15234 Federal Register / Vol. 77, No. 51 / Thursday, March 15, 2012 / Rules and Regulations 

1The Attorney General’s delegation of authority 

to DEA may be found at 28 CFR 0.100. 

2The 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)). 

3H.R. Rep. No. 91–1444 (1970), reprinted in 1970 

U.S.C.C.A.N. 4566, 4571–4572. 

4The 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 (Pub. L. 102–395, 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, Public Law 103–200, 107 Stat. 

2333. 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Parts 1301 and 1309 

[Docket No. DEA–346] 

RIN 1117–AB32 

Controlled Substances and List I 

Chemical Registration and 

Reregistration Fees 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Final rule. 

SUMMARY: This rule adjusts the fee 

schedule for DEA registration and 

reregistration fees necessary to recover 

the costs of the Diversion Control 

Program relating to the registration and 

control of the manufacture, distribution, 

dispensing, importation, and 

exportation of controlled substances and 

List I chemicals as mandated by the 

Controlled Substances Act. 

DATES: Effective: April 16, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Alan G. Santos, Associate Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, Mailing address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 307–7165. 

SUPPLEMENTARY INFORMATION: 

Background 

Legal Authority 

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’’).1 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. 

Pursuant to the CSA, each controlled 

substance is classified in one of five 

schedules based upon its potential for 

abuse, currently accepted medical use, 

and the degree of dependence it may 

cause if abused. 21 U.S.C. 812. 

Likewise, under the CSA, listed 

chemicals are separately classified 

based on their use and importance to 

the manufacture of controlled 

substances (List I or List II chemicals). 

21 U.S.C. 802(33)–(35). The CSA 

mandates that DEA register persons and 

entities who manufacture, distribute, 

import, or export controlled substances 

or List I chemicals, and those persons 

and entities who dispense or conduct 

research or chemical analysis with 

controlled substances. These registrants 

are permitted to handle controlled 

substances and List I chemicals as 

authorized by their registration and are 

required to comply with the applicable 

requirements associated with their 

registration. 21 U.S.C. 822, 958. The 

identification and registration of all 

individuals and entities authorized to 

handle controlled substances and List I 

chemicals establishes a closed system of 

distribution that DEA is charged to 

maintain. 

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.2

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. 

History of Fees 

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.3 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 4 of persons and 

entities engaged in the manufacture, 

distribution, dispensing, export, and 

import of controlled substances.5 To 

this end, BNDD established a threeVerDate Mar<15>2010 15:56 Mar 14, 2012 Jkt 226001 PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 E:\FR\FM\15MRR1.SGM 15MRR1

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Federal Register / Vol. 77, No. 51 / Thursday, March 15, 2012 / Rules and Regulations 15235 

6 36 FR 4928 (March 13, 1971); 36 FR 7776 (April 

24, 1971). 

7Reorganization 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, Public Law 102–395, codified in 

relevant part at 21 U.S.C. 886a. 

11 57 FR 60148 (December 18, 1992). 

12 58 FR 15272 (March 22, 1993). 

13American 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). 

19The Domestic Chemical Diversion Control Act 

of 1993, Public Law 103–200, 107 Stat. 2333. 

20Public 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). 

tiered fee structure for companies and 

individuals wishing to participate in the 

U.S. controlled substance industry.6

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.7 In 1982, the General 

Accounting Office (GAO) 8 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 

1983.9 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,10 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.11 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.12 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.13

Upon remand, the March 1993 final 

fee rule was reopened for further 

comment in 1996.14 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.15 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.16

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.17 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.18

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.’’ 19

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).20 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.21 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.22 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, 

2006.23 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 nondiversion control activities between FY 

2004 and FY 2007. To the contrary, the 

OIG found that DEA did not fully fund 


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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. 

all diversion control costs with the 

DCFA, as required by law.24

The Proposed Rule 

It has been more than five years since 

the last fee adjustment. DEA proposed a 

new fee schedule by publication of a 

NPRM on July 6, 2011. 76 FR 39318–41. 

DEA outlined the scope of the DCP, the 

need for a new fee calculation, the four 

different methodologies or options 

considered for calculating the fee, the 

proposed weighted-ratio methodology, 

and the calculation resulting in the 

proposed fee increase of approximately 

33 percent. The fee increase 

incorporates additional DCP costs 

identified in the above-mentioned OIG 

report, as well as an expanded diversion 

control program required by Congress, 

and it accounts for a number of current 

circumstances related to the diversion of 

controlled substance pharmaceuticals 

and listed chemicals. 

Methodology for Fee Calculation 

Fees must be ‘‘set at a level that 

ensures the recovery of the full costs of 

operating the various aspects of [the 

DCP].’’ 21 U.S.C. 886a(1)(C). In addition, 

any methodology for calculating fees 

must result in fees that are reasonable. 

21 U.S.C. 821 and 958(f). As outlined 

below in responses to comments, DEA 

must calculate and collect fees prior to 

actually expending the funds in order to 

have funds with which to operate the 

DCP. Moreover, each year DEA is 

required to transfer the first $15 million 

of fee revenues into the general fund of 

the Treasury, with the remainder 

deposited into a separate fund of the 

Treasury called the Diversion Control 

Fee Account or 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). 

In the NPRM, DEA outlined four 

alternative methodologies to calculate 

the registration and reregistration fees. 

76 FR 39329–32. These were the PastBased Option, Future-Based Option, 

Flat Fee Option, and Weighted-Ratio 

Option. For each of the options 

considered, the calculated fees are 

analyzed for reasonableness by 

examining: (1) The absolute amount of 

the fee increase, (2) the change in fee as 

a percentage of registrant revenue from 

2007 to 2012, and (3) the relative fee 

increase across registrant groups. 

Additionally, each calculation 

methodology is re-evaluated for its 

overall strengths and weaknesses in 

recovering the full costs of the DCP. 

Based on the analysis provided in the 

NPRM, DEA did not adopt the ‘‘PastBased Option.’’ There are two key 

reasons for rejecting this methodology. 

First, the fee increase would be 

disproportionately burdensome to a 

small number of registrants. 

Distributors’ fees would increase by 

over three fold, while the fees for the 

remaining registrant groups would 

increase by 10 percent and 32 percent. 

DEA believes this is unreasonable. 

Second, the past-based option uses FY 

2007–FY 2009 investigation work hour 

data to set the apportionment of cost to 

each registrant category. Pre-registration 

and scheduled investigation costs are 

assigned to registrant classes and all 

other costs are recovered on an equal, 

per-registrant basis. This method is 

retrospective and assumes that future 

investigations will be similar to the past. 

DEA cannot assume that past work hour 

data accurately reflects future workload 

because priorities change as the threats 

change. For example, in order to 

monitor registrant regulatory 

compliance and leverage the deterrent 

effect of scheduled investigations, DEA 

increased the frequency of all scheduled 

investigations beginning in 2008. In 

2011, DEA began pre-registration 

investigations of all pharmacies located 

in the State of Florida in order to 

address the rampant diversion in south 

Florida. And in 2010, DEA began 

conducting nationwide take back events 

to provide a mechanism for the public 

to dispose of their unwanted, unused, 

and expired controlled substance 

pharmaceutical drugs. The past-based 

option is vulnerable to short-term 

fluctuations in priorities which can 

greatly affect fees among the different 

categories. As a result, DEA has 

concluded that past work hour data 

alone is not the best basis for the 

calculation of registration fees. 

The second option analyzed in the 

NPRM is the ‘‘Future-Based Option’’ 

which is based on projected work hours 

for each registrant class using scheduled 

investigation work plan goals and 

anticipated/planned resources. Under 

this option, DEA based its calculations 

on projected work hour data by 

registrant group for FY 2012–2014. In 

other words, the future-based option is 

based on DEA’s projection of work plan 

goals and the resources required for 

these years—specifically examining the 

direct cost of anticipated scheduled 

investigations. 

DEA rejects this methodology because 

it would result in an unreasonable 

increase in fees for some registrants and 

a severe disparity of fees among the 

registrant groups. The large proportional 

increase in fees for two registrant 

categories may not pass the reasonable 

standard required by statute. The vast 

disparity in the increase, where fees for 

manufacturers increase by more than 

700 percent while fees for dispensers 

increase by 26 percent, is unreasonable. 

This method is unfair to the registrant 

categories because a variety of factors 

other than scheduled investigations 

affect cost allocations. Actual operations 

typically differ from scheduled work 

plans due to shifting threats and other 

operational demands. The future-based 

option is based on projected work hour 

data of anticipated scheduled 

investigations, however, only 3.5% of 

the workload is directly attributable to 

scheduled investigations. The remaining 

96.5% must be apportioned equally 

across all registrant categories. 

The third option analyzed in the 

NPRM is called the ‘‘Flat Fee Option.’’ 

This methodology would result in equal 

fees across all registrant groups 

regardless of the proportion of DCP 

costs and resources the registrant group 

may require (e.g., oversight and 

investigation resources). The fee 

calculation is straightforward: The total 

amount needed to be collected over the 

three-year period is divided by the total 

number of registration fee transactions 

over the three-year period, adjusting for 

registrants on the three-year registration 

cycle. 

DEA did not select this methodology 

because it would result in disparate 

changes in fees among registrant groups. 

Under this option, fees for 

manufacturers and distributors would 

decrease by 89 percent and 78 percent 

respectively, while fees for practitioners 

would increase by 34 percent. Thus, 

setting the fees at the same level across 

all registrant groups is not reasonable. 

