February 19, 2013 – Federal Register Recent Federal Regulation Documents

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Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act
Document Number: 2013-03705
Type: Notice
Date: 2013-02-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection involving interviews of pharmaceutical manufacturers who submit new molecular entity (NME) new drug applications (NDAs) and original biologics license applications (BLAs) to FDA under the Program for Enhanced Review Transparency and Communication (``the Program'') during fiscal years (FYs) 2013-2017. The Program is part of the FDA performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA), which allows FDA to collect user fees for the review of human drug and biologics applications for FYs 2013-2017.
NorthWestern Corporation; Notice of Petition for Rate Approval
Document Number: 2013-03703
Type: Notice
Date: 2013-02-19
Agency: Department of Energy, Federal Energy Regulatory Commission
Michigan Consolidated Gas Company, DTE Gas Company, DTE Gas Company; Notice of Petition
Document Number: 2013-03702
Type: Notice
Date: 2013-02-19
Agency: Department of Energy, Federal Energy Regulatory Commission
Dominion Transmission, Inc.; Notice of Request Under Blanket Authorization
Document Number: 2013-03701
Type: Notice
Date: 2013-02-19
Agency: Department of Energy, Federal Energy Regulatory Commission
Public Service Company of Colorado; Notice of Petition for Rate Approval
Document Number: 2013-03700
Type: Notice
Date: 2013-02-19
Agency: Department of Energy, Federal Energy Regulatory Commission
Houston Pipe Line Company LP; Notice of Petition for Rate Approval
Document Number: 2013-03698
Type: Notice
Date: 2013-02-19
Agency: Department of Energy, Federal Energy Regulatory Commission
Eastern Great Lakes Area Maritime Security Committee; Vacancies
Document Number: 2013-03696
Type: Notice
Date: 2013-02-19
Agency: Coast Guard, Department of Homeland Security
This notice solicits applications for membership in the Area Maritime Security Committee, Eastern Great Lakes, and its five regional subcommittees: Northeast Ohio Region, Northwestern Pennsylvania Region, Western New York Region, Lake Ontario Region, and St. Lawrence Region.
Notice of Availability of the Final Environmental Impact Statement for the Alta East Wind Project, Kern County, CA, and Proposed Land Use Plan Amendment
Document Number: 2013-03695
Type: Notice
Date: 2013-02-19
Agency: Department of the Interior, Bureau of Land Management
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) has prepared a Proposed California Desert Conservation Area (CDCA) Plan Amendment/Final Environmental Impact Statement (EIS) for the Alta East Wind Project (Project), and by this notice is announcing its availability.
Agency Information Collection Activity; Notice of Request for Public Comment and Submission to OMB for Information Collection: Confidential Close Call Reporting for Transit Rail System
Document Number: 2013-03694
Type: Notice
Date: 2013-02-19
Agency: Research and Innovative Technology Administration, Department of Transportation
In accordance with the requirements of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, BTS announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for approval. On November 5, 2012, BTS published a Federal Register notice (77 FR 66502), allowing for a 60-day comment period on the ICR. The comment period closed on January 4, 2013. The agency received one comment, from the National Safety Council (NSC), Docket Comment RITA-2008-0002-0037, in response to the notice which supported the need for the information collection. The NSC comment stated they agreed with BTS that '' there is a need for proper data collection and analysis on close calls and other unsafe occurrences in the WMATA rail system.'' The purpose of this Notice is to allow 30 days for public comment to OMB on this collection from all interested individuals and organizations.
Privacy Act of 1974; Implementation
Document Number: 2013-03693
Type: Rule
Date: 2013-02-19
Agency: Department of Justice
The Department of Justice (DOJ or Department), Federal Bureau of Prisons (BOP), is issuing a final rule for the modified system of records notice entitled ``Inmate Central Records System'' (ICRS) (JUSTICE/BOP-005). This system is being exempted from certain subsections of the Privacy Act of 1974 listed below for the reasons set forth in the following text.
