Document ID: FDA-2014-N-0002-0019
Agency: fda
Document Type: Rule
Title: 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
Posted Date: 2014-04-10T04:00Z

[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Rules and Regulations]
[Pages 19814-19815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08011]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

[Docket No. FDA-2014-N-0002]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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.

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.

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:

------------------------------------------------------------------------
               NADA                             Product name
------------------------------------------------------------------------
091-582 \1\.......................  Gilt Edge TYLAN (tylosin phosphate)
                                     Mix.
108-484 \1\.......................  HFA Tylosin-10 Plus Sulfa (tylosin
                                     phosphate and sulfamethazine).
110-045 \1\.......................  Good Life TYLAN 10 (tylosin
                                     phosphate) Premix.
110-439 \1\.......................  HFA HYGROMIX 0.48 (hygromycin B)
                                     Medicated Premix.
128-411 \1\.......................  TYLAN 5 Sulfa (tylosin phosphate and
                                     sulfamethazine) Premix.
------------------------------------------------------------------------

     Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX 
79105:

------------------------------------------------------------------------
               NADA                             Product name
------------------------------------------------------------------------
138-187 \1\.......................  TYLAN 40 or 100 (tylosin phosphate).
------------------------------------------------------------------------

     Ridley USA, Inc. d/b/a Ridley Feed Ingredients, 1609 First 
Ave., P.O. Box 110, Mendota, IL 61342:

------------------------------------------------------------------------
               NADA                             Product name
------------------------------------------------------------------------
099-468 \1\.......................  Waynextra for Swine (tylosin
                                     phosphate).
131-958 \1\.......................  TYLAN Sulfa-G (tylosin phosphate and
                                     sulfamethazine).
132-136...........................  Ban-A-Worm II (pyrantel tartrate).
------------------------------------------------------------------------

     Provimi North America, Inc., 6531 State Rte. 503, 
Lewisburg, OH 45338:

------------------------------------------------------------------------
               NADA                           Proprietary name
------------------------------------------------------------------------
103-089 \1\.......................  TYLAN 5, 10, 20, or 40 (tylosin
                                     phosphate).
118-814...........................  WORM-BAN 5 or 10 (pyrantel
                                     tartrate).
127-508 \1\.......................  HYGROMIX 0.6 (hygromycin B).
131-413...........................  FLAVOMYCIN 0.4 or 2 (bambermycins).
133-333 \1\.......................  STAFAC 10 (virginiamycin).
------------------------------------------------------------------------

     Virbac AH, Inc., 3200 Meacham Blvd., Fort Worth, TX 76137:

[[Page 19815]]

------------------------------------------------------------------------
               NADA                           Proprietary name
------------------------------------------------------------------------
013-214 \1\.......................  PURINA HYGROMIX (hygromycin B) for
                                     Swine.
042-660 \1\.......................  PURINA Pork-Plus (tylosin phosphate
                                     and sulfamethazine).
043-387 \1\.......................  PURINA Hog Plus II (tylosin
                                     phosphate).
099-767 \1\.......................  PURINA TYLAN 40 (tylosin) Plus
                                     Sulfamethazine.
132-574 \1\.......................  PURINA 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.

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.

    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:

PART 510--NEW ANIMAL DRUGS

0
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.

0
2. In Sec.  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''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

Sec.  558.95  [Amended]

0
4. In Sec.  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''.

Sec.  558.274  [Amended]

0
5. In Sec.  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''.

0
6. In Sec.  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.
    The addition and revision read as follows:

Sec.  558.325  Lincomycin.

    (a) Specifications. Type A medicated articles containing 20 or 50 
grams per pound lincomycin as lincomycin hydrochloride.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *

Sec.  558.485  [Amended]

0
7. In Sec.  558.485, remove and reserve paragraphs (b)(3) and (b)(6).

Sec.  558.625  [Amended]

0
8. In Sec.  558.625:
0
a. Remove paragraphs (b)(2) through (24), (b)(26) through (38), (b)(40) 
through (53), and (b)(55) through (88); and
0
b. Redesignate paragraphs (b)(25), (b)(39), (b)(54), (b)(89), and 
(b)(90) as paragraphs (b)(2) through (6).

0
9. In Sec.  558.630, revise paragraph (b) to read as follows:

Sec.  558.630  Tylosin and sulfamethazine.

* * * * *
    (b) Approvals. See sponsor in Sec.  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.
* * * * *

0
10. In Sec.  558.635, revise paragraph (a) to read as follows:

Sec.  558.635  Virginiamycin.

    (a) Approvals. See sponsors in Sec.  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.
* * * * *

    Dated: April 4, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-08011 Filed 4-9-14; 8:45 am]
BILLING CODE 4160-01-P