2018 – 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products.'' This draft guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as companion diagnostics in this document) to support the indicated uses of multiple drug or biologic oncology products (referred to as therapeutic products or oncology therapeutic products in this document), when appropriate. The draft guidance includes factors for considering when broader labeling (i.e., labeling that is expanded) of a companion diagnostic would be appropriate. Oncology companion diagnostics with broader evidence-based indications will optimally facilitate clinical use.

The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on a framework created by the Center for Drug Evaluation and Research and the Center for Biologic Evaluation and Research for implementing a program to evaluate the potential use of real-world evidence (RWE) in regulatory decision making. This framework is entitled ``Framework for the Real-World Evidence Program.'' The 21st Century Cures Act (Cures Act) was enacted on December 13, 2016, and requires that FDA establish a framework for implementing a program to evaluate the potential use of RWE to help support the approval of a new indication for a drug approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help support or satisfy postapproval study requirements. FDA has created this framework to satisfy the Cures Act mandate and is establishing a docket to receive public comments.

The Department of Commerce (Commerce) determines that welded carbon steel standard pipe and tube products (pipe and tube) from Turkey were sold at less than normal value during the period of review (POR), May 1, 2016, through April 30, 2017.

The U.S. Department of Transportation, Maritime Administration (MARAD) announces that the following U.S. Merchant Marine Academy (Academy) Board of Visitors (BOV) meeting will take place: 1. Date: December 14, 2018. 2. Time: 9:00 a.m.-3:00 p.m. 3. Location: U.S. Merchant Marine Academy, Kings Point, NY, Crabtree Room, Schuyler Otis Bland Memorial Library. 4. Purpose of the Meeting: The purpose of this meeting is to:

The Food Safety and Inspection Service (FSIS) is establishing January 1, 2022, as the uniform compliance date for new meat and poultry product labeling regulations that will be issued between January 1, 2019, and December 31, 2020. FSIS periodically announces uniform compliance dates for new meat and poultry product labeling regulations to minimize the economic impact of label changes.

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The U.S. Department of Agriculture (USDA) is issuing an interim rule for the Highly Erodible Land and Wetland Conservation Compliance provisions of the Food Security Act of 1985, as amended. This rulemaking clarifies how USDA delineates, determines, and certifies wetlands located on subject land in a manner sufficient for making determinations of ineligibility for certain USDA program benefits. USDA is seeking comments from the public about these clarifications that will be considered prior to issuing a final rule.

The OCC, Board, and FDIC (collectively, the agencies) are inviting comment on a proposed rule to amend the agencies' regulations requiring appraisals for certain real estate-related transactions. The proposed rule would increase the threshold level at or below which appraisals would not be required for residential real estate-related transactions from $250,000 to $400,000. Consistent with the requirement for other transactions that fall below applicable thresholds, regulated institutions would be required to obtain an evaluation of the real property collateral that is consistent with safe and sound banking practices. The proposed rule would make conforming changes to add transactions secured by residential property in rural areas that have been exempted from the agencies' appraisal requirement pursuant to the Economic Growth, Regulatory Relief and Consumer Protection Act to the list of exempt transactions. The proposed rule would require evaluations for these exempt transactions. Pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act, the proposed rule would amend the agencies' appraisal regulations to require regulated institutions to subject appraisals for federally related transactions to appropriate review for compliance with the Uniform Standards of Professional Appraisal Practice.

In accordance with the Paperwork Reduction Act of 1995, the Farm Service Agency (FSA) is requesting comments from all interested individuals and organizations on an extension of a currently approved information collection request associated with the Request for Special Priorities Assistance. The information collection established by the Agriculture Priorities and Allocations System (APAS) regulation is necessary for the program applicant (person) to request prioritizing of a contract above all other contracts. The purpose of the priority rating is to obtain item(s) in support of national defense programs that they are not able to obtain in time through normal market channels.