Record of Decision for Land Acquisition and Airspace Establishment To Support Large-Scale Marine Air Ground Task Force Live-Fire and Maneuver Training at the Marine Corps Air Ground Combat Center, Twentynine Palms, CA
Document Number: 2013-03692
Type: Notice
Date: 2013-02-19
Agency: Department of Defense, Department of the Navy
Pursuant to Section 102(2)(c) of the National Environmental Policy Act (NEPA) of 1969, 42 United States Code 4321-4370h, as implemented by the Council on Environmental Quality regulations, 40 Code of Federal Regulations (CFR) parts 1500-1508, the Department of Navy (DoN) NEPA regulations (32 CFR part 775), and Marine Corps Order P5090.2A (with Changes 1, 2) Marine Corps Environmental Compliance and Protection Manual, Chapter 12, the DoN, after carefully weighing the operational and environmental consequences of the proposed action in an Environmental Impact Statement (EIS), announces its decision to establish a large-scale Marine Air Ground Task Force (MAGTF) training facility at the Marine Corps Air Ground Combat Center in Twentynine Palms, California (``the Combat Center'') to accommodate a required new program of sustained, combined-arms, live-fire, and maneuver training for all elements of a Marine Expeditionary Brigade (MEB)-sized MAGTF, including full-scale MEB Exercises and associated MEB Building Block training. To accommodate the required MEB training activities, DoN, acting through the Combat Center, will: Purchase additional private and state lands adjacent to the Combat Center; request withdrawal by Act of Congress of additional public lands adjacent to the Combat Center; pursue through the Federal Aviation Administration the establishment and modification of military Special Use Airspace for proposed MEB- sized training range; and conduct the specified MEB training. Land withdrawal of more than 5,000 acres for the purposes of national defense may only be made by an Act of Congress. The DoN has selected Alternative 6, the Preferred Alternative, (with additional mitigation developed in consultation with the Bureau of Land Management [BLM]), for implementation and recommendation to Congress. Alternative 6 includes the withdrawal of public land and purchase of private and state lands collectively totaling approximately 167,971 acres west and south of the existing Combat Center. All practical means to avoid or minimize environmental harm from the Preferred Alternative that were identified in the Final EIS have been adopted.
Astronomy and Astrophysics Advisory Committee #13883; Notice of Meeting
Document Number: 2013-03691
Type: Notice
Date: 2013-02-19
Agency: National Science Foundation, Agencies and Commissions
Proposed Collection; Comment Request
Document Number: 2013-03690
Type: Notice
Date: 2013-02-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Proposed Collection; Comment Request
Document Number: 2013-03689
Type: Notice
Date: 2013-02-19
Agency: Department of Defense, Office of the Secretary
Notice of Lodging Proposed Consent Decree
Document Number: 2013-03688
Type: Notice
Date: 2013-02-19
Agency: Department of Justice
AdvisorShares Investments, LLC and AdvisorShares Trust; Notice of Application
Document Number: 2013-03686
Type: Notice
Date: 2013-02-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Summary of Application: Applicants request an order that would permit them to enter into and materially amend subadvisory agreements without shareholder approval and would grant relief from certain disclosure requirements. Applicants: AdvisorShares Investments, LLC (the ``Advisor'') and AdvisorShares Trust (the ``Trust'').
