[Federal Register Volume 71, Number 67 (Friday, April 7, 2006)]
[Unknown Section]
[Pages 17702-17703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Chlortetracycline

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 Pennfield Oil Co. that provides for a 0-day 
preslaughter withdrawal time following use of chlortetracycline in 
cattle feed.

DATES: This rule is effective April 7, 2006.

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: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68144, filed a supplement to NADA 138-935 for PENNCHLOR 
(chlortetracycline) Type A medicated articles used for making medicated 
feeds for the treatment of various bacterial diseases of livestock. The 
supplemental NADA provides for a 0-day withdrawal time before slaughter 
when Type C medicated feeds containing chlortetracycline are fed to 
cattle. The application is approved as of February 28, 2006, and the 
regulations are amended in 21 CFR 558.128 to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    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 
these applications 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.
    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 558

    Animal drugs, Animal feeds.

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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 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

[[Page 17703]]

Sec.  558.128  [Amended]

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2. In Sec.  558.128, amend the table in paragraph (e)(4) in the 
``Limitations'' column as follows:
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a. In paragraph (ii), remove ``To sponsor No. 046573: zero withdrawal 
time. To sponsor No. 053389: 1 d withdrawal time.'' and add in its 
place ``To sponsor Nos. 046573 and 048164: zero withdrawal time.'';
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b. In paragraph (iv) in entry 1, remove ``To sponsor No. 053389: 1 d 
withdrawal time. To sponsor No. 046573: zero withdrawal time.'' and add 
in its place ``To sponsor Nos. 046573 and 048164: zero withdrawal 
time.''; and
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c. In paragraph (viii) in entries 1 and 2, remove ``For sponsor 046573: 
zero withdrawal time. For sponsor 053389: 1 d withdrawal time.'' and 
add in its place ``To sponsor Nos. 046573 and 048164: zero withdrawal 
time.''.

    Dated: March 30, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-3352 Filed 4-6-06; 8:45 am]
BILLING CODE 4160-01-S