# ECONOMIC IMPACT ANALYSIS

o f
Final Rule on Schedules of Controlled Substances:
Placement of Tramadol i nto Schedule IV
DEA

- 351

Drug Enforcement Administration
U.S. Department of Justice



# June 2014

# Table of Contents

1. INTRODUCTION

........................................................................ ......... ...... 3

2. REGULATORY ANALYSES INVESTIGATED

.................................... ...... ........ 4

2.1

. E XECUTIVE 

## O RDERS 

## 12866 AND 

## 13563

.............................. ... ............... ... ...... 4

2.2

. R EGULATORY 

## F LEXIBILITY 

## A CT



## .......................................... ... ......... ...... ...... 6

2.3

. U NFUNDED 

## M ANDATES 

## R EFORM 

## A CT OF 

## 1995

........................... ... ........... ............. 7

2.4

. C ONGRESSIONAL 

## R EVIEW 

## A CT OF 

## 1996.....

................................. ... ........... .......... 8

3. ANTICIPATED ECONOMIC IMPACT OF REGULATORY ACTION

...... .......... ...... . 8

3.1 G ENERAL 

## R ELATIONSHIP 

## B ETWEEN 

## R EG ISTRATIONS



## , E NTITIES



## , AND 

## S MALL



## E NTITIES



## .................................................................. ......... ...... ... . .. 8

3.2 A FFECTED 

## E NTITIES



## ............................................................ ......... ...... .... 10

3.2.1 Number of Tramadol Handlers (Registration Requirements)

............... ... ....... 10 3.2.2 Number of Entities and Small Entities Handling Tramadol

............... ......... . .. 1 3

3.3 A NNUAL 

## C OST OF THE 

## R ULE



## ...................................................... ......... ...... 1 7

3.3.1

. Costs Associated with Registration Requirements

......... ......... ...... ............ 1 7

3.3.2. Costs Associated with Security Requirements

........................... ...... ........ 17

3.3. 3. Costs Associated with Labeling and Packaging Requirements

......... ... .......... 2 2

3.3. 4. Costs Associated with Recordkeeping and Reporting Requirements

... ...... ...... 2 5

3.3. 5. Costs Associated with Prescription Requirements

........................... ... ...... 2 8

3.3. 6. Costs Associated with Disposal Requirements

........................ ......... ........ 2 9

3.3. 7. Cost Summary and Annualized Cost

.......................................... .......... 2 9

3.4 A NNUAL 

## E CONOMIC 

## E FFECT ON THE 

## E CONOMY



## .............................. ............... 3 1

3.5 I MPACT ON 

## S MALL 

## E NTITIES



## ................................................... .................. 3 3

3.5.1. Criteria for “Significant” Economic Impact

.............................. ............... 3 3 3.5.2. Analysis

........................................................................... ........... 3 3

3.5.3. Criteria for “Substantial Number”

.......................................... ... .......... 3 7

3.6 E XAMINAT ION OF 

## I NDUSTRY 

## S EGMENTS WITH 

## S IGNIFICANT 

## E CONOMIC



## I MPACT



## ............................................. .... ......... ............ .. ............... 3 8

4. ECONOMIC ANALYSIS RESULTS

............................................................... 3 8

4.1

. E XECUTIVE 

## O RDERS 

## 12866 AND 

## 13563

....................................................... 3 8

4.2

. R EGULATORY 

## F LEXIBILITY 

## A CT



## ............................................................... 3 8

4.3

. U NFUNDED 

## M ANDATES 

## R EFORM 

## A CT OF 

## 1995

.............................................. 39

4.4

. C ONGRESSIONAL 

## R EVIEW 

## A CT



## ................................................................. 40

5. APPENDIX A: REGISTRANT LANDSCAPE

................................................... 41



# 6. APPENDIX B: BUSINESS WITH IMPACT 1% OR MORE OF ANNUAL

REVENUE

................................................................................. 51

# 1. INTRODUCTION

This document describes the economic analysis conducted by the Drug Enforcement

Administration (DEA) in support of the regulatory analyses statements published with the

final rule to schedule 2

- [ ( dimethylamino)methyl ]

- 1

- (3

- methoxyphenyl)cyclohexanol

(tramadol)

, including its salts, isomers, and salts of isomers, as a schedule IV controlled

substance under the Controlled Substances Act (CSA) [Docket No. DEA

- 351]. This

action was initiated by four p etitions to schedule tramadol under the CSA, and is

supported by, inter alia , a recommendation from the Assistant Secretary of the HHS and

an evaluation of all other relevant data by the DEA. This action imposes the regulatory

controls and administrative, civil, and criminal sanctions applicable to schedule I V

controlled substances on persons who handle or propose to handle tramadol

.

On September 16, 2010, the Assistant Secretary of the HHS provided to the DEA a

scientific and medical evaluation and sche duling recommendation entitled “Basis for the

Recommendation to Schedule Tramadol in Schedule IV of the Controlled Substances

Act.” After considering the eight factors in 21 U.S.C. 811(c), including consideration of

the substance’s abuse potential, legiti mate medical use, and dependence liability, the

Assistant Secretary of the HHS recommended that tramadol be controlled in s chedule IV

of the CSA under 21 U.S.C. 812 (b). T he DEA conducted its own eight

- factor analysis of

tramadol pursuant to 21 U.S.C. 811( c). After a review of the available data, including the

scientific and medical evaluation and the scheduling recommendation from the HHS, the

Deputy Administrator of the DEA published in the Federal Register a n otice of p roposed

r ulemaking (NPRM) entitled “ Schedules of Controlled Substances: Placement of

3

# Tramadol into Schedule IV ” which proposed placement of tramadol in s chedule IV of the

CSA. 78 FR 65923, Nov. 4, 2013.

Tramadol is an opioid analgesic that produces its primary opioid

- like action through

an active metabolite, referred to as the “M1” metabolite (O

- desmethyltramadol). Since

its approval by the Food and Drug Administration (FDA) in March 1995, tramadol has

been available in the United States as a non

- controlled and centrally acting o pioid

analgesic und er the trade name ULTRAM ®



# . Subsequently, the FDA approved for

marketing generic, combination, and extended release tramadol products.

Because of its chemical structure, 2

- [ (dimethylamino)methyl ]

- 1

- (3

- methoxyphenyl)

cyclohexanol can exis t as different isomeric forms. Thus, various prefixes can be

associated with the name. Some examples of these prefixes include dextro, levo, d, l, R,

S, cis, trans, erythro, threo, (+), (

- ), racemic, and may include combinations of these

prefixes sometim es with numerical designations. Any such isomer is, in fact,

2

- [ (dimethylamino)methyl ]

- 1

- (3

- methoxyphenyl)cyclohexanol. Tramadol is typically

formulated as a racemic mixture identified as (± )

- cis

- 2

- [ (dimethylamino)methyl ]

- 1

- (3

-

methoxyphenyl) cyclohexanol hydrochloride. 1



# 2. REGULATORY ANALYS E S INVESTIGATED

2.1 E XECUTIVE 

# O RDERS 

# 12866 AND 

# 13563

Pursuant to Executive Order 12866 of September 30, 1993 (58 FR 51735), an agency

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

1 

## For simplicity’s sake, from this point forward in the document, “tramadol” is used to refer to

2

- [(dimethylamino)methyl]

- 1

- (3

- methoxyphenyl)cyclohexanol, its salts, isomers, salts of isomers, and all isomeric configurations of possible forms.



# 4

# Regulatory Affairs (OIRA) a regulatory impact analysis for “significant regulatory

actions.”

[A] “significant regulatory action” [is] any regulatory action that is likely to result in a rulemaking that may: (1)
have an a nnual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communitie s; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients
ther eof; or (4) raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in [Executive Order 12866]. 2



# For purposes of E xecutive O rder 12866, “regulatory action” “means any substantive

action by an agency (normally published in the Federal Register ) that promulgates or is

expected to lead to the promulgation of a final rule or regulation, including notices of

inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking.” 3



# Of note, however, in the context of CSA scheduling actions is the fact that Executive

Order 12866 excepts from the meaning of a “regulation” or “rule”: (1) “regulations or

rules issued in accordance with the formal rulemaking provisions of 5 U.S.C. 556, 557;”

and (2) “any other category of regulations exempted by the Administrator of OIRA.” 4



# Pursuant to these categorical exemptions, DEA actions concerning the scheduling of

controlled substances are exempt from the centralized review requirements of E xec utive

2 

## Executive Order 12866

, sec. 3(f).

3 

## Id. , sec. 3(e).

4 

## Id. sec. 3(d). (Sec. 3(d) also exempts from the definition of regulation or rule regulations or rules that pertain to military or foreign affairs fun ction of the United States, other than procurement regulations and regulations involving the import or export of non

- defense articles and services; and regulations or rules that are limited to agency organization, management, or personnel matters.).



# 5

# O rder 12866. 5 

# Executive Order 13563 (76 FR 3821, Jan. 21, 2011) affirms and

supplements Executive Order 12866.

2.2 R EGULATORY 

# F LEXIBILITY 

# A CT



# The Regulatory Flexibility Act (RFA) 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. 6 

# “The RFA

does not seek preferential treatment for small entities, require agencies to adopt

regulations that impo se the least burden on small entities, or mandate exemptions for

small entities. Rather, it requires agencies to examine public policy issues using an

analytical process that identifies, among other things, barriers to small business

competiveness and see ks a level playing field for small entities, not an unfair

advantage.” 7



# The RFA applies to any rule requiring publication of a general notice of proposed

rulemaking under section 5 U.S.C. 553(b) of the Administrative Procedure Act or any

other law. Thre e types of small entities are defined in the RFA: small businesses, small

organizations, and small governmental jurisdictions. Pursuant to sec tion 601(3) of the

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

concern” unde r sec tion 3 of the Small Business Act. A small business concern is an

enterprise that is “independently owned and operated” and “not dominant in its field of

5 

## 21 U .S.C. 811(a) (“Rules of the Attorney General under this subsection shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by subchapter II of chapter 5 of Title 5.”); see also letter from Sally Katzen, Administrator, OIRA, OMB to Eleanor D. Acheson, Assistant Attorney General, OPD, USDOJ (Feb. 4, 1994) (exempting from OMB review requirements of EO 12866 DEA rulemaking actions concerning the scheduling of controlled substances which are made on the record after opportunity for a hearing pursuant to the Administrative Procedure Act).

6 

## Pub. L. 96

- 354, 94 Stat. 1164 (1980) (codified at 5 U.S.C. 601).

7 

## SBA O FFICE OF 

## A DVOCACY



## , A G UIDE FOR 

## G OVERNMENT 

## A GENCIES 

## : H OW TO 

## C OMPLY WITH THE


## R EGULATORY 

## F LEXIBILITY 

## A CT 

## 1 (May 2012).



# 6

# operation.” 8 

# Under the authority of the Small Business Act, the Small Business

Administration (S BA) Administrator has established standards to be used in the

determination of a small business concern. 9 

# SBA size standards have been established

for the types of economic activity or industry utilizing the North American Industry

Classification System ( NAICS) classifications. The SBA sets the maximum size

standards

— in millions of dollars or number of employees

— allowed for concerns

(including their affiliates) to be designated as small. 10 

# Section 601(4) of the RFA defines

a small organization as any not

- for

- profit enterprise that is independently owned and

operated and not dominant in its field. Section 601(5) of the RFA defines small

governmental jurisdictions as governments of cities, counties, towns, townships, villages,

school districts, or special d istricts with a population of less than 50,000. Most DEA

registrants are small businesses or employed by small businesses as defined under the

RFA; therefore, f or the purposes of this analysis, the terms “business” and “entity” are

used interchangeably.

