[Federal Register: February 18, 2003 (Volume 68, Number 32)]
[Proposed Rules]
[Page 7728-7734]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe03-11]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR PART 1301
[DEA-232P]
RIN 1117-AA70
Controlled Substances Registration and Reregistration Application
Fees
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of Proposed Rulemaking.
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SUMMARY: DEA is proposing to adjust the current fee schedule for DEA
controlled substances registration to adequately recover necessary
costs associated with the Diversion Control Program as mandated by the
Departments of Commerce, Justice, and State, the Judiciary, and Related
Agencies Appropriations Act of 1993.
DATES: Written comments must be submitted on or before April 21, 2003.
ADDRESSES: Written comments should be submitted to the Administrator,
Drug Enforcement Administration, Washington, DC 20537, Attention: DEA
Federal Register Representative/CCR.
FOR FURTHER INFORMATION, CONTACT: Patricia M. Good, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537; Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Background
The Departments of Commerce, Justice, and State, the Judiciary, and
Related Agencies Appropriations Act of 1993 (Pub. L. 102-395) requires
that the Drug Enforcement Administration (DEA) collect fees to ensure
the recovery of the full costs of operating the Diversion Control
Program. Section 111(b)(3) of the act, codified at 21 U.S.C. 886a(3),
requires that ``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.'' Section 111(b)(1) of the act also requires that
``there shall be deposited as offsetting receipts into that account all
fees collected by the Drug Enforcement Administration, in excess of
$15,000,000, for the operation of its diversion control program.''
Since 1970 the Controlled Substances Act (CSA) has authorized the
Attorney General to ``charge reasonable fees relating to the
registration and control of the manufacture, distribution, and
dispensing of controlled substances.'' 21 U.S.C. 821 and 958(f). This
fee is collected by the Deputy Administrator of DEA for the Attorney
General and is the only fee collected by DEA to support the Diversion
Control Program. DEA does collect a user fee to support its listed
chemical activities. However, this fee does not fall within the scope
of this notice (see below for a further discussion). The fee schedule
for the CSA was established in 1971 and was adjusted in 1984 and again
in 1993. The fees have remained unchanged since that time.
[[Page 7729]]
Following publication in the Federal Register of the fee adjustment
in 1993, the American Medical Association (AMA) and others filed a
complaint in the United States District Court for the District of
Columbia objecting to the new fees. The district court issued its final
order granting the government's motion for summary judgment and
disposing of all claims on July 5, 1994. AMA v. Reno, 857 F. Supp. 80
(D.D.C. 1994). The AMA appealed, and on July 27, 1995 the United States
Court of Appeals for the District of Columbia Circuit remanded, without
vacating, the rule to DEA. Specifically, the court required DEA ``to
identify the components of the fee-funded diversion control program and
provide a brief explanation of why it deemed each component to be a
part of that program.'' AMA v. Reno, 57 F.3d 1129, 1135 (D.C. Cir.
1995).
DEA responded to the remand requirement through a notice in the
Federal Register on December 30, 1996, describing the fee-funded
components and activities of the DCP with an explanation of how each
satisfies the statutory requirements for fee-funding. 61 FR 68624-32.
DEA accepted comments on this final rule and, based on these comments,
published its final rule on the Drug Diversion Control Fee Account
(DDCFA) in the Federal Register on August 9, 2002. This rule contains
information on the Specific DCP activities funded by the DDCFA. Copies
of both the December 30, 1996 and August 9, 2002 rulemakings may be
found on the Diversion Control Program Web site: http://www.deadiversion.usdoj.gov
.
This announcement establishes the fee structure under the existing
registration system to fully support the operations of the Diversion
Control Program for Fiscal Year 2004 through Fiscal Year 2006. Since
the last published rule in 1993, the Diversion Control Program has
experienced significant growth without any associated increase in
registrant fees to support the growth and increased funding needs. DEA
is required by law (see below) to collect the full costs of the
Diversion Control Program. The amount to be recovered is established by
the Congressional appropriations process. The projected amount required
to be recovered for Fiscal Year 2004, based on the President's Budget
Request, will be $133.6 million; the estimated amount required to be
recovered for Fiscal Year 2005 will be $157.3 million. The estimated
amount required to be recovered for Fiscal Year 2006 will be $160.3
million. These figures include required program growth and the
mandatory annual $15 million transfer to the U.S. Treasury.
