[Federal Register Volume 69, Number 65 (Monday, April 5, 2004)]
[Rules and Regulations]
[Page 17585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7534]



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  Federal Register / Vol. 69, No. 65 / Monday, April 5, 2004 / Rules 
and Regulations  

[[Page 17585]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Furosemide; 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 reflect the approved salts of injectable 
furosemide. This action is being taken to improve the accuracy of the 
regulations.

DATES: This rule is effective April 5, 2004.

FOR FURTHER INFORMATION CONTACT: Jeffrey L. Punderson, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4109, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA has found that the animal drug 
regulations do not correctly identify the monoethanolamine salt of 
furosemide sponsored by Boehringer Ingelheim Vetmedica, Inc., and 
approved under NADA 127-034 and NADA 131-538. This error occurred with 
the approval of NADA 127-034 (49 FR 26715, June 29, 1984). This 
document amends the regulations in 21 CFR 522.1010 to correct this 
error.
    Publication of this document constitutes final action on this 
change under the Administrative Procedure Act (5 U.S.C. 553). Notice 
and public procedure are unnecessary because FDA is merely correcting a 
nonsubstantive error.
    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 522

    Animal drugs.

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 part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Section 522.1010 is amended by revising paragraphs (a) and (b) to 
read as follows:


Sec.  522.1010  Furosemide.

    (a) Specifications--(1) Each milliliter (mL) of solution contains 
50 milligrams (mg) furosemide monoethanolamine.
    (2) Each mL of solution contains 50 mg furosemide diethanolamine.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use of products described in paragraph (a) of this section for use as 
in paragraph (d) of this section.
    (1) No. 000010 as described in paragraph (a)(1) of this section for 
use as in paragraphs (d)(1) and (d)(2)(ii) of this section.
    (2) No. 061623 as described in paragraph (a)(2) of this section for 
use as in paragraph (d)(2)(ii) of this section.
    (3) Nos. 057926 and 059130 as described in paragraph (a)(2) of this 
section for use as in paragraphs (d)(1), (d)(2)(i), and (d)(3) of this 
section.
* * * * *

    Dated: March 19, 2004.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 04-7534 Filed 4-2-04; 8:45 am]
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