[Federal Register Volume 78, Number 236 (Monday, December 9, 2013)]
[Rules and Regulations]
[Pages 73697-73698]
From the Federal Register Online via the Government Publishing 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,
[email protected].
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
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New animal drug
NADA/ANADA Sponsor product name Action 21 CFR section FOIA summary NEPA review
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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