[Federal Register Volume 66, Number 44 (Tuesday, March 6, 2001)]
[Rules and Regulations]
[Pages 13426-13427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5311]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510


New Animal Drugs; Change of Sponsor

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.

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.

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<Register>, 
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.

 List of Subjects in 21 CFR Part 510

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

     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 510 is 
amended as follows:

 PART 510--NEW ANIMAL DRUGS

     1. The authority citation for 21 CFR part 510 continues to read as 
follows:

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


Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

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

[[Page 13427]]



------------------------------------------------------------------------
       Firm name and address                  Drug labeler code
------------------------------------------------------------------------
 
*                  *                  *                  *
                 *                  *                  *
Sweetlix, LLC, 175 South Main St.,   036904
 suite 150, Salt Lake City, UT
 84111
 
*                  *                  *                  *
                 *                  *                  *
------------------------------------------------------------------------

    (2) *  *  *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
*                  *                  *                  *
                 *                  *                  *
036904                               Sweetlix, LLC, 175 South Main St.,
                                      suite 150, Salt Lake City, UT
                                      84111
 
*                  *                  *                  *
                 *                  *                  *
------------------------------------------------------------------------


    Dated: February 8, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-5311 Filed 3-5-01; 8:45 am]
BILLING CODE 4160-01-S