Reg-146384-05

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Federal Register / Vol. 71, No. 68 / Monday, April 10, 2006 / Proposed Rules
4. Section 211.94 is amended by
adding paragraph (e) to read as follows:
§ 211.94 Drug product containers and
closures.

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(e) Medical gas containers and
closures must meet the following
requirements:
(1) Except as provided in paragraph
(e)(2) of this section, cryogenic
containers or high-pressure cylinders
used at any time to hold a liquid or
compressed industrial gas may not be
subsequently used to hold any type of
liquid or compressed medical gas.
(2) The prohibition in paragraph (e)(1)
of this section does not apply to any
cryogenic container or high-pressure
cylinder that was once used to hold a
liquid or compressed industrial gas if
the container or cylinder:
(i) Was converted to use for holding
a liquid or compressed medical gas in
accordance with standard industry
practice before [effective date of final
regulation]; and
(ii) Is used solely to hold a liquid or
compressed medical gas on and after
[effective date of final regulation] and is
in compliance with all other applicable
requirements.
(3) Portable cryogenic medical gas
containers that are not manufactured
with permanent gas use outlet
connections (e.g., those that have been
silver-brazed) must have gas-specific
use outlet connections that are attached
to the valve body so that they cannot be
readily removed or replaced (without
making the valve inoperable and
preventing the containers’ use) except
by the manufacturer. For the purposes
of this paragraph, the term
‘‘manufacturer’’ includes any individual
or firm that fills high-pressure medical
gas cylinders or cryogenic medical gas
containers by any of the following
methods: Liquid to liquid, liquid to gas,
or gas to gas. For the purposes of
paragraphs (e)(3) and (e)(4) of this
section, a ‘‘portable cryogenic medical
gas container’’ is one that is capable of
being transported and is intended to be
attached to a medical gas supply system
within a hospital, health care entity,
nursing home, other facility, or home
health care setting. The term does not
include small cryogenic gas containers
for use by individual patients or
portable liquid oxygen units when
distributed empty, as defined at
§ 868.5655 of this chapter.
(4) Label and color requirements. (i)
Each portable cryogenic medical gas
container must be conspicuously
marked with a 360° wraparound label
identifying its contents.

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(A) The label must identify the
medical gas held in the container by the
gas’ standard name, as designated in
paragraph (e)(5) of this section.
(B) The standard name must be
printed on the label in one of the
following ways:
(1) Using lettering that appears in the
standard color designated for the gas in
paragraph (e)(5) of this section and that
is printed against a white background,
or
(2) Using lettering that appears in
white against a background that is
painted in the standard color for the gas
as designated in paragraph (e)(5) of this
section.
(C) The lettering for the name of the
gas on the label must be at least 2 3/4
inches high.
(D) The name of the gas must be
printed continuously around the label
and be capable of being read around the
entire container.
(E) The label must be on the sidewall
of the container, as close to the top of
the container as possible but below the
top weld seam.
(F) The label must be affixed to the
container so that it cannot be easily
detached or worn, and in a manner that
does not interfere with other labeling.
(G) If the shoulder portion of a
portable cryogenic medical gas
container is colored, the color used
must be that designated in paragraph
(e)(5) of this section for the gas held
within the container.
(ii) High-pressure medical gas
cylinders must be identified with FDAdesignated standard colors according to
the following:
(A) Non-aluminum high-pressure
medical gas cylinders must be colored
in whole in the standard color
designated in paragraph (e)(5) of this
section for the gas contained in the
cylinder.
(B) Aluminum high-pressure medical
gas cylinders must be colored on the
shoulder portion of the cylinder in the
standard color designated in paragraph
(e)(5) of this section for the gas
contained in the cylinder.
(C) The materials used for coloring
must be reasonably resistant to fading,
durable when exposed to atmospheric
conditions, and not readily soluble in
water after they have been applied and
properly dried or cured.
(D) High-pressure medical gas
cylinders containing a blend or
combination of medical gases must be
colored with the standard colors of each
component gas, as designated in
paragraph (e)(5) of this section. Each
such color must be visible when viewed
from the top of the cylinder and must
appear in rough proportion to the

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fraction of the gas it represents in the
combination or mixture.
(5) The standard names and colors
required to identify medical gases under
paragraph (e)(4) of this section are:
Standard Name

Standard Color

Medical Air

Yellow

Medical Carbon Dioxide

Gray

Medical Helium

Brown

Medical Nitrogen

Black

Medical Nitrous Oxide

Blue

Medical Oxygen

Green

Mixture or Blend of Medical Gases

Standard colors for
each component

5. Section 211.125 is amended by
adding a sentence to the end of
paragraph (c) to read as follows:
§ 211.125

Labeling issuance.

