67054 Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Proposed Rules 

this section of the preamble, we will 

refer to the proposed rule as a ‘‘proposed 

amendment.’’ These findings are 

discussed below. 

The amendment to the Standard is 

needed to adequately protect the public 

against unreasonable risk of the 

occurrence of fire. The current Standard 

specifies as the ignition source 

cigarettes that are no longer being 

produced. In order for the Standard to 

continue to be effective (and for labs to 

test mattresses and mattress pads to 

determine whether they comply with 

the Standard), it is necessary to change 

the ignition source specification. The 

proposed amendment is necessary to 

ensure that the testing is reliable and 

that results will not vary from one lab 

or manufacturer to another. Such 

variation would be likely if labs or 

manufacturers were able to use different 

ignition sources that have similar 

physical properties but different 

burning characteristics. 

The amendment to the Standard is 

reasonable, technologically practicable, 

and appropriate. The proposed 

amendment is based on technical 

research conducted by NIST, which 

established that the SRM cigarette is 

capable of providing reliable and 

reproducible results in flammability 

testing of mattresses and mattress pads. 

The proposed SRM represents an 

equivalent, safety-neutral ignition 

source for use in testing to establish 

compliance with the Standard. 

The amendment to the Standard is 

limited to fabrics, related materials, and 

products that present an unreasonable 

risk. The proposed amendment would 

continue to apply to the same products 

as the existing Standard. 

Voluntary standards. There is no 

applicable voluntary standard for 

mattresses. The proposal would amend 

an existing Federal mandatory standard. 

Relationship of benefits to costs. 

Amending the Standard to specify SRM 

cigarettes as the ignition source would 

allow testing to the Standard to 

continue without interruption, would 

maintain the effectiveness of the 

Standard, and would not significantly 

increase testing costs to manufacturers 

and importers of mattresses and 

mattress pads. Thus, there is a 

reasonable relationship between 

benefits and costs of the proposed 

amendment. Both expected benefits and 

costs of the proposed amendment are 

likely to be small. The likely effect on 

testing costs would be minor. 

Least burdensome requirement. No 

other alternative would allow the 

Standard’s level of safety and 

effectiveness to continue. Thus, the 

proposed amendment imposes the least 

burdensome requirement that would 

adequately address the risk of injury. 

J. Conclusion 

For the reasons discussed above, the 

Commission preliminarily finds that 

amending the mattress flammability 

standard (16 CFR part 1632) to specify 

SRM cigarettes as the ignition source is 

needed to adequately protect the public 

against the unreasonable risk of the 

occurrence of fire leading to death, 

injury, and significant property damage. 

The Commission also preliminarily 

finds that the amendment to the 

Standard is reasonable, technologically 

practicable, and appropriate. The 

Commission further finds that the 

amendment is limited to the fabrics, 

related materials, and products that 

present such unreasonable risks. 

K. References 

1. Gann, R.G., and Hnetkovsky E.J., 

Modification of ASTM E 2187 for 

Measuring the Ignition Propensity of 

Conventional Cigarettes, Technical Note 

1627, National Institute of Standards 

and Technology, Gaithersburg, MD 

20899, 2009. 

2. Directorate for Economic Analysis 

Report, Preliminary Regulatory 

Analysis: Smoldering Ignition Source 

Draft Proposed Technical Amendment 

to the Flammability Standard for 

Mattresses and Mattress Pads (16 CFR 

part 1632). 

List of Subjects in 16 CFR Part 1632 

Consumer protection, Flammable 

materials, Labeling, Mattresses and 

mattress pads, Records, Textiles, 

Warranties. 

For the reasons given above, the 

Commission proposes to amend 16 CFR 

part 1632 as follows: 

PART 1632—STANDARD FOR THE 

FLAMMABILITY OF MATTRESSES 

AND MATTRESS PADS (FF 4–72, 

AMENDED) 

1. The authority citation for part 1632 

continues to read as follows: 

Authority: 15 U.S.C. 1193, 1194; 15 U.S.C. 

2079(b). 

2. Section 1632.4 is amended by 

revising paragraph (a)(2) to read as 

follows: 

§ 1632.4 Mattress test procedure. 

(a) * * * 

(2) Ignition source. The ignition 

source shall be National Institute of 

Standards and Technology (‘‘NIST’’) 

Standard Reference Material (‘‘SRM’’) 

1196, available for purchase from the 

National Institute for Standards and 

Technology, 100 Bureau Drive, 

Gaithersburg, MD 20899. 

* * * * * 

Dated: October 26, 2010. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2010–27504 Filed 10–29–10; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–344P] 

Listing of Approved Drug Products 

Containing Dronabinol in Schedule III 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This proposed rule is issued 

by the Deputy Administrator of the Drug 

Enforcement Administration (DEA) to 

modify the listing of the Marinol®

formulation in schedule III so that 

certain generic drug products are also 

included in that listing. 

