[Federal Register: August 29, 2006 (Volume 71, Number 167)]
[Rules and Regulations]
[Page 51105-51115]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au06-5]
[[Page 51105]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1301 and 1309
[Docket No. DEA-266F]
RIN 1117-AA96
Controlled Substances and List I Chemical Registration and
Reregistration Application Fees
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final Rule.
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SUMMARY: This final rule establishes the fee schedule for DEA
registration and reregistration fees relating to the registration and
control of the manufacture, distribution and dispensing of controlled
substances and listed chemicals to appropriately reflect all costs
associated with its Diversion Control Program for the conduct of
activities as mandated by 21 U.S.C. 822 and 958. Specifically, this
final rule revises the fee schedule for controlled substances and List
I chemical handlers so that all manufacturers, distributors, importers,
exporters, and dispensers of controlled substances and of List I
chemicals pay an annual fee, by registrant category, irrespective of
whether they handle controlled substances or List I chemicals. In doing
so, this rule implements clarifications to the Diversion Control
Program and the Diversion Control Fee Account made by Congress in the
Consolidated Appropriations Act of 2005 (Pub. L. 108-447) that amended
21 U.S.C. 886a.
EFFECTIVE DATE: This rule is effective November 1, 2006. The new fee
schedule will be in effect for all new applications postmarked on or
after November 1, 2006 and for all renewal applications postmarked on
or after November 1, 2006.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537; Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The Drug Enforcement Administration published a Notice of Proposed
Rulemaking in the Federal Register on November 16, 2005 (70 FR 69474)
to adjust the registration and reregistration fees for controlled
substances and List I chemical handlers.
The Controlled Substances Act (CSA) requires that all
manufacturers, distributors, dispensers, importers and exporters of
controlled substances and List I chemicals obtain an annual
registration with DEA (21 U.S.C. 822 and 958(f)). In addition, the CSA,
as codified in 21 U.S.C. 821, authorizes the Attorney General, who in
turn redelegates this authority to the Administrator of DEA, to
``promulgate rules and regulations and to charge reasonable fees
relating to the registration and control of the manufacture,
distribution, and dispensing of controlled substances and listed
chemicals'' (21 U.S.C. 821 as amended by Pub. L. 108-447).
In October 1992, Congress passed the Departments of Commerce,
Justice and State, the Judiciary and Related Agencies Appropriations
Act of 1993 which changed the source of funding for DEA's Diversion
Control Program (DCP) from being part of DEA's Congressional
appropriation to full funding by registration and reregistration fees
through the establishment of the Diversion Control Fee Account (DCFA).
The Appropriations Act of 1993 required that ``[f]ees 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.'' The legislation did
not, however, provide clarification on what constituted the ``Diversion
Control Program,'' thus leaving open the issue as to what fee-setting
criteria should be used to determine which costs could be reimbursed
from the DCFA.
In response to the Appropriations Act of 1993, DEA published a
Notice of Proposed Rulemaking (NPRM) in December 1992 to adjust the
registration and reregistration fees for controlled substance
registrants (57 FR 60148, December 18, 1992). In the absence of
guidelines from Congress regarding the specific criteria to be followed
in identifying costs and setting the fees, DEA relied on the plain
language of the Appropriations Act of 1993 and proposed fees necessary
to cover the costs of the activities that were identified within the
budget decision unit known as the ``Diversion Control Program.''
At the time that the Appropriations Act of 1993 was passed, 21
U.S.C. 821 did not extend to chemical control activities; accordingly,
there were no registration or fee requirements for handlers of listed
chemicals. DEA therefore excluded chemical control costs from its Final
Rule implementing the requirements of the Appropriations Act of 1993
(58 FR 15272, March 22, 1993). 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); however, despite this amendment, DEA
continued to endeavor to maintain separate funding for its controlled
substances diversion control and its chemical diversion control
activities. That is, DEA has paid for its controlled substance
diversion control activities through the Diversion Control Fee Account
and registration fees and its chemical diversion control activities
through appropriated funds.
Following publication of DEA's Final Rule, the American Medical
Association (AMA) and others filed a lawsuit objecting to the increase
in registration and reregistration fees on the grounds that DEA had
failed to provide adequate information as to what activities were
covered by the fees and how they were justified. Upon appeal, the
United States Court of Appeals for the District of Columbia Circuit
remanded, without vacating, the rule to DEA, requiring the agency to
provide an opportunity for meaningful notice and comment on the fee-
funded components of the DCP. In doing so, the court confirmed the
boundaries of the DCP that DEA can fund by registration fees, finding
that the current statutory scheme (21 U.S.C. 821 and 958) required DEA
to set reasonable registration fees to recover the full costs of the
DCP. (AMA v. Reno, 57 F.3d 1129, 1135 (DC Cir. 1995)).
Thus, in the absence of a simple, objective measure by which DCP
costs could be identified and the appropriate fees calculated, both DEA
and the courts have looked to 21 U.S.C. 821 and 958 to define the
guidelines for determining what costs should be included in the
calculation of the fees and from whom the fees might be collected.
On November 20, 2004, Congress passed the Departments of Commerce,
Justice, and State, the Judiciary, and Related Agencies Appropriations
Act of 2005 which provided clarification as to the activities
constituting the DCP. This Act was included in the Consolidated
Appropriations Act of 2005, which was signed into law by the President
on December 8, 2004 (Pub. L. 108-447). The Act amended 21 U.S.C. 886a
to define the Diversion Control Program as ``the controlled substance
and chemical diversion control activities of the Drug Enforcement
Administration,'' which are further defined as the ``activities related
to the registration and control of the manufacture, distribution and
dispensing, importation and exportation of controlled substances and
listed
[[Page 51106]]
chemicals.'' It also amended the section to provide that reimbursements
from the DCFA ``* * * shall be made without distinguishing between
expenses related to controlled substances activities and expenses
related to chemical activities.'' Finally, the Act amended 21 U.S.C.
