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Home » 2014 Issues » 79 FR (04/10/2014) » 2014-08011. New Animal Drugs for Use in Animal Feeds; Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin

  2014-08011. New Animal Drugs for Use in Animal Feeds; Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin  

  • Start Preamble

    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 the withdrawal of approval of 19 new animal drug applications (NADAs) for certain Type A medicated articles and Type B medicated feeds. This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.

    DATES:

    This final rule is effective April 21, 2014.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079, john.bartkowiak@fda.hhs.gov.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    The following 5 sponsors have requested that FDA withdraw approval of the 19 NADAs listed in the following tables because the products are no longer manufactured or marketed:

    • ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115:
    NADAProduct name
    091-582 1Gilt Edge TYLAN (tylosin phosphate) Mix.
    108-484 1HFA Tylosin-10 Plus Sulfa (tylosin phosphate and sulfamethazine).
    110-045 1Good Life TYLAN 10 (tylosin phosphate) Premix.
    110-439 1HFA HYGROMIX 0.48 (hygromycin B) Medicated Premix.
    128-411 1TYLAN 5 Sulfa (tylosin phosphate and sulfamethazine) Premix.
    • Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX 79105:
    NADAProduct name
    138-187 1TYLAN 40 or 100 (tylosin phosphate).
    • Ridley USA, Inc. d/b/a Ridley Feed Ingredients, 1609 First Ave., P.O. Box 110, Mendota, IL 61342:
    NADAProduct name
    099-468 1Waynextra for Swine (tylosin phosphate).
    131-958 1TYLAN Sulfa-G (tylosin phosphate and sulfamethazine).
    132-136Ban-A-Worm II (pyrantel tartrate).
    • Provimi North America, Inc., 6531 State Rte. 503, Lewisburg, OH 45338:
    NADAProprietary name
    103-089 1TYLAN 5, 10, 20, or 40 (tylosin phosphate).
    118-814WORM-BAN 5 or 10 (pyrantel tartrate).
    127-508 1HYGROMIX 0.6 (hygromycin B).
    131-413FLAVOMYCIN 0.4 or 2 (bambermycins).
    133-333 1STAFAC 10 (virginiamycin).
    • Virbac AH, Inc., 3200 Meacham Blvd., Fort Worth, TX 76137:Start Printed Page 19815
    NADAProprietary name
    013-214 1PURINA HYGROMIX (hygromycin B) for Swine.
    042-660 1PURINA Pork-Plus (tylosin phosphate and sulfamethazine).
    043-387 1PURINA Hog Plus II (tylosin phosphate).
    099-767 1PURINA TYLAN 40 (tylosin) Plus Sulfamethazine.
    132-574 1PURINA Check-R-Ton Ll (lincomycin hydrochloride).
    1 The NADAs listed were identified as being affected by guidance for industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209,” December 2013.

    Elsewhere in this issue of the Federal Register, FDA gave notice that approval of the NADAs listed in this document, and all supplements and amendments thereto, is withdrawn. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval.

    In addition, FDA has noticed that conditions of use continue to be listed for an NADA that was voluntarily withdrawn in 1989. At this time, the regulations are being amended to remove the sponsor listing from the tables in 21 CFR 510.600(c) and the drug labeler code from 21 CFR 558.625. 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.

    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 558

    • Animal drugs
    • Animal feeds
    End List of Subjects

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 558 are amended as follows:

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    PART 510—NEW ANIMAL DRUGS

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    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 Start Amendment Part

    2. In § 510.600, in the table in paragraph (c)(1), remove the entries for “Gossett Nutrition, Inc.”, “Micro Beef Technologies LTD”, “Provimi North America, Inc.”, and “Wayne Feed Division, Continental Grain Co.”; and in the table in paragraph (c)(2), remove the entries for “017790”, “034936”, “047126”, and “050972”.

    End Amendment Part Start Part

    PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    End Part Start Amendment Part

    3. 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

    4. In § 558.95, in paragraph (a)(2), remove “Nos. 012286 and 017790” and in its place add “No. 012286”; and in paragraphs (d)(2)(i) and (ii), and paragraphs (d)(3)(i) and (ii), in the “Sponsor” column, remove “017790”.

    End Amendment Part
    [Amended]
    Start Amendment Part

    5. In § 558.274, in paragraph (a) introductory text, remove “or Type B medicated feeds”; remove paragraphs (a)(2) and (a)(3); redesignate paragraph (a)(4) as paragraph (a)(2); and in paragraphs (c)(1)(i) and (c)(2)(i), in the “Sponsor” column, remove “012286” and “017790”.

    End Amendment Part Start Amendment Part

    6. In § 558.325, redesignate paragraphs (a) through (d) as paragraphs (b) through (e), add new paragraph (a), revise newly redesignated paragraph (b), and in newly redesignated paragraph (e)(2), in the “Sponsor” column, remove “051311” wherever it occurs.

