ECONOMIC IMPACT ANALYSIS 

of

Proposed Rule on Schedules of Controlled Substances: 

Placement of Tramadol Into Schedule IV

DEA-351

Drug Enforcement Administration

U.S. Department of Justice

October 2013
Table of Contents

CHAPTER 1: INTRODUCTION...............................................................................................................................3

CHAPTER 2: REGULATORY ANALYSES INVESTIGATED .........................................................................................4

2.1 EXECUTIVE ORDERS 12866 AND 13563 ..................................................................................................................4

2.2 REGULATORY FLEXIBILITY ACT .................................................................................................................................4

2.3 UNFUNDED MANDATES REFORM ACT OF 1995.........................................................................................................5

2.4 CONGRESSIONAL REVIEW ACT .................................................................................................................................5

CHAPTER 3: ALTERNATIVES ANALYSIS ................................................................................................................6

CHAPTER 4: ANTICIPATED ECONOMIC IMPACT OF REGULATORY ACTION..........................................................6

4.1 AFFECTED BUSINESSES...........................................................................................................................................6

4.1.1 Number of Tramadol Handlers (Registrations)......................................................................................6

4.1.2 Number of Businesses and Small Entities Handling Tramadol...............................................................8

4.2 ANNUAL COST OF THE RULE ..................................................................................................................................10

4.2.1 Costs associated with storage requirements.......................................................................................11

4.2.2 Costs associated with inventory and record keeping requirements ....................................................13

4.2.3 Costs associated with disposal requirements ......................................................................................15

4.2.4 Cost Summary ......................................................................................................................................16

4.2.5 Annual Cost Per Business.....................................................................................................................17

4.3 ANNUAL ECONOMIC EFFECT ON THE ECONOMY .......................................................................................................18

4.4 IMPACT ON SMALL ENTITIES .................................................................................................................................19

4.4.1 Criteria for “Significant” Economic Impact ..........................................................................................19

4.4.2 Analysis................................................................................................................................................20

4.4.3 Criteria for “Substantial Number”........................................................................................................23

4.5 EXAMINATION OF INDUSTRY SEGMENTS WITH SIGNIFICANT ECONOMIC IMPACTS............................................................25

CHAPTER 5: COST-BENEFIT ANALYSIS OF REGULATORY ACTION....................................................................... 26

5.1 COSTS OF THE REGULATORY ACTION.......................................................................................................................26

5.2 BENEFITS OF THE REGULATORY ACTION (COST OF INACTION).......................................................................................26

5.2.1 Tramadol Diversion..............................................................................................................................26

5.2.2 Monetary Costs of Tramadol Diversion/Abuse ....................................................................................26

5.3 EVALUATION OF THE COSTS AND BENEFITS OF THE PROPOSED RULE.............................................................................27

CHAPTER 6: ECONOMIC ANALYSIS RESULTS ..................................................................................................... 29

6.1 EXECUTIVE ORDERS 12866 AND 13563 ................................................................................................................29

6.2 REGULATORY FLEXIBILITY ACT ...............................................................................................................................29

6.3 UNFUNDED MANDATES REFORM ACT OF 1995.......................................................................................................30

6.4 CONGRESSIONAL REVIEW ACT OF 1995 .................................................................................................................30

CHAPTER 7: DISCLOSURE OF ASSUMPTIONS..................................................................................................... 31

APPENDIX 1: REGISTRANT LANDSCAPE ............................................................................................................... 34

SUMMARY..................................................................................................................................................................34

DEA REGISTRANT POPULATION BY BUSINESS ACTIVITY .......................................................................................................35

CORRESPONDING NUMBER OF BUSINESSES .......................................................................................................................35

NUMBER OF AFFECTED BUSINESSES THAT ARE SMALL BUSINESSES ........................................................................................42

APPENDIX 2: NUMBER OF BUSINESSES WHOSE COST OF PROPOSED RULE IS 1% OR MORE OF REVENUE........... 45
3

CHAPTER 1: INTRODUCTION

The Drug Enforcement Administration (DEA) proposes to place the substance 2-

((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol, its salts, isomers, salts of isomers

and all isomeric configurations of possible forms including tramadol (the term of isomers 

includes the optical and geometric isomers), into Schedule IV of the Controlled Substances Act 

(CSA). This proposed action is based on a recommendation from the Assistant Secretary for 

Health of the Department of Health and Human Services (HHS) and on an evaluation of all other 

relevant data by the DEA. If finalized, this action would impose the regulatory controls and 

administrative, civil, and criminal sanctions of Schedule IV controlled substances on persons 

who handle (manufacture, distribute, dispense, import, export, engage in research, conduct of 

instructional activities, and possess) or propose to handle tramadol.

This document describes the economic analysis conducted by the DEA in support of 

regulatory analyses statements found in the published Notice of Proposed Rulemaking (NPRM)

for tramadol. Chapter 2 describes the regulatory analyses that have economic analysis 

components, which are analyzed in later chapters. Chapter 3 describes alternatives considered, if 

any. Chapter 4 contains the economic analysis. Chapter 5 analyzes the cost and benefit of the 

rule. Chapter 6 summarizes the results of the economic analysis. Finally, Chapter 7 contains the 

list of assumptions used in the economic analysis.
4

CHAPTER 2: REGULATORY ANALYSES INVESTIGATED

2.1 EXECUTIVE ORDERS 12866 AND 13563

Pursuant to Executive Order 12866 (58 FR 51735, October 4, 1993), an agency must 

submit to the Office of Management and Budget (OMB), Office of Information and Regulatory 

Affairs (OIRA) a regulatory impact analysis for matters identified or determined by OIRA to be 

a “significant regulatory action.” A “significant regulatory action” is any regulatory action that 

is likely to result in a rulemaking that may: (1) have an annual effect on the economy of $100 

million or more, or (2) adversely affect in a material way the economy, a sector of the economy, 

productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal 

governments or communities; (3) create a serious inconsistency or otherwise interfere with an 

action taken or planned by another agency; (4) materially alter the budgetary impact of 

entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients 

thereof; or (5) raise novel legal or policy issues arising out of legal mandates, the President’s 

priorities, or the principles set forth in Executive Order 12866.1 Executive Order 13563 (76 FR 

3821, January 18, 2011) affirms and supplements Executive Order 12866.

2.2 REGULATORY FLEXIBILITY ACT

The Regulatory Flexibility Act (RFA) (Pub.L. No. 96-354, 94 Stat. 1164 (codified at 5 

U.S.C. 601)) enacted in 1980 requires agencies to consider the impact of their regulatory 

proposals on small entities, analyze effective alternatives that minimize small entity impacts, and 

make their analyses available for public comment. The RFA does not seek preferential treatment 

for small entities, require agencies to adopt regulations that impose the least burden on small 

 

1

E.O. 12866, Section 3(f). 
5

entities, or mandate exemptions for small entities. Rather, it requires agencies to examine public 

policy issues using an analytical process that identifies, among other things, barriers to small 

business competiveness and seeks a level playing field for small entities, not an unfair 

advantage.2

2.3 UNFUNDED MANDATES REFORM ACT OF 1995

The Unfunded Mandates Reform Act (UMRA) was enacted to avoid imposing unfunded 

federal mandates on State, local, and tribal governments (SLTG), or the private sector. Most of 

UMRA's provisions apply to proposed and final rules:

 for which a general notice of proposed rulemaking was published, and

 that include a Federal mandate that may result in the expenditure of funds by 

State, local, or tribal governments (SLTG), in the aggregate, or by the private sector of $100 

million or more in any one year, adjusted for inflation.

2.4 CONGRESSIONAL REVIEW ACT

Under the Congressional Review Act (CRA), a rule generally cannot take effect until the 

agency submits a rule report to each House of Congress and to the Comptroller General of the 

United States (head of the United States Government Accountability Office). Rules that are not 

considered “major” under the CRA, may take effect as they otherwise would under other 

applicable law once a rule report is submitted. A rule is “major” if it results in an annual effect 

on the economy of $100 million or more; a major increase in costs or prices; or significant 

adverse effects on competition, employment, investment, productivity, or the ability of United 

States companies to compete with foreign companies.

 

2

SBA Office of Advocacy. “Introduction: The RFA and Related Law,” A Guide for Government Agencies: How 

to Comply with the Regulatory Flexibility Act (May 2012).
6

CHAPTER 3: ALTERNATIVES ANALYSIS

The DEA has identified no alternative regulatory actions (i.e. control in a different 

schedule or non-control) that would allow the agency to meet its statutory obligations under the 

Controlled Substances Act.

CHAPTER 4: ANTICIPATED ECONOMIC IMPACT OF REGULATORY

ACTION

4.1 AFFECTED BUSINESSES

The number of affected businesses is estimated by applying the DEA-estimated

registration-to-business ratio, explained in Appendix 1: Registrant Landscape, to the number of 

registrations for business activities affected by the rule. For manufactures, third party industry 

data was used to estimate the number of affected manufacturers rather than using the number of 

registrations as basis for estimating the number of businesses. Additionally, the number of 

affected small businesses is estimated for the RFA analysis in later sections.

4.1.1 Number of Tramadol Handlers (Registrations)

If finalized, the proposed rule on the placement of tramadol into Schedule IV of the CSA 

will affect all persons who handle, or propose to handle, tramadol. Tramadol is a widely 

prescribed drug for the treatment of pain. In 2012, nearly 40 million prescriptions were written, 

based on commercially available data.

3

 Tramadol handlers primarily include: manufacturer(s), 

distributors, pharmacies, individual practitioners, mid-level practitioners, and hospitals/clinics. 

For the purposes of this analysis the DEA assumes all legally operating manufacturers, 

distributors, importers/exporters, pharmacies, individual practitioners, mid-level practitioners, 

 

3

IMS Health.
7

and hospitals/clinics that handle tramadol are registered with the DEA4and all distributors, 

importers/exporters, pharmacies, individual practitioners, mid-level practitioners, and 

hospitals/clinics registered with the DEA are tramadol handlers. While the number of DEA 

registrations forms the basis of the number of businesses affected by this rule, the number of 

manufacturers affected by this rule is based on industry data.5

While 1,469,063 DEA registrations are estimated to be affected by this rule, 273,485 

registrations are in the 10 states that control tramadol as a Schedule IV controlled substance

under state law, with requirements that meet or exceed the DEA’s requirements for Schedule IV 

controlled substances discussed in the NPRM. These states include Arkansas, Illinois, Kentucky, 

Mississippi, New Mexico, New York, North Dakota, Oklahoma, Tennessee, and Wyoming. 

Therefore, only 1,195,578 registrations are estimated to be economically impacted by this rule. 

Below is the estimated number of tramadol handlers by DEA registrations,

6

business activity,

and control by state law:

Registrant Business Activity

Number of DEA 

Registrations in 

States where 

Tramadol Is 

Controlled 

Number of DEA 

Registrations in 

States where 

Tramadol Is Not 

Controlled Total 

Manufacturer 12 51 63 

Distributor/Importer/Exporter 291 1,175 1,466 

Pharmacy 13,487 55,251 68,738 

Practitioner 209,182 947,103 1,156,285 

Mid-level Practitioner 48,265 178,422 226,687 

Hospital/Clinic 2,248 13,576 15,824 

Total 273,485 1,195,578 1,469,063 

 

4

The DEA is aware that there are websites offering “free online physician consultation and prescriptions” that are 

“filled by affiliate pharmacies” for shipment of tramadol. However, the DEA believes these businesses are 

operating outside the legal framework for pharmacies, and thus considered outside the scope of this analysis.

5

The estimated 63 manufacturers is based on IMS Health data for tramadol manufacturers, and all 63 are estimated 

to be DEA registrants. In cases where more than one company was found with similar company names, the DEA 

made a determination in the identity and associated company information.

6

DEA registrations as of 6/30/2013. Available at http://www.deadiversion.usdoj.gov.
8

4.1.2 Number of Businesses and Small Entities Handling Tramadol

As described in ‘Appendix 1: Registrant Landscape,’ the RFA defines a “small entity” as 

a “small business” (5 U.S.C. 601(3)), a “small organization” (5 U.S.C. 601(4)), or a “small 

governmental jurisdiction” (5 U.S.C. 601(5)). Pursuant to the RFA, the term “small business” 

has the same meaning as the term “small business concern” under section 3 of the Small 

Business Act. The Small Business Act designates a “small-business concern,” as one which is 

independently owned and operated and is not dominant in its field of operation. 15 U.S.C. 

632(a)(1). Furthermore, the Small Business Administration (SBA) defines whether a business 

entity is small by size standards. These size standards have been established for the types of 

economic activity or industry under the North American Industry Classification System 

(NAICS). The SBA sets the maximum size standard – in millions of dollars or number of 

employees – allowed for concerns and their affiliates to be designated small. 13 CFR 121.201.

