October 16, 2020 – Federal Register Recent Federal Regulation Documents

This action amends and extends, with modifications to reflect conditions in Iraq and the risks to U.S. civil aviation, the Special Federal Aviation Regulation (SFAR) prohibiting certain flight operations in the Baghdad Flight Information Region (FIR) (ORBB) by all: U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when the operator of such aircraft is a foreign air carrier. The FAA finds this action necessary to address the risks to the safety of persons and aircraft engaged in such flight operations. Specifically, this action amends the SFAR to prohibit U.S. civil aviation operations in the Baghdad FIR (ORBB) at altitudes below Flight Level (FL) 320. This rule amends the SFAR prohibition from altitudes below FL260 to altitudes below FL320, based on an assessment of the current aviation safety risks. This action also extends the expiration date of the SFAR from October 26, 2020, to October 26, 2022. Additionally, the FAA republishes the approval process and exemption information for this SFAR, consistent with other recently published flight prohibition SFARs, and makes minor administrative revisions.

The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER) is announcing its Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program (QMM API Pilot Program) for foreign facilities manufacturing active pharmaceutical ingredients (APIs), including facilities manufacturing drug substance intermediates used to produce APIs, that are used in FDA-regulated prescription and over-the-counter (OTC) drug products. The purpose of the QMM API Pilot Program is to gain insight from third- party assessments of a facility's quality management system to inform future development of an FDA rating system to characterize quality management maturity (QMM). Such a rating system would allow a cross- sectional comparison of facilities. Facilities that choose to disclose their facility ratings to drug product manufacturers could benefit from a competitive advantage, as knowledge of QMM ratings would enable drug product manufacturers to differentiate among facilities when purchasing APIs. This notice invites foreign facilities that are interested in participating in the QMM API Pilot Program to submit a request to participate.

The U.S. Nuclear Regulatory Commission (NRC) issued 10 exemptions in response to requests from 8 licensees. The exemptions afford these licensees temporary relief from certain requirements under NRC regulations. The exemptions are in response to the licensees' requests for relief due to the coronavirus disease 2019 (COVID-19) public health emergency (PHE). The NRC is issuing a single notice to announce the issuance of the exemptions.

The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.

We, the U.S. Fish and Wildlife Service, have received two applications for enhancement of survival permits (permits) pursuant to the Endangered Species Act of 1973, as amended (ESA). The two applications, one from Mr. Ed Preston and one from Mr. Ward Glessner, were developed in accordance with the Template Safe Harbor Agreement (Template SHA) for the Columbia Basin pygmy rabbit. We are requesting comments from the public regarding the proposed issuance of a permit to each of the two applicants.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This document delays the effective date of the final rule entitled ``Head Start Designation Renewal System,'' published in the Federal Register on August 28, 2020. As published, the rule was to be effective October 27, 2020. ACF is postponing the effective date of the rule to November 9, 2020.

The FTA in cooperation with the Delaware River Port Authority (DRPA) is issuing this notice to advise the public that the Notice of Intent (NOI) to prepare an Environmental Impact Statement (EIS) for the proposed public transportation improvement project in Camden County, New Jersey is being rescinded.

The Department of Labor (DOL) is submitting this Office of Workers' Compensation Programs (OWCP)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

The Department of Labor (DOL) is submitting this Office of Workers' Compensation Programs (OWCP)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection FERC-583 (Annual Kilowatt Generating Report (Annual Charges)) and is submitting the information collection to the Office of Management and Budget (OMB) for review. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below.