November 24, 2008 – Federal Register Recent Federal Regulation Documents

NICEATM announces availability of the ICCVAM Test Method Evaluation Report: Validation Status of Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products (NIH Publication 08-6392). The test method evaluation report (TMER) describes five in vitro pyrogen test methods that can be used for detecting Gram-negative endotoxin in human parenteral pharmaceuticals. The report includes ICCVAM's (a) Recommendations on uses and limitations for each test method, (b) recommendations for standardized protocols, (c) recommendations for future studies, and (d) recommendations for the development of performance standards. ICCVAM concludes that none of these test methods can be considered as a complete replacement for the rabbit pyrogen test (RPT) for all testing situations for the detection of Gram-negative endotoxin. However, ICCVAM recommends that they can be considered for use on a case-by-case basis to detect Gram-negative endotoxin in human parenteral drugs, subject to product-specific validation to demonstrate equivalence to the RPT, in accordance with applicable U.S. Food and Drug Administration regulations. When used in this manner, these methods can reduce the number of animals needed for pyrogenicity testing. The report also recommends that these and other in vitro alternative test methods be considered prior to in vivo pyrogenicity testing, where determined appropriate for a specific testing situation. NICEATM also announces availability of the final ICCVAM Background Review Document: Validation Status of Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products (NIH Publication 08-6391). The final background review document (BRD) provides the data and analyses used to assess the current validation status of these five in vitro test methods. The ICCVAM TMER and supporting BRDs have been forwarded to U.S. Federal agencies for regulatory and other acceptance consideration, where applicable. Responses received will be posted on the NICEATM- ICCVAM Web site.

NOAA announces the availability for comment a joint Draft EIS/ EIR analyzing the environmental impacts of replacing its Southwest Fisheries Science Center (SWFSC) near the Scripps Institution of Oceanography (SIO) within the University of California at San Diego (UCSD) campus in La Jolla, California. Publication of this notice is to request public comment on the Draft EIS/EIR and its associated environmental findings and to provide information as to how to participate.

DoD has adopted as final, with changes, an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement Section 1017 of the National Defense Authorization Act for Fiscal Year 2007. Section 1017 requires DoD to establish an evaluation criterion, for use in obtaining carriage of cargo by vessel, that considers the extent to which an offeror has had overhaul, repair, and maintenance work for covered vessels performed in shipyards located in the United States or Guam.

DoD has issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to address review and documentation requirements pertaining to the use of time-and-materials contracts for the acquisition of non-commercial services. The rule provides for the same level of review for both commercial and non- commercial DoD time-and-materials contracts.

This is a notice of an Administrative declaration of a disaster for the State of Michigan dated 11/17/2008. Incident: Severe Storms and Flooding. Incident Period: 09/12/2008 through 10/14/2008. Effective Date: 11/17/2008. Physical Loan Application Deadline Date: 01/16/2009. Economic Injury (EIDL) Loan Application Deadline Date: 08/17/2009.

In this document, the Commission adopts new procedures for non-routine earth station applications, and adopts a reasonableness standard for contention protocol usage. These actions are necessary to expedite the licensing of earth stations often used to provide satellite-based broadband Internet access services.

In accordance with section 122(i) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (``CERCLA''), 42 U.S.C. 9622(i), the EPA is hereby providing notice of a proposed administrative settlement agreement and order on consent (``Settlement Agreement'') with Atlantic Richfield Company (``Respondent'') concerning the Leviathan Mine Superfund Site in Alpine County, California (``Site''). Section 122(h) of CERCLA, 42 U.S.C. 9622(h), provides EPA with the authority to enter into administrative settlements for claims for costs incurred by EPA under CERCLA. The Settlement Agreement resolves certain claims under Sections 106 and 107 of CERCLA, 42 U.S.C. 9606, 9607. Under the Settlement Agreement, Respondent will perform certain response actions at the Site through July 31, 2013, pay over $1.7 million to reimburse the United States for certain past costs, pay certain future response costs, pay a civil penalty of $90,000, and perform a specified supplemental environmental project in Douglas County, Nevada, with costs estimated at $400,000. EPA estimates that the response actions to be performed under the Settlement Agreement will cost approximately $5,600,000. The Settlement Agreement and its appendices may be examined at the U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, Office of Regional Counsel, San Francisco, California 94105, and also at any of the following public information repositories: Nevada State Library & Archives, 100 N. Stewart Street, Carson City, NV 89701; Douglas County Public Library, 1625 Library Lane, Minden, NV 89423; or Alpine County Library, 270 Laramie Street, Markleeville, CA 96120. The Settlement Agreement, together with descriptions of the removal action and the supplemental environmental project to be performed under the Settlement Agreement may also be examined at the following EPA Web site: https://www.epa.gov/region09/LeviathanMine. A copy of the Settlement Agreement may also be obtained by mail from Joshua Wirtschafter, U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street (mail code ORC-3), San Francisco, California 94105- 3901.

