E7-118. New Animal Drugs; Change of Sponsor

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.

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: [e-mail].

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)
048-480	Chloratet 50
065-256	Chlortet-Soluble-O
091-582	Gilt Edge TYLAN Mix
107-957	TYLAN 20 Sulfa-G, TYLAN 40 Sulfa-G
108-484	HFA Tylosin-10 Plus Sulfa
110-045	Good-Life TYLAN 10 Premix
110-439	HFA Hygromix 2.4 Medicated Premix
118-877	Ban-A-Worm Pyrantel Tartrate Ton Pack
128-411	TYLAN 5 Sulfa Premix
131-956	TYLAN Sulfa-G
131-957	TYLAN 10, TYLAN 20, TYLAN 40, TYLAN 5
132-448	FLAVOMYCIN
133-490	Ban-D-Wormer II BANMINTH
140-842	Hygromix 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.

List of Subjects

21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

21 CFR Part 520

• Animal drugs

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, 520, and 558 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.

§ 510.600

[Amended]

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”.

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.

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

§ 520.445b

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.

* * * * *

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

§ 558.95

[Amended]

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

§ 558.128

[Amended]

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”.

§ 558.274

[Amended]

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”.

§ 558.485

[Amended]

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

§ 558.625

[Amended]

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

§ 558.630

[Amended]

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

Dated: December 29, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.