January 27, 2006 – Federal Register Recent Federal Regulation Documents

NCUA is issuing proposed amendments to its rules regarding service to underserved areas. These amendments are being proposed because of NCUA's experience addressing field of membership issues and the uncertainty resulting from recent litigation challenging existing chartering policy. This proposed rule will ensure continued reliable and efficient service to federal credit union members located in underserved areas.

This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). The Committee generally provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. The charter also permits the MCAC to develop recommendations about other specific issues of Medicare coverage. This meeting concerns authoritative drug compendia that may be used in determining the medically accepted indications of drugs and biologicals used in an anti-cancer chemotherapeutic regimen under Part B of the Medicare program. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

The U.S. Fish and Wildlife Service and the National Marine Fisheries Service (Services) announce the availability for public review of a final Environmental Impact Statement (EIS), final Habitat Conservation Plan (HCP), and final Implementing Agreement (IA), related to an application by the State of Washington for Endangered Species Act (ESA) Incidental Take Permits (ITPs). The final documents reflect changes made to the draft documents resulting from comments received during the 90-day public comment period. Responses to comments received from the public are included in the EIS. This notice provides an opportunity for the public to review the final documents and responses to public comments. The EIS addresses the proposed issuance of ITPs by both Services under the ESA, to the Washington Department of Natural Resources, on behalf of the State of Washington (State), for forest practices activities conducted according to the Washington Forest Practices Rules (forest practices). The proposed ITPs would authorize incidental take of aquatic species (16 listed fish species, 54 unlisted fish species, 7 unlisted amphibian species), by covered forest practices implemented under the forest practices rules. The EIS also addresses a proposed limit to the ESA section 9 prohibition against take of listed species under the ESA, such that the prohibition would not apply to forest practices regulated by the State of Washington on non-Federal and non-tribal lands.

This is a request for proposals for loan guarantees under the section 538 Guaranteed Rural Rental Housing Program (GRRHP) pursuant to 7 CFR 3565.4 for Fiscal Year (FY) 2006 subject to the availability of funding. FY 2006 funding for the section 538 program is $99 million. Applicants will submit proposals in the form of ''RESPONSES.'' The commitment of program dollars will be made to applicants of selected responses that have fulfilled the necessary requirements for obligation. The commitment of program dollars will be made to applicants of selected responses that have fulfilled the necessary requirements for obligation, to the extent an appropriation act provides funding for GRRHP for FY 2006. Expenses incurred in developing applications will be at the applicant's risk. The following paragraphs outline the timeframes, eligibility requirements, lender responsibilities, and the overall response and application processes. The GRRHP operates under 7 CFR part 3565. The GRRHP Origination and Servicing Handbook (HB-1-3565) is available to provide lenders and the general public with guidance on program administration. HB-1-3565, which contains a copy of 7 CFR part 3565 in Appendix 1, can be found at the Rural Development Instructions Web site address https:// www.rurdev.usda.gov/regs/hblist.html#hbw6. Eligible lenders are invited to submit responses for the development or acquisition with rehabilitation of affordable rental housing to serve rural America. In addition, this fiscal year, guarantees will be available for the revitalization, repair, and transfer cost of existing direct section 515 housing (transfer costs are subject to Agency approval and must be an eligible use of loan proceeds as listed in 7 CFR 3565.205). In order to be considered, direct section 515 housing projects must need repairs and/or undergo revitalization of a minimum of $6,500 per unit. The Rural Housing Service (RHS) will review responses submitted by eligible lenders, on the lender's letterhead, and signed by both the prospective borrower and lender. Although a complete application is not required in response to this Notice of Funding Availability (NOFA), eligible lenders may submit a complete application concurrently with the response. However, submitting a complete application will not have an effect on the response's score.

The IC Clearance Official, Regulatory Information Management Services, Office of the Chief Information Officer invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined the regulatory review period for SPIRIVA HANDIHALER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.

