April 6, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 113
Marine Fisheries Advisory Committee Meeting
This notice sets forth the proposed schedule and agenda of a forthcoming meeting of the Marine Fisheries Advisory Committee (MAFAC). The members will discuss and provide advice on issues outlined under SUPPLEMENTARY INFORMATION below.
Funding Availability Under Supportive Services for Veteran Families Program
This notice corrects a provision requiring grantees to have spent a certain amount of their previous grant award by a certain date, as stated in the Department of Veterans Affairs' February 3, 2015 NOFA, as amended on March 17, 2015, Announcement Type: Amendment. Funding Opportunity Number: VA-SSVF-021015. Catalog of Federal Domestic Assistance Number: 64.033, VA Supportive Services for Veteran Families Program.
Mortgagee Review Board: Administrative Actions
In compliance with Section 202(c)(5) of the National Housing Act, this notice advises of the cause and description of administrative actions taken by HUD's Mortgagee Review Board against HUD-approved mortgagees.
Advisory Committee on Commercial Operations to U.S. Customs and Border Protection (COAC)
The Advisory Committee on Commercial Operations to U.S. Customs and Border Protection (COAC) will meet on April 24, 2015, in Washington, DC. The meeting will be open to the public.
Federal Travel Regulation (FTR); Relocation Allowances-Relocation Income Tax (RIT) Allowance Tables
The purpose of this notice is to inform agencies that FTR Bulletin 15-03 pertaining to Relocation AllowancesRelocation Income Tax (RIT) Allowance Tables is now available online at www.gsa.gov/ ftrbulletin.
Alaska, Outer Continental Shelf, Chukchi Sea Planning Area, Oil and Gas Lease Sale 193; MMAA 104000
BOEM announces the availability of the Record of Decision (ROD) for remanded Chukchi Sea Outer Continental Shelf (OCS) Oil and Gas Lease Sale 193 (Lease Sale 193), originally held on February 6, 2008. BOEM prepared the Chukchi Sea Oil and Gas Lease Sale 193 Final Second Supplemental Environmental Impact Statement (SEIS) to address a deficiency identified by the U.S. Court of Appeals for the Ninth Circuit (Court of Appeals) in its opinion of January 22, 2014. The Final Second SEIS considers the potential impacts of oil and gas activities that could result from leases issued in Lease Sale 193, including the full range of likely production if oil production were to occur (80 FR 9266, Feb. 20, 2015). In making her decision, the Assistant Secretary for Land and Minerals Management (ASLM) considered four alternatives for Lease Sale 193, the potential impacts for each alternative as presented in the Final Second SEIS, and all comments received throughout the National Environmental Policy Act (NEPA) process. After careful consideration, the ASLM selected BOEM's preferred alternative, to affirm Lease Sale 193 and leases previously issued. This selection meets the purpose and need for the proposed action, promotes orderly resource development with protection of the human, marine, and coastal environments, and ensures that the public receives an equitable return for these resources and that free-market competition is maintained.
Special Local Regulation; San Salvador Launch and Procession; San Diego Bay, San Diego, CA
The Coast Guard is establishing a marine event special local regulation for the launch of the historic vessel San Salvador located in the Captain of the Port San Diego Zone on San Diego Bay. This action is necessary to provide for the safety of life and property on navigable waters during this event. This special local regulation will establish restrictions upon, and control movement of, vessels in a portion of San Diego Bay during the initial launch and subsequent procession of the San Salvador around a portion of San Diego Bay. Unauthorized persons and vessels are prohibited from entering into, transiting through or anchoring within this regulated area unless authorized by the Captain of the Port, or his designated representative. The Coast Guard requests public comments on the temporary special local regulation.
Notice of Intent To Prepare an Environmental Impact Statement: Dane County, Wisconsin
The FHWA is issuing this notice to advise the public that an EIS will be prepared for a proposed freeway interchange improvement project on I-39/90 from the County N interchange in the south to the I- 39/90/94/WIS 30 interchange (Badger Interchange) in the north and on US 12/18 from the West Broadway interchange in the west to the County AB intersection in the east in Dane County in south-central Wisconsin. Along US 12/18, improvements at the US 51 (Stoughton Road) interchange will also be evaluated from the Voges Rd./Terminal Dr. intersection in the south and to the Broadway intersection at the north.
