Share |
Results 1 - 50 of 327,505
Document Number: FR-2015-06-18-ReaderAids
Type: Reader Aids
Date: 2015-06-18
Document Number: 2015-15134
Type: Notice
Date: 2015-06-18
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
Document Number: 2015-15120
Type: Notice
Date: 2015-06-18
Agency: Commission on Civil Rights
Document Number: 2015-15071
Type: Notice
Date: 2015-06-18
Agency: Department of Commerce, Patent and Trademark Office
On November 29, 1999, the President signed into law the Patent and Trademark Office Efficiency Act (the ``Act''), Public Law 106-113, which, among other things, established two Public Advisory Committees to review the policies, goals, performance, budget and user fees of the United States Patent and Trademark Office (USPTO) with respect to patents, in the case of the Patent Public Advisory Committee, and with respect to trademarks, in the case of the Trademark Public Advisory Committee, and to advise the Director on these matters (now codified at 35 U.S.C. 5). The America Invents Act Technical Corrections Act made several amendments to the 1999 Act, including the requirement that the terms of the USPTO Public Advisory Committee members be realigned by 2014, so that December 1 be used as the start and end date, with terms staggered so that each year three existing terms expire and three new terms begin on December 1. Through this Notice, the USPTO is requesting nominations for up to three (3) members of the Patent Public Advisory Committee, and for up to three (3) members of the Trademark Public Advisory Committee, for terms of three years that begin on December 1, 2015.
Document Number: 2015-15070
Type: Notice
Date: 2015-06-18
Agency: Department of Agriculture
Pursuant to the Federal Advisory Committee Act (FACA), the Office of Advocacy and Outreach (OAO) is announcing a meeting of the Beginning Farmers and Ranchers Advisory Committee's (BFRAC) Subcommittee on Land Tenure (Subcommittee). The Subcommittee is being convened to consider issues involving access to land, farm business transition and land tenure. The members will perform preliminary work on recommendations that will be submitted to the parent committee. The BFRAC will prepare recommendations for USDA Secretary Vilsack's consideration in making policy decisions affecting land tenure during its next public meeting.
Document Number: 2015-15065
Type: Notice
Date: 2015-06-18
Agency: Federal Communications Commission, Agencies and Commissions
The Enforcement Bureau (Bureau) gives notice of Wes Yui Chew's suspension from the federal Lifeline universal service support mechanism (Lifeline program) and the commencement of debarment proceedings against him. Suspension immediately excludes Mr. Chew from activities associated with or related to the Lifeline program pending completion of the debarment process. Mr. Chew, or any person who has an existing contract with or intends to contract with him to provide or receive services in matters arising out of activities associated with or related to the Lifeline program, may contest this suspension or its scope by filing an opposition and any relevant documentation.
Document Number: 2015-15064
Type: Notice
Date: 2015-06-18
Agency: Department of Agriculture
Pursuant to the Federal Advisory Committee Act (FACA, 5 U.S.C. App.), notice is hereby given that the Secretary of Agriculture is soliciting nominations for membership for the Advisory Committee on Beginning Farmers and Ranchers (the ``Committee'').
Document Number: 2015-15062
Type: Notice
Date: 2015-06-18
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Automatic Consent for Eligible Educational Institution to Change Reporting Methods.
Document Number: 2015-15059
Type: Notice
Date: 2015-06-18
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (the Department) determines that countervailable subsidies are being provided to producers and exporters of certain passenger vehicle and light truck tires (passenger tires) from the People's Republic of China (the PRC) as provided in section 705 of the Tariff Act of 1930, as amended (the Act). For information on the estimated subsidy rates, see the ``Final Determination'' section of this notice. The period of investigation is January 1, 2013, through December 31, 2013.
Document Number: 2015-15058
Type: Notice
Date: 2015-06-18
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (the Department) determines that imports of certain passenger vehicle and light truck tires (passenger tires) from the People's Republic of China (PRC) are being, or are likely to be, sold in the United States at less than fair value (LTFV), as provided in section 735 of the Tariff Act of 1930, as amended (the Act). The final weighted-average dumping margins for the investigation on passenger tires from the PRC are listed below in the ``Final Determination'' section of this notice.
Document Number: 2015-15057
Type: Notice
Date: 2015-06-18
Agency: Department of the Treasury
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Special Valuation Rules.
