Qualified Amended Returns; Correction, 43635-43636 [05-14902]
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Federal Register / Vol. 70, No. 144 / Thursday, July 28, 2005 / Rules and Regulations
hand pursuant to §§ 1304.03, 1304.04
and 1304.11 of Title 21 of the Code of
Federal Regulations on and after July 28,
2005. Every registrant who desires
registration in Schedule V for pregabalin
is required to conduct an inventory of
all stocks of the substance on hand at
the time of registration.
Records. All registrants must keep
records pursuant to §§ 1304.03, 1304.04,
1304.21, 1304.22, and 1304.23 of Title
21 of the Code of Federal Regulations on
and after July 28, 2005.
Prescriptions. All prescriptions for
pregabalin or prescriptions for products
containing pregabalin must be issued
pursuant to 21 CFR 1306.03–1306.06
and 1306.21, 1306.23–1306.27.
Importation and Exportation. All
importation and exportation of
pregabalin must be in compliance with
part 1312 of Title 21 of the Code of
Federal Regulations on and after July 28,
2005.
Criminal Liability. Any activity with
pregabalin not authorized by, or in
violation of, the Controlled Substances
Act or the Controlled Substances Import
and Export Act occurring on and after
July 28, 2005, shall be unlawful.
Regulatory Certifications
Administrative Procedure Act
The Administrative Procedure Act
permits an agency to make a rule
effective upon the date of publication
when the agency finds good cause exists
and publishes its findings with the rule
(5 U.S.C. 553(d)(3)). As noted
previously, on December 31, 2004, the
FDA approved pregabalin [(S)-3(aminomethyl)-5-methylhexanoic acid]
for marketing under the trade name
Lyrica. On April 4, 2005, the Acting
Assistant Secretary for Health of the
DHHS sent the Administrator of the
DEA a scientific and medical evaluation
and a scheduling recommendation that
pregabalin, and its salts, be placed in
Schedule V of the CSA. Since this is a
new drug not previously available in the
United States and the first drug product
specifically approved for the treatment
of neuropathic pain associated with
diabetic peripheral neuropathy (DPN)
and postherpetic neuralgia (PHN), in
order to prevent harm to the public
health and safety by delaying the
availability of this new drug, the DEA
finds good cause to make this Final Rule
effective immediately upon publication.
Executive Order 12866
In accordance with the provisions of
the CSA (21 U.S.C. 811(a)), this action
is a formal rulemaking ‘‘on the record
after opportunity for a hearing.’’ Such
proceedings are conducted pursuant to
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43635
the provisions of 5 U.S.C. 556 and 557
and, as such, are exempt from review by
the Office of Management and Budget
pursuant to Executive Order 12866,
section 3(d)(1).
on the ability of United States-based
companies to compete with foreign
based companies in domestic and
export markets.
Regulatory Flexibility Act
The Deputy Administrator, in
accordance with the Regulatory
Flexibility Act (5 U.S.C. 605(b)), has
reviewed this final rule and by
approving it certifies that it will not
have a significant economic impact on
a substantial number of small entities.
Pregabalin products will be prescription
drugs used for the treatment of
neuropathic pain. Handlers of
pregabalin often handle other controlled
substances used to treat pain which are
already subject to the regulatory
requirements of the CSA.
Pregabalin is a new drug in the United
States; recent approval of LyricaTM by
the FDA will allow it to be marketed
once it is placed into Schedule V of the
CSA. This final rule will allow medical
access to a new pharmaceutical product.
Administrative practice and
procedure, Drug traffic control,
Narcotics, Prescription drugs.
Executive Order 12988
This regulation 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 rulemaking 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 laws. Accordingly, this
rulemaking does not have federalism
implications warranting the application
of Executive Order 13132.
Unfunded Mandates Reform Act of
1995
This rule will not result in the
expenditure by State, local and 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 provisions of
the Unfunded Mandates Reform Act of
1995.
