2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of chewable tablets containing ivermectin, fenbendazole, and praziquantel for the treatment and control of various internal parasites and for the prevention of canine heartworm disease in adult dogs.

In this document the Federal Communications Commission's Public Safety and Homeland Security Bureau (PSHSB), on delegated authority, establishes reconfigured 800 MHz band plans in the U.S.- Canada border regions in order to accomplish the Commission's goals for band reconfiguration.

The Food and Drug Administration (FDA) is proposing to amend its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is proposing to remove the requirement for baseline reports. The removal of this requirement would eliminate unnecessary duplication and reduce the manufacturer's reporting burden. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.

EPA is proposing to determine that the Harrisburg-Lebanon- Carlisle, Pennsylvania nonattainment area for the 1997 fine particle (PM2.5) National Ambient Air Quality Standard (NAAQS) has attained the 1997 PM2.5 NAAQS. This proposed determination is based upon quality assured, quality controlled, and certified ambient air monitoring data that show that the area has monitored attainment of the 1997 PM2.5 NAAQS since the 2004-2006 monitoring period, and continues to monitor attainment of the standard based on 2005-2007 data. In addition, quality controlled and quality assured monitoring data for 2008 that are available in the EPA Air Quality System (AQS) database, but not yet certified, show this area continues to attain the 1997 PM2.5 NAAQS. If this proposed determination is made final, the requirements for this area to submit an attainment demonstration and associated reasonably available measures, a reasonable further progress plan, contingency measures, and other planning State Implementation Plans (SIPs) related to attainment of the standard shall be suspended for so long as the area continues to attain the 1997 PM2.5 NAAQS.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

We are revising an earlier NPRM for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

This rule revises a license exception in the Export Administration Regulations to allow the export of mobile phones as gifts sent by individuals to eligible recipients in Cuba. The Bureau of Industry and Security (BIS) is taking this action to provide support for individuals to support democracy-building efforts for Cuba by enabling the free exchange of information among Cuban citizens and with persons in other countries.

This rule amends title 19 of the Code of Federal Regulations (``CFR'') on an interim basis to implement the preferential tariff treatment and other customs-related provisions of the Dominican RepublicCentral AmericaUnited States Free Trade Agreement.

The Pension Benefit Guaranty Corporation's regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans prescribe interest assumptions for valuing and paying benefits under terminating single-employer plans. This final rule amends the regulations to adopt interest assumptions for plans with valuation dates in July 2008. Interest assumptions are also published on the PBGC's Web site (https://www.pbgc.gov).

The United States Commission on Civil Rights (Commission) is repealing its old employee conduct regulations, which have been superseded by the executive branch Standards of Ethical Conduct, financial disclosure and financial interests regulations issued by the Office of Government Ethics (OGE). In place of its old regulations, the Commission is adding a section of residual cross-references to those branchwide regulations as well as its new supplemental standards regulations and certain executive branchwide conduct rules promulgated by the Office of Personnel Management (OPM). The text of the rule was published in the Federal Register on August 30, 2006 at 71 FR 51546 as a proposed rule and provided that comments should have been received by September 29, 2006 to be considered in the formulation of the final rule. No comments were received.

The FAA is revising an existing airworthiness directive (AD) that applies to Sandel Avionics Incorporated Model ST3400 TAWS/RMI units as described above. The existing AD currently requires installing a warning placard on the TAWS/RMI and revising the Limitations section of the airplane flight manual (AFM). The existing AD also requires installing upgraded software in the TAWS/RMI. This new AD allows installing later revisions of the software described in the existing AD. This AD results from a report that an in-flight bearing error occurred in a Model ST3400 TAWS/RMI configured to receive bearing information from a very high frequency omnidirectional range (VOR) receiver interface via a composite video signal, due to a combination of input signal fault and software error. We are issuing this AD to prevent a bearing error, which could lead to an airplane departing from its scheduled flight path, which could result in a reduction in separation from, and a possible collision with, other aircraft or terrain.

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.

This final rule amends the NASA Grant and Cooperative Agreement Handbook regulations to remove NASA Form 1356, Committee on Academic Science and Engineering (C.A.S.E.) Report. This final rule also makes an amendment to clarify the general preference for internal administration of grants and cooperative agreements with no Government- furnished property.

The National Marine Fisheries Service (NMFS) publishes its proposed List of Fisheries (LOF) for 2009, as required by the Marine Mammal Protection Act (MMPA). The proposed LOF for 2009 reflects new information on interactions between commercial fisheries and marine mammals. NMFS must categorize each commercial fishery on the LOF into one of three categories under the MMPA based upon the level of serious injury and mortality of marine mammals that occurs incidental to each fishery. The categorization of a fishery in the LOF determines whether participants in that fishery are subject to certain provisions of the MMPA, such as registration, observer coverage, and take reduction plan requirements.

The U.S. Army Corps of Engineers (Corps) is proposing to establish a restricted area around the AUSTAL, USA shipbuilding facility located in Mobile, Alabama, because of the sensitive nature of the on-going and potential future activities at that facility. The Supervisor of Shipbuilding, Conversion and Repair (SUPERVISOR), located in Bath, Maine is responsible for United States Navy shipbuilding activities at AUSTAL, USA located in Mobile, Alabama. The proposed restricted area will be used for on-going construction when vessels are placed in the water. The proposed restricted area is essential to protect persons and property from the dangers associated with the operation and safeguard the area from accidents, sabotage and other subversive acts.