2 .3 U NFUNDED 

# M ANDATES 

# R EFORM 

# A CT OF 

# 1995

The Unfunded Mandates Reform Act (UMRA) 11 

# was enacted to avoid imposing

unfunded Federal mandates on State, local, and tribal governments (SLTG s ), or the

private sector. Most of UMRA’s provisions apply to proposed and final rules:

8 

## 15 U.S.C. 632.

9 

## Id. ; See also S IZE STANDARDS 

## D IVISION



## , O FFICE OF 

## G OV 

## ’ T 

## C ONTRACTING 

## &B USINESS 

## D EVELOPMENT



## , SBA S IZE 

## S TANDARDS 

## M ETHODOLOGY 

## (April 2009) (available at http://www.sba.gov/site/default/files/size_standards/methdology.pdf ) (describing SBA methodology for establishing and adjusting its small business size standards pursuant to the Small Business Act and related legislative guidelines).

10 

## 13 CFR 121.201.

11 

## Pub. L. 104

- 4, 109 Stat. 48 (1995) (codified at 2 U.S.C. 1501 et s eq.).



# 7

## • 

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

• 

# that include a Federal mandate that may result in the expenditure of funds by SLTGs, in the aggregate, or by the private sector of $100 million or more in

any one yea r , adjusted for inflation.

2.4 C ONGRESSIONAL REVIEW ACT OF 

# 1996

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 Sta tes (head of the United States Government Accountability

Office). 12 

# Rules 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.

3. A NTICIPATED ECONOMIC IMPACT OF REGULATORY ACTION

3.1 G ENERAL 

# R ELATIONSHIP BETWEEN 

# R EGISTRATIONS 

# , E NTITIES 

# , AND 

# S MALL


# E NTITIES



# DEA registrations are held by a variety of persons, including businesses such as

manufacturers, distributors, and pharmacies, as well as individuals such as practitioners

and mid

- level practitioners. 13 14 

# It is very common for businesses and individuals to hold

12 

## Pub.L. 104

- 121, sec. 251, 110 Stat. 847 (1996) (codified at 5 U.S.C. 801

– 808).

13 

## For the purposes of this Economic Impact Analysis, “ practitioner” means an individual registered with the DEA as a “practitioner” (physicians, veterinarians, podiatris ts, dentists) but does not include hospitals/clinics, pharmacists, pharmacies, or mid

- level practitioners as defined below.



# 8

# more than one registration, such as where a registrant handles controlled substances at

multiple locations or engages in mul tiple types of DEA registered activities. However,

RFA requirements and SBA size standards are applicable to entities and businesses.

Because the DEA does not, in the general course of business, collect or otherwise

maintain information regarding associa ted or parent organizations holding multiple

registrations, the DEA needs some way of correlating and applying the parameters of the

RFA and corresponding SBA size standards to DEA registrations (i.e., develop a

relationship between the number of registrat ions and the number of entities).

The DEA estimates the number of entities represented by the number of DEA

controlled substance registrations by relating NAICS classification data to the various

DEA business activity registration types. Utilizing this information, the DEA broadly

classifies registrations into two categories: (1) registrations associated with industries

where very few businesses in the industry are DEA registrants; and (2) registrations

associated with industries where most businesses i n the industry are DEA registrants.

The first category includes manufacturers, distributors, importers and exporters. Only a

small fraction of all businesses engaged in these activities across the United States are

DEA registrants. The second category i ncludes pharmacies, hospitals/clinics, offices of

physicians, etc. In contrast to the first category, nearly all the businesses engaged in

these activities across the United States are DEA registrants, employ registrants, or

represent multiple registratio ns. Based on this information, the DEA utilizes certain

assumptions unless more specific business information is readily available.

14 

## For the purposes of this Economic Impact Analysis, “ mid

- level practitioner” means an individual registered with the DEA as a “mid

- level practitioner” but does not include practitioners as defined above. Examples of mid

- level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialist s , and physician assistants.



# 9

# • The DEA estimates a 1

- to

- 1 entity

- to

- registration ratio for manufacturers, distributors, and importers/exporters (“category 1”).

• The DEA utilizes the number of entities in the NAICS codes as an estimate for the number of entities for pharmacies, hospitals/clinics, offices of physicians, etc. (“category 2”). Specifically, the DEA estimates:

o A 0.74

- to

- 1 entity

- to

- registrati on ratio for pharmacies; and

o A 0.23

- to

- 1 entity

- to

- registration ratio for practitioners, mid

- level practitioners, and hospitals/clinics (combined).

More in

- depth information on this topic is found in appendix A, which details the specific

methodology u sed by the DEA to determine the entity

- to

- registration ratios and the

percentages of entities that are small entities.

3.2 A FFECTED 

# E NTITIES



# 3.2.1 Number of Tramadol Handlers (Registrations)

The placement of tramadol into s chedule 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. Commercially available data shows that i n 2012 nearly 40 million

prescriptions for tramadol were written

. 15 

# Tramadol handlers primarily include:

manufacturers, distributors, importers, exporters, pharmacies, practitioners, mid

- level

practitioners, and hospitals/clinics. For the purposes of this analysis the DEA assumes all

legally operating manufact urers, distributors, importers/exporters, pharmacies,

practitioners, mid

- level practitioners, and hospitals/clinics that handle tramadol are

registered with the DEA and all distributors, importers/exporters, pharmacies,

practitioners, mid

- level practitione rs, and hospitals/clinics registered with the DEA are

tramadol handlers. While the number of DEA registrations forms the basis of the number

15 

## IMS Health, National Sales PerspectiveTM (NSP).



# 10

# of businesses affected by this rule, the number of manufacturers affected by this rule is

based on industry data.

The estimated 63 manufacturers are based on IMS Health , National Sales

PerspectiveTM (NSP) data for tramadol manufacturers. As stated in the economic analysis

that accompanied the published NPRM, a ll 63 manufacturers are estimated to be DEA

registrants for purposes of this economic analysis. T he DEA was unable to confirm with

100% c ertainty the current DEA registration status for each manufacturer listed on the

IMS Health report due to possible discrepancies between legal names and doing

business

- as names

. The DEA additionally notes that the list of manufacturers obtained

using IMS Health data varies from the list of approved tramadol applications posted on

the FDA’s website. However, such discrepancies, are understood as resulting from a

combination of the above factors combined with those associated with industry practices

of contract manufacturing of drugs and corporate affiliations, and the DEA believes such

discrepancies do not result in any material consideration that would affect the analysis.

T he DEA’s stated assumption in the analysis accompanying the NPRM that all

manufacturers of tramadol are currently registered with the DEA was not contradicted by

commenters. Therefore, the DEA concludes that its working model proposed in the

NPRM that all tr amadol manufacturers are currently registered, did not need

modification.

The DEA considers non

- registered pharmacies as being outside the scope of this

analysis. The DEA is aware of Web sites currently offering “free online physician

consultation and pre scriptions” that are filled by “ affiliate pharmacies” for shipment of

tramadol. However, many, if not all, of these “pharmacies” are operating from outside

11

# the United States and the DEA did not receive comments from any I nternet pharmacies,

or pharmacies asserting affiliations with such Web sites, in response to the published

NPRM or posted supporting materials. In addition, as of May 1, 2014, there are no

pharmacies registered with the DEA to dispense controlled substances by means of the

Internet pursua nt to 21 U.S.C. 823(f). Without additional information or considerations

provided by research or commenters to the contrary , the DEA concludes these businesses

will not be significantly impacted by the rule. All pharmacies desiring to offer, or to

contin ue to offer, tramadol for sale, delivery, distribution, or dispensing by means of the

Internet upon implementation of the final rule must register with the DEA, and provide

the notifications required by 21 CFR 1304.40

. They must comply with applicable Web

site disclosure requirements of 21 CFR 1304.45 and 1304.50 and reporting requirements

specific to online pharmacies offering controlled substances for sale, delivery,

distribution, or dispensing by means of the Internet , 21 CFR 1304.55, in addition to

compliance with general handling requirements for pharmacies and/or distributors.

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

of those registrations are in the 10 S tates that already control t ramadol as a s chedule I V

controlled substance under S tate law with requirements that meet or exceed the DEA ’s

requirements for s chedule IV controlled substances . These S tates include Arkansas,

Illinois, Kentucky, Mississippi, New Mexico, New York, North Dakota, Oklahoma,

Tennes see, and Wyoming

. 16 

# Therefore, only 1,195,578 registrations are estimated to be

economically impacted by this rule.

16 

## A RK



## . C ODE 

## A NN



## . § 5

- 64

- 210; 720 I LL 

## .C OMP 

## .S TAT 

## . 570/210; 902 K Y 

## .A DMIN 

## .R EGS



## . 55:030; M ISS



## . C ODE


## A NN



## . § 41

- 29

- 119; N.M. A DMIN



## . C ODE 

## § 16.19.20; N.Y. Public Health Law §3306 (McKinn ey (2013));



# 12

# Table 1 provides the estimated breakdown of number of tramadol handlers by DEA

registrations

, business activity

, and control by S tate law

.

Table 1

. N o. of Tramadol Handlers by Registered DEA Business Activity and Control by State Law

Business Activity N umber of Reg istrations in States

where Tramadol
Controlled w/ Federal
schedule

- IV requirements N umber of Reg istrations
in States where

Tramadol Not
Controlled w/ Federal
schedule

- IV requirements 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 

## Source: DEA, June 2013.



# 3.2.2 Number of Entities and Small Entities Handling Tramadol

As previously summarized, and as explained in detail in appendix A, the DEA utilizes

an entity

- to

- registration ratio to estimate the number of businesses represented by the

number of DEA registrations where specific data is not readily available. For

manufacturers, distributors, importers, and exporters, the DEA assumes a 1

- to

- 1 entity

- to

registration ratio. For pharmacies and “ot her” 17 

# registrants, where businesses are more

likely to hold multiple registrations, employ multiple registrants, or engage in controlled

substance activities at multiple locations, the DEA utilizes the number of businesses

reported under the potentially im pacted NAICS classification codes in the most recent

United States Economic Census (currently the 2007 Economic Census) to represent the

N.D. A DMIN



## . C ODE 

## 19

- 03.1

- 11; O KLA



## . S TAT



## . A NN



## . tit. 63, § 2

- 210; T ENN



## . C ODE 

## A NN



## . § 39

- 17

- 412; W YO



## . S TAT



## . A NN



## . § 35

- 7

- 1020.

17 

## Because individual practitioners and mid

- level practitioners primarily work in various physician and health care specialist offices as well as hospitals and clinics, the analysis in appendix A groups individual practitioners, mid

- level practitioners, and hospitals/clinics, a s “other.”



# 13

# number of businesses represented by DEA registrations. Comparing economic census

data for the number of employees and annual revenue with SBA size standards for each

potentially impacted NAICS code, the DEA estimated the percentage of businesses

(represented by DEA registrations) that are small businesses. Table A1 in appendix A

summarizes the relationship among controll ed substance registrations, entities, and small

entities. The number of DEA registrations changes daily and the number of registrations

in table 1 above can vary from the number of registrations in table A1 used to determine

the entity

- to

- registration rat io. However, the analysis contained in appendix A is updated

at least annually and any difference in the number of registrations between table 1 above

and table A1 has negligible impact on the entity

- to

- registration ratio.

