New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address, 11506-11509 [2017-03677]

Download as PDF 11506 Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations pmangrum on DSK3GDR082PROD with RULES Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222, as amended by Executive Order 13637. Rulemaking Requirements 1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866. 2. Notwithstanding any other provision of law, no person is required to respond to or be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694–0088, Simplified Network Application Processing System, which includes, among other things, license applications and carries a burden estimate of 43.8 minutes for a manual or electronic submission. Total burden hours associated with the PRA and OMB control number 0694–0088 are not expected to increase as a result of this rule. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email to Jasmeet_K._ Seehra@omb.eop.gov, or by fax to (202) 395–7285. 3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132. 4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public comment, and a delay in effective date are inapplicable because this regulation involves a military or foreign affairs function of the United States. (See 5 U.S.C. 553(a)(1)). If this rule were delayed to allow for notice and VerDate Sep<11>2014 14:13 Feb 23, 2017 Jkt 241001 comment and a delay in effective date, then the national security and foreign policy objectives of this rule would be harmed. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared. List of Subject in 15 CFR Part 744 Exports, Reporting and recordkeeping requirements, Terrorism. Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730 through 774) is amended as follows: PART 744—[AMENDED] 1. The authority citation for 15 CFR part 744 continues to read as follows: ■ Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; Notice of January 20, 2016, 81 FR 3937 (January 22, 2016); Notice of August 4, 2016, 81 FR 52587 (August 8, 2016); Notice of September 15, 2016, 81 FR 64343 (September 19, 2016); Notice of November 8, 2016, 81 FR 79379 (November 10, 2016). Supplement No. 7 to Part 744— [AMENDED] 2. In Supplement No. 7 to part 744, remove ‘‘February 27, 2017’’ and add in its place ‘‘March 29, 2017’’. ■ Dated: February 21, 2017. Matthew S. Borman, Deputy Assistant Secretary for Export Administration. [FR Doc. 2017–03664 Filed 2–23–17; 8:45 am] BILLING CODE 3510–33–P PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, and 558 [Docket No. FDA–2016–N–0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor’s Address AGENCY: Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of several applications and a change of a sponsor’s address. DATES: This rule is effective February 24, 2017, except for the amendment to 21 CFR 524.1465, which is effective March 6, 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: SUMMARY: I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during September and October 2016, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., E:\FR\FM\24FER1.SGM 24FER1 11507 Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/ AboutFDA/CentersOffices/ OfficeofFoods/CVM/ CVMFOIAElectronicReadingRoom/ default.htm. Marketing exclusivity and patent information may be accessed in FDA’s publication, Approved Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/ Products/ ApprovedAnimalDrugProducts/ default.htm. TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING SEPTEMBER AND OCTOBER 2016 Approval date File No. Sponsor Product name Species Effect of the action/indications for use Original approval for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. Original approval of a generic copy of NADA 055–099. October 26, 2016 .... 141–465 Elanco US Inc, 2500 Innovation Way, Greenfield, IN 46140. INTEPRITY (avilamycin) and COBAN (monensin) Type C medicated feeds. Chickens September 8, 2016 200–592 Putney, Inc., One Monument Sq., Suite 400, Portland, ME 04101. Amoxicillin Trihydrate and Clavulanate Potassium Tablets. Dogs ...... II. Change of Sponsorship informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Ceva Sogeval S. A., 200 Avenue de Mayenne, 53000 Laval, France has FOI Summary. FOI Summary. Sante Animale, 10 Avenue de la ` Ballastiere, 33500 Libourne, France: File No. Product name 099–667 ................................................... 110–399 ................................................... IMPOSIL (iron heptomer) Injection .......................................................................... GLEPTOSIL (gleptoferron) Injection ........................................................................ Following these changes of sponsorship, Sogeval S. A. is no longer the sponsor of an approved NADA. Accordingly, the firm’s name, address, and drug labeler code are being removed from § 510.600(c) (21 CFR 510.600(c)). In addition, Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has informed FDA that it has transferred ownership File No. 006–417 032–319 038–838 108–687 111–369 ................................................... ................................................... ................................................... ................................................... ................................................... III. Withdrawals of Approval Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort Collins, CO 80524 has informed FDA that it has changed its address to 1230 W. Ash St., Suite D, Windsor, CO 80550. In addition, FDA has noticed that a sponsor name in § 510.600 does not reflect the particular punctuation used in this sponsor’s applications and other correspondence. At this time, we are amending the list of sponsors of approved applications in § 510.600(c) to reflect this change of sponsor address and sponsor’s punctuation. In addition, Putney, Inc., One Monument Square, Suite 400, Portland, ME 04101 has requested that FDA withdraw approval of ANADA 200–524 for Mupirocin Ointment 2% because the product is no longer manufactured or marketed. Elsewhere in this issue of the Federal Register, FDA gave notice that approval of ANADA 200–524, and all supplements and amendments thereto, is withdrawn, effective March 6, 2017. 14:13 Feb 23, 2017 Jkt 241001 522.1182 522.1055 of, and all rights and interest in, the following applications to Kinetic Technologies, LLC, 961 Beasley St., Suite 270, Lexington, KY 40509: 21 CFR section RECOVR (tripelennamine hydrochloride) Injection ................................................. FUROX (furazolidone) Aerosol Powder .................................................................. ROBAXIN–V (methocarbamol) Injection ................................................................. PET DERM III (dexamethasone) Tablets ................................................................ Dexamethasone Sterile Solution ............................................................................. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect this voluntary withdrawal of approval. VerDate Sep<11>2014 21 CFR section Product name Following these changes of sponsorship, Kinetic Technologies, LLC is now the sponsor of an approved NADA. Accordingly, the firm’s name, address, and drug labeler code are being added to § 510.600(c). pmangrum on DSK3GDR082PROD with RULES Public documents IV. Technical Amendments PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 522.2615 524.1005 522.1380 520.540c 522.540 This rule does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because it is a rule of ‘‘particular applicability.’’ Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Parts 520, 522, and 524 Animal drugs. 21 CFR Part 558 Animal drugs, Animal feeds. E:\FR\FM\24FER1.SGM 24FER1 11508 Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations 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 parts 510, 520, 522, 524, and 558 are amended as follows: PART 510—NEW ANIMAL DRUGS 1. The authority citation for part 510 continues to read as follows: ■ Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. § 510.600 [Amended] ii. Revise the entry for ‘‘053923’’ iii. In the entry for ‘‘058198’’, remove ‘‘Elanco US, Inc.’’ and in its place add ‘‘Elanco US Inc.’’; and ■ iv. Remove the entry for ‘‘059120’’. The additions and revisions read as follows: ■ 2. Revise § 510.600 as follows: a. In the table in paragraph (c)(1): i. In the entry for ‘‘Elanco US, Inc.’’, remove ‘‘Elanco US, Inc.’’ and in its place add ‘‘Elanco US Inc.’’; ■ ii. Alphabetically add an entry for ‘‘Kinetic Technologies, LLC’’; ■ iii. Remove the entry for ‘‘Sogeval S. A.’’; and ■ iv. Revise the entry for ‘‘Wildlife Laboratories, Inc.’’ ■ b. In the table in paragraph (c)(2): ■ i. Numerically add an entry for ‘‘051031’’; ■ ■ ■ ■ § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * (c) * * * (1) * * * * * Drug labeler code Firm name and address * * * * * * Kinetic Technologies, LLC, 961 Beasley St., Suite 270, Lexington, KY 40509 .................................................................................. * * * * * * * Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D, Windsor, CO 80550 ....................................................................................... * * * * * * * 051031 053923 * (2) * * * Drug labeler code Firm name and address * * * 051031 ........................................................................................... * * * * Kinetic Technologies, LLC, 961 Beasley St., Suite 270, Lexington, KY 40509. * * * 