As determined in Appendix 1, the table below summarizes the relationship between the 

number of registrations to the number businesses, and the number of businesses to the number of 

small businesses. Other than manufacturers, the ‘Business-to-Registrant Ratio’ is used to 

estimate the number of businesses represented by DEA registrants, and the ‘% of Business 

Below SBA Size Standard’ is used to determine the number of businesses that are below the 

Small Business Administration (SBA) size standard (or number of businesses represented by 

DEA registrants that are small businesses). The estimate of 55 small business manufacturers is 

based on publically available data7for number of employees and annual sales data. The DEA 

estimates 376,904 businesses are affected by the proposed rule, and 367,046 of these businesses 

 

7

Lexis-Nexis, Dun & Bradstreet, Hoover’s, infogroup, W/D Partners Worldscope, http://www.manta.com. 

Relevant data was not found for nine of 63 manufacturers, all nine were assumed to be small businesses.
9

are estimated to be small businesses. Individual practitioners and mid-level practitioners 

primarily work in various physician and health care specialist offices as well as hospitals and 

clinics. The analysis in Appendix 1 groups Individual Practitioner, Mid-level Practitioner, and 

Hospital/Clinic, as “Others.” The number of DEA registrations changes daily and the number of 

registrations in this table can vary from the number of registrations in Appendix 1 used to 

determine the Business-to-Registrant Ratio. However, the analysis contained in Appendix 1 is 

updated at least annually and any difference in the number of registrations between this table and 

in Appendix 1 has minimal impact on the Business-to-Registrant Ratio.

All states, tramadol controlled and not controlled under state law

In states8 where tramadol is not controlled under state law, the DEA estimates 306,375

businesses are economically affected by the proposed rule, and 298,354 of these businesses are 

estimated to be small businesses. As state requirements for Schedule IV controlled substances

meet or exceed DEA requirements, business in these states are estimated to incur negligible

economic impact as a result of this rule. Therefore, the DEA estimates that 298,354 small 

businesses would be economically impacted by this rule.

 

8

The term “states” includes the District of Columbia and territories under United States jurisdiction.

Registrant Business Activity

 Number of 

DEA 

Registrations 

Business-toRegistrant 

Ratio

Estimated 

Number of 

Businesses 

Represented by 

DEA Registrants

 % of Business 

Below SBA 

Size Standard 

Number of 

Businesses 

Below SBA Size 

Standard

Manufacturer 63 1.00 63 87.3% 55

Distributor/Importer/Exporter 1,466 1.00 1,466 96.7% 1,418

Pharmacy 68,738 0.74 50,756 98.6% 50,032

Practitioner 1,156,285

Mid-level Practitioner 226,687

Hospital/Clinic 15,824

Total 1,469,063 376,904 97.4% 367,046

 0.23 324,619 97.2% 315,541
10

States where tramadol is not controlled as a Schedule IV controlled substance under state law

4.2 ANNUAL COST OF THE RULE

If this rule is finalized, persons who handle (manufacture, distribute, dispense, import, 

export, engage in research, conduct of instructional activities, and possess), or propose to handle,

tramadol would be subject to the CSA’s regulatory controls and administrative, civil, and 

criminal sanctions applicable to Schedule IV controlled substances.

As stated previously, for the purposes of this analysis, the DEA assumes that any entity 

currently handling tramadol also handles Schedule IV controlled substances in the normal course 

of business and thus is already a DEA registrant. Since no entity will be required to apply for a 

DEA registration, the DEA estimates there will be no registration costs as a result of this rule.

The DEA recognizes that there may be instances where an entity currently handling 

tramadol does not handle controlled substances. In such cases, the entity would be required to 

obtain a DEA registration to continue handling tramadol. However, the DEA believes such 

instances are rare.

Registrant Business Activity

 Number of 

DEA 

Registrations 

Business-toRegistrant 

Ratio

Estimated 

Number of 

Businesses 

Represented by 

DEA Registrants

 % of Business 

Below SBA 

Size Standard 

Number of 

Businesses 

Below SBA Size 

Standard

Manufacturer 51 1.00 51 84.3% 43

Distributor/Importer/Exporter 1,175 1.00 1,175 96.7% 1,137

Pharmacy 55,251 0.74 40,797 98.6% 40,215

Practitioner 947,103

Mid-level Practitioner 178,422

Hospital/Clinic 13,576

Total 1,195,578 306,375 97.4% 298,354

 0.23 264,352 97.2% 256,959
11

4.2.1 Costs associated with storage requirements

Pursuant to 21 CFR 1301.71(a): “All applicants and registrants shall provide effective 

controls and procedures to guard against theft and diversion of controlled substances.” Such 

controls and procedures are outlined more specifically in 21 CFR 1301.71–1301.77, including 

the storage requirements for Schedule III, IV, and V controlled substances described in in 21 

CFR 1301.72 for non-practitioners and in 21 CFR 1301.75 for practitioners. The costs 

associated with such security requirements as estimated by DEA are outlined in the following 

sections.

Manufacturers

While DEA assumes all manufacturers of tramadol are current DEA registrants, it 

understands that some modification to manufacturing and storage facilities may be necessary for 

current manufacturers of tramadol. Due to the uniqueness of each business, the DEA cannot 

account for potential modifications that may be required. However, based on its understanding 

of manufacturer operations and facilities, the DEA assumes any costs associated with such 

modifications, if needed, are negligible. 

Distributors, Importers, and Exporters

As previously stated, the DEA assumes distributors, importers, and exporters of tramadol 

are current DEA registrants with existing controlled substance storage that complies with DEA 

regulations. The DEA assumes, based on its understanding of distributor/importer/exporter 

operations and facilities, that 50% of distributors, importers, and exporters have existing 

controlled substance storage areas to store tramadol at negligible cost. DEA has estimated the 

cost of additional secure storage space for the remaining 50% that may require expansion.
12

Based on research of publicly available cost information, the DEA estimates that, 

depending on size, the addition of an enclosure with self-closing and self-locking hinged doors 

will cost $2,000 to $6,000. The $6,000 estimate is based on a cage size of 10’ high by 20’ long 

and 20’ wide. Including the estimated taxes, delivery, and installation, the DEA estimates a onetime cost of $10,000 per distributor, importer, or exporter that handles tramadol as a result of the 

scheduling action.

The DEA recognizes that businesses that handle larger volumes may require more space 

and incur higher cost, while businesses that handle smaller volumes may require less space and

incur lower cost. However, the DEA has no basis for further differentiating storage space 

requirements or costs. For the purposes of this analysis, the DEA assumes the cost of additional 

secure storage space is the same for all distributors, importers, and exporters.

Hospitals/Clinics

The DEA assumes all hospitals and clinics which hold a DEA registration already maintain 

an inventory of Schedule IV controlled substances and have existing controls against diversion 

that meet regulatory requirements. If the inventory of tramadol is not already stored in an 

appropriately secured area at these locations, the DEA assumes, based on its understanding of 

hospital/clinic operations and facilities, transferring the tramadol inventory to a secure storage 

area may be accomplished at negligible cost.

Pharmacies

The DEA assumes all registered pharmacies currently handle Schedule IV controlled 

substances and maintain secure storage areas for Schedule IV controlled substances. The DEA 

assumes, based on its understanding of pharmacy operations and facilities, that costs for 

pharmacies to comply with the security requirements for tramadol will be negligible.
13

Individual Practitioners and Mid-level Practitioners

The DEA assumes all registered practitioners currently handle Schedule IV controlled 

substances and maintain secure storage areas for Schedule IV controlled substances at a 

registered location, such as a physician’s office or other health care facilities. Because 

practitioners are estimated to maintain smaller quantities of tramadol, the DEA believes such 

inventory of tramadol may be secured at the current location within regulatory requirements at 

negligible cost. The DEA believes that a registrant may incur a one-time negligible cost for the 

placement of a lock or lock box, but that this or any other such costs for practitioners to comply 

with the additional security requirements for tramadol will be negligible.

4.2.2 Costs associated with inventory and record keeping requirements

In accordance with the CSA, every DEA registrant must maintain, on a current basis, a 

complete and accurate record of each controlled substance manufactured, received, sold, 

delivered, or otherwise disposed of. 21 U.S.C. 827(a). These records must be maintained 

separately from all other records of the registrant, or alternatively, in the case of non-narcotic 

controlled substances, be in such a form that required information is readily retrievable from the 

ordinary business records of the registrant. 21 U.S.C. 827(b)(2). The records must be kept and 

be available for at least two years for inspection and copying by officers or employees of the 

Attorney General. 21 U.S.C. 827(b)(3). To fulfill its regulatory responsibilities, the DEA 

assumes for the purpose of this analysis that registrants already maintain detailed records of 

controlled substances transactions.

This scheduling action adds one controlled substance to the existing recordkeeping 

systems of registrants. Because this would be a minor addition to the existing business practices 

of recordkeeping for most registrants, the DEA estimates that there will be no economic impact 
14

beyond the addition and initial inventory of registrants’ tramadol stock pursuant to the inventory 

requirements in 21 CFR 1304.11. The costs associated with inventory and record keeping 

requirements of the proposed rule are estimated below.

Inventory Management System Modification

The DEA estimates that a one-time modification will be required to add tramadol to a 

registrant’s existing controlled substance inventory management system. Varying degrees of 

automation are expected among the affected entities. “Inventory management system” is used 

generically to refer to a mix of automated and manual processes used to manage inventory. For 

some registrants, the one-time modification may be changes to paper forms. For some 

registrants, the one-time modification will require technical personnel to make changes to a 

computerized system. For the purposes of this analysis, the DEA estimates that the cost of the 

one-time change is the same regardless of the registrant’s business activity and regardless of the 

existing inventory management system.

The DEA estimates that in order to add one substance to the existing controlled substance 

inventory management system, the registrant may incur a one-time cost of a computer 

programmer to update the existing inventory management system. The DEA used Bureau of 

Labor Statistics, Occupational Employment and Wages, May 2012, data to determine the median 

wage of a Computer Programmer in the United States is $35.71 per hour.9 The DEA estimates 

that modifying an existing system to accommodate the integration of tramadol into a current 

inventory management system would be accomplished in four hours for a total one-time cost of 

$142.84 for all affected entities.

 

9

Bureau of Labor Statistics, http://www.bls.gov/oes/current/oes_nat.htm.
15

Initial Inventory

Inventory requirements in 21 CFR 1304.11 include an inventory of newly controlled 

substances as well as biennial inventories. Following this scheduling action, registrants will be 

required to take an inventory of all stocks of tramadol on hand. The DEA estimates an initial 

inventory will be conducted by two employees, a bookkeeping clerk and an information clerk, 

and will take one hour to complete. The DEA used Bureau of Labor Statistics, Occupational 

Employment and Wages, May 2012, data for median hourly wage for “Bookkeeping, 

Accounting, and Auditing Clerks” and “Receptionists and Information Clerks” which are $16.91 

and $12.49,10 respectively. The combined hourly rate of $29.40 for a period of one hour is 

$29.40. Therefore, for the purposes of this analysis, the DEA estimates that the cost of the 

required initial inventory will be a one-time cost of $29.40 for all affected entities.

Biennial Inventory

As discussed above, inventory requirements in 21 CFR 1304.11 also include biennial 

inventories. The DEA estimates that the cost of conducting a biennial inventory of tramadol will 

be the same as the initial inventory, $29.40 every two years. 

4.2.3 Costs associated with disposal requirements

The disposal of controlled substances by registrants is generally performed by procuring 

the services of a reverse distributor. The DEA recognizes that placing tramadol into Schedule IV 

of the CSA may increase the volume of material that registrants will need to dispose of through a 

reverse distributor. However, as tramadol is not currently a controlled substance, the DEA does 

not have information on the volume of tramadol currently disposed of, thus cannot determine 

 

10 Bureau of Labor Statistics, http://www.bls.gov/oes/current/oes_nat.htm.
16

what the increase in Schedule IV controlled substance disposal will be or how it will affect the 

fees charged by reversed distributors. Therefore, the DEA is unable to quantify the costs 

associated with the disposal of tramadol. However, since the affected entities are assumed to be 

already disposing controlled substances, the disposal of tramadol will be incorporated into 

existing business processes. The DEA believes that any cost increase, if one exits, will be 

negligible.

4.2.4 Cost Summary

In summary, the DEA anticipates there will be one-time and on-going costs to businesses 

that are affected by the proposed rule.

The DEA estimates that the 306,375 economically affected businesses will incur nonrecurring costs totaling $172.24 and biennially recurring cost of $29.40. Furthermore, 50% of 

distributors, importers, and exporters are estimated to incur an additional non-recurring cost of 

$10,000 for storage requirements. The table below summarizes the non-recurring costs.

Cost Category

Manufacturer, Pharmacy, 

Practitioner, Mid-level 

Practitioner, Hospital, 

Clinic, and 50% of 

Distributor, Importer, and 

Exporter*

50% of 

Distributor, 

Importer, and 

Exporter*

Registration $ - $ -

Storage $ - $ 10,000.00

Inventory and Recordkeeping

System Modification $ 142.84 $ 142.84

Initial Inventory $ 29.40 $ 29.40

Disposal $ - $ -

Total $ 172.24 $ 10, 172.24

* 50% of Distributor/Importer/Exporter are assumed to have enough storage and will not incur additional 

cost of storage.
17

The $29.40 cost of the biennial inventory does not occur until two years after 

implementation of the rule.