Agency Information Collection Activities: Renewed Approval of Information Collection
The Department of Transportation (DOT) invites public comments on our intention to request the Office of Management and Budget's (OMB) approval to reinstate a previously approved Information Collection Request (OMB Control Number 2105-0563) in accordance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3501 et seq.). The previous approval granted the Department of Transportation authority to collect information involving National Infrastructure Investments or ``TIGER'' Discretionary Grants pursuant to Title I of the Transportation, Housing and Urban Development, and Related Agencies Appropriations Act for 2010 (the ``FY 2010 Appropriations Act''). The Office of the Secretary of Transportation (``OST'') is referring to these grants as ``TIGER Discretionary Grants.'' The original collection of information was necessary in order to receive applications for grant funds pursuant to the Transportation, Housing and Urban Development, and Related Agencies Appropriations Act of 2010 (``FY 2010 Appropriations Act''), Title IDepartment of Transportation, Office of the Secretary, National Infrastructure Investments, Public Law 111-117, 123 Stat. 3034. The purpose of the TIGER Discretionary Grants program is to advance projects that will have a significant impact on the Nation, Metropolitan area or a region. This request for reinstatement advances the previously approved request of an information collection. The information to be collected will be used to, receive applications for grant funds, to evaluate the effectiveness of projects that have been awarded grant funds and to monitor project financial conditions and project progress in support of the National Infrastructure Investments, referred to by the Department as ``Grants for Transportation Investment Generating Economic Recovery'', or ``TIGER'' Discretionary Grants program authorized and implemented pursuant to the American Recovery and Reinvestment Act of 2009 (the ``Recovery Act'') (OMB Control Number: 2105-0563) and the grants for National Infrastructure Investments under the FY 2010 Appropriations Act or TIGER Discretionary Grant programs include promoting economic recovery and supporting projects that have a significant impact on the Nation, a metropolitan area, or a region.
Zion Solutions, LLC, Zion Nuclear Power Station, Units 1 and 2, License Termination Plan
On December 19, 2014, as supplemented on February 26, 2015, the U.S. Nuclear Regulatory Commission (NRC) received from Zion Solutions, LLC, (ZS), the License Termination Plan (LTP) for the Zion Nuclear Power Station (ZNPS), Units 1 and 2. The LTP provides details about the known radiological information for the site, the planned demolition and decommissioning tasks to be completed, and the final radiological surveys and data that will need to be obtained to allow termination of the NRC's license for ZNPS. The NRC is requesting public comments on ZS's LTP and will hold a public meeting to discuss the LTP.
RTCA Federal Advisory Committee
The FAA is issuing this notice to advise the public of the renewal of the RTCA Charter (FAA Order 1110.77V) for two years, effective April 1, 2015. The administrator is the sponsor of the committee. The FAA and seven other government agencies use RTCA as a federal advisory committee. On January 2, 1976, the FAA, the major government user of RTCA products, assumed sponsorship on behalf of all government agencies. RTCA brings together representatives of the government and industry to form special committees and steering committees to provide advice and recommendations on key operational and technological issues that impact the Next Generation Air Transportation System (NextGen) implementation and the Air Traffic Management System. The Secretary of Transportation has determined that that information and use of committee are necessary in the public interest in connection with the performance of duties imposed on the FAA by law.
Cooperative Research and Development Agreement: Unmanned Aircraft System Demonstration for Support of Coast Guard Missions in the Arctic
The Coast Guard announces its intent to enter into a Cooperative Research and Development Agreement (CRADA) with Conoco Phillips Company (COP) to evaluate unmanned aircraft system (UAS) capabilities, benefits, risks and technical limitations of operating UAS from land and/or off a Coast Guard Cutter in a maritime environment. The Coast Guard will conduct flight testing and evaluation of UASs under a wide variety of simulated but realistic and relevant real-world maritime operational scenarios, such as ice operations, marine environmental monitoring, marine safety, search and rescue, and potentially other Coast Guard mission sets. While the Coast Guard is currently considering partnering with COP, the agency solicits public comment on the possible nature of and participation of other parties in the proposed CRADA. In addition, the Coast Guard also invites other potential non-Federal participants, who have the interest and capability to bring similar contributions to this type of research, to consider submitting proposals for consideration for similar CRADAs.
Anchorage Grounds; South Timbalier Anchorages; South of Port Fourchon, LA; Gulf of Mexico
The Coast Guard is considering establishing two new anchorage grounds in the Gulf of Mexico for the port of Port Fourchon, LA. These actions are being considered to help accommodate increased vessel volume and future increases and improve navigation safety for vessels transiting the Port Fourchon area, providing for the overall safe and efficient flow of vessel traffic and commerce. The Coast Guard is seeking comments and information about what form the proposed regulations should take and the actual need for them.
