June 30, 2016 – Federal Register Recent Federal Regulation Documents

The United States Department of Commerce, International Trade Administration, is organizing an executive-led Healthcare Business Development Mission to China with an emphasis on the Sector. The mission is proposed at the Deputy Secretary level with participation from U.S. Department of Health and Human Services to ensure adequate access to Chinese government officials. The purpose of the mission is open access to Chinese government health officials and to introduce U.S. firms and trade associations to the Chinese Healthcare market as well as assist U.S. companies to find business partners and export their products and services to China. The mission is intended to include representatives from U.S. companies and U.S. trade associations with members that provide high end, innovative medical devices (especially imaging), healthcare technology equipment, innovative pharmaceuticals, hospital management or senior care management solutions, and medical education or training, hospital cooperation (i.e. management and education), as well as pharmaceuticals and senior care segments. Healthcare is an important issue for both the China. Today, China's annual healthcare spending is about $590.2 billion or 5.7% of its GDP. Commerce and health are not mutually exclusive, as workers become ill and as the cost of healthcare and insurance increases there is a direct impact on business through the loss of worker productivity and skilled workers, and reduced output. With fewer healthy workers earning incomes, businesses will also be harmed by decreased size and purchasing power of consumers. Families and individuals will be burdened with the impact of reduced incomes, increased health costs, and increased likelihood of long term care. As the world's two largest economies, how the two sides approach healthcare in the future has the potential to impact global macro-economic stability and future economic growth. In recent years China has prioritized the reform of its healthcare system, to ensure citizens have good quality and affordable care, especially given the trends in the population and the increase in various health issues. The aging population, chronic disease and lack of fitness for children create challenges and burdens on establishing an effective healthcare system. Incidence of non-communicable disease (NCDs) such as cardiovascular disease, cancer and diabetes has rapidly increased. Economic growth is also impeded because NCDs hit workers in their prime years of productivitycreating long term chronic conditions, withdrawal from the workforce, diminished family resources and early death. Tackling the prevalence and significance of NCDs is challenging. The causes are rooted in the universal trends of aging and rapid urbanization, demographic factors which will only increase in the future. Facing similar challenges and possessing common goals to achieve a successful healthcare ecosystem, the United States and China are well positioned to share experiences and find solutions to existing problems through uniting government and private sector forces at the intersection of commerce and healthcare. Areas of mutual collaboration in the healthcare could focus on improving patient access and services delivery, as well as areas of cooperation to benefit the health and lives of the population. As China reforms its' healthcare system and endeavors to create an innovative medical device and pharmaceutical industry it risks the alienation of foreign firms in the market. This trade mission will offer U.S. firms not only the opportunity to market their products and services, but also to explore ways that U.S. industry can support China's efforts to reform their healthcare system through win-win bilateral healthcare cooperation. The trade mission will include one-on-one business appointments with pre-screened potential buyers, agents, distributors and joint venture partners; meetings with national and regional government officials, chambers of commerce, and business groups; and networking receptions for companies and trade associations representing companies interested in expansion into the Chinese markets. Meetings will be offered with government authorities (such as the National Health and Family Planning Commission, China Food and Drug Administration, Ministry of Human Resources and Social Services, and Ministry of Civil Affairs) that can address questions about policies, tariff rates, incentives, regulations, etc.

This document contains final regulations that require annual country-by-country reporting by certain United States persons that are the ultimate parent entity of a multinational enterprise group. The final regulations affect United States persons that are the ultimate parent entity of a multinational enterprise group that has annual revenue for the preceding annual accounting period of $850,000,000 or more.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice entitled ``Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin; Request for Scientific Data, Information, and Comments'' that appeared in the Federal Register of March 4, 2016. The notice requested scientific data, information, and comments that would assist in the development of a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (including raw manure). In the Federal Register notice of April 22, 2016, the comment period for this request was initially extended to July 5, 2016. We are taking this action due to maintenance on the Federal eRulemaking portal in early July 2016.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice, published in the Federal Register of April 6, 2016 (81 FR 19976), announcing the availability of a draft guidance for industry entitled ``Inorganic Arsenic in Rice Cereals for Infants: Action Level,'' a supporting document entitled ``Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants,'' and a risk assessment report entitled ``Arsenic in Rice and Rice Products Risk Assessment: Report.'' We are taking this action due to maintenance on the Federal eRulemaking portal in early July 2016.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register of May 5, 2016. In the notice, FDA announced an opportunity for public comment on the proposed collection of certain information by the Agency. We are taking this action due to maintenance on the Federal eRulemaking portal from July 1 through July 5, 2016.

