February 2023 – Federal Register Recent Federal Regulation Documents

The Department of the Interior (DOI) is issuing a final rule to amend its regulations to exempt certain records in the INTERIOR/DOI- 45, Personnel Security Program Files, system of records from one or more provisions of the Privacy Act of 1974 because of criminal, civil, and administrative law enforcement requirements.

The U.S. Office of Government Ethics (OGE) requests comments on proposed changes to the Standards of Ethical Conduct for Employees of the Executive Branch (Standards). The proposed amendments seek to update the Standards based on OGE's experience gained from application of the regulation since its inception. The proposed amendments also would incorporate past interpretive guidance, add and update regulatory examples, improve clarity, update citations, and make technical corrections.

The Food and Drug Administration (FDA or Agency) has determined that ASACOL HD (Mesalamine) Delayed-Release Tablet, 800 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Genesis Alkali, LLC.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Product- Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.'' This draft guidance provides recommendations to industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) under the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, this draft guidance provides information on requesting and conducting PSG meetings with FDA (PSG teleconferences, pre-submission PSG meetings, and post- submission PSG meetings), as contemplated in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter). This draft guidance is intended to provide procedures that will promote well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA III commitment letter.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with current good manufacturing practice (CGMP) for blood and blood components, including information collection recommendations found in Agency guidance related to reducing the risk of transfusion- transmitted infection (TTI).

The DoD has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

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.

In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for review and approval. The FMCSA requests to renew an ICR titled, ``Commercial Driver's License Drug and Alcohol Clearinghouse.'' The Agency's final rule, published December 5, 2016, titled ``Commercial Driver's License Drug and Alcohol Clearinghouse'' (Clearinghouse) established the regulatory requirements for the Clearinghouse. The compliance date of the final rule was January 6, 2020. FMCSA began collecting data as authorized users began registering in the Clearinghouse in September 2019. This ICR renewal is needed to support the continuation of the querying and reporting requirements to address the problem of commercial driver's license (CDL) and commercial learner's permit (CLP) holders who test positive for the use of controlled substances or the misuse of alcohol and then continue to perform safety sensitive functions, including driving a commercial motor vehicle (CMV), without completing the required return-to-duty (RTD) process.

Motor Coach Industries, Inc. (MCI), MCI has determined that certain model year (MY) 1988-2022 MCI coaches do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 205, Glazing Materials. MCI filed an original noncompliance report dated March 22, 2022, and amended the report on April 14, 2022. MCI petitioned NHTSA on April 14, 2022, for a decision that the subject noncompliance is inconsequential as it relates to motor vehicle safety and submitted supplemental information on September 2, 2022. This document announces receipt of MCI's petition and supplemental information.

In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the OCC, the Board, and the FDIC (the agencies) may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The Federal Financial Institutions Examination Council (FFIEC), of which the agencies are members, has approved the agencies' publication for public comment of a proposal to revise and extend for three years the Consolidated Reports of Condition and Income (Call Reports) (FFIEC 031, FFIEC 041, and FFIEC 051), which are currently approved collections of information. The FFIEC has also approved the Board's publication for public comment, on behalf of the agencies, of a proposal to revise and extend for three years the Report of Assets and Liabilities of U.S. Branches and Agencies of Foreign Banks (FFIEC 002), and the Report of Assets and Liabilities of a Non-U.S. Branch that is Managed or Controlled by a U.S. Branch or Agency of a Foreign (Non-U.S.) Bank (FFIEC 002S), which are also currently approved collections of information. The agencies are requesting comment on: proposed revisions to eliminate and consolidate items in the Call Reports and the FFIEC 002 resulting from the statutorily mandated full review of the Call Reports as required under Section 604 of the Financial Services Regulatory Relief Act of 2006; proposed Call Report process revisions; and reporting of certain Federal Home Loan Mortgage Corporation and similar securitizations on the Call Report. The changes to the Call Reports and FFIEC 002 are proposed to take effect as of the June 30, 2023, report date.

The Internal Revenue Service, 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 IRS is soliciting comments concerning Form 6197, Gas Guzzler Tax.

The Office of the Assistant Secretary for Health published a document in the Federal Register of February 10, 2023, announcing a request for information on Promising Practices for Advancing Health Equity for Intersex Individuals. The document included incorrect information regarding the Addresses section and also Supplementary Information and also the collection for public comment.

The DoD is publishing this notice to announce that the following Federal Advisory Committee meeting of the National Security Education Board will take place.

The Commission is acknowledging a recent filing requesting the Commission initiate a rulemaking proceeding to consider changes to analytical principles relating to periodic reports (Proposal One). This document informs the public of the filing, invites public comment, and takes other administrative steps.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.

On December 5, 2022, the U.S. Army Corps of Engineers (Corps) published a proposed rule to modify an existing danger zone in the waters of the Potomac River near Dahlgren, Virginia. The comment period ended on January 4, 2023. The Corps received numerous requests to extend the comment period, so we are reopening the comment period for 45 days. Comments previously submitted on the proposed rule do not need to be resubmitted, as they have already been incorporated into the administrative record and will be fully considered in the Corps' decision-making process for this rulemaking action.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a meeting of the Puerto Rico Advisory Committee to the Commission will convene by virtual web conference on Monday, March 20, 2023, at 3:30 p.m. Atlantic Time/Eastern Time. The purpose is to discuss their project on the civil rights impacts of the Insular Cases in Puerto Rico.