Certain Other Dosage Form New Animal Drugs; Detomidine, 21162-21163 [2010-9371]

Download as PDF 21162 Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Rules and Regulations preamble section is not part of the final rule. We didn’t change the AD. Conclusion We have carefully reviewed the available data, including the comment[s] received, and determined that air safety and the public interest require adopting the AD as proposed. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. Costs of Compliance We estimate that this AD affects 13 engines installed on airplanes of U.S. registry. We also estimate that it will take about 96 work-hours per engine to perform the required actions, and that the average labor rate is $80 per workhour. Required parts will cost about $7,000 per engine. Based on these figures, we estimate the total cost of the AD to U.S. operators to be $190,840. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA’s authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency’s authority. We are issuing this rulemaking under the authority described in Subtitle VII, part A, subpart III, section 44701, ‘‘General requirements.’’ Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. mstockstill on DSKH9S0YB1PROD with RULES Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD: (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) Is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. VerDate Nov<24>2008 15:47 Apr 22, 2010 Jkt 220001 We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary at the address listed under ADDRESSES. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the Federal Aviation Administration amends 14 CFR part 39 as follows: ■ PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: ■ Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new airworthiness directive: ■ 2010–09–08 General Electric Company (GE): Amendment 39–16273. Docket No. FAA–2009–0502; Directorate Identifier 2009–NE–02–AD. Effective Date (a) This airworthiness directive (AD) becomes effective May 28, 2010. Affected ADs (b) None. Applicability (c) This AD applies to GE CJ610 series turbojet and CF700 series turbofan engines with AFT Technologies combustion liner, part number (P/N) AFT–5016T30G02, installed. These engines are installed on, but not limited to, Learjet Inc. model 24 series and model 25 series airplanes, Dassault Aviation Fan Jet Falcon series airplanes, and Sabreliner Corporation NA–265–70 and NA– 265–80 series airplanes. Unsafe Condition (d) This AD results from a report of an AFT Technologies combustion liner that released a large section of the inner combustion liner and reports of six combustion liners with premature cracks. We are issuing this AD to prevent premature cracks in the combustion liner, which could release pieces of the inner combustion liner. A release of pieces of the inner combustion liner could cause an uncontained failure of the engine turbine and damage to the airplane. Compliance (e) You are responsible for having the actions required by this AD performed within the compliance times specified unless the actions have already been done. Replacement of AFT Technologies Combustion Liner P/N AFT–5016T30G02 (f) For engines that have an AFT Technologies combustion liner, P/N AFT– PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 5016T30G02, with fewer than 200 hourssince-new (HSN) or 300 cycles-since-new (CSN), remove the AFT Technologies combustion liner, P/N AFT–5016T30G02, before exceeding 200 HSN or 300 CSN, whichever occurs first. (g) For engines that have an AFT Technologies combustion liner, P/N AFT– 5016T30G02, with 200 HSN or more or 300 CSN or more, remove the AFT Technologies combustion liner, P/N AFT–5016T30G02, within 15 hours-in-service or 10 cycles-inservice, after the effective date of this AD, whichever occurs first. (h) After the effective date of this AD, don’t install any AFT Technologies combustion liner, P/N AFT–5016T30G02, in any engine. Alternative Methods of Compliance (i) The Manager, New York Aircraft Certification Office, has the authority to approve alternative methods of compliance for this AD if requested using the procedures found in 14 CFR 39.19. Related Information (j) Contact Norman Perenson, Aerospace Engineer, New York Aircraft Certification Office, FAA, Engine & Propeller Directorate, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; e-mail: norman.perenson@faa.gov; telephone (516) 228–7337; fax (516) 794–5531, for more information about this AD. Material Incorporated by Reference (k) None. Issued in Burlington, Massachusetts, on April 19, 2010. Peter A. White, Assistant Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. 2010–9376 Filed 4–22–10; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 529 [Docket No. FDA–2010–N–0002] Certain Other Dosage Form New Animal Drugs; Detomidine 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 Orion Corp. The NADA provides for veterinary prescription use of detomidine hydrochloride oromucosal gel for sedation and restraint of horses. DATES: This rule is effective April 23, 2010. E:\FR\FM\23APR1.SGM 23APR1 Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Rules and Regulations 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. Orion Corp., Orionintie 1, 02200 Espoo, Finland, filed NADA 141–306 for veterinary prescription use of DORMOSEDAN GEL (detomidine hydrochloride) for sedation and restraint of horses. The application is approved as of March 22, 2010, and the regulations in 21 CFR part 529 are amended by adding new § 529.536 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), summaries of the safety and effectiveness data and information submitted to support approval of these applications 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)(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. SUPPLEMENTARY INFORMATION: List of Subjects in 21 CFR Part 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 the Center for Veterinary Medicine, 21 CFR part 529 is amended as follows: mstockstill on DSKH9S0YB1PROD with RULES ■ PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 529 continues to read as follows: ■ Authority: Authority: 21 U.S.C. 360b. ■ 2. Add § 529.536 to read as follows: VerDate Nov<24>2008 15:47 Apr 22, 2010 Jkt 220001 § 529.536 Detomidine. (a) Specifications. Each milliliter of gel contains 7.6 milligrams (mg) of detomidine hydrochloride. (b) Sponsor. See No. 052483 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 0.018 mg per pound (mg/lb) (0.040 mg/kilogram (kg) sublingually. (2) Indications for use. For sedation and restraint. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: April 19, 2010. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2010–9371 Filed 4–22–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF JUSTICE Bureau of Prisons 28 CFR Part 540 [BOP–1149–I] RIN 1120–AB49 Inmate Communication With News Media: Removal of Byline Regulations Bureau of Prisons, Justice. Interim rule. AGENCY: ACTION: SUMMARY: In this interim rule, the Bureau of Prisons (Bureau) revises its regulations regarding inmate contact with the community to delete two current Bureau regulations that prohibit inmates from publishing under a byline, due to a recent court ruling invalidating Bureau regulation language containing this prohibition. DATES: Comments are due by June 22, 2010. ADDRESSES: Rules Unit, Office of General Counsel, Bureau of Prisons, 320 First Street, NW., Washington, DC 20534. FOR FURTHER INFORMATION CONTACT: Sarah Qureshi, Office of General Counsel, Bureau of Prisons, phone (202) 307–2105. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received are considered part of the public record and made available for public inspection online at https:// www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 21163 If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online, you must include the phrase ‘‘PERSONAL IDENTIFYING INFORMATION’’ in the first paragraph of your comment. You must also locate all the personal identifying information you do not want posted online in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment but do not want it to be posted online, you must include the phrase ‘‘CONFIDENTIAL BUSINESS INFORMATION’’ in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment contains so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted on https:// www.regulations.gov. Personal identifying information identified and located as set forth above will be placed in the agency’s public docket file, but not posted online. Confidential business information identified and located as set forth above will not be placed in the public docket file. If you wish to inspect the agency’s public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph. In this interim rule, the Bureau revises its regulations regarding inmate contact with the community to delete two current Bureau regulations that prohibit inmates from publishing under a byline, due to a recent court ruling invalidating Bureau regulation language containing this prohibition. Currently, 28 CFR 540.20(b) states as follows: ‘‘The inmate may not receive compensation or anything of value for correspondence with the news media. The inmate may not act as reporter or publish under a byline.’’ Also, current 28 CFR 540.62(d) states as follows: ‘‘An inmate currently confined in an institution may not be employed or act as a reporter or publish under a byline.’’ On August 9, 2007, in Jordan v. Pugh, 504 F.Supp.2d 1109 (D. Colo. 2007), the court issued a decision invalidating the byline language of § 540.20(b). The court found that not all inmate publishing under a byline jeopardizes security, and overruled the byline portion of the provision as facially overbroad for prohibiting all such activity. The Bureau is not appealing this decision. We E:\FR\FM\23APR1.SGM 23APR1