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(c) * * * Labeling reconciliation is
also waived for 360° wraparound labels
on portable cryogenic medical gas
containers.
Dated: November 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–3370 Filed 4–7–06; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[REG–146384–05]
RIN 1545–BF02

Application of Section 338 to
Insurance Companies
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking
by cross-reference to temporary
regulation.
AGENCY:

SUMMARY: In the Rules and Regulations
section of this issue of the Federal
Register, the IRS is issuing temporary
regulations that provide guidance under
section 197 that apply to the treatment
of certain insurance contracts assumed
in an assumption reinsurance
transaction and section 338 that apply
to a deemed sale or acquisition of an
insurance company’s assets pursuant to
an election under section 338 of the
Internal Revenue Code, to a sale or
acquisition of an insurance trade or

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18054

Federal Register / Vol. 71, No. 68 / Monday, April 10, 2006 / Proposed Rules

business subject to section 1060, and to
the acquisition of insurance contracts
through assumption reinsurance. The
text of those regulations also serve as
the text of these proposed regulations.
DATES: Written or electronic comments,
and a request for a public hearing, must
be received by July 10, 2006.
ADDRESSES: Send submissions to:
CC:PA:LPD:PR (REG–138879–05), room
5203, Internal Revenue Service, P.O.
Box 7604, Ben Franklin Station,
Washington, DC 20044. Submissions
may be hand-delivered Monday through
Friday between the hours of 8 a.m. and
4 p.m. to CC:PA:LPD:PR (REG–138879–
05), Courier’s Desk, Internal Revenue
Service, 1111 Constitution Avenue,
NW., Washington, DC, or sent
electronically, via the IRS Internet site
at http://www.irs.gov/regs or via the
Federal eRulemaking Portal at http://
www.regulations.gov (IRS and REG–
146384–05).
FOR FURTHER INFORMATION CONTACT:
Concerning the proposed regulation,
Mark J. Weiss, (202) 622–7790,
concerning submissions of comments,
Richard Hurst, (202) 622–7180 (not tollfree numbers).
SUPPLEMENTARY INFORMATION:

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Background and Explanation of
Provisions
Temporary Regulations in the Rules
and Regulations section of this issue of
the Federal Register amend 26 CFR part
1 relating to section 338. The temporary
regulations add §§ 1.197–2T(g)(5)(ii),
1.338–11T(d), and 1.338–11T(e). The
texts of those regulations also serve as
the text of these proposed regulations.
The preamble to the temporary
regulations explain the amendments
included in these proposed regulations.
Special Analyses
It has been determined that this notice
of proposed rulemaking is not a
significant regulatory action as defined
in Executive Order 12866. Therefore, a
regulatory assessment is not required.
Further, it is hereby certified that these
proposed regulations will not have a
significant economic impact on a
substantial number of small entities.
This certification is based on the fact
that these regulations do not have a
substantial economic impact because
they merely provide guidance about the
operation of the tax law in the context
of acquisitions of insurance companies
and businesses. Moreover, they are
expected to apply predominantly to
transactions involving larger businesses.
Accordingly, a Regulatory Flexibility
Analysis under the Regulatory
Flexibility Act (5 U.S.C. chapter 6) is