821 and 958(f) to make the language of those sections consistent with
the definition of the DCP (Pub. L. 108-447). The net effect of the
amendments is to allow DEA to deposit all registration and
reregistration fees (controlled substance and chemical) into the Fee
Account and fund all controlled substance and chemical diversion
control activities from the account without distinguishing as to the
type of activity (controlled substance or chemical) being funded.
While the comingling of controlled substances diversion control and
chemical diversion control fees and activities might seem initially to
be incongruous, there is, in fact, a significant amount of overlap,
both in terms of activities and registrant populations. While it is
easy to distinguish between handlers of controlled substances and the
handlers of commodity chemicals such as red phosphorous, hydriotic
acid, acetic anhydride and nitroethane, the line between handlers of
controlled substances and handlers of drug products that contain listed
chemicals is blurred considerably. Not only are the drug products that
contain List I chemicals often manufactured by controlled substances
manufacturers, they are commonly distributed by controlled substances
distributors and routinely sold or dispensed by pharmacies, hospitals,
and individual practitioners. In calendar year 2004, there were over 30
million prescriptions filled for drug products containing the List I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, which is
still routinely used in veterinary products. There are undoubtedly many
instances in which practitioners also provided their patients with free
samples of allergy and cough and cold preparations that contain those
chemicals. Within this general environment, the use of a single,
unified account to fund the controlled substances and chemical
diversion control activities of DEA is consistent with the mandates of
the law.
DEA is bound by all of the above-referenced statutory requirements
in setting fees that recover the ``full cost'' of the Diversion Control
Program and its activities, as defined in the most recent lawmaking
action. Therefore, DEA has developed this rulemaking according to these
legislative mandates.
II. Comments Received
Following publication of the Notice of Proposed Rulemaking on
November 16, 2005, DEA received 12 comments to the notice. Three
comments were received from practitioners (one physician, one physician
assistant, and one dentist); three comments were received from
manufacturers or distributors; five comments were received from
organizations representing different registrant groups; and one comment
was submitted anonymously.
Most commenters raised concern about the increase in fees,
particularly for chemical registrants. Two commenters in particular
wrote that the increase in fees will have a significant impact on
chemical registrants compared to current fee rates and proposed an
alternative fee increase. One commenter wrote that programs within DEA
should be downsized or eliminated to maintain a ``neutral budget'' and
keep costs lower. Three commenters expressed concern that the fee
increase is coming at a time when Congress and other entities are re-
evaluating medical reimbursements; one physician commented that he
would pay the new fee as soon as his reimbursements increased by the
same percentage. Another expressed concern that the cost of the
increased fees would discourage physicians from registering with DEA
and using controlled substances, thus affecting patient care.
Five commenters objected to the removal of the waiver of the
chemical registration requirement for controlled substances registrants
that handle drug products that are regulated as List I chemicals. The
commenters wrote that they believed removal of this waiver would damage
the ability of affected registrants to service their customer base and
posed an unreasonable hardship. Two commenters also noted that removal
of the waiver could create expensive administrative burdens for both
registrants and for DEA.
Two registrants objected to the existing fee exemption for certain
entities such as some Federal agencies, certain charitable
organizations, law enforcement entities, and military personnel.
Commenters noted that exempting these organizations results in larger
fees for fee-paying registrants and requested reevaluation of this
policy by DEA.
Two commenters raised the issue of performance standards tied to
the increase in fees and requested clarification on DEA's expected
outcomes as a result of the increased fees and the performance measures
and metrics DEA has established to assess these outcomes.
One commenter wrote that the required $15 million annual transfer
to the U.S. Treasury out of collected fee funds was a significant
percentage of the total fees collected, and the commenter urged DEA to
request that Congress resume its annual $15 million appropriation to
offset this transfer. The commenter wrote that it, too, would work to
see this appropriation restored.
One anonymous commenter wrote that medical marijuana is ``most
popular in California especially with grayhaired men and women.''
Marijuana is not a licit controlled substance or listed chemical
covered by this rulemaking and is not affected by this final rule;
accordingly, this comment is not further addressed in this section.
Another commenter, a practitioner, submitted a request for
reregistration materials through the comment response vehicle. These
materials were provided to the commenter, and this matter is not
addressed further in this rulemaking.
Three commenters requested that DEA extend implementation of the
final rule, noting that the rule comes in the middle of budget cycles
for many registrants who had not planned for increased fees as part of
their budgets and that it also comes at a time of statutory and other
change for the industry. Each of these comments is addressed below.
III. Objection to Fee Increase
Nine of the twelve comments received by DEA expressed opposition to
the increase in fees. As described above, 21 U.S.C. 821 (as amended by
Pub. L. 108-447) authorizes DEA to collect reasonable fees relating to
the registration and control of the manufacture, distribution and
dispensing of controlled substances and listed chemicals. In addition,
the 1993 Departments of Commerce, Justice, and State, the Judiciary,
and Related Agencies Appropriations Act that established the Diversion
Control Fee Account (DCFA) specifically mandated that fees ``shall be
set at a level that ensures the recovery of the full costs of operating
the various aspects of that program'' (21 U.S.C. 886a(3)). Congress, in
using the mandatory term ``shall'' as opposed to the discretionary
``may,'' unambiguously required DEA to increase its then-existing
registration fees resulting in registrants fully funding DCP expenses.
DEA, therefore, lacks discretion in this matter and must fund the DCP
totally from registration fees (that is, not from fines, Congressional
appropriations or other potential sources).
