New Animal Drugs; Moxidectin, 36337-36338 [05-12421]
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Federal Register / Vol. 70, No. 120 / Thursday, June 23, 2005 / Rules and Regulations
FDA 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.
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 Fort Dodge
Animal Health. The NADA provides for
use of an injectable moxidectin solution
for the treatment and control of various
internal and external parasites of cattle.
DATES: This rule is effective June 23,
2005.
Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Animal drugs.
Administration, 7500 Standish Pl.,
I Therefore, under the Federal Food,
Rockville, MD 20855, 301–827–7571, eDrug, and Cosmetic Act and under
mail: jgotthar@cvm.fda.gov.
authority delegated to the Commissioner SUPPLEMENTARY INFORMATION: Fort
of Food and Drugs and redelegated to the Dodge Animal Health, Division of
Center for Veterinary Medicine, 21 CFR
Wyeth, 800 Fifth St. NW., Fort Dodge,
part 522 is amended as follows:
IA 50501, filed NADA 141–220 that
provides for use of CYDECTIN
PART 522—IMPLANTATION OR
(moxidectin) Injectable Solution for Beef
INJECTABLE DOSAGE FORM NEW
and Nonlactating Dairy Cattle for the
ANIMAL DRUGS
treatment and control of various internal
and external parasites. The NADA is
I 1. The authority citation for 21 CFR
approved as of May 20, 2005, and the
part 522 continues to read as follows:
regulations are amended in part 522 (21
Authority: 21 U.S.C. 360b.
CFR part 522) by adding § 522.1450 and
I 2. Section 522.810 is added to read as
in part 556 (21 CFR part 556) by revising
follows:
§ 556.426 to reflect the approval. The
basis of approval is discussed in the
§ 522.810 Embutramide, chloroquine, and
freedom of information summary.
lidocaine solution.
In accordance with the freedom of
(a) Specifications. Each milliliter (mL)
of solution contains 135 milligrams (mg) information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
embutramide; 45 mg chloroquine
phosphate, U.S.P.; and 1.9 mg lidocaine, summary of safety and effectiveness
data and information submitted to
U.S.P.
support approval of this application
(b) Sponsor. See No. 059130 in
may be seen in the Division of Dockets
§ 510.600(c) of this chapter.
Management (HFA–305), Food and Drug
(c) Conditions of use in dogs—(1)
Administration, 5630 Fishers Lane, rm.
Amount. One mL per 5 pounds of body
1061, Rockville, MD 20852, between 9
weight.
(2) Indications for use. For euthanasia. a.m. and 4 p.m., Monday through
(3) Limitations. Not for use in animals Friday.
Under section 512(c)(2)(F)(ii) of the
intended for food. Federal law restricts
Federal Food, Drug, and Cosmetic Act
this drug to use by or on the order of
(21 U.S.C. 360b(c)(2)(F)(ii)), this
a licensed veterinarian.
approval qualifies for 3 years of
Dated: June 10, 2005.
marketing exclusivity beginning May
Stephen F. Sundlof,
20, 2005.
Director, Center for Veterinary Medicine.
The agency has carefully considered
[FR Doc. 05–12422 Filed 6–22–05; 8:45 am]
the potential environmental impact of
BILLING CODE 4160–01–S
this action and has concluded that the
action will not have a significant impact
on the human environment and that an
DEPARTMENT OF HEALTH AND
environmental impact statement is not
HUMAN SERVICES
required. FDA’s finding of no significant
impact and the evidence supporting that
Food and Drug Administration
finding, contained in an environmental
assessment, may be seen in the Division
21 CFR Parts 522 and 556
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
New Animal Drugs; Moxidectin
This rule does not meet the definition
AGENCY: Food and Drug Administration, of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
HHS.
FOR FURTHER INFORMATION CONTACT:
List of Subject in 21 CFR Part 522
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19:30 Jun 22, 2005
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36337
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects
21 CFR Part 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to the
Center for Veterinary Medicine, 21 CFR
parts 522 and 556 are amended as
follows:
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. Section 522.1450 is added to read as
follows:
I
§ 522.1450
Moxidectin solution.
(a) Specifications. Each milliliter of
solution contains 10 milligrams (mg)
moxidectin.
(b) Sponsor. See No. 000856 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.426
of this chapter.
(d) Conditions of use in beef and
nonlactating dairy cattle.—(1) Amount.
0.2 mg/kilogram body weight (0.2 mg/
2.2 pound) as a single subcutaneous
injection.
