New Animal Drugs for Use in Animal Feeds; Ractopamine; Monensin, 5887-5888 [2010-2427]
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Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Rules and Regulations
notice is given that no objections or
requests for a hearing were filed in
response to the November 16, 2009,
final rule. Accordingly, the amendments
issued thereby became effective
December 17, 2009.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
Dated: January 22, 2010.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive
Safety, Center for Food Safety and Applied
Nutrition.
[Docket No. FDA–2007–C–0456] (formerly
Docket No. 2007C–0245)
Listing of Color Additives Exempt
From Certification; Paracoccus
Pigment; Confirmation of Effective
Date
AGENCY:
[FR Doc. 2010–2521 Filed 2–4–10; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION: Final rule; confirmation of
effective date.
SUMMARY: The Food and Drug
Administration (FDA) is confirming the
effective date of December 17, 2009, for
the final rule that appeared in the
Federal Register of November 16, 2009.
The final rule amended the color
additive regulations to provide for the
safe use of paracoccus pigment as a
color additive in the feed of salmonid
fish to enhance the color of their flesh.
DATES: The effective date for the final
rule that published in the Federal
Register on November 16, 2009 (74 FR
58843) is confirmed as December 17,
2009.
Mical E. Honigfort, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–1278.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 16, 2009
(74 FR 58843), FDA amended the color
additive regulations to add 21 CFR
73.352 to provide for the safe use of
paracoccus pigment as a color additive
in the feed of salmonid fish to enhance
the color of their flesh.
FDA gave interested persons until
December 16, 2009, to file objections or
requests for a hearing. The agency
received no objections or requests for a
hearing on the final rule. Therefore,
FDA finds that the effective date of the
final rule that published in the Federal
Register of November 16, 2009, should
be confirmed.
WReier-Aviles on DSKGBLS3C1PROD with RULES
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs,
Medical devices.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321,
341, 342, 343, 348, 351, 352, 355, 361,
362, 371, 379e) and under authority
delegated to the Commissioner of Food
and Drugs, and redelegated to the
Director, Office of Food Additive Safety,
14:20 Feb 04, 2010
Jkt 220001
21 CFR Part 73
[Docket No. FDA–2007–C–0044] (formerly
Docket No. 2007C–0474)
Listing of Color Additives Exempt
From Certification; Astaxanthin
Dimethyldisuccinate; Confirmation of
Effective Date
AGENCY:
HHS.
Final rule; confirmation of
effective date.
ACTION:
The Food and Drug
Administration (FDA) is confirming the
effective date of December 8, 2009, for
the final rule that appeared in the
Federal Register of November 5, 2009.
The final rule amended the color
additive regulations to provide for the
safe use of astaxanthin
dimethyldisuccinate as a color additive
in the feed of salmonid fish to enhance
the color of their flesh.
DATES: The effective date for the final
rule published in the Federal Register
of November 5, 2009 (74 FR 57248) is
confirmed as December 8, 2009.
FOR FURTHER INFORMATION CONTACT:
Felicia M. Ellison, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–1264.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 5, 2009
(74 FR 57248), FDA amended the color
additive regulations to add § 73.37 (21
CFR 73.37) to provide for the safe use
of astaxanthin dimethyldisuccinate as a
color additive in the feed of salmonid
fish to enhance the color of their flesh.
FDA gave interested persons until
December 7, 2009, to file objections or
requests for a hearing. The agency
received no objections or requests for a
hearing on the final rule. Therefore,
PO 00000
FDA finds that the effective date of the
final rule that published in the Federal
Register of November 5, 2009, should be
confirmed.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs,
Medical devices.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321,
341, 342, 343, 348, 351, 352, 355, 361,
362, 371, 379e) and under authority
delegated to the Commissioner of Food
and Drugs, and redelegated to the
Director, Office of Food Additive Safety,
notice is given that no objections or
requests for a hearing were filed in
response to the November 5, 2009, final
rule. Accordingly, the amendments
issued thereby became effective
December 8, 2009.
