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[Federal Register: November 19, 2001 (Volume 66, Number 223)]
[Rules and Regulations]               
[Page 57873]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no01-18]                         

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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; Arsanilic Acid; 
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 the animal 
drug regulations to reflect the dose range of arsanilic acid for Type C 
medicated poultry feeds reported by the National Academy of Sciences/
National Research Council (NAS/NRC) Drug Efficacy Study in 1972. This 
action is being taken to improve the accuracy of the regulations.

DATES: This rule is effective November 19, 2001.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0212, e-mail: <A HREF="mailto:dmcrae@cvm.fda.gov">dmcrae@cvm.fda.gov</A>.

SUPPLEMENTARY INFORMATION: FDA has found that the animal drug 
regulations do not reflect the dose range of arsanilic acid for Type C 
medicated poultry feeds reported to the agency by the NAS/NRC Drug 
Efficacy Study in 1972. At this time, the regulations are being amended 
in 21 CFR 558.62 to reflect a dose range of 45 to 90 grams per ton of 
medicated poultry feed.
    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.
    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.

    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

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

    Authority: 21 U.S.C. 360b, 371.
    2. Section 558.62 is amended in the table in paragraph (c)(1) by 
revising entries (i) and (ii) to read as follows:


Sec. 558.62  Arsanilic acid.

* * * * *
    (c) * * * 
    (1) * * * 

----------------------------------------------------------------------------------------------------------------
 Arsanilic acid in grams per
             ton              Combination in grams per ton   Indications for use      Limitations       Sponsor
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(i) 45 to 90                    ..........................  1. Growing chickens:  Withdraw 5 days         015565
                                                             For growth            before slaughter;
                                                             promotion and feed    as sole source of
                                                             efficiency;           organic arsenic.
                                                             improving
                                                             pigmentation.
                                ..........................  2. Growing turkeys:   .......do..........     015565
                                                             For growth
                                                             promotion and feed
                                                             efficiency;
                                                             improving
                                                             pigmentation.
                               ...........................  3. Growing swine:     .......do..........     015565
                                                             For increased rate
                                                             of weight gain and
                                                             improved feed
                                                             efficiency.
(ii) 90                        ...........................  Swine: As an aid in   .......do..........     015565
                                                             control of swine
                                                             dysentery
                                                             (hemorrhagic
                                                             enteritis, bloody
                                                             dysentery).

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    Dated: November 6, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-28765 Filed 11-16-01; 8:45 am]
BILLING CODE 4160-01-S

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