[Federal Register Volume 66, Number 132 (Tuesday, July 10, 2001)]
[Rules and Regulations]
[Pages 35898-35899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Chlortetracycline 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 Pennfield Oil Co. The ANADA provides for 
oral use of chlortetracycline soluble powder in solutions administered 
to cattle, swine, chickens, and turkeys for the control and treatment 
of various bacterial diseases. Technical amendments are also being 
made.

DATES: This rule is effective July 10, 2001.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68137, filed ANADA 200-295 for Pennchlor\TM\ 64 
(chlortetracycline) Soluble Powder. The application provides for oral 
use of chlortetracycline soluble powder administered in drinking water 
or in solutions dosed by mouth in cattle, swine, chickens, and turkeys 
for the control and treatment of various diseases caused by bacteria 
susceptible to chlortetracycline. Pennfield Oil Co.'s 
Pennchlor\TM\ 64 is approved as a generic copy of American 
Cyanamid's Aureomycin (chlortetracycline) Soluble Powder 
Concentrate, approved under NADA 65-440. The ANADA is approved as of 
April 27, 2001, and the regulations are amended in 21 CFR 520.445b to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    Section 520.445b is further amended in paragraph (d)(4)(iii)(C) by 
removing the Pennfield Oil Co. drug labeler code (DLC #053389) which 
was added in error (59 FR 39438, August 3, 1994) and by correcting the 
drug labeler code for ADM Animal Health & Nutrition Division (DLC 
#017519) which in error was not changed in this paragraph when the drug 
labeler code was changed elsewhere in this section (62 FR 27691, May 
21, 1997). Publication of this document constitutes final action on 
these changes under the Administrative Procedure Act (5 U.S.C. 553). 
Notice and public procedure are unnecessary because FDA is merely 
correcting nonsubstantive errors.
    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 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.
    The agency 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.


Sec. 520.445b  [Amended]

    2. Section 520.445b Chlortetracycline powder (chlortetracycline 
hydrochloride or chlortetracycline bisulfate) is amended in paragraph 
(b) by removing ``as in paragraphs (d)(1)(i)(A) and (d)(2)(i)(A)'' and 
adding in its place ``as in paragraph (d)''; and in paragraph 
(d)(4)(iii)(C) by removing ``, 012286, and 053389'' and adding in its 
place ``and 017519''.


[[Page 35899]]


    Dated: June 27, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-17104 Filed 7-9-01; 8:45 am]
BILLING CODE 4160-01-S