4.2.5 Annual Cost Per Business

The annual cost of the proposed rule is determined by determining the net present value

(NPV) of the estimated cash flows over 20 years at 7% and 3% discount rates, then determining 

the equal annual payments for the determined NPV at 7% and 3% interest rates11. For the 

distributors, importers, and exporters that need additional storage space, the DEA estimates the 

present value of cost of the proposed rule to be $10,322.71 and $10,387.71 at 7% and 3% 

discount rates, respectively. Annual cost is estimated to be $974.39 for $10,322.71 total present 

value of cost in equal annual payments at 7% interest rate for 20 years, and $698.22 for 

$10,387.71 total present value of cost in equal annual payments at 3% interest rate for 20 years.

For all other affected businesses and distributors, importers, and exporters that do not 

need additional storage space, the DEA estimates the present value of cost of the proposed rule 

to be $322.71 and $387.71 at 7% and 3% discount rates, respectively. Annual cost is estimated 

to be $30.46 for $322.71 total present value of cost in equal annual payments at 7% interest rate 

for 20 years, and $26.06 for $387.71 total present value of cost in equal annual payments at 3% 

interest rate for 20 years. The table below summarizes the results.

 

11 The use of 7% and 3% discount rates for present value calculation, annual payment calculation, and analysis time 

horizon is based on OMB Circular A-4, September 17, 2003. Also “Regulatory Impact Analysis: A Primer” (no 

date) and “Regulatory Impact Analysis: Frequently Asked Questions (FAQ)” February 7, 2011, Office of 

Information and Regulatory Affairs (OIRA). DEA used a 20 year time horizon for this analysis as there is no 

predetermined end to this rule.
18

* 50% of Distributor/Importer/Exporter are assumed to have enough storage and will not incur additional cost of 

storage.

4.3 ANNUAL ECONOMIC EFFECT ON THE ECONOMY 

The annual economic effect on the economy is the annual cost per business times the 

number of affected businesses. In Section 4.1, DEA estimated that 306,375 businesses, in states 

where tramadol is not controlled, were economically affected by the proposed rule. The annual 

cost of $974.39 is applied to the assumed 50% (588) of 1,175 Distributor/Importer/Exporters 

affected by the proposed rule. Annual cost of $30.46 is applied to remaining businesses affected 

by the proposed rule: 51 Manufacturer, 587 Distributor/Importer/Exporter, 40,797 Pharmacy, 

and 264,352 businesses that employ or hold Individual Practitioner, Mid-level Practitioner, 

and/or Hospital/Clinic registrations. To be conservative in analysis, the higher values for annual 

costs of $974.39 and $30.46 at 7% discount and interest rates is used rather than the annual costs 

of $698.22 and $26.06 at 3% discount and interest rates. The total annual cost is estimated to be 

$9,887,561. Table below details the calculation.

50% of Distributor, Importer, and 

Exporter* Year 0 Year 1 Year 2 Year 3 Year 4 ... Year 19 Year 20

Storage $10,000.00

System Modification $ 142.84 $ - $ - $ - $ - ... $ - $ -

Initial/Biennial Inventory $ 29.40 $ - $ 29.40 $ - $ 29.40 ... $ - $ 29.40

Total $10,172.24 $ - $ 29.40 $ - $ 29.40 ... $ - $ 29.40

Net Present Value (7% discount rate) $10,322.71 Net Present Value (3% discount rate) $10,387.71

Annual Cost (7% interest rate, 20 years) $974.39 Annual Cost (3% interest rate, 20 years) $698.22

All Other & 50% of Distibutor, Importer, 

and Exporter* Year 0 Year 1 Year 2 Year 3 Year 4 ... Year 19 Year 20

System Modification $ 142.84 $ - $ - $ - $ - ... $ - $ -

Initial/Biennial Inventory $ 29.40 $ - $ 29.40 $ - $ 29.40 ... $ - $ 29.40

Total $ 172.24 $ - $ 29.40 $ - $ 29.40 ... $ - $ 29.40

Net Present Value (7% discount rate) $ 322.71 Net Present Value (3% discount rate) $ 387.71

Annual Cost (7% interest rate, 20 years) $ 30.46 Annual Cost (3% interest rate, 20 years) $ 26.06
19

The DEA does not anticipate that this rulemaking will have an annual effect on the 

economy of $100 million or more, or adversely affect in a material way the economy, a sector of 

the economy, productivity, competition, jobs, the environment, public health or safety, or State, 

local, or tribal governments or communities.

4.4 IMPACT ON SMALL ENTITIES

To comply with the RFA, DEA conducted a preliminary analysis to determine whether, if 

promulgated, the rule will have a significant economic impact on a substantial number of small 

entities.

4.4.1 Criteria for “Significant” Economic Impact

When there are no special considerations for “significant economic impact” or criteria 

prescribed by external sources, the DEA uses one of two general criteria, revenue-based or profit 

based. The table below lists the criterion.

Registrant Business Activity

 Number of 

DEA 

Registrations 

Business-toRegistrant 

Ratio

Estimated 

Number of 

Businesses 

Represented by 

DEA Registrants

Number of 

Businesses 

with 

Economic 

Impact

Annual 

Cost Per 

Business

Total Annual 

Cost

Manufacturer 51 1.00 51 51 $ 30.46 $ 1,554

 588 $ 974.39 $ 572,942

 587 $ 30.46 $ 17,881

Pharmacy 55,251 0.74 40,797 40,797 $ 30.46 $ 1,242,723

Practitioner 947,103

Mid-level Practitioner 178,422

Hospital/Clinic 13,576

Total 1,195,578 306,375 306,375 $ 9,887,561

 264,352 $ 30.46 $ 8,052,462

Distributor/Importer/Exporter 1,175 1.00 1,175

 0.23 264,352
20

Revenue-based <1% of annual revenue Not significant economic 

impact

1% to 3% of annual revenue Possible significant economic 

impact

>3% of annual revenue Significant economic impact

Profit-based <5% of annual profit Not significant economic 

impact

5% or more of annual profit Significant economic impact

The revenue-based criteria are widely used, while the profit-based criteria can be used for 

some high-profit industries. For the purposes of this analysis, the revenue-based general criteria 

is used, where if the cost of the rule is greater than 1% of annual revenue, the rule has a 

“significant” economic impact on the business.

4.4.2 Analysis

To estimate the number of businesses “significantly” impacted by the proposed rule, the 

DEA first determined the revenue level associated with the 1% criteria for each North American 

Industry Classification System (NAICS) code associated with the affected entities. Then, using 

the revenue profile from the 2007 Economic Census, estimated the number of businesses where 

the cost of the rule is 1% or more than the revenue. 

For example, NAICS code “621111–Office of physicians (except mental health 

specialists)” would incur an annual cost of $30.46. The revenue level that corresponds to $30.46

as 1% of revenue is $3,046. Using the revenue profile for NAICS code 621111 from the 2007 

Economic Census, determine the number of business with revenue less than $3,046 (see table 

below). The 2007 Economic Census uses the term, “firm” 12 to describe businesses. There are 

 

12 Firm—A firm is a business organization consisting of one or more domestic establishments in the same state and 

industry that were specified under common ownership or control. The firm and the establishment are the same for 

single-establishment firms. For each multi-establishment firm, establishments in the same industry within a state 
21

technical differences in the definition; however, any difference is expected to have no impact on 

the analysis. For the purposes of this analysis, “firm,” “business,” and “entity” are used 

synonymously.

The revenue profile indicates that there are 7,415 firms with revenue less than $100,000. 

Using linear interpolation, the cost of the proposed rule is estimated to be 1% or more for 226

(3.0%) of 7,415 firms with revenue less than $100,000, or (0.1%) of 160,034 total firms operated 

for the entire year. Use of linear interpolation, implicitly assumes that the 7,415 firms with 

revenue less than $100,000 are evenly distributed across $0 to $100,000 revenue range. One 

may argue that it is likely that there are more firms in the upper ranges of annual revenue, such 

as $90,000 to $100,000, than at a lower range, such as $0 to $10,000. Additionally, one can 

argue that there are no economically viable firms with annual revenue below $3,046, suggesting 

that only the 50% of Distributor/Importer/Exporter that need additional storage be examined for 

significant economic impact. Although there is merit to these arguments, the DEA used linear 

 

will be counted as one firm- the firm employment and annual payroll are summed from the associated 

establishments. http://www.census.gov/econ/susb/definitions.html.

2007 

NAICS 

code 2007 NAICS code description Revenue size of firms operated entire year

Number 

of firms

621111 Offices of physicians (except mental health specialists) Firms operated for the entire year 160,034

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue less than $100,000 7,415

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 19,674

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 38,179

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 41,770

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 31,857

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 11,486

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 5,527

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 2,850

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 768

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 299

621111 Offices of physicians (except mental health specialists) Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 209
22

interpolation to be conservative and to account for possibility that some firms may not be 

operating full year and have annual revenue in the low range of $0 to $100,000.

This methodology was applied to all NAICS codes, except manufacturers. The estimate 

of zero small business manufacturers with significant economic impact is based on publically 

available data13 for annual sales data. The analysis combined the NAICS codes for each 

Registrant Business Activity to determine the percentage of small businesses with revenue below 

the 1% threshold. The percentages were applied to the number of small businesses located in 

states where tramadol is controlled as schedule IV under state law. DEA estimates that the 

proposed rule would have a significant economic impact on 573 small businesses: 0 

manufacturers, 47 distributors/importers/exporters, 74 pharmacies, and 452 small 

practitioners/mid-level practitioners/hospitals/clinic (“Other”). See “Appendix 2: Number of 

Businesses Whose Cost Is 1% or More of Revenue” for the detailed analysis. The table below 

summarizes the estimated number of affected small businesses with significant economic impact.

States where tramadol is not controlled as a Schedule IV controlled substance under state law

 

13 Lexis-Nexis, Dun & Bradstreet, Hoover’s, infogroup, W/D Partners Worldscope, http://www.manta.com. 

Relevant annual revenue data was not found for 16 of 55 small business manufactures. All 16 are estimated to be 

not significantly impacted based on threshold of $3,046 annual revenue, revenue at which cost of $30.46 is 1% of 

annual revenue. None of the businesses where relevant data was available were below this threshold.

Registrant Business Activity

 Number of 

DEA 

Registrations 

Business-toRegistrant 

Ratio

Estimated 

Number of 

Businesses 

Represented by 

DEA Registrants

 % of Business 

Below SBA 

Size Standard 

Number of 

Businesses 

Below SBA Size 

Standard

 Percentage 

of Small 

Businesses 

with Revenue 

Below 

Threshold 

 Number of 

Affected Small 

Businesses with 

Significant 

Economic 

Impact 

Manufacturer 51 1.00 51 84.3% 43 0.0% -

Distributor/Importer/Exporter 1,175 1.00 1,175 96.7% 1,137 4.2% 47

Pharmacy 55,251 0.74 40,797 98.6% 40,215 0.2% 74

Practitioner 947,103

Mid-level Practitioner 178,422

Hospital/Clinic 13,576

Total 1,195,578 306,375 97.4% 298,354 0.2% 573

 0.23 264,352 97.2% 256,959 0.2% 452
23

In Section 4.1.2, the DEA estimated 376,904 businesses would be affected by the 

proposed rule, and 367,046 of these businesses are estimated to be small businesses, including 

businesses located in states where tramadol is controlled as Schedule IV under state law. 

Therefore, 573 or 0.2% of 367,046 small businesses affected by the proposed rule are estimated 

to be significantly impacted economically. The table below summarizes the percentage of small 

businesses significantly impacted by the proposed rule for all states.

All states, tramadol controlled and not controlled under state law

The DEA examined the disproportionality of the economic impact. The DEA did not 

have a basis for differentiating costs for different business sizes, thus one cost estimate was made 

for each of the registrant business activity. This estimate suggests disproportionality, where 

smaller (of the small) businesses will bear a larger economic impact as a percentage of revenue. 

However, the DEA believes the disproportionality will be mitigated by business volume. A 

smaller business will handle a lower volume of tramadol, thus require less secure storage.

4.4.3 Criteria for “Substantial Number”

When there are no special considerations for “substantial number” or criteria prescribed 

by external sources, the DEA uses a general criteria based on percentage. See table below.

Registrant Business Activity

 Number of 

DEA 

Registrations 

Business-toRegistrant 

Ratio

Estimated 

Number of 

Businesses 

Represented by 

DEA Registrants

 % of Business 

Below SBA 

Size Standard 

Number of 

Businesses 

Below SBA Size 

Standard

 Number of 

Affected 

Small 

Businesses 

with 

Significant 

Economic 

Impact 

 % of Small 

Businesses 

Significantly 

Impacted 

Manufacturer 63 1.00 63 87.3% 55 - 0.0%

Distributor/Importer/Exporter 1,466 1.00 1,466 96.7% 1,418 47 3.3%

Pharmacy 68,738 0.74 50,756 98.6% 50,032 74 0.1%

Practitioner 1,156,285

Mid-level Practitioner 226,687

Hospital/Clinic 15,824

Total 1,469,063 376,904 97.4% 367,046 573 0.2%

0.1%

 0.23 324,619 97.2% 315,541 452
24

<10% of small businesses Not substantial number

10% to 30% of small 

businesses

Possible substantial number

>30% of small businesses Substantial number

For the purposes of this analysis, a “substantial number” is defined as greater than 30%.