To estimate the number of entiti es that are affected by the action to schedule

tramadol , the DEA applied the entity

- to

- registration ratio for that registration category

(other than manufacturers). Applying the 1

- to

- 1 entity

- to

- registration ratio for

distributors , importers, and exporter s , the DEA estimates that the 1,466 registrations

correspond to 1,466 entities. Applying the 0.74 ratio for pharmacies, the DEA estimates

that 68,738 registrations correspond to 50,756 entities. Applying the 0.23 ratio for

practitioners, mid

- level practi tioners, and hospitals/clinics (combined), the DEA

estimates that the 1,398,796 ( 1,156,285 practitioner + 226,687 mid

- level practitioner +

15,824 hospital/clinic) registrations correspond to 324,619 entities that employ

individuals holding individual pract itioner, mid

- level practitioner, or hold hospital/clinic

registrations. Based on research of DEA records and multiple subscription

- based and

public data sources, the DEA estimates that the 63 manufacturer registrations correspond

to 63 entities. In total , the DEA estimates that 1,469,063 registrations w ill be affected by

14

# the rule , corresponding to 376,904 entities affected by the scheduling of tramadol as a

schedule IV controlled substance under the CSA. Table s 2 and 3 contain the analysis, by

the DEA business activity, of the estimated number of affected entities and affected small

entities utilizing the applicable entity

- to

- registration ratios.

To determine the number of small manufacturer entities, the DEA estimated the

number of employees and annu al revenue and noted the NAICS code for each of the 63

affected manufacturer entities based on research of DEA records and multiple

subscription

- based and public data sources. Using the SBA size standard for the

respective NAICS code s , the DEA estimates t hat 55 of the 63 affected manufacturers are

small entities. 18



# For the remaining affected business activities, the DEA used the percentage of

businesses below SBA size standards, as explained in appendix A, to determine the

number of affected businesses belo w SBA size standards (i.e., the number of businesses

represented by DEA registrations that are small businesses). Applying the percentage

(96.7%) of small entities to distributors

, importers, and exporters , the DEA estimates that

1,418 of the 1,466 affect ed distributors , importers, and exporters are small entities.

Applying the percentages of 98.6 % for pharmacies and 97.2 % for practitioners, mid

- level

practitioners and h ospitals/clinics, the DEA estimates that 50,032 of 50,756 pharmacies

and 315,541 of 32 4,619 entities that employ practitioners, mid

- level practitioners, or hold

hospital/clinic registrations are small entities. In total, the DEA estimates that 367,046

( 97% ) of 376,904 affected entities are small entities.

18 

## Relevant data was not found for nine of 63 manufacturers. All nine were assumed to be small

businesses.



# 15

# In States 19 

# where tramadol is not already subject to controls e quivalent to Federal

schedule IV handling requirements under S tate law, the DEA estimates 306,375

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

estimated to be smal l businesses. As State requirements for schedule IV controlled

substances meet or exceed DEA requirements, business es in these States are estimated to

incur negligible economic impa ct as a result of this rule. Therefore, the DEA estimates

that 298,354 sm all businesses would be economically impacted by this rule. Table 2 lists

the estimated number of affected small entities by business activity for all States. Table 3

lists the estimated number of affected small entities by business activity for States w here

tramadol is not already subject to Federal schedule IV handling requirements.

Table 2 . Number of Affected Entities and Small Entities (all States) Business Activity N umber of Reg istrations Entity

- to

Reg istration
Ratio N umber of
Entities Percent of
Small
Entities Number of
Small
Entities

Manufacturer 63 N/A 63 N/A 55 Distributor/Importer/Exporter 1,466 1.00 1,466 96.7 1,418 Pharmacy 68,738 0.74 50,756 98.6 50,032

Practitioner 1,156,285

0.23 324,619 97.2 315,541 Mid

- level Practitioner 226,687 Hospital/Clinic 15,824

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



## Table 3 . Number of Affected Entities and Small Entities (Tramadol not C ontrolled as Federal
Schedule IV E quivalent under State L aw)

Business Activity Number of Reg istrations Entity

- to

Reg istration
Ratio N umber of
Entities Percent of
Small
Entities Number of
Small
Entities

Manufacturer 51 N/A 51 84.3 43 Distributor/Importer/Exporter 1,175 1.00 1,175 96.7 1,137 Pharmacy 55,251 0.74 40,797 98.6 40,215

Practitioner 947,103

0.23 264,352 97.2 256,959 Mid

- level Practitioner 178,422 Hospital/Clinic 13,576

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

19 

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



# 16

# 3.3 A NNUAL COST OF THE RULE



# Upon implementation of this final rule

, all persons who handle or propose to handle

tramadol w ill be subject to the CSA ’s regulatory controls applicable to schedule IV

controlled substances and may be subject to administrative, civil

, and /or criminal action

.

3.3.1 Costs Associated with Registration Requirements

As stated previously in s ection 3.2.1 , 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 would be required to apply for a DEA registration, the DEA estimates there will

be no registration costs as a result of this rule.

3.3.2 Costs Associated with Security Requirements

In accordance with 21 CFR 1301.71(a): “All applicants and registrants shall provide

effective controls and procedures to guard against theft and diversion of controlled

substances. In order to determine whether a registrant has provided effective controls

against diversio n, the Administrator shall use the security requirements set forth in

§§ 1301.72

– 1301.76 as standards for the physical security controls and operating

procedures necessary to prevent diversion. ” The DEA’s estimated costs associated with

such physical secu rity controls are outlined in the following subsections.

Manufacturers

T he DEA assumes current manufacturers of tramadol are DEA registrants and

therefore already have facilities that meet or exceed the security controls required by 21

CFR part 1301 for schedule IV controlled substances. Many of these manufacturers are

likely to have sufficient space in their existing vaults and/or cages to accommodate the

17

# addition of tramadol. However, the DEA understands that some current manufacturers

may need to mak e modification s to manufacturing and storage facilities. Due to the

uniqueness of each business, the DEA cannot specifically account for potential

modifications that may be required. However, based on its understanding of

manufacturer operations

, facilit ies , and existing security controls and procedures

,

including those related to suspicious orders and reporting of theft and losses, the DEA

assumes any costs associated with such modifications, if needed, are nominal

. While the

DEA recognizes that other steps may be involved, the DEA understands c osts associated

with such modifications w ill be primarily limited to one

- time expenditures for re

organizing existing stock in the vaults and cages to make room for tramadol and costs

associated with actually mov ing the product

. Due to costs directly associated with the

manufacturing of pharmaceuticals as well as indirect costs associated with security and

general overhead, the DEA assumes that manufacturers , traditionally for

- profit

businesses

, seek to maximize profits, in part by limit ing excess stock of pharmaceuticals,

including tramadol

, to that which they can readily sell. Not only does this prevent the

necessity of increased costs associated with storage, but will also decrease the amount of

available product that is potentially available for theft and diversion in accordance with

21 CFR 1301.71(a). Costs associated with self

- initiated

, contemporaneous evaluation of

storage and security for other products and equipment that do not directly result from the

scheduling of tramadol is outside the scope of this rulemaking and are not factored into

the economic costs associated with this rule making.

18

# 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. For purposes of this analysis, the DEA assumes that

50% of distributors, importers, and exporters have existing controlled substance storage

areas to store tramadol at negligible cost. While the DEA believes this requirement

affects far less than half of distributors , importers, and exporters, the DEA utilizes the top

half of the likely range to be conservative. The DEA’s understanding that far fewer than

50% of distributors, importers, and exporters will actually be affected by physical

security requirements is supp orted by comments from industry, with a leading national

association representing distributors stating in response to the published NPRM that most

of their members “believe that currently, there is adequate space within their warehouse

cages to store the a nticipated volume of tramadol products that will be subject to the

physical security requirements. Thus, for [ association ] members, construction or

expansion of cage space is unlikely to result from a tramadol scheduling decision. ” The

DEA has estimated the cost of additional secure storage space for the remaining 50% that

may require expansion

.

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

depending on size, the addition of an enclosure with self

- closing and self

- lock ing 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, import er, or exporter that

19

# requires addi tional secure storage space in order to continue to handle 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 bu sinesses 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 sec ure storage space is the same for all distributors,

importers, and exporters.

Hospitals/Clinics

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

maintain an inventory of s chedule IV controlled substances and have existing con trols

against diversion that meet DEA regulatory requirements. If the inventory of tramadol is

not already stored in a secured area appropriate to schedule IV controlled substances at

these locations in accordance with the physical security controls for practitioners in 21

CFR 1301.75(b)

, the DEA assumes, based on its understanding of hospital/clinic

operations and facilities, transferring the tramadol inventory to a secure storage area may

be accompl ished at negligible cost. In accordance with 21 CFR 1301.75(b), institutional

practitioners may disperse controlled substances , including tramadol, throughout the

stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of

the controlled substances as an alternative to being stored in a substantially constructed

cabinet. Depending on the individual stocks carried by a particular hospital/clinic of

tramadol and other pharmaceuticals, as well as their local security practices , in many

cases this will mean that no changes will be required at all. However, if a hospital/clinic

20

# carries larger stocks of tramadol tha n have been used as non

- controlled stock into which

controlled substances are dispersed in accordance with 21 CFR 13 01.75(b), it may

require a slight rearrangement so tha t disbursement of tramadol and other controlled

substance s meet the requirements of the regulation.

Pharmacies

The DEA assumes all registered pharmacies currently handle s chedule IV controlled

substance s and maintain secure storage areas for s chedule IV controlled substances , in

accordance with the physical security controls for practitioners in 21 CFR 1301.75(b)

.

The DEA assumes based on its understanding of pharmacy operations and facilities

, costs

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

In accordance with 21 CFR 1301.75(b), pharmacies may disperse controlled substances

,

including tramadol, throughout the stock of noncontrolled substances in such a mann er as

to obstruct the theft or diversion of the controlled substances as an alternative to being

stored in a substantially constructed cabinet. Depending on the individual stocks carried

by a particular pharmacy of tramadol and other pharmaceuticals, as w ell as their local

security practices, in many cases this will mean that no changes will be required at all.

However, if a pharmacy carries larger stocks of tramadol tha n have been used as non

controlled stock into which controlled substances are disperse d in accordance with 21

CFR 1301.75(b), it may require a slight rearrangement so that disbursement of tramadol

and other controlled substance s meet the requirements of the regulation.

Practitioners and Mid

- level Practitioners

The DEA assumes all registered practitioners currently handle s chedule IV controlled

substances and maintain secure storage areas for s chedule IV controlled substances at a

21

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

practitioners are est imated to maintain smaller quantities of tramadol, the DEA believes

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

requirements at negligible cost. The DEA believes that a registrant may incur a one

- time

cost for t he placement of a lock, but that this or any other such costs for practitioners to

comply with the additional physical security requirements for tramadol will be negligible.

3.3.3 Costs Associated with Labeling and Packaging Requirements

As of the effective date of the final rule, pursuant to 21 U.S.C. 821, 825, 871(b), and

958(e) and i n accordance with 21 CFR 1302.03 , m anufacturer s are required to print upon

the labeling of each commercial container of tramadol distributed by him the designation

of tramadol as “C

- IV.” It shall be unlawful for commercial containers of tramadol not

bearing the labeling requirements properly identifying it as a schedule IV controlled

substance in accordance with 21 CFR part 1302 to be distributed. As clearly stated i n 21

CFR 1302. 05 , “[a]ll labels on commercial containers of, and all labeling of, a controlled

substance which either is transferred to another schedule or is added to any schedule shall

comply with the requirements of § 1302.03, on or before the effective date established in

the final order for the transfer or addition.” Accordingly, t he DEA is requiring that

commercial containers of tramadol distributed on or after 45 days from the date of

publication of the final rule be labeled as “C

- IV” and be package d in accordance with 21

CFR part 1302.

Manufacturers

The DEA assumes that the activity of manufacturers making labeling changes is

routine and in their normal course of business. The DEA additionally notes the

22

# promotion and use of digital/print on

- demand technology by industry enabling just in

time printing that allows for small lead times and reducing or eliminating “over

- runs” and

excess pre

- printed label stock. The DEA therefore assumes that the cost of making this

change is nominal. Additionally, as discussed in the final rule, the DEA assumes that 45

days is a reasonable amount of time for the products with pre

- control labeling to be

distributed without supply disruption. Correspondingly, the DEA estimates that the cost

o f the labeling and packaging requirements of this rule for manufacturers is nominal.