053923 ........................................................................................... * * * * Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D, Windsor, CO 80550. * * * PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for part 520 continues to read as follows: ■ 4. In § 520.88g, in paragraph (b), remove ‘‘No. 054771’’ and in its place add ‘‘Nos. 026637 and 054771’’. ■ 5. In § 520.540c, in paragraph (b), remove ‘‘054771’’ and in its place add ‘‘051031’’. pmangrum on DSK3GDR082PROD with RULES PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 7. In § 522.540, in paragraph (d)(2)(i), remove ‘‘054771’’ and in its place add ‘‘051031’’. ■ [Amended] 8. In § 522.1055, in paragraph (b), remove ‘‘059120’’ and in its place add ‘‘013744’’. § 522.1182 [Amended] 9. In § 522.1182, in paragraph (b)(3), remove ‘‘059120’’ and in its place add ‘‘013744’’. § 522.1380 Authority: 21 U.S.C. 360b. Jkt 241001 [Amended] 10. In § 522.1380, in paragraph (b), remove ‘‘054771’’ and in its place add ‘‘051031’’. ■ § 522.2615 6. The authority citation for part 522 continues to read as follows: ■ 14:13 Feb 23, 2017 [Amended] ■ [Amended] ■ VerDate Sep<11>2014 * * [Amended] 12. The authority citation for part 524 continues to read as follows: ■ Authority: 21 U.S.C. 360b. Frm 00008 Fmt 4700 § 524.1005 [Amended] 13. In § 524.1005, in paragraph (b)(1), remove ‘‘054771’’ and in its place add ‘‘051031’’. ■ § 524.1465 [Amended] 14. Effective March 6, 2017, in § 524.1465, in paragraph (b), remove ‘‘026637’’. ■ PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 15. The authority citation for part 558 continues to read as follows: ■ 11. In § 522.2615, in paragraph (b), remove ‘‘054771’’ and in its place add ‘‘051031’’. ■ PO 00000 * PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS ■ [Amended] § 520.540c § 522.540 § 522.1055 Authority: 21 U.S.C. 360b. § 520.88g * Sfmt 4700 Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc–1, 371. E:\FR\FM\24FER1.SGM 24FER1 Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations § 558.68 16. In § 558.68, revise paragraph (e)(1)(ii) to read as follows: ■ * Avilamycin. * * * (e) * * * (1) * * * * Avilamycin in grams/ton Combination in grams/ton Indications for use * (ii) 13.6 to 40.9 ........ * Monensin 90 to 110; as provided by No. 058198 in § 510.600(c) of this chapter. * * Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. Limitations [Docket No. FDA–2016–N–0002] New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application Dated: February 21, 2017. Leslie Kux, Associate Commissioner for Policy. * * * * Dated: February 21, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–03677 Filed 2–23–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 AGENCY: Food and Drug Administration, ACTION: Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) at the sponsor’s request because the product is no longer manufactured or marketed. DATES: Withdrawal of approval is effective March 6, 2017. 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: Putney, Inc., One Monument Square, Suite 400, Portland, ME 04101 has requested that FDA withdraw approval of ANADA 200–524 for Mupirocin Ointment 2% because the product is no longer manufactured or marketed. SUMMARY: pmangrum on DSK3GDR082PROD with RULES [FR Doc. 2017–03678 Filed 2–23–17; 8:45 am] BILLING CODE 4164–01–P HHS. 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. The Food and Drug Administration (FDA) is withdrawing approval of 18 new animal drug applications (NADAs) and 2 abbreviated new animal drug applications (ANADAs). These withdrawals of SUMMARY: File No. LINCOMIX (lincomycin)/AMPROL PLUS (amprolium and ethopabate). 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 manufactured or marketed. These actions are consistent with the FDA Center for Veterinary Medicine’s initiative for the Judicious Use of Antimicrobials. Withdrawal of approval is effective February 24, 2017. DATES: 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 18 NADAs and 2 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: Product name 044–820 ...................................... VerDate Sep<11>2014 14:13 Feb 23, 2017 Jkt 241001 PO 00000 Frm 00009 Fmt 4700 Sponsor Sfmt 4700 Sponsor * * * Feed as the sole ration for 21 consecu058198 tive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 10 days of age. See § 558.355(d) of this chapter for additional required labeling. 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 ANADA 200–524, and all supplements and amendments thereto, is hereby withdrawn, effective March 6, 2017. Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of this application. * 11509 Zoetis Inc. 333 Portage St. Kalamazoo, MI 49007 (Zoetis Inc.). E:\FR\FM\24FER1.SGM 24FER1