Agencies

[Federal Register Volume 75, Number 78 (Friday, April 23, 2010)]
[Rules and Regulations]
[Pages 21162-21163]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

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


Certain Other Dosage Form New Animal Drugs; Detomidine

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 Orion Corp. The NADA provides for veterinary 
prescription use of detomidine hydrochloride oromucosal gel for 
sedation and restraint of horses.

DATES: This rule is effective April 23, 2010.

[[Page 21163]]


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: Orion Corp., Orionintie 1, 02200 Espoo, 
Finland, filed NADA 141-306 for veterinary prescription use of 
DORMOSEDAN GEL (detomidine hydrochloride) for sedation and restraint of 
horses. The application is approved as of March 22, 2010, and the 
regulations in 21 CFR part 529 are amended by adding new Sec.  529.536 
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), summaries of the safety and 
effectiveness data and information submitted to support approval of 
these applications 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)(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 529

    Animal drugs.

0
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 529 is 
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

0
2. Add Sec.  529.536 to read as follows:


Sec.  529.536  Detomidine.

    (a) Specifications. Each milliliter of gel contains 7.6 milligrams 
(mg) of detomidine hydrochloride.
    (b) Sponsor. See No. 052483 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 0.018 mg 
per pound (mg/lb) (0.040 mg/kilogram (kg) sublingually.
    (2) Indications for use. For sedation and restraint.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: April 19, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-9371 Filed 4-22-10; 8:45 am]
BILLING CODE 4160-01-S

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