Nutrition Labeling of Dietary Supplements; Technical Amendment, 51726-51727 [06-7306]
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Federal Register / Vol. 71, No. 169 / Thursday, August 31, 2006 / Rules and Regulations
Sections 12.104 through 12.104i also
issued under 19 U.S.C. 2612;
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agreements imposing import restrictions
on described articles of cultural
property of State Parties is revised to
read as follows:
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2. In § 12.104g, paragraph (a), the
entry for Cyprus in the table of list of
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§ 12.104g Specific items or categories
designated by agreements or emergency
actions.
(a) * * *
State party
Cultural property
Decision No.
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Cyprus ............................................
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Archaeological Material of pre-Classical and Classical periods ranging
approximately from the 8th millennium B.C. to 330 A.D. and ecclesiastical and ritual ethnological material representing the Byzantine
period ranging from approximately the 4th century A.D. through approximately the 15th century A.D.
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T.D. 02–37, as amended by CBP
Dec. 06–22.
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3. In § 12.104g, paragraph (b), the
table of the list of agreements imposing
emergency import restrictions on
described articles of cultural property of
State Parties is amended by removing
the entry for Cyprus, but by retaining
the table headings.
I
Approved: August 25, 2006.
Deborah J. Spero,
Acting Commissioner, Bureau of Customs and
Border Protection.
Timothy E. Skud,
Deputy Assistant Secretary of the Treasury.
[FR Doc. 06–7266 Filed 8–30–06; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 1994P–0036] (Formerly 94P–
0036)
Nutrition Labeling of Dietary
Supplements; Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
erjones on PROD1PC72 with RULES
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending its
nutrition labeling of dietary
supplements regulations. This action is
being taken to ensure the accuracy of
FDA’s regulations.
DATES: This rule is effective August 31,
2006.
FOR FURTHER INFORMATION CONTACT:
Susan Thompson, Center for Food
Safety and Applied Nutrition (HFS–
810), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–1784, FAX: 301–
VerDate Aug<31>2005
15:29 Aug 30, 2006
Jkt 208001
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436–2639, or e-mail:
Susan.Thompson@fda.hhs.gov.
In the
Federal Register of July 11, 2003 (68 FR
41434), FDA published a final rule
entitled ‘‘Food Labeling: Trans Fatty
Acids in Nutrition Labeling, Nutrient
Content Claims, and Health Claims’’
(the trans fat rule). Among other things,
the final rule amended § 101.36(b)(2)(i)
(21 CFR 101.36(b)(2)(i)) by incorporating
‘‘trans fat’’ as a dietary ingredient that
must be declared in the nutrition label
of a dietary supplement when it is
present in a dietary supplement in
quantitative amounts by weight that
exceed the amount that can be declared
as zero in nutrition labeling of foods in
accordance with § 101.9(c) (21 CFR
101.9(c)). Other than the addition of
‘‘trans fat’’ to the list of dietary
ingredients subject to the requirements
in § 101.36(b)(2)(i) (21 CFR
101.36(b)(2)(i)), no other changes to that
section were proposed or finalized.
However, in making this revision,
requirements for dietary ingredients set
forth in § 101.36(b)(2)(i) that were not
affected by the addition of the term
‘‘trans fat’’ in that section were
inadvertently deleted. The text of the
requirements that were inadvertently
removed from this section was ‘‘Calories
from saturated fat and polyunsaturated
fat, monounsaturated fat, soluble fiber,
insoluble fiber, sugar alcohol, and other
carbohydrate may be declared, but they
shall be declared when a claim is made
about them. Any other vitamins or
minerals listed in § 101.9(c)(8)(iv) or
(c)(9) may be declared, but they shall be
declared when they are added to the
product for purposes of
supplementation, or when a claim is
made about them. Any (b)(2)-dietary
ingredients that are not present, or that
are present in amounts that can be
declared as zero in § 101.9(c), shall not
be declared (e.g., amounts
SUPPLEMENTARY INFORMATION:
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corresponding to less than 2 percent of
the RDI for vitamins and minerals).
Protein shall not be declared on labels
of products that, other than ingredients
added solely for technological reasons,
contain only individual amino acids.’’
Accordingly, because this regulation is
not currently accurate, FDA is
publishing this amendment to
§ 101.36(b)(2)(i) to ensure that it
complete and accurate by restoring to
the regulation the text of the
requirements that were inadvertently
deleted as a consequence of the revision
introduced by the trans fat rule.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting
and recordkeeping requirements.
PART 101—FOOD LABELING
1. The authority citation for 21 CFR
part 101 continues to read as follows:
I
Authority: 15 U.S.C. 1453, 1454, 1455; 21
U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C.
243, 264, 271.