Several products are currently the 

subject of Abbreviated New Drug 

Applications (ANDAs) under review by 

the U.S. Food and Drug Administration 

(FDA). Each product is a generic 

formulation of Marinol® and contains 

dronabinol, the (-) isomer of delta-9- 

(trans)-tetrahydrocannabinol (THC), 

which is a schedule I controlled 

substance. Due to variations in 

formulation, these generic Marinol®

products do not meet the specific 

conditions specified in the current 

schedule III listing. 

This proposed action expands the 

schedule III listing to include 

formulations having naturally-derived 

dronabinol and products encapsulated 

in hard gelatin capsules. This would 

have the effect of transferring the FDAapproved versions of such generic 

Marinol® products from schedule I to 

schedule III. 

DATES: Written comments must be 

postmarked and electronic comments 

must be submitted on or before January 

3, 2011. Commenters should be aware 

that the electronic Federal Docket 

Management System will not accept 

comments after midnight Eastern Time 

on the last day of the comment period. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–344’’ on all written and 

electronic correspondence. Written 

comments sent via regular or express 


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1 21 U.S.C. 812(c), Schedule I(c)(17). Schedule I 

contains those controlled substances with ‘‘no 

currently accepted medical use in treatment in the 

Continued 

mail should be sent to the Drug 

Enforcement Administration, Attention: 

DEA Federal Register Representative/ 

ODL, 8701 Morrissette Drive, 

Springfield, VA 22152. Comments may 

be sent to DEA by sending an electronic 

message to 

dea.diversion.policy@usdoj.gov. 

Comments may also be sent 

electronically through http:// 

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at the 

http://www.regulations.gov Web site. 

DEA will accept attachments to 

electronic comments in Microsoft Word, 

WordPerfect, Adobe PDF, or Excel file 

formats only. DEA will not accept any 

file formats other than those specifically 

listed here. 

Please note that DEA is requesting 

that electronic comments be submitted 

before midnight Eastern Time on the 

day the comment period closes because 

http://www.regulations.gov terminates 

the public’s ability to submit comments 

at midnight Eastern Time on the day the 

comment period closes. Commenters in 

time zones other than Eastern Time may 

want to consider this so that their 

electronic comments are received. All 

comments sent via regular or express 

mail will be considered timely if 

postmarked on the day the comment 

period closes. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD, Chief, Drug 

and Chemical Evaluation Section, Office 

of Diversion Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152, Telephone (202) 

307–7183. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments: Please 

note that all comments received are 

considered part of the public record and 

made available for public inspection 

online at http://www.regulations.gov 

and in the Drug Enforcement 

Administration’s public docket. Such 

information includes personal 

identifying information (such as your 

name, address, etc.) voluntarily 

submitted by the commenter. 

If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all the personal identifying information 

you do not want posted online or made 

available in the public docket in the first 

paragraph of your comment and identify 

what information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be posted online or made 

available in the public docket. 

Personal identifying information and 

confidential business information 

identified and located as set forth above 

will be redacted and the comment, in 

redacted form, will be posted online and 

placed in the DEA’s public docket file. 

Please note that the Freedom of 

Information Act applies to all comments 

received. If you wish to inspect the 

agency’s public docket file in person by 

appointment, please see the FOR

FURTHER INFORMATION CONTACT

paragraph. 

Background 

The DEA has received four petitions 

from companies that have products that 

are currently the subject of ANDAs 

under review by the FDA. Each product 

is a generic formulation of Marinol® and 

contains dronabinol, the (-) isomer of 

delta-9-(trans)-tetrahydrocannabinol 

(THC), which is a schedule I controlled 

substance. These petitions each requests 

amendments to Controlled Substances 

Act (CSA) regulations that would have 

the effect of transferring the proposed 

generic Marinol® product from schedule 

I to schedule III. 

At present, the only formulation 

containing dronabinol that is in a 

schedule other than schedule I is the 

following, as set forth in 21 CFR 

1308.13(g)(1) as schedule III: 

‘‘Dronabinol (synthetic) in sesame oil 

and encapsulated in a soft gelatin 

capsule in a U.S. Food and Drug 

Administration approved product.’’ 

While the petitioners cite that their 

generic products are bioequivalent to 

Marinol®, their products do not meet 

schedule III current definition provided 

above. Therefore, these firms have 

requested that 21 CFR 1308.13(g)(1) be 

expanded to include: (1) Both naturallyderived or synthetically produced 

dronabinol; and (2) both hard or soft 

gelatin capsules. 

In response to these petitions, DEA 

prepared several scheduling review 

documents based upon petitionerprovided data. On June 22, 2007, and 

August 15, 2007, these analyses were 

submitted to the Department of Health 

and Human Services (DHHS) with 

requests for scientific and medical 

evaluation and scheduling 

recommendations. The submissions to 

DHHS also requested that they consider 

(1) whether dronabinol extracted from 

Cannabis sativa (i.e. naturally-derived), 

is identical to synthetically-produced 

dronabinol found in Marinol®; and (2) 

whether a formulation encapsulated in 

hard gelatin capsules, instead of soft 

gelatin capsules, changes a product’s 

abuse potential. 