Statutory Authority to Collect Fees
DEA's authority to collect registration fees derives from three
statutory provisions. DEA is authorized by 21 U.S.C. 821 to collect
``reasonable fees relating to the registration and control of the
manufacture, distribution and dispensing of controlled substances and
to the registration and control of regulated persons and of regulated
transactions.'' Secondly, 21 U.S.C. 958(f) permits DEA to collect
``reasonable fees relating to the registration of importers and
exporters of controlled substances or List I chemicals.'' Lastly, the
1993 Appropriations Act added a provision requiring DEA to set a fee
schedule ``that ensures the recovery of the full costs of operating the
various aspects of that program.'' 21 U.S.C. 886a(3). The United States
Court of Appeals for the District of Columbia Circuit noted that in
establishing the DDCFA, Congress left intact the fee collection
requirements of 21 U.S.C. 821, confirming boundaries of the DCP that
DEA can fund by registration fees. AMA v. Reno, 57 F.3d 1129, 1135
(D.C. Cir. 1995). Although the court made no specific mention of 21
U.S.C. 958(f), those same boundaries remain intact as well. The court
found that the current statutory scheme thus requires DEA to set
registration fees to recover the full costs of the DCP, while requiring
DEA to charge ``reasonable'' fees relating to the registration and
control of the manufacture, distribution and dispensing of controlled
substances and the registration and control of regulated persons and of
regulated transactions.
DEA, therefore, must examine DCP activities in conjunction with the
nexus requirements of 21 U.S.C. 821 and 958(f) to determine whether it
can properly fee-fund them while setting fees that recover the full
cost of these activities.
Diversion Control Program and Responsibilities
DEA's mission with respect to licit controlled pharmaceuticals is
to prevent, detect and eliminate the diversion of controlled
pharmaceuticals from legitimate channels to illegal use, while at the
same time ensuring their availability for legitimate medical and
scientific purposes. To facilitate these goals, Congress, through the
CSA, established a closed system of controlled substance distribution
encompassing manufacturers, distributors, pharmacies and practitioners;
that is, within this closed system a controlled substance can be traced
from the time it is manufactured to the time it is dispensed to the
ultimate user. This system has proven effective in reducing the
diversion of these substances from legitimate channels to the illicit
market. Components of this closed system include scheduling of all
controlled substances, registration of all controlled substance
handlers, recordkeeping for accountability, security, and manufacturing
quotas, all under DEA DCP oversight. (The DCP also possesses similar
chemical control responsibilities pursuant to the Chemical Diversion
and Trafficking Act (CDTA) and subsequent legislation.)
The plain language of the 1993 Appropriations Act requires DEA to
set and collect registration fees to cover the full costs of operating
its Diversion Control Program. In its 1993 final rule publication
setting new registration fees, DEA examined all activities that relate
to the registration and control of the manufacture, distribution and
dispensing of controlled substances and to the registration (and
control) of importers and exporters. DEA determined that ``activities
contained in the [diversion] program which give rise to the fees
consist of diversion investigators, analysts, technicians, and clerical
personnel salaries and expenses; and travel, rent, utilities, supplies,
equipment and services associated with these positions for the
registration and control of the manufacture, distribution and
dispensing of controlled substances.'' 58 FR 15273. DEA determined that
it would not fee-fund costs associated with chemical control efforts
(see below), clandestine laboratory efforts, overseas staff
(specifically diversion investigators assigned to foreign posts), DEA's
Office of Chief Counsel or executive direction. 58 FR 15273. DEA
concluded that these activities were excluded from the Attorney
General's budget delineation for the category of ``Diversion Control''
and thus not included in the determination of the fees. Id.
At the time this initial rule was published on March 22, 1993, 21
U.S.C. 821 did not extend to chemical control activities (``regulated
transactions''). Accordingly, there were no registration or fee
requirements for handlers of List I chemicals, and chemical control
activities were not included among those to be supported by the DDCFA.