[[Page 51107]]
Accordingly, while DEA recognizes the economic pressures facing
practitioners, such as declining Medicaid reimbursements and increasing
operating, equipment, and insurance costs, the current statutory scheme
requires DEA to set registration fees to recover the full costs of the
DCP, while limiting DEA to charge ``reasonable'' fees relating to the
registration and control of the manufacture, distribution and
dispensing of controlled substances and listed chemicals. DEA does not
have the discretion to partially fund the DCP or to find alternative
sources of funding for the program. Rather DEA is mandated by law to
fund the DCP fully through registration fees. The registration fees
outlined below are set at a level to support the full costs of the DCP
as mandated by law.
With clarification of the activities constituting the DCP in the
Appropriations Act of 2005, DEA is now required to evaluate the ``full
costs'' of the DCP to include all controlled substances and all listed
chemical diversion control activities; whereas, previously the only DCP
costs supported through registrant fees were controlled substances
diversion control costs, and listed chemical diversion control
activities were supported through appropriated funds. (See the Notice
of Proposed Rulemaking published on November 17, 2005, 70 FR 69474) for
additional discussion on this separation of activities.) In fact,
operating the DCP as a cohesive whole, that is without distinction in
activities between controlled substances and chemical diversion control
activities, offers scale efficiencies and ultimately cost savings and
improved services for registrants.
The fees set forth in this final rule reflect calculation of the
full costs of both the controlled substances and chemical diversion
control activities of the DCP. The revised fee structure contained in
this final rule includes annual fees (or fee equivalent) ranging from
$184 to $2,293. DEA recognizes that the increase in fees may represent
a budgeting challenge for registrants, particularly registrants with
multiple sites requiring separate registrations (e.g., chain drug
stores), however, because the fees do not represent a significant
financial burden on registrants, DEA has determined that the fees
contained in this final rule are reasonable. DEA expects that among all
registrants, mid-level practitioners and chemical distributors may feel
the greatest impact of the new fees (see discussion in Section XII).
However, for most registrants qualifying as small businesses the
revised fee will have a minimal impact, representing from 0.28 percent
to as little as 0.01 percent of average annual sales (or income). For
registrants that are large businesses with higher annual sales, the
impact of the fee is far less.
A. Differences in Fee Increase Among Registrant Categories
Two commenters expressed concern that the fees for chemical
registrants under this final rule reflect a higher percentage increase
than the change in fees for controlled substances registrants.
Commenters noted that fees for chemical manufacturers will increase by
approximately 300 percent and that fees for chemical distributors will
increase by about 100 percent compared to the current fee structure for
these chemical registrants. Commenters proposed an alternative fee
increase for these categories based on the same percentage increase as
controlled substances manufacturers and distributors.
Currently, chemical handlers pay a user fee that supports only the
costs of registration/reregistration and some administrative
oversight--not the operating costs of the DEA's chemical diversion
control program. With the transfer of DEA's chemical control program
costs to the DCFA, chemical registrants must, together with controlled
substances registrants, pay a fee to cover the full costs of the DCP.
The same circumstance occurred in 1993 with the establishment of the
DCFA; controlled substances registrants were faced with a substantial
increase in their fees as they transferred from a similar user fee that
supported registration costs only to a fee schedule to cover the full
costs of DEA's controlled substances diversion control activities. With
the transfer of the chemical control program costs to the DCFA and the
amendments to the law that reimbursements shall be made without
distinguishing between chemical and controlled substances activities,
chemical registrants must now be included in the DCFA population and
pay the fees necessary to sustain that account.
DEA does not have the discretion to adjust fees according to
percentages, such as was proposed by the commenters, as it is required
to fully fund the DCP through fees paid by the registrants while also
maintaining reasonable fees.
B. Program Costs
One commenter suggested that DEA downsize or eliminate programs to
maintain a neutral budget and keep fees low. DEA works diligently to
achieve administrative efficiencies in all of its programs, including
the Diversion Control Program. Through a scheduled, periodic review
process, virtually all aspects of the DCP are inspected to detect any
waste, fraud or abuse. All expenditures charged to the DCFA also are
reviewed and approved by an independent unit within DEA that reviews,
approves, and audits fee-funded expenditures.
Moreover, each of DEA's annual budget requests to Congress, which
contain all components of each DEA program, including the DCP, is
available for public review. Each budget request is examined and
approved by both the Department of Justice and the Office of Management
and Budget.
DEA has undertaken several initiatives to streamline aspects of the
DCP both for DEA and for registrants. For example, DEA is developing a
system to permit the electronic transmission of controlled substances
prescriptions through electronic creation, signature and record
retention, which will significantly increase the efficiency by which
prescriptions are transmitted from prescriber to pharmacy; however, it
will not reduce the review requirements of DEA employees that monitor
the prescription process for controlled substances. DEA has developed a
system that permits the electronic transmission of controlled
substances orders which provides increased efficiencies for industry.
Moreover, in 2005, DEA underwent an internal reorganization to increase
operational efficiencies and keep costs as low as possible. This
reorganization shifted the focus from business decision units to
activities that support the registration and control of the
manufacture, distribution, and dispensing of controlled substances and
listed chemicals. However, DEA is also subject to costs related to
inflation and additional costs of ``doing business'' that face all
organizations despite its best efforts to keep these expenses
reasonable.
C. Effect of Fee Increase on Practitioner Registration
One practitioner commenter noted concern that increases to annual
registrant fees could reduce the number of physicians registering with
DEA and using controlled substances as part of patient care. The
Controlled Substances Act requires that every person who manufactures,
distributes or dispenses any controlled substance or who proposes to
engage in the manufacture, distribution or dispensing of any controlled
substance obtain an annual
[[Page 51108]]
registration (21 U.S.C. 822(a)(1) and 822(a)(2)).
