June 26, 2015 – Federal Register Recent Federal Regulation Documents
Results 101 - 140 of 140
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Part 71 Federal Operating Permit Program (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), ``Part 71 Federal Operating Permit Program (Renewal)'' (EPA ICR No. 1713.11, OMB Control No. 2060.0336) 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 is a proposed extension of the ICR, which is currently approved through June 30, 2015. Public comments were previously requested via the Federal Register on February 10, 2015, 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; Information Collection Request for Green Power Partnership and Combined Heat and Power Partnership (Renewal)
The Environmental Protection Agency has submitted an information collection request (ICR), ``Information Collection Request for Green Power Partnership and Combined Heat and Power Partnership'' (EPA ICR No. 2173.06, OMB Control No. 2060-0578) 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 is a proposed extension of the ICR, which is currently approved through July 31, 2015. Public comments were previously requested via the Federal Register (80 FR 8640) on February 18, 2015 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.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Identification, Listing and Rulemaking Petitions (Renewal)
The Environmental Protection Agency has submitted an information collection request (ICR), ``Identification, Listing and Rulemaking Petitions (Renewal)'' (EPA ICR No. 1189.26, OMB Control No. 2050-0053) 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 is a proposed extension of the ICR, which is currently approved through June 30, 2015. Public comments were previously requested via the Federal Register (80 FR 13372) on March 13, 2015 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.
Defense Federal Acquisition Regulation Supplement: Inflation Adjustment of Acquisition-Related Thresholds (DFARS Case 2014-D025)
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement the inflation adjustment of acquisition-related dollar thresholds. A statute requires an adjustment every five years of acquisition-related thresholds for inflation using the Consumer Price Index for all urban consumers, except for the Construction Wage Rate Requirements statute (formerly Davis-Bacon Act), Service Contract Labor Standards statute, and trade agreements thresholds. DoD also used the same methodology to adjust nonstatutory DFARS acquisition-related thresholds.
Defense Federal Acquisition Regulation Supplement: Defense Contractors Outside the United States-Subpart Relocation (DFARS Case 2015-D015)
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to relocate the text of a DFARS subpart in order to conform with the Federal Acquisition Regulation (FAR) and to make minor related editorial revisions.
Defense Federal Acquisition Regulation Supplement: Clauses With Alternates-Prescriptions and Clause Prefaces (DFARS Case 2015-D016)
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to clarify prescriptions and clause prefaces for clauses with alternates.
Defense Federal Acquisition Regulation Supplement: Allowability of Legal Costs for Whistleblower Proceedings (DFARS Case 2013-D022)
DoD has adopted as final, without change, an interim rule that amended the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2013 that addresses the allowability of legal costs incurred by a contractor related to whistleblower proceedings.
Surplus Properties; Notice
This amended notice provides information regarding the properties that have been determined surplus to the United States needs in accordance with the Defense Base Closure and Realignment Act of 1990, Public Law 101-510, as amended, and the 2005 Base Closure and Realignment Commission Report, as approved, and following screening with Federal agencies and Department of Defense components. This Notice amends the Notices published in the Federal Register on May 9, 2006 (71 FR 26932) and May 25, 2012 (77 FR 31339).
Ending of the National Environmental Policy Act Emergency Alternative Arrangements for New Orleans Hurricane and Storm Damage Risk Reduction System (HSDRRS)
The U.S. Army Corps of Engineers (USACE), Mississippi Valley Division, New Orleans District (CEMVN) announces the formal termination of the Emergency Alternative Arrangements implemented by agreement with the Council on Environmental Quality (CEQ) pursuant to CEQ's National Environmental Policy Act (NEPA) regulations (40 CFR 1506.11).
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; GEAR UP Applications for Partnership and State Grants
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.
Prospective Grant of Exclusive License: The Development of an Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Patent Application 62/006,313 entitled ``Chimeric Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014/0-US-01], and all related continuing and foreign patents/patent applications for the technology family, to Kite Pharma, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be worldwide, and the field of use may be limited to: ``All prophylactic and therapeutic uses for CD19-associated diseases, states and conditions in humans.''
