Maryland Disaster #MD-00032
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Maryland (FEMA- 4261-DR), dated 03/04/2016. Incident: Severe Winter Storm and Snowstorm. Incident Period: 01/22/2016 through 01/23/2016. Effective Date: 03/04/2016. Physical Loan Application Deadline Date: 05/03/2016. Economic Injury (EIDL) Loan Application Deadline Date: 12/05/2016.
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.'' The draft guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion through the implementation of pathogen reduction technology (PRT) or bacterial testing. The draft guidance also provides recommendations for the use of secondary testing of platelets as the basis to extend the dating period of platelets, when appropriately labeled bacterial detection devices and storage containers are used. The draft guidance replaces the draft guidance entitled ``Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,'' dated December 2014. The draft guidance, when finalized, is intended to supersede the recommendation in section VII.A.2, in regard to bacterial contamination testing in the document entitled ``Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods'' dated December 2007.
Determination That KENALOG (Triamcinolone Acetonide) Lotion and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on extending Office of Management and Budget (OMB) approval on the existing recordkeeping requirements for this information collection, regarding animal proteins prohibited in ruminant feed.
Statement of Organization, Functions, and Delegations of Authority
This notice replaces all language in Part A (Office of the Secretary) of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS), Office of Inspector General (OIG) (70 FR 20147, as amended April 18, 2005; as last amended at 73 FR 7568, dated February 8, 2008). The statement of organization, functions, and delegations of authority conforms to and carries out the statutory requirements for operating OIG. The organizational changes reflected in this notice are primarily to realign the functions within OIG to better reflect the current work environment and priorities, and to more clearly delineate responsibilities for the various activities within OIG's offices. In addition, this notice removes all of Chapter A and establishes Chapter Q. OIG was established by law as an independent and objective oversight unit of the Department to carry out the mission of preventing fraud and abuse and promoting economy, efficiency and effectiveness of HHS programs and operations. In furtherance of this mission, the organization: A. Conducts and supervises audits, investigations, evaluations and inspections relating to HHS programs and operations. B. Identifies systemic weaknesses giving rise to opportunities for fraud and abuse in HHS programs and operations and makes recommendations to prevent their recurrence. C. Leads and coordinates activities to prevent and detect fraud and abuse in HHS programs and operations. D. Detects wrongdoers and abusers of HHS programs and beneficiaries so appropriate remedies may be brought to bear, including imposing administrative sanctions against providers of health care under Medicare and Medicaid who commit certain prohibited acts. E. Keeps the Secretary and Congress fully and currently informed about problems and deficiencies in the administration of HHS programs and operations and about the need for and progress of corrective action. In addition, OIG works with the Department of Justice (DOJ), on behalf of the Secretary, to operate the Health Care Fraud and Abuse Control Program. In accordance with authority enacted in its annual appropriations, OIG also provides protection services to the Secretary and conducts criminal investigations of violations of Federal child support provisions. In support of its mission, OIG carries out and maintains an internal quality assurance system and a peer review system with other Offices of Inspectors General, including periodic quality assessment studies and quality control reviews, to provide reasonable assurance that applicable laws, regulations, policies, procedures, standards, and other requirements are followed, are effective, and are functioning as intended in OIG operations.
Airworthiness Directives; Honeywell International Inc. Turboprop and Turboshaft Engines
We propose to adopt a new airworthiness directive (AD) for certain Honeywell International Inc. (Honeywell) TPE331 model turboprop engines and TSE331-3U model turboshaft engines. This proposed AD was prompted by the discovery of cracks in a 2nd stage compressor impeller during a routine shop visit. This proposed AD would require removal of the 2nd stage compressor impeller. We are proposing this AD to prevent failure of the compressor impeller, uncontained part release, damage to the engine, and damage to the airplane.
Airworthiness Directives; Engine Alliance Turbofan Engines
We are adopting a new airworthiness directive (AD) for certain Engine Alliance (EA) GP7270 turbofan engines. This AD was prompted by reports of the installation of non-conforming honeycomb cartridges in the high-pressure compressor (HPC) adjacent to the HPC rotor stage 2 to 5 spool and stage 7 to 9 spool. This AD requires removal and replacement of the affected HPC rotor stage 2 to 5 and stage 7 to 9 spools and adjacent honeycomb cartridges. We are issuing this AD to prevent failure of the HPC rotor stage 2 to 5 and stage 7 to 9 spools, which could lead to uncontained engine failure and damage to the airplane.
Airworthiness Directives; Rolls-Royce plc Turbofan Engines
We are superseding airworthiness directive (AD) 2015-04-03 that applies to certain Rolls-Royce plc (RR) RB211 Trent 768-60, 772- 60, and 772B-60 turbofan engines. AD 2015-04-03 required inspection of the sealing sleeve on the high-pressure/intermediate-pressure (HP/IP) turbine support internal oil feed tube and removal of those sealing sleeves affected by AD 2015-04-03. This AD requires removal of either the affected sealing sleeve only or both the affected sealing sleeve and the oil feed tube. This AD was prompted by fractures of the HP/IP turbine support internal oil feed tube. We are issuing this AD to prevent failure of the HP/IP turbine support internal oil feed tube, uncontained engine failure, and damage to the airplane.
Revision of Federal Migratory Bird Hunting and Conservation Stamp (Duck Stamp) Contest Regulations
We, the U.S. Fish and Wildlife Service (Service), are extending the comment period for our February 11, 2016, proposed rule to change the regulations governing the annual Migratory Bird Hunting and Conservation Stamp Contest (also known as the Federal Duck Stamp Contest). This action will allow interested persons additional time to comment on the proposal. Comments previously submitted need not be resubmitted as they will be fully considered in preparation of the final rule.
