[Federal Register Volume 60, Number 9 (Friday, January 13, 1995)]
[Rules and Regulations]
[Pages 3079-3080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-898]



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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

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 the 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 
chlortetracycline and roxarsone, or salinomycin with chlortetracycline, 
or salinomycin with oxytetracycline.

EFFECTIVE DATE: January 13, 1995.

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

SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., P.O. Box 2500, 
Somerville, NJ 08876-1258, filed the following ANADA's:
    ANADA 200-091, salinomycin with chlortetracycline and roxarsone, 
which 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) salinomycin sodium activity, chlortetracycline 
calcium complex equivalent to 500 g/t chlortetracycline hydrochloride, 
and 45.4 g/t roxarsone for prevention of coccidiosis and as an aid in 
reduction of mortality due to certain Escherichia coli infections.
     ANADA 200-095, salinomycin with chlortetracycline, which provides 
for using approved single ingredient Type A medicated articles to make 
Type C medicated broiler feeds containing 40 to 60 g/t salinomycin 
sodium activity with [[Page 3080]] chlortetracycline calcium complex 
equivalent to 500 g/t chlortetracycline hydrochloride for prevention of 
coccidiosis and as an aid in the reduction of mortality due to certain 
E. coli infections.
    ANADA 200-096, salinomycin with oxytetracycline, which provides for 
using approved single ingredient Type A medicated articles to make Type 
C medicated broiler feeds containing 40 to 60 g/t salinomycin sodium 
activity with 500 g/t oxytetracycline for prevention of coccidiosis and 
as an aid in the reduction of mortality due to airsacculitis caused by 
certain strains of E. coli.
    ANADA's 200-091 and 200-095 are approved as generic copies of 
American Cyanamid's NADA's 140-867 and 140-859. ANADA 200-096 is 
approved as a generic copy of Pfizer's NADA 140-448. ANADA 200-091 is 
approved as of January 13, 1995. ANADA's 200-095 and 200-096 are 
approved as of November 25, 1994. The regulations are amended in 
Secs. 558.450 and 558.550 (21 CFR 558.450 and 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 in 21 
CFR 558.4, requires an approved Form FDA 1900 for making a Type C 
medicated feed. Use of salinomycin, chlortetracycline, and roxarsone to 
make Type C medicated feeds as in ANADA 200-091 requires an approved 
Form FDA 1900.
    FDA has published several documents amending Sec. 558.550(a) to 
create paragraphs (a)(1) and (a)(2) and add a series of amendments to 
paragraph (a)(2). At this time, FDA is editorially amending the 
regulation following addition of these approvals to simplify the text.
    In addition, FDA provided for the use of 45 and 45.4 g/t of 
roxarsone in this regulation. Those used at 45 g/t are amended to read 
45.4 g/t.
    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 these applications 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. 558.450  [Amended]

    2. Section 558.450 Oxytetracycline is amended in paragraph (d)(1), 
in table 1, under the heading ``Sponsor,'' in entry (v) for 
``Salinomycin 40 to 60,'' by removing ``000069'' and adding in its 
place ``000069, 012799''.
     3. Section 558.550 is amended by revising paragraph (a)(2) and by 
amending paragraph (b)(1)(ii)(a) and (b)(1)(xv)(a) by removing ``45'' 
and adding in its place ``45.4'' to read as follows:


Sec. 558.550  Salinomycin.

     (a) * * *
     (2) To 012799 for use as in paragraphs (b)(1)(i), (b)(1)(iii) 
through (b)(1)(xvi), and (b)(3)(i) through (b)(3)(iii) of this section.
 * * * * *

    Dated: January 4, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-898 Filed 1-12-95; 8:45 am]
BILLING CODE 4160-01-F