2012 – Federal Register Recent Federal Regulation Documents
Results 2,451 - 2,500 of 29,268
Termination of Department of Defense Federal Advisory Committees
Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix), 41 CFR Sec. 102-3.55, and the Government in the Sunshine Act of 1976 (5 U.S.C. 552b), effective October 5, 2012, the Department of Defense gives notice that it is terminating the Naval Research Advisory Committee.
Interagency Task Force on Veterans Small Business Development; Notice of Meeting
The SBA is issuing this notice to announce the location, date, time, and agenda for its public meeting of the Interagency Task Force on Veterans Small Business Development. The meeting will be open to the public.
Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets; Expected Retirement Age
This rule amends the Pension Benefit Guaranty Corporation's regulation on Allocation of Assets in Single-Employer Plans by substituting a new table for determining expected retirement ages for participants in pension plans undergoing distress or involuntary termination with valuation dates falling in 2013. This table is needed in order to compute the value of early retirement benefits and, thus, the total value of benefits under a plan.
Intent To Prepare an Environmental Impact Statement for the Proposed Flood Risk Management Study for the Blanchard River Watershed Including Communities of Findlay and Ottawa, OH
Pursuant to Section 102(2)(c) of the National Environmental Policy Act (NEPA) of 1969 as implemented by the Council on Environmental Quality regulations (40 CFR parts 1500-1508) and Public Law 102-484 Section 2834, as amended by Public Law 104-106 Section 2867, the Department of the Army hereby gives notice of intent to prepare an Environmental Impact Statement (EIS) for the subject Flood Risk Management Study. The Buffalo District of the U.S. Army Corps of Engineers (USACE) will be the lead agency in preparing the EIS. The EIS will consider Federal actions associated with the proposed Flood Risk Management Study in the Blanchard River Watershed including the communities of the City of Findlay in Hancock County and the Village of Ottawa in Putnam County, OH. More specifically, this document will discuss measures to improve flood risk management, navigation, water quality, recreation, and fish and wildlife habitat in a comprehensive manner in the Blanchard River Watershed, Ohio. The overall goal of the study is to reduce flood risk by saving lives and minimizing property damage in the event of floods in Findlay and Ottawa, Ohio. The plan will consider a range of structural and nonstructural measures that may be used for flood risk management in the Blanchard River Watershed.
Notice of Correction to the Notice of Intent To Prepare a Joint Environmental Impact Statement (EIS) for the Gateway Pacific Terminals Bulk Dry Goods Shipping Facility and the Custer Spur Rail Expansion Projects
This notice corrects the location and date of one of the public scoping meetings listed in the Notice of Intent published in the Federal Register (77 FR 58531) on Friday, September 21, 2012. The venue for the Seattle public scoping meeting previously scheduled for November 13, 2012 is no longer available. The Seattle public scoping meeting will be held at the Washington State Convention Center, Rooms 6A, 6B, 6C, and 6D, 800 Convention Place, Seattle, WA 98101 on Monday, December 17, 2012, from 4:00 p.m. to 7:00 p.m.
Notice of Intent to License Government-Owned Inventions; Intent to License on a Partially-Exclusive Basis
The inventions listed below are assigned to the United States Government as represented by the Secretary of the Army. The US Army Edgewood Chemical Biological Center intends to license these inventions on a partially-exclusive basis to Lighthouse Worldwide Solutions, Inc, a California Corporation with principal offices at, 47300 Landing Parkway, Fremont, CA 94538. The inventions to be licensed collectively enable a Tactical Biological Detector (TAC-BIO), and are disclosed in U.S. Patent 6,967,338 Application Serial No10/720877 filed 11/24/2003, issued 11/22/2005 and entitled ``Micro UV particle detector,'' U.S. Patent 7,375,348 Application Serial No 11/268758 filed 11/03/2005, issued 05/20/2008 and entitled ``Micro UV detector,'' U.S. Patent 7,567,391 Application Serial No 11/748817 filed 05/15/2007, issued 07/ 28/2009 and entitled ``Radiation source with self-aligning optics,'' U.S. Patent 7,852,469 Application Serial No 11/867190 filed 10/04/2007, issued 12/14/2010 and entitled ``Particle detector,'' DAM 689-08 Application Serial No.12/380,366 filed 02/26/2009 and entitled ``Photon counting based particle detection method and apparatus.''
