Skip to Content

Rule

New Animal Drugs; Change of Sponsor

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 14 approved new animal drug applications (NADAs) from ADM Animal Health & Nutrition Division to ADM Alliance Nutrition, Inc.

DATES:

This rule is effective January 10, 2007.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: david.newkirk@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

ADM Animal Health & Nutrition Division, 1000 North 30th St., Box 1C, Quincy, IL 62305-3115 has informed FDA that it has transferred ownership of, and all rights and interest in, the following 14 approved NADAs to ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115:

Application No.Trade name(s)
048-480Chloratet 50
065-256Chlortet-Soluble-O
091-582Gilt Edge TYLAN Mix
107-957TYLAN 20 Sulfa-G, TYLAN 40 Sulfa-G
108-484HFA Tylosin-10 Plus Sulfa
110-045Good-Life TYLAN 10 Premix
110-439HFA Hygromix 2.4 Medicated Premix
118-877Ban-A-Worm Pyrantel Tartrate Ton Pack
128-411TYLAN 5 Sulfa Premix
131-956TYLAN Sulfa-G
131-957TYLAN 10, TYLAN 20, TYLAN 40, TYLAN 5
132-448FLAVOMYCIN
133-490Ban-D-Wormer II BANMINTH
140-842Hygromix 2.4 Premix

Accordingly, the agency is amending the regulations in 21 CFR 520.445b, 558.95, 558.128, 558.274, 558.485, 558.625, and 558.630 to reflect the transfer of ownership and a current format.

In addition, ADM Animal Health & Nutrition Division is no longer a sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove entries for the 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.

Start List of Subjects

List of Subjects

End List of Subjects Start Amendment Part

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,

End Amendment Part Start Part

PART 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

End Authority
[Amended]
Start Amendment Part

2. In § 510.600, in the table in paragraph (c)(1), remove the entry for “ADM Animal Health & Nutrition Division”; and in the table in paragraph (c)(2), remove the entry for “017519”.

End Amendment Part Start Part

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

3. The authority citation for

End Amendment Part Start Authority

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

End Authority Start Amendment Part

4. In § 520.445b, revise the section heading, and paragraphs (b) and (d)(4)(iii)(C) to read as follows:

End Amendment Part
Chlortetracycline powder.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 048164 for use as in paragraph (d) of this section.

(2) No. 053501 for use as in paragraph (d)(4) of this section.

(3) No. 000010 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) through (iv) of this section.

(4) Nos. 021930 and 059130 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), (d)(4)(ii), and (d)(4)(iii) of this section.

(d) * * *

(4) * * *

(iii) * * *

(C) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 5 days. For Nos. 000010 and 021930, do not slaughter animals for food within 5 days of treatment; for No. 053501, do not slaughter animals for food within 24 hours of treatment.

* * * * *
Start Part

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

End Part Start Amendment Part

5. The authority citation for

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

6. In paragraph (a)(4) of § 558.95, remove “016968, 017519, and 017790” and in its place add “Nos. 016968, 017790, and 021930”.

End Amendment Part
[Amended]
Start Amendment Part

7. In § 558.128, in paragraph (b)(2), remove “017519” and in its place add “021930”; and in the tables in paragraphs (e)(1) through (e)(4), in the “Sponsor” column remove “017519” wherever it occurs and in its place add “021930”.

End Amendment Part
[Amended]
Start Amendment Part

8. In § 558.274, in paragraph (a)(7), remove “017519” and in its place add “021930”; and in the table in paragraphs (c)(1)(i) and (c)(1)(ii), in the “Sponsor” column remove “017519” and in numerical sequence add “021930”.

End Amendment Part
[Amended]
Start Amendment Part

9. In paragraph (b)(3) of § 558.485, remove “017519” and in numerical sequence add “021930”.

End Amendment Part
[Amended]
Start Amendment Part

10. In paragraph (b)(10) of § 558.625, remove “017519” and in its place add “021930”.

End Amendment Part
[Amended]
Start Amendment Part

11. In § 558.630, remove and reserve paragraphs (b)(3) and (b)(8); and in paragraph (b)(10) remove “017519”.

End Amendment Part Start Signature

Dated: December 29, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. E7-118 Filed 1-9-07; 8:45 am]

BILLING CODE 4160-01-S