Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Propofol, 20268-20269 [2010-8945]

Download as PDF 20268 Federal Register / Vol. 75, No. 74 / Monday, April 19, 2010 / Rules and Regulations AD 2009–08–05 R1 Inspection Report Airplane Serial Number Airplane Tach Hours at time of inspection Propeller type (circle one) MT Sensenich Exhaust Type (circle one) Standard Reduced Sound Is Exhaust Cracked? (circle one) YES NO Did lower cowl require trimming at the tail pipe opening? (circle one) Not applicable after initial inspection YES NO Did the propeller clocking position need to be corrected? (circle one) Not applicable after initial inspection. YES NO Propeller Tach Hours at time of inspection Were any other discrepancies noticed during the inspection? Name: Telephone and/or e-mail address: Date: Send report to: Corey Spiegel, Aerospace Engineer, Atlanta ACO, 1701 Columbia Avenue, College Park, Georgia 30337; facsimile: (404) 474–5606; e-mail: corey.spiegel@faa.gov. Figure 1 Special Flight Permit (f) Under 14 CFR part 39.23, we are limiting the special flight permits for this AD by the following conditions: (1) The cabin heat turned off; and (2) The fresh air vents are open. WReier-Aviles on DSKGBLS3C1PROD with RULES Alternative Methods of Compliance (AMOCs) (g) The Manager, Atlanta Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to Attn: Corey Spiegel, Aerospace Engineer, Atlanta ACO, 1701 Columbia Avenue, College Park, Georgia 30337. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. Material Incorporated by Reference (h) You must use Liberty Aerospace, Inc. Service Document Critical Service Bulletin (CSB) CSB–09–001, Revision Level B, Revised on March 18, 2009, to do the actions required by this AD, unless the AD specifies otherwise. (1) On April 20, 2009 (74 FR 16117, April 9, 2009), the Director of the Federal Register previously approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51. (2) For service information identified in this AD, contact Liberty Aerospace, 100 Aerospace Drive, Melbourne, Florida 32901; telephone: (321) 752–0332 or (800) 759–5953; fax: (321) 752–0377; Internet: https:// www.libertyaircraft.com. VerDate Nov<24>2008 15:30 Apr 16, 2010 Jkt 220001 (3) You may review copies of the service information incorporated by reference for this AD at the FAA, Central Region, Office of the Regional Counsel, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the Central Region, call (816) 329–3768. (4) You may also review copies of the service information incorporated by reference for this AD at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741–6030, or go to: https://www.archives.gov/federal_register/ code_of_federal_regulations/ ibr_locations.html. Issued in Kansas City, Missouri, on April 7, 2010. Kim Smith, Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. 2010–8596 Filed 4–16–10; 8:45 am] BILLING CODE 4910–13–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 [Docket No. FDA–2010–N–0002] Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Propofol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Intervet, Inc., to Teva Animal Health, Inc. DATES: This rule is effective April 19, 2010. FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068, has informed FDA that it has transferred ownership of, and all rights and interest in, approved NADA 141– 070 for RAPINOVET (propofol), an Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\19APR1.SGM 19APR1 Federal Register / Vol. 75, No. 74 / Monday, April 19, 2010 / Rules and Regulations injectable anesthetic, to Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503. Accordingly, the agency is amending the regulations in 21 CFR 522.2005 to reflect the transfer of ownership and a current format. 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 522 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: Authority: 21 U.S.C. 360b. WReier-Aviles on DSKGBLS3C1PROD with RULES Propofol. (a) Specifications. Each milliliter of emulsion contains 10 milligrams (mg) propofol. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (1) No. 059130 for use as in paragraph (c) of this section. (2) No. 000074 for use as in paragraphs (c)(1)(i), (c)(2), and (c)(3) of this section. (c) Conditions of use in dogs and cats—(1) Amount. The drug is administered by intravenous injection as follows: (i) Dogs. For induction of general anesthesia without the use of preanesthetics the dosage is 5.5 to 7.0 mg per kilogram (mg/kg) (2.5 to 3.2 mg/ pound (lb)); for the maintenance of general anesthesia without the use of preanesthetics the dosage is 1.1 to 3.3 mg/kg (0.5 to 1.5 mg/lb). The use of preanesthetic medication reduces propofol dose requirements. (ii) Cats. For induction of general anesthesia without the use of preanesthetics the dosage is 8.0 to 13.2 mg/kg (3.6 to 6.0 mg/lb). For the maintenance of general anesthesia without the use of preanesthetics the dosage is 1.1 to 4.4 mg/kg (0.5 to 2.0 mg/ lb). The use of preanesthetic medication reduces propofol dose requirements. (2) Indications for use. As a single injection to provide general anesthesia Jkt 220001 I. Background On October 23, 2009 (74 FR 54886), HUD published for public comment a proposed rule to revise the reporting requirements for the Indian Community Development Block Grant (ICDBG) program. The purpose of the ICDBG program is the development of viable Indian and Alaska Native communities, including the creation of decent housing, suitable living environments, and economic opportunities primarily for persons with low and moderate incomes. HUD’s regulations implementing the ICDBG program are located at 24 CFR part 1003 (entitled ‘‘Community Development Block Grants for Indian Tribes and Alaska Native Villages’’). Section 1003.506 of the ICDBG program regulations establishes several reporting requirements for ICDBG grantees. Specifically, grantees are required to submit an annual status and evaluation report (ASER) on previously funded open grants 45 days after the end of the fiscal year (FY) and upon grant closeout (§ 1003.506(a)). ICDBG grantees are also required to report on minority-owned business enterprises on a semiannual basis, with reports being due to HUD on April 10 and October 10 of each year (§ 1003.506(b)). HUD requires submission of these semiannual reports to evaluate ICDBG grantee compliance with the government-wide grant requirements regarding contracting with minority-owned business enterprises codified at 24 CFR 85.36(e). HUD believes that a single report would be less burdensome for grantees to prepare and would be enough for HUD to monitor compliance with the part 85 minority business enterprise requirements. Therefore, this final rule, consistent with the October 23, 2009, proposed rule, revises § 1003.506(b) to provide for a single annual report to be due each October 10. Each year, HUD publishes NOFAs that announce funding availability for the majority of HUD’s competitive grant programs, including the ICDBG program. The FY 2004 NOFA process introduced a planning form known as the Logic Model (form HUD–96010). Most grantees are required to submit a Logic Model form that identifies the problem or need the grant will address, [FR Doc. 2010–8945 Filed 4–16–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 1003 AGENCY: Office of the Assistant Secretary for Public and Indian Housing, HUD. ACTION: Final rule. 2. Revise § 522.2005 to read as follows: ■ 15:30 Apr 16, 2010 Dated: April 13, 2010. Elizabeth Rettie, Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. Regulatory Reporting Requirements for the Indian Community Development Block Grant Program 1. The authority citation for 21 CFR part 522 continues to read as follows: VerDate Nov<24>2008 Broadway, 23rd Floor, Denver, CO 80202, telephone number 301–675–1600 (this is not a toll-free number). Hearingor speech-impaired individuals may access this number through TTY by calling the Federal Information Relay Service at 800–877–8339 (this is a tollfree number). SUPPLEMENTARY INFORMATION: RIN 2577–AC79 ■ § 522.2005 for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; for induction of general anesthesia where maintenance is provided by inhalant anesthetics. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [Docket No. FR–5232–F–02] PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 20269 SUMMARY: This final rule revises the reporting requirements for the Indian Community Development Block Grants (ICDBG) program. First, the rule provides for submission of a single annual report on the hiring of minority business enterprises, due each October. Currently, ICDBG grantees are required to report on these activities on a semiannual basis, with reports being due to HUD on April 10 and October 10 of each year. Second, this rule requires ICDBG grantees to use the Logic Model form developed as part of HUD’s Notice of Funding Availability (NOFA) process. The required use of the Logic Model will conform the ICDBG reporting requirements to those of other HUD competitive funding programs, and enhance the evaluation of grantee performance by ensuring uniformity in the information provided by ICDBG grantees on performance goals. This final rule follows publication of an October 23, 2009, proposed rule on which HUD received two public comments, both of which were supportive of the rule. DATES: Effective Date: May 19, 2010. FOR FURTHER INFORMATION CONTACT: Deborah Lalancette, Director, Office of Grants Management, Office of Native American Programs, Department of Housing and Urban Development, 1670 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\FR\FM\19APR1.SGM 19APR1

