Oral Dosage Form New Animal Drugs; Spinosad, 60550-60551 [E7-21058]
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60550
Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Rules and Regulations
§ 1301.56
Final determination.
The General Counsel makes the final
determination whether a demand for
testimony or production of records or
official testimony in a legal proceeding
in which TVA is not a party shall be
granted. All final determinations are
within the sole discretion of the General
Counsel. The General Counsel will
notify the requesting party and, when
necessary, the court or other authority of
the final determination, the reasons for
the grant or denial of the request, and
any conditions that the General Counsel
may impose on the production of
testimony or records or official
information.
§ 1301.57
Waiver.
The General Counsel may grant a
waiver of any procedure described by
this part where a waiver is considered
necessary to promote a significant
interest of TVA or the United States, or
for other good cause.
Maureen H. Dunn,
General Counsel.
[FR Doc. E7–20907 Filed 10–24–07; 8:45 am]
BILLING CODE 8120–08–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
supplement to NADA 140–958 that
provides for use of EQUIPHEN
(phenylbutazone) Paste in horses for
relief of inflammatory conditions
associated with the musculoskeletal
system. The supplemental NADA
provides for a revised human food
safety warning on product labeling. The
supplemental NADA is approved as of
September 26, 2007, and the regulations
are amended in 21 CFR 520.1720c 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.
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 520
Food and Drug Administration
Animal drugs.
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Phenylbutazone Paste
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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
Luitpold Pharmaceuticals, Inc. The
supplemental NADA provides for a
revised human food safety warning for
phenylbutazone paste, used in horses
for relief of inflammatory conditions
associated with the musculoskeletal
system.
DATES: This rule is effective October 25,
2007.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Luitpold
Pharmaceuticals, Inc., Animal Health
Division, Shirley, NY 11967, filed a
rwilkins on PROD1PC63 with RULES
SUMMARY:
VerDate Aug<31>2005
18:00 Oct 24, 2007
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 520 is amended as follows:
I
Jkt 214001
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 520.1720c
[Amended]
2. In § 520.1720c, in paragraph (c)(3),
remove ‘‘Not for use in horses intended
for food.’’ and add in its place ‘‘Do not
use in horses intended for human
consumption.’’
I
Dated: October 17, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–21054 Filed 10–24–07; 8:45 am]
BILLING CODE 4160–01–S
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Fmt 4700
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Spinosad
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 new animal drug
application (NADA) filed by Elanco
Animal Health. The NADA provides for
veterinary prescription use of spinosad
chewable tablets to kill fleas and for the
prevention and treatment of flea
infestations on dogs for 1 month.
DATES: This rule is effective October 25,
2007.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed NADA
141–277 that provides for veterinary
prescription use of COMFORTIS
(spinosad) Chewable Tablets to kill fleas
and for the prevention and treatment of
flea infestations (Ctenocephalides felis)
on dogs for 1 month. The NADA is
approved as of September 25, 2007, and
the regulations in 21 CFR part 520 are
amended by adding § 520.2130 to reflect
the approval.
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.
Under section 512(c)(2)(F)(i) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(i)), this
approval qualifies for 5 years of
marketing exclusivity beginning on the
date of approval.
FDA 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,
E:\FR\FM\25OCR1.SGM
25OCR1
Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Rules and Regulations
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 520
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 520 is amended as follows:
I
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
change of sponsor for five approved new
animal drug applications (NADAs) from
Merial Ltd., to Huvepharma AD.
DATES: This rule is effective October 25,
2007.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Merial
Ltd., 3239 Satellite Blvd., Bldg. 500,
Duluth, GA 30096–4640 has informed
FDA that it has transferred ownership
of, and all rights and interest in, the
following five approved NADAs to
Huvepharma AD, 33 James Boucher
Blvd., Sophia 1407, Bulgaria:
1. The authority citation for 21 CFR
part 520 continues to read as follows:
Application
No.
Authority: 21 U.S.C. 360b.
2. Add § 520.2130 to read as follows:
§ 520.2130
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 520.100
[Amended]
2. In paragraph (b)(1) of § 520.100,
remove ‘‘050604’’ and in its place add
‘‘016592’’.
I
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
§ 558.55
[Amended]
4. In paragraph (a) of § 558.55, remove
‘‘050604’’ and in its place add ‘‘No.
