislatively the future funding mechanism for Congressionally approved
resources related to ``the operation of the diversion control
program.'' In setting the parameters for this funding mechanism,
Congress identified the functions and resources within DEA which have
historically been assigned to the administratively determined budget
category ``DCP'', as submitted by DEA, the Department of Justice,
Office of Management and Budget, and the President of the United
States. Any future Congressionally approved adjustment of resources
devoted to these components, or Congressionally approved realignment of
appropriated resources from other DEA budget categories which are
related to the registration and control of the manufacture,
distribution, and dispensing of controlled substances and herein
identified, will be encompassed in the Diversion Control Fee Account.
Diversion Control Program and Responsibilities
The components of the DCP have their basis in the CSA and
international treaties to which the U.S. is a party. The resources
approved by Congress are directed toward these responsibilities. The
components of the DCP as they relate to the specific provisions of the
CSA and the treaties are set forth below:
Regulatory Development and Maintenance
(21 U.S.C. 821--Rules and regulations.)
The CSA sets the requirements with respect to the control of the
manufacture, distribution, and dispensing of controlled substances.
Development and refinement of the regulations set out in 21 CFR Parts
1301-1308, 1311-1312, and 1316 are an essential part of the DCP, for
they establish the specific procedures and guidelines that are
necessary to implement the requirements of the CSA.
The control of drug diversion and abuse is not static. Shifts in
health care practices, patterns of diversion and drug abuse, drug
treatment, industry practices, and technology present an ever-changing
milieu of diversion and abuse. Regulatory changes are necessary to
adjust to these shifts. The Attorney General (AG) is authorized to
promulgate rules and regulations relating to the registration and
control of the manufacture, distribution, and dispensing of controlled
substances. See 21 U.S.C. 821. The AG has delegated that authority to
DEA. See 28 CFR 0.100(b) and 0.104.
DEA, through the DCP, is responsible for regulatory development or
change. In order to carry out these functions DEA employs a specialist
staff that identifies the need for regulatory change or development,
performs the research and data collection in support of changes,
promulgates the regulatory changes, and provides guidance to DEA
personnel, other regulatory and law enforcement personnel, and industry
regarding the regulatory requirements.
Activities in support of these functions include meetings and
national conferences with representatives of the regulated industry,
representatives of the law enforcement community, and other interested
parties to discuss the current regulatory program and identify areas
that may need to be addressed. There are five different industry
workgroups: Practitioner, Distributor, Manufacturer, Pharmacy, and Mid-
Level Practitioner. Meetings with each workgroup are scheduled on a
regular basis. In addition, separate national conferences are held
approximately every 24 months for the pharmaceutical manufacturers and
distributors and for drug control personnel. In addition to the
administrative work required to prepare for such meetings and
conferences, including the solicitation of agenda topics from the
attendees, DCP personnel conduct research and prepare position papers
and briefing materials regarding the various agenda topics.
If regulatory change is needed, DCP personnel conduct the research,
reviews of scientific and technical literature and other Federal and
state laws and regulations; collect data; and consult with industry,
law enforcement/regulatory sources, or other interested parties.
Following drafting and publication of the notice of proposed
rulemaking, personnel review all comments and determine whether
substantive issues have been raised that require adjustment to the
proposed regulations. In drafting the final rule, issues raised in the
comments are
[[Page 68626]]
addressed and, where appropriate, adjustments to the proposed
regulations are made to accommodate any substantive issues. Following
establishment of new regulations, DCP staff prepare and distribute
interpretations, guidelines and informational material regarding the
new requirements for DEA personnel, industry, and other law
enforcement/regulatory personnel. As needed, direct consultations to
clarify the requirements of new regulations are also held with industry
and law enforcement/regulatory groups.
In addition to the activities relating to regulatory changes, DCP
personnel respond to requests from industry and law enforcement/
regulatory personnel for information and interpretation of existing
regulatory requirements and policy; respond to congressional inquiries
regarding issues related to controlled substances; draft legislation
relating to controlled substances; and prepare testimony and briefings
for congressional hearings on the diversion of controlled substances.
Classification of Substances
(21 U.S.C. 811, 812, and 813--Authority to Control; Authority and
criteria for classification of Substances; Schedules of Controlled
Substances; Treatment of analogues; 1961 Convention, Articles 2 and 3--
Substances under control; Changes in the scope of control; 1971
Convention, Articles 2 and 3--Scope of control; Control of
preparations)
The authority to control substances of abuse is central to the
effective application of the CSA and DEA's programs relating to the
registration and control of the manufacture, distribution and
dispensing of controlled substances. The CSA provides the criteria for
the classification of substances into five schedules of control. The
DCP collects, monitors, and analyzes data for recommendations to add,
transfer between, or delete from such schedules any drug or other
substance. These activities include the development of methodologies to
predict and confirm the abuse potential of substances and combinations
of substances; the application of scientific knowledge concerning the
actual and relative potential of abuse of substances; the collection
and appraisal of international scientific literature and information
from DEA, and other Federal, state, local and foreign sources regarding
the abuse, abuse and trafficking of substances; and the maintenance of
liaison and information exchange with the Department of Health and
Human Services (HHS) and other domestic and international agencies,
such as the World Health Organization and the International Narcotics
Control Board, having similar scientific, regulatory, law enforcement,
and drug control interests.
