Source: https://www.federalregister.gov/articles/2012/03/15/2012-6253/controlled-substances-and-list-i-chemical-registration-and-reregistration-fees
Timestamp: 2016-02-12 14:09:33
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Matched Legal Cases: ['arts 1300', 'ART 1301', '§ 1301', '§ 1301', 'art 1309', '§ 1309', '§ 1309', '§ 1309', '§ 1309']

Federal Register | Controlled Substances and List I Chemical Registration and Reregistration Fees
-15250 (17 pages)
Document Number: 2012-6253
Shorter URL: https://federalregister.gov/a/2012-6253 Related Topics
Controlled Substances and List I Chemical Registration and Reregistration Fees 3 actions from July 6th, 2011 to May 2012
76 FR 39318
Table 1—Change in Operational Continuity Fund Balance FY 2012-2014
Table 2—CMEA Collections FY 2012-2014
Table 3—Needed Fee Collections FY 2012-2014
Registrants on Three-Year Registration Cycle
Registrants on Annual Registration Cycle
Table 10—Number of Registrants by Business Activity
Table 11—Industrial Sectors of DEA Registrants
Table 12—New Fee as Percentage of Income FY 2004-2012
The Drug Enforcement Administration (DEA) is a component of the Department of Justice and is the primary agency responsible for coordinating the drug law enforcement activities of the United States. DEA also assists in the implementation of the President's National Drug Control Strategy. DEA's mission is to enforce U.S. controlled substances laws and regulations and bring to the criminal and civil justice system those organizations and individuals involved in the growing, manufacturing, or distribution of controlled substances and listed chemicals appearing in or destined for illicit traffic in the U.S., including organizations that use drug trafficking proceeds to finance terrorism. The diversion control program (DCP) is a strategic component of the DEA's law enforcement mission. The DCP implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and the Controlled Substances Import and Export Act (CSIEA) (21 U.S.C. 801-971), as amended (hereinafter, “CSA”).
DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1321. The CSA, together with these regulations, is designed to help prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring a sufficient supply of controlled substances and listed chemicals for legitimate medical, scientific, research, and industrial purposes.
Under the CSA, DEA is authorized to charge reasonable fees relating to the registration and control of the manufacture, distribution, dispensing, import, and export of controlled substances and listed chemicals. 21 U.S.C. 821 and 958(f). DEA must set fees at a level that ensures the recovery of the full costs of operating the various aspects of its DCP. 21 U.S.C. 886a. Each year, DEA is required by statute to transfer the first $15 million of fee revenues into the general fund of the Treasury, and the remainder of the fee revenues is deposited into a separate fund of the Treasury called the Diversion Control Fee Account (DCFA). 21 U.S.C. 886a(1). On at least a quarterly basis, the Secretary of the Treasury is required to reimburse DEA an amount from the DCFA “in accordance with estimates made in the budget request of the Attorney General for those fiscal years” for the operation of the DCP.
21 U.S.C. 886a(1)(B) and (D). A Notice of Proposed Rulemaking (NPRM) proposing an adjusted fee schedule for DEA registration and reregistration was published on July 6, 2011, at 76 FR 39318, with a 60 day comment period. The comment period closed on September 6, 2011.
In 1970, Congress consolidated more than 50 laws related to the control of narcotics and dangerous drugs into one statute—the CSA. The statute was “designed to improve the administration and regulation of the manufacturing, distribution, and dispensing of controlled substances by providing for a `closed' system of drug distribution for legitimate handlers of such drugs,” with criminal penalties for transactions outside the legitimate chain.
With the enactment of the CSA, the Bureau of Narcotics and Dangerous Drugs (BNDD) was granted the authority to charge reasonable fees relating to both registration and control
of persons and entities engaged in the manufacture, distribution, dispensing, export, and import of controlled substances.
To this end, BNDD established a three- tiered fee structure for companies and individuals wishing to participate in the U.S. controlled substance industry.
In 1973, BNDD was abolished, and all of its functions were transferred to the newly-created DEA, including the authority to charge registrants reasonable fees.
In 1982, the General Accounting Office (GAO)
advised that the 1971 fee schedule did not adequately recover the costs for the DCP administered by DEA. An increase in fees was proposed and finalized in 1983.
All fees collected through 1992 were deposited into the general fund of the United States Treasury.
