[Federal Register Volume 75, Number 208 (Thursday, October 28, 2010)]
[Rules and Regulations]
[Pages 66304-66305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27287]
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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:
[email protected].
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.
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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
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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.
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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) * * *
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Drug
Firm name and address labeler
code
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* * * * *
Land O' Lakes Purina Feed LLC, 100 Danforth Dr., Gray 066071
Summit, MO 63039...........................................
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
066071........................... Land O' Lakes Purina Feed LLC, 100
Danforth Dr., Gray Summit, MO 63039.
* * * * *
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
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3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1448a [Amended]
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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