[Federal Register Volume 75, Number 151 (Friday, August 6, 2010)]
[Proposed Rules]
[Pages 47503-47504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19345]
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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