April 17, 2014 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 149
Notice of Forum on the Guidance For Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, and Natural Products
The United States Patent and Trademark Office (Office) is hosting a forum to receive public feedback from organizations and individuals on its guidance memorandum titled, ``Guidance For Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, and Natural Products (Laws of Nature/Natural Products Guidance),'' issued on March 4, 2014 and available at www.uspto.gov/patents/announce/myriad-mayo.jsp. The Laws of Nature/Natural Products Guidance implemented a new procedure to address changes in the law relating to subject matter eligibility under 35 U.S.C. 101 in view of recent Supreme Court precedent. The forum will be open for any member of the public to participate. The forum will provide an opportunity for participants to present their interpretation of the impact of Supreme Court precedent on the complex legal and technical issues involved in subject matter eligibility analyses during patent examination. Participants who believe that the Supreme Court decisions could be implemented in an alternative manner from the approach taken in the Laws of Nature/Natural Products Guidance should use the forum to present their alternative approach and the legal rationale for the alternative. The forum also can be used by participants to suggest additional examples for use by the Office to create a more complete picture of the impact of Supreme Court precedent on subject matter eligibility.
Medicare Program; Comprehensive ESRD Care Initiative; Extension of the Submission Deadlines for the Letters of Intent and Applications
This notice reopens the application period and provides information on new dates for the submission of the Comprehensive ESRD Care initiative letters of intent and application. The letter of intent submission date for End-stage Renal Disease Seamless Care Organizations (ESCOs) that include a dialysis facility from a large dialysis organization (LDO) is June 23, 2014, and the submission deadline for the LDO application is June 23, 2014. The letter of intent submission date for ESCOs that include a non-LDO facility is September 15, 2014, and the submission deadline for the non-LDO application is September 15, 2014.
Privacy Act of 1974; Revised Systems of Records
The purpose of this document is to publish a new routine use to allow disclosure of information to the Internal Revenue Service as required by the Affordable Care Act for our Privacy Act Systems of Records, RRB-5 and RRB-29. We also updated our records retention and disposal for RRB-29.
Commission Information Collection Activities (FERC-516a); Comment Request; Extension
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, [FERC-516A, ``Small Generator Interconnection Agreements'' (OMB No. 1902-2003)].
Marine Mammals; File No. 18438
Notice is hereby given that the Alaska SeaLife Center (ASLC; Responsible Party, Tara Jones, Ph.D.) 301 Railway Avenue, P.O. Box 1329, Seward, AK 99664, has applied in due form for a permit to conduct research on Steller sea lions (Eumetopias jubatus).
Information Collection Being Submitted for Review and Approval to the Office of Management and Budget (OMB)
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3502-3520), the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimates; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on 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 OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB Control Number.
Fisheries off West Coast States; Pacific Coast Groundfish Fishery Management Plan; Commercial Groundfish Fishery Management Measures; Rockfish Conservation Area Boundaries for Vessels Using Bottom Trawl Gear
This final rule will implement revisions to the boundaries of the Rockfish Conservation Area (RCA) that is currently closed to vessels fishing groundfish with bottom trawl gear. This rule will affect the limited entry bottom trawl sector managed under the Pacific Coast Groundfish Fishery Management Plan (FMP) by liberalizing RCA boundaries to improve access to target species.
Agency Information Collection Activities; Comment Request; Nondiscrimination Compliance Information Reporting Under the Workforce Investment Act of 1998
The Department of Labor (DOL) is soliciting public comments concerning a proposed revision to the information collection request (ICR) titled, ``Nondiscrimination Compliance Information Reporting Under the Workforce Investment Act of 1998.'' This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq.
Airworthiness Directives; the Boeing Company Airplanes
We propose to adopt a new airworthiness directive (AD) for certain the Boeing Company Model DC-9-10, DC-9-20, DC-9-30, DC-9-40, and DC-9-50 series airplanes. This proposed AD was prompted by an evaluation by the design approval holder (DAH) indicating that the bulkhead dome tees, which connect the bulkhead web to the fuselage, are subject to widespread fatigue damage (WFD). This proposed AD would require repetitive inspections of the improved ventral aft pressure bulkhead tees and replacement if necessary. We are proposing this AD to detect and correct fatigue cracking of the bulkhead dome tees, which could result in reduced structural integrity and rapid decompression of the airplane.