Congress amended 21 U.S.C. 821 on December 17, 1993 to require
reasonable fees relating to ``the registration and control of regulated
persons and of regulated transactions.'' Domestic Chemical Diversion
Control Act of 1993, 3(a), Pub. L. 103-200, 107 Stat. 2333.
[[Page 7730]]
Despite this amendment, to date DEA's chemical control activities have
continued to be supported by appropriated funds and not by the DDCFA.
In its December 1996 Federal Register notice, DEA further excluded
from fee-funding those activities that incidentally support the DCP but
are funded elsewhere in the DEA Salaries Budget (and thus not fee-
funded). Specific examples listed in the notice include ``support
provided by the Attorneys in DEA's office of Chief Counsel Division
Regulatory Section; certain laboratory service 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.'' 61 FR 68631.
In summary, to date fee-fundable DCP activities have included:
scheduling, registration, investigation, inspection, data collection
and analysis, training, establishing production quotas, cooperative
efforts with state, local and other federal agencies, cooperative
efforts with the regulated industry, international activities relating
to the registration and control of the manufacture, distribution and
dispensing of controlled substances, and attendant management,
personnel, administrative and clerical oversight for the DCP because
they too relate to the fee-funding criteria of 21 U.S.C. 821 and
958(f). Fee-fundable activities also have included travel, rent,
utilities, supplies, equipment and services associated with the above-
listed activities. Fee-fundable activities also have included
activities related to the control of licit controlled substances in the
United States in which the initial source is foreign. For example,
smuggling a controlled substance into or introducing it into the United
States is importation, albeit illegal, and constitutes an activity for
which DEA registration and controls are required under the CSA and its
implementing regulations; therefore activities to prevent smuggling
fall under the purview of the DCP. Foreign-source substances
potentially threaten the integrity of the closed system of distribution
and undermine other diversion control efforts by DEA. They also may
pose a public health threat and/or unlawful competition to legal,
registered U.S. manufacturers and suppliers. The advance of the
Internet in particular has made foreign-source substances more
accessible in the United States and the diversion of these substances a
greater problem. The DCP now will address the activities that will be
funded by the DDCFA as part of its programmatic responsibilities.
A more detailed description of the activities funded through the
DDCFA is included in DEA's 1996 final rule (61 FR 68631) and amended
final rule published on August 9, 2002 (67 FR 51988).
Current Fee-Funding
Since the last published rule in 1993, the Budget Authority for the
Diversion Control Program has doubled without any associated increase
in registrant fees. Currently, the fees established in 1993 are no
longer adequate to recover the ``full costs'' of operating the DCP as
required by law.
The Congressional appropriation for the DCP for Fiscal Year 1994
was $57.1 million. For Fiscal Year 2004, the expected Budget Authority
will be $118,561,000 (this figure does not include the mandatory $15
million transfer to the U.S. Treasury). The growth in the DCP has been
driven by a number of factors some of which have been reflected in DEA
budget submissions such as the creation of Tactical Diversion Squads in
Fiscal Year 1997. Other DCP expansions include DEA's response to the
diversion of OxyContin[reg], involving the opening of 247 cases from
October 1999 through March 2002 (including 159 cases in Fiscal Year
2001 alone, a 270 percent increase from Fiscal Year 2000). These cases
have led to a total of 328 arrests. DEA is also expending increasing
time and resources on implementing its initial response to internet-
based drug diversion, for which it has opened a number of cases leading
to arrests and convictions. DEA has also seen an increase in the number
of drug diversion cases leading to arrests. (The number of diversion
arrests more than doubled in just five years, from 444 arrests in
Fiscal Year 1995 to 941 diversion arrests relating to drug cases alone
in Fiscal Year 2000. DEA made 871 diversion arrests relating to drug
cases in Fiscal Year 2001, and 341 arrests in the first six months of
Fiscal Year 2002. The slight decrease in arrests in Fiscal Year 2001
and the first half of Fiscal Year 2002 is attributable to a greater
emphasis on chemical investigative activities.) These additional
programmatic needs and responsibilities have required additional
investigators, headquarters staff and increased financial resources to
support these staff and their efforts to prevent the diversion of licit
controlled substances
The following table shows the annual growth in Budget Authority for
the DCP from Fiscal Year 1994 through Fiscal Year 2006 (expected Budget
Authority for FY03 and estimated Budget Authority for FY04, FY05, and
FY06). The Budget Authority is based on the President's Budget Request.
