October 18, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for the processing of live vaccines. FDA is amending the regulations due to advances in technology that will allow processing of live vaccines to be performed in multiproduct manufacturing areas. We are publishing this rule because the existing requirement regarding facilities and equipment for live vaccine processing is too prescriptive and is no longer necessary. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB) requesting a revision of their approval for the following collection of information: 1625-0003, Coast Guard Boating Accident Report Form (CG-3865). Before submitting this ICR to OMB, the Coast Guard is inviting comments as described below.

On August 9, 2007, FRA published a direct final rule in the Federal Register which made technical amendments to Appendix D of 49 CFR Part 222. As reflected in DOT Docket No. FRA-2007-27285, FRA did not receive any comments or requests for an oral hearing on the direct final rule. Therefore, FRA is issuing this document to confirm that the direct final rule took effect on October 9, 2007, the date specified in the rule.

The Coast Guard is removing the existing drawbridge operation regulation for the draw of the U.S. 165 bridge, mile 110.1, on the Ouachita River at Columbia, Louisiana. The drawbridge has been removed from the waterway. Therefore, the regulation controlling the operation of the drawbridge is no longer necessary.

EPA is approving a Section 111(d) Plan revision submitted by the Commonwealth of Virginia. The revision consists of amendments to the regulation that controls total reduced sulfur (TRS) from pulp and paper mills. This action is being taken under the Clean Air Act (CAA).

The EPA is announcing an extension of the public comment period on our proposed amendments for the Operating Permit Programs and Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): Flexible Air Permitting Rule; Proposed Rule (September 12, 2007). The EPA is extending the comment period that originally ends on November 13, 2007. The extended comment period will close on January 14, 2008. The EPA is extending the comment period because of the timely requests we received to do so.

The Federal Acquisition Institute (FAI) will hold a vendor meeting to provide information on the Federal Acquisition Certification in Program/Project Management (FAC-P/PM) to include program details, and opportunities for vendors to support the training of federal program and project managers. The purpose of this certification program is to establish the competencies, training, and experience requirements for program and project managers in civilian agencies. The FAC-P/PM focuses on essential competencies needed for program and project managers; the program does not include functional or technical competencies, such as those for information technology, or agency-specific competencies. The certification requirements will be accepted by, at minimum, all civilian agencies as evidence that an employee meets the core competencies, training and experience requirements. The FAC-P/PM was announced by the Office of Federal Procurement Policy (OFPP) on April 25, 2007. At this vendor meeting, FAI will present its approach for partnering with vendors on this initiative. WHO SHOULD ATTEND? Training developers, vendors with Commercial-Off-The- Shelf (COTS) training products, vendors with capabilities related to the full Instructional System Design (ISD) methodologies, professional associations, educational institutions and acquisition training experts. The meeting will be held October 30, 2007 from 2:00 pm to 3:30 pm, GSA Auditorium located at 1800 F Street, NW, Washington, D.C. Register by email: mariahernandez@sra.com, or call (703) 284- 6988.

In accordance with section 122(i) of the Comprehensive Environmental Response, Compensation and Liability Act (``CERCLA''), 42 U.S.C. 9622(i), notice is hereby given of a proposed administrative settlement of past response costs concerning the EPAC Superfund Site in Waterbury, Connecticut with the following settling parties: Waterbury Realty, LLC and Salvatore Cascino. The settling parties agree to reimburse the Agency $175,000 in past costs payable in two installments; $87,500 to be paid not later than forty-five (45) days following the effective date of the settlement agreement; and, $87,500 to be paid not later than ninety days from the effective date of the settlement agreement. Additionally, the Settling Parties shall pay to EPA twenty-five percent (25%) of any cash payment they receive as a result of any contribution suit or claim against or settlement agreement with Great Brook Realty, Inc., for matters related to the settlement agreement. This settlement includes a covenant not to sue the settling parties pursuant to section 107(a) of CERCLA, 42 U.S.C. 9607(a). For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at One Congress Street, Boston, MA 02114-2023.