Safety Zone; Rock and Roll Hall of Fame and Museum Fireworks Display; Lake Erie, Cleveland, OH
The Coast Guard is establishing a temporary safety zone on Lake Erie, Cleveland Harbor, Cleveland, OH. This safety zone is intended to restrict vessels from a portion of Lake Erie during the Rock and Roll Hall of Fame and Museum fireworks display. This temporary safety zone is necessary to protect mariners and vessels from the navigational hazards associated with a fireworks display.
Brass Sheet and Strip From Germany: Preliminary Results of Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2013-2014
In response to a request from Petitioners,\1\ the Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on brass sheet and strip from Germany. The period of review (POR) is March 1, 2013, through February 28, 2014.\2\ The review covers ten producers or exporters of subject merchandise.\3\ We preliminarily find that three of the producers or exporters for which the Department initiated a review, Schwermetall, ThyssenKrupp, and Wieland, had no shipments during the POR. Further, we preliminarily find that subject merchandise has been sold at less than normal value by seven of the companies subject to this review. Interested parties are invited to comment on these preliminary results.\4\
Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List the Gulf of Mexico Bryde's Whale as Threatened or Endangered Under the Endangered Species Act
We, NMFS, announce a 90-day finding on a petition to list the Gulf of Mexico Bryde's whale (Balaenoptera edeni) as an endangered distinct population segment (DPS) under the Endangered Species Act (ESA). We find that the petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted. Accordingly, we will conduct a review of the status of this species to determine if the petitioned action is warranted. To ensure that the status review is comprehensive, we solicit information pertaining to this species from any interested party.
Defense Federal Acquisition Regulation Supplement; Technical Amendment
DoD is making technical amendments to the Defense Federal Acquisition Regulation Supplement (DFARS) to provide needed editorial changes.
Endangered and Threatened Wildlife; Initial Finding on a Petition to Identify and Delist a Saint John River Distinct Population Segment of Shortnose Sturgeon Under the Endangered Species Act
We (NMFS) announce an initial finding on a petition to identify the Saint John River population of shortnose sturgeon (Acipenser brevirostrum) as a distinct population segment (DPS) and delist this DPS from the Endangered Species Act. We have reviewed the petition, the references provided by the petitioner, and information readily available in our files, and we find that the petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted. Therefore, we will conduct a status review of the shortnose sturgeon to determine if the petitioned actions are warranted. To ensure that our review is comprehensive, we are soliciting scientific and commercial information pertaining to this petition from any interested party.
Wooden Bedroom Furniture From the People's Republic of China: Final Results of Changed Circumstances Review, and Revocation of Antidumping Duty Order, in Part
On February 6, 2015, the Department of Commerce (the ``Department'') published its Preliminary Results of a changed circumstances review and intent to revoke, in part, the antidumping duty (``AD'') order on wooden bedroom furniture from the People's Republic of China (``PRC'') \1\ with respect to certain shoe cabinets.\2\ The Department preliminarily determined that the producers accounting for substantially all of the production of the domestic like product to which the Order pertains lack interest in the relief provided by the Order with respect to certain shoe cabinets. We invited interested parties to comment on the Preliminary Results. As no parties submitted comments, the Department is making no changes to the Preliminary Results.
Circular Welded Carbon Steel Pipes and Tubes From Thailand: Preliminary Results of Antidumping Duty Administrative Review; 2013-2014
The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on circular welded carbon steel pipes and tubes from Thailand. This review covers two producers or exporters of the subject merchandise, Saha Thai Steel Pipe (Public) Company, Ltd. (Saha Thai), and Pacific Pipe Company Limited (Pacific Pipe). The period of review (POR) is March 1, 2013, through February 28, 2014. The Department preliminarily determines that Saha Thai and Pacific Pipe did not sell subject merchandise at less than normal value (NV) during the POR. The preliminary results are listed below in the section titled ``Preliminary Results of Review.'' Interested parties are invited to comment on these preliminary results.
Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities
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.
Certain Cut-to-Length Carbon-Quality Steel Plate From the Republic of Korea: Initiation of Countervailing Duty New Shipper Review
The Department of Commerce (the Department) received a timely request for a new shipper review of the countervailing duty order on certain cut-to-length carbon-quality steel plate from the Republic of Korea. The Department has determined that the request meets the statutory and regulatory requirements for initiation.
