New Animal Drugs for Use in Animal Feeds; Tiamulin, 6 [E8-31128]
Download as PDF
<![CDATA[
6
Federal Register / Vol. 74, No. 1 / Friday, January 2, 2009 / Rules and Regulations
have been infested with or exposed to
fever ticks, may be imported from
Mexico for admission into the United
States, except into areas of Texas
quarantined because of said disease or
tick infestation as specified in § 72.5 of
this chapter, either at one of the land
border ports in Texas listed in
§ 93.403(c) or at the port of Santa
Teresa, NM, provided that the following
conditions are strictly observed and
complied with:
*
*
*
*
*
Done in Washington, DC, this 22nd day of
December 2008.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E8–31212 Filed 12–31–08; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2008–N–0039]
New Animal Drugs for Use in Animal
Feeds; Tiamulin
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 two supplemental new
animal drug applications (NADAs) filed
by Novartis Animal Health US, Inc. The
supplemental NADAs provide for
Tiamulin grams per
ton
(i) 10 ......................
*
*
This rule is effective January 2,
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, e-mail:
cindy.burnsteel@fda.hhs.gov.
Novartis
Animal Health US, Inc., 3200 Northline
Ave., suite 300, Greensboro, NC 27408,
filed a supplement to NADA 139–472
for DENAGARD (tiamulin) Medicated
Premixes used for the treatment or
control of certain bacterial enteric
diseases in swine. Novartis Animal
Health US, Inc., also filed a supplement
to NADA 141–011 for the use of
DENAGARD (tiamulin) Medicated
Premixes and Chlortetracycline Type A
medicated articles to manufacture 2-way
combination drug medicated swine
feeds used for the treatment or control
of certain bacterial enteric diseases. The
supplemental NADAs provide for
removal of a 250-pound weight
restriction and the addition of a
reproductive caution statement to
labeling. The supplemental NADAs are
approved as of December 9, 2008, and
21 CFR 558.600 is amended to reflect
the approval.
Approval of these supplemental
NADAs did not require review of
additional safety or effectiveness data or
SUPPLEMENTARY INFORMATION:
Indications for use
..............................................
*
*
DATES:
2009.
Combination in grams per ton
*
*
removal of a 250-pound weight
restriction and the addition of a
reproductive caution statement to
labeling of tiamulin medicated feeds
used for the treatment or control of
certain bacterial enteric diseases in
swine.
*
Dated: December 22, 2008.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E8–31128 Filed 12–31–08; 8:45 am]
*
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2008–N–0517]
rmajette on PRODPC74 with RULES
Medical Devices; Immunology and
Microbiology Devices; Classification of
Enterovirus Nucleic Acid Assay
Food and Drug Administration,
HHS.
14:01 Dec 31, 2008
Jkt 217001
PO 00000
Frm 00006
Fmt 4700
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 § 558.600, revise paragraphs
(d)(2) and (e)(1)(i) to read as follows:
■
§ 558.600
Tiamulin.
*
*
*
*
*
(d) * * *
(2) The effects of tiamulin on swine
reproductive performance, pregnancy,
and lactation have not been determined.
*
*
*
*
*
(e) * * *
(1) * * *
*
BILLING CODE 4160–01–S
VerDate Aug<31>2005
Animal drugs, animal feeds.
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:
■
Sfmt 4700
Sponsor
Feed continuously as the sole
ration. Not for use in swine
weighing over 250 pounds.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
List of Subjects in 21 CFR Part 558
Limitations
For increased rate of weight gain
and improved feed efficiency.
*
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33 that these actions are of a
type that do 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.
*
ACTION:
058198
*
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is classifying
enterovirus nucleic acid assay into class
II (special controls). The special control
that will apply to the device is the
guidance document entitled ‘‘Class II
Special Controls Guidance Document:
Nucleic Acid Amplification Assay for
the Detection of Enterovirus RNA’’
(ribonucleic acid). The agency is
classifying the device into class II
(special controls) in order to provide a
E:\FR\FM\02JAR1.SGM
02JAR1
]]>Agencies
[Federal Register Volume 74, Number 1 (Friday, January 2, 2009)]
[Rules and Regulations]
[Page 6]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-31128]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2008-N-0039]
New Animal Drugs for Use in Animal Feeds; Tiamulin
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 two supplemental new animal
drug applications (NADAs) filed by Novartis Animal Health US, Inc. The
supplemental NADAs provide for removal of a 250-pound weight
restriction and the addition of a reproductive caution statement to
labeling of tiamulin medicated feeds used for the treatment or control
of certain bacterial enteric diseases in swine.
DATES: This rule is effective January 2, 2009.
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, e-mail:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200
Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to
NADA 139-472 for DENAGARD (tiamulin) Medicated Premixes used for the
treatment or control of certain bacterial enteric diseases in swine.
Novartis Animal Health US, Inc., also filed a supplement to NADA 141-
011 for the use of DENAGARD (tiamulin) Medicated Premixes and
Chlortetracycline Type A medicated articles to manufacture 2-way
combination drug medicated swine feeds used for the treatment or
control of certain bacterial enteric diseases. The supplemental NADAs
provide for removal of a 250-pound weight restriction and the addition
of a reproductive caution statement to labeling. The supplemental NADAs
are approved as of December 9, 2008, and 21 CFR 558.600 is amended to
reflect the approval.
Approval of these supplemental NADAs 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 these actions are
of a type that do 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.
0
2. In Sec. 558.600, revise paragraphs (d)(2) and (e)(1)(i) to read as
follows:
Sec. 558.600 Tiamulin.
* * * * *
(d) * * *
(2) The effects of tiamulin on swine reproductive performance,
pregnancy, and lactation have not been determined.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Tiamulin grams per ton grams per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10........................ ................... For increased rate Feed continuously 058198
of weight gain and as the sole
improved feed ration. Not for
efficiency. use in swine
weighing over 250
pounds.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: December 22, 2008.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E8-31128 Filed 12-31-08; 8:45 am]
BILLING CODE 4160-01-S