Agencies

[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Pages 11506-11509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03677]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 558

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


New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of a New Animal Drug Application; Change of 
Sponsor; Change of Sponsor's Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during September and October 2016. FDA is also 
informing the public of the availability of summaries of the basis of 
approval and of environmental review documents, where applicable. The 
animal drug regulations are also being amended to reflect changes of 
sponsorship of several applications and a change of a sponsor's 
address.

DATES: This rule is effective February 24, 2017, except for the 
amendment to 21 CFR 524.1465, which is effective March 6, 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. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during September and October 2016, as 
listed in table 1. In addition, FDA is informing the public of the 
availability, where applicable, of documentation of environmental 
review required under the National Environmental Policy Act (NEPA) and, 
for actions requiring review of safety or effectiveness data, summaries 
of the basis of approval (FOI Summaries) under the Freedom of 
Information Act (FOIA). These public documents may be seen in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 
p.m.,

[[Page 11507]]

Monday through Friday. Persons with access to the Internet may obtain 
these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and 
patent information may be accessed in FDA's publication, Approved 
Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                             Table 1--Original and Supplemental NADAs and ANADAs Approved During September and October 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Effect of the action/
          Approval date            File No.        Sponsor            Product name           Species          indications for use      Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 26, 2016................    141-465  Elanco US Inc, 2500  INTEPRITY            Chickens...........  Original approval for    FOI Summary.
                                              Innovation Way,      (avilamycin) and                          the prevention of
                                              Greenfield, IN       COBAN (monensin)                          mortality caused by
                                              46140.               Type C medicated                          necrotic enteritis
                                                                   feeds.                                    associated with
                                                                                                             Clostridium
                                                                                                             perfringens in broiler
                                                                                                             chickens; and as an
                                                                                                             aid in the prevention
                                                                                                             of coccidiosis caused
                                                                                                             by Eimeria necatrix,
                                                                                                             E. tenella, E.
                                                                                                             acervulina, E.
                                                                                                             brunetti, E. mivati,
                                                                                                             and E. maxima.
September 8, 2016...............    200-592  Putney, Inc., One    Amoxicillin          Dogs...............  Original approval of a   FOI Summary.
                                              Monument Sq.,        Trihydrate and                            generic copy of NADA
                                              Suite 400,           Clavulanate                               055-099.
                                              Portland, ME 04101.  Potassium Tablets.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Change of Sponsorship

    Sogeval S. A., 200 Avenue de Mayenne, 53000 Laval, France has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, the following applications to Ceva Sante Animale, 10 
Avenue de la Ballasti[egrave]re, 33500 Libourne, France:

------------------------------------------------------------------------
           File No.                  Product name        21 CFR section
------------------------------------------------------------------------
099-667.......................  IMPOSIL (iron                   522.1182
                                 heptomer) Injection.
110-399.......................  GLEPTOSIL                       522.1055
                                 (gleptoferron)
                                 Injection.
------------------------------------------------------------------------

    Following these changes of sponsorship, Sogeval S. A. is no longer 
the sponsor of an approved NADA. Accordingly, the firm's name, address, 
and drug labeler code are being removed from Sec.  510.600(c) (21 CFR 
510.600(c)).
    In addition, Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, the following applications to Kinetic Technologies, LLC, 
961 Beasley St., Suite 270, Lexington, KY 40509:

------------------------------------------------------------------------
           File No.                  Product name        21 CFR section
------------------------------------------------------------------------
006-417.......................  RECOVR                          522.2615
                                 (tripelennamine
                                 hydrochloride)
                                 Injection.
032-319.......................  FUROX (furazolidone)            524.1005
                                 Aerosol Powder.
038-838.......................  ROBAXIN-V                       522.1380
                                 (methocarbamol)
                                 Injection.
108-687.......................  PET DERM III                    520.540c
                                 (dexamethasone)
                                 Tablets.
111-369.......................  Dexamethasone Sterile            522.540
                                 Solution.
------------------------------------------------------------------------

    Following these changes of sponsorship, Kinetic Technologies, LLC 
is now the sponsor of an approved NADA. Accordingly, the firm's name, 
address, and drug labeler code are being added to Sec.  510.600(c).

III. Withdrawals of Approval

    In addition, Putney, Inc., One Monument Square, Suite 400, 
Portland, ME 04101 has requested that FDA withdraw approval of ANADA 
200-524 for Mupirocin Ointment 2% because the product is no longer 
manufactured or marketed.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of ANADA 200-524, and all supplements and amendments 
thereto, is withdrawn, effective March 6, 2017. As provided in the 
regulatory text of this document, the animal drug regulations are 
amended to reflect this voluntary withdrawal of approval.

IV. Technical Amendments

    Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort 
Collins, CO 80524 has informed FDA that it has changed its address to 
1230 W. Ash St., Suite D, Windsor, CO 80550. In addition, FDA has 
noticed that a sponsor name in Sec.  510.600 does not reflect the 
particular punctuation used in this sponsor's applications and other 
correspondence. At this time, we are amending the list of sponsors of 
approved applications in Sec.  510.600(c) to reflect this change of 
sponsor address and sponsor's punctuation.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.


