[Federal Register Volume 64, Number 6 (Monday, January 11, 1999)]
[Rules and Regulations]
[Pages 1503-1504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-449]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 556


Oral Dosage Form New Animal Drugs; Albendazole 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 Pfizer, Inc. The supplemental NADA provides 
for anthelmintic use of the 11.36 percent albendazole suspension in 
sheep. Based on FDA's review of the data and information in the NADA, a 
tolerance for drug residues in muscle and an acceptable daily intake 
(ADI) are established.

EFFECTIVE DATE: January 11, 1999.
FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7575.

SUPPLEMENTARY INFORMATION:  Pfizer, Inc., 235 East 42d St., New York, 
NY 10017-5755, filed supplemental NADA 110-048 that provides for oral 
use of Valbazen (albendazole) 11.36 percent suspension in 
sheep as an anthelmintic. Currently, the 11.36 percent drug is approved 
for use in cattle in NADA 110-048, and the 4.55 percent drug is 
approved for use in sheep in NADA 140-934. Supplemental NADA 110-048 is 
approved as of December 2, 1998, and the regulations are amended in 
Sec. 520.45a(b)(1) (21 CFR 520.45a(b)(1)) to reflect the approval.
    In addition, FDA reviewed the data concerning anthelmintic use of 
albendazole in Pfizer, Inc.'s NADA 110-048 for cattle and NADA 140-934 
for sheep to determine a tolerance for residues of albendazole in 
muscle of cattle and sheep. Based on this review, a tolerance of 50 
parts per billion for albendazole 2-aminosulfone in both cattle and 
sheep muscle is established. Additionally, the previously established 
ADI of 5 micrograms per kilogram of body weight per day is codified. 
Also, the regulations are amended in 21 CFR 556.34 to reflect the ADI 
and the muscle tolerance.
    Furthermore, Sec. 520.45a is amended editorially in paragraph 
(a)(4) by removing the ``(i)'' after the ``(4)'' and adding the ``(i)'' 
in place of the ``(1)'' following the paragraph heading, and by 
removing paragraph (a)(4)(i)(2).

[[Page 1504]]

    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, 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(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 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:  21 U.S.C. 360b.

    2. Section 520.45a is amended by redesignating the heading of 
paragraph (a)(4)(i) as the heading of paragraph (a)(4), by 
redesignating paragraph (a)(4)(i)(1) as paragraph (a)(4)(i), by 
removing paragraph (a)(4)(i)(2), and by revising paragraph (b)(1) to 
read as follows:


Sec. 520.45a   Albendazole suspension.

    (a) * * *
    (4) Conditions of use in cattle--(i) Amount. * * *
    (b)(1) Specifications. The product contains 4.55 or 11.36 percent 
albendazole.
* * * * *

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 556.34 is revised to read as follows:


Sec. 556.34   Albendazole.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
albendazole is 5 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle. A tolerance is established for 
albendazole 2-aminosulfone (marker residue) in liver (target tissue) of 
0.2 part per million and in muscle of 0.05 part per million.
    (2) Sheep. A tolerance is established for albendazole 2-
aminosulfone (marker residue) in liver (target tissue) of 0.25 part per 
million and in muscle of 0.05 part per million.

    Dated: December 17, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-449 Filed 1-8-99; 8:45 am]
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