Prospective Grant of Exclusive License: The Development of an Anti-TSLPR Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Patent Application 61/912,948 entitled ``Thymic Stromal Lymphopoietin Receptor-Specific Chimeric Antigen Receptors and Methods Using Same'' [HHS Ref. E-008-2014/0-US-01], U.S. Provisional Patent Application 61/ 991,697 entitled ``Thymic Stromal Lymphopoietin Receptor-Specific Chimeric Antigen Receptors and Methods Using Same'' [HHS Ref. E-008- 2014/1-US-01], PCT Patent Application PCT/US2014/063096 entitled ``Thymic Stromal Lymphopoietin Receptor-Specific Chimeric Antigen Receptors and Methods Using Same'' [HHS Ref. E-008-2014/2-PCT-01], and all related continuing and foreign patents/patent applications for the technology family, to Lentigen Technology, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be worldwide, and the field of use may be limited to: ``The development of a TSLPR-CAR-based immunotherapy using chimeric antigen receptors (CARs) having:
Prospective Grant of an Exclusive License Agreement: Development of Bispecific and Multi-Specific Fusion Proteins for the Treatment of ROR1 Expressing Human Cancers
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license agreement to practice the inventions embodied in US Provisional Application No. 61/418,550 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed December 1, 2010 [HHS Ref. E-039-2011/0-US-01]; PCT Application No. PCT/US2011/062670 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-PCT- 02]; Australian Patent Application No. 2011336650 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039- 2011/0-AU-03]; Canadian Patent Application No. 2818992 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-CA-04]; European Patent Application No. 11791733.6 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-EP-05]; and U.S. Patent Application No. 13/ 990,977 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed May 31, 2013 [HHS Ref. E-039-2011/0-US-06] and all related continuing and foreign patents/patent applications for the technology family to Emergent BioSolutions. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights to develop, make, have made, sell, have sold, import and export bi-specific and multi-specific fusion proteins that are capable of eliciting redirected T-cell cytotoxicity for the treatment of human receptor tyrosine kinase-like orphan receptor 1 (ROR1) expressing cancers, wherein said fusion proteins comprise one or more single-chain variable fragment (scFv) ROR1 binding domains from the anti-ROR1 antibodies designated as R11 or R12, one or more of Licensee's proprietary scFv CD3 binding domains, and optionally a fragment crystallizable (Fc) domain.
Commission Information Collection Activities (FERC-725B); Comment Request
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory Commission (Commission or FERC) is submitting its information collection [FERC-725B, Mandatory Reliability Standards for Critical Infrastructure Protection] to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission previously issued a Notice in the Federal Register (80 FR 21230, 4/17/ 2015) requesting public comments. The Commission received one public comment on the FERC725B. The public comment and FERC's response are provided later in this notice.
Agency Information Collection Activities: Application To Register Permanent Residence or Adjust Status, Form I-485 Supplement A, and Instruction Booklet for Filing Form I-485 and Supplement A, Form I-485; Revision of a Currently Approved Collection
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on March 10, 2015, at 80 FR 12647, allowing for a 60-day public comment period. USCIS received eight comments in connection with the 60-day notice.
Investor Advisory Committee Meeting
The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, is providing notice that it will hold a public meeting. The public is invited to submit written statements to the Committee.
Source Data Capture From Electronic Health Records: Using Standardized Clinical Research Data
The Center for Drug Evaluation and Research (CDER) is interested in supporting demonstration projects to test the capability and evaluate performance of using an end-to-end Electronic Health Record (EHR)-to-Electronic Data Capture (EDC) single-point data capture approach, using established data and implementation standards in a regulated clinical research environment. A demonstration project should ideally test the use of a standards-based technology solution to enable the collection of related healthcare and clinical research information within a single system and workflow. Stakeholders may include regulated industry, EHR and EDC vendors, academic medical centers, and other interested parties.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Shortages Data Collection System
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Defense Federal Acquisition Regulation Supplement; Technical Amendments
DoD is making technical amendments to the Defense Federal Acquisition Regulation Supplement (DFARS) to provide needed editorial changes.
Notice of Availability (NOA) for the Draft Environmental Impact Statement (EIS) and Announcement of Public Hearings for the Proposed Great Northern Transmission Line (GNTL) Project
The U.S. Department of Energy (DOE) announces the availability of the ``Great Northern Transmission Line Project Draft Environmental Impact Statement'' (DOE/EIS-0499) for public review and comment. DOE is also announcing eight public hearings to receive comments on the Draft EIS. The Draft EIS evaluates the environmental impacts of DOE's proposed Federal action of issuing a Presidential permit to the Applicant: Minnesota Power, a regulated utility division of ALLETE, Inc., to construct, operate, maintain, and connect a new electric transmission line across the U.S./Canada border in northern Minnesota. It also addresses the potential human and environmental impacts of the project, and possible mitigation measures, including route, alignment, and site alternatives required for a transmission line route permit from the Minnesota Public Utilities Commission under the Minnesota Power Plant Siting Act. The EIS was jointly prepared by DOE with the Minnesota Department of CommerceEnvironmental Energy Review and Analysis (MN DOC-EERA) acting as state co-lead in order to avoid duplication, and to comply with the environmental review requirements under both federal and state regulations. Region 5 of the U.S. Environmental Protection Agency (USEPA), the St. Paul District Office of the U.S. Army Corps of Engineers (USACE), and the Twin Cities Ecology Field Office of the U.S. Fish and Wildlife Service (USFWS) are cooperating agencies in preparing the GNTL Project EIS.
Airworthiness Directives; ATR-GIE Avions de Transport Régional Airplanes
We are adopting a new airworthiness directive (AD) for certain ATR-GIE Avions de Transport R[eacute]gional Model ATR42-500 and ATR72- 212A airplanes. This AD requires inspection of the affected control systems rods and, depending on findings, a replacement of the affected rods. This AD was prompted by reports of non-conformity of certain control rods, which could result in failure of the control rods. We are issuing this AD to detect and correct failure of an affected control rod, which, under certain circumstances, could result in reduced control of the airplane.
Airworthiness Directives; Bombardier, Inc. Airplanes
We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc. Model DHC-8-400 series airplanes. This AD was prompted by reports of corrosion in the low-rate discharge tubes of the fire protection system leading to the forward baggage compartment, and perforation of one or more tubes. This AD requires repetitive checks for leakage of the discharge tubes of the fire protection system. This AD also mandates eventual replacement of all existing aluminum tube assemblies with new, improved corrosion-resistant stainless steel tube assemblies. We are issuing this AD to prevent perforation of the low- rate discharge tubes, which could result in insufficient fire extinguishing agent reaching the forward baggage compartment in the event of a fire, which could result in damage to the airplane and injury to the occupants.
Approval of Air Quality Implementation Plans; Minnesota; Infrastructure SIP Requirements for the 2008 Ozone, 2010 NO2, 2010 SO2, and 2012 PM2.
The Environmental Protection Agency (EPA) is proposing to approve some elements and disapprove other elements of state implementation plan (SIP) submissions from Minnesota regarding the infrastructure requirements of section 110 of the Clean Air Act (CAA) for the 2008 ozone, 2010 nitrogen dioxide (NO2), 2010 sulfur dioxide (SO2), and 2012 fine particulate matter (PM2.5) National Ambient Air Quality Standards (NAAQS). The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA. EPA proposes to disapprove certain elements of Minnesota's submissions relating to Prevention of Significant Deterioration (PSD) requirements. Minnesota already administers Federally promulgated regulations that address the proposed disapprovals described in today's rulemaking. Therefore, the state will not be obligated to submit any new or additional regulations as a result of a future final disapproval.
NASA FAR Supplement Regulatory Review No. 3
NASA adopts a final rule amending the NASA FAR Supplement with the goal of eliminating unnecessary regulation, streamlining burdensome regulation, clarifying language, and simplifying processes where possible.
Federal Property Suitable as Facilities To Assist the Homeless
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.
Approval and Promulgation of Implementation Plans; Georgia: Changes to Georgia Fuel Rule and Other Miscellaneous Rules
The Environmental Protection Agency (EPA) is proposing to approve the State of Georgia's February 5, 2015, State Implementation Plan (SIP) revision, submitted through the Georgia Environmental Protection Division (GA EPD), to modify the SIP by removing Georgia's Gasoline Marketing Rule and Consumer and Commercial Products Rule, revising the NOX Emissions from Stationary Gas Turbines and Stationary Engines Rule, and adding measures to offset the emissions increases expected from the changes to these rules. This modification to the SIP will affect, in varying ways, the 45 counties in and around the Atlanta, Georgia, metropolitan area covered by the Georgia Gasoline Marketing Rule (hereinafter referred to as the ``Georgia Fuel Area''). Additionally, EPA is also proposing to approve structural changes to the NOX Emissions from Stationary Gas Turbines and Stationary Engines Rule included in a SIP revision submitted by GA EPD on September 26, 2006. EPA has preliminarily determined that the portion of Georgia's September 26, 2006 SIP revision addressing changes to the NOX Emissions from Stationary Gas Turbines and Stationary Engines Rule and the February 5, 2015, SIP revision meet the applicable provisions of the Clean Air Act (CAA or Act).
Partner Vetting in USAID Assistance
The U.S. Agency for International Development (USAID) is implementing a pilot for a Partner Vetting System (PVS) for USAID assistance and acquisition awards. The purpose of the Partner Vetting System is to help mitigate the risk that USAID funds and other resources could inadvertently benefit individuals or entities that are terrorists, supporters of terrorists or affiliated with terrorists, while also minimizing the impact on USAID programs and its implementing partners. This final rule sets out the requirements for the vetting of Federal awards, requirements including award terms for PVS, and applies PVS to a pilot program and any subsequent implementation of PVS that is determined appropriate. It follows publication of a proposed rule and takes into consideration the public comments received.
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