    End Amendment Part

    The addition and revision read as follows:

    Lincomycin.

    (a) Specifications. Type A medicated articles containing 20 or 50 grams per pound lincomycin as lincomycin hydrochloride.

    (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

    * * * * *
    [Amended]
    Start Amendment Part

    7. In § 558.485, remove and reserve paragraphs (b)(3) and (b)(6).

    End Amendment Part
    [Amended]
    Start Amendment Part

    8. In § 558.625:

    End Amendment Part Start Amendment Part

    a. Remove paragraphs (b)(2) through (24), (b)(26) through (38), (b)(40) through (53), and (b)(55) through (88); and

    End Amendment Part Start Amendment Part

    b. Redesignate paragraphs (b)(25), (b)(39), (b)(54), (b)(89), and (b)(90) as paragraphs (b)(2) through (6).

    End Amendment Part Start Amendment Part

    9. In § 558.630, revise paragraph (b) to read as follows:

    End Amendment Part
    Tylosin and sulfamethazine.
    * * * * *

    (b) Approvals. See sponsor in § 510.600(c) of this chapter for use as in paragraph (e) of this section.

    (1) No. 000986: 10 or 40 grams per pound each for use as in paragraph (e)(2)(i) of this section; 5, 10, 20, or 40 grams per pound each for use as in paragraph (e)(2)(ii) of this section; and 40 grams per pound each for use as in paragraph (e)(2)(iii) of this section.

    (2) No. 054771: 5, 10, 20, or 40 grams per pound each for use as in paragraph (e)(2)(ii) of this section.

    * * * * *
    Start Amendment Part

    10. In § 558.635, revise paragraph (a) to read as follows:

    End Amendment Part
    Virginiamycin.

    (a) Approvals. See sponsors in § 510.600(c) of this chapter:

    (1) No. 066104: Type A medicated articles containing 5, 10, 20, 50, or 227 grams per pound virginiamycin for use as in paragraph (d) of this section; and 136.2 grams per pound for use as in paragraph (d)(3) of this section.

    (2) No. 054771: Type A medicated articles containing 10 grams per pound virginiamycin for use as in paragraphs (d)(1)(iv) and (v) of this section.

    * * * * *
    Start Signature

    Dated: April 4, 2014.

    Bernadette Dunham,

    Director, Center for Veterinary Medicine.

    End Signature End Supplemental Information

    [FR Doc. 2014-08011 Filed 4-9-14; 8:45 am]

    BILLING CODE 4160-01-P

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Document Information

Effective Date:
4/21/2014
Published:
04/10/2014
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule; technical amendment.
Document Number:
2014-08011
Dates:
This final rule is effective April 21, 2014.
Pages:
19814-19815 (2 pages)
Docket Numbers:
Docket No. FDA-2014-N-0002
Topics:
Administrative practice and procedure, Animal drugs, Animal feeds, Labeling, Reporting and recordkeeping requirements
PDF File:
2014-08011.pdf
Supporting Documents:
» FREEDOM OF INFORMATION SUMMARY ANADA 200-512 TRIAMULOX tiamulin hydrogen fumarate, 12.3% Liquid Concentrate Swine re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 034-267 GENTOCIN DURAFILM (Gentamicin Sulfate and Betamethasone) Sterile Ophthalmic Solution re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 141-349 DRAXXIN 25 Injectable Solution Tulathromycin Injection Cattle (suckling calves, dairy calves, and veal calves) re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 141-276 ZILMAX plus RUMENSIN plus TYLAN (zilpaterol hydrochloride 4.8%; monensin, USP; and tylosin phosphate) Type A Medicated Articles For Use in the Manufacture of Type B and C Medicated Feeds Cattle Fed in Confinemen
» FREEDOM OF INFORMATION SUMMARY NADA 141-258 ZILMAX Zilpaterol Hydrochloride 4.8% Type A medicated article to be used in the manufacture of Type B and C medicated feeds Cattle fed in confinement for slaughter re New Animal Drugs; Approval of New Animal Dru
» FREEDOM OF INFORMATION SUMMARY NADA 141-232 SIMPLICEF Cefpodoxime proxetil Chewable tablets Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 141-068 BAYTRIL 100 Injectable Solution Enrofloxacin Swine re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 141-034 GAINPRO bambermycins Type A Medicated Article to be used in the manufacture of Type C Medicated Feeds Pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers) re New Animal
» FREEDOM OF INFORMATION SUMMARY NADA 141-437 OSURNIA florfenicol, terbinafine, betamethasone acetate Otic gel Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY ANADA 200-575 Carprofen Chewable Tablets Carprofen Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
CFR: (7)
21 CFR 558.95
21 CFR 558.274
21 CFR 558.325
21 CFR 558.485
21 CFR 558.625
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