Note, these figures do not include the required annual $15 million
transfer to the U.S. Treasury.
------------------------------------------------------------------------
Budget authority (In
Fiscal year millions)
------------------------------------------------------------------------
FY94........................................... $57.1
FY95........................................... 58.4
FY96........................................... 62.2
FY97........................................... 67.8
FY98........................................... 73.2
FY99........................................... 76.7
FY00........................................... 80.3
FY01........................................... 83.5
FY02........................................... 86.2
FY03 (est)..................................... 89
FY04 (est.).................................... 118.6
FY05 (est.).................................... 142.3
FY06 (est.).................................... 145.3
------------------------------------------------------------------------
In reviewing the activities currently supported by the DDCFA and
the relevant legislation and regulatory actions governing the DCP and
fee funding, DEA identified several elements of DEA operations that,
though not part of the DCP, incidentally support the activities of the
DCP and which to date have been funded through Congressional
appropriations rather than through the DDCFA. Examples of such elements
include two sections within the Office of Chief Counsel that (a)
litigate administrative actions related to DEA registrants and (b)
provide legal support on regulatory policy matters; a section within
the Office of Training that is specifically dedicated to the DCP; a
portion of the Office of Forensic Sciences Special Testing Laboratory
that supports authentic sample analyses for licit drugs; and a portion
of the budget for DEA's agency-wide computer network, ``Firebird'',
related to the work of the DCP. As was discussed more fully in previous
rulemakings regarding the DDCFA, while these elements incidentally
support diversion control efforts, because their overall function is
not primarily devoted to diversion control, they have been included
elsewhere in the DEA budget and not as part of fee-fundable activities.
In the absence of specific guidance in the 1993 Appropriations Act as
to which activities were encompassed within the DCP and thus fee-
fundable, DEA has followed the plain language of the act and used the
budget categories that had historically been included in the DCP budget
request of the Attorney General. As described in DEA's 1996 Federal
Register notice, for the purposes of
[[Page 7731]]
budget formulation and appropriation, DEA historically has identified
only those resources (with their overhead costs) that were specifically
devoted to diversion control efforts as part of the DCP in its annual
budget submission to Congress. Other resources which support a broad
range of DEA activities, including diversion control, therefore have
been included in the budget formulation and appropriation process and
not funded through the DDCFA. 61 FR 68631. At this time these
activities will continue to be funded through appropriated funds as DEA
considers how to better comply with the applicable laws in the future.
Development of the New Fee Schedule
DEA set the current fee schedule for the Diversion Control Program
(DCP) through publication in the Federal Register on March 22, 1993.
This announcement outlined the general categories of cost to be borne
by the resulting Drug Diversion Control Fee Account (DDCFA) and
delineated the fee categories indicated below:
------------------------------------------------------------------------
Registrant class Annual cost
------------------------------------------------------------------------
Manufacturers.............................................. $875
Distributors, Importers/Exporters.......................... 438
Dispensers/Practitioners................................... 70
Researchers, Narcotic Treatment Programs................... 70
------------------------------------------------------------------------
Since this announcement, the fees, which as required by law support
the full cost of the Diversion Control Program, have not changed
despite growth in the program and additional costs borne by the program
(see the previous section). To recover the full costs of the DCP as
required by law, DEA plans to incrementally raise the fees in
accordance with its existing fee structure as follows:
------------------------------------------------------------------------
Registrant class Annual cost
------------------------------------------------------------------------
Manufacturers.............................................. $1,605
Distributors, Importers/Exporters.......................... 804
Dispensers/Practitioners................................... 131
Researchers, Narcotic Treatment Programs................... 131
------------------------------------------------------------------------
These increases in fees will go into effect 30 days after the
publication of the final rule.
