Schedules of Controlled Substances: Exempt Anabolic Steroid Products, 10835-10837 [06-2032]
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Federal Register / Vol. 71, No. 42 / Friday, March 3, 2006 / Rules and Regulations
Drug Enforcement Administration
action is part of the ongoing
implementation of the Anabolic
Steroids Control Act of 1990.
DATES: This rule is effective March 3,
2006. Written comments must be
postmarked, and electronic comments
must be sent, on or before April 3, 2006.
ADDRESSES: To ensure proper handling
of comments, please reference Docket
No. DEA–277 on all written and
electronic correspondence. Written
comments sent via regular mail should
be sent to the Deputy Assistant
Administrator, Office of Diversion
Control, Drug Enforcement
Administration, Washington, DC 20537,
Attention: DEA Federal Register
Representative/ODL. Written comments
sent via express mail should be sent to
DEA Headquarters, Attention: DEA
Federal Register Representative/ODL,
2401 Jefferson-Davis Highway,
Alexandria, VA 22301. Comments may
be sent electronically to
dea.diversion.policy@usdoj.gov.
Comments may also be sent
electronically through https://
www.regulations.gov using the
electronic comment form provided at
that site. DEA will accept attachments to
electronic comments in Microsoft Word,
Word Perfect, Adobe PDF, or Excel file
formats only. DEA will not accept any
file formats other than those specifically
listed here.
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:
21 CFR Part 1308
Background
[Docket No. DEA–277I]
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) (21 U.S.C. 801 et
seq.). 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
Administration Order 7400.9N,
Airspace Designations and Reporting
Points, dated September 1, 2005, and
effective September 15, 2005, is
amended as follows:
*
*
*
*
*
Paragraph 6005 Class E airspace extending
upward from 700 feet or more above the
surface of the earth.
*
*
*
*
*
AAL AK E5 Sand Point, AK [Revised]
Sand Point Airport, AK
(Lat. 55°18′54″ N., long. 160°31′22″ W)
Borland NDB/DME
(Lat. 55°18′56″ N., long. 160°31′06″ W.)
That airspace extending upward from 700
feet above the surface within a 6.4-mile
radius of the Sand Point Airport and within
3 miles each side of the 172° bearing of the
Borland NDB/DME extending from the 6.4mile radius to 13.9 miles south of the airport
and within 5 miles either side of the 318°
bearing of the Borland NDB/DME extending
from the 6.4-mile radius to 17 miles
northwest of the airport; and that airspace
within 5 miles either side of the 324° bearing
of the Borland NDB/DME extending from the
6.4-mile radius to 17 miles northwest of the
airport, and that airspace extending upward
from 1,200 feet above the surface within a 25mile radius of the Borland NDB/DME.
*
*
*
*
*
Issued in Anchorage, AK, on February 24,
2006.
Michael A. Tarr,
Manager, Operations Support.
[FR Doc. 06–2007 Filed 3–2–06; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
RIN 1117–AA98
Schedules of Controlled Substances:
Exempt Anabolic Steroid Products
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Interim rule and request for
comments.
AGENCY:
wwhite on PROD1PC65 with RULES
SUMMARY: The Drug Enforcement
Administration (DEA) is designating
two pharmaceutical preparations as
exempt anabolic steroid products under
the Controlled Substances Act. This
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10835
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 identify 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 agrees 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
has not found evidence of significant
abuse or trafficking of these types of
products.
The Deputy Assistant Administrator,
having reviewed the application,
recommendation of the Secretary, and
other relevant information, finds that
Essian and EssianTM H.S. have no
significant potential for abuse.
Information on these products is given
below.
E:\FR\FM\03MRR1.SGM
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10836
Federal Register / Vol. 71, No. 42 / Friday, March 3, 2006 / Rules and Regulations
EXEMPT ANABOLIC STEROID PRODUCTS
Trade name
Company
Form
Ingredients
Quantity
EssianTM H.S. ..................
Pharmaceutics International Inc. ............
Tablets ..
EssianTM ...........................
Pharmaceutics International Inc. ............
Tablets ..
Esterfied Estrogens .................................
Methyltestosterone ..................................
Esterfied Estrogens .................................
Methyltestosterone ..................................
0.625mg/Tablet.
1.25mg/Tablet.
1.25mg/Tablet.
2.5mg/Tablet.
Therefore, the Deputy Assistant
Administrator hereby orders that the
above anabolic steroid products be
added to the list of products excluded
from application of certain controls of
the CSA and referenced in 21 CFR
1308.34.