Certain Lined Paper Products From India: Notice of Final Results of Antidumping Duty Changed Circumstances Review
On July 14, 2014, the Department of Commerce (the Department) published the Preliminary Results of a changed circumstances review (CCR) of the antidumping duty order on certain lined paper products from India.\1\ The Department preliminarily determined that Kokuyo Riddhi Paper Products Private Limited (Kokuyo) is the successor-in- interest to Riddhi Enterprises (Riddhi). We received comments from interested parties on the Preliminary Results. Based on our analysis of these comments, for the final results, the Department continues to find that Kokuyo is the successor-in-interest to Riddhi.
Fiscal Years 2012 and 2013 Innovative Safety, Resiliency, and All-Hazard Emergency; Response and Recovery Program Project Selections; Fiscal Years 2013 and 2014 Low or No Emission Vehicle Deployment Program Project Selections; Fiscal Year 2012 Bus Efficiency Enhancements Research and Demonstrations Program Project Selections
The U.S. Department of Transportation's Federal Transit Administration announces the selection of research projects funded in support of three Notice of Funding Availability, as authorized under the Moving Ahead for Progress in the 21st Century, and prior legislation. Innovative Safety, Resiliency, and All-Hazard Emergency Response and Recovery Program: The U.S. Department of Transportation's (DOT) Federal Transit Administration (FTA) announces the selection of Innovative Safety, Resiliency, and All-Hazard Emergency Response and Recovery Program (SRER) Program projects (see Table 1) with Fiscal Year (FY) 2012 and FY 2013 appropriations for FTA's Research, Development, Demonstration and Deployment Program. The Consolidated and Further Continuing Appropriations Act, 2012, Public Law 112-55 made $25,000,000 available to carry out innovative research and demonstrations of national significance under 49 U.S.C. 5312. Of that amount, $20,800,000 was made available for innovative safety, resiliency, and all-hazards emergency response and recovery demonstration projects of national significance. An additional $8,200,000 in Section 5312 FY 2013 Research funds was made available for the same purpose for a combined amount of $29,000,000 in funds was made available from Fiscal Years 2012 and 2013. On October 1, 2013, FTA published a Notice of Funding Availability (NOFA) (78 FR 60369) announcing the availability of funding for SRER. These competitive research program funds will strengthen operational safety of public transportation, help transit systems better withstand natural disasters and other emergencies, and improve emergency response capabilities. Low or No Emission Vehicle Deployment Program: The U.S. Department of Transportation's (DOT) Federal Transit Administration (FTA) announces the selection of Low or No Emissions Vehicle Deployment Program (LONO) projects (see Table 2) with Fiscal Year (FY) 2013 and FY 2014 appropriations for deployment of low or no emission transit buses. The Moving Ahead for Progress in the 21st Century Act (MAP-21), Public Law 112-141, July 6, 2012, amended 49 U.S.C. 5312 to add a new paragraph (d)(5) authorizing FTA to make grants to finance eligible projects under the LONO Program. The Consolidated and Further Continuing Appropriations Act, 2013, (also referred to as the Full Year Continuing Appropriations Act, 2013) Public Law 113-6, March 26, 2013, made available $24,900,000 in FY 2013 (after sequestration) funds to carry out the LONO Program. Of that amount, $21,600,000 was made available for transit buses and $3,300,000 was made available for supporting facilities and related equipment. The Consolidated Appropriations Act, 2014, Public Law 113-76, January 17, 2014, made available $30,000,000 in FY 2014 to carry out the LONO Program. Of that amount, a minimum of $4,000,000 was made available for supporting facilities and related equipment. On January 9, 2014, FTA published a NOFA (79 FR 1668) announcing the availability of funding for the LONO program. The main purpose of the LONO Program is to deploy the cleanest and most energy efficient U.S.-made transit buses that have been largely proven in testing and demonstrations but are not yet widely deployed in transit agency fleets. The LONO Program provides funding for transit agencies for capital acquisitions and leases of zero-emission and low-emission transit buses, including acquisition, construction, and leasing of required supporting facilities such as recharging, refueling, and maintenance facilities. Bus Efficiency Enhancements Research and Demonstrations: The U.S. Department of Transportation's (DOT) Federal Transit Administration (FTA) announces the selection of five projects totaling $3,000,000 for Bus Efficiency Enhancements Research and Demonstrations (BEERD) program (see Table 3). On June 28, 2013, FTA published a Request for Proposals (RFP) on www.grants.gov and FTA's Web site announcing the availability of $3,000,000 of FY 2012 Section 5312/5314 National Research Program discretionary funds for innovative research, development, and demonstration projects targeting bus efficiency enhancements, specifically enhanced electrification of accessories, and improvements in thermal management of transit bus bodies. These projects will reduce energy use by transit buses and will have favorable impacts on meeting the needs of the riding public, public transportation operators, and the American bus industry and its supplier base. They will advance the DOT's research goals, which include but are not limited to improving safety, enhancing the state of good repair of public transit systems, providing more effective and efficient public transportation service, increasing capital and operating efficiencies, developing and deploying advanced vehicle designs and technology, reducing harmful emissions, and increasing energy efficiency. These projects also support an overarching FTA goal of developing and deploying new and innovative ideas, practices, and approaches for transit buses.