Empowering Consumers To Prevent and Detect Billing for Unauthorized Charges (“Cramming”); Consumer Information and Disclosure; Truth-in-Billing Format
In this document, the Federal Communications Commission (FCC) is correcting a final rule that appeared in the Federal Register of May 24, 2012. This document corrects rules adopted to help consumers prevent and detect the placement of unauthorized charges on their telephone bills, an unlawful and fraudulent practice commonly referred to as ``cramming.''
Empowering Consumers To Prevent and Detect Billing for Unauthorized Charges (“Cramming”); Consumer Information and Disclosure; Truth-in-Billing Format
In this document, the Federal Communications Commission (FCC) is correcting a final rule that appeared in the Federal Register of October 26, 2012. The document announces the effective date of rules containing information collection requirements approved by the Office of Management and Budget that were adopted to help consumers prevent and detect the placement of unauthorized charges on their telephone bills, an unlawful and fraudulent practice commonly referred to as ``cramming.''
Reconsideration of Certain New Source and Startup/Shutdown Issues: National Emission Standards for Hazardous Air Pollutants From Coal- and Oil-Fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units
On February 16, 2012, pursuant to sections 111 and 112 of the Clean Air Act (CAA), the EPA published the final rules titled ``National Emission Standards for Hazardous Air Pollutants from Coal- and Oil-fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-Fuel-Fired Electric Utility, Industrial- Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units.'' The National Emission Standards for Hazardous Air Pollutants (NESHAP) rule issued pursuant to CAA section 112 is referred to as the Mercury and Air Toxics Standards (MATS), and the New Source Performance Standards rule issued pursuant to CAA section 111 is referred to as the Utility NSPS. The Administrator received petitions for reconsideration of certain aspects of MATS and the Utility NSPS. In this notice, the EPA is announcing reconsideration of certain new source standards for MATS, the requirements applicable during periods of startup and shutdown for MATS, the startup and shutdown provisions related to the particulate matter (PM) standard in the Utility NSPS, and certain revisions to the definitional and monitoring provisions of the Utility NSPS. We are also proposing certain technical corrections to both MATS and the Utility NSPS. We seek comment only on the aspects of the final MATS and Utility NSPS rules specifically identified in this notice. We are not opening for reconsideration any other provisions of MATS or the Utility NSPS at this time.
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.
Notice of Intent To Prepare an Environmental Assessment for the Transfer of the Kansas City Plant, Kansas City, MO
Pursuant to the National Environmental Policy Act of 1969 (NEPA), and the Council on Environmental Quality and U.S. Department of Energy (DOE) regulations implementing NEPA, the National Nuclear Security Administration (NNSA), a semi-autonomous agency within DOE, announces its intention to prepare an Environmental Assessment (EA) for the transfer of the Kansas City Plant (KCP) (DOE/EA-1947), which is an NNSA-owned property at the Bannister Federal Complex (BFC). Concurrently, NNSA is canceling the Notice of Intent issued on January 23, 2012 (77 FR 3259) for the preparation of an Environmental Impact Statement for the Disposition of the Bannister Federal Complex, Kansas City, Missouri, and Notice of Wetlands Involvement (DOE/EIS-0475).
Texas: Final Authorization of State-initiated Changes and Incorporation by Reference of State Hazardous Waste Management Program
During a review of Texas' regulations, the EPA identified a variety of State-initiated changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). We have determined that these changes are minor and satisfy all requirements needed to qualify for Final authorization and are authorizing the State-initiated changes through this Direct Final action. The Solid Waste Disposal Act, as amended, commonly referred to as the Resource Conservation and Recovery Act (RCRA), allows the Environmental Protection Agency (EPA) to authorize States to operate their hazardous waste management programs in lieu of the Federal program. The EPA uses the regulations entitled ``Approved State Hazardous Waste Management Programs'' to provide notice of the authorization status of State programs and to incorporate by reference those provisions of the State statutes and regulations that will be subject to the EPA's inspection and enforcement. The rule codifies in the regulations the prior approval of Texas' hazardous waste management program and incorporates by reference authorized provisions of the State's statutes and regulations.
