[Federal Register Volume 64, Number 227 (Friday, November 26, 1999)]
[Rules and Regulations]
[Pages 66382-66383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Sulfamethazine Tablets

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 new animal drug application 
(NADA) filed by Lloyd, Inc. The NADA provides for oral use of 
sulfamethazine tablets for beef cattle and nonlactating dairy cattle to 
treat diseases caused by sulfamethazine sensitive organisms.

EFFECTIVE DATE: November 26, 1999.

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: Lloyd, Inc., P.O. Box 86, 604 West Thomas 
Ave., Shenandoah, IA 51601, filed NADA 140-908 that provides for oral 
use of Veta-Meth (sulfamethazine) tablets for beef cattle and 
nonlactating dairy cattle to treat diseases caused by sulfamethazine 
sensitive organisms such as bacterial pneumonia and bovine respiratory 
disease complex (shipping fever complex) (Pasteurella spp.), 
colibacillosis (bacterial scours) (Escherichia coli), necrotic 
pododermatitis (foot rot) (Fusobacterium necrophorum), calf diphtheria 
(F. necrophorum), acute mastitis (Streptococcus spp.), acute metritis 
(Streptococcus spp.), coccidiosis (Eimeria bovis, E. zurnii).
     The NADA is approved as of September 16, 1999, and the regulations 
are amended in Sec. 520.2260a(a)(1) (21 CFR 520.2260a(a)(1)) to reflect 
the approval. The basis for approval is discussed in the freedom of 
information summary.
     In addition, the regulation currently contains a paragraph 
reflecting that approval of NADA's were based on National Academy of 
Sciences/National Research Council (NAS/NRC) Drug Efficacy Study 
Implementation

[[Page 66383]]

evaluations of the products and FDA's conclusions based on those 
evaluations. Enactment of the Generic Animal Drug and Patent Term 
Restoration Act of 1988 has superseded the approval of NADA's based on 
NAS/NRC evaluations. At this time, the NAS/NRC status paragraph is 
removed.
     Also, the heading of Sec. 520.2260a is revised to include tablets 
in addition to oblets and boluses.
    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, 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 congressional review requirements in 5 
U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

     Animal drugs.
     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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

     1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

     2. Section 520.2260a is amended by revising the section heading 
and paragraph (a)(1), and by removing paragraph (a)(4) to read as 
follows:


Sec. 520.2260a  Sulfamethazine oblet, tablet, and bolus.

     (a)(1) Sponsor. See No. 010042 in Sec. 510.600(c) of this chapter 
for use of 2.5-, 5-, and 15-gram sulfamethazine oblet in beef cattle, 
nonlactating dairy cattle, and horses. See No. 061690
in Sec. 510.600(c) of this chapter for use of 5-, 15-, and 25-gram 
tablet in beef and nonlactating dairy cattle.
* * * * *

    Dated: November 10, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-30703 Filed 11-24-99; 8:45 am]
BILLING CODE 4160-01-F