December 7, 2018 – Federal Register Recent Federal Regulation Documents

Notice is hereby given, pursuant to the Government in the Sunshine Act, of the regular meeting of the Farm Credit Administration Board (Board).

As required by statute, FMCSA announces denials of 10 applications for exemptions from the hours-of service (HOS) electronic logging device (ELD) rule. The applicants are as follows: Power and Construction Contractors Association; Western Equipment Dealers Association; Association of Energy Service Companies; Cudd Energy Services, Inc.; SikhsPAC and North American Punjabi Trucker Association; Owner- Operator Independent Drivers Association, Inc.; American Disposal Service; Towing and Recovery Association of America; National Electrical Contractors Association; and the Agricultural Retailers Association. The Agency reviewed each application and any comments received and rendered each decision based upon the merits of the application.

The Coast Guard is establishing a temporary safety zone for the navigable waters within a 50 yard radius from the center point of the Barters Island Bridge, on the Back River, ME, approximately 4.6 miles north of the mouth of the waterway. The safety zone is necessary to protect personnel, vessels, and the marine environment from potential hazards which could pose as imminent hazard to persons and vessels operating in the area created by the demolition, subsequent removal, and replacement of the Barters Island Bridge and a temporary bridge. When enforced, persons and vessels are prohibited from being in the safety zone during bridge replacement operations unless authorized by the Captain of the Port Northern New England or a designated representative.

Consistent with the regulations implementing the National Environmental Policy Act (NEPA), the Bureau of Ocean Energy Management (BOEM) is announcing the availability of a Draft Environmental Impact Statement (EIS) for the Construction and Operation Plan (COP) submitted by Vineyard Wind LLC (Vineyard Wind). The Draft EIS analyzes the potential environmental impacts of the proposed action described in the Vineyard Wind COP and reasonable alternatives to the proposed action. This Notice of Availability (NOA) announces the start of the public review and comment period, as well as the dates and locations of public hearings on the Draft EIS. After BOEM holds the public hearings and addresses comments on the Draft EIS, BOEM will prepare a Final EIS.

The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new round of the Head Start Family and Child Experiences Survey (FACES).

Notice is hereby given that the Rural Utilities Service (RUS) has prepared a Draft Environmental Impact Statement (EIS) to meet its responsibilities under the National Environmental Policy Act (NEPA) and environmental policies and procedures related to providing financial assistance to Dairyland Power Cooperative (DPC). Further, in accordance with section 106 of the National Historic Preservation Act (NHPA) and pursuant to the regulations participation in the section 106 process and coordination with the National Environmental Policy Act, RUS is using its procedures for public involvement under NEPA to meet its responsibilities to solicit and consider the views of the public during the section 106 review for the proposed project. RUS would be providing financial assistance to DPC for its share in the construction of a proposed 345-kilovolt (kV) transmission line and associated infrastructure connecting the Hickory Creek Substation in Dubuque County, Iowa, with the Cardinal Substation in the Town of Middleton, Wisconsin (near Madison, Wisconsin). The Project also includes a new intermediate 345/138-kV substation near the Village of Montfort in either Grant County or Iowa County, Wisconsin. The total length of the 345- kV transmission lines associated with the proposed project will be approximately 125 miles. DPC and the other project participants have identified proposed and alternate segments and locations for transmission lines and associated facilities and for the intermediate substation. Dairyland Power Cooperative is requesting RUS to provide financing for its portion of the proposed project. DPC is participating in the proposed project with two other utilities, American Transmission Company LLC, and ITC Midwest LLC (Utilities). The purpose of the proposed project is to: Address reliability issues on the regional bulk transmission system, alleviate congestion that occurs in certain parts of the transmission system and remove constraints that limit the delivery of power, expand the access of the transmission system to additional resources, increase the transfer capability of the electrical system between Iowa and Wisconsin, reduce the losses in transferring power and increase the efficiency of the transmission system, and respond to public policy objectives aimed at enhancing the nation's transmission system and to support the changing generation mix. A more detailed explanation of the purpose and need for the project can be found in the Draft EIS.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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.