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Home » 2012 Issues » 77 FR (05/30/2012) » 2012-13010. New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate; Progesterone and Estradiol Benzoate; Trenbolone Acetate; Trenbolone Acetate and Estradiol; Melengestrol; Ractopamine; Zilpaterol

  2012-13010. New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate; Progesterone and Estradiol Benzoate; Trenbolone Acetate; Trenbolone Acetate and Estradiol; Melengestrol; Ractopamine; Zilpaterol  

  • Start Preamble

    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule.

    SUMMARY:

    The 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.

    DATES:

    This rule is effective May 30, 2012.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    Steven 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.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    Ivy 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.

    Start Printed Page 31723
    NADA/ANADAProprietary name (established name)21 CFR section
    110-315COMPONENT E-C (progesterone and estradiol benzoate) with TYLAN (tylosin tartrate)522.1940
     COMPONENT E-S (progesterone and estradiol benzoate) with TYLAN (tylosin tartrate).
    118-123COMPONENT 200 (estradiol benzoate)
     ENCORE (COMPUDOSE 400) (estradiol benzoate).522.840
    135-906COMPONENT E-H (estradiol benzoate and testosterone propionate) with TYLAN (tylosin tartrate)522.842
    200-221COMPONENT TE-IS (trenbolone acetate and estradiol)522.2477
     COMPONENT TE-S (trenbolone acetate and estradiol).
     COMPONENT TE-G (trenbolone acetate and estradiol).
     COMPONENT TE-IS (trenbolone acetate and estradiol) with TYLAN (tylosin tartrate).
     COMPONENT TE-S (trenbolone acetate and estradiol) with TYLAN (tylosin tartrate).
     COMPONENT TE-G (trenbolone acetate and estradiol) with TYLAN (tylosin tartrate).
     COMPONENT TE-ID (trenbolone acetate and estradiol) with TYLAN (tylosin tartrate).
    200-224COMPONENT T-H (trenbolone acetate) with TYLAN (tylosin tartrate)522.2476
     COMPONENT T-S (trenbolone acetate) with TYLAN (tylosin tartrate).
    200-343HEIFERMAX 500 (melengestrol acetate) Liquid Premix558.342
    200-346COMPONENT TE-H (trenbolone acetate and estradiol)522.2477
     COMPONENT TE-H (trenbolone acetate and estradiol) with TYLAN (tylosin tartrate).
     COMPONENT TE-IH (trenbolone acetate and estradiol).
     COMPONENT TE-200 (trenbolone acetate and estradiol).
     COMPONENT TE-200 (trenbolone acetate and estradiol) with TYLAN (tylosin tartrate).
    200-375HEIFERMAX 500 (melengestrol acetate) Liquid Premix/RUMENSIN (monensin)/TYLAN (tylosin phosphate)558.342
    200-422HEIFERMAX 500 (melengestrol acetate) Liquid Premix plus RUMENSIN (monensin)558.342
    200-424HEIFERMAX 500 (melengestrol acetate) Liquid Premix/OPTAFLEXX (ractopamine HCI)/RUMENSIN (monensin)/TYLAN (tylosin phosphate)558.500
    200-427HEIFERMAX 500 (melengestrol acetate) Liquid Premix plus TYLAN (tylosin phosphate)558.342
    200-430HEIFERMAX 500 (melengestrol acetate) Liquid Premix/BOVATEC (lasalocid)/TYLAN (tylosin phosphate)558.342
    200-448HEIFERMAX 500 (melengestrol acetate) Liquid Premix/OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)558.500
    200-451HEIFERMAX 500 (melengestrol acetate) Liquid Premix plus BOVATEC (lasalocid)558.342
    200-479HEIFERMAX 500 (melengestrol acetate) Liquid Premix/ZILMAX (zilpaterol)/RUMENSIN (monensin)558.665
    200-480HEIFERMAX 500 (melengestrol acetate) Liquid Premix/ZILMAX (zilpaterol)/RUMENSIN (monensin)/TYLAN (tylosin phosphate)558.665
    200-483HEIFERMAX 500 (melengestrol acetate) Liquid Premix plus ZILMAX (zilpaterol)558.665

    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.