Distributors

The DEA believes 45 days will be a reasonable amount of time for distributors to sell

existing stock with pre

- control labeling and packaging and to restock in ventory with post

control labeling and packaging. From the 2007 Economic Census, the DEA estimates

that the inventory turnover ratio for the pharmaceutical distribution industry 20 

# is

approximately 11.3. From the census, the inventory turnover ratio of 11. 3 was c alculated

by dividing the 2007 “ cost of goods sold ” for the industry of $280,481,051,000 by the

average end

- of

- year 2006 total inventories of $24,426,676,000 and 2007 total inventories

of $25,138,994,000 (average $24,782,835,000). The 11.3 inventory turnover ratio

equates to an average of 32 days to sell inventory. 21 

# The 11.3 turnover ratio is consistent

with that of large distributors where financial information was publicly available and

reviewed. This inventory turnover ratio is a reasonable estimate for the entire industry

and all products under the circumstances

. Publically reviewed data report that about 85%

of all revenues (an indirect indicator of dosage units moved) from drug distribution in the

20 

## 2007 Economic Census, NAICS 424210

- Drugs and druggists' sundries merchant wholesalers, Merchant wholesalers, except manufacturers' sales branches and offices.

21 

## Inventory turnover is a measure of how many times inventory is sold or used in a year. Average days to sell inventory = 365 days/Inventory Turnover Ratio.



# 23

# United States come from three public wholesalers , each with annual revenue in the

billions

. The DEA additionally notes that many regional and special ty pharmaceutical

wholesalers have been acquired by the largest three distribution companies. Because the

32 days to sell inventory is an average based on industry

- wide census data, i t is possible

for an in dividual company and/or product line to have shorter or longer time to sell. The

DEA believes 45 days will be a reasonable amount of time for distributors to sell existing

stock with pre

- control labeling and packaging and to restock inventory with post

- co ntrol

labeling and packaging. Additionally, the DEA believes that any distributor that requires

more than 45 days to sell tramadol inventory under normal circumstances can make

minor modifications to ordering and stocking procedure for a transitional peri od to meet

the established effective date at nominal cost.

Although the DEA considers this will likely be uncommon, in the event that a

distributor does find themselves with pre

- control labeled tramadol product after the

effective date of the final rule, the DEA notes that distributors do have the option of

returning excess stock of pre

- control labeled tramadol product to the manufacturer, as

authorized by 21 CFR 1307.12. The DEA assumes that the activity of manufacturers

receiving returned products stoc k for possible repackaging and/or relabeling is routine

and in their normal course of business. The DEA therefore assumes that the cost of

making this change is nominal.

Pharmacies

Labeling requirements for commercial containers do not apply to commerci al

containers that are not being distributed (e.g., that are in pharmacies for dispensing only).

21 CFR 1302.03 requires that the manufacturer print the required symbol on the labeling

24

# of only those products that the manufacturer packages after the establ ished effective date.

It does not require pharmacies to return stocks to the manufacturer for relabeling.

Accordingly, the cost of the labeling and packaging requirements of this rule for

pharmacies is nominal.

3.3.4 Costs A ssociated with R ecordkeeping and Reporting R equirements

Initial and biennial inventories are required for all schedule II

- V controlled

substances pursuant to 21 U.S.C. 827, 958 and in accordance with 21 CFR 1304.03,

1304.04, and 1304.11. In accordance with the CSA, every DEA registrant must maintain,

on a current basis, a complete and accurate record of each controlled substance

manufactured, received, sold, delivered, or otherwise disposed of. 21 U.S.C. 827(a).

These records must be maintained separately from all other records of the registrant, or

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

ordinary business records of the registrant. 21 CFR 1304.04 (f)(2) and (h)(3) . The

records must be kept and be available for at leas t two years for inspection and copying by

officers or employees of the Attorney General. 21 U.S.C. 827(b)(3). T he DEA assumes

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

controlled substance transactions , in fur therance of their regulatory responsibilities

.

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 r egistrants, the DEA estimates that there will be no

economic impact beyond the addition and initial and biennial inventory of registrants’

25

# tramadol stock pursuant to the inventory requirements in 21 CFR 1304.11. The costs

associated with inventory and recordkeeping requirements of the rule are estimated

below.

Inventory Management System Modification

The DEA estimates that a one

- time modification will be required to add tramadol to a

registrant’s existing controlled substance inventory management system . Varying

degrees of automation are expected among the affected entities. “Inventory management

system” is used generically to refer to a mix of automated and manual processes used to

manage inventory. For some registrants, the one

- time modification may be changes to

paper forms. For some registrants, the one

- time modification will require technical

personnel to make changes to a computerized system. For the purposes of this analysis,

the DEA estimates that the cost of the one

- time change is the same r egardless of the

registrant’s business activity and regardless of the existing inventory management

system.

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

substance inventory management system, the registrant may incur a on e

- 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 that the median wage of a Computer Programmer in the United St ates is

$35.71 per hour 22 

# and an additional 42.25% load 23 

# on the labor rate to account for

benefits. The DEA estimates that modifying an existing system to accommodate the

22 

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

. 23 

## Bureau of Labor Statist ics, “Employer Costs for Employee Compensation

– September 2013” reports that benefits for private industry is 29.7% of total compensation. The 29.7% of total compensation equates to 42.25% (29.3% / 70.3%) load on wages and salaries.



# 26

# integration of tramadol into a current inventory management system would be

accomplis hed in four hours for a total one

- time cost of $203.19 (4 hours x [$35.71 per

hour + $35.71 x 0.4225 load]) for each affected entity

.

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

e stimates 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

hourl y wage for “Bookkeeping, Accounting, and Auditing Clerks” and “Receptionists

and Information Clerks” which are $16.91 and $12.49, 24 

# respectively. The combined

hourly rate of $29.40 , plus an additional 42.25% load on the labor rate to account for

benefits 25 

# for a period of one hour is $41.82 (1 hour x [$29.40 per hour + $29.40 per hour

x 0.4225 load]) . 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 $ 41.82 for each aff ected

entit y

.

Biennial Inventory

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

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

tramadol will be the same as the initial inventory

, $ 41. 82 every two years

.

24 

## Bureau of Labor St atistics, http://www.bls.gov/oes/current/oes_nat.htm

. 25 

## See note 24.



# 27

# 3.3.5 Costs Associated with Prescription Requirements

The prescribing practitioner or mid

- level practitioner must be authorized by the

jurisdiction in which they practice and registered with the DEA to prescribe schedule IV

controlled substances. A prescription for a controlled substance to be effective must be

issued for a legitimate medical purpose by an individual practitioner acting in the usual

course of professional practice. 21 CFR 1306.04. As tramadol currently requires a

pr escription

, many States have limits on refills based on State law that may exceed that

allowed under federal law for schedule IV controlled substances. 2 1 CFR 1306.22(a)

states that n o prescription for a controlled substance listed in s chedule III or IV shall be

filled or refilled more than six months after the date on whic h such prescription was

issued; and n o prescription for a controlled substance listed in s chedule III or IV

authorized to be refilled may be refilled more than five times. Al though there may be

differences in the pre and post

- control refill requirements for tram a dol, the DEA

estimates that any limitation in the number of refills can be overcome with new

prescriptions so long as there exists a doctor

- patient relationship and th e new prescription

is issued for a legitimate medical purpose by a practitioner acting in the usual course of

his professional practice

. Any additional prescription

- related recordkeeping and/or

administrative responsibilities imposed on pharmacists and/or prescribers as a result of

scheduling tramadol should be minimal given that all affected pharmacists and providers

are already DEA registrants and are knowledgeable about schedule IV handling

requirements

— including those associated with prescribing schedu le IV controlled

substances. T herefore, any cost associated with prescription requirements is nominal.

28

# 3.3.6 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 s chedule IV of the CSA may increase the volume of material that

registrants will need to dispose of through a reverse distributor. However, as tramadol is

not currently a controlled substance, the DEA does not have information on the volume

of tramadol currently disposed of, thus cannot determine what the increase in s chedule IV

contr olled 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 exi s ts, will

be negligible

.

3.3.7 Cost Summary and Annualized Cost

In summary, the DEA estimat es there will be one

- time and on

- going costs to

businesses that are affected by the control of tramadol as a schedule IV controlled

substance

. These economic impacts would be associated with storage and inventory and

recordkeeping requirements.

The DEA es timates that the 306,375 economically affected businesses will incur non

recurring costs totaling $ 2 45.01 and biennially recurring cost s of $ 41.48

. (The $ 41.48

cost of the biennial inventory does not occur until two years after implementation of the

rule.) Furthermore, 50% of d istributors, i mporters, and e xporters are estimated to incur

29

# an additional non

- recurring cost of $10,000 for storage requirements

. T abl e 4

summarizes the non

- recurring costs.

Table 4 . Non

- recurring costs associated with controlling tramadol under schedule IV of the CSA Cost Category Manufacturer, Pharmacy, Practitioner, Mid

- level Practitioner, Hospital,

Clinic, an d 50% of Distributor, Importer, and Exporter* ($) 50% of Distributor, Importer, and

Exporter* ($)

Registration

- - Storage

- 10,000.00

Inventory and Recordkeeping

System Modification 203.19 203.19

Initial Inventory 41.82 41.82

Disposal

- -

Total 245.01 10,245.01 

## * 50% of d istributor s / i mporter s / e xporter s are assumed to have enough storage and will not incur additional cost of storage.



# The annual cost of the final 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

. 26 

# For the distributors, importers, and exporters that need additional storage space,

the DEA estimates the present value of cost of th e final rule to be $ 10,459.05 and

$ 10,551

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

$ 987.26 for $ 10,459.05 total present value of cost in equal annual payments at 7% rate

for 20 years, and $ 709.23 for $ 10,551

. 51 total present value of cost in equal annual

payments at 3 % rate for 20 years.

26 

## 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, Sept. 17, 2003. Also “Regulatory Impact Analysis: A Primer” (no date) and “Regulatory Impact Analysis: Frequently Asked Questions (FAQ)” Feb. 7, 2011, Office of Information and Regulatory Affairs (OIRA). The DEA used a 20 year time horizon for this analysis as there is no predetermined end to this rule.



# 30

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

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

be $ 459.05 and $ 551.51 at 7% and 3% discount rates, respectively. Annual cost is

estimated to be $ 43.33 for $ 459.05 total present value of cost in equal annual payments at

7% rate for 20 years, and $ 37.07 for $ 551.51 total present value of co st in equal annual

payments at 3 % rate for 20 years. T able 5 summarizes annualized cost results.

Table 5 . Annual ized Cost

* 50% of d istributor s / i mporter s / e xporter s are assumed to have enough storage and will not incur additional cost of storage.



