Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Proposed Rules 56533 

1Three of the commenters that supported the rule 

also said, in somewhat different ways, that the 

proposed rule should go further—for example, by 

also transferring marijuana and/or its derivatives 

out of schedule I or by granting a pending 

application by a person seeking to become 

registered to manufacture marijuana. 

2This commenter suggested that all forms of THC 

should either be in schedule I or schedule III, but 

that FDA-approved formulations containing THC 

should not be listed separately from illicit forms of 

the drug. 

3For a discussion of the formal rescheduling 

procedures under the CSA, see Gettman v. DEA, 

290 F.3d at 430, 432 (D.C. Cir. 2002). 

submitted on or after February 11, 2009, 

must include the information listed in 

this paragraph for any authorized 

generic drug that was marketed during 

the time period covered by an annual 

report submitted after January 1, 1999. 

If information is included in the annual 

report with respect to any authorized 

generic drug, a copy of that portion of 

the annual report must be sent to the 

Food and Drug Administration, Center 

for Drug Evaluation and Research, 

Office of Pharmaceutical Science, 10903 

New Hampshire Ave., Bldg. 51, rm. 

4183, Silver Spring, MD 20993–0002 

and marked ‘‘Authorized Generic 

Submission’’ or, if FDA has required 

that annual reports be submitted in an 

electronic format, the information 

required by this section must also be 

submitted in the electronic format. 

* * * * * 

Dated: September 16, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22829 Filed 9–26–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–308W] 

Technical Amendment to Listing in 

Schedule III of Approved Drug 

Products Containing 

Tetrahydrocannabinols; Withdrawal of 

Proposed Rule 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice 

ACTION: Withdrawal of proposed rule. 

SUMMARY: DEA is withdrawing a 

proposed rule that was published in the 

Federal Register on September 24, 2007 

(72 FR 54226) and is terminating the 

rulemaking. The proposed rule would 

have revised the DEA regulations with 

respect to the listing in schedule III of 

a synthetic isomer of 

tetrahydrocannabinols (THC) contained 

in a specific formulation of a drug 

product approved by the U.S. Food and 

Drug Administration (FDA). 

Specifically, the proposed rule would 

have revised the DEA regulation so that 

it would also include generic drug 

products approved by the FDA under 

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

Cosmetic Act (FDCA) (21 U.S.C. 355) 

that cite the drug product currently 

listed in schedule III as the reference 

listed drug. In view of the comments 

DEA received in response to the 

proposed rule, DEA has decided—in 

lieu of finalizing the proposed rule—to 

proceed with the process set out in 21 

U.S.C. 811 for transferring each such 

generic drug individually to schedule 

III. 

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: 

Under the Controlled Substances Act 

(CSA), the schedules of controlled 

substances are published on an updated 

basis in the DEA regulations. 21 U.S.C. 

812(a), (c) and n.1. Currently, one of the 

substances listed in schedule III is the 

following: ‘‘Dronabinol (synthetic) in 

sesame oil and encapsulated in a soft 

gelatin capsule in a U.S. Food and Drug 

Administration [FDA] approved 

product.’’ 21 CFR 1308.13(g)(1). This 

describes the drug product marketed 

under the brand name Marinol. As 

explained in the Notice of Proposed 

Rulemaking (NPRM) (72 FR 54226), it is 

possible that generic versions of Marinol 

could be approved by the FDA yet not 

fit within the same schedule III listing 

as Marinol. The proposed rule was 

intended to correct this situation so that 

certain generic versions of Marinol that 

might be approved by the FDA in the 

future would be in the same schedule as 

Marinol. 

During the comment period, DEA 

received comments from nine entities 

(firms, organizations, and one 

individual). Six of the nine commenters 

expressed support for the proposed 

rule,1 two opposed it, and one stated 

both that it was ‘‘a good idea’’ and ‘‘not 

a good idea.’’ 2 One of the commenters 

that opposed the rule asserted that the 

rule was not in conformity with the 

CSA. Specifically, this commenter 

asserted that, to achieve the intended 

result of the rule (transferring to 

schedule III any future FDA-approved 

generic versions of Marinol that do not 

fit within the current wording of 21 CFR 

1308.13(g)(1)), DEA must engage in 

formal rescheduling action, following 

the procedures set forth in 21 U.S.C. 

