Oral Dosage Form New Animal Drugs; Ivermectin Meal, 1817-1818 [05-523]
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Federal Register / Vol. 70, No. 7 / Tuesday, January 11, 2005 / Rules and Regulations
Material Incorporated by Reference
(m) You must use Bombardier-Rotax GmbH
Mandatory Service Bulletin SB–912–036/SB–
914–022 Revision 1, dated August 2002, to
perform the venting and inspecting required
by this AD. The Director of the Federal
Register previously approved the
incorporation by reference of this Mandatory
Service Bulletin in accordance with 5 U.S.C.
552(a) and 1 CFR part 51, on October 23,
2002 (67 FR 65033). You can get a copy from
Bombardier-Rotax GmbH, Gunskirchen,
Austria; telephone 7246–601–423; fax 7246–
601–760. You can review a copy at the FAA,
New England Region, Office of the Regional
Counsel, 12 New England Executive Park,
Burlington, MA; or at the National Archives
and Records Administration (NARA). For
information on the availability of this
material at NARA, call (202) 741–6030, or go
to: https://www.archives.gov/federal_register/
code_of_federal_regulations/
ibr_locations.html.
Related Information
(n) Austro Control airworthiness directives
No. 113R1, dated August 30, 2002, and No.
116, dated September 15, 2003, and Rotax
Service Instruction SI–04–1997, Revision 3,
dated September 2002 also address the
subject of this AD.
Issued in Burlington, Massachusetts, on
January 3, 2005.
Francis A. Favara,
Acting Manager, Engine and Propeller
Directorate, Aircraft Certification Service.
[FR Doc. 05–486 Filed 1–10–05; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Ivermectin Meal
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 Merial, Ltd.
The NADA provides for use of
ivermectin meal for the control of
various species of internal parasites in
horses.
DATES: This rule is effective January 11,
2005.
VerDate jul<14>2003
09:25 Jan 10, 2005
Jkt 205001
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: Merial,
Ltd., 3239 Satellite Blvd., Bldg. 500,
Duluth, GA 30096–4640, filed NADA
141–241 for ZIMECTERIN–EZ
(ivermectin) 0.6% w/w for Horses. The
application provides for use of
ivermectin meal for the control of
various species of internal parasites in
horses. The NADA is approved as of
December 16, 2004, and part 520 (21
CFR part 520) is amended by adding
new § 520.1194 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)(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
December 16, 2004.
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.
1817
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 520.1194 is added to read as
follows:
I
§ 520.1194
Ivermectin meal.
(a) Specifications. Each gram of meal
contains 6 milligrams ivermectin (0.6
percent).
(b) Sponsor. See No. 050604 in
§ 510.600(c) of this chapter.
(c) Special considerations. See
§ 500.25 of this chapter.
(d) Conditions of use in horses—(1)
Amount. Administer 136 micrograms
(mcg) ivermectin per pound (/lb) body
weight (300 mcg/kilogram) as a single
dose on approximately 2 lb grain or
sweet feed.
(2) Indications for use. For treatment
and control of Large Strongyles (adults):
Strongylus vulgaris (also early forms in
blood vessels), S. edentatus (also tissue
stages), S. equinus, Triodontophorus
spp. including T. brevicauda and T.
serratus, and Craterostomum
acuticaudatum; Small Strongyles
(adults, including those resistant to
some benzimidazole class compounds):
Coronocyclus spp. including C.
coronatus, C. labiatus, and C. labratus,
Cyathostomum spp. including C.
catinatum and C. pateratum,
Cylicocyclus spp. including C. insigne,
C. leptostomum, C. nassatus, and C.
brevicapsulatus, Cylicodontophorus
spp., Cylicostephanus spp. including C.
calicatus, C. goldi, C. longibursatus, and
C. minutus, and Petrovinema
poculatum; Small Strongyles (fourthstage larvae); Pinworms (adults and
fourth stage larvae): Oxyuris equi;
Ascarids (adults and third- and fourthstage larvae): Parascaris equorum;
Hairworms (adults): Trichostrongylus
axei; Large Mouth Stomach Worms
(adults): Habronema muscae; Bots (oral
and gastric stages): Gasterophilus spp.
