[Federal Register Volume 63, Number 148 (Monday, August 3, 1998)]
[Rules and Regulations]
[Pages 41191-41192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Melengestrol Acetate 
and Oxytetracycline

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 two original new animal drug 
applications (NADA's) filed by Pharmacia & Upjohn Co. The NADA's 
provide for the use of separately approved Type A medicated articles 
containing melengestrol acetate (dry and liquid form) and 
oxytetracycline (dry form) to make dry combination drug Type C 
medicated feeds. The Type C medicated feeds are for heifers fed in 
confinement for slaughter for increased rate of weight gain, improved 
feed efficiency, suppression of estrus, and reduced incidence of liver 
abscesses.

EFFECTIVE DATE: August 3, 1998.
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: Pharmacia & Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed original NADA's 46-718 and 46-719 that 
provide for combining separately approved melengestrol acetate (MGA) 
(dry and liquid form) and oxytetracycline (dry form) Type A medicated 
articles to make dry Type C medicated feeds for heifers fed in 
confinement for slaughter for increased rate of weight gain, improved 
feed efficiency, suppression of estrus (heat), and reduced incidence of 
liver abscesses. The NADA's are approved as of May 6, 1998, and 21 CFR 
558.342(d)(8) and 558.450(d)(3)(iii) are added to reflect the 
approvals.
    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 this application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33(a)(2) 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: 21 U.S.C. 360b, 371.

    2. Section 558.342 is amended by adding paragraph (d)(8) to read as 
follows:


Sec. 558.342   Melengestrol acetate.

* * * * *
    (d) * * *
    (8) Amount. Melengestrol acetate, 0.25 to 0.5 milligram per head 
per day, plus oxytetracycline, 75 milligrams per head per day.
    (i) Indications for use. For increased rate of weight gain, 
improved feed efficiency, suppression of estrus (heat), and reduction 
of liver condemnation due to liver abscesses.
    (ii) Limitations. Heifers fed in confinement for slaughter. Add at 
the rate of 0.5 to 2.0 pounds per head per day a medicated feed (liquid 
or dry) containing 0.125 to 1.0 milligram of melengestrol acetate per 
pound to a feed containing 6 to 10 grams of oxytetracycline per ton; or 
add at the rate of 0.5 to 2.0 pounds per head per day a dry medicated 
feed containing 0.125 to 1.0 milligram of melengestrol acetate plus 
37.5 to 150 milligrams of oxytetracycline per pound to provide 0.25 to 
0.5 milligram of melengestrol acetate and 75 milligrams of 
oxytetracycline per head per day. Liquid melengestrol acetate may not 
be mixed

[[Page 41192]]

with oxytetracycline in a common liquid feed supplement. Melengestrol 
acetate as provided by 000009, oxytetracycline by 000069, in 
Sec. 510.600(c) of this chapter.
    3. Section 558.450 is amended by adding paragraph (d)(3)(iii) to 
read as follows:


Sec. 558.450   Oxytetracycline.

* * * * *
    (d) * * *
    (3) * * *
    (iii) Melengestrol acetate as in Sec. 558.342.

    Dated: June 30, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-20535 Filed 7-31-98; 8:45 am]
BILLING CODE 4160-01-F