In addition to collecting information regarding the control of
substances, DEA provides scientific and other information for
international, national, and state scheduling of substances; responds
to scheduling petitions and reviews and determines the status of
controlled, excepted, excluded, or exempted drugs and analogues; and
provides training, guidance, expert testimony, assistance and/or
information on drug control and classification to law enforcement
agencies, the scientific community, industry, the public, and other
interested parties.
DEA has initiated over a dozen drug reviews of both controlled and
non-controlled substances in the recent past. Examples of controlled
substances reviewed are fenfluramine, methylphenidate, flunitrazepam,
quazepam, dronabinol, and marijuana (to Schedule II for medical or
industrial use). The review of noncontrolled substances being
considered for control include ketamine, butorphanol, gamma hydroxy
butyrate, and carisoprodol to determine if control of the manufacture,
distribution, and dispensing of the substances is appropriate. Each
review requires a comprehensive study of the national and international
scientific literature regarding the properties and use of the drugs,
the current national and international controls over the drugs, data
regarding annual production and consumption, and information from
domestic and international law enforcement, regulatory, and medical
sources regarding the diversion, trafficking, and abuse of the drugs.
As appropriate, action may be taken, through formal rulemaking on the
record with opportunity for hearing, to schedule, reschedule, or
decontrol the drugs.
Identification of Controlled Substances
(21 U.S.C. 825--Labeling and packaging; 1961 CONVENTION, ARTICLE
30--Trade and distribution; 1971 CONVENTION, ARTICLE 10--Warnings on
packages)
In conjunction with the classification of substances as controlled
under the law, the CSA and international treaties require that such
substances contain certain identifying symbols, warnings, and seals.
DCP personnel monitor compliance with the requirements of 21 U.S.C. 821
as promulgated by 21 CFR 1302 pertaining to labeling and packaging
requirements by reviewing 200 to 300 labels per year which are
collected by DEA or are submitted to DEA by manufacturers.
Additionally, DCP personnel provide interpretation of the requirements
to registrants and Federal and state authorities, and review and
enforce the requirements on an ongoing operational basis.
Registration
(21 U.S.C. 822, 823, 824, 957, 958--Persons required to register;
Registration Requirements; Denial, revocation, or suspension of
registration; 1961 Convention, Article 30--Trade and distribution; 1971
Convention, Article 8--Licenses)
Another component of the DCP is the registration of those persons
authorized to manufacture, distribute, dispense, import, or export
controlled substances. The CSA requires that every person who
manufactures, distributes, dispenses, imports, or exports a controlled
substance shall obtain a registration, and establishes the requirements
for such registration. The CSA also includes provisions relating to the
denial, revocation, or suspension of registrations. The international
treaties require that the signatories allow trade and distribution of
controlled substances only under license.
DEA manages and operates the registration and reregistration
process for over 900,000 handlers of controlled substances. DCP
personnel process an average of 300,000 renewal applications and 48,000
new applications per year. The process includes reviewing the forms,
processing and accounting for the fees, entering the appropriate data
into the registration system, obtaining corrections from applicants
when appropriate, and referring the applications to the appropriate
office for review of the applicant's qualifications and bona fides for
registration. Applications for the bulk manufacture or importation of
Schedule I and II controlled substances require the preparation of
notices of application for publication in the Federal Register. New
applications to conduct research with Schedule I controlled substances
and for narcotic treatment programs must be evaluated and considered in
conjunction with the Food and Drug Administration. Further, all new
applications for registration must be examined and evaluated with the
appropriate state authorities to ensure that the applicant has been
granted the appropriate state authorization.
DCP personnel process over 150,000 requests per year from
registrants for modification of registration (name, address, drug
schedule changes, etc.), voluntary retirement of registration, or
[[Page 68627]]
for order forms; respond to over 10,000 telephonic inquiries per month
from applicants and registrants regarding registration; respond to
Freedom of Information Act and Congressional requests regarding
registrant information; and prepare affidavits and certification
statements regarding the registration status of DEA registrants and
applicants for use in DEA hearings and other proceedings.
DCP personnel also prepare and distribute registrant information to
other DEA elements, Federal, state and local regulatory personnel, and
registrants for the purpose of confirming registrant status; and
initiate studies and new systems to support and enhance the
registration program.
Records and Reports
(21 U.S.C. 827, 828 AND 829--Records and Reports of Registrants;
Order Forms; Prescriptions; 1961 CONVENTION, ARTICLES 19, 20, AND 30--
Estimates of drug requirements, Statistical returns furnished to the
Board; Trade and distribution; 1971 CONVENTION, ARTICLES 11, 16 AND 9--
Records and Reports to be furnished by the parties; Prescriptions)
The CSA and international conventions provide for the maintenance
of a system of records and accountability for controlled substances by
authorized handlers. Registrants are required by the CSA to maintain
records and inventories of controlled substances manufactured,
received, distributed, dispensed, imported, exported, or otherwise
disposed of; make such records available for inspection and copying;
and make certain reports to the Attorney General (DEA).
Establishment and enforcement of the record-keeping and reporting
provisions of the CSA and examination of the records to identify
potential diversion constitute a substantial part of the DCP
activities. With respect to records, program personnel conduct
comprehensive cyclic investigations of registrants' records and
inventories to ensure the integrity of the diversion control system.
