December 10, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) is seeking sponsors interested in participating in a pilot project to test the electronic submission of margin of safety and nonclinical toxicology study data using the Standard for Exchange of Nonclinical Data (SEND), a new electronic data standard format which is used to support review activity. FDA anticipates that a successful pilot will enable CVM to accept margin of safety and nonclinical toxicology study data related to investigational new animal drug (INAD) files and new animal drug applications (NADA's) electronically in SEND format.

The Coast Guard is establishing a temporary safety and security zone on the Chicago Sanitary and Ship Canal (CSSC) near Romeoville, IL. This temporary final rule is intended to restrict all vessels from transiting the navigable waters of the CSSC. The safety and security zone is necessary to protect the waters, waterway users and vessels from hazards associated with the U.S. Army Corps of Engineers (USACE) electrical dispersal barrier and for the preparation and safe application of a fish toxicant during a period of time when the barrier will be disabled to conduct maintenance.

The Coast Guard is conducting a Port Access Route Study (PARS) to evaluate the continued applicability of and the need for modifications to current vessel routing measures in the approaches to San Francisco. The goal of the study is to help reduce the risk of marine casualties and increase the efficiency of vessel traffic in the study area. The recommendations of the study may lead to future rulemaking action or appropriate international agreements.

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, 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.

Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning Patents. This OMB clearance currently expires on May 31, 2010.

The Federal Aviation Administration (FAA) is issuing this notice to advise the public that the FAA has prepared, and approved on November 18, 2009, a Finding of No Significant Impact (FONSI)/Record of Decision (ROD) based on the Final Environmental Assessment (Final EA) for a Proposed Airport Traffic Control Tower (ATCT) with Associated Base Building and an Airport Surveillance Radar, Model 9 (ASR-9), Replacement/Relocation at Cleveland Hopkins International Airport, (CLE) Cleveland, Ohio. The FAA prepared the Final EA in accordance with the National Environmental Policy Act and the FAA's regulations and guidelines for environmental documents. The Final EA was reviewed and evaluated by the FAA, and was accepted on October 22, 2009 as a Federal document by the FAA's Responsible Federal Official.

The Commission is adding Priority Mail Contract 22 to the Competitive Product List. This action is consistent with changes in a recent law governing postal operations. Republication of the lists of market dominant and competitive products is also consistent with new requirements in the law.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees of Area IV of the Santa Susana Field Laboratory to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:

The National Security Agency hereby gives notice of its intent to grant the University of Maryland a revocable, non-assignable, exclusive license to practice the following Government-Owned invention as described in U.S. Provisional Patent Application Serial No. 61/ 119,848 entitled: ``RF Power Harvesting Circuit Design,'' filed 04 December 2008, and any related non-provisional patent application and all Letters Patent issuing thereon, and any continuation, continuation- in-part or division of said non-provisional patent application and any reissue or extension of said Letters Patent, in the field of RF Power Harvesting Technologies. The above-mentioned invention is assigned to the United States Government as represented by the National Security Agency.

We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

As required by the Privacy Act of 1974, 5 U.S.C. 552a(e), notice is hereby given that the Department of Veterans Affairs (VA) is amending the system of records entitled ``The Revenue ProgramBilling and Collections RecordsVA'' (114VA16) as set forth in the Federal Register 69 FR 4205 and as amended in 70 FR 55207. VA is amending the system of records by revising the Categories of Records in the System.

In accordance with Section 122(i) of the Comprehensive Environmental Response Compensation and Liability Act, as amended (CERCLA), 42 U.S.C. 9622(i), notice is hereby given of a proposed administrative settlement with Coffeyville Resources Refining & Marketing, LLC (CRRM), Coffeyville, Kansas, for recovery of past response costs concerning the response actions taken by CRRM relative to the manufacture of propane containing higher than normal concentrations of organic fluoride. The settlement requires CRRM to pay the Hazardous Substances Superfund for costs incurred by the United States Environmental Protection Agency, Region 7, in response to overseeing and investigating this response. The settlement requires CRRM to pay $54,625.06, to the Hazardous Substances Superfund. The settlement includes a covenant not to sue the settling party 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, EPA will receive written comments relating to the settlement. EPA will consider all comments 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. EPA's response to any comments received will be available for public inspection at the EPA Region 7 office located at 901 N. 5th Street, Kansas City, Kansas.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``PET DrugsCurrent Good Manufacturing Practice (CGMP).'' Elsewhere in this issue of the Federal Register, we are issuing final regulations on CGMPs for positron emission tomography (PET) drugs. We are issuing the guidance to help PET drug producers better understand FDA's thinking concerning compliance with the PET CGMP regulations.

This document corrects several technical and typographical errors in the final rule with comment period that appeared in the November 25, 2009, Federal Register entitled ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010''.

EPA is approving a State Implementation Plan (SIP) revision

This rule modifies the import regulations for Irish potatoes by reducing the number of marketing order areas determined as being in the most direct competition with imported potatoes from five to three; exempting U.S. No. 1 grade potatoes imported in certain small containers from size requirements; and removing certain language from Marketing Orders No. 948 and 953 that reference the regulation of imported Irish potatoes. In addition, this rule makes minor administrative changes to the potato, onion, and tomato import regulations to update informational references. The modifications to the import regulations are expected to benefit potato importers and consumers.

This document is issued under the joint authority of the Secretary of Defense, the Administrator of General Services and the Administrator of the National Aeronautics and Space Administration. This Small Entity Compliance Guide has been prepared in accordance with Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996. It consists of a summary of rules appearing in Federal Acquisition Circular (FAC) 2005-38 which amend the FAR. Interested parties may obtain further information regarding these rules by referring to FAC 2005-38 which precedes this document. These documents are also available via the Internet at https://www.regulations.gov.

The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) are issuing a final rule amending the Federal Acquisition Regulation (FAR) to change the travel cost principle to ensure a consistent application of the limitation on allowable contractor airfare costs.