Oral Dosage Form New Animal Drugs; Orbifloxacin Suspension, 26646-26647 [2010-11245]
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WReier-Aviles on DSKGBLS3C1PROD with RULES
26646
Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations
contact for correspondence between the
FAA and the certificate holder and the
name and mailing address of the
certificate holder’s agent for service.
(2) Other business names under
which the certificate holder may
operate.
(3) Reference to the economic
authority issued by the Department of
Transportation, if required.
(4) Type of aircraft, registration
markings, and serial number of each
aircraft authorized for use.
(i) Subject to the approval of the
Administrator with regard to form and
content, the certificate holder may
incorporate by reference the items listed
in paragraph (b)(4) of this section into
the certificate holder’s operations
specifications by maintaining a current
listing of those items and by referring to
the specific list in the applicable
paragraph of the operations
specifications.
(ii) The certificate holder may not
conduct any operation using any aircraft
not listed.
(5) Kinds of operations authorized.
(6) Authorization and limitations for
routes and areas of operations.
(7) Special airport authorizations and
limitations.
(8) Time limitations, or standards for
determining time limitations, for
overhauling, inspecting, and checking
airframes, engines, propellers,
appliances, and emergency equipment.
(9) Authorization for the method of
controlling weight and balance of
aircraft.
(10) Aircraft wet lease information
required by § 119.53(c).
(11) Any authorization or requirement
to conduct supplemental operations as
provided by § 119.21(a)(3).
(12) Any authorized deviation or
exemption from any requirement of this
chapter.
(13) An authorization permitting, or a
prohibition against, accepting, handling,
and transporting materials regulated as
hazardous materials in transport under
49 CFR parts 171 through 180.
(14) Any other item the Administrator
determines is necessary.
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Issued in Washington, DC on May 7, 2010.
Pamela Hamilton-Powell,
Director, Office of Rulemaking, Aviation
Safety.
[FR Doc. 2010–11266 Filed 5–11–10; 8:45 am]
BILLING CODE 4910–13–P
VerDate Mar<15>2010
12:59 May 11, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA–2010–N–0002]
Oral Dosage Form New Animal Drugs;
Orbifloxacin Suspension
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 of a new animal drug
application (NADA) filed by Intervet,
Inc. The NADA provides for the
veterinary prescription use of an oral
suspension containing orbifloxacin for
the treatment of various bacterial
infections in dogs and cats.
DATES: This rule is effective May 12,
2010.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet,
Inc., 56 Livingston Ave., Roseland, NJ
07068, filed NADA 141–305 that
provides for veterinary prescription use
of ORBAX (orbifloxacin) Oral
Suspension for the treatment of various
bacterial infections in dogs and cats.
The NADA is approved as of March 25,
2010, and the regulations are amended
in 21 CFR part 520 by adding new
§ 520.1618 to reflect the approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
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.
FDA has determined under 21 CFR
25.33 that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
Under section 512(c)(2)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
approval qualifies for 3 years of
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
marketing exclusivity beginning on the
date of approval.
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 in 21 CFR Part 520
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 520 is amended as follows:
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 520.1616
[Amended]
2. Revise the section heading of
§ 520.1616 to read ‘‘Orbifloxacin
tablets.’’.
■ 3. Add § 520.1618 to read as follows:
■
§ 520.1618
Orbifloxacin suspension.
(a) Specifications. Each milliliter of
suspension contains 30 milligrams (mg)
orbifloxacin.
(b) Sponsor. See No. 000061 in
510.600(c) of this chapter.
(c) Special considerations. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
Federal law prohibits the extralabel use
of this drug in food-producing animals.
(d) Conditions of use—(1) Dogs—(i)
Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/
kg) of body weight once daily.
