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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
CFR Citation: 21 CFR Part 558
NOTICE: RULES
ACTION: Animal drugs, feeds, and related products:
DOCUMENT ACTION: Final rule; technical amendment.
SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Arsanilic Acid; Technical Amendment
DATES: This rule is effective November 19, 2001.
DOCUMENT 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.
SUMMARY: Arsanilic acid; technical amendment,
SUPPLEMENTAL 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. 801808.
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 558NEW 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
(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).
* * * * * * *
* * * * *
Dated: November 6, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 0128765 Filed 111601; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT Dianne T. McRae, Center for Veterinary Medicine (HFV102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018270212, email: dmcrae@cvm.fda.gov.
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