including G. intestinalis and G. nasalis;
List of Subjects in 21 CFR Part 520
Lungworms (adults and fourth-stage
Animal drugs.
larvae): Dictyocaulus arnfieldi;
Intestinal Threadworms (adults):
I Therefore, under the Federal Food,
Strongyloides westeri; Summer Sores
Drug, and Cosmetic Act and under
authority delegated to the Commissioner caused by Habronema and Draschia
of Food and Drugs and redelegated to the spp. cutaneous third-stage larvae;
Dermatitis caused by neck threadworm
Center for Veterinary Medicine, 21 CFR
microfilariae, Onchocerca sp.
part 520 is amended as follows:
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1818
Federal Register / Vol. 70, No. 7 / Tuesday, January 11, 2005 / Rules and Regulations
(3) Limitations. Do not use in horses
intended for human consumption.
Dated: December 29, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–523 Filed 1–10–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Lincomycin Hydrochloride Soluble
Powder
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 an abbreviated new animal
drug application (ANADA) filed by
Cross Vetpharm Group Ltd. The
ANADA provides for oral use of
lincomycin soluble powder to make
medicated drinking water for
administration to swine for the
treatment of swine dysentery or to
broiler chickens for the control of
necrotic enteritis.
DATES: This rule is effective January 11,
2005.
FOR FURTHER INFORMATION CONTACT:
Lonnie W. Luther, Center for Veterinary
Medicine (HFV 104), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 301–827–8549, email: lonnie.luther@fda.gov.
SUPPLEMENTARY INFORMATION: Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed
ANADA 200–377 for LINCOMED
(lincomycin hydrochloride) Soluble
Powder. The application provides for
oral use of lincomycin soluble powder
to make medicated drinking water for
administration to swine for the
treatment of swine dysentery or to
broiler chickens for the control of
necrotic enteritis. Cross Vetpharm
Group Ltd.’s LINCOMED Soluble
Powder is approved as a generic copy of
Pharmacia & Upjohn Co.’s LINCOMIX
Soluble Powder, approved under NADA
111–636. ANADA 200–377 is approved
as of December 6, 2004, and the
regulations are amended in 21 CFR
520.1263c 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
VerDate jul<14>2003
09:25 Jan 10, 2005
Jkt 205001
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.
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
congressional review requirements in 5
U.S.C. 801–808.
DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Parts 1 and 3
[Docket No.: 2004–P–034]
RIN 0651–AB76
Changes To Implement the
Cooperative Research and Technology
Enhancement Act of 2004
United States Patent and
Trademark Office, Commerce.
ACTION: Interim rule.
AGENCY:
SUMMARY: The Cooperative Research and
Technology Enhancement Act of 2004
(CREATE Act) amends the patent laws
to provide that subject matter developed
by another person shall be treated as
owned by the same person or subject to
an obligation of assignment to the same
person for purposes of determining
obviousness if three conditions are met:
The claimed invention was made by or
on behalf of parties to a joint research
List of Subjects in 21 CFR Part 520
agreement that was in effect on or before
Animal drugs.
the date the claimed invention was
made; the claimed invention was made
I Therefore, under the Federal Food,
as a result of activities undertaken
Drug, and Cosmetic Act and under
authority delegated to the Commissioner within the scope of the joint research
agreement; and the application for
of Food and Drugs and redelegated to the
patent for the claimed invention
Center for Veterinary Medicine, 21 CFR
discloses or is amended to disclose the
part 520 is amended as follows:
names of the parties to the joint research
agreement. The United States Patent and
PART 520—ORAL DOSAGE FORM
Trademark Office (Office) is revising the
NEW ANIMAL DRUGS
rules of practice in patent cases to
implement the CREATE Act.
