Schedules of Controlled Substances: Exempt Anabolic Steroid Products, 61876-61877 [E6-17522]
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61876
Federal Register / Vol. 71, No. 203 / Friday, October 20, 2006 / Rules and Regulations
Lock Haven, PA, William T. Piper Memorial,
Takeoff Minimums and Textual DP, Amdt
1
Mifflintown, PA, Mifflintown, Takeoff
Minimums and Textual DP, Amdt 1
Wise, VA, Lonesome Pine, RNAV (GPS) RWY
24, Orig
Wise, VA, Lonesome Pine, GPS RWY 24,
Orig-A, CANCELLED
Green Bay, WI, Austin Straubel International,
ILS OR LOC RWY 36, Amdt 8
Evanston, WY, Evanston-Uinta County Burns
Field, RNAV (GPS) RWY 5, Amdt 2
Evanston, WY, Evanston-Uinta County Burns
Field, RNAV (GPS) RWY 23, Amdt 2
Evanston, WY, Evanston-Uinta County Burns
Field, VOR/DME RWY 5, Orig
Evanston, WY, Evanston-Uinta County Burns
Field, VOR/DME RWY 23, Amdt 1
[FR Doc. E6–17373 Filed 10–19–06; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–277F]
RIN 1117–AA98
Schedules of Controlled Substances:
Exempt Anabolic Steroid Products
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
AGENCY:
The Drug Enforcement
Administration (DEA) is finalizing an
Interim Rule designating two
pharmaceutical preparations as exempt
anabolic steroid products under the
Controlled Substances Act. This action
is part of the ongoing implementation of
the Anabolic Steroids Control Act of
1990.
SUMMARY:
Effective Date: This final rule is
effective October 20, 2006.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section,
Office of Diversion Control, Drug
Enforcement Administration,
Washington, DC 20537, Telephone:
(202) 307–7183.
SUPPLEMENTARY INFORMATION:
DATES:
Background
The Anabolic Steroids Control Act
(ASCA) of 1990 (Title XIX of Pub. L.
101–647) placed anabolic steroids into
Schedule III of the Controlled
Substances Act (CSA). Section 1903 of
the ASCA provides that the Attorney
General may exempt products which
contain anabolic steroids from all or any
part of the Controlled Substances Act
(CSA) (21 U.S.C. 801 et seq.) if the
products have no significant potential
for abuse. The authority to exempt these
products was delegated from the
Attorney General to the Administrator
of the Drug Enforcement Administration
(28 CFR 0.100(b)), who in turn,
redelegated this authority to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration (28 CFR part 0,
Appendix to Subpart R, Section 7(g)).
The procedure for implementing this
section of the ASCA is found in
§ 1308.33 of Title 21 of the Code of
Federal Regulations. An application
which was in conformance with
§ 1308.33 of Title 21 of the Code of
Federal Regulations was received and
was forwarded to the Secretary of
Health and Human Services for
evaluation. The purpose of this rule is
to finalize an interim rule regarding two
products which the Deputy Assistant
Administrator, Office of Diversion
Control, finds meet the exempt anabolic
steroid product criteria.
Anabolic Steroid Products Being Added
to the List of Products Exempted From
Application of the CSA
DEA received a letter dated January
12, 2004, written to the DEA on behalf
of Pharmaceutics International Inc. (PII),
and an application to exempt from
control under the CSA two products
each containing esterified estrogens and
methyltestosterone. In a letter dated
April 1, 2004, DEA provided a copy of
this application to the Department of
Health and Human Services (DHHS)
along with a request for evaluation and
a recommendation. In a letter dated
September 22, 2005, the Assistant
Secretary of Health for DHHS
recommended that both EssianTM and
EssianTM H.S. be exempted from control
under the CSA based on their similarity
to the products, Estratest and
Estratest H.S., respectively, both of
which have been exempted from control
under the CSA.
DEA agreed with DHHS regarding the
similarity of these products to products
which have already been exempted from
the regulatory controls of the Controlled
Substances Act. Further, after reviewing
several law enforcement databases, DEA
did not find evidence of significant
abuse or trafficking of these types of
products. Therefore, DEA published an
Interim rule with request for comments
(71 FR 10835, March 3, 2006).
Comments Received
The DEA received no comments in
response to the Interim Rule. Thus, the
rule is being finalized without change.
