Food and Drug Administration, HHS.
Final rule; correcting amendments.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect revised human food safety warnings or updated pathogen nomenclature on dosage form new animal drug product labeling that have not been codified. The regulations are also being amended to correct the wording of certain other conditions of use, to correct minor errors, and to revise some sections to reflect a current format. These actions are being taken to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to improve the accuracy and readability of the regulations.
This rule is effective March 29, 2011.
George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9019, e-mail:
FDA has found that the animal drug regulations do not reflect certain human food safety warnings or the scientific nomenclature of pathogens that have been updated on labeling of various dosage form new animal drug products. At this time, the regulations are being amended to reflect approved labeling. The regulations are also being amended to correct the wording of certain other conditions of use and to correct minor errors. As the opportunity has presented itself, some sections have been revised to a current format. These actions are being taken to comply with the FD&C Act and to improve the accuracy and readability 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.
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520, 522, 526, and 529 are amended as follows:
21 U.S.C. 360b.
(a)
(c) * * *
(1) Glucose/glycine/electrolyte is indicated for use in the control of dehydration associated with diarrhea (scours) in calves.* * *
(3) The product should not be used in animals with severe dehydration (down, comatose, or in a state of shock). Such animals need intravenous therapy. A veterinarian should be consulted in severely scouring calves. The product is not nutritionally complete if administered by itself for long periods of time. It should not be administered beyond the recommended treatment period without the addition of milk or milk replacer.
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(i)
(iii)
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(iii)
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(2) No. 000010: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section.
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(iii)
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(iii)
21 U.S.C. 360b.
(a)
(b)
(c)
(2)
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(iii)
21 U.S.C. 360b.
(d) * * *
(1)
(3)
21 U.S.C. 360b.
(a)
(b)
(c)
(2)
(3)
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(1) * * *
(i) Select finfish. For control of external protozoa
(iv) All finfish. For control of external protozoa