[Federal Register Volume 59, Number 244 (Wednesday, December 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31298]
[[Page Unknown]]
[Federal Register: December 21, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 556
Animal Drugs, Feeds, and Related Products; 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 new animal drug application
(NADA) filed by SmithKline Beecham Animal Health Products. The NADA
provides for use of albendazole suspension (Valbazen) as an
anthelmintic in sheep. The regulations are also amended to establish a
tolerance for albendazole residue in sheep liver.
EFFECTIVE DATE: December 21, 1994.
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: SmithKline Beecham Animal Health Products,
1600 Paoli Pike, West Chester, PA 19380, filed NADA 140-934, which
provides for oral use of a 4.55 percent albendazole suspension
(Valbazen) as an anthelmintic in sheep. It is used for
removal and control of: Adult liver flukes; heads and segments of
common and fringed tapeworms; adult and fourth stage larvae of certain
stomach worms (brown stomach worm, barberpole worm, and small stomach
worm); adult and fourth stage larvae of certain intestinal worms
(thread-necked intestinal worm, Cooper's worm, bankrupt worm, nodular
worm, and large-mouth bowel worm); and adult and larval stages of
lungworms.
The NADA is approved as of November 10, 1994, and the regulations
are amended in 21 CFR 520.45a to reflect the approval. Additionally,
the regulations are amended in 21 CFR 556.34 to establish a tolerance
for albendazole residue in sheep liver. The basis for approval is
discussed in the freedom of information summary.
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)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning November 10, 1994, because
the application contains reports of new clinical or field
investigations (other than bioequivalence or residue studies) essential
to the approval of the application and 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 520.45a is amended by redesignating existing paragraphs
(a) through (d)(3) as paragraphs (a)(1), (a)(2), (a)(3), (a)(4)(i),
(a)(4)(ii), and (a)(4)(iii), respectively, and by adding new paragraph
(b) to read as follows:
Sec. 520.45a Albendazole suspension.
* * * * *
(b)(1) Specifications. The product contains 4.55 percent
albendazole.
(2) Sponsor. See No. 053571 in Sec. 510.600(c) of this chapter.
(3) Related tolerances. See Sec. 556.34 of this chapter.
(4) Conditions of use in sheep--(i) Amount. 7.5 milligrams per
kilogram of body weight (3.4 milligrams per pound).
(ii) Indications for use. For removal and control of the following
internal parasites of sheep: Adult liver flukes (Fasciola hepatica,
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. Administer as a single oral dose using dosing
gun or dosing syringe. 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. 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. Section 556.34 is revised to read as follows:
Sec. 556.34 Albendazole.
Tolerances are established for residues of albendazole in uncooked
edible tissues as follows:
(a) Cattle. The tolerance for the 2-aminosulfone metabolite (marker
residue) in cattle liver (target tissue) is 0.2 part per million. The
tolerance refers to the concentration of marker residue in the target
tissue used to monitor for total drug residues in the target animals.
(b) Sheep. The tolerance for the 2-aminosulfone metabolite (marker
residue) in sheep liver (target tissue) is 0.25 part per million.
Dated: December 13, 1994.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 94-31298 Filed 12-20-94; 8:45 am]
BILLING CODE 4160-01-F