Gulf of the Farallones and Monterey Bay National Marine Sanctuaries Regulations on Introduced Species
On March 18, 2013 (78 FR 16622), NOAA proposed to prohibit the introduction of introduced species into the state waters of Gulf of the Farallones and Monterey Bay national marine sanctuaries (GFNMS and MBNMS, respectively). On March 27, 2014 (79 FR 17073) NOAA proposed to amend the March 2013 proposed rule to allow GFNMS and MBNMS to authorize certain introduced species of shellfish from commercial mariculture projects in all state waters of the sanctuaries. The comment period on this amendment closed on April 11, 2014. In response to significant public interest in this amended proposed action, NOAA is re-opening the public comment period until May 5, 2014.
Proposed Information Collection; Procedures for State, Tribal, and Local Government Historic Preservation Programs
We (National Park Service) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public; State, Tribal, and local government partners; and, other Federal agencies to take this opportunity to comment on this IC. This IC is scheduled to expire on August 31, 2014. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Airworthiness Directives; Airbus Airplanes
We propose to adopt a new airworthiness directive (AD) for all Airbus Model A300 series airplanes. This proposed AD was prompted by our determination of the need to incorporate new life limits for the main landing gear (MLG) barrel assembly, retraction actuator assembly linkage, and flange duct. This proposed AD would require revising the maintenance or inspection program to include the new life limits. We are proposing this AD to prevent reduced structural integrity of the airplane and possible loss of controllability of the airplane.
Airworthiness Directives; The Boeing Company Airplanes
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model DC-8-55, DC-8F-54, and DC-8F-55 airplanes, Model DC-8-60 series airplanes, Model DC-8-60F series airplanes, Model DC-8-70 series airplanes, and Model DC-8-70F series airplanes. This proposed AD was prompted by multiple reports of cracking of the upper aft skin panel of the fuselage. An evaluation by the design approval holder (DAH) indicates that the upper aft skin panel of the fuselage is subject to widespread fatigue damage (WFD). This proposed AD would require removing any previously installed local repairs; installing a full-length improvement modification with finger doublers or a full-length repair with finger doublers; and repetitive inspections for cracking of the doublers, and repair if necessary. We are proposing this AD to detect and correct fatigue cracking of the upper aft skin panel of the fuselage, which could result in loss of structural integrity and consequent rapid decompression of the airplane.
Temporary Rule To Establish Separate Annual Catch Limits and Accountability Measures for Blueline Tilefish in the South Atlantic Region
NMFS issues this temporary rule to reduce the amount of blueline tilefish that may be harvested in the exclusive economic zone (EEZ) of the South Atlantic by removing the blueline tilefish portion from the deep-water complex annual catch limit (ACL) and establishing separate commercial and recreational ACLs and accountability measures (AMs) for blueline tilefish. At its December 2013 meeting, the South Atlantic Fishery Management Council (Council) requested emergency action regarding blueline tilefish given new stock assessment results that indicate the blueline tilefish stock is overfished and undergoing overfishing in the South Atlantic. This temporary rule is based upon the best scientific information available, and will be effective for 180 days, unless superseded by subsequent rulemaking. NMFS may extend the rule's effectiveness for an additional 186 days pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson- Stevens Act). The intent of this rulemaking is to reduce overfishing of blueline tilefish in the South Atlantic.