DEA registrants include some of the 

largest corporations in the world 

although the vast majority of registrants 

are individual practitioners, such as 

physicians, physician assistants, 

dentists, and nurse practitioners. To 

satisfy the reasonable standard, 

registration fees should account for 

differences in regulatory investigations 

and other DCP costs that vary among the 

registrant categories. 

The fourth methodology evaluated 

and ultimately selected in the NPRM is 

the ‘‘Weighted-Ratio Option.’’ This 

option distinguishes among the 

categories to establish a reasonable fee 

for each category. To determine the fee, 

a weighted ratio is assigned based on 


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registrant group, and the amount needed 

to be collected over the FY 2012–FY 

2014 period to cover the costs of the 

DCP is divided by the weighted number 

of estimated registrations. 

Historically, costs vary and a fee must 

be set in advance. Since the inception 

of registration fees, even before DEA 

was required to recover the full costs of 

the DCP, DEA has utilized a weighted 

method of fee allocation. On April 24, 

1971, DEA’s precursor agency, the 

Bureau of Narcotics and Dangerous 

Drugs, published regulations 

implementing the Comprehensive Drug 

Abuse Prevention and Control Act of 

1970. Those regulations required 

registration/reregistration fees in the 

following amounts: $50 for 

manufacturers; $25 for distributors; and 

$5 for dispensers and persons 

conducting research, instructional 

activities, or chemical analysis. In 1983, 

DEA published a NPRM which 

indicated that a 1982 GAO report found 

that DEA’s previous fees did not 

adequately recover the costs incurred by 

the Government. The GAO 

recommended that DEA set a fee 

schedule of $250 for manufacturers, 

$125 for distributors, and $25 for 

practitioners. DEA, however, ultimately 

set the fee based on its own estimates as 

follows: $250 for manufacturers; $125 

for distributors, importers, and 

exporters; and $20 for dispensers and 

persons conducting research, 

instructional activities, or chemical 

analysis. DEA indicated that these 

estimates were based on ‘‘an increase in 

the number of practitioner registrants 

since 1980 * * *.’’ 48 FR 14640. 

The first known published discussion 

which attempted to capture the specific 

ratio of fees occurred in the Final Rule; 

Remanded for Further Notice and 

Comment, published by DEA in 1996. 

That Final Rule augmented DEA’s first 

fee-setting rule initiated to recover the 

full costs of the DCP as defined by 

Congress. It was published in response 

to a decision by the United States Court 

of Appeals which required DEA to 

identify the components of the DCP and 

provide a brief explanation of why DEA 

deemed each component to be part of 

the program. In that Final Rule, DEA 

stated that the ratio of fees implemented 

with the CSA in 1971 was as follows: 

‘‘A distributor’s fee is 50% of the 

manufacturer’s fee and a dispenser’s fee 

is 16–20% of the distributor’s fee. The 

fee ratios have remained consistent 

[since 1971] and have not been the 

subject of any substantive comment or 

objection by the regulated industry.’’ 61 

FR 68632. A variation of this ratio has 

been applied in each fee structure since 

the implementation of the fee system, 

usually as expressed above. 

The fee structure established by this 

rule is based on the same ratios that 

have been utilized since the first 

amendment to the fee structure, as 

follows: 1 for researchers, canine 

handlers, analytical labs, and narcotic 

treatment programs, who are on a oneyear registration cycle; 3 for registrants 

on three-year registration cycles such as 

pharmacies, hospitals/clinics, 

practitioners, teaching institutions, and 

mid-level practitioners; 6.25 for 

distributors and importers/exporters; 

and 12.5 for manufacturers. The ratio of 

1 represents a base annual fee by which 

each ratio is multiplied to determine the 

total fee per cycle, i.e., one year or three 

years. 

The weighted-ratio methodology, 

much like the flat fee methodology, is 

straightforward and easy to understand. 

Unlike the flat fee, however, this 

method applies historic weighted ratios 

to differentiate fees among registrant 

groups. The fees calculated using this 

methodology are similar to fees 

calculated in the past-based option, 

which allocates three years of historical 

pre-registration and scheduled 

investigation costs to registrant groups. 

This method, however, does not create 

a disproportionate fee increase in any 

registrant group. The proposed fee 

published in the NPRM was calculated 

using this methodology and resulted in 

an increase of approximately 33 percent 

for all registrant groups. 

DEA is finalizing the fee schedule 

using the weighted-ratio methodology as 

proposed. This approach has been used 

since Congress established registrant 

fees and continues to be a reasonable 

reflection of differing costs. The 

registration fees under the weightedratio option result in differentiated fees 

among registrant groups, where 

registrants with higher revenues and 

costs pay higher fees than registrants 

with lower revenues and costs. 

Furthermore, the weighted-ratio avoids 

the disparity that resulted from the pastbased methodology. The weighted ratios 

used by DEA to calculate the fees have 

proven effective and reasonable over 

time. Additionally, the selected 

calculation methodology accurately 

reflects the differences in registration 

and other DCP activities by registrant 

category. For example, these costs are 

greater for manufacturers. The 

weighted-ratio methodology results in 

reasonable fees for all registrant groups 

at a level sufficient to ensure the 

recovery of the full costs of operating 

the DCP. 

Discussion of Comments 

DEA received 195 comments on the 

NPRM published on July 6, 2011, at 76 

FR 39318. Of these comments, 121 were 

from mid-level practitioners (e.g. nurse 

practitioners, nurse mid-wives, nurse 

anesthetists, clinical nurse specialist, 

and physician assistants), 4 were from 

practitioners, 9 were from associations 

or corporations and 61 commenters did 

not identify their registration category. 

Comments: The majority of 

commenters opposed the fee increase on 

principle or as coming at a bad time due 

to the economic climate. Some 

commenters believed it was a tax on 

practitioners and other registrants. 

DEA Response: DEA outlined the 

legal authority, the history of the fees, 

the need for an increase in fees, the 

methodology, and the proposed fee 

calculation in the NPRM in an attempt 

to make it transparent why there is a fee, 

why there is a periodic recalculation, 

and how the proposed new fee schedule 

was calculated. Rather than a ‘‘tax,’’ the 

registration fee is a statutory 

requirement for those seeking to 

participate in the closed system of 

distribution by handling, or having 

access to, controlled substances or List 

I chemicals. The fee funds the DCP 

under the Controlled Substances Act 

which includes providing and 

maintaining services to DEA registrants. 

One commenter suggested DEA 

postpone a fee increase until the 

economy improves and several 

suggested imposing incremental 

increases over a period of time. DEA is 

sensitive to the economic challenges 

facing many registrants and has 

endeavored to set the fee as low as 

possible consistent with its statutory 

mandates. DEA continually strives to be 

fiscally responsible. The last fee 

increase was set in FY 2006 and was 

designed to encompass only FYs 2006– 

2008. Through various efforts and costsaving measures, the DCP has been able 

to operate under that fee structure 

through FY 2011. However, DEA cannot 

further postpone any increase because 

without an adjustment in the annual 

registration fees, the DCP will be unable 

to continue current operations and will 

be in violation of the statutory mandate 

that fees charged ‘‘shall be set at a level 

that ensures the recovery of the full 

costs of operating the various aspects of 

[the diversion control program.]’’ 21 

U.S.C. 886a(1)(C). For example, 

collections under the current fee 

schedule would require the DCP to 

significantly cut existing and planned 

DCP operations vital to its mission. DEA 

relies on the DCP to maintain the 

integrity of the closed system of 


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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. 

distribution, particularly at this time of 

increased abuse and diversion outlined 

in the proposed rule. 

It is not feasible for DEA to implement 

an incremental increase while ensuring 

the recovery of the full costs of 

operating the various aspects of the 

DCP, as required by the CSA, and such 

an increase would not be fair or 

equitable to registrants. Under the 

current fee structure, the vast majority 

of registrants renew their registration 

once every three years. If DEA were to 

implement an incremental increase 

within the three-year cycle, registrants 

who must renew their registration in the 

third year of that cycle would pay a 

substantially higher amount than those 

registrants who must renew in the first 

year of the cycle. Additionally, DEA 

must have reliable collection estimates 

for budget formulation and execution 

activities throughout the three-year 

collection cycle. 

Comments: A number of comments 

suggested that the calculation recognize 

that other non-federal licensure and 

registration fees are also increasing. 

DEA Response: DEA recognizes there 

may be other fee increases by states. 

However, the CSA requires that DEA 

fees be based on the full costs of 

operating the various aspects of the 

DCP. 

Comments: Mid-level practitioners 

expressed the belief that any fee 

increase is unfair to certain types of 

registrants, such as mid-level 

practitioners, who make less money 

than other types of practitioners. 

DEA Response: The fees are on a 

graduated scale based on the three 

categories of registration established by 

statute. Under current authority, DEA 

has not created additional fee categories 

or differentiated within a fee category. 

As discussed, the fees are based on DCP 

program costs and individual 

practitioners, regardless of professional 

occupation, require similar DCP 

expenditures related to registration and 

oversight. Furthermore, as outlined in 

the economic analysis using estimated 

2012 average income based on 2004– 

2009 data provided by the Bureau of 

Labor Statistics, the fee as a percentage 

of average income for physicians and 

dentists is 0.1% and it is 0.26% for 

physician assistants. These percentages 

are essentially the same as in 2006, the 

year of the previous fee adjustment, 

where the fee as a percentage of average 

income was 0.1% for physicians and 

dentists and 0.25% for physician 

assistants. 