# 3.4 A NNUAL 

# E CONOMIC 

# E FFECT ON THE 

# E CONOMY



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

number of affected businesses. In sec tion 3.2 .2

, the DEA estimated that 306,375

businesses, in States where tramadol is not controlled, were economically affected by the

rule. The a nnual cost of $ 987.26 is applied to the assumed 50% ( 588 ) of 1,175

distributor s / importer s / exporters affected by the rule. Annual cost of $ 43.33 is applie d to

remaining businesses affected by the rule: 51 manufacturer s ; 587

distributor s / importer s / exporter s ; 40,797 pharmac ies ; and 264,352 businesses that employ 50% of Distributor, Importer, and
Exporter* Year 0 Year 1 Year 2 Year 3 Year 4

... Year 19 Year 20

Storage 10,000.00 $
System Modification 203.19 $

- $

- $

- $

- $

... - $

- $
Initial/Biennial Inventory 41.82 $

- $ 41.82 $

- $ 41.82 $

... - $ 41.82 $

Total 10,245.01 $

- $ 41.82 $

- $ 41.82 $

... - $ 41.82 $

Net Present Value (7% discount rate) 10,459.05 $ Net Present Value (3% discount rate) 10,551.51 $
Annual Cost (7% rate, 20 years) $987.26 Annual Cost (3% rate, 20 years) $709.23

All Other & 50% of Distibutor, Importer,
and Exporter* Year 0 Year 1 Year 2 Year 3 Year 4

... Year 19 Year 20

System Modification 203.19 $

- $

- $

- $

- $

... - $

- $
Initial/Biennial Inventory 41.82 $

- $ 41.82 $

- $ 41.82 $

... - $ 41.82 $

Total 245.01 $

- $ 41.82 $

- $ 41.82 $

... - $ 41.82 $

Net Present Value (7% discount rate) 459.05 $ Net Present Value (3% discount rate) 551.51 $
Annual Cost (7% rate, 20 years) 43.33 $ Annual Cost (3% rate, 20 years) 37.07 $



# 31

# or hold practitioner

, mid

- level practitioner , and/or hospital / clinic registrations. To be

conservative in analysis, the higher values for annual cost s of $ 987.26 and $ 43.33 at 7%

discount rate is used rather than the annual costs of $ 709.23 and $ 37.07 at 3% discount

rate

. The total annual cos t is estimated to be $ 13,830,260 . Table 6 details t he total

annual cost calculation

.

Table 6 . Total A nnual C ost

Business Activity N umber of Reg istrations Entity

- to

Registration
Ratio Number
of
Entities N umber of
Entities

with
Economic

Impact Annual Cost per

Entity

($) Total Annual
Cost ($)

Manufacturer 51 1.0 51 51 43.33 2,210

Distributor/ Importe r / Exporter 1,175 1.0 1,175 588 987.26 580,509

587 43.33 25,435

Pharmacy 55,251 0.74 40,797 40,797 43.33 1,767,734

Practitioner 947,103

0.23 264,352 264,352 43.33 11,454,372 Mid

- level
Practitioner 178,422

Hospital/Clinic 13,576

Total 1,195,578 306,375 306,375 13,830,260



# 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.

32

# 3.5 I MPACT ON 

# S MALL 

# E NTITIES



# To comply with the RFA, the 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

.

3.5.1 Criteria for “Significant” Economic Impact

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

prescribed by external sources, the DEA uses the revenue

- based criterion for “significant

economic impact” evaluation

. T able 7 summarizes the general criteria for “significant”

eco nomic impact.

Table 7 . General Criteria for "Significant" Economic Impact

Criteria Basis Criteria Result

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



# 3.5.2 Analysis

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

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

American Industry Classification System ( NAICS ) code associated with the affected

entities. Then, using the revenue profile from the 2007 Economic Census, estimated the

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

For example, NAICS code “621111

– Office of physicians (except mental health

specialists)” would incur a n annual cost of $ 43.33 . The revenue l evel that corresponds to

$ 43.33 as 1% of revenue is $ 4,333 . Using the revenue profile for NAICS code 621111

from the 2 007 Economic Census, the number of business es with revenue less than $ 4,333

33

# is estimated ( See table 8 ). The 2007 Economic Census uses the term, “firm” 27 

# to

describe businesses. There are 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.

Table 8 : Revenue Profile for NAICS Code 621111 (Example)



# The revenue profile indicates that there are 7,415 firms with revenue less than

$100,000. Using linear interpolation for revenue range of $0 to $100,000 ([$4,333 /

$100,000] x 7,415) , the cost of the rule is estimated to be 1% or more for 321 ( 4.3 %) of

7,415 firms with revenue less th an $100,000, or (0. 2 %) of 160,034 total firms operated

for the entire year

. Use of linear interpolation, implicitly assumes that the 7,415 firms

with revenue less than $100,000 are evenly distributed across $0 to $100,000 revenue

range. One may argue tha t it is likely that there are more firms in the upper ranges of

27 

## Firm

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

S tate 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 S tate will be counted as one firm

- the firm employment and annual payroll are summed

from the assoc iated establishments. http://www.census.gov/econ/susb/definitions.html.

2007

NAICS

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

of firms

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

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

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

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

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

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

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

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

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

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

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

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



# 34

# 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 $ 4 ,333 , suggesting that only the 50% of distributor / e xporter that

need additional storage be examined for significant economic impact

. Although there is

merit to these arguments

, the DEA used linear interpolation to be conservative and to

account for possib ility that some firms may not be operating year

- round 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 eco nomic impact is based

on multiple publically available data 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 : 4.4% for d istributor/importer/exporter,

0.3% for pharmacy, and 0.3% for practitioner/mid

- level practitioner/hospital/clinic

business activities . The percentages were applied to the number of small businesses

located in States where tramadol is not controlled as a F ederal schedule IV equivalent

under State law. The DEA estimates that the rule may have a significant economic

impact on 818 small businesses: 0 manufacturers ; 50 distrib utors/ importers/exporters ;

107 pharmacies ; and 661 small practitioners/mid

- level practitioners/hospitals/clinic s

(“ other ”). See “Appendix B : Number of Businesses Whose Cost Is 1% or More of

Revenue” for the detailed analysis. T able 9 summarizes the estimated number of affected

small businesses with significant economic impact.

35

## Tabl e 9

. Number of Affected Small Entities with Significant Economic Impact in States W here

T ramadol is not Currently C ontrolled as a S chedule IV C ontrolled S ubstance under State law

Business Activity N umber of Reg istrations Entity

- to

Reg istra

tion Ratio N umber
of
Entities Percent of
Entities

Below SBA

s ize

s tandard N umber
of
Entities

Below
SBA s ize

s tandard Percent
of Small
Entities Signifi

cantly Impacted Number of
Affected

Small
Entities

with Significant
Economic

Impact

Manufacturer 51 1.0 51 84.3 43 0.0

- Distributor/ Importer/ Exporter 1,175 1.0 1,175 96.7 1,137 4.4 50 Pharmacy 55,251 0.74 40,797 98.6 40,215 0.3 107

Practitioner 947,103

0.23 264,352 97.2 256,959 0.3 661 Mid

- level
Practitioner 178,422 Hospital/
Clinic 13,576

Total 1,195,578 306,375 97.4 298,354 0.3 818



# In section 3.2.2, the DEA estimated 376,904 businesses would be affected by the rule,

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

businesses located in States where tramadol is controlled as a Federal schedule IV

equival ent under State law. Since only the businesses in States where tramadol is not

controlled under State law are impacted economically, the number of small businesses

with significant economic impact in these states also represents the number of small

busine sses with significant economic impact in all States. Therefore, this rule has a

significant economic impac t on 0 (0.0%) of 55 affected manufacturers, 50 (3.5%) of

1,418 affected distributors/importers/exporters, 107 (0.2%) of 50,032 affected

pharmacies, a nd 661 (0.2%) of 315,541 affected practitioners/mid

- level

practitioners/hospitals/clinics, totaling 818 ( 0.2% ) of 367,046 small businesses. Table 10

summarizes the percentage of small businesses significantly impacted by the final rule for

all States.

36

## Table 10

. Percentage of Small Businesses Significantly Impacted by Control of Tramadol in
Schedule IV across all of the United States



# The DEA also 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 registrant business activity. Th is estimate suggests

disproportionality, where smaller (of the small) businesses will bear a larger economic

impact as a percentage of revenue. However, the DEA believes the disproportionality

will be mitigated by business volume . A smaller business will handle a lower volume of

tramadol, thus require less secure storage.

3.5.3 Criteria for “Substantial Number”

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

prescribed by external sources, the DEA uses a general criterion based on percentage of

affected entities . Table 11 summarizes the general criteria for “ substantial ” number

.

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

30%.

Business Activity Number of Reg istration s Entity

- to

Reg istra

tion Ratio N umber
of
Entities Percent
of
Entities

Below
SBA s ize

s tandard N umber
of
Entities

Below
SBA s ize

s tandard N umber of
Affected

Small
Entities w/ Significan t
Economic

Impact Percent of
Small
Entities Significantly

Impacted

Manufacturer 63 1.0 63 87.3 55

- 0.0

Distributor/ Importer/ Exporter 1,466 1.0 1,466 96.7 1,418 50 3.5 Pharmacy 68,738 0.74 50,756 98.6 50,032 107 0.2

Practitioner 1,156,285

0.23 324,619 97.2 315,541 661 0.2 Mid

- level
Practitioner 226,687 Hospital/
Clinic 15,824

Total 1,469,063 376,904 97.4 367,046 818 0.2



# 37

## Table 11

. General Criteria for " Substantial " Number

Criteria Result

<10% of small businesses Not substantial number

10% to 30% of small businesses Possible substantial number

>30% of small businesses Substantial number



# As estimated in sec tion 3.5.2

, 818 or 0. 2 % of 367,046 affected small businesses are

expected to experience significant economic impact by the finalized rule , far below the

30% criteria for all registrant categories.

3.6. E XAMINATION OF 

# I NDUSTRY 

# S EGMENTS WITH 

# S IGNIFICANT 

# E CONOMIC 

# I MPACT



# 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.”

4. ECONOMIC ANALYSIS RESULTS

4.1 E XECUTIVE 

# O RDERS 

# 12866 AND 

# 13563

The estimated annual impac t of this rule is $ 13,830,260 ; thus, this rule will not have

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

economically significant.

4.2 R EGULATORY 

# F LEXIBILITY 

# A CT



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

entities . Specifically, the DEA examined the registration, storage, labeling and

packaging, record keeping and reporting

, prescriptions, and disposal requirements for the

367,046 small businesses estimated to be affected by the rule : 55 manufacturers, 1,4 18

distribu tors/importers/exporters, 50,032 pharmacies, and 315,541 practitioners/mid

- level

38

# p ractitioners/hospitals/clinics

. 28 

# All legally operating businesses that currently hand le

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 $ 245.01 for all businesses and an add itional

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

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

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

r equirements of the 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; 50 of 1,418 (3. 5 %) of small business distributors; 107 of 50,032

( 0. 2 %) small business pharmacies; and 661 of 315,541 ( 0. 2 %) of practitioners/mid

- level

practitioners/hospitals/clinics , totaling 818 of 367,046 (0. 2 %) of all small businesses.

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 rule will not have a significant effect on a substantial number

of these small business entities.

4.3 U NFUNDED 

# M ANDATES 

# R EFORM 

# A CT OF 

# 1995

The estimated annual impact of this rule is $ 13,830,260 ; thus will not have an annual

effect on the economy of $100 million or more

.

28 

## The practitioners and mid

- level practitioners primarily work in various physician and health care specialist offices as well as hospitals and clinics. The numbers represent the est imated number of businesses for which the registrants work.



# 39

# 4.4 C ONGRESSIONAL 

# R EVIEW 

# A CT OF 

# 199 6

The estimated annual impact of this rule is $ 13,830,260 ; thus

, the rule will n ot have

an annual effect on the economy of $100 million (adjusted for inflation) or more

.

40

# APPENDIX A: REGISTR ANT LANDSCAPE

The results of the analysis are summarized in the table A1 and detailed in the

following sections.

Table A1. DEA registrants who are Small Entities

Registrant Business Activity N umber of Registrations Est. Number of
Entities Represented by
DEA Registrants Entity

- to

Reg istration
Ratio Number of
Entities Below
SBA s ize

s tandard Percent
Small
Entities

Manufacturer 544 544 1.00 533 97.9 Distributor/Importer/Exporter 1,481 1,481 1.00 1,433 96.7 Pharmacy 69,404 51,248 0.74 50,517 98.6

Other * 

### 1,414,596 328,286 0.23 319,105 97.2

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

Note: The number of DEA registrations changes daily and the number of registrations in table 1 in the main body of

the document can vary from the number of registrations in table A1 used to determine the entity

- to

- registration ratio. However, the analysis conta ined in appendix A is updated at least annually and any difference in the number of registrations between table 1 and table A1 has nominal impact on the entity

- to

- registration ratio.