In 1993, Congress determined that the DCP would be fully funded by fees rather than by appropriations,
and established the DCFA as a separate account of the Treasury to “[ensure] the recovery of the full costs of operating the various aspects of [the diversion control program]” from fees charged by DEA. 21 U.S.C. 886a(1)(C). Congress also specified the general operation of the DCFA. Each fiscal year, the first $15 million of collected fees are transferred to the general fund of the Treasury and are not directly available for use by the DCP. Fees collected in excess of $15 million are used to reimburse DEA for expenses incurred in the operation of the DCP, in accordance with estimates made in the budget request of the Attorney General. 21 U.S.C. 886a(1).
Shortly after enactment of the 1993 Appropriations Act, DEA published a NPRM proposing to increase the existing fee schedule to comply with Congress's direction to set fees at a level that ensures the recovery of the full costs of operating the DCP.
After a comment period, a final rule was published on March 22, 1993, implementing changes to the fee structure and excluding chemical control costs from the calculation of fees.
Several registrants impacted by the fee increase challenged it, first in federal district court, where it was upheld, and subsequently on appeal, where it was remanded for additional information to support the fees.
Upon remand, the March 1993 final fee rule was reopened for further comment in 1996.
DEA undertook studies and internal reorganizations to enable it to better identify DCP activities and costs, and, in 2002, DEA published for additional public comment more information on the components and activities of the fee-funded DCP.
After that publication, the Office of the Inspector General, Department of Justice (OIG) concluded its review of the DCP, and determined that DEA was not adequately supporting the DCP.
In February 2003, DEA published a proposed rule to raise registration and reregistration fees so as to comply with the statutory requirement to charge fees at a level ensuring the recovery of the full costs of operating the various aspects of the DCP.
Shortly thereafter, DEA created the Validation Unit to ensure that DCFA-funded expenditures support registration and diversion control-related activities. The Validation Unit reports to the DEA Deputy Administrator and independently reviews specified expenditures attributable to the DCFA. If an expense only partially supports the DCP, such as a field office's rent or utility cost, the Validation Unit determines the amount that may be properly apportioned to the DCFA. On October 10, 2003, a new fee was finalized by publication of a final rule.
Meanwhile, in December 1993, the Domestic Chemical Diversion Control Act of 1993 amended the CSA to require that manufacturers, distributors, importers, and exporters of List I chemicals obtain a registration from DEA. DEA was also authorized to charge “reasonable fees relating * * * to the registration and control of regulated persons and regulated transactions.”
In 2004, the CSA was amended to define the DCP as “the controlled substance and chemical diversion control activities of the Drug Enforcement Administration.” 21 U.S.C. 886a(2)(A).
Furthermore, “controlled substance and chemical diversion control activities” means “those activities related to the registration and control of the manufacture, distribution, dispensing, importation, and exportation of controlled substances and listed chemicals.” 21 U.S.C. 886a(2)(B). Congress further provided that reimbursements from the DCFA “shall be made without distinguishing between expenses related to controlled substance activities and expenses related to chemical activities” (21 U.S.C. 886a(1)(B)) and amended the language of 21 U.S.C. 821 and 958(f) to be consistent with the definition of the DCP articulated in 21 U.S.C. 886a(2). As a result, all fees collected in excess of $15 million are deposited into the DCFA, and reimbursements by the Secretary of the Treasury are made without distinction between controlled substance and List I chemical activities.
In 2005, based upon internal organizational changes and the 2005 Appropriations Act, DEA proposed an adjusted fee schedule to appropriately reflect all costs associated with the DCP.
In July 2006, the OIG reported on its Follow-up Review of DEA's Efforts to Control the Diversion of Controlled Pharmaceuticals and recommended that DEA apply more resources to diversion control, including more Special Agent support.
The OIG also recommended that DEA increase training for those individuals who support the DCP. The OIG also noted that the diversion of controlled substance pharmaceuticals had dramatically increased over recent years and that the increase coincided with the use of emerging technologies such as the Internet. Twelve comments were received and analyzed in response to DEA's proposed fee rule, and DEA published the final rule on August 29, 2006.
Collections associated with that fee adjustment did not begin until FY 2007, on November 1, 2006.
The OIG completed a Review of DEA's Use of the Diversion Control Fee Account in 2008 and did not find that any DCFA funds were misused for non-diversion control activities between FY 2004 and FY 2007. To the contrary, the OIG found that DEA did not fully fund all diversion control costs with the DCFA, as required by law.