On March 17, 2010, and June 1, 2010, 

the Assistant Secretary for Health, 

DHHS, sent the Deputy Administrator of 

DEA scientific and medical evaluations 

and letters recommending that FDAapproved drug products containing 

dronabinol (both naturally-derived or 

synthetic) in sesame oil in a gelatin 

capsule (either hard or soft gelatin) be 

placed into schedule III of the CSA. 

Enclosed with the March 17, 2010, 

letter, was a document prepared by the 

FDA entitled, ‘‘Basis for the 

Recommendation to Control FDAApproved Drug Products Containing 

Synthetic Dronabinol in Sesame Oil in 

a Hard Gelatin Capsule to Schedule III 

of the Controlled Substances Act.’’ The 

June 1, 2010, letter included a document 

entitled, ‘‘Basis for the Recommendation 

to Reschedule FDA-Approved Drug 

Products Containing Naturally-Derived 

Dronabinol in Sesame Oil in a Gelatin 

Capsule to Schedule III of the 

Controlled Substances Act.’’ These 

documents contained a review of the 

factors which the CSA requires the 

Secretary to consider 21 U.S.C. 811(b). 

Therefore, in this rulemaking, DEA is 

proposing that 21 CFR 1308.13(g)(1) be 

modified to include generic equivalents 

of Marinol® which are (1) both synthetic 

or naturally-derived dronabinol; and/or 

(2) hard or soft gelatin capsules. 

Background Regarding Dronabinol 

Dronabinol is a name of a particular 

isomer of a class of chemicals known as 

tetrahydrocannabinols (THC). 

Specifically, dronabinol is the United 

States Adopted Name (USAN) for the 

(-)-isomer of [Delta]\9\-(trans)- 

tetrahydrocannabinol [(-)-[Delta]\9\- 

(trans)-THC], which is believed to be the 

major psychoactive component of the 

cannabis plant (marijuana). 

THC, as a general category, is listed in 

schedule I of the CSA,1 while 


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United States’’ and ‘‘a lack of accepted safety for use 

* * * under medical supervision.’’ 21 U.S.C. 

812(b)(1). 

2The introductory language to schedule I(c) states 

that any material, compound, mixture, or 

preparation that contains any of the substances 

listed in schedule I(c) (including 

‘‘tetrahydrocannabinols’’) is a schedule I controlled 

substance ‘‘[u]nless specifically excepted or unless 

listed in another schedule.’’ The only material, 

compound, mixture, or preparation that contains 

THC but is listed in another schedule is the 

Marinol® formulation, which is listed in schedule 

III. 

3 51 FR 17476 (May 13, 1986). DEA subsequently 

transferred the FDA-approved Marinol®

formulation from schedule II to schedule III. 64 FR 

35928 (July 2, 1999). 

4 Generally, substances are listed in the CSA 

schedules based on their chemical classification, 

rather than any drug product formulation in which 

they might appear. Because of this, there have been 

no other situations in which a slight variation 

between the brand name drug formulation and the 

generic drug formulation was consequential for 

scheduling purposes. 5See id. Sec. 811(a), (b). 

dronabinol contained in the product 

Marinol® is listed separately in 

schedule III. Any other formulation 

containing dronabinol (or any other 

isomer of THC), that does not meet the 

definition provided in 21 CFR 

1308.13(g)(1), remains a schedule I 

controlled substance.2

The current wording of the Marinol®

formulation in schedule III (21 CFR 

1308.13(g)(1)) was added to the DEA 

regulations in 1986, when the substance 

was transferred from schedule I to 

schedule II after the FDA approved 

Marinol® for marketing.3 The wording 

of this listing was not specific to 

Marinol® and thereby could include any 

generic product meeting that 

description that might be approved by 

the FDA in the future. However, at the 

time the regulation was promulgated, 

DEA did not anticipate the possibility 

that a generic formulation could be 

developed that did not fit precisely the 

wording of the listing that currently 

appears in schedule III. 

Recently, firms have submitted to 

FDA ANDAs for their proposed generic 

versions of Marinol®. As these ANDAs 

remain pending with the FDA, the 

precise nature of these formulations is 

not available for public disclosure. 

However, these formulations might 

differ from the Marinol® formulation 

currently listed in schedule III. 

Nonetheless, the firms that have 

submitted the ANDAs assert that their 

formulations would meet the approval 

requirements under 21 U.S.C. 355(j), 

because, among other things, they have 

the same active ingredient, strength, 

dosage form, and route of 

administration as Marinol®, and are 

bioequivalent to Marinol®. 

Products are bioequivalent if there is 

no significant difference in the rate and 

extent to which the active ingredient or 

active moiety becomes available at the 

site of drug action 21 CFR 320.1. There 

is no requirement under 21 U.S.C. 

