January 10, 2014 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2014-01-10-ReaderAids
Type: Reader Aids
Date: 2014-01-10
First Responder Network Authority; National Environmental Policy Act Implementing Procedures and Categorical Exclusions
Document Number: C1-2013-31493
Type: Notice
Date: 2014-01-10
Agency: Department of Commerce, National Telecommunications and Information Administration
Airworthiness Directives; Dowty Propellers Propellers
Document Number: C1-2013-30882
Type: Proposed Rule
Date: 2014-01-10
Agency: Federal Aviation Administration, Department of Transportation
2014 Rate Changes for the Basetime, Overtime, Holiday, and Laboratory Services Rates
Document Number: 2014-00372
Type: Notice
Date: 2014-01-10
Agency: Department of Agriculture, Food Safety and Inspection Service
The Food Safety and Inspection Service (FSIS) is announcing the 2014 rates it will charge meat and poultry establishments, egg products plants, and importers and exporters for providing voluntary, overtime, and holiday inspection and identification, certification, and laboratory services. The 2014 basetime, overtime, holiday, and laboratory services rates will be applied on the first FSIS pay period approximately 30 days after the publication of this notice, which begins on February 9, 2014.
Sunshine Act Meeting; National Science Board
Document Number: 2014-00362
Type: Notice
Date: 2014-01-10
Agency: National Science Foundation, Agencies and Commissions
Application To Export Electric Energy; NextEra Energy Power Marketing, LLC
Document Number: 2014-00316
Type: Notice
Date: 2014-01-10
Agency: Department of Energy
NextEra Energy Power Marketing, LLC (NEPM) has applied to renew its authority to transmit electric energy from the United States to Canada pursuant to section 202(e) of the Federal Power Act.
Record of Decision and Floodplain Statement of Findings for the Lake Charles Carbon Capture and Sequestration Project
Document Number: 2014-00299
Type: Notice
Date: 2014-01-10
Agency: Department of Energy
The U.S. Department of Energy (DOE) announces its decision to provide cost-shared funding to Leucadia Energy, LLC (Leucadia) for its Lake Charles Carbon Capture and Sequestration project (Lake Charles CCS project) under DOE's Industrial Carbon Capture Sequestration (ICCS) Program. DOE prepared an environmental impact statement (EIS) to evaluate the potential environmental impacts associated with DOE's proposed action of providing financial assistance to the Lake Charles CCS project. The EIS evaluated the impacts associated with construction and operation of the proposed project and Leucadia's Gasification Plant, which is a connected action. DOE's proposed action is to provide financial assistance through a cooperative agreement with Leucadia to capture carbon dioxide (CO2) from the Gasification Plant and transport the CO2 via pipelines to the West Hastings oil field, for use in existing, commercial enhanced oil recovery (EOR). The West Hastings research monitoring, verification, and accounting (MVA) program will provide an accurate accounting of approximately 1 million tons of stored CO2.
Union County Industrial Railroad Company-Operation Exemption-SEDA-COG Joint Rail Authority
Document Number: 2014-00288
Type: Notice
Date: 2014-01-10
Agency: Surface Transportation Board, Department of Transportation
Drawbridge Operation Regulation; Upper Mississippi River, Sabula, IA
Document Number: 2014-00284
Type: Rule
Date: 2014-01-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Sabula Railroad Drawbridge across the Upper Mississippi River, mile 535.0, at Sabula, Iowa. The deviation is necessary to allow the bridge owner time to perform repairs and maintenance that is essential to the continued safe operation of the drawbridge. This deviation allows the bridge to remain in the closed- to-navigation position while a damaged gear assembly is replaced and structural steel repairs are completed.
Endangered and Threatened Wildlife and Plants; Endangered Status for the Sierra Nevada Yellow-Legged Frog and the Northern Distinct Population Segment of the Mountain Yellow-Legged Frog, and Threatened Status for the Yosemite Toad and Designation of Critical Habitat
Document Number: 2014-00281
Type: Proposed Rule
Date: 2014-01-10
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the public comment period on our April 25, 2013, proposed rule to list the Sierra Nevada yellow-legged frog and the northern distinct population segment (DPS) of the mountain yellow-legged frog (populations that occur north of the Tehachapi Mountains) as endangered species, and the Yosemite toad as a threatened species under the Endangered Species Act of 1973, as amended (Act). We are also reopening the public comment period on our April 25, 2013, proposed rule to designate critical habitat for these species. We also announce the availability of a draft economic analysis (DEA) of the proposed designation of critical habitat for the Sierra Nevada yellow-legged frog, the northern DPS of the mountain yellow-legged frog, and the Yosemite toad and an amended required determinations section of the proposal. We are also announcing the location and time of a public hearing to receive public comments on the proposals, as well as the times and locations of two public meetings. We are reopening the comment periods to allow all interested parties an opportunity to comment simultaneously on the proposed rules, the associated DEA, and the amended required determinations section. Comments previously submitted need not be resubmitted, as they will be fully considered in preparation of the final rule.