DEA has been and will continue to be fiscally responsible and will remain vigilant towards identifying methods to improve efficiencies or identifying other cost saving measures. As discussed, the DCP has been evaluated by the OIG and it did not find that DCFA funds were misused. As noted earlier, the OIG found that DEA did not fully fund all diversion control costs with the DCFA as required.
The DCP plans to continue cost-saving technology improvements in doing business and to implement such improvements for those that do business with the DCP through its regulatory functions such as registration and reporting systems.
DEA Response: Registration fee exemptions are set forth in the existing regulations. Generally, hospitals and other institutions operated by an agency of the United States or of any state or any political subdivision or agency thereof, as well as any individual required to obtain a registration in order to carry out his or her duties as an official of an agency of the United States or of any state or any political subdivision or agency thereof may be exempt from payment of a registration or reregistration fee. 21 CFR 1301.21. Such an individual is not exempt if his/her registration is used for appropriate private activities unrelated to the performance of his/her official duties. Tribal governments are also exempt pursuant to the Indian Health Care Improvement Act of 2010.
DEA is committed to carefully reviewing all applications for fee exempt status to ascertain that such exemptions are not inappropriately granted. Approximately 96,000 individual and institutional registrants, or 7% of all registrants, are exempt from registration fees.
Need for New Fee Calculation Back to Top
As discussed in the NPRM, DEA last adjusted the fee schedule in August 2006. This fee schedule was calculated to cover the “full costs” of the DCP for FY 2006 through FY 2008 or October 1, 2005 through September 30, 2008. However, collections did not begin until FY 2007.
The DCP program has continued to operate under this fee schedule due to cost savings through reorganization and modernization efforts and by inadvertently excluding certain costs from the DCP. As indicated by the above-referenced 2008 OIG report, additional salary and other costs attributable to diversion control activities need to be incorporated into the DCP. In addition, the scope of the DCP has been expanded by Congress and by the need to address the diversion of controlled substances and listed chemicals that seriously impact public health and safety.
Fee Calculation Back to Top
DEA must ensure the recovery of the full costs of operating the DCP while charging registrants reasonable fees relating to the registration and control of the manufacture, distribution, import, and export of controlled substances and listed chemicals, as well as the dispensing of controlled substances. For the DCP to have funds to function, DEA must determine, in advance of actual expenditures, a reasonable fee to be charged. As a result, historical data and projections must be used to project the annual costs of the DCP. Additionally, a reasonable fee must be calculated that will fully recover the costs of the DCP based on the variability over time of the number of registrants in the different categories of registration. The fees collected must be available to fully fund the DCFA and to reimburse DEA for expenses incurred in the operation of the DCP (21 U.S.C. 886a); therefore, there must always be more collected than is actually spent to avoid running a deficit in violation of federal fiscal law.
In operating the DCP, DEA must be prepared for changes in investigative priorities, diversion trends, and emerging drugs and chemicals posing new threats to the public health and safety.
In calculating fees to recover the full costs of operating the DCP, DEA estimates the costs of operating the DCP for the next three fiscal years.
To develop the DCFA budget estimates for Fiscal Year (FY) 2012, FY 2013 and FY 2014, DEA compiles: (1) The actual DCFA financial data for FY 2011; (2) the FY 2012 President's Budget Request; (3) the estimated budgets for FY 2013 and FY 2014; and (4) the required annual $15 million transfer to the United States Treasury as mandated by the CSA (21 U.S.C. 886a). The following paragraphs explain the annual revenue calculations and how the total amount to be collected for the FY 2012-2014 period was calculated. In developing this figure, DEA begins with annual projected DCP obligations, including payroll, operational expenses and necessary equipment. The DCP budget has increased due to inflationary adjustments for rent and payroll and to increase staffing resources that support the regulatory and law enforcement activities of the program. These additional costs have not been reflected in the fees until now because the fees were last adjusted for the time period of FY 2006-2008. Specific details on the DCP budget are available in the annual President's Budget Submission and supplemental budget justification documents provided to Congress.
Total obligations for the DCP have increased from FY 2007 to FY 2010 by approximately 49 percent. For the FY 2006-2008 period, payroll expenses (staff compensation and benefits) composed the largest component of DCP costs at 55.7 to 57.6 percent per year. Between the period of FY 2006 and FY 2010, payroll constituted an average of 56.7 percent of DCP expenses. Operating expenses and capital expenditures made up the remainder of DCP costs. Operating expenses (an average of 39.3 percent for the FY 2006-2010 period) include daily operation costs such as investigative costs, travel, and purchases of goods and services. Capital expenditures, including equipment and furniture purchases, capital leases, and land/structure improvements and purchases, averaged 4.0 percent during this same period.