Interested persons are invited to
submit their comments to this interim
rule. If any comments or objections raise
significant issues regarding any finding
of fact or conclusion of law upon which
this order is based, the Deputy Assistant
Administrator shall immediately
suspend the effectiveness of this order
until he may reconsider the application
in light of the comments and objections
filed. Thereafter, the Deputy Assistant
Administrator shall reinstate, revoke, or
amend his original order as he
determines appropriate.
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 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.
Executive Order 12988
This interim 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 interim 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 interim 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 interim 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.
Administrative Procedure Act
An agency may find good cause to
exempt a rule from certain provisions of
the Administrative Procedure Act (5
U.S.C. 553), including Notice of
Proposed Rulemaking and the
opportunity for public comment, if it is
determined to be unnecessary,
impracticable, or contrary to the public
interest (5 U.S.C. 553(b)(3)(B)). Further,
the Administrative Procedure Act
permits an agency to make this rule
effective upon the date of publication if
the rule is ‘‘a substantive rule which
grants or recognizes an exemption or
relieves a restriction’’ (5 U.S.C.
553(d)(1)). As the rule adds two
anabolic steroid products to the list of
products exempted from regulatory
control under the Controlled Substances
Act and provides a benefit to the
affected public, DEA finds that this rule
meets the criteria set forth in 5 U.S.C.
553(b)(3)(B) and 5 U.S.C. 553(d)(1) for
an exception to the usual notice and
comment process.
Part 1308 Schedules of Controlled
Substances
Pursuant to the authority vested in the
Attorney General by section 1903 of the
Anabolic Steroids 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 orders that the
following compounds, mixtures, or
preparations containing anabolic
steroids be exempted from application
of sections 302 through 309 and sections
1002 through 1004 of the Controlled
Substances Act (21 U.S.C. 822–829 and
21 U.S.C. 952–954) and 21 CFR 1301.13,
1301.71 through 1301.76 for
administrative purposes only and be
included in the list of products
described in 21 CFR 1308.34.
EXEMPT ANABOLIC STEROID PRODUCTS
wwhite on PROD1PC65 with RULES
Trade name
Company
Form
Ingredients
Quantity
EssianTM H.S. ..................
Pharmaceutics International Inc. ............
Tablets ..
EssianTM ...........................
Pharmaceutics International Inc. ............
Tablets ..
Esterfied Estrogens .................................
Methyltestosterone ..................................
Esterfied Estrogens .................................
Methyltestosterone ..................................
0.625mg/Tablet.
1.25mg/Tablet.
1.25mg/Tablet.
2.5mg/Tablet.
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PO 00000
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Federal Register / Vol. 71, No. 42 / Friday, March 3, 2006 / Rules and Regulations
Dated: February 27, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control.
[FR Doc. 06–2032 Filed 3–2–06; 8:45 am]
U.S. Forest Service, 421 F.3d 797, that
found defects in the 1997 Final EIS and
Record of Decision for the Tongass Land
Management Plan. The court’s analysis
of the 1997 forest plan was made in the
context of the 1982 planning
regulations. Thus, the agency wishes to
have the option of using the 1982
planning regulations during the remand.
For this unique situation, this final rule
amends 36 CFR 219.14(d)(1) to allow
the Tongass National Forest land
management plan to be revised using
either the 1982 planning rule or the
2005 planning rule.
BILLING CODE 4410–09–P
DEPARTMENT OF AGRICULTURE
Forest Service
36 CFR Part 219
RIN 0596–AC43
National Forest System Land
Management Planning
Forest Service, USDA.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Department of
Agriculture is revising the transition
language contained in the 2005
planning rule (70 FR 1023). This final
rule modifies the transition language to
allow the Tongass National Forest to
revise its land management plan either
under the 2005 Rule or the planning
regulations in effect before November 9,
2000. The preamble of this rule includes
a discussion of the public comments
received on the proposed rule published
January 4, 2006 (71 FR 307), and the
Department’s responses to the
comments.
EFFECTIVE DATE:
This rule is effective
March 3, 2006.
FOR FURTHER INFORMATION CONTACT:
Cherie Shelley, Director, Ecosystem
Planning, Alaska Region, Forest Service,
USDA at (907) 586–8887; or Dave
Barone, Planning Specialist, Ecosystem
Management Coordination Staff, Forest
Service, USDA at (202) 205–1019.
SUPPLEMENTARY INFORMATION:
wwhite on PROD1PC65 with RULES
Background
On January 5, 2005, the Department of
Agriculture published a final planning
rule (70 FR 1023) governing the
development of land management plans
required by the National Forest
Management Act. The 2005 planning
regulations provide for a transition
period from the previous planning
regulations (1982 planning rule) to the
new regulations (2005 planning rule).