Submission for OMB Review; Comment Request
Document Number: 2013-03680
Type: Notice
Date: 2013-02-19
Agency: Department of Commerce
Special Conditions: Embraer S.A., Model EMB-550 Airplane; Landing Pitchover Condition
Document Number: 2013-03679
Type: Proposed Rule
Date: 2013-02-19
Agency: Federal Aviation Administration, Department of Transportation
This action proposes special conditions for the Embraer S.A. Model EMB-550 airplane. This airplane will have a novel or unusual design feature(s) associated with landing loads due to the automatic braking system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Special Conditions: Embraer S.A., Model EMB-550 Airplane; Interaction of Systems and Structures
Document Number: 2013-03678
Type: Rule
Date: 2013-02-19
Agency: Federal Aviation Administration, Department of Transportation
These special conditions are issued for the Embraer S.A. Model EMB-550 airplane. This airplane will have a novel or unusual design feature(s) associated with the interaction of systems and structures. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Special Conditions: Embraer S.A., Model EMB-550 Airplane; Electronic Flight Control System: Lateral-Directional and Longitudinal Stability and Low Energy Awareness
Document Number: 2013-03677
Type: Rule
Date: 2013-02-19
Agency: Federal Aviation Administration, Department of Transportation
These special conditions are issued for the Embraer S.A. Model EMB-550 airplane. This airplane will have a novel or unusual design feature(s) associated with an electronic flight control system with respect to lateral-directional and longitudinal stability and low energy awareness. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Special Conditions: Embraer S.A., Model EMB-550 Airplanes; Flight Envelope Protection: High Speed Limiting
Document Number: 2013-03676
Type: Rule
Date: 2013-02-19
Agency: Federal Aviation Administration, Department of Transportation
These special conditions are issued for the Embraer S.A. Model EMB-550 airplane. This airplane will have a novel or unusual design feature, specifically an electronic flight control system which contains fly-by-wire control laws, including envelope protections, for the overspeed protection and roll limiting function. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Notice of ACHP Quarterly Business Meeting
Document Number: 2013-03674
Type: Notice
Date: 2013-02-19
Agency: Historic Preservation, Advisory Council, Agencies and Commissions
Notice is hereby given that the Advisory Council on Historic Preservation (ACHP) will meet. Friday, March 1, 2013. The meeting will be held in the Room SR325 at the Russell Senate Office Building at Constitution and Delaware Avenues NE., Washington, DC at 8:30 a.m. The ACHP was established by the National Historic Preservation Act of 1966 (16 U.S.C. 470 et seq.) to advise the President and Congress on national historic preservation policy and to comment upon federal, federally assisted, and federally licensed undertakings having an effect upon properties listed in or eligible for inclusion in the National Register of Historic Places. The ACHP's members are the Architect of the Capitol; the Secretaries of the Interior, Agriculture, Defense, Housing and Urban Development, Commerce, Education, Veterans Affairs, and Transportation; the Administrator of the General Services Administration; the Chairman of the National Trust for Historic Preservation; the President of the National Conference of State Historic Preservation Officers; a Governor; a Mayor; a Native American; and eight non-federal members appointed by the President.
Qualification of Drivers; Exemption Applications; Vision
Document Number: 2013-03673
Type: Notice
Date: 2013-02-19
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 12 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemption renewals will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
Pilot Project on NAFTA Trucking Provisions
Document Number: 2013-03672
Type: Notice
Date: 2013-02-19
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
On September 12, 2011, FMCSA announced and requested public comment on data and information concerning the Pre-Authorization Safety Audit (PASA) for Grupo Behr de Baja California SA de CV (Grupo Behr), USDOT 861744, a motor carrier that applied to participate in the Agency's long-haul pilot program. That action was required by the ``U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007'' and all subsequent appropriations. While Grupo Behr successfully completed the PASA process, commenters raised concerns about the company's safety record. In addition, during the Agency's safety vetting process, an operating authority violation was discovered. As a result, the Agency placed Grupo Behr's application on hold. The purpose of this notice is to respond to the comments received in response to the September 12, 2011, notice, and to explain the enforcement action that the Agency took as a result of the operating authority violation. In addition, this notice advises that the Agency will now issue provisional authority to Grupo Behr for participation in the long-haul pilot program.