Comments: One comment suggested 

that the length of registration should be 

extended at the same time there is an 

increase in the fee. 

DEA Response: The statute clearly 

sets forth the period of registration: 

‘‘Every person who manufactures or 

distributes any controlled substance or list I 

chemical, or who proposes to engage in the 

manufacture or distribution of any controlled 

substance or list I chemical, shall obtain 

annually a registration issued by the 

Attorney General in accordance with the 

rules and regulations promulgated by him.’’ 

21 U.S.C. 822(a)(1) (emphasis added). 

‘‘Every person who dispenses, or who 

proposes to dispense, any controlled 

substance, shall obtain from the Attorney 

General a registration issued in accordance 

with the rules and regulations promulgated 

by him. The Attorney General shall, by 

regulation, determine the period of such 

registrations. In no event, however, shall such 

registrations be issued for less than one year 

nor for more than three years. 21 U.S.C. 

822(a)(2) (emphasis added). 

DEA currently allows for the 

maximum three-year registrations for 

dispensers of controlled substances, 

except certain practitioners who 

dispense narcotic drugs for narcotic 

treatment, who are statutorily required 

to obtain annual registrations. 21 U.S.C. 

823(g)(1). 

Comments: Some commenters 

indicated that DEA should not raise 

registration fees but instead decrease its 

spending, be more efficient with the fees 

it currently collects or find another 

source of funds. One commenter 

questioned whether increased funding 

would improve the effectiveness of the 

DCP. 

DEA Response: By statute, DEA 

cannot use another source of funds for 

the DCP. By enacting 21 U.S.C. 886a, 

Congress mandated that the DCP be 

fully funded through the collection of 

fees rather than appropriated funds. The 

CSA specifically states 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.’’ 21 U.S.C. 886a(1)(C). 

It has been more than five years since 

the last fee adjustment. DEA last 

adjusted the fee schedule in August 

2006, and that fee schedule was 

intended to be sufficient to cover the 

‘‘full costs’’ of the DCP for FY 2006 

through FY 2008. The DCP has 

continued to operate under this fee 

schedule due to cost savings through 

reorganization, modernization efforts, 

and by delays in execution of planned 

programs. As indicated by the abovereferenced 2008 OIG report, additional 

salary and other costs attributable to 

diversion control activities needed to be 

incorporated into the DCP as was done 

in this fee calculation. In addition, 

Congress has expanded the scope of the 

DCP through budgetary and legislative 

action in order to address an increase in 

the diversion of controlled substances 

and listed chemicals that seriously 

impact public health and safety. 

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.25 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. 

The DCP exercises a variety of 

management controls, including 

independent review of certain DCFA 

expenditures. This is accomplished by 

the Validation Unit which was 

established in 2003 to review DCFA 

expenditures of $500 or more to ensure 

that each expense is in support of 

diversion-related activities. DEA 

continues to evaluate the appropriate 

mix of management controls. The costs 

to the DCP associated with additional 

review of expenditures must be 

balanced against the risks of error. DEA 

may adjust the expenditure threshold 

level for review and validation up to 

$2,500 to adjust the review process and 

reduce the associated costs to the DCP. 

The DCP will continue to provide 

managerial oversight on expenditures 

involving DCFA funds to include 

oversight by agency managers and by 

the Validation Unit. 

The DCP is expanding its use of 

Tactical Diversion Squads and is 

conducting more investigations, 

inspections, and scheduling actions 

now than ever before due to the increase 

in prescription drug abuse and the 

corresponding efforts to divert such 

substances to illicit use. Similarly, an 

ever expanding number of synthetic 

substances, such as synthetic 

cannabinoids (a large family of 

chemically unrelated structures 

functionally similar to [Delta]9- 

tetrahydrocannabinol (THC), the active 

principle of marijuana) and synthetic 

cathinones (drugs of the 

phenethylamine class which are 

structurally and pharmacologically 

similar to amphetamine and other 


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related substances, and are commonly 

falsely marketed as bath salts or plant 

food) require the DCP to dedicate 

resources to analyze and respond to new 

and emerging threats more often now 

than at any time in the past to protect 

the public health and safety. 

The DCP also establishes and 

maintains various IT systems for use by 

registrants. These systems result in cost 

savings and help both DEA and the 

registrants perform day-to-day functions 

more efficiently. 

Comments: One commenter felt DEA 

appropriations and not DCP funds 

should be used to pursue illicit entities 

operating via the internet and ‘‘pill 

mills’’ since they are the major sources 

of controlled substance abuse and 

diversion. 

DEA Response: DEA must set fees at 

a level that ensures the recovery of the 

full costs of operating the various 

aspects of the DCP. 21 U.S.C. 886a(1)(C). 

As discussed above under the History of 

Fees, the fees are for the ‘‘registration 

and control’’ of the manufacture, 

distribution, and dispensing as well as 

importing and exporting of controlled 

substances and listed chemicals. 21 

U.S.C. 821 and 958(f). The ‘‘control’’ of 

controlled substances and listed 

chemicals includes enforcement costs 

where the DCP carries out the mandates 

of the Controlled Substances Act. In 

doing so, the DCP may investigate the 

diversion of controlled substances 

regardless of the method or source of 

diversion, including illicit operations 

involving the internet and ‘‘pill mills.’’ 

Comments: Several commenters 

requested more specificity on what the 

fee increase will support. 

DEA Response: A supplemental 

document titled the Proposed Fee 

Calculation, located with the NPRM on 

www.regulations.gov, and an updated 

version of this document titled New 

Registrant Fee Schedule Calculations, 

posted with this final rule, also on 

www.regulations.gov, outline specific 

costs of the DCP used in calculating the 

fee. As discussed in the NPRM and 

above, the DCP is defined as ‘‘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’’ is defined as ‘‘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). 

Additionally, detailed program costs 

may be found in the annual President’s 

Budget, as well as supporting budget 

documents released on the Department 

of Justice’s Web site at http:// 

www.justice.gov/about/bpp.htm. See in 

particular pages 97–101 of the FY 2012 

DEA budget. 

Comments: One registrant 

recommended that DCP funds be better 

used to provide for adequate staffing for 

the DCP functions involving quota 

requests, scheduling determinations, 

and policy and regulatory 

interpretations in order to be more 

responsive to the regulated community. 

DEA Response: DEA continuously 

monitors and adjusts the number of 

employees assigned to various DCP 

tasks, including those that respond to 

inquiries from the registrant 

community. The DCP maintains a robust 

public Web site that is continually 

updated with information on topics of 

interest to registrants such as 

administrative final orders, significant 

guidance documents, ‘‘questions and 

answers’’ on common topics, 

registration tools and resources, and 

registrant reporting requirements. The 

Web site is intended to alleviate the 

burden of responding to multiple 

inquiries regarding similar or common 

topics, and to communicate new 

policies and/or views to registrants. The 

DCP regulates a registrant population of 

approximately 1.4 million that 

continues to grow every year, and each 

written inquiry requires a thorough 

review of the pertinent facts in order to 

provide a fair, measured response. 

While awaiting a response from the 

DCP, registrants are encouraged to 

review the DCP Web site for information 

and guidance, and to seek assistance 

from their local DEA offices and state 

licensing bodies. The DCP also 

organizes regional conferences designed 

to provide information and resources to 

registrants. Finally, all quota requests 

are scrutinized in detail and the 

supplemental information provided by 

quota applicants is verified and crosschecked in order to ensure the DCP is 

fulfilling all of its statutory obligations. 

The volume of quota applications and 

the level of review required for an 

appropriate assessment is time 

consuming. Accordingly, DEA is 

undertaking a comprehensive review of 

its quota regulations pursuant to 

Executive Order 13563 with the goal of 

updating and streamlining the quota 

application process. 

Comments: Several comments stated 

that any fee increase is unfair to persons 

who do not prescribe controlled 

substances but are required by an 

employer or an insurance company to 

maintain a DEA registration. Similarly, 

some allege that many registrants are 

not reimbursed for their payment of the 

registration fee by their employer or that 

fewer reimbursements occur than in the 

past. 

DEA Response: DEA issues 

registrations to practitioners for the 

purpose of prescribing or dispensing 

controlled substances. DEA does not 

control or otherwise have authority over 

requirements by outside entities such as 

insurance companies or employers. 

Furthermore, DEA expends resources to 

review applications to determine 

qualifications, and it expends resources 

to maintain registrations once they are 

issued. As such, DEA cannot consider 

the underlying reasons registrants apply 

for a registration, other than those 

related to the handling of controlled 

substances, nor can DEA consider 

whether a particular registrant is 

reimbursed for the fee. 

Comments: Other comments stated 

that any fee increase is detrimental to 

persons with registrations in multiple 

states. Another commenter suggested 

that a DEA number should be assigned 

to a provider throughout their career, 

regardless of their practice location. 

DEA Response: By statute, ‘‘[a] 

separate registration shall be required at 

each principal place of business or 

professional practice where the 

applicant manufactures, distributes, or 

dispenses controlled substances or List 

I chemicals.’’ 21 U.S.C. 822(e). Thus, 

some registrants, based upon their 

particular circumstances and business 

decisions, may have more than one 

registration within the same state or in 

multiple states where more than one 

state has authorized the registrant to 

conduct the above described activities. 