School Boards for DoD Domestic Dependent Elementary and Secondary Schools (DDESS)
This proposed rule establishes policy, assigns responsibilities, and provides procedures for the establishment and operation of elected school boards for elementary, middle and high schools operated by the DoD Education Activity in the Continental United States and the Territories, Possessions and Commonwealths. Specific direction is given to facilitate compliance with 10 U.S.C. 2164(d), as implemented by DoD Instruction 1342.25, regarding the election of board members, composition, roles and responsibilities, operating procedures and resolution of conflicts.
Train Crew Staffing
FRA proposes regulations establishing minimum requirements for the size of train crew staffs depending on the type of operation. A minimum requirement of two crewmembers is proposed for all railroad operations, with exceptions proposed for those operations that FRA believes do not pose significant safety risks to railroad employees, the general public, and the environment by using fewer than two-person crews. This proposed rule would also establish minimum requirements for the roles and responsibilities of the second train crewmember on a moving train, and promote safe and effective teamwork. Additionally, FRA co-proposes two different options for situations where a railroad wants to continue an existing operation with a one-person train crew or start up an operation with less than two crewmembers. Under both co- proposal options, a railroad that wants to continue an existing operation or start a new operation with less than a two-person train crew would be required to describe the operation and provide safety- related information to FRA; however, proposed Option 1 includes an FRA review and approval period lasting up to 90 days while Option 2 proposes permitting such operations to initiate or continue without a mandatory FRA review and approval waiting period or while such review is taking place. For start-up freight operations with less than two crewmembers, proposed Option 2 also requires a statement signed by the railroad officer in charge of the operation certifying a safety hazard analysis of the operation has been completed and that the operation provides an appropriate level of safety.
Airworthiness Directives; B-N Group Ltd. Airplanes
We are superseding an airworthiness directive (AD) 2007-06-06 for B-N Group Ltd. Models BN-2, BN-2A, BN-2A-2, BN-2A-3, BN-2A-6, BN- 2A-8, BN-2A-9, BN-2A-20, BN-2A-21, BN-2A-26, BN-2A-27, BN-2B-20, BN-2B- 21, BN-2B-26, BN-2B-27, BN2A MK. III, BN2A MK. III-2, BN2A MK. III-3 BN2A, BN2B, and BN2A MKIII (all models on TCDS A17EU and A29EU) airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as cracks in the inner shell of certain pitot/static pressure heads. We are issuing this AD to require actions to address the unsafe condition on these products.
Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations
Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued, from February 13, 2016, to February 29, 2016. The last biweekly notice was published on March 1, 2016.
Amendments to the HUD Acquisition Regulation (HUDAR)
This final rule amends the HUDAR to implement miscellaneous changes necessary to update the HUDAR. These changes include a correction to the designation of Source Selection Authorities, limited delegation of Head of Contracting Activity authorities, incorporation of the HUDAR Matrix, addition of new clauses including clauses relating to labor categories and prices per hour, and post-award conferences. HUD is transitioning to the Department of Treasury's Bureau of Fiscal Services' Invoice Platform Processing System (IPP), and this final rule revises clauses related to payments and invoicing to take into account both the situations where invoicing and payment will not be made through the IPP and where invoices are required to be submitted electronically through the IPP. This final rule also clarifies that where funding has been made available for a contract, and the limit of the funding has been reached or the necessary funding modification is not in place, the contractor must stop performing work and may not start again until notified through a contract funding modification that funds are available to continue work. This final rule also modifies the proposed provision on post-award conferences to limit the clause to cases where a conference is required, and provides an alternate clause for attendance at such conferences via telephone or video conference. The rule makes certain administrative corrections, and incorporation of alternates to various clauses to allow for electronic invoicing.
National Performance Management Measures: Highway Safety Improvement Program
The purpose of this final rule is to establish performance measures for State departments of transportation (State DOT) to use to carry out the Highway Safety Improvement Program (HSIP) and to assess the: Number of motor vehicle crash-related serious injuries and fatalities; number of serious injuries and fatalities of non-motorized users; and serious injuries and fatalities per vehicle miles traveled (VMT). The FHWA issues this final rule based on section 1203 of the Moving Ahead for Progress in the 21st Century Act (MAP-21), which identifies national transportation goals and requires the Secretary to promulgate a rulemaking to establish performance measures and standards in specified Federal-aid highway program areas. The FHWA also considered the provisions in the Fixing America's Surface Transportation Act (FAST Act) in the development of this final rule. The HSIP is a Federal-aid highway program with the purpose of achieving a significant reduction in fatalities and serious injuries on all public roads, including non- State-owned public roads and roads on tribal lands.
Highway Safety Improvement Program
The purpose of this final rule is to incorporate changes to the Highway Safety Improvement Program (HSIP) regulations to address provisions in the Moving Ahead for Progress in the 21st Century Act (MAP-21) as well as to incorporate clarifications to better explain existing regulatory language. The DOT also considered the HSIP provisions in the Fixing America's Surface Transportation Act (FAST Act) in the development of the HSIP final rule. Specifically, this rule removes the requirement for States to prepare a Transparency Report that describes not less than 5 percent of locations that exhibit the most severe safety needs, removes the High Risk Rural Roads (HRRR) set- aside, and removes the 10 percent flexibility provision for States to use safety funding in accordance with Federal law. This rule also establishes a subset of roadway data elements, and creates procedures to ensure that States adopt and use the subset. Finally, this rule adds State Strategic Highway Safety Plan update requirements and requires States to report HSIP performance targets.