Accordingly, the Deputy Assistant
Administrator hereby affirms his order
that the following anabolic steroid
products be added to the list of products
excluded from application of certain
controls of the Controlled Substances
Act and referenced in 21 CFR 1308.34.
EXEMPT ANABOLIC STEROID PRODUCTS
Trade name
EssianTM H.S ....................
EssianTM ............................
Company
Pharmaceutics International Inc
Pharmaceutics International Inc.
Regulatory Certifications
mstockstill on PROD1PC61 with RULES
Regulatory Flexibility Act
The granting of exemption status
relieves persons who handle the
exempted products in the course of
legitimate business from the
registration, recordkeeping, security,
and other requirements imposed by the
CSA. Accordingly, the Deputy Assistant
VerDate Aug<31>2005
Form
13:58 Oct 19, 2006
Jkt 211001
Ingredients
Tablets ..............................
Esterfied Estrogens ...........
Methyltestosterone ............
Esterfied Estrogens ...........
Methyltestosterone ............
Tablets ..............................
Administrator certifies that this action
will not have a significant economic
impact upon a substantial number of
small entities whose interests must be
considered under the Regulatory
Flexibility Act (5 U.S.C. 605(b)).
Executive Order 12866
The Deputy Assistant Administrator
has determined that this is not a
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
Quantity
0.625mg/Tablet.
1.25mg/Tablet.
1.25mg/Tablet.
2.5mg/Tablet.
‘‘significant rule,’’ as that term is used
in Executive Order 12866. This final
rule exempts the identified steroid
products from the regulatory controls
that apply to controlled substances.
Therefore, this rule has not been
reviewed by the Office of Management
and Budget.
E:\FR\FM\20OCR1.SGM
20OCR1
Federal Register / Vol. 71, No. 203 / Friday, October 20, 2006 / Rules and Regulations
Executive Order 12988
This final rule meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of Executive Order 12988 Civil
Justice Reform.
Dated: October 10, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control.
[FR Doc. E6–17522 Filed 10–19–06; 8:45 am]
BILLING CODE 4410–09–P
Executive Order 13132
This final rule does not preempt or
modify any provision of state law; nor
does it impose enforcement
responsibilities on any state; nor does it
diminish the power of any state to
enforce its own law. Accordingly, this
rulemaking does not have federalism
implications warranting the application
of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This final rule will not result in the
expenditure by State, local or tribal
governments, in the aggregate, or by the
private sector, of $115,000,000 or more
in any one year, and will not
significantly or uniquely affect small
governments. Therefore, no actions were
deemed necessary under the provisions
of the Unfunded Mandates Reform Act
of 1995.
Small Business Regulatory Enforcement
Fairness Act of 1996
This final rule is not a major rule as
defined by § 804 of the Small Business
Regulatory Enforcement Fairness Act of
1996. This rule will not result in an
annual effect on the economy of
$100,000,000 or more, a major increase
in costs or prices, or significant adverse
effects on competition, employment,
investment, productivity, innovation, or
on the ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
Pursuant to the authority vested in the
Attorney General by section 1903 of the
Anabolic Steroid Control Act of 1990,
delegated to the Administrator of the
Drug Enforcement Administration
pursuant to 21 U.S.C. 871(a) and 28 CFR
0.100, and redelegated to the Deputy
Assistant Administrator of the DEA
Office of Diversion Control pursuant to
28 CFR part 0, Appendix to Subpart R,
Section 7(g), the Deputy Assistant
Administrator hereby adopts as a final
rule, without change, the interim rule
which was published at 71 FR 10835, on
March 3, 2006 amending the list
described in 21 CFR 1308.34.
mstockstill on PROD1PC61 with RULES
I
VerDate Aug<31>2005
13:58 Oct 19, 2006
Jkt 211001
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 1, 35, and 54
[TD 9294]
RIN 1545–BD68
Use of Electronic Media for Providing
Employee Benefit Notices and Making
Employee Benefit Elections and
Consents
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulation.
AGENCY:
This document contains final
regulations setting forth standards for
electronic systems that make use of an
electronic medium to provide a notice
to a recipient, or to make a participant
election or consent, with respect to a
retirement plan, an employee benefit
arrangement, or an individual
retirement plan. These regulations
reflect the provisions of the Electronic
Signatures in Global and National
Commerce Act (E–SIGN). These final
regulations generally affect sponsors of,
and individuals entitled to benefits
under, certain retirement plans,
employee benefit arrangements, and
individual retirement plans.