As estimated in Section 4.4.2, 573 or 0.2% of 367,046 affected small businesses would 

experience significant economic impact if the proposed rule were finalized, far below the 30% 

criteria for all registrant categories.

The DEA estimates that a higher percentage (3.3%) of small businesses in the 

distributor/importer/exporter category will experience a significant economic impact than the 

overall percentage (0.2%) of all small businesses affected by the proposed rule. However, the 

3.3% is less than the 30% criteria, and is not a substantial number, and the overall 0.2% is far 

below the 30% criteria. Additionally, the number of distributors/importers/exporters with 

significant economic impact is sensitive to the assumption that 50% will incur the $10,000 in 

storage cost. If fewer businesses need to incur the cost or less cost of storage, the percentage of 

distributors/importers/exporters that would experience significant economic impact would 

decrease. Furthermore, as stated in Section 4.2, the DEA does not have a basis for differentiating 

costs for different distributor/importer/exporter businesses, thus one cost estimate was made for 

this category. However, the DEA believes a smaller business will handle a lower volume of 

tramadol, requiring less space, thus mitigating the economic impact of the proposed rule.
25

4.5 EXAMINATION OF INDUSTRY SEGMENTS WITH SIGNIFICANT ECONOMIC 

IMPACTS

No industry segment is estimated to experience significant economic impact. The 

number of small businesses that are estimated to experience significant economic impact is less 

than the criteria for a “substantial number.”
26

CHAPTER 5: COST-BENEFIT ANALYSIS OF REGULATORY ACTION

5.1 COSTS OF THE REGULATORY ACTION

As discussed in Section 4.3, the DEA estimates this rule will cost $9,887,561 annually. 

5.2 BENEFITS OF THE REGULATORY ACTION (COST OF INACTION)

The citizens and residents of the United States bear an enormous cost from the diversion 

of tramadol from legitimate drug channels, not only monetarily but also in public health and 

safety. 

5.2.1 Tramadol Diversion

According to Drug Abuse Warning Network (DAWN) data, the estimated number of 

emergency department (ED) visits due to non-medical use of tramadol significantly increased 

from 4,849 in 2004 to 16,251 in 2010; and according to National Poison Data System (NPDS), 

the number of case mentions of human toxic exposures to tramadol during 2004 through 2008 

increased annually from 3,769 to 9,623. Additionally, according to NPDS, the number of 

reported tramadol poison exposures totaled 10,255, 11,225 and 12,424, data in 2009, 2010 and 

2011, respectively. Of these totals, intentional exposures to tramadol alone were 2,677, 2,867 

and 3,170 resulting in 4, 3 and 6 deaths in 2009, 2010 and 2011, respectively. 

5.2.2 Monetary Costs of Tramadol Diversion/Abuse

The placement of tramadol into Schedule IV of the CSA is expected to contribute to the 

decrease in diversion and abuse of tramadol, as discussed in the published NPRM. Because of 

the many unknowns, the DEA is unable to quantify the reduction in monetary cost of tramadol 

diversion and the monetary benefit of this rule.
27

5.3 EVALUATION OF THE COSTS AND BENEFITS OF THE PROPOSED RULE

In evaluating the costs and benefits of the rule, the annual cost of the rule is compared 

with the anticipated reduction, from baseline—without the rule, in costs associated with 

diversion and abuse of tramadol. 

It is preferable to conduct a discounted cash flow analysis where the costs and benefits 

are quantified and the net benefits are calculated and presented in present dollar value. However, 

with the many unknowns, the DEA is unable to quantify the benefits. Therefore, a quantitative 

analysis is not possible and a preliminary analysis is utilized.

The preliminary analysis considers whether the benefits of the rule are greater than or 

equal to the cost of the rule.

As discussed above, the estimated annual cost of the rule is $9,887,561, or $9.9 million.

The benefits of the rule are represented as the difference between the costs associated 

with diversion and abuse of tramadol at the baseline and the costs associated with the diversion 

and abuse of tramadol under the rule.
28

The DEA has determined this rule will have an annual economic cost of $9.9 million. 

The DEA believes the placement of tramadol into Schedule IV will reduce the cost associated 

with the diversion of tramadol by more than $9.9 million annually. Therefore, this rule will have 

a positive economic benefit and benefit for the health and safety of the citizens and residents of 

the United States.
29

CHAPTER 6: ECONOMIC ANALYSIS RESULTS

6.1 EXECUTIVE ORDERS 12866 AND 13563

The estimated annual impact of this rule is $9,887,561; thus, this rule will not have an 

annual effect on the economy of $100 million or more and is therefore not economically 

significant.

6.2 REGULATORY FLEXIBILITY ACT

In accordance with the RFA, the DEA evaluated the impact of this proposed rule on small 

entities. Specifically, the DEA examined the registration, storage, inventory and recordkeeping, 

and disposal requirements for the 367,046 small businesses estimated to be affected by the 

proposed rule, 55 manufacturers, 1,418 distributors/importers/exporters, 50,032 pharmacies, and 

315,541 individual practitioners/mid-level practitioners/hospitals/clinics.

14

 All legally operating 

businesses that currently handle tramadol are assumed to be DEA registrants. Based on the 

DEA’s understanding of its registrants’ operations and facilities, the DEA estimates a nonrecurring expense for system modification and initial inventory of $172.24 for all businesses and 

an additional $10,000 for secure storage for 50% of distributors, importers, and exporters. 

Manufacturers, pharmacies, physician offices/hospitals/clinics/other health care facilities, and 

50% of distributors, importers, and exporters are assumed to meet the requirements of the 

proposed rule without the need to expand secure storage area. The DEA estimates these costs 

will have significant economic impact on 0 of 55 (0%) of small business manufacturers; 47 of 

1,418 (3.3%) of small business distributors; 74 of 50,032 (0.1%) small business pharmacies; and 

 

14 The individual practitioner and mid-level practitioners primarily work in various physician and health care 

specialist offices as well as hospitals and clinics. The numbers represent the estimated number of businesses for 

which the registrants work.
30

452 of 315,541 (0.1%) of individual practitioners/mid-level practitioners/hospitals/clinics, 

totaling 573 of 367,046 (0.1%) of all small businesses if the proposed rule were finalized. The 

percentage of small businesses with significant economic impact is below the 30% threshold for 

all registrant categories. The DEA’s assessment of economic impact by size category indicates

that the proposed rule will not have a significant effect on a substantial number of these small 

business entities.

6.3 UNFUNDED MANDATES REFORM ACT OF 1995

The estimated annual impact of this rule is $9,887,561; thus will not have an annual 

effect on the economy of $100 million or more.

6.4 CONGRESSIONAL REVIEW ACT OF 1995

The estimated annual impact of this rule is $9,887,561; thus, the rule will not have an 

annual effect on the economy of $100 million or more.
31

CHAPTER 7: DISCLOSURE OF ASSUMPTIONS

The DEA’s key assumptions for this analysis are listed below:

 Section 4.1.1: [Number of Tramadol Handlers] For the purposes of this analysis the DEA 

assumes all legally operating manufacturers, distributors, importers/exporters, pharmacies, 

individual practitioners, and mid-level practitioners that handle tramadol are registered with 

the DEA and all distributors, importers/exporters, pharmacies, individual practitioners, midlevel practitioners, and hospitals/clinics registered with the DEA are tramadol handlers.

 Section 4.1.2: [Number of Small Entities Handling Tramadol] The DEA assumes any small 

organization or small governmental jurisdiction affected by the proposed rule is included in 

Appendix 1 to estimate the number of businesses, as represented by DEA registrations, and 

the number of businesses considered small. Therefore, the term “entity” and “businesses” 

are used synonymously.

 Chapter 4.2: [Annual Cost of the Rule] The DEA assumes that any entity currently handling 

tramadol also handles Schedule IV controlled substances in the normal course of business,

thus is a DEA registrant. Since no entity will be required to apply for a DEA registration, the 

DEA estimates there will be no registration costs as a result of the proposed scheduling 

action.

 Section 4.2.1: [Cost of Storage Requirements] 

o Manufacturer: The DEA assumes any costs associated with such modifications, if 

needed, are negligible.

o Distributor/Importer/Exporter
32

 The DEA assumes distributors, importers, and exporters of tramadol are 

current DEA registrants with existing controlled substance storage that 

complies with DEA regulations.

 The DEA estimates that 50% of distributors, importers, and exporters have 

existing controlled substance storage areas to store tramadol at negligible cost. 

 The DEA assumes the cost of additional secure storage space is the same for 

all distributors, importers, and exporters.

o Hospital/Clinic: The DEA assumes all hospitals and clinics which hold a DEA 

registration already maintain an inventory of Schedule IV controlled substances and 

have existing controls against diversion that meet regulatory requirements. If the 

inventory of tramadol is not already stored in an appropriately secured area at these 

locations, the DEA believes transferring the tramadol inventory to a secure storage 

area may be accomplished at negligible cost.

o Pharmacy: The DEA assumes all registered pharmacies currently handle Schedule IV 

controlled substances and maintain secure storage areas for Schedule IV controlled 

substances. The DEA believes that costs for pharmacies to comply with the security 

requirements for tramadol will be negligible.

o Individual Practitioner/Mid-level Practitioner: The DEA assumes all registered 

practitioners currently handle Schedule IV controlled substances and maintain secure 

storage areas for Schedule IV controlled substances at a registered location, such as a 

physician’s office or other health care facilities. Because practitioners are estimated 

to maintain smaller quantities of tramadol, the DEA believes such inventory of 

tramadol may be secured at the current location within regulatory requirements at 
33

negligible cost. The DEA believes that a registrant may need to pay a one-time 

negligible cost for the placement of a lock or lock box, but that this or any other such 

costs for practitioners to comply with the additional security requirements for 

tramadol will be negligible.

 Section 4.2.3: [Costs Associated with Disposal Requirements] As the affected entities are 

assumed to be already disposing controlled substances, the disposal of tramadol will be 

incorporated into existing business processes. The DEA believes that any cost increase, if 

one exits, will be negligible. 

 Section 5.3: [Evaluation of Costs and Benefit] The DEA believes this rule reduces, below 

baseline, the cost of tramadol diversion from legitimate drug channels by more than $9.5 

million annually.
34

APPENDIX 1: REGISTRANT LANDSCAPE

SUMMARY

The results of the analysis are summarized in the table below and detailed in the following 

sections. The number of registrations were used in conjunction with 2007 Economic Census 

data to estimate the number of businesses represented by DEA registrations. For manufacturers, 

distributors, importers, and exporters, where the majority companies under the NAICS code are 

not DEA registrants, a one-to-one relationship was assumed between the number of businesses 

and the number of registrations. For pharmacies and ‘Other’ registrants, where businesses are 

likely to employ multiple registrants, the number of business reported under the NAICS code in 

the Economic Censes is used to represent the number of businesses represented by DEA 

registrants. Comparing economic data contained in the Economic Census with Small Business 

Administration (SBA) size standards for each NAICS category, the number of small businesses 

is estimated. The DEA estimates that the vast majority of DEA registrants are, or are employed 

by, small businesses.

Registrant Business 

Activity

Number of 

Registrations

Estimated 

Number of 

Businesses 

Represented 

by DEA 

Registrants

Business-toRegistrant 

Ratio

Number of 

Businesses 

Below SBA 

Size Standard

 % Small 

Business 

Manufacturer 544 544 1.00 533 97.9%

Distributor/Importer/Exporter 1,481 1,481 1.00 1,433 96.7%

Pharmacy 69,404 51,248 0.74 50,517 98.6%

Other 1,414,596 328,286 0.23 319,105 97.2%

Total 1,486,025 381,559 371,588 97.4%
35

DEA REGISTRANT POPULATION BY BUSINESS ACTIVITY

As of June 2013, there were 1,486,025 controlled substances registrants as shown in 

Table 1.

Table 1: Number of Registrants by Business Activity

Registrant Business Activity Controlled Substances

Pharmacy 69,404 

Hospital/Clinic 15,899 

Individual Practitioner 1,156,879 

Teaching Institution 318 

Mid-Level Practitioner 228,926 

Researcher/Canine Handler 9,739 

Analytical Lab 1,518 

Narcotic Treatment Program 1,317 

Distributor 954 

Reverse Distributor 60 

Importer 223 

Exporter 244 

Manufacturer 544 

Total 1,486,025 

*Data as of June 2013. The number of DEA registrations changes daily and the number of 

DEA registrations at time of the analysis can vary slightly from the number of DEA

registrations contained in this table. However, the base analysis contained in this section is 

updated at least annually and any difference in the number of DEA registrations between 

the time of the analysis and the number of DEA registrations contained in this table has 

minimal impact on the overall results.

CORRESPONDING NUMBER OF BUSINESSES

Most DEA registrants are small entities or employed by small entities as defined by the 

RFA. The RFA defines a “small entity” as a “small business” (5 U.S.C. 601(3)), a “small 

organization” (5 U.S.C. 601(4)), or a “small governmental jurisdiction” (5 U.S.C. 601(5)). 

