Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Technical Amendment, 13123-13124 [E8-4870]
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Federal Register / Vol. 73, No. 49 / Wednesday, March 12, 2008 / Rules and Regulations
Order 7400.9 and publication of
conforming amendments.
FOR FURTHER INFORMATION CONTACT:
Richard Roberts, Federal Aviation
Administration, System Support Group,
Western Service Area, 1601 Lind
Avenue, SW., Renton, WA, 98057;
telephone (425) 203–4517.
SUPPLEMENTARY INFORMATION:
History
On August 29, 2007 the FAA
published in the Federal Register a
notice of proposed rulemaking to
modify Class E airspace at Tucson, AZ
(72 FR 49677). This action would
enhance the safety and management of
Instrument Flight Rules (IFR) operations
at Tucson International Airport, Tucson,
AZ.
Interested parties were invited to
participate in this rulemaking effort by
submitting written comments on the
proposal to the FAA. No comments
were received.
Class E airspace designations are
published in paragraph 6005 of FAA
Order 7400.9R signed August 15, 2007,
and effective September 15, 2007, which
is incorporated by reference in 14 CFR
part 71.1. The Class E airspace
designations listed in this document
will be published subsequently in that
Order.
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The Rule
This action amends Title 14 Code of
Federal Regulations (14 CFR) part 71 by
modifying Class E airspace at Tucson
International Airport, Tucson, AZ.
Additional controlled airspace is
necessary to encompass hold-in-lieu
patterns at the LIPTE Initial Fix/
Instrument Approach Fix (IF/IAF) at
Tucson International Airport, Tucson,
AZ and encompass intermediate
segments from the ILEEN Distance
Measuring Equipment (DME) fix to
COPEY DME fix. The FAA is proposing
this action to enhance the safety and
management of IFR operations at
Tucson International Airport, Tucson,
AZ.
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. Therefore, this regulation: (1) Is
not a ‘‘significant regulatory action’’
under Executive Order 12866; (2) is not
a ‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
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17:40 Mar 11, 2008
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traffic procedures and air navigation, it
is certified that this rule, when
promulgated, will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
This rulemaking is promulgated under
the authority described in Subtitle VII,
Part A, Subpart I, Section 40103. Under
that section, the FAA is charged with
prescribing regulations to assign the use
of airspace necessary to ensure the
safety of aircraft and the efficient use of
airspace. This regulation is within the
scope of that authority as it modifies
controlled airspace at Tucson
International Airport, Tucson, AZ.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air)
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
I
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
I
13123
of the Tucson International Airport;
thence clockwise via the 8.7-mile radius
to the point of beginning; and that
airspace within a 4.3-mile radius of
Ryan Field and within 3.5 mile each
side of the Ryan Field localizer course
extending from the 4.3-mile radius to 7
miles west of the outer marker. That
airspace extending upward from 1,200
feet above the surface bounded by a line
beginning at lat. 32°33′00″ N, long.
111°45′02″ W; to lat.32°33′00″ N, long.
110°52′02″ W; thence north via long.
110°52′00″ W; to the south boundary of
V–94, thence southeast via the south
boundary of V–94; to long. 110°00′02″
W, thence south to lat. 31°39′00″ N; long
110°00′02″ W; to lat. 31°39′00″ N, long.
111°00′02″ W; to lat. 32°00′00″ N, long.
111°45′02″ W, to the point of origin.
*
*
*
*
*
Issued in Seattle, Washington, on February
28, 2008.
Kevin Nolan,
Acting Manager, System Support Group,
Western Service Center.
[FR Doc. 08–996 Filed 3–11–08; 8:45 am]
BILLING CODE 4910–13–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
Food and Drug Administration
§ 71.1
[Docket No. FDA–2008–N–0152] (formerly
Docket No. 1996N–0417)
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of the Federal Aviation
Administration Order 7400.9R, Airspace
Designations and Reporting Points,
signed August 15, 2007, and effective
September 15, 2007 is amended as
follows:
I
Paragraph 6005. Class E airspace areas
extending upward from 700 feet or more
above the surface of the earth.
*
*
*
*
*
AWP AZ E5 Tucson, AZ 2 spaces
[Modified]
Tucson International Airport, AZ
(Lat. 32°06′58″ N, long. 110°56′28″ W)
Ryan Field, AZ
(Lat. 32°08′32″ N, long. 111°10′28″ W)
That airspace extending upward from
700 feet above the surface within an 8.7mile radius of Tucson International
Airport and within that airspace
bounded by a line beginning at lat.
32°11′01″ N, long. 111°05′33″ W; to lat.
32°21′28″ N, long. 111°16′33″ W; to lat.
32°35′55″ N, long. 110°57′47″ W; to lat.
32°01′35″ N, long. 110°21′18″ W; to
lat.31°44′6″ N, long. 110°42′30″ W; to
lat.31°58′20″ N, long. 110°57′51″ W; to
intercept the 8.7-mile radius southwest
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21 CFR Part 111
RIN 0910–AB88
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements; Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
final rule that appeared in the Federal
Register of June 25, 2007 (72 FR 34752).
The final rule established current good
manufacturing practice (CGMP)
requirements in manufacturing,
packaging, labeling, or holding
operations for dietary supplements. The
final rule was published with an
inadvertent error in the codified section.
This document corrects that error. This
action is being taken to improve the
accuracy of the agency’s regulations.
DATES: This rule is effective March 12,
2008.
FOR FURTHER INFORMATION CONTACT:
Vasilios H. Frankos, Center for Food
E:\FR\FM\12MRR1.SGM
12MRR1
13124
Federal Register / Vol. 73, No. 49 / Wednesday, March 12, 2008 / Rules and Regulations
Safety and Applied Nutrition (HFS–
810), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–1696.
Dated: March 5, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–4870 Filed 3–11–08; 8:45 am]
In the
Federal Register of June 25, 2007 (72 FR
34752), FDA established CGMP
requirements in manufacturing,
packaging, labeling, or holding
operations for dietary supplements. The
preamble of that final rule discusses the
requirements of § 111.27(b) (21 CFR
111.27(b)) for a person subject to the
rule to calibrate instruments and
controls used in manufacturing or
testing a component or dietary
supplement both before and after first
use (72 FR 34752 at 34824).
The provisions regarding calibration
of such instruments and controls, both
before and after first use, also appeared
in both the preamble and codified
sections of the proposed rule (proposed
21 CFR 111.25(b)) (68 FR 12157 at
12191 and 12255, March 13, 2003). Due
to an inadvertent error, the codified
section of the final rule omitted the
word ‘‘and’’ between § 111.27(b)(1) and
(b)(2) (72 FR 34752 at 34947).
Consequently, it is less clear that
calibration must be carried out both
before and after first use, as intended.
This document corrects that error, by
inserting the word ‘‘and’’ at the end of
§ 111.27(b)(1) so that § 111.27(b)(1) and
(b)(2) are read together as one
requirement.
BILLING CODE 4160–01–S
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 111
Dietary foods, Drugs, Foods,
Packaging and containers.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 111 is
amended as follows:
I
PART 111—CURRENT GOOD
MANUFACTURING PRACTICE IN
MANUFACTURING, PACKAGING,
LABELING, OR HOLDING
OPERATIONS FOR DIETARY
SUPPLEMENTS
1. The authority citation for 21 CFR
part 111 continues to read as follows:
I
Authority: 21 U.S.C. 321, 342, 343, 371,
374, 381, 393; 42 U.S.C. 264.
2. Revise § 111.27(b)(1) to read as
follows:
jlentini on PROD1PC65 with RULES
I
§ 111.27 What requirements apply to the
equipment and utensils that you use?
*
*
*
*
*
(b)(1) Before first use; and
*
*
*
*
*
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9386]
RIN 1545–BE80
Abandonment of Stock or Other
Securities
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
AGENCY:
SUMMARY: This document contains final
regulations concerning the availability
and character of a loss deduction under
section 165 of the Internal Revenue
Code (Code) for losses sustained from
abandoned stock or other securities. The
final regulations clarify the tax
treatment of losses from abandoned
securities, and affect any taxpayer
claiming a deduction for a loss from
abandoned securities after the date these
regulations are published in the Federal
Register.
DATES: Effective Date: These final
regulations are effective on March 12,
2008.
Applicability Date: For dates of
applicability, see § 1.165–5(i)(2).
FOR FURTHER INFORMATION CONTACT:
Sean M. Dwyer at (202) 622–5020 or
Peter C. Meisel at (202) 622–7750 (not
toll-free numbers).
SUPPLEMENTARY INFORMATION:
Background
This document contains amendments
to 26 CFR part 1. On July 30, 2007, the
IRS published a notice of proposed
rulemaking (REG–101001–05) in the
Federal Register (72 FR 41468). The
notice of proposed rulemaking clarified
the treatment of abandoned stock or
other securities under section 165 of the
Code, specifically providing that a loss
from an abandoned security is governed
by section 165(g), and that the loss is
only allowed if all rights in the security
are permanently surrendered and
relinquished for no consideration. The
IRS received no comments in response
to the notice of proposed rulemaking.