Small Business Regulatory Enforcement
Fairness Act of 1996
This 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
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List of Subjects in 21 CFR Part 1308
Under the authority vested in the
Attorney General by section 201(a) of the
CSA (21 U.S.C. 811(a)), and delegated to
the Administrator of DEA by Department
of Justice regulations (28 CFR 0.100), and
redelegated to the Deputy Administrator
pursuant to 28 CFR 0.104, the Deputy
Administrator hereby amends 21 CFR
part 1308 as follows:
I
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
[AMENDED]
1. The authority citation for 21 CFR
part 1308 continues to read as follows:
I
Authority: 21 U.S.C. 811, 812, 871(b)
unless otherwise noted.
2. Section 1308.15 is amended by
adding a new paragraph (e) to read as
follows:
I
§ 1308.15
Schedule V.
*
*
*
*
*
(e) Depressants. Unless specifically
exempted or excluded or unless listed
in another schedule, any material,
compound, mixture, or preparation
which contains any quantity of the
following substances having a
depressant effect on the central nervous
system, including its salts:
(1) Pregabalin [(S)-3-(aminomethyl)-5methylhexanoic acid] 2782
(2) [Reserved]
Dated: July 22, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05–15036 Filed 7–27–05; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9186]
RIN 1545–BD42
Qualified Amended Returns;
Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correction to a correction to
temporary regulations.
AGENCY:
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Federal Register / Vol. 70, No. 144 / Thursday, July 28, 2005 / Rules and Regulations
SUMMARY: This document corrects a
correction to temporary regulations (TD
9186) which was published in the
Federal Register on June 23, 2005 (70
FR 36345). The temporary regulations
modify the rules relating to qualified
amended returns by providing
additional circumstances that end the
period within which a taxpayer may file
an amended return that constitutes a
qualified amended return.
DATES: This correction is effective on
March 2, 2005.
FOR FURTHER INFORMATION CONTACT:
Nancy Galib, (202) 622–4940 (not a tollfree number).
SUPPLEMENTARY INFORMATION:
Background
The temporary regulations (TD 9186)
that is the subject of this correction is
under section 6664 of the Internal
Revenue Code.
Need for Correction
As published, the correction to the
temporary regulations (TD 9186)
contains an error that may prove to be
misleading and is in need of
clarification.
Correction of Publication
Accordingly, the publication of the
correction to the temporary regulations
(TD 9186) that is the subject of FR Doc.
05–12386, is corrected as follows:
On page 36345, column 2, in the
preamble, under the paragraph heading
‘‘Background’’, line 3, the language ‘‘are
under section 6227 of the Internal’’ is
corrected to read ‘‘are under section
6664 of the Internal’’.
Cynthia E. Grigsby,
Acting Chief, Publications and Regulations
Branch, Legal Processing Division, Associate
Chief Counsel, (Procedures and
Administration).
[FR Doc. 05–14902 Filed 7–27–05; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[CGD13–05–030]
RIN 1625–AA11
Safety Zone: Camp Rilea Offshore
Small Arms Firing Range; Warrenton,
OR
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
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SUMMARY: The Coast Guard is
establishing a temporary safety zone
offshore of Camp Rilea, Warrenton,
Oregon. Small arms training and fire
will be conducted within this zone, and
a safety zone is needed to ensure the
safety of persons and vessels operating
in this area during the specified periods.
Entry into this safety zone is prohibited
unless authorized by the Captain of the
Port or his/her designated
representative.
Background and Purpose
This rule is effective from 6 a.m.
July 25, 2005 through 9 p.m. July 29,
2005.
This safety zone will be in effect to
ensure the safety of persons and vessels
in the vicinity of the live fire training.
Entry into this safety zone is prohibited
unless authorized by the Captain of the
Port or his/her designated
representative. A Coast Guard vessel
will be on scene to ensure that the
public is aware that the firing exercises
are in progress and that the firing area
is clear of traffic before firing
commences. All persons and vessels
shall comply with the instructions of
the Captain of the Port or his/her
designated on-scene U.S. Coast Guard
representative. On-scene Coast Guard
patrol personnel include commissioned,
warrant, and petty officers of the Coast
Guard on board Coast Guard, Coast
Guard Auxiliary, and local, state, and
federal law enforcement vessels.
DATES:
Documents indicated in this
preamble as being available in the
docket are part of docket CGD13–05–
030 and are available for inspection or
copying at Coast Guard Sector Portland,
6767 North Basin Avenue, Portland, OR
97217–3992 between 7 a.m. and 3 p.m.,
Monday through Friday, except Federal
holidays.
