Rules and Regulations. Final rule

796 words·~4 min read·/register/2005/11/01/05-21641

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BILLING CODE 4910-13-P 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, e-mail: *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—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* ; 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* ; Large-mouth 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]

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