Rules and Regulations. Final rule
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/register/2000/02/29/00-4668A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4820-02-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 520 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. [FR Doc. 00-4668 Filed 2-28-00; 8:45 am]
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- 5 USC 801-808
- 21 CFR 510
- 21 CFR 520
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