[Federal Register: July 18, 2003 (Volume 68, Number 138)]
[Rules and Regulations]
[Page 42589-42590]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy03-14]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
New Animal Drugs; Laidlomycin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Alpharma Inc. The supplemental NADA
provides for the establishment of a tolerance for residues of
laidlomycin in cattle liver. The previously established acceptable
daily intake (ADI) for total residues of laidlomycin is also being
codified.
DATES: This rule is effective July 18, 2003.
FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0232, e-mail: edubbin@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, filed a supplement to NADA 141-025 for use of
CATTLYST (laidlomycin propionate potassium) Type A medicated articles
used to formulate Type C medicated feeds for cattle. The supplemental
NADA provides for the establishment of a tolerance for residues of
laidlomycin in cattle livers. FDA is also taking this opportunity to
codify the previously established ADI for total residues of
laidlomycin. The supplemental NADA is approved as of May 12, 2003, and
parts 556 and 558 (21 CFR parts 556 and 558) are amended by adding new
Sec. 556.346 and by revising Sec. 558.305. The basis of approval is
discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(1) that this action
is of a type that does not individually or
[[Page 42590]]
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.
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
21 CFR Part 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
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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 parts 556 and
558 are amended as follows:
PART 556-TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
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1. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
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2. Section 556.346 is added to read as follows:
Sec. 556.346 Laidlomycin.
(a) Acceptable daily intake (ADI). The ADI for total residues of
laidlomycin is 7.5 micrograms per kilogram of body weight per day.
(b) Tolerance. The tolerance for parent laidlomycin (the marker
residue) in the liver (the target tissue) of cattle is 0.2 part per
million (ppm).
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
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3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
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4. Section 558.305 is amended by redesignating paragraphs (c) and (d)
as paragraphs (d) and (e); and by adding new paragraph (c) to read as
follows:
Sec. 558.305 Laidlomycin.
* * * * *
(c) Tolerances. See Sec. 556.346 of this chapter.
* * * * *
Dated: July 7, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-18162 Filed 7-17-03; 8:45 am]
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