Document Number: 2015-15056
Type: Notice
Date: 2015-06-18
Agency: Department of the Treasury
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). The IRS is soliciting comments concerning information collection requirements related to Tax Shelter Regulations.
Document Number: 2015-15054
Type: Notice
Date: 2015-06-18
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 5884-C, Work Opportunity Credit for Qualified Tax-Exempt Organizations Hiring Qualified Veterans.
Document Number: 2015-15050
Type: Notice
Date: 2015-06-18
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 5310-A, Notice of Plan Merger or Consolidation, Spinoff, or Transfer of Plan Assets or Liabilities; Notice of Qualified Separate Lines of Business.
Document Number: 2015-15049
Type: Notice
Date: 2015-06-18
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 712, Life Insurance Statement.
Document Number: 2015-15048
Type: Rule
Date: 2015-06-18
Agency: Department of Agriculture, Farm Service Agency, Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service
On May 20, 2015, USDA published an interim rule establishing a priority for projects that support the implementation of strategic economic and community development plans across multi-jurisdictional areas. This priority applies to several specific programs with the Rural Business-Cooperative Service, the Rural Housing Service, and the Rural Utilities Service. The effective date was listed as June 19, 2015 and is being delayed to July 17, 2015.
Document Number: 2015-15042
Type: Notice
Date: 2015-06-18
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning excise tax on greenmail.
Document Number: 2015-15041
Type: Notice
Date: 2015-06-18
Agency: Department of Agriculture
Document Number: 2015-15040
Type: Notice
Date: 2015-06-18
Agency: Department of Agriculture
Document Number: 2015-15039
Type: Notice
Date: 2015-06-18
Agency: Department of the Treasury
In accordance with the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the Department of the Treasury (``Treasury'') proposes to establish new Privacy Act systems of records titled ``Treasury .017 Correspondence and Contact Information.'' The systems will be used to facilitate mailings and correspondence to multiple addressees and other activities in furtherance of Treasury duties. Treasury bureaus and Departmental Offices will use the systems to account for all individuals appearing on contact lists and individuals who choose to be placed on Treasury mailing lists; maintaining lists of individuals who attend meetings; maintaining information regarding individuals who enter Treasury-sponsored contests; and for other purposes for which mailing or contact lists may be created.
Document Number: 2015-15037
Type: Proposed Rule
Date: 2015-06-18
Agency: Alcohol and Tobacco Tax and Trade Bureau, Department of Treasury, Department of the Treasury
The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to establish the 12,897-square mile (8,254,151-acre) ``Loess Hills District'' viticultural area in western Iowa and northwestern Missouri. The proposed viticultural area is not located within, nor does it contain, any other established viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase. TTB invites comments on this proposed addition to its regulations.
Document Number: 2015-15036
Type: Proposed Rule
Date: 2015-06-18
Agency: Alcohol and Tobacco Tax and Trade Bureau, Department of Treasury, Department of the Treasury
The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to expand the approximately 5,360-square mile ``Willamette Valley'' viticultural area in northwestern Oregon by approximately 29 square miles. The established Willamette Valley viticultural area and the proposed expansion area do not lie within any other viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase. TTB invites comments on this proposed addition to its regulations.
Document Number: 2015-15034
Type: Notice
Date: 2015-06-18
Agency: Department of Health and Human Services, National Institutes of Health
The HOPE Act requires the Secretary of Health and Human Services (the Secretary) to develop and publish criteria for research involving transplantation of HIV-infected (HIV+) donor organs in HIV+ recipients. The goals of these criteria are, first, to ensure that research using organs from HIV+ donors is conducted under conditions protecting the safety of research participants and the general public; and second, that the results of this research provide a basis for evaluating the safety of solid organ transplantation (SOT) from HIV+ donors to HIV+ recipients. The National Institutes of Health (NIH), U.S. Department of Health and Human Services, invites the public to submit comments regarding the proposed HOPE Act criteria.
Document Number: 2015-15033
Type: Notice
Date: 2015-06-18
Agency: Information Security Oversight Office, National Archives and Records Administration, Agencies and Commissions
In accordance with the Federal Advisory Committee Act (5 U.S.C. app 2) and implementing regulation 41 CFR 101-6, NARA announces the following committee meeting.
