Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin, 27734-27735 [E7-9515]
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27734
Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations
is approved as a generic copy of Merial,
Ltd.’s IVOMEC Plus Injection for Cattle,
approved under NADA 140–833. The
ANADA is approved as of April 23,
2007, and the regulations are amended
in 21 CFR 522.1193 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.
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 522
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 522 is amended as follows:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–9517 Filed 5–16–07; 8:45 am]
Authority: 21 U.S.C. 360b.
2. Amend § 522.1193 as follows:
a. Revise the section heading and
paragraphs (a) and (b);
b. Redesignate paragraph (d) as
paragraph (e);
c. Add new paragraph (d); and
d. Revise newly redesignated
paragraph (e).
The revisions, redesignation, and
addition read as follows:
I
cprice-sewell on PROD1PC71 with RULES
§ 522.1193
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Ivermectin and clorsulon.
(a) Specifications. Each milliliter (mL)
of solution contains 10 milligrams (mg)
(1 percent) ivermectin and 100 mg (10
percent) clorsulon.
(b) Sponsors. See Nos. 050604 and
055529 in § 510.600(c) of this chapter
VerDate Aug<31>2005
for use as in paragraph (e) of this
section.
*
*
*
*
*
(d) Special considerations. See
§ 500.25 of this chapter.
(e) Conditions of use in cattle—(1)
Amount. Administer 1 mL (10 mg
ivermectin and 100 mg clorsulon) per 50
kilograms (110 pounds) by
subcutaneous injection.
(2) Indications for use. For the
treatment and control of gastrointestinal
nematodes (adults and fourth-stage
larvae) (Haemonchus placei, Ostertagia
ostertagi (including inhibited larvae), O.
lyrata, Trichostrongylus axei, T.
colubriformis, Cooperia oncophora, C.
punctata, C. pectinata,
Oesophagostomum radiatum,
Nematodirus helvetianus (adults only),
N. spathiger (adults only), Bunostomum
phlebotomum; lungworms (adults and
fourth-stage larvae) (Dictyocaulus
viviparus); liver flukes (adults only)
(Fasciola hepatica); grubs (parasitic
stages) (Hypoderma bovis, H. lineatum);
lice (Linognathus vituli, Haematopinus
eurysternus, Solenopotes capillatus);
mites (Psoroptes ovis (syn. P. communis
var. bovis), Sarcoptes scabiei var. bovis);
and for control of infections of D.
viviparus and O. radiatum for 28 days
afer treatment; O. ostertagi, T. axei, and
C. punctata for 21 days after treatment;
and H. placei and C. oncophora for 14
days after treatment.
(3) Limitations. For subcutaneous use
only. Not for intravenous or
intramuscular use. Do not treat cattle
within 49 days of slaughter. Because a
withdrawal time in milk has not been
established, do not use in female dairy
cattle of breeding age. Do not use in
other animal species because severe
adverse reactions, including fatalities in
dogs, may result. A withdrawal period
has not been established for this product
in preruminating calves. Do not use in
calves to be processed for veal.
15:37 May 16, 2007
Jkt 211001
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Ivermectin
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
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
Norbrook Laboratories, Ltd. The
ANADA provides for use of a one
percent ivermectin solution by
subcutaneous injection in cattle, swine,
reindeer, and American bison for the
treatment and control of various internal
and external parasites.
DATES: This rule is effective May 17,
2007.
John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook
Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed
supplemental ANADA 200–437 that
provides for use of NOROMECTIN
(ivermectin) Injection for Cattle and
Swine by subcutaneous injection in
cattle, swine, reindeer, and American
bison for the treatment and control of
various internal and external parasites.
Norbrook Laboratories, Ltd.’s
NOROMECTIN Injection for Cattle and
Swine is approved as a generic copy of
Merial, Ltd.’s IVOMEC Injection for
Cattle and Swine approved under
NADA 128–409. The ANADA is
approved as of April 20, 2007, and the
regulations are amended in 21 CFR
522.1192 to reflect the approval and a
current format.
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.
