[Federal Register Volume 69, Number 65 (Monday, April 5, 2004)]
[Rules and Regulations]
[Pages 17585-17586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7606]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Penicillin G Procaine Aqueous Suspension; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the approved preslaughter withdrawal period 
in cattle following use of a penicillin G procaine injectable 
suspension. This action is being taken to improve the accuracy of the 
regulations.

DATES: This rule is effective April 5, 2004.

FOR FURTHER INFORMATION CONTACT: Jeffrey L. Punderson, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4109, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA has found that the animal drug 
regulations do not reflect the preslaughter withdrawal period in cattle 
for Penicillin G Procaine Aqueous Suspension sponsored by G.C. Hanford 
Manufacturing Co. and approved under NADA 065-493. This error was 
introduced into the regulations when sections for certain pencillin-
containing products were recodified (57 FR 37318, August 18, 1992). At 
this time, the regulations are being amended in 21 CFR 522.1696b to 
correct this error.
    Publication of this document constitutes final action on this 
change under the Administrative Procedure Act (5 U.S.C. 553). Notice 
and public procedure are unnecessary because FDA is merely correcting a 
nonsubstantive error.
    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 522

    Animal drugs.

[[Page 17586]]


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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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  522.1696b  [Amended]

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2. Section 522.1696b Penicillin G procaine aqueous suspension is 
amended in paragraph (d)(2)(iii)(A) by removing ``010515,'' and in 
paragraph (d)(2)(iii)(B) by removing ``No. 055529'' and by adding in 
its place ``Nos. 010515 and 055529''.

    Dated: March 19, 2004.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 04-7606 Filed 4-4-04; 8:45 am]
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