Registration is an essential component 

of the closed system of distribution 

established under the CSA and is 

predicated on compliance with all 

applicable state and local laws, 

including state licensure in each state 

the registrant practices. 

Comments: A number of commenters 

focused on situations where one person 

may be more impacted by the fee 

increase than another, such as persons 

working in low-income areas where 

there is little or no reimbursement for 

registration fees, persons working in 

rural areas, and persons in sole practice 

or in small practices. Several 

commenters expressed concern that fee 

increases will affect patient care as some 

registrants may not renew or seek to 

register because of the cost. 

DEA Response: DEA may only operate 

within its statutory authority, which 

requires that the fees be set at a level 

that ensures the recovery of the full 

costs of operating the DCP. DEA notes 

that there are currently 1.4 million 

active registrants and, as such, even if 

business model or size of practice could 


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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). 

be objectively measured and accounted 

for in individualized fee calculations, 

such individual calculations would be 

costly. It is likely that any cost savings 

would be offset by the increased need 

for personnel to perform the individual 

fee calculations. It should also be noted 

that historically, DCP costs are higher 

for rural areas because of the additional 

travel costs from DEA office locations. 

Each applicant for registration must 

evaluate their need to be able to handle 

controlled substances or listed 

chemicals. 

Comments: One commenter suggested 

that those state, federal, and tribal 

organizations that are exempt from 

payment of the fee should be required 

to pay a fee before the current fee is 

increased. 

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 2010.26 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. 

Comments: Some commenters 

suggested that persons who overprescribe or violate the law should be 

charged additional fees and penalties to 

help make up any shortfall in 

collections. Likewise, it was suggested 

that the end users of controlled 

substances be charged an additional fee. 

Others suggested that DEA legalize 

‘‘agriculture-based controlled substance 

production’’ to either decrease costs or 

charge a fee to fund the DCP. 

DEA Response: DEA has no authority 

to implement these suggestions. DEA’s 

statutory authority is to charge 

reasonable registration fees set at a level 

that ensures the recovery of the full 

costs of operating the various aspects of 

the DCP. In addition, the CSA provides 

for mechanisms independent of the 

registration fee by which to exact 

financial remuneration from registrants 

who violate the law. Registrants who 

violate the law with regard to controlled 

substances may be subject to civil and 

criminal penalties, as well as forfeitures. 

21 U.S.C. 841, 842, 843, 881. 

Comments: Some commenters 

suggested that the fee should be based 

on the rate of prescribing of controlled 

substances or pro-rated to the salary of 

the prescriber or based on the 

registrant’s number of Medicaid and 

Medicare patients. 

DEA Response: DEA does not have 

access to the controlled substance 

prescribing rates of practitioners. In fact, 

many states with prescription drug 

monitoring programs prohibit law 

enforcement entities from using 

prescribing data without specific, 

independent legal authority to do so, 

e.g., a subpoena or warrant. Even so, 

DEA does not have the expertise or 

resources to calculate the rate of 

prescribing for each registrant in order 

to personalize each registrant’s 

registration fee. Additionally, allowing 

individualized calculations based on 

prescribing rates, income, or type of 

patients served would introduce 

uncertainty and unpredictable 

fluctuations in the collection cycle, 

thereby jeopardizing the statutory 

mandate to recover the full costs of 

operating the DCP. 

Comment: One association felt DEA 

fails to recognize the unfairness of the 

‘‘Weighted-Ratio’’ methodology for fee 

calculation because dispensers or 

practitioners make no income from 

writing a prescription whereas 

manufacturers and distributors more 

directly benefit from their authorization 

by registration to handle controlled 

substances. This commenter believed 

the difference in annual revenue or 

income for a practitioner compared to a 

manufacturer or distributor was more 

than the 9 times ratio for distributors 

and the 12 times ratio for 

manufacturers. 

DEA Response: It is important to 

emphasize that the focus of DEA’s fee 

calculation methodology is to account 

for DCP program costs among the 

registrant categories and not to set fees 

according to a percentage of registrant 

revenue from use of a DEA registration. 

DEA provided an analysis of incomes to 

show the economic impact of the 

relatively minor proportion of that 

income that may be expended for 

payment of a registration fee. 

Additionally, the analysis showed that 

the fees as percentages of income/ 

revenue are essentially the same as in 

2006, the year of the last fee adjustment. 

Need for New Fee Calculation 

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 2007.27 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. 

The Office of Diversion Control at 

DEA is focused on the supply side of 

this serious threat to the public health 

and safety. At the end of FY 2008, a 

reorganization within DEA expanded 

the use of Tactical Diversion Squads 

across the country to allow Diversion 

Investigators to focus their expertise on 

regulatory oversight, thereby increasing 

the deterrent effect of increased 

regulatory investigations. Tactical 

Diversion Squads incorporate the 

criminal investigative skills and 

statutory authority of Special Agents as 

well as state and local Task Force 

Officers in an effort to stop those 

organizations and individuals who 

violate the CSA by diverting controlled 

substances and listed chemicals into the 

illicit market. Diversion Investigators 

are a key asset as they lend their keen 

knowledge of the closed system of 

distribution to the Tactical Diversion 

Squads. Diversion Investigators’ 

familiarity and detailed understanding 

of the closed system of distribution 

require, however, that they continue to 

lead the regulatory oversight of DEA 

registrants. DCP costs increase with the 

need to expand the number and use of 

Tactical Diversion Squads. 

Due to the rise in controlled substance 

diversion and abuse, as well as the 

recent emergence of designer drug 

abuse, the DCP has increased scheduled 


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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. 

investigations of registrants and drug 

scheduling initiatives, as well as other 

modifications in its diversion control 

efforts. The DCP continues to draw 

technical expertise from Diversion 

Investigators, and the DCP has 

incorporated greater numbers of Special 

Agents, Chemists, Information 

Technology Specialists, Attorneys, 

Intelligence Research Specialists, and 

state and local personnel. It is essential 

to utilize a diverse skilled workforce 

and constantly review and modify all 

aspects of the DCP to help successfully 

execute the drug trafficking disruption 

goals of the National Drug Control 

Strategy and effectively prevent, detect, 

and eliminate the diversion of 

controlled substances and listed 

chemicals into the illicit market while 

ensuring a sufficient supply of these 

substances for legitimate medical, 

scientific, research, and industrial 

purposes. 

DEA has been and will continue to be 

fiscally responsible and will remain 

vigilant in identifying methods to 

improve efficiencies or identifying other 

cost saving measures. As discussed 

above, however, a new fee calculation is 

needed. Without an adjustment in the 

annual registration fees, DEA will be 

unable to continue current operations 

and will be in violation of the statutory 

mandate that fees charged ‘‘shall be set 

at a level that ensures the recovery of 

the full costs of operating the various 

aspects of [the diversion control 

program].’’ 21 U.S.C. 886a(1)(C). For 

example, in FY 2009, the DCP’s 

regulatory activities included more 

outreach programs to help the registrant 

population better comply with the CSA. 

The DCP increased investigation cycles 

as well as depth of review. In FY 2009, 

there were 1,065 scheduled 

investigations; in FY 2012, DEA 

projected performance targets of 3,906 

scheduled investigations—an increase 

of 2,841. Additionally, DEA coordinates 

National Prescription Drug Take-Back 

Day initiatives, providing an 

opportunity for the safe disposal of 

unwanted or unused prescription drugs. 

DEA also projects to increase the 

number of Diversion Priority Target 

Organizations not Linked to 

Consolidated Priority Organization 

Targets Disrupted or Dismantled to 85 

(disrupted)/90 (dismantled), an increase 

of 32 (disrupted)/66 (dismantled) over 

FY 2007’s 53 (disrupted)/24 

(dismantled), and is authorized and 

plans to establish an additional 12 

Tactical Diversion Squads, which 

conduct criminal enforcement activities, 

across the United States. The new fee 

schedule will allow DEA to sustain 

current, planned, and future operations 

and employ additional personnel in 

support of important program initiatives 

during Fiscal Years 2012–2014. 

Fee Calculation 

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.28 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. 

Current options to calculate fees are 

also limited by the ability and 

practicability of tracking and allocating 

detailed costs, although the agency 

continues to improve its capabilities on 

this front. Part of the difficulty stems 

from the fact that the mission of DEA 

involves investigations and actions that 

often involve poly-drug organizations 

(drug trafficking organizations that 

traffic multiple drugs), various types of 

registrants, or investigations that may 

start out as one type of investigation and 

result in another, based upon the way 

the facts develop. It is apparent that 

Congress recognized that the costs of the 

registration and control of controlled 

substances and listed chemicals are not 

properly attributed on a per registrant 

basis when Congress differentiated 

among the categories of registrants for 

purposes of calculating a reasonable fee, 

i.e., manufacturers, distributors, 

importers, exporters, and dispensers. 

The weighted ratio of 12.5 for 

manufacturers, 6.25 for distributors 

(including importers and exporters), and 

1 for dispensers is consistent with 

Congress’s differentiation between the 

categories of registrants. 

Because of the complexity of many 

diversion investigations, tracking costs 

within the DCP according to registrant 

categories or within a given registrant 

category has not been possible or costefficient. Such detailed cost attribution 

may or may not be feasible in the future. 

DEA is in the process of testing a system 

where personnel would account for 

their daily hours according to whether 

their time is spent on DCP or other DEA 

mission activities. DEA has also made 

progress through reorganization and 

there is recognition throughout the 

agency of the need to identify and 

separate DCP costs from other agency 

costs. 

Thus, the fee is calculated by 

assigning registrants to a business 

activity or category (e.g., researcher, 

practitioner, distributor, manufacturer) 

based on the statutory fee categories. 

Then a base fee rate is established 

according to the annual estimated costs 

of the DCP. A projected population is 

calculated for each business activity or 

category. That figure is then multiplied 

by a ratio of 1.0 for researchers, 3.0 for 

practitioners (for administrative 

convenience the fee is collected every 

three years for practitioners), 6.25 for 

distributors, and 12.5 for manufacturers. 

By utilizing these different ratios, the 

agency recognizes the statutory need to 

charge reasonable fees relating to the 

registration and control of the 

manufacture, distribution, dispensing, 

importation, and exportation of 

controlled substances and listed 

chemicals. Historically, registration and 

other DCP activities are greatest for 

manufacturers. This is because there is 

great risk and grave consequences 

associated with the quantity and purity 

of controlled substances and/or 

chemicals with each manufacturer at 

this point in the closed system. All of 

the individual business activity figures 

are then added together to form a 

weighted sum for one projected year. 

This process is performed for two more 

years using future projected registrant 

populations for those years multiplied 

by the ratio. The annual figures for these 

three years are then added together and 

divided into the total budget 

requirements for that three-year period 

to arrive at the base rate fee to be 

charged to each category of registrant. 

In calculating fees to recover the full 

costs of operating the DCP, DEA 

estimates the costs of operating the DCP 


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29See ‘‘New Registrant Fee Schedule 

Calculations’’ in this rulemaking docket found at 

www.regulations.gov. 

30See ‘‘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, Public Law 102–395, codified in 

relevant part at 21 U.S.C. 886a. 

for the next three fiscal years.29 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.30

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. 

For the FY 2012–2014 period covered 

by this rulemaking, the overall 

breakdown of DCP major cost categories 

does not depart significantly from 

previous years in terms of percentage of 

costs; however, totals for each of these 

major cost categories do increase to 

reflect additional costs in each of these 

categories. 

In addition to the budget estimates for 

each of the fiscal years, the cost 

components outlined below are also 

considered in determining required 

registration fee collections. 

Recoveries From Money Not Spent as 

Planned (Deobligation of Prior Year 

Obligations) 

At times, DEA enters into an 

obligation to purchase a product or 

service that is not delivered 

immediately, such as in a multi-year 

contract. Changes in obligations can 

occur for a variety of reasons, e.g., 

changes in planned operations, delays 

in staffing, implementation of cost 

savings, changes in vendor capabilities, 

etc. When DEA does not expend its 

obligation, the ‘‘deobligated’’ funds are 

‘‘recovered’’ and the funds become 

available for DCP use. Based on 

historical trends and for purposes of 

calculating the fee levels, the recovery 

from deobligation of prior year 

obligations is estimated at $13.5 million 

per year. 

Transfer to Treasury 

As discussed, in 1993, Congress 

determined that the DCP would be fully 

funded by registration fees rather than 

by appropriations.31 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. 

Operational Continuity Fund (OCF) 

DEA maintains an operational 

continuity fund (OCF) based on the 

need to maintain DCP operations when 

monthly collections and obligations 

fluctuate. Historically, current 

obligations sometimes exceed current 

collections consecutively for several 

months. Therefore, an operational 

continuity fund is maintained in order 

to avoid operational disruptions due to 

these fluctuations and monthly 

differences in collections and 

obligations. Using statistical analysis of 

the historical fluctuations between 

amounts collected and amounts 

obligated, DEA has determined that 

seven percent of the projected 

obligations is adequate to avoid 

operational disruptions. The amount 

required to bring the operational 

continuity fund balance to the $15 

million plus seven percent level is 

added to projected costs. 

The FY 2012–FY 2014 OCF balance 

projections have been changed from 

those shown in the NPRM to reflect 

actual FY 2011 financial data. The FY 

2012 beginning OCF balance of 

$41,726,554 is higher than the FY 2014 

end of year target OCF balance of 

$40,943,670 by $782,884. The higher 

beginning OCF balance allows lower 

required collections from registration 

fees. The incremental changes in OCF 

balance for FY 2012, FY 2013, and FY 

2014 are ¥$2,047,144, $863,240, and 

$401,020 respectively (or a cumulative 

decrease of $782,884). The cumulative 

decrease of $782,884 is a change from 

the cumulative increase of $8,320,115 

estimated in the NPRM. The two main 

factors that contributed to the change 

from the NPRM calculation estimated in 

early 2011 to the final rule calculation 

performed after the end of FY 2011 

(September 30, 2011) are: (1) Lower than 

estimated actual FY 2011 spending 

which led to a higher beginning FY 

2012 OCF balance; and (2) lower 

estimated budgets for FY 2013 and FY 

2014, which lowered the target OCF 

balance. 

TABLE 1—CHANGE IN OPERATIONAL CONTINUITY FUND BALANCE FY 2012–2014 

FY2012 FY2013 FY2014 

Budget .................................................................................................................................... $322,000,000 $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 .......................... ..........................


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TABLE 1—CHANGE IN OPERATIONAL CONTINUITY FUND BALANCE FY 2012–2014—Continued 

FY2012 FY2013 FY2014 

Needed Change to Achieve Target OCF .............................................................................. (2,047,144 ) 863,240 401,020 

3-year cumulative change ..................................................................................................... .......................... .......................... (782,884 ) 

Combat Methamphetamine Act of 2005 

(CMEA) Collections 

Under the CMEA, DEA collects a selfcertification fee for regulated sellers of 

scheduled listed chemical products, 

which is included as part of the total 

collections. The fee is waived for any 

person in good standing and holding a 

current DEA registration to dispense 

controlled substances, such as a 

pharmacy. DEA has observed an 

approximately 26 percent decline in 

self-certifications from FY 2008 to FY 

2011 and anticipates that the decline 

will stabilize at approximately 5,000 per 

year from FY 2012 to FY 2014. The selfcertification fee is $21. CMEA selfcertification fee collection estimates for 

FY 2012, FY 2013, and FY 2014 for 

purposes of calculating the fee levels are 

$105,000 annually. 

TABLE 2—CMEA COLLECTIONS FY 2012–2014 

FY2012 FY2013 FY2014 

Number of paying self-cert .......................................................................................................... 5,000 5,000 5,000 

Fee ............................................................................................................................................... $21 $21 $21 

CMEA collection estimate ............................................................................................................ $105,000 $105,000 $105,000 

Other Collections 

DEA also derives revenue from the 

sale/salvage of official government 

vehicles dedicated to DCP use. DEA’s 

estimate for all other collections is 

$533,766 per year. This is the actual 

amount for FY 2011. 

Estimated Total Required Collections 

Based on these figures, DEA 

calculated the total amount required to 

be collected for the FY 2012–2014 

period for purposes of calculating the 

fee levels as follows: 

Required registration fee collections 

for FY 2012 are $320,814,090. This 

figure includes the budget of 

$322,000,000, plus $15 million for 

transfer to the Treasury, minus $13.5 

million in recoveries, $2,047,144 for the 

decrease in the OCF balance, $105,000 

in CMEA self-certification collections, 

and $533,766 in other collections. 

Required registration fee collections 

for FY 2013 are $354,287,474. This 

figure includes the estimated budget of 

$352,563,000, plus $15 million for 

transfer to the Treasury and $863,240 

for the increase in the OCF balance, 

minus $13.5 million in recoveries, 

$105,000 in CMEA self-certification 

collections, and $533,766 in other 

collections. 

Required registration fee collections 

for FY 2014 are $366,157,254. This 

figure includes the estimated budget of 

$364,895,000, plus $15 million for 

transfer to the Treasury and $401,020 

for the increase in the OCF balance, 

minus $13.5 million in recoveries, 

$105,000 in CMEA self-certification 

collections, and $533,766 in other 

collections. 

TABLE 3—NEEDED FEE COLLECTIONS FY 2012–2014 

FY2012 FY2013 FY2014 3-yr total 

Budget/Estimated Budget ................................................ $322,000,000 $352,563,000 $364,895,000 $1,039,458,000 

Recoveries ....................................................................... (13,500,000 ) (13,500,000 ) (13,500,000 ) (40,500,000 ) 

Net Budget ............................................................... 308,500,000 339,063,000 351,395,000 998,958,000 

Transfer to the Treasury .................................................. 15,000,000 15,000,000 15,000,000 45,000,000 

Change to Achieve Target OCF ...................................... (2,047,144 ) 863,240 401,020 (782,884 ) 

CMEA Self-cert collections .............................................. (105,000 ) (105,000 ) (105,000 ) (315,000 ) 

Other collections .............................................................. (533,766 ) (533,766 ) (533,766 ) (1,601,297 ) 

Required collections from Registration Fees .................. 320,814,090 354,287,474 366,157,254 1,041,258,818 

Numbers are rounded. 

In total, DEA needs to collect 

$1,041,258,818 in registration fees over 

the three year period, FY 2012–FY 2014, 

to fully fund the DCP. 

