September 22, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

The Pacific Fishery Management Council (Pacific Council) will convene a meeting of its Coastal Pelagic Species Management Team (CPSMT). The meeting will be a work session to further develop the draft environmental assessment for Pacific sardine harvest faction.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the Food and Drug Administration, an agency within the Department of Health and Human Services, through the National Institutes of Health Office of Technology Transfer is contemplating the grant of an exclusive worldwide license to practice the inventions embodied in HHS Ref. No. E-258-2011/0, ``Direct Impact Corona Ionization (DICI) Mass Spectrometry;'' U.S. Patent 8,704,169, to Vivione Biosciences, Inc., a corporation incorporated under the laws of the State of Arkansas, having a principle place of business at 515 W. Matthews Ave., Jonesboro, AR 72401. The United States of America is the assignee of the patent rights pertaining to this invention. The exclusivity period of the contemplated license may be granted for no more than seven (7) years, may be territorially limited to the United States and may be limited to a field of use directed to direct impact corona ionization mass spectrometry pattern recognition devices and systems for detection of small molecules and microbiological agents.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Draft Guidance on Estradiol.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for estradiol vaginal cream. This draft guidance is a revised version of a previously issued draft guidance of the same subject.

NMFS proposes regulations to implement Amendment 18 to the Pacific Coast Salmon Fishery Management Plan for Commercial and Recreational Salmon Fisheries off the Coasts of Washington, Oregon, and California (FMP). Amendment 18, which was transmitted by the Pacific Fishery Management Council (PFMC) on June 10, 2014, revises the description and identification of essential fish habitat (EFH) for Pacific salmon managed under the FMP, designates habitat areas of particular concern (HAPCs), updates the current information on fishing activities, and updates the list of non-fishing related activities that may adversely affect EFH and potential conservation and enhancement measures to minimize those effects.

The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995, 44 U.S.C Chapter 35 requires federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.

The Coast Guard is establishing a temporary safety zone for all waters of the Missouri River, covering all waters within a 700 foot radius of the barge located at mile 372.0. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during the Riverside Music Festival. Entry into, transit through or remaining within this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Upper Mississippi River or a designated representative.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (``CERCLA'' or ``the Act''), as amended, requires that the National Oil and Hazardous Substances Pollution Contingency Plan (``NCP'') include a list of national priorities among the known releases or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The National Priorities List (``NPL'') constitutes this list. The NPL is intended primarily to guide the Environmental Protection Agency (``the EPA'' or ``the agency'') in determining which sites warrant further investigation. These further investigations will allow the EPA to assess the nature and extent of public health and environmental risks associated with the site and to determine what CERCLA-financed remedial action(s), if any, may be appropriate. This rule adds five sites to the General Superfund section of the NPL.

The Federal Maritime Commission (FMC or Commission) is confirming the effective date of the direct final rule published on July 24, 2014, and responds to the comment received. The rule changes the method the Commission uses to provide public notice of Ocean Transportation Intermediary (OTI) license applications, revocations and suspensions by publishing this information on the FMC's official public Web site rather than publishing the same information in the Federal Register. This change provides more timely public notification of official FMC action on OTI licensing matters, simplifies the Commission's business processes, and reduces agency administrative costs.

The Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA'' or ``the Act''), as amended, requires that the National Oil and Hazardous Substances Pollution Contingency Plan (``NCP'') include a list of national priorities among the known releases or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The National Priorities List (``NPL'') constitutes this list. The NPL is intended primarily to guide the Environmental Protection Agency (``EPA'' or ``the agency'') in determining which sites warrant further investigation. These further investigations will allow the EPA to assess the nature and extent of public health and environmental risks associated with the site and to determine what CERCLA-financed remedial action(s), if any, may be appropriate. This rule proposes to add three sites to the General Superfund section of the NPL.

The Environmental Protection Agency (EPA) is taking direct final action to approve a revision to the West Virginia State Implementation Plan (SIP). The revision pertains to amendments of West Virginia's Legislative Rule on Ambient Air Quality Standards which change the effective date of the incorporation by reference of the National Ambient Air Quality Standards (NAAQS) as well as their monitoring reference and equivalent methods. EPA is approving these revisions in accordance with the requirements of the Clean Air Act (CAA).

