Document ID: FDA-2009-N-0665-0042
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Nitrofurazone Ointment - Final Rule
Posted Date: 2009-08-03T04:00Z

[Federal Register: August 3, 2009 (Volume 74, Number 147)]
[Rules and Regulations]               
[Page 38341-38342]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03au09-7]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 524

[Docket No. FDA-2009-N-0665]

 
New Animal Drugs; Nitrofurazone Ointment

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 an original abbreviated new 
animal drug application (ANADA) filed by First Priority, Inc. The ANADA 
provides for use of nitrofurazone ointment on horses for prevention or 
treatment of superficial bacterial infections.

DATES: This rule is effective August 3, 2009.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr., 
Elgin, IL 60123, filed ANADA 200-425 for use of Nitrofurazone Soluble 
Dressing in horses for prevention or treatment of superficial bacterial 
infections of wounds, burns, and cutaneous ulcers. First Priority, 
Inc.'s Nitrofurazone Soluble Dressing is approved as a generic copy of 
FURA-ZONE (nitrofurazone) ointment, sponsored by Squire Laboratories, 
Inc., under NADA 132-427. In addition, First Priority, Inc., has 
informed FDA of a change of address. The ANADA is approved as of July 
13, 2009, and

[[Page 38342]]

Sec. Sec.  510.600 and 524.1580b (21 CFR 510.600 and 524.1580b) are 
amended to reflect the approval.
    In addition, FDA has found that the pioneer sponsor's drug labeler 
code (DLC) was inadvertently omitted from Sec.  524.1580b during format 
changes in 2005 (70 FR 50181; August 26, 2005). At this time, Sec.  
524.1580b is amended to include Squire Laboratories, Inc.'s DLC. 
Section 524.1580b is also amended to reflect current food safety 
warnings.
    In accordance with the freedom of information provisions of 21 CFR 
part 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 Division of Dockets Management 
(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.
    FDA 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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 524

    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 parts 510 and 
524 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), in the entry for 
``First Priority, Inc.'' and in the table in paragraph (c)(2), in the 
entry for ''058829'', remove ``1585 Todd Farm Dr.'' and in its place 
add ``1590 Todd Farm Dr.''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

0
4. In Sec.  524.1580b, add paragraph (b)(3) and revise paragraph (d)(3) 
to read as follows:

Sec.  524.1580b  Nitrofurazone ointment.

* * * * *
    (b) * * *
    (3) See Nos. 017153 and 058829 for use on horses.
* * * * *
    (d) * * *
    (3) Limitations. For use only on dogs, cats, and horses. Do not use 
in horses intended for human consumption. Federal law prohibits the use 
of this product in food-producing animals. In case of deep or puncture 
wounds or serious burns, use only as recommended by veterinarian. If 
redness, irritation, or swelling persists or increases, discontinue 
use; consult veterinarian.

    Dated: July 28, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-18337 Filed 7-31-09; 8:45 am]

BILLING CODE 4160-01-S