September 28, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations to modernize, simplify, and enhance the current system for oversight of FDA-regulated human subject research. This proposed rule, if finalized, would harmonize certain sections of FDA's regulations on human subject protection and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule), in accordance with the 21st Century Cures Act (Cures Act). We believe the proposed changes, if finalized, will reduce regulatory burden on IRBs, sponsors, and investigators. In addition, we propose related changes to the investigational device exemption (IDE) regulations to clarify and update the requirements for the submission of progress reports.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

NHTSA invites public comments about our intention to request the Office of Management and Budget (OMB) for an extension with modification of a currently approved information collection. Before a federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes collections of information for which NHTSA intends to seek OMB approval that collect for NHTSA's Crash Report Sampling System (CRSS), Non-Traffic Surveillance (NTS), and special studies.

FMR Bulletin 2022-F1. This bulletin clarifies, highlights, and reminds agencies of the importance of accurately reporting the cost of federal advisory committees to Congress and the public. It also adds the requirement to include financial reporting instructions in agency administrative procedures. This requirement will result in greater assurance that data reported in the FACA database is consistent with agencies' actual costs, and Congress will have greater assurance that it can rely on these data to inform decisions about funding for FACA committees.

In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval in accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to allow renewal of the currently approved information collection via the FAA's deployed Web-based Frequency Coordination system (WebFCR), which collects certain broadcast and transmitter frequency information under OMB control number 2120-0786. The information collected is needed to perform the aeronautical studies, technical evaluations required and to meet the specified requirements for the radio frequency engineering pursuant to the FAA Order. The Federal Aviation Administration (FAA) Order 6050.32.B, Chapter 3, Section 302 outlines the US National Organizations, and the role of the National Telecommunications and Information Administration (NTIA) is assigning the Aviation Assignment Group (AAG) of the radio spectrum to FAA which support aeronautical services. Hence, FAA must ``authorize'' aeronautical frequencies of broadcast applications which impact the AAG bands.

The Administration for Children and Families (ACF) has redelegated the authorities for the Preschool Development Grants Birth Through Five (PDG B-5) and Tribal Maternal Infant and Early Childhood Home Visiting (MIECHV) Program from the Office of Child Care to the Office of Early Childhood Development.

The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.

HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

The Food and Drug Administration's (FDA), Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT) has modified its organizational structures.

The Administration for Children and Families (ACF), of the U.S. Department of Health and Human Services (HHS), is proposing to extend data collection activity for BEES. We are not proposing any changes to the currently approved materials. Data collected is being used to estimate the effects of the participating programs on employment, earnings, and other key outcomes for the purpose of assessing the effectiveness of the program.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Clinical Decision Support Software.'' This final guidance provides clarity on FDA's oversight of clinical decision support (CDS) software intended for health care professionals with the purpose of describing FDA's regulatory approach to CDS software functions. This guidance clarifies the types of CDS functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act).

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them. Additionally, OFAC is publishing updates to the identifying information of one person currently included on the SDN List. OFAC is further publishing the name of one person that has been removed from the SDN List.

NASA hereby gives notice of its intent to grant an Exclusive, Co-Exclusive or Partially Exclusive Patent License to practice the inventions described and claimed in the patents and/or patent applications listed in SUPPLEMENTARY INFORMATION below.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Stationary Combustion Turbines (EPA ICR Number 2177.08, OMB Control Number 2060-0582), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2022. Public comments were previously requested, via the Federal Register, on April 8, 2022 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.