Agencies

[Federal Register Volume 75, Number 74 (Monday, April 19, 2010)]
[Rules and Regulations]
[Pages 20268-20269]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8945]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2010-N-0002]


Implantation or Injectable Dosage Form New Animal Drugs; Change 
of Sponsor; Propofol

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for a new animal drug 
application (NADA) from Intervet, Inc., to Teva Animal Health, Inc.

DATES:  This rule is effective April 19, 2010.

FOR FURTHER INFORMATION CONTACT:  David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave., 
Roseland, NJ 07068, has informed FDA that it has transferred ownership 
of, and all rights and interest in, approved NADA 141-070 for RAPINOVET 
(propofol), an

[[Page 20269]]

injectable anesthetic, to Teva Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503. Accordingly, the agency is amending 
the regulations in 21 CFR 522.2005 to reflect the transfer of ownership 
and a current format.
    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 522

    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:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. Revise Sec.  522.2005 to read as follows:


Sec.  522.2005   Propofol.

    (a) Specifications. Each milliliter of emulsion contains 10 
milligrams (mg) propofol.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 059130 for use as in paragraph (c) of this section.
    (2) No. 000074 for use as in paragraphs (c)(1)(i), (c)(2), and 
(c)(3) of this section.
    (c) Conditions of use in dogs and cats--(1) Amount. The drug is 
administered by intravenous injection as follows:
    (i) Dogs. For induction of general anesthesia without the use of 
preanesthetics the dosage is 5.5 to 7.0 mg per kilogram (mg/kg) (2.5 to 
3.2 mg/pound (lb)); for the maintenance of general anesthesia without 
the use of preanesthetics the dosage is 1.1 to 3.3 mg/kg (0.5 to 1.5 
mg/lb). The use of preanesthetic medication reduces propofol dose 
requirements.
    (ii) Cats. For induction of general anesthesia without the use of 
preanesthetics the dosage is 8.0 to 13.2 mg/kg (3.6 to 6.0 mg/lb). For 
the maintenance of general anesthesia without the use of preanesthetics 
the dosage is 1.1 to 4.4 mg/kg (0.5 to 2.0 mg/lb). The use of 
preanesthetic medication reduces propofol dose requirements.
    (2) Indications for use. As a single injection to provide general 
anesthesia for short procedures; for induction and maintenance of 
general anesthesia using incremental doses to effect; for induction of 
general anesthesia where maintenance is provided by inhalant 
anesthetics.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: April 13, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-8945 Filed 4-16-10; 8:45 am]
BILLING CODE 4160-01-S

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