August 2012 – Federal Register Recent Federal Regulation Documents

This document seeks comment on post-reconfiguration 800 MHz band channel plans along the U.S.-Mexico border. The Public Safety and Homeland Security Bureau (Bureau), by this action, affords interested parties an opportunity to submit comments and reply comments on proposals for establishing and implementing reconfigured 800 MHz channel plans along the U.S.-Mexico border.

The Secretary announces the members of the Performance Review Board (PRB) for the Department of Education for the Senior Executive Service (SES). Under 5 U.S.C. 4314(c)(1) through (5), each agency is required to establish one or more PRBs.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle.'' The topic to be discussed is best practices for use of registries with medical device data for postmarket surveillance, clinical studies, and evidence appraisal.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for Building Global Medical Device Epidemiology and Surveillance Capabilities.'' The topic to be discussed is setting strategic priorities and implementing an action plan for sustainable partnership toward improving regulatory science and the public health.

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Rudolf Nureyev: A Life in Dance'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Fine Arts Museums of San Francisco, San Francisco, CA, from on or about October 6, 2012, until on or about February 17, 2013, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.

The Mid-Atlantic Fishery Management Council's (Council) Spiny Dogfish Advisory Panel (AP) will meet in Philadelphia, PA.

The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on this proposed information collection, as required by the Paperwork Reduction Act of 1995. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. Currently, the FDIC is soliciting comment concerning a proposed new regulatory reporting requirement for state nonmember banks and state savings associations titled, ``Annual Stress Test Reporting Template and Documentation for Covered Banks with Total Consolidated Assets of $50 Billion or More under the Dodd-Frank Wall Street Reform and Consumer Protection Act.'' The proposal describes the scope of reporting and the proposed reporting requirements.

The Food and Drug Administration (FDA) is announcing the withdrawal of Compliance Policy Guide (CPG) Sec. 420.300 Changes in Compendial Specifications and New Drug Application (NDA) Supplements. CPG Sec. 420.300 is included in FDA's Compliance Policy Guides Manual available on the Agency's Web site at https://www.fda.gov/ICECI/ ComplianceManuals/CompliancePolicyGuidanceManual/default.htm.

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), announcement is made of the following committee meeting: Name of Committee: Board on Coastal Engineering Research. Date of Meeting: September 18-20, 2012. Place: Starboard/Windward Ballroom, Wyndham Jacksonville Riverwalk, 1515 Prudential Drive, Jacksonville, FL 32207. Time: 8 a.m. to 5:20 p.m. (September 18, 2012). 8:30 a.m. to 12:50 p.m. (September 19, 2012). 8 a.m. to 12 p.m. (September 20, 2012).

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Medical Countermeasures (MCM) for a Burn Mass Casualty Incident.'' The purpose of this public workshop is to describe medical countermeasure requirements for burn injuries of radiological, nuclear, or chemical origin in a scarce resources environment; identify gaps in the product landscape so as to articulate a consensus-based needs assessment; discuss testing approaches and regulatory pathways; and to educate workshop attendees on the concept of medical utilization and response integration. The overall goal is to engage stakeholders across the public and private sector in strategic dialogue related to development, evaluation, deployment, and monitoring of medical countermeasures to mitigate the adverse health consequences arising from public health emergencies, specifically those involving radiological, nuclear, or chemical threats. Date and Time: The public workshop will be held on September 27, 2012, from 8:30 a.m. to 5 p.m. and September 28, 2012, from 8:30 a.m. to 12 p.m. Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503A), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA-employees) is through Building 1 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.htm. Contact: Suzanne Schwartz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. G439, 301-796-6970, Fax: 301-847-8507, email: Suzanne.Schwartz@fda.hhs.gov. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 5 p.m. on September 21, 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 permit, onsite registration on the day of the public workshop will be provided beginning at 7 a.m. If you need special accommodations due to a disability, please contact Cindy Garris, email: Cynthia.garris@fda.hhs.gov or phone: 301 796-5861 no later than September 21, 2012. To register for the public workshop, please visit FDA's Medical Devices News & EventsWorkshops & Conferences calendar at https:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Suzanne Schwartz to register (see Contact). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be webcast. Persons interested in viewing the webcast must register online by 5 p.m. September 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 September 21, 2012. If you have never attended a Connect Pro event before, test your connection at https:// collaboration.fda.gov/common/help/en/support/meetingtest.htm. To get a quick overview of the Connect Pro program, 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.) Requests for Poster Presentations: This public workshop will include a poster session. During online registration you may indicate if you wish to present an abstract during the poster session. FDA has identified general topics in this document. FDA will do its best to accommodate requests for poster presentation and will select and notify participants by September 7, 2012. All abstract submissions for poster presentations must be emailed to Suzanne Schwartz (see Contact) no later than 5 p.m. on August 31, 2012. No commercial promotional material will be permitted to be presented or distributed at the public workshop. Comments: FDA is holding this public workshop to obtain information on medical countermeasures for a burn mass casualty incident. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is October 31, 2012. However, only comments received prior to August 31, 2012 will be incorporated into the workshop while comments received after that date will be reviewed by FDA after the conclusion of the workshop. Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Please identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific topics as outlined in section II of this document, please identify the topic you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday and will be posted to the docket at https://www.regulations.gov. 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 (see Comments). 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.)