Schedules of Controlled Substances; Placement of 2,5-Dimethoxy-4-(n)-propylthiophenethylamine and N-Benzylpiperazine Into Schedule I of the Controlled Substances Act; Correction, 47451-47452 [2010-19348]

Download as PDF erowe on DSK5CLS3C1PROD with RULES Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Rules and Regulations (i) Does not object to all or part of the assessments or determination of the PCAOB and the stay of publication is terminated; or (ii) Remands to the PCAOB with instructions that the stay of publication is permanent or that the PCAOB take such other actions as the Commission deems necessary or appropriate with respect to publication, including, but not limited to, revising the final inspection report or determinations before publication. (5) The review pursuant to this section shall be completed and a written notice pursuant to this section shall be sent no more than 75 calendar days after notification to the firm and the PCAOB that the Commission is granting the request for an interim review, unless the Commission extends the period for good cause. (f) Treatment of review. (1) Time periods in this section shall be computed as provided in the Commission’s Rules of Practice, 17 CFR 201.160. (2) Unless otherwise determined by the Commission, the decision to grant or deny a review request and the conclusions of the Commission’s review shall be non-public, and the information or documents submitted, created, or obtained by the Commission or its staff in the course of the review shall be deemed non-public. Nothing in this rule shall be construed to impair or limit the ability of any party to request confidential treatment under the Freedom of Information Act, 15 U.S.C. 7215(b)(5), or any other applicable law. (3) Pursuant to 15 U.S.C. 7214(h)(2), any decision of the Commission as a result of an interim review with respect to a PCAOB inspection report, including whether a request for review is granted or denied, shall not be reviewable under 15 U.S.C. 78y and shall not be deemed to be ‘‘final agency action’’ for purposes of 5 U.S.C. 704. (4) Any action taken by the Commission relates solely to the publication of the relevant inspection report and does not affect the ability of the Commission or PCAOB to take appropriate action. (g) Designation of address; Representation. (1) When a registered public accounting firm first submits a request for interim Commission review, or an associated person first submits information related to a request, the firm or associated person shall submit to the Commission, and keep current, an address at which any notice or other written communication furnished to the firm or associated person may be sent, a contact name and telephone number VerDate Mar<15>2010 14:05 Aug 05, 2010 Jkt 220001 where the firm or associated person may be reached during business hours and, if represented, the representative’s name, business address, and telephone number. (2) If the firm, PCAOB, or associated person will be represented by a representative, the initial submission of that person shall be accompanied by the notice of appearance required by § 201.102(d). The other provisions of § 201.102 with respect to representation before the Commission shall apply. § 202.11 [Redesignated as § 202.190] 7. Redesignate § 202.11 as § 202.190 under Subpart A. ■ Dated: July 26, 2010. By the Commission. Elizabeth M. Murphy, Secretary. [FR Doc. 2010–18860 Filed 8–5–10; 8:45 am] BILLING CODE 8010–01–P 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 NBenzylpiperazine Into Schedule I of the Controlled Substances Act; Correction Drug Enforcement Administration (DEA), Department of Justice. ACTION: Final rule: correction. AGENCY: 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 NBenzylpiperazine (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. SUMMARY: 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 DATES: PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 47451 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 nBenzylpiperazine (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 E:\FR\FM\06AUR1.SGM 06AUR1 47452 Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Rules and Regulations 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. erowe on DSK5CLS3C1PROD with RULES 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 VerDate Mar<15>2010 14:05 Aug 05, 2010 Jkt 220001 DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 199 [Docket ID: DoD–2010–HA–0068] RIN 0720–AB39 Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Retired Reserve for Members of the Retired Reserve Office of the Secretary, DoD. Interim final rule with comment AGENCY: ACTION: period. This interim final rule establishes requirements and procedures for implementation of TRICARE Retired Reserve. This interim final rule addresses provisions of the National Defense Authorization Act for Fiscal Year 2010 (NDAA–10). The purpose of this interim final rule is to establish the TRICARE Retired Reserve program that implements section 705 of the NDAA–10. Section 705 allows members of the Retired Reserve who are qualified for non-regular retirement, but are not yet 60 years of age, to qualify to purchase medical coverage equivalent to the TRICARE Standard (and Extra) benefit unless that member is either enrolled in, or is eligible to enroll in, a health benefit plan under Chapter 89 of Title 5, United States Code, as well as certain survivors. The amount of the premium that qualified members pay to purchase these benefits will represent the full cost as determined on an appropriate actuarial basis for coverage under the TRICARE Standard (and Extra) benefit including the cost of the program administration. There will be one premium for member-only coverage and a separate premium for member and family coverage. The rules and procedures otherwise outlined in Part 199 of 32 CFR relating to the operation and administration of the TRICARE Standard and Extra programs including the required cost-shares, deductibles and catastrophic caps for retired members and their dependents will apply to this program. The rule is being published as an interim final rule with comment period in order to comply with statutory effective dates. DATES: This rule is effective August 6, 2010. Written comments received at the address indicated below by October 5, 2010 will be considered and addressed in the final rule. ADDRESSES: You may submit comments, identified by docket number and/or RIN number and title, by any of the following methods: SUMMARY: PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Federal Docket Management System Office, 1160 Defense Pentagon, Washington, DC 20301–1160. Instructions: All submissions received must include the agency name and docket number or RIN for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at https:// www.regulations.gov as they are received without change, including any personal identifiers or contact information. Jody Donehoo, TRICARE Management Activity, TRICARE Policy and Operations, telephone (703) 681–0039. Questions regarding payment of specific claims under the TRICARE allowable charge method should be addressed to the appropriate TRICARE contractor. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Introduction and Background The purpose of this interim final rule is to establish the TRICARE Retired Reserve program that implements section 705 of the National Defense Authorization Act for Fiscal Year 2010 (NDAA–10) (Pub. L. 111–84). Section 705 added new section 1076e to Title 10, United States Code. Section 1076e allows members of the Retired Reserve who are qualified for non-regular retirement, but are not yet 60 years of age, as well as certain survivors to qualify to purchase medical coverage equivalent to the TRICARE Standard (and Extra) benefit unless that member is either enrolled in, or eligible to enroll in, a health benefits plan under Chapter 89 of Title 5, United States Code. II. Provisions of the Rule Regarding the TRICARE Retired Reserve Program A. Establishment of the TRICARE Retired Reserve Program (paragraph 199.25(a)). This paragraph describes the nature, purpose, statutory basis, scope, and major features of TRICARE Retired Reserve, a premium-based medical coverage program that was made available for purchase worldwide by certain members of the Retired Reserve, their family members and their surviving family members. TRICARE Retired Reserve is authorized by 10 U.S.C. 1076e. The major features of the program include making coverage available for purchase by any Retired Reserve member who is qualified for non-regular E:\FR\FM\06AUR1.SGM 06AUR1

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[Federal Register Volume 75, Number 151 (Friday, August 6, 2010)]
[Rules and Regulations]
[Pages 47451-47452]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19348]


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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: 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

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