New Animal Drugs for Use in Animal Feeds; Monensin; Tylosin, 52885 [E9-24716]
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Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Rules and Regulations
PART 774—[AMENDED]
19. The authority citation for part 774
continues to read as follows:
■
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C.
7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et
seq., 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u);
42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C.
1354; 46 U.S.C. app. 466c; 50 U.S.C. app. 5;
22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001
Comp., p. 783; Notice of August 13, 2009, 74
FR 41,325 (August 14, 2009).
20. In Supplement No. 1 to part 774
(the Commerce Control List), Category 5
Telecommunications and ‘‘Information
Security’’, Part 2 Information Security,
Export Control Classification Number
(ECCN) 5B002 is amended by revising
the License Exception section to read as
follows:
■
5B002 Information Security—test,
inspection and ‘‘production’’ equipment.
*
*
*
*
*
License Exceptions
LVS: N/A
GBS: N/A
CIV: N/A
ENC: Yes for certain EI controlled
equipment, see § 740.17 of the EAR for
eligibility.
*
*
*
*
*
21. In Supplement No. 1 to part 774
(the Commerce Control List), Category 5
Telecommunications and ‘‘Information
Security’’, Part 2 Information Security,
Export Control Classification Number
(ECCN) 5E002 is amended by revising
the License Exception section to read as
follows:
■
5E002 ‘‘Technology’’ according to the
General Technology Note for the
‘‘development’’, ‘‘production’’ or ‘‘use’’ of
equipment controlled by 5A002 or 5B002 or
‘‘software’’ controlled by 5D002.
*
*
*
*
*
License Exceptions
CIV: N/A
TSR: N/A
ENC: Yes for certain EI controlled
technology, see § 740.17 of the EAR for
eligibility.
*
*
*
*
*
22. In Supplement No. 1 to part 774
(the Commerce Control List), Category 5
Telecommunications and ‘‘Information
Security’’, Part 2 Information Security,
Export Control Classification Number
(ECCN) 5E992 is amended by revising
the Heading to read as follows:
jlentini on DSKJ8SOYB1PROD with RULES
■
5E992 ‘‘Information Security’’
‘‘technology’’ according to the General
Technology Note, not controlled by 5E002.
*
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VerDate Nov<24>2008
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16:27 Oct 14, 2009
Jkt 220001
Dated: October 7, 2009.
Matthew S. Borman,
Acting Assistant Secretary for the Bureau of
Industry and Security.
[FR Doc. E9–24697 Filed 10–14–09; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2009–N–0665]
New Animal Drugs for Use in Animal
Feeds; Monensin; Tylosin
AGENCY:
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
Food and Drug Administration,
Animal drugs, Animal feeds.
HHS.
ACTION:
Final rule.
Frm 00019
Fmt 4700
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:
■
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, A Division of Eli
Lilly & Co. The supplemental NADA
revises limitations for liquid Type B
medicated cattle feeds containing
tylosin phosphate.
DATES: This rule is effective October 15,
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: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 12–491 for use of
TYLAN (tylosin phosphate) Type A
medicated article. For liquid Type B
medicated cattle feeds containing
tylosin phosphate, the supplement
removes the presolubilization
instructions previously required for
manufacture and reduces the expiry
from 8 weeks to 31 days. The
supplemental NADA is approved as of
September 8, 2009, and the regulations
in 21 CFR 558.625 are amended to
reflect the approval. In addition, the
limitations for two-way combination
drug medicated liquid feeds containing
tylosin and monensin in 21 CFR
558.355 are amended to reflect the
revised limitations for tylosin liquid
feeds.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
PO 00000
52885
Sfmt 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 § 558.355, revise paragraph
(f)(3)(ii)(b) to read as follows:
■
§ 558.355
Monensin.
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*
*
*
*
(f) * * *
(3) * * *
(ii) * * *
(b) Limitations. Feed only to cattle
being fed in confinement for slaughter.
Feed continuously as sole ration at the
rate of 50 to 480 milligrams of monensin
and 60 to 90 milligrams of tylosin per
head per day. Combination drug liquid
Type B medicated feeds may be used to
manufacture dry Type C medicated
feeds as in § 558.625(c) of this chapter.
*
*
*
*
*
§ 558.625
[Amended]
3. In § 558.625, remove and reserve
paragraph (c)(2)(i); and in paragraph
(c)(3), remove ‘‘8 weeks’’ and in its
place add ‘‘31 days’’.
■
Dated: September 25, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E9–24716 Filed 10–14–09; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\15OCR1.SGM
15OCR1
]]>Agencies
[Federal Register Volume 74, Number 198 (Thursday, October 15, 2009)]
[Rules and Regulations]
[Page 52885]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24716]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2009-N-0665]
New Animal Drugs for Use in Animal Feeds; Monensin; Tylosin
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, A Division of Eli
Lilly & Co. The supplemental NADA revises limitations for liquid Type B
medicated cattle feeds containing tylosin phosphate.
DATES: This rule is effective October 15, 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: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 12-491 for use of TYLAN (tylosin phosphate) Type A
medicated article. For liquid Type B medicated cattle feeds containing
tylosin phosphate, the supplement removes the presolubilization
instructions previously required for manufacture and reduces the expiry
from 8 weeks to 31 days. The supplemental NADA is approved as of
September 8, 2009, and the regulations in 21 CFR 558.625 are amended to
reflect the approval. In addition, the limitations for two-way
combination drug medicated liquid feeds containing tylosin and monensin
in 21 CFR 558.355 are amended to reflect the revised limitations for
tylosin liquid feeds.
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 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. 558.355, revise paragraph (f)(3)(ii)(b) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(3) * * *
(ii) * * *
(b) Limitations. Feed only to cattle being fed in confinement for
slaughter. Feed continuously as sole ration at the rate of 50 to 480
milligrams of monensin and 60 to 90 milligrams of tylosin per head per
day. Combination drug liquid Type B medicated feeds may be used to
manufacture dry Type C medicated feeds as in Sec. 558.625(c) of this
chapter.
* * * * *
Sec. 558.625 [Amended]
0
3. In Sec. 558.625, remove and reserve paragraph (c)(2)(i); and in
paragraph (c)(3), remove ``8 weeks'' and in its place add ``31 days''.
Dated: September 25, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-24716 Filed 10-14-09; 8:45 am]
BILLING CODE 4160-01-S
