November 7, 2012 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 158
Time Limit for Completion of Voluntary Self-Disclosures and Revised Notice of the Institution of Administrative Enforcement Proceedings
Document Number: 2012-27206
Type: Proposed Rule
Date: 2012-11-07
Agency: Department of Commerce, Bureau of Industry and Security
This proposed rule would require that the final, comprehensive narrative account required in voluntary self-disclosures (VSDs) of violations of the Export Administration Regulations (EAR) be submitted to the Office of Export Enforcement within 180 days of the initial VSD notification. This proposed rule also would authorize the use of delivery services other than registered or certified mail for providing notice of the issuance of a charging letter instituting an administrative enforcement proceeding under the EAR. It also would remove the phrase ``if delivery is refused'' from a provision relating to determining the date of service of notice of a charging letter's issuance based on an attempted delivery to the respondent's last known address. The Bureau of Industry and Security is proposing these changes to be better able to resolve administrative enforcement proceedings in a timely manner and provide more efficient notice of administrative charging letters.
Appraisal Subcommittee Notice of Meeting
Document Number: 2012-27203
Type: Notice
Date: 2012-11-07
Agency: Federal Financial Institutions Examination Council, Agencies and Commissions
Appraisal Subcommittee; Notice of Meeting
Document Number: 2012-27201
Type: Notice
Date: 2012-11-07
Agency: Federal Financial Institutions Examination Council, Agencies and Commissions
Fluazinam; Pesticide Tolerances
Document Number: 2012-27198
Type: Rule
Date: 2012-11-07
Agency: Environmental Protection Agency
This regulation establishes tolerances for residues of fluazinam in or on melon subgroup 9A and pepper/eggplant subgroup 8- 10B, associated with pesticide petition (PP) 1E7959; and soybean, seed and soybean, hulls, associated with PP 2F7977. Interregional Research Project Number 4 (IR-4) and ISK Biosciences Corporation requested the tolerances associated with PPs 1E7959 and 2F7977, respectively, under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Notice of Receipt of Pesticide Products; Registration Applications To Register New Uses
Document Number: 2012-27197
Type: Notice
Date: 2012-11-07
Agency: Environmental Protection Agency
This notice announces receipt of applications to register new uses for pesticide products containing currently registered active ingredients pursuant to the provisions of section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This notice provides the public with an opportunity to comment on the applications.
Radio Broadcasting Services; Crowell, Knox City, Quanah, and Rule, TX
Document Number: 2012-27195
Type: Rule
Date: 2012-11-07
Agency: Federal Communications Commission, Agencies and Commissions
The Audio Division modified the FM Table of Allotments by substituting Channel 293A for vacant Channel 291A at Knox City, Texas; Channel 288C2 for vacant Channel 239C2 at Rule, Texas; Channel 255C3 for vacant Channel 293C3 at Crowell, Texas; and Channel 251C3 for vacant Channel 255C3 at Quanah, Texas. Channel 255C3 can be allotted to Crowell, Texas at reference coordinates 34-03-58 NL and 99-43-52 WL, at a site 9.2 km (5.7 miles) north of Crowell. Channel 293A can be allotted to Knox City, Texas at reference coordinates 33-25-55 NL and 99-47-43 WL, at a site 2.7 km (1.6 miles) northeast of Knox City. Channel 251C3 can be allotted at Quanah, Texas at reference coordinates 34-24-09 NL and 99-46-02 WL, at a site 11.9 km (7.4 miles) north of Quanah. Channel 288C2 can be allotted at Rule, Texas at reference coordinates 33-10-29 NL and 99-49-26 WL, at a site 6.6 km (4.1 miles) east of Rule. See SUPPLEMENTARY INFORMATION, supra.