Pursuant to the RFA, the term “small business” has the same meaning as the term “small 

business concern” under section 3 of the Small Business Act (SBA). The SBA designates a 
36

“small-business concern,” as one which is independently owned and operated and is not 

dominant in its field of operation. 15 U.S.C. 632(a)(1). Furthermore, the SBA defines whether a 

business entity is small by size standards. These size standards have been established for the 

types of economic activity or industry under the North American Industry Classification System 

(NAICS). SBA sets the maximum size standard—in millions of dollars or number of 

employees—allowed for concerns and their affiliates to be designated small.

The RFA requirements and SBA size standards apply to entities and businesses, not to 

individual DEA registrations, and much of the cost impact of most proposed rules is at the 

business level, not at the individual registration level. Therefore, the DEA has associated the 

number of registrants to a corresponding number of businesses. The DEA registrations are held 

by businesses such as manufacturers, distributors, and pharmacies as well as individuals such as 

individual practitioners and mid-level practitioners. Additionally, many businesses hold more 

than one registration in situations where a single business has more than one location or more 

than one business activity. Therefore, the DEA related the 1.5 million DEA registrants to the 

number of businesses, as described below. 

First, since the SBA size standards are organized by NAICS codes, the 1.5 million affected

registrants are organized by NAICS codes. Because the DEA does not collect NAICS code 

information from its registrants, the DEA reviewed all NAICS codes15 and developed a table that 

relates various registrant groups to NAICS codes based on the DEA’s estimate. Table 2 lists the 

DEA registrant groupings with NAICS titles and codes.

 

15 http://www.census.gov/eos/www/naics/.
37

Table 2: DEA Registrants and Estimated NAICS Codes

Second, using 2007 Economic Census data, the DEA determined the number of businesses for 

each NAICS code. See Table 3.

Registrant Categories and NAICS Code 

Titles

Number of 

DEA 

Registrations

NAICS Codes 

Represented 

by DEA 

Registrants

Manufacturers 544 

Petrochemical Manufacturing 325110

Medicinal and Botanical Manufacturing 325411

Pharmaceutical Preparation Manufacturing 325412

Adhesive Manufacturing 325520

Toilet Preparation Manufacturing 325620

All Other Miscellaneous Chemical Product 

and Preparation Manufacturing

325998

Manufacturer Summary

Distributors/Importer/Exporter 1,481 

Drugs and Druggists’ Sundries Merchant 

Wholesalers

424210

General Line Grocery Merchant 

Wholesalers

424410

Confectionery Merchant Wholesalers 424450

Other Chemical and Allied Products 

Merchant Wholesalers

424690

Tobacco and Tobacco Product Merchant 

Wholesalers

424940

Other Miscellaneous Nondurable Goods 

Merchant Wholesalers

424990

Packaging and Labeling Services 561910

Distributors/Importers/Exporters 

Summary

Pharmacies 69,404

Supermarkets and Other Grocery (except 

Convenience) Stores 445110

Pharmacies and Drug Stores 446110

Discount Department Stores 452112

Warehouse Clubs and Superstores 452910

Pharmacies Summary

Others 1,414,596 

Colleges, Universities and Professional 

Schools

611310

Offices of Physicians (except Mental Health 

Specialists) 621111

Offices of Physicians, Mental Health 

Specialists

621112

Offices of Dentists 621210

Offices of Optometrists 621320

Offices of Podiatrists 621391

Offices of All Other Miscellaneous Health 

Practitioners

621399

Outpatient Mental Health and Substance 

Abuse Centers

621420

HMO Medical Centers 621491

General Medical and Surgical Hospitals 622110

Psychiatric and Substance Abuse Hospitals 622210

Specialty (except Psychiatric and Substance 

Abuse) Hospitals 622310

Testing Laboratories 541380

Others Summary

Total Controlled Substance Registrants 1,486,025 
38

Table 3: Number of Businesses by NAICS Codes

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

* Manufacturer data is in number of establishments while all other sectors are in number of firms. A firm 

may have more than one establishment. Based on sectors with both firm and establishment data, the 

number of establishments are similar to the number of firms. The term “firm” used in the source data is 

used synonymously with “business” for the purposes of this analysis.

Registrant Categories and NAICS Code 

Titles

Number of 

DEA 

Registrations

NAICS Codes 

Represented 

by DEA 

Registrants

Total 

Number of 

Businesses 

by NAICS 

Code* 

Manufacturers 544 

Petrochemical Manufacturing 325110 56

Medicinal and Botanical Manufacturing 325411 410

Pharmaceutical Preparation Manufacturing 325412 991

Adhesive Manufacturing 325520 600

Toilet Preparation Manufacturing 325620 854

All Other Miscellaneous Chemical Product 

and Preparation Manufacturing

325998

 1,261

Manufacturer Summary 4,172

Distributors/Importer/Exporter 1,481 

Drugs and Druggists’ Sundries Merchant 

Wholesalers

424210

 5,430

General Line Grocery Merchant 

Wholesalers

424410

 1,842

Confectionery Merchant Wholesalers 424450 1,544

Other Chemical and Allied Products 

Merchant Wholesalers

424690

 5,948

Tobacco and Tobacco Product Merchant 

Wholesalers

424940

 1,053

Other Miscellaneous Nondurable Goods 

Merchant Wholesalers

424990

 10,043

Packaging and Labeling Services 561910 1,541

Distributors/Importers/Exporters 

Summary 27,401

Pharmacies 69,404

Supermarkets and Other Grocery (except 

Convenience) Stores 445110 34,009

Pharmacies and Drug Stores 446110 17,217

Discount Department Stores 452112 11

Warehouse Clubs and Superstores 452910 11

Pharmacies Summary 51,248

Others 1,414,596 

Colleges, Universities and Professional 

Schools

611310

 2,149

Offices of Physicians (except Mental Health 

Specialists) 621111 160,034

Offices of Physicians, Mental Health 

Specialists

621112

 9,075

Offices of Dentists 621210 111,013

Offices of Optometrists 621320 16,659

Offices of Podiatrists 621391 7,566

Offices of All Other Miscellaneous Health 

Practitioners

621399

 9,094

Outpatient Mental Health and Substance 

Abuse Centers

621420

 4,113

HMO Medical Centers 621491 30

General Medical and Surgical Hospitals 622110 3,051

Psychiatric and Substance Abuse Hospitals 622210 423

Specialty (except Psychiatric and Substance 

Abuse) Hospitals 622310 352

Testing Laboratories 541380 4,727

Others Summary 328,286

Total Controlled Substance Registrants 1,486,025 

Category 1 Category 2
39

There are many more businesses for the Manufacturers and 

Distributors/Importers/Exporter NAICS codes than the number of DEA registrants that fall 

within these NAICS codes. There are 544 and 1,481 Manufacturer and 

Distributor/Importer/Exporter registrants, respectively, while the numbers of businesses for these 

NAICS codes are 4,172 and 27,401, respectively. Meanwhile, the number of businesses for 

Pharmacies and Other (remaining) NAICS codes are far fewer than the number of DEA 

registrants that fall within these business activities. There are 69,404 and 1,414,596 Pharmacies 

and Other registrants, respectively, while the numbers of establishments for the corresponding 

NAICS codes are only 51,248 and 328,286, respectively. Therefore, the DEA broadly classified 

registrants in two categories: 1) Category 1: registrants in industries where very few businesses 

in the industry are registrants; 2) Category 2: registrants in industries where most businesses in 

the industry are registrants. 

Only a small fraction of Manufacturers, Distributors, and Importers/Exporters are DEA 

registrants—2,025 of 31,573, while nearly all Pharmacies, Hospitals/Clinics, Offices of Doctors, 

etc., are registrants, employ registrants, or may represent multiple registrations, such as several 

Physicians and/or Mid-level practitioners working in the same office or hospital. Therefore, 

while recognizing that DEA registrants with Manufacturer, Distributor, or Importer/Exporter 

registrations can also have more than one registration, the DEA estimates a one-to-one ratio and 

that 544 Manufacturer and 1,481 Distributor, Importer/Exporter registrations roughly equate to 

544 and 1,481 businesses, respectively, for registrants in Category 1. 

For registrants in the Category 2, Pharmacies, Hospitals/Clinics, Offices of Doctors, etc., 

nearly all businesses counted by the NAICS codes are expected to be or to hire DEA registrants. 

Therefore, the number of businesses in these NAICS codes is used as an estimate for the number 
40

of businesses that are in the Pharmacies and Other registrant categories. The DEA estimates that 

69,404 ‘Pharmacy’ and 1,414,596 remaining ‘Other’ registrations roughly equate to 379,534 

Category 2 businesses. In total, the DEA estimates that the nearly 1.5 million DEA registrants 

represent 381,559 businesses. See Table 4. The DEA recognizes that this estimate is not 

precise, but instead provides understanding of orders of magnitude.
41

Table 4: Number of Businesses Represented by DEA Controlled Substances 

Registrants

Registrant Categories and NAICS Code 

Titles

Number of 

DEA 

Registrations

NAICS Codes 

Represented 

by DEA 

Registrants

Total 

Number of 

Businesses 

by NAICS 

Code* 

Estimated 

Number of 

Businesses 

Represented 

by DEA 

Registrants

Manufacturers 544 544

Petrochemical Manufacturing 325110 56

Medicinal and Botanical Manufacturing 325411 410

Pharmaceutical Preparation Manufacturing 325412 991

Adhesive Manufacturing 325520 600

Toilet Preparation Manufacturing 325620 854

All Other Miscellaneous Chemical Product 

and Preparation Manufacturing

325998

 1,261

Manufacturer Summary 4,172

Distributors/Importer/Exporter 1,481 1,481

Drugs and Druggists’ Sundries Merchant 

Wholesalers

424210

 5,430

General Line Grocery Merchant 

Wholesalers

424410

 1,842

Confectionery Merchant Wholesalers 424450 1,544

Other Chemical and Allied Products 

Merchant Wholesalers

424690

 5,948

Tobacco and Tobacco Product Merchant 

Wholesalers

424940

 1,053

Other Miscellaneous Nondurable Goods 

Merchant Wholesalers

424990

 10,043

Packaging and Labeling Services 561910 1,541

Distributors/Importers/Exporters 

Summary 27,401

Pharmacies 69,404 51,248

Supermarkets and Other Grocery (except 

Convenience) Stores 445110 34,009

Pharmacies and Drug Stores 446110 17,217

Discount Department Stores 452112 11

Warehouse Clubs and Superstores 452910 11

Pharmacies Summary 51,248

Others 1,414,596 328,286

Colleges, Universities and Professional 

Schools

611310

 2,149

Offices of Physicians (except Mental Health 

Specialists) 621111 160,034

Offices of Physicians, Mental Health 

Specialists

621112

 9,075

Offices of Dentists 621210 111,013

Offices of Optometrists 621320 16,659

Offices of Podiatrists 621391 7,566

Offices of All Other Miscellaneous Health 

Practitioners

621399

 9,094

Outpatient Mental Health and Substance 

Abuse Centers

621420

 4,113

HMO Medical Centers 621491 30

General Medical and Surgical Hospitals 622110 3,051

Psychiatric and Substance Abuse Hospitals 622210 423

Specialty (except Psychiatric and Substance 

Abuse) Hospitals 622310 352

Testing Laboratories 541380 4,727

Others Summary 328,286

Total Controlled Substance Registrants 1,486,025 381,559 

Category 1 Category 2
42

NUMBER OF AFFECTED BUSINESSES THAT ARE SMALL BUSINESSES

After estimating that 1.5 million DEA registrants represent 381,559 businesses, the DEA 

then determined how many of the estimated 381,559 businesses represented by DEA registrants 

are small businesses based on the SBA size standard. Because the DEA does not collect data on 

company size of its registrants, it used 2007 Economic Census data to make this determination. 

The Economic Census provides the number of businesses by annual revenue ranges as well as 

the number of businesses by number of employee ranges by NAICS codes. This data was 

compared to the SBA size standard for each NAICS code to determine the number of businesses 

that are small businesses for each NAICS code. See Table 5. 

The DEA determined that 97.9% of Manufacturers and 96.7% of 

Distributors/Importers/Exporters by NAICSs are small businesses. These percentages were 

applied to the total affected businesses (544 Manufacturers and 1,481 Distributors), resulting in 

number of businesses (533 Manufacturers and 1,433 Distributors) estimated to be small 

businesses. The estimate for Category 2 registrants/businesses that are small businesses is 

derived directly from the 2007 Economic Census. 98.6% (50,517 of 51,248) of pharmacies and 

97.2% (319,105 of 328,286) of other businesses are estimated to be small businesses. 

Combining the results of Manufacturers, Distributors/Importers/Exporters, Pharmacies, and 

Others, DEA estimates 371,588 of the 381,559 (97.4%) businesses that represent the registrant 

population are considered “small entities” in accordance with the RFA and SBA standards, 5 

U.S.C. 601(6) and 15 U.S.C. 632. Again, the DEA recognizes that its estimate is not precise, but 

instead provides understanding of orders of magnitude, so that the DEA can assess whether or 

not the number of significantly impacted businesses constitute a substantial number of small 

businesses.
43

Table 5: Number of Affected Businesses that Are Small Businesses

Source: 2007 Economic Census, http://www.census.gov/econ/census07; and 13 CFR 121.201.