As discussed, in 1993, Congress determined that the DCP would be fully funded by registration fees rather than by appropriations.
Congress established the DCFA as a separate account of the Treasury to “[ensure] the recovery of the full costs of operating the various aspects of [the diversion control program]” from fees charged by DEA. 21 U.S.C. 886a(1)(C). Collected fees are deposited into the DCFA. Each fiscal year, the first $15 million is transferred to the Treasury and is not available for use by the DCP. Therefore, DEA needs to collect an additional $15 million per year beyond estimated costs for transfer to the Treasury.
Table 1—Change in Operational Continuity Fund Balance FY 2012-2014 Back to Top
$352,563,000
$364,895,000
Target OCF ($15M + 7%)
39,679,410
40,542,650
40,943,670
Beginning OCF balance
41,726,554
Needed Change to Achieve Target OCF
(2,047,144)
(782,884)
Table 2—CMEA Collections FY 2012-2014 Back to Top
Number of paying self-cert
CMEA collection estimate
Table 3—Needed Fee Collections FY 2012-2014 Back to Top
Budget/Estimated Budget
$1,039,458,000
(40,500,000)
339,063,000
351,395,000
998,958,000
Change to Achieve Target OCF
CMEA Self-cert collections
(533,766)
(1,601,297)
Required collections from Registration Fees
320,814,090
354,287,474
366,157,254
1,041,258,818
Note: Due to rounding of the fees to the whole dollar, the total 3-year registration fee collection estimate of $1,040,934,380 does not equal the target collection amount of $1,041,258,818 used to calculate the fees.
Congressional Budget/Cost Estimates
Operational Continuity Fund (OCF) Brought Forward From Prior Year
39,701,112
36,496,165
Collections: Registration Fees
320,835,793
350,219,287
369,879,300
Collections: CMEA
305,940,793
335,324,287
354,984,300
Recoveries from Deobligations
Subtotal Availability
361,701,112
389,059,165
405,514,231
352,563,000
364,895,000
EOY OCF Balance
40,619,231
Target OCF ($15M+7% of Budget)
Registrants on Three-Year Registration Cycle Back to Top
Registrant class/business
* Pharmacies, hospitals/clinics, practitioners, teaching institutions, and mid-level practitioners currently pay a fee for a three-year period. Fee of $731 is equivalent to approximately $244 annually.
Registrants on Annual Registration Cycle Back to Top
Registrants class/business
Researcher/Canine Handler
Maintenance and Detoxification
Compounder/Maintenance
Compounder/Detoxification
Compounder/Maintenance/Detoxification
Distributor (chemical and controlled substances)
Importer (chemical and controlled substances)
Exporter (chemical and controlled substances)
Manufacturer (chemical and controlled substances)
DEA Efforts To Control DCP Costs Back to Top
Summary of Impact of New Fee Relative to Current Fee Back to Top
Table 10—Number of Registrants by Business Activity Back to Top
* Data as of August 2011.
1,406,021
Total (all registrants)
Table 11—Industrial Sectors of DEA Registrants Back to Top
*Source: 2007 Economic Census. http://www.census.gov/econ/census07.
Petro-chemical Manufacturing (organic, inorganic)
$1,390,485,971
27,601,834
144,173,821
17,482,468
50,322,290
13,720,807
Drugs and Druggist Sundries Wholesalers
64,793,480
45,518,407
Confectionary Merchant Wholesalers
17,175,982
12,856,993
71,437,205
2,741,857
7,247,540
4,829,487
26,535,201
76,300,280
1,907,414
2,696,904
108,286,641
The registration fee may be a deductible business expense for some registrants. As a result, the increase in the fee may be dampened by reduced tax liability as a result of the increase in registration fee expense. For example, if a practitioner pays an additional $60 per year in registration fees and the combined federal and state income tax is 35 percent, the net cash impact is $39, not $60. The additional $60 causes income/profit to decrease by $60, decreasing the tax liability by $21. The net cash outlay is $39.
DEA examined the new fees as a percentage of income for physicians, dentists, and physician's assistants in the practitioner registrant group and as a percentage of revenue for pharmacies, manufacturers, and distributors. This analysis indicates the fee adjustment is expected to have the greatest effect on small businesses in the practitioner registrant group. The majority of practitioners work in small businesses. Physicians, dentists, and physician's assistants reflect a representative sub-group of the practitioner registrant group. The effect of the fee increase is diminished by any increase in registrant income.
