[Federal Register Volume 62, Number 121 (Tuesday, June 24, 1997)]
[Rules and Regulations]
[Pages 33997-33998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16398]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 524 and 556
Animal Drugs, Feeds, and Related Products; 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 new animal drug application
(NADA) filed by Merck Research Laboratories, Division of Merck & Co.,
Inc. The NADA provides for use of eprinomectin on cattle for treatment
and control of certain gastrointestinal roundworms, lungworms, cattle
grubs, lice, mange mites, and flies. The regulations are also amended
to provide for a tolerance for residues of the drug in milk and in
edible tissues.
EFFECTIVE DATE: June 24, 1997.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Merck Research Laboratories, Division of
Merck & Co., Inc., P.O. Box 2000, Rahway, NJ 07065-0914, filed NADA
141-079, which provides for the use of Ivomec
EprinexTM Pour-On (5 milligrams per milliliter eprinomectin)
on cattle for the treatment and control of gastrointestinal roundworm,
lungworm, cattle grub, lice, mange mite, and fly infections. The NADA
is approved as of April 16, 1997, and the regulations are amended by
adding new Sec. 524.814 to reflect the approval. The regulations are
also amended to provide for a tolerance for eprinomectin residues in
milk and edible cattle tissues in new Sec. 556.227. The basis of
approval is discussed in the freedom of information summary.
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 application
may be seen in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857,
between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and
Cosmetic Act, this approval qualifies for a 5-year period of marketing
exclusivity beginning April 16, 1997, because no active ingredient
(including any ester or salt of the active ingredient) of the drug has
been approved in any other application filed under section 512(b)(1) of
the act.
FDA has carefully considered the potential environmental effects of
this action. FDA has concluded that the action will not have a
significant impact on the human environment, and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Dockets Management Branch
(address above) between 9 a.m. and 4 p.m., Monday through Friday.
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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. New Sec. 524.814 is added to read as follows:
Sec. 524.814 Eprinomectin.
(a) Specifications. Each milliliter contains 5 milligrams of
eprinomectin.
(b) Sponsor. See No. 000006 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.227 of this chapter.
(d) Conditions of use--(1) Amount. One milliliter (5 milligrams)
per 10 kilograms of body weight (500 micrograms per kilogram).
(2) Indications for use. The drug used in beef and dairy cattle for
the treatment and control of adult and fourth stage larvae (L4)
gastrointestinal nematodes (Haemonchus placei, Ostertagia
[[Page 33998]]
ostertagi (including inhibited L4)), Trichostrongylus axei, T.
colubriformis, Cooperia oncophora, C. punctata, C. surnabada,
Nematodirus helvetianus, Bunostomum phlebotomum, Oesophagostomum
radiatum, Trichuris spp. (adults); lungworms (adult and L4)
(Dictyocaulus viviparus); 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 flies (Haematobia irritans).
Controls H. irritans for 7 days and D. vivaparus for 21 days after
treatment.
(3) Limitations. Apply topically along backbone from withers to
tailhead. Consult your veterinarian for assistance in the diagnosis,
treatment, and control of parasitism.
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: Secs. 402, 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342, 360b, 371).
4. New Sec. 556.227 is added to subpart B to read as follows:
Sec. 556.227 Eprinomectin.
Tolerances are established for residues of eprinomectin B1a (marker
residue) in milk of 12 parts per billion and in liver (target tissue)
of 4.8 parts per million.
Dated: June 5, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-16398 Filed 6-23-97; 8:45 am]
BILLING CODE 4160-01-F
