Document ID: FDA-2016-N-0002-0036
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug
Applications; Withdrawal of Approval of New Animal Drug Applications
Posted Date: 2017-02-24T05:00Z

[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Pages 11510-11513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03596]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2016-N-0002]

New Animal Drugs for Use in Animal Feed; Approval of New Animal 
Drug Applications; Withdrawal of Approval of New Animal Drug 
Applications

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 approval of eight supplemental new animal 
drug applications (NADAs). The effect of these supplemental 
applications will be to change the marketing status from over-the-
counter (OTC) use to use by veterinary feed directive (VFD) for these 
antimicrobial drugs of importance to human medicine, administered to 
food-producing animals in medicated feed. Where applicable, FDA is also 
withdrawing approval of those parts of the NADAs that pertain to use of 
these antimicrobial drugs for production indications. These actions are 
being taken at the sponsors' requests because these particular 
medicated feeds will no longer be manufactured or marketed. These 
applications were submitted in voluntary compliance with the goals of 
FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. 
In addition, the animal drug regulations are being amended to reflect 
the voluntary withdrawal of approval of certain entire NADAs and 
abbreviated new animal drug applications (ANADAs) that were affected by 
this initiative.

DATES: This rule is effective February 24, 2017.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Supplemental Approval of Revised Labeling and Withdrawal of Approval 
of Portions of NADAs Pertaining to Production Indications

    FDA is amending the animal drug regulations to reflect approval of 
eight supplemental NADAs for revised labeling reflecting a change in 
marketing status from OTC use to use by VFD for antimicrobial drugs of 
importance to human medicine administered to food-producing animals in 
medicated feed. Where applicable, FDA is also withdrawing approval of 
those parts of the NADAs that pertain to use of these antimicrobial 
drugs for production indications. These actions are being taken at the 
sponsors' requests because these particular medicated feeds will no 
longer be manufactured or marketed.
    These applications were identified as being affected by guidance 
for industry (GFI) #213, ``New Animal Drugs and

[[Page 11511]]

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 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their 
change from OTC to VFD marketing status is consistent with FDA CVM's 
initiative for the Judicious Use of Antimicrobials.
    The affected applications for Type A medicated articles for which 
supplemental applications with revised labeling were approved are as 
follows:

------------------------------------------------------------------------
        File No.           Animal drug product            Sponsor
------------------------------------------------------------------------
091-467................  STAFAC 500               Phibro Animal Health
                          (virginiamycin) Type A   Corp., GlenPointe
                          Medicated Article.       Centre East, 3d
                                                   Floor, 300 Frank W.
                                                   Burr Blvd., Suite 21,
                                                   Teaneck, NJ 07666
                                                   (Phibro Animal Health
                                                   Corp.).
140-998................  V-MAX (virginiamycin)    Phibro Animal Health
                          Type A Medicated         Corp.
                          Article.
------------------------------------------------------------------------

    The affected applications for manufacturing combination drug 
medicated feeds follow:

------------------------------------------------------------------------
        File No.           Animal drug product            Sponsor
------------------------------------------------------------------------
046-718................  TERRAMYCIN               Zoetis Inc., 333
                          (oxytetracycline)/MGA    Portage St.,
                          (melengestrol acetate).  Kalamazoo, MI 49007
                                                   (Zoetis Inc.).
046-719................  TERRAMYCIN               Zoetis Inc.
                          (oxytetracycline)/MGA
                          (melengestrol acetate).
140-579................  TERRAMYCIN               Zoetis Inc.
                          (oxytetracycline)/
                          BOVATEC (lasalocid).
141-114................  STAFAC (virginiamycin)/  Phibro Animal Health
                          AVIAX (semduramicin).    Corp.
141-289................  STAFAC (virginiamycin)/  Phibro Animal Health
                          AVIAX II                 Corp.
                          (semduramicin)
                          (biomass).
141-430................  STAFAC (virginiamycin)/  Phibro Animal Health
                          COBAN (monensin).        Corp.
------------------------------------------------------------------------

II. Withdrawals of Approval

    At the sponsors' requests, approval of applications is being 
withdrawn for medicated feeds containing antimicrobial drugs of 
importance to human medicine administered to food-producing animals 
because these products are no longer manufactured or marketed. The 
applications being withdrawn are as follows:

------------------------------------------------------------------------
        File No.               Product name               Sponsor
------------------------------------------------------------------------
044-820................  LINCOMIX (lincomycin)/   Zoetis Inc., 333
                          AMPROL PLUS (amprolium   Portage St.,
                          and ethopabate).         Kalamazoo, MI 49007
                                                   (Zoetis Inc.).
044-972................  LINCOMIX (lincomycin)/   Zoetis Inc.
                          COYDEN (clopidol).
047-261................  LINCOMIX (lincomycin)/   Zoetis Inc.
                          DECCOX (decoquinate).
047-262................  LINCOMIX (lincomycin)/   Zoetis Inc.
                          DECCOX (decoquinate).
048-954................  LINCOMIX (lincomycin)/   Zoetis Inc.
                          ZOAMIX (zoalene).
091-513................  STAFAC (virginiamycin)   Phibro Animal Health
                          Type A Medicated         Corp., GlenPointe
                          Article.                 Centre East, 3d
                                                   Floor, 300 Frank W.
                                                   Burr Blvd., Suite 21,
                                                   Teaneck, NJ 07666
                                                   (Phibro Animal Health
                                                   Corp.).
092-482................  LINCOMIX (lincomycin)/   Zoetis Inc.
                          COBAN (monensin).
093-106................  LINCOMIX (lincomycin)/   Zoetis Inc.
                          ROBENZ (robenidine).
101-689................  LINCOMIX (lincomycin)/   Zoetis Inc.
                          AVATEC (lasalocid).
122-481................  STAFAC (virginiamycin)/  Phibro Animal Health
                          COBAN (monensin).        Corp.
122-608................  STAFAC (virginiamycin)/  Phibro Animal Health
                          AVATEC (lasalocid).      Corp.
122-822................  STAFAC (virginiamycin)/  Phibro Animal Health
                          AMPROL PLUS (amprolium   Corp.
                          and ethopabate).
137-537................  LINCOMIX (lincomycin)/   Zoetis Inc.
                          BIO-COX (salinomycin).
138-792................  TYLAN (tylosin)/         Zoetis Inc.
                          RUMENSIN (monensin)/
                          MGA (melengestrol
                          acetate).
138-828................  STAFAC (virginiamycin)/  Phibro Animal Health
                          BIO-COX (salinomycin).   Corp.
138-904................  TYLAN (tylosin)/BOVATEC  Zoetis Inc.
                          (lasalocid)/MGA
                          (melengestrol acetate).
141-110................  STAFAC (virginiamycin)/  Phibro Animal Health
                          COBAN (monensin).        Corp.
141-150................  STAFAC (virginiamycin)/  Phibro Animal Health
                          AVATEC (lasalocid).      Corp.
200-092................  STAFAC (virginiamycin)/  Huvepharma EOOD, 5th
                          SACOX (salinomycin).     Floor, 3A Nikolay
                                                   Haytov Str., 1113
                                                   Sophia, Bulgaria
                                                   (Huvepharma EOOD).
200-093................  LINCOMIX (lincomycin)/   Huvepharma EOOD.
                          SACOX (salinomycin).
------------------------------------------------------------------------

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 044-820, 044-972, 047-261, 047-262, 048-954, 
091-513, 092-482, 093-106, 101-689, 122-481, 122-608, 122-822, 137-537, 
138-792, 138-828, 138-904, 141-110, and 141-150, and ANADAs 200-092 and 
200-093, and all supplements and amendments thereto, is withdrawn, 
effective February 24, 2017. As provided in the regulatory text of this 
document, the animal drug

[[Page 11512]]

regulations are amended to reflect these voluntary withdrawals of 
approval.
    A similar rule published in the Federal Register of December 27, 
2016 (81 FR 94991), amended the approved conditions of use in 21 CFR 
part 558 to reflect approval of an additional 106 supplemental NADAs 
and supplemental ANADAs for the manufacture of medicated feeds for 
administration of antimicrobial drugs to food-producing animals and the 
voluntary withdrawal of approval of 11 NADAs and 4 ANADAs.
    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 in 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 part 558 is 
amended as follows:

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

0
1. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
2. In Sec.  558.450, redesignate paragraph (e)(4)(iii) as paragraph 
(e)(4)(v) and add paragraphs (e)(4)(iii) and (iv) to read as follows:

Sec.  558.450   Oxytetracycline.

* * * * *
    (e) * * *
    (4) Cattle--

----------------------------------------------------------------------------------------------------------------
                                    Combination in grams/
      Oxytetracycline amount                 ton           Indications for use       Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iii) 75 mg/head/day..............  Lasalocid 25 to 30..  Heifers fed in        Feed continuously to      054771
                                                           confinement for       provide 250 to 360
                                                           slaughter (over 400   mg lasalocid and 75
                                                           lb): For reduction    mg of
                                                           of incidence of       oxytetracycline per
                                                           liver abscesses;      head per day.
                                                           and for increased     Lasalocid as
                                                           rate of weight gain   provided by No.
                                                           and improved feed     054771 in Sec.
                                                           efficiency.           510.600(c) of this
                                                                                 chapter.
(iv) 75 mg/head/day...............  Melengestrol          Heifers fed in        Feed continuously to      054771
                                     acetate, 0.25 to      confinement for       provide 0.25 to 0.5
                                     2.0.                  slaughter (over 400   mg of melengestrol
                                                           lb): For reduction    acetate and 75 mg
                                                           of incidence of       of oxytetracycline
                                                           liver abscesses;      per head per day.
                                                           and for increased     Melengestrol as
                                                           rate of weight        provided by No.
                                                           gain, improved feed   054771 in Sec.
                                                           efficiency, and       510.600(c) of this
                                                           suppression of        chapter.
                                                           estrus (heat).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
3. In Sec.  558.635, revise paragraphs (a) and (e) and add paragraphs 
(d)(1) and (2) to read as follows:

Sec.  558.635   Virginiamycin.

