[Federal Register Volume 61, Number 113 (Tuesday, June 11, 1996)]
[Rules and Regulations]
[Pages 29477-29478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14645]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520, 556, and 558


Animal Drugs, Feeds, and Related Products; Fenbendazole-
Containing Animal Drug and Feed Products

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 three supplemental new animal 
drug applications (NADA's) filed by Hoechst-Roussel Agri-Vet Co. The 
supplemental NADA's expand use of fenbendazole-containing suspension, 
paste, and medicated animal feed products to include use in dairy 
cattle of breeding age for the removal and control of gastrointestinal 
parasites and lungworm. They also provide for the establishment of a 
safe concentration and tolerance for fenbendazole residues in milk of 
treated dairy cattle and no requirement for discard of milk from the 
animals.

EFFECTIVE DATE: June 11, 1996.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Place, Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., Rt. 202-206 
North, P.O. Box 2500, Somerville, NJ 08876-1258, is the sponsor of 
NADA's which cover the following fenbendazole-containing animal drug 
and medicated feed products: 128-620 for 10 percent suspension, 132-872 
for 10 percent paste, and 137-600 for 20 percent Type A medicated 
article, 0.5 percent pelleted top dressing, and 35 percent free-choice 
mineral feed. The firm holds approvals for use of the products in beef 
and dairy cattle not of breeding age for the removal and control of 
gastrointestinal parasites and lungworm (as provided for in 
Secs. 520.905a, 520.905c, and 558.258 (21 CFR 520.905a, 520.905c, and 
558.258)). The firm has submitted supplements to the NADA's providing 
for expanding use of the drug products to include use in dairy cattle 
of breeding age for the same uses currently approved for the above-
mentioned production classes.
    Safe concentrations for total fenbendazole residues in edible 
cattle tissues, a tolerance for parent fenbendazole in cattle liver (21 
CFR 556.275), and a safe withdrawal time for treated beef cattle were 
established based on data and information submitted with the original 
NADA 128-620. Based on the evaluation of data generated by additional 
studies submitted with these supplements, the agency is establishing a 
safe concentration and tolerance for fenbendazole residues in milk of 
treated dairy cattle. Also, based on the data, no discard of milk (zero 
milk withdrawal) is required and the slaughter

[[Page 29478]]

withdrawal time for treated dairy cattle of breeding age is the same as 
that established for beef cattle in the original NADA 128-620.
    Supplemental NADA's 128-620 and 132-872 are approved as of March 
28, 1996, and Secs. 520.905a and 520.905c are amended to reflect the 
approvals. Supplemental NADA 137-600 is approved as of (insert date of 
publication in the Federal Register), and Sec. 558.258 is amended to 
reflect the approval. The basis for the approvals is discussed in the 
freedom of information summaries.
    Approval of NADA 137-600 is for use of fenbendazole Type A 
medicated article to make Type C medicated feed. Fenbendazole is a 
Category II drug which, as provided in 21 CFR 558.4, requires an 
appproved Form FDA 1900 for making a Type C medicated feed. Therefore, 
use of fenbendazole Type A medicated articles to Type C medicated feeds 
as in NADA 137-600 requires an approved Form FDA 1900.
    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)), 
summaries of safety and effectiveness data and information submitted to 
support approval of these applications may be seen in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, 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)), these approvals for food-
producing animals do not qualify for exclusivity because the 
supplemental applications do not contain new clinical or field 
investigations (other than bioequivalence or residue studies) and new 
human food safety studies (other than bioequivalence or residue 
studies) essential to the approvals 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.

21 CFR Part 558

    Animal drugs, Animal feeds.
    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, 
556, and 558 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).

Sec. 520.905a  [Amended]

    2. Section 520.905a Fenbendazole suspension is amended in paragraph 
(d)(2) by revising the paragraph heading to read ``Beef and dairy 
cattle'' and in paragraph (d)(2)(i)(B) by removing the third sentence.


Sec. 520.905c  [Amended]

    3. Section 520.905c Fenbendazole paste is amended in paragraph 
(d)(2) by revising the paragraph heading to read ``Beef and dairy 
cattle'' and in paragraph (d)(2)(iii) by removing the third sentence.

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

    4. 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).
    5. Section 556.275 is amended by adding new paragraph (c) to read 
as follows:


Sec. 556.275  Fenbendazole.

* * * * *
    (c) Cattle milk. A safe concentration of 1.67 parts per million is 
established for total fenbendazole residues. A tolerance of 0.6 part 
per million is established based on the fenbendazole sulfoxide 
metabolite (marker residue).

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

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

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

    7. Section 558.258 is amended by revising the introductory text of 
paragraph (c)(2), by removing the last sentence of paragraph 
(c)(2)(iii), by revising the introductory text of paragraph (c)(3) , 
and by removing the fourth sentence of paragraph (c)(3)(iii) to read as 
follows:


Sec. 558.258  Fenbendazole.

* * * * *
    (c) * * *
    (2) It is used in the feed of beef and dairy cattle as follows:
* * * * *
    (3) It is used in free-choice beef and dairy cattle feed as 
follows:
* * * * *

    Dated: May 28, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-14645 Filed 6-10-96; 8:45 am]
BILLING CODE 4160-01-F