Texas: Final Authorization of State-initiated Changes and Incorporation by Reference of State Hazardous Waste Management Program
During a review of Texas' regulations, the EPA identified a variety of State-initiated changes to Texas' hazardous waste program under the Resource Conservation and Recovery Act, as amended (RCRA), for which the State had not previously sought authorization. The EPA proposes to authorize the State for the program changes. In addition, the EPA proposes to codify in the regulations entitled ``Approved State Hazardous Waste Management Programs'', Texas' authorized hazardous waste program. The EPA will incorporate by reference into the Code of Federal Regulations (CFR) those provisions of the State regulations that are authorized and that the EPA will enforce under RCRA.
Updates to Voluntary Consensus Standards Incorporated by Reference
Many of the Coast Guard's regulations incorporate industry standards. The Coast Guard is reviewing these regulations to determine whether they contain outdated standards and, if so, whether and how these regulations should be updated to incorporate more current standards. We request comments from the public on which current industry standards should be incorporated, which currently incorporated standards are outdated, and how the Coast Guard should ensure incorporated standards are kept current.
Revisions to Electric Quarterly Report Filing Process
The Federal Energy Regulatory Commission (Commission) amends its regulations to change the process for filing Electric Quarterly Reports (EQR). Due to technology changes that will render the current filing process outmoded, ineffective, and unsustainable, the Commission will discontinue the use of Commission-distributed software to file an EQR. Instead, the Commission adopts a web-based approach to filing EQRs that will allow a public or non-public utility to file an EQR directly through the Commission's Web site, either through a web interface or by submitting an Extensible Mark-Up Language-formatted file. By adopting a process with two options for filing EQRs, the Commission seeks to provide the flexibility needed to accommodate a public or non-public utility's technical preference. The Commission also requires a public or non-public utility to identify itself with a company identification number rather than the existing software-based EQR identifier. The changes to the process for filing EQRs will apply to EQR filings beginning with the third quarter 2013 EQR, which will provide data for July through September 2013.
Final Fair Market Rents for the Housing Choice Voucher Program and Moderate Rehabilitation Single Room Occupancy Program Fiscal Year 2013; Revised
This notice updates the FMRs for Hood River County, OR, based on a survey of rents conducted by the Public Housing Agency (PHA) in August 2012.
Addition of Certain Persons to the Entity List
This rule amends the Export Administration Regulations (EAR) by adding two persons to the Entity List and revising one existing entry. The persons who are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. These persons will be listed on the Entity List under one destination. The two entries added to the Entity List consist of two entries in Pakistan. This rule is also revising one existing entry in the U.A.E. to clarify the scope of the entry by providing an additional alias and alternate address for this listed person. The Entity List notifies the public that certain exports, reexports, and transfers (in-country) of items subject to the EAR to entities identified on the Entity List require licenses from the Bureau of Industry and Security (BIS) and that in most instances license exceptions are unavailable for such transactions. BIS usually applies a license review policy of denial because it considers such entities to present significant risks of diversion to weapons of mass destruction (WMD) programs, terrorism, or other activities that are contrary to U.S. national security or foreign policy interests. By publicly listing such entities, BIS seeks to assist legitimate exporters, reexporters and transferors, and other parties participating in transactions that are subject to the EAR by providing them with information to detect and avoid high risk transactions with those entities, which in most cases means any transaction that involves items that are subject to the EAR.
