August 24, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is extending to October 28, 2005, the comment period for the draft guidance for industry entitled ``Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention.'' The draft guidance is intended to assist sponsors in conducting clinical trials for drug products that treat or prevent gingivitis. It addresses specific protocol design elements as well as general concerns about drugs for this indication. FDA published a notice of availability of the draft guidance, with a comment period that closes on August 29, 2005. FDA is taking this action in response to a request for extension of the comment period to allow interested persons additional time to review the draft guidance and submit comments.

This notice announces the availability of EPA's Tolerance Reassessment Decision (TRED) for the pesticide procymidone, and opens a public comment period on this document. EPA has reviewed the pesticide procymidone through a modified, streamlined version of the public participation process that the Agency uses to involve the public in developing pesticide tolerance reassessment and reregistration decisions. Through the tolerance reassessment program, EPA is ensuring that all pesticides meet current health and food safety standards.

The Defense Finance and Accounting Service is amending a system of records notice to its existing inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

The Defense Finance and Accounting Service is amending a system of records notice to its existing inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

The Department of the Navy proposes to add a system of records to its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

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, Public Law No. 104-13. 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 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, 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 of 1995, Public Law 104-13. 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.

This document provides notice that the Wireline Competition Bureau has approved the plan to refund interstate access customers of BellSouth Telecommunications, Inc. (BellSouth) for refunds associated with its 1993 and 1994 annual interstate access tariffs. It also provides information as to how refunds may be obtained by BellSouth interstate access customers that are either no longer readily identifiable or that are due refunds of less than $100.

This document provides notice that the Wireline Competition Bureau has approved the plan to refund interstate access customers of certain Sprint/United incumbent Local Exchange Carriers (the Sprint/ United LECs) for refunds associated with their 1993 and 1994 annual interstate access tariffs. It also provides information as to how refunds may be obtained by interstate access customers of the Sprint/ United LECs that are either no longer readily identifiable or that are due refunds of less than $100.

The Office of Justice Programs (``OJP'') proposes the following regulations to implement provisions of the Victims of Crime Act of 1984 (the ``VOCA'') (42 U.S.C. 10601 et seq.), which authorize the Director of the Office for Victims of Crime (``OVC''), a component of OJP, to establish an International Terrorism Victim Expense Reimbursement Program (hereinafter referred to as the ``ITVERP'') to reimburse eligible ``direct'' victims of acts of international terrorism that occur outside the United States for ``expenses associated with that victimization.''

Today, EPA is proposing actions to address the interstate transport of emissions of nitrogen oxides (NOX) and sulfur dioxide (SO2) that contribute significantly to nonattainment and maintenance problems with respect to the national ambient air quality standards (NAAQS) for fine particulate matter (PM2.5) and 8-hour ozone. As one part of today's action, EPA is proposing its response to a petition submitted to EPA by the State of North Carolina under section 126 of the Clean Air Act (CAA). The petition requests that EPA find that SO2 and/or NOX emissions from electric generating units (EGUs) in 13 States are significantly contributing to PM2.5 and/or 8-hour ozone nonattainment and maintenance problems in North Carolina, and requests that EPA establish control requirements to prohibit such significant contribution. The EPA's proposed response is based on extensive analyses conducted for the recently issued Clean Air Interstate Rule (CAIR). The EPA is proposing to deny the petition for sources in States not shown to be linked to nonattainment and maintenance problems in North Carolina under the CAIR. For sources in States that are linked to North Carolina under the CAIR, EPA is proposing in the alternative to deny the petition if EPA promulgates Federal implementation plans (FIPs) to address the interstate transport no later than the final section 126 response or to grant the petition if EPA does not promulgate the FIPs prior to or concurrently with the section 126 response. The EPA's preferred option is to promulgate the FIP concurrently with the final section 126 response. In today's action, EPA is also proposing FIPs for all jurisdictions that are covered by the CAIR. The FIPs would regulate EGUs in the affected States and achieve the emissions reductions requirements established by the CAIR until States have approved State implementation plans (SIPs) to achieve the reductions. The EPA intends the FIP to satisfy the concerns cited in the section 126 petition and provide a Federal backstop for the CAIR. In no way should the FIP for CAIR be viewed as a sign of any concern about States meeting the SIP responsibilities under CAIR. As the control requirements for both the section 126 action and the FIP, EPA is proposing Federal NOX and SO2 trading programs that provide emissions reductions equal to those required under the CAIR in affected States. The Section 126 and FIP actions would not constrain States in their selection of control strategies to meet the CAIR. The EPA intends to withdraw section 126 or FIP requirements in a State if that State submits and EPA approves a SIP meeting the requirements of CAIR. Today's action also proposes revisions to the CAIR in order to address the interaction between the EPA-administered Federal CAIR trading programs proposed today and the EPA-administered State CAIR trading programs that will be created by any State that elects to submit a SIP establishing such a trading program to meet the requirements of the CAIR. In addition, EPA is proposing revisions to the CAIR to correct certain minor errors. Today's action also proposes revisions to the Acid Rain Program in order to make the administrative appeals procedures, which currently apply to final determinations by the Administrator under the EPA- administered State CAIR trading programs, also apply to the EPA- administered trading programs under the section 126 and FIP actions. In addition, we are proposing certain minor revisions to the Acid Rain Program that would apply to all affected units.