2. In § 101.36, revise paragraph
(b)(2)(i) to read as follows:
I
§ 101.36 Nutrition labeling of dietary
supplements.
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(b) * * *
(2) * * *
(i) The (b)(2)-dietary ingredients to be
declared, that is, total calories, calories
from fat, total fat, saturated fat, trans fat,
cholesterol, sodium, total carbohydrate,
dietary fiber, sugars, protein, vitamin A,
vitamin C, calcium and iron, shall be
declared when they are present in a
dietary supplement in quantitative
amounts by weight that exceed the
amount that can be declared as zero in
nutrition labeling of foods in accordance
with § 101.9(c). Calories from saturated
fat and polyunsaturated fat,
monounsaturated fat, soluble fiber,
insoluble fiber, sugar alcohol, and other
carbohydrate may be declared, but they
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31AUR1
Federal Register / Vol. 71, No. 169 / Thursday, August 31, 2006 / Rules and Regulations
shall be declared when a claim is made
about them. Any other vitamins or
minerals listed in § 101.9(c)(8)(iv) or
(c)(9) may be declared, but they shall be
declared when they are added to the
product for purposes of
supplementation, or when a claim is
made about them. Any (b)(2)-dietary
ingredients that are not present, or that
are present in amounts that can be
declared as zero in § 101.9(c), shall not
be declared (e.g., amounts
corresponding to less than 2 percent of
the RDI for vitamins and minerals).
Protein shall not be declared on labels
of products that, other than ingredients
added solely for technological reasons,
contain only individual amino acids.
*
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Dated: August 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–7306 Filed 8–30–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 529
Certain Other Dosage Form New
Animal Drugs; Gentamicin Sulfate
Intrauterine Solution
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by
Sparhawk Laboratories, Inc. The
ANADA provides for use of a generic
gentamicin sulfate solution as an
intrauterine infusion for the control of
bacterial metritis and as an aid in
improving conception in mares.
DATES: This rule is effective August 31,
2006.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Sparhawk
Laboratories, Inc., 12340 Santa Fe Trail
Dr., Lenexa, KS 66215, filed ANADA
200–395 for the use of Gentamicin
Sulfate Solution for the control of
bacterial infections of the uterus
(metritis) and as an aid in improving
conception in mares with uterine
erjones on PROD1PC72 with RULES
SUMMARY:
VerDate Aug<31>2005
15:29 Aug 30, 2006
Jkt 208001
infections caused by bacteria sensitive
to gentamicin. Sparhawk Laboratories,
Inc.’s gentamicin sulfate solution is
approved as a generic copy of ScheringPlough Animal Health Corp.’s
GENTOCIN (gentamicin sulfate)
solution veterinary, approved under
NADA 46–724. The ANADA is
approved as of July 31, 2006, and the
regulations in 21 CFR 529.1044a are
amended to reflect the approval and a
current format. The basis of approval is
discussed in the freedom of information
summary.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
FDA has determined under 21 CFR
25.33(a)(1) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects in 21 CFR Part 529
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 529 is amended as follows:
I
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 529 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. Revise § 529.1044a to read as
follows:
I
§ 529.1044a Gentamicin sulfate
intrauterine solution.
(a) Specifications. Each milliliter of
solution contains 50 or 100 milligrams
gentamicin sulfate.
(b) Sponsors. See Nos. 000010,
000061, 000856, 057561, 058005,
059130, and 061623 in § 510.600(c) of
this chapter.
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Fmt 4700
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51727
(c) Conditions of use in horses—(1)
Amount. Infuse 2 to 2.5 grams per day
for 3 to 5 days during estrus.
(2) Indications for use. For control of
bacterial infections of the uterus
(metritis) and as an aid in improving
conception in mares with uterine
infections caused by bacteria sensitive
to gentamicin.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
Dated: August 11, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06–7307 Filed 8–30–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9283]
RIN 1545–BB57
Special Depreciation Allowance
Internal Revenue Service (IRS),
Treasury.
ACTION: Final and temporary
regulations.
AGENCY:
SUMMARY: This document contains final
regulations relating to the depreciation
of property subject to section 168 of the
Internal Revenue Code (MACRS
property) and the depreciation of
computer software subject to section
167. Specifically, these final regulations
provide guidance regarding the
additional first year depreciation
allowance provided by sections 168(k)
and 1400L(b) for certain MACRS
property and computer software. The
regulations reflect changes to the law
made by the Job Creation and Worker
Assistance Act of 2002, the Jobs and
Growth Tax Relief Reconciliation Act of
2003, the Working Families Tax Relief
Act of 2004, the American Jobs Creation
Act of 2004, and the Gulf Opportunity
Zone Act of 2005.
DATES: Effective Dates: These
regulations are effective August 31,
2006.
