[Federal Register Volume 59, Number 224 (Tuesday, November 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28778]


[[Page Unknown]]

[Federal Register: November 22, 1994]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

 

Certain Other Dosage Form New Animal Drugs; Formalin Solution; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to clarify approval of a supplemental new animal drug 
application (NADA) 140-989 filed by Western Chemical, Inc. This action 
is being taken to reflect that only Western Chemical, Inc., has 
approval for the use of formalin to treat shrimp infected with external 
parasites.

EFFECTIVE DATE: November 8, 1993.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1642.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 8, 1993 
(58 FR 59168), FDA published a document reflecting approval of a 
supplement to NADA 140-989 filed by Western Chemical, Inc. The 
supplement provides for use of formalin solution (aqueous solution of 
37 percent formaldehyde) in tanks, raceways, and ponds to control the 
external penaeid shrimp protozoa Bodo spp., Epistylis spp., and 
Zoothamnium spp. The regulations amended 21 CFR 529.1030 to reflect 
that approval. Although the preamble to the November 8, 1993, final 
rule specifically limited approval of Formalin for this use, the 
regulations did not specifically limit approval to Western Chemical, 
Inc. Because Western Chemical, Inc., is the only firm that has an 
approved supplemental NADA for this use, this document corrects that 
amendment.

List of Subjects in 21 CFR Part 529

    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 529 is 
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

    2. Section 529.1030 is amended by revising paragraph (b) and by 
redesignating paragraph (d) as paragraph (c)(3) to read as follows:


Sec. 529.1030  Formalin solution.

* * * * *
    (b) Sponsor. Approval to firms identified in Sec. 510.600(c) of 
this chapter for use as indicated:
    (1) No. 050378 for use as in paragraph (c) of this section.
    (2) Nos. 049968 and 051212 for use as in paragraphs (c)(1)(i), 
(c)(1)(ii), (c)(2)(i), (c)(2)(ii), and (c)(3) of this section.

    Dated: October 26, 1994.
Stephen F. Sunlof,
Director, Center for Veterinary Medicine.
[FR Doc. 94-28778 Filed 11-21-94; 8:45 am]
BILLING CODE 4160-01-F