Registrant Categories and NAICS Code 

Titles

Number of 

DEA 

Registrations

NAICS Codes 

Represented 

by DEA 

Registrants

Total 

Number of 

Businesses 

by NAICS 

Code* 

Estimated 

Number of 

Businesses 

Represented 

by DEA 

Registrants

SBA Size 

Standards: 

Number of 

Employees or 

Millions of 

Dollars**

Number of 

Businesses 

Below SBA 

Size 

Standard

% of 

Businesses 

Below SBA 

Size 

Standard Note

Manufacturers 544 544 533

Petrochemical Manufacturing 325110 56 1,000 56

Medicinal and Botanical Manufacturing 325411 410 750 406 ***

Pharmaceutical Preparation Manufacturing 325412 991 750 943 ***

Adhesive Manufacturing 325520 600 500 600

Toilet Preparation Manufacturing 325620 854 500 828

All Other Miscellaneous Chemical Product 

and Preparation Manufacturing

325998

 1,261

500 

 1,253

Manufacturer Summary 4,172 4,086 97.9%

Distributors/Importer/Exporter 1,481 1,481 1,433

Drugs and Druggists’ Sundries Merchant 

Wholesalers

424210

 5,430

100 

 5,155

General Line Grocery Merchant 

Wholesalers

424410

 1,842

100 

 1,739

Confectionery Merchant Wholesalers 424450 1,544 100 1,506

Other Chemical and Allied Products 

Merchant Wholesalers

424690

 5,948

100 

 5,824

Tobacco and Tobacco Product Merchant 

Wholesalers

424940

 1,053

100 

 978

Other Miscellaneous Nondurable Goods 

Merchant Wholesalers

424990

 10,043

100 

 9,926

Packaging and Labeling Services 561910 1,541 $7.0 1,381 ***

Distributors/Importers/Exporters 

Summary 27,401 26,509 96.7%

Pharmacies 69,404 51,248 50,517

Supermarkets and Other Grocery (except 

Convenience) Stores 445110 34,009

$30.0 

 33,444 ***

Pharmacies and Drug Stores 446110 17,217 $25.5 17,069 ***

Discount Department Stores 452112 11 $27.0 3 ***

Warehouse Clubs and Superstores 452910 11 $27.0 1 ***

Pharmacies Summary 51,248 50,517 98.6%

Others 1,414,596 328,286 319,105

Colleges, Universities and Professional 

Schools

611310

 2,149

$7.0 Not 

Available 

Offices of Physicians (except Mental Health 

Specialists) 621111 160,034

$10.0 

 155,908

Offices of Physicians, Mental Health 

Specialists

621112

 9,075

$10.0 

 9,056

Offices of Dentists 621210 111,013 $7.0 110,634 ***

Offices of Optometrists 621320 16,659 $7.0 16,611 ***

Offices of Podiatrists 621391 7,566 $7.0 7,556 ***

Offices of All Other Miscellaneous Health 

Practitioners

621399

 9,094

$7.0 

 9,070 ***

Outpatient Mental Health and Substance 

Abuse Centers

621420

 4,113

$10.0 

 3,826

HMO Medical Centers 621491 30 $10.0 17

General Medical and Surgical Hospitals 622110 3,051 $34.5 1,285 ***

Psychiatric and Substance Abuse Hospitals 622210 423 $34.5 334 ***

Specialty (except Psychiatric and Substance 

Abuse) Hospitals 622310 352

$34.5 

 200 ***

Testing Laboratories 541380 4,727 $12.0 4,608 ***

Others Summary 328,286 319,105 97.2%

Total Controlled Substance Registrants 1,486,025 381,559 371,588 Category 1 Category 2
44

* Manufacturer data is in number of establishments while all other sectors are in number of firms. A firm 

may have more than one establishment. The term “firm” used in the source data is used synonymously 

with “business” for the purposes of this analysis. 

** SBA size standards for Manufacturers and Distributor/Reverse Distributors are by number of 

employees, while size standard for Pharmacies Other, and Other-Practitioner/Hospital/Clinic are by dollar 

amount of annual revenue.

*** Number of establishments/firms data by number of employees/annual revenue is available in specific 

increments. When the SBA size standard/threshold is in between increments, half of the number in the 

increment was used to estimate the number below the threshold. For example, number of Offices of 

Dentists was available for various increments $4,999,999 and below is 110,410 and increment $5,000,000-

$9,999,999 is 448. Because the size standard is $7M, half of 448 (224) was estimated for $5,000,000-

$7,000,000 resulting in total of 110,634.
45

APPENDIX 2: NUMBER OF BUSINESSES WHOSE COST OF 

PROPOSED RULE IS 1% OR MORE OF REVENUE

To estimate the number of businesses “significantly” impacted by the proposed rule, the 

DEA first determined the revenue level associated with the 1% criteria for each NAICS code 

associated with the affected entities. Then, using the revenue profile from the 2007 Economic 

Census, estimated the number of businesses where the cost of the rule is 1% or more than the 

revenue. See table below for the number of firms with revenue below the 1% threshold, whose 

cost would be 1% or more of revenue. Revenue profile for manufacturers is unavailable.

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

424210

Drugs and druggists' 

sundries merchant 

wholesalers All firms 6,261 3,131 $ 97,439

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated for the entire 

year 5,430 2,715 $ 97,439 2,715

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 909 455 $ 97,439 177

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 626 313 $ 97,439

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 744 372 $ 97,439

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 1,059 530 $ 97,439

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 651 326 $ 97,439

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 505 253 $ 97,439

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 425 213 $ 97,439

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 193 97 $ 97,439

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 114 57 $ 97,439

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 204 102 $ 97,439

424210 Drugs and druggists' Firms not operated for the 831 416 $ 97,439
46

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

sundries merchant 

wholesalers

entire year

424410

General line grocery 

merchant 

wholesalers All firms 2,208 1,104 $ 97,439

424410

General line grocery 

merchant 

wholesalers

Firms operated for the entire 

year 1,842 921 $ 97,439 921

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 195 98 $ 97,439 38

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 187 94 $ 97,439

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 243 122 $ 97,439

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 365 183 $ 97,439

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 273 137 $ 97,439

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 188 94 $ 97,439

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 193 97 $ 97,439

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 75 38 $ 97,439

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 42 21 $ 97,439

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 81 41 $ 97,439

424410

General line grocery 

merchant 

wholesalers

Firms not operated for the 

entire year 366 183 $ 97,439

424450

Confectionery 

merchant 

wholesalers All firms 1,798 899 $ 97,439

424450

Confectionery 

merchant 

wholesalers

Firms operated for the entire 

year 1,544 772 $ 97,439 772

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 287 144 $ 97,439 56

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 238 119 $ 97,439

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 238 119 $ 97,439

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 291 146 $ 97,439

424450

Confectionery 

merchant 

Firms operated entire year 

with sales/receipts/revenue of 163 82 $ 97,439
47

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

wholesalers $2,500,000 to $4,999,999

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 132 66 $ 97,439

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 91 46 $ 97,439

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 46 23 $ 97,439

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 28 14 $ 97,439

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 30 15 $ 97,439

424450

Confectionery 

merchant 

wholesalers

Firms not operated for the 

entire year 254 127 $ 97,439

424690

Other chemical and 

allied products 

merchant 

wholesalers All firms 6,527 3,264 $ 97,439

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated for the entire 

year 5,948 2,974 $ 97,439 2,974

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 886 443 $ 97,439 173

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 706 353 $ 97,439

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 894 447 $ 97,439

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 1,164 582 $ 97,439

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 771 386 $ 97,439

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 562 281 $ 97,439

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 494 247 $ 97,439

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 220 110 $ 97,439

424690

Other chemical and 

allied products 

Firms operated entire year 

with sales/receipts/revenue of 101 51 $ 97,439
48

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

merchant 

wholesalers

$50,000,000 to $99,999,999

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 150 75 $ 97,439

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms not operated for the 

entire year 579 290 $ 97,439

424940

Tobacco and 

tobacco product 

merchant 

wholesalers All firms 1,135 568 $ 97,439

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated for the entire 

year 1,053 527 $ 97,439 527

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 56 28 $ 97,439 11

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 55 28 $ 97,439

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 74 37 $ 97,439

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 139 70 $ 97,439

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 118 59 $ 97,439

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 159 80 $ 97,439

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 181 91 $ 97,439

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 99 50 $ 97,439

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 81 41 $ 97,439

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 91 46 $ 97,439

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms not operated for the 

entire year 82 41 $ 97,439
49

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers All firms 12,118 6,059 $ 97,439

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated for the entire 

year 10,043 5,022 $ 97,439 5,022

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 2,941 1,471 $ 97,439 573

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 1,807 904 $ 97,439

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 1,736 868 $ 97,439

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 1,732 866 $ 97,439

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 827 414 $ 97,439

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 447 224 $ 97,439

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 348 174 $ 97,439

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 112 56 $ 97,439

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 54 27 $ 97,439

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 39 20 $ 97,439

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms not operated for the 

entire year 2,075 1,038 $ 97,439

561910

Packaging and 

labeling services All firms 1,809 904.5 $ 97,439

561910

Packaging and 

labeling services

Firms operated for the entire 

year 1,541 770.5 $ 97,439 771

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 164 82 $ 97,439 80

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 221 110.5 $ 97,439
50

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

$100,000 to $249,999

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 278 139 $ 97,439

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 247 123.5 $ 97,439

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 257 128.5 $ 97,439

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 161 80.5 $ 97,439

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 105 52.5 $ 97,439

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 74 37 $ 97,439

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 25 12.5 $ 97,439

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 6 3 $ 97,439

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 3 1.5 $ 97,439

561910

Packaging and 

labeling services

Firms not operated for the 

entire year 268 134 $ 97,439

424210

Drugs and druggists' 

sundries merchant 

wholesalers All firms 6,261 3,131 $ 3,046

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated for the entire 

year 5,430 2,715 $ 3,046 2,715

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 909 455 $ 3,046 6

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 626 313 $ 3,046

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 744 372 $ 3,046

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 1,059 530 $ 3,046

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 651 326 $ 3,046

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 505 253 $ 3,046

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 425 213 $ 3,046

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 193 97 $ 3,046
51

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 114 57 $ 3,046

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 204 102 $ 3,046

424210

Drugs and druggists' 

sundries merchant 

wholesalers

Firms not operated for the 

entire year 831 416 $ 3,046

424410

General line grocery 

merchant 

wholesalers All firms 2,208 1,104 $ 3,046

424410

General line grocery 

merchant 

wholesalers

Firms operated for the entire 

year 1,842 921 $ 3,046 921

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 195 98 $ 3,046 1

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 187 94 $ 3,046

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 243 122 $ 3,046

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 365 183 $ 3,046

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 273 137 $ 3,046

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 188 94 $ 3,046

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 193 97 $ 3,046

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 75 38 $ 3,046

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 42 21 $ 3,046

424410

General line grocery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 81 41 $ 3,046

424410

General line grocery 

merchant 

wholesalers

Firms not operated for the 

entire year 366 183 $ 3,046

424450

Confectionery 

merchant 

wholesalers All firms 1,798 899 $ 3,046

424450

Confectionery 

merchant 

wholesalers

Firms operated for the entire 

year 1,544 772 $ 3,046 772

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 287 144 $ 3,046 2

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 238 119 $ 3,046

424450 Confectionery Firms operated entire year 238 119 $ 3,046
52

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

merchant 

wholesalers

with sales/receipts/revenue of 

$500,000 to $999,999

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 291 146 $ 3,046

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 163 82 $ 3,046

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of

$5,000,000 to $9,999,999 132 66 $ 3,046

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 91 46 $ 3,046

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 46 23 $ 3,046

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 28 14 $ 3,046

424450

Confectionery 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 30 15 $ 3,046

424450

Confectionery 

merchant 

wholesalers

Firms not operated for the 

entire year 254 127 $ 3,046

424690

Other chemical and 

allied products 

merchant 

wholesalers All firms 6,527 3,264 $ 3,046

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated for the entire 

year 5,948 2,974 $ 3,046 2,974

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 886 443 $ 3,046 5

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 706 353 $ 3,046

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 894 447 $ 3,046

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 1,164 582 $ 3,046

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 771 386 $ 3,046

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 562 281 $ 3,046

424690

Other chemical and 

allied products 

merchant 

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 494 247 $ 3,046
53

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

wholesalers

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 220 110 $ 3,046

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 101 51 $ 3,046

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 150 75 $ 3,046

424690

Other chemical and 

allied products 

merchant 

wholesalers

Firms not operated for the 

entire year 579 290 $ 3,046

424940

Tobacco and 

tobacco product 

merchant 

wholesalers All firms 1,135 568 $ 3,046

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated for the entire 

year 1,053 527 $ 3,046 527

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 56 28 $ 3,046 -

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 55 28 $ 3,046

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 74 37 $ 3,046

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 139 70 $ 3,046

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 118 59 $ 3,046

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 159 80 $ 3,046

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 181 91 $ 3,046

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 99 50 $ 3,046

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 81 41 $ 3,046
54

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 91 46 $ 3,046

424940

Tobacco and 

tobacco product 

merchant 

wholesalers

Firms not operated for the 

entire year 82 41 $ 3,046

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers All firms 12,118 6,059 $ 3,046