* Because individual practitioners and mid

- level practitioners primarily work in various physician and health care specialist offices as well as hospitals and clinics, this analysis groups individual practitioners, mid

- level practitioners, and hospitals/clinics, as “other.”



## DEA Registrant Population by Business Activity



# As of June 2013, the date of the current update of the entity

- to

- registration ratio, there

were 1,486,025 controlled substances registrants as shown in table A2.

Table A2. Number of Registrants by Business Activity

Registrant Business Activity Controlled Su bstances Pharmacy 69,404 Hospital/Clinic 15,899

Individual Practitioner 1,156,879 Teaching Institution 318

Mid

- Level Practitioner 22,826

Researcher/Canine Handler 9,739 Analytical Lab 1,518 Narcotic Treatment Program 1,317

Distributor 954

Reverse Distributor 60 Importer 223 Exporter 244

Manufacturer 544

Total 1,486,025
Source: DEA, June 2013.

Note: The number of DEA registrations fluctuates daily and the number of DEA registrations at the 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.



# 41

## Corresponding Number of Businesses



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

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

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

601(5)). Pursuant to the RFA, the term “small b usiness” has the same meaning as the

term “small business concern” under sec tion 3 of the Small Business Act (SBA). The

SBA designates a “small

- business concern,” as one which is independently owned and

operated and is not dominant in its field of operati on. 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 based on the types of economic activity or industry under

NAICS. The SBA sets the maximum size standa rds

— 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

.

Because the DEA does not, in the general course of business, collect information

regarding associated or parent organizations holding multiple registrations , the DEA has

associated the number of registrants to a corresponding number of businesses. The DEA

registrations are held by businesses such as manufacturers, distributors, and pharmacies

as well as individuals such as 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 approximately 1.5 million DEA registrations to the number of businesses, as

described below. First, since the SBA size standards are organized by NAICS codes, the

approximately 1.5 million affected registrations are organized by NAICS codes. Because

the DEA does not collect NAICS code information from its registrants, the DEA

42

# reviewed all NAICS codes 29 

# and developed a table that relates various registrant groups

to NAICS codes. Table A3 lists the DEA registrant c ategories with NAICS titles and

codes. Second, using 2007 Economic Census data, the DEA determined the number of

businesses for each NAICS code. See table A4.

29 

## http://www.census.gov/eos/www/naics/.



# 43

### Table A3. DEA Registrant Categories and Corresponding Estimated NAICS Codes Registrant Categor ies and NAICS Code Titles

Titles N umber of

DEA Reg istrations NAICS Codes Represented by DEA Reg istrations

Manufacturers

544 Petrochemical Manufacturing 325110

Medicinal and Botanical Manufacturing 325411

Pharmaceutical Preparation Manufacturing 325412

Adhesive Manufacturing 325520

Toilet Preparation Manufacturing 325620

All Other Msc. Chemical Product and Preparation Manufacturing 325998

Distributors/Importers/Exporter s

1,481 424210

Drugs and Druggists’ Sundries Merchant Wholesalers 424410

General Line Grocery Merchant Wholesalers 424450

Confectionary Merchant Wholesalers 424690

Tobacco and Tobacco Product Merchant Wholesalers 424940

Other Msc. Nondurable Goods Merchant Wholesalers 424990

Packaging and Labeling Services 651910

Pharmacies

69,404 Supermarkets and Other Grocery (except Convenience)
Stores 445110

Pharmacies and Drug Stores 446110

Discount Department Stores 452112

Warehouse Clubs and Superstores 452910

Others

1,414,596 Colleges, Universities and Professional Schools 611310

Offices of Physicians (except Mental Health Specialists) 621111

Offices of Physicians, Mental Health Specialists 621112

Offices of Dentists 621210

Offices of Optometrists 621320

Offices of Podiatrists 621391

Offices of All Other Msc. Health Practitioners 621399

Outpatient Mental Health and Substance Abuse Centers 621420

HMO Medical Centers 621491

General Medical and Surgical Hsps. 622110

Psychiatric and Substance Abuse Hsps. 622210

Specialty (except Psychiatric and Substance Abuse) Hsps. 622310

Testing Laboratories 541380

Total Controlled Substance Registrants 1,486,025



# 44

### Table A4. Number of Businesses by NAICS Codes

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

. * Manufacturer data is in number of establishments while all other sectors are in number of firms. A firm may have more than one establishment. Based on sectors with both firm and establishment data, the number
of establish ments are similar to the number of firms. The term “firm” used in the source data is used synonymously with “business” for the purposes of this analysis. Registrant Categories and NAICS Code

Titles Number of

DEA
Registrations NAICS Codes
Represented
by DEA
Registrants Total

Number of

Businesses
by NAICS

Code*

Manufacturers 544 Petrochemical Manufacturing 325110 56 Medicinal and Botanical Manufacturing 325411 410

Pharmaceutical Preparation Manufacturing 325412 991

Adhesive Manufacturing 325520 600 Toilet Preparation Manufacturing 325620 854

All Other Miscellaneous Chemical Product
and Preparation Manufacturing 325998 1,261 Manufacturer Summary 4,172 Distributors/Importers/Exporters 1,481 Drugs and Druggists’ Sundries Merchant

Wholesalers 424210 5,430 General Line Grocery Merchant

Wholesalers 424410 1,842 Confectionery Merchant Wholesalers 424450 1,544

Other Chemical and Allied Products

Merchant Wholesalers 424690 5,948

Tobacco and Tobacco Product Merchant

Wholesalers 424940 1,053

Other Miscellaneous Nondurable Goods

Merchant Wholesalers 424990 10,043 Packaging and Labeling Services 561910 1,541 Distributors/Importers/Exporters

Summary 27,401

Pharmacies 69,404 Supermarkets and Other Grocery (except
Convenience) Stores 445110 34,009 Pharmacies and Drug Stores 446110 17,217
Discount Department Stores 452112 11 Warehouse Clubs and Superstores 452910 11 Pharmacies Summary 51,248

Others 1,414,596 Colleges, Universities and Professional

Schools 611310 2,149 Offices of Physicians (except Mental Health
Specialists) 621111 160,034 Offices of Physicians, Mental Health
Specialists 621112 9,075

Offices of Dentists 621210 111,013 Offices of Optometrists 621320 16,659

Offices of Podiatrists 621391 7,566

Offices of All Other Miscellaneous Health

Practitioners 621399 9,094 Outpatient Mental Health and Substance

Abuse Centers 621420 4,113

HMO Medical Centers 621491 30 General Medical and Surgical Hospitals 622110 3,051 Psychiatric and Substance Abuse Hospitals 622210 423 Specialty (except Psychiatric and Substance
Abuse) Hospitals 622310 352 Testing Laboratories 541380 4,727 Others Summary 328,286 Total Controlled Substance Registrants 1,486,025Category 1Category 2



# 45

# There are many more businesses under the manufacturers and distributors/importers/

exporters NAICS co des than the number of DEA registrations 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, resp ectively. Meanwhile, the number of businesses under 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:

• Category 1: Registrants in industries where very few bu sinesses in the industry are registrants; and

• Category 2: Registrants in industries where most businesses in the industry are registrants.

As shown in table A4, only a small fraction of manufacturers, distributors, and

importers/exporters are DEA regi strants

— 2,025 (544 + 1,481) of 31,573 (4,172 +

27,401), while nearly all pharmacies, hospitals/clinics, offices of physicians, etc., are

registrants, employ registrants, or may represent multiple registrations, such as several

individual practitioners 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 1

- to

- 1 ra tio 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.

46

# For registrants in category 2 (pharmacies, hospitals/clinics, offices of physic ians,

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 of businesses that are in the pharmacies and other registrant

categories. The DEA estimates that 69,404 pharmacy registrations roughly equate to

51,248 businesses resulting in a 0.74

- to

- 1 business

- to

- registration ratio, and 1,414,596

remaining other registrations roughly equate to 328,286 businesses resul ting in a 0.23

- to

1 business

- to

- registration ratio. In total, the DEA estimates that the nearly 1.5 million

DEA registrants represent approximately 381,559 businesses. See table A5. The DEA

recognizes that this estimate is not precise, but instead provi des understanding of orders

of magnitude.

Number of Affected Businesses that Are Small Businesses

After estimating that approximately 1.5 million DEA registrants represent 381,559

businesses, the DEA then determined how many of the estimated 381,559 busine sses

represented by DEA registrants are small businesses based on the SBA size standards.

Because the DEA does not collect data on company size of its registrants, it used 2007

Economic Census data to make this determination. The Economic Census provides the

number of businesses by annual revenue ranges as well as the number of businesses by

number of employee ranges by NAICS codes. This data was compared to the SBA size

standards for each NAICS code to determine the number of businesses that are small

b usinesses for each NAICS code. See table A6.

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

distributors/importers/exporters by NAICSs are small businesses. These percentages

47

# 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 Economi c Census. 98.6% (50,517 of

51,248) of pharmacies and 97.2% (319,105 of 328,286) of other businesses are estimated

to be small businesses. Combining the results of manufacturers, distributors/importers/

exporters, pharmacies, and other, the DEA estimates 371,588 of the 381,559 (97.4%)

businesses that represent the registrant population are considered “small entities” in

accordance with the RFA and SBA standards, 5 U.S.C. 601(6) and 15 U.S.C. 632.

Again, the DEA recognizes that its estimate is not precise, but instead provides

understanding of orders of magnitude, so that the DEA can assess whether or not the

number of significantly impacted businesses constitute a substantial number of small

businesses.

48

### Table A5: Number of Businesses Represented by DEA Controlled Substances Registrants

Registrant Categories and NAICS Code

Titles Number of

DEA Registrations NAICS

Codes Represented

by DEA Registrants Total

Number of

Businesses by NAICS

Code* Estimated

Number of

Businesses Represented

by DEA Registrants

Manufacturers 544 544 Petrochemical Manufacturing 325110 56 Medicinal and Botanical Manufacturing 325411 410

Pharmaceutical Preparation Manufacturing 325412 991

Adhesive Manufacturing 325520 600 Toilet Preparation Manufacturing 325620 854

All Other Miscellaneous Chemical Product and Preparation Manufacturing 325998 1,261
Manufacturers Summary 4,172
Distributors/Importers/Exporters 1,481 1,481 Drugs and Druggists’ Sundries Merchant

Wholesalers 424210 5,430 General Line Grocery Merchant Wholesalers 424410 1,842 Confectionery Merchant Wholesalers 424450 1,544

Other Chemical and Allied Products Merchant

Wholesalers 424690 5,948

Tobacco and Tobacco Product Merchant

Wholesalers 424940 1,053

Other Miscellaneous Nondurable Goods

Merchant Wholesalers 424990 10,043 Packaging and Labeling Services 561910 1,541

Distributors/Importers/Exporters Summary 27,401

Pharmacies 69,404 51,248 Supermarkets and Other Grocery (except
Convenience) Stores 445110 34,009 Pharmacies and Drug Stores 446110 17,217 Discount Department Stores 452112 11 Warehouse Clubs and Superstores 452910 11
Pharmacies Summary 51,248

Others 1,414,596 328,286

Colleges, Universities and Professional Schools 611310 2,149 Offices of Physicians (except Mental Health Specialists) 621111 160,034