Regulated Navigation Areas and Limited Access Areas Waterway Management; Apra Harbor, Guam
Document Number: 2014-00280
Type: Proposed Rule
Date: 2014-01-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is considering revising and consolidating existing Regulated Navigation Areas, Security Zones and Safety Zones currently in place in Apra Harbor, Guam. This action is intended to replace a number of redundant, potentially confusing and outdated navigation regulations with a cogent regulatory framework. The goal is to better meet the needs of the community today and ensure the safe and efficient use of the harbor by clarifying and streamlining requirements thereby reducing vessel operator confusion while transiting the waters of Apra Harbor, Guam. We are soliciting comments related to navigation in Apra Harbor, Guam including ways the Coast Guard can streamline the regulations in place while promoting safety on the waterway.
Marine Casualty Reporting on the Outer Continental Shelf
Document Number: 2014-00278
Type: Proposed Rule
Date: 2014-01-10
Agency: Coast Guard, Department of Homeland Security
The Coast Guard proposes broadening the regulatory requirements for reporting marine casualties that occur on the U.S. Outer Continental Shelf (OCS). The limited reporting requirements currently applicable to foreign-flag OCS units in those waters would be replaced with the broader requirements currently applicable to U.S.- flag OCS units and to marine casualties occurring elsewhere in U.S. waters. The proposed changes would improve the Coast Guard's ability to collect and analyze casualty data for incidents on the OCS, in the interest of maintaining and improving safety on the OCS. This proposed rule would support the Coast Guard's maritime safety and stewardship missions.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2014; Correction
Document Number: 2014-00277
Type: Rule
Date: 2014-01-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors in the correcting document that appeared in the January 2, 2014 Federal Register entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2014; Correction.''
Approval and Promulgation of Implementation Plans; Idaho
Document Number: 2014-00274
Type: Proposed Rule
Date: 2014-01-10
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to partially approve the May 9, 2013, State Implementation Plan (SIP) submittal from Idaho to revise the SIP to update the incorporation by reference of Federal air quality regulations into the SIP and make minor edits and clarifications. The EPA is proposing to grant limited approval, as SIP strengthening, to a portion of the submittal that incorporates by reference updates to the Federal nonattainment new source review (nonattainment NSR) requirements that have been recently remanded to the EPA by a court. In addition, the EPA is proposing to partially disapprove Idaho's incorporation by reference of two provisions of the Federal prevention of significant deterioration (PSD) permitting rules that have been recently vacated in a separate decision by a court. Finally, we are proposing to take no action on Idaho's incorporation by reference of another provision of the Federal PSD permitting rules that has been the subject of a court action. Upon final action, the Idaho SIP would incorporate by reference certain Federal regulations as of July 1, 2012.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation; Payment Policies Related to Patient Status; Corrections
Document Number: 2014-00273
Type: Rule
Date: 2014-01-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors in the correcting document that appeared in the January 2, 2014 Federal Register entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation; Payment Policies Related to Patient Status; Corrections.''
Notice of Availability of Certain Revised Consumer Information Publications
Document Number: 2014-00272
Type: Notice
Date: 2014-01-10
Agency: Bureau of Consumer Financial Protection
The Bureau of Consumer Financial Protection (Bureau or CFPB) announces the availability of three revised consumer publications, including a consumer information brochure and two booklets required under the Real Estate Settlement Procedures Act (RESPA), Regulation X, the Truth in Lending Act (TILA), and Regulation Z. These publications are titled: What You Should Know About Home Equity Lines of Credit, the Consumer Handbook on Adjustable-Rate Mortgages, and the Shopping for Your Home Loan: Settlement Cost Booklet.
Lead-Based Paint Renovation, Repair and Painting, and Pre-Renovation Education Activities in Target Housing and Child Occupied Facilities; Oklahoma; Notice of Self-Certification Program Authorization, and Request for Public Comment on Self-Certification
Document Number: 2014-00270
Type: Proposed Rule
Date: 2014-01-10
Agency: Environmental Protection Agency
This document announces that on March 25, 2013, the State of Oklahoma was deemed authorized under section 404(a) of the Toxic Substances Control Act (TSCA), to administer and enforce requirements for a renovation, repair and painting program (RRP) and a lead-based paint pre-renovation education program (PRE) in accordance with 406(b) of TSCA. This document also announces that EPA is seeking comment during a 45-day public comment period on the State of Oklahoma's self- certification. This document also announces that the authorization of the Oklahoma 402(c)(3) and 406(b) programs, which was deemed authorized by regulation and statute on March 25, 2013, will continue without further notice unless EPA, based on its own review and/or comments received during the comment period, disapproves this Oklahoma program application.
International Fisheries; Pacific Tuna Fisheries; Fishing Restrictions for Pacific Bluefin Tuna in the Eastern Pacific Ocean
Document Number: 2014-00269
Type: Proposed Rule
Date: 2014-01-10
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is proposing regulations under the Tuna Conventions Act to implement Resolution C-13-02 of the Inter-American Tropical Tuna Commission (IATTC or the Commission) by specifying limits on U.S. commercial catch of Pacific bluefin tuna from the eastern Pacific Ocean (EPO) waters of the IATTC Convention Area in 2014. This action is necessary for the United States to satisfy its obligations as a member of the IATTC.
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure
Document Number: 2014-00267
Type: Rule
Date: 2014-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final rule amending the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure.
Fisheries of the Northeastern United States; Atlantic Mackerel, Squid, and Butterfish Fisheries; Specifications and Management Measures
Document Number: 2014-00265
Type: Proposed Rule
Date: 2014-01-10
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS proposes the specifications for the 2014 fishing year for butterfish, as well as other management measures for the species managed under the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan. NMFS previously set specifications for longfin squid and Illex squid for 3 years in 2012 (2012-2014) and, therefore, new specifications will not be included in this year's specification rulemaking. Likewise, NMFS set specifications for mackerel for 3 years in 2013 (2013-2015), and new specifications will also not be included in this action. The proposed specifications for butterfish would increase the butterfish acceptable biological catch by 8 percent and would increase the butterfish landings limit by 24 percent compared to 2013. This action also proposes to increase the butterfish Phase 3 trip limit from 500 lb (0.23 mt) to 600 lb (0.27 mt) for longfin squid/ butterfish moratorium permit holders; establish a 236-mt cap on river herring (blueback and alewife) and shad (American and hickory) catch in the mackerel fishery; and raise the post-closure possession limit for longfin squid to 15,000 lb (6.80 mt) for vessels targeting Illex squid.
Organization, Function, and Delegations of Authority; Part G; Proposed Functional Statement
Document Number: 2014-00264
Type: Notice
Date: 2014-01-10
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service is announcing the name change of the Aberdeen Area Indian Health Service to the Great Plains Area Indian Health Service at the request of Tribes served by the Aberdeen Area Indian Health Service.
Certain Steel Nails From the People's Republic of China: Continuation of Antidumping Duty Order
Document Number: 2014-00263
Type: Notice
Date: 2014-01-10
Agency: Department of Commerce, International Trade Administration
As a result of the determinations by the Department of Commerce (the ``Department'') and the International Trade Commission (the ``ITC'') that revocation of the antidumping duty order on certain steel nails (``nails'') from the People's Republic of China (``PRC'') would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, the Department is publishing a notice of continuation of the antidumping duty order.
Notice of Availability of the Draft Environmental Impact Statement (DEIS) for the Installation of a Terminal Groin Structure at the Western End of South Beach, Bald Head Island, Adjacent to the Federal Wilmington Harbor Channel of the Cape Fear River (Brunswick County, North Carolina)
Document Number: 2014-00262
Type: Notice
Date: 2014-01-10
Agency: Department of Defense, Department of the Army, Corps of Engineers
The U.S. Army Corps of Engineers (USACE), Wilmington District, Wilmington Regulatory Field Office, has received a request for Department of the Army authorization, pursuant to Section 404 of the Clean Water Act and Section 10 of the Rivers and Harbor Act, from the Village of Bald Head Island (VBHI) to develop and implement a shoreline protection plan that includes the installation of a terminal groin structure on the east side of the Wilmington Harbor Bald Head Shoal Entrance Channel (a federally-maintained navigation channel of the Cape Fear River) at the ``Point'' of Bald Head Island.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-00261
Type: Notice
Date: 2014-01-10
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. The current OMB clearance expires on May 31, 2014. We are required to publish this notice in the Federal Register under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Information pertaining to the requirement to be submitted: 1. The title of the information collection: 10 CFR Part 63, ``Disposal of High-Level Radioactive Wastes in a Geologic Repository at Yucca Mountain, Nevada.'' 2. Current OMB approval number: 3150-0199. 3. How often the collection is required: One time. 4. Who is required or asked to report: The State of Nevada, local governments, or affected Indian tribes, or their representatives, requesting consultation with the NRC staff regarding review of the potential high-level waste geologic repository site, or wishing to participate in a license application review for the potential geologic repository. 5. The number of annual respondents: 6. 6. The number of hours needed annually to complete the requirement or request: 726. 7. Abstract: Part 63 of Title 10 of the Code of Federal Regulations (10 CFR), requires the State of Nevada, local governments, or affected Indian tribes to submit certain information to the NRC if they request consultation with the NRC staff concerning the review of the potential repository site, or wish to participate in a license application review for the potential repository. Representatives of the State of Nevada, local governments, or affected Indian tribes must submit a statement of their authority to act in such a representative capacity. The information submitted by the State, local governments, and affected Indian tribes is used by the Director of the Office of Nuclear Material Safety and Safeguards as a basis for decisions about the commitment of the NRC staff resources to the consultation and participation efforts. Submit, by March 11, 2014, comments that address the following questions: 1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? 2. Is the burden estimate accurate? 3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? 4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology? The public may examine and have copied for a fee publicly-available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. The OMB clearance requests are available at the NRC's Web site: https://www.nrc.gov/public-involve/ doc-comment/omb/. The document will be available on the NRC's home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC-2013-0280. You may submit your comments by any of the following methods: Electronic comments go to https:// www.regulations.gov and search for Docket No. NRC-2013-0280. Mail comments to the NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Questions about the information collection requirements may be directed to the NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6258, or by email to INFOCOLLECTS.Resource@NRC.GOV.
Proposed Establishment of a Federally Funded Research and Development Center
Document Number: 2014-00260
Type: Notice
Date: 2014-01-10
Agency: Department of Commerce, National Institute of Standards and Technology
The National Institute of Standards and Technology (NIST), Department of Commerce, intends to sponsor a Federally Funded Research and Development Center (FFRDC) to facilitate public-private collaboration for accelerating the widespread adoption of integrated cybersecurity tools and technologies. NIST published three notices in the Federal Register advising the public of the agency's intention to sponsor an FFRDC and requesting comments from the public. This notice provides NIST's analysis of the comments related to NIST's proposed establishment of the FFRDC received in response to those notices. These responses, as well as NIST's responses to the many acquisition-related comments and questions received in response to the three notices will be posted on FedBizOpps.
Draft Guidance for Industry on Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease; Availability
Document Number: 2014-00259
Type: Notice
Date: 2014-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease.'' This draft guidance provides a statement of qualification for the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) patient-reported outcome instrument and summarizes the concept of interest and context of use (COU) for which the tool is qualified through the Center for Drug Evaluation and Research's (CDER's) drug development tool (DDT) qualification program. Qualification of the EXACT represents a conclusion that, within the stated COU, the instrument can be relied on to have a specific interpretation and application in drug development and regulatory review. This draft guidance is an attachment to the guidance for industry entitled ``Qualification Process for Drug Development Tools.''
Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks in Drug Regulatory Decision-Making; Public Workshop; Request for Comments
Document Number: 2014-00258
Type: Notice
Date: 2014-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the following workshop convened by the Institute of Medicine (IOM): ``Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks in Drug Regulatory Decision-Making.'' The purpose of the workshop is twofold: To explore potential approaches to addressing and communicating uncertainty and to identify key considerations on developing, evaluating, and incorporating potential approaches for addressing uncertainty into the assessment of benefits and risks in the human drug review process. The format of the meeting consists of a series of presentations on topics related to uncertainty in the assessment of benefits and risks, followed by a discussion on those topics with invited panelists and audience members. This workshop satisfies an FDA commitment that is part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).
Unapproved and Misbranded Oral and Injectable Drugs Labeled for Prescription Use Containing Codeine Sulfate, Codeine Phosphate, or Dihydrocodeine Bitartrate; Enforcement Action Dates
Document Number: 2014-00257
Type: Notice
Date: 2014-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing its intention to take enforcement action against unapproved and misbranded oral and injectable drug products labeled for prescription use and containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate, and against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. Prescription drug products containing these ingredients pose serious risks, including the risk of addiction, and some unapproved drug products may lack warnings or other information required in the labeling of approved drug products that is important for safe use. These unapproved drug products compete with approved drug products and thus pose a direct challenge to the drug approval system. This document covers the following unapproved drug products labeled for prescription use: Single-ingredient codeine sulfate oral tablets and solutions, single-ingredient codeine phosphate injection products, fixed-dose combination products containing codeine phosphate, and fixed-dose combination products containing dihydrocodeine bitartrate. A new drug containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate requires an approved new drug application (NDA) or abbreviated new drug application (ANDA) to be legally marketed.
Drugs for Human Use; Drug Efficacy Study Implementation; Certain Prescription Drugs Offered for Various Indications; Final Resolution of Hearing Requests Under Dockets
Document Number: 2014-00256
Type: Notice
Date: 2014-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that all outstanding hearing requests pertaining to Docket Nos. FDA-1975-N-0355 (formerly 75N-0185) (DESI 3265); FDA-1976-N-0272 (formerly 76N-0056), FDA-1976-N-0344 (formerly 76N-0057), and FDA-1978-N-0701 (formerly 78N- 0070) (DESI 1626); FDA-1979-N-0224 (formerly 79N-0169) (DESI 12283); and FDA-1983-N-0297 (formerly 83N-0030) (DESI 50213) have been withdrawn. Shipment in interstate commerce of any of the products identified in these dockets, or any identical, related, or similar (IRS) product to the products in these dockets, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph) is unlawful as of the effective date of this notice.
Draft Guidance for Industry on Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment; Availability
Document Number: 2014-00255
Type: Notice
Date: 2014-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Community- Acquired Bacterial Pneumonia: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antibacterial drugs for the treatment of community-acquired bacterial pneumonia (CABP). The science of clinical trial design and our understanding of this disease have advanced in recent years, and this draft guidance informs sponsors of our current recommendations for clinical development. FDA is specifically requesting comment on critical areas of scientific interest including the appropriate primary efficacy endpoints, the use of an intent-to-treat (ITT) population for the primary analysis population, and the use of antibacterial therapy by patients before participating in clinical trials. This draft guidance revises the draft guidance of the same name that published March 20, 2009.
Base Closure and Realignment
Document Number: 2014-00254
Type: Notice
Date: 2014-01-10
Agency: Department of Defense, Office of the Secretary
This notice is provided pursuant to section 2905(b)(7)(B)(ii) of the Defense Base Closure and Realignment Act of 1990. It provides the point of contact, address, and telephone number for the Local Redevelopment Authority (LRA) for the Pueblo Chemical Depot, Colorado. The Pueblo Depot Activity Development Authority was recognized as the LRA by the Secretary of Defense, acting through the Department of Defense, Office of Economic Adjustment (OEA) on June 29, 1995. The Army Surplus Property Notice for the Pueblo Chemical Depot was published in the Federal Register on December 20, 2013 (78 FR 77108). Representatives of state and local governments, homeless providers, and other parties interested in the redevelopment of the installation should contact this LRA.
Exelon Generation Company, LLC; License Exemption Request for Oyster Creek Nuclear Generating Station
Document Number: 2014-00253
Type: Notice
Date: 2014-01-10
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to an October 14, 2013, request from Exelon Generation Company (the licensee) for a one-time exemption from the requirement to participate in the biennial Emergency Preparedness (EP) exercise. The licensee requested to delay conduct of the exercise from October 8, 2013, to March 18, 2014.
Response Systems to Adult Sexual Assault Crimes Panel; Notice of Federal Advisory Committee Meeting
Document Number: 2014-00251
Type: Notice
Date: 2014-01-10
Agency: Department of Defense, Office of the Secretary
The Department of Defense is publishing this notice to announce the following Federal Advisory Committee meeting of the Response Systems to Adult Sexual Assault Crimes Panel. This meeting is open to the public.
Duke Energy Progress, Inc.; Brunswick Steam Electric Plant, Units 1 and 2
Document Number: 2014-00250
Type: Notice
Date: 2014-01-10
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Notice is hereby given that the Director, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission (NRC) has issued a Director's Decision on a petition filed by Mr. David Lochbaum, on behalf of the Union of Concerned Scientists; the North Carolina Waste Awareness & Reduction Network; and the Nuclear Information and Resource Service (hereafter referred to as ``the petitioner'').
Emergency Planning Exemption Requests for Decommissioning Nuclear Power Plants
Document Number: 2014-00249
Type: Notice
Date: 2014-01-10
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is soliciting public comment on its draft Interim Staff Guidance (ISG) NSIR/DPR-ISG- 02, ``Emergency Planning Exemption Requests for Decommissioning Nuclear Power Plants.'' This document would provide guidance for NRC staff to ensure clear and consistent reviews of requests for exemptions from emergency preparedness regulations and license amendments for defueled station emergency plans submitted by nuclear power plant licensees after permanent cessation of plant operations. Nuclear power plants that have ceased operating and are permanently defueled provide less risk of radiological releases than operating nuclear power plants. Licensees of these decommissioning plants have historically submitted exemption requests based on this lower risk. The ISG also could be used by nuclear power plant licensees when drafting these exemption requests.
Defense Business Board; Notice of Federal Advisory Committee Meeting
Document Number: 2014-00248
Type: Notice
Date: 2014-01-10
Agency: Department of Defense, Office of the Secretary
The Department of Defense is publishing this notice to announce the following Federal advisory committee meeting of the Defense Business Board. This meeting is open to the public.
Aging Management of Loss of Coating Integrity for Internal Service Level III (Augmented) Coatings
Document Number: 2014-00247
Type: Notice
Date: 2014-01-10
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) requests public comment on the draft License Renewal Interim Staff Guidance (LR-ISG), LR-ISG-2013-01, ``Aging Management of Loss of Coating Integrity for Internal Service Level III (augmented) Coatings.'' The draft LR-ISG proposes to add a new NRC staff-recommended aging management program (AMP), new aging management review (AMR) items, and new age-related definitions in NUREG-1801, Revision 2, ``Generic Aging Lessons Learned (GALL) Report.'' The draft LR-ISG also adds new AMR items and changes to the Final Safety Analysis Supplement program description in NUREG- 1800, Revision 2, ``Standard Review Plan for Review of License Renewal Applications for Nuclear Power Plants'' (SRP-LR). These changes address new recommendations related to Service Level III (augmented) (a new term) internal coatings in piping, tanks, and heat exchangers.
Notice of Proposals To Engage in or To Acquire Companies Engaged in Permissible Nonbanking Activities
Document Number: 2014-00245
Type: Notice
Date: 2014-01-10
Agency: Federal Reserve System, Agencies and Commissions
Conceptual Example of a Proposed Risk Management Regulatory Framework Policy Statement
Document Number: 2014-00244
Type: Notice
Date: 2014-01-10
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is extending the public comment period on the document entitled, ``White Paper on a Conceptual Example of a Proposed Risk Management Regulatory Framework Policy Statement (the white paper),'' from January 10, 2014, to February 28, 2014. The NRC also plans to hold a public meeting to discuss and receive comments on the white paper.
Notice of Availability of the Draft Environmental Impact Statement and Public Hearing
Document Number: 2014-00243
Type: Notice
Date: 2014-01-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the availability of the Roybal Campus 2025 Master Plan Draft Environmental Impact Statement (DEIS) for public review and comment. This notice also announces the date, location and time for the public hearing. The DEIS analyzes the potential impacts associated with the implementation of the 2015-2025 Master Plan (Master Plan) for HHS/CDC's Edward R. Roybal Campus (Roybal Campus) located at 1600 Clifton Road NE., in Atlanta, Georgia. This announcement follows the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR Part 1500-1508); and, the Department of Health and Human Services (HHS) General Administration Manual Part 30 Environmental Procedures, dated February 25, 2000.