Investigations of registrants for failure to comply with the record-
keeping and reporting provisions of the CSA are conducted and the
appropriate administrative, civil, or criminal action is pursued.
Additional discussion of these investigations can be found in the
section relating to Enforcement Activities.
DCP personnel conduct a variety of duties utilizing various reports
required to be submitted by registrants. As part of the closed system
to control the manufacture, distribution and dispensing of controlled
substances, registrants must make reports to DEA regarding the bulk or
dosage form manufacture of all Schedule I and II controlled substances,
all narcotic controlled substances in Schedules III-V, and certain
psychotropic controlled substances in Schedules III and IV; and the
repackaging and relabeling of and the distribution of all Schedule I
and II controlled substances and all narcotic controlled substances in
Schedule III. In addition, registrants must provide copies of order
forms documenting the distribution of Schedule I and II controlled
substances, excessive purchase and suspicious order reports, theft or
loss reports, and reports of the disposal of controlled substances.
The order forms, excessive purchase, suspicious order, and theft or
loss of reports are reviewed by DCP personnel, both on an individual
basis and with reference to other reports that have been filed to
determine whether further investigation is required. Theft or loss data
are also electronically compiled and tracked to allow for
identification of suspicious or unusual local, regional, or national
trends in the theft or loss of controlled substances.
Manufacturing reports are reviewed by DCP personnel to determine if
registrants are complying with quota requirements and to determine
various trends and availability of substances. The information is then
extracted and collated for domestic manufacturing reports required by
the U.N. conventions.
DCP personnel receive and process over 9,500 reports per year
regarding controlled substances distributions, commonly referred to as
``ARCOS'' reports, from approximately 1,400 registrants. The reports
contain data regarding approximately 14,000,000 controlled substances
transactions per year. Each report must be processed, corrected, and
entered into the ARCOS system. From this, as mandated by the CSA, DEA
operates a diversion targeting system for DEA and state and local
officials. In addition, special reports regarding regional distribution
and distributions to specific registrants are generated as needed.
Production Quotas
(21 U.S.C. 826--Production Quotas for Controlled Substances; 1961
CONVENTION, ARTICLE 21--Limitations on Manufacture and Importation;
1971 CONVENTION, ARTICLE 5--Limitation of use to medical and scientific
purposes)
The CSA and international treaties require that DEA determine the
total quantity of certain controlled substances that is necessary for
medical, scientific, research, and industrial use in the U.S. and that
the manufacture of such substances be limited accordingly through a
system of production quotas.
In fulfilling this mandate, the DCP collects and analyzes
information regarding the legitimate use, trafficking and abuse of
Schedule I and II controlled substances in the U.S. from such sources
as manufacturing and distribution reports, treatment and prescription
utilization data, case data, drug abuse indicators, and HHS estimates
of medical use. Based on the information collected, more than 1200
manufacturing and procurement quotas are established annually for
Schedule I and II controlled substances. Aggregate production quotas
are then determined for each basic class of controlled substance in
Schedule I and II. Notices regarding the aggregate production quotas
are provided to the Federal Register for publication. The DCP monitors
the manufacture, utilization, trafficking and abuse of controlled
substances against the quotas, processes requests for adjustments to
specific quotas, and, where appropriate, drafts notices adjusting
specific quotas for publication in the Federal Register. To facilitate
the quota process, DCP staff also conduct training seminars for the
industry. The DCP conducts domestic and international reviews of
controlled substances utilization trends and coordinates with the UN
control and scientific bodies regarding such trends, and prepares
reports concerning the domestic manufacture of controlled substances.
Import and Export of Controlled Substances
(21 U.S.C. 952, 953, 954 AND 958--Importation of controlled
substances; Exportation of controlled substances; Transshipment and in-
transit shipment of controlled substances; 1961 CONVENTION, ARTICLE
31--Special provisions relating to international trade; 1971
CONVENTION, ARTICLE 12--Provisions relating to international trade)
The CSA and the international treaties require that controlled
substance imports and exports be subject to registration requirements;
be allowed only when necessary to provide for the medical, scientific,
or other legitimate needs of the United States; and be subject to a
system of permits or declarations for each individual importation or
exportation. Further, the U.N. International Narcotics Control Board
(INCB), which administers the international conventions, establishes
annual ``estimates'' of the amount of
[[Page 68628]]
Schedule I and II narcotic drugs that each country may import.
In addressing these requirements, the DCP operates a system of
declarations and permits for imports and exports. Under this system,
DCP personnel receive and examine requests for permission to import or
export controlled substances to determine if they are in compliance
with the CSA, the international treaties, and the laws of the country
that is involved in the transaction. DCP personnel maintain records of
all controlled substance imports and exports, and of international
treaty and specific foreign country provisions relating to the import
and export of controlled substances. DCP personnel also monitor all
Schedule I and II narcotic imports and exports to insure that they are
consistent with the legitimate needs of the United States and the INCB
estimates. If an import or export appears inconsistent with legitimate
need or will exceed the estimates, DCP personnel will examine the
circumstances of the request to import or export. DEA will subsequently
either pursue a course of action to comply with the international
obligations or initiate proceedings to deny the request to import or
export.
As required by the international conventions, DCP personnel prepare
reports of controlled substances imports and exports for submission to
the UN control bodies; provide support and assistance to foreign
governments in the establishment and maintenance of import/export
control programs; and coordinate with foreign authorities and the INCB
in monitoring the international commerce of controlled substances.
