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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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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.

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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.

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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.

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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
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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:

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

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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”.

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

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[Amended]
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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”.

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[Amended]
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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”.

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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.

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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.

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

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[Amended]
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8. In § 558.625:

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

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

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

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Tylosin and sulfamethazine.
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(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.

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

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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.

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Dated: April 4, 2014.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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

BILLING CODE 4160-01-P