Document ID: FDA-2008-N-0039-0036
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Enrofloxacin Final Rule
Posted Date: 2008-04-23T04:00Z

[Federal Register: April 23, 2008 (Volume 73, Number 79)]
[Rules and Regulations]               
[Page 21819]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ap08-5]                         

[[Page 21819]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556

 
New Animal Drugs; Enrofloxacin

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 Bayer HealthCare LLC. The supplemental NADA 
provides for use of enrofloxacin injectable solution in swine for the 
treatment and control of respiratory disease.

DATES: This rule is effective April 23, 2008.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Bayer HealthCare LLC, Animal Health 
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement 
to NADA 141-068 for BAYTRIL 100 (enrofloxacin) injectable solution. The 
supplemental NADA provides for use of enrofloxacin injectable solution 
in swine for the treatment and control of swine respiratory disease 
(SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella 
multocida, Haemophilus parasuis, and Streptococcus suis. The 
supplemental NADA is approved as of March 14, 2008, and the regulations 
in 21 CFR 522.812 and 556.228 (Sec. Sec.  522.812 and 556.228) are 
amended to reflect the approval.
    In addition, FDA has noticed that Sec.  556.228 is not in 
alphabetical sequence in 21 CFR part 556. At this time, that section is 
being redesignated to correct this error. A conforming change is also 
being made in Sec.  522.812 to reflect the correction in part 556.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning on the date of 
approval. The agency has determined under 21 CFR 25.33(d)(5) 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 522

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

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 522 and 
556 are 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 522.812, is amended by revising paragraph (c) and adding 
paragraph (e)(3) to read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (c) Related tolerance. See Sec.  556.226 of this chapter
* * * * *
    (e) * * *
    (3) Swine. Use the product described in paragraph (a)(2) of this 
section as follows:
    (i) Amount. Administer 7.5 mg/kg of body weight once, by 
subcutaneous injection behind the ear.
    (ii) Indications for use. For the treatment and control of swine 
respiratory disease (SRD) associated with Actinobacillus 
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and 
Streptococcus suis.
    (iii) Limitations. Animals intended for human consumption must not 
be slaughtered within 5 days of receiving a single-injection dose.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
3. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

Sec.  556.228  [Redesignated as Sec.  556.226]

0
4. Redesignate Sec.  556.228 as Sec.  556.226 and revise newly 
redesignated Sec.  556.226 to read as follows:

Sec.  556.226  Enrofloxacin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
enrofloxacin is 3 micrograms per kilogram of body weight per day.
    (b) Tolerances. The tolerances for enrofloxacin are:
    (1) Cattle--(i) Liver (target tissue). 0.1 part per million (ppm) 
desethylene ciprofloxacin (the marker residue).
    (ii) [Reserved]
    (2) Swine--(i) Liver (target tissue). 0.5 ppm enrofloxacin (the 
marker residue).
    (ii) [Reserved]
    (c) Related conditions of use. See Sec.  522.812 of this chapter.

    Dated: April 11, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-8713 Filed 4-22-08; 8:45 am]

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