Fisheries of the South Atlantic, Gulf of Mexico, and Caribbean; Southeast Data, Assessment, and Review (SEDAR); Public Meeting
Document Number: 2014-00242
Type: Notice
Date: 2014-01-10
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The SEDAR Steering Committee will meet via webinar. See SUPPLEMENTARY INFORMATION.
Pacific Fishery Management Council; Online Webinar
Document Number: 2014-00241
Type: Notice
Date: 2014-01-10
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Pacific Fishery Management Council's (Pacific Council's) Scientific and Statistical Committee (SSC) Groundfish Subcommittee will hold an online webinar to review data-poor overfishing limit (OFL) estimates for kelp greenling in Oregon and Washington, new OFL estimates for the Washington stock of cabezon, and other business in preparation for the SSC's March 2014 meeting. The online SSC Groundfish Subcommittee webinar is open to the public.
Subsistence Management Regulations for Public Lands in Alaska-2015-16 and 2016-17 Subsistence Taking of Fish and Shellfish Regulations
Document Number: 2014-00239
Type: Proposed Rule
Date: 2014-01-10
Agency: Department of Agriculture, Forest Service, Fish and Wildlife Service, Department of the Interior
This proposed rule would establish regulations for fish and shellfish seasons, harvest limits, methods and means related to taking of fish and shellfish for subsistence uses during the 2015-2016 and 2016-2017 regulatory years. The Federal Subsistence Board (Board) is on a schedule of completing the process of revising subsistence taking of fish and shellfish regulations in odd-numbered years and subsistence taking of wildlife regulations in even-numbered years; public proposal and review processes take place during the preceding year. The Board also addresses customary and traditional use determinations during the applicable cycle. When final, the resulting rulemaking will replace the existing subsistence fish and shellfish taking regulations. This proposed rule would also amend the general regulations on subsistence taking of fish and wildlife.
Procurement List, Proposed Additions and Deletions
Document Number: 2014-00238
Type: Notice
Date: 2014-01-10
Agency: Committee for Purchase from People Who Are
The Committee is proposing to add products to the Procurement List that will be furnished by a nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products and a service previously furnished by such agencies. Comments Must be Received on or Before: 2/10/2014.
Procurement List Deletions
Document Number: 2014-00237
Type: Notice
Date: 2014-01-10
Agency: Committee for Purchase from People Who Are
This action deletes products and services from the Procurement List previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Meeting Invitation to Industry and Comment Period on Draft Edition 3 of Standardization Agreement (STANAG) 4671
Document Number: 2014-00236
Type: Notice
Date: 2014-01-10
Agency: Department of Defense, Office of the Secretary
The NATO STANAG 4671 Custodial Support Team is inviting industries from NATO countries to review Edition 3 and provide comments and/or concerns prior to finalization and publication for topics of discussion during Industry Day. Interested Industry Day participants may request copy of the draft update to STANAG 4671 (with comment sheet for feedback) by email and copies will be provided within 3 business days of receipt by email only. Upon request from an industry participant to attend Industry Day a formal invitation will be sent via email prior to February 4, 2014 with details for date, location and access requirements. The objective of the March meetings will be to conduct a technical dialogue on the STANAG 4671. Industry Day discussion topics will be generated based on Industry's feedback as well as specific topics identified by the Custodial Support Team. Comments will be prioritized and addressed in an open forum.
Airworthiness Directives; The Boeing Company Airplanes
Document Number: 2014-00234
Type: Proposed Rule
Date: 2014-01-10
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 777 airplanes. This proposed AD was prompted by reports of latently failed fuel shutoff valves discovered during fuel filter replacement. This proposed AD would require revising the maintenance or inspection program to include a new airworthiness limitation. We are proposing this AD to detect and correct latent failures of the fuel shutoff valve to the engine, which could result in the inability to shut off fuel to the engine and, in case of certain engine fires, an uncontrollable fire that could lead to wing failure.
Submission for OMB Review; Comment Request
Document Number: 2014-00233
Type: Notice
Date: 2014-01-10
Agency: Department of Commerce
Qualification of Drivers; Exemption Applications; Vision
Document Number: 2014-00231
Type: Notice
Date: 2014-01-10
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces receipt of applications from 33 individuals for exemption from the vision requirement in the Federal Motor Carrier Safety Regulations. They are unable to meet the vision requirement in one eye for various reasons. The exemptions would enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye.
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