DEA notes that the impact of the annual registration fee on
practitioners ($184 annual equivalent) is not significant, ranging from
a high of 0.28% to a low of 0.13% based on annual income for this
registrant category (see discussion below on small business impacts).
The majority of registered practitioners (71 percent) are physicians
whose annual income averages more than $140,000 and for whom the $184
annual fee equivalent represents approximately 0.13 percent of annual
income. Other large practitioner groups in this category include
dentists (16 percent of practitioners) for whom the annual fee
equivalent represents about 0.14 percent of their average annual income
of $133,000 and veterinarians (5 percent of practitioners) for whom the
annual fee equivalent equates to 0.25 percent of their average annual
income of $76,000. The revised fee will have greater impacts on other
types of practitioners (less than 5 percent of all registered
practitioners) with lower annual incomes, including nurse
practitioners, physician assistants, optometrists, and others for whom
the annual fee equivalent has an average impact of approximately 0.16-
0.28 percent.
IV. Removal of Waiver for Chemical Registrants Holding an Existing
Controlled Substances Registration
Four commenters objected to the removal of the waiver of the
registration requirement for persons who distribute, import or export a
drug product containing a List I chemical if that person is already
registered with DEA to manufacture, distribute or dispense, import or
export a controlled substance. Commenters noted that removal of this
waiver could dramatically increase the annual registration fees for
affected registrants and would damage their ability to service their
customers, would pose an ``unreasonable hardship,'' and could adversely
affect the List I chemical supply chain since many affected registrants
also hold a controlled substances registration. One commenter also
noted that removal of this waiver could require significant changes to
internal operations for affected registrants who would have to maintain
two DEA registrations, imposing significant paperwork, technological
and operational burdens. The commenter also suggested removal of the
waiver could result in increased operational burdens for DEA.
After careful review of these comments and consideration of the
benefits compared to the drawbacks associated with removal of this
waiver, DEA has decided to retain the current registration waiver for
persons who distribute, import, or export a product containing a List I
chemical who already hold a valid DEA registration to manufacture,
distribute or dispense, import, or export a controlled substance.
Accordingly, the proposed changes to the waiver provision are
removed.
DEA will address registration issues created by passage of the
Combat Methamphetamine Epidemic Act of 2005, included in the USA
PATRIOT Improvement and Reauthorization Act of 2005 (Pub. L. 109-177)
as part of the Act's implementing regulations.
V. Registration Fee Waivers for Certain Organizations and Persons
Two commenters objected to DEA's fee exemption for certain entities
and persons. Currently, government institutions, law enforcement
agencies, and military personnel are exempt from fees. In addition, DEA
waives fees for some charitable organizations. The commenters objected
to these fee waivers suggesting that the process is inequitable and
that the net result is higher fees for fee-paying registrants than if
these organizations were also required to pay annual registration and
reregistration fees. The commenters also asserted that fee-paying
registrants are paying a ``hidden contribution'' or ``forced donation''
to charitable organizations, without tax relief, by partially
subsidizing their fee requirements.
DEA appreciates these comments. DEA recognizes that exempting
certain entities from paying annual fees provides a benefit to some at
the expense of others and is evaluating its current practice of
exempting certain organizations and persons from annual registration
fees. Any changes to this practice will require a separate regulatory
process, including notice and comment.
VI. Performance Standards
Two commenters objected to the omission of anticipated outcomes or
results expected by DEA as a result of the increased fees. The
commenters requested detail on how DEA will track such results and
correlate them to the higher fees while recommending the development of
a system of metrics, accountability and reporting for the DCP.
The Government Performance and Results Act (GPRA) and the
President's Management Agenda (PMA), requires DEA, like all other
agencies and components, to provide a budget summary that incorporates
performance information on a quarterly basis. In response to these
requirements, DEA already integrates budget and performance in order to
evaluate the effectiveness of programs relative to long-term,
measurable outcome goals.
More specifically, in response to GPRA and the PMA, the DCP's
budgetary reporting on outlays from the DCFA includes performance
measures that are consistent with DEA's Strategic Plan and that reflect
the effectiveness of programmatic activities funded by registrant fees.
Among the objectives included in DEA Strategic Plan is continued
support to the registrant population through improved technology,
including E-commerce and customer support, while maintaining
cooperation, support, and assistance from the regulated industry. These
efforts, funded through registration fees, are intended to provide
benefits to the registrant population such as streamlined processing
and improved access to information. They are also intended to reduce
the paperwork burden on small businesses; reduce forged or stolen
prescriptions; improve authentication and verification of the
prescribing or ordering party and reduce processing time; increase
overall security; and improve DEA's data quality, agency efficiency and
responsiveness in carrying out its mission.
All budget submissions for the Diversion Control Program, like
submissions for all programs across DEA, are subject to multiple levels
of scrutiny and review within DEA, the Department of Justice, and the
Office of Management and Budget before being included in the
President's annual Budget Request to Congress.
VII. $15 Million Treasury Transfer
One commenter urged DEA to request that Congress resume the annual
$15 million appropriation to offset the requirement that the first $15
million in fee collections be transferred to the Treasury, so that all
fee funds may be used for DCP activities. The commenter noted that the
annual $15 million transfer represents a ``significant component'' of
the amounts to be collected each year.
The Appropriations Act of 1993 requires that DEA 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 from Fiscal Year 1993
through Fiscal Year 1998, Congress appropriated an additional $15
million to offset this requirement (a total infusion to the DCFA of $90
million). However, beginning in Fiscal Year 1999, Congress
[[Page 51109]]
discontinued this additional appropriation. Accordingly, since Fiscal
Year 1999, DEA has to include the annual $15 million transfer for fee
calculations; that is, DEA must pay for all operational costs of the
DCP plus the $15 million transfer out of fee funds collected from
registrants.