On November 30, 2005, at 70 FR 71892, CDC published a proposed rule, ``Control of Communicable Diseases,'' to revise existing regulations related to preventing the introduction, transmission, or spread of communicable diseases from foreign countries into the U.S. and from one state or possession into another. CDC provided a 60 day public comment period. Written comments were to be received on or before January 30, 2006. We have received requests asking for an extension of the comment period. In consideration of these requests, CDC is extending the comment period by 30 days to March 1, 2006.

In compliance with the Paperwork Reduction Act, this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. This ICR is scheduled to expire on April 30, 2006. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This ICR describes the nature of the information collection and its estimated burden and cost.

Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (``ALJ's'') initial determination (``ID'') granting a joint motion to terminate the above-captioned investigation on the basis of two settlement agreements.

The NRC has prepared a final Environmental Assessment as its evaluation of a request by Entergy Nuclear Vermont Yankee, LLC and Entergy Nuclear Operations, Inc. (Entergy or the licensee) for a license amendment to increase the maximum thermal power at Vermont Yankee Nuclear Power Station (VYNPS) from 1593 megawatts-thermal (MWt) to 1912 MWt. This represents a power increase of approximately 20 percent for VYNPS. As stated in the NRC staff's position paper dated February 8, 1996, on the Boiling-Water Reactor Extended Power Uprate (EPU) Program, the NRC staff will prepare an environmental impact statement if it believes a power uprate will have a significant impact on the human environment. The NRC staff did not identify any significant impact from the information provided in the licensee's EPU application for VYNPS or the NRC staff's independent review; therefore, the NRC staff is documenting its environmental review in an environmental assessment. The final environmental assessment and finding of no significant impact is being published in the Federal Register. The NRC published a draft environmental assessment and finding of no significant impact on the proposed action for public comment in the Federal Register on November 9, 2005 (70 FR 68106). Two sets of comments were received as discussed below. The licensee provided three comments in a letter dated December 8, 2005 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML053500122). The first comment clarified operation of the three modes of operation of the circulating water system. Based on this comment, the NRC revised the description of the system in the ``Plant Site and Environs'' and ``Water Use Impacts'' sections of the final environmental assessment. The second comment clarified that transmission lines are owned and operated by different transmission operators, rather than Entergy as was indicated in the draft environmental assessment. Based on this comment, the NRC revised the ``Transmission Facility Impacts'' section of the final environmental assessment. The third comment provided information regarding replacement of 21 of the 22 cooling tower fan motors with higher horsepower motors. Since Entergy indicated that the conclusions in the draft environmental assessment regarding cooling tower operation (including noise) were correctly stated, no changes were made based on this comment. Mr. David L. Deen of the Connecticut River Watershed Council (CRWC) provided three comments in an e-mail dated December 9, 2005 (ADAMS Accession No. ML053500124). The first comment raised concerns that the current National Pollutant Discharge Elimination System (NPDES) permit for VYNPS places no upper bound on the temperature of the river at which the licensee must stop adding waste heat through its cooling tower discharge and that a draft amendment to this permit fails to address this shortcoming. The CRWC proposed that Entergy should not raise the ambient water temperature beyond 85 [deg]F at any point within the Connecticut River. This comment exceeds the scope of the NRC's review of the proposed EPU amendment. The purpose of the NRC's environmental assessment is to evaluate the potential impact of the proposed action (i.e., the change due to the proposed EPU). As discussed in the NRC's draft environmental assessment, Entergy has requested that the State of Vermont issue an amendment to the current NPDES permit which would allow a one-degree increase in the thermal discharge limits, for certain river water temperature ranges. Entergy stated that the NPDES permit amendment is not necessary for the proposed EPU and the licensee will comply with the current NPDES permit thermal discharge limits if the permit amendment is not granted. The current NPDES permit represents the upper bound on the current impact on the river water temperatures in the vicinity of the discharge. The NRC's draft environmental assessment found that any discharge impacts for the proposed action will be the same as the current