December 4, 2007 – Federal Register Recent Federal Regulation Documents

NMFS announces that fish quotas and an effort allocation are available for harvest by U.S. fishermen in the Northwest Atlantic Fisheries Organization (NAFO) Regulatory Area. This action is necessary to make available to U.S. fishermen a fishing privilege on an equitable basis.

NMFS announces that the 2007 summer flounder commercial quota allocated to the State of Connecticut has been harvested. Vessels issued a commercial Federal fisheries permit for the summer flounder fishery may not land summer flounder in Connecticut for the remainder of calendar year 2007, unless additional quota becomes available through a transfer from another state. Regulations governing the summer flounder fishery require publication of this notification to advise Connecticut that the quota has been harvested and to advise vessel permit holders and dealer permit holders that no commercial quota is available for landing summer flounder in Connecticut.

The Farm Credit Administration (FCA, Agency, we) issues this final rule amending our regulations to allow Farm Credit System (System) institutions 90 calendar days to prepare and distribute annual reports to shareholders, while retaining the 75 calendar day requirement for electronic reporting and distribution to the FCA.

EPA is taking direct final action to approve a revision to the Missouri State Implementation Plan (SIP) to amend the General Conformity Rule to include de minimis emission levels for Particulate Matter 2.5 (PM2.5). This update ensures consistency with the Federal General Conformity Rule.

EPA is proposing to approve revisions to the Wisconsin State Implementation Plan (SIP) submitted by the Wisconsin Department of Natural Resources (WDNR) on May 1, 2007. The WDNR has submitted for approval into its SIP a revision which allows the State to issue a waiver to a source allowing it to commence construction prior to a construction permit being issued, in certain cases. This provision is only allowed for minor sources which meet specific criteria, and WDNR must follow established procedures to grant a waiver. In addition, the revision also contains changes to Wisconsin's fee provisions to allow a fee to be charged for the waiver. EPA is proposing to approve this revision because it is consistent with Federal regulations governing state permit programs.

The Nuclear Regulatory Commission (NRC or Commission) is amending its regulations related to the reporting of annual dose to workers, the definition of Total Effective Dose Equivalent (TEDE), the labeling of certain containers holding licensed material, and the determination of cumulative occupational radiation dose. This final rule limits the routine reporting of annual doses to those workers whose annual dose exceeds a specific dose threshold or who request a report. This final rule also modifies the labeling requirements for certain containers holding licensed material within posted areas in nuclear power facilities. This final rule also amends the definition of TEDE to be consistent with current Commission policy. Finally, this rule removes the requirement that licensees attempt to obtain cumulative exposure records for workers unless these individuals are being authorized to receive a planned special exposure. These revisions reduce the administrative and information collection burdens on NRC and Agreement State licensees without affecting the level of protection for either the health and safety of workers and the public, or for the environment.

We are revising an earlier proposed airworthiness directive (AD) that applies to certain Cirrus Design Corporation (CDC) Models SR20 and SR22 airplanes. The earlier NPRM would have required you to inspect and, as necessary, adjust the aileron and rudder rigging and would have required you to modify, inspect, and, as necessary, adjust the rudder-aileron interconnect system. The earlier NPRM resulted from a jamming of the aileron and rudder controls on a Model SR20 airplane, which resulted in loss of rudder and aileron flight controls. Since issuance of the NPRM, CDC revised the service information as a result of comments received on the NPRM, and the FAA has determined the changes to the service information are necessary to address the unsafe condition. The changes in the revised service information include the addition of airplanes to the Applicability; a requirement to check rudder, aileron, and rudder-aileron interconnect rigging; a requirement to replace the attaching hardware and clamp at the end of the rudder- aileron interconnect arm; and an increase in work-hours to do the proposed actions. This proposed AD would require you to use the revised service information and would require you to report any out-of-rig condition found. Since these actions impose an additional burden over that proposed in the NPRM, we are reopening the comment period to allow the public the chance to comment on these additional actions.

The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection. We are issuing a direct final rule for this action because FDA expects there will be no significant adverse comments on these amendments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under our usual notice-and- comment rulemaking procedures, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.

The Food and Drug Administration (FDA) is announcing the withdrawal of a proposed rule published in the Federal Register of May 3, 1996 (61 FR 20103) (the May 1996 proposed rule). The May 1996 proposed rule would have amended certain requirements of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. These proposed changes would have clarified certain manufacturing, quality control, and documentation requirements and would have updated the requirements for process and methods validation. In light of more recent scientific and technical advances and evolving quality systems and risk management concepts, FDA concludes that, at this time, it is appropriate to withdraw the May 1996 proposed rule and newly evaluate the issues raised in that proposal.

In this final rule, we (NHTSA) address the problem of motor home and recreation vehicle trailer overloading by amending the Federal Motor Vehicle Safety Standards (FMVSS) on tire selection and rims. This final rule requires manufacturers of all motor homes and recreation vehicle trailers to provide information to consumers in a label that informs the consumer about the vehicle's load carrying capacity. This information is helpful both at the time the consumer is making a purchase decision and as the consumer uses his or her vehicle. We also require that the size of tires on motor homes and recreation vehicle trailers be the same as the size of the tires listed on the tire information label. In addition, this rule provides regulatory relief for dealers from a labeling requirement in the safety standard on tire selection and rims for light vehicles. The standard's requirement can currently require dealers which add even small amounts of weight to re-label the vehicles. Under today's amendment, any party that adds weight to a completed vehicle exceeding the lesser of 1.5 percent of the vehicle's gross vehicle weight rating or 100 pounds (before first sale to the retail customer) is required to disclose this extra weight on labels affixed to the vehicles. Lesser amounts of weight may be added without changing or adding labels. It is our belief that this rule complements the efforts of the recreation vehicle industry to provide consumers with information in order to help reduce overloading motor homes and recreation vehicle trailers. This rulemaking was initiated in response to a petition from Ms. Justine May.

This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on September 5, 2007 entitled ``Medicare Program, Physicians'' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase III).''

This document amends the Federal Motor Vehicle Safety Standard (FMVSS) No. 108 on lamps, reflective devices, and associated equipment by reorganizing the regulatory text so that it provides a more straightforward and logical presentation of the applicable regulatory requirements, which includes the agency's interpretation of the existing requirements. It also greatly reduces the need to consult relevant third-party standards by including applicable requirements directly into the main body of Standard No. 108, rather than incorporating such provisions by reference. This final rule does not impose any new substantive requirements on manufacturers. In addition, this document amends 49 CFR Part 564, Replaceable Light Source Information, by adding a newly created Appendix C, which relocates figures addressing sealed beam headlamps that currently reside in FMVSS No. 108 and a relevant Society of Automotive Engineers (SAE) standard there. We believe few lighting manufacturers still produce sealed beam headlamps, and their diminishing use is unlikely to draw new manufacturers of this type of lamp. Accordingly, we see no drawbacks to consolidating the information regarding sealed beam light sources with other light source information currently located in 49 CFR Part 564.