Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin, 72619 [2011-30328]
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Federal Register / Vol. 76, No. 227 / Friday, November 25, 2011 / Rules and Regulations
intended for human consumption must
not be slaughtered within 48 days of the
last treatment. Do not use in female
dairy cattle 20 months of age or older.
Use in lactating dairy cows may cause
drug residues in milk. A withdrawal
period has not been established for preruminating calves. Do not use in calves
to be processed for veal.
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, (240) 276–
8341, email:
cindy.burnsteel@fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Merial
Ltd., 3239 Satellite Blvd., Bldg. 500,
Duluth, GA 30096–4640 filed a
supplement to NADA 141–079 for
EPRINEX (eprinomectin) Pour-On for
Beef and Dairy Cattle, a topical solution
used for the treatment and control of
internal and external parasites of cattle
on pasture with persistent effectiveness.
The supplemental NADA provides for
addition of a warning statement against
the use of eprinomectin topical solution
in preruminating calves intended for
veal. The NADA is approved as of
September 23, 2011, and the regulations
are amended in 21 CFR part 524 to
reflect the approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The Agency has determined under 21
CFR 25.33 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 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.
Food and Drug Administration
List of Subjects in 21 CFR Part 524
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
5. The authority citation for 21 CFR
part 556 continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
6. In § 556.227, revise paragraph (b)
and add paragraph (c) to read as follows:
■
§ 556.227
Eprinomectin.
*
*
*
*
*
(b) Tolerances. The tolerances for
eprinomectin B1a (marker residue) are:
(1) Cattle—(i) Liver (target tissue): 1.5
parts per million.
(ii) Muscle: 100 parts per billion
(ppb).
(iii) Milk: 12 ppb.
(2) [Reserved]
(c) Related conditions of use. See
§§ 522.814 and 524.814 of this chapter.
Dated: November 17, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–30329 Filed 11–23–11; 8:45 am]
BILLING CODE 4160–01–P
21 CFR Part 524
[Docket No. FDA–2011–N–0003]
Ophthalmic and Topical Dosage Form
New Animal Drugs; Eprinomectin
AGENCY:
Food and Drug Administration,
HHS.
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 Merial
Ltd. The supplemental NADA provides
for addition of a warning statement
against the use of eprinomectin topical
solution in preruminating calves
intended for veal.
DATES: This rule is effective November
25, 2011.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
wreier-aviles on DSK7SPTVN1PROD with RULES
SUMMARY:
13:38 Nov 23, 2011
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 524 is amended as follows:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
Final rule; technical
amendment.
ACTION:
VerDate Mar<15>2010
SUPPLEMENTARY INFORMATION:
Jkt 226001
1. The authority citation for 21 CFR
part 524 continues to read as follows:
■
72619
(d) Special considerations. See
§ 500.25 of this chapter.
(e) Conditions of use in cattle—(1)
Amount. Apply 5 mg (1 mL) per 10
kilograms (kg) of body weight (500
micrograms/kg) applied topically along
backbone from withers to tailhead.
(2) Indications for use. For treatment
and control of gastrointestinal
roundworms (Haemonchus placei (adult
and L4), Ostertagia ostertagi (adult and
L4, including inhibited L4),
Trichostrongylus axei (adult and L4), T.
colubriformis (adult and L4), T.
longispicularis (adult), Cooperia
oncophora (adult and L4), C. punctata
(adult and L4), C. surnabada (adult and
L4), Nematodirus helvetianus (adult and
L4), Bunostomum phlebotomum (adult
and L4), Oesophagostomum radiatum
(adult and L4), Strongyloides papillosus
(adults), Trichuris spp. (adults));
lungworms (Dictyocaulus viviparus,
adult and L4); cattle grubs (all parasitic
stages Hypoderma lineatum, H. bovis);
lice (Damalinia bovis, Linognathus
vituli, Haematopinus eurysternus,
Solenopotes capillatus); mange mites
(Chorioptes bovis, Sarcoptes scabiei);
and horn flies (Haematobia irritans).