International Activities
The registration and control of the manufacture, distribution, and
dispensing of controlled substances is not restricted by domestic
borders. The CSA's system of controls was not developed, and is not
administered, parochially; it is part of a global system comprised of
international laws and obligations designed to establish a consistent,
worldwide structure of control of the manufacture, distribution, and
dispensing of controlled substances to prevent the compromise of any
country's systems of controls by preventing the diversion of
pharmaceutical controlled substances from one country for abuse in
another. The international treaties mandate that each party to the
conventions shall establish a domestic program of controls relating to
the registration and control of the manufacture, distribution
(including import/export), and dispensing of controlled substances. The
treaty provisions include requirements for licensure, scheduling,
quotas, records and reports, import/export investigation, control and
cooperation, prescriptions, penalties, and mutual assistance. The
international community, through the International Narcotics Control
Board and the Commission on Narcotic Drugs, continuously monitors the
workings of the treaties and recommends and adopts resolutions to
maintain the safeguards against trafficking, with which the United
States is obliged to comply. The United States participates in the
debates and discussions to insure that its interests are considered.
The United States' obligations under the conventions are recognized
in the specific language of the CSA and the implementing regulations
(see 21 USC 801, 801(a), 811(d)(1), 823(a) and 958(a), and 21 CFR
1307.02). Further, upon the United States becoming a signatory to the
Psychotropic Convention, Congress acknowledged that before the Senate
could ratify the convention, the CSA would have to be amended to bring
it into compliance with the requirements of the convention,
acknowledging that the conventions are an integral part of the United
States' programs regarding the registration and control of the
manufacture, distribution, dispensing, import, and export of controlled
substances. By implementing the CSA and ratifying the international
treaties, Congress recognized that a strong domestic program relating
to the registration and control of the manufacture, distribution,
dispensing, import, and export of controlled substances is inter-
dependent on the establishment and maintenance of strong international
controls.
In meeting the U.S. treaty obligations, the DCP participates in
international policy activities, including the development and
formulation of United Nations (UN) resolutions, position papers, other
background documents, and briefing materials relating to controlled
substances for use by U.S. delegations to several UN bodies. DCP
personnel also participate in a number of international conferences and
meetings related to drug control. For example, in Fiscal Year (FY) 1995
there were two such conferences which were organized, sponsored, and
funded jointly by DEA and the European Union (EU): the first was held
in Austria to improve the design and administration of, and cooperation
regarding, controlled substance and chemical controls in the
Commonwealth of Independent States (CIS) [the former Soviet Republics]
which was attended by representatives from the CIS, EC and the INCB.
The second conference was held in Istanbul regarding illicit drug
traffic, the diversion of psychotropic substances, and chemical
controls in the Middle East, which was attended by national authorities
in the region, the EC, Interpol, and the INCB. The DEA share of the
costs for these multi-topic conferences (approximately 50% of total
conference cost) was split between the free account and appropriated
funds in approximation to the subject matter covered. In FY 1995, DCP
personnel also participated in the annual Commission on Narcotic Drugs
meeting in Austria, a meeting with EC officials in Spain to discuss
programs to control the manufacture and distribution of steroids, and
an INCB drug training seminar for African drug control authorities
regarding the establishment of effective national controls of the
manufacture and distribution of controlled substances. The fee account
expenditures for these activities totaled less than $150,000 in FY
1995.
In addition to those activities directly related to the
administration of the controls under the international conventions, DCP
personnel conduct conferences and operational initiatives with
representatives from the appropriate foreign governments regarding
specific controlled substances to provide and collect information
regarding the use and abuse of the substances and, where necessary, to
promote the strengthening of controls of the manufacture, distribution,
dispensing, import, and export of the substances to prevent their
diversion from international sources into the United States. Recent
examples include meetings with officials of several European
governments to discuss programs relating to pain management, the
distribution and use of methylphenidate, narcotic treatment programs,
and the medical use of marihuana, and meetings with officials in
Colombia and Mexico regarding the manufacture and distribution of
products containing flunitrazepam which are being illegally distributed
and abused in the U.S.
The DCP compiles and analyzes information on the U.S. production
and distribution of, and estimated needs for narcotic and psychotropic
substances, as well as trafficking data, and prepares periodic reports
for submission to the UN.
The above demonstrates the variety of international activities that
fall within the purview of the Diversion Control Fee Account by virtue
of the United States' obligations under the international conventions
relating to the
[[Page 68629]]
registration and control of the manufacture, distribution, and
dispensing of controlled substances. However, these activities, as
funded through the fee account, are limited to those carried out by
personnel assigned to domestic offices of DEA; expenses of diversion
personnel assigned to overseas positions are funded by appropriated
funds, not through the Diversion Control Fee Account, even though they
may conduct activities in support of the DCP.
Enforcement Activities
(21 U.S.C. 841, 842, 843, 853, 875, 876, 878, 879, 880, 881, 883,
886, 960, 961, and Related Penalty and Enforcement Proceedings
Sections--Penalties for violations of the CSA, and related enforcement
proceedings; 1961 CONVENTION, ARTICLES 36 AND 37--Penal provisions;
Seizure and Confiscation; 1971 CONVENTION, ARTICLE 22--Penal
provisions)
The DCP has responsibility for monitoring, in large part through
investigations, all activities related to legitimately manufactured
substances for which registration is required or excepted and where
those controls are circumvented or disregarded. As such, it initiates
and conducts investigations of individuals and institutions which are
suspected of violating the CSA or which undermine public confidence in
the safety and authenticity of controlled substances found within
pharmaceutical and health care channels. 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 non-registered, 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.
