Rules - 2010
[Federal Register: August 6, 2010 (Volume 75, Number 151)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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.
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
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.
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,
[FR Doc. 2010-19345 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 Publishing Office (GPO).