As in the past, DEA is calculating the 

fee for each registrant category for a 

three-year period (FY 2012–2014). The 

vast majority of registrants are 

practitioners who pay a three-year 

registration fee. These registrants are 

divided into three separate groups who 

pay their three-year registration fees on 

alternate year cycles. Because 

registration cycles may differ from year 

to year, the total amount collected 

through fees in a given year may not 

exactly match the projected amount. For 

purposes of calculating the new fee 

schedule, DEA used a new fee collection 

start date of March 1, 2012, and used the 

current fee schedule for calculating the 

first five months of FY 2012 registration 

fee collections. 

In calculating the new fees through 

FY 2014 using the selected weightedratio methodology, DEA has updated the 

data used in the calculation set forth in 

the proposed rule. Instead of budget 

estimates for FY 2012, 2013, and 2014, 

the final fee calculation uses the actual 

FY 2012 budget, revised budget 

estimates for FY 2013 and FY 2014, and 

revised estimates for recoveries from 

deobligations and for the Operational 

Continuity Fund. These revisions are 


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outlined in the overview of the 

Diversion Control Fee Account below: 

FY2012 FY2013 FY2014 

Congressional Budget/Cost Estimates ................................................................ $322,000,000 $352,563,000 $364,895,000 

Operational Continuity Fund (OCF) Brought Forward From Prior Year ............. 41,726,554 39,701,112 36,496,165 

Collections: Registration Fees ............................................................................. 320,835,793 350,219,287 369,879,300 

Collections: CMEA ............................................................................................... 105,000 105,000 105,000 

Treasury ........................................................................................................ (15,000,000 ) (15,000,000 ) (15,000,000 ) 

Net Collections ............................................................................................. 305,940,793 335,324,287 354,984,300 

Recoveries from Deobligations ............................................................................ 13,500,000 13,500,000 13,500,000 

Other Collections ................................................................................................. 533,766 533,766 533,766 

Subtotal Availability ...................................................................................... 361,701,112 389,059,165 405,514,231 

Obligations ........................................................................................................... 322,000,000 352,563,000 364,895,000 

EOY OCF Balance .............................................................................................. 39,701,112 36,496,165 40,619,231 

Target OCF ($15M+7% of Budget) ..................................................................... 39,679,410 40,542,650 40,943,670 

Numbers are rounded. 

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. 

Based upon careful consideration of 

all of the comments and applying the 

above, a new fee schedule is set forth 

below. This new fee schedule is slightly 

less than the fee schedule proposed in 

the NPRM on July 6, 2011, due to the 

completion of FY 2011 and the 

availability of actual financial data for 

the fiscal year as well as progression in 

the budget process due to the passage of 

time since the NPRM was prepared. 

REGISTRANTS ON THREE-YEAR

REGISTRATION CYCLE

Registrant class/business Fee 

Pharmacy .......................................... $731 

Hospital/Clinic ................................... 731 

Practitioner ........................................ 731 

Teaching Institution .......................... 731 

Mid-Level Practitioner ....................... 731 

* 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

Registrants class/business Fee 

Researcher/Canine Handler ............. $244 

Analytical Lab ................................... 244 

Maintenance ..................................... 244 

Detoxification .................................... 244 

Maintenance and Detoxification ....... 244 

Compounder/Maintenance ............... 244 

Compounder/Detoxification .............. 244 

Compounder/Maintenance/Detoxification ........................................... 244 

Distributor (chemical and controlled 

substances) ................................... 1,523 

Reverse distributor ........................... 1,523 

Importer (chemical and controlled 

substances) ................................... 1,523 

REGISTRANTS ON ANNUAL

REGISTRATION CYCLE—Continued 

Registrants class/business Fee 

Exporter (chemical and controlled 

substances) ................................... 1,523 

Manufacturer (chemical and controlled substances) ........................ 3,047 

This fee schedule replaces the current 

fee schedule for controlled substance 

and chemical registrants in order to 

recover the full costs of the DCP so that 

it may continue to meet the 

programmatic responsibilities set forth 

by statute, Congress, and the President. 

As discussed, without an adjustment to 

fees, the DCP will be unable to continue 

current operations, necessitating 

dramatic program reductions, and 

possibly weakening the closed system of 

distribution. Particularly in light of 

increased needs for diversion control 

and demands upon the DCP outlined in 

the NPRM, the following fees for the FY 

2012–2014 period will be effective April 

16, 2012. 

DEA continues to review possible 

methodologies as technology continues 

to afford increased tracking and 

allocation of specific costs. However, at 

this time, DEA has determined that it is 

both practicable and reasonable to 

continue to apply the weighted-ratio 

methodology. Consistent with the 

statutory direction to charge reasonable 

fees relating to the registration and 

control of the manufacture of controlled 

substances and listed chemicals, the 

12.5 ratio is applied to the 

manufacturing registrant group. The 

6.25 ratio applies to the ‘‘distribution’’ 

of controlled substances and listed 

chemicals, or the distributor registrant 

group. The ‘‘dispensing’’ registrant 

group has the largest number of 

registrants and each registrant has a 

relatively low registration and control 

cost, and a relatively smaller quantity 

and lower purity of controlled 

substances within their physical 

possession. Thus, the base fee, or the 1 

ratio, is applied to the dispensing 

registrant group. The practitioner fee is 

the base fee on an annual basis but is 

collected every three years for 

administrative convenience. 

Thus, the new fees, some of which are 

paid annually and some of which are 

paid every three years, range from $244 

for ratio 1 to $3,047 for ratio 12.5, 

depending upon the particular registrant 

category. Specifically, the annual 

registration fee for practitioners, midlevel practitioners, dispensers, 

researchers, and narcotic treatment 

programs is $244. For administrative 

convenience for both the collection and 

the payment, practitioners will pay a 

combined registration fee of $731 every 

three years. The annual registration fee 

for distributors, importers, and 

exporters is $1,523, and for 

manufacturers the annual fee is $3,047. 

21 CFR 1301.13 and 1309.11. 

DEA Efforts To Control DCP Costs 

DEA continually reviews the DCP and 

its methods of operation to ensure that 

it is fiscally responsible. The DCP works 

diligently to provide the registrants with 

cost effective and state-of-the-art means 

for complying with laws and regulations 

related to manufacturing, distributing, 

dispensing, importing, and exporting 

controlled substances and listed 

chemicals. Some examples of this 

include online registration, the 

Controlled Substance Ordering System 


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(CSOS) for electronic controlled 

substance ordering between registrants, 

and electronic reporting of thefts and 

significant losses of controlled 

substances. 

DEA takes seriously its 

responsibilities to manage the DCP in an 

efficient and effective manner, 

particularly in light of the current 

economy. DEA cannot foresee 

Congressionally-mandated changes to 

the DCP, emerging trends, or how such 

trends may impact the DCP, but it is 

committed to managing in a fiscally 

responsible manner. The Office of 

Diversion Control is committed to 

reviewing the registration process to 

ensure efficiency and accountability as 

well as reviewing current regulations 

related to fee exempt registrants. 

Summary of Impact of New Fee 

Relative to Current Fee 

Affected Entities 

In updating the number of registrants 

since the NPRM and the proposed fee 

calculation, there is a slight increase, 

with a total of 1,407,119 controlled 

substances and listed chemical 

registrants as of August 2011 (1,406,021 

controlled substances registrants and 

1,098 chemical registrants), as shown in 

Table 10. 

TABLE 10—NUMBER OF REGISTRANTS BY BUSINESS ACTIVITY

Registrant class/business Controlled 

substances Chemicals 

Pharmacy ................................................................................................................................................................. 66,934 ........................

Hospital/Clinic .......................................................................................................................................................... 15,737 ........................

Practitioner ............................................................................................................................................................... 1,115,398 ........................

Teaching Institution .................................................................................................................................................. 336 ........................

Mid-Level Practitioner .............................................................................................................................................. 193,877 ........................

Researcher/Canine Handler .................................................................................................................................... 9,120 ........................

Analytical Lab .......................................................................................................................................................... 1,500 ........................

Narcotic Treatment Program ................................................................................................................................... 1,267 ........................

Distributor ................................................................................................................................................................. 828 550 

Reverse Distributor .................................................................................................................................................. 60 ........................

Importer .................................................................................................................................................................... 209 182 

Exporter ................................................................................................................................................................... 233 159 

Manufacturer ............................................................................................................................................................ 522 207 

Total .................................................................................................................................................................. 1,406,021 1,098 

Total (all registrants) ......................................................................................................................................... 1,407,119 

* Data as of August 2011. 

Not all registrants listed in Table 10 

are subject to the fees. Publicly owned 

institutions, law enforcement agencies, 

the Indian Health Service, the 

Department of Veterans Affairs, Federal 

Bureau of Prisons, and military 

personnel are exempt from fees. 

The number of registrations exceeds 

the number of individual registrants 

because some registrants are required to 

hold more than one registration. The 

CSA requires a separate registration for 

each location where controlled 

substances are handled and a separate 

registration for each business activity; 

that is, a registration for activities 

related to the handling of controlled 

substances and a registration for 

activities related to the handling of List 

I chemicals. Some registrants may 

conduct multiple activities under a 

single registration (e.g., manufacturers 

may distribute substances they have 

manufactured without being registered 

as a distributor), but firms may hold 

multiple registrations for a single 

location. Individual practitioners who 

prescribe, but do not store controlled 

substances, may use a single registration 

at multiple locations within a state, but 

need separate registrations for each state 

in which they prescribe controlled 

substances. 

