[Federal Register Volume 68, Number 23 (Tuesday, February 4, 2003)]
[Rules and Regulations]
[Pages 5562-5563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529


Certain Other Dosage Form New Animal Drugs; Formalin Solution

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 reflect approval of a supplemental new animal drug 
application (NADA) filed by Natchez Animal Supply Co. The supplemental 
NADA provides for use of formalin in a water bath for the control of 
certain external parasites on finfish and shrimp and for the control of 
certain fungi on finfish eggs. Minor corrections to the regulations are 
also being made.

DATES: This rule is effective February 4, 2003.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-131), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Natchez Animal Supply Co., 201 John R. 
Junkin Dr., Natchez, MS 39120, filed a supplement to NADA 137-687 that 
provides for use of formalin in a water bath for the control of certain 
external parasites on finfish and shrimp and for the control of certain 
fungi on finfish eggs. The supplemental NADA is approved as of November 
25, 2002, and the regulations are amended in 21 CFR 529.1030 to reflect 
the approval. The basis of approval is discussed in the freedom of 
information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part

[[Page 5563]]

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 Dockets Management Branch (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 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: 21 U.S.C. 360b.


Sec.  529.1030  [Amended]

    2. Section 529.1030 Formalin solution is amended as follows:
    (a) In the section heading and in paragraph (a) by removing the 
word ``solution'' following the word ``Formalin'';
    (b) By revising the introductory text of paragraph (b);
    (c) In paragraph (b)(1) by removing ``No. 050378'' and by adding in 
its place ``Nos. 049968 and 050378'';
    (d) In paragraph (b)(2) by removing ``Nos. 049968 and'' and by 
adding in its place ``No.'';
    (e) In paragraph (d)(2)(i), in the table, in the heading to the 
second column, by adding ``daily'' after ``1 hour''; and
    (f) In paragraph (d)(2)(iv), in the first column in the table by 
removing ``[frac12]F'' each time it occurs and by adding in its place 
``[deg]F''.
    The revision is to read as follows:


Sec.  529.1030  Formalin.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
* * * * *

    Dated: January 21, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-2601 Filed 2-3-03; 8:45 am]
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