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.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\17MYR1.SGM
17MYR1
Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations
List of Subjects in 21 CFR Part 522
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 522 is amended as follows:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. Revise § 522.1192 to read as
follows:
I
cprice-sewell on PROD1PC71 with RULES
§ 522.1192
Ivermectin.
(a) Specifications—(1) Each milliliter
(mL) of solution contains 20 milligrams
(mg) ivermectin.
(2) Each mL of solution contains 10
mg ivermectin.
(3) Each mL of solution contains 2.7
mg ivermectin.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (e) of this section.
(1) No. 050604 for use of the product
described in paragraph (a)(1) of this
section as in paragraph (e)(1) of this
section; the product described in
paragraph (a)(2) of this section as in
paragraphs (e)(2)(i), (e)(2)(ii)(A),
(e)(2)(ii)(C), (e)(2)(iii), (e)(3), (e)(4) and
(e)(5) of this section; and the product
described in paragraph (a)(3) of this
section as in paragraphs (e)(3) and (e)(6)
of this section.
(2) Nos. 059130 and 055529 for use of
the product described in paragraph
(a)(2) of this section as in paragraphs
(e)(2)(i), (e)(2)(ii)(A), (e)(2)(ii)(B),
(e)(2)(iii), (e)(3), (e)(4), and (e)(5) of this
section.
(c) Related tolerances. See § 556.344
of this chapter.
(d) Special considerations—(1) See
§ 500.25 of this chapter.
(2) Labeling shall bear the following
precaution: ‘‘This product should not be
used in other animal species as severe
adverse reactions, including fatalities in
dogs, may result.’’
(e) Conditions of use—(1) Horses—(i)
Amount. 200 micrograms per kilogram
(µg/kg) of body weight by intramuscular
injection.
(ii) Indications for use. For the
treatment and control of large strongyles
(adult) (Strongylus vulgaris, S.
edentatus, Triodontophorus spp.), small
strongyles (adult and fourth stage
larvae) (Cyathostomum spp.,
Cylicocyclus spp., Cylicostephanus
spp.), pinworms (adult and fourth-stage
VerDate Aug<31>2005
16:07 May 16, 2007
Jkt 211001
larvae) (Oxyuris equi), large
roundworms (adult) (Parascaris
equorum), hairworms (adult)
(Trichostrongylus axei), large mouth
stomach worms (adult) (Habronema
muscae), neck threadworms
(microfilariae) (Onchocerca spp.), and
stomach bots (Gastrophilus spp.).
(iii) Limitations. Not for use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
(2) Cattle—(i) Amount. 200 µg/kg of
body weight by subcutaneous injection.
(ii) Indications for use—(A) For the
treatment and control of gastrointestinal
nematodes (adults and fourth-stage
larvae) (Haemonchus placei, Ostertagia
ostertagi (including inhibited larvae), O.
lyrata, T. axei, T. colubriformis,
Cooperia oncophora, C. punctata, C.
pectinata, Oesophagostomum radiatum,
Nematodirus helvetianus (adults only),
N. spathiger (adults only), Bunostomum
phlebotomum); lungworms (adults and
fourth-stage larvae) (Dictyocaulus
viviparus); grubs (parasitic stages)
(Hypoderma bovis, H. lineatum);
sucking lice (Linognathus vituli,
Haematopinus eurysternus, Solenopotes
capillatus); mites (scabies) (Psoroptes
ovis (syn. P. communis var. bovis),
Sarcoptes scabiei var. bovis).
(B) For control of infections of D.
viviparus for 28 days after treatment,
and O. ostertagi for 21 days after
treatment, and H. placei, T. axei, C.
punctata, C. oncophora, and O.
radiatum for 14 days after treatment.
(C) For control of infections and to
protect from reinfection with D.
viviparus and O. radiatum for 28 days
after treatment; O. ostertagi, T. axei, and
C. punctata for 21 days after treatment;
H. placei and C. oncophora for 14 days
after treatment.
(iii) Limitations. Do not treat cattle
within 35 days of slaughter. Because a
withdrawal time in milk has not been
established, do not use in female dairy
cattle of breeding age. A withdrawal
period has not been established for this
product in pre-ruminating calves. Do
not use in calves to be processed for
veal.
(3) Swine—(i) Amount. 300 µg/kg of
body weight by subcutaneous injection.
