# ECONOMIC IMPACT ANALYSIS

o f 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 E XECUTIVE 

### O RDERS 

### 12866 AND 

### 13563

................................ ................................ ................................ .................. 4
2.2 R EGULATORY 

### F LEXIBILITY 

### A CT



### ................................ ................................ ................................ ................................ . 4
2.3 U NFUNDED 

### M ANDATES 

### R EFORM 

### A CT OF 

### 1995

................................ ................................ ................................ ......... 5
2.4 C ONGRESSIONAL REVIEW ACT



### ................................ ................................ ................................ ................................ . 5

CHAPTER 3: ALTERNATIVES ANALYSI S

................................ ................................ ................................ ................ 6

CHAPTER 4: ANTICIPATED ECONOMIC IMPACT OF REGULATORY ACTION

................................ .......................... 6

4.1 A FFECTED 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 A NNUAL COST OF THE RU LE



### ................................ ................................ ................................ ................................ .. 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 Busi ness

................................ ................................ ................................ ..................... 17
4.3 A NNUAL 

### E CONOMIC 

### E FFECT ON THE 

### E CONOMY



### ................................ ................................ ................................ ....... 18

4.4 I MPACT ON 

### S MALL 

### E NTITIES



### ................................ ................................ ................................ ................................ . 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 E XAMINATION OF 

### I NDUSTRY 

### S EGMENTS WITH 

### S IGNIFICANT 

### E CONOMIC 

### I MPACTS



### ................................ ............................ 25

CHAPTER 5: COST

- BENEFIT ANALYSIS OF REGULATORY ACTION

................................ ................................ ....... 26

5.1 C OSTS OF THE REGULATO RY ACTION



### ................................ ................................ ................................ ....................... 26
5.2 B ENEFITS OF THE REGUL ATORY ACTION 

### (C OST OF 

### I NACTION 

### )

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

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

................................ ................................ .................... 26
5.3 E VALUATION OF THE 

### C OSTS AND 

### B ENEFITS OF THE 

### P ROPOSED 

### R ULE



### ................................ ................................ ............. 27

CHAPTER 6: ECONOMIC ANALYSIS RE SULTS

................................ ................................ ................................ ..... 29

6.1 E XECUTIVE 

### O RDERS 

### 12866 AND 

### 13563

................................ ................................ ................................ ................ 29
6.2 R EGULATORY 

### F LEXIBILITY 

### A CT



### ................................ ................................ ................................ ............................... 29
6.3 U NFUNDED 

### M ANDATES 

### R EFORM 

### A CT OF 

### 1995

................................ ................................ ................................ ....... 30
6.4 C ONGRESSIONAL 

### R EVIEW 

### A CT OF 

### 1995

................................ ................................ ................................ ................. 30

CHAPTER 7: DISCLOSURE OF ASSUMP TIONS

................................ ................................ ................................ ..... 31

APPENDIX 1: REGISTRANT LANDSCAPE

................................ ................................ ................................ ............... 34

S UMMARY



### ................................ ................................ ................................ ................................ ................................ .. 34

DEA R EGISTRANT 

### P OPULATION BY 

### B USINESS 

### A CTIVITY



### ................................ ................................ ................................ ....... 35
C ORRESPONDING NUMBER OF 

### B USINESSES



### ................................ ................................ ................................ ....................... 35

N UMBER OF 

### A FFECTED 

### B USINESSES THAT 

### A RE 

### S MALL 

### B USINESSES



### ................................ ................................ ........................ 42

APPENDIX 2: NUMBER OF BUSINESSES WHOSE COST OF PROPOSED RUL E IS 1% OR MORE OF R EVENUE

........... 45

## 3 

# CHAPTER 1: INTRODUCTION

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

-

( (dimethylamin o )methyl )

- 1

- (3

- methoxyphenyl)cyclohexanol, its salts, isomers, salts of isomers

and all isomeric configurations of possibl e 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 th e 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, distribut e , dispens e , import, export

, engage in research , cond uct 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 tra madol. 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 ANALYS E S INVESTIGATED

2.1 EXECUTIVE ORDERS 128 66 AND 13563

Pursuant to Execut ive Order 12866 ( 58 FR 51735, October 4, 1993), an agenc y must

submit to the Office of Management and Budget (OMB)

, Office of Information and Regulatory

Affairs (OIRA) a regulatory impact analysis for m atters 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

p riorities, 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 FLEXIBILI TY A CT

The R egulatory 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

poli cy 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 RE FORM ACT OF 1995

The Unfunded Mandates Re form Act (UMRA) was enacted to avoid imposin g unfunded

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

UMRA's provisions apply to proposed and final rules:

 

## f or which a general notice of proposed rule making w as published, and

 

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

S tate, 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 CONGRES SIONAL 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 Accou ntability 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: ALTERNATIVE S 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

ACTI ON

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 use d 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 hos pitals/clinics that handle tramadol are registered with the DEA 4 

## and all distributors,

importers/exporters, pharmacies, individual practitioners, mid

- level practitioners, and

hospitals/clinics registered with the DEA are tramadol handlers. While the numbe r 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

reg istrations are in the 10 states that control t ramadol as a S chedule 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 Ark ansas, 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 framew ork 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 f ound 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 d ominant 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 i ndustry 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 determi ned in Appendix 1, t he 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 us ed 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 busines ses represented by

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

based on publically available data 7 

## for 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, H oover’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 p ractitioners 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 “O thers

. ” The number of DEA r egistrations 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 s tates , tramadol controlled and not controlled under state law

In st ates 8 

## where t ramadol 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 S chedule 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.

## 10

States where tramadol is not controlled as a S chedule 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 regis tration costs as a result of this rule

.

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

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.

## 11

4.2.1 Costs associated with storage requirements

Pur suant 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 DE A 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

modi fications, 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 c ost. 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 sel f

- closing and self

- locking hinged doors

will cost $2,000 to $6,000. The $6,000 e stimate 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 one

time 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 an d

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 dis tributors, 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 alre ady 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.

P harmacies

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 faciliti es, 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 s uch

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 mai ntained

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 purpo se 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 130 4.11. 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 invent ory. 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 est imates 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

i nventory 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 m edian

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

$29.4 0. 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, inv entory 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 re gistrants 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 Sc hedule 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 non

recurring costs totaling $ 172.2 4 and biennially recurring cost of $ 29.40

. Furtherm ore, 50% of

d istributors, i mporters, and e xporters 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 co st of the biennial inventory does not occur until two years after

implementation of the rule.

4.2.5 Annual C ost 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 rates 11



## . For the

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

present value of cost of th e 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% i nterest 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 sp ace, 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% interes t rate

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

interest rate for 20 years. The t able 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 Analy sis: 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 EFFE CT 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 a nnual

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 appl ied 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 registration s. To be conservative in analysis, the higher values for annual

cost s 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 cos t is estimated to be

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

## 19

The DEA does not anticipate that this rulemaking will have an annua l effec t 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 environmen t, public health or safety, or S tate,

local, or tribal governments or communities.

4.4 IMPACT ON SMALL E NTITIES

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.

## 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 A merican

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 e xample, NAICS code “621111

– Office of physicians (except mental health

specialists)” would incur a n annual cost of $ 30.46 . The revenue l evel 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 consist ing 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 1 60,034 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 a re 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 Distrib utor/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/defini tions.html

.

## 22

interpolation to be conservative and to account for possibility that some fi rms 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 bas ed on publically

available data 13 

## 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 n umber 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 distrib utors/importers/exp orters, 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 S chedule IV controlled substance under state law

13 

### Lexis

- Nexis, Dun & Bradstreet, H oover’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 estimate d 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.

## 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 S chedule IV under state law.

Therefore, 573 or 0. 2 % of 367,046 small businesses aff ected by the proposed rule are estimated

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

businesses significantly impacted by th e proposed rule for all states

.

All s tates , tramadol controlled and not controll ed 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 ha ndle 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 per centage. See table below.

## 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 estim ates 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 th e 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 t hat 50% will inc ur 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, requi ring less space, thus mitigating the economic impact of the proposed rule.

## 25

4.5 EXAMINATION OF INDUS TRY SEGMENTS WITH SI GNIFICANT 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 REGULATO RY ACTION

5.1 COST S OF THE REGULATORY ACTION

As discussed in Section 4.3

, the DEA estimates this rule will cost $ 9,887,561 annually

.

5.2 B ENEFIT S 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 p ublic health and

safety

.

5.2.1 Tramadol Diversion

According to Drug Abuse Warning Network (DAWN) data, t he 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 poiso n 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 in to S chedule 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 CO STS 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, i n 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 benefi ts 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 cons iders 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 b enefits of the rule are represented as the difference between the cos ts 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 . T herefore, this rule will have

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

the United States.

## 29 

# CHAPTER 6: ECONOMIC ANALYSIS RE SULTS

6.1 EXECUTIVE ORDERS 128 66 AND 13563

The estimated annual impac t 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 FLEXIBILI TY ACT

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

entities . Specifically, the DEA examined the registratio n, storage, inventory and recordkeeping,

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

proposed rule, 55 manufacturers, 1,4 18 distribu tors/importers/exporters, 50,032 pharmacies, and

315,541 individual practitio ners/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 non

recurring 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/clinic s/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 57 3 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 RE FORM ACT OF 1995

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

effect on the economy of $100 million or more

.

6.4 CONGRESSIONAL R EVIEW 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 ASSUMP TIONS

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, mid

level 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 ru le is included in

Appendix 1 to estimate the number of businesses, as represented b y 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

ac tion.

 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 Sche dule 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 tramado l 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 substa nces 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 be lieves 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 thi s 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 con trolled 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: REGISTR ANT LANDSCAPE

SUMMARY

The results of the analysis are summarized in the table below and d etailed 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 mul tiple 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

Admin istration (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.

## 35

DEA REGISTRANT POPUL ATION BY BUSINESS AC TIVITY

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 9,73 9 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 r egistrations 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 registra nts 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 s ame 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 set s 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, a nd 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 b usinesses 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 codes 15 

## and developed a table that

relates various registrant groups to NAICS codes based on the DEA’s estim ate. 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.

## 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 establishm ent. 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.

## 39

There are many more businesses for the Manufacturers and

D istributors/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 Manufactur ers, 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

Physicia ns 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 on e

- 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, Off ices 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

## 42

NUMBER OF AFFECTED B USI NESSES THAT ARE SMAL L BUSINESSES

After estimating that 1.5 million DEA registrants represent 381,559 businesses, t he 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 busi nesses 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 M anufacturers 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) o f o ther 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 co nsidered “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 wh ether 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

.

## 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 resul ting 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 wit h 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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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 A djusted

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.

## 68

The above table is further summarized below.