May 7, 2015 – Federal Register Recent Federal Regulation Documents

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Determination of Regulatory Review Period for Purposes of Patent Extension; OVUGEL
Document Number: 2015-11003
Type: Notice
Date: 2015-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for OVUGEL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of U.S. Patents and Trademarks Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; OSENI
Document Number: 2015-11002
Type: Notice
Date: 2015-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for OSENI 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; HVAD ROTARY BLOOD PUMP
Document Number: 2015-11001
Type: Notice
Date: 2015-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for HVAD ROTARY BLOOD PUMP 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 medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; GATTEX
Document Number: 2015-11000
Type: Notice
Date: 2015-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for GATTEX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ISTENT TRABECULAR MICRO-BYPASS STENT
Document Number: 2015-10999
Type: Notice
Date: 2015-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for the ISTENT TRABECULAR MICRO-BYPASS STENT 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 medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; COFLEX INTERLAMINAR TECHNOLOGY
Document Number: 2015-10998
Type: Notice
Date: 2015-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for COFLEX INTERLAMINAR TECHNOLOGY 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. Patents and Trademarks Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification for a New Dietary Ingredient
Document Number: 2015-10997
Type: Notice
Date: 2015-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Premarket Notification for a New Dietary Ingredient'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing
Document Number: 2015-10996
Type: Notice
Date: 2015-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
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; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting
Document Number: 2015-10995
Type: Notice
Date: 2015-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on medical device reporting (MDR); manufacturer, importer, user facility, and distributor reporting.
Determination of Regulatory Review Period for Purposes of Patent Extension; SIGNIFOR
Document Number: 2015-10994
Type: Notice
Date: 2015-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for SIGNIFOR 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.
Request for Information on Early Intervention Strategies for Serving Individuals With Disabilities
Document Number: 2015-10993
Type: Notice
Date: 2015-05-07
Agency: Social Security Administration, Agencies and Commissions
The Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), provided us with money under section 1110 of the Social Security Act to begin the design, development, and implementation of an early intervention demonstration to test innovative strategies aimed at helping people with disabilities remain in the workforce. The President's FY 2016 Budget requested additional funds to support a complete demonstration project. In order to inform the development of that demonstration, this request for information (RFI) seeks recommendations on targeted design features related to improving employment and earnings outcomes for people with disabilities, specifically individuals with mental impairments. The input we receive will inform and complement ongoing interagency deliberations about the best use of funds for an initial demonstration project relevant to future policy discussions for the Social Security Disability Insurance (DI) and Supplemental Security Income (SSI) programs.
Proposal Review Panel for Computing and Communication Foundations Notice of Meeting
Document Number: 2015-10992
Type: Notice
Date: 2015-05-07
Agency: National Science Foundation, Agencies and Commissions
Transportation for Individuals With Disabilities; Reasonable Modification of Policies and Practices; Correction
Document Number: 2015-10991
Type: Rule
Date: 2015-05-07
Agency: Department of Transportation
This document corrects two typographical errors in the final rule that appeared in the Federal Register on March 13, 2015, entitled ``Transportation for Individuals With Disabilities; Reasonable Modification of Policies and Practices.''
Notice of Intent To Grant Partially Exclusive Patent License; Epitracker, LLC
Document Number: 2015-10990
Type: Notice
Date: 2015-05-07
Agency: Department of Defense, Department of the Navy
The Department of the Navy hereby gives notice of its intent to grant to Epitracker, LLC, a revocable, nonassignable, partially exclusive license in the United States to practice the Government-Owned inventions described in U.S. Patent Application No. 14/591660``Use of heptadecanoic acid (C17:0) to detect risk of and treat hyperferritinemia and metabolic syndrome''.
Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Florida
Document Number: 2015-10989
Type: Notice
Date: 2015-05-07
Agency: Environmental Protection Agency
This notice announces EPA's approval of the State of Florida's request to revise/modify certain of its EPA-authorized programs to allow electronic reporting.
Proposed Information Collection Activity; Comment Request
Document Number: 2015-10988
Type: Notice
Date: 2015-05-07
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2015-10987
Type: Notice
Date: 2015-05-07
Agency: Department of Health and Human Services, Administration for Children and Families
Petition for Exemption; Summary of Petition Received; Aviation Fabricators, Inc.