Pursuant to section 102(2)(c) of the National Environmental Policy Act (NEPA) of 1969, and the regulations implemented by the Council on Environmental Quality (40 CFR parts 1500 through 1508), the Department of the Navy (DON) announces its intent to prepare a Supplemental Environmental Impact Statement (SEIS). This SEIS supplements the Navy's 1999 Final Environmental Impact Statement (FEIS), ``Developing Home Port Facilities for Three NIMITZ-Class Aircraft Carriers in Support of the U.S. Pacific Fleet,'' as authorized by the Record of Decision (ROD) dated January 28, 2000 and published in the Federal Register on February 8, 2000 (65 FR 6181). The limited purpose of this SEIS is to supplement the traffic analysis contained in the 1999 FEIS, to assess potential new information, validate impacts to traffic and to analyze the effectiveness of existing traffic mitigation measures implemented per the 2000 ROD when three CVNs home ported at Naval Air Station North Island (NASNI), California are simultaneously in port. Completion of the SEIS is necessary under 40 CFR 1502.9 to assess potential new information and to validate impacts to traffic during infrequent periods when three CVNs home ported at NASNI are simultaneously in port. The SEIS will analyze the effectiveness of existing traffic mitigation measures implemented per the 2000 ROD under these conditions. The SEIS will evaluate impacts such as changes in local traffic conditions, changes in personnel loading and potential changes in CVN operational deployment and maintenance schedules that could affect the average number of days three carriers are simultaneously in port. The SEIS will also evaluate the effects of traffic mitigation measures implemented pursuant to the 2000 ROD. Past, present and reasonably foreseeable future regional actions impacting traffic will be examined from a cumulative impacts perspective. In addition, the SEIS will address infrastructure improvements for Berth LIMA, which include utilities upgrades previously analyzed under the 1999 FEIS and newly defined site improvements and other minor alterations to existing infrastructure. Utilities upgrades include: repairs and upgrades to electrical power, communications and information systems, security lighting, fire protection, steam, compressed air, potable water, wastewater and fueling systems. Site improvements and other alterations include: Demolition of existing fenders, moorings, and pier pavement; installation of new fender pile system (with 200-300 fender piles) and mooring fittings; construction of Anti-Terrorism/Force Protection (AT/FP) features (watch tower, guard kiosk, fencing and surveillance equipment); and demolition, repair and paving of the wharf, sidewalks, curbing, storm water drainage features and vehicle parking areas; and landscaping. It is anticipated that the construction of infrastructure improvements to Berth LIMA will take approximately one year to accomplish. Public input is requested to ensure the scope of the SEIS analysis incorporates public concerns and affords the public an input in the decision making process.

NMFS announces the availability of the Strategic Plan for Fisheries Research (2007). The Magnuson-Stevens Act requires the Secretary of Commerce to develop, triennially, a strategic plan for fisheries research for the subsequent years.

In conformance with the Civil Service Reform Act of 1978, 5 U.S.C. 4314(c)(4), the United States Patent and Trademark Office announces the appointment of persons to serve as members of its Performance Review Board.

There has been a change in location of the previously noticed Pacific Fishery Management Council's (Council) Salmon Technical Team (STT), Scientific and Statistical Committee (SSC) Salmon Subcommittee, and Model Evaluation Workgroup (MEW) joint work session, which is open to the public.

