[Federal Register Volume 65, Number 144 (Wednesday, July 26, 2000)]
[Rules and Regulations]
[Page 45880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18872]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Penicillin; Technical 
Amendment

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule; technical amendment.

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

SUMMARY:  The Food and Drug Administration (FDA) is updating the animal 
drug regulations to correctly reflect a previously approved 227 grams 
per pound (g/lb) strength of penicillin G Type A medicated article for 
use in the feed of several domestic species which was omitted from the 
regulation in the 1998 notice of approval.

DATES:  This rule is effective July 26, 2000.

FOR FURTHER INFORMATION CONTACT:  Dianne T. McRae, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0212.

SUPPLEMENTARY INFORMATION:  Pfizer, Inc., 235 East 42d St., New York, 
NY 10017-5755, is sponsor of NADA 046-668 that provides for use of 
Penicillin 100 (100 g/lb penicillin G procaine) and Penicillin 50 (227 
g/lb penicillin G procaine) Type A medicated articles to make Type C 
medicated feeds used for increased rate of weight gain and improved 
feed efficiency in poultry and swine. In its approval letter of April 
10, 1998, to Pfizer, Inc., the Center for Veterinary Medicine approved 
the use of these products to make Type C medicated feeds, but did not 
codify the approval of the 227 g/lb strength of Type A medicated 
article for this sponsor (63 FR 36179, July 2, 1998). At this time, 21 
CFR 558.460(b) is amended by adding the 227 g/lb strength of Type A 
medicated article to reflect the 1998 approval.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

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. 558.460  [Amended]

    2. Section 558.460 Penicillin is amended in the first sentence in 
paragraph (b) by adding ``and 227'' after ``To 000069, 100''.

    Dated: July 18, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-18872 Filed 7-25-00; 8:45 am]
BILLING CODE 4160-01-F