2008 – 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of MedWatch\Plus\ Portal and Rational Questionnaire to collect electronically all adverse event, consumer complaint/product problem and medication use error data submitted to FDA.

This publishes notice of an Amendment to a Compact between the Pokagon Band of Potawatomi Indians and the State of Michigan providing for the conduct of Tribal-State Class III gaming by the Pokagon Band of Potawatomi Indians taking effect.

In accordance with the Privacy Act of 1974 and as part of the Department of Homeland Security's ongoing effort to review and update legacy system of record notices, the Department of Homeland Security is giving notice that it proposes to consolidate one legacy system of records notice, DOT/CG 536 Contract and Real Property File System as a Department of Homeland Security-wide system of records notice titled Department of Homeland Security Contractors and Consultants. The Department of Homeland Security also proposes to partially consolidate one legacy record system, Treasury/USSS.001 Administrative Information System into this Department-wide system of records. This system will allow the Department of Homeland Security to collect and maintain records on the Department's contractors and consultants. Categories of individuals, categories of records, and the routine uses of this legacy system have been reviewed and updated to better reflect the Department's contractor and consultant record system. This reclassified system, titled Department of Homeland Security Contractors and Consultants, will be included in the Department of Homeland Security's inventory of record systems.

The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a guidance document entitled, ``OHRP Guidance on Engagement of Institutions in Human Subjects Research.'' The guidance document describes: (1) Scenarios that, in general, would result in an institution being considered engaged in a human subjects research project; (2) scenarios that would result in an institution being considered not engaged in a human subjects research project; and (3) IRB review considerations for cooperative research in which multiple institutions are engaged in the same non-exempt human subjects research project. The guidance document is intended primarily for institutional review boards (IRBs), research administrators and other relevant institutional officials, investigators, and funding agencies that may be responsible for the conduct, review and oversight of human subject research that is conducted or supported by the Department of Health and Human Services (HHS). The guidance document announced in this notice finalizes the draft guidance with the same title that was made available for public comment in the Federal Register on December 8, 2006 (71 FR 71169). OHRP received twenty-four comments on the draft guidance document, and those comments were considered as the guidance was finalized. The final guidance document replaces two existing OHRP guidance documents on the engagement of institutions in human subjects research: (1) The January 26, 1999, document on ``Engagement of Institutions in Research,'' and (2) the December 23, 1999, document on ``Engagement of Pharmaceutical Companies in HHS Supported Research.''

This notice announces actions taken by the FHWA that are final within the meaning of 23 U.S.C. 139(1)(1). The actions relate to a proposed highway project on new location, Route 460, between the Route 58 Bypass in Suffolk and Interstate 295 in Prince George County, in the City of Suffolk, Isle of Wight County, Town of Waverly, Southampton County, Sussex County, and Prince George County, State of Virginia. Those actions grant approvals for the project.

In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing that the information collection request for 30 CFR 870 Abandoned Mine Reclamation FundFee Collection and Coal Production Reporting and the form OSM-1 has been forwarded to the Office of Management and Budget (OMB) for review and comment. The information collection request describes the nature of the information collection and its expected burden and cost.

In this document, comment is sought on a May 20, 2008 petition for rulemaking (Petition) filed by Rural Cellular Association (RCA) (Petitioner). The Petitioner asks the Federal Communications Commission to initiate a rulemaking to investigate the widespread use and anticompetitive effects of exclusivity arrangements between commercial wireless carriers and handset manufacturers, and, as necessary, adopt rules that prohibit such arrangements when contrary to the public interest.

Pursuant to section 215 of the Federal Power Act, the Commission is proposing to approve three revised Reliability Standards developed by the North American Electric Reliability Corporation (NERC), which the Commission has certified as the Electric Reliability Organization responsible for developing and enforcing mandatory Reliability Standards. The three revised Reliability Standards, designated by NERC as FAC-010-2, FAC-011-2 and FAC-014-2, set requirements for the development and communication of system operating limits of the Bulk-Power System for use in the planning and operation horizons.

The U.S. Department of Agriculture (USDA) is proposing to amend the Guidelines for Designating Biobased Products for Federal Procurement, by adding nine sections to designate the following nine items within which biobased products would be afforded Federal procurement preference: Chain and cable lubricants; corrosion preventatives; food cleaners; forming lubricants; gear lubricants; general purpose household cleaners; industrial cleaners; multipurpose cleaners; and parts wash solutions. USDA also is proposing minimum biobased content for each of these items.

