[Federal Register Volume 69, Number 196 (Tuesday, October 12, 2004)]
[Rules and Regulations]
[Page 60547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22760]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 558


New Animal Drugs; Change of Sponsor; Sulfaquinoxaline

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 a change of sponsor for an approved new 
animal drug application (NADA) from Hess & Clark, Inc., to Phoenix 
Scientific, Inc.

DATES: This rule is effective October 12, 2004.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
<a href="/cdn-cgi/l/email-protection#94f0f5e2fdf0bafaf1e3fffde6ffd4f2f0f5baf3fbe2"><span class="__cf_email__" data-cfemail="096d687f606d27676c7e62607b62496f6d68276e667f">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Hess & Clark, Inc., 944 Nandino Blvd., 
Lexington, KY 40511, has informed FDA that it has transferred ownership 
of , and all rights and interest in, the following three approved 
NADAs, to Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. 
Joseph, MO 64503:

------------------------------------------------------------------------
          NADA Number                          Trade Name
------------------------------------------------------------------------
6-391                           S.Q. (sulfaquinoxaline) 40% Medicated
                                 Feed
6-677                           S.Q. (sulfaquinoxaline) 20% Solution
7-087                           Sulfaquinoxaline Solubilized
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
520.2325a and 558.586 to reflect the transfer of ownership and a 
current format.
    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 520

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

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 520 and 
558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  520.2325a  [Amended]

0
2. Section 520.2325a is amended in paragraph (a)(1) by removing 
``050749'' and by adding in its place ``059130''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.
0
4. Section 558.586 is amended by revising the section heading; by 
removing paragraphs (c) and (d); by redesignating paragraphs (e) and 
(f) as paragraphs (c) and (d); and by revising paragraph (a) and adding 
paragraph (b) to read as follows:


Sec.  558.586  Sulfaquinoxaline.

    (a) Specifications. Type A medicated articles containing 40 percent 
sulfaquinoxaline.
    (b) Approvals. See No. 059130 in Sec.  510.600(c) of this chapter.
* * * * *

    Dated: September 27, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-22760 Filed 10-8-04; 8:45 am]
BILLING CODE 4160-01-S


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