[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]
BILLING CODE 4160-01-S