Pesticide Experimental Use Permit; Receipt of Application; Comment Request
This notice announces EPA's receipt of an application 59639- EUP-RI from Valent U.S.A. Corp., requesting an experimental use permit (EUP) for Clothianidin. The Agency has determined that the permit may be of regional and national significance. Therefore, because of the potential significance, EPA is seeking comments on this application.
Advisory Committee on Climate Change and Natural Resource Science
In accordance with the requirements of the Federal Advisory Committee Act, 5 U.S.C. App. 2, we announce that the Advisory Committee on Climate Change and Natural Resource Science will hold a meeting.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Health Care Practitioners for Device Labeling Format and Content
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.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Urethral Insert With Pump for Bladder Drainage
The Food and Drug Administration (FDA) is classifying the urethral insert with pump for bladder drainage into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the urethral insert with pump for bladder drainage's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
International Labour Office (ILO) Reference Radiographs
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease and Prevention is collaborating with the Labour Inspection, Labour Administration and Occupational Safety and Health Branch of the International Labour Office (ILO) in developing a set of digital reference radiographs for the ILO International Classification of Radiographs of Pneumoconiosis (ILO Classification). The current ILO Classification depends on 22 standard reference radiographs that are used to formally identify and characterize pneumoconiosis and related pulmonary abnormalities arising from occupational exposure. The original standards were based on film radiography, but the advent of digital radiography has led to the need for reference standards based on digitally-acquired images. NIOSH is assisting the ILO in the process of identifying such digital images. For this purpose, NIOSH is requesting trained users of the ILO Classification (e.g., NIOSH B-Readers [1] and other such experts) to submit comments regarding any of the current standard reference images that are felt to be deficient and for which improvements could be made. The current structure and format of the ILO Classification is to remain unchanged at the present time. NIOSH is not soliciting comments on the ILO Classification itself. Comments received on the ILO Classification will be considered irrelevant to the purpose of this docket.
Agency Forms Submitted for OMB Review, Request for Comments
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 35), the Railroad Retirement Board (RRB) is an forwarding Information Collection Request (ICR) to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB). Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens. The RRB invites comments on the proposed collections of information to determine (1) the practical utility of the collections; (2) the accuracy of the estimated burden of the collections; (3) ways to enhance the quality, utility, and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to the RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if the RRB and OIRA receive them within 30 days of the publication date. 1. Title and purpose of information collection: Appeal Under the Railroad Retirement and Railroad Unemployment Insurance Act; OMB 3220- 0007. Under section 7(b)(3) of the Railroad Retirement Act (RRA), and section 5(c) of the Railroad Unemployment Insurance Act (RUIA) any person aggrieved by a decision made by an office of the RRB on his or her application for an annuity or benefit under those Acts has the right to appeal to the RRB. This right is prescribed in 20 CFR part 260 and 20 CFR part 320. The notification letter, which is provided at the time of filing the original application, informs the applicant of such right. When an applicant protests a decision, the concerned RRB office reviews the entire file and any additional evidence submitted and sends the applicant a letter explaining the basis of the determination. The applicant is then notified that to protest further, they can appeal to the RRB's Bureau of Hearings and Appeals. The appeal process is prescribed in 20 CFR 260.5 and 260.9 and 20 CFR 320.12 and 320.38. To file a request for an appeal the applicant must complete Form HA-1, Appeal Under the Railroad Retirement Act or Railroad Unemployment Insurance Act. The form asks the applicant to explain the basis for their request for an appeal and, if necessary, to describe any additional evidence they wish to submit in support of the appeal. Completion is voluntary, however, if the information is not provided the RRB cannot process the appeal. Previous Requests for Comments: The RRB has already published the initial 60-day notice (80 FR 3266, on January 22, 2015) required by 44 U.S.C. 3506(c)(2). That request elicited no comments.