355(j), or FDA’s implementing 

regulations, that solid oral dosage forms 

such as capsules that are proposed for 

approval in ANDAs contain the same 

inactive ingredients as the listed drug 

referenced. The generic drug, therefore, 

would not fall within the scope of the 

current regulation. This situation, in 

which a generic version of a drug would 

not necessarily fall within the schedule 

for the referenced listed drug, is unique 

among the CSA schedules in the 

following respect. The Marinol®

formulation listed in schedule III is the 

only listing in the schedules that has the 

effect of excluding potential generic 

versions of the brand name 

formulation.4 As indicated above, this 

came about because DEA did not 

anticipate that other drug products 

could be approved by FDA that did not 

fit the description that was included in 

the schedules. Moreover, Congress 

structured the CSA so that there would 

be no distinction—for scheduling 

purposes—between brand name drug 

products and their generic equivalents. 

The rule being proposed here would 

ensure that this aspect of the CSA holds 

true for generic drug products approved 

under 21 U.S.C. 355(j) that reference 

Marinol® as the listed drug. 

In addition, 21 U.S.C. 355(j)(2)(C) 

permits applicants to petition FDA for 

approval of an ANDA for a drug product 

that may differ from the listed drug in 

certain specified ways, if clinical 

studies are not necessary to establish the 

safety and effectiveness of the drug 

product. Among the types of differences 

permitted is a change in dosage form, or 

manner in which the active ingredient 

is produced. 

This proposed rule would amend the 

description in schedule III [21 CFR 

1308.13(g)(1)] to include products 

referencing Marinol® that are either 

(1) naturally derived or synthetic; or 

(2) in hard or soft gelatin capsules, as 

long as the formulations otherwise meet 

the approval requirements in 21 U.S.C. 

355(j). 

The CSA Scheduling Structure 

To understand the legal justification 

for the rule being proposed here, the 

scheduling scheme established by 

Congress under the CSA must first be 

considered. One court has succinctly 

summarized this scheme as follows: 

The [CSA] sets forth initial schedules of 

drugs and controlled substances in 21 U.S.C. 

812(c). However, Congress established 

procedures for adding or removing 

substances from the schedules (control or 

decontrol), or to transfer a drug or substance 

between schedules (reschedule). 21 U.S.C. 

811(a). This responsibility is assigned to the 

Attorney General in consultation with the 

Secretary of Health and Human Services 

(‘‘HHS’’) Id. Sec. 811(b). The Attorney General 

has delegated his functions to the 

Administrator of the DEA 28 CFR 0.100(b). 

Current schedules are published at 21 CFR 

1308.11–1308.15. 

There are three methods by which the DEA 

may initiate rulemaking proceedings to revise 

the schedules: (1) By the DEA’s own motion; 

(2) at the request of DHHS; (3) on the petition 

of any interested party. 21 U.S.C. 811(a); 

21 CFR 1308.43(a). Before initiating 

rulemaking proceedings, the DEA must 

request a scientific and medical evaluation 

from DHHS and a scheduling 

recommendation. The statute requires the 

DEA and DHHS to consider eight factors with 

respect to the drug or controlled substance. 

21 U.S.C. 811(b), (c). 

These factors are: 

(1) Its actual or relative potential for abuse. 

(2) Scientific evidence of its 

pharmacological effect, if known. 

(3) The state of current scientific 

knowledge regarding the drug or other 

substance. 

(4) Its history and current pattern of abuse. 

(5) The scope, duration, and significance of 

abuse. 

(6) What, if any, risk there is to the public 

health. 

(7) Its psychic or physiological dependence 

liability. 

(8) Whether the substance is an immediate 

precursor of a substance already controlled 

under this subchapter. 

Although the recommendations of DHHS 

are binding on the DEA as to scientific and 

medical considerations involved in the eightfactor test, the ultimate decision as to 

whether to initiate rulemaking proceedings to 

reschedule a controlled substance is made by 

the DEA.5

Gettman v. DEA, 290 F.3d 430, 432 (DC 

Cir. 2002). 

The FDA plays an important role 

within DHHS in the development of the 

DHHS scientific and medical 

determinations that bear on eight-factor 

analyses referred to above (required 

under section 811(c) for scheduling 

decisions). Thus, when it comes to 

newly developed drug products that 

contain controlled substances, FDA 

makes scientific and medical 

determinations for purposes of both the 

Food Drug and Cosmetic Act (in 

connection with decisions on whether 

to approve drugs for marketing) and the 

CSA (in connection with scheduling 

decisions). As explained below, the 

eight-factor analysis can be expected to 

yield the same conclusions with respect 

to a brand name drug product and 

certain generic drugs referencing that 

product that meet the approval 

requirements under 21 U.S.C. 355(j). 


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6See also Approved Drug Products with 

Therapeutic Equivalence Evaluations (commonly 

known as the ‘‘Orange Book’’), Intro. at p. vi, (27th 

ed.). 

7When Congress enacted the CSA in 1970, it 

scheduled codeine and certain other opiates in 

three different schedules depending on their 

respective concentrations. See 21 U.S.C. 812(c), 

schedule II(a)(1), schedule III(d), and schedule V. 

However, this differential scheduling for opiates 

does not specify drug product formulation in a 

manner that would result in a generic version of an 

opiate drug product being scheduled separately 

from the innovator drug. 

The ANDA Approval Process 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(known as the ‘‘Hatch-Waxman 

Amendments’’), codified at 21 U.S.C. 

