October 2, 2006 – Federal Register Recent Federal Regulation Documents

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 information collection requirements for Postmarket Surveillance under 21 CFR part 822.

In compliance with the Paperwork Reduction Act of 1995, this request for comments announces that the Coast Guard is forwarding two Information Collection Requests (ICRs), abstracted below, to the Office of Information and Regulatory Affairs (OIRA) of the Office of Management and Budget (OMB) to request an extension of their approval of the following collections of information. The ICRs are: (1) 1625- 0104, Barges Carrying Bulk Hazardous Materials; and (2) 1625-0110, Maritime Identification CredentialsTitle 33 CFR Part 125. Our ICRs describe the information we seek to collect from the public. Review and comment by OIRA ensures that we impose only paperwork burdens commensurate with our performance of duties.

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 a currently approved collection of information: 1625-0086, Great Lakes Pilotage. Before submitting the ICR to OMB, the Coast Guard is inviting comments on it as described below.

In compliance with the Paperwork Reduction Act of 1995, this request for comments announces that the Coast Guard is forwarding three Information Collection Requests (ICRs), abstracted below, to the Office of Information and Regulatory Affairs (OIRA) of the Office of Management and Budget (OMB) to request an extension of their approval of the following collections of information. The ICRs are: (1) 1625- 0052, Nondestructive Testing of Certain Cargo Tanks on Unmanned Barges; (2) 1625-0057, Small Passenger VesselsTitle 46 CFR Subchapters K and T; and (3) 1625-0065, Offshore Supply VesselsTitle 46 CFR Subchapter L. Our ICRs describe the information we seek to collect from the public. Review and comment by OIRA ensures that we impose only paperwork burdens commensurate with our performance of duties.

The Food and Drug Administration (FDA) is requesting nominations for voting and nonvoting consumer representatives to serve on its advisory committees/panels that are under the purview of the Office of the Commissioner, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the National Center for Toxicological and Research (NCTR). FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on its advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

In accordance with section 751(c) of the Tariff Act of 1930, as amended (``the Act''), the Department of Commerce (``the Department'') is automatically initiating a five-year (``Sunset Review'') of the antidumping and countervailing duty orders listed below. The International Trade Commission (``the Commission'') is publishing concurrently with this notice its notice of Institution of Five-Year Review which covers these same orders.

This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. 139(1)(1). These actions relate to a proposed highway project on State Route 65 Lincoln Bypass between kilo post 19.3 to 38.3 (post miles 12.0 to 23.8) in Placer County, State of California. These actions grant approvals for the project.

The National Marine Fisheries Service (NMFS) announces its intent to prepare an EIS to assess the potential impacts on the human environment resulting from proposed regulations to protect wild spinner dolphins (Stenella longirostris) in the main Hawaiian Islands from ``take,'' as defined in the Marine Mammal Protection Act (MMPA) and its implementing regulations; and announces public scoping meetings.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Harry S. Truman Scholarship Foundation [Foundation] will publish periodic summaries of proposed projects. Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Notice is hereby given of the U.S. Trade and Development Agency's notification of employee rights and protections under Federal Antidiscrimination Laws and Whistleblower Protection Laws (No FEAR Act).

This notice advises of the cause and effect of termination of Origination Approval Agreements taken by HUD's Federal Housing Administration (FHA) against HUD-approved mortgagees through the FHA Credit Watch Termination Initiative. This notice includes a list of mortgagees which have had their Origination Approval Agreements terminated.

An influenza pandemic has greater potential than any other naturally occurring infectious disease to cause large and rapid global and domestic increases in death and serious illness. Preparedness is the key to substantially reducing the health, social, and economic impacts of an influenza pandemic and other public-health emergencies. On November 1, 2005, President George W. Bush announced the U.S. National Strategy for Pandemic Influenza and the following day, Secretary Michael O. Leavitt released the HHS Pandemic Influenza Plan. One of the primary objectives of both documents is to leverage global partnerships to increase preparedness and response capabilities around the world with the intent of stopping, slowing, or otherwise limiting the spread of a pandemic to the United States.\1\ Pillars Two and Three of the National Strategy set out the clear goals of ensuring the rapid reporting of outbreaks and containing outbreaks beyond the borders of the United States, by taking the following actions:

The Office of Public Health Emergency Preparedness (OPHEP) and the Office of Global Health Affairs (OGHA) within the U.S. Department of Health and Human Services (HHS) announces that up to $2,100,000 in fiscal year (FY) 2006 funds is available for a cooperative agreement to provide support to develop a cadre of in-country trainers who can improve their ongoing hospital infection-control programs to achieve better adherence by health-care workers to infection-control and case- management principles and practices. This effort is an undertaking by the Department of Health and Human Services (HHS). The project will be approved for up to a program period of three (3) years with a budget period of one-year for a total of $2,100,000. Under certain circumstances especially in support of HHS International efforts, OGHA and OPHEP are required to collaborate on programs, issues and initiatives regarding international public health (i.e. Avian Influenza, disease surveillance, etc.). Normally, OGHA is often tasked as to devise, award, and administer international Federal assistance actions (grants, cooperative agreements, IAA's, etc.). When emergency preparedness issues are to be addressed as part of the program plan, OGHA partners with OPHEP to provide assistance in ensuring risks mitigation and emergency preparedness elements are included. The Regional Emerging Diseases Intervention (REDI) Center in Singapore will design the program around mentorship principles so trainers can gain advice and support for their efforts in teaching infection-control and case-management practices in local languages. While there is no current pandemic influenza outbreak, there is still reason to be concerned about the spread of the H5N1 virus from Southeast Asia to countries in Europe, the Middle East, and Africa. In the last century, three influenza pandemics have affected the United States, and viruses from birds contributed to all of them. Medical practitioners have also discovered several other, new, avian viruses human beings can transmit among one another. Although the H5N1 virus has primarily infected domesticated birds and long-range migratory birds, the virus has demonstrated the ability to infect and produce fatal illness in humans. Influenza experts believe an avian virus could become efficiently transmissible between humans, and result in a worldwide outbreak, which would overwhelm health and medical capabilities. Furthermore, an influenza pandemic could result in hundreds of thousands of deaths, millions of hospitalizations, and hundreds of billions of dollars in direct costs in the United States alone. On November 1, 2005, President Bush announced the National Strategy on Pandemic Influenza, and the following day Secretary Michael O. Leavitt released the HHS Pandemic Influenza Plan. Building on these efforts, President Bush released the Implementation Plan for the National Strategy for Pandemic Influenza on May 3, 2006, which describes more than 300 critical actions to address the threat of pandemic influenza. All relevant Federal Departments and agencies must take steps to address the threat of avian and pandemic influenza. Drawing on the combined efforts of Government officials and the public- health, medical, veterinary, and law-enforcement communities, as well as the private sector, this strategy is designed to meet three critical goals: Detecting human or animal outbreaks that occur anywhere in the world; protecting the American people by stockpiling vaccines and antiviral drugs, while improving the capacity to produce new vaccines; and preparing to respond at the Federal, State, and local levels in the event an avian or pandemic influenza reaches the United States. HHS technical expertise in applied epidemiology, rapid laboratory diagnostics, infection control, virology research, vaccine delivery, and other areas is a critical component of both the domestic and the international response to the threat of pandemic influenza. One of the primary objectives of both the National Strategy and the HHS Pandemic Plan is to leverage global partnerships to increase preparedness and response capabilities around the world with the intent of stopping, slowing, or otherwise limiting the spread of a pandemic to the United States.\1\ The U.S. cannot mount an effective response to an influenza pandemic without effective worldwide partnerships. As such, we are working bilaterally with partner countries, with multilateral organizations, and with private, non-profit organizations, to amplify our efforts. Our international effort to contain and mitigate the effects of an outbreak of pandemic influenza is a central component of our overall strategy. In many ways, the character and quality of the U.S. response and that of our international partners could play a determining role in the severity of a pandemic. Pillars Two and Three of the National Strategy set out clear goals for ensuring the rapid reporting of outbreaks and containing outbreaks beyond the borders of the U.S. by taking the following actions:

EPA is proposing to approve a redesignation request and a State Implementation Plan (SIP) revision for the Weirton, West Virginia portion of the Steubenville-Weirton, OH-WV interstate area (herein referred to as the ``Area'') from nonattainment to attainment of the 8- hour ozone National Ambient Air Quality Standard (NAAQS). The West Virginia Department of Environmental Protection (WVDEP) is requesting that the Brooke and Hancock County, West Virginia (Weirton) portion of the area be redesignated as attainment for the 8-hour ozone NAAQS. The interstate 8-hour ozone nonattainment area is comprised of three counties (Brooke and Hancock Counties, West Virginia (Weirton) and Jefferson County, Ohio (Steubenville)). EPA is proposing to approve the ozone redesignation request for the Weirton portion of the area. In conjunction with its redesignation request, the WVDEP submitted a SIP revision consisting of a maintenance plan for Weirton that provides for continued attainment of the 8-hour ozone NAAQS for the next 12 years. EPA is proposing to make a determination that Weirton has attained the 8-hour ozone NAAQS based upon three years of complete, quality-assured ambient air quality ozone monitoring data for 2002-2004. EPA's proposed approval of the 8-hour ozone redesignation request is based on its determination that Weirton has met the criteria for redesignation to attainment specified in the Clean Air Act (CAA). EPA is providing information on the status of its adequacy determination for the motor vehicle emission budgets (MVEBs) that are identified in the Weirton maintenance plan for purposes of transportation conformity, and is also proposing to approve those MVEBs. EPA is proposing approval of the redesignation request and of the maintenance plan revision to the West Virginia SIP in accordance with the requirements of the CAA.

In accordance with the Privacy Act of 1974, as amended (Privacy Act), the Department of Education (the Department) publishes this notice of a new system of records entitled ``Impact Evaluation of a School-based Violence Prevention Program,'' 18-13-15. The purpose of the impact evaluation is to determine the effectiveness of a violence prevention program comprised of two violence prevention interventions for middle schools using a rigorous research design. Currently, there is lack of rigorous research concerning school-based violence prevention in middle schools. The Department's contractor, RTI International (RTI), selected the violence prevention interventions to be evaluated through an open competition with advisement from a panel of experts in the field of violence prevention. RTI selected the Responding in Peaceful and Positive Ways (RiPP) and Best Behavior interventions and combined the two approaches into a single violence prevention program with two components: (1) A curriculum-based model to facilitate students' social competency, problem solving, and self- control skills, and (2) a whole-school model that targets school practices and policies usually through classroom management or teaching strategies, or through systemic reorganization and modification of school management, disciplinary policies, and enforcement procedures. The RiPP intervention will provide the curriculum-based component of the program , and the Best Behavior intervention will provide the whole-school component of the program. The system will contain information about students, teachers, and other school staff members in schools that are randomly assigned either to implement the violence prevention program or not to implement the program. The sample will consist of approximately 20,000 students and approximately 3,000 teachers and other school staff members drawn from approximately 40 schools over 3 years. Each of the 40 schools that participate in the study will be randomly assigned either to receive the violence prevention program or not to receive the program so that approximately 20 schools are in each study condition. At each school, sixth graders will be surveyed in the 2006-2007 school year, seventh graders in the 2007-2008 school year, and eighth graders in the 2008- 2009 school year. The teacher survey will be administered to a random sample of 24 teachers (stratified by grade) at each of the middle schools participating in the study. Teachers will complete the survey in spring of 2007, 2008, and 2009, with a new random sample of teachers selected each year. Other school staff members will be interviewed about victimization and their experiences implementing the program. The system of records will include students' names, demographic information (such as date of birth and race/ethnicity), self-reported attitudes about violence and feelings of safety, self-reported victimization, and self-reported violent and delinquent behaviors. The system also will include information from school records such as records of students' attendance, suspensions, expulsions, and school policy violations. The system also will include teachers' and other school staff members' self-reported victimization at school as well as their experiences with training and technical assistance related to their schools' violence prevention efforts.