Oral Dosage Form New Animal Drugs; Estriol, 78149-78150 [2011-32214]
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78149
Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Rules and Regulations
7th Floor, Number 17, Zhonghua Rd.,
Sec 2, Xinzhuang City, Taipei, Taiwan’’
and ‘‘In-Tech Company, a.k.a., In-Tech
Telecom, Number 15, Lane 347,
Jhongjheng Road, Sinjihuang City,
Taipei, Taiwan, and 7th Floor, Number
17, Zhonghua Rd., Sec 2, Xinzhuang
City, Taipei, Taiwan’’; and
(d) By adding under United Arab
Emirates, in alphabetical order, two
U.A.E. entities:
The additions and revisions read as
follows:
■
SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST
Country
Entity
*
*
License requirement
*
*
License review policy
*
*
Federal
Register citation
*
Malaysia
*
*
*
*
*
VTE Industrial Automation SDN BHD, 97C, For all items subject
Jalan Kenari 23, Puchong Jaya, Puchong,
to the EAR. (See
Selangor, Malaysia; and 45–02, Jalan
§ 744.11 of the
Kenari 19A, Puchong Jaya, 47100 MalayEAR)
sia.
*
United Arab Emirates
*
*
*
*
Presumption of denial
*
*
*
73 FR 54503, 9/22/08.
76 FR [INSERT FR
PAGE NUMBER]
12/16/11.
*
*
*
*
*
*
Infotec, a.k.a., Info Tech, Ras Al Khaimah For all items subject
Free Trade Zone (RAKFTZ), U.A.E.
to the EAR. (See
§ 744.11 of the
EAR)
*
Presumption of denial
*
76 FR [INSERT FR
PAGE NUMBER]
12/16/11.
*
*
*
*
*
Waseem Jawad, Ras Al Khaimah Free For all items subject
Trade Zone (RAKFTZ), U.A.E.; and P.O.
to the EAR. (See
Box: 25123, Dubai U.A.E.
§ 744.11 of the
EAR)
*
Presumption of denial
*
76 FR [INSERT FR
PAGE NUMBER]
12/16/11.
*
*
*
Dated: December 12, 2011.
Kevin J. Wolf,
Assistant Secretary for Export
Administration.
*
*
responsive urinary incontinence in
ovariohysterectomized female dogs.
This rule is effective December
16, 2011.
DATES:
[FR Doc. 2011–32341 Filed 12–15–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Lisa
M. Troutman, Center for Veterinary
Medicine (HFV–116), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, (240) 276–8322,
email: lisa.troutman@fda.hhs.gov.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 3510–33–P
21 CFR Part 520
[Docket No. FDA–2011–N–0003]
Oral Dosage Form New Animal Drugs;
Estriol
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original new animal drug
application (NADA) filed by Intervet,
Inc. The NADA provides for the
veterinary prescription use of estriol
tablets for the control of estrogen-
jlentini on DSK4TPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
16:23 Dec 15, 2011
Jkt 226001
Intervet,
Inc., 556 Morris Ave., Summit, NJ
07901, filed NADA 141–325 that
provides for the veterinary prescription
use of INCURIN (estriol) Tablets for the
control of estrogen-responsive urinary
incontinence in ovariohysterectomized
female dogs. The NADA is approved as
of July 24, 2011, and the regulations are
amended in 21 CFR part 520 to reflect
the approval.
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.
PO 00000
Frm 00057
Fmt 4700
Sfmt 4700
*
*
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.
Under section 512(c)(2)(F)(i) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(i)), this
approval qualifies for 5 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.
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 520 is amended as follows:
E:\FR\FM\16DER1.SGM
16DER1
78150
Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Rules and Regulations
Rockville, MD 20855, (240) 276–8322,
email: lisa.troutman@fda.hhs.gov.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
Authority: 21 U.S.C. 360b.
2. Add § 520.852 to read as follows:
§ 520.852
Estriol.
(a) Specifications. Each tablet
contains 1 milligram (mg) estriol.
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer at an initial dose of
2 mg per dog per day. The dosage may
be titrated to as low as 0.5 mg per dog
every second day, depending on
response.
(2) Indications for use. For the control
of estrogen-responsive urinary
incontinence in ovariohysterectomized
female dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: December 9, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–32214 Filed 12–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
[Docket No. FDA–2011–N–0003]
Ophthalmic and Topical Dosage Form
New Animal Drugs; Hydrocortisone
Aceponate, Miconazole Nitrate, and
Gentamicin Sulfate Otic Suspension
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original new animal drug
application (NADA) filed by Virbac AH,
Inc. The NADA provides for the
veterinary prescription use of a
hydrocortisone aceponate, miconazole
nitrate, and gentamicin sulfate
suspension for the treatment of otitis
externa in dogs.