(ii) Indications for use. For the
treatment of urinary tract infections
(cystitis) in dogs caused by susceptible
strains of Staphylococcus
pseudintermedius, Proteus mirabilis,
Escherichia coli, and Enterococcus
faecalis and skin and soft tissue
infections (wounds and abscesses) in
dogs caused by susceptible strains of
Staphylococcus pseudintermedius,
Staphylococcus aureus, coagulasepositive staphylococci, Pasteurella
multocida, Proteus mirabilis,
Pseudomonas spp., Klebsiella
pneumoniae, E. coli, Enterobacter spp.,
Citrobacter spp., E. faecalis, b-hemolytic
streptococci (Group G), and
Streptococcus equisimilis.
(2) Cats—(i) Amount. 3.4 mg/lb (7.5
mg/kg) of body weight once daily.
(ii) Indications for use. For the
treatment of skin infections (wounds
and abscesses) in cats caused by
E:\FR\FM\12MYR1.SGM
12MYR1
Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations
susceptible strains of S. aureus, E. coli,
and P. multocida.
Dated: May 6, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–11245 Filed 5–11–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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.
[Docket No. FDA–2010–N–0002]
List of Subjects in 21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Ivermectin
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
the Center for Veterinary Medicine, 21
CFR part 522 is amended as follows:
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 of an abbreviated new animal
drug application (ANADA) filed by
Sparhawk Laboratories, Inc. The
ANADA provides for use of an
ivermectin injectable solution in cattle
and swine for treatment and control of
various internal and external parasites.
DATES: This rule is effective May 12,
2010.
WReier-Aviles on DSKGBLS3C1PROD with RULES
FOR FURTHER INFORMATION CONTACT:
John
K. Harshman, Center for Veterinary
Medicine (HFV–170), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Sparhawk
Laboratories, Inc., 12340 Santa Fe Trail
Dr., Lenexa, KS 66215, filed ANADA
200–429 for the use of Ivermectin
Injection in cattle and swine for
treatment and control of various internal
and external parasites. Sparhawk
Laboratories, Inc.’s, Ivermectin Injection
is approved as a generic copy of Merial
Ltd.’s IVOMEC Injection for Cattle and
Swine, approved under NADA 128–409.
The ANADA is approved as of March
26, 2010, and the regulations in 21 CFR
522.1192 are amended to reflect the
approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
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
VerDate Mar<15>2010
12:59 May 11, 2010
Jkt 220001
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
26647
N. spathiger (adults only), Bunostomum
phlebotomum); lungworms (adults and
fourth-stage larvae) (Dictyocaulus
viviparus); grubs (parasitic stages)
(Hypoderma bovis, H. lineatum);
sucking lice (Linognathus vituli,
Haematopinus eurysternus, Solenopotes
capillatus); mites (scabies) (Psoroptes
ovis (syn. P. communis var. bovis),
Sarcoptes scabiei var. bovis). For control
of infections and to protect from
reinfection with D. viviparus and O.
radiatum for 28 days after treatment; O.
ostertagi, T. axei, and C. punctata for 21
days after treatment; H. placei and C.
oncophora for 14 days after treatment.
*
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Dated: May 7, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–11282 Filed 5–11–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
[Docket No. FDA–2010–N–0002]
Authority: 21 U.S.C. 360b.
2. In § 522.1192, revise paragraphs
(b)(1), (b)(2), and (e)(2)(ii) to read as
follows:
■
§ 522.1192.
AGENCY:
Ivermectin
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(b)* * *
(1) No. 050604 for use of the product
described in paragraph (a)(1) of this
section as in paragraph (e)(1) of this
section; the product described in
paragraph (a)(2) of this section as in
paragraphs (e)(2), (e)(3), (e)(4), and (e)(5)
of this section; and the product
described in paragraph (a)(3) of this
section as in paragraphs (e)(3) and (e)(6)
of this section.
(2) Nos. 055529, 058005, and 059130
for use of the product described in
paragraph (a)(2) of this section as in
paragraphs (e)(2), (e)(3), (e)(4), and (e)(5)
of this section.