VIII. Extension of Implementation of the Final Rule
Three commenters requested delay of implementation of the final
rule to Fiscal Year 2007 or later. Two commenters requested the delay
because of the potential effects of removal of the registration waiver
for chemical handlers holding a current controlled substance
registration. Following careful review of comments, DEA has decided to
keep this waiver intact (see discussion above).
Three commenters requested the delay because of ongoing changes in
the industry, including pending state and Federal legislation affecting
over-the-counter products containing listed chemicals (such as products
containing pseudoephedrine and ephedrine). One commenter noted that
such pending legislation could affect distributors carrying these
products and therefore DEA registrations and revenue projections. The
commenters also noted that the fee modifications are coming at a time
when Congress, Federal agencies, and private party payers are exploring
methods for reducing reimbursement for prescription drugs. Two
commenters wrote that implementation of the final rule would come in
the middle of budget cycles for affected registrants and would,
therefore, impose financial challenges because of the unanticipated
additional expenses in the annual fees, particularly for chain drug
stores with many separately registered sites. DEA notes that very few
chain registrants have registrations expiring during the current
calendar year, thus limiting the potential impact of the fee increase
in the current budget cycle. With respect to pending legislation and
its possible effect on DEA registrations, DEA takes into account the
potential ebb and flow of the registrant population through the
retirement of old registrations and new applications for registration
when calculating the fees. DEA cannot delay implementation of the new
fee schedule as the agency is required, by statute, to recover the full
costs of the diversion control program through registration fees.
IX. Overview of Diversion Control Program Responsibilities
The mission of DEA's Diversion Control Program (DCP) is to enforce
the provisions of the Controlled Substances Act as they pertain to
ensuring the availability of controlled substances and listed chemicals
for legitimate uses in the United States while exercising controls to
prevent the diversion of these substances and chemicals for illegal
uses.
DCP activities include: Program priorities and field management
oversight; coordination of major investigations; drafting and
promulgating of regulations relating to the enforcement of the CSA and
other legislation; establishment of national policy on diversion;
fulfillment of U.S. obligations under drug control treaties; advice and
leadership on state legislation/regulation; legal control of drugs and
chemicals not previously under Federal control; control of imports and
exports of licit controlled substances and chemicals; and program
resource planning and allocation, among other activities.
As was outlined in the Notice of Proposed Rulemaking, DCP
activities funded to date out of the DCFA have been limited to
controlled substances diversion control activities, including
controlled substances 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. Fee-fundable activities also have included
travel, rent, utilities, supplies, equipment, and services associated
with the above-listed activities and activities related to the control
of licit controlled substances in the U.S. in which the initial source
is foreign. One commenter wrote that administrative expenses should not
be paid for out of the DCFA and fee funds; however, the courts have
found that all activities and expenses that are directly related to
diversion control may be funded with registration and reregistration
fees (AMA v. Reno, 57 F.3d 1129, 1135 (DC Cir. 1995)). Administrative
and other operational costs are directly related to the ongoing
diversion control efforts of the DCP.
With the inclusion of the chemical diversion control activities in
the DCFA and registrant fees by the Appropriations Act, activities
related to the overall control of listed chemicals, registration,
investigation, inspection, data collection and analysis, cooperative
efforts with the regulated industry, related management and
administrative positions devoted to diversion control activities, other
personnel, and administrative and clerical oversight have been included
in the budget calculations that are used to determined the registration
fees.
For detail on the specific DCP components to be funded through the
DCFA and their associated costs for the Fiscal Year 2006-2008 period
covered by this rulemaking, please see DEA's Notice of Proposed
Rulemaking, published in the Federal Register on November 16, 2005 (70
FR 69474).
X. Budget Changes
In calculating the registration and reregistration fees contained
in this Final Rule, DEA has included all DCP activities associated with
the ``registration and control of the manufacture, distribution and
dispensing, importation and exportation of controlled substances and
listed chemicals'' (Pub. L. 108-447).
As discussed in detail in the Notice of Proposed Rulemaking (70 FR
69474), beginning in Fiscal Year 2006, both controlled substance and
chemical diversion control costs must be included in the calculation of
DCFA registration and reregistration fees. Among the chemical diversion
control costs to be included among the ``full costs'' of operating the
DCP are a portion of the Office of Training (TR) that specifically
supports the activities of the DCP by providing training, guidance and
instruction for Diversion Investigators, Diversion Task Force Officers,
regulatory agencies, state and local law enforcement, and DCP personnel
on controlled substances and chemical diversion control, advanced
skills and technical knowledge, and systems applications. Also included
are 188 chemical diversion control positions; 12 overseas diversion
investigators dedicated to the DCP; and costs associated with the
chemical transaction system (CTRANS).
The chemical diversion control costs that will be supported through
the DCFA total $24,499,000 for Fiscal Year 2006, $24,880,000 for Fiscal
Year 2007, and $25,235,000 for Fiscal Year 2008, accounting for salary
growth and inflation.
In addition to the chemical control costs, DEA is including among
fee-fundable activities certain other internal resources that support
the DEA's diversion control activities, but that, as was discussed more
fully in previous rulemakings regarding the DCFA, had previously been
supported through appropriated funds despite their direct
[[Page 51110]]
relationship to and support of the DCP. These activities include
portions of the Office of Chief Counsel, the Office of Forensic
Sciences Special Testing Laboratory, and the Special Operations
Division; and additional special agent and intelligence analyst costs
not previously supported through the DCFA. These components and
associated costs are described below. A portion of DEA's internal
computer system, Firebird, which already is supported through the DCFA,
is included in the fee-fundable cost. The total cost of these non-
chemical additions for Fiscal Year 2006 is $26,996,000; for Fiscal Year
2007 is $31,198,000; and for Fiscal Year 2008 is $34,736,000.