Document Number: 2015-15032
Type: Notice
Date: 2015-06-18
Agency: Department of the Interior, Bureau of Land Management
This notice provides for two related actions, one a proposed land use plan amendment involving approximately 19,054 acres of public land in Latah, Clearwater, Nez Perce, Lewis, Idaho, and Adams counties of Idaho; and the other proposed land sales involving 22.46 acres of public land in Idaho County being considered in the proposed plan amendment. In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) Cottonwood Field Office, Cottonwood, Idaho, intends to prepare a resource management plan (RMP) amendment and associated environmental assessment (EA) for the Cottonwood RMP including the proposed land sales involving 22.46 acres of public land, and by this notice is announcing the beginning of the scoping process to solicit public comments and identify related issues.
Document Number: 2015-15020
Type: Notice
Date: 2015-06-18
Agency: Department of Commerce
The Department of Commerce (Commerce) publishes this notice to announce the effective date of a Privacy Act System of Records entitled Commerce/Department-12, OIG Investigative Records. The notice of proposed amendment to this system of records was published in the Federal Register on May 7, 2015.
Document Number: 2015-15019
Type: Notice
Date: 2015-06-18
Agency: Department of Commerce
The Department of Commerce (Commerce) publishes this notice to announce the effective date of a Privacy Act System of Records entitled Commerce/ITA-8, Salesforce Customer Relationship Management System. The notice of proposed amendment to this system of records was published in the Federal Register on May 11, 2015.
Document Number: 2015-15018
Type: Notice
Date: 2015-06-18
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to grant the Specialized Carriers & Rigging Association (SC&RA) an exemption from the minimum 30-minute rest break provision of the Agency's hours-of-service (HOS) regulations for commercial motor vehicle (CMV) drivers. The exemption enables all specialized carriers and drivers responsible for the transportation of loads that exceed normal weight and dimensional limitsoversize/ overweight (OS/OW) loadsand require a permit issued by a government authority, to be exempt from the 30-minute rest break provision in 49 CFR 395.3(a)(3)(ii). FMCSA has analyzed the exemption application and the public comments and has determined that the exemption, subject to the terms and conditions imposed, will achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption.
Document Number: 2015-15014
Type: Notice
Date: 2015-06-18
Agency: Joint Board for the Enrollment of Actuaries
The Executive Director of the Joint Board for the Enrollment of Actuaries gives notice of a meeting of the Advisory Committee on Actuarial Examinations (portion of which will be open to the public) in Arlington, VA on July 13-14, 2015.
Document Number: 2015-15010
Type: Notice
Date: 2015-06-18
Agency: Department of Labor, Occupational Safety and Health Administration
The Department of Labor (DOL), in coordination with the Department of Homeland Security (DHS) and the Environmental Protection Agency (EPA), is announcing a Webinar to update stakeholders on action items since the June 6, 2014 release of ``Executive Order [EO] 13650: Actions to Improving Chemical Facility Safety and SecurityA Shared Commitment.''
Document Number: 2015-15009
Type: Notice
Date: 2015-06-18
Agency: Department of Commerce, International Trade Administration
On May 22, 2015, the United States Court of International Trade (CIT) sustained the Final Redetermination issued by the Department of Commerce (Department), in which it determined that Fedmet Resources Corporation's (Fedmet) Bastion[supreg] magnesia alumina carbon bricks (MACBs) are outside the scope of the antidumping and countervailing duty orders on certain magnesia carbon bricks (MCBs) from Mexico and the People's Republic of China (PRC),\1\ pursuant to the CIT's remand order in Fedmet Resources Corporation v. United States, Court No. 12-00215 (CIT February 23, 2015).\2\
Document Number: 2015-15008
Type: Notice
Date: 2015-06-18
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of Hass avocados from Peru into the continental United States.
Document Number: 2015-15007
Type: Notice
Date: 2015-06-18
Agency: Department of the Interior, Bureau of Land Management
Subject to valid existing rights, this order withdraws 240.59 acres of National Forest System lands in the Fremont National Forest from location and entry under the United States mining laws, but not from leasing under the mineral leasing laws, for a period of 20 years for the United States Forest Service to protect the integrity and functionality of the mine reclamation work on the White King/Lucky Lass Mines. The withdrawal will protect the $4.9 million Federal investment for reclamation work that has been completed to contour, cap, and restore vegetation at the mine sites located in the Fremont National Forest in Lake County, Oregon.
