[Federal Register Volume 59, Number 100 (Wednesday, May 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12805]


[[Page Unknown]]

[Federal Register: May 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520 and 556

 

Animal Drugs, Feeds, and Related Products; Fenbendazole 
Suspension

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 Hoechst-Roussel Agri-Vet Co. The 
supplemental NADA provides for oral administration of fenbendazole 
suspension to goats as an anthelmintic. The regulations are also 
amended to establish a tolerance for drug residues in edible goat 
tissues.

EFFECTIVE DATE: May 25, 1994.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1644.

SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., Rt. 202-206 
North, Somerville, NJ 08876, filed a supplemental NADA 128-620 that 
provides for oral administration of a suspension containing 10 percent 
fenbendazole to nonlactating goats for removal and control of stomach 
and intestinal worms Haemonchus contortus and Ostertagia circumcincta. 
Also, a tolerance for residues of fenbendazole and its metabolites in 
edible goat tissues is established. Approval is based in part on data 
and information in Public Master File (PMF) 5118 established under the 
Interregional Research Project No. 4 (IR-4), Northcentral Region, 
Michigan State University, East Lansing, MI 48824.
    The supplement is approved as of April 25, 1994, and the 
regulations are amended in 21 CFR 520.905a and 556.275 to reflect the 
approval. The basis for approval is discussed in the freedom of 
information summary. Additionally, the regulations for tolerances and 
safe concentrations for residues of the drug or its metabolites in 
cattle and swine are editorially revised to remove any reference to 
safe concentrations because they are irrelevant for residue monitoring 
purposes.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii), this approval does not 
qualify for marketing exclusivity because no new clinical or field 
investigations (other than bioequivalence or residue studies) and no 
new human food safety studies (other than bioequivalence or residue 
studies) essential to approval of the supplement were conducted or 
sponsored by the applicant.
    The agency 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. The agency'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 520

    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 520 and 
556 are 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 520.905a is amended by adding new paragraph (d)(3) to 
read as follows:


Sec. 520.905a  Fenbendazole suspension.

* * * * *
    (d) * * *
    (3) Goats--(i) Amount. Administer orally 5 milligrams per kilogram 
of body weight (2.3 milligrams per pound).
    (ii) Indications for use. For the removal and control of stomach 
and intestinal worms Haemonchus contortus and Ostertagia circumcincta.
    (iii) Limitations. Retreatment may be needed after 4 to 6 weeks. 
Goats must not be slaughtered for food within 6 days following last 
treatment. Do not use in lactating goats. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
* * * * *

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. Section 556.275 is revised to read as follows:


Sec. 556.275  Fenbendazole.

    (a) Cattle and goats. A tolerance\1\ of 0.8 part per million is 
established for parent fenbendazole (the marker residue) in the liver 
of cattle and goats.
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    \1\As used in this section: ``tolerance'' refers to a 
concentration of a marker residue in the target tissue selected to 
monitor for total residues of the drug in the target animal.
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    (b) Swine. A tolerance\1\ for marker residues of fenbendazole in 
swine is not needed.

    Dated: May 17, 1994.
 Richard H. Teske,
 Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-12805 Filed 5-24-94; 8:45 am]
BILLING CODE 4160-01-F