February 10, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the following public workshop entitled, ``Advancing the Development of Biomarkers in Traumatic Brain Injury.'' This workshop aims to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for traumatic brain injury (TBI). By convening the relevant stakeholders, the goal is to obtain input on the scientific, clinical, patient, and regulatory considerations associated with TBI biomarker development to improve diagnosis and clinical utility for TBI.

The Environmental Protection Agency (EPA) today proposes to amend federal regulations that designated, and placed restrictions on the use of, the Central Long Island Sound and Western Long Island Sound dredged material disposal sites, located offshore from New Haven and Stamford, Connecticut, respectively. The amended regulation incorporates standards and procedures for the use of those sites as recommended in the Long Island Sound Dredged Material Management Plan, which was completed by the U.S. Army Corps of Engineers on January 11, 2016. The Dredged Material Management Plan identifies a wide range of alternatives to open-water disposal and recommends standards and procedures for determining which alternatives to pursue for different dredging projects, so as to reduce or eliminate wherever practicable the open-water disposal of dredged material.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

On December 10, 2015, the State of Arkansas, through the Arkansas Department of Environmental Quality (ADEQ), submitted a request for the Environmental Protection Agency (EPA) to redesignate the portion of Arkansas that is within the Memphis, Tennessee- Mississippi-Arkansas (Memphis, TN-MS-AR) 2008 8-hour ozone nonattainment area (hereafter referred to as the ``Memphis, TN-MS-AR Area'' or ``Area'') and to approve a State Implementation Plan (SIP) revision containing a maintenance plan for the Area. EPA is proposing to determine that the Memphis, TN-MS-AR Area is continuing to attain the 2008 8-hour ozone national ambient air quality standards (NAAQS); to approve the State's plan for maintaining attainment of the 2008 8- hour ozone standard in the Area, including the motor vehicle emission budgets (MVEBs) for nitrogen oxides (NOX) and volatile organic compounds (VOC) for the years 2012 and 2027 for the Arkansas portion of the Area, into the SIP; and to redesignate the Arkansas portion of the Area to attainment for the 2008 8-hour ozone NAAQS. EPA is also notifying the public of the status of EPA's adequacy determination for the MVEBs for the Arkansas portion of the Memphis, TN-MS-AR Area.

This action proposes to establish Class E airspace at Ketchum, OK. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures developed at South Grand Lake Regional Airport, for the safety and management of Instrument Flight Rules (IFR) operations at the airport.

The Agricultural Marketing Service (AMS) is amending regulations pertaining to administrative and operational procedures for the classification of foreign-growth cotton. In anticipation that cotton merchants may want to use AMS cotton quality determinations to establish foreign-growth cotton as tenderable against the World Cotton futures contract offered by the Intercontinental Exchange (ICE), representatives of the U.S. cotton industry and ICE formally requested that AMS make any regulatory amendments necessary to better accommodate the classification of foreign-growth cotton. Consequently, AMS seeks to clarify the existing language, update the terms and practices described to comply with today's industry norms and current cotton classification technologies, and establish procedural safeguards to the classification process for foreign-growth cotton that promote accuracy.