Source: https://www.federalregister.gov/documents/2001/12/04/01-29983/new-animal-drugs-for-use-in-animal-feeds-diclazuril
Timestamp: 2018-02-18 18:55:35
Document Index: 642552360

Matched Legal Cases: ['§\u2009556', '§\u2009556', '§\u2009556', 'art 556', 'art 20', '§\u2009556', '§\u2009556', '§\u2009556']

A Rule by the Food and Drug Administration on 12/04/2001
This rule is effective December 4, 2001.
66 FR 62916
01-29983
https://www.federalregister.gov/d/01-29983 https://www.federalregister.gov/d/01-29983
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 Schering-Plough Animal Health Corp. The NADA provides for use of the approved diclazuril Type A medicated article to make Type B and Type C medicated feeds used for prevention of coccidiosis in growing turkeys. Also, tolerances for diclazuril residues in turkey liver, muscle, and skin with adherent fat are being established.
Schering-Plough Animal Health Corp., 1095 Morris Ave., P.O. Box 3182, Union, NJ 07083, filed a supplement to NADA 140-951 that provides for use of CLINACOX (0.2 percent diclazuril) Type A medicated article to make Type B and Type C medicated turkey feeds used for the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis. The NADA is approved as of September 21, 2001, and the regulations are being amended in §§ 556.175 and 558.198 (21 CFR 556.175 and 558.198) to reflect the approval. In addition, § 556.175 is being redesignated as § 556.185 to place it in alphabetical order in 21 CFR part 556. The basis of approval is discussed in the freedom of information summary.
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 each 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.Start Printed Page 62917
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 qualifies for 3 years of marketing exclusivity beginning September 21, 2001, 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 approval of the application and conducted or sponsored by the applicant.
§ 556.175
[Redesignated as § 556.185]
2. Section 556.175 is redesignated as § 556.185 and is amended by revising paragraph (b)(1) and by adding paragraph (b)(2) to read as follows:
(b) Tolerances—(1) Chickens—(i) Liver. The tolerance for parent diclazuril (the marker residue) is 3 parts per million (ppm).
(2) Turkeys—(i) Liver. The tolerance for parent diclazuril (the marker residue) is 3 ppm.
4. Section 558.198 is amended in paragraph (b) by removing “556.175” and by adding in its place “556.185”; and in paragraph (d)(1) by adding a heading and by revising the introductory text, and by adding paragraph (d)(2) to read as follows:
(d) Conditions of use—(1) Chickens. For chickens it is used as follows:
(2) Turkeys. For turkeys it is used as follows:
(i) 0.91 (1 ppm) Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. gallopavonis and E. meleagrimitis. Feed continuously as the sole ration. Do not feed to breeding turkeys. Not for use in hens producing eggs for human consumption. 000061
[FR Doc. 01-29983 Filed 12-3-01; 8:45 am]