Document Number: 2015-10986
Type: Notice
Date: 2015-05-07
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Endangered and Threatened Wildlife and Plants; Permit Applications
Document Number: 2015-10985
Type: Notice
Date: 2015-05-07
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (USFWS), invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (Act) prohibits activities with endangered or threatened species unless a Federal permit allows such activity. The Act requires that we invite public comment before issuing these permits.
Proposed Collection; Comment Request; Office of the Procurement Executive
Document Number: 2015-10984
Type: Notice
Date: 2015-05-07
Agency: Department of the Treasury
The Department of the Treasury invites the general public and other Federal agencies to comment on an extension of an existing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). The Department of the Treasury, Office of the Procurement Executive, is soliciting comments concerning the Solicitation of Proposal Information for Award of Public Contracts, which is scheduled to expire August 31, 2015.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members
Document Number: 2015-10983
Type: Notice
Date: 2015-05-07
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven current members' terms will expire in November 2015. To fill these positions, we are seeking individuals who are distinguished in: (1) The conduct of research, demonstration projects, and evaluations with respect to health care; (2) the fields of health care quality research or health care improvement; (3) the practice of medicine; (4) other health professions; (5) representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) representing the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in activities specified in the summary above.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-10982
Type: Notice
Date: 2015-05-07
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Pilot Test of the Proposed Hospital Survey on Patient Safety Culture Version 2.0.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-10981
Type: Notice
Date: 2015-05-07
Agency: Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed changes to the currently approved information collection project: ``Medical Expenditure Panel SurveyInsurance Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on February 18th, 2015 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Draft Environmental Assessment and Draft Habitat Conservation Plan for the Fender's Blue Butterfly on Private Lands in Yamhill County, Oregon; Reopening of Comment Period
Document Number: 2015-10980
Type: Notice
Date: 2015-05-07
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), are reopening the comment period for an application from the Yamhill Soil and Water Conservation District (SWCD) for an incidental take permit (permit) under the Endangered Species Act of 1973, as amended (ESA). The permit application includes a draft Habitat Conservation Plan (HCP) addressing private land management activities within upland prairie in Yamhill County, Oregon, that may result in the incidental take of the endangered Fender's blue butterfly. The Service also announces the availability of a draft environmental assessment (EA) addressing the proposed HCP and issuance of a permit that was prepared in accordance with the National Environmental Policy Act of 1969, as amended (NEPA). We invite comments from all interested parties on the permit application, including the HCP and the EA. We are reopening the comment period to correct a technical error with the electronic email box associated with the email address provided in our original Federal Register notice. The public could send comments to the Service's email address but we were not able to retrieve the comments for review; therefore, the comments could not be considered and recognized as part of the record. If you have previously submitted comments via email, please resubmit them to the new email address in order to be considered since they were unfortunately not retrievable for consideration.
Privacy Act of 1974; System of Records
Document Number: 2015-10979
Type: Notice
Date: 2015-05-07
Agency: Department of Commerce
In accordance with the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4) and (11), and Office of Management and Budget (OMB) Circular A-130, Appendix I, ``Federal Agency Responsibility for Maintaining Records about Individuals,'' DOC OIG proposes to amend the system of records entitled ``OIG Investigative RecordsCOMMERCE/DEPT- 12,'' to reflect a new investigative case management system and an electronic discovery tool; update OIG routine uses; update OIG's practices for storing, retrieving, and safeguarding records in the system; and generally update the system's notice. OIG's changes will generally improve the organization, security, ability to search, and reporting capability of OIG's investigative records. Accordingly, ``OIG Investigative RecordsCOMMERCE/DEPT-12,'' is proposed to be amended as shown below. DOC OIG invites public comment on the amended system announced in this publication.
Information Collection Approved by the Office of Management and Budget (OMB)
Document Number: 2015-10978
Type: Notice
Date: 2015-05-07
Agency: Federal Communications Commission, Agencies and Commissions
The Federal Communications Commission (FCC) has received Office of Management and Budget (OMB) approval for a revision of a currently approved public information collection pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). An agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number, and no person is required to respond to a collection of information unless it displays a currently valid control number. Comments concerning the accuracy of the burden estimates and any suggestions for reducing the burden should be directed to the person listed in the FOR FURTHER INFORMATION CONTACT section below.