Characteristics of Entities 

This rule affects those manufacturers, 

distributors, dispensers, importers, and 

exporters of controlled substances and 

List I chemicals that are required to 

obtain and pay a registration fee with 

DEA pursuant to the CSA (21 U.S.C. 822 

and 958(f)). As of August 2011, there 

was an increase of registrants from 

December 2010, with 1,407,119 

controlled substances and List I 

chemical registrants (1,406,021 

controlled substances registrants and 

1,098 List I chemical registrants), as 

shown above in Table 10. 

Pharmacies, hospitals/clinics, 

practitioners, teaching institutions, and 

mid-level practitioners comprise 98.9 

percent of all registrants. These 

registrants register every three years. 

Other registrants maintain an annual 

registration. Registration and 

reregistration costs vary by registrant 

category as described in more detail in 

the sections below. 

The fees affect a wide variety of 

entities. Table 11 indicates the sectors 

affected by this rule and their average 

annual revenue/income. Most DEA 

registrants are considered small entities 

under Small Business Administration 

(SBA) standards. There are 1,309,275 

registered practitioners and mid-level 

practitioners as of August 2011, and 

almost all practitioners are considered 

small (annual revenues of less than $6 

million to $8.5 million, depending on 

specialty). 

TABLE 11—INDUSTRIAL SECTORS OF DEA REGISTRANTS

Sector NAICS code Average annual 

revenue * 

Manufacturers: 


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32This example is for illustration purposes only. 

Each entity should seek competent tax advice for 

tax consequences of this rule. 

33Source: 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. 

TABLE 11—INDUSTRIAL SECTORS OF DEA REGISTRANTS—Continued 

Sector NAICS code Average annual 

revenue * 

Petro-chemical Manufacturing (organic, inorganic) ........................................................................................ 32511 $1,390,485,971 

Medicinal and Botanical Manufacturing ......................................................................................................... 325411 27,601,834 

Pharmaceutical Manufacturing ....................................................................................................................... 325412 144,173,821 

Adhesive Manufacturing ................................................................................................................................. 325520 17,482,468 

Toilet Preparation Manufacturing ................................................................................................................... 325620 50,322,290 

Other Chemical Manufacturing ....................................................................................................................... 325998 13,720,807 

Distributors: 

Drugs and Druggist Sundries Wholesalers .................................................................................................... 424210 64,793,480 

General Line Grocery Wholesalers ................................................................................................................ 424410 45,518,407 

Confectionary Merchant Wholesalers ............................................................................................................ 414450 17,175,982 

Chemical Wholesalers .................................................................................................................................... 424690 12,856,993 

Tobacco Wholesalers ..................................................................................................................................... 424940 71,437,205 

Miscellaneous Wholesalers ............................................................................................................................ 424990 2,741,857 

Pharmacies: 

Supermarkets ................................................................................................................................................. 445110 7,247,540 

Drug Stores .................................................................................................................................................... 446110 4,829,487 

Discount Stores .............................................................................................................................................. 452112 26,535,201 

Warehouse Clubs and Superstores ............................................................................................................... 452910 76,300,280 

Other: 

Testing Labs ................................................................................................................................................... 541380 1,907,414 

Packaging and Labeling Services .................................................................................................................. 561910 2,696,904 

Other Practitioners: 

Professional Schools ...................................................................................................................................... 611310 1,373,855 

Ambulatory Health Care Services .................................................................................................................. 621 1,236,852 

Hospitals ......................................................................................................................................................... 622 108,286,641 

*Source: 2007 Economic Census. http://www.census.gov/econ/census07. 

Supermarkets, discount stores, 

warehouse clubs, and superstores 

handle controlled substances through 

their distribution centers and 

pharmacies. Drug products containing 

List I chemicals are primarily 

distributed as over-the-counter 

medicines. These are distributed by 

drug wholesalers who specialize in nonprescription drugs, wholesalers who 

supply convenience stores, and grocery, 

pharmacy, and discount stores that 

operate their own distribution centers. 

Economic Impact Analysis of Fee 

This fee is expected to have two levels 

of impact. Initially, the fee adjustment 

will impact the registrants. Then the fee 

or portion of the fee increase may be 

passed on to the general public. The 

analysis below assumes that the impact 

of the fee adjustment is absorbed 

entirely by the registrants. Some 

commenters have confirmed this 

statement and have indicated some 

registrants may decide not to renew 

their registration as a result of the higher 

fees. 

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 $39.32

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 subgroup 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 business expense. 

TABLE 12—NEW FEE AS PERCENTAGE OF INCOME FY 2004–2012 

Year 

Average income 33 Fee Fee as percent of average income 

Physicians Dentists Physician 

assistants 

(Annual 

basis) Physicians Dentists Physician assistants 

2004 ......................................................... 137,610 130,300 68,780 .................... .................... .................... ....................

2005 ......................................................... 138,910 133,680 71,070 .................... .................... .................... ....................

2006 ......................................................... 142,220 140,950 74,270 184 0.129 0.131 0.248 


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34See 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. 

36See 21 CFR 1301.21 for complete requirements 

for exemption of registration fees. 

37See ‘‘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. 

TABLE 12—NEW FEE AS PERCENTAGE OF INCOME FY 2004–2012—Continued 

Year 

Average income 33 Fee Fee as percent of average income 

Physicians Dentists Physician 

assistants 

(Annual 

basis) Physicians Dentists Physician assistants 

2007 ......................................................... 155,150 147,010 77,800 184 0.119 0.125 0.237 

2008 ......................................................... 165,000 154,270 81,610 184 0.112 0.119 0.225 

2009 ......................................................... 173,860 156,850 84,830 184 0.106 0.117 0.217 

2010 ......................................................... 179,370 163,901 87,933 184 0.103 0.112 0.209 

2011 ......................................................... 187,154 169,632 91,230 184 0.098 0.108 0.202 

2012 ......................................................... 194,939 175,363 94,528 244 0.125 0.139 0.258 

Increase from 2007 to 2012 .................... 26 19 22 33 6 11 9 

Increase from 2006 to 2012 .................... 37 24 27 33 ¥3 7 4 

In 2007, the current fee of $184 on an 

annual basis represents 0.119 percent, 

0.125 percent, and 0.237 percent of 

annual income for physicians, dentists, 

and physician’s assistants respectively. 

In 2012, the new fee of $244 (on an 

annual basis) would represent 

approximately 0.125 percent, 0.139 

percent, and 0.258 percent of annual 

income for physicians, dentists, and 

physician’s assistants respectively. 

While the new fee is approximately 33 

percent above the current fees 

implemented at the end of 2006, average 

incomes for physicians, dentists, and 

physician’s assistants have increased 26 

percent, 19 percent, and 22 percent 

respectively over the same period. This 

estimated increase in average income 

dampens the effect of the fee increase as 

a percentage of average income. The 

diminishing effect is more apparent 

when comparing 2012 to 2006, the year 

for which the current fee was calculated 

and implemented. Additionally, as the 

average income grows in 2013 and 2014, 

the income adjusted fees are not any 

higher than in recent history. 

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.34 Fee 

exempt registrants are not affected by 

the new fees. 

Conclusion 

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.35 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.36

Moreover, DEA believes that this final 

rule will enhance the public health and 

safety. 

Regulatory Analyses 

This final rule is necessary to ensure 

the full funding of the DCP through 

registrant fees as required by 21 U.S.C. 

886a. It has been five years since the last 

fee change. As discussed above, 

statutory and operational changes to the 

DCP cannot be fully offset by improved 

operational efficiencies and require a 

recalculation of registrant fees. This rule 

does not change the requirement to 

register to handle controlled substances 

and/or List I chemicals but rather 

changes the annual fee associated with 

registration and reregistration that will 

allow DEA to meet its statutory 

obligations. DEA recognizes that the fee 

changes affect small businesses, but 

does not believe the relative individual 

impact is significant. The average 

annual increase in estimated registration 

fee collections is less than $100 million 

at an estimated annual increase of 

$76,226,568. 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3511) 

This rule will not impose additional 

information collection requirements on 

the public. 

Regulatory Flexibility Act 

Under the Regulatory Flexibility Act 

of 1980 (5 U.S.C. 601–612) (RFA), 

federal agencies must evaluate the 

impact of rules on small entities and 

consider less burdensome alternatives. 

DEA has evaluated the impact of this 

final rule on small entities as 

summarized above and concluded that 

although the rule will affect a 

substantial number of small entities, it 

will not impose a significant economic 

impact on any regulated entities. 

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.37 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. 

This rule is not a discretionary action 

but implements statutory direction to 

charge reasonable fees to recover the full 


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15248 Federal Register / Vol. 77, No. 51 / Thursday, March 15, 2012 / Rules and Regulations 

costs of activities constituting the DCP 

through registrant fees (21 U.S.C. 821, 

886a, and 958(f)). As discussed above 

and in the Economic Impact Analysis of 

the Final Rule found in the rulemaking 

docket at www.regulations.gov, DEA 

analyzed four fee calculation 

methodologies—Past-Based, FutureBased, Flat Fee, and Weighted-Ratio. 

DEA selected the weighted-ratio 

methodology to calculate the new fee 

structure. This approach has been used 

since Congress established registrant 

fees and continues to be a reasonable 

reflection of differing costs. 

Furthermore, the weighted-ratio does 

not create a disparity in the relative 

increase in fees from the current to the 

new fees. The weighted-ratios used by 

DEA to calculate the fee have proven 

effective and reasonable over time. 

