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Federal Register / Vol. 72, No.

84 / Wednesday, May 2, 2007 / Rules and Regulations 24185

the Center for Veterinary Medicine, 21 improve the accuracy of the animal drug of body weight. Retreatment at intervals
CFR part 510 is amended as follows: regulations. of 6 to 8 weeks may be required.
DATES: This rule is effective May 2, (B) For control of arteritis caused by
PART 510—NEW ANIMAL DRUGS 2007. the fourth-stage larvae of S. vulgaris: 4.6
mg/lb of body weight daily for 5 days.
■ 1. The authority citation for 21 CFR FOR FURTHER INFORMATION CONTACT:
Treatment should be initiated in the
part 510 continues to read as follows: George K. Haibel, Center for Veterinary spring and repeated in 6 months.
Authority: 21 U.S.C. 321, 331, 351, 352, Medicine (HFV–6), Food and Drug (C) For treatment of encysted mucosal
353, 360b, 371, 379e. Administration, 7519 Standish Pl., cyathostome (small strongyle) larvae
■ 2. In § 510.600, in the table in Rockville, MD 20855, 240–276–9019, e- including early third-stage (hypobiotic),
paragraph (c)(1), revise the entry for mail: george.haibel@fda.hhs.gov. late third-stage, and fourth-stage larvae:
‘‘Alpharma, Inc.’’; and in the table in SUPPLEMENTARY INFORMATION: FDA is 4.6 mg/lb of body weight daily for 5
paragraph (c)(2), revise the entry for amending the animal drug regulations consecutive days.
‘‘046573’’ to read as follows: in 21 CFR 558.95 to correct an (D) Fenbendazole paste 10 percent
inadvertent error in the conditions of may be used concomitantly with
§ 510.600 Names, addresses, and drug use of fenbendazole paste in horses and
labeler codes of sponsors of approved
approved forms of trichlorfon for the
cattle. The error in the agency’s indications provided in paragraph
applications.
regulations was introduced in a final (e)(1)(i)(A) of this section and for
* * * * * rule reflecting the approval of a
(c) * * * treating infections of stomach bots as
supplemental new animal drug provided in § 520.2520.
(1) * * *
application that published in the (ii) Limitations. Do not use in horses
Drug labeler Federal Register on March 9, 2007 (72 intended for human consumption.
Firm name and address FR 10595). This action is being taken to (2) Cattle—(i) Amount. 2.3 mg/lb of
code
improve the accuracy of the animal drug body weight. Retreatment may be
* * * * * regulations. needed after 4 to 6 weeks.
Alpharma, Inc., 440 Rte. 046573 This rule does not meet the definition (ii) Indications for use. For the
22, Bridgewater, NJ of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because removal and control of lungworms
08807. it is a rule of ‘‘particular applicability.’’ (Dictyocaulus viviparus), stomach
* * * * *
Therefore, it is not subject to the worms (Haemonchus contortus,
(2) * * * congressional review requirements in 5 Ostertagia ostertagi, Trichostrongylus
U.S.C. 801–808. axei), and intestinal worms
Drug labeler (Bunostomum phlebotomum,
Firm name and address List of Subjects in 21 CFR Part 520
code Nematodirus helvetianus, Cooperia
Animal drugs. punctata, C. oncophora,
* * * * * ■ Therefore, under the Federal Food, Trichostrongylus colubriformis, and
046573 Alpharma, Inc., 440 Rte. Drug, and Cosmetic Act and under the Oesophagostomum radiatum).
22, Bridgewater, NJ
authority delegated to the Commissioner (iii) Limitations. Cattle must not be
08807
* * * * * of Food and Drugs and redelegated to slaughtered within 8 days following last
the Center for Veterinary Medicine, 21 treatment.
CFR part 520 is amended as follows: Dated: April 24, 2007.
Dated: April 24, 2007.
Bernadette Dunham, Bernadette Dunham,
PART 520—ORAL DOSAGE FORM
Deputy Director, Center for Veterinary NEW ANIMAL DRUGS Deputy Director, Center for Veterinary
Medicine. Medicine.
[FR Doc. E7–8322 Filed 5–1–07; 8:45 am] ■ 1. The authority citation for 21 CFR [FR Doc. E7–8391 Filed 5–1–07; 8:45 am]
part 520 continues to read as follows: BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
Authority: 21 U.S.C. 360b.
■ 2. Section 520.905c is revised to read
DEPARTMENT OF HEALTH AND as follows: DEPARTMENT OF HOMELAND
HUMAN SERVICES SECURITY
§ 520.905c Fenbendazole paste.
Food and Drug Administration (a) Specifications. Each gram of paste Coast Guard
contains 100 milligrams (mg)
21 CFR Part 520 fenbendazole (10 percent). 33 CFR Part 165
(b) Sponsor. See No. 057926 in [CGD05–06–112]
Oral Dosage Form New Animal Drugs; § 510.600(c) of this chapter.
Fenbendazole Paste (c) Related tolerances. See § 556.275 RIN 1625–AA87
AGENCY: Food and Drug Administration, of this chapter.
(d) Special considerations. See Security Zone; Severn River and
HHS. College Creek, Annapolis, MD
Final rule; technical
ACTION: § 500.25 of this chapter.
amendment. (e) Conditions of use—(1) Horses—(i) AGENCY: Coast Guard, DHS.
Indications for use and amounts—(A) ACTION: Final rule.
SUMMARY: The Food and Drug For control of large strongyles
Administration (FDA) is amending the (Strongylus edentatus, S. equinus, S. SUMMARY: The Coast Guard is
ycherry on PROD1PC64 with RULES

animal drug regulations to correct an vulgaris), small strongyles, pinworms establishing a permanent security zone
inadvertent error in the conditions of (Oxyuris equi), and ascarids (Parascaris on certain waters of the Severn River
use of fenbendazole paste in horses and equorum): 2.3 mg per pound (/lb) of and College Creek. This action is
cattle. This action is being taken to body weight, or for foals and weanlings necessary to ensure the security of high-
(less than 18 months of age), 4.6 mg/lb ranking public officials and safeguard

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