[Federal Register Volume 70, Number 52 (Friday, March 18, 2005)]
[Rules and Regulations]
[Pages 13098-13099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5380]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Oral Dosage Form New Animal Drugs; Tiamulin Soluble Powder

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

-----------------------------------------------------------------------

[[Page 13099]]

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 use of tiamulin soluble powder to prepare medicated 
drinking water for the treatment of swine dysentery and swine 
pneumonia.

DATES:  This rule is effective March 18, 2005.

FOR FURTHER INFORMATION CONTACT:  Daniel A. Benz, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-344 
that provides for use of Tiamulin Soluble Antibiotic to prepare 
medicated drinking water for the treatment of swine dysentery and swine 
pneumonia. Phoenix Scientific, Inc.'s Tiamulin Soluble Antibiotic is 
approved as a generic copy of Boehringer Ingelheim Vetmedica, Inc.'s 
DENAGARD (tiamulin) Soluble Antibiotic approved under NADA 134-644. The 
ANADA is approved as of February 16, 2005, and the regulations are 
amended in 21 CFR 520.2455 to reflect the approval. The basis of 
approval is discussed in the freedom of information summary.
    FDA is also amending the regulations in 21 CFR 520.2455 to reflect 
a more recent genus name for the causative pathogen for swine dysentery 
and in the tables in 21 CFR 510.600(c) to reflect accepted style for 
the sponsor's street address. These actions are being taken 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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 520

    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 parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec.  510.600  [Amended]

0
2. Section 510.600 is amended in the table in paragraph (c)(1) in the 
entry for ``Phoenix Scientific, Inc.'' and in the table in paragraph 
(c)(2) in the entry for ``059130'' by removing ``St. Terrace'' and by 
adding in its place ``Street Ter.''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.2455  [Amended]

0
4. Section 520.2455 is amended in paragraph (b) by removing ``Sponsor. 
See No. 000010'' and by adding in its place ``Sponsors. See Nos. 000010 
and 059130''; and in paragraph (d)(1)(i) by removing ``Treponema'' and 
by adding in its place ``Brachyspira''.

    Dated: March 9, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-5380 Filed 3-17-05; 8:45 am]
BILLING CODE 4160-01-S