Offices of Physicians, Mental Health Specialists 621112 9,075

Offices of Dentists 621210 111,013 Offices of Optometrists 621320 16,659

Offices of Podiatrists 621391 7,566

Offices of All Other Miscellaneous Health

Practitioners 621399 9,094 Outpatient Mental Health and Substance Abuse

Centers 621420 4,113

HMO Medical Centers 621491 30 General Medical and Surgical Hospitals 622110 3,051 Psychiatric and Substance Abuse Hospitals 622210 423 Specialty (except Psychiatric and Substance Abuse) Hospitals 622310 352 Testing Laboratories 541380 4,727
Others Summary 328,286 Total Controlled Substance Registrants 1,486,025 381,559Category 1Category 2



# 49

### Table A6. Number of Affected Businesses that Are Small Businesses

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

* 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 s /reverse distributors are by number of employees, while size standards for pharmacies and others (practitioner s / hospitals/clinics ) are by dollar amount of annual revenue.
*** Number of establishme nts/firms data by number of employees/annual revenue is ava ilable in specific increments. When the SBA size standard/threshold is between increments, half of the number in the increment was used to estimate the number below the threshold. For example, th e number of offices of dentists was available for various increments ; $4,999,999 and below is 110,410 and increment $5,000,000

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

- $7,000,000 resulting in a to tal of 110,634

. Registrant Categories and NAICS Code

Titles Number of

DEA Registrations NAICS

Codes Represented

by DEA Registrants Total

Number of

Businesses by NAICS

Code* Estimated

Number of

Businesses Represented

by DEA Registrants SBA Size

Standards:

Number of Employees or

Millions of

Dollars** Number of

Businesses

Below SBA

Size

Standard % of

Businesses

Below SBA

Size

Standard Note

Manufacturers 544 544 533 Petrochemical Manufacturing 325110 56 1,000 56 Medicinal and Botanical Manufacturing 325411 410 750 406 ***

Pharmaceutical Preparation Manufacturing 325412 991 750 943 *** Adhesive Manufacturing 325520 600 500 600 Toilet Preparation Manufacturing 325620 854 500 828

All Other Miscellaneous Chemical Product and Preparation Manufacturing 325998 1,261 500 1,253
Manufacturers Summary 4,172 4,086 97.9%
Distributors/Importers/Exporters 1,481 1,481 1,433 Drugs and Druggists’ Sundries Merchant

Wholesalers 424210 5,430 100 5,155 General Line Grocery Merchant Wholesalers 424410 1,842 100 1,739 Confectionery Merchant Wholesalers 424450 1,544 100 1,506

Other Chemical and Allied Products Merchant

Wholesalers 424690 5,948 100 5,824

Tobacco and Tobacco Product Merchant

Wholesalers 424940 1,053 100 978

Other Miscellaneous Nondurable Goods

Merchant Wholesalers 424990 10,043 100 9,926 Packaging and Labeling Services 561910 1,541 $7.0 1,381 ***

Distributors/Importers/Exporters Summary 27,401 26,509 96.7%

Pharmacies 69,404 51,248 50,517 Supermarkets and Other Grocery (except
Convenience) Stores 445110 34,009 $30.0 33,444 *** Pharmacies and Drug Stores 446110 17,217 $25.5 17,069 *** Discount Department Stores 452112 11 $27.0 3 *** Warehouse Clubs and Superstores 452910 11 $27.0 1 ***
Pharmacies Summary 51,248 50,517 98.6%

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

Colleges, Universities and Professional Schools 611310 2,149 $7.0 Not

Available Offices of Physicians (except Mental Health Specialists) 621111 160,034 $10.0 155,908

Offices of Physicians, Mental Health Specialists 621112 9,075 $10.0 9,056

Offices of Dentists 621210 111,013 $7.0 110,634 *** Offices of Optometrists 621320 16,659 $7.0 16,611 ***

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

Offices of All Other Miscellaneous Health

Practitioners 621399 9,094 $7.0 9,070 *** Outpatient Mental Health and Substance Abuse

Centers 621420 4,113 $10.0 3,826

HMO Medical Centers 621491 30 $10.0 17 General Medical and Surgical Hospitals 622110 3,051 $34.5 1,285 *** Psychiatric and Substance Abuse Hospitals 622210 423 $34.5 334 *** Specialty (except Psychiatric and Substance Abuse) Hospitals 622310 352 $34.5 200 *** Testing Laboratories 541380 4,727 $12.0 4,608 ***
Others Summary 328,286 319,105 97.2% Total Controlled Substance Registrants 1,486,025 381,559 371,588Category 1Category 2



# 50

# APPENDIX B: BUSINES SES WITH IMPACT 1% O R MORE OF ANNUAL

REVENUE

Table B 1 contains the complete revenue profile for distributors as well as the

summary of analysis conducted. Table B2 contains the summary results for percentage

of small businesses whose cost is greater than 1% of revenue.

Table B 1 . Complete Revenue Profile for Distributors Based On 2007 NAICS Codes and Summary of Analysis
Conducted

NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

424210 Drugs and druggists'
sundries

merchant

wholesalers All firms 6,261 3,131 98,726

Firms operated for the entire year 5,430 2,715 98,726 Firms operated entire year with sales/receipts/revenue less than $250,000 909 455 98,726 179 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 626 313 98,726 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 744 372 98,726 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 1,059 530 98,726 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 651 326 98,726 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 505 253 98,726 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 425 213 98,726 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 193 97 98,726 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 114 57 98,726 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 204 102 98,726 0

Firms not operated for the entire year 831 416 98,726

424410 General line

grocery merchant

wholesalers All firms 2,208 1,104 98,726

Firms operated for the entire year 1,842 921 98,726 Firms operated entire year with sales/receipts/revenue less than $250,000 195 98 98,726 39 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 187 94 98,726 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 243 122 98,726 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 365 183 98,726 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 273 137 98,726 0



# 51NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 188 94 98,726 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 193 97 98,726 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 75 38 98,726 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 42 21 98,726 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 81 41 98,726 0

Firms not operated for the entire year 366 183 98,726

424450 Confectionery

merchant

wholesalers All firms 1,798 899 98,726

Firms operated for the entire year 1,544 772 98,726 Firms operated entire year with sales/receipts/revenue less than $250,000 287 144 98,726 57 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 238 119 98,726 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 238 119 98,726 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 291 146 98,726 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 163 82 98,726 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 132 66 98,726 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 91 46 98,726 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 46 23 98,726 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 28 14 98,726 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 30 15 98,726 0

Firms not operated for the entire year 254 127 98,726

All firms 6,527 3,264 98,726

424690 Other
chemical and
allied products

merchant

wholesalers Firms operated for the entire year 5,948 2,974 98,726 Firms operated entire year with sales/receipts/revenue less than $250,000 886 443 98,726 175 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 706 353 98,726 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 894 447 98,726 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 1,164 582 98,726 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 771 386 98,726 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 562 281 98,726 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 494 247 98,726 0



# 52NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 220 110 98,726 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 101 51 98,726 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 150 75 98,726 0

Firms not operated for the entire year 579 290 98,726

424940 Tobacco and

tobacco product

merchant

wholesalers All firms 1,135 568 98,726

Firms operated for the entire year 1,053 527 98,726 Firms operated entire year with sales/receipts/revenue less than $250,000 56 28 98,726 11 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 55 28 98,726 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 74 37 98,726 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 139 70 98,726 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 118 59 98,726 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 159 80 98,726 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 181 91 98,726 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 99 50 98,726 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 81 41 98,726 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 91 46 98,726 0

Firms not operated for the entire year 82 41 98,726

424990 Other
miscellaneous

nondurable

goods

merchant

wholesalers All firms 12,118 6,059 98,726

Firms operated for the entire year 10,043 5,022 98,726

Firms operated entire year with sales/receipts/revenue less than $250,000 2,941 1,471 98,726 581
Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 1,807 904 98,726 0
Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 1,736 868 98,726 0
Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 1,732 866 98,726 0
Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 827 414 98,726 0
Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 447 224 98,726 0
Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 348 174 98,726 0
Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 112 56 98,726 0
Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 54 27 98,726 0



# 53NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 39 20 98,726 0

Firms not operated for the entire year 2,075 1,038 98,726

561910 Packaging and labeling

services All firms 1,809 904.5 98,726

Firms operated for the entire year 1,541 770.5 98,726 Firms operated entire year with sales/receipts/revenue less than $100,000 164 82 98,726 81 Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 221 110.5 98,726 0 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 278 139 98,726 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 247 123.5 98,726 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 257 128.5 98,726 0

Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 161 80.5 98,726 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 105 52.5 98,726 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 74 37 98,726 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 25 12.5 98,726 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 6 3 98,726 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 3 1.5 98,726 0

Firms not operated for the entire year 268 134 98,726

424210 Drugs and druggists'
sundries

merchant

wholesalers All firms 6,261 3,131 4,333

Firms operated for the entire year 5,430 2,715 4,333 Firms operated entire year with sales/receipts/revenue less than $250,000 909 455 4,333 8 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 626 313 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 744 372 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 1,059 530 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 651 326 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 505 253 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 425 213 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 193 97 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 114 57 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 204 102 4,333 0



# 54NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms not operated for the entire year 831 416 4,333

424410 General line

grocery merchant

wholesalers All firms 2,208 1,104 4,333

Firms operated for the entire year 1,842 921 4,333
Firms operated entire year with sales/receipts/revenue less than $250,000 195 98 4,333 2
Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 187 94 4,333 0
Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 243 122 4,333 0
Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 365 183 4,333 0
Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 273 137 4,333 0
Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 188 94 4,333 0
Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 193 97 4,333 0
Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 75 38 4,333 0
Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 42 21 4,333 0
Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 81 41 4,333 0

Firms not operated for the entire year 366 183 4,333

424450 Confectionery

merchant

wholesalers All firms 1,798 899 4,333

Firms operated for the entire year 1,544 772 4,333 Firms operated entire year with sales/receipts/revenue less than $250,000 287 144 4,333 2 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 238 119 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 238 119 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 291 146 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 163 82 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 132 66 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 91 46 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 46 23 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 28 14 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 30 15 4,333 0



# 55NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms not operated for the entire year 254 127 4,333

424690 Other

chemical and
allied products

merchant

wholesalers All firms 6,527 3,264 4,333

Firms operated for the entire year 5,948 2,974 4,333

Firms operated entire year with sales/receipts/revenue less than $250,000 886 443 4,333 8 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 706 353 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 894 447 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 1,164 582 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 771 386 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 562 281 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 494 247 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 220 110 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 101 51 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 150 75 4,333 0

Firms not operated for the entire year 579 290 4,333

424940 Tobacco and

tobacco product

merchant

wholesalers All firms 1,135 568 4,333

Firms operated for the entire year 1,053 527 4,333 Firms operated entire year with sales/receipts/revenue less than $250,000 56 28 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 55 28 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 74 37 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 139 70 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 118 59 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 159 80 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 181 91 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 99 50 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 81 41 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 91 46 4,333 0



# 56NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms not operated for the entire year 82 41 4,333

424990 Other
miscellaneous

nondurable

goods

merchant

wholesalers All firms 12,118 6,059 4,333

Firms operated for the entire year 10,043 5,022 4,333 Firms operated entire year with sales/receipts/revenue less than $250,000 2,941 1,471 4,333 25 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 1,807 904 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 1,736 868 4,333 0

Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 1,732 866 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 827 414 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 447 224 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 348 174 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 112 56 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 54 27 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 39 20 4,333 0

Firms not operated for the entire year 2,075 1,038 4,333

561910 Packaging and labeling

services All firms 1,809 904.5 4,333

Firms operated for the entire year 1,541 770.5 4,333

Firms operated entire year with sales/receipts/revenue less than $100,000 164 82 4,333 4
Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 221 110.5 4,333 0
Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 278 139 4,333 0
Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 247 123.5 4,333 0
Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 257 128.5 4,333 0
Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 161 80.5 4,333 0
Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 105 52.5 4,333 0
Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 74 37 4,333 0
Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 25 12.5 4,333 0



