May 14, 2019 – Federal Register Recent Federal Regulation Documents

The Department of Veterans Affairs (VA) amends its medical regulations to implement its authority to furnish necessary care to covered individuals through certain agreements. Section 102 of the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018 authorizes VA to enter into agreements to furnish required care and services when such care and services are not feasibly available to certain individuals through a VA facility, a contract, or a sharing agreement. This interim final rule establishes the parameters of those agreements, to include: Establishing a certification process for providers who will furnish such care or services; establishing a methodology by which rates will be calculated for payment of care or services under an agreement; and establishing an administrative process for adjudicating disputes arising under or related to such agreements, including those pertaining to claims for payment for care or services provided under an agreement.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Considerations in Demonstrating Interchangeability With a Reference Product.'' This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). This guidance is one in a series of guidances that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

This final rule amends the Export Administration Regulations (EAR) by adding twelve entities, under a total of sixteen entries, to the Entity List. These twelve entities have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States and will be listed on the Entity List under the destinations of China, Hong Kong, Pakistan and the United Arab Emirates. This rule also modifies one existing entry on the Entity List under the destination of the United Arab Emirates. Finally, this rule removes one entity under the destination of the United Arab Emirates. The removal is made in connection with a request for removal that BIS received pursuant to sections of the EAR used for requesting removal or modification of an Entity List entry and a review of information provided in that request.

FMCSA announces its decision to exempt 13 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. They are unable to meet the vision requirement in one eye for various reasons. The exemptions enable these individuals to operate CMVs in interstate commerce without meeting the vision requirement in one eye.

FMCSA announces its decision to renew exemptions for 173 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirements in one eye.

FMCSA announces its decision to exempt 30 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.

The Commission hereby gives notice of the institution of Investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-624-625 and 731-TA-1450- 1451 (Preliminary) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of quartz surface products from India and Turkey, provided for in subheading 6810.99.00 (statistical reporting number 6810.99.0010) of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Governments of India and Turkey. Unless the Department of Commerce (``Commerce'') extends the time for initiation, the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by June 24, 2019. The Commission's views must be transmitted to Commerce within five business days thereafter, or by July 1, 2019.

The Bureau of Land Management (BLM), Glennallen Field Office is issuing for public comment the Supplemental Draft Environmental Impact Statement (EIS) for the Haines Amendment to the Ring of Fire Resource Management Plan. BLM Alaska will hold a public meeting in Haines to receive comments on the Haines Amendment Supplemental Draft EIS. The Supplemental Draft EIS will supplement the December 2012 Draft Resource Management Plan Amendment/Draft Environmental Impact Statement for the Haines Planning Area that originally analyzed which, if any, designations and associated management practices best fulfill the resource needs and multiple use demands within the Haines Planning Area.

The Environmental Protection Agency (EPA) is proposing to approve a request from Georgia for EPA to relax the federal Reid Vapor Pressure (RVP) standard applicable to gasoline introduced into commerce from June 1 to September 15 of each year for the following Georgia counties: Cherokee, Clayton, Cobb, Coweta, DeKalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett, Henry, Paulding, and Rockdale (the ``Atlanta RVP Area''). Specifically, EPA is proposing to amend the regulations to allow the RVP standard for the Atlanta RVP Area to change from 7.8 pounds per square inch (psi) to 9.0 psi for gasoline. EPA has preliminarily determined that this change to the federal RVP regulation is consistent with the applicable provisions of the Clean Air Act (CAA).

In accordance with the requirements of the Privacy Act of 1974, as amended, HHS is revising a department-wide system of records, System No. 09-90-1601 titled Outside Experts Recruited for Non-FACA Activities, to add records about outside consultants used by HHS' Administration for Children and Families, Office of Trafficking in Persons (ACF/OTIP).

The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) regarding the development of national health promotion and disease prevention objectives for 2030. The meeting will be held online via webinar and is open to the public. The Committee will discuss the nation's proposed health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will deliberate and prioritize its recommendations for implementing the Healthy People 2030 objectives and develop recommendations regarding graphics for communicating key Healthy People 2030 elements. Pursuant to the Committee's charter, the Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.

The Export-Import Bank of the United States (EXIM), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. The purpose of this collection is to gather information necessary to make a determination of eligibility of a transaction for EXIM assistance under its medium-term guarantee and insurance program. The form can be viewed at: https://www.exim.gov/sites/default/files/ pub/pending/eib03-02_0.pdf.

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 Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) is proposing to revise the information collection 0348-0065 it uses to for members of the public who request a meeting with OIRA on rules under review at the time pursuant to Executive Order 12866. The information collected would be subject to the Paperwork Reduction Act (PRA) and this notice announces and requests comment on OIRA's proposal for such a collection.

In accordance with the Paperwork Reduction Act of 1995, we, the National Park Service (NPS) are proposing to renew an information collection.

In accordance with the Paperwork Reduction Act of 1995, we, the National Park Service (NPS) are proposing to renew an information collection with revisions.

The Commercial Customs Operations Advisory Committee (COAC) will hold its quarterly meeting on Thursday, May 30, 2019, in Laredo, Texas. The meeting will be open to the public to attend either in person or via webinar.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Florida Advisory Committee (Committee) will hold a meeting on Thursday, May 16, 2019, at 2.00 p.m. (EST) for the purpose of planning future public meetings on voting rights in the state.

The U.S. Copyright Office is extending the deadline for the submission of written comments in response to its March 15, 2019, notice announcing the release of a public draft of an update to its administrative manual, the Compendium of U.S. Copyright Office Practices, Third Edition.

The Department of the Navy (DoN) announces the availability of the inventions listed below, assigned to the United States Government, as represented by the Secretary of the Navy, for domestic and foreign licensing by the Department of the Navy.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the Sac & Fox Tribe of the Mississippi in Iowa (FEMA-4430-DR), dated 04/29/2019. Incident: Severe Storms and Flooding. Incident Period: 03/13/2019 through 04/01/2019.