(ii) Indications for use. For the
treatment and control of gastrointestinal
roundworms (adults and fourth-stage
larvae) (large roundworm, Ascaris
suum; red stomach worm,
Hyostrongylus rubidus; nodular worm,
Oesophagostomum spp.; threadworm,
Strongyloides ransomi (adults only));
somatic roundworm larvae
(threadworm, S. ransomi (somatic
larvae)); lungworms (Metastrongylus
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
27735
spp. (adults only)); lice (H. suis); and
mites (S. scabiei var. suis).
(iii) Limitations. Do not treat swine
within 18 days of slaughter.
(4) American bison—(i) Amount. 200
µg/kg of body weight by subcutaneous
injection.
(ii) Indications for use. For the
treatment and control of grubs (H.
bovis).
(iii) Limitations. Do not slaughter
within 56 days of last treatment.
(5) Reindeer—(i) Amount. 200 µg/kg
of body weight by subcutaneous
injection.
(ii) Indications for use. For the
treatment and control of warbles
(Oedemagena tarandi).
(iii) Limitations. Do not treat reindeer
within 56 days of slaughter.
(6) Ranch-raised foxes—(i) Amount.
200 µg/kg of body weight by
subcutaneous injection. Repeat in 3
weeks.
(ii) Indications for use. For treatment
and control of ear mites (Otodectes
cynotis).
Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–9515 Filed 5–16–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[CGD13–07–013]
RIN 1625–AA00
Special local regulation: ULHRA
Hydroplane Races, Howard Amon
Park, Richland, WA
Coast Guard, DHS.
Special local regulation
temporary final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is
undertaking two actions with regard to
the above captioned regulation. The first
is to withdraw the temporary final rule
previously published on April 23, 2007
because it erroneously described the
race area. The second is to correct the
previous error by establishing a
temporary special local regulation for
the ULHRA National Series Hydroplane
Race to be held on the waters of the
Columbia River in the vicinity of
Howard Amon Park, Richland, WA.
These special local regulations limit the
movement of non-participating vessels
in the regulated race area. This
E:\FR\FM\17MYR1.SGM
17MYR1
]]>Agencies
[Federal Register Volume 72, Number 95 (Thursday, May 17, 2007)]
[Rules and Regulations]
[Pages 27734-27735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9515]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Ivermectin
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 Norbrook Laboratories, Ltd. The ANADA
provides for use of a one percent ivermectin solution by subcutaneous
injection in cattle, swine, reindeer, and American bison for the
treatment and control of various internal and external parasites.
DATES: This rule is effective May 17, 2007.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed supplemental ANADA 200-437 that
provides for use of NOROMECTIN (ivermectin) Injection for Cattle and
Swine by subcutaneous injection in cattle, swine, reindeer, and
American bison for the treatment and control of various internal and
external parasites. Norbrook Laboratories, Ltd.'s NOROMECTIN Injection
for Cattle and Swine is approved as a generic copy of Merial, Ltd.'s
IVOMEC Injection for Cattle and Swine approved under NADA 128-409. The
ANADA is approved as of April 20, 2007, and the regulations are amended
in 21 CFR 522.1192 to reflect the approval and a current format.
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.
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.
[[Page 27735]]
List of Subjects in 21 CFR Part 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Revise Sec. 522.1192 to read as follows:
Sec. 522.1192 Ivermectin.
(a) Specifications--(1) Each milliliter (mL) of solution contains
20 milligrams (mg) ivermectin.
(2) Each mL of solution contains 10 mg ivermectin.
(3) Each mL of solution contains 2.7 mg ivermectin.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (e) of this section.
(1) No. 050604 for use of the product described in paragraph (a)(1)
of this section as in paragraph (e)(1) of this section; the product
described in paragraph (a)(2) of this section as in paragraphs
(e)(2)(i), (e)(2)(ii)(A), (e)(2)(ii)(C), (e)(2)(iii), (e)(3), (e)(4)
and (e)(5) of this section; and the product described in paragraph
(a)(3) of this section as in paragraphs (e)(3) and (e)(6) of this
section.
