New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, 11510-11513 [2017-03596]

Download as PDF 11510 Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations File No. Product name Sponsor Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). Zoetis Inc. Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp. Phibro Animal Health Corp. Phibro Animal Health Corp. 044–972 047–261 047–262 048–954 091–513 ...................................... ...................................... ...................................... ...................................... ...................................... LINCOMIX (lincomycin)/COYDEN (clopidol) ............... LINCOMIX (lincomycin)/DECCOX (decoquinate) ....... LINCOMIX (lincomycin)/DECCOX (decoquinate) ....... LINCOMIX (lincomycin)/ZOAMIX (zoalene) ................ STAFAC (virginiamycin) Type A Medicated Article ..... 092–482 093–106 101–689 122–481 122–608 122–822 ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... 141–110 ...................................... 141–150 ...................................... 200–092 ...................................... LINCOMIX (lincomycin)/COBAN (monensin) .............. LINCOMIX (lincomycin)/ROBENZ (robenidine) ........... LINCOMIX (lincomycin)/AVATEC (lasalocid) .............. STAFAC (virginiamycin)/COBAN (monensin) ............. STAFAC (virginiamycin)/AVATEC (lasalocid) ............. STAFAC (virginiamycin)/AMPROL PLUS (amprolium and ethopabate). LINCOMIX (lincomycin)/BIO–COX (salinomycin) ........ TYLAN (tylosin)/RUMENSIN (monensin)/MGA (melengestrol acetate). STAFAC (virginiamycin)/BIO–COX (salinomycin) ....... TYLAN (tylosin)/BOVATEC (lasalocid)/MGA (melengestrol acetate). STAFAC (virginiamycin)/COBAN (monensin) ............. STAFAC (virginiamycin)/AVATEC (lasalocid) ............. STAFAC (virginiamycin)/SACOX (salinomycin) .......... 200–093 ...................................... LINCOMIX (lincomycin)/SACOX (salinomycin) ........... 137–537 ...................................... 138–792 ...................................... 138–828 ...................................... 138–904 ...................................... Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given 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, 141–150, 200–092, and 200–093, and all supplements and amendments thereto, is hereby withdrawn, effective February 24, 2017. Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications. Dated: February 17, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–03595 Filed 2–23–17; 8:45 am] pmangrum on DSK3GDR082PROD with RULES BILLING CODE 4164–01–P VerDate Sep<11>2014 14:13 Feb 23, 2017 Jkt 241001 Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp. Zoetis Inc. Phibro Animal Health Corp. Phibro Animal Health Corp. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). Huvepharma EOOD. 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. Final rule; technical amendment. ACTION: 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 foodproducing 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 SUMMARY: PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 (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 foodproducing 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 E:\FR\FM\24FER1.SGM 24FER1 Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations 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 11511 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 (virginiamycin) Type A Medicated Article .......... 140–998 ............. V–MAX (virginiamycin) Type A Medicated Article ................... Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). Phibro Animal Health Corp. The affected applications for manufacturing combination drug medicated feeds follow: File No. Animal drug product Sponsor 046–718 ............. TERRAMYCIN (oxytetracycline)/MGA (melengestrol acetate) 046–719 140–579 141–114 141–289 141–430 TERRAMYCIN (oxytetracycline)/MGA (melengestrol acetate) TERRAMYCIN (oxytetracycline)/BOVATEC (lasalocid) .......... STAFAC (virginiamycin)/AVIAX (semduramicin) ..................... STAFAC (virginiamycin)/AVIAX II (semduramicin) (biomass) STAFAC (virginiamycin)/COBAN (monensin) .......................... Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp. Phibro Animal Health Corp. Phibro Animal Health 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 foodproducing 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)/AMPROL PLUS (amprolium and ethopabate). LINCOMIX (lincomycin)/COYDEN (clopidol) ........................... LINCOMIX (lincomycin)/DECCOX (decoquinate) .................... LINCOMIX (lincomycin)/DECCOX (decoquinate) .................... LINCOMIX (lincomycin)/ZOAMIX (zoalene) ............................. STAFAC (virginiamycin) Type A Medicated Article ................. Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). Zoetis Inc. Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp. Phibro Animal Health Corp. Phibro Animal Health Corp. 044–972 047–261 047–262 048–954 091–513 ............. ............. ............. ............. ............. 092–482 093–106 101–689 122–481 122–608 122–822 ............. ............. ............. ............. ............. ............. 141–110 ............. 141–150 ............. 200–092 ............. LINCOMIX (lincomycin)/COBAN (monensin) ........................... LINCOMIX (lincomycin)/ROBENZ (robenidine) ....................... LINCOMIX (lincomycin)/AVATEC (lasalocid) ........................... STAFAC (virginiamycin)/COBAN (monensin) .......................... STAFAC (virginiamycin)/AVATEC (lasalocid) .......................... STAFAC (virginiamycin)/AMPROL PLUS (amprolium and ethopabate). LINCOMIX (lincomycin)/BIO–COX (salinomycin) .................... TYLAN (tylosin)/RUMENSIN (monensin)/MGA (melengestrol acetate). STAFAC (virginiamycin)/BIO–COX (salinomycin) ................... TYLAN (tylosin)/BOVATEC (lasalocid)/MGA (melengestrol acetate). STAFAC (virginiamycin)/COBAN (monensin) .......................... STAFAC (virginiamycin)/AVATEC (lasalocid) .......................... STAFAC (virginiamycin)/SACOX (salinomycin) ....................... 200–093 ............. LINCOMIX (lincomycin)/SACOX (salinomycin) ........................ 