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Closed meeting of the Art Advisory Panel will be held in Washington, DC.
The SEDAR 41 assessments of the South Atlantic stocks of red snapper and gray triggerfish will consist of a series of workshops and webinars: A Data Workshop; an Assessment Workshop; and a Review Workshop. See SUPPLEMENTARY INFORMATION.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Observer Policy Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
In the Rules and Regulations section of this issue of the Federal Register, the IRS is issuing temporary regulations relating to the branded prescription drug fee. This fee was enacted by section 9008 of the Patient Protection and Affordable Care Act, as amended by section 1404 of the Health Care and Education Reconciliation Act of 2010, and the Health Care and Reconciliation Act of 2010 (collectively the ACA). The proposed regulations modify the definition of controlled group for purposes of the branded prescription drug fee. The proposed regulations affect persons engaged in the business of manufacturing or importing certain branded prescription drugs. The text of the temporary regulations also serves as the text of the proposed regulations.
This document contains final regulations that provide guidance on the annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs. This fee was enacted by section 9008 of the Patient Protection and Affordable Care Act, as amended by section 1404 of the Health Care and Education Reconciliation Act of 2010. This document also withdraws the Branded Prescription Drug Fee temporary regulations and contains new temporary regulations regarding the definition of controlled group that apply beginning on January 1, 2015. The final regulations and the new temporary regulations affect persons engaged in the business of manufacturing or importing certain branded prescription drugs. The text of the temporary regulations in this document also serves as the text of proposed regulations set forth in a notice of proposed rulemaking (REG-123286- 14) on this subject in the Proposed Rules section in this issue of the Federal Register.
In the Rules and Regulations section of this issue of the Federal Register, the IRS is issuing final and temporary regulations under section 36B of the Internal Revenue Code (Code) relating to the health insurance premium tax credit. The regulations provide guidance to individuals who enroll in qualified health plans through Affordable Insurance Exchanges (Exchanges) and claim the premium tax credit, and Exchanges that make qualified health plans available to individuals and employers. The text of those temporary regulations also serves as the text of these proposed regulations.
This document contains final and temporary regulations relating to the health insurance premium tax credit enacted by the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, as amended by the Medicare and Medicaid Extenders Act of 2010, the Comprehensive 1099 Taxpayer Protection and Repayment of Exchange Subsidy Overpayments Act of 2011, and the Department of Defense and Full-Year Continuing Appropriations Act of 2011 and the 3% Withholding Repeal and Job Creation Act. These regulations affect individuals who enroll in qualified health plans through Affordable Insurance Exchanges (Exchanges) and claim the premium tax credit, and Exchanges that make qualified health plans available to individuals. The text of the temporary regulations in this document also serves as the text of proposed regulations set forth in a notice of proposed rulemaking (REG-104579-13) on this subject in the Proposed Rules section in this issue of the Federal Register.
Exploring the Possibility of Proprietary Name Reservation for Drug Products; Establishment of a Public Docket
The Food and Drug Administration (FDA or Agency) is establishing a public docket to discuss issues related to reserving proprietary names for drug products. During the negotiations for the 2007 reauthorization of the Prescription Drug User Fee Amendments Act (PDUFA IV), FDA agreed to several performance goals related to the review of drug and biological product proprietary names to reduce medication error. Among those goals, FDA and industry expressed an interest in exploring the possibility of ``reserving'' proprietary names for companies once the names have been tentatively accepted by the Agency. Accordingly, FDA is initiating a public process to discuss issues around reserving proprietary names.
Method of Accounting for Gains and Losses on Shares in Certain Money Market Funds; Broker Returns With Respect to Sales of Shares in Money Market Funds
This document contains proposed regulations that provide a simplified method of accounting for gains and losses on shares in money market funds (MMFs) that distribute, redeem, and repurchase their shares at prices that reflect market-based valuation of the MMFs' portfolios and more precise rounding than has been required previously (floating net asset value MMFs, or floating-NAV MMFs). The proposed regulations also provide guidance regarding information reporting requirements for shares in MMFs. The proposed regulations respond to Securities and Exchange Commission (SEC) rules that change how certain MMF shares are priced. The proposed regulations affect floating-NAV MMFs and their shareholders. This document also contains requests for comments and provides notice of a public hearing on these proposed regulations.
The Coast Guard is establishing a safety zone for the Marine Week Seattle Seahawks Demonstration area on Lake Washington, Seattle, WA. This event will occur on July 30, 2014 and July 31, 2014. This action is necessary to protect participants and the maritime public from the safety hazards associated with this event, which involves low flying aircraft, combat equipment, and other on-water displays, and will do so by prohibiting any person or vessel from entering or remaining in the safety zone unless authorized by the Captain of the Port (COTP) or a Designated Representative.
The Coast Guard published a final rule in the Federal Register on July 7, 2014, that made non-substantive corrections throughout Title 33 of the Code of Federal Regulations. One of the amendatory instructions, which was intended to update a mailing stop number, contained a reference to the wrong paragraph in a section. This rule corrects that error.
