Oral Dosage Form New Animal Drugs; Estriol, 78149-78150 [2011-32214]

Download as PDF 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]


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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

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