Specifically, § 219.14 of the 2005
planning rule allows plans to be
amended under either the 1982
planning rule or the 2005 planning rule
during the transition period; however,
newly initiated revisions may only use
the 2005 planning rule.
On August 5, 2005, the Ninth Circuit
Court of Appeals issued a decision in
Natural Resources Defense Council v.
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16:36 Mar 02, 2006
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Summary of Public Comments and the
Department’s Responses
The proposed rule was published in
the Federal Register on January 4, 2006,
for a 30-day public comment period (71
FR 307). The Forest Service received
eight comments on the proposed rule,
one from an individual, one from an
Alaska Native tribe, and six from
environmental organizations. All
comments were considered in reaching
a decision on the final rule. All
comments received supported the
proposed rule and encouraged the
Forest Service to use the 1982 planning
rule instead of the 2005 planning rule in
revising the Tongass Land Management
Plan to respond to the decision of the
Ninth Circuit. The Department
appreciates the support for the proposed
rule and the flexibility it will provide.
The Forest Service will decide to use
either the 1982 or 2005 planning rule in
revising the Tongass Land Management
Plan, and will take the comments
received on the proposed rule into
account in making that decision.
Regulatory Certifications
Regulatory Impact
This final rule has been reviewed
under USDA procedures and Executive
Order 12866, Regulatory Planning and
Review. It has been determined that this
is not a significant rule. This rule will
not have an annual effect of $100
million or more on the economy nor
adversely affect productivity,
competition, jobs, the environment,
public health or safety, nor State or local
governments. This rule will not interfere
with an action taken or planned by
another agency nor raise new legal or
policy issues. Finally, this action will
not alter the budgetary impact of
entitlements, grants, user fees, or loan
programs or the rights and obligations of
recipients of such programs.
Accordingly, this final rule is not
subject to Office of Management and
Budget review under Executive Order
12866.
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10837
Proper Consideration of Small Entities
This final rule has been considered in
light of Executive Order 13272 regarding
proper consideration of small entities
and the Small Business Regulatory
Enforcement Fairness Act of 1996
(SBREFA), which amended the
Regulatory Flexibility Act (5 U.S.C. 601
et seq.). The final rule makes a technical
change to the transition language of the
2005 planning rule, to allow the
Tongass National Forest to use either
the current planning regulations or the
regulations in effect before November 9,
2000, for its next land management plan
revision. An initial small entities
flexibility assessment has been made,
which indicates that the final rule will
impose no additional requirements on
the affected public, which includes
small businesses, small not-for-profit
organizations, or small units of
government. Accordingly, it has been
determined that this final rule will not
have a significant economic impact on
a substantial number of small entities as
defined by SBREFA.
No Environmental Impact
This final rule allows the Tongass
National Forest to use either the existing
planning regulations or the planning
regulations in effect before November 9,
2000, for the next revision of its land
management plan to respond to the
court’s order. As such, the final rule has
no direct and immediate effects
regarding the occupancy and actual use
of the Tongass National Forest. Section
31.12 (2) of Forest Service Handbook
1909.15 (57 FR 43168; September 18,
1992) excludes from documentation in
an environmental assessment or impact
statement ‘‘rules, regulations, or policies
to establish Service-wide administrative
procedures, program processes, or
instruction.’’ The 2005 planning
regulations are a Service-wide program
process. The Department’s assessment is
that this rule falls within this category
of actions and that no extraordinary
circumstances exist which would
require preparation of an environmental
assessment or an environmental impact
statement.
Energy Effects
This final rule has been reviewed
under Executive Order 13211 of May 18,
2001, Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use. It has been
determined that this rule does not
constitute a significant energy action as
defined in the Executive order.
Procedural in nature, this final rule
allows the Tongass National Forest to
use either the regulations currently in
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]]>Agencies
[Federal Register Volume 71, Number 42 (Friday, March 3, 2006)]
[Rules and Regulations]
[Pages 10835-10837]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-2032]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-277I]
RIN 1117-AA98
Schedules of Controlled Substances: Exempt Anabolic Steroid
Products
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Interim rule and request for comments.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is 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: This rule is effective March 3, 2006. Written comments must be
postmarked, and electronic comments must be sent, on or before April 3,
2006.
ADDRESSES: To ensure proper handling of comments, please reference
Docket No. DEA-277 on all written and electronic correspondence.