To comply with 43 CFR 8365.1-4(a)(2) Public Health, Safety and Comfort, approximately 6,000 acres of public lands in the Table Mesa Road area, north of Phoenix, Arizona, will be temporarily closed to recreational shooting and all other potentially unsafe or conflicting activities on October 20, 2007 during an all-day BLM sponsored National Public Lands Day (NPLD) volunteer clean-up project.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Special Protocol Assessment'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Six Rivers National Forest proposes to address hazardous fuels and forest health concerns through the Orleans Community Fuels Reduction and Forest Health (OCFR) Project, under the Healthy Forest Restoration Act. The area affected by the proposal includes National Forest System lands surrounding the community of Orleans, California, which includes Tribal Trust Lands and portions of the Panamnik World Renewal Ceremonial District. The objective of these treatments is to provide strategic suppression locations across the landscape while reducing contiguous fuel accumulations and chance of catastrophic fires. Approximately 2,721 acres of forest would be treated by either ground-based, skyline, or hand systems. The planning area is located on National Forest System lands administered by the Orleans Ranger District in Humboldt County, California, specifically, within the upper tributaries of the Lower Middle Klamath watersheds. The units are located in portions of: T. 10 N., R. 5 E., Sections 1, 12, 13; T. 10 N., R. 6 E., Sections 4-9, 16- 17; T. 11 N., R. 5 E., Sections 1, 12, 13, 24, 25, 36; and T. 11 N., R. 6 E., Sections 4-9, 16-21, and 28-33.

Pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4332(2)(C), the National Park Service (NPS) announces the availability of the Record of Decision for the Final Environmental Impact Statement for the General Management Plan, Rock Creek Park and the Rock Creek and Potomac Parkway, Washington, DC. On June 6, 2007 the National Capital Regional Director approved the Record of Decision for the General Management Plan for the Final Environmental Impact Statement. Specifically, the NPS has selected the preferred alternative (Alternative A) as described in the Final General Management Plan for the Environmental Impact Statement based on consideration of economic, environmental, technical, and other factors. The selected alternative and three other alternatives, including a no-action alternative, were analyzed in the Draft and Final Environmental Impact Statements. Each alternative considered (a) how traffic should be managed in the park and on the parkway; (b) the most appropriate levels of service and locations for visitor interpretation and education in the park; (c) the appropriate balance between rehabilitation of historic structures and cultural landscapes and preservation of natural resources; and (d) the most appropriate locations to support park administration and operations functions to minimize resource disturbance. The full range of foreseeable environmental consequences was assessed. The NPS believes Alternative A would best accomplish its goals for managing Rock Creek Park and the Rock Creek and Potomac Parkway. Alternative A was selected by the NPS based on its ability to maintain traditional visitor experiences and activities, enhance resources protection, improve control over non- recreational use of park roads to heighten safety and the quality of the visitor experience, and optimize the use of structures for park purposes. The selected alternative will not result in the impairment of resources and values. The most difficult decision to be made in this general management planning process was the management of traffic on the park road system because these park roads are recognized historic resources and are also the primary means for most visitors to experience the park. They are also heavily used as commuter routes. Under the selected alternative, the existing park roadway system will be retained and non-recreational through-traffic will be accommodated. It continues weekday auto travel throughout the park, but will use traffic-calming and speed enforcement measures to reduce traffic speeds and volumes to improve visitor safety and better control traffic volumes and speeds through the park. Speed tables and additional traffic signs will be installed on Beach Drive in the gorge area. The selected alternative will also enhance interpretation and education opportunities and improve the use of park resources, especially cultural resources. It generally retains the current scope of visitor uses. Additional aspects of this alternative include trail improvement; rehabilitation of the Peirce Mill complex to better focus on history; the moving of park administrative offices from the Peirce- Klingle Mansion at Linnean Hill which will be rehabilitated for adaptive use compatible with park values; the relocation of the U.S. Park Police substation from the Lodge House on Beach Drive with the Lodge House converted to a visitor contact station; and that the nature center will be rehabilitated and expanded, and the planetarium upgraded. The Record of Decision includes a statement of the decision made, synopses of other alternatives considered, the basis for the decision, a finding of no impairment of park resources and values and an overview of public involvement in the decision-making process. This decision is the result of a public planning process that began in 1996. The official responsible for this decision is the NPS Regional Director, National Capital Region.