Public Availability of FY 2011 Service Contract Inventory Analysis, FY 2012 Service Contract Inventory, and FY 2012 Service Contract Inventory Planned Analysis for the National Transportation Safety Board
Document Number: 2013-03668
Type: Notice
Date: 2013-02-19
Agency: National Transportation Safety Board, Agencies and Commissions
In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), the National Transportation Safety Board is publishing this notice to advise the public of the availability of the FY 2011 Service Contract Inventory Analysis, the FY 2012 Service Contract Inventory, and the FY 2012 Service Contract Inventory Planned Analysis. The FY 2011 inventory analysis provides information on specific service contract actions that were analyzed as part of the FY 2011 inventory. The FY 2012 inventory provides information on service contract actions over $25,000 that were made in FY 2012. The inventory information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at https://www.whitehouse.gov/sites/default/files/omb/procurement /memo/ service-contract-inventories-guidance-11052010.pdf. The FY 2012 inventory planned analysis provides information on which functional areas will be reviewed by the agency. The National Transportation Safety Board has posted its FY 2012 inventory, FY 2012 planned analysis, and FY 2011 inventory analysis at the following link: https:// www.ntsb.gov/about/open.html.
WTO Dispute Settlement Proceeding Regarding Indonesia Importation of Horticultural Products, Animals and Animal Products
Document Number: 2013-03667
Type: Notice
Date: 2013-02-19
Agency: Office of the United States Trade Representative
The Office of the United States Trade Representative (``USTR'') is providing notice that on January 10, 2013, the United States requested consultations with the Government of the Republic of Indonesia (``Indonesia'') under the Marrakesh Agreement Establishing the World Trade Organization (``WTO Agreement'') concerning certain measures imposed by Indonesia on the importation of horticultural products, animals and animal products. That request may be found at www.wto.org, contained in a document designated as WT/DS455/1. USTR invites written comments from the public concerning the issues raised in this dispute.
New England Fishery Management Council; Public Meeting
Document Number: 2013-03666
Type: Notice
Date: 2013-02-19
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The New England Fishery Management Council's (Council) Groundfish Oversight Committee will meet jointly with its Groundfish Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).
Western Pacific Fishery Management Council; Public Meetings
Document Number: 2013-03665
Type: Notice
Date: 2013-02-19
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Western Pacific Fishery Management Council (Council) will hold meetings of its Executive and Budget Standing Committee and 156th Council to take actions on fishery management issues in the Western Pacific Region.
Notice of Availability: Beta Test of Electronic Product Fulfillment for Addressing and Delivery Management Products
Document Number: 2013-03664
Type: Notice
Date: 2013-02-19
Agency: Postal Service, Agencies and Commissions
The National Customer Support Center (NCSC) is seeking current National Change of Address Link (NCOA[supreg]), Delivery Point Verification (DPV[supreg]), Delivery Sequence File, Second Generation (DSF[supreg]), and Address Matching System-Application Program Interface (AMS API) licensees to test a beta web service that allows the electronic download of these products through the USPS[supreg] Electronic Product Fulfillment (EPF) Web site.
Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB
Document Number: 2013-03663
Type: Notice
Date: 2013-02-19
Agency: Federal Reserve System, Agencies and Commissions
Notice is hereby given of the final approval of a proposed information collection by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320.16 (OMB Regulations on Controlling Paperwork Burdens on the Public). Board- approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
International Mail Contract
Document Number: 2013-03662
Type: Notice
Date: 2013-02-19
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is noticing a recent Postal Service filing concerning a successor International Reply Service Competitive Contract 3 Negotiated Service Agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Division of Federal Employees' Compensation; Proposed Extension of Existing Collection; Comment Request
Document Number: 2013-03661
Type: Notice
Date: 2013-02-19
Agency: Department of Labor, Office of Workers' Compensation Programs
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation Programs is soliciting comments concerning the proposed collection: Claim for Reimbursement Assisted Reemployment (CA-2231). A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.
Notice of Intent To Repatriate Cultural Items: Rochester Museum & Science Center, Rochester, NY
Document Number: 2013-03660
Type: Notice
Date: 2013-02-19
Agency: Department of the Interior, National Park Service
The Rochester Museum & Science Center, in consultation with the appropriate Indian tribe, has determined that the cultural items listed meet the definition of sacred objects and objects of cultural patrimony and repatriation to the Indian tribe stated below may occur if no additional claimants come forward. Representatives of any Indian tribe that believes itself to be culturally affiliated with the cultural items may contact the Rochester Museum & Science Center.
Division of Federal Employees' Compensation, Proposed Extension of Existing Collection; Comment Request
Document Number: 2013-03659
Type: Notice
Date: 2013-02-19
Agency: Department of Labor, Office of Workers' Compensation Programs
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation Programs is soliciting comments concerning the proposed collection: Death Gratuity Forms (CA- 40, CA-41, and CA-42). A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.
Special Conditions: Embraer S.A., Model EMB-550 Airplane; Design Roll Maneuver for Electronic Flight Controls
Document Number: 2013-03658
Type: Rule
Date: 2013-02-19
Agency: Federal Aviation Administration, Department of Transportation
These special conditions are issued for the Embraer S.A. Model EMB-550 airplane. This airplane will have a novel or unusual design feature(s) associated with the design roll maneuver for electronic flight controls, specifically an electronic flight control system that provides control of the aircraft through pilot inputs to the flight computer. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Special Conditions: Embraer S.A., Model EMB-550 Airplane, Limit Pilot Forces for Sidestick Control
Document Number: 2013-03657
Type: Rule
Date: 2013-02-19
Agency: Federal Aviation Administration, Department of Transportation
These special conditions for the Embraer S.A. Model EMB-550 airplane. This airplane will have a novel or unusual design feature, specifically sidestick controllers designed to be operated with only one hand. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Special Conditions: Embraer S.A., Model EMB-550 Airplane; Electronic Flight Control System: Control Surface Awareness and Mode Annunciation
Document Number: 2013-03656
Type: Rule
Date: 2013-02-19
Agency: Federal Aviation Administration, Department of Transportation
These special conditions are issued for the Embraer S.A. Model EMB-550 airplane. This airplane will have a novel or unusual design feature(s) associated with the control surface awareness and mode annunciation of the electronic flight control system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Notice of Intent To Repatriate Cultural Items: Grand Rapids Public Museum, Grand Rapids, MI
Document Number: 2013-03655
Type: Notice
Date: 2013-02-19
Agency: Department of the Interior, National Park Service
The Grand Rapids Public Museum, in consultation with the appropriate Indian tribe, has determined that the cultural items meet the definition of unassociated funerary objects and repatriation to the Indian tribe stated below may occur if no additional claimants come forward. Representatives of any Indian tribe that believes itself to be culturally affiliated with the cultural items may contact the Grand Rapids Public Museum.
Notice of Intent To Repatriate a Cultural Item: Binghamton University, State University of New York, Binghamton, NY
Document Number: 2013-03654
Type: Notice
Date: 2013-02-19
Agency: Department of the Interior, National Park Service
Binghamton University, in consultation with the appropriate Indian tribes, has determined that a cultural item meets the definition of sacred object and repatriation to the Indian tribe stated below may occur if no additional claimants come forward. Representatives of any Indian tribe that believes itself to be culturally affiliated with the cultural item may contact Binghamton University.
Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2013-03652
Type: Notice
Date: 2013-02-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is issuing this guidance document to describe how to compile and submit the readily available pediatric use information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time.
Notice of Inventory Completion: Thomas Burke Memorial Washington State Museum, University of Washington, Seattle, WA
Document Number: 2013-03649
Type: Notice
Date: 2013-02-19
Agency: Department of the Interior, National Park Service
The Thomas Burke Memorial Washington State Museum (Burke Museum) has completed an inventory of human remains, in consultation with the appropriate Indian tribes, and has determined that there is no cultural affiliation between the remains and any present-day Indian tribe. Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains may contact the Burke Museum. Disposition of the human remains to the Indian tribes stated below may occur if no additional requestors come forward.
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure
Document Number: 2013-03647
Type: Proposed Rule
Date: 2013-02-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 1, 2010, along with a companion direct final rule. The proposed rule proposed to amend the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. The Agency received significant adverse comment and withdrew the direct final rule. The Agency is issuing this supplemental notice of proposed rulemaking re-proposing the amendments reflecting comments received.
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