Federal Housing Administration (FHA): Temporary Waiver of FHA's Regulation on Property Flipping; Extension of Waiver
This notice of waiver extension announces that FHA is extending the availability of the temporary waiver of its regulation that prohibits the use of FHA financing to purchase single family properties that are being resold within 90 days of the previous acquisition, until December 31, 2014. This waiver, which was first issued in January 2010, took effect for all sales contracts executed on or after February 1, 2010. On January 28, 2011, FHA extended the waiver through calendar 2011. On December 28, 2011, FHA extended the waiver through calendar 2012. Prior to the waiver, a mortgage was not eligible for FHA insurance if the contract of sale for the purchase of the property that secured the mortgage was executed within 90 days of the prior acquisition by the seller, and the seller did not come under any of the exemptions to this 90-day period specified in the regulation. Through the regulatory waiver, FHA encourages investors that specialize in acquiring and renovating properties to renovate foreclosed and abandoned homes, with the objective of increasing the availability of affordable homes for first-time and other purchasers, helping to stabilize real estate prices as well as neighborhoods and communities where foreclosure activity has been high. The waiver is applicable to all single family properties being resold within the 90- day period after prior acquisition, and is not limited to foreclosed properties. Additionally, the waiver is subject to certain conditions, and mortgages must meet these conditions to be eligible for the waiver. The waiver is not applicable to mortgages insured under HUD's Home Equity Conversion Mortgage (HECM) Program.
Request for Information: Establish a Public-Private Collaboration, “Drug Development Initiative” (DDI), for New Pharmacological Treatments for Post-Traumatic Stress Disorder (PTSD)
The Department of Veterans Affairs (VA) ORD publishes this Request for Information (RFI) to solicit interest in forming public- private collaborations to develop new pharmacological treatments for PTSD. ORD is interested in developing collaborations with organizations that are interested in pursuing clinical trials specifically focused on PTSD. Such research would be detailed through a Cooperative Research and Development Agreement (CRADA) under the authority of the Federal Technology Transfer Act of 1986 (FTTA), Public Law 99-502, codified as amended in scattered sections of title 15, United States Code (U.S.C.). The CRADA will delineate the collaboration for PTSD treatment intended to test new drugs to benefit Veterans.
Multilayered Wood Flooring From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Determination of Countervailing Duty Investigation and Notice of Amended Countervailing Duty Order
On November 15, 2012,\1\ the United States Court of International Trade (``CIT'') sustained the Department of Commerce's (``the Department'') results of redetermination \2\ pursuant to the CIT's Remand Order.\3\
Folding Metal Tables and Chairs From the People's Republic of China: Final Results of Sunset Review and Revocation of Order
On October 1, 2012, the Department of Commerce (``the Department'') initiated the sunset review of the antidumping duty order on folding metal tables and chairs from the People's Republic of China (``PRC''). Because the domestic interested parties did not participate in this sunset review, the Department is revoking this antidumping duty order.
Notice of Final Federal Agency Actions on Proposed Highway and Bridge in the Cities of Cincinnati, Ohio, and Covington, Kentucky
This notice corrects an error in the FHWA notice published on November 2, 2012, at 77 FR 66215. That notice provided an incorrect reference to a statute of limitations timeframe, and an incorrect date.
Approval and Promulgation of Implementation Plans; New Mexico; New Source Review (NSR) Preconstruction Permitting Program
EPA is proposing to approve revisions to the applicable New Source Review (NSR) State Implementation Plan (SIP) for New Mexico. Among the changes, EPA is proposing to approve are the following: The establishment of a new minor NSR (MNSR) general construction permitting program; changes to the MNSR Public Participation requirements; the establishment of three different types of MNSR Permit Revisions; and the addition of exemptions for de minimis emission sources and activities from obtaining a MNSR permit. EPA proposes to find that these revisions to the New Mexico SIP comply with the Federal Clean Air Act (the Act or CAA) and EPA regulations and are consistent with EPA policies. EPA is proposing this action under section 110 of the Act.
