New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications, 95025-95026 [2016-31082]

Download as PDF Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 42. In § 558.665, remove and reserve paragraphs (e)(5) and (6); remove paragraphs (e)(11) and (12); and add paragraph (f) to read as follows: DEPARTMENT OF HEALTH AND HUMAN SERVICES § 558.665 21 CFR Part 558 ■ Food and Drug Administration Zilpaterol. * * * * * (f) Zilpaterol may also be used in combination with tylosin as in § 558.625. [Docket No. FDA–2016–N–0002] 43. In § 558.680, remove paragraph (d)(1)(x); and add paragraph (e)(3) to read as follows: § 558.680 AGENCY: Food and Drug Administration, HHS. ACTION: Zoalene. Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing approval of 11 new animal drug applications (NADAs) and 4 abbreviated new animal drug applications (ANADAs). These withdrawals of approval of NADAs and ANADAs for antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed are being made because the products are no longer being manufactured or marketed. These actions are consistent with the FDA Center for Veterinary Medicine’s initiative for the Judicious Use of Antimicrobials. DATES: Withdrawal of approval is effective December 30, 2016. SUMMARY: * * * * * (e) * * * (3) Zoalene may also be used in combination with lincomycin as in § 558.325. Dated: December 20, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016–31083 Filed 12–23–16; 8:45 am] BILLING CODE 4164–01–P File No. 035–287 .... LINCOMIX (lincomycin hydrochloride monohydrate) Type A Medicated Article. OM–5 Premix (oleandomycin) Type A Medicated Article ............ 046–668 .... Penicillin G Procaine 50% Type A Medicated Article .................. 091–668 .... CHLORMAX–SP 500 (chlortetracycline, sulfamethazine, penicillin G procaine) Type A Medicated Article. LINCOMIX (lincomycin)/NICARB (nicarbazin) .............................. 108–116 .... 133–334 .... 139–473 .... FDA is withdrawing approval of 11 NADAs and 4 ANADAs. These applications 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 (https://www.fda.gov/downloads/ AnimalVeterinary/GuidanceCompliance Enforcement/GuidanceforIndustry/ UCM299624.pdf). Their withdrawal of approval is consistent with the FDA Center for Veterinary Medicine’s initiative for the Judicious Use of Antimicrobials. Approval of the following applications for new animal drugs administered in medicated feed is being voluntarily withdrawn at the sponsors’ requests because these products are no longer manufactured or marketed: Sponsor 140–443 .... 140–947 .... 141–090 .... Virginiamycin Type A Medicated Article ....................................... STAFAC (virginiamycin)/STENEROL (halofuginone hydrobromide). LINCOMIX (lincomycin)/STENOROL (halofuginone hydrobromide). HYGROMIX 1.6 (hygromycin B) Type A Medicated Article ......... LINCOMIX (lincomycin)/MAXIBAN (narasin and nicarbazin) ....... STAFAC (virginiamycin)/CLINICOX (diclazuril) ............................ 200–171 .... LINCOMIX (lincomycin)/NICARMIX (nicarbazin) .......................... 200–569 .... TYLAN (tylosin)/SACOX (salinomycin) ......................................... 200–570 .... TYLOVET 100 (tylosin)/BIO–COX (salinomycin) ......................... 200–580 .... TYLOVET 100 (tylosin)/SACOX (salinomycin) ............................. 140–340 .... asabaliauskas on DSK3SPTVN1PROD with RULES Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5761, sujaya.dessai@fda.hhs.gov. Product name 034–085 .... FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications ■ Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053–120, Campinas, Sao Paulo, Brazil. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR PO 00000 95025 Frm 00117 Fmt 4700 Sfmt 4700 514.116), notice is given that approval of NADAs 034–085, 035–287, 046–668, 091–668, 108–116, 133–334, 139–473, E:\FR\FM\27DER1.SGM 27DER1 95026 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 140–340, 140–443, 140–947, 141–090, 200–171, 200–569, 200–570, and 200– 580, and all supplements and amendments thereto, is hereby withdrawn, effective December 31, 2016. 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: December 20, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016–31082 Filed 12–23–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA–2015–F–4282] Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete poultry feeds. This action is in response to a food additive petition filed by BASF Corp. DATES: This rule is effective December 27, 2016. Submit either written or electronic objections and requests for a hearing by January 26, 2017. See section V of this document for information on the filing of objections. ADDRESSES: You may submit objections and requests for a hearing as follows: SUMMARY: asabaliauskas on DSK3SPTVN1PROD with RULES Electronic Submissions Submit electronic objections in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on https://www.regulations.gov. • If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper objections submitted to the Division of Dockets Management, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2015–F–4282 for ‘‘Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate.’’ Received objections will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of objections. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be PO 00000 Frm 00118 Fmt 4700 Sfmt 4700 made publicly available, you can provide this information on the cover sheet and not in the body of your objections and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper objections received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–6729, chelsea.trull@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In a notice published in the Federal Register of November 24, 2015 (80 FR 73153), FDA announced that we had filed a food additive petition (animal use) (FAP 2293) submitted by BASF Corp., 100 Park Ave., Florham Park, NJ 07932. The petition proposed that the regulations for food additives permitted in feed and drinking water of animals be amended to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete poultry feeds. II. Conclusion FDA concludes that the data establish the safety and utility of feed grade sodium formate for use as a feed acidifying agent in complete poultry feeds and that the food additive regulations should be amended as set forth in this document. III. Public Disclosure In accordance with § 571.1(h) (21 CFR 571.1(h)), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in § 571.1(h), we will delete from the documents any materials that are not available for public disclosure. E:\FR\FM\27DER1.SGM 27DER1

Agencies

[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Rules and Regulations]
[Pages 95025-95026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31082]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

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


New Animal Drugs; Withdrawal of Approval of New Animal Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 11 new animal drug applications (NADAs) and 4 abbreviated new animal 
drug applications (ANADAs). These withdrawals of approval of NADAs and 
ANADAs for antimicrobial drugs of importance to human medicine that are 
administered to food-producing animals in medicated feed are being made 
because the products are no longer being manufactured or marketed. 
These actions are consistent with the FDA Center for Veterinary 
Medicine's initiative for the Judicious Use of Antimicrobials.