The three Mississippi River locks in Minneapolis, MN (Upper St. Anthony Falls, Lower St. Anthony Falls, and Lock and Dam 1) currently operate 19 hours per day/7 days per week during the navigation season. This level of service follows the guidance from the Corps Inland Marine Transportation System (IMTS) Board of Directors. Section 2010 of the Water Resources Reform and Development Act of 2014 (WRRDA) directed the Secretary of the Army to close the Upper St. Anthony Falls Lock and Dam located on the Mississippi River at river mile 853.9 no later than 1 year after the enactment date of WRRDA 2014. With the expected closing of the Upper St. Anthony Falls lock, it is anticipated the remaining two Minneapolis locks will have less than 500 commercial lockages per year. To meet IMTS guidance, it is proposed Lower St. Anthony Falls and Lock and Dam 1 transition to one 10-hour shift per day/7 days per week during the 2015 navigation season and beyond. The navigation season on the Upper Mississippi normally begins in March, depending on river conditions, and wraps up by the end of November. Pool levels will not be affected by change of operating hours.

The Commission is noticing a recent Postal Service filing concerning an addition of Global Reseller Expedited Package Contracts 4 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

To comply with the Paperwork Reduction Act of 1995 (PRA), BSEE is notifying the public that we have submitted to OMB an information collection request (ICR) for review approval of the paperwork requirements in the regulations under Subpart M, Unitization. This notice also provides the public a second opportunity to comment on the revised paperwork burden of these regulatory requirements.

The Assistant Secretary of the Interior for Land and Minerals Management on behalf of the Bureau of Land Management (BLM) proposes to withdraw approximately 2,560 acres of public lands in Yuma County, Arizona, from location or entry under the United States mining laws, to protect and preserve for a 20-year period, the Agua Caliente Solar Energy Zone (SEZ). The lands will remain open to leasing under the mineral and geothermal leasing laws, and disposal under the Materials Act of 1947.

The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, ``Employment and Training Administration Disaster Unemployment Assistance Handbook,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). Public comments on the ICR are invited.

The Coast Guard is issuing this final rule to remove references to type codes in its regulations on the carriage and labeling of Coast Guard-approved personal flotation devices (PFDs). Removing these type codes from our regulations will facilitate future incorporation by reference of new industry consensus standards for PFD labeling that more effectively convey safety information, and is a step toward harmonization of our regulations with PFD requirements in Canada and in other countries.

The National Aeronautics and Space Administration (NASA) is deleting existing drug-free workplace requirements for financial assistance in one Title of the Code of Federal Regulations (CFR), and moving it to another Title, consistent with the Office of Management and Budget's (OMB) guidance on drug-free workplace requirements for financial assistance. Further, NASA is implementing, and thereby giving regulatory effect to, the OMB guidance on drug-free workplace requirements for financial assistance.

This document makes a correction to a notice published in the Federal Register on August 19, 2014, regarding entry-level driver training; consideration of negotiated rulemaking process. The correction involves a clarification of the contractual relationship that FMCSA has with the convener, Mr. Richard Parker.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, AHRQ [has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery,'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.). This proposed information collection was previously published in the Federal Register on June 4th 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Board and the Bureau are publishing final rules amending the official interpretations and commentary for the agencies' regulations that implement the Truth in Lending Act (TILA). The Dodd- Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) amended TILA by requiring that the dollar threshold for exempt consumer credit transactions be adjusted annually by any annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). Based on the annual percentage increase in the CPI-W as of June 1, 2014, the Board and the Bureau are adjusting the exemption threshold to $54,600, effective January 1, 2015. Because the Dodd-Frank Act also requires similar adjustments in the Consumer Leasing Act's threshold for exempt consumer leases, the Board and the Bureau are making similar amendments to each of their respective regulations implementing the Consumer Leasing Act in a joint rulemaking published elsewhere in this issue of the Federal Register.