2012 Recreational Water Quality Criteria
Pursuant to section 304(a) of the Clean Water Act (CWA), the Environmental Protection Agency (EPA) is announcing the availability of the 2012 Recreational Water Quality Criteria (RWQC). The document contains the EPA's recreational water quality criteria recommendations for protecting human health in ambient waters that are designated for primary contact recreation. CWA Section 304(a) water quality criteria recommendations are intended as guidance to States and authorized Tribes in developing water quality standards. The 2012 RWQC document describes the relevant scientific findings, explains how these findings were used to derive criteria for two indicators of fecal contamination (enterrococcus and E. coli) as measured by culture based test methods. On December 21, 2011, EPA made available draft national recommended recreational water quality criteria (2011 Draft RWQC) and provided the public an opportunity to provide scientific views. The 2012 RWQC differs from the current 1986 Ambient Water Quality Criteria in the following ways: the EPA recommends States use one of two sets of criteria values, and no longer recommends multiple ``use intensity'' values; the RWQC consist of both a geometric mean (GM) and a Statistical Threshold Value (STV); the RWQC are now comprised of a magnitude, a duration, and frequency of excursion for the GM and STV; the EPA introduces a rapid analytical technique for beach monitoring, quantitative polymerase chain reaction (qPCR), for the detection of enterococci in recreational water (EPA Method 1611; the EPA provides information on tools for evaluating and managing recreational waters, such as predictive modeling; the EPA is providing a beach action value for use in beach notification programs; and the EPA is providing tools for developing site-specific criteria. The CWA, as amended by the Beaches Environmental Assessment and Coastal Health (BEACH) Act of 2000, directed the EPA to conduct studies associated with pathogens and human health under section 104(v), and to publish new or revised criteria for pathogens and pathogen indicators based on those studies under section 304(a)(9). The criteria announced today are the new or revised criteria that EPA is directed to publish under section 304(a)(9) of the CWA, as amended by the BEACH Act.
Approval and Promulgation of Air Quality Implementation Plans; Connecticut; NOX
The EPA is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Connecticut. This revision allows facilities to create and/or use emission credits to comply with the NOX emission limits required by Regulations of Connecticut State Agencies (RCSA) section 22a-174-22 (Control of Nitrogen Oxides) using NOx Emission Trading Orders (trading orders). The intended effect of this action is to propose approval of the individual trading orders to allow facilities to determine the most cost-effective way to comply with the state regulation. This action is being taken in accordance with the Clean Air Act.
Agency Information Collection Activities; Proposed Collection; Comment Request; Revision of the Requirements for Constituent Materials
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 regarding the requirement for the use of constituent materials in licensed biological products.
Electronic Filing in the Copyright Office of Notices of Intention To Obtain a Section 115 Compulsory License
The Copyright Office is amending its regulations for filing Notices of Intention to obtain a Section 115 compulsory license with the Copyright Office to provide an option for electronically filing notices. By law, such notices may be filed in the Office only when the public records of the Copyright Office do not identify the copyright owner of the musical work and include an address at which notice can be served. In addition, the Copyright Office is amending its regulations to clarify the rules for filing physical Notices of Intention, to clarify that it does not examine Notices of Intention filed with the Office for legal sufficiency, and to include a Privacy Act Advisory Statement.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Distribution of Characteristics of the Insured Unemployed
On November 30, 2012, the Department of Labor (DOL) will submit the Employment and Training Administration (ETA) sponsored information collection request (ICR) titled, ``Distribution of Characteristics of the Insured Unemployed,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Jobs for Veterans State Grants Reports
On November 30, 2012, the Department of Labor (DOL) will submit the Veterans' Employment and Training Service (VETS) sponsored information collection request (ICR) revision titled, ``Jobs for Veterans State Grants Reports,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).
Termination of Department of Defense Federal Advisory Committees
Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix), 41 CFR 102-3.55, and the Government in the Sunshine Act of 1976 (5 U.S.C. 552b), effective October 5, 2012, the Department of Defense gives notice that it is terminating the Chief of Naval Operations Executive Panel.
Privacy Act of 1974; System of Records
The Department of the Air Force proposes to alter a system of records notice to its existing inventory of records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.
Privacy Act of 1974; System of Records
The Department of the Navy proposes to alter a system of records in its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.
