81_FR_95273 81 FR 95025 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

81 FR 95025 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 248 (December 27, 2016)

Page Range95025-95026
FR Document2016-31082

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.

Federal Register, Volume 81 Issue 248 (Tuesday, December 27, 2016) 
[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Rules and Regulations]
[Pages 95025-95026]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

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 (http://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

Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 95025 ■ 42. In § 558.665, remove and reserve DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: paragraphs (e)(5) and (6); remove HUMAN SERVICES Sujaya Dessai, Center for Veterinary paragraphs (e)(11) and (12); and add Medicine (HFV–212), Food and Drug paragraph (f) to read as follows: Food and Drug Administration Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5761, § 558.665 Zilpaterol. 21 CFR Part 558 sujaya.dessai@fda.hhs.gov. * * * * * [Docket No. FDA–2016–N–0002] SUPPLEMENTARY INFORMATION: FDA is (f) Zilpaterol may also be used in withdrawing approval of 11 NADAs and combination with tylosin as in New Animal Drugs; Withdrawal of Approval of New Animal Drug 4 ANADAs. These applications were § 558.625. identified as being affected by guidance Applications ■ 43. In § 558.680, remove paragraph for industry (GFI) #213, ‘‘New Animal AGENCY: Food and Drug Administration, Drugs and New Animal Drug (d)(1)(x); and add paragraph (e)(3) to HHS. Combination Products Administered in read as follows: ACTION: Notification of withdrawal. or on Medicated Feed or Drinking Water § 558.680 Zoalene. of Food-Producing Animals: SUMMARY: The Food and Drug * * * * * Administration (FDA) is withdrawing Recommendations for Drug Sponsors for (e) * * * approval of 11 new animal drug Voluntarily Aligning Product Use applications (NADAs) and 4 abbreviated Conditions With GFI #209,’’ December (3) Zoalene may also be used in new animal drug applications 2013 (http://www.fda.gov/downloads/ combination with lincomycin as in (ANADAs). These withdrawals of AnimalVeterinary/GuidanceCompliance § 558.325. approval of NADAs and ANADAs for Enforcement/GuidanceforIndustry/ Dated: December 20, 2016. antimicrobial drugs of importance to UCM299624.pdf). Their withdrawal of Tracey H. Forfa, human medicine that are administered approval is consistent with the FDA Deputy Director, Center for Veterinary to food-producing animals in medicated Center for Veterinary Medicine’s Medicine. feed are being made because the initiative for the Judicious Use of [FR Doc. 2016–31083 Filed 12–23–16; 8:45 am] products are no longer being Antimicrobials. manufactured or marketed. These BILLING CODE 4164–01–P actions are consistent with the FDA Approval of the following Center for Veterinary Medicine’s applications for new animal drugs initiative for the Judicious Use of administered in medicated feed is being Antimicrobials. voluntarily withdrawn at the sponsors’ requests because these products are no DATES: Withdrawal of approval is longer manufactured or marketed: effective December 30, 2016. File No. Product name Sponsor 034–085 .... LINCOMIX (lincomycin hydrochloride monohydrate) Type A Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. Medicated Article. 035–287 .... OM–5 Premix (oleandomycin) Type A Medicated Article ............ Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. 046–668 .... Penicillin G Procaine 50% Type A Medicated Article .................. Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. 091–668 .... CHLORMAX–SP 500 (chlortetracycline, sulfamethazine, peni- Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. cillin G procaine) Type A Medicated Article. 108–116 .... LINCOMIX (lincomycin)/NICARB (nicarbazin) .............................. Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. 133–334 .... Virginiamycin Type A Medicated Article ....................................... Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. 139–473 .... STAFAC (virginiamycin)/STENEROL (halofuginone Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 hydrobromide). Sophia, Bulgaria. 140–340 .... LINCOMIX (lincomycin)/STENOROL (halofuginone Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 hydrobromide). Sophia, Bulgaria. 140–443 .... HYGROMIX 1.6 (hygromycin B) Type A Medicated Article ......... Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. 140–947 .... LINCOMIX (lincomycin)/MAXIBAN (narasin and nicarbazin) ....... Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140. 141–090 .... STAFAC (virginiamycin)/CLINICOX (diclazuril) ............................ Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. 200–171 .... LINCOMIX (lincomycin)/NICARMIX (nicarbazin) .......................... Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053–120, Campinas, Sao Paulo, Brazil. 200–569 .... TYLAN (tylosin)/SACOX (salinomycin) ......................................... Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. 200–570 .... TYLOVET 100 (tylosin)/BIO–COX (salinomycin) ......................... Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. asabaliauskas on DSK3SPTVN1PROD with RULES 200–580 .... TYLOVET 100 (tylosin)/SACOX (salinomycin) ............................. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Therefore, under authority delegated Veterinary Medicine, and in accordance 514.116), notice is given that approval to the Commissioner of Food and Drugs with § 514.116 Notice of withdrawal of of NADAs 034–085, 035–287, 046–668, and redelegated to the Center for approval of application (21 CFR 091–668, 108–116, 133–334, 139–473, VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00117 Fmt 4700 Sfmt 4700 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, third party may not wish to be posted, made publicly available, you can 200–171, 200–569, 200–570, and 200– such as medical information, your or provide this information on the cover 580, and all supplements and anyone else’s Social Security number, or sheet and not in the body of your amendments thereto, is hereby confidential business information, such objections and you must identify this withdrawn, effective December 31, as a manufacturing process. Please note information as ‘‘confidential.’’ Any 2016. that if you include your name, contact information marked as ‘‘confidential’’ Elsewhere in this issue of the Federal information, or other information that will not be disclosed except in Register, FDA is amending the animal identifies you in the body of your accordance with 21 CFR 10.20 and other drug regulations to reflect the voluntary objection, that information will be applicable disclosure law. For more withdrawal of approval of these posted on https://www.regulations.gov. information about FDA’s posting of applications. • If you want to submit an objection comments to public dockets, see 80 FR with confidential information that you 56469, September 18, 2015, or access Dated: December 20, 2016. do not wish to be made available to the the information at: http://www.fda.gov/ Tracey H. Forfa, public, submit the objection as a regulatoryinformation/dockets/ Deputy Director, Center for Veterinary written/paper submission and in the default.htm. Medicine. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to [FR Doc. 2016–31082 Filed 12–23–16; 8:45 am] Submissions’’ and ‘‘Instructions’’). read background documents or the BILLING CODE 4164–01–P electronic and written/paper objections Written/Paper Submissions received, go to https:// Submit written/paper submissions as www.regulations.gov and insert the DEPARTMENT OF HEALTH AND follows: docket number, found in brackets in the HUMAN SERVICES • Mail/Hand delivery/Courier (for heading of this document, into the written/paper submissions): Division of ‘‘Search’’ box and follow the prompts Food and Drug Administration Dockets Management (HFA–305), Food and/or go to the Division of Dockets and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. 21 CFR Part 573 Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. [Docket No. FDA–2015–F–4282] • For written/paper objections FOR FURTHER INFORMATION CONTACT: submitted to the Division of Dockets Chelsea Trull, Center for Veterinary Food Additives Permitted in Feed and Management, FDA will post your Medicine, Food and Drug Drinking Water of Animals; Feed Grade objection, as well as any attachments, Administration, 7519 Standish Pl., Sodium Formate except for information submitted, Rockville, MD 20855, 240–402–6729, marked and identified, as confidential, chelsea.trull@fda.hhs.gov. AGENCY: Food and Drug Administration, if submitted as detailed in HHS. SUPPLEMENTARY INFORMATION: ‘‘Instructions.’’ ACTION: Final rule. Instructions: All submissions received I. Background must include the Docket No. FDA– In a notice published in the Federal SUMMARY: The Food and Drug 2015–F–4282 for ‘‘Food Additives Administration (FDA, we, the Agency) Register of November 24, 2015 (80 FR Permitted in Feed and Drinking Water 73153), FDA announced that we had is amending the regulations for food of Animals; Feed Grade Sodium additives permitted in feed and drinking filed a food additive petition (animal Formate.’’ Received objections will be use) (FAP 2293) submitted by BASF water of animals to provide for the safe placed in the docket and, except for use of feed grade sodium formate as a Corp., 100 Park Ave., Florham Park, NJ those submitted as ‘‘Confidential 07932. The petition proposed that the feed acidifying agent in complete Submissions,’’ publicly viewable at poultry feeds. This action is in response regulations for food additives permitted https://www.regulations.gov or at the in feed and drinking water of animals be to a food additive petition filed by BASF Division of Dockets Management Corp. amended to provide for the safe use of between 9 a.m. and 4 p.m., Monday feed grade sodium formate as a feed DATES: This rule is effective December through Friday. acidifying agent in complete poultry 27, 2016. Submit either written or • Confidential Submissions—To feeds. electronic objections and requests for a submit an objection with confidential hearing by January 26, 2017. See section information that you do not wish to be II. Conclusion V of this document for information on made publicly available, submit your FDA concludes that the data establish the filing of objections. objections only as a written/paper the safety and utility of feed grade ADDRESSES: You may submit objections submission. You should submit two sodium formate for use as a feed and requests for a hearing as follows: copies total. One copy will include the acidifying agent in complete poultry information you claim to be confidential feeds and that the food additive Electronic Submissions with a heading or cover note that states regulations should be amended as set Submit electronic objections in the ‘‘THIS DOCUMENT CONTAINS forth in this document. following way: CONFIDENTIAL INFORMATION.’’ The • Federal eRulemaking Portal: Agency will review this copy, including III. Public Disclosure https://www.regulations.gov. Follow the the claimed confidential information, in In accordance with § 571.1(h) (21 CFR instructions for submitting comments. its consideration of objections. The 571.1(h)), the petition and the asabaliauskas on DSK3SPTVN1PROD with RULES Objections submitted electronically, second copy, which will have the documents that we considered and including attachments, to https:// claimed confidential information relied upon in reaching our decision to www.regulations.gov will be posted to redacted/blacked out, will be available approve the petition will be made the docket unchanged. Because your for public viewing and posted on available for public disclosure (see FOR objection will be made public, you are https://www.regulations.gov. Submit FURTHER INFORMATION CONTACT). As solely responsible for ensuring that your both copies to the Division of Dockets provided in § 571.1(h), we will delete objection does not include any Management. If you do not wish your from the documents any materials that confidential information that you or a name and contact information to be are not available for public disclosure. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00118 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1


Document Created: 2018-02-14 09:13:26
Document Modified: 2018-02-14 09:13:26
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionNotification of withdrawal.
DatesWithdrawal of approval is effective December 30, 2016.
ContactSujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, [email protected]
FR Citation81 FR 95025 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR