[Federal Register Volume 59, Number 146 (Monday, August 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18621]


[[Page Unknown]]

[Federal Register: August 1, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

 

Animal Drugs, Feeds, and Related Products; 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 a new animal drug application 
(NADA) filed by SmithKline Beecham Animal Health. The NADA provides for 
use of a virginiamycin Type A article to make a Type B feed used in 
turn to make a Type C feed for cattle fed in confinement for slaughter.

EFFECTIVE DATE: August 1, 1994.

FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center For Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1638.

SUPPLEMENTARY INFORMATION: SmithKline Beecham Animal Health, 1600 Paoli 
Pike, West Chester, PA 19380, filed NADA 140-998 which provides for a 
V-MaxTM Type A article containing 50 percent virginiamycin to make 
a 1,000 gram per ton (g/t) virginiamycin Type B feed to make a Type C 
cattle feed containing 16 to 22.5 g/t virginiamycin for increased rate 
of weight gain, 11 to 16 g/t for improved feed efficiency, or 13.5 to 
16 g/t for reduction in the incidence of liver abscesses. The 
application is approved as of June 24, 1994, and the regulations are 
amended in 21 CFR 556.750 and 558.635 to reflect the approval. The 
basis for approval is discussed in the freedom of information summary.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act, this approval for food producing animals qualifies for 3 
years of marketing exclusivity beginning June 24, 1994, because the 
NADA contains reports of new clinical or field investigations (other 
than bioequivalence or residue studies) and, in the case of food 
producing animals, human food safety studies (other than bioequivalence 
or residue studies) essential to the approval and conducted or 
sponsored by the applicant.
    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 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 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 556 and 
558 are amended as follows:

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

    1. 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).
    2. Section 556.750 is amended by adding new paragraph (c) to read 
as follows:

Sec. 556.750  Virginiamycin.

 * * * * *
    (c) Cattle. A tolerance for residues of virginiamycin in cattle is 
not required.

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

    3. 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).

    4. Section 558.635 is revised by redesignating paragraph (f)(3) as 
(f)(4) and by adding new paragraph (f)(3) to read as follows:

Sec. 558.635  Virginiamycin.

 * * * * *
    (f) * * *
    (3) Cattle. It is used as follows:
    (i) 16.0 to 22.5 grams per ton to provide 100 to 340 milligrams per 
head per day for increased rate of weight gain.
    (ii) 13.5 to 16.0 grams per ton to provide 85 to 240 milligrams per 
head per day for reduction of incidence of liver abscesses.
    (iii) 11.0 to 16.0 grams per ton to provide 70 to 240 milligrams 
per head per day for improved feed efficiency.
    (iv) Feed continuously as sole ration to cattle fed in confinement 
for slaughter. Not for use in animals intended for breeding.
* * * * *

    Dated: July 23, 1994.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 94-18621 Filed 7-29-94; 8:45 am]
BILLING CODE 4160-01-F