[Federal Register Volume 63, Number 189 (Wednesday, September 30, 1998)]
[Rules and Regulations]
[Pages 52157-52158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26081]
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DEPARTMENT OF HEALTH AND HUMAN RESOURCES
Food and Drug Administration
21 CFR Parts 522 and 556
Implantation or Injectable Dosage Form New Animal Drugs;
Oxytetracycline Injection
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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 Pfizer, Inc. The supplemental NADA provides
for intramuscular, intravenous, and subcutaneous use of oxytetracycline
injection in lactating dairy cattle in addition to use in beef cattle,
nonlactating dairy cattle, calves including preruminating (veal)
calves, and swine.
EFFECTIVE DATE: September 30, 1998.
FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1652.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed supplemental NADA 113-232 that provides for intramuscular,
intravenous, and subcutaneous use of Liquamycin LA-
200 (oxytetracycline injection) for treatment of lactating
dairy cattle in addition to treatment of beef cattle, nonlactating
dairy cattle, calves including preruminating (veal) calves, and swine
as in Sec. 522.1660(d)(1) and (d)(2) (21 CFR 522.1660(d)(1) and
(d)(2)). The supplemental NADA is approved as of July 21, 1998, and the
regulations in Sec. 522.1660(d)(1) are amended to reflect the approval.
The basis of approval is discussed in the freedom of information
summary.
Also Sec. 522.1660(c) is revised to cross-reference the tolerances
for oxytetracycline in 21 CFR 556.500. In addition, the tolerances are
amended to provide for an acceptable daily intake (ADI) (see 61 FR
67453, December 23, 1996) and for a tolerance for residues in milk.
Because the December 23, 1996, publication amends tolerances for all
tetracyclines (chlortetracycline, oxytetracycline, and tetracycline),
this document also amends 21 CFR 556.150 and 556.720 to reflect the
tetracycline ADI.
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 this approval may be seen in
the Dockets Management Branch (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
for food-producing animals qualifies for 3 years of marketing
exclusivity beginning July 21, 1998, because the supplement contains
substantial evidence of effectiveness of the drug involved, any studies
of animal safety or, in the case of food-producing animals, human food
safety studies (other than bioequivalence or residue studies) required
for approval of the supplement and conducted or sponsored by the
applicant. The 3 years of marketing exclusivity applies only to use of
this drug in lactating dairy cattle for the labeled indications for
which the supplemental application is approved.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects
21 CFR Part 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 522.1660 is amended by adding paragraph (c), by revising
the heading in paragraph (d)(1) and the two last sentences in paragraph
(d)(1)(iii) to read as follows:
[[Page 52158]]
Sec. 522.1660 Oxytetracycline injection.
* * * * *
(c) Related tolerances. See Sec. 556.500 of this chapter.
(d) * * *
(1) Beef cattle, dairy cattle, and calves including preruminating
(veal) calves. * * *
(iii) * * * For sponsors 000010, 053389, 059130, and 061623: Not
for use in lactating dairy cattle. For sponsor 000069: Milk taken from
animals during treatment and for 96 hours after the last treatment must
not be used for food; use subcutaneously with a maximum of 10
milliliters per injection site in adult cattle as well as
intramuscularly and intravenously.
* * * * *
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:
Authority: 21 U.S.C. 342, 360b, 371.
4. Section 556.150 is revised to read as follows:
Sec. 556.150 Chlortetracycline.
(a) Acceptable daily intake (ADI). The ADI for total residues of
tetracyclines including chlortetracycline, oxytetracycline, and
tetracycline is 25 micrograms per kilogram of body weight per day.
(b) Beef cattle, nonlactating dairy cows, calves, swine, sheep,
chickens, turkeys, and ducks. Tolerances are established for the sum of
residues of the tetracyclines including chlortetracycline,
oxytetracycline, and tetracycline, in tissues as follows:
(1) 2 parts per million (ppm) in muscle.
(2) 6 ppm in liver.
(3) 12 ppm in fat and kidney.
5. Section 556.500 is revised to read as follows:
Sec. 556.500 Oxytetracycline.
(a) Acceptable daily intake (ADI). The ADI for total residues of
tetracyclines including chlortetracycline, oxytetracycline, and
tetracycline is 25 micrograms per kilogram of body weight per day.
(b) Beef cattle, dairy cattle, calves, swine, sheep, chickens,
turkeys, catfish, lobster, and salmonids. Tolerances are established
for the sum of residues of the tetracyclines including
chlortetracycline, oxytetracycline, and tetracycline, in tissues and
milk as follows:
(1) 2 parts per million (ppm) in muscle.
(2) 6 ppm in liver.
(3) 12 ppm in fat and kidney.
(4) 0.3 ppm in milk.
6. Section 556.720 is revised to read as follows:
Sec. 556.720 Tetracycline.
(a) Acceptable daily intake (ADI). The ADI for total residues of
tetracyclines including chlortetracycline, oxytetracycline, and
tetracycline is 25 micrograms per kilogram of body weight per day.
(b) Calves, swine, sheep, chickens, and turkeys. Tolerances are
established for the sum of residues of the tetracyclines including
chlortetracycline, oxytetracycline, and tetracycline, in tissues as
follows:
(1) 2 parts per million (ppm) in muscle.
(2) 6 ppm in liver.
(3) 12 ppm in fat and kidney.
Dated: September 8, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-26081 Filed 9-29-98; 8:45 am]
BILLING CODE 4160-01-F
