New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor, 27859 [2013-11283]
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Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Rules and Regulations
27859
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Reporting and recordkeeping
requirements.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
Food and Drug Administration
21 CFR Part 558
■
Animal drugs, Animal feeds.
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:
3. The authority citation for 21 CFR
part 558 continues to read as follows:
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
Final rule.
1. The authority citation for 21 CFR
part 510 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
§ 558.355
[Amended]
4. In § 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
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
DEPARTMENT OF THE INTERIOR
FOR FURTHER INFORMATION CONTACT:
emcdonald on DSK67QTVN1PROD with RULES
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.
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
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.
2. In § 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:
■
*
*
*
(c) * * *
(1) * * *
*
*
*
*
Purina Nutrition LLC, 1080
County Road F West,
Shoreview, MN 55126–2910 ...
*
*
*
*
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007 .............
*
*
*
Drug
labeler
code
Firm name and address
*
017800 ...
*
*
*
*
Purina Nutrition LLC, 1080 County Road F West, Shoreview,
MN 55126–2910.
*
*
*
*
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
Administrative practice and
procedure, Animal drugs, Labeling,
Jkt 229001
*
PO 00000
*
Frm 00007
*
Fmt 4700
*
Sfmt 4700
RIN 1076–AE73
Residential, Business, and Wind and
Solar Resource Leases on Indian Land
SUMMARY: The Bureau of Indian Affairs
(BIA) published a rule in the Federal
Register of December 5, 2012,
Drug
announcing the revisions to regulations
labeler
addressing non-agricultural surface
code
leasing of Indian land. This notice
makes a minor correction to redesignate
section numbers for sections that were
*
moved to a new subpart.
DATES: This correction is effective on
017800 May 13, 2013.
FOR FURTHER INFORMATION CONTACT:
*
Elizabeth Appel, Acting Director, Office
054771 of Regulatory Affairs & Collaborative
Action, (202) 273–4680;
elizabeth.appel@bia.gov.
*
SUPPLEMENTARY INFORMATION:
(2) * * *
21 CFR Part 510
14:14 May 10, 2013
*
25 CFR Part 162
Bureau of Indian Affairs,
Interior.
ACTION: Final rule; correcting
amendment.
*
Firm name and address
[K00103 12/13 A3A10; 134D0102DR–
DS5A300000–DR.5A311.IA000113]
AGENCY:
*
054771 ...
List of Subjects
VerDate Mar<15>2010
*
Bureau of Indian Affairs
*
Need for Correction
The final regulations (77 FR 72440)
addressing non-agricultural surface
leasing of Indian land, and
redesignating certain sections related to
agricultural leases, failed to specifically
redesignate the section numbers of
sections being moved to subpart F. This
document corrects that error.
List of Subjects in 25 CFR Part 162
Indians—lands.
Accordingly, 25 CFR part 162 is
corrected by making the following
correcting amendment:
E:\FR\FM\13MYR1.SGM
13MYR1
]]>Agencies
[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]]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