(2) Nos. 059130 and 055529 for use of the product described in
paragraph (a)(2) of this section as in paragraphs (e)(2)(i),
(e)(2)(ii)(A), (e)(2)(ii)(B), (e)(2)(iii), (e)(3), (e)(4), and (e)(5)
of this section.
(c) Related tolerances. See Sec. 556.344 of this chapter.
(d) Special considerations--(1) See Sec. 500.25 of this chapter.
(2) Labeling shall bear the following precaution: ``This product
should not be used in other animal species as severe adverse reactions,
including fatalities in dogs, may result.''
(e) Conditions of use--(1) Horses--(i) Amount. 200 micrograms per
kilogram ([micro]g/kg) of body weight by intramuscular injection.
(ii) Indications for use. For the treatment and control of large
strongyles (adult) (Strongylus vulgaris, S. edentatus, Triodontophorus
spp.), small strongyles (adult and fourth stage larvae) (Cyathostomum
spp., Cylicocyclus spp., Cylicostephanus spp.), pinworms (adult and
fourth-stage larvae) (Oxyuris equi), large roundworms (adult)
(Parascaris equorum), hairworms (adult) (Trichostrongylus axei), large
mouth stomach worms (adult) (Habronema muscae), neck threadworms
(microfilariae) (Onchocerca spp.), and stomach bots (Gastrophilus
spp.).
(iii) Limitations. Not for use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
(2) Cattle--(i) Amount. 200 [micro]g/kg of body weight by
subcutaneous injection.
(ii) Indications for use--(A) For the treatment and control of
gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus
placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata,
T. axei, T. colubriformis, Cooperia oncophora, C. punctata, C.
pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults
only), N. spathiger (adults only), Bunostomum phlebotomum); lungworms
(adults and fourth-stage larvae) (Dictyocaulus viviparus); grubs
(parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice
(Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus);
mites (scabies) (Psoroptes ovis (syn. P. communis var. bovis),
Sarcoptes scabiei var. bovis).
(B) For control of infections of D. viviparus for 28 days after
treatment, and O. ostertagi for 21 days after treatment, and H. placei,
T. axei, C. punctata, C. oncophora, and O. radiatum for 14 days after
treatment.
(C) For control of infections and to protect from reinfection with
D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi,
T. axei, and C. punctata for 21 days after treatment; H. placei and C.
oncophora for 14 days after treatment.
(iii) Limitations. Do not treat cattle within 35 days of slaughter.
Because a withdrawal time in milk has not been established, do not use
in female dairy cattle of breeding age. A withdrawal period has not
been established for this product in pre-ruminating calves. Do not use
in calves to be processed for veal.
(3) Swine--(i) Amount. 300 [micro]g/kg of body weight by
subcutaneous injection.
(ii) Indications for use. For the treatment and control of
gastrointestinal roundworms (adults and fourth-stage larvae) (large
roundworm, Ascaris suum; red stomach worm, Hyostrongylus rubidus;
nodular worm, Oesophagostomum spp.; threadworm, Strongyloides ransomi
(adults only)); somatic roundworm larvae (threadworm, S. ransomi
(somatic larvae)); lungworms (Metastrongylus spp. (adults only)); lice
(H. suis); and mites (S. scabiei var. suis).
(iii) Limitations. Do not treat swine within 18 days of slaughter.
(4) American bison--(i) Amount. 200 [micro]g/kg of body weight by
subcutaneous injection.
(ii) Indications for use. For the treatment and control of grubs
(H. bovis).
(iii) Limitations. Do not slaughter within 56 days of last
treatment.
(5) Reindeer--(i) Amount. 200 [micro]g/kg of body weight by
subcutaneous injection.
(ii) Indications for use. For the treatment and control of warbles
(Oedemagena tarandi).
(iii) Limitations. Do not treat reindeer within 56 days of
slaughter.
(6) Ranch-raised foxes--(i) Amount. 200 [micro]g/kg of body weight
by subcutaneous injection. Repeat in 3 weeks.
(ii) Indications for use. For treatment and control of ear mites
(Otodectes cynotis).
Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-9515 Filed 5-16-07; 8:45 am]
BILLING CODE 4160-01-S