The determination of fees for the Fiscal Year 2004-2006 period
covered by this notice is based on the expected Budget Authority for
Fiscal Year 2004 (based on the President's Budget Request) and the
estimated budget request and appropriation for each subsequent year
plus the annual $15 million transfer to the U.S. Treasury. In addition
to covering with fee funds all program elements and activities related
to the registration and control of the manufacture, distribution and
dispensing of controlled substances, DEA must transfer the first $15
million of fee revenue to the General Fund of the Treasury each year.
21 U.S.C. 886a(1). For each fiscal year between Fiscal Year 1993
through Fiscal Year 1998, Congress appropriated an additional $15
million to offset this requirement (a total infusion to the DDCFA of
$90 million). However, beginning in Fiscal Year 1999, Congress
discontinued this additional appropriation.
The expected Budget Authority for Fiscal Year 2004 is $118,561,000,
which accounts for increases in program costs due to inflation,
increases in federal staff salaries, and additional funds to undertake
a number of new initiatives to prevent, detect and eliminate the
diversion of controlled substances while ensuring an adequate supply
for legitimate medical and scientific purposes. Funds include
$12,518,000 for diversion investigation (for 93 positions), including
OxyContin[reg] diversion control and implementation of a system to
detect Internet sites that may divert controlled substances and
investigation of those sites, as warranted. This will permit DEA to
conduct additional and more complex investigations into the diversion
of pharmaceutical controlled substances. Other funds accounted for
include $12,098,000 (for 40 positions) to develop a system to permit
the electronic transmission of controlled substances prescriptions from
prescriber to pharmacy and to develop an electronic order form for
Schedule I and II controlled substances. These electronic alternatives
will provide a similar or higher degree of security/integrity than
current paper-based systems and will help DEA to meet its legal
mandates under the Government Paperwork Elimination Act. The total cost
of program enhancements for Fiscal Year 2004 is $24,873,000. Including
the mandatory transfer to Treasury of $15 million, the total amount
required to be recovered for Fiscal Year 2004 is $133,561,000.
The anticipated President's Budget Request for Fiscal Year 2005 is
$142,265,000. This figure accounts for increases in program costs due
to inflation (including such items as postage rate increase, increases
in cost of employee health benefits, increases in GSA rent, etc.),
costs of federal staff pay increases, and an additional $20,578,000
(for 39 positions). This figure includes costs to support the systems
to permit the electronic transmission of controlled substances
prescriptions and electronic orders of Schedule I and II controlled
substances, the support and operation of DEA's Internet investigations,
a major upgrade to the Automation of Reports and Consolidated Orders
System (ARCOS), and significant improvements to registration customer/
forms service. Other funds accounted for include liaison, policy,
regulatory, and analytical activities of the Diversion Control Program.
Including the mandatory transfer to Treasury of $15 million, the total
amount required to be recovered for Fiscal Year 2005 is $157,265,000.
The anticipated President's Budget Request for Fiscal Year 2006 is
$145,307,000 which accounts for inflationary growth from the previous
fiscal year estimate and increases in Federal staff salaries. Including
the mandatory transfer to Treasury of $15 million, the total amount
required to be recovered for Fiscal Year 2006 is $160,307,000.
To calculate inflationary growth, DEA used inflation figures of 1.5
percent for Fiscal Year 2004, 1.6 percent for Fiscal Year 2005 and 1.7
percent for Fiscal Year 2006 and salary increase assumptions of 2.0
percent for Fiscal Year 2004 and 3.4 percent for both Fiscal Year 2005
and Fiscal Year 2006, based on the President's Economic Assumptions.
The total amount necessary to collect through fee funds for the Fiscal
Year 2004-2006 period is $451,133,000. Based on the amounts required to
be collected for the 2004-2006 period to comply with the law, DEA
developed the specific fee levels for each registrant category
reflected in the previous table. To calculate these fees, DEA first
estimated the number of paying registrants for this period and then
used this figure combined with the amount required to be collected to
set the new fee rate. To calculate the number of paying registrants,
DEA used logarithmic regression analysis to project the yearly
registrant figures based on historical registrant data for the period
of Fiscal Year 1994 through Fiscal Year 2001.
DEA then estimated the number of registrants for each registrant
category since different registrant categories pay different fees.
Because there were insufficient data for some activities to perform
regression analysis, DEA used the percentage for each category using
data from the corresponding cycle years in the past.