EPA is proposing to approve a revision to the State Implementation Plan (SIP) submitted by the State of Tennessee on October 12, 2007. The revision pertains to the Knox County portion of the Tennessee SIP and includes changes to Knox County Air Quality Management Regulation (Knox County Regulation) Section 25.10Permit by Rule. Specifically, Section 25.10 was changed so that it clearly states that turbines and other internal combustion engines are excluded from the ``Permit by Rule'' provision. This revision is considered by the Tennessee Department of Environment and Conservation (TDEC), to be as or more stringent than the State of Tennessee's SIP requirements. This action is being taken pursuant to section 110 of the Clean Air Act (CAA). In the Final Rules section of this Federal Register, EPA is approving the SIP revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this document. Any parties interested in commenting on this document should do so at this time.

EPA is proposing to approve revisions to the Imperial County Air Pollution Control District (ICAPCD), Mojave Desert Air Quality Management District (MDAQMD), South Coast Air Quality Management District (SCAQMD), and Ventura County Air Pollution Control District (VCAPCD) portions of the California State Implementation Plan (SIP). These revisions concern volatile organic compound emissions from storage of reactive organic compound liquids, polyester resin operations, coatings of metal parts and products, and adhesives and sealants. We are proposing to approve local rules that regulate these emission sources under the Clean Air Act as amended in 1990 (CAA or the Act).

Notice is hereby given that renewal of an exemption to the Land Disposal Restrictions under the 1984 Hazardous and Solid Waste Amendments to the Resource Conservation and Recovery Act has been granted to Occidental Chemical Corporation (Occidental) for five Class I hazardous waste injection wells, identified as Well Nos. 3, 4, 7, 8, and 9, and located at Occidental's chemical manufacturing facility near Wichita, Kansas. As required by Code of Federal Regulations (CFR) Part 148, Occidental has satisfactorily demonstrated to the Environmental Protection Agency by petition and supporting documentation that, to a reasonable degree of certainty, there will be no migration of hazardous constituents from the injection zone for as long as the waste remains hazardous, and therefore is protective of underground sources of drinking water. This time period is defined by 40 CFR 148.20 as 10,000 years. The final decision allows the underground injection by Occidental of the specific restricted hazardous waste, identified in the Petition, into Well Numbers 3, 4, 7, 8, and 9 for as long as the basis for granting approval of the petition remains valid, under provisions of 40 CFR 148.24. For the purpose of the required demonstration of no-migration of hazardous waste out of the injection zone over a 10,000 year period, modeling and projections were based on an operational lifetime projection date of December 31, 2020. Therefore, on or by the closing date of the aforementioned operational period, the operator will be required to obtain another exemption re- issuance from EPA. Included in this approval is the stipulation that Occidental acquires and continues to maintain approved Class I hazardous waste injection well permits from the Kansas Department of Health and Environment. As required by 40 CFR 124.10, a public notice was issued on July 21, 2008. In addition to having solicited written comments regarding the Agency's proposed approval, EPA also announced that a formal public hearing would be held if there was a significant degree of public interest, but no interest was expressed, hence no formal public hearing was conducted. The public comment period ended on September 3, 2008. All comments have been addressed and considered in the final decision. This decision constitutes final Agency action and there is no administrative appeal process that can be applied to a final petition decision.