A majority of the efforts of the field elements of the DCP is
devoted to the investigation of manufacturing, distributing,
dispensing, importing, and exporting activities under the requirements
of the law and regulations and to collecting evidence and preparing
material in support of administrative, civil, and criminal proceedings
against violators. The investigations conducted by DCP personnel fall
into three categories.
Pre-Registrant Investigations
The CSA requires that all individuals and institutions proposing to
manufacture, distribute, or dispense controlled substances must obtain
a registration from the Attorney General who is further authorized to
inspect the establishment of a registrant or applicant for
registration. DEA Diversion Investigators and registration personnel
must insure that all applicants for registration and reregistration are
authorized to conduct the activities for which they are applying within
their jurisdiction. DEA Diversion Investigators are required to inspect
the physical premises, interview appropriate applicant personnel,
conduct employee background checks, and review record-keeping and
security procedures for manufacturers, distributors, importers,
exporters, and narcotic treatment programs to determine if the proposed
registration is consistent with the public interest.
Cyclic Investigations
In exercising the controls of the CSA, DCP personnel conduct
periodic investigations of all controlled substance manufacturers,
distributors, importers, exporters, and narcotic treatment programs for
the purpose of (1) ensuring that the registrants are complying with the
requirements of the CSA by maintaining effective controls and
procedures to prevent the diversion of controlled substances, and (2)
detecting criminal or civil violations by such registrants or practices
which undermine or neglect such controls. See 21 CFR 1316.01-1316.13.
In the course of conducting such investigations, DCP personnel perform
a wide variety of activities. These include taking a physical inventory
of controlled substances; interviewing the appropriate registrant
personnel; reviewing records relating to the receipt, distribution, and
disposal of controlled substances; verifying transactions against the
records of other registrants; reviewing manufacturing/distribution
records and reports to ascertain their accuracy and validity;
inspecting and testing the adequacy of physical and procedural
safeguards to detect and deter diversion; identifying and pursuing
questionable or illegal distributions; and collecting samples of
controlled substances.
Complaint Investigations
Complaint investigations are those investigations that may result
in an administrative, civil, or criminal complaint being filed against
the subject for violations of the CSA or regulations. Complaint
investigations are initiated upon information or evidence received from
public sources, other law enforcement or regulatory personnel, or
review of registrant records or reports, etc., that violations of the
CSA have, or may have, occurred. DCP personnel undertake investigative
activities to determine the type and extent of the violations, the
identity of the violators, and the source and methods of diversion. The
types of investigative activities performed include: audits of
controlled substance records, examination and collection of related
business records, prescription surveys, interviews and debriefings,
undercover purchases of evidence, reviews of manufacturer/distribution
records and reports, service of administrative inspection warrants and
search warrants, and intelligence gathering and analysis.
The conduct of complaint investigations often involves cooperation
and coordination with other Federal, state, and local law enforcement
and regulatory officials and occasionally international officials. In
some instances, investigations may also involve cooperation and
coordination with members of the legitimate drug industry.
Investigators, in conjunction with other agencies, evaluate and pursue
evidence of health care fraud, falsification of records, and other
crimes that can establish key elements of proof that controlled
substance violations have occurred.
Upon completion of the investigation, a number of actions may be
undertaken depending on the severity of the
[[Page 68630]]
violations. The case may be referred to the United States Attorney's
Office or State's Attorney for civil or criminal prosecution. Violators
may be referred for an enforcement hearing pursuant to 21 U.S.C. 883
and 21 CFR 1316.31, at which the registrant is provided with details
regarding alleged violations and afforded the opportunity to present
his/her views and proposed actions to come into compliance with the
law. The investigation may result in an administrative hearing,
pursuant to a show cause order, to determine whether registration of
the person should be revoked or denied.
Cooperative Efforts
(21 U.S.C. 801, 801a, 872, and 873--Congressional findings;
Education and research programs of Attorney General; Cooperative
Arrangements; 1961 Convention, Preamble; 1971 Convention, Article 21--
Action against the illicit traffic)
DEA is not alone in the efforts to combat the diversion of
controlled substances. There are related authorities regarding the
control of the manufacture, distribution, dispensing, import, and
export of controlled substances in other Federal, state, and local
regulatory and law enforcement agencies. In addition, the national and
local organizations representing the pharmaceutical and health care
industry actively participate in diversion control efforts.
Internationally, there are foreign government agencies and
international organizations, such as the United Nations International
Narcotics Control Board and the Drug Control Program which administer
the requirements of the international conventions; the World Health
Organization, which is involved with international drug scheduling
matters; and Interpol which helps coordinate international law
enforcement activities directed against the international traffic in
licitly produced controlled substances, committed to the establishment
and maintenance of consistent international control of the manufacture,
distribution, and dispensing of controlled substances. The CSA and the
international treaties, recognizing the need for a coordinated effort
against diversion, demand cooperative efforts between the interested
parties.
