2018 – Federal Register Recent Federal Regulation Documents

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The National Institutes of Health (NIH) announces the persons who will serve on the National Institutes of Health's Senior Executive Service 2018 Performance Review Board.

The Department of Commerce, 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.

The U.S. Nuclear Regulatory Commission (NRC) is soliciting public comment on draft NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition,'' Section 2.5.3, ``Surface Deformation.'' SRP Section 2.5.3, Surface Deformation, was last updated in 2014. This proposed update to the SRP focuses on risk-informing the staff's review in this area on the potential for tectonic or non-tectonic surface deformation that could adversely affect the safe operation of a nuclear power plant at the proposed site.

In accordance with Section 3(b) of the Wild and Scenic Rivers Act, the USDA Forest Service, Washington Office, is transmitting the final boundary of the Black Butte National Wild and Scenic River, including portions of Cold Creek, to Congress.

In this notice, OSHA announces the final decision to expand the scope of recognition for FM Approvals, LLC (FM), as a NRTL to include twenty six additional test standards. In addition, OSHA announces the addition of four test standards to the NRTL Program's List of Appropriate Test Standards.

The National Credit Union Administration (NCUA) will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice.

The U.S. Army Corps of Engineers (Corps) Seattle District received a permit application from the Chehalis River Basin Flood Control Zone District (applicant) for the construction of a flood retention structure on the upper Chehalis River and the raising of levees at the Centralia-Chehalis Airport. A Department of the Army (DA) permit is required for the project pursuant to Section 404 of the Clean Water Act. The Corps has determined the proposed project may have significant individual and/or cumulative impacts on the human environment. An environmental impact statement (EIS) will be prepared in accordance with the National Environmental Policy Act (NEPA). Preparation of the EIS will support the Corps' eventual decision to either issue, issue with modification or deny the DA permit for the proposed action. The EIS will assess the potential social, economic, and environmental impacts of the projects and is intended to be sufficient in scope to address Federal, State, and local requirements, environmental and socio-economic issues concerning the proposed action, and permit reviews. The EIS process begins with the publication of this Notice of Intent. The EIS will be prepared according to the Corps' procedures for implementing NEPA, and consistent with the Corps' policy to facilitate public understanding and review of agency proposals. The Corps will serve as the lead federal agency for this EIS pursuant to the requirements of NEPA. The Washington State Department of Ecology (Ecology) will serve as the lead agency for the separate EIS pursuant to the requirements of the State Environmental Policy Act (SEPA). The Corps and Ecology have agreed to participate in joint scoping to simplify the public comment process for the two separate EISs.

In accordance with applicable laws and regulations, announcement is made of the intent to grant an exclusive within a field of use, royalty-bearing, revocable biological materials license.

The Food and Drug Administration (FDA or we) 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 we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name, and to make technical amendments to improve the accuracy of the regulations.

The Food Safety and Inspection Service (FSIS) is responding to public comments on a petition submitted by the National Chicken Council (NCC) on September 1, 2017, and is also providing information on the criteria applicable to line speed waivers for young chicken establishments. The NCC submitted a petition to FSIS requesting that the Agency establish a waiver program to permit young chicken slaughter establishments to operate without line speed limits if they participate in the New Poultry Inspection System (NPIS) and the FSIS Salmonella Initiative Program (SIP) and develop a system for monitoring and responding to loss of process control. FSIS issued a response denying the petition on January 29, 2018. The response explained that instead of establishing a separate line speed waiver program under the conditions requested in the petition, FSIS would make available criteria that it will use under its existing waiver procedures to consider individual waiver requests from young chicken establishments to operate at line speeds of up to 175 bpm. FSIS published these criteria in the February 23, 2018, Constituent Update. This notice provides additional information on the criteria that FSIS will use to evaluate new line speed waiver request submissions. Additionally, FSIS is announcing that the 20 young chicken establishments already operating under line speed waivers must meet the new criteria to remain eligible for the waiver. FSIS will issue these establishments new waiver letters that reflect the eligibility criteria described in this document. Failure by establishments already operating under line speed waivers to meet the new criteria within 120 days of receipt of these letters may result in the revocation of the waivers.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``The Special 510(k) Program.'' FDA established the Special 510(k) Program to facilitate the submission, review, and clearance of changes to a manufacturer's own legally marketed predicate device. This draft guidance, when finalized, will provide the framework that FDA will use when considering whether a premarket notification (510(k)) is appropriate for review as a Special 510(k). This draft guidance is not final nor is it in effect at this time.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Surface Transportation Board (Board) gives notice of its intent to request from the Office of Management and Budget (OMB) approval without change of the six existing collections described below. The Board previously published a notice about this collection in the Federal Register (July 11, 2018). That notice allowed for a 60-day public review and comment period. No comments were received.

The Commission is noticing a recently filed Postal Service request proposing modifications to its market dominant service performance measurement systems. This document informs the public of this proceeding and the technical conference, invites public comment, and takes other administrative steps.

The Food and Drug Administration (FDA, Agency, we) is announcing the withdrawal of two proposed rules that published in the Federal Register. These proposed rules are not currently considered viable candidates for final action. FDA is taking this action because the regulatory requirements set forth in the proposed rules are not needed at this time to protect the public health.

The National Science Foundation (NSF) is required to publish a notice of requests to modify permits issued to conduct activities regulated under the Antarctic Conservation Act of 1978. This is the required notice of a requested permit modification.

Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.

With the issuance of this final order, the Acting Administrator of the Drug Enforcement Administration places certain drug products that have been approved by the Food and Drug Administration (FDA) and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act (CSA). Specifically, this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V. This action is required to satisfy the responsibility of the Acting Administrator under the CSA to place a drug in the schedule he deems most appropriate to carry out United States obligations under the Single Convention on Narcotic Drugs, 1961. Also consistent therewith, DEA is adding such drugs to the list of substances that may only be imported or exported pursuant to a permit.

Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.

This is a notice of the Presidential declaration of a major disaster for the State of Minnesota (FEMA-4390-DR), dated September 5, 2018, and related determinations.