March 28, 2016 – Federal Register Recent Federal Regulation Documents

We (National Park Service, NPS) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated burden and cost. This information collection is scheduled to expire on March 31, 2016. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. However, under OMB regulations, we may continue to conduct or sponsor this information collection while it is pending at OMB.

NMFS is adjusting the 2016 seasonal apportionments of the total allowable catch (TAC) for pollock in the Gulf of Alaska (GOA) by re-apportioning unharvested pollock TAC in Statistical Areas 610, 620, and 630 of the GOA. This action is necessary to provide opportunity for harvest of the 2016 pollock TAC, consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Gulf of Alaska.

The U.S Department of Energy (DOE) is implementing a consent- based siting process to establish an integrated waste management system to transport, store, and dispose of spent nuclear fuel and high-level radioactive waste. In a consent-based siting approach, DOE will work with communities, tribal governments and states across the country that express interest in hosting any of the facilities identified as part of an integrated waste management system. As part of this process, the Department is hosting a series of public meetings to engage communities and individuals and discuss the development of a consent-based approach to managing our nation's nuclear waste. A public meeting will be held in Atlanta, GA on April 11, 2016.

The Department of Energy (DOE) has submitted an information collection request to the OMB for extension under the provisions of the Paperwork Reduction Act of 1995. The information collection requests a three-year extension of its Contractor Legal Management Requirements, OMB Control Number 1910-5115. The proposed collection will require covered DOE contractors and subcontractors to submit to DOE counsel a legal management plan within 60 days following execution of a contract or request of the contracting officer. Covered contractors must also submit an annual legal budget that includes cost projections for matters defined as significant matters. The budget detail will depend on the nature of the activities and complexity of the matters included in the budget. The regulation further requires covered contractors to submit staffing and resource plans addressing matters defined as significant matters in litigation. The regulation requires covered contractors to submit certain information related to litigation initiated against the contractor before initiating defensive litigation, offensive litigation, or entering into a settlement agreement.

The Coast Guard will enforce the Michigan City Summerfest Fireworks Safety Zone on a portion of Lake Michigan on July 4, 2016. This action is necessary and intended to ensure safety of life and property on navigable waters prior to, during, and immediately after the fireworks display. During the enforcement period listed below, the Coast Guard will enforce restrictions upon, and control movement of, vessels in the safety zone. No person or vessel may enter, transit, or anchor in the safety zone while it is being enforced without permission of the Captain of the Port Lake Michigan or a designated representative.

The Advisory Committee was established by P.L. 98-181, November 30, 1983, to advise the Export-Import Bank on its programs and to provide comments for inclusion in the report on competitiveness of the Export-Import Bank of the United States to Congress. Time and Place: Thursday, April 7, 2016 from 7:30 a.m. until 8:00 a.m. and 4:00 p.m. until 5:00 p.m. The meeting will be held at the Omni Shoreham Hotel in the Cabinet Roomlobby level, 2500 Calvert Street NW., Washington, DC 20008. Agenda: Agenda items include updates for the Advisory Committee members regarding: past recommendations and 2016 recommendations, EXIMs business and pipeline, and EXIMs report on competitiveness to Congress. Public Participation: The following portions of the meeting will be open to public participation: 7:30 a.m.-8 a.m. and from 4:00 p.m.-5:00 p.m., and 10 minutes will be set aside for oral questions or comments. Members of the public may also file written statement(s) before or after the meeting. If you plan to attend, a photo ID must be presented at the sign-in table in the meeting room, you may contact Tia Pitt at tia.pitt@exim.gov to have your name placed on an attendee list. If any person wishes auxiliary aids (such as a sign language interpreter) or other special accommodations, please email Tia Pitt at tia.pitt@exim.gov by April 1, 2016. Members of the Press: For members of the Press planning to attend the meeting please email Tia Pitt at tia.pitt@exim.gov to be placed on an attendee list.

HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.

The Lake Tahoe Basin Federal Advisory Committee (Committee) will meet in Incline Village, Nevada. The Committee is established consistent with the Federal Advisory Committee Act of 1972. Additional information concerning the Committee, including meeting summary/ minutes, can be found by visiting the Committee's Web site at: https:// www.fs.usda.gov/goto/ltbmu/LTFAC. The summary/minutes of the meetings will be posted within 21 days of the meetings.