355, 360cc, and 35 U.S.C. 156, 271, 282, 

permits the submission of ANDAs for 

approval of generic versions of 

approved drug products. 21 U.S.C. 

355(j). The ANDA process shortens the 

time and effort needed for approval by, 

among other things, allowing the 

applicant to demonstrate its product’s 

bioequivalence to a drug already 

approved under a New Drug 

Application (NDA) (the ‘‘listed’’ drug) 

rather than having to reproduce the 

safety and effectiveness data for that 

drug. If an ANDA applicant establishes 

that its proposed drug product has the 

same active ingredient, strength, dosage 

form, route of administration, labeling, 

and conditions of use as a listed drug, 

and that it is bioequivalent to that drug, 

the applicant can rely on FDA’s 

previous finding that the listed drug is 

safe and effective [See id].6 Once 

approved, an ANDA sponsor may 

manufacture and market the generic 

drug to provide a safe, effective, and low 

cost alternative to the American public. 

The majority of drugs approved under 

21 U.S.C. 355(j) are therapeutically 

equivalent to the listed drug they 

reference. This means that the generic 

drug and the referenced innovator drug 

contain identical amounts of the active 

ingredient, and are bioequivalent. 

Therapeutic equivalents can be 

expected to have the same clinical effect 

and safety profile when administered to 

patients under the conditions specified 

in the labeling. 

The key point, for purposes of the rule 

being proposed here, is that the generic 

drug can be substituted for the 

innovator drug with the full expectation 

that the generic drug will produce the 

same clinical effect and safety profile as 

the innovator drug. Consequently, for 

CSA scheduling purposes, the eightfactor analysis conducted by the FDA 

and DEA under 21 U.S.C. 811(c) would 

necessarily result in the same 

scheduling determination for an 

approved generic drug product as for 

the innovator drug to which the generic 

drug is a therapeutic equivalent. This is 

because, in conducting the eight-factor 

analysis, the FDA and DEA would be 

examining precisely the same medical, 

scientific, and abuse data for the generic 

drug product as would be considered for 

the innovator drug. The same would be 

true of the innovator drug and a drug 

product approved pursuant to a petition 

under 21 U.S.C. 355(j)(2)(C), where the 

drug approved in the ANDA differs from 

the listed drug only because it is a hard 

gelatin capsule and the listed drug is a 

soft gelatin capsule; or the active 

ingredient is naturally-derived, rather 

than synthetically produced. 

As noted earlier, these considerations 

never previously arose for any other 

controlled substance because the 

regulation citing the Marinol®

formulation is the only scheduling 

regulation that is drug product 

formulation-specific and thereby 

(inadvertently) excludes certain generic 

versions.7 This unintended result is not 

consistent with the structure and 

purposes of the CSA, which generally 

lists categories of substances in the 

schedules, rather than product 

formulations. Thus, by ensuring that 

generic versions of the Marinol®

formulation which might be approved 

by the FDA in the future are in the same 

schedule as Marinol®, the rule being 

proposed here would make the DEA 

regulations more consistent with the 

structure and purposes of the CSA. 

Finally, for additional clarity, the 

proposed rule would amend 21 CFR 

1308.13(g)(1) to change the phrase ‘‘U.S. 

Food and Drug Administration 

approved product’’ to ‘‘drug product 

approved for marketing by the U.S. 

Food and Drug Administration.’’ 

On June 22, 2007, and August 15, 

2007, DEA submitted scheduling review 

documents for several dronabinol 

generic products to the DHHS, and 

requested that DHHS provide scientific 

and medical evaluation and scheduling 

recommendations under the CSA. 

(These documents are available for 

review online at http:// 

www.deadiversion.usdoj.gov.) 

On March 17, 2010, and June 1, 2010, 

the Assistant Secretary for Health, 

DHHS, sent the Deputy Administrator of 

DEA scientific and medical evaluations 

and letters recommending that FDAapproved drug products containing 

dronabinol (naturally-derived or 

synthetic) in sesame oil in a gelatin 

capsule (hard or soft) be placed into 

schedule III of the CSA. Enclosed with 

the March 17, 2010, letter was a 

document prepared by the FDA entitled, 

‘‘Basis for the Recommendation to 

Control FDA-Approved Drug Products 

Containing Synthetic Dronabinol in 

Sesame Oil in a Hard Gelatin Capsule to 

Schedule III of the Controlled 

Substances Act.’’ The June 1, 2010 letter 

included a document entitled, ‘‘Basis for 

the Recommendation to Reschedule 

FDA-Approved Drug Products 

Containing Naturally-Derived 

Dronabinol in Sesame Oil in a Gelatin 

Capsule to Schedule III of the 

Controlled Substances Act.’’ These 

documents contained a review of the 

factors which the CSA requires the 

Secretary to consider. 21 U.S.C. 811(b). 

Note: The DHHS scheduling 

recommendations of March 17, 2010, and 

June 1, 2010, are available for review online 

at http://www.deadiversion.usdoj.gov. 

