New Animal Drugs; Hyaluronate Sodium; Hydrogen Peroxide; Imidacloprid and Moxidectin; Change of Sponsor, 73697-73698 [2013-29234]

Download as PDF 73697 Federal Register / Vol. 78, No. 236 / Monday, December 9, 2013 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 522, 524, and 529 [Docket No. FDA–2013–N–0002] New Animal Drugs; Hyaluronate Sodium; Hydrogen Peroxide; Imidacloprid and Moxidectin; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October 2013. 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 SUMMARY: amended to reflect a change of sponsorship of an ANADA. DATES: This rule is effective December 9, 2013. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9019, george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during October 2013, 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., 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. In addition, Eka Chemicals, Inc., 1850 Parkway Pl. SE., suite 1200, Marietta, GA 30067 has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141–255 for PEROX–AID (hydrogen peroxide) 35% Solution to Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248. Following this change of sponsorship, Eka Chemicals, Inc., is no longer a sponsor of an approved NADA. Accordingly, the Agency is amending the regulations to reflect this change of sponsorship and change of sponsor status. 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. TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER 2013 New animal drug product name FOIA summary Sponsor 200–432 ........... Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601. Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. NEXHA (hyaluronate sodium) Injectable Solution. Original approval as a generic copy of NADA 140–883. 522.1145 yes .............. CE.1 2 ADVANTAGE MULTI for Dogs (imidacloprid and moxidectin) Topical Solution. 524.1146 yes .............. CE.1 3 Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. ADVANTAGE MULTI for Cats (imidacloprid and moxidectin) Topical Solution. Supplemental approval for the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs and the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis. Supplemental approval for the prevention of heartworm disease caused by Dirofilaria immitis; kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets. 524.1146 yes .............. CE.1 3 141–251 ........... pmangrum on DSK3VPTVN1PROD with RULES 141–254 ........... Action 21 CFR section NADA/ANADA NEPA review 1 The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the human environment. 2 CE granted under 21 CFR 25.33(a)(1). 3 CE granted under 21 CFR 25.33(d)(1). List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Parts 522, 524, and 529 Animal drugs. VerDate Mar<15>2010 14:40 Dec 06, 2013 Jkt 232001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to E:\FR\FM\09DER1.SGM 09DER1 73698 Federal Register / Vol. 78, No. 236 / Monday, December 9, 2013 / Rules and Regulations the Center for Veterinary Medicine, 21 CFR parts 510, 522, 524, and 529 are amended as follows: PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: ■ Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. § 510.600 [Amended] 2. In § 510.600, in the table in paragraph (c)(1), remove the entry for ‘‘Eka Chemicals, Inc.’’; and in the table in paragraph (c)(2), remove the entry for ‘‘061088’’. ■ PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 522 continues to read as follows: ■ PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS Authority: 21 U.S.C. 360b. 4. In § 522.1145, revise paragraph (e)(2) and the heading of paragraph (e)(3) to read as follows: ■ § 522.1145 7. The authority citation for 21 CFR part 529 continues to read as follows: ■ Authority: 21 U.S.C. 360b. Hyaluronate sodium. § 529.1150 * * * * * (e) * * * (2) Sponsors. See sponsors in § 510.600(c) of this chapter: (i) No. 000859 for use of products described in paragraph (e)(1) as in paragraph (e)(3) of this section. (ii) No. 064847 for use of product described in paragraph (e)(1)(i) as in paragraph (e)(3) of this section. (3) Conditions of use— * * * * * 8. In paragraph (b) of § 529.1150, remove ‘‘061088’’ and in its place add ‘‘050378’’. Dated: December 2, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2013–29234 Filed 12–6–13; 8:45 am] BILLING CODE 4160–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 51 and 52 [EPA–HQ–OAR–2006–0605; FRL–9903–84– OAR] 5. The authority citation for 21 CFR part 524 continues to read as follows: ■ Authority: 21 U.S.C. 360b. RIN 2060–AR99 6. In § 524.1146, revise paragraphs (a)(2) and (d)(1)(ii); and add paragraph (d)(3) to read as follows: ■ pmangrum on DSK3VPTVN1PROD with RULES Imidacloprid and moxidectin. (a) * * * (2) Each milliliter of solution contains 100 mg imidacloprid and 10 mg moxidectin for use as in paragraphs (d)(2) and (d)(3) of this section. * * * * * (d) * * * (1) * * * (ii) Indications for use—(A) For the prevention of heartworm disease caused by Dirofilaria immitis; and the treatment and control of intestinal roundworms (Toxocara canis and Toxascaris VerDate Mar<15>2010 14:40 Dec 06, 2013 [Amended] ■ PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.1146 leonina), hookworms (Ancylostoma caninum and Uncinaria stenocephala), and whipworms (Trichuris vulpis); kills adult fleas and treats flea infestations (Ctenocephalides felis). (B) For treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs and the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis. * * * * * (3) Ferrets—(i) Amount. Topically apply 9.0 mg/lb body weight (20 mg/kg) imidacloprid and 0.9 mg/lb (2 mg/kg) moxidectin, once a month. (ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis; kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets. Jkt 232001 Prevention of Significant Deterioration for Particulate Matter Less Than 2.5 Micrometers—Significant Impact Levels and Significant Monitoring Concentration: Removal of Vacated Elements Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: On January 22, 2013, the United States Court of Appeals for the District of Columbia Circuit (the Court) granted a request from the EPA to vacate and remand to the EPA portions of two Prevention of Significant Deterioration (PSD) regulations, promulgated in 2010 SUMMARY: PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 under the authority of the Clean Air Act (CAA), regarding the Significant Impact Levels (SILs) for particulate matter less than 2.5 micrometers (PM2.5). The Court further vacated the portions of the PSD regulations establishing a PM2.5 Significant Monitoring Concentration (SMC). The EPA is amending its regulations to remove the vacated PM2.5 SILs and SMC provisions from the PSD regulations in the Code of Federal Regulations (CFR). This action is exempt from notice-and-comment rulemaking because it is ministerial in nature. The EPA will initiate a separate rulemaking in the future regarding the PM2.5 SILs that will address the Court’s remand. DATES: This final rule is effective December 9, 2013. ADDRESSES: The EPA has established a docket for this action under Docket ID No. EPA–HQ–OAR–2006–0605. All documents in the docket are listed on the www.regulations.gov Web site. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the EPA Docket Center (Air Docket), EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744. FOR FURTHER INFORMATION CONTACT: Mr. Ben Garwood, Office of Air Quality Planning and Standards (C504–03), U.S. EPA, Research Triangle Park, North Carolina 27709, telephone number (919) 541–1358, facsimile number (919) 541– 5509, email: garwood.ben@epa.gov. SUPPLEMENTARY INFORMATION: I. Does this regulation apply to me? The entities potentially affected by this rule include new and modified major stationary sources in all industry groups. To determine whether your facility would be affected by this action, you should carefully examine the applicability criteria in 40 CFR 51.166 and 52.21. Entities potentially affected by this final action also include state, local and tribal governments that issue PSD permits. II. Background and Rationale for This Final Action The PSD permit program applies to any new major stationary source or major modification at a stationary source located in a designated attainment or unclassifiable area for any regulated NSR pollutant.1 The PSD 1 The PSD program stems from part C of title I of the CAA. E:\FR\FM\09DER1.SGM 09DER1

