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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
CFR Citation: 21 CFR Part 558
NOTICE: RULES
DOCUMENT ACTION: Final rule.
SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Diclazuril, Bacitracin Methylene Disalicylate, Bambermycins, and Virginiamycin
DATES: This rule is effective August 17, 2000.
DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of three new animal drug applications (NADA's) filed by ScheringPlough Animal Health Corp. The NADA's provide for use of the approved, singleingredient diclazuril Type A medicated article together with approved, singleingredient Type A medicated articles for either bacitracin methylene disalicylate (BMD), virginiamycin, or bambermycins to make twoway combination Type C medicated feeds used for prevention of coccidiosis, increased rate of weight gain, and improved feed efficiency in broiler chickens.
SUMMARY: Animal drugs, feeds, and related products; Diclazuril, et al.,
SUPPLEMENTAL INFORMATION
Schering-Plough Animal Health Corp., 1095 Morris Ave., P.O. Box 3182, Union, NJ 07083, filed three NADA's that provide for use of ClinacoxTM (0.91 grams per pound (g/lb) diclazuril activity) Type A medicated article together with other approved, singleingredient Type A medicated articles to make twoway combination Type C medicated broiler chicken feeds used for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. The combination Type C medicated feeds are also used for increased rate of weight gain and for improved feed efficiency. NADA 141153 provides for use of ClinacoxTM and
BMD
NADA 141158 provides for use of ClinacoxTM and
Flavomycin
NADA 141090 provides for use of ClinacoxTM and
Stafac
The regulations are amended in 21 CFR 558.76, Secs. 558.95, 558.198 and 558.635 (21 CFR 558.95, 558.198 and 558.635) to reflect these approvals. The basis of approval for each application is discussed in separate freedom of information summaries.
Sections 558.95 and 558.635 are also amended editorially to consolidate the crossreferences for approved combinations in paragraph (d) and to list them in alphabetical order.
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 (HFA305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(2) that these actions are of a type that do not individually or cumulatively have a significant effect on the human environment. Therefore, neither environmental assessments nor environmental impact statements are 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. 801808.
List of Subjects in 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 part 558 is amended as follows:
PART 558NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
2. Section 558.76 is amended by redesignating paragraphs (d)(3)(v)
through (d)(3)(xvii) as (d)(3)(vi) through (d)(3)(xviii) and by adding new paragraph (d)(3)(v) to read as follows:
Sec. 558.76 Bacitracin methylene disalicylate.
* * * * *
(d) * * *
(3) * * *
(v) Diclazuril as in Sec. 558.198.
* * * * *
3. Section 558.95 is amended by revising paragraphs (d)(5)(i) through (d)(5)(iv) to read as follows:
Sec. 558.95 Bambermycins.
* * * * *
(d) * * *
(5) Bambermycins may be used in combination with:
(i) Diclazuril as in Sec. 558.198.
(ii) Halofuginone as in Sec. 558.265.
(iii) Narasin alone or with roxarsone as in Sec. 558.363. (iv) Nicarbazine as in Sec. 558.366.
4. Section 558.198 is amended by revising paragraph (d) to read as follows:
Sec. 558.198 Diclazuril.
* * * * *
(d) Conditions of use. (1) It is used in Type C feed as follows:
Diclazuril grams/ton Combination grams/ton Indications for use Limitations Sponsor
(i) 0.91 (1 part per million Broiler chickens: For the prevention of coccidiosis caused Feed continuously. Not for use in hens 000061
(ppm)) by Eimeria tenella, E. necatrix, E. acervulina, E. producing eggs for human food.
brunetti, E. mitis (mivati), and E. maxima. Because
diclazuril is effective against E. maxima later in its
life cycle, subclinical intestinal lesions may be present
for a short time after infection. Diclazuril was shown in
studies to reduce lesion scores and improve performance
and health of birds challenged with E. maxima.
(ii) 0.91 (1 ppm) Bacitracin methylene disalicylate Broiler chickens: As in item (i) of this table; for As in item (i) of this table. 000061
4 to 50 increased rate of weight gain and improved feed Bacitracin methylene disalicylate
efficiency. provided by 046573. [[Page 50135]]
(iii) 0.91 (1 ppm) Bambermycins 1 to 2 Broiler chickens: As in item (i) of this table); for As in item (i) of this table. 000061
increased rate of weight gain and improved feed Bambermycins provided by 012799.
efficiency.
(iv) 0.91 (1 ppm) Virginiamycin 5 Broiler chickens: As in item (i) of this table; for As in item (i) of this table; 000061
increased rate of weight gain and improved feed Virginiamycin provided by 000069.
efficiency.
(v) 0.91 (1 ppm) Virginiamycin 5 to 15 Broiler chickens: As in item (i) of this table; for As in item (i) of this table. 000061
increased rate of weight gain. Virginiamycin provided by 000069. (2) [Reserved]
5. Section 558.635 is amended by revising paragraphs (d)(4)(i) through (d)(4)(vii) to read as follows:
Sec. 558.635 Virginiamycin.
* * * * *
(d) * * *
(4) Virginiamycin may be used in combination with:
(i) Amprolium and ethopabate as in Sec. 558.58.
(ii) Diclazuril as in Sec. 558.198.
(iii) Halofuginone as in Sec. 558.265.
(iv) Lasalocid as in Sec. 558.311.
(v) Monensin alone or with roxarsone as in Sec. 558.355.
(vi) Salinomycin alone or with roxarsone as in Sec. 558.550. (vii) Semduramicin as in Sec. 558.555.
Dated: July 26, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 0020936 Filed 81600; 8:45 am]
BILLING CODE 416001F
FOR FURTHER INFORMATION CONTACT Charles J. Andres, Center for
Veterinary Medicine (HFV128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018271600.
[[Page 50134]]
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