Information Collection Being Submitted for Emergency Review and Approval to the Office of Management and Budget
Document Number: 2015-10977
Type: Notice
Date: 2015-05-07
Agency: Federal Communications Commission, Agencies and Commissions
The Federal Communications Commission (FCC), as part of its continuing effort to reduce paperwork burden, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995. Comments are requested concerning: (a) Whether the proposed collection(s) of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection(s) of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) ways to further reduce the information burden for small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid OMB Control Number.
Electronic Filing Protocols for Commission Forms; Notice of Conference With North American Energy Standards Board
Document Number: 2015-10976
Type: Notice
Date: 2015-05-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Notice of Settlement Agreement and Soliciting Comments
Document Number: 2015-10974
Type: Notice
Date: 2015-05-07
Agency: Department of Energy, Federal Energy Regulatory Commission
BP Products North America Inc. v. Sunoco Pipeline L.P.; Notice of Complaint
Document Number: 2015-10971
Type: Notice
Date: 2015-05-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Navigator BSG Transportation & Storage, LLC; Notice of Petition for Declaratory Order
Document Number: 2015-10970
Type: Notice
Date: 2015-05-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #2
Document Number: 2015-10967
Type: Notice
Date: 2015-05-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2015-10966
Type: Notice
Date: 2015-05-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Qualification of Drivers; Exemption Applications; Vision
Document Number: 2015-10965
Type: Notice
Date: 2015-05-07
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 17 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemption renewals will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
Atlantic Highly Migratory Species (HMS); 2006 Consolidated HMS Fishery Management Plan (FMP); Amendment 7
Document Number: 2015-10960
Type: Rule
Date: 2015-05-07
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is announcing that the final location for the May 2015 installations of electronic monitoring (EM) systems required by Amendment 7 will be Fairhaven, MA, in addition to the previously- announced Barnegat Light, NJ. NMFS is also informing vessel owners with Atlantic tunas permits that funding for such EM installation and training is now available on a `first come, first served' basis for a limited number of pelagic longline vessels that were not eligible for Individual Bluefin Quota (IBQ) based on criteria in Amendment 7 to the 2006 Consolidated HMS FMP (Amendment 7). Funding for EM installation and training originally was limited to the 135 vessels eligible for IBQ shares.
Petition for Exemption; Summary of Petition Received; Airlines for America
Document Number: 2015-10959
Type: Notice
Date: 2015-05-07
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Mid-Atlantic Fishery Management Council (MAFMC); Fisheries of the Northeastern United States; Public Meeting.
Document Number: 2015-10958
Type: Notice
Date: 2015-05-07
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Council's Mackerel-Squid-Butterfish (MSB) Monitoring Committee will meet via webinar to develop recommendations for future MSB specifications.
Notice of Availability of Government-Owned Inventions; Available for Licensing
Document Number: 2015-10954
Type: Notice
Date: 2015-05-07
Agency: Department of Defense, Department of the Navy
The following invention is assigned to the United States Government as represented by the Secretary of the Navy and made available for licensing by the Department of the Navy: U.S. Patent Application No. 14/591660``Use of heptadecanoic acid (C17:0) to detect risk of and treat hyperferritinemia and metabolic syndrome''.
Submission for OMB Review; Comment Request
Document Number: 2015-10951
Type: Notice
Date: 2015-05-07
Agency: Department of Agriculture
Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest
Document Number: 2015-10950
Type: Notice
Date: 2015-05-07
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Electric Skin Care Devices, Brushes and Chargers Therefor, and Kits Containing Same, DN 3067; 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)).
Brazos Electric Power Cooperative, Inc.; Notice of Intent To Hold a Public Workshop and Prepare an Environmental Assessment
Document Number: 2015-10943
Type: Notice
Date: 2015-05-07
Agency: Department of Agriculture, Rural Utilities Service
The Rural Utilities Service (RUS) intends to hold a public scoping workshop and prepare an Environmental Assessment (EA) in connection with possible impacts related to the construction and operation of a new gas-fired combustion turbine generation facility. The project, Hill County Generation Facility, is proposed by Brazos Electric Power Cooperative, Inc. (Brazos), of Waco, Texas. RUS may provide financial assistance for the project. The public scoping workshop is scheduled for Thursday, May 21, 2015, from 4:00 p.m. until 7:00 p.m. in the Community Hall of the First Presbyterian Church at 106 N. Lamar, Itasca, TX 76055.
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