811. Under these procedures, DEA 

requests from the Department of Health 

and Human Services (HHS) a scientific 

and medical evaluation and scheduling 

recommendation, with DEA and HHS 

being required to consider the eight 

factors set forth in 21 U.S.C. 811(b).3 In 

addition, both of the commenters that 

objected to the proposed rule asserted 

that the unique formulation of Marinol 

(that which meets the current wording 

of 21 CFR 1308.13(g)(1)) prevents the 

drug from having the ‘‘high potential for 

abuse’’ commensurate with controlled 

substances in schedules I and II. 

Further, these commenters asserted, 

generic versions of Marinol that might 

be approved by the FDA in the future 

cannot be assumed to have the same 

potential for abuse as Marinol if they 

were to differ from Marinol in their 

formulations or routes of 

administration. Based on these 

considerations, one of the objecting 

commenters asked that DEA withdraw 

the proposed rule or, in the alternative, 

grant an administrative hearing to 

address the issues raised in its 

objections. 

In the NPRM (in the preamble to the 

proposed rule), DEA addressed the 

foregoing legal and factual issues raised 

by the objecting commenters. Having 

considered the comments, DEA 

continues to believe that the proposed 

rule is legally permissible within the 

structure of the CSA, for the reasons set 

forth in the NPRM. In addition, having 

obtained the input and concurrence of 

the FDA during the development of the 

proposed rule, DEA believes that the 

proposed rule accurately reflects the 

relevant legal considerations under the 

FDCA and further that it is grounded in 

sound scientific considerations. It 

should also be noted that two of the 

commenters that supported the rule 

agreed with DEA regarding the core 

legal and factual issues raised by those 

commenters that objected to the rule. 

Nonetheless, DEA must consider what 

would likely be the practical realities of 

going forward with the proposed rule at 

this time. 

First, if DEA were to grant the 

objecting commenter’s request for a 

hearing, the administrative proceedings 

within the agency would likely take at 

least two years to complete, taking into 

account the time to conduct the hearing 

presided over by an administrative law 

judge (ALJ), the issuance by the ALJ of 

a recommended decision, and the 


hsrobinson on PROD1PC76 with PROPOSALS
56534 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Proposed Rules 

issuance by the Deputy Administrator of 

a final order. Thereafter, if DEA were to 

finalize the proposed rule, any person 

aggrieved by the final rule would be 

permitted to seek review in the United 

States Court of Appeals. It can never be 

automatically assumed that the Court of 

Appeals will uphold a challenge to an 

agency rule. Thus, it is conceivable that 

going forward toward finalizing the 

proposed rule at this time could result 

in years of litigation followed by no 

final rule that actually takes effect. 

Given these considerations, DEA 

believes that the most sound approach 

from this point forward is to withdraw 

the proposed rule and proceed instead 

with a continuation of the formal 

rescheduling procedures set forth in 21 

U.S.C. 811 that are already underway for 

each of the proposed generic versions of 

Marinol affected by the proposed rule 

(those for which the sponsor has 

submitted to FDA an abbreviated new 

drug application referencing Marinol 

but which fall outside the current 

wording of 21 CFR 1308.13(g)(1)). For 

each such product, where the proposed 

marketer has petitioned DEA to initiate 

rulemaking proceedings to transfer the 

product into schedule III, DEA has 

already—prior to the publication of the 

NPRM—forwarded the petition to FDA 

for a scheduling evaluation in 

accordance with the procedures set 

forth in 21 U.S.C. 811(b). 

Thus, the net result of the withdrawal 

of this proposed rule is that FDA and 

DEA will continue with the ongoing 

scheduling evaluations and any 

resultant rescheduling proceedings for 

each of the individual proposed generic 

versions of Marinol, rather than 

attempting to reschedule all of them 

simultaneously through the issuance of 

this proposed rule. DEA believes the 

former approach, as compared to the 

latter, is most likely to result in such 

rescheduling becoming effective in the 

shortest period of time. 