Finally, based on the analyses conducted, DEA developed the fees
for each registrant category consistent with
[[Page 7732]]
its current fee structure. In doing so, DEA opted to set the fee level
for a three-year period (FY 2004-2006) to avoid the heavy burden on
registrants and the additional administrative expenses to DEA that
resetting the fee each year would impose. Accordingly, the fees above
reflect the total amount necessary to be collected for the full three-
year period (FY 2004-2006) divided by projected registrants and
accounting for projected registrant growth by category for each fiscal
year. Because different categories of registrants pay different
amounts, DEA weighted the number of registrants in each category to
ensure the appropriate reflection in the fee schedule. Because the fees
reflect the total amount necessary to be collected for the Fiscal Year
2004-2006 period, DEA may accumulate additional funds beyond those
necessary for actual program operations in the initial year (Fiscal
Year 2004), but in the final year of the period (Fiscal Year 2006) fee
collections are anticipated to fall short of the amount necessary to
cover expenditures in that year, so DEA will then draw down the
previously collected surplus. The alternatives to this approach would
be to reset the fee each year or to set a different fee for each fiscal
year; both of these options would cause unnecessary confusion and would
impose greater administrative burdens on DEA and registrants.
Regulatory Analyses
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 605(b)), has reviewed this regulation, and by approving it
certifies that this regulation will not have a significant economic
impact on a substantial number of small entities. While DEA recognizes
that this regulation will have a financial effect on registrants with
the increase in fees, the change in fees is not significant. Moreover,
the fees have not been changed in nine years, and DEA is legally
mandated to collect fees to cover the full costs of the Diversion
Control Program. The appropriations process was used to determine the
budget on which the fees are based. The increase in fees after nine
years covers both inflation and enhancements to address additional
responsibilities assumed by the Diversion Control Program.
In considering options for collecting the full costs of the
Diversion Control Program as mandated by law (21 U.S.C. 886a(3)), DEA
considered several alternatives to the approach proposed in this
regulation. One alternative would be to reset the fee each year for
each category of registrant according to the Budget Authority. Another
alternative would be to set a different fee for each fiscal year. DEA
determined that both of these options would cause unnecessary confusion
with fee changes each year and would impose greater administrative and
financial burdens on DEA and registrants than the approach proposed in
this regulation.
Executive Order 12866
The Deputy Administrator further certifies that this rulemaking has
been drafted in accordance with the principles in Executive Order 12866
Section 1(b). DEA has determined that this is not a significant
regulatory action, but this action has been reviewed by the Office of
Management and Budget.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state
law; nor does it impose enforcement responsibilities on any state; nor
does it diminish the power of any state to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by State, local, and
tribal governments, in the aggregate of $100,000,000 or more in any one
year, and will not significantly or uniquely affect small governments.
While it will affect the private sector in excess of $100,000,000 per
year, the effect on individual entities and practitioners is minimal.
The majority of the affected entities will pay $131 per year (or $391
for a three year registration period). Moreover, this rule is
promulgated in compliance with Congressional mandate that the full cost
of operating the DCP be collected through registrant fees as stipulated
in the 1993 Departments of Commerce, Justice, and State, the Judiciary,
and Related Agencies Appropriations Act (Pub. L. 102-395) and codified
in 21 U.S.C. 886a(3). Detailed estimates and analyses, including
specific fee amounts for individual registrants, are included in the
text of the proposed rule.
Small Business Regulatory Enforcement Fairness Act of 1996
This rule is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. While this
rule will result in an annual effect on the economy of $100,000,000 or
more, it will not result in a major increase in costs or prices or
cause significant adverse effects on competition, employment,
investment, productivity, innovation, or on the ability of United
States-based companies to compete with foreign-based companies in
domestic and export markets. This rule is not a discretionary action
but rather responds to the Congressional mandate that the full
operating costs of the DCP be collected through registrant fees as
described above. The individual effect on small business registrants is
minimal ranging from $131 to $1,605 per year with the majority of
affected registrants paying an annual fee of $131 (or $391 for three
years).
