Document ID: FDA-2008-N-0039-0013
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Albendazole
Posted Date: 2008-02-29T05:00Z

[Federal Register: February 29, 2008 (Volume 73, Number 41)]
[Rules and Regulations]               
[Page 11026-11027]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29fe08-14]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 556

 
New Animal Drugs; Albendazole

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 use of albendazole oral suspension in nonlactating goats for the 
treatment of liver flukes.

DATES: This rule is effective February 29, 2008.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8342, e-mail: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed a supplement to NADA 110-048 that provides for the use of 
VALBAZEN (albendazole) Oral Suspension for the treatment of liver 
flukes in nonlactating goats. The approval of this supplemental NADA 
relied on publicly available safety and effectiveness data contained in 
Public Master File (PMF) 5582, which were compiled under National 
Research Support Project-7 (NRSP-7), a national agricultural research 
program for obtaining clearances for use of new drugs in minor animal 
species and for special uses. The supplemental NADA is approved as of 
January 24, 2008, and the regulations are amended in 21 CFR 520.45a and 
556.34 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of the 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.

[[Page 11027]]

    Under section 573(c) of the Federal Food, Drug, and Cosmetic Act 
(the Act) (21 U.S.C.360ccc-2(c)), this approval qualifies for 7 years 
of exclusive marketing rights beginning on the date of approval, 
because the new animal drug has been declared a designated drug by FDA 
under section 573(a) of the Act.
    The agency has determined under 21 CFR 25.33(d)(4) 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

21 CFR Part 520

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. Revise Sec.  520.45a to read as follows:

Sec.  520.45a  Albendazole suspension.

    (a) Specifications. Each milliliter of suspension contains 45.5 
milligrams (mg) (4.55 percent) or 113.6 mg (11.36 percent) albendazole.
    (b) Sponsor. See No. 000069 in Sec.  510.600 of this chapter.
    (c) Related tolerances. See Sec.  556.34 of this chapter.
    (d) Special considerations. See Sec.  500.25 of this chapter.
    (e) Conditions of use--(1) Cattle. Administer 11.36 percent 
suspension:
    (i) Amount. 4.54 mg/pound (lb) body weight (10 mg/kilogram (kg)) as 
a single oral dose using dosing gun or dosing syringe.
    (ii) Indications for use. For removal and control of adult liver 
flukes (Fasciola hepatica); heads and segments of tapeworms (Moniezia 
benedeni and M. expansa); adult and 4th stage larvae of stomach worms 
(brown stomach worms including 4th stage inhibited larvae (Ostertagia 
ostertagi), barberpole worm (Haemonchus contortus and H. placei), small 
stomach worm (Trichostrongylus axei)); adult and 4th stage larvae of 
intestinal worms (thread-necked intestinal worm (Nematodirus spathiger 
and N. helvetianus), small intestinal worm (Cooperia punctata and C. 
oncophora)); adult stages of intestinal worms (hookworm (Bunostomum 
phlebotomum), bankrupt worm (Trichostrongylus colubriformis), nodular 
worm (Oesophagostomum radiatum)); adult and 4th stage larvae of 
lungworms (Dictyocaulus viviparus).
    (iii) Limitations. Do not slaughter within 27 days of last 
treatment. Do not use in female dairy cattle of breeding age: Do not 
administer to female cattle during first 45 days of pregnancy or for 45 
days after removal of bulls.
    (2) Sheep. Administer 4.45 or 11.36 percent suspension:
    (i) Amount. 3.4 mg/lb body weight (7.5 mg/kg) as a single oral dose 
using dosing gun or dosing syringe.
    (ii) Indications for use. For removal and control of adult liver 
flukes (Fasciola hepatica and Fascioloides magna); heads and segments 
of common tapeworms (Moniezia expansa) and fringed tapeworm 
(Thysanosoma actinioides); adult and fourth stage larvae of stomach 
worms (brown stomach worm (Ostertagia circumcinta and Marshallagia 
marshalli), barberpole worm (Haemonchus contortus), small stomach worm 
(Trichostrongylus axei)); adult and fourth stage larvae of intestinal 
worms (thread-necked intestinal worm (Nematodirus spathiger and N. 
filicollis), Cooper's worm (Cooperia oncophora), bankrupt worm 
(Trichostrongylus colubriformis), nodular worm (Oesophagostomum 
columbianum), and large-mouth bowel worm (Chabertia ovina)); adult and 
larval stages of lungworms (Dictyocaulus filaria).
    (iii) Limitations. Do not slaughter within 7 days of last 
treatment. Do not administer to ewes during first 30 days of pregnancy 
or for 30 days after removal of rams.
    (3) Goats. Administer 11.36 percent suspension:
    (i) Amount. 4.54 mg/lb body weight (10 mg/kg) as a single oral dose 
using dosing gun or dosing syringe.
    (ii) Indications for use. For the treatment of adult liver flukes 
(Fasciola hepatica) in nonlactating goats.
    (iii) Limitations. Do not slaughter within 7 days of last 
treatment. Do not administer to does during the first 30 days of 
pregnancy or for 30 days after removal of bucks.

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

0
3. The authority citation for 21 CFR part 556 continues to read as 
follows:

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

0
4. In Sec.  556.34, revise paragraph (b) and add paragraph (c) to read 
as follows:

Sec.  556.34  Albendazole.

* * * * *
    (b) Tolerances. The tolerances for albendazole 2-aminosulfone 
(marker residue) are:
    (1) Cattle--(i) Liver (target tissue): 0.2 parts per million (ppm).
    (ii) Muscle: 0.05 ppm.
    (2) Sheep--(i) Liver (target tissue): 0.25 ppm.
    (ii) Muscle: 0.05 ppm.
    (3) Goat--(i) Liver (target tissue): 0.25 ppm.
    (ii) [Reserved]
    (c) Related conditions of use. See Sec.  520.45 of this chapter.

    Dated: February 19, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-3877 Filed 2-28-08; 8:45 am]

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