[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.

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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.
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\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