Document ID: FDA-2013-N-0002-0013
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor
Posted Date: 2013-05-13T04:00Z

[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Rules and Regulations]
[Page 27859]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11283]

[[Page 27859]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

[Docket No. FDA-2013-N-0002]

New Animal Drugs; Change of Sponsor's Name and Address; Change of 
Sponsor

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's name and address from 
Purina Mills, Inc., to Purina Nutrition LLC, and a change of sponsor 
for a new animal drug application (NADA) from Land O'Lakes Purina Feed 
LLC to Purina Nutrition LLC. The regulations are also being amended to 
reflect that Zoetis Inc. is a sponsor of approved NADAs.

DATES: This rule is effective May 13, 2013.

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, email: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Purina Mills, Inc., P.O. Box 66812, St. 
Louis, MO 63166-6812, has informed FDA that it has changed its name and 
address to Purina Nutrition LLC, 1080 County Road F West, Shoreview, MN 
55126-2910. Land O'Lakes Purina Feed LLC, has informed FDA that it has 
transferred ownership of, and all rights and interest in, NADA 118-509 
for Pasture Gainer Block 37 R350 and Pasture Gainer Block 20 R350 to 
Purina Nutrition LLC. Accordingly, the Agency is amending the 
regulations in 21 CFR parts 510 and 558 to reflect the change of name 
and address and the transfer of ownership.
    In addition, Zoetis Inc. is a sponsor of approved NADAs. At this 
time, FDA is amending 21 CFR 510.600 to add entries for this firm.
    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 558

    Animal drugs, Animal feeds.

    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 
558 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 ``Land O'Lakes Purina Feed LLC'' and ``Purina Mills, Inc.'', and 
alphabetically add entries for ``Purina Nutrition LLC'' and ``Zoetis 
Inc.''; and in the table in paragraph (c)(2), remove the entry for 
``066071'', revise the entry for ``017800'', and numerically add an 
entry for ``054771'' to read as follows:

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

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

------------------------------------------------------------------------
                                                                 Drug
                    Firm name and address                       labeler
                                                                 code
------------------------------------------------------------------------
 
                                * * * * *
Purina Nutrition LLC, 1080 County Road F West, Shoreview, MN      017800
 55126-2910.................................................
 
                                * * * * *
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007...........      054771
 
                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
        Drug  labeler  code                 Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
017800............................  Purina Nutrition LLC, 1080 County
                                     Road F West, Shoreview, MN 55126-
                                     2910.
 
                                * * * * *
054771............................  Zoetis Inc., 333 Portage St.,
                                     Kalamazoo, MI 49007.
 
                                * * * * *
------------------------------------------------------------------------

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority:  21 U.S.C. 360b, 371.

Sec.  558.355  [Amended]

0
4. In Sec.  558.355, paragraph (f)(7)(iii)(a), remove ``066071'' and 
add in its place ``017800''.

    Dated: May 8, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-11283 Filed 5-10-13; 8:45 am]
BILLING CODE 4160-01-P