Applicability Dates: For dates of
applicability, see §§ 1.167(a)–14(e),
1.168(d)–1(d), 1.168(d)–1T(d), 1.168(k)–
1(g), 1.169–3(g), and 1.1400L(b)–1(g).
FOR FURTHER INFORMATION CONTACT:
Douglas Kim, (202) 622–3110 (not a tollfree number).
SUPPLEMENTARY INFORMATION:
E:\FR\FM\31AUR1.SGM
31AUR1
]]>Agencies
[Federal Register Volume 71, Number 169 (Thursday, August 31, 2006)]
[Rules and Regulations]
[Pages 51726-51727]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-7306]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 1994P-0036] (Formerly 94P-0036)
Nutrition Labeling of Dietary Supplements; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
nutrition labeling of dietary supplements regulations. This action is
being taken to ensure the accuracy of FDA's regulations.
DATES: This rule is effective August 31, 2006.
FOR FURTHER INFORMATION CONTACT: Susan Thompson, Center for Food Safety
and Applied Nutrition (HFS-810), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-1784, FAX: 301-436-
2639, or e-mail: Susan.Thompson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 11, 2003 (68
FR 41434), FDA published a final rule entitled ``Food Labeling: Trans
Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health
Claims'' (the trans fat rule). Among other things, the final rule
amended Sec. 101.36(b)(2)(i) (21 CFR 101.36(b)(2)(i)) by incorporating
``trans fat'' as a dietary ingredient that must be declared in the
nutrition label of a dietary supplement when it is present in a dietary
supplement in quantitative amounts by weight that exceed the amount
that can be declared as zero in nutrition labeling of foods in
accordance with Sec. 101.9(c) (21 CFR 101.9(c)). Other than the
addition of ``trans fat'' to the list of dietary ingredients subject to
the requirements in Sec. 101.36(b)(2)(i) (21 CFR 101.36(b)(2)(i)), no
other changes to that section were proposed or finalized.
However, in making this revision, requirements for dietary
ingredients set forth in Sec. 101.36(b)(2)(i) that were not affected
by the addition of the term ``trans fat'' in that section were
inadvertently deleted. The text of the requirements that were
inadvertently removed from this section was ``Calories from saturated
fat and polyunsaturated fat, monounsaturated fat, soluble fiber,
insoluble fiber, sugar alcohol, and other carbohydrate may be declared,
but they shall be declared when a claim is made about them. Any other
vitamins or minerals listed in Sec. 101.9(c)(8)(iv) or (c)(9) may be
declared, but they shall be declared when they are added to the product
for purposes of supplementation, or when a claim is made about them.
Any (b)(2)-dietary ingredients that are not present, or that are
present in amounts that can be declared as zero in Sec. 101.9(c),
shall not be declared (e.g., amounts corresponding to less than 2
percent of the RDI for vitamins and minerals). Protein shall not be
declared on labels of products that, other than ingredients added
solely for technological reasons, contain only individual amino
acids.'' Accordingly, because this regulation is not currently
accurate, FDA is publishing this amendment to Sec. 101.36(b)(2)(i) to
ensure that it complete and accurate by restoring to the regulation the
text of the requirements that were inadvertently deleted as a
consequence of the revision introduced by the trans fat rule.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
PART 101--FOOD LABELING
0
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
0
2. In Sec. 101.36, revise paragraph (b)(2)(i) to read as follows:
Sec. 101.36 Nutrition labeling of dietary supplements.
* * * * *
(b) * * *
(2) * * *
(i) The (b)(2)-dietary ingredients to be declared, that is, total
calories, calories from fat, total fat, saturated fat, trans fat,
cholesterol, sodium, total carbohydrate, dietary fiber, sugars,
protein, vitamin A, vitamin C, calcium and iron, shall be declared when
they are present in a dietary supplement in quantitative amounts by
weight that exceed the amount that can be declared as zero in nutrition
labeling of foods in accordance with Sec. 101.9(c). Calories from
saturated fat and polyunsaturated fat, monounsaturated fat, soluble
fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be
declared, but they
[[Page 51727]]
shall be declared when a claim is made about them. Any other vitamins
or minerals listed in Sec. 101.9(c)(8)(iv) or (c)(9) may be declared,
but they shall be declared when they are added to the product for
purposes of supplementation, or when a claim is made about them. Any
(b)(2)-dietary ingredients that are not present, or that are present in
amounts that can be declared as zero in Sec. 101.9(c), shall not be
declared (e.g., amounts corresponding to less than 2 percent of the RDI
for vitamins and minerals). Protein shall not be declared on labels of
products that, other than ingredients added solely for technological
reasons, contain only individual amino acids.
* * * * *
Dated: August 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-7306 Filed 8-30-06; 8:45 am]
BILLING CODE 4160-01-S