DATES: Effective date: These regulations
are effective on October 20, 2006.
Applicability date: These regulations
generally apply to applicable notices
provided, and participant elections
made, on or after January 1, 2007. See
§ 1.401(a)–21(g).
FOR FURTHER INFORMATION CONTACT:
Pamela R. Kinard at (202) 622–6060 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
Paperwork Reduction Act
The collections of information
referenced in these final regulations
were previously reviewed and approved
by the Office of Management and
Budget in accordance with the
Paperwork Reduction Act of 1995 (44
U.S.C. 3507(d)) under control number
1545–1632, in conjunction with the
Treasury Decision (TD 8873), relating to
New Technologies in Retirement Plans,
published on February 8, 2000 in the
Federal Register (65 FR 6001), and
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
61877
control number 1545–1780, in
conjunction with the Treasury Decision
(TD 9052), relating to Notice of
Significant Reduction in the Rate of
Future Benefit Accrual, published on
April 9, 2003 in the Federal Register (68
FR 17277). Responses to these
collections of information are
mandatory.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid control
number assigned by the Office of
Management and Budget.
Books or records relating to these
collections of information must be
retained as long as their contents may
become material in the administration
of any internal revenue law. Generally,
tax returns and tax return information
are confidential, as required by 26
U.S.C. 6103.
Background
This document contains amendments
to 26 CFR parts 1, 35, and 54 under
section 401 of the Internal Revenue
Code (Code) and other sections of the
Code relating to retirement plans,
employee benefit arrangements, and
individual retirement plans. This
Treasury Decision adds § 1.401(a)–21 to
the Treasury regulations, which sets
forth standards for the use of an
electronic medium to provide
applicable notices to recipients, or to
make participant elections, with respect
to a retirement plan, an employee
benefit arrangement, or an individual
retirement plan. These final regulations
reflect the applicable provisions of the
Electronic Signatures in Global and
National Commerce Act, Public Law
106–229 (114 Stat. 464 (2000)) (E-SIGN)
as it relates to the electronic delivery of
notices.
The Code and regulations thereunder,
and the parallel provisions of the
Employee Retirement Income Security
Act of 1974 (ERISA), include a number
of rules that require certain notices,
elections, or consents to be written or in
writing. Examples of notices, elections,
or consents required to be written or in
writing include a section 402(f) notice
(describing rollover rights), a section
411(a)(11) notice (describing a
participant’s benefit commencement
rights), a spousal consent under section
417(a)(2), and a section 204(h) notice
(notice to participants of significant
reduction in rate of future benefit
accrual). For a more in-depth
description of retirement plan notices,
elections, or consents that are required
to be written or in writing, see the
background section to the preamble of
E:\FR\FM\20OCR1.SGM
20OCR1
]]>Agencies
[Federal Register Volume 71, Number 203 (Friday, October 20, 2006)]
[Rules and Regulations]
[Pages 61876-61877]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-17522]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-277F]
RIN 1117-AA98
Schedules of Controlled Substances: Exempt Anabolic Steroid
Products
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is finalizing an
Interim Rule designating two pharmaceutical preparations as exempt
anabolic steroid products under the Controlled Substances Act. This
action is part of the ongoing implementation of the Anabolic Steroids
Control Act of 1990.
DATES: Effective Date: This final rule is effective October 20, 2006.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-
7183.
SUPPLEMENTARY INFORMATION:
Background
The Anabolic Steroids Control Act (ASCA) of 1990 (Title XIX of Pub.
L. 101-647) placed anabolic steroids into Schedule III of the
Controlled Substances Act (CSA). Section 1903 of the ASCA provides that
the Attorney General may exempt products which contain anabolic
steroids from all or any part of the Controlled Substances Act (CSA)
(21 U.S.C. 801 et seq.) if the products have no significant potential
for abuse. The authority to exempt these products was delegated from
the Attorney General to the Administrator of the Drug Enforcement
Administration (28 CFR 0.100(b)), who in turn, redelegated this
authority to the Deputy Assistant Administrator, Office of Diversion
Control, Drug Enforcement Administration (28 CFR part 0, Appendix to
Subpart R, Section 7(g)). The procedure for implementing this section
of the ASCA is found in Sec. 1308.33 of Title 21 of the Code of
Federal Regulations. An application which was in conformance with Sec.
