[Federal Register Volume 69, Number 231 (Thursday, December 2, 2004)]
[Rules and Regulations]
[Pages 70056-70057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26529]


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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; Coumaphos

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 remove conditions of use in cattle and chickens for 
a coumaphos Type A medicated article for which approval was withdrawn 
in July 1996. This action is being taken to improve the accuracy of the 
agency's regulations.

DATES: This rule is effective December 2, 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: 
<a href="/cdn-cgi/l/email-protection#cbacaea4b9acaee5a3aaa2a9aea78badafaae5aca4bd"><span class="__cf_email__" data-cfemail="d6b1b3b9a4b1b3f8beb7bfb4b3ba96b0b2b7f8b1b9a0">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: FDA has found that parts 500 to 599 (21 CFR 
parts 500 to 599) of the Code of Federal Regulations reflect conditions 
of use in cattle for a coumaphos Type A medicated article for which 
approval was withdrawn by FDA, at the sponsors request, on July 3, 1996 
(61 FR 34727). At this time, FDA is amending the regulations in Sec.  
558.185 to reflect the remaining approved uses of coumaphos in 
medicated cattle feeds.
    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 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 558.185 is amended by redesignating paragraph (d) as 
paragraph (e); by revising paragraphs (a), (b), and newly redesignated 
(e)(1); and by adding paragraph (d) to read as follows:


Sec.  558.185  Coumaphos.

    (a) Specifications. Type A medicated articles containing 1.12, 2.0, 
11.2, or 50 percent coumaphos.
    (b) Approvals. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) No. 000859 for use of Type A medicated articles containing 
1.12, 2.0, 11.2, or 50 percent coumaphos as in paragraphs (e)(2) and 
(e)(3) of this section.
    (2) No. 017800 for use of Type A medicated articles containing 1.12 
or 11.2 percent coumaphos as in paragraph (e)(1) of this section.
* * * * *
    (d) Special considerations. Labeling shall bear the following 
caution statement: ``The active ingredient coumaphos is a 
cholinesterase inhibitor. Do not use this product on animals 
simultaneously or within a few days before or after treatment with or 
exposure to cholinesterase-inhibiting drugs, pesticides, or 
chemicals.'' Also, see Sec.  500.25 of this chapter.
    (e) Conditions of use--(1) Beef and dairy cattle--(i) Amount. 
0.0002 lb. (0.091 gram) per 100 lb. body weight per day for 6 
consecutive days. Should conditions warrant, repeat treatment at 30-day 
intervals.
    (ii) Indications for use. Control of gastrointestinal roundworms 
(Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., 
Trichostrongylus spp.).
    (iii) Limitations. Feed in the normal grain ration to which the 
animals are accustomed, but not in rations containing more than 0.1 
percent coumaphos. Do not feed to animals less than 3 months old. Do 
not feed to sick animals or animals under stress, such as those just 
shipped, dehorned, castrated, or weaned within the last 3 weeks. Do not 
feed in conjunction with oral

[[Page 70057]]

drenches or with feeds containing phenothiazine.
* * * * *

    Dated: November 16, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-26529 Filed 12-1-04; 8:45 am]
BILLING CODE 4160-01-S


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