[Federal Register: July 12, 2005 (Volume 70, Number 132)]
[Rules and Regulations]
[Page 39918-39919]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy05-9]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
Implantation or Injectable Dosage Form New Animal Drugs;
Tulathromycin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a new animal drug application
(NADA) filed by Pfizer, Inc. The NADA provides for the veterinary
prescription use of tulathromycin solution in cattle and in swine, by
injection, for the management of respiratory disease. FDA is also
amending the regulations to add the acceptable daily intake for total
residues of tulathromycin and tolerances for residues of tulathromycin
in edible tissues of cattle and swine.
DATES: This rule is effective July 12, 2005.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed NADA 141-244 for DRAXXIN (tulathromycin) Injectable
Solution. The NADA provides for the veterinary prescription use of
tulathromycin solution in cattle, by subcutaneous injection, for the
treatment of bovine respiratory disease (BRD) associated with
Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni
(Haemophilus somnus); for the control of respiratory disease in cattle
at high risk of developing BRD associated with M. haemolytica, P.
multocida, and H. somni; and in swine, by intramuscular injection, for
the treatment of swine respiratory disease (SRD) associated with
Actinobacillus pleuropneumoniae, P. multocida, Bordetella
bronchiseptica, and H. parasuis. The application is approved as of May
24, 2005, and the regulations are amended in part 522 (21 CFR part 522)
by adding Sec. 522.2630 and in part 556 (21 CFR part 556) by adding
Sec. 556.745 to reflect the approval. The basis of approval is
discussed in the freedom of information (FOI) summary.
In accordance with the FOI 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.
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for
5 years of marketing exclusivity beginning May 24, 2005.
The agency has determined under 21 CFR 25.33(d)(5) that these
actions are of a type that do 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, Foods.
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 522.2630 is added to read as follows:
Sec. 522.2630 Tulathromycin.
(a) Specifications. Each milliliter of solution contains 100
milligrams (mg) tulathromycin.
(b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.745 of this chapter.
(d) Conditions of use--(1) Beef and nonlactating dairy cattle--(i)
Amount. 2.5 mg per kilogram (/kg) body weight as a single subcutaneous
injection in the neck.
(ii) Indications for use. For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni (Haemophilus somnus); for the control
of respiratory disease in cattle at high risk of developing BRD
associated with M. haemolytica, P. multocida, and H. somni.
(iii) Limitations. Cattle intended for human consumption must not
be slaughtered within 18 days from the last treatment. Do not use in
female dairy cattle 20 months of age or older. A withdrawal period has
not been established for this product in preruminating calves. Do not
use in calves to be processed for veal. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(2) Swine--(i) Amount. 2.5 mg/kg body weight as a single
intramuscular injection in the neck.
(ii) Indications for use. For the treatment of swine respiratory
disease (SRD) associated with Actinobaccillus pleuropneumoniae, P.
multocida, Bordetella bronchiseptica, and H. parasuis.
(iii) Limitations. Swine intended for human consumption must not be
slaughtered within 5 days from the last treatment. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
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.
0
4. Section 556.745 is added to read as follows:
Sec. 556.745 Tulathromycin.
(a) Acceptable daily intake (ADI). The ADI for total residues of
tulathromycin is 15 micrograms per kilogram of body weight per day.
[[Page 39919]]
(b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The
tolerance for CP-60,300 (the marker residue) is 5.5 parts per million
(ppm).
(ii) [Reserved]
(2) Swine--(i) Kidney (the target tissue). The tolerance for CP-
60,300 (the marker residue) is 15 ppm.
(ii) [Reserved]
(c) Related conditions of use. See Sec. 522.2630 of this chapter.
Dated: June 20, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-13586 Filed 7-11-05; 8:45 am]
BILLING CODE 4160-01-S