Additionally, the selected calculation 

methodology accurately reflects the 

differences in activity level, notably in 

pre-registration and scheduled 

investigations, by registrant category— 

for example, these costs are greatest for 

manufacturers. DEA selected this option 

because it is the only option that 

resulted in reasonable fees for all 

registrant groups. 

Under the weighted-ratio 

methodology, the individual effect on 

small business registrants is minimal. 

Practitioners represent 93 percent of all 

registrants, and nearly all practitioners 

are employed by small businesses 

pursuant to SBA standards. 

Practitioners will pay a three-year 

registration fee of $731 or the equivalent 

of $244 per year. 

For consideration of the impact of the 

fee on small businesses, DEA analyzed 

the new registration fee as a percentage 

of annual income for a representative 

practitioner group: physicians, dentists, 

and physician’s assistants. While there 

are many specialists listed in the Bureau 

of Labor Statistics income data, incomes 

for physicians, dentists, and physician’s 

assistants are representative of the 

practitioner registrant group. For 

practitioners, the new fee, on an annual 

basis, would be $244; the annual 

increase would be $60 from the current 

fee. From the calculation performed in 

the preceding section, Economic Impact 

Analysis of Final Rule, the impacts of 

the new fees, $60 per year increase from 

current fees, were found to be 0.007 

percent, 0.014 percent, and 0.022 

percent (rounded to the third decimal) 

of annual income for physicians, 

dentists, and physician’s assistants 

respectively, when normalized for 

income increases. In consideration of 

the calculated impact and potentially 

further mitigating factors discussed in 

the Economic Impact Analysis of Final 

Rule, DEA concludes that the final rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

Executive Orders 13563 and 12866 

This final rule increasing registrant 

fees has been developed in accordance 

with the principles of Executive Orders 

13563 and 12866. Supporting 

information may be found at 

www.regulations.gov. The difference 

between the current fee and the new 

fee—the fee increase—is less than $100 

million annually. Specifically, the 

difference in the fees projected to be 

collected under the current fee rates and 

in the fees projected to be collected 

under the new fee rates for the three 

years of FY 2012–FY 2014 is 

$228,679,704. Thus, the annual increase 

is $76,226,568. This rule has been 

reviewed by the Office of Management 

and Budget. 

The primary cost of this final rule is 

the increase in the registration fees paid 

by registrants. Benefits of the rule are an 

extension of the benefits of the DCP. 

The DCP is a strategic component of 

United States law and policy aimed at 

preventing, detecting, and eliminating 

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. The absence of or significant 

reduction in this program would result 

in enormous costs for the citizens and 

residents of the United States due to the 

diversion of controlled substances and 

listed chemicals into the illicit market 

as outlined in the Economic Impact 

Assessment found in the rulemaking 

docket. 

Executive Order 12988 

This final regulation meets the 

applicable standards set forth in 

Sections 3(a) and 3(b)(2) of Executive 

Order 12988 Civil Justice Reform to 

eliminate ambiguity, minimize 

litigation, establish clear legal 

standards, and reduce burden. 

Executive Order 13132 

This rulemaking does not preempt or 

modify any provision of state law, 

impose enforcement responsibilities on 

any state or 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 does not contain a federal 

mandate and will not result in the 

expenditure by state, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $136,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. DEA notes 

that many governmental entities operate 

DEA-registered facilities and that they 

are currently fee exempt. Moreover, the 

effect of this fee adjustment on 

individual entities and practitioners is 

minimal. The majority of the affected 

entities will pay a fee of $731 for a three 

year registration period ($244 per year 

or an increase of $60 per year). This rule 

is promulgated in compliance with 21 

U.S.C. 886a that the full costs of 

operating the DCP be collected through 

registrant fees. 

Executive Order 13175 

This rule is required by statute, will 

not have tribal implications and will not 

impose substantial direct compliance 

costs on Indian tribal governments. 

Congressional Review Act 

This rule is not a major rule as 

defined by the Congressional Review 

Act (5 U.S.C. 804). This rule will not 

result in an annual effect on the 

economy of $100,000,000 or more, a 

major increase in costs or prices, or have 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or the ability 

of United States-based companies to 

compete with foreign based companies 

in domestic and export markets. 

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. 

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 

■ 1. The authority citation for part 1301 

continues to read as follows: 

Authority: 21 U.S.C. 821, 822, 823, 824, 

831, 871(b), 875, 877, 886a, 951, 952, 953, 

956, 957, 958. 


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Federal Register / Vol. 77, No. 51 / Thursday, March 15, 2012 / Rules and Regulations 15249 

■ 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. 

* * * * * 

(e) * * * 

(1) 

Business activity Controlled substances 

DEA Application 

forms 

Application 

fee 

($) 

Registration 

period 

(years) 

Coincident activities allowed 

(i) Manufacturing Schedules I–V ... New–225 Renewal–225a.$3,047 1 Schedules I–V: May distribute that substance or 

class for which registration was issued; may not 

distribute or dispose of 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 Renewal–225a.1,523 1 

(iii) Reverse distributing.Schedules I–V ... New–225 Renewal–225a.1,523 1 

(iv) Dispensing or 

instructing (includes Practitioner, Hospital/ 

Clinic, Retail 

Pharmacy, 

Central fill 

pharmacy, 

Teaching Institution).

Schedules II–V .. New–224 Renewal–224a.731 3 May conduct research and instructional activities 

with those substances for which registration was 

granted, except that a mid-level practitioner may 

conduct such research only to the extent expressly authorized under state statute. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a 

narcotic controlled substance in Schedule II–V in 

a proportion not exceeding 20% of the complete 

solution, compound or mixture. A retail pharmacy 

may perform central fill pharmacy activities. 

(v) Research ....... Schedule I .......... New–225 Renewal–225a.244 1 A researcher may 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 § 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. 

(vi) Research ...... Schedules II–V .. New–225 Renewal–225a.244 1 May conduct chemical 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 § 1301.24; and conduct instructional activities with controlled substances. 

(vii) Narcotic 

Treatment Program (including 

compounder).

Narcotic Drugs in 

Schedules II–V.

New–363 Renewal–363a.244 1 

(viii) Importing ..... Schedules I–V ... New–225 Renewal–225a.1,523 1 May distribute that 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 Renewal–225a.1,523 1 


sroberts on DSK5SPTVN1PROD with RULES
15250 Federal Register / Vol. 77, No. 51 / Thursday, March 15, 2012 / Rules and Regulations 

Business activity Controlled substances 

DEA Application 

forms 

Application 

fee 

($) 

Registration 

period 

(years) 

Coincident activities allowed 

(x) Chemical 

Analysis.

Schedules I–V ... New–225 Renewal–225a.244 1 May manufacture and 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 § 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 

■ 3. The authority citation for part 1309 

is revised to read as follows: 

Authority: 21 U.S.C. 802, 821, 822, 823, 

824, 830, 871(b), 875, 877, 886a, 952, 953, 

957, 958. 

■ 4. Revise § 1309.11 to read as follows: 

§ 1309.11 Fee amounts. 

(a) For each application for 

registration or reregistration to 

manufacture the applicant shall pay an 

annual fee of $3,047. 

(b) For each application for 

registration or reregistration to 

distribute, import, or export a List I 

chemical, the applicant shall pay an 

annual fee of $1,523. 

■ 5. In § 1309.21, revise paragraph (c) to 

read as follows: 

§ 1309.21 Persons required to register. 

* * * * * 

(c) * * * 

SUMMARY OF REGISTRATION REQUIREMENTS AND LIMITATIONS

Business 

activity Chemicals DEA Forms Application fee 

Registration 

period 

(years) 

Coincident activities allowed 

Manufacturing .. List I ..................................... New–510 ....... $3,047 1 May distribute that chemical for which registration was issued; may not distribute 

any chemical for which not registered. 

Drug products containing 

ephedrine, 

pseudoephedrine, phenylpropanolamine.

Renewal– 

510a.

3,047 

Distributing ....... List I ..................................... New–510 ....... 1,523 1 

Scheduled listed chemical 

products.

Renewal– 

510a.

1,523 

Importing .......... List I ..................................... New–510 ....... 1,523 1 May distribute that chemical for which registration was issued; may not distribute 

any chemical for which not registered. 

Drug Products containing 

ephedrine, 

pseudoephedrine, phenylpropanolamine.

Renewal– 

510a.

1,523 

Exporting .......... List I ..................................... New–510 ....... 1,523 1 

Scheduled listed chemical 

products.

Renewal– 

510a.

1,523 

Dated: March 12, 2012. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2012–6253 Filed 3–12–12; 11:15 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF TRANSPORTATION 

Federal Highway Administration 

23 CFR Part 627 

[FHWA Docket No. FHWA–2011–0046] 

RIN 2125–AF40 

Value Engineering 

AGENCY: Federal Highway 

Administration (FHWA), DOT. 

ACTION: Final rule. 

SUMMARY: This rule updates regulations 

to enhance the integration of value 

engineering (VE) analysis in the 

planning and development of highway 

improvement projects. In issuing the 

final rule, FHWA revises the VE 

regulations to make them consistent 

with prior changes in legislation and 

regulations. This rulemaking does not 

otherwise impose any new burdens on 

States, revise the threshold of projects 

for which a VE analysis is required, or 

change the reporting structure now in 

place. 


sroberts on DSK5SPTVN1PROD with RULES