impacts from plant operation and, as such, the NRC concluded that there will be no significant impact on the Connecticut River from VYNPS discharge due to the EPU. The CRWC comment pertains to concerns regarding lack of an upper bound temperature limit in the NPDES permit. The ``upper bound'' referenced in the NRC's draft environmental assessment refers to an upper bound on the impact of the proposed EPU. Since the CRWC comment focuses on issues regarding the NPDES permit and does not provide any information regarding the impact of the proposed EPU, no changes were made to the final environmental assessment based on this comment. The second comment from the CRWC stated that if the NPDES permit thermal discharge limits are increased, there would be harm to specific aquatic species (i.e., American shad, Atlantic salmon, spottail shiner, smallmouth bass, yellow perch, walleye, largemouth bass, fallfish, white sucker, and white perch). Similar to the first comment, since the CRWC comment focuses on issues regarding the proposed amendment to the NPDES permit and does not provide any information regarding the impact of the proposed EPU, no changes were made to the final environmental assessment based on this comment. The third comment from the CRWC questioned the NRC's draft environmental assessment statement that there are no threatened and endangered aquatic species in the Connecticut River. The CRWC stated that the dwarf wedge mussel was listed as endangered under the Endangered Species Act in 1990, and that in 1993, the U.S. Fish and Wildlife Service approved a recovery plan to attempt to reestablish populations of the dwarf wedge mussel throughout its historical range including the Connecticut River. The CRWC stated that reestablishing the population in or near VYNPS would require the presence of one of its host species, the tessellated darter. The CRWC stated that although the nearest population of the wedge mussel is relatively far north of VYNPS, since the species is endangered and depends on the tessellated darter for its survival, the tessellated darter should be included in the threatened and endangered species review for the proposed EPU. According to the U.S. Fish and Wildlife Service's 1993 recovery plan, the dwarf wedge mussel (Alasmidonta heterodon) is an endangered species located in the Connecticut River system. To assess the impact of the proposed action, the aquatic species evaluated in the draft environmental assessment were those in the vicinity of the VYNPS intake and discharge structures. The dwarf wedge mussel is not located in Windham County, Vermont and, therefore, was not included in the draft environmental assessment. The dwarf wedge mussel larvae attach to a host species for survival. One host species for the dwarf wedge mussel is the tessellated darter (Etheostoma olmstedi), which is also found in the Connecticut River system. The tessellated darter is not threatened or endangered and, therefore, was not included in the draft environmental assessment for the VYNPS EPU. As noted above, the proposed EPU does not require an increase in discharge temperature limits. Further, following implementation of the EPU, the flow rate of water being withdrawn from the Connecticut River through the intake structure would not increase, and there would not be a configuration change to the intake structure to support the EPU. Therefore, the EPU would not change existing impacts on the tessellated darter. In addition, according to Ecological Studies of the Connecticut RiverVernon, VermontReport 32, dated May 2003, the quantity of tessellated darters impinged on the VYNPS traveling screens is small compared to other impinged species. Impingement from the VYNPS intake does not significantly impact the tessellated darter population. The inter-governmental Environmental Advisory Committee (comprised of certain Vermont, New Hampshire, Massachusetts, and federal agencies) established limits for impingement of American shad (Alosa sapidissima) and Atlantic salmon (Salmo salar), and because VYNPS has not approached the impingement limits set for these species, the Vermont Agency of Natural Resources (ANR) concluded that the impingement of other species at VYNPS meets applicable laws. Entrainment of all aquatic species was monitored for over a decade beginning in 1972 and determined to be insignificant by the Environmental Advisory Committee. Entrainment was subsequently removed from the VYNPS NPDES permit. Therefore, the staff concludes that there would be no significant impact from impingement or entrainment to the tessellated darter or the dwarf wedge mussel associated with the proposed action.

This notice establishes the aggregate quantity of 250,383 metric tons, raw value, of sugar that may enter the United States Customs Territory from Mexico during fiscal year (FY) 2006 under the market access provisions of Chapter 7, Annex 703.2 of the North American Free Trade Agreement (NAFTA) under subheadings 1701.11.10, 1701.12.10, 1701.91.10, 1701.99.10, 1702.90.10, and 2106.90.44 of the Harmonized Tariff Schedule of the United States (HTS).

