Federal Register / Vol. 72, No. 84 / Wednesday, May 2, 2007 / Rules and Regulations 24185 

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 Drug labeler 

code 

* * * * * 

Alpharma, Inc., 440 Rte. 

22, Bridgewater, NJ 

08807.

046573 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

046573 Alpharma, Inc., 440 Rte. 

22, Bridgewater, NJ 

08807 

* * * * * 

Dated: April 24, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–8322 Filed 5–1–07; 8:45 am] 

BILLING CODE 4160–01–S 

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, 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. 

List of Subjects in 21 CFR Part 520 

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: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. Section 520.905c is revised to read 

as follows: 

§ 520.905c 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 

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 

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 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

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 

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