37300 Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Rules and Regulations 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–313F] 

RIN 1117–AB26 

Correction of Code of Federal 

Regulations: Removal of Temporary 

Listing of Benzylfentanyl and 

Thenylfentanyl as Controlled 

Substances 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice 

ACTION: Final rule. 

SUMMARY: This rulemaking corrects Title 

21 Code of Federal Regulations (CFR) by 

deleting regulations which list the 

substances benzylfentanyl and 

thenylfentanyl as being temporarily 

subject to schedule I controls under the 

emergency scheduling provisions of the 

Controlled Substances Act (CSA). The 

temporary scheduling of benzylfentanyl 

and thenylfentanyl expired on 

November 29, 1986. DEA determined 

that these compounds were both 

essentially inactive, with no evidence of 

abuse potential. As such, these 

compounds are no longer schedule I 

controlled substances and all references 

to these compounds are being deleted 

from DEA regulations. 

DATES: This rulemaking becomes 

effective June 29, 2010. 

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 at (202) 307– 

7183. 

SUPPLEMENTARY INFORMATION: The CSA 

was amended by the Comprehensive 

Crime Control Act of 1984 (Pub. L.98– 

473) which became effective on October 

12, 1984. This Act included a provision 

(21 U.S.C. 811(h)) which allows the 

DEA Administrator to place a substance, 

on a temporary basis, into schedule I 

when necessary to avoid an imminent 

hazard to the public safety. This 

emergency scheduling authority permits 

scheduling a substance that is not 

currently controlled, is being abused, 

and is a risk to the public health while 

the formal rulemaking procedures 

(21 U.S.C. 811) described in the CSA are 

being conducted. A temporary 

scheduling order may be issued for one 

year with a possible extension of up to 

six months if formal scheduling 

procedures have been initiated. The 

proposal and order are published in the 

Federal Register as are the proposals 

and orders for formal scheduling. The 

emergency scheduling authority was 

given to DEA in an effort to streamline 

the scheduling process in response to 

the growing problem of controlled 

substance analogues (‘‘designer drugs’’). 

On October 29, 1985, DEA published 

a Final Rule (50 FR 43698) which 

temporarily placed Acetyl-alphamethylfentanyl, Alphamethylthiofentanyl, Betahydroxyfentanyl, Beta-hydroxy-3- 

methylfentanyl, 3-Methylthiofentanyl, 

Thiofentanyl, Benzylfentanyl and 

Thenylfentanyl into schedule I of the 

CSA. This control action became 

effective on November 29, 1985. 

These substances were emergency 

scheduled based on their appearance in 

the illicit market, their similarity in 

chemical structure to that of controlled 

substances, and the likelihood that they 

would produce pharmacological effects 

similar to those of prototypic schedule 

I or II substances. Often there is no 

biological data available prior to the 

emergency control of illicitly produced 

and abused substances. Therefore, 

information derived from structureactivity relationship considerations 

plays an important role in emergency 

scheduling. To keep an emergency 

scheduled substance in schedule I, DEA 

must initiate traditional scheduling 

procedures (21 U.S.C. 811) for that 

substance during the one year period in 

which it is emergency controlled and 

complete the action before the 

expiration of 18 months. The time 

limitations of emergency scheduling 

underscore the need for timely abuse 

liability data and the need to determine 

the most efficient tests to provide the 

data necessary to make permanent 

scheduling decisions. During the oneyear temporary scheduling period, DEA 

must acquire sufficient data to make a 

determination as to whether the 

emergency scheduled substance should 

remain under the CSA. Often the 

substances have never been studied nor 

are they available for study. DEA, as 

soon as possible after identifying a 

newly abused substance, provides for 

the synthesis of this substance for 

analytical reference standards and 

biological testing. Only then can the 

appropriate pharmacological and abuse 

liability tests be conducted. 

In an effort to assess the addiction 

liability of these compounds, DEA 

contracted studies of each of the 

temporarily scheduled fentanyl 

compounds at the University of 

Michigan Medical School in Ann Arbor 

and at the Medical College of Virginia 

in Richmond. The studies indicated that 

while most of the fentanyl compounds 

had abuse liability profiles that 

warranted control, two of these 

temporarily scheduled compounds 

(benzylfentanyl and thenylfentanyl) did 

not have an addiction-forming or 

addiction-sustaining liability similar to 

morphine. 

Based on the results of these studies, 

on November 28, 1986, the DEA 

extended the temporary scheduling of 

six of these substances in schedule I. 

However, benzylfentanyl and 

thenylfentanyl were specifically omitted 

from this extension (and any future 

permanent control) because the 

pharmacological and biological testing 

of the substances, which included 

assessment of morphine-like activity, 

addiction liability, and analgesic effect, 

indicated that the compounds were both 

essentially inactive, with no evidence of 

abuse potential. 

Both of these substances were 

temporarily controlled because they 

were initially found in street samples 

with other fentanyl analogues and were 

most likely unreacted intermediates in 

the synthesis of the target fentanyl 

analogues. The DEA, having concluded 

that these two drugs lacked morphinelike addictive properties, allowed the 

temporary regulation of benzylfentanyl 

and thenylfentanyl to expire on 

November 29, 1986. Therefore, these 

two substances were no longer regulated 

as controlled substances upon that date. 

