Ophthalmic and Topical Dosage Form New Animal Drugs; Selamectin, 19877-19878 [E9-9901]

Download as PDF Federal Register / Vol. 74, No. 82 / Thursday, April 30, 2009 / Rules and Regulations 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. 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. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: ■ PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: ■ VerDate Nov<24>2008 14:59 Apr 29, 2009 Jkt 217001 Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration (FAA) amends § 39.13 by removing amendment 39–14474 (71 FR 6665, February 9, 2006) and by adding the following new airworthiness directive (AD): ■ 2009–09–05 Airbus: Amendment 39–15891. Docket No. FAA–2007–0391; Directorate Identifier 2007–NM–271–AD. Effective Date (a) This AD becomes effective June 4, 2009. Affected ADs (b) This AD supersedes AD 2006–03–10. Applicability (c) This AD applies to Airbus Model A318– 111 and 112; A319–111, –112, –113, –114, –115, –131, –132, and –133; A320–111, –211, –212, –214, –231, –232, and –233; and A321– 111, –112, –131, –211, –212, –213, –231, and –232 airplanes; certificated in any category; all manufactured serial numbers; except for those airplanes on which Airbus Modification 36115 has been done in production or Airbus Mandatory Service Bulletin A320–25–1535, dated April 27, 2007, has been done in service. Unsafe Condition (d) This AD results from a report indicating that electrical wire damage was found in the 103VU electrical panel due to contact between the hinge pin and the adjacent electrical wire harness. We are issuing this AD to prevent contact between the horizontal hinge pin and the adjacent electrical wire harness, which could result in damage to electrical wires, and consequent arcing and/ or failure of associated systems. 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. Installation (f) Within 18 months after the effective date of this AD, install a hinge pin stopper on the internal door of the 103VU electrical panel in accordance with the Accomplishment Instructions of Airbus Mandatory Service Bulletin A320–25–1535, dated April 27, 2007. Alternative Methods of Compliance (AMOCs) (g)(1) The Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19. (2) To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. 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. PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 19877 Related Information (h) European Aviation Safety Agency Airworthiness Directive 2007–0214, dated August 7, 2007, also addresses the subject of this AD. Material Incorporated by Reference (i) You must use Airbus Mandatory Service Bulletin A320–25–1535, dated April 27, 2007, to do the actions required by this AD, unless the AD specifies otherwise. (1) The Director of the Federal Register 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 Airbus, Airworthiness Office—EAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; e-mail: account.airworth-eas@airbus.com; Internet https://www.airbus.com. (3) You may review copies of the service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information on the availability of this material at the FAA, call 425–227–1221 or 425–227–1152. (4) You may also review copies of the service information that is incorporated by reference 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 Renton, Washington, on April 15, 2009. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E9–9714 Filed 4–29–09; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 [Docket No. FDA–2009–N–0665] Ophthalmic and Topical Dosage Form New Animal Drugs; Selamectin 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 supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA revises the minimum age of treatment from 6 weeks to 8 weeks for kittens treated with a topical selamectin solution. DATES: This rule is effective April 30, 2009. E:\FR\FM\30APR1.SGM 30APR1 19878 Federal Register / Vol. 74, No. 82 / Thursday, April 30, 2009 / 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, e-mail: melanie.berson@fda.hhs.gov. Pfizer, Inc., 235 East 42d St., New York, NY 10017–5755, filed a supplement to NADA 141–152 that provides for topical veterinary prescription use of REVOLUTION (selamectin) in dogs and cats. The supplemental NADA revises the minimum age of treatment from 6 weeks to 8 weeks for kittens. The supplemental NADA is approved as of April 6, 2009, and the regulations are amended in 21 CFR 524.2098 to reflect the approval. Approval of these supplemental NADAs did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. The agency has determined under 21 CFR 25.33(a)(1) 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. Dated: April 23, 2009. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E9–9901 Filed 4–29–09; 8:45 am] BILLING CODE 4160–01–S SUPPLEMENTARY INFORMATION: 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. § 524.2098 [Amended] 2. In § 524.2098, in the last sentence in paragraph (d)(2), remove ‘‘For dogs and cats 6 weeks of age and older’’ and in its place add ‘‘For dogs 6 weeks of age and older, and cats 8 weeks of age and older’’. ■ VerDate Nov<24>2008 14:59 Apr 29, 2009 Jkt 217001 DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 This notice is issued under authority of 33 CFR 165.1312 and 5 U.S.C. 552(a). In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with notification of this enforcement period via Local Notice to Mariners and marine information broadcasts. Dated: April 16, 2009. F.G. Myer, Captain, U.S. Coast Guard, Captain of the Port Portland. [FR Doc. E9–9992 Filed 4–29–09; 8:45 am] BILLING CODE 4910–15–P [Docket No. USCG–2009–0296] Security Zone; Portland Rose Festival on Willamette River ENVIRONMENTAL PROTECTION AGENCY Coast Guard, DHS. Notice of enforcement of regulation. 40 CFR Part 82 AGENCY: ACTION: SUMMARY: The Coast Guard will enforce the Portland Rose Festival Security Zone on the Willamette River from 1 p.m. on June 3, 2009, until 10 a.m. June 8, 2009. This action is necessary to ensure the safety and security of maritime traffic, including the public vessels present, on the Willamette River during the Portland Rose Festival. During the enforcement period, entry into the security zone detailed in 33 CFR 165.1312 is prohibited unless authorized by the Captain of the Port Portland or his designated representative. DATES: The regulations in 33 CFR 165.1312 will be enforced from 1 p.m. on June 3, 2009, through 10 a.m. on June 8, 2009. FOR FURTHER INFORMATION CONTACT: If you have questions on this notice, call or e-mail MST1 Jaime Sayers, Waterways Management, U.S. Coast Guard Sector Portland; telephone 503– 240–9319, e-mail Jaime.A.Sayers@uscg.mil. SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the security zone for the Portland Rose Festival detailed in 33 CFR 165.1312 from 1 p.m. on June 3, 2009, until 10 a.m. on June 8, 2009. Under the provisions of 33 CFR 165.1312, entry into the zone established by that section is prohibited unless authorized by the Captain of the Port Portland or his designated representative. Spectator vessels may transit outside the security zone but may not anchor, block, loiter in, or impede the transit of ship parade participants or official patrol vessels. The Coast Guard may be assisted by other Federal, State or local law enforcement agencies in enforcing this regulation. PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 [EPA–HQ–OAR–2008–0009; FRL–8899–5] RIN 2060–AO78 Protection of Stratospheric Ozone: The 2009 Critical Use Exemption From the Phaseout of Methyl Bromide AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This final rule authorizes uses of methyl bromide that qualify for the 2009 critical use exemption and the amount of methyl bromide that may be produced, imported, or supplied from existing pre-phaseout inventory for those uses in 2009. EPA is taking action under the authority of the Clean Air Act to reflect a consensus decision taken at the Nineteenth Meeting of by the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer. DATES: This rule is effective on April 30, 2009. ADDRESSES: EPA has established a docket for this action identified under EPA–HQ–OAR–2008–0009. All documents in the docket are listed on the https://www.regulations.gov site. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available only through https:// www.regulations.gov or in hard copy. To obtain copies of materials in hard copy, please call the EPA Docket Center at (202) 564–1744 between the hours of 8:30 a.m.–4:30 p.m. E.S.T., Monday– Friday, excluding legal holidays, to schedule an appointment. The EPA E:\FR\FM\30APR1.SGM 30APR1

