New Animal Drugs; Changes of Sponsors: Estradiol; Estradiol Benzoate and Testosterone Propionate; Progesterone and Estradiol Benzoate; etc.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, and 558
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate; Progesterone and Estradiol Benzoate; Trenbolone Acetate; Trenbolone Acetate and Estradiol; Melengestrol; Ractopamine; ZilpaterolAgencyFood and Drug Administration, HHS. ActionFinal rule. SummaryThe Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for various steroid ear implants for cattle and for melengestrol acetate liquid Type A medicated article and use in combination medicated feeds for heifers fed in confinement for slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc., to Elanco Animal Health, Division of Eli Lilly & Co. DatesThis rule is effective May 30, 2012. For Further Information ContactSteven D. Vaughn,Center for Veterinary Medicine (HFV-100),Food and Drug Administration,7520 Standish Pl.,Rockville, MD 20855,240-276-8300,email: steven.vaughn@fda.hhs.gov. Supplementary InformationIvy Laboratories, Division of Ivy Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, has informed FDA that it has transferred ownership of, and all rights and interest in, the NADAs and ANADAs in this table to Elanco Animal Health, Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285.
Accordingly, the Agency is amending the regulations in parts 522 and 558 (21 CFR parts 522, and 558) to reflect the transfer of ownership. Following these changes of sponsorship, Ivy Laboratories, Division of Ivy Animal Health, Inc., is no longer the sponsor of an approved application. Accordingly, § 510.600 (21 CFR 510.600) is being amended to remove the entries for this 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 522
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, 522, and 558 are amended as follows:
Regulatory Text
Part 510 New Animal Drugs1. 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)(l), remove the entry for “Ivy Laboratories, Div. of Ivy Animal Health, Inc.”; and in the table in paragraph (c)(2), remove the entry for “021641”. Part 522 Implantation or Injectable Dosage Form New Animal Drugs3. The authority citation for 21 CFR part 522 continues to read as follows: Authority:21 U.S.C. 360b. § 522.840 [Amended]4. In paragraph (b) of § 522.840, remove “021641” and in its place add “000986”. § 522.842 [Amended]5. In paragraph (a)(2) of § 522.842, remove “021641” and in its place add “000986”. § 522.1940 [Amended]6. In paragraph (a)(2) of § 522.1940, remove “021641” and in its place add “000986”. § 522.2476 [Amended]7. In paragraph (b)(l) of § 522.2476, remove “021641” and in its place add “000986”. § 522.2477 [Amended]8. In paragraph (b)(l) of § 522.2477, remove “021641” and in its place add “000986”. Part 558 New Animal Drugs for Use in Animal Feeds9. The authority citation for 21 CFR part 558 continues to read as follows: Authority:21 U.S.C. 360b, 371. § 558.342 [Amended]10. In § 558.342, in paragraph (b)(2) and in the “Sponsor” column of the table, in paragraphs (e)(l)(i), (e)(1)(ii), (e)(l)(iii), and (e)(l)(ix) remove “021641”and in its place add “000986”; in paragraphs (e)(1)(iv) and (e)(1)(x) add “000986”; and in paragraph (e)(1)(xi), remove “02164” and in its place add “000986”. § 558.500 [Amended]11. In § 558.500, in the “Sponsor” column of the table, in paragraphs (e)(2)(viii) and (e)(2)(x), remove “021641”. § 558.665 [Amended]12. In § 558.665, in the “Sponsor” column of the table, in paragraphs (e)(2), (e)(4), and (e)(6), remove “021641” and in its place add “000986”.
Dated: May 23, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 2012-13010 Filed 5-29-12; 8:45 am]
BILLING CODE 4160-01-P
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ID:
FDA-2012-N-0002-0011
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Date Posted:
May 30, 2012
CFR:
21 CFR Parts 510, 522, and 558
Federal Register Number:
2012-13010
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