New Animal Drugs for Use in Animal Feeds; Florfenicol, 34361 [2010-14611]
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Federal Register / Vol. 75, No. 116 / Thursday, June 17, 2010 / Rules and Regulations
ACTION: Final rule; confirmation of
effective date.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Food and Drug
Administration (FDA) is confirming the
effective date of April 27, 2010, for the
final rule that appeared in the Federal
Register of March 26, 2010. The final
rule amended the color additive
regulations by increasing the permitted
use level of bismuth citrate as a color
additive in cosmetics intended for
coloring hair on the scalp.
Food and Drug Administration
SUMMARY:
DATES: The effective date for the final
rule published in the Federal Register
of March 26, 2010 (75 FR 14491) is
confirmed as April 27, 2010.
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.
In the
Federal Register of March 26, 2010 (75
FR 14491), FDA amended the color
additive regulations in § 73.2110 (21
CFR 73.2110) by increasing the
permitted use level of bismuth citrate as
a color additive in cosmetics intended
for coloring hair on the scalp.
FDA gave interested persons until
April 26, 2010, 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 March 26, 2010, should be
confirmed.
SUPPLEMENTARY INFORMATION:
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 March 26, 2010, final
rule. Accordingly, the amendments
issued thereby became effective April
27, 2010.
wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
■
Dated: June 11, 2010.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive
Safety, Center for Food Safety and Applied
Nutrition.
[FR Doc. 2010–14598 Filed 6–16–10; 8:45 am]
21 CFR Part 558
[Docket No. FDA–2010–N–0002]
New Animal Drugs for Use in Animal
Feeds; Florfenicol
AGENCY:
14:49 Jun 16, 2010
ACTION:
Final rule.
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.
§ 558.4
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by
Intervet, Inc. The supplemental NADA
provides for the manufacture of
florfenicol Type B medicated swine
feeds.
DATES:
This rule is effective June 17,
[Amended]
2. In paragraph (d) of § 558.4, in the
‘‘Category II’’ table, in the ‘‘Type B
maximum (100x)’’ column, in the entry
for ‘‘Florfenicol’’, remove ‘‘Swine feed:
n/a’’ and in its place add ‘‘Swine feed:
9.1 g/lb (2.0%)’’.
■
Dated: June 14, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
2010.
[FR Doc. 2010–14611 Filed 6–16–10; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4160–01–S
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, email:
cindy.burnsteel@fda.hhs.gov.
Intervet,
Inc., 56 Livingston Ave., Roseland, NJ
07068, filed a supplement to NADA
141–264 for use of NUFLOR (florfenicol)
Antibiotic Type A Medicated Article for
Swine by veterinary feed directive that
provides for the manufacture of Type B
medicated swine feeds. The
supplemental NADA is approved as of
May 13, 2010, and the regulations are
amended in 21 CFR 558.4 to reflect the
approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
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.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Jkt 220001
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 558 is amended as follows:
■
HHS.
BILLING CODE 4160–01–S
VerDate Mar<15>2010
Food and Drug Administration,
34361
PO 00000
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[USCG–2010–0446]
Safety Zone, Milwaukee Harbor,
Milwaukee, WI
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
SUMMARY: The Coast Guard will enforce
the Milwaukee Harbor safety zone
during eight separate periods between
10 p.m. on July 15, 2010 through 10
p.m. on July 25, 2010. This action is
necessary and intended to ensure safety
of life on the navigable waters
immediately prior to, during, and
immediately after fireworks events. This
rule will establish restrictions upon, and
control movement of, vessels in a
specified area immediately prior to,
during, and immediately after fireworks
events. During the enforcement period,
no person or vessel may enter the safety
zones without permission of the Captain
of the Port, Sector Lake Michigan.
DATES: The regulations in 33 CFR
165.935 will be enforced during eight
separate periods between from 10 p.m.
on July 15, 2010 through 10 p.m. on July
25, 2010.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice, call
E:\FR\FM\17JNR1.SGM
17JNR1
]]>Agencies
[Federal Register Volume 75, Number 116 (Thursday, June 17, 2010)]
[Rules and Regulations]
[Page 34361]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14611]
-----------------------------------------------------------------------
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; Florfenicol
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 a supplemental new animal drug
application (NADA) filed by Intervet, Inc. The supplemental NADA
provides for the manufacture of florfenicol Type B medicated swine
feeds.
DATES: This rule is effective June 17, 2010.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8341, email:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave.,
Roseland, NJ 07068, filed a supplement to NADA 141-264 for use of
NUFLOR (florfenicol) Antibiotic Type A Medicated Article for Swine by
veterinary feed directive that provides for the manufacture of Type B
medicated swine feeds. The supplemental NADA is approved as of May 13,
2010, and the regulations are amended in 21 CFR 558.4 to reflect the
approval.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
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
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.
Sec. 558.4 [Amended]
0
2. In paragraph (d) of Sec. 558.4, in the ``Category II'' table, in
the ``Type B maximum (100x)'' column, in the entry for ``Florfenicol'',
remove ``Swine feed: n/a'' and in its place add ``Swine feed: 9.1 g/lb
(2.0%)''.
Dated: June 14, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-14611 Filed 6-16-10; 8:45 am]
BILLING CODE 4160-01-S