Radio Broadcasting Services; AM or FM Proposals To Change The Community of License
Document Number: 2012-27194
Type: Notice
Date: 2012-11-07
Agency: Federal Communications Commission, Agencies and Commissions
The following applicants filed AM or FM proposals to change the community of license: ALEX MEDIA, INC., Station NEW, Facility ID 189557, BMPH-20121002ACH, From MCCALL, ID, To HUNTINGTON, OR; GATEWAY RADIO WORKS, INC., Station WKYN, Facility ID 23345, BPH-20121002ACW, From OWINGSVILLE, KY, To MOUNT STERLING, KY; GENESIS COMMUNICATIONS OF TAMPA BAY, INC., Station WMGG, Facility ID 67135, BP-20120808ABK, From DUNEDIN, FL, To EGYPT LAKE, FL.
Notice of Filing of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities
Document Number: 2012-27193
Type: Proposed Rule
Date: 2012-11-07
Agency: Environmental Protection Agency
This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Brunswick Steam Electric Plant, Units 1 and 2
Document Number: 2012-27192
Type: Notice
Date: 2012-11-07
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC or the Commission) is giving notice that by petition dated July 10, 2012, Mr. David Lochbaum (the petitioner) and two copetitioners on behalf of the North Carolina Waste Awareness & Reduction Network, the Nuclear Information and Resource Service, and the Union of Concerned Scientists have requested that the NRC take action with regard to Brunswick Steam Electric Plant, Units 1 and 2 (Brunswick). The petition is included in the SUPPLEMENTARY INFORMATION section of this document.
Metconazole; Pesticide Tolerances
Document Number: 2012-27191
Type: Rule
Date: 2012-11-07
Agency: Environmental Protection Agency
This regulation amends the tolerance for residues of metconazole in or on corn, sweet, stover. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Notification of Contact Information Change for the Benghazi Accountability Review Board
Document Number: 2012-27189
Type: Notice
Date: 2012-11-07
Agency: Department of State
On October 1, 2012, the Department of State announced the formation of the Benghazi Accountability Review Board (ARB) in the Federal Register (FR Doc. 2012-24504). Effective November 5, 2012, the ARB will permanently change offices. The main telephone number will change to (202) 647-2316. The main fax number will change to (202) 647- 3301.
Freedom of Information Act Request for Papers Submitted to DARPA for the 2011 100 Year Starship Symposium
Document Number: 2012-27186
Type: Notice
Date: 2012-11-07
Agency: Department of Defense, Office of the Secretary
Authors who submitted full papers based on selected abstracts submitted as proposed talks for panels at the 2011 100 Year Starship Symposium must provide DARPA a written response explaining how disclosure of his or her paper, either in its entirety or portions thereof, would likely cause substantial competitive harm to their competitive position and/or impair the Government's ability to obtain similar information in the future if the submitter of the information believes that some or all of the paper submitted to DARPA should be withheld in response to a request received by DARPA under the Freedom of Information Act.
Environmental Assessment and Finding of No Significant Impact
Document Number: 2012-27185
Type: Notice
Date: 2012-11-07
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Notice of Submission of Proposed Information Collection to OMB Electronic Stakeholder Survey-Office for International and Philanthropic Innovation
Document Number: 2012-27184
Type: Notice
Date: 2012-11-07
Agency: Department of Housing and Urban Development
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. The Electronic Stakeholder Survey is necessary to collect information for demonstrating the outputs and outcomes of meetings, conferences, and other activities presented by HUD's Office for International and Philanthropic Innovation (IPI). The Office for International and Philanthropic Innovation (IPI) supports HUD's efforts to find new solutions and align ideas and resources by working across public, private, and civil sectors to further HUD's mission. IPI works towards these goals by developing networks and facilitating collaboration of key partners and resources. To gather feedback on the various meetings, conferences, and other events and activities IPI presents, it is necessary to survey participants at both immediate and medium-term intervals. IPI is seeking to understand the effectiveness of these events in sharing information, connecting participants, establishing plans for coordination, and influencing programmatic, research, and funding agendas and resources. As we increase the effectiveness of these cross-sector convenings, HUD benefits from increased access to and synthesis of information regarding successes and failures in domestic and global housing and urban development. Residents and communities across the country also benefit from the increased impact achieved by alignment of cross-sector resources and ideas.