Written comments sent via regular mail should be sent to the Deputy
Assistant Administrator, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, Attention: DEA Federal Register
Representative/ODL. Written comments sent via express mail should be
sent to DEA Headquarters, Attention: DEA Federal Register
Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301.
Comments may be sent electronically to dea.diversion.policy@usdoj.gov.
Comments may also be sent electronically through https://
www.regulations.gov using the electronic comment form provided at that
site. DEA will accept attachments to electronic comments in Microsoft
Word, Word Perfect, Adobe PDF, or Excel file formats only. DEA will not
accept any file formats other than those specifically listed here.
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) (21 U.S.C. 801 et seq.). 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
identify 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[reg] and Estratest[reg] H.S., respectively, both of which
have been exempted from control under the CSA.
DEA agrees 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 has not found evidence of significant abuse
or trafficking of these types of products.
The Deputy Assistant Administrator, having reviewed the
application, recommendation of the Secretary, and other relevant
information, finds that Essian and Essian\TM\ H.S. have no significant
potential for abuse. Information on these products is given below.
[[Page 10836]]
Exempt Anabolic Steroid Products
----------------------------------------------------------------------------------------------------------------
Trade name Company Form Ingredients Quantity
----------------------------------------------------------------------------------------------------------------
EssianTM H.S................. Pharmaceutics Tablets..... Esterfied Estrogens.. 0.625mg/Tablet.
International Inc.. Methyltestosterone... 1.25mg/Tablet.
EssianTM..................... Pharmaceutics Tablets..... Esterfied Estrogens.. 1.25mg/Tablet.
International Inc.. Methyltestosterone... 2.5mg/Tablet.
----------------------------------------------------------------------------------------------------------------
Therefore, the Deputy Assistant Administrator hereby orders that
the above anabolic steroid products be added to the list of products
excluded from application of certain controls of the CSA and referenced
in 21 CFR 1308.34.
Interested persons are invited to submit their comments to this
interim rule. If any comments or objections raise significant issues
regarding any finding of fact or conclusion of law upon which this
order is based, the Deputy Assistant Administrator shall immediately
suspend the effectiveness of this order until he may reconsider the
application in light of the comments and objections filed. Thereafter,
the Deputy Assistant Administrator shall reinstate, revoke, or amend
his original order as he determines appropriate.
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 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.
Executive Order 12988
This interim 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 interim 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 interim 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 interim 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.
Administrative Procedure Act
An agency may find good cause to exempt a rule from certain
provisions of the Administrative Procedure Act (5 U.S.C. 553),
including Notice of Proposed Rulemaking and the opportunity for public
comment, if it is determined to be unnecessary, impracticable, or
contrary to the public interest (5 U.S.C. 553(b)(3)(B)). Further, the
Administrative Procedure Act permits an agency to make this rule
effective upon the date of publication if the rule is ``a substantive
rule which grants or recognizes an exemption or relieves a
restriction'' (5 U.S.C. 553(d)(1)). As the rule adds two anabolic
steroid products to the list of products exempted from regulatory
control under the Controlled Substances Act and provides a benefit to
the affected public, DEA finds that this rule meets the criteria set
forth in 5 U.S.C. 553(b)(3)(B) and 5 U.S.C. 553(d)(1) for an exception
to the usual notice and comment process.
Part 1308 Schedules of Controlled Substances
Pursuant to the authority vested in the Attorney General by section
1903 of the Anabolic Steroids 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 orders that the following compounds, mixtures, or
preparations containing anabolic steroids be exempted from application
of sections 302 through 309 and sections 1002 through 1004 of the
Controlled Substances Act (21 U.S.C. 822-829 and 21 U.S.C. 952-954) and
21 CFR 1301.13, 1301.71 through 1301.76 for administrative purposes
only and be included in the list of products described in 21 CFR
1308.34.
Exempt Anabolic Steroid Products
----------------------------------------------------------------------------------------------------------------
Trade name Company Form Ingredients Quantity
----------------------------------------------------------------------------------------------------------------
EssianTM H.S................. Pharmaceutics Tablets..... Esterfied Estrogens.. 0.625mg/Tablet.
International Inc.. Methyltestosterone... 1.25mg/Tablet.
EssianTM..................... Pharmaceutics Tablets..... Esterfied Estrogens.. 1.25mg/Tablet.
International Inc.. Methyltestosterone... 2.5mg/Tablet.
----------------------------------------------------------------------------------------------------------------
[[Page 10837]]
Dated: February 27, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 06-2032 Filed 3-2-06; 8:45 am]
BILLING CODE 4410-09-P
