Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Paste, 29447 [05-10221]
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Federal Register / Vol. 70, No. 98 / Monday, May 23, 2005 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Pyrantel Pamoate 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
Phoenix Scientific, Inc. The NADA
provides for the oral use of pyrantel
pamoate paste for the removal and
control of mature infections of
tapeworms in horses and ponies.
DATES: This rule is effective May 23,
2005.
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: Phoenix
Scientific, Inc., 3915 South 48th Street
Ter., St. Joseph, MO 64503, filed
supplemental NADA 200–342 that
provides for the use of Pyrantel Pamoate
Paste for the removal and control of
mature infections of tapeworms
(Anoplocephala perfoliata) in horses
and ponies. The supplemental NADA is
approved as of April 18, 2005, and the
regulations are amended in 21 CFR
520.2044 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.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
supplemental approval qualifies for 3
years of marketing exclusivity beginning
April 18, 2005.
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,
SUMMARY:
VerDate jul<14>2003
14:30 May 20, 2005
Jkt 205001
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.
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 520 is amended as follows:
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. Section 520.2044 is revised to read
as follows:
I
§ 520.2044
Pyrantel pamoate paste.
(a) Specifications—(1) Each milliliter
(mL) contains 180 milligrams (mg)
pyrantel base (as pyrantel pamoate).
(2) Each mL contains 226 mg pyrantel
base (as pyrantel pamoate).
(3) Each mL contains 171 mg pyrantel
base (as pyrantel pamoate).
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter.
(1) No. 000069 for use of product
described in paragraph (a)(1) of this
section as in paragraph (d)(1)(i) and
(d)(2) of this section.
(2) No. 059130 for use of product
described in paragraph (a)(2) of this
section as in paragraph (d) of this
section.
(3) No. 061623 for use of product
described in paragraph (a)(3) of this
section as in paragraph (d)(1)(i) and
(d)(2) of this section.
(c) Special considerations. See
§ 500.25 of this chapter.
(d) Conditions of use. It is used in
horses and ponies as follows:
(1) Amounts and indications for use—
(i) 3 mg per pound (/lb) body weight as
single oral dose for removal and control
of infections from the following mature
parasites: large strongyles (Strongylus
vulgaris, S. edentatus, S. equinus); small
strongyles; pinworms (Oxyuris equi);
and large roundworms (Parascaris
equorum).
(ii) 6 mg/lb body weight as single oral
dose for the removal and control of
mature infections of tapeworms
(Anoplocephala perfoliata).
(2) Limitations. Not for use in horses
intended for food.
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
29447
Dated: May 11, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–10221 Filed 5–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9204]
RIN 1545–BC59
Mortgage Revenue Bonds
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
AGENCY:
SUMMARY: This document contains final
regulations that provide guidance
regarding the limitation on the effective
rate of mortgage interest for purposes of
mortgage revenue bonds issued by State
and local governments. These
regulations provide guidance to State
and local governments that issue taxexempt mortgage revenue bonds.
DATES: Effective Date: These regulations
are effective May 23, 2005.
Applicability Date: For dates of
applicability, see § 1.143(g)-1(d) of these
regulations.
FOR FURTHER INFORMATION CONTACT:
Michael P. Brewer, (202) 622–3980 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
This document amends the Income
Tax Regulations (26 CFR part 1) under
section 143(g) of the Internal Revenue
Code by providing rules regarding the
limitation on the effective rate of
mortgage interest for purposes of
mortgage revenue bonds issued by State
and local governments. On November 5,
2003, the IRS published in the Federal
Register a notice of proposed
rulemaking (REG–146692–03)(68 FR
62549)(the proposed regulations). The
proposed regulations would add
§ 1.143(g)–1 to provide rules for
calculating the effective rate of mortgage
interest. A public hearing on the
proposed regulations was scheduled for
January 28, 2004. The public hearing
was cancelled because no requests to
speak were received. Written comments
were received regarding the proposed
regulations. After consideration of the
written comments, the proposed
regulations are adopted by this Treasury
decision without change (other than
E:\FR\FM\23MYR1.SGM
23MYR1
]]>Agencies
[Federal Register Volume 70, Number 98 (Monday, May 23, 2005)]
[Rules and Regulations]
[Page 29447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10221]
[[Page 29447]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Pyrantel Pamoate 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 new animal drug
application (NADA) filed by Phoenix Scientific, Inc. The NADA provides
for the oral use of pyrantel pamoate paste for the removal and control
of mature infections of tapeworms in horses and ponies.
DATES: This rule is effective May 23, 2005.
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, e-mail:
melanie.berson@fda.gov.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed supplemental NADA 200-342 that
provides for the use of Pyrantel Pamoate Paste for the removal and
control of mature infections of tapeworms (Anoplocephala perfoliata) in
horses and ponies. The supplemental NADA is approved as of April 18,
2005, and the regulations are amended in 21 CFR 520.2044 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. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning April 18,
2005.
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 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. Section 520.2044 is revised to read as follows:
Sec. 520.2044 Pyrantel pamoate paste.
(a) Specifications--(1) Each milliliter (mL) contains 180
milligrams (mg) pyrantel base (as pyrantel pamoate).
(2) Each mL contains 226 mg pyrantel base (as pyrantel pamoate).
(3) Each mL contains 171 mg pyrantel base (as pyrantel pamoate).
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
(1) No. 000069 for use of product described in paragraph (a)(1) of
this section as in paragraph (d)(1)(i) and (d)(2) of this section.
(2) No. 059130 for use of product described in paragraph (a)(2) of
this section as in paragraph (d) of this section.
(3) No. 061623 for use of product described in paragraph (a)(3) of
this section as in paragraph (d)(1)(i) and (d)(2) of this section.
(c) Special considerations. See Sec. 500.25 of this chapter.
(d) Conditions of use. It is used in horses and ponies as follows:
(1) Amounts and indications for use--(i) 3 mg per pound (/lb) body
weight as single oral dose for removal and control of infections from
the following mature parasites: large strongyles (Strongylus vulgaris,
S. edentatus, S. equinus); small strongyles; pinworms (Oxyuris equi);
and large roundworms (Parascaris equorum).
(ii) 6 mg/lb body weight as single oral dose for the removal and
control of mature infections of tapeworms (Anoplocephala perfoliata).
(2) Limitations. Not for use in horses intended for food.
Dated: May 11, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 05-10221 Filed 5-20-05; 8:45 am]
BILLING CODE 4160-01-S