Controls and protects from reinfection
of D. viviparus for 21 days after
treatment and H. irritans for 7 days after
treatment.
(3) Limitations. A withdrawal period
has not been established for
preruminating calves. Do not use in
calves to be processed for veal.
Dated: November 18, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2011–30328 Filed 11–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 300
[TD 9559]
RIN 1545–BK24
Authority: 21 U.S.C. 360b.
■
User Fee To Take the Registered Tax
Return Preparer Competency
Examination
2. Revise § 524.814 to read as follows:
AGENCY:
§ 524.814
Eprinomectin.
(a) Specifications. Each milliliter (mL)
contains 5 milligrams (mg) of
eprinomectin.
(b) Sponsor. See No. 050604 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.227
of this chapter.
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
This document contains
amendments to the user fee regulations.
The final regulations redesignate rules
pertaining to fees for obtaining a
preparer tax identification number.
These final regulations also establish a
SUMMARY:
E:\FR\FM\25NOR1.SGM
25NOR1
]]>Agencies
[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Rules and Regulations]
[Page 72619]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30328]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
[Docket No. FDA-2011-N-0003]
Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
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 Merial Ltd. The supplemental NADA provides
for addition of a warning statement against the use of eprinomectin
topical solution in preruminating calves intended for veal.
DATES: This rule is effective November 25, 2011.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, (240) 276-8341, email:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA 30096-4640 filed a supplement to NADA 141-079 for
EPRINEX (eprinomectin) Pour-On for Beef and Dairy Cattle, a topical
solution used for the treatment and control of internal and external
parasites of cattle on pasture with persistent effectiveness. The
supplemental NADA provides for addition of a warning statement against
the use of eprinomectin topical solution in preruminating calves
intended for veal. The NADA is approved as of September 23, 2011, and
the regulations are amended in 21 CFR part 524 to reflect the approval.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
The Agency has determined under 21 CFR 25.33 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 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.
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. Revise Sec. 524.814 to read as follows:
Sec. 524.814 Eprinomectin.
(a) Specifications. Each milliliter (mL) contains 5 milligrams (mg)
of eprinomectin.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.227 of this chapter.
(d) Special considerations. See Sec. 500.25 of this chapter.
(e) Conditions of use in cattle--(1) Amount. Apply 5 mg (1 mL) per
10 kilograms (kg) of body weight (500 micrograms/kg) applied topically
along backbone from withers to tailhead.
(2) Indications for use. For treatment and control of
gastrointestinal roundworms (Haemonchus placei (adult and L4),
Ostertagia ostertagi (adult and L4, including inhibited L4),
Trichostrongylus axei (adult and L4), T. colubriformis (adult and L4),
T. longispicularis (adult), Cooperia oncophora (adult and L4), C.
punctata (adult and L4), C. surnabada (adult and L4), Nematodirus
helvetianus (adult and L4), Bunostomum phlebotomum (adult and L4),
Oesophagostomum radiatum (adult and L4), Strongyloides papillosus
(adults), Trichuris spp. (adults)); lungworms (Dictyocaulus viviparus,
adult and L4); cattle grubs (all parasitic stages Hypoderma lineatum,
H. bovis); lice (Damalinia bovis, Linognathus vituli, Haematopinus
eurysternus, Solenopotes capillatus); mange mites (Chorioptes bovis,
Sarcoptes scabiei); and horn flies (Haematobia irritans). Controls and
protects from reinfection of D. viviparus for 21 days after treatment
and H. irritans for 7 days after treatment.
(3) Limitations. A withdrawal period has not been established for
preruminating calves. Do not use in calves to be processed for veal.
Dated: November 18, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2011-30328 Filed 11-23-11; 8:45 am]
BILLING CODE 4160-01-P
