May 8, 2013 – Federal Register Recent Federal Regulation Documents

The Bureau of Land Management (BLM) Colorado is proposing supplementary rules for public lands included in the Gunnison Basin Federal Lands Travel Management Plan (TMP), approved on June 28, 2010. These proposed supplementary rules would apply to public lands administered by the BLM, Gunnison Field Office in Gunnison, Montrose, Hinsdale, and Saguache counties, Colorado. The proposed rules would implement decisions found in the TMP relating to the use of motorized and non-motorized vehicles.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components'' dated May 2013. The guidance document recognizes the abbreviated donor history questionnaire and accompanying materials (aDHQ documents), version 1.3 dated December 2012, prepared by the AABB Donor History Task Force, as an acceptable mechanism for collecting blood donor history information from frequent donors of blood and blood components that is consistent with FDA's requirements and recommendations for collecting donor history information. The aDHQ documents will provide blood establishments that collect blood and blood components with a specific process for administering questions to frequent donors of blood and blood components to determine their eligibility to donate. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2011.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Public Health Service Guideline on Infectious Disease Issues on Xenotransplantation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 which is abstracted below describes the nature of the collection and the estimated burden and cost.

This document announces the Office of Management and Budget (OMB) responses to Agency Clearance requests, in compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et. Seq.). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

In accordance with Coast Guard regulations, Martin Operating Partnership LP has submitted a Letter of Intent and a Waterway Suitability Assessment to the Coast Guard Captain of the Port, Port Arthur regarding the company's proposed expansion of its Liquefied Hazardous Gas (LHG) facility in Beaumont, Texas, and increased LHG marine traffic in the associated waterway. The Coast Guard is notifying the public of this action to solicit public comments on the proposed increase in LHG marine traffic in Beaumont, Texas.

The Department of Labor (DOL) is submitting the Bureau of Labor Statistics (BLS) sponsored information collection request (ICR) titled, ``Well-being Supplement to the American Time Use Survey,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).

The Rural Utilities Service (RUS) has issued a Record of Decision (ROD) for the Environmental Impact Statement (EIS) related to providing financial assistance to the Oglethorpe Power Corporation (Oglethorpe) for the construction of a 100 megawatt (MW) biomass plant and related facilities (Proposal) in Warren County, Georgia. The Administrator of RUS has signed the ROD, which was effective upon signing. The EIS was prepared pursuant to the National Environmental Policy Act (NEPA) (U.S.C. 4231 et seq.) and in accordance with the Council on Environmental Quality's (CEQ) regulations for implementing the procedural provisions of NEPA (40 CFR Parts 1500-1508) and RUS' Environmental Policies and Procedures (7 CFR part 1794). As the lead federal agency, and as part of its broad environmental review process, RUS must take into account the effect of the Proposal on historic properties in accordance with Section 106 of the National Historic Preservation Act (16 U.S.C. 470f) and its implementing regulation ``Protection of Historic Properties'' (36 CFR Part 800). Pursuant to 36 CFR 800.2(d)(3), RUS used its procedures for public involvement under NEPA, in part, to meet its responsibilities to solicit and consider the views of the public and other interested parties during the Section 106 review process. Accordingly, comments submitted in the EIS process also informed RUS's decision making in the Section 106 review process. The purpose of the Proposal is to provide a reliable, long-term supply of renewable and sustainable energy at a reasonable cost to meet part of the electric energy needs of Oglethorpe's members. The Final EIS evaluated the potential environmental impacts of and alternatives to the Project proposed by Oglethorpe for RUS financing to construct the 100 megawatt (MW) biomass plant and related facilities (Proposal) in Warren County, Georgia

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to Pace Biologics, LLC, a company having a place of business in Elkridge, Maryland, to practice the inventions embodied in U.S. Provisional Patent Application No. 61/ 180,491, filed May 22, 2009 (HHS Ref. No. E-134-2009/0-US-01), PCT Patent Application No. PCT/US2010/035823, filed May 21, 2010 (HHS Ref. No. E-134-2009/0-PCT-02), and U.S. Patent Application No. 13/322,066, filed November 22, 2011 (HHS Ref. No. E-134-2009/0-US-03), all entitled ``Engineered Biological Pacemakers.'' The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``Gene therapy and cell-based therapy for cardiac arrhythmias in humans.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, Pace Biologics will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

In this order, the Federal Communications Commission (Commission) grants limited forbearance from the requirement of the Commission's rules that the service area of an eligible telecommunications carrier (ETC) conform to the service area of any rural telephone company serving the same area. In particular, this grant of forbearance applies to any ETC that has been designated by a state or the Commission, as well as pending and future requests by telecommunications carriers that seek limited designation, as an ETC to participate only in the Lifeline program (Lifeline-only ETC). The Commission concludes that forbearance furthers the Act's and Commission's goals of ensuring the availability of voice service to low-income consumers.

In accordance with the Privacy Act of 1974, the Department of Transportation's Office of the Secretary of Transportation (DOT/OST) intends to establish a DOT-wide System of Records of Transportation system of records titled, ``DOT/ALL-25, Department of Transportation Biographies System of Records.'' The Department also intends to consolidate the following legacy record systems DOT/FAA 837 Photographs and Biographical Information (April 11, 2000) and DOT/MARAD 011 Biographical Files (April 11, 2000) as part of the same. This system of records will allow the Department of Transportation, to include its Operating Administrations and Secretarial Offices, to collect and maintain biographical information of Department of Transportation employees and other individuals for the purpose of publicizing skills, experiences, and expertise relevant to Department of Transportation activities and services. These records are separate and distinct from and are not compiled from records maintained by the Department for any other function including but not limited to human resources. This system, titled Biographies, will be included in the Department of Transportation's inventory of record systems.

This action provides notice that on April 30, 2013, the Acting EPA Administrator, Bob Perciasepe, signed a letter denying a petition to add coal mines to the Clean Air Act (CAA) section 111 list of stationary source categories. The agency denied the petition because the EPA must prioritize its actions in light of limited resources and ongoing budget uncertainties, and at this time, cannot commit to conducting the process to determine whether coal mines should be added to the list of categories under CAA 111(b)(1)(A). The letter explains in detail the EPA's reasons for the denial.

The Farm Credit Administration (FCA) published a final rule in the Federal Register on April 18, 2013 to strengthen liquidity risk management at Farm Credit System (System) banks, improve the quality of assets in their liquidity reserves, and bolster the ability of System banks to fund their obligations and continue operations during times of economic, financial, or market adversity. This document corrects that rule by replacing a term that was inadvertently used.

This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2014 (for discharges occurring on or after October 1, 2013 and on or before September 30, 2014) as required by the statute. We are also proposing to revise the list of diagnosis codes that are used to determine presumptive compliance under the ``60 percent rule,'' update the IRF facility-level adjustment factors, revise sections of the Inpatient Rehabilitation Facility-Patient Assessment Instrument, revise requirements for acute care hospitals that have IRF units, clarify the IRF regulation text regarding limitation of review, update references to previously changed sections in the regulations text, and revise and update quality measures and reporting requirements under the IRF quality reporting program.

EPA is revising the data requirements for antimicrobial pesticide products to reflect current scientific and regulatory practice, and to provide the regulated community with clearer and transparent information about the data needed to support pesticide registration decisions for antimicrobial products. The updated data requirements also serve to further enhance EPA's ability to make regulatory decisions about the human health, and environmental fate and effects of antimicrobial pesticide products. These revisions are also expected to help protect human health and the environment by providing an up-to-date scientific framework for identifying and assessing the risks of antimicrobial pesticides sold or distributed in the United States.