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[Federal Register: August 6, 2010 (Volume 75, Number 151)]
[Proposed Rules]               
[Page 47503-47504]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au10-20]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-247C]

 
Schedules of Controlled Substances; Placement of 2,5-Dimethoxy-4-
(n)-propylthiophenethylamine and N-Benzylpiperazine Into Schedule I of 
the Controlled Substances Act; Correction

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice of proposed rulemaking: correction.

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SUMMARY: The Drug Enforcement Administration (DEA) is correcting a 
notice of proposed rulemaking that appeared in the Federal Register of 
September 8, 2003. The proposed rule pertained to the scheduling of N-
Benzylpiperazine (BZP), and contained an error regarding the potency of 
BZP relative to amphetamine. Although DEA used the correct figures in 
arriving at its scheduling determination, the agency is publishing this 
correction to provide an official statement of the actual figures. This 
correction does not address the scheduling of 2,5-dimethoxy-4-(n)-
propylthiophenethylamine (2C-T-7) which was also placed into schedule I 
as a result of the above cited rulemaking.

DATES: This correction is effective August 6, 2010 without further 
action.

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:

Background

    DEA is correcting an inadvertent error that occurred in a Notice of 
Proposed Rulemaking that scheduled the substance n-Benzylpiperazine 
(BZP) as a schedule I controlled substance. The Notice of Proposed 
Rulemaking, published on September 8, 2003 (68 FR 52872), proposed the 
control of BZP in schedule I of the Controlled Substances Act (CSA). 
The Final Rule, published on March 18, 2004 (69 FR 12794), finalized 
the placement of BZP in schedule I of the CSA.
    Each of these rules contained a misstatement in the ``Supplementary 
Information'' section, with regard to the potency differences between 
BZP and amphetamine. In each rule, it was erroneously stated that BZP 
is 10 to 20 times more potent than amphetamine. In actuality, the 
converse is true (i.e., BZP is 10 to 20 times less potent than 
amphetamine.) Therefore this Rulemaking corrects this misstatement in 
the Notice of Proposed Rulemaking. Under separate rulemaking, DEA is 
publishing a correction to the Final Rule, published March 18, 2004 (68 
FR 12794).
    DEA emphasizes that these errors were made solely in the rules as 
published in the Federal Register. Both DEA and the U.S. Department of 
Health and Human Services (HHS) considered the correct BZP potencies 
during their scheduling deliberations. The correct potencies were 
included in both the HHS scientific and medical evaluation document, 
and in DEA's scheduling document, which were used to make the 
determination for control. The public docket for BZP contains both of 
these review documents. In addition, DEA has already published on the 
agency's Web site the correct figures regarding relative potency.
    The determination of control of BZP was made after consideration of 
all the available data and all eight factors and the criteria for 
schedule I as specified in 21 U.S.C. 811 and 812. The amphetamine-like 
property of BZP was determined following the collective review and 
consideration of all the available evidence including drug 
discrimination and self-administration and other information. These 
studies were briefly mentioned in the rules controlling BZP as a 
schedule I controlled substance and were discussed in detail in the 
scientific and medical evaluation and scheduling documents prepared by 
both HHS and DEA.
    Although the potency difference between BZP and amphetamine was 
discussed in the rules proposing and

[[Page 47504]]

finalizing control of BZP as a part of the scientific background 
information, comparisons of potency differences are only one piece of 
background scientific data used to evaluate the abuse potential of 
drugs or other substances. In addition, potency itself is not one of 
the factors determinative of control. In fact, there are many examples 
of substances of varying potencies in each schedule, including 
stimulants and opiates previously scheduled under the CSA.
    Even though the scheduling of BZP was finalized more than six years 
ago, DEA has been advised that in criminal proceedings, for sentencing 
purposes, courts have sought to ascertain: (1) The controlled 
substance, for which a sentencing guideline equivalency exists, that is 
the most closely analogous to BZP (which is d-amphetamine) and (2) the 
relative potency of BZP to that of the most analogous controlled 
substance. As indicated above, DEA has already published on the 
agency's Web site the correct figures regarding relative potency. This 
correction is being issued to provide such an official statement in the 
Federal Register for ease of reference by courts, litigants, and others 
who need the information for sentencing purposes.
    This correction does not address the scheduling of 2,5-dimethoxy-4-
(n)-propylthiophenethylamine (2C-T-7) which was also placed into 
schedule I as a result of the above cited rulemakings.

Correction

    Accordingly, the publication on Monday, September 8, 2003, of the 
Notice of Proposed Rulemaking [Docket No. DEA-247P], at 68 FR 52872 [FR 
Doc. 03-22684], is corrected in the preamble as follows:
    On page 52873, in the third column, paragraph 2 is corrected to 
read as follows: ``Consistent with the above-mentioned animal studies, 
it has been shown that BZP is about 20 times less potent than 
amphetamine in producing stimulant-like subjective and cardiovascular 
effects in humans (Bye C, et al., Eur. J. Clin. Pharmacol. 6: 163-169, 
1973). Similarly, Campbell and colleagues (Eur. J. Clin. Pharmacol. 6: 
170-176, 1973), using a double-blind clinical study involving 18 
subjects with a history of amphetamine dependence, reported that the 
nature and the timecourse of behavioral, autonomic and subjective 
effects following BZP administration are similar to those of 
amphetamine. BZP was found to be about 10 times less potent than 
amphetamine in this study.''

    Dated: July 9, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-19345 Filed 8-5-10; 8:45 am]
BILLING CODE 4410-09-P
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