Federal Register / Vol. 70, No. 210 / Tuesday, November 1, 2005 / Rules and Regulations 65835 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

Oral Dosage Form New Animal Drugs; 

Ivermectin and Praziquantel Paste 

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 supplemental new animal 

drug application (NADA) filed by Virbac 

AH, Inc. The supplemental NADA 

provides revised labeling for ivermectin 

and praziquantel oral paste used in 

horses for the treatment and control of 

various internal parasites. 

DATES: This rule is effective November 

1, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.gov. 

SUPPLEMENTARY INFORMATION: Virbac 

AH, Inc., 3200 Meacham Blvd., Ft. 

Worth, TX 76137, filed a supplement to 

NADA 141–215 for EQUIMAX 

(ivermectin 1.87%/praziquantel 

14.03%) Paste for horses. This 

supplement amends product labeling to 

separate parasite life stages in the 

indications section. The supplemental 

NADA is approved as of September 16, 

2005, and the regulations in 21 CFR 

520.1198 are amended to reflect the 

approval. The basis of approval is 

discussed in the freedom of information 

summary. The current regulations for 

ivermectin and praziquantel paste are 

also being revised to remove redundant 

language. These changes are being made 

to improve the readability of the 

regulations. 

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. 

The agency 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. 

List of Subjects in 21 CFR Part 520 

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 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 520.1198 is amended by 

revising paragraphs (d)(2)(i) and 

(d)(2)(ii) to read as follows: 

§ 520.1198 Ivermectin and praziquantel 

paste. 

* * * * * 

(d) * * * 

(2) * * * 

(i) Tapeworms—Anoplocephala 

perfoliata; Large strongyles (adults)—

Strongylus vulgaris (also early forms in 

blood vessels), S. edentatus (also tissue 

stages), S. equinus, Triodontophorus 

spp. including T. brevicauda and T. 

serratus, and Craterostomum 

acuticaudatum; Small Strongyles 

(adults, including those resistant to 

some benzimidazole class 

compounds)—Coronocyclus spp. 

including C. coronatus, C. labiatus, and 

C. labratus, Cyathostomum spp. 

including C. catinatum and C. 

pateratum, Cylicocyclus spp. including 

C. insigne, C. leptostomum, C. nassatus, 

and C. brevicapsulatus, 

Cylicodontophorus spp., 

Cylicostephanus spp. including C. 

calicatus, C. goldi, C. longibursatus, and 

C. minutus, and Petrovinema 

poculatum; Small Strongyles—fourthstage larvae; Pinworms (adults and 

fourth-stage larvae)—Oxyuris equi; 

Ascarids (adults and third- and fourthstage larvae)—Parascaris equorum; 

Hairworms (adults)—Trichostrongylus 

axei; Large-mouth Stomach Worms 

(adults)—Habronema muscae; Bots (oral 

and gastric stages)—Gasterophilus spp. 

including G. intestinalis and G. nasalis; 

Lungworms (adults and fourth-stage 

larvae)—Dictyocaulus arnfieldi; 

Intestinal Threadworms (adults)—

Strongyloides westeri; Summer Sores 

caused by Habronema and Draschia 

spp. cutaneous third-stage larvae; 

Dermatitis caused by neck threadworm 

microfilariae, Onchocerca sp. 

(ii) Tapeworms—Anoplocephala 

perfoliata; Large Strongyles (adults)—

Strongylus vulgaris (also early forms in 

blood vessels), S.edentatus (also tissue 

stages), S. equinus, Triodontophorus 

spp.; Small Strongyles (adults, 

including those resistant to some 

benzimidazole class compounds)—

Cyathostomum spp., Cylicocyclus spp., 

Cylicostephanus spp., 

Cylicodontophorus spp.; Small 

Strongyles—fourth-stage larvae; 

Pinworms (adults and fourth-stage 

larvae)—Oxyuris equi; Ascarids (adults 

and third- and fourth-stage larvae)—

Parascaris equorum; Hairworms 

(adults)—Trichostrongylus axei; Largemouth Stomach Worms (adults)—

Habronema muscae; Bots (oral and 

gastric stages)—Gasterophilus spp.; 

Lungworms (adults and fourth-stage 

larvae)—Dictyocaulus arnfieldi; 

Intestinal Threadworms (adults)—

Strongyloides westeri; Summer Sores 

caused by Habronema and Draschia 

spp. cutaneous third-stage larvae; 

Dermatitis caused by neck threadworm 

microfilariae, Onchocerca sp. 

* * * * * 

Dated: October 14, 2005. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 05–21641 Filed 10–31–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[COTP Jacksonville 05–140] 

RIN 1625–AA87 

Security Zone; Sea Buoy at the 

Entrance of St. Mary’s River to Kings 

Bay, GA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary moving 

security zone around foreign naval 

submarines in transit within the area 

between 12 nautical miles offshore from 

the baseline, also known as the 

shoreline, at the mouth of the St. Mary’s 

River to the Kings Bay Naval Submarine 

Base, Kings Bay, GA. The security zone 

includes all waters within 500 yards in