DATES: This rule is effective December
16, 2011.
FOR FURTHER INFORMATION CONTACT: Lisa
M. Troutman, Center for Veterinary
Medicine (HFV–116), Food and Drug
Administration, 7500 Standish Pl.,
jlentini on DSK4TPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
16:23 Dec 15, 2011
Jkt 226001
(a) Specifications. Each milliliter (mL)
of suspension contains 1.11 milligrams
(mg) of hydrocortisone aceponate, 15.1
mg of miconazole nitrate, and 1,505
micrograms of gentamicin sulfate.
(b) Sponsor. See No.051311 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Instill 1.0 mL in the affected
ear once daily for 5 days.
(2) Indications for use. For the
treatment of otitis externa in dogs
associated with susceptible strains of
yeast (Malassezia pachydermatis) and
bacteria (Staphylococcus
pseudintermedius).
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
SUPPLEMENTARY INFORMATION:
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
■
Virbac
AH, Inc., 3200 Meacham Blvd., Fort
Worth, TX 76137, filed NADA 141–330
for the veterinary prescription use of
EASOTIC (hydrocortisone aceponate,
miconazole nitrate, gentamicin sulfate)
Suspension for the treatment of otitis
externa in dogs associated with
susceptible strains of yeast (Malassezia
pachydermatis) and bacteria
(Staphylococcus pseudintermedius).
The NADA is approved as of October
31, 2011, and 21 CFR part 524 is
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
a.m. and 4 p.m., Monday through
Friday.
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.
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.
§ 524.1132 Hydrocortisone aceponate,
miconazole nitrate, gentamicin sulfate otic
suspension.
List of Subjects in 21 CFR Part 524
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 524 is amended as follows:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
2. Add § 524.1132 to read as follows:
PO 00000
Frm 00058
Fmt 4700
Sfmt 4700
Dated: December 13, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–32226 Filed 12–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Part 1980
[Docket Number OSHA–2011–0126]
RIN 1218–AC53
Procedures for the Handling of
Retaliation Complaints Under Section
806 of the Sarbanes-Oxley Act of 2002,
as Amended; Correction
Occupational Safety and Health
Administration, Labor.
ACTION: Interim final rule; correction.
AGENCY:
The Occupational Safety and
Health Administration is correcting an
interim final rule on the procedures for
the handling of retaliation complaints
under Section 806 of the SarbanesOxley Act of 2002, As Amended,
published in the Federal Register of
November 3, 2011 (76 FR 68084).
DATES: Effective December 16, 2011.
FOR FURTHER INFORMATION CONTACT:
Sandra Dillon, Acting Director, Office of
the Whistleblower Protection Program,
Occupational Safety and Health
Administration, U.S. Department of
Labor, Room N–3610, 200 Constitution
Avenue NW., Washington, DC 20210;
telephone (202) 693–2199.
SUPPLEMENTARY INFORMATION: In FR Doc.
2011–28274 on page 68084 in the
Federal Register of Thursday,
SUMMARY:
E:\FR\FM\16DER1.SGM
16DER1
]]>Agencies
[Federal Register Volume 76, Number 242 (Friday, December 16, 2011)]
[Rules and Regulations]
[Pages 78149-78150]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32214]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2011-N-0003]
Oral Dosage Form New Animal Drugs; Estriol
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 original new animal drug
application (NADA) filed by Intervet, Inc. The NADA provides for the
veterinary prescription use of estriol tablets for the control of
estrogen-responsive urinary incontinence in ovariohysterectomized
female dogs.
DATES: This rule is effective December 16, 2011.
FOR FURTHER INFORMATION CONTACT: Lisa M. Troutman, Center for
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, (240) 276-8322, email:
lisa.troutman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., 556 Morris Ave., Summit, NJ
07901, filed NADA 141-325 that provides for the veterinary prescription
use of INCURIN (estriol) Tablets for the control of estrogen-responsive
urinary incontinence in ovariohysterectomized female dogs. The NADA is
approved as of July 24, 2011, and the regulations are amended in 21 CFR
part 520 to reflect the approval.
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.
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.
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for
5 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.
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 520 is
amended as follows:
[[Page 78150]]
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.
0
2. Add Sec. 520.852 to read as follows:
Sec. 520.852 Estriol.
(a) Specifications. Each tablet contains 1 milligram (mg) estriol.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer at an initial
dose of 2 mg per dog per day. The dosage may be titrated to as low as
0.5 mg per dog every second day, depending on response.
(2) Indications for use. For the control of estrogen-responsive
urinary incontinence in ovariohysterectomized female dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: December 9, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-32214 Filed 12-15-11; 8:45 am]
BILLING CODE 4160-01-P