016592’’.
I 5. In § 558.58, in the table in
paragraph (e)(1)(i), in the first entry, in
the ‘‘Sponsor’’ column, add ‘‘050604’’
and ‘‘016592’’; add paragraph (a)(3); and
revise paragraph (b) to read as follows:
I
I
I
60551
012–350
Spinosad.
(a) Specifications. Each chewable
tablet contains 140, 270, 560, 810, or
1620 milligrams (mg) spinosad.
(b) Sponsor. See No. 000986 in
§ 510.600 of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer tablets once a
month at a recommended minimum
dosage of 13.5 mg per pound (30 mg per
kilogram) of body weight.
(2) Indications for use. To kill fleas
and for the prevention and treatment of
flea infestations (Ctenocephalides felis)
on dogs for 1 month.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: October 17, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–21058 Filed 10–24–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Trade name(s)
AMPROVINE (amprolium)
25% Type A Medicated
Article; CORID
(amprolium) 25% Type A
Medicated Article
013–149
AMPROVINE (amprolium)
9.6% Solution
013–461
Broiler PMX No. 1620
(amprolium/ethopabate)
033–165
AMPROVINE (amprolium)
20% Soluble Powder;
CORID (amprolium) 20%
Soluble Powder
034–393
COYDEN 25 (clopidol);
Lerbek 25
Accordingly, the agency is amending
the regulations in 21 CFR 520.100,
558.55, 558.58, and 558.175 to reflect
the transfer of ownership.
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.
§ 558.58
Amprolium and ethopabate.
(a) * * *
(3) 25 percent amprolium and 0.8
percent ethopabate.
(b) Approvals. See § 510.600(c) of this
chapter.
(1) No. 050604 for products described
in paragraph (a) of this section.
(2) No. 016592 for product described
in paragraph (a)(3) of this section.
§ 558.175
[Amended]
6. In § 558.175, in paragraph (b) and
in the table in paragraph (d)(1) in the
‘‘Sponsor’’ column, remove ‘‘050604’’
and in its place add ‘‘016592’’.
I
Dated: October 17, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–21057 Filed 10–24–07; 8:45 am]
BILLING CODE 4160–01–S
List of Subjects
21 CFR Part 520
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Animal drugs.
21 CFR Parts 520 and 558
21 CFR Part 558
New Animal Drugs; Change of Sponsor
rwilkins on PROD1PC63 with RULES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
SUMMARY:
VerDate Aug<31>2005
18:00 Oct 24, 2007
Jkt 214001
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 parts 520 and 558 are amended as
follows:
New Animal Drugs For Use in Animal
Feeds; Change of Sponsor
I
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
E:\FR\FM\25OCR1.SGM
25OCR1
]]>Agencies
[Federal Register Volume 72, Number 206 (Thursday, October 25, 2007)]
[Rules and Regulations]
[Pages 60550-60551]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21058]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Spinosad
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 new animal drug application
(NADA) filed by Elanco Animal Health. The NADA provides for veterinary
prescription use of spinosad chewable tablets to kill fleas and for the
prevention and treatment of flea infestations on dogs for 1 month.
DATES: This rule is effective October 25, 2007.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA
141-277 that provides for veterinary prescription use of COMFORTIS
(spinosad) Chewable Tablets to kill fleas and for the prevention and
treatment of flea infestations (Ctenocephalides felis) on dogs for 1
month. The NADA is approved as of September 25, 2007, and the
regulations in 21 CFR part 520 are amended by adding Sec. 520.2130 to
reflect the approval.
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.
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for
5 years of marketing exclusivity beginning on the date of approval.
FDA 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,
[[Page 60551]]
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 520
Animal drugs.
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Add Sec. 520.2130 to read as follows:
Sec. 520.2130 Spinosad.
(a) Specifications. Each chewable tablet contains 140, 270, 560,
810, or 1620 milligrams (mg) spinosad.
(b) Sponsor. See No. 000986 in Sec. 510.600 of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer tablets once
a month at a recommended minimum dosage of 13.5 mg per pound (30 mg per
kilogram) of body weight.
(2) Indications for use. To kill fleas and for the prevention and
treatment of flea infestations (Ctenocephalides felis) on dogs for 1
month.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: October 17, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21058 Filed 10-24-07; 8:45 am]
BILLING CODE 4160-01-S
