[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