[Federal Register Volume 65, Number 163 (Tuesday, August 22, 2000)]
[Rules and Regulations]
[Pages 50913-50914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21413]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


New Animal Drugs for Use in Animal Feeds; Fenbendazole

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 Vet. The supplemental NADA 
provides for use of an approved fenbendazole Type A medicated article 
to make Type B and Type C medicated feeds used for the removal and 
control of gastrointestinal worms in growing turkeys. Also, tolerances 
for fenbendazole residues in turkey liver and muscle are being 
established.

DATES: This rule is effective August 22, 2000.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, Perryville Corporate 
Park III, P.O. Box 4010, Clinton, NJ 08809-4010, filed a supplement to 
NADA 131-675 that provides for the use of Safe-Guard 
(fenbendazole) 20% Type A medicated article to make Type B and Type C 
medicated feeds for cattle, swine, and zoo and wildlife animals. The 
supplemental NADA provides for the use of the approved fenbendazole 
Type A medicated article to make Type B and Type C medicated feeds used 
for the removal and control of gastrointestinal worms: Round worms, 
adult and larvae (Ascaridia dissimilis) and cecal worms, adult and 
larvae (Heterakis gallinarum), an important vector of Histomonas 
meleagridis (Blackhead) in growing turkeys. Also, tolerances for 
fenbendazole sulfone in turkey liver and muscle are established. The 
supplemental NADA is approved as of July 3, 2000, and the regulations 
are amended in Secs. 556.275 and 558.258 (21 CFR 556.275 and 558.258) 
to reflect the approval.
    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.
    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 for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning on July 3, 2000, because the application contains substantial 
evidence of the effectiveness of the drug involved, any studies of 
animal safety, or in the case of food-producing animals, human food 
safety studies (other than bioequivalence or residue studies) required 
for the approval of the application and conducted or sponsored by the 
applicant. The 3 years of marketing exclusivity applies only to the new 
species for which the supplemental application was approved.
    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.
    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 556

    Animal drugs, Food.

21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner

[[Page 50914]]

of Food and Drugs and redelegated to the Center for Veterinary 
Medicine, 21 CFR parts 556 and 558 are amended as follows:

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

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

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

    2. Section 556.275 is amended by redesignating paragraph (b)(3) as 
paragraph (b)(4) and by adding new paragraph (b)(3) to read as follows:


Sec. 556.275  Fenbendazole.

* * * * *
    (b) * * *
    (3) Turkeys--(i) Liver (the target tissue). The tolerance for 
fenbendazole sulfone (the marker residue) is 6 ppm.
    (ii) Muscle. The tolerance for fenbendazole sulfone (the marker 
residue) is 2 ppm.
* * * * *

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    3. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

    4. Section 558.258 is amended by redesignating paragraphs (d)(1), 
(d)(2), (d)(3), and (d)(4) as paragraphs (d)(2), (d)(3), (d)(4), and 
(d)(5) and by adding new paragraph (d)(1) to read as follows:


Sec. 558.258  Fenbendazole.

* * * * *
    (d) * * *
    (1) Turkeys--(i) Amount. Fenbendazole, 14.5 grams per ton (16 parts 
per million).
    (A) Indications for use. For the removal and control of 
gastrointestinal worms: Round worms, adult and larvae (Ascaridia 
dissimilis); cecal worms, adult and larvae (Heterakis gallinarum), an 
important vector of Histomonas meleagridis (Blackhead).
    (B) Limitations. Feed continuously as the sole ration for 6 days. 
For growing turkeys only.
    (ii) [Reserved]
* * * * *

    Dated: July 25, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-21413 Filed 8-21-00; 8:45 am]
BILLING CODE 4160-01-F