The factors considered by the 

Assistant Secretary of Health and DEA 

with respect to these products were: 

(1) Its actual or relative potential for 

abuse; 

(2) Scientific evidence of its 

pharmacological effects; 

(3) The state of current scientific 

knowledge regarding the drug; 

(4) Its history and current pattern of 

abuse; 

(5) The scope, duration, and 

significance of abuse; 

(6) What, if any, risk there is to the 

public health; 

(7) Its psychic or physiological 

dependence liability; and 

(8) Whether the substance is an 

immediate precursor of a substance 

already controlled under this 

subchapter. 21 U.S.C. 811(c). 

The DHHS scheduling 

recommendation of March 17, 2010, 

concluded that drug products 

containing synthetic dronabinol in 

sesame oil and encapsulated in a hard 

gelatin capsule, have a similar potential 

for abuse as Marinol®. ‘‘These products 

contain the same Active Pharmaceutical 

Ingredient (API), have similar chemistry 

and pharmacokinetics and have similar 

formulations in sesame oil.’’ FDA and 

National Institute on Drug Abuse 

(NIDA), after reviewing the available 

information conclude ‘‘that drug 

products approved for marketing by 

FDA that contain synthetic dronabinol 

in sesame oil in a hard gelatin capsule 

be controlled in Schedule III of the 

CSA.’’ 

The DHHS scheduling 

recommendation of June 1, 2010, 

concluded that drug products that 

contain naturally-derived dronabinol in 

sesame oil and in a gelatin capsule, have 

a similar potential for abuse as 

Marinol®. FDA and NIDA, after 

reviewing the available information, 

concluded ‘‘that drug products approved 


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67058 Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Proposed Rules 

for marketing by FDA that contain 

naturally-derived dronabinol in sesame 

oil in a gelatin capsule should be 

rescheduled to Schedule III of the CSA.’’ 

Based on the recommendations of the 

Assistant Secretary for Health, received 

in accordance with section 201(b) of the 

Act [21 U.S.C. 811(b)], and the 

independent review of the available 

data by DEA, the Deputy Administrator 

of DEA, pursuant to sections 201(a) and 

201(b) of the Act [21 U.S.C. 811(a) and 

811(b)], finds that FDA-approved 

generic dronabinol products, both 

naturally-derived or synthetically 

produced, in sesame oil and 

encapsulated in both hard gelatin or soft 

gelatin capsules meet the criteria for 

placement in schedule III set in 21 

U.S.C. 812(b), as follows: 

A. The Drug or Other Substance Has a 

Potential for Abuse Less Than the Drugs 

or Other Substances in Schedule II 

FDA-approved generic drug products 

that contain dronabinol (both naturallyderived or synthetically produced) in 

sesame oil in a gelatin capsule (both 

hard or soft gelatin) and reference 

Marinol®, have a similar potential for 

abuse as Marinol®, a schedule III drug 

product and have similar chemistry and 

pharmacokinetics as similar 

formulations in sesame oil. 

B. The Drug or Other Substance Has a 

Currently Accepted Medical Use in 

Treatment in the United States 

Marinol® was initially approved by 

FDA in 1985. When drug products that 

reference Marinol® receive FDA 

approval, they will have a currently 

accepted medical use in the United 

States. 

C. Abuse of the Drug or Other Substance 

May Lead to Moderate or Low Physical 

Dependence or Psychological 

Dependence and Such Dependence 

Would Be Less Than the Drugs or Other 

Substances in Schedule II 

The withdrawal syndrome associated 

with dronabinol, the API in Marinol®, 

produces symptoms in humans such as 

restlessness, irritability, mild agitation, 

anxiety, anger, insomnia, sleep EEG 

disturbances, nausea, decreased 

appetite, and decreased weight. Since a 

withdrawal syndrome is indicative of 

physical dependence, it is reasonable to 

conclude that generic dronabinol 

products (both naturally-derived or 

synthetically produced, and in hard or 

soft gelatin capsules) in sesame oil, will 

also produce physical dependence 

similar to those produced by Marinol®. 

Therefore, in this rulemaking, DEA is 

proposing that 21 CFR 1308.13(g)(1) be 

modified to include generic equivalents 

of Marinol® which are (1) naturallyderived or synthetically produced 

dronabinol; and/or (2) hard or soft 

gelatin capsules. These products, once 

approved by FDA, shall meet the criteria 

for inclusion in schedule III of the CSA. 

Comments and Requests for Hearing 

In accordance with the provisions of 

the CSA (21 U.S.C. 811(a)), this action 

is a formal rulemaking ‘‘on the record 

after opportunity for a hearing.’’ Such 

proceedings are conducted pursuant to 

the provisions of the Administrative 

Procedure Act 5 U.S.C. 556 and 557. All 

persons are invited to submit their 

comments or objections with regard to 

this proposal. Requests for a hearing 

may be submitted by interested persons 

and must conform to the requirements 

of 21 CFR 1308.44 and 1316.47. The 

request should state, with particularity, 

the issues concerning which the person 

desires to be heard and the requestor’s 

interest in the proceeding. Only 

interested persons, defined in the 

regulations as those ‘‘adversely affected 

or aggrieved by any rule or proposed 

rule issuable pursuant to section 201 of 

the Act (21 U.S.C. 811),’’ may request a 

hearing 21 CFR 1308.42. Please note 

that DEA may grant a hearing only ‘‘for 

the purpose of receiving factual 

evidence and expert opinion regarding 

the issues involved in the issuance, 

amendment or repeal of a rule issuable’’ 

pursuant to 21 U.S.C. 811(a). All 

correspondence regarding this matter 

should be submitted to the DEA using 

the address information provided above. 

