[Federal Register Volume 70, Number 81 (Thursday, April 28, 2005)]
[Rules and Regulations]
[Pages 21946-21947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8510]


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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 Benzathine and Penicillin G Procaine Sterile Suspension

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 supplemental new animal drug 
application (NADA) filed by Cross Vetpharm Group Ltd. The supplemental 
NADA provides for the addition of

[[Page 21947]]

statements to labeling of an injectable penicillin suspension warning 
against the use of this product in calves to be processed for veal. FDA 
is also amending the regulations to correctly identify approved 
indications for use for several penicillin products. This action is 
being taken to improve the accuracy of the regulations.

DATES: This rule is effective April 28, 2005.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:  Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed a supplement to NADA 65-506 that 
provides for the addition of statements to labeling of COMBI-PEN-48 
(penicillin G benzathine and penicillin G procaine) injectable 
suspension warning against the use of this product in calves to be 
processed for veal. The supplemental NADA is approved as of March 23, 
2005, and the regulations are amended in Sec.  522.1696a (21 CFR 
522.1696a) to reflect the approval. FDA is also amending Sec.  
522.1696a to correct an error in the indications for use for several 
penicillin products which was introduced during reformatting of this 
section in 2001 (66 FR 711, January 4, 2001). This is being done to 
improve the accuracy of the regulations.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency 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.
    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.

0
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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

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2. Section 522.1696a is amended by revising the section heading and 
paragraphs (b)(2), (b)(3), and (d)(2)(iii) to read as follows:


Sec.  522.1696a  Penicillin G benzathine and penicillin G procaine 
suspension.

* * * * *
    (b) * * *
    (2) Nos. 010515, 059130, and 061623 for use as in paragraphs 
(d)(2)(i), (d)(2)(ii)(A), and (d)(2)(iii) of this section.
    (3) Nos. 000856 and 049185 for use as in paragraphs (d)(2)(i), 
(d)(2)(ii)(B), and (d)(2)(iii) of this section.
* * * * *
    (d) * * *
    (2) * * *
    (iii) Limitations. Limit treatment to two doses. Not for use within 
30 days of slaughter. For Nos. 010515, 049185, 059130, and 061623: A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.

    Dated: April 8, 2005.
Stephen D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-8510 Filed 4-27-05; 8:45 am]
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