Agencies

[Federal Register Volume 74, Number 82 (Thursday, April 30, 2009)]
[Rules and Regulations]
[Pages 19877-19878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9901]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

[Docket No. FDA-2009-N-0665]


Ophthalmic and Topical Dosage Form New Animal Drugs; Selamectin

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 supplemental new animal drug 
application (NADA) filed by Pfizer, Inc. The supplemental NADA revises 
the minimum age of treatment from 6 weeks to 8 weeks for kittens 
treated with a topical selamectin solution.

DATES: This rule is effective April 30, 2009.

[[Page 19878]]


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: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed a supplement to NADA 141-152 that provides for 
topical veterinary prescription use of REVOLUTION (selamectin) in dogs 
and cats. The supplemental NADA revises the minimum age of treatment 
from 6 weeks to 8 weeks for kittens. The supplemental NADA is approved 
as of April 6, 2009, and the regulations are amended in 21 CFR 524.2098 
to reflect the approval.
    Approval of these supplemental NADAs did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(a)(1) 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.

List of Subjects in 21 CFR Part 524

    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 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


Sec.  524.2098  [Amended]

0
2. In Sec.  524.2098, in the last sentence in paragraph (d)(2), remove 
``For dogs and cats 6 weeks of age and older'' and in its place add 
``For dogs 6 weeks of age and older, and cats 8 weeks of age and 
older''.

    Dated: April 23, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-9901 Filed 4-29-09; 8:45 am]
BILLING CODE 4160-01-S
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.