Document Number: 2015-15006
Type: Notice
Date: 2015-06-18
Agency: Department of the Interior, Bureau of Land Management
In accordance with the National Environmental Policy Act of 1969 (NEPA), as amended, the Bureau of Land Management (BLM) has prepared a Supplemental Draft Environmental Impact Statement (EIS) for the Alton Coal Tract Lease by Application (LBA) and by this notice is announcing its availability and the start of a comment period on the Supplemental Draft EIS.
Document Number: 2015-15005
Type: Notice
Date: 2015-06-18
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with the regulations to prevent the spread of citrus greening and its vector, Asian citrus psyllid, to noninfested areas of United States.
Document Number: 2015-15004
Type: Notice
Date: 2015-06-18
Agency: Department of Energy
To ensure a wide range of candidates and a balanced committee, the U.S. Department of Energy (DOE) announces the solicitation of nominations to fill upcoming vacancies on the Appliance Standards and Rulemaking Federal Advisory Committee.
Document Number: 2015-15003
Type: Notice
Date: 2015-06-18
Agency: Department of State
The Department of State and the Office of the United States Trade Representative are providing notice that the parties to the Dominican Republic-Central America-United States Free Trade Agreement (CAFTA-DR) intend to hold the ninth meeting of the Environmental Affairs Council (Council) established under Chapter 17 (Environment) of that agreement in Guatemala City, Guatemala on July 9-10. The Council will meet on July 9 to review implementation of Chapter 17 of CAFTA-DR and the CAFTA-DR Environmental Cooperation Agreement (ECA). All interested persons are invited to attend the Council's public session beginning at 9:30 a.m. on July 10 at Universidad del Valle de Guatemala. During the Council meeting, Council Members will present the progress made and challenges in implementing Chapter 17 obligations and the impacts of environmental cooperation in their respective countries. The Council will also receive a presentation from the CAFTA-DR Secretariat for Environmental Matters (SEM). More information on the Council is included below under SUPPLEMENTARY INFORMATION. All interested persons are invited to attend a public session where they will have an opportunity to ask questions and discuss implementation of Chapter 17 and the Environmental Cooperation Agreement with Council Members. At the public session, the Council hopes to receive input from the public on current environmental challenges and ideas for future cooperation. The Department of State and Office of the United States Trade Representative also invite written comments or suggestions regarding topics to be discussed at the meeting. In preparing comments, we encourage submitters to refer to Chapter 17 of the CAFTA-DR, the Final Environmental Review of the CAFTA-DR, and the Agreement among the CAFTA-DR countries on Environmental Cooperation (ECA) (all documents available at http://www.state.gov/e/oes/eqt/trade/caftadr/index.htm).
Document Number: 2015-15002
Type: Proposed Rule
Date: 2015-06-18
Agency: Environmental Protection Agency
The Environmental Protection Agency EPA proposes to modify the use restrictions of the Galveston, TX Dredged Material Site, Freeport Harbor, TX, New Work (45 Foot Project), Freeport Harbor, TX, Maintenance (45 Foot Project), Matagorda Ship Channel, TX, Corpus Christi Ship Channel, TX, Port Mansfield, TX, Brazos Island Harbor, TX and Brazos Island Harbor (42-Foot Project), TX Ocean Dredged Material Disposal Sites (ODMDSs) located in the Gulf of Mexico offshore of Galveston, Freeport, Matagorda, Corpus Christi, Port Mansfield and Brownsville, Texas, respectively. These sites are EPA designated ocean dumping sites for the disposal of suitable dredged material. This proposed action is being taken because there are current restrictions in place with language that prevent disposal of suitable dredged material from locations other than the federal channels. The United States Army Corps of Engineers Galveston District has requested EPA amend the restrictions to allow disposal of suitable dredged material from the vicinity of federal navigation channels to alleviate pressure on the capacity of their upland dredged material placement areas, when necessary.
