[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Rules and Regulations]
[Page 59715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29614]



[[Page 59715]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 524 and 556


Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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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 Merial Ltd. The supplemental NADA provides 
for topical use of eprinomectin on cattle for treatment and control of 
two additional gastrointestinal roundworms and to establish of an 
acceptable daily intake (ADI) and tolerance for eprinomecrin residues 
in cattle muscle.

EFFECTIVE DATE: November 5, 1998.

FOR FURTHER INFORMATION CONTACT:  Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION:  Merial Ltd., 2100 Ronson Rd., Iselin, NJ 
08830-3077, is sponsor of NADA 141-079 that provides for use of 
Ivomec EprinexTM Pour-On (5 milligrams per 
milliliter eprinomectin) on beef and dairy cattle for treatment and 
control of gastrointestinal roundworm, lungworm, cattle grub, lice, 
mange mite, and horn fly infections. The sponsor filed a supplemental 
NADA that provides for use of the product for treatment and control of 
Strongyloides papillosus (adults) and Trichostrongylus longispicularis 
(adults). The supplemental NADA is approved as of August 9, 1998, and 
21 CFR 524.814(d)(2) is revised to reflect the approval. The basis of 
approval is discussed in the freedom of information summary.
    A tolerance for residues of eprinomectin in the muscle of cattle 
has not previously been established. At this time, 21 CFR 556.227 is 
amended to establish a tolerance for eprinomectin residues in cattle 
muscle. Also, the regulation is amended to establish an ADI for safe 
daily human intake of residues of eprinomectin. The ADI is the amount 
of total drug residue that can be safely consumed by humans every day.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this supplemental 
application may be seen in the Dockets Management Branch (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.
    Under 21 U.S.C. 360b(c)(2)(F)(iii), this supplemental approval for 
food-producing animals qualifies for 3 years of marketing exclusivity 
beginning August 9, 1998, because the supplement contains substantial 
evidence of the effectiveness of the drug involved, studies of animal 
safety or, in the case of food-producing animals, human food safety 
studies (other than bioequivalence or residue studies) required for 
approval of the supplement and conducted or sponsored by the applicant. 
The 3 years of marketing exclusivity applies only to use of the drug as 
approved in this supplemental NADA.
    The agency has determined under 21 CFR 25.33(a)(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.

List of Subjects

21 CFR Part 524

     Animal drugs.

21 CFR Part 556

     Animal drugs, Foods.
    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 parts 524 and 
556 are amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

     1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

    2. Section 524.814 is amended by revising paragraph (d)(2) to read 
as follows:


Sec. 524.814   Eprinomectin.

* * * * *
    (d) * * *
    (2) Indications for use. The drug is used in beef and dairy cattle 
for treatment and control of gastrointestinal roundworms (Haemonchus 
placei (adult and L4), Ostertagia ostertagi (adult and L4, including 
inhibited L4), Trichostrongylus axei (adult and L4), T. colubriformis 
(adult and L4), T. longispicularis (adult), Cooperia oncophora (adult 
and L4), C. punctata (adult and L4), C. surnabada (adult and L4), 
Nematodirus helvetianus (adult and L4), Bunostomum phlebotomum (adult 
and L4), Oesophagostomum radiatum (adult and L4), Strongyloides 
papillosus (adults), Trichuris spp. (adults)); lungworms (Dictyocaulus 
viviparus, adult and L4); cattle grubs (all parasitic stages Hypoderma 
lineatum, H. bovis); lice (Damalinia bovis, Linognathus vituli, 
Haematopinus eurysternus, Solenopotes capillatus); mange mites 
(Chorioptes bovis, Sarcoptes scabiei); and horn flies (Haematobia 
irritans). Controls and protects from reinfection of D. vivaparus for 
21 days after treatment and H. irritans for 7 days after treatment.
* * * * *

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    3. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority:  21 U.S.C. 342, 360b, 371.

    4. Section 556.227 is revised to read as follows:


Sec. 556.227   Eprinomectin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
eprinomectin is 10 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle. Tolerances are established for residues 
of eprinomectin B1a (marker residue) in milk of 12 parts per billion, 
in liver (target tissue) of 4.8 parts per million, and in muscle of 100 
parts per billion.
    (2) [Reserved]

    Dated: September 20, 1998.
 Margaret Ann Miller,
 Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-29614 Filed 11-4-98; 8:45 am]
BILLING CODE 4160-01-F