2010-27287. New Animal Drugs; Change of Sponsor; Monensin Blocks

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 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: [e-mail].

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, § 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, § 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

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

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. In § 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:

§ 510.600

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

* * * * *

(c) * * *

(1) * * *

Firm name and address	Drug labeler code
*    *    *    *    *
Land O' Lakes Purina Feed LLC, 100 Danforth Dr., Gray Summit, MO 63039	066071
*    *    *    *    *

(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

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

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

§ 520.1448a

[Amended]

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.