Dated: January 22, 2010.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive
Safety, Center for Food Safety and Applied
Nutrition.
[FR Doc. 2010–2522 Filed 2–4–10; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration,
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
VerDate Nov<24>2008
Food and Drug Administration
5887
Frm 00011
Fmt 4700
Sfmt 4700
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2010–N–0002]
New Animal Drugs for Use in Animal
Feeds; Ractopamine; Monensin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original new animal drug
application (NADA) filed by Elanco
Animal Health, A Division of Eli Lilly
& Co. The NADA provides for use of
single-ingredient Type A medicated
articles containing ractopamine
hydrochloride and monensin to
formulate two-way combination Type C
medicated feeds for finishing hen and
tom turkeys.
DATES: This rule is effective February 5,
2010.
FOR FURTHER INFORMATION CONTACT:
Linda M. Wilmot, Center for Veterinary
Medicine (HFV–120), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8101, email: linda.wilmot@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
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05FER1
5888
Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Rules and Regulations
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed NADA
141–301 for use of TOPMAX
(ractopamine hydrochloride) and
COBAN (monensin, USP) singleingredient Type A medicated articles to
formulate two-way combination Type C
medicated feeds for finishing hen and
tom turkeys. The NADA is approved as
of December 11, 2009, and the
regulations in 21 CFR 558.500 are
amended to reflect the approval.
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.
Ractopamine in
grams/ton
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33 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 558
*
Animal drugs, Animal feeds.
Combination in
grams/ton
*
*
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
2. In § 558.500, add paragraphs
(e)(3)(iii) and (e)(3)(iv) to read as
follows:
■
§ 558.500
Indications for use
*
Ractopamine.
*
*
(e) * * *
(3) * * *
*
*
Limitations
*
*
*
Sponsor
*
(iii) 4.6 to 11.8 (5 to 13
ppm)
Monensin 54 to 90
Finishing hen turkeys: As in paragraph (e)(3)(i) of this section; and
for the prevention of coccidiosis in
growing turkeys caused by Eimeria
adenoeides, E. meleagrimitis and
E. gallopavonis.
Feed continuously as sole ration during the last 7 to 14 days prior to
slaughter. See § 558.355(d).
000986
(iv) 4.6 to 11.8 (5 to 13
ppm)
Monensin 54 to 90
Finishing tom turkeys: As in paragraph (e)(3)(ii) of this section; and
for the prevention of coccidiosis in
growing turkeys caused by Eimeria
adenoeides, E. meleagrimitis and
E. gallopavonis.
Feed continuously as sole ration during the last 14 days prior to slaughter. Feeding ractopamine to tom
turkeys during periods of excessive
heat can result in increased mortality. See § 558.355(d).
000986
Dated: February 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
certain classes of statements by HUD
relating to manufactured housing
requirements are subject to proposal,
review, and comment processes
involving a consensus committee. The
consensus committee includes
representatives of manufactured
housing producers and users, as well as
general interest and public officials.
This rule interprets the statutory
requirement to clarify the types of
statements that are subject to the
proposal, review, and comment
processes.
[FR Doc. 2010–2427 Filed 2–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Parts 3280 and 3282
[Docket No. FR–5343–IN–01]
RIN 2502–AI77
DATES:
WReier-Aviles on DSKGBLS3C1PROD with RULES
Federal Manufactured Home
Construction and Safety Standards
and Other Orders: HUD Statements
That Are Subject to Consensus
Committee Processes
AGENCY: Office of the Assistant
Secretary for Housing—Federal Housing
Commissioner, HUD.
ACTION: Interpretive rule.
SUMMARY: The National Manufactured
Housing Construction and Safety
Standards Act of 1974 provides that
VerDate Nov<24>2008
14:20 Feb 04, 2010
Jkt 220001
Effective Date: February 5, 2010.