The Environmental Protection Agency (EPA) Region 5 is issuing a Notice of Intent to Delete the Tomah Armory Landfill Superfund Site (Tomah Armory Site), located in Tomah, Wisconsin, from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). EPA and the State of Wisconsin, through the Wisconsin Department of Natural Resources (WDNR), have determined that all appropriate response actions under CERCLA, other than operation and maintenance, monitoring and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund.

The Environmental Protection Agency (EPA) Region 5 announces the partial deletion of all media at the 20-acre Former Research Center Property of the Beloit Corporation Superfund Site (Site), in Rockton, Illinois from the National Priorities List (NPL). The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The remainder of the Site will remain on the NPL and is not being considered for deletion as part of this action. EPA and the State of Illinois through the Illinois Environmental Protection Agency (IEPA), have determined that all appropriate response actions under CERCLA, other than operation and maintenance, monitoring and five-year reviews, have been completed. However, the deletion of this parcel does not preclude future actions under Superfund.

The Federal Housing Finance Agency (FHFA) is adopting a final rule pertaining to the operation of the Financing Corporation (FICO), a vehicle established by one of FHFA's predecessors to issue bonds, the proceeds of which were used to help fund the resolution of failed savings and loan associations during the 1980s. The last of those FICO bonds will mature in September 2019. By statute, FICO obtains the monies to pay the interest on those bonds by assessing depository institutions (FICO assessments) that are insured by the Federal Deposit Insurance Corporation (FDIC). The final rule addresses the manner in which FICO will conduct the 2019 FICO assessments, which will be the last of those assessments. Specifically, the final rule provides that all payments made by FDIC-insured depository institutions during 2019 are final, and that no adjustments to prior FICO assessments will be permitted after March 26, 2019, the projected date as of which the FDIC will finalize the amounts of the final collection for the 2019 FICO assessments.

Establishment of the Office of Economics and Analytics. This action is taken to enhance the role of economic analysis, the design and implementation of auctions, and the use and management of data at the Federal Communications Commission (the Commission or FCC). The Commission determined that the proper dispatch of its business and the public interest will be served by creating an Office of Economics and Analytics (the Office or OEA). In the Order, the Commission amended its Rules to reflect the new organizational structure, describe the Office's functions and delegated authority, and make other conforming changes. The Commission found it appropriate to make these organizational changes to integrate the use of economics and data analysis into the Commission's various rulemakings and other actions in a more comprehensive and thorough manner.

This document contains proposed regulations that provide guidance relating to the determination of the foreign tax credit under the Internal Revenue Code (the ``Code''). The guidance relates to changes made to the applicable law by the Tax Cuts and Jobs Act (the ``Act''), which was enacted on December 22, 2017. Guidance on other foreign tax credit issues, including in relation to pre-Act statutory amendments, is also included in this document. The proposed regulations provide guidance needed to comply with statutory changes and affect individuals and corporations claiming foreign tax credits.

This notice announces the members of the Senior Executive Service (SES) and Senior Level (SL) and Scientific or Professional (ST) Performance Review Board. Agriculture has two PRBs that are represented by each Mission Area. The PRB is comprised of a Chairperson and a mix of career and noncareer senior executives and senior professionals that meet annually to review and evaluate performance appraisal documents and provides a written recommendation to the Secretary for final approval of each executive's performance rating, performance-based pay adjustment, and performance award.

In this document, the Federal Communications Commission (Commission) adopts limited changes to the rules governing Priority Access Licenses (PALs) that will be issued in the 3500-3700 MHz Band (3.5 GHz band)including larger license areas, longer license terms, renewability, and performance requirementsas well as changes to the competitive bidding rules for the issuance of PALs and to the ability to partition and disaggregate areas within PALs. These changes are consistent with the rules that helped foster the development of 4G and LTE services in the United States, and adopting similar rules in this band will help promote additional investment in the next generation of wireless services. The Commission also adopts changes to the technical rules to facilitate transmissions over wider bandwidth channels without significant power reduction and changes to the information security requirements to better safeguard commercially sensitive information and protect critical infrastructure. These targeted changes will spur additional investment and broader deployment in the band, promote robust and efficient spectrum use, and help ensure the rapid deployment of advanced wireless technologiesincluding 5Gin the United States.