[Federal Register Volume 59, Number 97 (Friday, May 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12288]
[[Page Unknown]]
[Federal Register: May 20, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use In Animal Feeds; Salinomycin In
Combination With Roxarsone and Lincomycin, or Virginiamycin, or
Roxarsone and Virginiamycin
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 abbreviated new animal
drug applications (ANADA's) filed by Hoechst-Roussel Agri-Vet Co. The
ANADA's provide for using approved Type A medicated articles to make
Type C medicated broiler feeds containing salinomycin with
virginiamycin, salinomycin with roxarsone and virginiamycin, or
salinomycin with roxarsone and lincomycin.
EFFECTIVE DATE: May 20, 1994.
FOR FURTHER INFORMATION CONTACT: Glenn A. Peterson, Center for
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1602.
SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., P.O. Box 2500,
Somerville, NJ 08876-1258, filed the following ANADA's:
ANADA 200-090, salinomycin with roxarsone and lincomycin, provides
for using approved single ingredient Type A medicated articles to make
Type C medicated broiler feeds containing 40 to 60 grams per ton (g/t)
of salinomycin sodium activity with 45.4 g/t of roxarsone and 2 g/t of
lincomycin for the prevention of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati,
including some field strains of E. tenella that are more susceptible to
roxarsone combined with salinomycin than to salinomycin alone, and for
improved feed efficiency. The ANADA is approved as a generic copy of
Agri-Bio Corp.'s new animal drug application (NADA) 140-581.
ANADA 200-092, salinomycin with virginiamycin, provides for using
approved single ingredient Type A medicated articles to make Type C
medicated broiler feeds containing 40 to 60 g/t of salinomycin sodium
activity with either: (1) 5 g/t of virginiamycin for the prevention of
coccidiosis caused by the aforementioned Eimeria species, and for
increased rate of weight gain and improved feed efficiency, or (2) 5 to
15 g/t of virginiamycin for the prevention of coccidiosis caused by the
aforementioned Eimeria species and for increased rate of weight gain.
The ANADA is approved as a generic copy of SmithKline Beecham Animal
Health's NADA 138-828.
ANADA 200-094, salinomycin with roxarsone and virginiamycin,
provides for using approved single ingredient Type A medicated articles
to make Type C medicated broiler feeds containing 40 to 60 g/t of
salinomycin sodium activity with 45.4 g/t of roxarsone and 5 g/t
virginiamycin for prevention of coccidiosis caused by the
aforementioned Eimeria species, including some field strains of E.
tenella which are more susceptible to roxarsone combined with
salinomycin than to salinomycin alone, and for improved feed
efficiency. The ANADA is approved as a generic copy of SmithKline
Beecham Animal Health's NADA 138-953.
ANADA's 200-090 and 200-094 are approved as of May 20, 1994. ANADA
200-092 is approved as of April 6, 1994. The regulations are amended in
Sec. 558.550 Salinomycin (21 CFR 558.550) to reflect the approvals.
These approvals are for use of Type A medicated articles to make
Type C medicated feeds. Roxarsone is a Category II drug which, as is
provided in Sec. 558.4(a) and (d), requires an approved Form FDA 1900
to make Type C medicated feeds. Use of salinomycin in combination with
roxarsone and lincomycin, or salinomycin in combination with roxarsone
and virginiamycin to make Type C medicated feeds as in ANADA's 200-090
and 200-094, respectively, requires an approved Form FDA 1900.
In addition, FDA published a final rule in the Federal Register of
October 8, 1991 (56 FR 50652), that announced a change of sponsor name
from ``SmithKline Animal Health Products, Division of SmithKline
Beckman Corp.'' to ``SmithKline Beecham Animal Health.'' The change of
sponsor name affected NADA 091-467 (virginiamycin), however, the
references concerning virginiamycin in Sec. 558.550(b)(1)(x),
(b)(1)(xi), and (b)(1)(xii) were not amended to reflect the new sponsor
name. At this time, those references are amended.
Finally, when Sec. 558.550(b)(1)(xii)(b) was codified, an error
was made in the indications language and it is now corrected to read
``* * * which are more susceptible to roxarsone combined with
salinomycin than to salinomycin alone, * * *.''
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.
The agency has determined under 21 CFR 25.24(d)(1)(ii) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
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 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. 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).
Sec. 558.550 [Amended]
2. Section 558.550 Salinomycin is amended in paragraph (a)(2) by
adding ``(b)(1)(x), (b)(1)(xi), (b)(1)(xii), and (b)(1)(xiv)'' after
``(b)(1)(viii)'', in paragraphs (b)(1)(x)(c) and (b)(1)(xii)(c) by
removing ``000007'' and adding in its place ``053571'', and paragraph
(b)(1)(xii)(b) by revising the phrase ``salinomycin than to roxarsone
alone,'' to read ``salinomycin than to salinomycin alone''.
Dated: May 13, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-12288 Filed 5-19-94; 8:45 am]
BILLING CODE 4160-01-F
