Oral Dosage Form New Animal Drugs; Fenbendazole Paste, 24185 [E7-8391]
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Federal Register / Vol. 72, No. 84 / Wednesday, May 2, 2007 / Rules and Regulations
the Center for Veterinary Medicine, 21
CFR part 510 is amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), revise the entry for
‘‘Alpharma, Inc.’’; and in the table in
paragraph (c)(2), revise the entry for
‘‘046573’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*****
Alpharma, Inc., 440 Rte.
22, Bridgewater, NJ
08807.
*****
Drug labeler
code
046573
(2) * * *
List of Subjects in 21 CFR Part 520
Drug labeler
code
Firm name and address
Animal drugs.
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 part 520 is amended as follows:
■
*****
Alpharma, Inc., 440 Rte.
22, Bridgewater, NJ
08807
*****
046573
improve the accuracy of the animal drug
regulations.
DATES: This rule is effective May 2,
2007.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019, email: george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending the animal drug regulations
in 21 CFR 558.95 to correct an
inadvertent error in the conditions of
use of fenbendazole paste in horses and
cattle. The error in the agency’s
regulations was introduced in a final
rule reflecting the approval of a
supplemental new animal drug
application that published in the
Federal Register on March 9, 2007 (72
FR 10595). This action is being taken to
improve the accuracy of the animal drug
regulations.
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.
Dated: April 24, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–8322 Filed 5–1–07; 8:45 am]
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
2. Section 520.905c is revised to read
as follows:
■
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
§ 520.905c
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Fenbendazole Paste
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
mmaher on DSK3CLS3C1PROD with $$_JOB
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to correct an
inadvertent error in the conditions of
use of fenbendazole paste in horses and
cattle. This action is being taken to
VerDate Mar 15 2010
02:49 Aug 19, 2011
of body weight. Retreatment at intervals
of 6 to 8 weeks may be required.
(B) For control of arteritis caused by
the fourth-stage larvae of S. vulgaris: 4.6
mg/lb of body weight daily for 5 days.
Treatment should be initiated in the
spring and repeated in 6 months.
(C) For treatment of encysted mucosal
cyathostome (small strongyle) larvae
including early third-stage (hypobiotic),
late third-stage, and fourth-stage larvae:
4.6 mg/lb of body weight daily for 5
consecutive days.
(D) Fenbendazole paste 10 percent
may be used concomitantly with
approved forms of trichlorfon for the
indications provided in paragraph
(e)(1)(i)(A) of this section and for
treating infections of stomach bots as
provided in § 520.2520.
(ii) Limitations. Do not use in horses
intended for human consumption.
(2) Cattle—(i) Amount. 2.3 mg/lb of
body weight. Retreatment may be
needed after 4 to 6 weeks.
(ii) Indications for use. For the
removal and control of lungworms
(Dictyocaulus viviparus), stomach
worms (Haemonchus contortus,
Ostertagia ostertagi, Trichostrongylus
axei), and intestinal worms
(Bunostomum phlebotomum,
Nematodirus helvetianus, Cooperia
punctata, C. oncophora,
Trichostrongylus colubriformis, and
Oesophagostomum radiatum).
(iii) Limitations. Cattle must not be
slaughtered within 8 days following last
treatment.
Dated: April 24, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–8391 Filed 5–1–07; 8:45 am]
BILLING CODE 4160–01–S
Authority: 21 U.S.C. 360b.
BILLING CODE 4160–01–S
AGENCY:
24185
Jkt 223001
Fenbendazole paste.
(a) Specifications. Each gram of paste
contains 100 milligrams (mg)
fenbendazole (10 percent).
(b) Sponsor. See No. 057926 in §
510.600(c) of this chapter.
(c) Related tolerances. See § 556.275
of this chapter.
(d) Special considerations. See §
500.25 of this chapter.
(e) Conditions of use—(1) Horses—(i)
Indications for use and amounts—(A)
For control of large strongyles
(Strongylus edentatus, S. equinus, S.
vulgaris), small strongyles, pinworms
(Oxyuris equi), and ascarids (Parascaris
equorum): 2.3 mg per pound (/lb) of
body weight, or for foals and weanlings
(less than 18 months of age), 4.6 mg/lb
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[CGD05–06–112]
RIN 1625–AA87
Security Zone; Severn River and
College Creek, Annapolis, MD
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is
establishing a permanent security zone
on certain waters of the Severn River
and College Creek. This action is
necessary to ensure the security of highranking public officials and safeguard
E:\FEDREG\02MYR1.LOC
02MYR1
]]>Agencies
[Federal Register Volume 72, Number 84 (Wednesday, May 2, 2007)]
[Rules and Regulations]
[Page 24185]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8391]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Fenbendazole Paste
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 correct an inadvertent error in the conditions of
use of fenbendazole paste in horses and cattle. This action is being
taken to improve the accuracy of the animal drug regulations.
DATES: This rule is effective May 2, 2007.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail:
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
in 21 CFR 558.95 to correct an inadvertent error in the conditions of
use of fenbendazole paste in horses and cattle. The error in the
agency's regulations was introduced in a final rule reflecting the
approval of a supplemental new animal drug application that published
in the Federal Register on March 9, 2007 (72 FR 10595). This action is
being taken to improve the accuracy of the animal drug regulations.
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 the
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 520.905c is revised to read as follows:
Sec. 520.905c Fenbendazole paste.
(a) Specifications. Each gram of paste contains 100 milligrams (mg)
fenbendazole (10 percent).
(b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.275 of this chapter.
(d) Special considerations. See Sec. 500.25 of this chapter.
(e) Conditions of use--(1) Horses--(i) Indications for use and
amounts--(A) For control of large strongyles (Strongylus edentatus, S.
equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and
ascarids (Parascaris equorum): 2.3 mg per pound (/lb) of body weight,
or for foals and weanlings (less than 18 months of age), 4.6 mg/lb of
body weight. Retreatment at intervals of 6 to 8 weeks may be required.
(B) For control of arteritis caused by the fourth-stage larvae of
S. vulgaris: 4.6 mg/lb of body weight daily for 5 days. Treatment
should be initiated in the spring and repeated in 6 months.
(C) For treatment of encysted mucosal cyathostome (small strongyle)
larvae including early third-stage (hypobiotic), late third-stage, and
fourth-stage larvae: 4.6 mg/lb of body weight daily for 5 consecutive
days.
(D) Fenbendazole paste 10 percent may be used concomitantly with
approved forms of trichlorfon for the indications provided in paragraph
(e)(1)(i)(A) of this section and for treating infections of stomach
bots as provided in Sec. 520.2520.
(ii) Limitations. Do not use in horses intended for human
consumption.
(2) Cattle--(i) Amount. 2.3 mg/lb of body weight. Retreatment may
be needed after 4 to 6 weeks.
(ii) Indications for use. For the removal and control of lungworms
(Dictyocaulus viviparus), stomach worms (Haemonchus contortus,
Ostertagia ostertagi, Trichostrongylus axei), and intestinal worms
(Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia punctata, C.
oncophora, Trichostrongylus colubriformis, and Oesophagostomum
radiatum).
(iii) Limitations. Cattle must not be slaughtered within 8 days
following last treatment.
Dated: April 24, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-8391 Filed 5-1-07; 8:45 am]
BILLING CODE 4160-01-S