Agencies

[Federal Register Volume 78, Number 236 (Monday, December 9, 2013)]
[Rules and Regulations]
[Pages 73697-73698]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29234]



[[Page 73697]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, 524, and 529

[Docket No. FDA-2013-N-0002]


New Animal Drugs; Hyaluronate Sodium; Hydrogen Peroxide; 
Imidacloprid and Moxidectin; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval actions for new animal drug 
applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) during October 2013. 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 a change of sponsorship of an ANADA.

DATES: This rule is effective December 9, 2013.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for NADAs and ANADAs during October 2013, 
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., 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.
    In addition, Eka Chemicals, Inc., 1850 Parkway Pl. SE., suite 1200, 
Marietta, GA 30067 has informed FDA that it has transferred ownership 
of, and all rights and interest in, NADA 141-255 for PEROX-AID 
(hydrogen peroxide) 35% Solution to Western Chemical, Inc., 1269 
Lattimore Rd., Ferndale, WA 98248. Following this change of 
sponsorship, Eka Chemicals, Inc., is no longer a sponsor of an approved 
NADA. Accordingly, the Agency is amending the regulations to reflect 
this change of sponsorship and change of sponsor status.
    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.

                                    Table 1--Original and Supplemental NADAs and ANADAs Approved During October 2013
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   New animal drug
       NADA/ANADA                Sponsor            product name             Action         21 CFR section       FOIA summary           NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-432.................  Bioniche Animal       NEXHA (hyaluronate    Original approval as        522.1145  yes..................  CE.1 2
                           Health USA, Inc.,     sodium) Injectable    a generic copy of
                           119 Rowe Rd.,         Solution.             NADA 140-883.
                           Athens, GA 30601.
141-251.................  Bayer HealthCare      ADVANTAGE MULTI for   Supplemental                524.1146  yes..................  CE.1 3
                           LLC, Animal Health    Dogs (imidacloprid    approval for the
                           Division, P.O. Box    and moxidectin)       treatment of
                           390, Shawnee          Topical Solution.     Dirofilaria immitis
                           Mission, KS 66201.                          circulating
                                                                       microfilariae in
                                                                       heartworm-positive
                                                                       dogs and the
                                                                       treatment and
                                                                       control of
                                                                       sarcoptic mange
                                                                       caused by Sarcoptes
                                                                       scabiei var. canis.
141-254.................  Bayer HealthCare      ADVANTAGE MULTI for   Supplemental                524.1146  yes..................  CE.1 3
                           LLC, Animal Health    Cats (imidacloprid    approval for the
                           Division, P.O. Box    and moxidectin)       prevention of
                           390, Shawnee          Topical Solution.     heartworm disease
                           Mission, KS 66201.                          caused by
                                                                       Dirofilaria
                                                                       immitis; kills
                                                                       adult fleas
                                                                       (Ctenocephalides
                                                                       felis) and is
                                                                       indicated for the
                                                                       treatment of flea
                                                                       infestations on
                                                                       ferrets.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
  assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the
  human environment.
\2\ CE granted under 21 CFR 25.33(a)(1).
\3\ CE granted under 21 CFR 25.33(d)(1).

List of Subjects

21 CFR Part 510

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

21 CFR Parts 522, 524, and 529

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to

[[Page 73698]]

the Center for Veterinary Medicine, 21 CFR parts 510, 522, 524, and 529 
are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR 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. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``Eka Chemicals, Inc.''; and in the table in paragraph (c)(2), 
remove the entry for ``061088''.

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

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


0
4. In Sec.  522.1145, revise paragraph (e)(2) and the heading of 
paragraph (e)(3) to read as follows:


Sec.  522.1145  Hyaluronate sodium.

* * * * *
    (e) * * *
    (2) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (i) No. 000859 for use of products described in paragraph (e)(1) as 
in paragraph (e)(3) of this section.
    (ii) No. 064847 for use of product described in paragraph (e)(1)(i) 
as in paragraph (e)(3) of this section.
    (3) Conditions of use--
* * * * *

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

0
5. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


0
6. In Sec.  524.1146, revise paragraphs (a)(2) and (d)(1)(ii); and add 
paragraph (d)(3) to read as follows:


Sec.  524.1146  Imidacloprid and moxidectin.

    (a) * * *
    (2) Each milliliter of solution contains 100 mg imidacloprid and 10 
mg moxidectin for use as in paragraphs (d)(2) and (d)(3) of this 
section.
* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use--(A) For the prevention of heartworm 
disease caused by Dirofilaria immitis; and the treatment and control of 
intestinal roundworms (Toxocara canis and Toxascaris leonina), 
hookworms (Ancylostoma caninum and Uncinaria stenocephala), and 
whipworms (Trichuris vulpis); kills adult fleas and treats flea 
infestations (Ctenocephalides felis).
    (B) For treatment of Dirofilaria immitis circulating microfilariae 
in heartworm-positive dogs and the treatment and control of sarcoptic 
mange caused by Sarcoptes scabiei var. canis.
* * * * *
    (3) Ferrets--(i) Amount. Topically apply 9.0 mg/lb body weight (20 
mg/kg) imidacloprid and 0.9 mg/lb (2 mg/kg) moxidectin, once a month.
    (ii) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis; kills adult fleas (Ctenocephalides 
felis) and is indicated for the treatment of flea infestations on 
ferrets.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
7. The authority citation for 21 CFR part 529 continues to read as 
follows:

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


Sec.  529.1150  [Amended]

0
8. In paragraph (b) of Sec.  529.1150, remove ``061088'' and in its 
place add ``050378''.

    Dated: December 2, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-29234 Filed 12-6-13; 8:45 am]
BILLING CODE 4160-01-P