No public hearing was requested or
held.
The proposed regulations are adopted
as final regulations by this Treasury
decision.
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Special Analyses
It has been determined that this
Treasury decision is not a significant
regulatory action as defined in
Executive Order 12866. Therefore, a
regulatory assessment is not required. It
also has been determined that section
553(b) of the Administrative Procedure
Act (5 U.S.C. chapter 5) does not apply
to these regulations. Because the
regulations do not impose a collection
of information on small entities, the
Regulatory Flexibility Act (5 U.S.C.
chapter 6) does not apply. Pursuant to
section 7805(f) of the Internal Revenue
Code, the notice of proposed rulemaking
that preceded this final regulation was
submitted to the Chief Counsel for
Advocacy of the Small Business
Administration for comment on its
impact on small business.
Drafting Information
The principal authors of these final
regulations are Sean M. Dwyer, Office of
the Associate Chief Counsel (Income
Tax & Accounting), and Peter C. Meisel,
Office of the Associate Chief Counsel
(Corporate). However, other personnel
from the IRS and Treasury Department
participated in their development.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Adoption of Amendments to the
Regulations
Accordingly, 26 CFR part 1 is
amended as follows:
I
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 continues to read, in part, as
follows:
I
Authority: 26 U.S.C. 7805 * * *
I Par. 2. Section 1.165–5 is amended
by:
I 1. Redesignating paragraph (i) as
paragraph (j).
I 2. Adding a new paragraph (i).
The addition reads as follows:
§ 1.165–5
Worthless securities.
*
*
*
*
*
(i) Abandonment of securities—(1) In
general. For purposes of section 165 and
this section, a security that becomes
wholly worthless includes a security
described in paragraph (a) of this
section that is abandoned and otherwise
satisfies the requirements for a
deductible loss under section 165. If the
abandoned security is a capital asset
and is not described in section 165(g)(3)
and paragraph (d) of this section
(concerning worthless securities of
E:\FR\FM\12MRR1.SGM
12MRR1
]]>Agencies
[Federal Register Volume 73, Number 49 (Wednesday, March 12, 2008)]
[Rules and Regulations]
[Pages 13123-13124]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4870]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 111
[Docket No. FDA-2008-N-0152] (formerly Docket No. 1996N-0417)
RIN 0910-AB88
Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements; Technical
Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule that appeared in the Federal Register of June 25, 2007 (72 FR
34752). The final rule established current good manufacturing practice
(CGMP) requirements in manufacturing, packaging, labeling, or holding
operations for dietary supplements. The final rule was published with
an inadvertent error in the codified section. This document corrects
that error. This action is being taken to improve the accuracy of the
agency's regulations.
DATES: This rule is effective March 12, 2008.
FOR FURTHER INFORMATION CONTACT: Vasilios H. Frankos, Center for Food
[[Page 13124]]
Safety and Applied Nutrition (HFS-810), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1696.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 25, 2007 (72
FR 34752), FDA established CGMP requirements in manufacturing,
packaging, labeling, or holding operations for dietary supplements. The
preamble of that final rule discusses the requirements of Sec.
111.27(b) (21 CFR 111.27(b)) for a person subject to the rule to
calibrate instruments and controls used in manufacturing or testing a
component or dietary supplement both before and after first use (72 FR
34752 at 34824).
The provisions regarding calibration of such instruments and
controls, both before and after first use, also appeared in both the
preamble and codified sections of the proposed rule (proposed 21 CFR
111.25(b)) (68 FR 12157 at 12191 and 12255, March 13, 2003). Due to an
inadvertent error, the codified section of the final rule omitted the
word ``and'' between Sec. 111.27(b)(1) and (b)(2) (72 FR 34752 at
34947). Consequently, it is less clear that calibration must be carried
out both before and after first use, as intended. This document
corrects that error, by inserting the word ``and'' at the end of Sec.
111.27(b)(1) so that Sec. 111.27(b)(1) and (b)(2) are read together as
one requirement.
List of Subjects in 21 CFR Part 111
Dietary foods, Drugs, Foods, Packaging and containers.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
111 is amended as follows:
PART 111--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
0
1. The authority citation for 21 CFR part 111 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42
U.S.C. 264.
0
2. Revise Sec. 111.27(b)(1) to read as follows:
Sec. 111.27 What requirements apply to the equipment and utensils
that you use?
* * * * *
(b)(1) Before first use; and
* * * * *
Dated: March 5, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4870 Filed 3-11-08; 8:45 am]
BILLING CODE 4160-01-S