FOR FURTHER INFORMATION CONTACT:
William W. Matchneer III, Associate
Deputy Assistant Secretary for
Regulatory Affairs and Manufactured
Housing, Office of Manufactured
Housing Programs, Department of
Housing and Urban Development, 451
Seventh Street, SW., Room 9164,
Washington, DC 20410; telephone
number 202–708–6401 (this is not a tollfree number). Persons with hearing or
speech impairments may access this
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
number via TTY by calling the toll-free
Federal Information Relay Service at
1–800–877–8339.
SUPPLEMENTARY INFORMATION:
I. Background
The National Manufactured Housing
Construction and Safety Standards Act
of 1974 (42 U.S.C. 5401–5426) (‘‘the
Act’’), as amended by the Manufactured
Housing Improvement Act of 2000 (Title
VI, Pub. L. 106–659), provides for the
establishment and revision of Federal
construction and safety standards for
manufactured housing, as well as for
procedural and enforcement regulations
and interpretive bulletins related to
implementation of these standards.
Section 604(a) of the Act provides,
among other things, the process for the
development, proposal, and issuance of
revisions of Federal construction and
safety standards, which govern the
construction, design, and performance
of a manufactured home. Section 604(a)
establishes a consensus committee,
which is comprised of representatives of
manufactured housing producers and
E:\FR\FM\05FER1.SGM
05FER1
]]>Agencies
[Federal Register Volume 75, Number 24 (Friday, February 5, 2010)]
[Rules and Regulations]
[Pages 5887-5888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-2427]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2010-N-0002]
New Animal Drugs for Use in Animal Feeds; Ractopamine; Monensin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an original new animal drug
application (NADA) filed by Elanco Animal Health, A Division of Eli
Lilly & Co. The NADA provides for use of single-ingredient Type A
medicated articles containing ractopamine hydrochloride and monensin to
formulate two-way combination Type C medicated feeds for finishing hen
and tom turkeys.
DATES: This rule is effective February 5, 2010.
FOR FURTHER INFORMATION CONTACT: Linda M. Wilmot, Center for Veterinary
Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8101, e-mail: linda.wilmot@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly
[[Page 5888]]
& Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 141-
301 for use of TOPMAX (ractopamine hydrochloride) and COBAN (monensin,
USP) single-ingredient Type A medicated articles to formulate two-way
combination Type C medicated feeds for finishing hen and tom turkeys.
The NADA is approved as of December 11, 2009, and the regulations in 21
CFR 558.500 are amended to reflect the approval.
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.
The agency has determined under 21 CFR 25.33 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 558
Animal drugs, Animal feeds.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
2. In Sec. 558.500, add paragraphs (e)(3)(iii) and (e)(3)(iv) to read
as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(3) * * *
----------------------------------------------------------------------------------------------------------------
Ractopamine in Combination in
grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(iii) 4.6 to 11.8 Monensin 54 to 90 Finishing hen turkeys: As in Feed continuously as sole 000986
(5 to 13 ppm) paragraph (e)(3)(i) of this ration during the last 7
section; and for the to 14 days prior to
prevention of coccidiosis slaughter. See Sec.
in growing turkeys caused 558.355(d).
by Eimeria adenoeides, E.
meleagrimitis and E.
gallopavonis.
----------------------------------------------------------------------------------------------------------------
(iv) 4.6 to 11.8 (5 Monensin 54 to 90 Finishing tom turkeys: As in Feed continuously as sole 000986
to 13 ppm) paragraph (e)(3)(ii) of ration during the last 14
this section; and for the days prior to slaughter.
prevention of coccidiosis Feeding ractopamine to tom
in growing turkeys caused turkeys during periods of
by Eimeria adenoeides, E. excessive heat can result
meleagrimitis and E. in increased mortality.
gallopavonis. See Sec. 558.355(d).
----------------------------------------------------------------------------------------------------------------
Dated: February 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-2427 Filed 2-4-10; 8:45 am]
BILLING CODE 4160-01-S