As noted, the DCP engages in extensive cooperative efforts with
other officials involved in diversion control activities. DCP personnel
meet regularly with state and local law enforcement and regulatory
personnel to share information, identify areas of concern, and
coordinate joint initiatives and investigations. DCP personnel also
provide special training regarding controlled substances diversion to
local regulatory and law enforcement personnel and hold a national
conference regarding the control and diversion of controlled substances
approximately every 24 months, to which regulatory and law enforcement
administrators from each state and territory are invited. DCP personnel
also engage in a variety of activities with UN bodies, international
organizations, and foreign governments in meeting the U.S.
responsibilities under the international conventions.
In addition to its activities with other law enforcement and
regulatory agencies, the DCP maintains an active program of liaison
with the pharmaceutical industry. DCP activities in this area include
scheduling biannual workgroup meetings with five different industry
groups (manufacturers, distributors, pharmacies, practitioners, and
mid-level practitioners) and a national industry conference held
approximately every 24 months, which is attended by representatives
from the national associations representing the controlled substances
industry and by individual registrants. DCP personnel also prepare and
conduct training sessions at universities for medical and pharmacy
students, make presentations to industry conferences and meetings,
participate in the development of pharmacy certification examinations;
and draft for publication articles regarding the controlled substances
laws and programs.
To assist registrants in understanding and complying with the
controlled substances laws, DCP personnel create informational manuals
(Pharmacist's Manual, Practitioner's Manual, Mid-Level Practitioner's
Manual, and the Security Outline to the Controlled Substances Act)
which are distributed to registrants. Where new laws or regulations
require, specific guides and informational circulars are prepared and
made available to the affected parties. DCP personnel also meet
directly with individual registrants to provide information and
assistance regarding the controlled substances laws.
New Initiatives
Since publication of the proposed rule in 1993, DEA has established
two new initiatives, the National Forensic Laboratory Information
System (NFLIS) and the Tactical Diversion Squads (TDS), which were not
previously identified in the rulemaking. Each of these initiatives will
enhance the DCP's ability to administer and enforce the program
relating to the registration and control of the manufacture,
distribution, and dispensing of controlled substances, and investigate
and act against persons who would violate those controls, as discussed
above. Congress has been notified of these new initiatives and has
approved funding for them.
The collection of accurate and validated data concerning the abuse
of controlled substances and the scientific review of actual or
potential drugs of abuse is a necessary function for scheduling
controlled substances, setting quotas for manufacturing levels, and to
provide more effective leadership in establishing drug policy under the
CSA. The NFLIS will provide in a single system information from
analyzed drug evidence associated with criminal activity collected from
non-Federal forensic laboratories across the country. That information
must currently be obtained by separate contacts with individual
laboratories across the country. The system will also enhance the
investigative ability of DCP personnel by allowing efficient and quick
identification of local, regional, and national division and abuse
trends and distribution patterns of diverted and abused controlled
substances.
The TDS program is a modernization of a program that was operated
in the late 1970's and early 1980's in as many as 24 states in a form
designed to address present diversion trends. DEA has received approval
to fund the formation of two 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 from legitimate manufacturing, distributing, and
dispensing sources. The program will allow the unification of separate,
and sometimes disparate, Federal, state, and local information,
authorities, and enforcement programs; provide State and local law
enforcement authorities with assistance in developing more effective
enforcement programs against diversion; and help coordinate the various
jurisdictional responsibilities of agencies that otherwise may hinder
investigations and prosecutions of those involved in the diversion of
controlled substances. Funding has also been provided to establish
another 2 to 3 TDS's in 1997.
Budget and Appropriations
In order to accomplish the mandates of the CSA and the
international treaties, Congress in past years authorized and
appropriated funds within the ``Diversion Control Decision Unit'' of
the DEA Salaries and Expenses Appropriation. The President's annual
budget request to Congress contained
[[Page 68631]]
proposed appropriations for the Department of Justice, including the
DEA. DEA's budget requests are required to meet OMB policy guidelines
for budget preparation. [OMB Circular No. A-11]
Once Congress and the President approve the appropriation level,
funds are made available from the appropriate source in the U.S.
Treasury. Prior to fiscal year 1993, registration fees collected under
the CSA were deposited into the general fund of the U.S. Treasury.
Prior to fiscal year 1993, registration fees collected under the CSA
were deposited into the general fund of the U.S. Treasury and scored to
DEA's Salaries and Expenses Appropriation. [31 U.S.C. 3302; 21 U.S.C.
821; OMB Circular No. A-25 (1959)].
On October 6, 1992, the President signed the Departments of
Commerce, Justice and State, the Judiciary and Related Agencies
Appropriations Act of 1993, Pub. L. No. 102-395, 102d Cong. 2d Sess.,
106 Stat. 1828, 1835 (1992) (``Appropriations Act'') (DEA Salaries and
Expenses Appropriation). Section 111(b) of the Appropriations Act
established in the U.S. Treasury, for fiscal year 1993 and thereafter,
a separate account, to be known as the Diversion Control Fee Account.
The Appropriations Act directed that ``[n]otwithstanding [a]ny [o]ther
[p]rovision of [l]aw * * *] fees charged by the Drug Enforcement
Administration under its Diversion Control Program shall be set at a
level that ensures the recovery of the full costs of operating the
various aspects of that program''. Congress specified that the amount
``required to be refunded'' to DEA from the Diversion Control Fee
Account for fiscal year 1994 and thereafter ``shall be refunded in
accordance with estimates made in the budget request of the Attorney
General for those fiscal years''.