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not required. Pursuant to section 7805(f)
of the Code, this notice of proposed
rulemaking will be submitted to the
Chief Counsel for Advocacy of the Small
Business Administration for comment
on its impact on small business.
Comments and Requests for a Public
Hearing
Before these proposed regulations are
adopted as final regulations,
consideration will be given to any
written comments (a signed original and
eight copies) that are submitted timely
to the IRS. Alternatively, taxpayers may
submit comments electronically via the
IRS Internet site at http://www.irs.gov/
regs or via the Federal eRulemaking
Portal at http://www.regulations.gov.
The IRS and Treasury Department
request comments on the clarity of the
proposed rules and how they can be
made easier to understand. All
comments will be available for public
inspection and copying. A public
hearing may be scheduled if requested
in writing by any person who timely
submits written comments. If a public
hearing is scheduled, notice of the date,
time, and place of the hearing will be
published in the Federal Register.
Drafting Information
The principal author of these
regulations is Mark J. Weiss of the Office
of Associate Chief Counsel (Corporate).
Other personnel from Treasury and the
IRS participated in their development.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Proposed Amendments to the
Regulations
Accordingly, 26 CFR part 1 is
proposed to be amended as follows:
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 continues to read, in part, as
follows:
Authority: 26 U.S.C. 7805 * * *
Section 1.197–2 also issued under 26
U.S.C. 197. * * *
Section 1.338–11 also issued under 26
U.S.C. 338. * * *

Par. 2. Section 1.197–2 is amended by
revising paragraph (g)(5)(ii) to read as
follows:
§ 1.197–2T Amortization of goodwill and
certain other intangibles (temporary).

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(g) * * *
(5)(ii) [The text of the proposed
§ 1.197–2(g)(5) is the same as the text for

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§ 1.197–2T(g)(5) published elsewhere in
this issue of the Federal Register].
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Par. 3. Section 1.338–1 is amended by
redesignating existing paragraph
(b)(2)(vii) as paragraph (b)(2)(viii) and
adding new paragraph (b)(2)(vii) to read
as follows:
§ 1.338–1 General principles; status of old
target and new target.

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(b) * * *
(2) * * *
(vii) [The text of the proposed
§ 1.338–1(b)(2)(vii) is the same as the
text for § 1.338–1T(b)(2)(vii) published
elsewhere in this issue of the Federal
Register].
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Par. 4. Section 1.338–11 is amended
by revising paragraphs (d) and (e) to
read as follows:
§ 1.338–11 Effect of section 338 election
on insurance company targets.

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(d) Reserve increases by new target
after the deemed asset sale.
[The text of the proposed § 1.338–
11(d) is the same as the text for § 1.338–
11T(d) published elsewhere in this issue
of the Federal Register].
(e) Effect of section 338 election on
section 846(e) election.
[The text of the proposed § 1.338–
11(e) is the same as the text for § 1.338–
11T(e) published elsewhere in this issue
of the Federal Register].
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Par. 5. Section 1.846–2 as amended
by adding new paragraph (d) to read is
follows:
§ 1.846–2 Election by taxpayer to use its
own historical loss payment pattern.

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(d) Effect of section 338 election on
section 846(e) election.
[The text of the proposed § 1.846–2(d)
is the same as the text for § 1.846–2T(d)
published elsewhere in this issue of the
Federal Register].
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Par. 6. Section 1.846–4 is amended
by:
1. The section heading is revised.
2. Redesignating the existing text as
paragraph (a).
3. Adding new paragraph (b).
The revision and addition read as
follows:
§ 1.846–4

Effective dates.

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(b) Section 338 election.
[The text of the proposed § 1.846–4(b)
is the same as the text for § 1.846–4T(b)

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Federal Register / Vol. 71, No. 68 / Monday, April 10, 2006 / Proposed Rules
published elsewhere in this issue of the
Federal Register].
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Mark E. Matthews,
Deputy Commissioner for Services and
Enforcement.
[FR Doc. 06–3321 Filed 4–7–06; 8:45 am]

ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2005–0015; FRL–7779–7]
RIN 2070–AJ18

Perfluoroalkyl Sulfonates; Proposed
Significant New Use Rule; Extension of
Comment Period

BILLING CODE 4830–01–P

Environmental Protection
Agency (EPA).
ACTION: Proposed rule; extension of
comment period.
AGENCY:

DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[CGD05–06–024]
RIN 1625–AA08

Special Local Regulations for Marine
Events; Rappahannock River, Essex
County, Westmoreland County,
Layton, VA; Correction
AGENCY:
ACTION:

Coast Guard, DHS.

Proposed rule; correction.