1308.33 of Title 21 of the Code of Federal Regulations was received and
was forwarded to the Secretary of Health and Human Services for
evaluation. The purpose of this rule is to finalize an interim rule
regarding two products which the Deputy Assistant Administrator, Office
of Diversion Control, finds meet the exempt anabolic steroid product
criteria.
Anabolic Steroid Products Being Added to the List of Products Exempted
From Application of the CSA
DEA received a letter dated January 12, 2004, written to the DEA on
behalf of Pharmaceutics International Inc. (PII), and an application to
exempt from control under the CSA two products each containing
esterified estrogens and methyltestosterone. In a letter dated April 1,
2004, DEA provided a copy of this application to the Department of
Health and Human Services (DHHS) along with a request for evaluation
and a recommendation. In a letter dated September 22, 2005, the
Assistant Secretary of Health for DHHS recommended that both
EssianTM and EssianTM H.S. be exempted from
control under the CSA based on their similarity to the products,
Estratest[supreg] and Estratest[supreg] H.S., respectively, both of
which have been exempted from control under the CSA.
DEA agreed with DHHS regarding the similarity of these products to
products which have already been exempted from the regulatory controls
of the Controlled Substances Act. Further, after reviewing several law
enforcement databases, DEA did not find evidence of significant abuse
or trafficking of these types of products. Therefore, DEA published an
Interim rule with request for comments (71 FR 10835, March 3, 2006).
Comments Received
The DEA received no comments in response to the Interim Rule. Thus,
the rule is being finalized without change. Accordingly, the Deputy
Assistant Administrator hereby affirms his order that the following
anabolic steroid products be added to the list of products excluded
from application of certain controls of the Controlled Substances Act
and referenced in 21 CFR 1308.34.
Exempt Anabolic Steroid Products
----------------------------------------------------------------------------------------------------------------
Trade name Company Form Ingredients Quantity
----------------------------------------------------------------------------------------------------------------
EssianTM H.S.................... Pharmaceutics Tablets........... Esterfied 0.625mg/Tablet.
International Inc Estrogens. 1.25mg/Tablet.
Methyltestosterone
EssianTM........................ Pharmaceutics Tablets........... Esterfied 1.25mg/Tablet.
International Inc. Estrogens. 2.5mg/Tablet.
Methyltestosterone
----------------------------------------------------------------------------------------------------------------
Regulatory Certifications
Regulatory Flexibility Act
The granting of exemption status relieves persons who handle the
exempted products in the course of legitimate business from the
registration, recordkeeping, security, and other requirements imposed
by the CSA. Accordingly, the Deputy Assistant Administrator certifies
that this action will not have a significant economic impact upon a
substantial number of small entities whose interests must be considered
under the Regulatory Flexibility Act (5 U.S.C. 605(b)).
Executive Order 12866
The Deputy Assistant Administrator has determined that this is not
a ``significant rule,'' as that term is used in Executive Order 12866.
This final rule exempts the identified steroid products from the
regulatory controls that apply to controlled substances. Therefore,
this rule has not been reviewed by the Office of Management and Budget.
[[Page 61877]]
Executive Order 12988
This final rule meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This final rule does not preempt or modify any provision of state
law; nor does it impose enforcement responsibilities on any state; nor
does it diminish the power of any state to enforce its own law.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This final rule will not result in the expenditure by State, local
or tribal governments, in the aggregate, or by the private sector, of
$115,000,000 or more in any one year, and will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995.
Small Business Regulatory Enforcement Fairness Act of 1996
This final rule is not a major rule as defined by Sec. 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. This rule
will not result in an annual effect on the economy of $100,000,000 or
more, a major increase in costs or prices, or significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based companies to
compete with foreign-based companies in domestic and export markets.
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
Pursuant to the authority vested in the Attorney General by section
1903 of the Anabolic Steroid Control Act of 1990, delegated to the
Administrator of the Drug Enforcement Administration pursuant to 21
U.S.C. 871(a) and 28 CFR 0.100, and redelegated to the Deputy Assistant
Administrator of the DEA Office of Diversion Control pursuant to 28 CFR
part 0, Appendix to Subpart R, Section 7(g), the Deputy Assistant
Administrator hereby adopts as a final rule, without change, the
interim rule which was published at 71 FR 10835, on March 3, 2006
amending the list described in 21 CFR 1308.34.
Dated: October 10, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E6-17522 Filed 10-19-06; 8:45 am]
BILLING CODE 4410-09-P
