New Animal Drugs; Enrofloxacin, 21819 [E8-8713]

Download as PDF Federal Register / Vol. 73, No. 79 / Wednesday, April 23, 2008 / Rules and Regulations 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. Final rule; technical amendment. ACTION: 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. SUMMARY: DATES: List of Subjects This rule is effective April 23, 2008. 21 CFR Part 522 Animal drugs. 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. 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 (§§ 522.812 and 556.228) are amended to reflect the approval. In addition, FDA has noticed that § 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 § 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. mstockstill on PROD1PC66 with RULES SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 15:54 Apr 22, 2008 Jkt 214001 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. 21 CFR Part 556 Animal drugs, Food. I 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: 21819 slaughtered within 5 days of receiving a single-injection dose. PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 3. The authority citation for 21 CFR part 556 continues to read as follows: I Authority: 21 U.S.C. 342, 360b, 371. § 556.228 [Redesignated as § 556.226] 4. Redesignate § 556.228 as § 556.226 and revise newly redesignated § 556.226 to read as follows: I § 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 § 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] BILLING CODE 4160–01–S PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS DEPARTMENT OF THE INTERIOR 1. The authority citation for 21 CFR part 522 continues to read as follows: Office of Surface Mining Reclamation and Enforcement I Authority: 21 U.S.C. 360b. 2. Section 522.812, is amended by revising paragraph (c) and adding paragraph (e)(3) to read as follows: I § 522.812 * * * * (c) Related tolerance. See § 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 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 [VA–124–FOR; Docket ID OSM–2007–0013] Virginia Regulatory Program Enrofloxacin. * 30 CFR Part 946 Office of Surface Mining Reclamation and Enforcement (OSM), Interior. ACTION: Final rule; Approval of amendment. AGENCY: SUMMARY: We are approving an amendment to the Virginia regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). The revisions concern Virginia’s standards for revegetation success for certain postmining land uses, distribution of topsoil and subsoil materials, and allow approval of natural stream restoration channel design, as developed in consultation with the Army Corps of Engineers. The amendment is intended E:\FR\FM\23APR1.SGM 23APR1

Agencies

[Federal Register Volume 73, Number 79 (Wednesday, April 23, 2008)]
[Rules and Regulations]
[Page 21819]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-8713]



[[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]
BILLING CODE 4160-01-S