Notice of Realty Action: Direct Sale of Public Lands in Sublette County, Wyoming
The Bureau of Land Management (BLM) proposes to sell a 40-acre parcel of public land in Sublette County, Wyoming, for the appraised fair market value to G&E Livestock to resolve an unintentional unauthorized use of public lands.
Draft Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New Drug Applications for Products Intended to Repair or Replace Knee Cartilage; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage'' dated July 2007. The draft guidance provides to sponsors recommendations about certain information that should be included in an investigational device exemption (IDE) or investigational new drug application (IND) for a product intended to repair or replace knee cartilage. The draft guidance, when finalized, will supplement other FDA publications on IDEs and INDs.
Nippon Oil Corp.; Filing of Color Additive Petition
The Food and Drug Administration (FDA) is announcing that Nippon Oil Corp. has filed a petition proposing that the color additive regulations be amended to provide for the safe use of Paracoccus carotinifaciens granules as a color additive in the feed of salmonid fish to enhance the color of their flesh.
Otsuka Pharmaceutical Co., Ltd.; Withdrawal of Approval of a New Drug Application; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 14, 2007 (72 FR 32852). The agency issued a withdrawal of a new drug application (NDA) for RAXAR (grepafloxacin hydrochloride (HCl)) Tablets held by Otsuka Pharmaceutical Co., Ltd. (Otsuka), c/o Otsuka Pharmaceutical Development & Commercialization, Inc., 2440 Research Blvd., Rockville, MD 20850. The document published with typographical errors and cited a section of the Code of Federal Regulations that no longer exists. This document corrects those errors. The agency is also announcing the removal of RAXAR Tablets from the list of approved drug products in FDA's ``Approved Drug Products With Therapeutic Equivalence Evaluations'' (the Orange Book).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing information collection, and to allow 60 days for public comment in response to the notice. This notice solicits comments on recordkeeping requirements related to the medical devices current good manufacturing practice (CGMP) quality system (QS) regulation (CGMP/QS regulation).
Grant to Forty-Nine Community Services State Associations; Office of Community Services
Notice is hereby given that awards will be made to forty-nine Community Services State Associations (CAA), in the amount of $65,000 each for ongoing capacity-building within the Community Services Network of Federal, State and local organizations to continue their work of addressing CSBG program needs. State CAA Associations have developed a shared vision for addressing the causes and effects of poverty; established a framework to convene fragmented programs across State and local governments; and utilized technological advances to better serve communities and track program successes. The period of this funding will extend from September 30, 2007 through September 29, 2008.
Announcement of Solicitation and Application Procedure for State Participation in the Surface Transportation Project Delivery Pilot Program
Section 6005 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) provided FHWA the authority to allow up to five States to assume the Secretary's responsibilities for the environmental review, consultation, and other actions pertaining to the review or approval of highway projects. In selecting States for the five available slots in the pilot program, Congress gave priority to the selection of the States of Alaska, California, Ohio, Oklahoma, and Texas. However, at this time, two States, Ohio and Texas, have declined to participate in the pilot program. Accordingly, this notice solicits applications from all other States for participation in this pilot program.
Funding Opportunity Title: Training of Latin American Health Care Workers through the Gorgas Memorial Institute, Republic of Panama
This project will support the Gorgas Memorial Institute (GMI) to: (a) Develop a regional training center in Panama and (b) train community health workers, clinicians (physicians, nurses, and auxiliary medical workers) and select public-health professionals from Central and South America (i.e. Latin America), (c) facilitate partnerships between U.S. universities and their Latin American counterparts to develop human resources for health in Latin America, and (d) harness the energies of U.S. and other non-governmental organizations by partnering with them to advance community health training and program efforts in Latin America. These efforts will help engage significantly more areas of these countries to prepare for and respond to public health emergencies such as pandemic influenza, and they will contribute to improved and expanded provision of prevention and primary health care. This training of nurses, community health workers and physicians will focus on improving and expanding coverage and access to both public health emergency care and preventive and primary health care in underserved parts of Latin America (i.e., both underserved rural and poor urban communities). It is anticipated that as a result of this project, the healthcare work force will be better prepared to respond to public health emergencies such as pandemic influenza. Key to the selection of recipients for this training will be their availability and willingness to provide their health and medical care skills in underserved areas within the region. In addition to all appropriate medical care and health education or communication subjects, training supported by this project will emphasize infectious diseases, epidemiology, disease surveillance and outbreak response, among other subjects so graduates of training programs will be prepared to play contributing roles to any pandemic preparation and response.
Electronic Filing and Simplification of Form D
The Securities and Exchange Commission is publishing for comment proposals that would mandate the electronic filing of information required by Securities Act of 1933 Form D. We also are proposing revisions to Form D and to Regulation D in connection with the electronic filing proposals. The revisions would simplify and restructure Form D and update and revise its information requirements. The information required by Form D would be filed with us electronically through a new online filing system that would be accessible from any computer with Internet access. The data filed would be available on our Web site and would be interactive and easily searchable by regulators and members of the public who choose to access it.
