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Oral Dosage Form New Animal Drugs; Tetracycline Hydrochloride Soluble Powder

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: November 7, 2005 (Volume 70, Number 214)]
[Rules and Regulations]
[Page 67352-67353]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no05-8]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
 
Oral Dosage Form New Animal Drugs; Tetracycline Hydrochloride 
Soluble Powder

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 an abbreviated new animal drug 
application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA 
provides for use of tetracycline hydrochloride soluble powder in the 
drinking water of calves, swine, chickens, and turkeys for the 
treatment and control of various bacterial infections.

DATES: This rule is effective November 7, 2005.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: 
john.harshman@fda.gov.

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-374 that provides for use 
of TETRAMED 324 HCA (tetracycline hydrochloride), a soluble powder used 
in the drinking water of calves, swine, chickens, and turkeys for the 
treatment and control of various bacterial infections. Cross Vetpharm 
Group Ltd.'s

[[Page 67353]]

TETRAMED 324 HCA is approved as a generic copy of Boehringer Ingelheim 
Vetmedica, Inc.'s TETRASURE 324 (tetracycline hydrochloride), approved 
under NADA 65-496. The ANADA is approved as of September 13, 2005, and 
the regulations are amended in Sec.  520.2345d (21 CFR 520.2345d) to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    In addition, FDA has noticed that certain withdrawal times for 
other approved generic products are not reflected in Sec.  520.2345d. 
At this time, the regulations are amended to reflect the correct 
withdrawal times in calves and swine. This action is being taken to 
improve the accuracy of the regulations.
    In accordance with the freedom of information 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.
    FDA has determined under 21 CFR 25.33(a)(1) 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 in 21 CFR Part 520

    Animal drugs.

? 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 part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

? 1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

? 2. Section 520.2345d is amended by revising the section heading, 
paragraphs (a) through (c), the heading and introductory text of 
paragraph (d), and paragraphs (d)(1)(iii) and (d)(2)(iii) to read as 
follows:

Sec.  520.2345d  Tetracycline powder.

    (a) Specifications. Each pound of powder contains 25, 102.4, or 324 
grams tetracycline hydrochloride.
    (b) Sponsors. See sponsors listed in Sec.  510.600(c) of this 
chapter for conditions of use as in paragraph (d) of this section:
    (1) No. 000069: 25 grams per pound as in paragraphs (d)(3) and 
(d)(4) of this section.
    (2) Nos. 000010 and 046573: 102.4 and 324 grams per pound as in 
paragraph (d) of this section.
    (3) No. 053501: 102.4 and 324 grams per pound as in paragraphs 
(d)(1) and (d)(2) of this section.
    (4) No. 046573: 102.4 and 324 grams per pound as in paragraph 
(d)(3) of this section.
    (5) Nos. 051259, 057561, 059130, and 061623: 324 grams per pound as 
in paragraph (d) of this section.
    (c) Related tolerances. See Sec.  556.720 of this chapter.
    (d) Conditions of use. It is administered in drinking water as follows:
    (1) * * *
    (iii) Limitations. Administer for 3 to 5 days; do not slaughter 
animals for food within 4 days of treatment for sponsor No. 053501 and 
within 5 days of treatment for sponsor Nos. 000010, 046573, 051259, 
057561, 059130, and 061623; prepare a fresh solution daily; use as the 
sole source of tetracycline. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.
    (2) * * *
    (iii) Limitations. Administer for 3 to 5 days; do not slaughter 
animals for food within 7 days of treatment for sponsor No. 053501 and 
within 4 days of treatment for sponsor Nos. 000010, 046573, 051259, 
057561, 059130, and 061623; prepare a fresh solution daily; use as the 
sole source of tetracycline.
* * * * *

    Dated: October 19, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-21889 Filed 11-4-05; 8:45 am]
BILLING CODE 4160-01-S

 
 

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