[Federal Register Volume 70, Number 136 (Monday, July 18, 2005)]
[Rules and Regulations]
[Pages 41139-41140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14017]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 529


Certain Other Dosage Form New Animal Drugs; Oxytetracycline

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 Pfizer, Inc. The supplemental NADA provides 
for use of oxytetracycline hydrochloride soluble powder for skeletal 
marking of finfish fry and fingerlings by immersion.

DATES: This rule is effective July 18, 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: 
[email protected].

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed a supplement to NADA 8-622 that provides for use of 
TERRAMYCIN-343 (oxytetracycline HCl) Soluble Powder for skeletal 
marking of finfish fry and fingerlings by immersion. The approval of 
this supplemental NADA relied on publicly available safety and 
effectiveness data contained in Public Master File (PMF) 5667 which 
were compiled under National Research Support Project-7 (NRSP-7), a 
national agricultural research program for obtaining clearances for use 
of new drugs in minor animal species and for special uses. In addition, 
the supplemental NADA provides for the addition of statements to 
product labeling warning against the use of this product in drinking 
water of lactating dairy cattle. The supplemental NADA is approved as 
of June 13, 2005, and the regulations in 21 CFR 529.1660 are amended to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    In addition, FDA has found that the regulations contain incorrect 
statements warning against the use of oxytetracycline soluble powder in 
calves intended for veal. Accordingly, the regulations in 21 CFR 
520.1660d are amended to reflect appropriate warning statements for 
this product. 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(d)(4) 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 Parts 520 and 529

    Animal drugs.

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 520 and 
529 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. Section 520.1660d is amended by revising paragraph (d)(1)(iv)(C) to 
read as follows:


Sec.  520.1660d  Oxytetracycline hydrochloride soluble powder.

* * * * *
    (d) * * *
    (1) * * *
    (iv) * * *
    (C) Limitations. Prepare a fresh solution daily. Administer up to 
14 days. Do not use for more than 14 consecutive days. Use as sole 
source of oxytetracycline. Do not administer this product with milk or 
milk replacers. Administer 1 hour before or 2 hours after feeding milk 
or milk replacers. Withdraw 5 days prior to slaughter. A milk discard 
period has not been established for this product in lactating dairy 
cattle. Do not use in female dairy cattle 20 months of age or older.
* * * * *

[[Page 41140]]

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 529 continues to read as 
follows:

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


Sec.  529.1660   [Amended]

0
4. Section 529.1660 is amended in paragraph (b)(2) by removing ``No. 
059130'' and by adding in its place ``Nos. 000069 and 059130''.

    Dated: July 1, 2005.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-14017 Filed 7-15-05; 8:45 am]
BILLING CODE 4160-01-S