# 57NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 6 3 4,333 0
Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 3 1.5 4,333 0

Firms not operated for the entire year 268 134 4,333

445110 Supermarkets

and other

grocery (except convenience)

stores All firms 41,885 4,333

Firms operated for the entire year 34,009 4,333 Firms operated entire year with sales/receipts/revenue less than $250,000 6,836 4,333 118 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 6,473 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 6,327 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 6,290 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 3,598 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 2,360 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 1,373 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 373 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 162 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 to $249,999,999 109 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000,000 or more 108 4,333 0

Firms not operated for the entire year 7,876 4,333

446110 Pharmacies and drug

stores All firms 19,067 4,333

Firms operated for the entire year 17,217 4,333 Firms operated entire year with sales/receipts/revenue less than $250,000 943 4,333 16

Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 769 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 1,486 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 5,674 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 5,264 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 2,311 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 622 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 89 4,333 0



# 58NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 27 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 to $249,999,999 8 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000,000 or more 24 4,333 0

Firms not operated for the entire year 1,850 4,333

452112 Discount department

stores All firms 14 4,333

Firms operated for the entire year 11 4,333 Firms operated entire year with sales/receipts/revenue less than $250,000 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 1 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 3 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 to $249,999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000,000 or more 7 4,333 0

Firms not operated for the entire year 3 4,333

452910 Warehouse

clubs and supercenters All firms 12 4,333

Firms operated for the entire year 11 4,333 Firms operated entire year with sales/receipts/revenue less than $250,000 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 1 4,333 0



# 59NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 1 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 to $249,999,999 1 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000,000 or more 8 4,333 0

Firms not operated for the entire year 1 4,333

621111 Offices of physicians

(except

mental health

specialists) All firms 182,287 4,333

Firms operated for the entire year 160,034 4,333
Firms operated entire year with sales/receipts/revenue less than $100,000 7,415 4,333 321
Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 19,674 4,333 0
Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 38,179 4,333 0
Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 41,770 4,333 0
Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 31,857 4,333 0
Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 11,486 4,333 0
Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 5,527 4,333 0
Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 2,850 4,333 0

Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 768 4,333 0
Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 299 4,333 0
Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 209 4,333 0

Firms not operated for the entire year 22,253 4,333

621112 Offices of physicians,

mental health

specialists All firms 10,714 4,333

Firms operated for the entire year 9,075 4,333 Firms operated entire year with sales/receipts/revenue less than $100,000 1,705 4,333 74 Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 2,905 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 2,558 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 1,192 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 528 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 134 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 34 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 15 4,333 0



# 60NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 4 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 0 4,333 0

Firms not operated for the entire year 1,639 4,333

621210 Offices of
dentists All firms 121,048 4,333

Firms operated for the entire year 111,013 4,333 Firms operated entire year with sales/receipts/revenue less than $100,000 3,827 4,333 166 Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 12,634 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 27,715 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 40,599 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 22,949 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 2,686 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 448 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 116 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 13 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 13 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 13 4,333 0

Firms not operated for the entire year 10,035 4,333

621320 Offices of optometrists All firms 18,407 4,333

Firms operated for the entire year 16,659 4,333
Firms operated entire year with sales/receipts/revenue less than $100,000 1,296 4,333 56
Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 3,493 4,333 0
Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 5,163 4,333 0
Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 4,450 4,333 0
Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 1,950 4,333 0
Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 233 4,333 0
Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 51 4,333 0
Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 20 4,333 0



# 61NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 1 4,333 0
Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 2 4,333 0
Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 0 4,333 0

Firms not operated for the entire year 1,748 4,333

621391 Offices of podiatrists All firms 8,211 4,333

Firms operated for the entire year 7,566 4,333
Firms operated entire year with sales/receipts/revenue less than $100,000 636 4,333 28
Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 2,041 4,333 0
Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 2,564 4,333 0
Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 1,594 4,333 0
Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 623 4,333 0
Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 88 4,333 0
Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 20 4,333 0

Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 0 4,333 0
Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 0 4,333 0
Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 0 4,333 0
Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 0 4,333 0

Firms not operated for the entire year 645 4,333

621399 Offices of all

other
miscellaneous

health practitioners All firms 11,734 4,333

Firms operated for the entire year 9,094 4,333 Firms operated entire year with sales/receipts/revenue less than $100,000 3,061 4,333 133 Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 3,054 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 1,646 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 767 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 443 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 83 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 31 4,333 0



# 62NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 8 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 1 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 0 4,333 0

Firms not operated for the entire year 2,640 4,333

621420 Outpatient

mental health

and substance

abuse centers All firms 4,555 4,333

Firms operated for the entire year 4,113 4,333
Firms operated entire year with sales/receipts/revenue less than $100,000 518 4,333 22
Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 641 4,333 0
Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 487 4,333 0
Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 594 4,333 0

Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 761 4,333 0
Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 447 4,333 0
Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 378 4,333 0
Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 234 4,333 0
Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 45 4,333 0
Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 6 4,333 0
Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 2 4,333 0

Firms not operated for the entire year 442 4,333

621491 HMO
medical

centers All firms 35 4,333

Firms operated for the entire year 30 4,333
Firms operated entire year with sales/receipts/revenue less than $100,000 0 4,333 0
Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 5 4,333 0
Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 4 4,333 0
Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 3 4,333 0
Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 2 4,333 0



# 63NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 2 4,333 0
Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 1 4,333 0
Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 2 4,333 0
Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 4 4,333 0
Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 0 4,333 0
Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 7 4,333 0

Firms not operated for the entire year 5 4,333

622110 General
medical and

surgical hospitals All firms 3,076 4,333

Firms operated for the entire year 3,051 4,333 Firms operated entire year with sales/receipts/revenue less than $100,000 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 2 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 1 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 18 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 117 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 316 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 613 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 436 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 416 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 1,132 4,333 0

Firms not operated for the entire year 25 4,333

622210 Psychiatric

and substance

abuse hospitals All firms 429 4,333

Firms operated for the entire year 423 4,333 Firms operated entire year with sales/receipts/revenue less than $100,000 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 1 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 22 4,333 0



# 64NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 55 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 140 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 115 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 63 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 27 4,333 0

Firms not operated for the entire year 6 4,333

622310 Specialty (except psychiatric

and substance abuse) hospitals All firms 375 4,333

Firms operated for the entire year 352 4,333 Firms operated entire year with sales/receipts/revenue less than $100,000 0 4,333 0

Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 0 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 1 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 7 4,333 0 Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 27 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 49 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 73 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 86 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 55 4,333 0

Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 54 4,333 0

Firms not operated for the entire year 23 4,333

541380 Testing
laboratories All firms 5,288 4,333

Firms operated for the entire year 4,727 4,333 Firms operated entire year with sales/receipts/revenue less than $100,000 493 4,333 21 Firms operated entire year with sales/receipts/revenue of $100,000 to $249,999 771 4,333 0 Firms operated entire year with sales/receipts/revenue of $250,000 to $499,999 817 4,333 0 Firms operated entire year with sales/receipts/revenue of $500,000 to $999,999 872 4,333 0 Firms operated entire year with sales/receipts/revenue of $1,000,000 to $2,499,999 934 4,333 0



# 65NAICS

code NAICS

code description Revenue size of firms operated entire year N umber
of firms Adjusted

N umber of
firms for

50% Distributor, Importer, Exporter Revenue
where cost is
1% ($) N umber of
Firms with

Revenue
below 1%

Threshold

Firms operated entire year with sales/receipts/revenue of $2,500,000 to $4,999,999 413 4,333 0 Firms operated entire year with sales/receipts/revenue of $5,000,000 to $9,999,999 247 4,333 0 Firms operated entire year with sales/receipts/revenue of $10,000,000 to $24,999,999 123 4,333 0 Firms operated entire year with sales/receipts/revenue of $25,000,000 to $49,999,999 31 4,333 0 Firms operated entire year with sales/receipts/revenue of $50,000,000 to $99,999,999 16 4,333 0 Firms operated entire year with sales/receipts/revenue of $100,000,000 or more 10 4,333 0

Firms not operated for the entire year 561 4,333
Total with impact greater than 1% of

revenue 2,127



# 66

### Table B 2

. Summary of percentage of small businesses whose cost is greater than 1% of revenue (or “ below

threshold ” )

Registrant Categories and NAICS Code Titles NAICS Codes
Represented

by DEA
Registrants Number of

Businesses

Below SBA

Size

Standard Revenue at

threshold

(1%) Sum of Firms
operated for

the entire

year Number of

Firms w/Revenue

below

Threshold Percentage

of Small

Businesss

below

threshold



### Manufacturers 533 Petrochemical Manufacturing 325110 56 4,333 $ 56

- Medicinal and Botanical Manufacturing 325411 406 4,333 $ 410

- Pharmaceutical Preparation Manufacturing 325412 943 4,333 $ 991

- Adhesive Manufacturing 325520 600 4,333 $ 600

- Toilet Preparation Manufacturing 325620 828 4,333 $ 854

- All Other Miscellaneous Chemical Product and
Preparation Manufacturing 325998 1,253 4,333 $ 1,261

- Manufacturer Summary 4,086 4,172

- 0.0% Distributors/Importer/Exporter 1,433 Drugs and Druggists’ Sundries Merchant

Wholesalers 424210 5,155 98,726 $ 5,430 187 General Line Grocery Merchant Wholesalers 424410 1,739 98,726 $ 1,842 41 Confectionery Merchant Wholesalers 424450 1,506 98,726 $ 1,544 59

Other Chemical and Allied Products Merchant

Wholesalers 424690 5,824 98,726 $ 5,948 183

Tobacco and Tobacco Product Merchant

Wholesalers 424940 978 98,726 $ 1,053 11

Other Miscellaneous Nondurable Goods Merchant

Wholesalers 424990 9,926 98,726 $ 10,043 606 Packaging and Labeling Services 561910 1,381 98,726 $ 1,541 85 Distributors/Importers/Exporters Summary 26,509 27,401 1,172 4.4%

Pharmacies 50,517 Supermarkets and Other Grocery (except
Convenience) Stores 445110 33,444 4,333 $ 34,009 118 Pharmacies and Drug Stores 446110 17,069 4,333 $ 17,217 16
Discount Department Stores 452112 3 4,333 $ 11

- Warehouse Clubs and Superstores 452910 1 4,333 $ 11

- Pharmacies Summary 50,517 51,248 134 0.3%

Others 319,105

Colleges, Universities and Professional Schools** 611310 Not

Available 4,333 $ 2,149 Not

Available Offices of Physicians (except Mental Health
Specialists) 621111 155,908 4,333 $ 160,034 321 Offices of Physicians, Mental Health Specialists 621112 9,056 4,333 $ 9,075 74

Offices of Dentists 621210 110,634 4,333 $ 111,013 166 Offices of Optometrists 621320 16,611 4,333 $ 16,659 56

Offices of Podiatrists 621391 7,556 4,333 $ 7,566 28

Offices of All Other Miscellaneous Health

Practitioners 621399 9,070 4,333 $ 9,094 133 Outpatient Mental Health and Substance Abuse

Centers 621420 3,826 4,333 $ 4,113 22

HMO Medical Centers 621491 17 4,333 $ 30

- General Medical and Surgical Hospitals 622110 1,285 4,333 $ 3,051

- Psychiatric and Substance Abuse Hospitals 622210 334 4,333 $ 423

- Specialty (except Psychiatric and Substance Abuse)
Hospitals 622310 200 4,333 $ 352

- Testing Laboratories 541380 4,608 4,333 $ 4,727 21 Others Summary 319,105 328,286 821 0.3% Total Controlled Substance Registrants 371,588 2,127Category 1Category 2



# 67