    Start List of Subjects

    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
    End List of Subjects

    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:

    Start Part

    PART 510—NEW ANIMAL DRUGS

    End Part Start Amendment Part

    1. The authority citation for 21 CFR part 510 continues to read as follows:

    End Amendment Part Start Authority

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

    End Authority
    [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”.

    Start Part

    PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    End Part Start Amendment Part

    3. The authority citation for 21 CFR part 522 continues to read as follows:

    End Amendment Part Start Authority

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

    End Authority
    [Amended]
    Start Amendment Part

    4. In paragraph (b) of § 522.840, remove “021641” and in its place add “000986”.

    End Amendment Part
    [Amended]
    Start Amendment Part

    5. In paragraph (a)(2) of § 522.842, remove “021641” and in its place add “000986”.

    End Amendment Part
    [Amended]
    Start Amendment Part

    6. In paragraph (a)(2) of § 522.1940, remove “021641” and in its place add “000986”.

    End Amendment Part
    [Amended]
    Start Amendment Part

    7. In paragraph (b)(l) of § 522.2476, remove “021641” and in its place add “000986”.

    End Amendment Part
    [Amended]
    Start Amendment Part

    8. In paragraph (b)(l) of § 522.2477, remove “021641” and in its place add “000986”.

    End Amendment Part Start Part

    PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    End Part Start Amendment Part

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

    End Amendment Part Start Authority

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

    End Authority
    [Amended]
    Start Amendment Part

    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” Start Printed Page 31724and 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”.

    End Amendment Part
    [Amended]
    Start Amendment Part

    11. In § 558.500, in the “Sponsor” column of the table, in paragraphs (e)(2)(viii) and (e)(2)(x), remove “021641”.

    End Amendment Part
    [Amended]
    Start Amendment Part

    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”.

    End Amendment Part Start Signature

    Dated: May 23, 2012.

    Elizabeth Rettie,

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

    End Signature End Supplemental Information

    [FR Doc. 2012-13010 Filed 5-29-12; 8:45 am]

    BILLING CODE 4160-01-P

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Document Information

Comments Received:
0 Comments
Effective Date:
5/30/2012
Published:
05/30/2012
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
2012-13010
Dates:
This rule is effective May 30, 2012.
Pages:
31722-31724 (3 pages)
Docket Numbers:
Docket No. FDA-2012-N-0002
Topics:
Administrative practice and procedure, Animal drugs, Animal feeds, Labeling, Reporting and recordkeeping requirements
PDF File:
2012-13010.pdf
Supporting Documents:
» Freedom of Information Summary ANADA 200-543 Cefpodoxime Proxetil
» Freedom of Information Summary ANADA 200-491, Loxicom (meloxicam)
» Freedom of Information Summary ANADA 200-485, Meloxicam Injection (meloxicam)
» Freedom of Information Summary NADA 200-496 96% Solution Growing chickens, turkeys and laying hens
» Freedom of Information Summary NADA 200-534 Melengestrol acetate plus monensin USP plus tylosin phosphate
» Freedom of Information Summary NADA 141-068 BAYTRIL 100 Injectable Solution
» Freedom of Information Summary NADA 141-346 OroCAM
» Freedom of Information Summary NADA 141-344 VERAFLOX Suspension for Cats
» Freedom of Information Summary ANADA 200-466 SPARMECTIN Plus Clorsulon
» Freedom of Information Summary NADA 141-342 ALFAXAN
CFR: (9)
21 CFR 510.600
21 CFR 522.840
21 CFR 522.842
21 CFR 522.1940
21 CFR 522.2476
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