The Coast Guard is establishing a temporary safety zone on the Cuyahoga River, Cleveland, OH. This temporary safety zone is intended to restrict vessels from a portion of the Cuyahoga River during the installation operation for the new Columbus Road Bridge spanning the Cuyahoga River. This temporary safety zone is necessary to protect mariners and vessels and construction crews from the navigational hazards associated with blocking the river for the large scale heavy lift of the bridge structure and securing it to the towers on either side of the river.
The Kidney Interagency Coordinating Committee (KICC) will hold a meeting on September 12, 2014 about assessing public health interventions in chronic kidney disease (CKD). The meeting is open to the public.
Proposed Collection; 60-Day Comment Request; Progress Reports for Center for Global Health's Low and Mid-Income Countries; (LMICs) Global Health Collaborations
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Teri Brown, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W530, Rockville, MD 20850 or call non-toll-free number 240-276-5810 or Email your request, including your address to: firstname.lastname@example.org. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Progress Reports for Center for Global Health's Low and Mid-Income Countries (LMICs) Global Health Collaborations, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Global Health's (CGH) Low and Mid-Income Countries (LMICs) Global Health Collaborations is proposing new program specific progress report guidelines. The CGH LMIC Global Health Collaborations are part of a pilot initiative and partnership, between the NCI CGH and the Office of Cancer Centers (OCC), to promote collaborations between the NCI designated Cancer Centers and foreign institutions from Low and Middle Income Countries (LMICs). This collaboration is designed to develop and implement mutually beneficial global cancer research programs by increasing the capability of these countries to participate and partner in cancer research. The proposed guidelines request information about award performance related to objectives, accomplishments, barriers and challenges, collaborators, and findings. The information is gathered six months into the award and 12 months after the award (upon expiry). This information is needed to monitor the performance of this special program within NCI, funded through three Request for Proposals (RFPs); the first was released April 18, 2013 and CGH expects to release another in 2014 and the final one in 2015. The respondents are the Principal Investigators of the awards. The information will be used to monitor individual award performance and the effectiveness of the program as a whole. Since these projects are funded through the contract mechanism, the PIs will not be required to submit interim and final progress reports like other National Institutes of Health grantees must. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 83.
National School Lunch, Special Milk, and School Breakfast Programs: National Average Payments/Maximum Reimbursement Rates
This document contains a correction to the notice published in the Federal Register on July 16, 2014 entitled, ``National School Lunch, Special Milk, and School Breakfast Programs: National Average Payments/Maximum Reimbursement Rates.''
Fresenius Kabi USA, LLC applied to be registered as an importer of a basic class of narcotic controlled substance. The Drug Enforcement Administration grants Fresenius Kabi USA, LLC registration as an importer of this controlled substance.
Amendments to Compliance Certification Content Requirements for State and Federal Operating Permits Programs
The Environmental Protection Agency (EPA) is amending the compliance certification requirements for state and federal operating permits programs that were published in the Federal Register on June 27, 2003. In that action, one sentence was removed from the rules inadvertently. This action restores the sentence to its original location in the rules.
The U.S. Federal Highway Administration (FHWA) in coordination with the District of Columbia Department of Transportation (DDOT) in Washington, DC is issuing this notice to advise agencies and the public that a Supplemental Final Environmental Impact Statement (SFEIS) will be prepared for the South Capitol Street Project (the Project). The Project proposes to make major changes to the South Capitol Street Corridor from Firth Sterling Avenue SE to Independence Avenue and the Suitland Parkway from Martin Luther King, Jr. Avenue SE., to South Capitol Street, including replacing the existing Frederick Douglass Memorial Bridge over the Anacostia River.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
The Department of Agriculture, Forest Service, will prepare an environmental impact statement (EIS) on a proposal to construct, operate and maintain a new electrical transmission line intertie that would extend west across the Tongass National Forest from the Petersburg area to the community of Kake. The proposed action is to construct a new transmission line, and associated features, that would transmit power at either 69 or 138 kilovolt (kV) and consist of single wood-pole structures with horizontal post insulators, with average span of lengths between poles of 350 to 400 feet. The proposed project would also include a 24-strand fiber optic communication cable. Construction access would be via existing roads, temporary shovel trails and matting panels, and temporary access spurs, with helicopter support as needed. The proposed project would cross National Forest System (NFS) lands in the Petersburg Ranger District of the Tongass National Forest. The length of the proposed electrical transmission line is approximately 60 miles and would follow a route identified as a Transportation and Utility Systems (TUS) land use designation (LUD) corridor; labeled ``Potential Power Transmission Corridor'' on the 2008 Tongass National Forest Land and Resource Management Plan (Forest Plan) LUD map. An estimated 59 percent, or 35.2 miles, of the overhead portion of the proposed transmission line would follow existing roads. No new road segments would be built; existing roads would be used for long-term maintenance access where possible.
The purpose of this notice is to request public nominations to fill four positions for the Bureau of Land Management (BLM) Wyoming 10- member Resource Advisory Council (RAC). The RAC provides advice and recommendations to the BLM on land use planning and management of the National System of Public Lands within Wyoming.