The Department of Homeland Security is issuing a final rule to amend its regulations to exempt portions of a new system of records entitled the ``Immigration and Customs Enforcement Student and Exchange Visitor Information System'' (SEVIS) from certain provisions of the Privacy Act. Specifically, the Department exempts portions of the SEVIS system from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.

The Department of Homeland Security is issuing a final rule to amend its regulations to exempt portions of a new system of records entitled the ``Immigration and Customs Enforcement General Counsel Electronic Management System'' (GEMS) from certain provisions of the Privacy Act. Specifically, the Department exempts portions of the GEMS system from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.

Pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4332(2)(C), the National Park Service announces the availability of a Draft Environmental Impact Statement for the Fire Management Plan for Grand Canyon National Park, Arizona. The document describes and analyzes the environmental impacts of several action alternatives including the preferred alternative for management of fire in Grand Canyon National Park. The preferred alternative analyzes the use of prescribed fire, wildland fire use, suppression fire and manual and mechanical thinning. A no action alternative was also evaluated.

This Guideline sets forth the administrative, programmatic, and financial requirements attendant to Fiscal Year 2009 State Justice Institute grants, cooperative agreements, and contracts.

Withdraw from publication the Notice of Intent dated Thursday, March 22, 2007, Federal Register/Vol. 72. No. 55, the Natural Resources Conservation Service (NRCS) announced its intention to prepare an Environmental Impact Statement (EIS) in accordance with the National Environmental Policy Act for the Manoa Watershed Plan to mitigate residential and commercial flooding in Manoa Valley, City and County of Honolulu, Hawaii. The Manoa Watershed Plan and joint EIS would be prepared by NRCS, State of Hawaii Department of Land and Natural Resources, and the City and County of Honolulu. The federal authority for the project was the Watershed Protection and Flood Prevention Act (Pub. L. 83-566, as amended). The EIS would evaluate the full range of alternatives to mitigate flooding of the magnitude experienced on October 30, 2004, when an intense rainstorm hit the upper Manoa Valley, causing nearly $100 million in flood damage to residences, businesses, and facilities at the University of Hawaii. The Manoa Watershed project has not received funding in the 2007 and 2008 fiscal years. The Manoa Watershed area will be incorporated into the Ala Wai Canal Project, administered by the U.S. Army Corps of Engineers which will continue to pursue a flood protection plan for Manoa Valley. The U.S. Army Corps of Engineers published a Notice of Intent to prepare an Environmental Impact Statement for the Ala Wai Canal Project in the Federal Register on October 2, 2008. Therefore, NRCS is withdrawing its Notice of Intent to prepare an EIS.

This notice publishes the Approval of the Tribal-State Compact for Class III Gaming Amendments between the State of Washington and the Snoqualmie Tribe.

The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501-3520. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.

The Federal Communications Commission (FCC) has received Office of Management and Budget (OMB) approval for the following public information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). An agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number, and no person is required to respond to a collection of information unless it displays a currently valid OMB control number. Comments concerning the accuracy of the burden estimates and any suggestions for reducing the burden should be directed to the person listed in the FOR FURTHER INFORMATION CONTACT section below.

The Secretary announces dates for the submission by State educational agencies (SEAs) of expenditure and revenue data and average daily attendance statistics on ED Form 2447 (the National Public Education Financial Survey (NPEFS)) for FY 2008. The Secretary sets these dates to ensure that data are available to serve as the basis for timely distribution of Federal funds. The U.S. Bureau of the Census (Bureau of the Census) is the data collection agent for the National Center for Education Statistics (NCES). The data will be published by NCES and will be used by the Secretary in the calculation of allocations for FY 2010 appropriated funds.

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), 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. The ICR that is abstracted below describes the nature of the collection and the estimated burden and cost.

The Bureau of Industry and Security (BIS) will hold a public meeting on October 27, 2008 for those companies, organizations, and individuals that have an interest in learning about the new license exception entitled ``Intra-Company Transfer (ICT)'' that would be established under the Export Administration Regulations (EAR) as presented in the proposed rule published in the Federal Register on October 3, 2008. U.S. Government officials will explain the amendments to the EAR proposed in the rule and answer questions from the public.