New Animal Drugs for Use in Animal Feeds; Melengestrol and Monensin, 20533 [06-3820]
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Federal Register / Vol. 71, No. 77 / Friday, April 21, 2006 / Rules and Regulations
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Issued in Burlington, Massachusetts, on
April 14, 2006.
Robert G. Mann,
Acting Manager, Engine and Propeller
Directorate, Aircraft Certification Service.
[FR Doc. 06–3765 Filed 4–20–06; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal
Feeds; Melengestrol and 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 abbreviated new animal
drug application (ANADA) filed by Ivy
Laboratories, Division of Ivy Animal
Health, Inc. The ANADA provides for
use of single-ingredient Type A
medicated articles containing
melengestrol and monensin to make
two-way combination drug Type C
medicated feeds for heifers fed in
confinement for slaughter.
DATES: This rule is effective April 21,
2006.
wwhite on PROD1PC61 with RULES
FOR FURTHER INFORMATION CONTACT:
Daniel A. Benz, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0223, email: daniel.benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Ivy
Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland
Park, KS 66214, filed ANADA 200–422
for use of HEIFERMAX 500
(melengestrol acetate) Liquid Premix
and RUMENSIN (monensin sodium)
single-ingredient Type A medicated
articles to make, two-way combination
drug Type C medicated feeds for heifers
fed in confinement for slaughter. Ivy
Laboratories’ ANADA 200–422 is
approved as a generic copy of
Pharmacia and Upjohn’s NADA 125–
VerDate Aug<31>2005
16:06 Apr 20, 2006
Jkt 208001
476 for combination use of MGA 500
(melengestrol acetate) Liquid Premix
and RUMENSIN in cattle feed. The
application is approved as of March 22,
2006, and the regulations are amended
in 21 CFR 558.342 to reflect the
approval. The basis of approval is
discussed in 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.
The agency has determined under 21
CFR 25.33(a)(2) 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.
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:
I
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
§ 558.342
[Amended]
2. In § 558.342, amend the table in
paragraphs (e)(1)(v) and (e)(1)(vi) in the
‘‘Sponsor’’ column by adding in
numerical sequence ‘‘021641’’.
I
Dated: April 7, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06–3820 Filed 4–20–06; 8:45 am]
BILLING CODE 4160–01–S
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Frm 00011
Fmt 4700
Sfmt 4700
20533
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 610
[Docket No. 2005N–0355]
RIN 0910–AF20
Revocation of Status of Specific
Products; Group A Streptococcus;
Confirmation of Effective Date
AGENCY:
Food and Drug Administration,
HHS.
Direct final rule; confirmation of
effective date.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is confirming the
effective date of June 2, 2006, for the
direct final rule that appeared in the
Federal Register of December 2, 2005
(70 FR 72197). The direct final rule
removes the regulation applicable to the
status of specific products; Group A
streptococcus. FDA is removing the
regulation because the existing
requirement for Group A streptococcus
organisms and derivatives is both
obsolete and a perceived impediment to
the development of Group A
streptococcus vaccines. This document
confirms the effective date of the direct
final rule.
DATES: Effective date confirmed: June 2,
2006.
FOR FURTHER INFORMATION CONTACT:
Valerie A. Butler, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION: In the
Federal Register of December 2, 2005
(70 FR 72197), FDA solicited comments
concerning the direct final rule for a 75day period ending February 15, 2006.
FDA stated that the effective date of the
direct final rule would be on June 2,
2006, 6 months after the date of
publication in the Federal Register,
unless any significant adverse comment
was submitted to FDA during the
comment period. FDA did not receive
any significant adverse comments.
Therefore, FDA is removing from the
regulation 21 CFR 610.19 because this
provision is obsolete and a perceived
impediment to the development of
Group A streptococcus vaccines.
Authority: Therefore, under the Federal
Food, Drug, and Cosmetic Act and the Public
Health Service Act and under authority
delegated to the Commissioner of Food and
Drugs, the amendment issued thereby
becomes effective on June 2, 2006.
E:\FR\FM\21APR1.SGM
21APR1
]]>Agencies
[Federal Register Volume 71, Number 77 (Friday, April 21, 2006)]
[Rules and Regulations]
[Page 20533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3820]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Melengestrol and
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 abbreviated new animal drug
application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal
Health, Inc. The ANADA provides for use of single-ingredient Type A
medicated articles containing melengestrol and monensin to make two-way
combination drug Type C medicated feeds for heifers fed in confinement
for slaughter.
DATES: This rule is effective April 21, 2006.
FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-
422 for use of HEIFERMAX 500 (melengestrol acetate) Liquid Premix and
RUMENSIN (monensin sodium) single-ingredient Type A medicated articles
to make, two-way combination drug Type C medicated feeds for heifers
fed in confinement for slaughter. Ivy Laboratories' ANADA 200-422 is
approved as a generic copy of Pharmacia and Upjohn's NADA 125-476 for
combination use of MGA 500 (melengestrol acetate) Liquid Premix and
RUMENSIN in cattle feed. The application is approved as of March 22,
2006, and the regulations are amended in 21 CFR 558.342 to reflect the
approval. The basis of approval is discussed in 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.
The agency has determined under 21 CFR 25.33(a)(2) 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. 558.342 [Amended]
0
2. In Sec. 558.342, amend the table in paragraphs (e)(1)(v) and
(e)(1)(vi) in the ``Sponsor'' column by adding in numerical sequence
``021641''.
Dated: April 7, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-3820 Filed 4-20-06; 8:45 am]
BILLING CODE 4160-01-S
