Oral Dosage Form New Animal Drugs; Ivermectin Paste, 34184 [E8-13607]
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Federal Register / Vol. 73, No. 117 / Tuesday, June 17, 2008 / Rules and Regulations
information in the administrative
record, including any submission made
by the manufacturer or person. The
decision of whether a cease and desist
order should be issued shall be made
within 30 days after receipt of any
information and argument submitted by
the manufacturer or person. The cease
and desist order shall be final unless the
affected manufacturer or person
requests a reconsideration of the order
to the Administrator, Agricultural
Marketing Service, within 30 days after
the date of the issuance of the order.
§ 1170.15
Appeals.
If the cease and desist order is
confirmed by the Administrator,
Agricultural Marketing Service, the
manufacturer or person may appeal the
order in the appropriate United States
District Court not later than 30 days
after the date of the confirmation of the
order.
§ 1170.16
Enforcement.
(a) If a person subject to the Dairy
Product Mandatory Reporting program
fails to obey a cease and desist order
after the order has become final and
unappealable, or after the appropriate
United States district court has entered
a final judgment in favor of the
Administrator, Agricultural Marketing
Service, the United States may apply to
the appropriate United States district
court for enforcement of the order.
(b) If the court determines that the
cease and desist order was lawfully
made and duly served and that the
manufacturer or person violated the
order, the court shall enforce the order.
(c) If the court finds that the
manufacturer or person violated the
cease and desist order, the manufacturer
or person shall be subject to a civil
penalty of not more than $10,000 for
each offense.
Dated: June 10, 2008.
Lloyd C. Day,
Administrator, Agricultural Marketing
Service.
[FR Doc. E8–13550 Filed 6–16–08; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
new animal drug application (ANADA)
filed by Cross Vetpharm Group Ltd. The
supplemental ANADA adds
effectiveness claims against various
species of internal parasites when
horses are treated with ivermectin paste.
DATES:
2008.
John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed a
supplement to ANADA 200–326 for
BIMECTIN (ivermectin) Paste 1.87%
adding effectiveness claims against
various species of internal parasites of
horses. The supplemental ANADA is
approved as of May 23, 2008, and 21
CFR 520.1192 is amended 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.
The agency 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.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 520
yshivers on PROD1PC62 with RULES
21 CFR Part 520
Animal drugs.
Oral Dosage Form New Animal Drugs;
Ivermectin Paste
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
VerDate Aug<31>2005
13:09 Jun 16, 2008
This rule is effective June 17,
Jkt 214001
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
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
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.
2. In § 520.1192, remove paragraphs
(b)(4) and (e)(1)(ii)(C) and revise
paragraph (b)(3) to read as follows:
I
§ 520.1192
Ivermectin paste.
*
*
*
*
*
(b) * * *
(3) Nos. 051311, 054925, and 061623
for use of a 1.87 percent paste for use
as in paragraphs (e)(1)(i), (e)(1)(ii)(A),
and (e)(1)(iii) of this section.
*
*
*
*
*
Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–13607 Filed 6–16–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feeds; 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
provides for revision of an effectiveness
claim and pathogen nomenclature for a
tylosin phosphate and sulfamethazine
Type A medicated article used to
manufacture medicated swine feeds.
DATES: This rule is effective June 17,
2008.
FOR FURTHER INFORMATION CONTACT:
Timothy Schell, Center for Veterinary
Medicine (HFV–128), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8116, email: timothy.schell@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 41–275 that
provides for use of TYLAN 40 SULFA–
G (tylosin phosphate and
sulfamethazine) Elliptical Pellets, a
Type A medicated article. The
E:\FR\FM\17JNR1.SGM
17JNR1
]]>Agencies
[Federal Register Volume 73, Number 117 (Tuesday, June 17, 2008)]
[Rules and Regulations]
[Page 34184]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13607]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Ivermectin Paste
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 abbreviated new
animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The
supplemental ANADA adds effectiveness claims against various species of
internal parasites when horses are treated with ivermectin paste.
DATES: This rule is effective June 17, 2008.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed a supplement to ANADA 200-326 for
BIMECTIN (ivermectin) Paste 1.87% adding effectiveness claims against
various species of internal parasites of horses. The supplemental ANADA
is approved as of May 23, 2008, and 21 CFR 520.1192 is amended 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.
The agency 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
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. In Sec. 520.1192, remove paragraphs (b)(4) and (e)(1)(ii)(C) and
revise paragraph (b)(3) to read as follows:
Sec. 520.1192 Ivermectin paste.
* * * * *
(b) * * *
(3) Nos. 051311, 054925, and 061623 for use of a 1.87 percent paste
for use as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of
this section.
* * * * *
Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-13607 Filed 6-16-08; 8:45 am]
BILLING CODE 4160-01-S
