May 2015 – Federal Register Recent Federal Regulation Documents

In accordance with the Paperwork Reduction Act of 1995 and its implementing regulations, the Federal Railroad Administration (FRA) hereby announces that it is seeking an extension of the following currently approved information collection activities. On April 23, 2015, FRA and the Pipeline and Hazardous Materials Administration (PHMSA) jointly published in the Federal Register a Safety Advisory titled Hazardous Materials: Information Requirements Related to the Transportation of Trains Carrying Specified Volumes of Flammable Liquids (FRA Safety Advisory 2015-02; Docket No. PHMSA-2015-0118, Notice 15-11). See 80 FR 22778. The information collection activities associated with the Joint Safety Advisory received a six-month emergency approval from OMB on April 30, 2015. FRA seeks a regular clearance (extension of the current approval for three years) so that its personnel and PHMSA personnel can continue to collect certain information that is essential during the course of an investigation immediately following a train accident. Before submitting these information collection requirements for clearance by the Office of Management and Budget (OMB), FRA is soliciting public comment on specific aspects of the activities identified below.

In accordance with the Paperwork Reduction Act of 1995 and its implementing regulations, the Federal Railroad Administration (FRA) hereby announces that it is seeking an extension of the following currently approved information collection activities. On April 27, 2015, FRA published in the Federal Register its Emergency Order No. 30 titled Emergency Order Establishing a Maximum Operating Speed of 40 mph in High-Threat Urban Areas for Certain Trains Transporting Large Quantities of Class 3 Flammable Liquids. See 80 FR 23321. The information collection activities associated with the Joint Safety Advisory received a six-month emergency approval from OMB on April 30, 2015. FRA seeks a regular clearance (extension of the current approval for one year) so that it can continue to receive and evaluate special petitions of approval from railroads requesting relief from this Emergency Order. In these petition requests, railroads must state their proposed alternative action that will provide at least an equivalent level of safety to that provided by this Emergency Order. Before submitting these information collection requirements for clearance by the Office of Management and Budget (OMB), FRA is soliciting public comment on specific aspects of the activities identified below.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.

The DoD is publishing this notice to announce two days of meetings of the National Commission on the Future of the Army (``the Commission''). The meetings will be partially closed to the public.

The current version of the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs. Subpart MMedical Review Officer (MRO), Section 13.1(b) of the Mandatory Guidelines, ``Who may serve as an MRO?'' states as follows: ``Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal employee drug test results that seek approval by the Secretary must submit their qualifications and a sample examination. Based on an annual objective review of the qualifications and content of the examination, the Secretary shall annually publish a list in the Federal Register of those entities and boards that have been approved.'' HHS has completed its review of entities that certify MROs, in accordance with requests submitted by such entities to HHS. The HHS Secretary approves the following MRO certifying entities that offer MRO certification through examination:

The Susquehanna River Basin Commission published a document in the Federal Register of May 15, 2015, concerning projects approved by rule by the Susquehanna River Basin Commission during the period set forth in DATES. The document contained incorrect dates.

The Coast Guard is establishing a temporary safety zone encompassing a portion of the Detroit River in Detroit, Michigan. This safety zone is necessary to protect Belle Isle Grand Prix participants, spectators and vessels from the hazards associated with a high speed automobile race in close proximity to a navigable waterway. This safety zone will establish restrictions upon, and control movement of, vessels in a portion of the Detroit River. During the enforcement period, no person or vessel may enter the regulated area without permission of the Captain of the Port.

The Coast Guard is temporarily modifying the operating schedule that governs the East Venetian Causeway Bridge across Miami Beach Channel, Miami-Dade County, Florida. For approximately nine months, the West Venetian Causeway Bridge will remain in the open position to complete necessary repairs. This rule will temporarily authorize the fulltime closure of the East Venetian Causeway Bridge to ensure that vehicular traffic will be able to access and depart from the Venetian Causeway while emergency repairs are completed.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to the current licensee, Lion Biotechnologies, Inc., which is located in Woodland Hills, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications: 1. U.S. Provisional Patent Application No. 61/237,889, filed August 26, 2009 entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No. E-273-2009/0-US-01); 2. U.S. Patent No. 8,383,099 issued February 26, 2013 entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No. E-273-2009/0- US-02); 3. U.S. Patent Application No. 13/742,541 filed January 16, 2013 entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No. E- 273-2009/0-US-03); 4. U.S. Provisional Patent Application No. 61/466,200 filed March 22, 2011 entitled ``Methods of growing tumor infiltrating lymphocytes in gas-permeable containers'' (HHS Ref No. E-114-2011/0-US-01); 5. PCT Application No. PCT/US2012/029744 filed March 20, 2012 entitled ``Methods of growing tumor infiltrating lymphocytes in gas- permeable containers'' (HHS Ref No. E-114-2011/0-US-01); 6. U.S. Patent Application No. 13/424,646 filed May 20, 2012 entitled ``Methods of growing tumor infiltrating lymphocytes in gas- permeable containers'' (HHS Ref No. E-114-2011/0-US-01); 7. U.S. Provisional Patent Application No. 61/846,161 filed July 15, 2013 entitled ``Methods of Preparing Anti-human Papillomavirus Antigen T Cells'' (HHS Ref No. E-494-2013/0-US-01); 8. PCT Application No. PCT/US2014/046478 filed July 14, 2014 entitled ``Methods of Preparing Anti-human Papillomavirus Antigen T Cells'' (HHS Ref No. E-494-2013/0-PCT-02); The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights to develop, manufacture, distribute, sell and use unselected whole autologous tumor infiltrating lymphocyte (TIL) adoptive cell therapy products for the treatment of lung, breast, bladder, and HPV- positive cancers. Specifically excluded from this license are methods of generating or using selected subpopulations of TIL and the use of T cell receptors isolated from TIL.

