December 12, 2013 – Federal Register Recent Federal Regulation Documents

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.

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.

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.

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.

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.

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.

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.

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.

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.