New Animal Drugs; Hyaluronate Sodium; Hydrogen Peroxide; Imidacloprid and Moxidectin; Change of Sponsor, 73697-73698 [2013-29234]
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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: https://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
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Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
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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
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]]>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]]
=======================================================================
-----------------------------------------------------------------------
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: https://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
