October 22, 2021 – Federal Register Recent Federal Regulation Documents

The Coast Guard will enforce a special local regulation for the Perrysburg Regatta from 7:30 a.m. through 3:30 p.m. on October 23, 2021 to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within the Ninth Coast Guard District identifies the regulated area for this event in Toledo, OH. During the enforcement period, the operator of any vessel in the regulated area must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.

The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

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 Coast Guard announces the completion of the Port Access Route Study for the Approaches to the Chesapeake Bay, Virginia. The study was conducted to determine whether to recommend changes to enhance navigational safety by examining existing shipping routes and waterway uses as offshore energy development matures and to evaluate the need for establishing or changing existing vessel routing measures. This notice summarizes the study's recommendation.

Because a comment filed by settling parties included additional material (in particular a memorandum of understanding) that relates to statements in some of the comments the Copyright Royalty Judges received, the Judges are reopening the comment period for an additional 30 days. The proposed rule published for comment sets certain rates and terms applicable during the period beginning January 1, 2023, and ending December 31, 2027, for the section 115 statutory license for making and distributing phonorecords of nondramatic musical works and is based on regulations proposed pursuant to a partial settlement among the settling parties.

EPA is required under the Toxic Substances Control Act (TSCA) to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA Section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 09/01/2021 to 09/30/2021.

In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM), Las Vegas Field Office (LVFO), will prepare a Resource Management Plan Amendment Environmental Assessment (EA) for the proposed Logandale Trails Special Recreational Management Area, approximately 60 miles northeast of Las Vegas, Nevada, and west of the communities of Logandale and Overton, Nevada. This notice will include a Recreation Area Management Plan and a Travel Management Plan. Publication of this notice initiates the scoping process and opens a 30-day public comment period to solicit public comments and identify issues.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Data Standards for Drug and Biological Product Submissions Containing Real- World Data.'' This guidance provides recommendations to sponsors to help support compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) when submitting study data derived from real-world data (RWD) sources in applicable regulatory submissions using standards specified in the Data Standards Catalog (Catalog). FDA is publishing this draft guidance as part of a series of guidance documents under its program to evaluate the use of real-world evidence (RWE) in regulatory decision making.

The Committee is proposing to add product(s) and service(s) to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities and deletes product(s) and service(s) previously furnished by such agencies.

The United States Forest Service (USFS) has filed an application with the Bureau of Land Management (BLM) requesting that the Secretary of the Interior extend the duration of Public Land Order (PLO) No. 7549 for an additional 20-year term. PLO No. 7549 withdrew 1,328.84 acres of National Forest System land from location and entry under the United States mining laws to protect the Lemhi Pass National Historic Landmark. The withdrawal created by PLO No. 7549 will expire on December 26, 2022, unless it is extended. The land will remain open to the general land laws and leasing under the mineral leasing laws. This notice also gives an opportunity for the public to comment and to request a public meeting on the withdrawal extension application.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NUBEQA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Notice is being provided that the Securities and Exchange Commission Asset Management Advisory Committee (``AMAC'') will hold a public meeting on October 28, 2021, by remote means. The meeting will begin at 10:00 a.m. (ET) and will be open to the public via webcast on the Commission's website at www.sec.gov. Persons needing special accommodations to take part because of a disability should notify the contact person listed below. The public is invited to submit written statements to the Committee. The meeting will include a discussion of matters in the asset management industry relating to the Evolution of Advice and the Small Advisers and Small Funds Subcommittees, including panel discussions and potential recommendations.

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.