00-4668. Oral Dosage Form New Animal Drugs; Change of Sponsor

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the change of sponsor for 13 new animal drug applications (NADA's) from I. D. Russell Co., Laboratories to Alpharma Inc.

DATES:

This rule is effective February 29, 2000.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION:

I. D. Russell Co., Laboratories, 1301 Iowa Ave., Longmont, CO 80501, has informed FDA that it has transferred the ownership of, and all rights and interest in, the following approved NADA's to Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024:

NADA No.	Product name
6-019	Zuco Poultry Tabs
6-081	Korum
6-776	10% Sulfaquinoxaline
6-860	Ruco Tablets
6-891	Liquid Sul-Q-Nox
8-902	Hepasol
100-094	Poultry Sulfa
100-175	20% Sulfaquinoxaline
100-176	34% Sulfaquinoxaline
130-435	Oxytet Soluble
200-106	R-Pen
200-189	Lincomycin Soluble
200-274	Lincomycin Injectable 30%

The agency is amending parts 510 and 520 (21 CFR parts 510 and 520) to reflect the change of sponsor. The agency is amending § 510.600(c)(1) and (c)(2) to remove the sponsor name for I. D. Russell Co., Laboratories because the firm no longer is the holder of any approved NADA's.

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 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. Section 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications is amended in the table in paragraphs (c)(1) by removing the entry for “I. D. Russell Co., Laboratories” and in the table in paragraph (c)(2) by removing the entry for “017144”.

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.

§ 520.1263c

[Amended]

4. Section 520.1263c Lincomycin hydrochloride soluble powder is amended in paragraph (b) by removing “017144” and adding in its place “046573”.

§ 520.1660d

[Amended]

5. Section 520.1660d Oxytetracycline hydrochloride soluble powder is amended in paragraphs (b)(2), (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and (d)(1)(iii)(C) by removing “017144” and adding in its place “046573”.

§ 520.1696b

[Amended]

6. Section 520.1696b Penicillin G potassium in drinking water is amended in paragraph (b) by removing “017144,”.

§ 520.2088

[Amended]

7. Section 520.2088 Roxarsone tablets is amended in paragraph (c)(2) by removing “017144” and adding in its place “046573”.

§ 520.2089

[Amended]

8. Section 520.2089 Roxarsone liquid is amended in paragraph (b) by removing “017144” and adding in its place “046573”.

§ 520.2325a

[Amended]

9. Section 520.2325a Sulfaquinoxaline drinking water is amended in paragraph (a)(3) by removing “017144” and adding in its place “046573”.

Dated: February 16, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.