Regulatory Certifications 

Executive Order 12866 

In accordance with the provisions of 

the CSA [21 U.S.C. 811(a)], this action 

is a formal rulemaking ‘‘on the record 

after opportunity for a hearing.’’ Such 

proceedings are conducted pursuant to 

the provisions of 5 U.S.C. 556 and 557 

and, as such, are exempt from review by 

the Office of Management and Budget 

pursuant to Executive Order 12866, 

section 3(d)(1). 

Regulatory Flexibility Act 

The Deputy Administrator hereby 

certifies that this rulemaking has been 

drafted in accordance with the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), has reviewed this regulation, 

and by approving it certifies that this 

regulation will not have a significant 

economic impact on a substantial 

number of small entities. DEA is hereby 

proposing to modify the listing of the 

Marinol® formulation in schedule III so 

that certain generic drug products are 

also included in that listing. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in Sections 3(a) and 

3(b)(2) of Executive Order 12988 Civil 

Justice Reform. 

Executive Order 13132 

This rulemaking does not preempt or 

modify any provision of state law; nor 

does it impose enforcement 

responsibilities on any state; nor does it 

diminish the power of any state to 

enforce its own laws. Accordingly, this 

rulemaking does not have federalism 

implications warranting the application 

of Executive Order 13132. 

Unfunded Mandates Reform Act of 1995 

This rule will not result in the 

expenditure by state, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $126,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed necessary under 

the provisions of the Unfunded 

Mandates Reform Act of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act). This rule will not result in 

an annual effect on the economy of 

$100,000,000 or more; a major increase 

in costs or prices: or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreign 

based companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Narcotics, Prescription drugs. 

Pursuant to the authority vested in the 

Attorney General under sections 201, 

202, and 501(b) of the CSA (21 U.S.C. 

811, 812, and 871(b)), delegated to the 

Administrator and Deputy 

Administrator pursuant to section 

501(a) (21 U.S.C. 871(a)) and as 

specified in 28 CFR 0.100 and 0.104, 

and appendix to subpart R, sec. 12, the 

Deputy Administrator hereby orders 

that Title 21 of the Code of Federal 

Regulations, part 1308, is proposed to be 

amended as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 


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Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Proposed Rules 67059 

Authority: 21 U.S.C. 811, 812, 871(b) 

unless otherwise noted. 

2. Section 1308.13 is amended by 

revising paragraph (g) to read as follows: 

§ 1308.13 Schedule III. 

* * * * * 

(g) Hallucinogenic substances. 

(1)(i) Dronabinol in sesame oil and 

encapsulated in a gelatin capsule in a 

drug product approved for marketing by 

the U.S. Food and Drug Administration 

(FDA)—7369. 

(ii) Any drug product in hard or soft 

gelatin capsule form containing natural 

dronabinol (derived from the cannabis 

plant) or synthetic dronabinol 

(produced from synthetic materials) in 

sesame oil, for which an abbreviated 

new drug application (ANDA) has been 

approved by the FDA under section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(j)) which 

references as its listed drug the drug 

product referred to in the preceding 

paragraph (g)(1)(i) of this section—7369. 

Note to paragraph (g)(1): Some other 

names for dronabinol: (6a R-trans)-6a,7,8,10atetrahydro-6,6,9-trimethyl-3-pentyl-6 Hdibenzo [b,d]pyran-1-ol] or (-)-delta-9-(trans)- 

tetrahydrocannabinol] 

(2) [Reserved] 

* * * * * 

Dated: October 19, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–27502 Filed 10–29–10; 8:45 am] 

BILLING CODE 4410–09–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 85, 86, 1036, 1037, 1065, 

1066, and 1068 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Parts 523, 534, and 535 

[EPA–HQ–OAR–2010–0162; NHTSA–2010– 

0079; FRL–9219–2] 

RIN 2060–AP61; RIN 2127–AK74 

Public Hearings for Greenhouse Gas 

Emissions Standards and Fuel 

Efficiency Standards for Medium- and 

Heavy-Duty Engines and Vehicles 

AGENCIES: Environmental Protection 

Agency (EPA) and National Highway 

Traffic Safety Administration (NHTSA). 

ACTION: Notice of public hearings. 

SUMMARY: EPA and NHTSA are 

announcing public hearings to be held 

for the joint proposed rules ‘‘Greenhouse 

Gas Emissions Standards and Fuel 

Efficiency Standards for Medium- and 

Heavy-Duty Engines and Vehicles,’’ 

which will be published in the near 

future in the Federal Register. The 

agencies will also accept comment on 

NHTSA’s Draft Environmental Impact 

Statement. Two hearings will be held, 

on November 15 and 18, 2010. 