For fiscal year 1993, in order to provide the opportunity to
establish and implement a new fee structure to meet the legislative
requirement, Congress appropriated funds, as it had in past years, for
the DCP from the general fund of the U.S. Treasury, less $12 million.
The $12 million was to be funded through increased CSA registration
fees established as a result of the creation of the Diversion Control
Fee Account in 1993. Congress further directed in the Appropriations
Act that ``[a]ny proposed changes in the amounts designated in said
budget requests shall only be made after notification to the Committees
on Appropriations of the House of Representatives and the Senate
fifteen days in advance''.
The fiscal year 1997 resources for the DCP, as authorized by
Congress, include 598 full-time employees charged with the
responsibility for overseeing the activities of one of the largest
pharmaceutical industries in the world to ensure controlled substances
are manufactured, imported, exported, distributed, and dispensed for
legitimate medical and scientific reasons.
These resources includes a staff of Diversion Investigators,
Special Agents, Administrative Law Judges, program analysts,
pharmacologists, chemists, information systems specialists,
registration assistants, examiners, and management and support staff
assigned to field offices across the country and assigned to DEA
Headquarters. Overhead and program expenses include salaries and
employee benefits (retirement, health and life insurance); travel; rent
and utilities; equipment and supplies, including vehicles, computers,
communications, furniture, etc.
In the overall Budget process, the estimated cost per full time
employee is based on a module which includes salary and overhead items.
Modular costs are part of the specific Congressionally approved
positions, as they are with the positions within the rest of the DEA
Budget. For example, when Congress authorized 588 positions for the DCP
in 1994, included therein are the modular costs of maintaining those
positions (such as rent, equipment, per diem and travel, background
investigation costs, etc.)
There are separate DEA activities which support the DCP, but are
covered elsewhere in the DEA Salaries and Expenses Budget and are
therefore not supported by CSA Registration Fees. Examples of this
include: Support provided by the Attorneys in DEA's Office of Chief
Counsel Diversion/Regulatory Section; laboratory Services support; DEA
Automated Data Processing systems support (except ARCOS and CSA);
Office of Training staff, DEA Management and Administrative support;
Office of Congressional and Public Affairs; Intelligence Support and
Diversion Investigators assigned overseas.
Resources not initially identified in the 1993 Federal Register
establishing the fee (57 FR 60,148 and 58 FR 15,272) which have been
subsequently approved and funded through CSA registration fees as part
of the above discussed DCP components include: (1) Congressional
approval in FY 1994 for 11 Special Agents to enforce the Anabolic
Steroid Control Act; (2) Transfer of 7 positions and associated costs
previously provided for in the DEA Salaries and Expenses Budget for
operation of the ARCOS and CSA data systems--these systems exist at DEA
solely to support the DCP; (3) Authorization to establish a National
Forensic Laboratory Information System (as discussed above); (4)
Authorization to expand assistance and cooperation with state and local
law enforcement with the establishment of Tactical Diversion Squads (as
discussed above).
While DEA's budget is formulated, reviewed, and approved on an
annual basis, the majority of DEA registrations, from which the fees to
fund DCP activities are derived, are issued for a three year term.
Further, the registrant population is not evenly distributed across the
three year registration cycle; current figures indicate approximately
320,103 renewals will be received for October 1996 to September 1997,
305,200 renewals for October 1997 to September 1998, and 290,698 for
October 1998 to September 1999. Thus, attempting to calculate the fee
on an annual basis would preclude a uniform application of the costs of
the DCP for each year across either the entire registrant population or
the registrants that would renew in each of the individual years.
Either a return to a one year registration term for all registrants or
a multi-year fee schedule would be necessary.
Rather than establish an annual registration, which would impose an
enormous burden on both the registrants and DEA, a fee schedule which
averages income over three years was adopted. Use of the three year fee
schedule allows for (1) uniform application of fees necessary to cover
the costs of the DCP across the entire registrant population, (2)
accommodation of such factors as inflation and an uneven number of
registration renewals in each of the individual years, and (3)
minimizing the administrative burden associated with frequent
adjustment to the fee schedule. Use of a multi-year cycle does,
however, require that estimated fee collection and funding
authorization figures be used in calculating the fees.
During the transition to the Diversion Fee Account (DFA) system in
FY 93, funding was provided from the general fund in the United States
Treasury to cover the period leading up to the implementation date of
the DFA. Because the rule implementing the Diversion Fee Account system
became effective two months early, a $7 million surplus resulted.
Additional surplus funds have accrued as a result of DEA estimates of
the costs of the program, as reflected in the Congressional Budget
Authorization, that were greater than the actual expenses, in part due
to
[[Page 68632]]
hiring constraints within DEA that resulted in a diversion investigator
vacancy rate of between 50 and 70 positions from 1993 to present; and
DEA estimates of fee income that were less than the actual income. As a
result, the DFA surplus was 45 million dollars as of September, 1996.
While some surplus in the DFA is necessary to cover the variations
in the fees collected each year and the need for some carry-over funds
from one fiscal year to the next, the current surplus exceeds the
amounts necessary to insure the fiscal continuity of the DCP. However,
the surplus will delay the need for any fee increases for a number of
years; based on out-year projections for collections and
appropriations, the surplus will begin to be drawn down in FY 98 and
will be exhausted by FY 2001.