SUMMARY: This document corrects the
preamble to a proposed rule published
in the Federal Register of April 3, 2006,
regarding a temporary special local
regulation for ‘‘2006 Rappahannock
River Boaters Association Spring and
Fall Radar Shootout’’, power boat races
to be held on the waters of the
Rappahannock River near Layton, VA.
This correction changes the date by
which comments and related material
must reach the Coast Guard, from June
2, 2006 to May 3, 2006. The change is
necessary because the June 2 date does
not allow adequate time to issue a final
rule before June 3, 2006, the date of the
first event affected by the proposed rule.
FOR FURTHER INFORMATION CONTACT:

Dennis Sens, Marine Events
Coordinator, Fifth Coast Guard District,
at (757) 398–6204.
Correction

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In proposed rule FR Doc. E6–4788,
beginning on page 16525 in the issue of
April 3, 2006, make the following
correction in the DATES section. On page
16525 in the second column, change
‘‘June 2, 2006’’ to ‘‘May 3, 2006.’’
Dated: April 4, 2006.
S.G. Venckus,
Chief, Office of Regulations and
Administrative Law.
[FR Doc. E6–5208 Filed 4–7–06; 8:45 am]
BILLING CODE 4910–15–P

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SUMMARY: This document extends the
public comment period established for
the Proposed Significant New Use Rule
for Perfluoroalkyl Sulfonates in the
Federal Register issued on March 10,
2006 (71 FR 12311) (FRL–7740–6). In
that proposed rule, EPA proposed to
amend a significant new use rule
(SNUR) under section 5(a)(2) of the
Toxic Substances Control Act (TSCA) to
include certain perfluoroalkyl
sulfonates (PFAS) substances. EPA
proposed to amend the PFAS SNUR at
40 CFR 721.9582 by adding a new Table
3 containing the remaining PFAS
chemicals on the TSCA Inventory that
are not already regulated by the SNUR.
EPA believes that action is necessary
because these chemical substances may
be hazardous to human health and the
environment. The required notice will
provide EPA the opportunity to evaluate
intended significant new uses and
associated activities before they occur
and, if necessary, to prohibit or limit
those uses or activities.
DATES: Comments must be received on
or before May 10, 2006.
ADDRESSES: Follow the detailed
instructions as provided under
ADDRESSES in the Federal Register
document of March 10, 2006 (71 FR
12311).
FOR FURTHER INFORMATION CONTACT: For
general information contact: Colby
Lintner, Regulatory Coordinator,
Environmental Assistance Division
(7408M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 554–1404; e-mail address:
[email protected].
For technical information contact:
Amy Breedlove, Chemical Control
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (202) 564–
9823; e-mail address:
[email protected].

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18055

SUPPLEMENTARY INFORMATION:

I. General Information
The Agency included in the proposed
rule a list of those who may be
potentially affected by this action. If you
have questions regarding the
applicability of this action to a
particular entity, consult the person
listed under the FOR FURTHER
INFORMATION CONTACT.
II. What Action is EPA taking?
This document extends the public
comment period established in the
Federal Register issued on March 10,
2006 (71 FR 12311). In that document,
EPA proposed to amend a significant
new use rule (SNUR) under section
5(a)(2) of the Toxic Substances Control
Act (TSCA) to include certain
perfluoroalkyl sulfonates (PFAS)
substances. EPA proposed to amend the
PFAS SNUR at 40 CFR 721.9582 by
adding a new Table 3 containing the
remaining PFAS chemicals on the TSCA
Inventory that are not already regulated
by the SNUR. EPA is hereby extending
the comment period, which was set to
end on April 10, 2006, to May 10, 2006.
III. What is the Agency’s Authority for
Taking this Action?
Section 5(a)(2) of TSCA (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by promulgating a
rule after considering all relevant
factors, including those listed in TSCA
section 5(a)(2). These factors include the
projected production volume of a
chemical substance; the extent to which
a use changes or increases the type,
form, magnitude, or duration of
exposure to the substance; and the
reasonably anticipated manner of
producing, processing, distributing, or
disposing of the substance. EPA
construes the statute to allow
consideration of any other relevant
factors, in addition to those listed in
section 5(a)(2). Once EPA determines
that a use of a chemical substance is a
significant new use, and promulgates a
SNUR, section 5(a)(1)(B) of TSCA
requires persons to submit a Significant
New Use Notice (SNUN) to EPA at least
90 days before they manufacture,
import, or process the chemical
substance for that use.
IV. Do Any Statutory and Executive
Order Reviews Apply to this Action?
No. This action is not a rulemaking,
it merely extends the date by which
public comments on a proposed rule
must be submitted to EPA on a
proposed rule that previously published

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