Evaluation of State Coastal Management Programs
The NOAA Office of Ocean and Coastal Resource Management (OCRM) announces its intent to evaluate the performance of the Massachusetts, Texas, and Michigan Coastal Management Programs. The Coastal Zone Management Program evaluations will be conducted pursuant to section 312 of the Coastal Zone Management Act of 1972, as amended (CZMA) and regulations at 15 CFR part 923, Subpart L. The CZMA requires continuing review of the performance of states with respect to coastal program implementation. Evaluation of a Coastal Management Program requires findings concerning the extent to which a state has met the national objectives, adhered to its Coastal Management Program document approved by the Secretary of Commerce, and adhered to the terms of financial assistance awards funded under the CZMA. The evaluations will include a public meeting, consideration of written public comments and consultations with interested Federal, state, and local agencies and members of the public. When the evaluation is completed, OCRM will place a notice in the Federal Register announcing the availability of the Final Evaluation Findings. Notice is hereby given of the date, local time, and location of the public meeting. Date and Time: The Massachusetts Coastal Management Program public meeting will be held on Thursday, June 5th at 4:30 p.m. local time at the Executive Office of Energy and Environmental Affairs, 2nd Floor Conference Room D, 100 Cambridge Street, Boston, Massachusetts 02114. A picture ID is required for building entry. The Michigan Coastal Management Program public meeting will be held on Wednesday, June 4th, at 5:00 p.m. local time at Lansing Community College-West Campus, 5708 Cornerstone Drive, Room M119Section 1, Lansing, Michigan, 48917. The Texas Coastal Management Program public meeting will be held on Wednesday, June 4th, at 5:00 p.m. local time at Texas A&M University Corpus Christi Natural Resources Center, 6300 Ocean Drive, Room 1003, Corpus Christi, Texas 78412.
Pine Shoot Beetle; Addition of Quarantined Areas and Regulated Articles
We are amending the pine shoot beetle regulations by adding areas in the States of Illinois, Maryland, Missouri, New York, and Virginia and the States of Indiana and New Jersey in their entirety to the list of quarantined areas. We are taking this action following the detection of pine shoot beetle in those areas. In addition, we are updating the list of regulated articles. These actions are necessary to prevent the spread of pine shoot beetle, a pest of pine trees, into noninfested areas of the United States.
Ozark-Ouachita Resource Advisory Committee
The Ozark-Ouachita Resource Advisory Committee (RAC) will meet in Waldron, Arkansas. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L 110-343) (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with the title II of the Act. The meeting is open to the public. The purpose of the meeting is to review and recommend projects authorized under title II of the Act.
Asian Longhorned Beetle; Quarantined Areas in Ohio
We are adopting as a final rule, without change, an interim rule that amended the Asian longhorned beetle regulations by adding a portion of Clermont County, OH, to the list of quarantined areas and restricting the interstate movement of regulated articles from that area. The interim rule was necessary to prevent the artificial spread of the Asian longhorned beetle to noninfested areas of the United States.
Meeting of the California Desert District Advisory Council
Notice is hereby given, in accordance with Public Laws 92-463 and 94-579, that the California Desert District Advisory Council (DAC) to the Bureau of Land Management (BLM), U.S. Department of the Interior, will participate in a field tour of BLM-administered public lands on Friday, May 9, 2014, from 8:30 a.m. to 4:30 p.m. and will meet in formal session on Saturday, May 10, 2014, from 8:00 a.m. to 4:30 p.m. in Needles, CA. The location of the Saturday public meeting is yet to be determined. Agenda for the Saturday meeting will include updates by council members, the BLM California Desert District Manager, five Field Managers, and Council Subgroups. Final agenda items for the field trip, the public meeting, and meeting location will be posted on the DAC Web page at https://www.blm.gov/ca/st/en/info/rac/dac.html when finalized.
Proposed Collection; Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Assistant Secretary of Defense for Health Affairs announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Civil Nuclear Trade Advisory Committee (CINTAC) Meeting
This notice sets forth the schedule and proposed agenda for a meeting of the CINTAC.
Agency Information Collection Activities; Comment Request; Measures and Methods for the National Reporting System for Adult Education
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.
Notice of Receipt of Petition for Decision That Nonconforming 2007-2010 Mercedes-Benz S-Class Passenger Cars Are Eligible for Importation
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that nonconforming 2007-2010 Mercedes-Benz S-Class passenger cars that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified version of the 2007-2010 Mercedes-Benz S- Class and they are capable of being readily altered to conform to the standards.