Dated: September 18, 2008. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E8–22839 Filed 9–26–08; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–121698–08] 

RIN 1545–B100 

Amendments to Section 7216 

Regulations—Disclosure or Use of 

Information by Preparers of Returns; 

Hearing Cancellation 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Cancellation of notice of public 

hearing on proposed rulemaking. 

SUMMARY: This document cancels a 

public hearing on proposed regulations 

that provide rules relating to the 

disclosure and use of tax return 

information by tax return preparers. 

DATES: The public hearing, originally 

scheduled for October 6, 2008 at 10 a.m. 

is cancelled. 

FOR FURTHER INFORMATION CONTACT: 

Funmi Taylor of the Publications and 

Regulations Branch, Legal Processing 

Division, Associate Chief Counsel 

(Procedure and Administration) at (202) 

622–3628 (not a toll-free number). 

SUPPLEMENTARY INFORMATION: A notice 

of proposed rulemaking by crossreference to temporary regulations and a 

notice of public hearing that appeared 

in the Federal Register on Wednesday, 

July 2, 2008 (73 FR 37910) announced 

that a public hearing was scheduled for 

October 6, 2008, at 10 a.m. in the NYU 

Room (room 2615), Internal Revenue 

Building, 1111 Constitution Avenue, 

NW., Washington, DC. The subject of 

the public hearing is under the section 

7216 of the Internal Revenue Code. 

Outlines of topics to be discussed at 

the hearing were due on September 15, 

2008. The notice of proposed 

rulemaking and notice of public hearing 

instructed those interested in testifying 

at the public hearing to submit a request 

to speak and an outline of the topics to 

be addressed. As of Monday, September 

22, 2008, no one has requested to speak. 

Therefore, the public hearing scheduled 

for October 6, 2008 is cancelled. 

LaNita Van Dyke, 

Chief, Publications and Regulations Branch, 

Legal Processing Division, Associate Chief 

Counsel (Procedure and Administration). 

[FR Doc. E8–22824 Filed 9–26–08; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–143716–04] 

RIN 1545–BD67 

Declaratory Judgments—Gift Tax 

Determinations; Hearing Cancellation 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Cancellation of notice of public 

hearing on proposed rulemaking. 

SUMMARY: This document cancels a 

public hearing on proposed regulations 

under section 7477 of the Internal 

Revenue Code (Code) regarding 

petitions filed with the United States 

Tax Court for declaratory judgments as 

to the valuation of gifts. 

DATES: The public hearing, originally 

scheduled for October 16, 2008 at 10 

a.m. is cancelled. 

FOR FURTHER INFORMATION CONTACT: 

Funmi Taylor of the Publications and 

Regulations Branch, Legal Processing 

Division, Associate Chief Counsel 

(Procedure and Administration) at (202) 

622–3628 (not a toll-free number). 

SUPPLEMENTARY INFORMATION: A notice 

of proposed rulemaking and a notice of 

public hearing that appeared in the 

Federal Register on Monday, June 9, 

2008 (73 FR 32503) announced that a 

public hearing was scheduled for 

October 16, 2008, at 10 a.m. in the IRS 

Auditorium, Internal Revenue Building, 

1111 Constitution Avenue, NW., 

Washington, DC. The subject of the 

public hearing is under section 7447 of 

the Internal Revenue Code. 

The public comment period for these 

regulations expired on September 8, 

2008. Outlines of topics to be discussed 

at the hearing were due on September 

16, 2008. The notice of proposed 

rulemaking and notice of public hearing 

instructed those interested in testifying 

at the public hearing to submit a request 

to speak and an outline of the topics to 

be addressed. As of Monday, September 

22, 2008, no one has requested to speak. 

Therefore, the public hearing scheduled 

for October 16, 2008, is cancelled. 

LaNita Van Dyke, 

Chief, Publications and Regulations Branch, 

Legal Processing Division, Associate Chief 

Counsel (Procedure and Administration). 

[FR Doc. E8–22825 Filed 9–26–08; 8:45 am] 

BILLING CODE 4830–01–P 


hsrobinson on PROD1PC76 with PROPOSALS