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].'' This guidance document describes FDA's current review practices for premarket notification (510(k)) submissions by describing in greater detail the regulatory framework, policies, and practices underlying FDA's review of traditional 510(k) submissions. This guidance document does not address the special and abbreviated 510(k) programs. FDA intends to finalize those sections separately.
Fisheries of the Exclusive Economic Zone Off Alaska: Pacific Halibut and Sablefish Individual Fishing Quota Program
NMFS publishes regulations to amend the hired master provisions of the Individual Fishing Quota Program (IFQ Program) for the fixed-gear commercial Pacific halibut and sablefish fisheries in the Bering Sea and Aleutian Islands (BSAI) and the Gulf of Alaska (GOA). The IFQ Program allows initial recipients of catcher vessel halibut and sablefish quota share (QS) to hire a vessel master to harvest an annual allocation of individual fishing quota (IFQ) derived from the QS. This rule prohibits an initial QS recipient from using a hired master to harvest IFQ derived from catcher vessel QS received by transfer after February 12, 2010, with a limited exception for small amounts of QS. This final rule is necessary to maintain progress toward a predominantly owner-onboard fishery. In addition, this action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the Northern Pacific Halibut Act of 1982, the Fishery Management Plan for Groundfish of the BSAI, the Fishery Management Plan for Groundfish of the GOA, and other applicable laws.
Department of Defense Science and Technology Reinvention Laboratory (STRL) Personnel Management Demonstration Project Program
STRLs will implement Senior Scientific Technical Manager (SSTM) positions, which are defined as senior professional scientific and technical positions classified above the GS-15 level of the General Schedule (GS). The primary functions of these positions shall be (1) to engage in research and development in the physical, biological, medical, or engineering sciences, or another field closely related to the mission of such STRL; and (2) to carry out technical supervisory responsibilities. These positions may only be established at authorized STRLs with personnel demonstration projects. STRLs will also implement two new direct-hire authorities to appoint bachelor's degree candidates into scientific and engineering positions and veteran candidates into scientific, technical, engineering, and mathematics positions. The current direct-hire authority to appoint candidates with an advanced degree into scientific and engineering positions is also being included in this notice so that all STRL direct-hire authorities are documented in one location.
Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act
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 National Endowment for the Arts (NEA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery, This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection,
The Surface Transportation Board (STB or Board), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Extension of Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3519 (PRA). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on the Board's service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection. Comments are requested concerning: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose, or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Submitted comments will be summarized and included in the Board's request for OMB approval.
Notice is hereby given that the North Carolina Department of Marine Fisheries (NCDMF) has been issued a permit for the incidental take of Atlantic sturgeon (Acipenser oxyrinchus oxyrinchus) Distinct Population Segments (DPSs) associated with the otherwise lawful commercial inshore gillnet fishery in North Carolina.
Amended and Restated Order Designating the Provider of Legal Entity Identifiers To Be Used in Recordkeeping and Swap Data Reporting Pursuant to the Commission's Regulations
The Commodity Futures Trading Commission (``Commission'') has issued an Amended and Restated Order to extend the Commission's designation of the Depository Trust and Clearing Corporation (``DTCC'') and Society for Worldwide Interbank Financial Telecommunication (``SWIFT'') joint venture (``DTCC-SWIFT'') as the provider of legal entity identifiers, or ``LEIs,'' pursuant to the Commodity Exchange Act and the Commission's regulations. DTCC-SWIFT's designation was made by Commission order issued on July 23, 2012. The designation was made for a term of two years. The Amended and Restated Order amends the Commission's order of July 23, 2012, as previously amended on June 7, 2013, to extend DTCC-SWIFT's designation for an additional one year, while the terms of transition to a fully operational global LEI system are finalized and implemented. Consistent with the terms of the Commission's order of July 23, 2012, as amended on June 7, 2013, the Amended and Restated Order permits registered entities and swap counterparties subject to the Commission's jurisdiction to comply with the specified legal entity identifier requirements of the Commission's regulations by using identifiers issued by DTCC-SWIFT, or any other pre-Local Operating Unit (``pre-LOU'') that has been endorsed by the Regulatory Oversight Committee of the global LEI system as being globally acceptable and as issuing globally acceptable legal entity identifiers.
On April 25, 2014, FEMA published in the Federal Register a proposed flood hazard determination notice that contained an erroneous table. This notice provides corrections to that table, to be used in lieu of the information published at 79 FR 23008. The table provided here represents the proposed flood hazard determinations and communities affected for Daviess County, Missouri, and Incorporated Areas.
Order Granting Limited Exemptions from Exchange Act Rule 10b-17 and Rules 101 and 102 of Regulation M to First Trust Dorsey Wright International Focus 5 ETF Pursuant to Exchange Act Rule 10b-17(b)(2) and Rules 101(d) and 102(e) of Regulation M
Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Instituting Proceedings To Determine Whether To Disapprove a Proposed Rule Change Relating to Proposed Changes To Remove From the Exchange Rules Fee Provisions Regarding Re-Transmission of “Third-Party Data”
Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change Proposing To List and Trade Shares of InfraCap Active MLP ETF Under NYSE Arca Equities Rule 8.600