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated for the entire 

year 10,043 5,022 $ 3,046 5,022

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 2,941 1,471 $ 3,046 18

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 1,807 904 $ 3,046

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 1,736 868 $ 3,046

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 1,732 866 $ 3,046

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 827 414 $ 3,046

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 447 224 $ 3,046

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 348 174 $ 3,046

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 112 56 $ 3,046

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 54 27 $ 3,046

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 39 20 $ 3,046

424990

Other miscellaneous 

nondurable goods 

merchant 

wholesalers

Firms not operated for the 

entire year 2,075 1,038 $ 3,046

561910

Packaging and 

labeling services All firms 1,809 904.5 $ 3,046
55

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

561910

Packaging and 

labeling services

Firms operated for the entire 

year 1,541 770.5 $ 3,046 771

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 164 82 $ 3,046 2

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$100,000 to $249,999 221 110.5 $ 3,046

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 278 139 $ 3,046

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 247 123.5 $ 3,046

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 257 128.5 $ 3,046

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 161 80.5 $ 3,046

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 105 52.5 $ 3,046

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 74 37 $ 3,046

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 25 12.5 $ 3,046

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 6 3 $ 3,046

561910

Packaging and 

labeling services

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 3 1.5 $ 3,046

561910

Packaging and 

labeling services

Firms not operated for the 

entire year 268 134 $ 3,046

445110

Supermarkets and 

other grocery 

(except 

convenience) stores All firms 41,885 $ 3,046

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms operated for the entire 

year 34,009 $ 3,046 34,009

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 6,836 $ 3,046 83

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 6,473 $ 3,046

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 6,327 $ 3,046

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 6,290 $ 3,046
56

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 3,598 $ 3,046

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 2,360 $ 3,046

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 1,373 $ 3,046

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 373 $ 3,046

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 162 $ 3,046

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 to 

$249,999,999 109 $ 3,046

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms operated entire year 

with sales/receipts/revenue of 

$250,000,000 or more 108 $ 3,046

445110

Supermarkets and 

other grocery 

(except 

convenience) stores

Firms not operated for the 

entire year 7,876 $ 3,046

446110

Pharmacies and 

drug stores All firms 19,067 $ 3,046

446110

Pharmacies and 

drug stores

Firms operated for the entire 

year 17,217 $ 3,046 17,217

446110

Pharmacies and 

drug stores

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 943 $ 3,046 11

446110

Pharmacies and 

drug stores

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 769 $ 3,046

446110

Pharmacies and 

drug stores

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 1,486 $ 3,046

446110

Pharmacies and 

drug stores

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 5,674 $ 3,046

446110

Pharmacies and 

drug stores

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 5,264 $ 3,046

446110

Pharmacies and 

drug stores

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 2,311 $ 3,046

446110

Pharmacies and 

drug stores

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 622 $ 3,046

446110

Pharmacies and 

drug stores

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 89 $ 3,046

446110 Pharmacies and Firms operated entire year 27 $ 3,046
57

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

drug stores with sales/receipts/revenue of 

$50,000,000 to $99,999,999

446110

Pharmacies and 

drug stores

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 to 

$249,999,999 8 $ 3,046

446110

Pharmacies and 

drug stores

Firms operated entire year 

with sales/receipts/revenue of 

$250,000,000 or more 24 $ 3,046

446110

Pharmacies and 

drug stores

Firms not operated for the 

entire year 1,850 $ 3,046

452112

Discount department 

stores All firms 14 $ 3,046

452112

Discount department 

stores

Firms operated for the entire 

year 11 $ 3,046 11

452112

Discount department 

stores

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 0 $ 3,046 -

452112

Discount department 

stores

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 0 $ 3,046

452112

Discount department 

stores

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 0 $ 3,046

452112

Discount department 

stores

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 0 $ 3,046

452112

Discount department 

stores

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 0 $ 3,046

452112

Discount department 

stores

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 0 $ 3,046

452112

Discount department 

stores

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 1 $ 3,046

452112

Discount department 

stores

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 3 $ 3,046

452112

Discount department 

stores

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 0 $ 3,046

452112

Discount department 

stores

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 to 

$249,999,999 0 $ 3,046

452112

Discount department 

stores

Firms operated entire year 

with sales/receipts/revenue of 

$250,000,000 or more 7 $ 3,046

452112

Discount department 

stores

Firms not operated for the 

entire year 3 $ 3,046

452910

Warehouse clubs 

and supercenters All firms 12 $ 3,046

452910

Warehouse clubs 

and supercenters

Firms operated for the entire 

year 11 $ 3,046 11

452910

Warehouse clubs 

and supercenters

Firms operated entire year 

with sales/receipts/revenue 

less than $250,000 0 $ 3,046 -

452910

Warehouse clubs 

and supercenters

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 0 $ 3,046
58

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

452910

Warehouse clubs 

and supercenters

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 0 $ 3,046

452910

Warehouse clubs 

and supercenters

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 0 $ 3,046

452910

Warehouse clubs 

and supercenters

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 0 $ 3,046

452910

Warehouse clubs 

and supercenters

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 0 $ 3,046

452910

Warehouse clubs 

and supercenters

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 0 $ 3,046

452910

Warehouse clubs 

and supercenters

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 1 $ 3,046

452910

Warehouse clubs 

and supercenters

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 1 $ 3,046

452910

Warehouse clubs 

and supercenters

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 to 

$249,999,999 1 $ 3,046

452910

Warehouse clubs 

and supercenters

Firms operated entire year 

with sales/receipts/revenue of 

$250,000,000 or more 8 $ 3,046

452910

Warehouse clubs 

and supercenters

Firms not operated for the 

entire year 1 $ 3,046

621111

Offices of physicians 

(except mental 

health specialists) All firms 182,287 $ 3,046

621111

Offices of physicians 

(except mental 

health specialists)

Firms operated for the entire 

year 160,034 $ 3,046 160,034

621111

Offices of physicians 

(except mental 

health specialists)

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 7,415 $ 3,046 226

621111

Offices of physicians 

(except mental 

health specialists)

Firms operated entire year 

with sales/receipts/revenue of 

$100,000 to $249,999 19,674 $ 3,046

621111

Offices of physicians 

(except mental 

health specialists)

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 38,179 $ 3,046

621111

Offices of physicians 

(except mental 

health specialists)

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 41,770 $ 3,046

621111

Offices of physicians 

(except mental 

health specialists)

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 31,857 $ 3,046

621111

Offices of physicians 

(except mental 

health specialists)

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 11,486 $ 3,046

621111

Offices of physicians 

(except mental 

health specialists)

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 5,527 $ 3,046

621111

Offices of physicians 

(except mental 

health specialists)

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 2,850 $ 3,046

621111 Offices of physicians Firms operated entire year 768 $ 3,046
59

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

(except mental 

health specialists)

with sales/receipts/revenue of 

$25,000,000 to $49,999,999

621111

Offices of physicians 

(except mental 

health specialists)

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 299 $ 3,046

621111

Offices of physicians 

(except mental 

health specialists)

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 209 $ 3,046

621111

Offices of physicians 

(except mental 

health specialists)

Firms not operated for the 

entire year 22,253 $ 3,046

621112

Offices of 

physicians, mental 

health specialists All firms 10,714 $ 3,046

621112

Offices of 

physicians, mental 

health specialists

Firms operated for the entire 

year 9,075 $ 3,046 9,075

621112

Offices of 

physicians, mental 

health specialists

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 1,705 $ 3,046 52

621112

Offices of 

physicians, mental 

health specialists

Firms operated entire year 

with sales/receipts/revenue of 

$100,000 to $249,999 2,905 $ 3,046

621112

Offices of 

physicians, mental 

health specialists

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 2,558 $ 3,046

621112

Offices of 

physicians, mental 

health specialists

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 1,192 $ 3,046

621112

Offices of 

physicians, mental 

health specialists

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 528 $ 3,046

621112

Offices of 

physicians, mental 

health specialists

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 134 $ 3,046

621112

Offices of 

physicians, mental 

health specialists

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 34 $ 3,046

621112

Offices of 

physicians, mental 

health specialists

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 15 $ 3,046

621112

Offices of 

physicians, mental 

health specialists

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 4 $ 3,046

621112

Offices of 

physicians, mental 

health specialists

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 0 $ 3,046

621112

Offices of 

physicians, mental 

health specialists

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 0 $ 3,046

621112

Offices of 

physicians, mental 

health specialists

Firms not operated for the 

entire year 1,639 $ 3,046

621210 Offices of dentists All firms 121,048 $ 3,046

621210 Offices of dentists

Firms operated for the entire 

year 111,013 $ 3,046 111,013

621210 Offices of dentists

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 3,827 $ 3,046 117

621210 Offices of dentists

Firms operated entire year 

with sales/receipts/revenue of 12,634 $ 3,046
60

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

$100,000 to $249,999

621210 Offices of dentists

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 27,715 $ 3,046

621210 Offices of dentists

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 40,599 $ 3,046

621210 Offices of dentists

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 22,949 $ 3,046

621210 Offices of dentists

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 2,686 $ 3,046

621210 Offices of dentists

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 448 $ 3,046

621210 Offices of dentists

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 116 $ 3,046

621210 Offices of dentists

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 13 $ 3,046

621210 Offices of dentists

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 13 $ 3,046

621210 Offices of dentists

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 13 $ 3,046

621210 Offices of dentists

Firms not operated for the 

entire year 10,035 $ 3,046

621320

Offices of 

optometrists All firms 18,407 $ 3,046

621320

Offices of 

optometrists

Firms operated for the entire 

year 16,659 $ 3,046 16,659

621320

Offices of 

optometrists

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 1,296 $ 3,046 39

621320

Offices of 

optometrists

Firms operated entire year 

with sales/receipts/revenue of 

$100,000 to $249,999 3,493 $ 3,046

621320

Offices of 

optometrists

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 5,163 $ 3,046

621320

Offices of 

optometrists

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 4,450 $ 3,046

621320

Offices of 

optometrists

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 1,950 $ 3,046

621320

Offices of 

optometrists

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 233 $ 3,046

621320

Offices of 

optometrists

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 51 $ 3,046

621320

Offices of 

optometrists

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 20 $ 3,046

621320

Offices of 

optometrists

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 1 $ 3,046
61

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

621320

Offices of 

optometrists

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 2 $ 3,046

621320

Offices of 

optometrists

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 0 $ 3,046

621320

Offices of 

optometrists

Firms not operated for the 

entire year 1,748 $ 3,046

621391 Offices of podiatrists All firms 8,211 $ 3,046

621391 Offices of podiatrists

Firms operated for the entire 

year 7,566 $ 3,046 7,566

621391 Offices of podiatrists

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 636 $ 3,046 19

621391 Offices of podiatrists

Firms operated entire year 

with sales/receipts/revenue of 

$100,000 to $249,999 2,041 $ 3,046

621391 Offices of podiatrists

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 2,564 $ 3,046

621391 Offices of podiatrists

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 1,594 $ 3,046

621391 Offices of podiatrists

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 623 $ 3,046

621391 Offices of podiatrists

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 88 $ 3,046

621391 Offices of podiatrists

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 20 $ 3,046

621391 Offices of podiatrists

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 0 $ 3,046

621391 Offices of podiatrists

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 0 $ 3,046

621391 Offices of podiatrists

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 0 $ 3,046

621391 Offices of podiatrists

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 0 $ 3,046

621391 Offices of podiatrists

Firms not operated for the 

entire year 645 $ 3,046

621399

Offices of all other 

miscellaneous 

health practitioners All firms 11,734 $ 3,046

621399

Offices of all other 

miscellaneous 

health practitioners

Firms operated for the entire 

year 9,094 $ 3,046 9,094

621399

Offices of all other 

miscellaneous 

health practitioners

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 3,061 $ 3,046 93

621399

Offices of all other 

miscellaneous 

health practitioners

Firms operated entire year 

with sales/receipts/revenue of 

$100,000 to $249,999 3,054 $ 3,046

621399

Offices of all other 

miscellaneous 

health practitioners

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 1,646 $ 3,046
62

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

621399

Offices of all other 

miscellaneous 

health practitioners

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 767 $ 3,046

621399

Offices of all other 

miscellaneous 

health practitioners

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 443 $ 3,046

621399

Offices of all other 

miscellaneous 

health practitioners

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 83 $ 3,046

621399

Offices of all other 

miscellaneous 

health practitioners

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 31 $ 3,046

621399

Offices of all other 

miscellaneous 

health practitioners

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 8 $ 3,046

621399

Offices of all other 

miscellaneous 

health practitioners

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 1 $ 3,046

621399

Offices of all other 

miscellaneous 

health practitioners

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 0 $ 3,046

621399

Offices of all other 

miscellaneous 

health practitioners

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 0 $ 3,046

621399

Offices of all other 

miscellaneous 

health practitioners

Firms not operated for the 

entire year 2,640 $ 3,046

621420

Outpatient mental 

health and 

substance abuse 

centers All firms 4,555 $ 3,046

621420

Outpatient mental 

health and 

substance abuse 

centers

Firms operated for the entire 

year 4,113 $ 3,046 4,113

621420

Outpatient mental 

health and 

substance abuse 

centers

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 518 $ 3,046 16

621420

Outpatient mental 

health and 

substance abuse 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000 to $249,999 641 $ 3,046

