July 2014 – Federal Register Recent Federal Regulation Documents

This document announces that Media Bureau of the Federal Communications Commission is seeking comment on a Petition for Blanket Extension or Waiver filed by Advanced Television Broadcasting Alliance requesting that the Commission grant a ``blanket extension or waiver'' and extend the expiration date of all outstanding construction permits for new digital low power television and TV translator stations to the September 1, 2015 digital transition deadline.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Animal Generic Drug User Fee Cover Sheet'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority for the Research Fellowships Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, this notice announces a priority for a Distinguished Residential Disability and Rehabilitation Policy Fellowship. We take this action to focus attention on an area of national need. We intend the priority to build research capacity by providing support to highly qualified, experienced researchers, including those who are individuals with disabilities, to conduct policy research in the areas of disability and rehabilitation.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orderembodied in the consent agreementthat would settle these allegations.

Closed meeting of the Art Advisory Panel will be held in Washington, DC.

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.

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.

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.

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.

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 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.

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: brownte@mail.nih.gov. 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.

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 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.

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.

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,