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(e) * * *
(2) * * *
(ii) Indications for use. For the
treatment and control of gastrointestinal
nematodes (adults and fourth-stage
larvae) (Haemonchus placei, Ostertagia
ostertagi (including inhibited larvae), O.
lyrata, Trichostrongylus axei, T.
colubriformis, Cooperia oncophora, C.
punctata, C. pectinata,
Oesophagostomum radiatum,
Nematodirus helvetianus (adults only),
PO 00000
Frm 00005
Fmt 4700
Ophthalmic and Topical Dosage Form
New Animal Drugs; Ivermectin Topical
Solution
Sfmt 4700
Food and Drug Administration,
HHS.
ACTION: Final rule, technical
amendment.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by First
Priority, Inc. The supplemental ANADA
adds claims for persistent effectiveness
against various species of external and
internal parasites when cattle are treated
with a topical solution of ivermectin.
DATES: This rule is effective May 12,
2010.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–170), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: First
Priority, Inc., 1590 Todd Farm Dr.,
Elgin, IL 60123, filed a supplement to
ANADA 200–340 for PRIVERMECTIN
(ivermectin), a topical solution used on
cattle to control infestations of certain
species of external and internal
parasites. The supplemental ANADA
E:\FR\FM\12MYR1.SGM
12MYR1
]]>Agencies
[Federal Register Volume 75, Number 91 (Wednesday, May 12, 2010)]
[Rules and Regulations]
[Pages 26646-26647]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11245]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2010-N-0002]
Oral Dosage Form New Animal Drugs; Orbifloxacin Suspension
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 of a new animal drug application
(NADA) filed by Intervet, Inc. The NADA provides for the veterinary
prescription use of an oral suspension containing orbifloxacin for the
treatment of various bacterial infections in dogs and cats.
DATES: This rule is effective May 12, 2010.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave.,
Roseland, NJ 07068, filed NADA 141-305 that provides for veterinary
prescription use of ORBAX (orbifloxacin) Oral Suspension for the
treatment of various bacterial infections in dogs and cats. The NADA is
approved as of March 25, 2010, and the regulations are amended in 21
CFR part 520 by adding new Sec. 520.1618 to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application 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.
FDA has determined under 21 CFR 25.33 that this action is of a type
that does not individually or cumulatively have a significant effect on
the human environment. Therefore, neither an environmental assessment
nor an environmental impact statement is required.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning on the date of approval.
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 in 21 CFR Part 520
Animal drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1616 [Amended]
0
2. Revise the section heading of Sec. 520.1616 to read ``Orbifloxacin
tablets.''.
0
3. Add Sec. 520.1618 to read as follows:
Sec. 520.1618 Orbifloxacin suspension.
(a) Specifications. Each milliliter of suspension contains 30
milligrams (mg) orbifloxacin.
(b) Sponsor. See No. 000061 in 510.600(c) of this chapter.
(c) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian. Federal law prohibits
the extralabel use of this drug in food-producing animals.
(d) Conditions of use--(1) Dogs--(i) Amount. 1.1 to 3.4 mg/lb (2.5
to 7.5 mg/kg) of body weight once daily.
(ii) Indications for use. For the treatment of urinary tract
infections (cystitis) in dogs caused by susceptible strains of
Staphylococcus pseudintermedius, Proteus mirabilis, Escherichia coli,
and Enterococcus faecalis and skin and soft tissue infections (wounds
and abscesses) in dogs caused by susceptible strains of Staphylococcus
pseudintermedius, Staphylococcus aureus, coagulase-positive
staphylococci, Pasteurella multocida, Proteus mirabilis, Pseudomonas
spp., Klebsiella pneumoniae, E. coli, Enterobacter spp., Citrobacter
spp., E. faecalis, [beta]-hemolytic streptococci (Group G), and
Streptococcus equisimilis.
(2) Cats--(i) Amount. 3.4 mg/lb (7.5 mg/kg) of body weight once
daily.
(ii) Indications for use. For the treatment of skin infections
(wounds and abscesses) in cats caused by
[[Page 26647]]
susceptible strains of S. aureus, E. coli, and P. multocida.
Dated: May 6, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-11245 Filed 5-11-10; 8:45 am]
BILLING CODE 4160-01-S
