98-31573. New Animal Drugs for Use In Animal Feeds; Melengestrol Acetate and Lasalocid; Technical Amendment

[Federal Register Volume 63, Number 230 (Tuesday, December 1, 1998)]
[Rules and Regulations]
[Page 66018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31573]



[[Page 66018]]

-----------------------------------------------------------------------

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 Lasalocid; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending and 
clarifying the animal drug regulations concerning melengestrol acetate 
(MGA) and the special considerations related to making type B and C 
feeds and lasalocid type B liquid feed specifications used for making 
lasalocid/MGA type C heifer feed.

EFFECTIVE DATE: December 1, 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, is sponsor of NADA's 39-402 and 140-288 that 
provide for combining separately approved melengestrol acetate (MGA) 
(dry and liquid) and lasalocid (dry and liquid) type A medicated 
articles to make lasalocid/MGA (dry and liquid) type B feeds. The type 
B feeds are used to make dry type C feeds for heifers fed in 
confinement for slaughter for increased rate of weight gain, improved 
feed efficiency, and suppression of estrus (heat). The sponsor 
requested that Sec. 558.342 (21 CFR 558.342) be amended to change the 
special considerations in paragraph (c)(1) to read ``type B or C 
medicated feeds'' and to change the limitations in paragraph (d)(3)(ii) 
by adding the specification ``The liquid medicated feeds are required 
to be manufactured in accordance with Sec. 558.311(d).'' FDA concurs 
with the sponsor's request and extends the amendments to special 
considerations to include all type B or C feeds for clarity as 
originally intended. The regulations are amended in paragraph (c) of 
Sec. 558.342 as requested.
    FDA has determined under 21 CFR 25.33(a)(1) 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.


Sec. 558.342   [Amended]

    2. Section 558.342 Melengestrol acetate is amended in paragraph (c) 
after the phrase ``Type B'' each place it appears by adding the phrase 
``or C'' and in paragraph (d)(3)(ii) by adding a sentence after the 
first sentence to read ``The liquid medicated feeds are required to be 
manufactured in accordance with Sec. 558.311(d).''.

    Dated: November 10, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-31573 Filed 11-30-98; 8:45 am]
BILLING CODE 4160-01-F