Source: https://www.federalregister.gov/documents/2008/04/23/E8-8713/new-animal-drugs-enrofloxacin
Timestamp: 2017-09-26 16:48:06
Document Index: 318268902

Matched Legal Cases: ['§\u2009522', '§\u2009556', 'art 556', '§\u2009522', 'art 556', '§\u2009556', '§\u2009556', '§\u2009556', '§\u2009556', '§\u2009556', '§\u2009556']

Federal Register :: New Animal Drugs; Enrofloxacin
A Rule by the Food and Drug Administration on 04/23/2008
This rule is effective April 23, 2008.
73 FR 21819
E8-8713
https://www.federalregister.gov/d/E8-8713 https://www.federalregister.gov/d/E8-8713
Start Preamble Start Printed Page 21819
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.
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.
2. Section 522.812, is amended by revising paragraph (c) and adding paragraph (e)(3) to read as follows:
(c) Related tolerance. See § 556.226 of this chapter
(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.
[Redesignated as § 556.226]
4. Redesignate § 556.228 as § 556.226 and revise newly redesignated § 556.226 to read as follows:
§ 556.226
(a) Acceptable daily intake (ADI). The ADI for total residues of enrofloxacin is 3 micrograms per kilogram of body weight per day.
(1) Cattle—(i) Liver (target tissue). 0.1 part per million (ppm) desethylene ciprofloxacin (the marker residue).
(2) Swine—(i) Liver (target tissue). 0.5 ppm enrofloxacin (the marker residue).
[FR Doc. E8-8713 Filed 4-22-08; 8:45 am]