New Animal Drugs For Use in Animal Feeds; Monensin, 1689-1690 [06-228]
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Federal Register / Vol. 71, No. 7 / Wednesday, January 11, 2006 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Hyaluronate
Sodium Injection
AGENCY:
Food and Drug Administration,
HHS.
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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 Bayer
HealthCare LLC. The supplemental
NADA provides for veterinary
prescription use of a hyaluronate
sodium solution, formulated with a
benzyl alcohol preservative, for
intravenous administration to horses for
the treatment of osteoarthritis.
DATES: This rule is effective January 11,
2006.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.gov.
SUPPLEMENTARY INFORMATION: Bayer
HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee
Mission, KS 66201, filed a supplement
to NADA 140–883 that provides for
veterinary prescription use of LEGEND
Multi-dose (hyaluronate sodium)
Injectable Solution. The supplemental
NADA provides for use of this
hyaluronate sodium solution,
formulated with a benzyl alcohol
preservative, from a multi-dose vial for
intravenous administration to horses for
the treatment of carpal or fetlock
osteoarthritis. The supplemental NADA
is approved as of December 15, 2005,
and the regulations are amended in 21
CFR 522.1145 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.
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The agency has determined under 21
CFR 25.33(d)(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.
Dated: January 4, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 06–229 Filed 1–10–06; 8:45 am]
List of Subject in 21 CFR Part 522
New Animal Drugs For Use in Animal
Feeds; Monensin
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 522 is amended as follows:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. Section 522.1145 is amended by
revising paragraph (e) to read as follows:
I
§ 522.1145
Hyaluronate sodium injection.
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(e)(1) Specifications. Each milliliter of
solution contains:
(i) 10 milligrams (mg) hyaluronate
sodium; or
(ii) 10 mg hyaluronate sodium with
benzyl alcohol as a preservative.
(2) Sponsor. See No. 000859 in
§ 510.600(c) of this chapter.
(3) Conditions of use in horses—(i)
Amount. 20 mg of the product described
in paragraph (e)(1)(i) of this section by
intra-articular injection into the carpus
or fetlock; or 40 mg of the product
described in paragraph (e)(1)(i) or
(e)(1)(ii) of this section by slow
intravenous injection into the jugular
vein. Treatment may be repeated at
weekly intervals for a total of three
treatments.
(ii) Indications for use. For treatment
of carpal or fetlock joint dysfunction
due to noninfectious synovitis
associated with equine osteoarthritis.
(iii) 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.
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BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
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
Elanco Animal Health. The
supplemental NADA provides for use of
monensin Type C medicated feeds in
component feeding systems (including
top dress) for increased milk production
efficiency in dairy cows.
DATES: This rule is effective January 11,
2006.
FOR FURTHER INFORMATION CONTACT: Eric
S. Dubbin, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0232, email: edubbin@cvm.fda.gov
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 95–735 that
provides for the use of RUMENSIN 80
(monensin sodium) Type A medicated
article in Type C medicated feeds fed in
component feeding systems (including
top dress) used for increased milk
production efficiency (production of
marketable solids-corrected milk per
unit of feed intake) in dairy cows. The
supplemental NADA is approved as of
December 15, 2005, and the regulations
in 21 CFR 558.355 are amended to
reflect the approval. 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.
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Federal Register / Vol. 71, No. 7 / Wednesday, January 11, 2006 / Rules and Regulations
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.
Federal Bureau of Investigation
28 CFR Part 105
[Docket No. FBI 112; AG Order No. 2796–
2006]
RIN 1110–AA23
Implementation of the Private Security
Officer Employment Authorization Act
of 2004
Federal Bureau of Investigation
(FBI), Department of Justice.
ACTION: Interim final rule with request
for comments.
AGENCY:
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
I 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:
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SUPPLEMENTARY INFORMATION:
DEPARTMENT OF JUSTICE
SUMMARY: The Department of Justice
(the Department) hereby amends title 28
of the Code of Federal Regulations to
authorize access to FBI-maintained
criminal justice information systems to
effectuate the Private Security Officer
Employment Authorization Act of 2004,
which was enacted as section 6402 of
the Intelligence Reform and Terrorism
PART 558—NEW ANIMAL DRUGS FOR Prevention Act of 2004. This law
USE IN ANIMAL FEEDS
authorizes a fingerprint-based check of
state and national criminal history
I 1. The authority citation for 21 CFR
records to screen prospective and
part 558 continues to read as follows:
current private security officers and
Authority: 21 U.S.C. 360b, 371.
requires the Attorney General to issue
rules to regulate the ‘‘security,
I 2. Section 558.355 is amended in the
confidentiality, accuracy, use,
last sentence in paragraph (f)(3)(xiii)(B)
by removing ‘‘(d)(12)’’ and adding in its submission, dissemination, destruction
of information and audits, and record
place ‘‘(d)(13)’’; and by adding
keeping’’ of the criminal history record
paragraph (f)(3)(xiv) to read as follows:
information (CHRI) and related
§ 558.355 Monensin.
information; standards for qualifying as
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an authorized employer; and the
(f) * * *
imposition of fees.
(3) * * *
DATES: The rule is effective January 11,
(xiv) Amount per ton. Monensin, 11
2006. Written comments must be
to 400 grams.
received on or before March 13, 2006.
(A) Indications for use. For increased
ADDRESSES: All comments may be
milk production efficiency (production
submitted to Assistant General Counsel
of marketable solids-corrected milk per
Harold M. Sklar, Federal Bureau of
unit of feed intake) in dairy cows.