    (a) Specifications. Type A medicated articles containing 10, 20, 
50, or 227 grams virginiamycin per pound.
* * * * *
    (d) Special considerations. (1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for virginiamycin medicated feeds 
must not exceed 6 months from the date of issuance. VFDs for 
virginiamycin shall not be refilled.
* * * * *
    (e) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                    Combination in grams/
      Virginiamycin grams/ton                ton           Indications for use       Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 20............................  ....................  Broiler chickens:     Not for use in            066104
                                                           For prevention of     layers.
                                                           necrotic enteritis
                                                           caused by
                                                           Clostridium spp.
                                                           susceptible to
                                                           virginiamycin.
(ii)-(vi) [Reserved]
(vii) 20..........................  Monensin, 90 to 110.  Broiler chickens:     Feed continuously as      066104
                                                           For prevention of     the sole ration. Do
                                                           necrotic enteritis    not feed to laying
                                                           caused by             chickens. Monensin
                                                           Clostridium spp.      as provided by No.
                                                           susceptible to        058198 in Sec.
                                                           virginiamycin; and    510.600(c) of this
                                                           as an aid in the      chapter.
                                                           prevention of
                                                           coccidiosis caused
                                                           by Eimeria
                                                           necatrix, E.
                                                           tenella, E.
                                                           acervulina, E.
                                                           brunetti, E.
                                                           maxima, and E.
                                                           mivati.
(viii) [Reserved]

[[Page 11513]]

 
(ix) 20...........................  Semduramicin, 22.7..  Broiler chickens:     Feed continuously as      066104
                                                           For prevention of     the sole ration. Do
                                                           necrotic enteritis    not feed to laying
                                                           caused by             hens. Semduramicin
                                                           Clostridium spp.      as provided by No.
                                                           susceptible to        066104 in Sec.
                                                           virginiamycin; for    510.600(c) of this
                                                           the prevention of     chapter.
                                                           coccidiosis caused
                                                           by Eimeria
                                                           acervulina, E.
                                                           brunetti, E.
                                                           maxima, E mivati/
                                                           mitis, E. necatrix,
                                                           and E. tenella.
(x) 20............................  Semduramicin          Broiler chickens:     Feed continuously as      066104
                                     (biomass), 22.7.      For prevention of     the sole ration.
                                                           necrotic enteritis    Withdraw 1 day
                                                           caused by             before slaughter.
                                                           Clostridium spp.      Do not feed to
                                                           susceptible to        laying hens.
                                                           virginiamycin; for    Semduramicin as
                                                           the prevention of     provided by No.
                                                           coccidiosis caused    066104 in Sec.
                                                           by Eimeria            510.600(c) of this
                                                           acervulina, E.        chapter.
                                                           brunetti, E.
                                                           maxima, E mivati/
                                                           mitis, E. necatrix,
                                                           and E. tenella.
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
                                    Combination in grams/
      Virginiamycin grams/ton                ton           Indications for use       Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 25............................  ....................  Growing-finishing     ....................      066104
                                                           swine: As an aid in
                                                           control of
                                                           dysentery in swine
                                                           up to 120 pounds in
                                                           animals or on
                                                           premises with a
                                                           history of swine
                                                           dysentery but where
                                                           symptoms have not
                                                           yet occurred.
(ii) 50 or 100....................  ....................  Growing-finishing     Feed 100 grams per        066104
                                                           swine: For            ton for 2 weeks, 50
                                                           treatment and         grams per ton
                                                           control of swine      thereafter.
                                                           dysentery in swine
                                                           up to 120 pounds.
(iii) 100.........................  ....................  Growing-finishing     Feed for 2 weeks....      066104
                                                           swine: For
                                                           treatment of swine
                                                           dysentery in
                                                           nonbreeding swine
                                                           over 120 pounds.
----------------------------------------------------------------------------------------------------------------

    (3) Cattle--

----------------------------------------------------------------------------------------------------------------
                                    Combination in grams/
      Virginiamycin grams/ton                ton           Indications for use       Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 13.5 to 16.0..................  ....................  Cattle fed in         Feed continuously as      066104
                                                           confinement for       the sole ration to
                                                           slaughter: For        provide 85 to 240
                                                           reduction of          milligrams per head
                                                           incidence of liver    per day. Not for
                                                           abscesses.            use in animals
                                                                                 intended for
                                                                                 breeding.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    Dated: February 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03596 Filed 2-23-17; 8:45 am]
BILLING CODE 4164-01-P