NMFS proposes regulations to implement section 401(g) of the Magnuson-Stevens Fishery Conservation and Management Act (MSA). The regulations would establish a national registry of recreational fishers fishing in the Exclusive Economic Zone (EEZ), for anadromous species throughout their range or for Continental Shelf fishery resources beyond the EEZ. It also would exempt persons from that requirement if licensed by a state that provides registration data determined to be sufficient for the agency's needs. The requirement is intended to improve existing angling effort surveys in order to improve their efficiency, to reduce possible sources of bias and to improve confidence in survey results by anglers and fishery managers.

NMFS is prohibiting directed fishing for species that comprise the shallow-water species fishery for catcher processors subject to sideboard limits established under the Central Gulf of Alaska (GOA) Rockfish Program in the GOA. This action is necessary because the 2008 Pacific halibut prohibited species catch (PSC) sideboard limit specified for the shallow-water species fishery for catcher processors subject to sideboard limits established under the Central GOA Rockfish Program in the GOA is insufficient to support directed fishing for the shallow-water species fisheries.

NMFS is prohibiting directed fishing for species that comprise the deep-water species fishery for catcher vessels subject to sideboard limits established under the Central Gulf of Alaska (GOA) Rockfish Program in the GOA. This action is necessary because the 2008 Pacific halibut prohibited species catch (PSC) sideboard limit specified for the deep-water species fishery for catcher vessels subject to sideboard limits established under the Central GOA Rockfish Program in the GOA is insufficient to support directed fishing for the deep-water species fisheries.

We are reopening the comment period for our proposed rule that would amend our domestic quarantine regulations to provide for the interstate movement of Hass avocados from Mexican fruit fly and sapote fruit fly quarantined areas in the United States with a certificate if the fruit is safeguarded after harvest in accordance with specific measures. The proposed rule would also amend our foreign quarantine regulations to remove trapping and bait spray treatment requirements related to Anastrepha spp. fruit flies for imported Hass avocados from Michoacan, Mexico. This action will allow interested persons additional time to prepare and submit comments.

The Federal Communications Commission (Commission) invites additional submissions regarding the treatment under its hearing aid compatibility rules of multi-mode and multi-band handsets and regarding the application of the de minimis exception to those rules.

This interim rule lists communities where modification of the Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because of new scientific or technical data. New flood insurance premium rates will be calculated from the modified BFEs for new buildings and their contents.

This document amends the Customs and Border Protection (``CBP'') Regulations in title 19 of the Code of Federal Regulations (19 CFR) in order to remove a provision that draws a distinction between preservative and decorative painting for purposes of the partial duty exemption under subheading 9802.00.80, Harmonized Tariff Schedule of the United States (``HTSUS''). The change is made to conform the CBP Regulations with the holding of a court decision in which the regulatory distinction between preservative and decorative painting was found to be invalid.

This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date.

The Nuclear Regulatory Commission (NRC) is amending its regulations by revising the Holtec International HI-STORM 100 cask system listing within the ``List of approved spent fuel storage casks'' to include Amendment No. 5 to Certificate of Compliance (CoC) Number 1014. Amendment No. 5 includes deletion of the requirement to perform thermal validation tests on thermal systems; an increase in the design basis maximum decay heat loads, namely, to 34 kilowatts (kW) for uniform loading and 36.9 kW for regionalized loading, and introduction of a new decay heat regionalized scheme; an increase in the maximum fuel assembly weight for boiling water reactor fuel in the Multi- Purpose Canister (MPC)-68 from 700 to 730 pounds; an increase in the maximum fuel assembly weight of up to 1,720 pounds for assemblies not requiring spacers, otherwise 1,680 pounds; changes to the assembly characteristics of 16 x 16 pressurized water reactor fuel assemblies to be qualified for storage in the HI-STORM 100 cask system; a change in the fuel storage locations in the MPC-32 for fuel with axial power shaping rod assemblies and in the fuel storage locations in the MPC-24, MPC-24E, and the MPC-32 for fuel with control rod assemblies, rod cluster control assemblies, and control element assemblies; elimination of the restriction that fuel debris can only be loaded into the MPC- 24EF, MPC-32F, MPC-68F, and MPC-68FF canisters; introduction of a requirement that all MPC confinement boundary components and any MPC components exposed to spent fuel pool water or the ambient environment be made of stainless steel or, for MPC internals, neutron absorber or aluminum; the addition of a threshold heat load below which operation of the Supplemental Cooling System would not be required and modification of the design criteria to simplify the system; minor editorial changes to include clarification of the description of anchored casks, correction of typographical/editorial errors, clarification of the definitions of loading operations, storage operations, transport operations, unloading operations, cask loading facility, and transfer cask in various locations throughout the CoC and Final Safety Analysis Report; and modification of the definition of non-fuel hardware to include the individual parts of the items defined as non-fuel hardware. This final rule allows the holders of power reactor operating licenses to store spent fuel in this approved cask as specified in the revised conditions under the NRC's general license provisions.

This document is issued under the joint authority of the Secretary of Defense, the Administrator of General Services and the Administrator of the National Aeronautics and Space Administration. This Small Entity Compliance Guide has been prepared in accordance with Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996. It consists of a summary of the rule appearing in Federal Acquisition Circular (FAC) 2005-26 which amends the FAR. Interested parties may obtain further information regarding this rule by referring to FAC 2005-26 which precedes this document. These documents are also available via the Internet at https://www.regulations.gov.