Pursuant to Section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)), the National Park Service (NPS) is announcing its intent to prepare a General Management Plan/ Environmental Impact Statement (GMP/EIS) for Mount Rushmore National Memorial (Memorial), South Dakota. This effort will update the 1980 GMP. The GMP/EIS will establish the overall direction for the Memorial, setting broad management goals for managing the area over the next 15 to 20 years. The GMP/EIS will prescribe desired resource conditions and visitor experiences that are to be achieved and maintained throughout the Memorial based on such factors as the Memorial's purpose, significance, special mandates, the body of laws and policies directing Memorial management, resource analysis, and the range of public expectations and concerns. The GMP/EIS also will outline the kinds of resource management activities, visitor activities, and developments that would be appropriate in the Memorial in the future. A range of reasonable alternatives for managing the Memorial will be developed through this planning process and will include, at a minimum, a no-action and a preferred alternative. Major issues the GMP/ EIS will address include changes in visitor use patterns and special events, adequacy and sustainability of existing facilities for visitor opportunities and activities and for Memorial operations, and partnership roles and opportunities. The need for new facilities such as maintenance, museum curation and storage, and interpretation will be examined. The GMP/EIS will evaluate the potential environmental effects of the alternative management approaches. As the first phase of the planning process, the NPS is beginning to scope the issues to be addressed in the GMP/EIS. All interested persons, organizations, Agencies, and Tribes are encouraged to submit comments and suggestions on issues and concerns that should be addressed in the GMP/EIS, and the range of appropriate alternatives that should be examined.

On October 1, 2008, the Department of Homeland Security (DHS) published a Notice in the Federal Register extending the designation of Nicaragua for Temporary Protected Status (TPS) through July 5, 2010. USCIS has decided to extend the re-registration period through December 30, 2008. Beneficiaries of TPS for Nicaragua are required to re- register and obtain new Employment Authorization Documents (EADs), when an EAD is requested by the beneficiary. Since, USCIS will not be able to process and re-issue new EADs for all such beneficiaries by the January 5, 2009, expiration date, USCIS has decided to automatically extend the validity of EADs issued to Nicaraguan nationals (or aliens having no nationality who last habitually resided in Nicaragua) until July 5, 2009. This Notice announces that extension and also explains how TPS beneficiaries and their employers may determine which EADs are automatically extended.

We, the U.S. Fish and Wildlife Service, published a final rule in the Federal Register on November 5, 2008, that sets forth regulations that authorize measures to increase harvest of certain populations of light geese, revise the regulations for the management of overabundant light goose populations, and modify the conservation order that will increase take of birds from such populations. That final rule contained errors in two amendatory instructions and certain corresponding text of the regulations; one error would incorrectly remove changes made to the regulations at 50 CFR part 20 in a series of final rules we published concerning hunting methods for resident Canada geese and the other mischaracterizes the contents of subpart E of 50 CFR part 21. This document corrects those errors.

The Gulf of Mexico Fishery Management Council (Council) will convene scoping meetings to address loggerhead sea turtle interactions with reef fish bottom longlines.

This notice announces the availability of approximately $9.5 million in grant funds to make emergency capital repairs to eligible multifamily projects owned by private nonprofit entities that are designated for occupancy by elderly tenants. The capital repair needs must relate to items that present an immediate threat to the health, safety, and quality of life of the tenants. The intent of these grants is to provide one-time assistance for emergency items that could not be absorbed within the project's operating budget and other project resources, and where the tenants' continued occupancy in the immediate near future would be jeopardized by a delay in initiating the proposed cure. The notice provides instructions for owners of multifamily projects to request funding and instructions for the HUD field offices to process requests.

The U.S. Department of Agriculture (USDA) proposes to establish regulations to implement the Federal Policy on Research Misconduct applicable to extramural research. The proposed regulation defines research misconduct and establishes basic USDA requirements for the conduct of fair and timely investigations of alleged or suspected infractions. The proposed regulation also includes instructions on USDA administrative actions when research misconduct is found.

This notice proposes special conditions for General Electric Company (GE) GEnx-2B67 and GEnx-2B69 model turbofan engines. The fan blades of these engines will have novel or unusual design features when compared to the state of technology envisioned in the part 33 airworthiness standards. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for these design features. These special conditions contain the added safety standards the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards of 14 CFR part 33.