DATES: NHTSA and EPA will jointly 

hold a public hearing on Monday, 

November 15, 2010, beginning at 

11 a.m. local time, and a second hearing 

on Thursday, November 18, 2010, 

beginning at 10 a.m. local time. EPA and 

NHTSA will make every effort to 

accommodate all speakers that arrive 

and register. Each hearing will continue 

until 5 p.m. or until everyone has had 

a chance to speak. If you would like to 

present oral testimony at one of these 

public hearings, please contact the 

person identified under FOR FURTHER

INFORMATION CONTACT, at least ten days 

before the hearing. 

ADDRESSES: The November 15 hearing 

will be held at the Millennium 

Knickerbocker Hotel Chicago, 163 East 

Walton Place (at N. Michigan Ave.), 

Chicago, Illinois 60611. The November 

18, 2010 hearing will be held at the 

Hyatt Regency Cambridge, 575 

Memorial Drive, Cambridge, 

Massachusetts 02139–4896. The 

hearings will be held at sites accessible 

to individuals with disabilities. 

FOR FURTHER INFORMATION CONTACT: If 

you would like to present oral testimony 

at a public hearing, please contact Julia 

MacAllister at EPA by the date specified 

under DATES, at: Office of 

Transportation and Air Quality, 

Assessment and Standards Division 

(ASD), Environmental Protection 

Agency, 2000 Traverwood Drive, Ann 

Arbor, MI 48105; telephone number: 

(734) 214–4131; fax number: (734) 214– 

4050; e-mail address: 

macallister.julia@epa.gov (preferred 

method for registering), or Assessment 

and Standards Division Hotline; 

telephone number; (734) 214–4636; 

e-mail: asdinfo@epa.gov. Please provide 

the following information: Time you 

wish to speak (morning, afternoon), 

name, affiliation, address, e-mail 

address, and telephone and fax 

numbers, and whether you require 

accommodations such as a sign 

language interpreter. 

Questions concerning the proposed 

rules should be addressed to NHTSA: 

Rebecca Yoon, Office of Chief Counsel, 

National Highway Traffic Safety 

Administration, 1200 New Jersey 

Avenue, SE., Washington, DC 20590. 

Telephone: (202) 366–2992. EPA: 

Lauren Steele, Office of Transportation 

and Air Quality, Assessment and 

Standards Division (ASD), 

Environmental Protection Agency, 2000 

Traverwood Drive, Ann Arbor, MI 

48105; telephone number: (734) 214– 

4788; fax number: (734) 214–4816; 

e-mail address: steele.lauren@epa.gov, 

or Assessment and Standards Division 

Hotline; telephone number; (734) 214– 

4636; e-mail: asdinfo@epa.gov. You may 

learn more about the proposal by 

visiting NHTSA’s or EPA’s Web pages at 

http://www.nhtsa.gov/fuel-economy or 

http://www.epa.gov/otaq/climate/ 

regulations.htm or by searching the 

rulemaking dockets (NHTSA–2010– 

0079; EPA–HQ–OAR–2010–0162) at 

http://www.regulations.gov. 

SUPPLEMENTARY INFORMATION: The 

purpose of the public hearings is to 

provide the public an opportunity to 

present oral comments regarding 

NHTSA and EPA’s proposal for 

‘‘Greenhouse Gas Emissions Standards 

and Fuel Efficiency Standards for 

Medium- and Heavy-Duty Engines and 

Vehicles.’’ These hearings also offer an 

opportunity for the public to provide 

oral comments regarding NHTSA’s draft 

Environmental Impact Statement, 

accompanying the proposed NHTSA 

fuel efficiency standards. The proposed 

rules would establish a comprehensive 

Heavy-Duty National Program that will 

reduce greenhouse gas emissions and 

increase fuel efficiency for on-road 

heavy-duty vehicles. NHTSA’s proposed 

fuel consumption standards and EPA’s 

proposed carbon dioxide (CO2) 

emissions standards would be tailored 

to each of three regulatory categories: (1) 

Combination Tractors; (2) Heavy-duty 

Pickup Trucks and Vans; and (3) 

Vocational Vehicles, as well as gasoline 

and diesel heavy-duty engines. EPA’s 

proposed hydrofluorocarbon emissions 

standards would apply to air 

conditioning systems in tractors, pickup 

trucks, and vans, and EPA’s proposed 

nitrous oxide (N2O) and methane (CH4) 

emissions standards would apply to all 

heavy-duty engines, pickup trucks, and 

vans. The proposal also includes a 

request for comment on possible 

alternative CO2-equivalent approaches 

for light-duty vehicles in model years 

2012–14. 

The proposal for which EPA and 

NHTSA are holding the public hearings 

will be published in the near future in 

the Federal Register and is available at 

the Web pages listed above under FOR

FURTHER INFORMATION CONTACT and also 

in the rulemaking dockets. NHTSA’s 

draft Environmental Impact Statement is 

available on the NHTSA Web page and 

in NHTSA’s rulemaking docket, both 


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