Rules - 2010
FR Doc 2010-19348[Federal Register: August 6, 2010 (Volume 75, Number 151)]
[Rules and Regulations]
[Page 47451-47452]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au10-3]
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: Final rule: correction.
SUMMARY: The Drug Enforcement Administration (DEA) is correcting a
final rule that appeared in the Federal Register of March 18, 2004. The
final 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 Final
Rule that scheduled the substance n-Benzylpiperazine (BZP) as a
schedule I controlled substance. In a Notice of Proposed Rulemaking,
published on September 8, 2003 (68 FR 52872), DEA proposed the control
of BZP in schedule I of the Controlled Substances Act (CSA). A 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 Final Rule. Under separate rulemaking, DEA is publishing a
correction to the Notice of Proposed Rulemaking, published September 8,
2003 (68 FR 52872).
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
[[Page 47452]]
documents prepared by both HHS and DEA.
Although the potency difference between BZP and amphetamine was
discussed in the rules proposing and 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 Thursday, March 18, 2004, of the
Final Rule [Docket No. DEA-247F], at 69 FR 12794 [FR Doc. 04-6110], is
corrected in the preamble as follows:
On page 12795, in the first column, paragraph 4, sentences 4 and 5
are corrected to read as follows: "BZP is about 20 times less potent
than amphetamine in producing these effects. However, in subjects with
a history of amphetamine dependence, BZP was found to be about 10 times
less potent than amphetamine.''
Dated: July 26, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-19348 Filed 8-5-10; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |
