February 17, 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing to reclassify the sorbent hemoperfusion system, a preamendments class III device, into class II (special controls) for the treatment of poisoning and drug overdose, and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the treatment of hepatic coma and metabolic disturbances. FDA is identifying the proposed special controls that the Agency believes will reasonably ensure the safety and effectiveness of the device for the treatment of poisoning and drug overdose. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the devices mentioned in this document based on new information. This action implements certain statutory requirements.

NMFS is opening directed fishing for pollock in Statistical Area 630 of the Gulf of Alaska (GOA). This action is necessary to fully use the A season allowance of the 2012 total allowable catch of pollock in Statistical Area 630 of the GOA.

The Bureau of Consumer Financial Protection (Bureau) is proposing a new regulation pursuant to section 1024 of the Consumer Financial Protection Act of 2010. That provision grants the Bureau authority to supervise certain nonbank covered persons for compliance with Federal consumer financial laws and for other purposes. The Bureau has the authority to supervise nonbank covered persons of all sizes in the residential mortgage, private education lending, and payday lending markets. In addition, the Bureau has the authority to supervise nonbank ``larger participant[s]'' in markets for other consumer financial products or services. The Bureau must define such ``larger participants'' by rule, and such an initial rule must be issued by July 21, 2012. In this proposal, the Bureau proposes to define larger participants in the markets for consumer debt collection and consumer reporting. The Bureau intends that this proposal and subsequent initial rule will be followed by a series of rulemakings covering additional markets for consumer financial products and services. The Bureau also proposes to include provisions in this proposal that will facilitate the supervision of nonbank covered persons.

The Food and Drug Administration (FDA) is announcing that the American Chemistry Council (ACC) has filed a petition proposing that the food additive regulations be amended to no longer provide for the use of polycarbonate (PC) resins in infant feeding bottles and spill- proof cups designed to help train babies to drink from cups because these uses have been abandoned. PC resins are formed by the condensation of 4,4'-isopropylenediphenol (i.e., Bisphenol A (BPA)), and carbonyl chloride or diphenyl carbonate.

The Executive Office for Immigration Review (EOIR) is reviewing and considering amendments to the regulations governing the recognition of organizations and accreditation of representatives who appear before EOIR. EOIR seeks public comment on issues affecting these regulations and will host two open public meetings to discuss these regulations. The first meeting will be limited to a discussion of the recognition of organizations and the second will address accreditation of representatives.

EPA is granting full approval of Missouri's attainment demonstration State Implementation Plan (SIP) and control strategy for the lead National Ambient Air Quality Standard (NAAQS) nonattainment area of Herculaneum, Missouri. This action is based on a proposed conditional approval of the SIP published on October 8, 2008, and a proposed approval of the supplemental SIP submittal received by EPA on September 3, 2009, published in the Federal Register on August 27, 2010. The applicable standard addressed in this action is the lead NAAQS promulgated by EPA in 1978. EPA has determined that both SIP submittals from the State of Missouri satisfy the applicable requirements of the Clean Air Act (CAA or Act) and demonstrates attainment of the 1.5 microgram per cubic meter ([mu]g/m\3\) lead NAAQS in the Herculaneum, Missouri area. This action does not address the obligations which Missouri has relative to the revised lead NAAQS promulgated by EPA in 2008.

The U.S. Nuclear Regulatory Commission (NRC or the Commission) is amending its spent fuel storage regulations by revising the Holtec International HI-STORM 100 dry cask storage system listing within the ``List of Approved Spent Fuel Storage Casks'' to include Amendment No. 8 to Certificate of Compliance (CoC) No. 1014. Amendment No. 8 adds a new multipurpose canister (MPC)-68M to the approved models currently included in CoC No. 1014 with two new boiling water reactor fuel assembly/array classes, and a new pressurized water reactor fuel assembly/class to CoC No. 1014 for loading into the MPC-32. In addition, the amendment makes several other changes as described under the ``Discussion'' heading in the SUPPLEMENTARY INFORMATION section of this document.

This rule establishes air quality designations for all areas in the United States for the 2010 Primary Nitrogen Dioxide (NO2) National Ambient Air Quality Standards (NAAQS). Based on air quality monitoring data, the EPA is issuing this rule to designate all areas of the country as ``unclassifiable/attainment'' for the 2010 NO2 NAAQS. The EPA is designating areas as ``unclassifiable/attainment'' to mean that available information does not indicate that the air quality in these areas exceeds the 2010 NO2 NAAQS.

We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 767-200, -300, and -300F series airplanes. This AD was prompted by reports of loss of avionics cooling due to an unserviceable relay installed on a panel as part of the cabin air conditioning and temperature control system (CACTCS). This AD requires doing certain wiring changes, installing a new relay and necessary wiring in the CACTCS, and performing an operational test of the cooling pack system. We are issuing this AD to prevent loss of electrical equipment bay cooling and the overheating of flight deck instruments, which would result in the eventual loss of primary flight displays, an unusually high pilot workload, and depressurization of the cabin.