621420

Outpatient mental 

health and 

substance abuse 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 487 $ 3,046

621420

Outpatient mental 

health and 

substance abuse 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 594 $ 3,046

621420

Outpatient mental 

health and 

substance abuse 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 761 $ 3,046

621420

Outpatient mental 

health and 

substance abuse 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 447 $ 3,046

621420

Outpatient mental 

health and 

Firms operated entire year 

with sales/receipts/revenue of 378 $ 3,046
63

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

substance abuse 

centers

$5,000,000 to $9,999,999

621420

Outpatient mental 

health and 

substance abuse 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 234 $ 3,046

621420

Outpatient mental 

health and 

substance abuse 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 45 $ 3,046

621420

Outpatient mental 

health and 

substance abuse 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 6 $ 3,046

621420

Outpatient mental 

health and 

substance abuse 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 2 $ 3,046

621420

Outpatient mental 

health and 

substance abuse 

centers

Firms not operated for the 

entire year 442 $ 3,046

621491

HMO medical 

centers All firms 35 $ 3,046

621491

HMO medical 

centers

Firms operated for the entire 

year 30 $ 3,046 30

621491

HMO medical 

centers

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 0 $ 3,046 -

621491

HMO medical 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000 to $249,999 5 $ 3,046

621491

HMO medical 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 4 $ 3,046

621491

HMO medical 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 3 $ 3,046

621491

HMO medical 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 2 $ 3,046

621491

HMO medical 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 2 $ 3,046

621491

HMO medical 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 1 $ 3,046

621491

HMO medical 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 2 $ 3,046

621491

HMO medical 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 4 $ 3,046

621491

HMO medical 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 0 $ 3,046

621491

HMO medical 

centers

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 7 $ 3,046

621491

HMO medical 

centers

Firms not operated for the 

entire year 5 $ 3,046
64

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

622110

General medical and 

surgical hospitals All firms 3,076 $ 3,046

622110

General medical and 

surgical hospitals

Firms operated for the entire 

year 3,051 $ 3,046 3,051

622110

General medical and 

surgical hospitals

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 0 $ 3,046 -

622110

General medical and 

surgical hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$100,000 to $249,999 2 $ 3,046

622110

General medical and 

surgical hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 1 $ 3,046

622110

General medical and 

surgical hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 0 $ 3,046

622110

General medical and 

surgical hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 18 $ 3,046

622110

General medical and 

surgical hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 117 $ 3,046

622110

General medical and 

surgical hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 316 $ 3,046

622110

General medical and 

surgical hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 613 $ 3,046

622110

General medical and 

surgical hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 436 $ 3,046

622110

General medical and 

surgical hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 416 $ 3,046

622110

General medical and 

surgical hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 1,132 $ 3,046

622110

General medical and 

surgical hospitals

Firms not operated for the 

entire year 25 $ 3,046

622210

Psychiatric and 

substance abuse 

hospitals All firms 429 $ 3,046

622210

Psychiatric and 

substance abuse 

hospitals

Firms operated for the entire 

year 423 $ 3,046 423

622210

Psychiatric and 

substance abuse 

hospitals

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 0 $ 3,046 -

622210

Psychiatric and 

substance abuse 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$100,000 to $249,999 0 $ 3,046

622210

Psychiatric and 

substance abuse 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 0 $ 3,046

622210

Psychiatric and 

substance abuse 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 0 $ 3,046

622210

Psychiatric and 

substance abuse 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 1 $ 3,046

622210 Psychiatric and Firms operated entire year 22 $ 3,046
65

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

substance abuse 

hospitals

with sales/receipts/revenue of 

$2,500,000 to $4,999,999

622210

Psychiatric and 

substance abuse 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 55 $ 3,046

622210

Psychiatric and 

substance abuse 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 140 $ 3,046

622210

Psychiatric and 

substance abuse 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 115 $ 3,046

622210

Psychiatric and 

substance abuse 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 63 $ 3,046

622210

Psychiatric and 

substance abuse 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 27 $ 3,046

622210

Psychiatric and 

substance abuse 

hospitals

Firms not operated for the 

entire year 6 $ 3,046

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals All firms 375 $ 3,046

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals

Firms operated for the entire 

year 352 $ 3,046 352

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 0 $ 3,046 -

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$100,000 to $249,999 0 $ 3,046

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 0 $ 3,046

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 1 $ 3,046

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 7 $ 3,046

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 27 $ 3,046

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 49 $ 3,046

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 73 $ 3,046

622310 Specialty (except Firms operated entire year 86 $ 3,046
66

2007 

NAICS 

code

2007 NAICS code 

description

Revenue size of firms 

operated entire year

Number 

of firms

Adjusted 

Number of 

firms for 

50% 

Distributor, 

Importer, 

Exporter

Revenue 

where cost 

is 1%

Firms 

operated 

for the 

entire 

year

Number 

of Firms 

with 

Revenue 

below 1% 

Threshold

psychiatric and 

substance abuse) 

hospitals

with sales/receipts/revenue of 

$25,000,000 to $49,999,999

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 55 $ 3,046

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 54 $ 3,046

622310

Specialty (except 

psychiatric and 

substance abuse) 

hospitals

Firms not operated for the 

entire year 23 $ 3,046

541380 Testing laboratories All firms 5,288 $ 3,046

541380 Testing laboratories

Firms operated for the entire 

year 4,727 $ 3,046 4,727

541380 Testing laboratories

Firms operated entire year 

with sales/receipts/revenue 

less than $100,000 493 $ 3,046 15

541380 Testing laboratories

Firms operated entire year 

with sales/receipts/revenue of 

$100,000 to $249,999 771 $ 3,046

541380 Testing laboratories

Firms operated entire year 

with sales/receipts/revenue of 

$250,000 to $499,999 817 $ 3,046

541380 Testing laboratories

Firms operated entire year 

with sales/receipts/revenue of 

$500,000 to $999,999 872 $ 3,046

541380 Testing laboratories

Firms operated entire year 

with sales/receipts/revenue of 

$1,000,000 to $2,499,999 934 $ 3,046

541380 Testing laboratories

Firms operated entire year 

with sales/receipts/revenue of 

$2,500,000 to $4,999,999 413 $ 3,046

541380 Testing laboratories

Firms operated entire year 

with sales/receipts/revenue of 

$5,000,000 to $9,999,999 247 $ 3,046

541380 Testing laboratories

Firms operated entire year 

with sales/receipts/revenue of 

$10,000,000 to $24,999,999 123 $ 3,046

541380 Testing laboratories

Firms operated entire year 

with sales/receipts/revenue of 

$25,000,000 to $49,999,999 31 $ 3,046

541380 Testing laboratories

Firms operated entire year 

with sales/receipts/revenue of 

$50,000,000 to $99,999,999 16 $ 3,046

541380 Testing laboratories

Firms operated entire year 

with sales/receipts/revenue of 

$100,000,000 or more 10 $ 3,046

541380 Testing laboratories

Firms not operated for the 

entire year 561 $ 3,046
67

Summary

The table below details the number and percentage of businesses for each registrant 

categories whose cost of implementing the requirements of the proposed rule is 1% or more of 

revenue.

Registrant Categories and NAICS Code Titles

NAICS 

Codes 

Represente

d by DEA 

Registrants

Total 

Number of 

Businesses 

by NAICS 

Code* 

Estimated 

Number of 

Businesses 

Represente

d by DEA 

Registrants

SBA Size 

Standards: 

Number of 

Employees 

or Millions 

of 

Dollars**

Number of 

Businesses 

Below SBA 

Size 

Standard

Cost 

Impact

Revenue at 

threshold 

(1%)

Sum of Firms 

operated for 

the entire 

year

Number of 

Firms 

w/Revenue 

below 

Threshold

Percentage 

of Business 

Groups 

below 

threshold

Manufacturers 544 533

Petrochemical Manufacturing 325110 56 1,000 56 $ 30 $ 3,046 56 -

Medicinal and Botanical Manufacturing 325411 410 750 406 $ 30 $ 3,046 410 -

Pharmaceutical Preparation Manufacturing 325412 991 750 943 $ 30 $ 3,046 991 -

Adhesive Manufacturing 325520 600 500 600 $ 30 $ 3,046 600 -

Toilet Preparation Manufacturing 325620 854 500 828 $ 30 $ 3,046 854 -

All Other Miscellaneous Chemical Product and 

Preparation Manufacturing

325998

 1,261

500 

 1,253

$ 30 $ 3,046

 1,261 -

Manufacturer Summary 4,172 4,086 4,172 - 0.0%

Distributors/Importer/Exporter 1,481 1,433

Drugs and Druggists’ Sundries Merchant 

Wholesalers

424210

 5,430

100 

 5,155

$ 974 $ 97,439

 5,430 183

General Line Grocery Merchant Wholesalers 424410 1,842 100 1,739 $ 974 $ 97,439 1,842 39

Confectionery Merchant Wholesalers 424450 1,544 100 1,506 $ 974 $ 97,439 1,544 58

Other Chemical and Allied Products Merchant 

Wholesalers

424690

 5,948

100 

 5,824

$ 974 $ 97,439

 5,948 178

Tobacco and Tobacco Product Merchant 

Wholesalers

424940

 1,053

100 

 978

$ 974 $ 97,439

 1,053 11

Other Miscellaneous Nondurable Goods Merchant 

Wholesalers

424990

 10,043

100 

 9,926

$ 974 $ 97,439

 10,043 591

Packaging and Labeling Services 561910 1,541 $7.0 1,381 $ 974 $ 97,439 1,541 82

Distributors/Importers/Exporters Summary 27,401 26,509 27,401 1,142 4.2%

Pharmacies 51,248 50,517

Supermarkets and Other Grocery (except 

Convenience) Stores 445110 34,009

$30.0 

 33,444

$ 30 $ 3,046

 34,009 83

Pharmacies and Drug Stores 446110 17,217 $25.5 17,069 $ 30 $ 3,046 17,217 11

Discount Department Stores 452112 11 $27.0 3 $ 30 $ 3,046 11 -

Warehouse Clubs and Superstores 452910 11 $27.0 1 $ 30 $ 3,046 11 -

Pharmacies Summary 51,248 50,517 51,248 94 0.2%

Others 328,286 319,105

Colleges, Universities and Professional Schools** 611310

 2,149

$7.0 Not 

Available 

$ 30 $ 3,046

 2,149

Offices of Physicians (except Mental Health 

Specialists) 621111 160,034

$10.0 

 155,908

$ 30 $ 3,046

 160,034 226

Offices of Physicians, Mental Health Specialists 621112 9,075 $10.0 9,056 $ 30 $ 3,046 9,075 52

Offices of Dentists 621210 111,013 $7.0 110,634 $ 30 $ 3,046 111,013 117

Offices of Optometrists 621320 16,659 $7.0 16,611 $ 30 $ 3,046 16,659 39

Offices of Podiatrists 621391 7,566 $7.0 7,556 $ 30 $ 3,046 7,566 19

Offices of All Other Miscellaneous Health 

Practitioners

621399

 9,094

$7.0 

 9,070

$ 30 $ 3,046

 9,094 93

Outpatient Mental Health and Substance Abuse 

Centers

621420

 4,113

$10.0 

 3,826

$ 30 $ 3,046

 4,113 16

HMO Medical Centers 621491 30 $10.0 17 $ 30 $ 3,046 30 -

General Medical and Surgical Hospitals 622110 3,051 $34.5 1,285 $ 30 $ 3,046 3,051 -

Psychiatric and Substance Abuse Hospitals 622210 423 $34.5 334 $ 30 $ 3,046 423 -

Specialty (except Psychiatric and Substance Abuse) 

Hospitals

622310

 352

$34.5 

 200

$ 30 $ 3,046

 352 -

Testing Laboratories 541380 4,727 $12.0 4,608 $ 30 $ 3,046 4,727 15

Others Summary 328,286 319,105 328,286 577 0.2%

Total Controlled Substance Registrants 381,559 371,588 411,107 1,813 Category 1 Category 2
68

The above table is further summarized below.

States Tramadol Not Controlled

Registrant Business Activity

 Number of 

DEA 

Registrations 

Business-toRegistrant 

Ratio

Estimated 

Number of 

Businesses 

Represented by 

DEA Registrants

 % of Business 

Below SBA 

Size Standard 

Number of 

Businesses 

Below SBA Size 

Standard

 Percentage 

of Small 

Businesses 

with Revenue 

Below 

Threshold 

 Number of 

Affected Small 

Businesses with 

Significant 

Economic 

Impact 

Manufacturer 51 1.00 51 84.3% 43 0.0% -

Distributor/Importer/Exporter 1,175 1.00 1,175 96.7% 1,137 4.2% 47

Pharmacy 55,251 0.74 40,797 98.6% 40,215 0.2% 74

Practitioner 947,103

Mid-level Practitioner 178,422

Hospital/Clinic 13,576

Total 1,195,578 306,375 97.4% 298,354 0.2% 573

 0.23 264,352 97.2% 256,959 0.2% 452