The table below describes the average income for physicians, dentists, and physician's assistants from 2004 to 2012, and reflects the impact of the fee as a percentage of average income. This analysis assumes that the fee is absorbed personally by each practitioner and is not passed on to customers in such forms as higher prices for medical services or products. The analysis also ignores the dampening effect of registration fees as a potentially deductible businessexpense.
Table 12—New Fee as Percentage of Income FY 2004-2012 Back to Top
Average income33
Fee as percent of average income
Increase from 2007 to 2012
Increase from 2006 to 2012
Exempt from the payment of registration fees is any hospital or other institution that is operated by an agency of the United States, of any state, or of any political subdivision or agency thereof. Likewise, an individual who is required to obtain a registration in order to carry out his/her duties as an official of a federal or state agency is also exempt from registration fees.
Fee exempt registrants are not affected by the new fees.
DEA concludes that this new fee schedule is not an economically significant regulatory action because it does not result in a materially adverse effect on the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities.
The new fee will initially affect all fee paying registrants. The fees may eventually be passed on to the general public, diminishing the impact of the fee adjustment on individual registrants. The impact of the fee on registrants may also be diminished by a reduction in tax liabilities and an increase in average income. Additionally, hospitals and institutions operated by federal, state, or local governments, and their employees are exempt from registration fees.
Moreover, DEA believes that this final rule will enhance the public health and safety.
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3511) Back to Top
In accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Deputy Assistant Administrator hereby certifies that this rulemaking has been drafted consistent with the Act and that a regulatory analysis on the effects or impact of this rulemaking on small entities has been done and summarized above.
While DEA recognizes that this increase in fees will have a financial effect on registrants, the change in fees will not have a significant economic impact. A change in fees is necessary to fully comply with 21 U.S.C. 886a and related statutes governing the DCP and the Diversion Control Fee Account by which DEA is legally mandated to collect fees to cover the full costs of the DCP as defined by all activities relating to the registration and control of the manufacture, distribution, import, export, and dispensing of controlled substances and listed chemicals.
Executive Orders 13563 and 12866 Back to Top
PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS AND DISPENSERS OF CONTROLLED SUBSTANCES Back to Top
2.Amend § 1301.13 by revising paragraph (e)(1) to read as follows: § 1301.13 Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.
3.The authority citation for part 1309 is revised to read as follows: Authority:
4.Revise § 1309.11 to read as follows: § 1309.11 Fee amounts.
5.In § 1309.21, revise paragraph (c) to read as follows: § 1309.21 Persons required to register.
2. The diversion control program (DCP) consists of the controlled substance and chemical diversion control activities of DEA. These activities are related to the registration and control of the manufacture, distribution, dispensing, importation, and exportation of controlled substances and listed chemicals (21 U.S.C. 886a(2)).
3. H.R. Rep. No. 91-1444 (1970), reprinted in 1970 U.S.C.C.A.N. 4566, 4571-4572.
4. The term “control” as defined in 21 U.S.C. 802(5) specifically applies to Part B of Title II of the CSA only (21 U.S.C. 811-814). In general, “diversion control” is a broad term encompassing activities related to preventing and detecting the diversion of controlled substances and listed chemicals from legitimate commerce into the illicit market. In 1992, Congress established the Diversion Control Fee Account and required that the fees charged by DEA under its diversion control program be set at a level that ensures the recovery of the full costs of operating the various aspects of that program (102, 106 Stat. 1843). In 2004, Congress amended the CSA and defined “diversion control program” and “controlled substance and chemical diversion control activities” (Pub. L. 108-447, 118 Stat. 2921, codified in 21 U.S.C. 886a). The “diversion control program” means the controlled substance and chemical diversion control activities of the Drug Enforcement Administration. 21 U.S.C. 886a(2)(A). The term “controlled substance and chemical diversion control activities” means those activities related to the registration and control of the manufacture, distribution, dispensing, importation, and exportation of controlled substances and listed chemicals. 21 U.S.C. 886a(2)(B).
5. DEA's authority to charge reasonable fees was later expanded to include manufacturers, distributors, importers, and exporters of List I chemicals. The Domestic Chemical Diversion Control Act of 1993, 103, 107 Stat. 2333.
6. 36 FR 4928 (March 13, 1971); 36 FR 7776 (April 24, 1971).
