Skip to Content

Rule

New Animal Drugs; Change of Sponsor

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three approved new animal drug applications (NADA’s) from PM Ag Products, Inc., to Sweetlix, LLC.

DATES:

This rule is effective March 6, 2001.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Norman J. Turner, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0214.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

PM Ag Products, Inc., 1055 West 175th St., Homewood, IL 60430, has informed FDA that it has transferred ownership of, and all rights and interests in NADA 033-773 for Sweetlix Bloat Guard Block, NADA 109-471 for Staley Sweetlix with Rumensin®, and NADA 136-214 for Enproal Bloat Blox to Sweetlix, LLC, 175 South Main St., suite 150, Salt Lake City, UT 84111. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the transfer of ownership. The agency is removing the sponsor name for PM Ag Products, Inc., because the firm no longer is the holder of any approved NADA's, and the drug labeler code assigned to PM Ag Products, Inc., is being retained as the drug labeler code for Sweetlix, LLC.

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.

Start List of Subjects

List of Subjects in 21 CFR Part 510

End List of Subjects Start Amendment Part

Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.

End Amendment Part Start Amendment Part

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,

End Amendment Part Start Part

PART 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

End Authority Start Amendment Part

2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for “PM Ag Products, Inc.” and by alphabetically adding an entry for “Sweetlix, LLC ” and in the table in paragraph (c)(2) by revising the entry for “036904 ” to read as follows:

End Amendment Part
Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *

(c) * * *

(1) * * *

Start Printed Page 13427
Firm name and addressDrug labeler code
*         *         *         *        *         *         *
Sweetlix, LLC, 175 South Main St., suite 150, Salt Lake City, UT 84111036904
*         *         *         *        *         *         *

(2) * * *

Drug labeler codeFirm name and address
*         *         *         *        *         *         *
036904Sweetlix, LLC, 175 South Main St., suite 150, Salt Lake City, UT 84111
*         *         *         *        *         *         *
Start Signature

Dated: February 8, 2001.

Claire M. Lathers,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. 01-5311 Filed 3-5-01; 8:45 am]

BILLING CODE 4160-01-S