Limitation on Claims Against Proposed Public Transportation Projects
This notice announces final environmental actions taken by the Federal Transit Administration (FTA) for projects in the Cities of San Bernardino and Redlands, CA, and the Cities of Santa Ana and Garden Grove, CA. The purpose of this notice is to announce publicly the environmental decisions by FTA on the subject projects and to activate the limitation on any claims that may challenge these final environmental actions.
Commercial Driver's License Standards: Recreation Vehicle Industry Association Application for Exemption
FMCSA announces its decision to grant an exemption from the Federal commercial driver's license (CDL) requirements for drivers who deliver certain newly manufactured motorhomes and recreational vehicles (RVs) to dealers or trade shows before retail sale (driveaway operations). The Recreation Vehicle Industry Association (RVIA) requested the exemption because compliance with the CDL requirements prevents its members from implementing more efficient operations due to a shortage of CDL drivers. The exemption covers employees of all U.S. driveaway companies, RV manufacturers, and RV dealers transporting RVs between manufacturing sites and dealer locations and for movements prior to first retail sale. Drivers engaged in driveaway deliveries of RVs with gross vehicle weight ratings of 26,001 pounds or more will not be required to have a CDL as long as the empty RVs have gross vehicle weights or gross combination weights that do not meet or exceed 26,001 pounds, and any RV trailers towed by other vehicles weigh 10,000 pounds or less. RV units that have a combined gross vehicle weight exceeding 26,000 pounds are not covered by the exemption.
Society of Clinical Research Associates-Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practice
The Food and Drug Administration (FDA) is announcing an educational conference cosponsored with the Society of Clinical Research Associates (SOCRA). The public conference regarding FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process including informed consent documents, regulations relating to drugs, devices, and biologics, as well as inspections of clinical investigators, IRBs, and research sponsors. Date and Time: The public conference will be held on May 13 and 14, 2015, from 8 a.m. to 5 p.m. Location: The conference will be held at The Westin Cincinnati, 21 East Fifth Street, Cincinnati, OH 45202; 513-621-7700. Attendees are responsible for their own accommodations. Please mention SOCRA to receive the hotel room rate of $169 plus applicable taxes (available until April 15, 2015, or until the SOCRA room block is filled). Contact: John Fraser, Cincinnati District Office, Food and Drug Administration, 6751 Steger Dr., Cincinnati OH 45237, 513-679-2700, FAX: 513-679-2771 or Society of Clinical Research Associates (SOCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, 800-762-7292 or 215-822-8644, FAX: 215-822-8633, email: Office@socra.org, Web site: https://www.socra.org. (FDA has verified the Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Registration: The registration fee will cover actual expenses including refreshments, lunch, materials, and speaker expenses. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. The cost of the registration is as follows: SOCRA member, $575; SOCRA nonmember (includes membership), $650; Federal Government member, $450; Federal Government nonmember, $525; FDA employee, free (fee waived). If you need special accommodations due to a disability, please contact SOCRA (see Contact) at least 21 days in advance. Extended periods of question and answer and discussion have been included in the program schedule. SOCRA designates this education activity for a maximum of 13.3 Continuing Education (CE) Credits for SOCRA CE and Continuing Nurse Education (CNE). SOCRA designates this live activity for a maximum of 13.3 American Medical Association Physicians Recognition Award Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation. Continuing Medical Education for physicians: SOCRA is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for nurses: SOCRA is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association (PSNA), an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation(ANCC). ANCC/PSNA Provider Reference Number: 205-3-A-09. Registration Instructions: To register, please submit a registration form with your name, affiliation, mailing address, telephone, fax number, and email, along with a check or money order payable to ``SOCRA''. Mail to: SOCRA (see Contact for address). To register via the Internet, go to https://www.socra.org/html/ FDA_Conference.htm. Payment by major credit card is accepted (Visa/ MasterCard/AMEX only). For more information on the meeting registration, or for questions on the workshop, contact SOCRA (see Contact).
Determination of Regulatory Review Period for Purposes of Patent Extension; JUXTAPID
The Food and Drug Administration (FDA) has determined the regulatory review period for JUXTAPID and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
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