In calculating the revised fee schedule, DEA used the Fiscal Year
2006 enacted Appropriation, the President's Budget Request for Fiscal
Year 2007, the expected Budget Request for Fiscal Year 2008, and the
annual $15 million transfer to the U.S. Treasury as mandated by the CSA
(21 U.S.C. 886a). In addition to fee funding all program elements and
activities related to the registration and control of the manufacture,
distribution, dispensing, importation, and exportation of controlled
substances and listed chemicals, DEA must transfer the first $15
million of fee revenue to the General Fund of the Treasury each year as
described above (21 U.S.C. 886a(1)).
The Fiscal Year 2006 cost of the DCP is $201,673,000, including a
base of $150,178,000 for controlled substances diversion control
activities, $24,499,000 in chemical diversion control activities, and
$26,996,000 for the additional non-chemical DCP support activities
outlined above and described in detail in the November 16, 2005 Notice
of Proposed Rulemaking (70 FR 69474), including 52 additional special
agent positions; a portion of the Forensic Sciences Special Testing
Laboratory; a portion of the Office of Chief Counsel that directly
supports diversion control activities; 34 of the 67 field intelligence
analysts to be phased in between Fiscal Year 2006-2007 and 6
Headquarters intelligence analysts to support domestic and
international diversion control investigations (the remaining 33 field
intelligence analysts will be phased in during Fiscal Year 2007); a
portion of the Special Operations Division directly related to
diversion control efforts; and Firebird operations costs to support
communication and infrastructure of the diversion control program.
With the addition of the required $15 million transfer to the U.S.
Treasury, the total amount necessary to collect through registrant fees
in Fiscal Year 2006 is $216,673,000.
The DCP cost for Fiscal Year 2007, including all activities
relating to the registration and control of the manufacture,
distribution and dispensing of controlled substances and listed
chemicals, is $212,078,000, as reflected in the President's Budget
Request to Congress. Including the required $15 million transfer to the
U.S. Treasury, the total amount necessary to collect through registrant
fees in Fiscal Year 2007 is $227,078,000. The anticipated costs of the
DCP for Fiscal Year 2008, including all activities relating to the
registration and control of the manufacture, distribution and
dispensing of controlled substances and listed chemicals, is
$218,669,000. Including the required $15 million transfer to the U.S.
Treasury, the total amount necessary to collect through registrant fees
in Fiscal Year 2008 is $233,669,000.
The total amount that must be collected through fee funds for the
Fiscal Year 2006-2008 period to fully fund the DCP as mandated by
statute is $677,420,000. Without an increase in fees, DEA would fall
short by $185,475,536 in funds to support the operations of the DCP.
The new fee structure contained in this final rule, therefore, provides
the necessary additional funds to ensure that the operational costs of
the DCP are fully funded through registrant fees as mandated by
statute. As explained above, DEA is required by statute to collect the
``full costs'' associated with operating the DCP.
XI. Calculation of Fees
Based on the total amount necessary to collect for Fiscal Years
2006-2008, DEA developed the specific fee levels for each registrant
category according to its current fee structure and the fee-paying
ratios that have been in existence since the inception of registrant
fees. New fees are shown in the table below. For discussion on DEA's
analysis of alternative fee schedules and approaches to calculating
registrant fees, please see DEA's 2002 Final Rule (67 FR 51988, August
9, 2002) and its 1996 Final Rule (61 FR 68624, December 30, 1996).
In developing the fee schedule, DEA opted to set the fee level for
a three-year period (FY 2006-2008) for two reasons. First, the vast
majority of registrants are practitioners who pay a three-year
registration fee. These registrants are divided into roughly three
separate groups who pay their three-year registration fees on alternate
year cycles. Accordingly, the fees below reflect the total amount
necessary to be collected for the full three-year period (FY 2006-
2008), 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. In calculating the final fee schedule
reflected below, DEA relied on the latest and current registrant
population figures, which have fluctuated since the proposed fees
contained in the Notice of Proposed Rulemaking. Because the fees
reflect the total amount necessary for collection over a three-year
period (Fiscal Years 2006-2008) and because the type and number of
registrants varies from year to year, the total amount of fees
collected may not equal the requested budget level for any given year.
Surplus fees collected in one year are used to offset fee collection
shortfalls in another year. In no case are fees spent in excess of the
levels enacted by Congress.
In evaluating options to structure the fee schedule, DEA opted to
remain with the current fee structure to reduce reporting burdens on
registrants and operational costs associated with the DCP which would
then be passed on to registrants through annual fees.
To recover the full costs of the DCP as required by statute and as
outlined in the preceding sections, DEA is adjusting the fees in
accordance with its existing fee structure as shown in the following
table. Under this fee schedule, controlled substances registrants and
chemical registrants in the same registrant category (e.g.,
manufacturers) pay the same fee regardless of the substance or chemical
being handled. The table also includes the current fees paid by each
category.
------------------------------------------------------------------------
Current annual
Registrant class New annual fee fee
------------------------------------------------------------------------
Manufacturers (controlled substances)... $2,293 $1,625
[[Page 51111]]
Manufacturers (chemical)................ 2,293 595
(registration)
Distributors, Importers/Exporters 1,147 813
(controlled substances), including
reverse distributors...................