Pursuant to the authorities in the Federal Advisory Committee Act (Pub. L. 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000 (Pub. L. 106-393) the Helena National Forest's Lewis and Clark County Resource Advisory Committee will meet on Monday February 27 from 3 p.m. until 6 p.m. in Helena, Montana, for a business meeting. The meeting is open to the public.

The Committee is proposing to add to the Procurement List products and services to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and to delete a product previously furnished by such agencies. Comments Must Be Received on or Before: February 26, 2006.

This notice advises the public that the U.S. Fish and Wildlife Service (Service) has prepared a Final Comprehensive Conservation Plan (Final CCP) and related Finding of No Significant Impact (FONSI) for the Steigerwald Lake, Franz Lake, and Pierce National Wildlife Refuges (Gorge Refuges). The Gorge Refuges are located in southwest Washington within the Columbia River Gorge National Scenic Area. The Final CCP was prepared pursuant to the National Wildlife Refuge System Administration Act, as amended, and in accordance with the National Environmental Policy Act of 1969 (NEPA) and its implementing regulations. The Service's Regional Director for the Pacific Region has considered a reasonable range of management alternatives and has selected Alternative B of the CCP for managing the Gorge Refuges for the next 15 years.

This notice announces a public meeting on the subject of the continued airworthiness of the U.S. general aviation fleet of aircraft. The purpose of the meeting is to gather information and discuss technical issues related to problems associated with the increasing average age of the general aviation fleet. Particular emphasis will be given to actions that have potential to mitigate the inevitable effects of fatigue, corrosion, and deterioration on aging general aviation airplanes.

In October 2005, the Humane Society of the United States (HSUS) submitted a nomination to NICEATM requesting that alternative test methods to the mouse LD50 assay for botulinum toxin potency testing be assessed and prioritized for prevalidation and validation efforts. The nomination proposed that an initial key step in this process would be for the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) to organize a workshop on this topic. ICCVAM considered the nomination and supports with a high priority the concept of a workshop to discuss alternative methods and approaches that might reduce, refine, or replace the use of animals for botulinum potency testing. The Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) considered the nomination and the ICCVAM proposal at its meeting on December 12, 2005, and agreed that the proposed activity should have a high priority. At this time, NICEATM requests (1) information on development and/or validation activities relevant to reduction, refinement (less pain and distress), and/or replacement alternatives for botulinum toxin potency testing, (2) public comments on the appropriateness and relative priority of proceeding with a workshop on this topic, (3) the nomination of scientific experts who might participate if a workshop occurs, and (4) the submission of data from mouse LD50 botulinum potency testing and ex vivo and in vitro test methods used for botulinum toxin potency testing. The HSUS nomination is available at https:// iccvam.niehs.nih.gov/ see ``Nominations and Submissions.''

FMCSA announces its decision to exempt 22 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs). The exemptions will enable these individuals to qualify as drivers of commercial motor vehicles (CMVs) in interstate commerce without meeting the vision standard prescribed in 49 CFR 391.41 (b)(10).

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to seek the approval of OMB for the renewal of four Information Collection Requests (ICRs). The ICRs are: (1) 1625- 0009, Oil Record Book for Ships; (2) 1625-0014, Request for Designation and Exemption of Oceanographic Research Vessels; (3) 1625-0038, Plan Approval and Records for Tank, Passenger, Cargo and Miscellaneous Vessels, Mobile Offshore Drilling Units, Nautical School Vessels, Oceanographic Research Vessels and Electrical Engineering ? 46 CFR Subchapters D, H, I, I-A, J, R, and U; and (4) 1625-0039, Declaration of Inspection Before Transfer of Liquid Cargo in Bulk. Before submitting the ICRs to OMB, the Coast Guard is inviting comments on them as described below.