[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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Restoration Act of 1988 has superseded the approval of NADA's based on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