Proposed Information Collection; Comment Request; Generic Clearance for Master Address File (MAF) and Topologically Integrated Geographic Encoding and Referencing (TIGER) Update Activities
Document Number: 2012-27183
Type: Notice
Date: 2012-11-07
Agency: Census Bureau, Department of Commerce
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Delegation of Concurrent Authority to the Deputy Secretary
Document Number: 2012-27182
Type: Notice
Date: 2012-11-07
Agency: Department of Housing and Urban Development
The Secretary of the Department of Housing and Urban Development, delegates to the Deputy Secretary concurrent authority, vested in or delegated or assigned to the Secretary of Housing and Urban Development, with the exception of the power to sue and be sued.
Notice of Sunshine Act Meetings
Document Number: 2012-27181
Type: Notice
Date: 2012-11-07
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Soo Line Railroad Company-Abandonment Exemption-in Cook County, IL
Document Number: 2012-27180
Type: Notice
Date: 2012-11-07
Agency: Surface Transportation Board, Department of Transportation
Columbia Gas Transmission, LLC.; Notice of Application
Document Number: 2012-27178
Type: Notice
Date: 2012-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel E SEA RIDER; Invitation for Public Comments
Document Number: 2012-27176
Type: Notice
Date: 2012-11-07
Agency: Maritime Administration, Department of Transportation
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel PURE INSANITY; Invitation for Public Comments
Document Number: 2012-27175
Type: Notice
Date: 2012-11-07
Agency: Maritime Administration, Department of Transportation
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel FIVE O'CLOCK HERE; Invitation for Public Comments
Document Number: 2012-27174
Type: Notice
Date: 2012-11-07
Agency: Maritime Administration, Department of Transportation
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Records Schedules; Availability and Request for Comments
Document Number: 2012-27173
Type: Notice
Date: 2012-11-07
Agency: National Archives and Records Administration, Agencies and Commissions
The National Archives and Records Administration (NARA) publishes notice at least once monthly of certain Federal agency requests for records disposition authority (records schedules). Once approved by NARA, records schedules provide mandatory instructions on what happens to records when no longer needed for current Government business. They authorize the preservation of records of continuing value in the National Archives of the United States and the destruction, after a specified period, of records lacking administrative, legal, research, or other value. Notice is published for records schedules in which agencies propose to destroy records not previously authorized for disposal or reduce the retention period of records already authorized for disposal. NARA invites public comments on such records schedules, as required by 44 U.S.C. 3303a(a).
Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG Turbojet Engines
Document Number: 2012-27170
Type: Proposed Rule
Date: 2012-11-07
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for certain Rolls-Royce Deutschland Ltd & Co KG (RRD) Spey 511-8 turbojet engines. This proposed AD was prompted by a recent quality review determination that bolts with reduced material properties may have been installed in some engines. This proposed AD would require inspection and replacement if necessary, of affected bolts, and if any bolt is found broken, inspection of the adjacent disc(s) for damage. We are proposing this AD to prevent uncontained turbine disc fracture and damage to the airplane.
Airworthiness Directives; Pratt & Whitney Canada Corp. Turboshaft Engines
Document Number: 2012-27169
Type: Proposed Rule
Date: 2012-11-07
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for certain serial number Pratt & Whitney Canada Corp. (P&WC) PW206B, PW206B2, PW206C, PW207C, PW207D, PW207D1, PW207D2, and PW207E turboshaft engines. This proposed AD was prompted by the discovery that certain power turbine (PT) disks were made to specific heat codes that may not achieve the maximum in-service life. This proposed AD would require re-identification of the PT disk to a part number (P/N) with a lower life limit. We are proposing this AD to prevent possible uncontained PT disk failure and loss of helicopter control.
Record of Decision for the Oil and Gas Management Plan, Big South Fork National River and Recreation Area and Obed Wild and Scenic River
Document Number: 2012-27167
Type: Notice
Date: 2012-11-07
Agency: Department of the Interior, National Park Service
Pursuant to the National Environmental Policy Act (NEPA) of 1969, 42 U.S.C. 4332(2)(C), the National Park Service (NPS) announces the availability of the Record of Decision (ROD) for the Oil and Gas Management Plan (Plan) for Big South Fork National River and Recreation Area and Obed Wild and Scenic River. On September 5, 2012, the Southeast Regional Director, approved the ROD for the plan. The ROD identifies Alternative C (Comprehensive Implementation of 9B Regulations, a New Management Framework for Plugging and Reclamation, and Establishment of Special Management Areas) as the NPS's selected action.
Agency Information Collection Activities: Notice of Intent To Extend Collection 3038-0098: Exemptive Order Regarding Compliance With Certain Swap Regulations
Document Number: 2012-27166
Type: Notice
Date: 2012-11-07
Agency: Commodity Futures Trading Commission, Agencies and Commissions
The Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is announcing an opportunity for public comment on the proposed extension of its current approval from the Office of Management and Budget (``OMB '') of an information collection request (``ICR'') titled ``Exemptive Order Regarding Compliance with Certain Swap Regulations,'' OMB Control No. 3038-0098. OMB approved the Commission's initial ICR request on August 13, 2012, utilizing emergency review procedures in accordance with the Paperwork Reduction Act of 1995 (``PRA''), 44 U.S.C. 3501 et seq., and Office of Management and Budget (``OMB'') regulation 5 CFR 1320.13. The Commission's notice of its initial submission for OMB emergency review of the ICR was published in the Federal Register, 77 FR 43271, on July 24, 2012. The Commission is inviting interested parties to comment on the proposed extension of the currently approved ICR, relating to the proposed Exemptive Order Regarding Compliance with Certain Swap Regulations (``Proposed Exemptive Order'') pursuant to Section 4(c) of the Commodity Exchange Act (``CEA'').\1\ If approved, the collection of information will be required to obtain or retain a benefit.
National Register of Historic Places; Notification of Pending Nominations and Related Actions
Document Number: 2012-27165
Type: Notice
Date: 2012-11-07
Agency: Department of the Interior, National Park Service
Notice of November 15, 2012, Meeting for Na Hoa Pili O Kaloko-Honokohau National Historical Park Advisory Commission Meeting
Document Number: 2012-27164
Type: Notice
Date: 2012-11-07
Agency: Department of the Interior, National Park Service
This notice sets forth the date of the November 15, 2012, meeting of the Na Hoa Pili O Kaloko-Honokohau National Historical Park Advisory Commission.
Agency Information Collection Activities: Submission for OMB Review; Comment Request, The Declaration Process: Requests for Preliminary Damage Assessment (PDA), Requests for Supplemental Federal Disaster Assistance, Appeals, and Requests for Cost Share Adjustments
Document Number: 2012-27163
Type: Notice
Date: 2012-11-07
Agency: Federal Emergency Management Agency, Department of Homeland Security
The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use.
Update to Notice of Financial Institutions for Which the Federal Deposit Insurance Corporation Has Been Appointed Either Receiver, Liquidator, or Manager
Document Number: 2012-27162
Type: Notice
Date: 2012-11-07
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
Notice is hereby given that the Federal Deposit Insurance Corporation (Corporation) has been appointed the sole receiver for the following financial institutions effective as of the Date Closed as indicated in the listing. This list (as updated from time to time in the Federal Register) may be relied upon as ``of record'' notice that the Corporation has been appointed receiver for purposes of the statement of policy published in the July 2, 1992 issue of the Federal Register (57 FR 29491). For further information concerning the identification of any institutions which have been placed in liquidation, please visit the Corporation Web site at www.fdic.gov/ bank/individual/failed/banklist.html or contact the Manager of Receivership Oversight in the appropriate service center.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Participation by Disadvantaged Business Enterprises in Procurement Under EPA Financial Assistance Agreements (Reinstatement)
Document Number: 2012-27161
Type: Notice
Date: 2012-11-07
Agency: Environmental Protection Agency
The Environmental Protection Agency has submitted an information collection request (ICR), ``Participation by Disadvantaged Business Enterprises in Procurement under EPA Financial Assistance Agreements (Reinstatement)'' (EPA ICR No. 2047.04, OMB Control No. 2090-0030) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This ICR expired on January 31, 2011. This is a request for reinstatement of a previously approved collection. Public comments were previously requested via the Federal Register (77 FR 32087) on May 31, 2012 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Secondary Aluminum Production (Renewal)
Document Number: 2012-27160
Type: Notice
Date: 2012-11-07
Agency: Environmental Protection Agency
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR which is abstracted below describes the nature of the collection and the estimated burden and cost.
