# [Amended]
**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's drug labeler code for ADM Alliance Nutrition, Inc. This action is being taken to improve the accuracy of the regulations.
**DATES:**
This rule is effective June 23, 2008.
**FOR FURTHER INFORMATION CONTACT:**
Charise Kasser, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9069, e-mail: *[email protected]* .
**SUPPLEMENTARY INFORMATION:**
ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115, has informed FDA that it has obtained a new drug labeler code (DLC) in 2007, which has not been reflected in the animal drug regulations. Accordingly, the regulations in 21 CFR 510.600, 520.445b, 520.2380a, 558.95, 558.128, 558.274, 558.311, 558.355, 558.485, 558.625, and 558.630 are amended to reflect this new DLC. This action is being taken to improve the accuracy of the regulations.
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**
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Animal drugs.
Animal drugs, Animal feeds.
**21 CFR Part 520**
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**
**21 CFR Part 510**
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.
**21 CFR Part 510**
§ 510.600
2. In § 510.600, in the table in paragraph (c)(1), revise the entry for “ADM Alliance Nutrition, Inc.”; and in the table in paragraph (c)(2), remove the entry for “021930” and in numerical sequence add an entry for “012286” to read as follows:
**21 CFR Part 510**
§ 510.600
(c) * * *
(1) * * *
| Firm name and address | Drug labeler code |
| --- | --- |
| * * * * * | |
| ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115 | 012286 |
| * * * * * | |
(2) * * *
| Drug labeler code | Firm name and address |
| --- | --- |
| * * * * * | |
| 012286 | ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115 |
| * * * * * | |
**21 CFR Part 520**
**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.
**21 CFR Part 520**
§ 520.445b
4. In paragraph (b)(4) of § 520.445b, remove “021930” and in its place add “012286”.
**21 CFR Part 520**
§ 520.2380a
5. In paragraph (c)(3) of § 520.2380a, remove “021930” and in its place add “012286”.
**21 CFR Part 558**
**PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS**
**21 CFR Part 558**
6. The authority citation for 21 CFR part 558 continues to read as follows:
**Authority:**
21 U.S.C. 360b, 371.
**21 CFR Part 558**
§ 558.95
7. In paragraph (a)(4) of § 558.95, remove “016968, 017790, and 021930” and in its place add “012286, 016968, and 017790”.
**21 CFR Part 558**
§ 558.128
8. In § 558.128, in paragraph (b)(2), remove “021930” and in its place add “012286”; and in the tables in paragraphs (e)(1) through (e)(4), in the “Sponsor” column, remove “021930” wherever it occurs and in its place add “012286”.
**21 CFR Part 558**
§ 558.274
9. In § 558.274, in paragraph (a)(7), remove “021930” and in its place add “No. 012286”; and in the table in paragraphs (c)(1)(i) and (c)(1)(ii) in the “Sponsor” column, remove “021930” and in numerical sequence add “012286”.
**21 CFR Part 558**
§ 558.311
10. In paragraph (b)(5) of § 558.311, remove “017800 and 021930” and in its place add “012286 and 017800”.
**21 CFR Part 558**
§ 558.355
11. In paragraph (b)(13) of § 558.355, remove “021930” and in its place add “No. 012286”.
**21 CFR Part 558**
§ 558.485
12. In paragraph (b)(3) of § 558.485, remove “021930” and in numerical sequence add “012286”.
**21 CFR Part 558**
§ 558.625
13. In paragraphs (b)(10) and (b)(12) of § 558.625, remove “021930” and in its place add “No. 012286”.
§ 558.630
**21 CFR Part 558**
14. In § 558.630, in paragraph (b)(2), remove “021930” and in its place add “012286; and in paragraph (b)(5), remove “021930” and in numerical sequence add “012286”.
Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.