The Department of Agriculture's (USDA) Grain Inspection, Packers and Stockyards Administration (GIPSA) is seeking nominations for individuals to serve on the USDA Grain Inspection Advisory Committee (Advisory Committee). The Advisory Committee meets twice annually to advise GIPSA on the programs and services it delivers under the U.S. Grain Standards Act (USGSA). Recommendations by the Advisory Committee help GIPSA better meet the needs of its customers who operate in a dynamic and changing marketplace.

The Export-Import Bank of the United States (Ex-Im Bank), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. The Application for Global Credit Express Revolving Line of Credit is used to determine the eligibility of the applicant and the transaction for Export-Import Bank assistance under its Working Capital Guarantee and Direct Loan Program. This form is used by small U.S. businesses with limited export experience. This program relies to a large extent on the exporter's qualifying score on the FICO (Fair Isaac Corporation) SBSS (Small Business Scoring Service). Therefore the financial and credit information needs are minimized. This is a request to renew an existing form. The only change is to enhance a question about company ownership so as to improve the quality of information derived from the question. The form can be viewed at: https://www.exim.gov/pub/pending/EIB11- 08-Final.pdf.

On February 20, 2015, the Ohio Environmental Protection Agency (Ohio EPA) submitted a request to the Environmental Protections Agency (EPA) to make a determination under the Clean Air Act (CAA) that the Cleveland and Delta nonattainment areas have attained the 2008 lead (Pb) national ambient air quality standard (NAAQS or standard). In this action, EPA is determining that the Cleveland and Delta nonattainment areas (hereafter also referred to as the ``Cleveland area'', ``Delta area'' or ``areas'') have attained the 2008 Pb NAAQS. These determinations of attainment are based upon complete, quality-assured and certified ambient air monitoring data for the 2012-2014 design period showing that the areas have monitored attainment of the 2008 Pb NAAQS. Additionally, as a result of this determination, EPA is suspending the requirements for the areas to submit attainment demonstrations, together with reasonably available control measures (RACM), reasonable further progress (RFP) plans, contingency measures for failure to meet RFP, and attainment deadlines for as long as the areas continue to attain the 2008 Pb NAAQS.

The Environmental Protection Agency (EPA) is reissuing its final approval of the Colorado regional haze State Implementation Plan (SIP) revision submitted on May 25, 2011 with respect to the State's best available retrofit technology (BART) determination for the Comanche Generating Station (Comanche) near Pueblo, Colorado. EPA originally finalized its approval of the Colorado regional haze SIP on December 31, 2012. In response to a petition for review of that final action in the United States Court of Appeals for the Tenth Circuit, EPA successfully moved for a voluntary remand, without vacatur, to more adequately respond to public comments concerning Comanche. EPA is providing new responses to those comments in this rulemaking notice.

The Environmental Protection Agency (EPA) is proposing to disapprove a State Implementation Plan (SIP) revision submitted by the Delaware Department of Natural Resources and Environmental Control (DNREC) for the State of Delaware on October 15, 2013. EPA is proposing this action because the submittal does not satisfy the requirements of Clean Air Act (CAA) or the Federal implementing regulations, which establish the criteria under which the owner or operator of a new or modified major stationary source must obtain the required emission offsets ``from the same source or other sources in the same nonattainment area'' with limited exceptions, for Delaware's nonattainment New Source Review (NSR) preconstruction permitting program. In addition, EPA is proposing disapproval of the SIP revision because Delaware exercises authorities that are reserved for EPA under section 107 of the CAA. This action is being taken under the CAA.

The Federal Energy Regulatory Commission (Commission) proposes to approve Reliability Standard TPL-007-1 (Transmission System Planned Performance for Geomagnetic Disturbance Events). Proposed Reliability Standard TPL-007-1 establishes requirements for certain entities to assess the vulnerability of their transmission systems to geomagnetic disturbance events (GMDs), which occur when the sun ejects charged particles that interact and cause changes in the earth's magnetic fields. Entities that do not meet certain performance requirements, based on the results of their vulnerability assessments, must develop a plan to achieve the requirements. The North American Electric Reliability Corporation (NERC), the Commission-certified Electric Reliability Organization, submitted the proposed Reliability Standard for Commission approval in response to a Commission directive in Order No. 779. In addition, the Commission proposes to direct that NERC develop modifications to the benchmark GMD event definition set forth in Attachment 1 of the proposed Reliability Standard so that the definition is not based solely on spatially-averaged data. The Commission also proposes to direct NERC to submit a work plan, and subsequently one or more informational filings, that address specific GMD-related research areas.

The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, ``Requests to Non-Agreement States for Information.''

The Environmental Protection Agency (EPA) is approving the removal of general conformity regulations from the Ohio state implementation plan (SIP) under the Clean Air Act. These regulations are no longer necessary since the establishment of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users transportation act removed the requirement for states to maintain general conformity regulations.

This action amends Class E Airspace at Clarksburg, WV, as the Clarksburg VOR/DME has been decommissioned, requiring airspace redesign at North Central West Virginia Airport, formerly Benedum Airport. This action enhances the safety and management of Instrument Flight Rules (IFR) operations at the airport. This action also updates the geographic coordinates of the airport.

This action removes Class E Airspace at Lexington, TN, as the Franklin Wilkins Airport has been abandoned, and controlled airspace is no longer required. This action enhances the safety and airspace management around the Lexington, TN, area.