ADDRESSES:
LT
Shadrack Scheirman, Chief Port
Operations, USCG Sector, Portland, OR
97217, telephone number (503) 240–
9310.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Regulatory Information
We did not publish a notice of
proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B) and
5 U.S.C. 553(d)(3), the Coast Guard finds
that good cause exists for not publishing
an NPRM and for making this rule
effective less than 30 days after
publication in the Federal Register.
In order to maintain an increased
maritime security posture, the Coast
Guard has increased training
requirements for the carriage of
weapons during homeland security
operations. The crews required to carry
out homeland security operations must
be trained to perform their operational
obligations. Crews from multiple units
along the Oregon and Washington coasts
are participating in this exercise. Unit
operational schedules converged to
make July 25–29 the only date to
accommodate all parties.
Publishing an NPRM and delaying the
effective date of this rule would be
contrary to the public interest since
immediate action is necessary to
minimize potential danger to the public
from small arms fire during the live fire
training. Such training is necessary in
order to ensure Coast Guard crews are
qualified to carry Crew Served Weapons
required to fulfill their Military and
Homeland Security responsibilities.
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Changes in Coast Guard policy and
procedures require small boat crews to
train on and fire crew served weapons
from a vessel. In order to ensure the
safety of persons and vessels operating
in vicinity of this training from July 25,
2005 through July 29, 2005 a safety zone
will be in effect during all small arms
firing evolutions.
Discussion of Rule
Regulatory Evaluation
This rule is not a ‘‘significant
regulatory action’’ under section 3(f) of
Executive Order 12866, Regulatory
Planning and Review, and does not
require an assessment of potential costs
and benefits under section 6(a)(3) of that
Order. The Office of Management and
Budget has not reviewed it under that
Order. It is not ‘‘significant’’ under the
regulatory policies and procedures of
the Department of Homeland Security
(DHS). This rule only affects a small
area for a limited duration. The
proposed regulations have been tailored
in scope to impose the least impact on
maritime interests, yet provide the level
of safety necessary for such an event.
Small Entities
Under the Regulatory Flexibility Act
(5 U.S.C. 601–612), we have considered
whether this rule would have a
significant economic impact on a
substantial number of small entities.
The term ‘‘small entities’’ comprises
small businesses, not-for-profit
organizations that are independently
owned and operated and are not
dominant in their fields, and
governmental jurisdictions with
populations of less than 50,000.
The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have
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[Federal Register Volume 70, Number 144 (Thursday, July 28, 2005)]
[Rules and Regulations]
[Pages 43635-43636]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14902]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9186]
RIN 1545-BD42
Qualified Amended Returns; Correction
AGENCY: Internal Revenue Service (IRS), Treasury.
ACTION: Correction to a correction to temporary regulations.
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[[Page 43636]]
SUMMARY: This document corrects a correction to temporary regulations
(TD 9186) which was published in the Federal Register on June 23, 2005
(70 FR 36345). The temporary regulations modify the rules relating to
qualified amended returns by providing additional circumstances that
end the period within which a taxpayer may file an amended return that
constitutes a qualified amended return.
DATES: This correction is effective on March 2, 2005.
FOR FURTHER INFORMATION CONTACT: Nancy Galib, (202) 622-4940 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
Background
The temporary regulations (TD 9186) that is the subject of this
correction is under section 6664 of the Internal Revenue Code.
Need for Correction
As published, the correction to the temporary regulations (TD 9186)
contains an error that may prove to be misleading and is in need of
clarification.
Correction of Publication
Accordingly, the publication of the correction to the temporary
regulations (TD 9186) that is the subject of FR Doc. 05-12386, is
corrected as follows:
On page 36345, column 2, in the preamble, under the paragraph
heading ``Background'', line 3, the language ``are under section 6227
of the Internal'' is corrected to read ``are under section 6664 of the
Internal''.
Cynthia E. Grigsby,
Acting Chief, Publications and Regulations Branch, Legal Processing
Division, Associate Chief Counsel, (Procedures and Administration).
[FR Doc. 05-14902 Filed 7-27-05; 8:45 am]
BILLING CODE 4830-01-P