Investigation, CJIS Division, 1000 Custer
(B) Limitations. Feed continuously to
Hollow Road, Module E–3, Clarksburg,
dry and lactating dairy cows in a
West Virginia 26306, or by telefacsimile
component feeding system (including
to (304) 625–3944. To ensure proper
top dress). The Type C medicated feed
must be fed in a minimum of 1 lb of feed handling, please reference FBI Docket
No. 112 on your correspondence. You
to provide 185 to 660 mg/head/day
may view an electronic version of this
monensin to lactating cows or 115 to
proposed rule at https://
410 mg/head/day monensin to dry
www.regulations.gov. You may also
cows. See paragraphs (d)(2), (d)(5),
comment via electronic mail at
(d)(6), (d)(7)(i), (d)(7)(ii), (d)(7)(iii),
enexreg@leo.gov or by using the https://
(d)(7)(vi), (d)(8), and (d)(13) of this
www.regulations.gov comment form for
section.
this regulation. When submitting
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comments electronically you must
Dated: January 4, 2006.
include RIN 1110-AA23 or FBI Docket
Steven D. Vaughn,
No 112 in the subject box.
Director, Office of New Animal Drug
FOR FURTHER INFORMATION CONTACT:
Evaluation, Center for Veterinary Medicine.
Assistant General Counsel Harold M.
[FR Doc. 06–228 Filed 1–10–06; 8:45 am]
Sklar, telephone number (304) 625–
2000.
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Background
On December 17, 2004, the
Intelligence Reform and Terrorism
Prevention Act of 2004, Public Law
108–458, became law. Section 6402 of
that Act (The Private Security Officer
Employment Authorization Act of 2004)
authorizes a fingerprint-based criminal
history check of state and national
criminal history records to screen
prospective and current private security
officers. Section 6402(d)(2) requires the
Attorney General to publish an interim
final or final regulation within 180 days
of the statute’s enactment to regulate the
‘‘security, confidentiality, accuracy, use,
submission, dissemination, destruction
of information and audits, and record
keeping’’ of the CHRI and related
information; standards for qualifying an
authorized employer; and the
imposition of fees.
The FBI maintains several criminal
justice information systems, notably the
Fingerprint Identification Record
System (FIRS) and the National Crime
Information Center (NCIC). Access to
the FIRS is predicated upon fingerprint
submission through the Integrated
Automated Fingerprint Identification
System (IAFIS). Previously enacted
federal law authorizes similar criminal
history record checks for persons
engaged in other professions and
occupations, such as the banking,
securities, and nursing home industries.
In implementing section 6402, the
interim rule seeks to ensure that the
exchange of CHRI and related
information relating to the employment
of private security guards is
accomplished as fully and effectively as
possible, achieving the public safety
goals of section 6402 and recognizing
the sensitive nature of the information
involved. To that end, the Department is
amending title 28 of the Code of Federal
Regulations (CFR) to regulate the
exchange of CHRI authorized by section
6402.
Additional Information
The following discussion provides
additional information to participating
States, authorized employers, and
prospective and current private security
officers on the operation of the interim
rule.
a. To initiate a criminal history record
check, section 6402(d)(1)(A) requires the
submission of ‘‘fingerprints or other
means of positive identification * * *.’’
The IAFIS presently utilizes ten rolled
fingerprints (captured or submitted
manually or electronically) to effectuate
a search of the FBI’s criminal history
repository. Effective June 15, 2005,
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[Federal Register Volume 71, Number 7 (Wednesday, January 11, 2006)]
[Rules and Regulations]
[Pages 1689-1690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-228]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feeds; 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 a supplemental new animal drug
application (NADA) filed by Elanco Animal Health. The supplemental NADA
provides for use of monensin Type C medicated feeds in component
feeding systems (including top dress) for increased milk production
efficiency in dairy cows.
DATES: This rule is effective January 11, 2006.
FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0232, e-mail: edubbin@cvm.fda.gov
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 95-735 that provides for the use of RUMENSIN 80
(monensin sodium) Type A medicated article in Type C medicated feeds
fed in component feeding systems (including top dress) used for
increased milk production efficiency (production of marketable solids-
corrected milk per unit of feed intake) in dairy cows. The supplemental
NADA is approved as of December 15, 2005, and the regulations in 21 CFR
558.355 are amended to reflect the approval. 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.
[[Page 1690]]
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 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. Section 558.355 is amended in the last sentence in paragraph
(f)(3)(xiii)(B) by removing ``(d)(12)'' and adding in its place
``(d)(13)''; and by adding paragraph (f)(3)(xiv) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(3) * * *
(xiv) Amount per ton. Monensin, 11 to 400 grams.
(A) Indications for use. For increased milk production efficiency
(production of marketable solids-corrected milk per unit of feed
intake) in dairy cows.
(B) Limitations. Feed continuously to dry and lactating dairy cows
in a component feeding system (including top dress). The Type C
medicated feed must be fed in a minimum of 1 lb of feed to provide 185
to 660 mg/head/day monensin to lactating cows or 115 to 410 mg/head/day
monensin to dry cows. See paragraphs (d)(2), (d)(5), (d)(6), (d)(7)(i),
(d)(7)(ii), (d)(7)(iii), (d)(7)(vi), (d)(8), and (d)(13) of this
section.
* * * * *
Dated: January 4, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 06-228 Filed 1-10-06; 8:45 am]
BILLING CODE 4160-01-S