7. Reorganization Plan No. 2 of 1973, 38 FR 18380 (July 2, 1973).
8. GAO/GGD-83-2, October 29, 1982.
9. 48 FR 14640 (April 5, 1983); 48 FR 56043 (December 19, 1983).
10. Departments of Commerce, Justice, and State, the Judiciary and Related Agencies Appropriations Act of 1993, 102, codified in relevant part at 21 U.S.C. 886a.
11. 57 FR 60148 (December 18, 1992).
12. 58 FR 15272 (March 22, 1993).
13. American Medical Association v. Reno, 857 F. Supp. 80 (D.D.C. 1994), aff'd, 57 F.3d 1129 (DC Cir. 1995).
14. 61 FR 68624 (December 30, 1996).
15. 67 FR 51988 (August 9, 2002).
16. “Review of the Drug Enforcement Administration's Control of the Diversion of Controlled Pharmaceuticals,” I-2002-010, September 2002, www.usdoj.gov/oig/reports/DEA/e0210/index.htm.
17. 68 FR 7728 (February 18, 2003).
18. 68 FR 58587 (October 10, 2003). DEA published a correction to this final rule where the internal DEA computer system, Firebird, was identified as being solely funded through appropriations. The Firebird system costs are properly apportioned as a DCP cost as well as a non-DCP appropriations expense. 69 FR 34568 (June 22, 2004).
19. The Domestic Chemical Diversion Control Act of 1993, 103, 107 Stat. 2333.
20. Public Law 108-447, Departments of Commerce, Justice, and State, the Judiciary and Related Agencies Appropriations Act of 2005, signed into law on December 8, 2004.
21. 70 FR 69474 (November 16, 2005).
22. “Follow-Up Review of the Drug Enforcement Administration's Efforts to Control the Diversion of Controlled Pharmaceuticals,” I-2006-004, July 2006, www.usdoj.gov/oig/reports/DEA/e0604/final.pdf.
23. 71 FR 51105 (August 29, 2006).
24. “Review of the Drug Enforcement Administration's Use of the Diversion Control Fee Account,” I-2008-002, February 2008, www.usdoj.gov/oig/reports/DEA/e0802/final.pdf.
25. “Review of the Drug Enforcement Administration's Use of the Diversion Control Fee Account,” I-2008-002, February 2008, www.usdoj.gov/oig/reports/DEA/e0802/final.pdf.
26. In accordance with 25 U.S.C. 1616q, employees of a tribal health or urban Indian organization are exempt from “payment of licensing, registration, and any other fees imposed by a Federal agency to the same extent that officers of the commissioned corps of the Public Health Service and other employees of the Service are exempt from those fees.”
27. 71 FR 51105 (August 29, 2006).
28. In general, no officer or employee of the United States Government may make or authorize an expenditure or obligation in excess of an amount available in an appropriation or fund. 31 U.S.C. 1341.
29. See “New Registrant Fee Schedule Calculations” in this rulemaking docket found at www.regulations.gov.
30. See “U.S. Department of Justice, Drug Enforcement Administration, FY 2012 Performance Budget Congressional Submission” for details on the FY 2012 budget. The budget document is available online at http://www.justice.gov/jmd/2012justification/pdf/fy12-dea-justification.pdf.
31. Departments of Commerce, Justice, and State, the Judiciary and Related Agencies Appropriations Act of 1993, 102, codified in relevant part at 21 U.S.C. 886a.
32. This example is for illustration purposes only. Each entity should seek competent tax advice for tax consequences of this rule.
33. Source: Bureau of Labor Statistics, http://www.bls.gov. Average income data for 2004 to 2009 is provided by the Bureau of Labor Statistics. 2010 to 2012 are estimated figures based on linear regression, where a straight-line increase is calculated from years 2004 to 2009, then using the line to estimate average income for 2010 to 2012.
34. See 21 CFR 1301.21 for complete fee exemption requirements.
35. In accordance with 25 U.S.C. 1616q, employees of a tribal health or urban Indian organization are exempt from “payment of licensing, registration, and any other fees imposed by a Federal agency to the same extent that officer of the commissioned corps of the Public Health Service and other employees of the Service are exempt from those fees.” To the extent that any hospital or other institution operated by or any individual practitioner associated with an Indian Tribal Government must pay fees, the economic impact is not substantial.
36. See 21 CFR 1301.21 for complete requirements for exemption of registration fees.
37. See “Economic Impact Analysis of Final Rule on Controlled Substances and List I Chemical Registration and Reregistration Fees, DEA-346” in this rulemaking docket found at www.regulations.gov.