August 17, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants planning to submit new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. This draft guidance revises the guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co- Crystals'' issued in April 2013.

The interagency Trade Policy Staff Committee (TPSC) will convene a public hearing and seek public comment to assist the Office of the United States Trade Representative (USTR) in the preparation of its annual report to Congress on Russia's implementation of its commitments as a Member of the World Trade Organization (WTO).

The Privacy Act of 1974 (5 U.S.C. 552(e) (4)) requires that all agencies publish in the Federal Register a notice of the existence and character of their systems of records. Notice is hereby given that the Department of Veterans Affairs (VA) is establishing a new system of records entitled ``VA National Cemetery Pre-Need Eligibility Determination Records''VA (SORN # 175VA41A).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.'' The guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) in donor testing for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). The guidance finalizes the draft guidance of the same title dated January 2016 and supplements previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc), in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007 (2007 Donor Eligibility Guidance).

National Aeronautics and Space Administration (NASA) is proposing to amend the NASA FAR Supplement (NFS) to remove NFS clause 1852.243-70, Engineering Change Proposals (ECPs) basic clause with its Alternate I & II and associated information collection from the NFS.

The General Services Administration's Fiscal Year (FY) 2017 per diem reimbursement rates review has resulted in lodging and meal allowance changes for certain locations within CONUS to provide for reimbursement of Federal employees' subsistence expenses while on official travel.

Notice is hereby given that the U.S. International Trade Commission has determined to institute an advisory opinion proceeding in the above-captioned investigation.

The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 3 to Regulatory Guide (RG) 1.140, ``Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units of Normal Atmosphere Cleanup Systems in Light Water Cooled Nuclear Power Plants.'' This RG describes a method that the NRC staff considers acceptable to implement regulatory requirements with regard to the design, inspection, and testing of normal atmosphere cleanup systems for controlling releases of airborne radioactive materials to the environment during normal operations, including anticipated operational occurrences. This guide applies to all types of nuclear power plants that use water as the primary means of cooling.

This action proposes to modify Class C airspace at El Paso International Airport, El Paso, TX, by removing a cutout from the Class C airspace area that excludes the airspace within a 2-mile radius of West Texas Airport and the airspace beyond an 8-mile arc from the El Paso International Airport beginning at the 115[deg] bearing from the airport clockwise to the Rio Grande River. Additionally, this proposal would update the El Paso International Airport geographic coordinates to reflect the current airport reference point (ARP) information in the FAA's aeronautical database and remove the West Texas Airport and geographic coordinate references from the Class C airspace description. The FAA is proposing this action to enable more efficient operations at El Paso International Airport.

This final rule implements changes that were proposed on May 22, 2015, in a proposed rule entitled Revisions to the Export Administration Regulations (EAR): Harmonization of the Destination Control Statements. This final rule revises the destination control statement in Sec. 758.6 of the Export Administration Regulations (EAR) to harmonize the statement required for the export of items subject to the EAR with the destination control statement in Sec. 123.9(b)(1) of the International Traffic in Arms Regulations (ITAR).

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Kite Pharma, Inc. (``Kite'') located in Santa Monica, CA to practice the inventions embodied in the following patent applications:

The Environmental Protection Agency (EPA) is approving a revision to the Pennsylvania state implementation plan (SIP) submitted by the Commonwealth of Pennsylvania. This SIP revision pertains to Pennsylvania's regulation for fiberglass boat manufacturing materials found in section 129.74 of the Pennsylvania Code. This regulation meets the requirement to adopt reasonably available control technology (RACT) for sources covered by EPA's control techniques guidelines (CTG) standards for fiberglass boat manufacturing materials. EPA is, therefore, approving this revision to the Pennsylvania SIP in accordance with the requirements of the Clean Air Act (CAA).