I 1. The authority citation for 21 CFR
DATES: Effective Date: December 10,
part 520 continues to read as follows:
2004.
Authority: 21 U.S.C. 360b.
Comment Deadline Date: To be
ensured of consideration, written
I 2. Section 520.1263c is amended by
revising paragraph (b) to read as follows: comments must be received on or before
February 10, 2005. No public hearing
§ 520.1263c Lincomycin hydrochloride
will be held.
soluble powder.
ADDRESSES: Comments should be sent
*
*
*
*
*
by electronic mail message over the
Internet addressed to:
(b) Sponsors. See Nos. 000009,
046573, 054925, 059130, and 061623 in ab76comments@uspto.gov. Comments
§ 510.600(c) of this chapter for use as in may also be submitted by mail
addressed to: Box Comments—Patents,
paragraph (d) of this section.
Commissioner for Patents, P.O. Box
*
*
*
*
*
1450, Alexandria, VA, 22313–1450, or
by facsimile to (571) 273–7735, marked
Dated: December 29, 2004 .
to the attention of Robert A. Clarke.
Stephen F. Sundlof,
Although comments may be submitted
Director, Center for Veterinary Medicine.
by mail or facsimile, the Office prefers
[FR Doc. 05–524 Filed 1–10–05; 8:45 am]
to receive comments via the Internet. If
BILLING CODE 4160–01–S
comments are submitted by mail, the
Office prefers that the comments be
submitted on a DOS formatted 31⁄2 inch
disk accompanied by a paper copy.
Comments may also be sent by
electronic mail message over the
Internet via the Federal eRulemaking
Portal. See the Federal eRulemaking
PO 00000
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11JAR1
]]>Agencies
[Federal Register Volume 70, Number 7 (Tuesday, January 11, 2005)]
[Rules and Regulations]
[Pages 1817-1818]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-523]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Ivermectin Meal
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 Merial, Ltd. The NADA provides for use of ivermectin
meal for the control of various species of internal parasites in
horses.
DATES: This rule is effective January 11, 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: Merial, Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA 30096-4640, filed NADA 141-241 for ZIMECTERIN-EZ
(ivermectin) 0.6% w/w for Horses. The application provides for use of
ivermectin meal for the control of various species of internal
parasites in horses. The NADA is approved as of December 16, 2004, and
part 520 (21 CFR part 520) is amended by adding new Sec. 520.1194 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)(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 December 16, 2004.
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 520.1194 is added to read as follows:
Sec. 520.1194 Ivermectin meal.
(a) Specifications. Each gram of meal contains 6 milligrams
ivermectin (0.6 percent).
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Special considerations. See Sec. 500.25 of this chapter.
(d) Conditions of use in horses--(1) Amount. Administer 136
micrograms (mcg) ivermectin per pound (/lb) body weight (300 mcg/
kilogram) as a single dose on approximately 2 lb grain or sweet feed.
(2) Indications for use. For treatment and control of Large
Strongyles (adults): Strongylus vulgaris (also early forms in blood
vessels), S. edentatus (also tissue stages), S. equinus,
Triodontophorus spp. including T. brevicauda and T. serratus, and
Craterostomum acuticaudatum; Small Strongyles (adults, including those
resistant to some benzimidazole class compounds): Coronocyclus spp.
including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp.
including C. catinatum and C. pateratum, Cylicocyclus spp. including C.
insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus,
Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C.
goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum;
Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth
stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-
stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus
axei; Large Mouth Stomach Worms (adults): Habronema muscae; Bots (oral
and gastric stages): Gasterophilus spp. including G. intestinalis and
G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus
arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri;
Summer Sores caused by Habronema and Draschia spp. cutaneous third-
stage larvae; Dermatitis caused by neck threadworm microfilariae,
Onchocerca sp.
[[Page 1818]]
(3) Limitations. Do not use in horses intended for human
consumption.
Dated: December 29, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-523 Filed 1-10-05; 8:45 am]
BILLING CODE 4160-01-S
