[Federal Register Volume 61, Number 232 (Monday, December 2, 1996)]
[Rules and Regulations]
[Page 63711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30651]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520


Oral Dosage Form New Animal Drugs; Sulfaquinoxaline Drinking 
Water

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 supplemental new animal drug 
application (NADA) filed by I. D. Russell Co. Laboratories. The 
supplement provides for a revised formulation of sulfaquinoxaline 
liquid used in animal drinking water.

EFFECTIVE DATE:  December 2, 1996.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION: I. D. Russell Co. Laboratories, 1301 Iowa 
Ave., Longmont, CO 80501, filed supplemental NADA 6-891 that provides 
for reformulation of the 34-percent sulfaquinoxaline solution to a 
31.92-percent sulfaquinoxaline solution (as sodium and potassium salts) 
used in animal drinking water. The supplement is approved as of October 
22, 1996, and the regulations are amended in Sec. 520.2325a(a) (21 CFR 
520.2325a(a)) to reflect the approval.
    In addition, Sec. 520.2325a(a) is revised to specify the base and 
salt content of several other approved sulfaquinoxaline drinking water 
products.
    The supplemental approval is for a revised formulation of an 
approved product and does not affect the basis of approval or 
conditions of use in the currently approved application. No additional 
safety or effectiveness data were required. Therefore, a freedom of 
information summary is not required for this approval.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), approval of this 
supplemental NADA does not qualify for marketing exclusivity because 
the supplement does not contain reports of new clinical or field 
investigations (other than bioequivalence or residue studies) or new 
human food safety studies (other than bioequivalence or residue 
studies) essential to the approval and conducted or sponsored by the 
applicant.
    The agency has determined under 21 CFR 25.24(d)(1)(iii) 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.

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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 520.2325a is amended by revising paragraph (a) to read 
as follows:

Sec. 520.2325a  Sulfaquinoxaline drinking water.

    (a) Sponsor. See Sec. 510.600(c) of this chapter for identification 
of the sponsors.
    (1) To No. 050749 for use of a 25-percent sulfaquinoxaline soluble 
powder and a 20-percent sulfaquinoxaline sodium solution as provided 
for in paragraph (c) of this section.
    (2) To No. 060594 for use of 3.44- and 12.85-percent 
sulfaquinoxaline sodium solutions as provided for in paragraphs (c)(1), 
(c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this section.
    (3) To No. 017144 for use of a 31.92-percent sulfaquinoxaline 
solution (sodium and potassium salts) as provided for in paragraphs 
(c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this section.
* * * * *

    Dated: November 18, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-30651 Filed 11-29-96; 8:45 am]
BILLING CODE 4160-01-F