Ophthalmic and Topical Dosage Form New Animal Drugs; Emodepside and Praziquantel, 42291 [E7-14945]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Rules and Regulations
Authority: 21 U.S.C. 360b.
2. Section 522.1662a is amended by
revising paragraph (h)(2) to read as
follows:
I
§ 522.1662a
injection.
Oxytetracycline hydrochloride
*
*
*
*
*
(h) * * *
(2) Sponsors. See No. 000010 in
§ 510.600(c) of this chapter for use of 50
and 100 milligrams per milliliter
solution; and Nos. 055529 and 059130
in § 510.600(c) for use of 100 milligrams
per milliliter solution.
*
*
*
*
*
Dated: July 17, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7–14950 Filed 8–1–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
Ophthalmic and Topical Dosage Form
New Animal Drugs; Emodepside and
Praziquantel
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 Bayer
HealthCare LLC. The NADA provides
for veterinary prescription use of an
emodepside and praziquantel topical
solution on cats for the treatment and
control of infections by several internal
parasites.
DATES: This rule is effective August 2,
2007.
amended in 21 CFR part 524 by adding
§ 524.775 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)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
approval qualifies for 3 years of
marketing exclusivity beginning on the
date of the approval.
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.
List of Subjects in 21 CFR Part 524
Animal drugs.
I 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 524 is amended as follows:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 524 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. Add § 524.775 to read as follows:
jlentini on PROD1PC65 with RULES
FOR FURTHER INFORMATION CONTACT:
I
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: Bayer
HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee
Mission, KS 66201, filed NADA 141–
275 that provides for veterinary
prescription use of PROFENDER
(emodepside and praziquantel) Topical
Solution for the treatment and control of
infections by several internal parasites
of cats. The NADA is approved as of
June 29, 2007, and the regulations are
§ 524.775
VerDate Aug<31>2005
16:10 Aug 01, 2007
Jkt 211001
Emodepside and praziquantel.
(a) Specifications. Each milliliter of
solution contains 21.4 milligrams (mg)
emodepside and 85.7 mg praziquantel.
(b) Sponsor. See No. 000859 in
§ 510.600(c) of this chapter.
(c) Conditions of use in cats—(1)
Amount. The recommended minimum
dose is 1.36 mg/pound (lb) (3 mg/
kilogram (kg)) emodepside and 5.45 mg/
lb (12 mg/kg) praziquantel applied as a
single topical dose.
(2) Indications for use. For the
treatment and control of hookworm
infections caused by Ancylostoma
tubaeforme (adults, immature adults,
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
42291
and fourth stage larvae), roundworm
infections caused by Toxocara cati
(adults and fourth stage larvae), and
tapeworm infections caused by
Dipylidium caninum (adults) and
Taenia taeniaeformis (adults).
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: July 17, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7–14945 Filed 8–1–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 1, 26, and 602
[TD 9348]
RIN 1545–BC50
Qualified Severance of a Trust for
Generation-Skipping Transfer (GST)
Tax Purposes
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
AGENCY:
SUMMARY: This document contains final
regulations providing guidance
regarding the qualified severance of a
trust for generation-skipping transfer
(GST) tax purposes under section
2642(a)(3) of the Internal Revenue Code
(Code), which was added to the Code by
the Economic Growth and Tax Relief
Reconciliation Act of 2001 (EGTRRA).
The regulations will affect trusts that are
subject to the GST tax.
DATES: Effective Date: The regulations
are effective August 2, 2007.
Applicability Date: For dates of
applicability, see § 26.2642–6(k)(1) and
§ 26.2642–6(k)(2).
FOR FURTHER INFORMATION CONTACT:
Mayer R. Samuels, (202) 622–3090 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
Paperwork Reduction Act
The collection of information
contained in these final regulations has
been previously reviewed and approved
by the Office of Management and
Budget in accordance with the
Paperwork Reduction Act of 1995 (44
U.S.C. 3507(d)) under control number
1545–1902.
The collection of information in these
final regulations is in § 26.2642–6(e).
This information is requested by the IRS
to identify whether a trust is exempt
from the GST tax. This information is
E:\FR\FM\02AUR1.SGM
02AUR1
]]>Agencies
[Federal Register Volume 72, Number 148 (Thursday, August 2, 2007)]
[Rules and Regulations]
[Page 42291]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14945]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
Ophthalmic and Topical Dosage Form New Animal Drugs; Emodepside
and Praziquantel
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 Bayer HealthCare LLC. The NADA provides for veterinary
prescription use of an emodepside and praziquantel topical solution on
cats for the treatment and control of infections by several internal
parasites.
DATES: This rule is effective August 2, 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: Bayer HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed NADA 141-275
that provides for veterinary prescription use of PROFENDER (emodepside
and praziquantel) Topical Solution for the treatment and control of
infections by several internal parasites of cats. The NADA is approved
as of June 29, 2007, and the regulations are amended in 21 CFR part 524
by adding Sec. 524.775 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)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning on the date of the approval.
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.
List of Subjects in 21 CFR Part 524
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 524 is
amended as follows:
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Add Sec. 524.775 to read as follows:
Sec. 524.775 Emodepside and praziquantel.
(a) Specifications. Each milliliter of solution contains 21.4
milligrams (mg) emodepside and 85.7 mg praziquantel.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats--(1) Amount. The recommended minimum
dose is 1.36 mg/pound (lb) (3 mg/kilogram (kg)) emodepside and 5.45 mg/
lb (12 mg/kg) praziquantel applied as a single topical dose.
(2) Indications for use. For the treatment and control of hookworm
infections caused by Ancylostoma tubaeforme (adults, immature adults,
and fourth stage larvae), roundworm infections caused by Toxocara cati
(adults and fourth stage larvae), and tapeworm infections caused by
Dipylidium caninum (adults) and Taenia taeniaeformis (adults).
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: July 17, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-14945 Filed 8-1-07; 8:45 am]
BILLING CODE 4160-01-S