List of Subjects in 21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures. For the reasons set out above, 21 CFR part 1301 is
proposed to be amended as follows:
PART 1301--[AMENDED]
1. The authority citation for part 1301 continues to read as
follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877.
2. Section 1301.13 is proposed to be amended by revising paragraph
(e)(1) to read as follows:
Sec. 1301.13 Application for registration; time for application;
expiration date; registration for independent activities; application
forms, fees, contents and signature; coincident activities.
* * * * *
(e) * * *
(1)
[[Page 7733]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registration
Business activity Controlled substances DEA application forms Application period Coincident activities
fee ($) (years) allowed
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) Manufacturing................. Schedules I-V................. New--225...................... 1,605 1 Schedules I-V: May
Renewal--225a................. 1,605 distribute that
substance or class for
which registration was
issued; may not
distribute or dispose
any substance or class
for which not
registered. Schedules II-
V: Except a person
registered to dispose of
any controlled substance
may conduct chemical
analysis and preclinical
research (including
quality control
analysis) with
substances listed in
those schedules for
which authorization as a
mfg. Was issued.
(ii) Distributing................. Schedules I-V................. New--225...................... 804 1 .........................
Renewal--225a................. 804
(iii) Dispensing or instructing Schedules II-V................ New--224...................... 391 3 May conduct research and
(includes Practitioner, Hospital/ Renewal--224a................. 391 instructional activities
Clinic, Retail Pharmacy, Teaching with those substances
Institution). for which registration
was granted, except that
a mid-level practitioner
may conduct such
research only to the
extent expressly
authorized under state
statute. A pharmacist
may manufacture an
aqueous or oleaginous
solution or solid dosage
form containing a
narcotic controlled
substance in Schedule II-
V in a proportion not
exceeding 20% of the
complete solution,
compound or mixture.
(iv) Research..................... Schedule I.................... New--225...................... 131 1 A researcher may
Renewal--225a................. 131 manufacture or import
the basic class of
substance or substances
for which registration
was issued, provided
that such manufacture or
import is set forth in
the protocol required in
Section 1301.18 and to
distribute such class to
persons registered or
authorized to conduct
research with such class
of substance or
registered or authorized
to conduct chemical
analysis with controlled
substances.
(v) Research...................... Schedules II-V................ New--225...................... 131 1 May conduct chemical
Renewal--225a................. 131 analysis with controlled
substances in those
schedules for which
registration was issued;
manufacture such
substances if and to the
extent that such
manufacture is set forth
in a statement filed
with the application for
registration or
reregistration and
provided that the
manufacture is not for
the purposes of dosage
form development; import
such substances for
research purposes;
distribute such
substances to persons
registered or authorized
to conduct chemical
analysis, instructional
activities or research
with such substances,
and to persons exempted
from registration
pursuant to Section
1301.24; and conduct
instructional activities
with controlled
substances.
(vi) Narcotic Treatment Program Narcotic Drugs in Schedules II- New--363...................... 131 1 .........................
(including compounder). V. Renewal--363a................. 131
(vii) Importing................... Schedules I-V................. New--225...................... 804 1 May distribute that
Renewal--225a................. 804 substance or class for
which registration was
issued; may not
distribute any substance
or class for which not
registered.
(viii) Exporting.................. Schedules I-V................. New--225...................... 804 1 .........................
Renewal--225a................. 804
(ix) Chemical Analysis............ Schedules I-V................. New--225...................... 131 1 May manufacture and
Renewal--225a................. 131 import controlled
substances for
analytical or
instructional
activities; may
distribute such
substances to persons
registered or authorized
to conduct chemical
analysis, instructional
activities, or research
with such substances and
to persons exempted from
registration pursuant to
section 1301.24; may
export such substances
to persons in other
countries performing
chemical analysis or
enforcing laws related
to controlled substances
or drugs in those
countries; and may
conduct instructional
activities with
controlled substances.
[[Page 7734]]
(x) Disposer...................... Schedules I-V................. New--225...................... 131 1
Renewal--225a................. 131
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* * * * *
Dated: February 5, 2003.
John B. Brown III,
Deputy Administrator.
[FR Doc. 03-3765 Filed 2-14-03; 8:45 am]
BILLING CODE 4410-09-P