[Federal Register: March 11, 2004 (Volume 69, Number 48)]
[Rules and Regulations]
[Page 11506-11507]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11mr04-3]
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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;
Lincomycin
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 an abbreviated new animal drug
application (ANADA) filed by Phoenix Scientific, Inc. The ANADA
provides for the use of lincomycin injectable solution in swine for the
treatment of infectious arthritis and mycoplasma pneumonia.
DATES: This rule is effective March 11, 2004.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail:
lluther@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
St. Terrace, St. Joseph, MO 64503, filed ANADA 200-351 that provides
for use of Lincomycin (lincomycin hydrochloride monohydrate)
Injectable, USP in swine for the treatment of infectious arthritis and
mycoplasma pneumonia. Phoenix Scientific's Lincomycin Injectable is
approved as a generic copy of Pharmacia & Upjohn Co.'s LINCOMIX
Injectable, approved under NADA 034-025. The ANADA is approved as of
February 13, 2004, and the regulations are amended in 21 CFR 522.1260
to reflect the approval. The basis of approval is discussed in the
freedom of information summary.
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.
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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.
[[Page 11507]]
Sec. 522.1260 [Amended]
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2. Section 522.1260 Lincomycin is amended in paragraph (b)(2) by
removing ``No. 000857'' and by adding in its place ``Nos. 000857 and
059130''.
Dated: March 3, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-5488 Filed 3-10-04; 8:45 am]
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