DATES: Withdrawal of approval is effective December 30, 2016.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is withdrawing approval of 11 NADAs and 
4 ANADAs. These applications 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 (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their 
withdrawal of approval is consistent with the FDA Center for Veterinary 
Medicine's initiative for the Judicious Use of Antimicrobials.
    Approval of the following applications for new animal drugs 
administered in medicated feed is being voluntarily withdrawn at the 
sponsors' requests because these products are no longer manufactured or 
marketed:

------------------------------------------------------------------------
     File No.              Product name                 Sponsor
------------------------------------------------------------------------
034-085...........  LINCOMIX (lincomycin       Zoetis Inc., 333 Portage
                     hydrochloride              St., Kalamazoo, MI
                     monohydrate) Type A        49007.
                     Medicated Article.
035-287...........  OM-5 Premix                Phibro Animal Health
                     (oleandomycin) Type A      Corp., GlenPointe Centre
                     Medicated Article.         East, 3d Floor, 300
                                                Frank W. Burr Blvd.,
                                                Suite 21, Teaneck, NJ
                                                07666.
046-668...........  Penicillin G Procaine 50%  Phibro Animal Health
                     Type A Medicated Article.  Corp., GlenPointe Centre
                                                East, 3d Floor, 300
                                                Frank W. Burr Blvd.,
                                                Suite 21, Teaneck, NJ
                                                07666.
091-668...........  CHLORMAX-SP 500            Zoetis Inc., 333 Portage
                     (chlortetracycline,        St., Kalamazoo, MI
                     sulfamethazine,            49007.
                     penicillin G procaine)
                     Type A Medicated Article.
108-116...........  LINCOMIX (lincomycin)/     Phibro Animal Health
                     NICARB (nicarbazin).       Corp., GlenPointe Centre
                                                East, 3d Floor, 300
                                                Frank W. Burr Blvd.,
                                                Suite 21, Teaneck, NJ
                                                07666.
133-334...........  Virginiamycin Type A       Zoetis Inc., 333 Portage
                     Medicated Article.         St., Kalamazoo, MI
                                                49007.
139-473...........  STAFAC (virginiamycin)/    Huvepharma EOOD, 5th
                     STENEROL (halofuginone     Floor, 3A Nikolay Haytov
                     hydrobromide).             Str., 1113 Sophia,
                                                Bulgaria.
140-340...........  LINCOMIX (lincomycin)/     Huvepharma EOOD, 5th
                     STENOROL (halofuginone     Floor, 3A Nikolay Haytov
                     hydrobromide).             Str., 1113 Sophia,
                                                Bulgaria.
140-443...........  HYGROMIX 1.6 (hygromycin   Zoetis Inc., 333 Portage
                     B) Type A Medicated        St., Kalamazoo, MI
                     Article.                   49007.
140-947...........  LINCOMIX (lincomycin)/     Elanco US, Inc., 2500
                     MAXIBAN (narasin and       Innovation Way,
                     nicarbazin).               Greenfield, IN 46140.
141-090...........  STAFAC (virginiamycin)/    Huvepharma EOOD, 5th
                     CLINICOX (diclazuril).     Floor, 3A Nikolay Haytov
                                                Str., 1113 Sophia,
                                                Bulgaria.
200-171...........  LINCOMIX (lincomycin)/     Planalquimica Industrial
                     NICARMIX (nicarbazin).     Ltda., Rua das Magnolias
                                                nr. 2405, Jardim das
                                                Bandeiras, CEP 13053-
                                                120, Campinas, Sao
                                                Paulo, Brazil.
200-569...........  TYLAN (tylosin)/SACOX      Huvepharma EOOD, 5th
                     (salinomycin).             Floor, 3A Nikolay Haytov
                                                Str., 1113 Sophia,
                                                Bulgaria.
200-570...........  TYLOVET 100 (tylosin)/BIO- Huvepharma EOOD, 5th
                     COX (salinomycin).         Floor, 3A Nikolay Haytov
                                                Str., 1113 Sophia,
                                                Bulgaria.
200-580...........  TYLOVET 100 (tylosin)/     Huvepharma EOOD, 5th
                     SACOX (salinomycin).       Floor, 3A Nikolay Haytov
                                                Str., 1113 Sophia,
                                                Bulgaria.
------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with Sec.  514.116 Notice of withdrawal of approval of 
application (21 CFR 514.116), notice is given that approval of NADAs 
034-085, 035-287, 046-668, 091-668, 108-116, 133-334, 139-473,

[[Page 95026]]

140-340, 140-443, 140-947, 141-090, 200-171, 200-569, 200-570, and 200-
580, and all supplements and amendments thereto, is hereby withdrawn, 
effective December 31, 2016.
    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: December 20, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-31082 Filed 12-23-16; 8:45 am]
 BILLING CODE 4164-01-P
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