Distributors, Importers/Exporters 1,147 595
(chemical)............................. (registration)
Chemical Retail Distributors............ 1,147 255
(registration)
Dispensers/Practitioners *.............. 184 130
Researchers, Narcotic Treatment Programs 184 130
------------------------------------------------------------------------
* Practitioners, mid-level practitioners, pharmacies, hospitals/clinics,
and teaching institutions will pay a fee of $551 for a three-year
registration period.
The fee structure above supplants the current fee structure for
controlled substances and for chemical registrants. These fees go into
effect November 1, 2006.
XI. Related Issues and Waivers
Also by this Notice, DEA is removing differentiation between retail
and non-retail distributors of List I chemicals. As of the effective
date of this final rule, both retail and non-retail distributors must
pay the same fee as described above.
DEA also is withdrawing, by this notice, its Notice of Proposed
Rulemaking issued on December 1, 1999, which proposed changes in
registration and reregistration fees for manufacturers, distributors,
importers, exporters and retail distributors of List I chemicals (64 FR
67216, December 1, 1999).
DEA also is rescinding the 1997 Notice of Fee Waiver published on
October 17, 1997 (62 FR 53958) which had waived a portion of the
registration fee for non-retail distributors of pseudoephedrine,
phenylpropanolamine, and combination ephedrine drug products.
XII. Effects on Small Businesses
The new registrant fees range from $184 to $2,293 annually per
location and per registered business activity. To assess whether the
fees could impose a significant economic impact on a small entity, DEA
considered whether the fees represent more than one percent of annual
revenues for the registrant groups that qualify as small entities under
the Small Business Administration (SBA) standards. As discussed below,
DEA does not anticipate that the increase in fees will have a
significant impact on a substantial number of small entities.
Most DEA registrants qualify as small entities under the SBA
standards. Almost all practitioners, who compose 85 percent of all
registrants affected by this rulemaking, would be considered small. For
practitioners and dispensers, the annual revenues would have to be
below $18,400 to have the annual registration fee or equivalent
represent more than one percent of revenues. Medical practitioners who
are granted authority to handle controlled substances have annual
incomes well above that level. Eighty-six percent of all practitioners
have annual incomes in excess of $133,000 (Bureau of Labor Statistics
salary information). For these practitioners, the new annual fee
equivalent of $184 represents less than 0.14 percent of annual income.
Physician assistants, the mid-level practitioner with the lowest
average salary, have annual salaries of about $65,000 (ibid.). For this
practitioner group, which represents about 2 percent of registered
practitioners, the annual fee equivalent equates to 0.28 percent of
annual income.
The higher fees also will not impose a significant burden on
dispensers. The average independent pharmacy has sales of almost $2
million according to the National Association of Chain Drug Stores. The
smallest clinics have revenue streams higher than $18,400. Among
dispensers, the greatest impact of this regulatory fee change will be
on chain pharmacies which must hold a registration for each of their
locations. The largest chain holds retail pharmacy registrations for
more than 5,000 locations as well as almost 40 registrations for its
distribution centers. However, these businesses do not qualify as small
entities; moreover, for the annual fee to have a significant economic
impact, annual revenues would have to be less than $18,400.
DEA acknowledges the concerns of one commenter that fee increases
going into effect in the middle of a budget cycle represent a non-
controllable and, perhaps, unanticipated, expense for large chain drug
stores and chain pharmacy distribution centers; however, as discussed
above, only a small fraction of registered chain drug stores must renew
their DEA registration in the second half of Calendar Year 2006 and are
thus affected by the budgetary implications of the fee increase.
For manufacturers, the 2002 Census data indicate that the value of
shipments for the smallest chemical manufacturers (including drugs)
ranged from $477,000 to $1.1 million per location (establishment). For
this registrant group, therefore, the fee of $2,293 does not represent
more than one percent of revenues and will not impose a significant
burden.
The one registrant group for which the fees could exceed one
percent of revenues and have a significant economic impact is chemical
distributors. According to 2004 Duns data, between one percent and 11
percent of the wholesale sectors handling listed chemicals have
revenues below $100,000. DEA does not collect financial data on its
registrants, but it is possible that some chemical distributor
registrants have revenues below $100,000. The increase in the annual
reregistration fee for chemical distributors (from $477 to $1,147) may
impose a significant burden on these registrants. The increase in the
initial registration fee (from a subsidized $116 for certain entities
to $1,147 annually) also could be a barrier to entrance for these very
small firms. Based on its experience, however, DEA considers it
unlikely that any firm that lacked the resources to pay the initial
registration fee would be granted a registration because it would be
unlikely to have the resources necessary to prevent diversion of the
products. Moreover, the new registration fees for all wholesale level
activities are far less than the estimated annual fee of $6,400 that
chemical registrants would be charged if they were required to
independently fund the chemical portion of the diversion control
program, as previously discussed in the Notice of Proposed Rulemaking
(70 FR 69474, November 16, 2005).
In short, combining all diversion control activities into a single
Diversion Control Program, as mandated by the Consolidated
Appropriations Act of
[[Page 51112]]
2005, results in scale efficiencies and overall reduced costs to all
registrants.
XIII. Regulatory Analysis
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)) and has provided above detailed regulatory analysis on
the effects of this rulemaking on small entities. The rule will not
have a significant economic impact on a substantial number of small
entities as discussed in Section XII. While DEA recognizes that this
regulation will have a financial effect on registrants, the change in
fees is necessary to fully comply with 21 U.S.C. 886a and related
statutes, which mandate that DEA establish the fees at a level
necessary to recover the full costs of the Diversion Control Program.