Submission for Review: Initial Certification of Full-Time School Attendance, RI 25-41
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on a revised information collection request (ICR) 3206-0099, Initial Certification of Full-Time School Attendance. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. The information collection was previously published in the Federal Register on June 4, 2012 at Volume 77 FR 33007 allowing for a 60-day public comment period. No comments were received for this information collection. The purpose of this notice is to allow an additional 30 days for public comments. The Office of Management and Budget is particularly interested in comments that: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.
Submission for Review: 3206-0140, Representative Payee Application (RI 20-7) and Information Necessary for a Competency Determination (RI 30-3)
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on a revised information collection request (ICR) 3206-0140, Representative Payee Application (RI 20-7) and Information Necessary for a Competency Determination (RI 30-3). As required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. The Office of Management and Budget is particularly interested in comments that: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.
Hispanic Council on Federal Employment
The Hispanic Council on Federal Employment (HCFE) will hold a meeting on Monday, December 13th, at the time and location shown below. The Council is an advisory committee composed of representatives from Hispanic organizations and senior government officials. Along with its other responsibilities, the Council shall advise the Director of the Office of Personnel Management on matters involving the recruitment, hiring, and advancement of Hispanics in the Federal workforce. The Council is co-chaired by the Chief of Staff of the Office of Personnel Management. The meeting is open to the public. Please contact the Office of Personnel Management at the address shown below if you wish to present material to the Council at the meeting. The manner and time prescribed for presentations may be limited, depending upon the number of parties that express interest in presenting information.
Notice of Public Roundtable on Genetic Diagnostic Testing
The United States Patent and Trademark Office (``USPTO'') is interested in gathering additional information on independent second opinion genetic diagnostic testing for purposes of preparing a report on the subject as required by the America Invents Act (``AIA'' or ``Act''). To assist in gathering this information, the USPTO invites the public to attend a roundtable focused on genetic diagnostic testing. Public Roundtable: The USPTO will hold a public roundtable in support of the genetic testing study. The roundtable will be held on Thursday, January 10, 2013, beginning at 1:00 p.m. Eastern Standard Time (EST) and ending at 4:00 p.m. (EST) in Alexandria, Virginia. Those wishing to share commentary at the roundtable must request an opportunity to do so in writing no later than December 20, 2012. The request must include the following: (1) The name of the person wishing to share commentary; (2) the person's contact information (telephone number and email address); (3) the organization(s) the person represents, if any; and (4) an indication of the amount of time requested for the commentary. Requests to share commentary must be submitted by email to Saurabh Vishnubhakat at saurabh.vishnubhakat@uspto.gov. Based upon the requests received, an agenda will be sent to all requesters and posted on the USPTO Internet Web site (address: www.uspto.gov/americainventsact). Speakers sharing commentary at the roundtable must submit a document explaining their position for inclusion in the record of the proceedings no later than thirty days after the roundtable. Written commentary should not exceed 25 pages using at least 12-point and double-spaced font. Because written commentary will be made available for public inspection, information that a speaker does not desire to be made public, such as a telephone number, should not be included in the written comments. The public roundtable will be available via Web cast. Information about how to access the Web cast will be posted on the USPTO's Internet Web site (address: https://www.uspto.gov/americainventsact) before the public roundtable. A transcript of the roundtable will be available on the USPTO Internet Web site (address: www.uspto.gov/americainventsact) shortly after the roundtable.
Meeting of the Uniform Formulary Beneficiary Advisory Panel
Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended) and the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended) the Department of Defense (DoD) announces a Federal Advisory Committee Meeting of the Uniform Formulary Beneficiary Advisory Panel (hereafter referred to as the Panel).
Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products,'' dated November 2012. The draft guidance document provides sponsors and individuals that design and implement preclinical studies with recommendations on the substance and scope of preclinical information needed to support clinical trials for investigational products regulated by the Center for Biologics Research and Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination, and xenotransplantation. The guidance is intended to clarify current expectations regarding the preclinical information that supports an investigational new drug application (IND) and a biologics license application (BLA) for these product areas.
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