Third Periodic Review of the Commission's Rules and Policies Affecting the Conversion to Digital Television
This document begins the Commission's third periodic review of the transition of the nation's broadcast television system from analog to digital television. It provides a progress report on the DTV transition and considers the procedures and rule changes necessary to ensure that broadcasters timely complete their transitions. Congress has mandated that after February 17, 2009, full-power television broadcast stations must transmit only digital signals, and may no longer transmit analog signals. This document considers how to ensure that broadcasters complete construction of their final, post-transition (digital) facilities by the statutory deadline.
Department of Labor Regulatory Review and Update
The Department of Labor (DOL) is amending existing regulations to update obsolete non-substantive or nomenclature references in the Code of Federal Regulations (CFR). This action is intended to improve the accuracy of the agency's regulations and does not impose any new regulatory or technical requirements.
Endangered and Threatened Wildlife and Plants; Draft Post-Delisting Monitoring Plan for the Bald Eagle (Haliaeetus leucocephalus) and Proposed Information Collection
We, the U.S. Fish and Wildlife Service (Service), announce the availability of the draft post-delisting monitoring plan (draft PDM Plan) for the bald eagle (Haliaeetus leucocephalus). The Endangered Species Act (ESA) requires that the Service implement a system, in cooperation with the States, to monitor effectively for at least 5 years, the status of all species that have been recovered and no longer need protection of the ESA. The bald eagle in the contiguous 48 states will be removed from the Federal List of Threatened and Endangered Wildlife and Plants (delisted) due to recovery. We are publishing the final rule for the delisting simultaneously with this notice elsewhere in today's Federal Register. We will also ask the Office of Management and Budget (OMB) to approve the information collection (IC) for the draft PDM Plan described below.
Endangered and Threatened Wildlife and Plants; Removing the Bald Eagle in the Lower 48 States From the List of Endangered and Threatened Wildlife
The best available scientific and commercial data indicate that the bald eagle has recovered. Therefore, under the authority of the Endangered Species Act of 1973, as amended (Act), we, the U.S. Fish and Wildlife Service, remove (delist) the bald eagle (Haliaeetus leucocephalus) in the lower 48 States of the United States from the Federal List of Endangered and Threatened Wildlife. This determination is based on a thorough review of all available information, which indicates that the threats to this species have been eliminated or reduced to the point that the species has recovered and no longer meets the definition of threatened or endangered under the Act. Fueled by a reduction in the threats to the bald eagle, the population in the lower 48 States has increased from approximately 487 breeding pairs in 1963, to an estimated 9,789 breeding pairs today. The recovery of the bald eagle is due in part to the reduction in levels of persistent organochlorine pesticides (such as DDT) occurring in the environment and habitat protection and management actions. The protections provided to the bald eagle under the Bald and Golden Eagle Protection Act (BGEPA) and the Migratory Bird Treaty Act (MBTA) will continue to remain in place after the species is delisted. To help provide more clarity on the management of bald eagles after delisting, we recently published a regulatory definition of ``disturb'', the final National Bald Eagle Management Guidelines and a proposed rule for a new permit that would authorize limited take under BGEPA and grandfather existing Act authorizations.
Sunshine Act Meetings; Department of Defense Task Force on the Future of Military Health Care
Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Sunshine in the Government Act of 1976 (5 U.S.C. 552b, as amended) and 41 Code of Federal Regulations (CFR) 102-3.140 through 160, the Department of Defense announces the following committee meeting: Name of Committee: Department of Defense Task Force on the Future of Military Health Care, a duly established subcommittee of the Defense Health Board. Date of Meeting: July 25, 2007. Time of Meeting: 8:30 a.m. to 3:30 p.m. Place of Meeting: National Transportation Safety Board Conference Center, 429 L'Enfant Plaza, Washington, D.C. 20594. Purpose of Meeting: To obtain, review, and evaluate information related to the Task Force's congressionally-directed mission to examine matters relating to the future of military health care. The Task Force members will receive briefings on topics related to the delivery of military health care during the public meeting. Agenda: Discussion topic will be Acquisition and Procurement issued related to the military healthcare system. Prior to the public meeting the Task Force will conduct a Preparatory Work Meeting from 8 a.m.-8:25 a.m. to solely analyze relevant issues and facts in preparation for the Task Force's next public meeting. In addition, the Task Force, following its public meeting, will conduct an additional Preparatory Work Meeting from 3:30 p.m. to 4 p.m. to analyze relevant issues and facts in preparation for the Task Force's next public meeting. Both Preparatory Meetings will be held at the National Transportation Safety Board Conference Center, and pursuant to 41 Code of Federal Regulations, Part 102-3.160(a), both Preparatory Work Meetings are closed to the public. Additional information and meeting registration is available online at the Task Force Web site: www.DoDfuturehealthcare.net.