Notice of Receipt of Petition for Decision That Nonconforming 2012 Mercedes-Benz S-Class Passenger Cars Are Eligible for Importation
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that nonconforming 2012 Mercedes-Benz S-Class passenger cars that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified version of the 2012 Mercedes-Benz S- Class) and they are capable of being readily altered to conform to the standards.
Ford Motor Company, Grant of Petition for Decision of Inconsequential Noncompliance
Ford Motor Company (Ford) has determined that certain model year 2009-2012 Ford F-650 and F-750 trucks manufactured from April 14, 2008, through May 1, 2012 do not fully comply with paragraph S5.3.2(a) of Federal Motor Vehicle Safety Standard (FMVSS) No. 105, Hydraulic and Electric Brake Systems. Ford has filed an appropriate report dated July 2, 2012 pursuant to 49 CFR part 573 Defect and Noncompliance Responsibility and Reports.
Information Collection: Leasing for Minerals Other Than Oil, Gas, and Sulphur in the Outer Continental Shelf; Proposed Collection for OMB Review; Comment Request
To comply with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Ocean Energy Management (BOEM) is inviting comments on a collection of information that we will submit to the Office of Management and Budget (OMB) for review and approval. The information collection request (ICR) concerns the paperwork requirements in the regulations under 30 CFR 581 Leasing for Minerals Other than Oil, Gas, and Sulphur in the Outer Continental Shelf.
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices.'' National outbreaks of Toxic Anterior Segment Syndrome (TASS) have been associated with single-use intraocular ophthalmic devices (IODs) and single-use intraocular ophthalmic surgical instruments/accessories that are contaminated with endotoxins. These devices can become contaminated as part of the manufacturing, sterilization, or packaging processes. This guidance document provides recommendations for endotoxin limits as well as endotoxin testing to manufacturers and other entities involved in submitting premarket applications (PMAs) or premarket notification submissions (510(k)s) for different categories of IODs to mitigate future outbreaks of TASS. This draft guidance is not final nor is it in effect at this time.
Live Case Presentations During Investigational Device Exemption Clinical Trials; Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff.'' This guidance is intended, in part, to improve the quality of information submitted by sponsors in an IDE application or supplement to an IDE application and to ensure consistency in the review of those submissions. This draft guidance is intended to clarify FDA's regulations and policies regarding live case presentations using unapproved or uncleared investigational devices in the United States. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys
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 voluntary customer satisfaction service surveys to implement Executive Order 12862.
Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations
The Food and Drug Administration (FDA or we) 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 information collection provisions in FDA's cosmetic labeling regulations.
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies must publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and allow 60 days for public comment. This notice solicits comments on the information collection provisions of our recordkeeping and records access requirements for food facilities.
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Novel Influenza A (H7N9) Virus; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the novel influenza A (H7N9) virus (detected in China in 2013). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Quidel Corporation. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the April 19, 2013, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the novel influenza A (H7N9) virus. On the basis of such determination, the Secretary of HHS also declared on April 19, 2013, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the novel influenza A (H7N9) virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Proposed Information Collection; Comment Request; Economic Surveys of American Samoa, Guam, and the Commonwealth of the Northern Mariana Islands Small Boat-Based Fisheries
The Department of Commerce, 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.
Proposed Information Collection; Comment Request; Emergency Beacon Registrations
The Department of Commerce, 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.
National Protection and Programs Directorate; Notice of Completion of Notification of Cyber-Dependent Infrastructure and Process for Requesting Reconsideration of Determinations of Cyber Criticality
The Secretary of Homeland Security has been directed to identify critical infrastructure where a cybersecurity incident could reasonably result in catastrophic regional or national effects on public health or safety, economic security, or national security. In addition to identifying such infrastructure, the Secretary has also been directed to confidentially notify owners and operators of critical infrastructure identified and establish a mechanism through which entities can request reconsideration of that identification, whether inclusion or exclusion from this list. This notice informs owners and operators of critical infrastructure that the confidential notification process is complete and describes the process for requesting reconsideration.
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