New Animal Drugs for Use in Animal Feeds; Chlortetracycline, 53966 [E6-15103]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 177 (Wednesday, September 13, 2006)]
[Rules and Regulations]
[Page 53966]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15103]


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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, 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 Alpharma Inc. The supplemental NADA 
provides for use of an approved Type A medicated article containing 
chlortetracycline to formulate a free-choice loose mineral Type C 
medicated feed for beef and nonlactating dairy cattle.

DATES: This rule is effective September 13, 2006.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: eric.dubbin@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., Fort Lee, 
NJ 07024, filed NADA 48-761 for use of AUREOMYCIN 90 Granular 
(chlortetracycline) Type A medicated article to formulate a free-choice 
loose mineral Type C medicated feed for beef and nonlactating dairy 
cattle as an aid in the control of active infection of anaplasmosis 
caused by Anaplasma marginale susceptible to chlortetracycline. The 
supplemental NADA is approved as of July 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 
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.
    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.

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 part 558 is 
amended as follows:

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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

0
2. In Sec.  558.128, redesignate paragraph (e)(6) as paragraph (e)(7); 
and add new paragraph (e)(6) to read as follows:


Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (6) It is used as a free-choice, loose mineral Type C feed as 
follows:
    (i) Specifications.

------------------------------------------------------------------------
         Ingredient                Percent        International Feed No.
------------------------------------------------------------------------
Dicalcium Phosphate          46.20               6-26-335
Sodium Chloride (Salt)       15.00               6-04-152
Magnesium Oxide              10.67               6-02-756
Cottonseed Meal              10.00               5-01-625
Trace Mineral/Vitamin        3.80                .......................
 Premix\1\
Calcium Carbonate            3.50                6-01-069
Dried Cane Molasses          3.00                4-04-695
Potassium Chloride           2.00                6-03-755
Mineral Oil                  2.00                8-03-123
Iron Oxide                   0.50                6-02-431
Chlortetracycline Type A     3.33                .......................
 medicated article (90 gram/
 lb)
------------------------------------------------------------------------
\1\Content of vitamin and trace mineral premixes may be varied. However,
  they should be comparable to those used for other free-choice feeds.
  Formulation modifications require FDA approval prior to marketing.
  Selenium must comply with 21 CFR 573.920. Ethylenediamine
  dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides
  Sec. 651.100 (CPG 7125.18).

    (ii) Amount. 6,000 grams per ton.
    (iii) Indications for use. Beef and nonlactating dairy cattle: As 
an aid in the control of active infection of anaplasmosis caused by 
Anaplasma marginale susceptible to chlortetracycline.
    (iv) Limitations. Feed continuously on a free-choice basis at a 
rate of 0.5 to 2.0 mg chlortetracycline per head per day.
    (v) Sponsor. See No. 046573 in Sec.  510.600(c) of this chapter.
* * * * *

    Dated: August 30, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-15103 Filed 9-12-06; 8:45 am]
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