December 12, 2013 – Federal Register Recent Federal Regulation Documents

Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-29613
Type: Notice
Date: 2013-12-12
Agency: Department of Health and Human Services, National Institutes of Health
Independent Assessment of the Process for the Review of Device Submissions; High Priority Recommendations
Document Number: 2013-29612
Type: Notice
Date: 2013-12-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is presenting Booz Allen Hamilton's high priority recommendations submitted as part of their independent assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years 2013 to 2017. The assessment is described in section V, ``Independent Assessment of Review Process Management'', of the commitment letter entitled ``MDUFA Performance Goals and Procedures'' \1\ (MDUFA III Commitment Letter). The assessment is being conducted in two phases. The high priority recommendations are the first of a series of deliverables, as outlined in the contract statement of work,\2\ to be published as part of Phase 1 of the assessment.
New Jersey Regulations on Transportation of Regulated Medical Waste
Document Number: 2013-29604
Type: Notice
Date: 2013-12-12
Agency: Pipeline and Hazardous Materials Safety Administration, Department of Transportation
Federal hazardous material transportation law preempts the following requirements in the New Jersey Administrative Code (N.J.A.C.) because the requirements are not substantively the same as the requirements in the HMR: 1. N.J.A.C. 7:26-3A.10(a) that generators must separate into different containers before transport sharps, fluids (greater than 20 cc), and other regulated medical waste; 2. N.J.A.C. 7:26-3A.11(d) which allows a generator to ship oversized medical waste without placing it in a packaging as required by the HMR; 3. N.J.A.C. 7:26-3A.14 that the words ``Medical Waste'' or ``Infectious Waste'' must be labeled on the outside of the package when there is untreated regulated medical waste; 4. N.J.A.C. 7:26-3A:15 that each ``generator shall mark each individual container of regulated medical waste in accordance with all applicable Federal regulations. . . . ,'' and that the markings must include details of the transporter's name, the date of shipment, the intermediate handler's name, and other specific information; 5. N.J.A.C. 7:26-3A.19 and those provisions in 7:26-3A.31 which require the use of a specific ``tracking form'' to accompany shipments of regulated medical waste that are prescribed for either the generator or the transporter; 6. N.J.A.C. 7:26-3A.28 that, when transferring between transporters, each transporter must place a water resistant tag below the generator's marking on the outer surface of the container with the transporter's name, solid waste registration number, and date of receipt; and 7. N.J.A.C. 7:26-3A.30 which requires that a vehicle used to transport regulated medical waste must have: 1) the name of the transporter; 2) the New Jersey Department of Environmental Protection (NJDEP) solid waste transporter registration number; and 3) either the words ``Medical Waste'' or ``Infectious Waste'' on two sides and the back of the cargo-carrying body. 8. N.J.A.C. 7:26-3A.45, to the extent that it requires rail transporters to comply with the transporter requirements of 7:26-3A.28 and 7:26-3A.30. 9. N.J.A.C. 7:26-3A.46 which requires a specific tracking form to accompany shipments of regulated medical waste for rail transporters. Federal hazardous material transportation law does not preempt the following requirements because they do not create an obstacle in complying with the HMR. 1. N.J.A.C. 7:26-3A.21(a)(1) to the extent that it requires the generator to retain a copy of the shipping paper for at least three years from the date the regulated medical waste was accepted by the transporter; 2. N.J.A.C. 7:26-3A.21(a)(2) to the extent that it requires the generator to retain a copy of any exception report for at least three years after the day the exception report was submitted; 3. N.J.A.C. 7:26-3A.22 to the extent that it requires the generator of regulated medical waste to file an exception report with the state when a transporter and/or destination facility notifies the generator of any discrepancy between the shipment as accepted by the initial transporter and delivered to the destination facility; 4. N.J.A.C. 7:26-3A.32 to the extent that it requires the transporter to deliver the entire quantity of regulated medical waste to the proper party listed on the tracking form; 5. N.J.A.C. 7:26-3A.33 to the extent that does not require a particular form to be used to consolidate the multiple shipments; 6. N.J.A.C. 7:26-3A.34 to the extent that it requires that the transporter of regulated medical waste to retain a copy of the shipping paper for at least three years from the date the regulated medical waste was accepted by the next party; and 7. N.J.A.C. 7:26-3A.41 to the extent that it requires intermediate handlers and destination facilities to certify that they had received the listed regulated medical waste.
Low Enriched Uranium From France
Document Number: 2013-29603
Type: Notice
Date: 2013-12-12
Agency: International Trade Commission, Agencies and Commissions
Notice of Request for Additional Information
Document Number: 2013-29599
Type: Notice
Date: 2013-12-12
Agency: Federal Maritime Commission, Agencies and Commissions
Pacific Halibut Fisheries; Catch Sharing Plan for Guided Sport and Commercial Fisheries in Alaska
Document Number: 2013-29598
Type: Rule
Date: 2013-12-12
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS issues regulations to implement a catch sharing plan for the guided sport (charter) and commercial fisheries for Pacific halibut in waters of International Pacific Halibut Commission Regulatory Areas 2C (Southeast Alaska) and 3A (Central Gulf of Alaska). This catch sharing plan replaces the Guideline Harvest Level program, defines an annual process for allocating halibut between the charter and commercial fisheries in Area 2C and Area 3A, and establishes allocations for each fishery. The commercial fishery will continue to be managed under the Individual Fishing Quota system. To allow flexibility for individual commercial and charter fishery participants, the catch sharing plan also authorizes annual transfers of commercial halibut quota to charter halibut permit holders for harvest in the charter fishery. This action is necessary to achieve the halibut fishery management goals of the North Pacific Fishery Management Council.
Airworthiness Directives; The Boeing Company Airplanes
Document Number: 2013-29593
Type: Proposed Rule
Date: 2013-12-12
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 737-600, -700, 700C, -800, -900, and - 900ER series airplanes. This proposed AD was prompted by a report of installation of incorrect wire support clamps within the left and right Environmental Control Systems (ECS) bay area during production, which is a flammable leakage zone. Use of incorrect wire support clamps that are not fully cushioned could allow electrical power wiring to come in contact with the exposed metal of the improper clamp, causing a short circuit and subsequent electrical arcing. This proposed AD would require inspecting to identify the part number of the wire support clamp, and related investigative and corrective actions if necessary. We are proposing this AD to prevent electrical arcing and a potential ignition source, which, in combination with flammable fuel vapors, could result in a fuel tank explosion, and consequent loss of the airplane.
Application for Final Commitment for a Long-Term Loan or Financial Guarantee in Excess of $100 Million: AP088406XX
Document Number: 2013-29575
Type: Notice
Date: 2013-12-12
Agency: Export-Import Bank, Agencies and Commissions
This Notice is to inform the public, in accordance with Section 3(c)(10) of the Charter of the Export-Import Bank of the United States (``Ex-Im Bank''), that Ex-Im Bank has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million (as calculated in accordance with Section 3(c)(10) of the Charter). Comments received within the comment period specified below will be presented to the Ex-Im Bank Board of Directors prior to final action on this Transaction.
Combined Notice of Filings #1
Document Number: 2013-29570
Type: Notice
Date: 2013-12-12
Agency: Department of Energy, Federal Energy Regulatory Commission
Zero Rate Reactive Power Rate Schedules; Notice of Staff Workshop
Document Number: 2013-29569
Type: Notice
Date: 2013-12-12
Agency: Department of Energy, Federal Energy Regulatory Commission
MarkWest Pipeline Company L.L.C.; Notice of Petition for Waiver
Document Number: 2013-29568
Type: Notice
Date: 2013-12-12
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2013-29565
Type: Notice
Date: 2013-12-12
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2013-29564
Type: Notice
Date: 2013-12-12
Agency: Department of Energy, Federal Energy Regulatory Commission
Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Operation of Offshore Oil and Gas Facilities in the U.S. Beaufort Sea
Document Number: 2013-29553
Type: Rule
Date: 2013-12-12
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS, upon application from BP Exploration (Alaska) Inc. (BP), is issuing regulations pursuant to the Marine Mammal Protection Act (MMPA) to govern the unintentional taking of marine mammals incidental to operation of offshore oil and gas facilities in the U.S. Beaufort Sea, Alaska, for the period January 2014-January 2019. These regulations, which allow for the issuance of Letters of Authorization (LOAs) for the incidental take of marine mammals during the described activities and specified timeframes, prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat, as well as requirements pertaining to the monitoring and reporting of such taking.
National Priorities List, Final Rule No. 57
Document Number: 2013-29350
Type: Rule
Date: 2013-12-12
Agency: Environmental Protection Agency
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (``CERCLA'' or ``the Act''), as amended, requires that the National Oil and Hazardous Substances Pollution Contingency Plan (``NCP'') include a list of national priorities among the known releases or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The National Priorities List (``NPL'') constitutes this list. The NPL is intended primarily to guide the Environmental Protection Agency (``the EPA'' or ``the agency'') in determining which sites warrant further investigation. These further investigations will allow the EPA to assess the nature and extent of public health and environmental risks associated with the site and to determine what CERCLA-financed remedial action(s), if any, may be appropriate. This rule adds nine sites to the General Superfund section of the NPL and changes the name of one NPL site.
National Priorities List, Proposed Rule No. 59
Document Number: 2013-29349
Type: Proposed Rule
Date: 2013-12-12
Agency: Environmental Protection Agency
The Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA'' or ``the Act''), as amended, requires that the National Oil and Hazardous Substances Pollution Contingency Plan (``NCP'') include a list of national priorities among the known releases or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The National Priorities List (``NPL'') constitutes this list. The NPL is intended primarily to guide the Environmental Protection Agency (``EPA'' or ``the agency'') in determining which sites warrant further investigation. These further investigations will allow the EPA to assess the nature and extent of public health and environmental risks associated with the site and to determine what CERCLA-financed remedial action(s), if any, may be appropriate. This rule proposes to add eight sites to the NPL, all to the General Superfund Section. This proposed rule also solicits additional comments on the Smurfit-Stone Mill site based on additional references to the site's Hazard Ranking System (HRS) documentation record being made available to the public.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
Document Number: 2013-29309
Type: Rule
Date: 2013-12-12
Agency: Federal Aviation Administration, Department of Transportation
This rule establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
Document Number: 2013-29308
Type: Rule
Date: 2013-12-12
Agency: Federal Aviation Administration, Department of Transportation
This rule establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Federal Management Regulation (FMR); Shipping Household Goods
Document Number: 2013-29212
Type: Rule
Date: 2013-12-12
Agency: General Services Administration, Agencies and Commissions
GSA is amending the Federal Management Regulation (FMR) to update information on the commuted rate schedule and correct a Web site address. Commuted rate and actual expense are two authorized methods of transporting and paying for the movement of Household Goods (HHG), Professional Books, Paper and Equipment, and temporary storage. This final rule addresses changes only to the commuted rate method. Using the commuted rate method, the individual assumes responsibility for shipment and payment. The commuted rate schedule establishes the reimbursement rate.
Federal Travel Regulation (FTR); Relocation Allowances; Commuted Rate
Document Number: 2013-29209
Type: Rule
Date: 2013-12-12
Agency: General Services Administration, Agencies and Commissions
The GSA, OGP, is providing a workable commuted rate to be used by agencies in determining a benchmark for payment on the transportation of household goods and temporary storage under a ``do it yourself'' move cost scenario. This final rule will meet the requirements set forth in the U.S. Code for Relocation Expenses.
Federal Government Participation in the Automated Clearing House
Document Number: 2013-29202
Type: Proposed Rule
Date: 2013-12-12
Agency: Fiscal Service, Public Debt Bureau, Department of Treasury, Department of the Treasury
The Department of the Treasury, Bureau of the Fiscal Service (Service) is proposing to amend its regulation governing the use of the Automated Clearing House (ACH) system by Federal agencies. Our regulation adopts, with some exceptions, the NACHA Operating Rules developed by NACHAThe Electronic Payments Association (NACHA) as the rules governing the use of the ACH Network by Federal agencies. We are issuing this proposed rule to address changes that NACHA has made to the NACHA Operating Rules since the publication of NACHA's 2009 ACH Rules book. These changes include amendments set forth in NACHA's 2010, 2011, 2012 and 2013 Operating Rules books.
Addition of Certain Persons to the Entity List; Amendment of Entity List Entries; and Removal of One Person From the Entity List Based on a Removal Request
Document Number: 2013-28663
Type: Rule
Date: 2013-12-12
Agency: Department of Commerce, Bureau of Industry and Security
This rule amends the Export Administration Regulations (EAR) by adding thirty-six persons under forty-six entries to the Entity List, revising three existing entries, and removing one entry. The persons who are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. These persons will be listed on the Entity List under the following destinations: Armenia, Canada, China, Germany, Greece, Hong Kong, Iran, Malaysia, Thailand, Turkey, and the United Arab Emirates (U.A.E.). This rule is also revising one existing entry under Sweden to correct the entry by providing an address for this listed person under the destination of Estonia, and revising two entries in Canada, the first by removing two addresses, and the second by updating an address. Lastly, this rule removes one person in Russia from the Entity List. This person is being removed from the Entity List as a result of a request for removal submitted by the person, a review of information provided in the removal request in accordance with the procedures for requesting removal or modification of an Entity List entity, and further review conducted by the ERC.
Position Limits for Derivatives
Document Number: 2013-27200
Type: Proposed Rule
Date: 2013-12-12
Agency: Commodity Futures Trading Commission, Agencies and Commissions
The Commission proposes to amend regulations concerning speculative position limits to conform to the Wall Street Transparency and Accountability Act of 2010 (``Dodd-Frank Act'') amendments to the Commodity Exchange Act (``CEA'' or ``Act''). The Commission proposes to establish speculative position limits for 28 exempt and agricultural commodity futures and option contracts, and physical commodity swaps that are ``economically equivalent'' to such contracts. In connection with establishing these limits, the Commission proposes to update some relevant definitions; revise the exemptions from speculative position limits, including for bona fide hedging; and extend and update reporting requirements for persons claiming exemption from these limits. The Commission proposes appendices that would provide guidance on risk management exemptions for commodity derivative contracts in excluded commodities permitted under the proposed definition of bona fide hedging position; list core referenced futures contracts and commodities that would be substantially the same as a commodity underlying a core referenced futures contract for purposes of the proposed definition of basis contract; describe and analyze fourteen fact patterns that would satisfy the proposed definition of bona fide hedging position; and present the proposed speculative position limit levels in tabular form. In addition, the Commission proposes to update certain of its rules, guidance and acceptable practices for compliance with Designated Contract Market (``DCM'') core principle 5 and Swap Execution Facility (``SEF'') core principle 6 in respect of exchange- set speculative position limits and position accountability levels.