Suspension of Community Eligibility
Document Number: 2012-27159
Type: Rule
Date: 2012-11-07
Agency: Federal Emergency Management Agency, Department of Homeland Security
This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/fema/csb.shtm.
Agency Information Collection Activities OMB Responses
Document Number: 2012-27158
Type: Notice
Date: 2012-11-07
Agency: Environmental Protection Agency
This document announces the Office of Management and Budget (OMB) responses to Agency Clearance requests, in compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
Proposed Flood Elevation Determinations for Allegheny County, PA (All Jurisdictions)
Document Number: 2012-27157
Type: Proposed Rule
Date: 2012-11-07
Agency: Federal Emergency Management Agency, Department of Homeland Security
The Federal Emergency Management Agency (FEMA) is withdrawing its proposed rule concerning proposed flood elevation determinations for Allegheny County, Pennsylvania (All Jurisdictions).
Proposed Flood Elevation Determinations for Yakima County, WA, and Incorporated Areas
Document Number: 2012-27156
Type: Proposed Rule
Date: 2012-11-07
Agency: Federal Emergency Management Agency, Department of Homeland Security
The Federal Emergency Management Agency (FEMA) is withdrawing its proposed rule concerning proposed flood elevation determinations for Yakima County, Washington, and Incorporated Areas.
Combined Notice of Filings #2
Document Number: 2012-27155
Type: Notice
Date: 2012-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2012-27154
Type: Notice
Date: 2012-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Notice of Compliance Filings
Document Number: 2012-27153
Type: Notice
Date: 2012-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Proposed Flood Elevation Determinations for Wicomico County, MD, and Incorporated Areas
Document Number: 2012-27152
Type: Proposed Rule
Date: 2012-11-07
Agency: Federal Emergency Management Agency, Department of Homeland Security
The Federal Emergency Management Agency (FEMA) is withdrawing its proposed rule concerning proposed flood elevation determinations for Wicomico County, Maryland, and Incorporated Areas.
Proposed Flood Elevation Determinations for Madison County, AL and Incorporated Areas
Document Number: 2012-27151
Type: Proposed Rule
Date: 2012-11-07
Agency: Federal Emergency Management Agency, Department of Homeland Security
The Federal Emergency Management Agency (FEMA) is withdrawing its proposed rule concerning proposed flood elevation determinations for Madison County, Alabama and Incorporated Areas.
Final Flood Elevation Determinations
Document Number: 2012-27150
Type: Rule
Date: 2012-11-07
Agency: Federal Emergency Management Agency, Department of Homeland Security
Base (1% annual-chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Submission for OMB Review; Comment Request
Document Number: 2012-27149
Type: Notice
Date: 2012-11-07
Agency: Department of Agriculture
North American Free-Trade Agreement, Article 1904; NAFTA Panel Reviews; Request for Panel Review
Document Number: 2012-27148
Type: Notice
Date: 2012-11-07
Agency: Department of Commerce, International Trade Administration
On October 9, 2012, Eastman Chemical, Co. filed a First Request for Panel Review with the Mexican Section of the NAFTA Secretariat pursuant to Article 1904 of the North American Free Trade Agreement. Panel Review was requested of the Final Results of the Antidumping Administrative Review, regarding the importation of ethylene glycol monobutyl ether from the United States of America, regardless of country of origin. This determination was published in the Diario Oficial de la Federaci[oacute]on, on September 11, 2012 . The NAFTA Secretariat has assigned Case Number MEX-USA-2012-1904-02 to this request.
Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation; Public Workshop
Document Number: 2012-27147
Type: Notice
Date: 2012-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation.'' FDA is co-sponsoring this public workshop together with the Board of Regents of the University System of Georgia by and on behalf of the Georgia Institute of Technology's Translational Research Institute for Biomedical Engineering and Science (TRIBES). The purpose of this public workshop is to bring together a wide variety of stakeholders to discuss key topics relating to minimum clinically important difference (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic extremity device-related procedures in order to streamline evidence-based scientific rationales for regulatory guidance of clinical trials and device study design. Date and Time: The public workshop will be held on November 27, 2012, from 7:45 a.m. to 5:30 p.m., and on November 28, 2012, from 7:45 a.m. to 1 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993, on November 27, 2012 (Day 1), and Building 66, Atrium, on November 28, 2012 (Day 2). Entrance for the public workshop participants (non-FDA employees) is through Building 1 on Day 1 and Building 66 on Day 2, where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/ BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.ht m. Contact Person: Faisal Mirza, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1558, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6910 or 6311, FAX: 301-847-8117, email: faisal.mirza@fda.hhs.gov. Registration: TRIBES will charge a registration fee for non-federal employees to cover its share of the expenses associated with the workshop. The registration fee is $230 for non-federal employees. Registration is available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by November 13, 2012. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on Day 1 of the public workshop will be provided beginning at 6:45 a.m. The onsite registration fee is $275. If you need special accommodations due to a disability, please contact Joyce Raines at 301-796-5709, email: joyce.raines@fda.hhs.gov no later than November 13, 2012. To register for the public workshop, please visit the Georgia Institute of Technology's TRIBES Web site at https:// www.tribes.gatech.edu/mcid-conf-2012. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. For more information on the public workshop, please see FDA's Medical Devices News & EventsWorkshops and Conferences calendar at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConfere nces/ default.htm. (Select this public workshop from the posted events list.) Streaming Webcast of the Public Workshop: This public workshop will also be available as a Webcast for registrants only. Persons interested in viewing the Webcast must register online by November 13, 2012. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after November 13, 2012. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_ test.htm. To get a quick overview of the Connect Pro program, please visit: https://www.adobe.com/go/connectprooverview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConfere nces/ default.htm. (Select this public workshop from the posted events list).
Public Workshop on Burkholderia: Exploring Current Issues and Identifying Regulatory Science Gaps
Document Number: 2012-27146
Type: Notice
Date: 2012-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following meeting: ``Public Workshop on Burkholderia: Exploring Current Issues and Identifying Regulatory Science Gaps.'' An interagency planning committee led by FDA, in collaboration with the Defense Threat Reduction Agency; the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health; the Centers for Disease Control and Prevention; the U.S. Army Medical Research Institute of Infectious Diseases; the Biomedical Advanced Research and Development Authority; the Chemical Biological Medical Systems Joint Project Management Office; the U.S. Strategic Command Center for Combating Weapons of Mass Destruction; and the Joint Science and Technology Office for Chemical and Biological Defense, developed this workshop to present the most current information on melioidosis (caused by Burkholderia pseudomallei) and glanders (caused by B. mallei), with the general purpose of building on information presented at previous meetings and identifying future areas of research needed to advance animal model development and to advance candidate medical countermeasures (MCMs) for approval, licensure, or clearance.
Airworthiness Directives; Airbus Airplanes
Document Number: 2012-27142
Type: Proposed Rule
Date: 2012-11-07
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for all Airbus Model A330-200 Freighter, A330-200, A330-300, A340-200, A340- 300, A340-500, and A340-600 series airplanes. This proposed AD was prompted by several reports of a burning smell and/or smoke in the cockpit during cruise phase leading, in some cases, to diversion to alternate airports. This proposed AD would require an inspection to identify the installed windshields and replacement of any affected windshield. We are proposing this AD to prevent significantly increased workload for the flightcrew, which could, under some flight phases and/ or circumstances, constitute an unsafe condition.
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