Executive Order 12866
The Deputy Administrator certifies that this rulemaking has been
drafted in accordance with the principles in Executive Order 12866
Sec. 1(b). DEA has determined that, because the increased fees will
result in a total increase of less than $70 million annually to be
collected through fees (that is the difference between the amount
collected annually under the previous fee structure and the amount to
be collected under the new fee structure), this is not a significant
regulatory action; however, it was reviewed by the Office of Management
and Budget. The fees to be collected represent an increase of less than
$70 million each year for the Fiscal Year 2006-2008 period (based on
estimated fee collection figures and compared to the previous fee
schedule) and are required to fully support the President's budget for
the DCP, as approved by Congress through the appropriations process.
Therefore, DEA has no discretion in the establishment of the new fees
and is required by law to collect registration and reregistration fees
of sufficient amount to fully support the DCP.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sec. Sec. 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 $118,000,000 or more in any one
year, and will not significantly or uniquely affect small governments.
The increase in fees for private sector entities and individuals will
result in a total increase of less than $70 million annually to be
collected through fees (that is the difference between the amount
collected annually under the prior fee structure and the amount to be
collected under the new fee structure). Moreover, the effect on
individual entities and practitioners is minimal. The majority of the
affected entities will pay a fee of $551 for a three year registration
period (the equivalent of $184 per year) which equates to about 0.13
percent of annual income for most practitioners (the vast majority of
all registrants). This rule is promulgated in compliance with 21 U.S.C.
886a that the full cost of operating the DCP be collected through
registrant fees.
Small Business Regulatory Enforcement Fairness Act of 1996
This rule is not a major rule as defined by Sec. 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,
in that it will result in the collection of approximately $216-$234
million annually, the increase in fees (that is, the difference between
the amount collected annually under the previous fee structure compared
to the new fee structure) will result in a total increase of less than
$70 million annually. Moreover, 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
U.S.-based companies to compete with foreign-based companies in
domestic and export markets. This rule is not a discretionary action
but rather responds to statutory clarification as to the activities
constituting the DCP which, by law, must be fully funded through
registrant fees (21 U.S.C. 821 and 958 and 21 U.S.C. 886a,
respectively). Moreover, the individual effect on small business
registrants is minimal. The majority of registrants considered to be
small businesses are practitioners who will pay a three-year
registration fee of $551 or the equivalent of $184 per year. For the
majority of these practitioners, who compose the vast majority of
registrants and registrants qualifying as small businesses, this annual
fee equivalent represents about 0.13 percent of their annual mean
salary. The impact on other small business entities is described in
greater detail in the preceding regulatory analysis.
List of Subjects
21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
21 CFR Part 1309
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Security measures.
0
For the reasons set out above, 21 CFR parts 1301 and 1309 are amended
as follows:
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS AND
DISPENSERS OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1301 is revised to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 886a,
951, 952, 953, 956, 957.
0
2. Section1301.13 is 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 51113]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application Registration
Business activity Controlled substances DEA application forms fee period Coincident activities
(dollars) (years) allowed
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) Manufacturing................ Schedules I-V............. New--225........................... 2,293 1 Schedules I-V: May
Renewal--225a...................... 2,293 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........................... 1,147 1 .........................
Renewal--225a...................... 1,147
(iii) Reverse distributing....... Schedules I-V............. New--225........................... 1,147 1 .........................
Renewal--225a...................... 1,147
(iv) Dispensing or instructing Schedules II-V............ New--224........................... 551 3 May conduct research and
(includes Practitioner, Hospital/ Renewal--224a...................... 551 instructional activities
Clinic, Retail Pharmacy, Central with those substances
fill pharmacy, Teaching for which registration
Institution). 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. A
retail pharmacy may
perform central fill
pharmacy activities.
(v) Research..................... Schedule I................ New--225........................... 184 1 A researcher may
Renewal--225a...................... 184 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
Sec. 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.
[[Page 51114]]
(vi) Research.................... Schedules II-V............ New--225........................... 184 1 May conduct chemical
Renewal--225a...................... 184 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 Sec.
1301.24; and conduct
instructional activities
with controlled
substances.
(vii) Narcotic Treatment Program Narcotic Drugs in New--363........................... 184 1 .........................
(including compounder). Schedules II-V. Renewal--363a...................... 184
(viii) Importing................. Schedules I-V............. New--225........................... 1,147 1 May distribute that
Renewal--225a...................... 1,147 substance or class for
which registration was
issued; may not
distribute any substance
or class for which not
registered.
(ix) Exporting................... Schedules I-V............. New--225........................... 1,147 1
Renewal--225a...................... 1,147
(x) Chemical Analysis............ Schedules I-V............. New--225........................... 184 1 May manufacture and
Renewal--225a...................... 184 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
Sec. 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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS,
AND EXPORTERS OF LIST I CHEMICALS
0
3. The authority citation for part 1309 is amended to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 830, 871(b), 875, 877,
886a, 958.
0
4. Section 1309.11 is revised to read as follows:
Sec. 1309.11 Fee amounts.
(a) For each application for registration or reregistration to
manufacture for distribution the applicant shall pay an annual fee of
$2,293.
(b) For each application for registration or reregistration to
distribute (either retail distribution or non-retail distribution),
import, or export a List I chemical, the applicant shall pay an annual
fee of $1,147.
0
5. Section 1309.12 is revised to read as follows:
Sec. 1309.12 Time and method of payment; refund.
(a) For each application for registration or reregistration to
manufacture for distribution, distribute (either retail distribution or
non-retail distribution), import, or export a List I chemical, the
applicant shall pay the fee when the application for registration or
reregistration is submitted for filing.
[[Page 51115]]
(b) Payment should be made in the form of a personal, certified, or
cashier's check or money order made payable to ``Drug Enforcement
Administration.'' Payments made in the form of stamps, foreign
currency, or third party endorsed checks will not be accepted. These
application fees are not refundable.
Dated: August 22, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-14286 Filed 8-28-06; 8:45 am]
BILLING CODE 4410-09-P