In contrast, however, DEA chose to 

extend temporary control of the other 

four fentanyl compounds in a Final Rule 

published November 26, 1986 (51 FR 

42834) and permanently controlled 

them in a Final Rule published May 29, 

1987 (52 FR 20070). 

Action of This Rulemaking 

After the temporary listing of 

benzylfentanyl and thenylfentanyl 

expired in November of 1986, these 

compounds were no longer controlled 

under the CSA. However, DEA never 

deleted 21 CFR 1308.11(g)(1) and (g)(2) 

that reference the listing of these 

compounds temporarily in schedule I. 

This rulemaking hereby corrects the 

CFR to delete 21 CFR 1308.11(g)(1) and 

(g)(2) which previously stated: 

(1) N-[1-benzyl-4-piperidyl]-N-phenylpropanamide (benzylfentanyl), its optical isomers, salts and salts of isomers ........................... 9818 

(2) N-[1-(2-thienyl)methyl-4-piperidyl]-N-phenylpropanamide (thenylfentanyl), its optical isomers, salts and salts of isomers .......... 9834 


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Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Rules and Regulations 37301 

This action therefore corrects part 

1308 to remove any reference to control 

of benzylfentanyl and thenylfentanyl in 

schedule I. 

Regulatory Certifications 

Administrative Procedure Act (5 U.S.C. 

553) 

An agency may find good cause to 

exempt a rule from certain provisions of 

the Administrative Procedure Act (5 

U.S.C. 553), including notice of 

proposed rulemaking and the 

opportunity for public comment, if it is 

determined to be unnecessary, 

impracticable, or contrary to the public 

interest. The temporary placement of 

benzylfentanyl and thenylfentanyl in 

Schedule I expired on November 29, 

1986. The substances were never 

scheduled and should have been 

removed from Title 21 of the Code of 

Federal Regulations, part 1308. This 

Final Rule corrects this by removing 

benzylfentanyl and thenylfentanyl from 

the listing of controlled substances in 

schedule I. As this Final Rule makes a 

technical correction by removing 

benzylfentanyl and thenylfentanyl from 

the Code of Federal Regulations, DEA 

finds it unnecessary and impracticable 

to permit public notice and comment. 

Therefore, DEA is publishing this 

document as a final rule. Further, as the 

removal of these substances prevents 

confusion about the scheduling of these 

substances, DEA finds there is good 

cause to make this final rule effective 

immediately upon publication. 

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), and by approving it certifies 

that this regulation will not have a 

significant economic impact upon a 

substantial number of small entities. 

This action removes the substances 

benzylfentanyl and thenylfentanyl from 

the schedules of controlled substances. 

These substances were temporarily 

scheduled in 1985 under the emergency 

scheduling provisions (21 U.S.C. 811, 21 

CFR 1308.11(g)) and that temporary 

scheduling expired on November 29, 

1986; however, the substances were 

never removed from the listing. 

Executive Order 12866 

The Deputy Administrator certifies 

that this rulemaking has been drafted in 

accordance with the principles in 

Executive Order 12866 § 1(b). It has 

been determined that this is not ‘‘a 

significant regulatory action.’’ Therefore, 

this action has not been reviewed by the 

Office of Management and Budget. 

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 $120,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions are 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 cost or prices; or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

■ For the reasons set out above, 21 CFR 

part 1308 is amended as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for part 1308 

continues to read as follows: 

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

unless otherwise noted. 

■ 2. Section 1308.11 is amended by 

revising paragraph (g) to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(g) Temporary listing of substances 

subject to emergency scheduling. Any 

material, compound, mixture or 

preparation which contains any 

quantity of the following substances: 

(1) [Reserved.] 

(2) [Reserved.] 

Dated: June 19, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–15529 Filed 6–28–10; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1310 

[Docket No. DEA–222F] 

RIN 1117–AA64 

Exempt Chemical Mixtures Containing 

Gamma-Butyrolactone 

AGENCY: Drug Enforcement 

Administration (DEA), Justice. 

ACTION: Final rule. 

SUMMARY: This rulemaking finalizes a 

November 12, 2008, Notice of Proposed 

Rulemaking in which DEA proposed 

that chemical mixtures that are 70 

percent or less gamma-butyrolactone 

(GBL), by weight or volume, be 

automatically exempt from regulatory 

controls under the Controlled 

Substances Act (CSA). DEA is seeking 

through this rulemaking to exempt only 

those chemical mixtures that do not 

represent a significant risk of diversion. 

This regulation makes GBL chemical 

mixtures, in concentrations greater than 

70 percent, subject to List I chemical 

regulatory requirements of the CSA, 

except if exempted through an existing 

categorical exemption. DEA is taking 

this action because there is a serious 

threat to the public safety associated 

with the ease by which GBL is 

chemically converted to the schedule I 

controlled substance gammahydroxybutyric acid (GHB). 

DEA recognizes that concentration 

criteria alone cannot identify all 

mixtures that warrant exemption. As a 

result, DEA regulations provide for an 

application process by which 

manufacturers may obtain exemptions 

from CSA regulatory controls for those 

GBL chemical mixtures that are not 

automatically exempt under the 

concentration criteria. 

DATES: This rulemaking becomes 

effective July 29, 2010. Persons seeking 

registration must apply on or before 

July 29, 2010 to continue their business 

pending final action by DEA on their 

application. 


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