November 16, 2018 – Federal Register Recent Federal Regulation Documents

In accordance with the Federal Land Policy and Management Act of 1976, and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) California Desert District Advisory Council (DAC) will meet as indicated below.

This notice will serve to announce that the U.S. Department of Health and Human Services (HHS) is seeking nominations of non-federal individuals who represent diverse scientific disciplines and views and are interested in being considered for appointment to the Tick-Borne Disease Working Group (Working Group). Resumes or curricula vitae from qualified individuals who wish to be considered for appointment as a member of the Working Group are currently being accepted.

The Environmental Protection Agency (EPA) is reopening the comment period for the proposed approval to a state implementation plan (SIP) revision submitted by the State of Maryland pertaining to the Code of Maryland Regulations (COMAR) 26.11.32Control of Emissions of Volatile Organic Compounds (VOCs) from Consumer Products. The proposed rule was published in the Federal Register on August 8, 2018 (83 FR 39009). Written comments on the proposed rule were to be submitted to EPA on or before September 7, 2018. The purpose of this document is to reopen the comment period for an additional 30 days. This extension of the comment period is provided to allow the public additional time to provide comment on the August 8, 2018 proposed rule. All comments submitted between the close of the original comment period and the reopening of this comment period will be accepted and considered.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs), that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.

This action deletes a product and services from the Procurement List previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

The Committee is proposing to add products to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and services previously furnished by such agencies.

Notice is hereby given that on October 22, 2018, the U.S. Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on an Administrative Law Judge's finding of research misconduct against Rakesh Srivastava, Ph.D., former Eminent Scholar and Professor, University of Kansas Medical Center (KUMC). Dr. Srivastava engaged in research misconduct in research proposed or reported in grant application 1 R01 CA175776-01, submitted to the National Cancer Institute (NCI), National Institutes of Health (NIH), on June 5, 2012. The administrative actions, including two (2) years of debarment, were implemented beginning on October 22, 2018, and are detailed below.

The Food and Drug Administration (FDA, the Agency, or we) is announcing three public meetings entitled ``Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) Using International Council for Harmonisation (ICH) E2B(R3) Standards.'' The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic submission standards for drug, biological, and drug/ biologic-led combination products for the premarket and postmarket safety surveillance programs managed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). These meetings will focus on enhancements to electronic submission of Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards. FDA is seeking input from stakeholders as it fulfills its commitment to implement ICH E2B(R3) standards by holding three public meetings. FDA will use the information provided by the public to inform the enhancements to FAERS required for the implementation of ICH E2B(R3) standards and relevant regional variations.

The Heppner and North Fork John Day Ranger Districts propose the Ellis Integrated Vegetation Project (Ellis Project) to reduce overstocking, improve ecosystem health, and enhance resilient landscapes by creating and maintaining heterogeneous vegetative conditions at multiple scales. As a result, this action will reduce the risk of uncharacteristic disturbances; enhance vegetative communities; provide well-distributed, high quality wildlife habitat for associated species; aid in protecting values at risk; promote the health and safety of the public and firefighters; and contribute to social, cultural, and economic needs. The project area is approximately 15 miles southeast of Heppner and 7 miles west of Ukiah, Oregon, in Morrow, Umatilla, and Grant Counties. Based on internal and external issues raised early in proposal development; and the scope, scale, and potentially significant beneficial impacts to distribution of wildlife, forest health, and fuels reduction, the Umatilla National Forest plans to prepare an environmental impact statement (EIS).

The Salmon-Challis National Forest is initiating the land management planning process pursuant to the 2012 Planning Rule. This process will result in a revised land management plan that describes the strategic direction for management of forest resources for the next 10 to 15 years on the Salmon-Challis National Forest. The Salmon- Challis is inviting the public to help us identify the need to change the existing Challis and Salmon Land Management Plans, as well as, the appropriate plan components that will become a proposed action for the land management plan revision.

The Gulf of Mexico Fishery Management Council (Council) will hold ten in-person public hearings and a webinar public hearing to solicit public comments on Draft Amendment 50State Management of Recreational Red Snapper.

This is a notice of an Administrative declaration of a disaster for the Commonwealth of Pennsylvania dated 10/23/2018. Incident: Flooding. Incident Period: 07/21/2018 through 07/27/2018.

On September 28, 2018, the U.S. Small Business Administration (SBA) published a notice of proposed rulemaking in the Federal Register to solicit public comments on, among other things, Express loan programs and affiliation standards. This document announces the extension of the current comment period for an additional 15 business days until December 18, 2018.

The National Park Service is soliciting comments on the significance of properties nominated before October 27, 2018, for listing or related actions in the National Register of Historic Places.