137–537 ............. 138–792 ............. pmangrum on DSK3GDR082PROD with RULES 138–828 ............. 138–904 ............. 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, VerDate Sep<11>2014 14:13 Feb 23, 2017 Jkt 241001 Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp. Zoetis Inc. Phibro Animal Health Corp. Phibro Animal Health Corp. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). Huvepharma EOOD. 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 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 supplements and amendments thereto, is withdrawn, effective February 24, 2017. As provided in the regulatory text of this document, the animal drug E:\FR\FM\24FER1.SGM 24FER1 11512 Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations 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 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: Combination in grams/ton * * (iii) 75 mg/head/day .................. * Lasalocid 25 to 30 ................... (iv) 75 mg/head/day .................. Melengestrol acetate, 0.25 to 2.0. * * * * * * 3. In § 558.635, revise paragraphs (a) and (e) and add paragraphs (d)(1) and (2) to read as follows: ■ § 558.450 * Oxytetracycline. * * (e) * * * (4) Cattle— * * Limitations * * * Heifers fed in confinement for Feed continuously to provide slaughter (over 400 lb): For 250 to 360 mg lasalocid and reduction of incidence of 75 mg of oxytetracycline per liver abscesses; and for inhead per day. Lasalocid as creased rate of weight gain provided by No. 054771 in and improved feed efficiency. § 510.600(c) of this chapter. Heifers fed in confinement for Feed continuously to provide slaughter (over 400 lb): For 0.25 to 0.5 mg of reduction of incidence of melengestrol acetate and 75 liver abscesses; and for inmg of oxytetracycline per creased rate of weight gain, head per day. Melengestrol improved feed efficiency, as provided by No. 054771 and suppression of estrus in § 510.600(c) of this chap(heat). ter. * § 558.635 2. In § 558.450, redesignate paragraph (e)(4)(iii) as paragraph (e)(4)(v) and add paragraphs (e)(4)(iii) and (iv) to read as follows: ■ Indications for use * * 1. The authority citation for part 558 continues to read as follows: ■ Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc–1, 371. Animal drugs, Animal feeds. Oxytetracycline amount PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS * 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 * Sponsor * 054771 054771 * veterinarian. See § 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/ton Indications for use Limitations (i) 20 ......................................... .................................................. Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin. Not for use in layers ................ 066104 (ii)–(vi) [Reserved] (vii) 20 ...................................... pmangrum on DSK3GDR082PROD with RULES Virginiamycin grams/ton Monensin, 90 to 110 ............... Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati. Feed continuously as the sole ration. Do not feed to laying chickens. Monensin as provided by No. 058198 in § 510.600(c) of this chapter. 066104 (viii) [Reserved] VerDate Sep<11>2014 14:13 Feb 23, 2017 Jkt 241001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\24FER1.SGM 24FER1 Sponsor Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations 11513 Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsor (ix) 20 ....................................... Semduramicin, 22.7 ................ Feed continuously as the sole ration. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (x) 20 ........................................ Semduramicin (biomass), 22.7 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, and E. tenella. Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, and E. tenella. Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (2) Swine— Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 25 ......................................... .................................................. .................................................. 066104 (ii) 50 or 100 ............................. .................................................. Feed 100 grams per ton for 2 weeks, 50 grams per ton thereafter. 066104 (iii) 100 ..................................... .................................................. Growing-finishing 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. Growing-finishing swine: For treatment and control of swine dysentery in swine up to 120 pounds. Growing-finishing swine: For treatment of swine dysentery in nonbreeding swine over 120 pounds. Feed for 2 weeks .................... 066104 (3) Cattle— Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations (i) 13.5 to 16.0 .......................... .................................................. Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses. Feed continuously as the sole ration to provide 85 to 240 milligrams per head per day. Not for use in animals intended for breeding. Sponsor 066104 (ii) [Reserved] Dated: February 17, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–03596 Filed 2–23–17; 8:45 am] ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 174 [EPA–HQ–OPP–2014–0457; FRL–9957–97] BILLING CODE 4164–01–P pmangrum on DSK3GDR082PROD with RULES VNT1 Protein in Potato; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of VNT1 protein in potato when used as a plant- SUMMARY: VerDate Sep<11>2014 14:13 Feb 23, 2017 Jkt 241001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 incorporated protectant. J.R. Simplot Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting a permanent exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of VNT1 protein in potato under FFDCA. This regulation is effective February 24, 2017. Objections and requests for hearings must be received on or before April 25, 2017 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also DATES: E:\FR\FM\24FER1.SGM 24FER1

Agencies

[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]


-----------------------------------------------------------------------

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