Document ID: FDA-2010-N-0002-0074
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor; Monensin Blocks
Posted Date: 2010-10-28T04:00Z

[Federal Register: October 28, 2010 (Volume 75, Number 208)]
[Rules and Regulations]               
[Page 66304-66305]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc10-8]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

[Docket No. FDA-2010-N-0002]

 
New Animal Drugs; Change of Sponsor; Monensin Blocks

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 a change of sponsor from Farmland 
Industries, Inc., to Land O' Lakes Purina Feed LLC for a free-choice 
supplement block containing monensin for pasture cattle.

DATES: This rule is effective October 28, 2010.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8300, e-mail: 
steven.vaughn@fda. hhs.gov.

SUPPLEMENTARY INFORMATION: Farmland Industries, Inc., Kansas City, MO 
64116, has informed FDA that it has transferred ownership of, and all 
rights and interest in, NADA 118-509 for Pasture Gainer Block-37 R350 
(monensin) to Land O' Lakes Purina Feed LLC, 100 Danforth Dr., Gray 
Summit, MO 63039. Accordingly, the regulations are amended in 21 CFR 
520.1448a to reflect this change of sponsorship.
    Following this change of sponsorship, Farmland Industries, Inc., is 
no longer the sponsor of an approved application. Accordingly, Sec.  
510.600 (21 CFR 510.600) is being amended to remove the entries for 
this firm.
    In addition, Land O' Lakes Purina Feed LLC is not currently listed 
in the animal drug regulations as a sponsor of an approved application. 
Accordingly, Sec.  510.600 is being amended to add entries for this 
sponsor.
    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 510

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

21 CFR Part 520

    Animal drugs.

0
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 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
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.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``Farmland Industries, Inc.'', and alphabetically add a new entry 
for ``Land O' Lakes Purina Feed LLC''; and in the table in paragraph 
(c)(2), remove the entry for ``021676'' and numerically add an entry 
for ``066071'' to read as follows:

[[Page 66305]]

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

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

------------------------------------------------------------------------
                                                                 Drug
                    Firm name and address                       labeler
                                                                 code
------------------------------------------------------------------------

                                * * * * *
Land O' Lakes Purina Feed LLC, 100 Danforth Dr., Gray            066071
 Summit, MO 63039...........................................

                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
       Drug  labeler  code                 Firm name and address
------------------------------------------------------------------------

                                * * * * *
066071...........................  Land O' Lakes Purina Feed LLC, 100
                                    Danforth Dr., Gray Summit, MO 63039.

                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.1448a  [Amended]

0
4. Section 520.1448a is amended in paragraph (c)(2) by removing 
``021676'' and by adding in its place ``No. 066071''.

    Dated: October 21, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-27287 Filed 10-27-10; 8:45 am]
BILLING CODE 4160-01-P