[[Page 11508]]


    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 parts 510, 
520, 522, 524, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec.  510.600  [Amended]

0
2. Revise Sec.  510.600 as follows:
0
a. In the table in paragraph (c)(1):
0
i. In the entry for ``Elanco US, Inc.'', remove ``Elanco US, Inc.'' and 
in its place add ``Elanco US Inc.'';
0
ii. Alphabetically add an entry for ``Kinetic Technologies, LLC'';
0
iii. Remove the entry for ``Sogeval S. A.''; and
0
iv. Revise the entry for ``Wildlife Laboratories, Inc.''
0
b. In the table in paragraph (c)(2):
0
i. Numerically add an entry for ``051031'';
0
ii. Revise the entry for ``053923''
0
iii. In the entry for ``058198'', remove ``Elanco US, Inc.'' and in its 
place add ``Elanco US Inc.''; and
0
iv. Remove the entry for ``059120''.
    The additions and revisions read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
Kinetic Technologies, LLC, 961 Beasley St., Suite 270,            051031
 Lexington, KY 40509....................................
 
                              * * * * * * *
Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D,            053923
 Windsor, CO 80550......................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
             Drug labeler code                                                          Firm name and address
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
051031.....................................  Kinetic Technologies, LLC, 961 Beasley St., Suite 270, Lexington, KY 40509.
 
                                                                      * * * * * * *
053923.....................................  Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D, Windsor, CO 80550.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

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


Sec.  520.88g  [Amended]

0
4. In Sec.  520.88g, in paragraph (b), remove ``No. 054771'' and in its 
place add ``Nos. 026637 and 054771''.


Sec.  520.540c  [Amended]

0
5. In Sec.  520.540c, in paragraph (b), remove ``054771'' and in its 
place add ``051031''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for part 522 continues to read as follows:

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


Sec.  522.540  [Amended]

0
7. In Sec.  522.540, in paragraph (d)(2)(i), remove ``054771'' and in 
its place add ``051031''.


Sec.  522.1055  [Amended]

0
8. In Sec.  522.1055, in paragraph (b), remove ``059120'' and in its 
place add ``013744''.


Sec.  522.1182  [Amended]

0
9. In Sec.  522.1182, in paragraph (b)(3), remove ``059120'' and in its 
place add ``013744''.


Sec.  522.1380  [Amended]

0
10. In Sec.  522.1380, in paragraph (b), remove ``054771'' and in its 
place add ``051031''.


Sec.  522.2615  [Amended]

0
11. In Sec.  522.2615, in paragraph (b), remove ``054771'' and in its 
place add ``051031''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
12. The authority citation for part 524 continues to read as follows:

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


Sec.  524.1005  [Amended]

0
13. In Sec.  524.1005, in paragraph (b)(1), remove ``054771'' and in 
its place add ``051031''.


Sec.  524.1465  [Amended]

0
14. Effective March 6, 2017, in Sec.  524.1465, in paragraph (b), 
remove ``026637''.

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

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

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

[[Page 11509]]


0
16. In Sec.  558.68, revise paragraph (e)(1)(ii) to read as follows:


Sec.  558.68  Avilamycin.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in
    Avilamycin in grams/ton           grams/ton        Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 13.6 to 40.9..............  Monensin 90 to      Broiler chickens: For    Feed as the sole ration     058198
                                  110; as provided    the prevention of        for 21 consecutive
                                  by No. 058198 in    mortality caused by      days. To assure
                                  Sec.   510.600(c)   necrotic enteritis       responsible
                                  of this chapter.    associated with          antimicrobial drug use
                                                      Clostridium              in broiler chickens,
                                                      perfringens in broiler   treatment
                                                      chickens; and as an      administration must
                                                      aid in the prevention    begin on or before 10
                                                      of coccidiosis caused    days of age. See Sec.
                                                      by Eimeria necatrix,      558.355(d) of this
                                                      E. tenella, E.           chapter for additional
                                                      acervulina, E.           required labeling.
                                                      brunetti, E. mivati,
                                                      and E. maxima.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03677 Filed 2-23-17; 8:45 am]
 BILLING CODE 4164-01-P