(2) Indications for use. For treatment
and control of gastrointestinal
roundworms: Ostertagia ostertagi
(adults and inhibited fourth-stage
larvae), Haemonchus placei (adults),
Trichostrongylus axei (adults), T.
colubriformis (fourth-stage larvae),
Cooperia oncophora (adults), C.
punctata (adults and fourth-stage
larvae), C. surnabada (adults and fourthstage larvae), Oesophagostomum
radiatum (adults and fourth-stage
larvae), Trichuris spp. (adults);
lungworms: Dictyocaulus viviparus
(adults and fourth-stage larvae); grubs:
Hypoderma bovis and H. lineatum;
mites: Psoroptes ovis (P. communis var.
bovis); lice: Linognathus vituli and
Solenopotes capillatus; for protection of
cattle from reinfection with D. viviparus
and O. radiatum for 42 days after
treatment, with H. placei for 35 days
after treatment, and with O. ostertagi
and T. axei for 14 days after treatment.
(3) Limitations. Do not slaughter cattle
within 21 days of treatment. Because a
withholding time for milk has not been
established, do not use in female dairy
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23JNR1
36338
Federal Register / Vol. 70, No. 120 / Thursday, June 23, 2005 / Rules and Regulations
cattle of breeding age. A withdrawal
period has not been established for
preruminating calves. Do not use in
calves to be processed for veal.
§ 522.1451
[Amended]
3. Section 522.1451 is amended by
revising the section heading to read
‘‘Moxidectin for suspension.’’
I
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
4. The authority citation for 21 CFR
part 556 continues to read as follows:
I
Authority: 21 U.S.C. 342, 360b, 371.
5. Section 556.426 is amended by
redesignating paragraphs (b)(1)(i)
through (b)(1)(iii) as paragraphs (b)(1)(ii)
through (b)(1)(iv); by revising newly
redesignated paragraphs (b)(1)(ii) and
(b)(1)(iv); and by adding new paragraphs
(b)(1)(i) and (c) to read as follows:
I
§ 556.426
Moxidectin.
*
*
*
*
*
(b) * * *
(1) * * *
(i) Fat (the target tissue). The
tolerance for parent moxidectin (the
marker residue) is 900 parts per billion
(ppb).
(ii) Liver. The tolerance for parent
moxidectin (the marker residue) is 200
ppb.
(iii) * * *
(iv) Milk. The tolerance for parent
moxidectin (the marker residue) is 40
ppb.
*
*
*
*
*
(c) Related conditions of use. See
§ 522.1451 of this chapter.
Dated: June 10, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–12421 Filed 6–22–05; 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; Gentamicin
Sulfate, Mometasone Furoate,
Clotrimazole Otic Suspension;
Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
VerDate jul<14>2003
19:30 Jun 22, 2005
Jkt 205001
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by
Schering-Plough Animal Health Corp.
The supplemental NADA provides for a
new container size, a 7.5-gram dropper
bottle, from which gentamicin sulfate,
mometasone furoate, clotrimazole otic
suspension may be administered for the
treatment of otitis externa in dogs. The
regulations are also being amended to
correct the description of a previously
approved container size. This action is
being taken to improve the accuracy of
the regulations.
DATES:
This rule is effective June 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, 301–827–7540, email: melanie.berson@fda.gov.
ScheringPlough Animal Health Corp., 1095
Morris Ave., Union, NJ 07083, filed a
supplement to NADA 141–177 for use of
MOMETAMAX (gentamicin sulfate,
U.S.P.; mometasone furoate
monohydrate; and clotrimazole, U.S.P.)
Otic Suspension for the treatment of
otitis externa in dogs. The supplement
provides for a new container size, a 7.5gram dropper bottle. The supplemental
NADA is approved as of June 1, 2005,
and the regulations are amended in 21
CFR 524.1044h to reflect the approval.
The regulations are also being
amended to correct the description of a
previously approved container size.
This action is being taken to improve
the accuracy of the regulations.
The agency has determined under 21
CFR 25.33(a)(4) 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:
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. Section 524.1044h is amended by
revising paragraphs (b) and (c)(1) to read
as follows:
I
§ 524.1044h Gentamicin sulfate,
mometasone furoate, clotrimazole otic
suspension.
*
*
*
*
*
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. For dogs weighing less than 30
pounds (lb), instill 4 drops from the 7.5, 15-, or 30-gram (g) bottle into the ear
canal (2 drops from the 215-g bottle) or,
for dogs weighing 30 lb or more, instill
8 drops from the 7.5-, 15-, or 30-g bottle
into the ear canal (4 drops from the 215g bottle), once or twice daily for 7 days.
*
*
*
*
*
Dated: June 15, 2005.
Steven D. Vaugh,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–12402 Filed 6–22–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1301 and 1306
[Docket No. DEA–202F]
RIN 1117–AA68
Authority for Practitioners To Dispense
or Prescribe Approved Narcotic
Controlled Substances for
Maintenance or Detoxification
Treatment
Drug Enforcement
Administration (DEA), Justice.
ACTION: Final rule.
AGENCY:
SUMMARY: DEA is amending its
regulations to allow qualified
practitioners not otherwise registered as
a narcotic treatment program to
dispense and prescribe to narcotic
List of Subject in 21 CFR Part 524
dependent persons Schedule III, IV, and
V narcotic controlled drugs approved by
Animal drugs.
the Food and Drug Administration
specifically for use in maintenance or
I Therefore, under the Federal Food,
detoxification treatment. This Final
Drug, and Cosmetic Act and under
authority delegated to the Commissioner Rule is in response to amendments to
of Food and Drugs and redelegated to the the Controlled Substances Act by the
Drug Addiction Treatment Act of 2000
Center for Veterinary Medicine, 21 CFR
(DATA) that are designed to expand and
part 524 is amended as follows:
PO 00000
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]]>Agencies
[Federal Register Volume 70, Number 120 (Thursday, June 23, 2005)]
[Rules and Regulations]
[Pages 36337-36338]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12421]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
New Animal Drugs; Moxidectin
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 Fort Dodge Animal Health. The NADA provides for use of
an injectable moxidectin solution for the treatment and control of
various internal and external parasites of cattle.
DATES: This rule is effective June 23, 2005.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
jgotthar@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth,
800 Fifth St. NW., Fort Dodge, IA 50501, filed NADA 141-220 that
provides for use of CYDECTIN (moxidectin) Injectable Solution for Beef
and Nonlactating Dairy Cattle for the treatment and control of various
internal and external parasites. The NADA is approved as of May 20,
2005, and the regulations are amended in part 522 (21 CFR part 522) by
adding Sec. 522.1450 and in part 556 (21 CFR part 556) by revising
Sec. 556.426 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 May 20, 2005.
The agency has carefully considered the potential environmental
impact of this action and has concluded that the action will not have a
significant impact on the human environment and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
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
21 CFR Part 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 522 and
556 are 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. Section 522.1450 is added to read as follows:
Sec. 522.1450 Moxidectin solution.
(a) Specifications. Each milliliter of solution contains 10
milligrams (mg) moxidectin.
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.426 of this chapter.
(d) Conditions of use in beef and nonlactating dairy cattle.--(1)
Amount. 0.2 mg/kilogram body weight (0.2 mg/2.2 pound) as a single
subcutaneous injection.
(2) Indications for use. For treatment and control of
gastrointestinal roundworms: Ostertagia ostertagi (adults and inhibited
fourth-stage larvae), Haemonchus placei (adults), Trichostrongylus axei
(adults), T. colubriformis (fourth-stage larvae), Cooperia oncophora
(adults), C. punctata (adults and fourth-stage larvae), C. surnabada
(adults and fourth-stage larvae), Oesophagostomum radiatum (adults and
fourth-stage larvae), Trichuris spp. (adults); lungworms: Dictyocaulus
viviparus (adults and fourth-stage larvae); grubs: Hypoderma bovis and
H. lineatum; mites: Psoroptes ovis (P. communis var. bovis); lice:
Linognathus vituli and Solenopotes capillatus; for protection of cattle
from reinfection with D. viviparus and O. radiatum for 42 days after
treatment, with H. placei for 35 days after treatment, and with O.
ostertagi and T. axei for 14 days after treatment.
(3) Limitations. Do not slaughter cattle within 21 days of
treatment. Because a withholding time for milk has not been
established, do not use in female dairy
[[Page 36338]]
cattle of breeding age. A withdrawal period has not been established
for preruminating calves. Do not use in calves to be processed for
veal.
Sec. 522.1451 [Amended]
0
3. Section 522.1451 is amended by revising the section heading to read
``Moxidectin for suspension.''
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
4. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
5. Section 556.426 is amended by redesignating paragraphs (b)(1)(i)
through (b)(1)(iii) as paragraphs (b)(1)(ii) through (b)(1)(iv); by
revising newly redesignated paragraphs (b)(1)(ii) and (b)(1)(iv); and
by adding new paragraphs (b)(1)(i) and (c) to read as follows:
Sec. 556.426 Moxidectin.
* * * * *
(b) * * *
(1) * * *
(i) Fat (the target tissue). The tolerance for parent moxidectin
(the marker residue) is 900 parts per billion (ppb).
(ii) Liver. The tolerance for parent moxidectin (the marker
residue) is 200 ppb.
(iii) * * *
(iv) Milk. The tolerance for parent moxidectin (the marker residue)
is 40 ppb.
* * * * *
(c) Related conditions of use. See Sec. 522.1451 of this chapter.
Dated: June 10, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-12421 Filed 6-22-05; 8:45 am]
BILLING CODE 4160-01-S