Sunshine Act Meetings
Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended) and the Sunshine in the Government Act of 1976 (5 U.S.C. 552b, as amended) announcement of the following meeting: Name of Committee: Board of Regents of the Uniformed Services University of the Health Sciences. Date of Meeting: August 7, 2007. Location: Board of Regents Conference Room (D3001), Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, Maryland 20814. Times:
Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to the U.S. Navy Operations of Surveillance Towed Array Sensor System Low Frequency Active Sonar
NMFS has received a request from the U.S. Navy for an authorization under the Marine Mammal Protection Act (MMPA) to take marine mammals, by harassment, incidental to conducting operations of Surveillance Towed Array Sensor System (SURTASS) Low Frequency Active (LFA) sonar from August 16, 2007, through August 15, 2012. By this document, NMFS is proposing regulations to govern that take. In order to issue Letters of Authorization (LOAs) and final regulations governing the take, NMFS must determine that the taking will have a negligible impact on the affected species or stocks of marine mammals. NMFS regulations must set forth the permissible methods of take and other means of effecting the least practicable adverse impact on the affected species or stocks of marine mammals and their habitat. NMFS invites comment on the proposed regulations and findings.
Notice of Intent To Request Approval From the Office of Management and Budget of a New Information Collection Activity, Request for Comments; 2008 Newly Certificated Airframe and/or Powerplant Mechanics: Assessment of the Mechanic's Practical Test Program
The FAA invites public comments about our intention to request the Office of Management and Budget (OMB) to approve a new information collection. This project involves collecting data from individual applicants who have recently taken, for the first time, and passed an oral and/or practical Airframe and/or Powerplant (A and/or P) Mechanic Certification test.
Good Neighbor Environmental Board
Under the Federal Advisory Committee Act, Public Law 92463, EPA gives notice of a meeting of the Good Neighbor Environmental Board. The Board meets three times each calendar year at different locations along the U.S.-Mexico border and in Washington, DC. It was created by the Enterprise for the Americas Initiative Act of 1992. An Executive Order delegates implementing authority to the Administrator of EPA. The Board is responsible for providing advice to the President and the Congress on environmental and infrastructure issues and needs within the States contiguous to Mexico. The statute calls for the Board to have representatives from U.S. Government agencies; the States of Arizona, California, New Mexico and Texas; tribal representation; and a variety of non-governmental officials. One purpose of this meeting is to hear presentations on the theme selected for the Board's Eleventh Report, natural disasters and the environment. The meeting also will include a public comment session and a business meeting on the second day. A copy of the meeting agenda will be posted at http://www.epa.gov/ ocem/gneb.
Rules and Procedures Applicable to Commodity Transactions Financed by USAID: Miscellaneous Amendments
The U.S. Agency for International Development (USAID) proposes to amend its regulation governing commodity transactions that are financed by USAID to: 1. Revise the criteria for noncompetitive procurement for private- sector programs to more closely reflect private-sector practices; 2. revise the commodity and package marking requirements to address the use of the new USAID Identity; 3. revise and add definitions to better specify the terminology used; 4. revise agency organizational names and acronyms to specify the current USAID usage; 5. reinstate Sec. 201.13 coverage on ocean transportation costs because it was inadvertently deleted from prior editions; 6. provide for advertising public-sector procurements over $25,000 in the USAID Procurement Bulletins as the primary means of advertising these procurements to U.S. suppliers (in lieu of advertising public-sector procurements over $100,000 in ``FedBizOpps,'' the successor to ``Commerce Business Daily'') to facilitate prompt public notification of procurement opportunities and minimize government expense in providing notice; 7. make numerous clarifications and editorial amendments to better specify the regulation; and 8. specify the current Paperwork Reduction Act approval expirations, as required by the Act.
Glenn/Colusa County Resource Advisory Committee
The Glenn/Colusa County Resource Advisory Committee (RAC) will meet in Willows, California. Agenda items covered include: (1) Introductions, (2) Approve Minutes, (3) Public Comment, (4) Project Proposals/Possible Action, (5) Status of Funding, (6) Reports on Completed Projects, (7) General Discussion, (8) Next Agenda.
Humboldt-Toiyabe National Forest; Mountain City Ranger District, Big Springs Exploration Drilling Project
Gateway Gold Corporation has submitted a Plan of Operations to explore for, locate, and delineate precious metals on National Forest System lands within the Big Springs Mine area. In response to that proposed plan of operations, the Mountain City Ranger District of the Humboldt-Toiyabe National Forest will prepare an Environmental Impact Statement for the Big Springs Exploration Drilling Project. This proposal is for the drilling on up to 1000 drill sites over a five year period on National Forest System (NFS) lands. The Project Area is located in Elko County, Nevada. Analysis for this project was initiated in 2005 with the preparation of an Environmental Assessment. In late October 2006, two lakes that had formed in existing mine pits (pit lakes) and the surrounding aquifer began draining. The pit lakes are now dry and the aquifer level has dropped about 150 feet below previous levels measured prior to October 2006. It is unknown where the aquifer is draining to or what the impacts, if any, would be to water quality and surface and groundwater resources. Based upon these changed environmental conditions of the hydrology at the site, the Forest Service has decided to document the analysis in an Environmental Impact Statement.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
On Monday, July 9, 2007, Postal Regulatory Commissioners and advisory staff members will tour an Amazon.com facility in New Castle, Delaware and the United States Postal Service processing and distribution plant in Philadelphia, Pennsylvania. The purpose of the tours is to observe operations.