The Western Pacific Fishery Management Council (Council) will convene a meeting of its Fishery Ecosystem Plan Team (Insular fisheries and Pelagic fisheries teams) and the Fishery Data Collection and Research CommitteeTechnical Committee (FDCRC-TC). The FEP Team will review the revised annual report to serve as the Stock Assessment and Fishery Evaluation (SAFE) Report for the Western Pacific region, conduct the evaluation of the 2015 catches to the 2015 Annual Catch Limits (ACL) for the coral reef, crustacean, and Territory bottomfish fisheries, and look at options for changing the current risk determination process and specification of optimum yield (OY). The FDCRC-TC will review the status of the data collection improvement efforts in the Western Pacific region and address the data collection gaps identified by the FEP Teams to support the monitoring of the fisheries in the SAFE report.

The New England Fishery Management Council (Council) is scheduling a public meeting of its Ecosystem Based Fishery Management (EBFM) 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.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to the notice.

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 Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for diagnosis of Zika virus infection in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Department of Health and Human Services (HHS) Secretary that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the HHS Secretary declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

The Food and Drug Administration (FDA or Agency) is amending its regulations to update the address for applicants to submit investigational new drug applications (INDs) for biological products regulated by the Center for Drug Evaluation and Research (CDER). FDA is also amending its regulations on the criteria and evidence to assess actual and potential bioequivalence problems (bioequivalence regulations) to correct a typographical error. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

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, the 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 to address one or more of the following points: 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; 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; The quality, utility, and clarity of the information to be collected; and 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*: Michele M. Doody, Radiation Epidemiology Branch, National Cancer Institute, 9609 Medical Center Drive, Room 7E566, Rockville, MD 20850, or call non-toll-free at 301-414-0308. Or Email your request, including your address to: doodym@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: US Nuclear Medicine Technologists Study, 0925- 0656, Expiration Date 04/30/2015REINSTATEMENT WITH CHANGE, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: We propose to collect, from U.S. nuclear medicine technologists (USNMT) certified after 1980, historical information about nuclear medicine procedures performed, radioisotopes used, related work and safety practices, and places of employment. The primary objectives of the current feasibility effort are: (a) To identify a cohort of nuclear medicine technologists certified after 1980 by the American Registry of Radiologic Technologists (ARRT) and/or the Nuclear Medicine Technologist Certification Board (NMTCB); and (b) to characterize individual organ- specific occupational radiation doses from radioisotope procedures. More recently certified technologists, who specialized in nuclear medicine, are expected to have greater exposures to radioisotopes than the general radiologic technologists in the U.S. Radiologic Technologist (USRT) cohort owing to performing such procedures with greater frequency. The proposed USNMT study would be a direct follow-on to the USRT Study to assess health risks associated with occupational exposure to these much higher-energy radiopharmaceuticals. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 125.

This notice is to advise interested parties of a Military Health System (MHS) demonstration project under the authority of Title 10, United States Code, Section 1092, entitled TRICARE Bundled Payment for Lower Extremity Joint Replacement or Reattachment (LEJR) Surgeries that will test bundled payment and quality measurement on an ``episode of care'' basis to encourage hospitals, physicians, and post-acute care providers to work together to improve the quality and coordination of care from the initial hospitalization through recovery. This demonstration is being conducted in compliance with Section 726 of the National Defense Authorization Act (NDAA) for 2016. This particular TRICARE demonstration will be based on Centers for Medicare and Medicaid Services' (CMS) Comprehensive Care for Joint Replacement (CJR) Model, which will be implemented in 67 metropolitan statistical areas (MSAs) beginning April 1, 2016. CMS's CJR Model is designed to promote better and more efficient care for beneficiaries undergoing LEJR surgery (DRG 469 (major joint replacement or reattachment of lower extremity with major complications or comorbidities) or 470 (major joint replacement or reattachment of lower extremity without major complications or comorbidities)). Participant hospitals in the CMS model will be held financially accountable for the quality and cost of the entire episode of care, which begins with hospital admission of a beneficiary and ends 90 days post-discharge in order to cover all related costs for the complete recovery period. This ``bundled'' episode includes all related items and services paid under Medicare Part A and Part B for all Medicare fee-for-service beneficiaries. The TRICARE demonstration project will test this value-based payment model in the Tampa-St. Petersburg MSA for DRG 470 only (including 90 days of related post-operative care) to assess whether value-driven bundled payment incentives will result in a reduction in the rate of increase in health care spending and improvements in health care quality, patient experience of care, and overall health of TRICARE beneficiaries. All network and non-network hospitals with at least 20 TRICARE admissions for DRG 470 over the three years of Fiscal Year (FY) 2013, 2014, and 2015 shall be required to participate in the demonstration project (excluding admissions for beneficiaries with primary Other Health Insurance (OHI), Active Duty Service Members (ADSMs), and Medicare-TRICARE dual eligible beneficiaries). Once selected for participation, hospitals will remain in the project throughout the duration of this demonstration (regardless of actual TRICARE utilization) unless the Government directs otherwise.