Conclusion
In sum, DEA is mandated to maintain a multi-faceted endeavor
encompassing scientific, cooperative, regulatory, criminal, and
international programs to prevent the diversion of controlled
substances to illicit uses. The DCP has been authorized and has served
for the past 25 years as an effective vehicle for carrying out these
mandates. Creation of the Diversion Control Fee Account in 1993 altered
the funding mechanism of the program, but not its duties, objectives,
or priorities.
The Acting Deputy Administrator of the Drug Enforcement
Administration hereby certifies that this rule will not have a
significant economic impact upon entities whose interests must be
considered under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
The majority of DEA registrants are practitioners, pharmacies, and
hospital/clinics, for whom the annual impact of the fee increase is
$50.00 per registrant. Further, the total annual impact of the fee
increase for the entire registrant population is less than $50 million.
However, consistent with the principles of the Regulatory Flexibility
Act, DEA gave consideration to alternative approaches to the fee
schedule.
Since 1971, the CSA has permitted the Attorney General to collect
fees relating to the registration and control of the manufacture,
distribution, import, export and dispensing of controlled substances
(21 U.S.C. 821 and 958). DEA and its predecessor agency have collected
such fees pursuant to a schedule based upon the five basic activities
cited in the law. That fee schedule was proposed for public comment as
part of the regulations to implement the CSA which were finalized in
1971. The ration of fees was: A distributor's fee is 50% of the
manufacturer's fee and a dispenser's fee is 16-20% of the distributor's
fee. The fee ratios have remained consistent for the past 25 years and
have not been the subject of any substantive comment or objection by
the regulated industry.
The Federal Register notice proposing the new fee structure (57 FR
60148, December 18, 1992) specifically noted that this fee schedule was
to be continued since the administrative structure to collect it was
well established and operating efficiently. There were no practical or
substantive alternative proposals submitted on the record regarding the
fee structure. Individual interest groups questioned the possibility of
alternative structures after the rule was finalized.
In reaching the decision to propose the existing fee ratio as the
basis for establishing the new fees, several alternatives were
discussed by DEA, including:
(1) Establish a fee based on volume of drugs handled by individual
registrants. This was rejected as impractical on several grounds: (a)
DEA has no way of determining the volume handled; (b) the volume
changes due to a variety of market, health care, and competition
issues, thus requiring frequent modification of individual fees; and
(c) DEA would be unable to budget due to income fluctuations.
(2) Establish a fee based upon DEA work hours expended per class of
registrant. This was rejected as impractical because: (a) Work hours
vary from year to year based upon particular drug problems,
identification of violative firms, political or mandated priorities,
travel restrictions, and many other factors; (b) due to the degree of
control established over the past years, less work hours are currently
expended at the wholesale level than at the retail level; however
indications of diversion at the wholesale level will always receive
priority attention. Therefore, this measure would fluctuate year to
year, causing an administrative burden on both the registrants and DEA
due to frequent fee modifications.
(3) Establish a different fee for various types of practitioner
activities (i.e., hospital, medical doctor, dentist, veterinarian,
narcotic treatment program, teaching institution). Again , this was
rejected as impractical because: (a) Many of the same issues in items 1
and 2 above apply equally; (b) a new administrative system to handle 8-
10 registration categories, rather than five, would have to be created,
with attendant costs of computer programming, staffing, form design,
printing, inventory, etc.; and (c) an entirely new system of criteria
would have to be developed to distinguish between categories (i.e., a
general practice dentist may prescribe less than a general practice
M.D., but an oral surgeon may prescribe more; a small rural hospital/
clinic my utilize less controlled substances than an M.D. specialist in
cancer treatment).
(4) Charge for Order Forms (DEA 222) used to order Schedule II
drugs. This was impractical because: (a) A substantial number of
registrants are not registered for Schedule II so an additional fee
system would have to be used for registrants in Schedules III-V; and
(b) order form volume is not reflective of activity, i.e.,
practitioners who prescribe rather than dispense do not use many order
forms.
Therefore, although various options were considered, none offered a
feasible alternative, each would require the establishment of complex,
labor-intensive, expensive new programs (the cost of which would be
borne by the registrants) with complicated fee schedules that would be
difficult to understand and administer. The existing fee structure,
which is operating efficiently and is well understood by the registrant
population, remained the most suitable choice.
This document has been drafted and reviewed in accordance with
Executive Order 12866. The Acting Deputy Administrator of the Drug
Enforcement Administration has determined that this is not a
significant action under the provisions of Executive Order 12866,
section 3(f); accordingly this rule has not been reviewed by the Office
of Management and Budget. This action involves the implementation of
non-discretionary mandate under the Departments of Commerce, Justice,
and State, the Judiciary, and Related Agencies Appropriations Act of
1993 (Pub. L. 102-395), the annual impact of which is less than $100
million.
This action has been analyzed in accordance with the principles and
criteria contained in E.O. 12612, and it has been determined that the
rule has no implications which would warrant the preparation of a
Federalism Assessment.
Dated: December 20, 1996.
James S. Milford,
Acting Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 96-32953 Filed 12-27-96; 8:45 am]
BILLING CODE 4410-09-M
