[Federal Register Volume 69, Number 221 (Wednesday, November 17, 2004)]
[Rules and Regulations]
[Pages 67263-67265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25441]


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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; Decoquinate; Technical 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its animal 
drug regulations to more accurately describe the approved feeding 
instructions for decoquinate Type C medicated feeds for cattle and 
calves, including nonruminating veal calves, and for young sheep and 
young goats. This action is being made to improve the accuracy of the 
regulations.

DATES: This rule is effective November 17, 2004.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV 6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA has found that the April 1, 2004, 
edition of the Code of Federal Regulations part 500 to 599 (21 CFR 500 
to 599) does not reflect the feeding instructions for decoquinate in 
Type C medicated feeds for cattle and calves, including nonruminating 
veal calves, and for young sheep and young goats approved under NADA 
39-417 (67 FR 72370, December 5, 2002). At this time, FDA is amending 
the regulations to correct this error in Sec.  558.195. An inaccurate 
and unnecessary description of a Type B medicated feed is also being 
removed. These changes are being made to improve the accuracy of the 
regulations.
    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 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner

[[Page 67264]]

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. Section 558.195 is amended by revising paragraphs (e)(2)(i), 
(e)(2)(ii), and (e)(3)(ii) in the table to read as follows:


Sec.  558.195   Decoquinate.

* * * * *
    (e) * * *
    (2) * * *

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                                 Combination in
  Decoquinate in grams/ton         grams/ton         Indications for use          Limitations          Sponsor
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(i) 12.9 to 90.8              ...................  Cattle (including        Feed Type C feed or           046573
                                                    ruminating and           milk replacer to
                                                    nonruminating calves     provide 22.7
                                                    and veal calves): For    milligrams (mg) per
                                                    prevention of            100 pounds (lb) of
                                                    coccidiosis caused by    body weight (0.5 mg/
                                                    Eimeria bovis and E.     kg) per day. Feed at
                                                    zuernii                  least 28 days during
                                                                             periods of exposure to
                                                                             coccidiosis or when it
                                                                             is likely to be a
                                                                             hazard. Do not feed to
                                                                             cows producing milk
                                                                             for food. See
                                                                             paragraph (d)(3) of
                                                                             this section
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(ii) 90.9 to 535.7            ...................  Cattle (including        Feed Type C medicated         046573
                                                    ruminating and           feed supplements as a
                                                    nonruminating calves     top dress or mix into
                                                    and veal calves): As     the daily ration to
                                                    in paragraph (e)(2)(i)   provide 22.7 mg per
                                                    of this section          100 lb of body weight
                                                                             (0.5 mg/kg) per day.
                                                                             Feed at least 28 days
                                                                             during periods of
                                                                             exposure to
                                                                             coccidiosis or when it
                                                                             is likely to be a
                                                                             hazard. Do not feed to
                                                                             cows producing milk
                                                                             for food. See
                                                                             paragraph (d)(3) of
                                                                             this section
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
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    (3) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combination in
  Decoquinate in grams/ton         grams/ton         Indications for use          Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(ii) 90.9 to 535.7            ...................  1. Young sheep: As in    Feed Type C medicated         046573
                                                    item 1 of paragraph      feed supplements as a
                                                    (e)(3)(i) of this        top dress or mix into
                                                    section                  the daily ration to
                                                                             provide 22.7 mg per
                                                                             100 lbs of body weight
                                                                             (0.5 mg per kg) per
                                                                             day; feed for at least
                                                                             28 days during periods
                                                                             of exposure to
                                                                             coccidiosis or when it
                                                                             is likely to be a
                                                                             hazard. Do not feed to
                                                                             sheep producing milk
                                                                             for food
                              ...................  2. Young goats: As in    Feed Type C medicated    ...........
                                                    item 2 of paragraph      feed supplements as a
                                                    (e)(3)(i) of this        top dress or mix into
                                                    section                  the daily ration to
                                                                             provide 22.7 mg per
                                                                             100 lbs of body weight
                                                                             (0.5 mg per kg) per
                                                                             day; feed for at least
                                                                             28 days during periods
                                                                             of exposure to
                                                                             coccidiosis or when it
                                                                             is likely to be a
                                                                             hazard. Do not feed to
                                                                             goats producing milk
                                                                             for food
----------------------------------------------------------------------------------------------------------------
 
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[[Page 67265]]

    Dated: November 4, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine .
[FR Doc. 04-25441 Filed 11-16-04; 8:45 am]
BILLING CODE 4160-01-S