Document Number: 2015-15001
Type: Proposed Rule
Date: 2015-06-18
Agency: Department of Energy, Office of Energy Efficiency and Renewable Energy
The U.S. Department of Energy (DOE) is initiating an effort to determine whether to amend the current energy conservation standards for room air conditioners (room ACs). According to the Energy Policy and Conservation Act's 6-year review requirement, DOE must publish by April 8, 2017 a notice of proposed rulemaking (NOPR) to propose new standards for room ACs or a notice of determination that the existing standards do not need to be amended. This RFI seeks to solicit information from the public to help DOE determine whether amended standards for room ACs would result in a significant amount of additional energy savings and whether those standards would be technologically feasible and economically justified. In addition, DOE has identified several issues associated with the currently applicable test procedure for room ACs on which DOE is particularly interested in receiving comment.
Document Number: 2015-15000
Type: Notice
Date: 2015-06-18
Agency: Department of Veterans Affairs
Document Number: 2015-14999
Type: Notice
Date: 2015-06-18
Agency: Department of Veterans Affairs
Document Number: 2015-14997
Type: Notice
Date: 2015-06-18
Agency: Department of Agriculture, Forest Service
The Land Between The Lakes Advisory Board (Board) will meet in Golden Pond, Kentucky. The Board is authorized under Section 450 of the Land Between The Lakes Protection Act of 1998 (Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the Board is to advise the Secretary of Agriculutre on the means of promoting public participation for the land and resource management plan for the recreation area; and environmental education. Additional Board information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site: http:// www.landbetweenthelakes.us/about/working-together/.
Document Number: 2015-14996
Type: Notice
Date: 2015-06-18
Agency: Fish and Wildlife Service, Department of the Interior
The Fish and Wildlife Service (Service) announces the receipt of nine Enhancement of Survival Permit applications that were developed in accordance with the Template Safe Harbor Agreement (Template SHA) for the Columbia Basin pygmy rabbit (Brachylagus idahoensis) and pursuant to section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (Act). The nine permit applicants are: (1) Morris Farms; (2) Overen Living Trust; (3) North Ranches, LLC; (4) Baird Springs Environmental; (5) Buster Boruff, LLC; (6) Ms. Susan Chace; (7) Mr. Garey Clements; (8) Mr. Greg Lehr and Ms. Christine Lehr; and (9) Sandygren Properties Limited Partnership. Issuance of permits to these applicants would exempt incidental take of the Columbia Basin pygmy rabbit, which would otherwise be prohibited by section 9 of the Act, that is above the baseline conditions of properties enrolled under the Template SHA and that may result from the permittees' otherwise lawful land-use activities. The Service requests comments from the public regarding the proposed issuance of permits to these nine applicants.
Document Number: 2015-14988
Type: Notice
Date: 2015-06-18
Agency: Department of Agriculture, Commodity Credit Corporation, Farm Service Agency
This notice presents a summary of the Record of Decision (ROD) regarding the alternative selected for implementation from the Supplemental Programmatic Environmental Impact Statement (SPEIS) for the Conservation Reserve Program (CRP). CRP is a voluntary program that supports the implementation of long-term conservation measures designed to improve the quality of ground and surface waters, control soil erosion, and enhance wildlife habitat on environmentally sensitive agricultural land. The Farm Service Agency (FSA) administers CRP on behalf of the Commodity Credit Corporation (CCC). The ROD was signed on April 17, 2015, but will not be implemented for at least 30 days following publication of this notice.
Document Number: 2015-14987
Type: Notice
Date: 2015-06-18
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Lip Balm Products, Containers for Lip Balm, and Components Thereof, DN 3071; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing under section 210.8(b) of the Commission's Rules of Practice and Procedure (19 CFR 210.8(b)).
Document Number: 2015-14985
Type: Notice
Date: 2015-06-18
Agency: Federal Reserve System, Agencies and Commissions
Document Number: 2015-14983
Type: Notice
Date: 2015-06-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use.'' The purpose of this workshop is to receive input from stakeholders and discuss approaches to the study of non-microbial biomarkers for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for establishing appropriate comparator methods and clinically relevant performance standards for non-microbial based in vitro diagnostics for infection.
Document Number: 2015-14982
Type: Notice
Date: 2015-06-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs).'' The purpose of this draft guidance is to provide greater clarity for FDA staff and IDE sponsors and sponsor- investigators regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical study. The draft guidance also characterizes benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others (to the extent they are indirect benefits to subjects or reflect the importance of knowledge to be gained). This draft guidance is not final nor is it in effect at this time.
Document Number: 2015-14981
Type: Notice
Date: 2015-06-18
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
1 2 3 4 5 6 7 8 9 Next