The Commodity Futures Trading Commission (``CFTC'' or ``Commission'') is announcing an opportunity for public comment on the proposed collection renewal of certain information by the agency. Under the Paperwork Reduction Act (``PRA''), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment. This notice solicits comments on the reporting requirements related to Commission regulation 50.51, which permits certain cooperatives to elect not to clear certain swaps that otherwise would be required to be cleared, provided that they meet certain conditions.

On May 13, 2016, the Department of Commerce (the Department) published the notice of initiation and preliminary results of the changed circumstances review of the antidumping duty order on circular welded non-alloy steel pipe (CWP) from the Republic of Korea.\1\ In that notice, we preliminarily determined that Hyundai Steel Corporation (Hyundai Steel) is the successor-in-interest to Hyundai HYSCO (HYSCO) for purposes of determining antidumping duty cash deposits and liabilities. No interested party submitted comments on, or requested a public hearing to discuss, the initiation and preliminary results. For these final results, the Department continues to find that Hyundai Steel is the successor-in-interest to HYSCO.

The current version of the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs.

The Department of Labor (DOL), Employment and Training Administration (ETA) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, ``Unemployment Insurance Benefits Operations State Self-Assessment Report of Responses.'' In 2014, ETA embarked on a major multi-year initiative to reengineer its program accountability processes for state unemployment insurance (UI) benefits operations by integrating peer reviews with new operational review processes that recognizes both Federal and state capacity and ensures that the UI program is administered with a focus on accountability and integrity. Recognizing the need to assess and adequately monitor state UI benefit program operations in the 53 jurisdictions with state UI programs, the ETA has developed a new comprehensive state self-assessment tool, which is a set of questionnaires related to state UI benefits operations. The new collection has two distinct and complimentary purposes: (1) Assisting state UI agencies in making improvements to their UI benefits operations; and (2) assisting ETA in oversight and monitoring of state UI benefit program operations. This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq.

The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The United States Postal Service[supreg] (Postal Service) is proposing to modify two Customer Privacy Act Systems of Records (SOR). These changes are being made to support the automatic and seamless update of National Change of Address (NCOA) information, voluntarily provided by customers, in related customer databases that require the same NCOA information.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8288, U.S. Withholding Tax Return for Disposition by Foreign Persons of U.S. Real Property Interests, and Form 8288-A, Statement of Withholding on Dispositions by Foreign Persons of U.S. Real Property Interests.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 6478, Biofuel Producer Credit.

The Commission will consider a Report and Order that would revise the Emergency Alert System rules by adding new event codes covering extreme high winds and storm surges caused by Category 3 (and greater) hurricanes. * * * * *

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on approaches and/or technologies currently used for identifying potential developmental toxicants. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the potential of chemicals to induce adverse effects in offspring.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development.

The Coast Guard is establishing temporary safety zones for multiple locations and dates within the Captain of the Port New Orleans zone. These safety zones are necessary to protect persons and vessels from potential safety hazards associated with fireworks displays on or over federal waterways. Entry into these zones is prohibited unless specifically authorized by the Captain of the Port New Orleans or a designated representative.

The Coast Guard is establishing a safety zone in Lake Superior near Bayfield, WI. This safety zone is intended to restrict vessels from specified waters in Lake Superior during the Bayfield Fourth of July Fireworks Display. This safety zone is necessary to protect spectators from the hazards associated with the fireworks display.

Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations Part 44 govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning e- Services registration TIN matchingapplication and screens for TIN matching interactive.