November 7, 2022 – Federal Register Recent Federal Regulation Documents

The Board of Directors of the U.S. International Development Finance Corporation (``DFC'') will hold a public hearing on December 7, 2022. This hearing will afford an opportunity for any person to present views in accordance the BUILD Act of 2018. Those wishing to present at the hearing must provide advance notice to the agency as detailed below.

The FHWA, on behalf of the FDOT, is issuing this notice to announce actions taken by FDOT and other Federal Agencies that are final agency actions. These actions relate to the proposed State Road (S.R.) 85 Project Development and Environment (PD&E) Study (Financial Management Number 220171-2-22-01). The proposed S.R. 85 project will add capacity to S.R. 85 from S.R. 123 (Roger J. Clary Highway) to Mirage Avenue, a distance of approximately 12.2 miles. Improvements consist of roadway widening from four to six lanes, bridge replacements, improvements at signalized intersections, reconstruction of the interchange at I-10 as a Diverging Diamond Interchange (DDI), and the construction of stormwater management facilities. These actions grant licenses, permits, or approvals for the project.

Pursuant to the requirements of the National Environmental Policy Act (NEPA) of 1969, as amended, the Baltimore District of the U.S. Army Corps of Engineers (USACE), in partnership with the Maryland Department of Transportation's Maryland Port Administration, the non- federal sponsor, plans to prepare a supplemental Environmental Impact Statement (sEIS) for the Mid-Chesapeake Bay Island Ecosystem Restoration Project at James Island (Mid-Bay Island Project). The Mid- Chesapeake Islands Restoration Project recommends remote island restoration at James Island and Barren Island, both on the Eastern Shore of Maryland and in Dorchester County, MD, through the beneficial use of dredged material. The project addresses two needs: (1) the restoration of remote island habitat to benefit wildlife including a diverse assemblage of birds, fish, herpetofauna, and invertebrates; and (2) the beneficial use of dredged material from the maintenance of the approach channels to Baltimore Harbor. Remote islands, a critical ecosystem component in the Chesapeake Bay, are offshore landforms that provide isolation, lack of human disturbance, and few predators. These conditions uniquely support isolated nesting and foraging habitat for a diverse assemblage of wildlife. Extensive island habitat loss has occurred within the Mid-Chesapeake Bay, and James Island has nearly vanished. Sea level rise and related erosion, as well as land subsidence and wave action are the primary drivers of island loss. The project provides an opportunity to utilize 30 to 70 million cubic yards of clean dredged material over a 20-year period to restore 2,072 acres of remote island habitat at James Island including uplands and wetlands. The project would convert over 2,000 acres of shallow water habitat in the waters surrounding James Island to external dikes and island habitat. There are expected to be long-term changes to the aesthetics of the project area as an effect of the restoration of James Island in the landscape. The sEIS will update documentation for NEPA focused on the James Island component of the project. USACE is requesting to be provided any supporting information, analyses, and alternative identification relevant to the action being evaluated by this sEIS.

On July 18, 2022, the Bureau of Transportation Statistics (BTS) announced its intention in a Federal Register Notice (87 FR 42796) to request that the Office of Management and Budget (OMB) approve the following information collection: The Freight Logistics Optimization Works (FLOW) Project. Over the past several years, the U.S. supply chain has struggled with unprecedented congestion under COVID-induced surges of containerized cargo through our ports and intermodal networks. In March of this year, the White House announced the launch of the Freight Logistics Optimization Works (FLOW) initiative with the Department of Transportation and the freight industry to facilitate a collaboration and sharing of intermodal trade data. This collaboration would help improve supply chain efficiencies and reduce overall costs to U.S. consumers. The FLOW initiative builds on previous work by the Administration's Supply Chain Disruptions Task Force to ensure the expeditious movement of cargo from ship to shelf. In accordance with the Paperwork Reduction Act of 1995, BTS announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for its review and approval. BTS encouraged interested parties to submit comments to docket number 2022- 15247, during the 60-day comment period. No comments were received.

The Food and Drug Administration (FDA, Agency, or we) 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.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANGELMED GUARDIAN SYSTEM 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 medical device.

On October 21, 2021, the Consumer Financial Protection Bureau (Bureau or CFPB) ordered six large technology companies operating payments systems in the United States to provide information about certain of their business practices. Accompanying the orders, the Director of the Bureau issued a statement and invited interested parties to submit comments to inform the Bureau's inquiry. The statement and request for comment was published in the Federal Register on November 5, 2021, in a document titled, ``Notice and Request for Comment Regarding the CFPB's Inquiry into Big Tech Payment Platforms.'' The Bureau has determined that it is appropriate to re-open the docket for 30 days from Federal Register publication and add two questions.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ``Drug Supply Chain Security Act Implementation and Readiness Efforts for 2023'' to allow supply chain stakeholders an opportunity to share their perspectives. The topics to be discussed are stakeholder experiences with implementation and overall readiness regarding implementation of enhanced drug distribution security requirements that will go into effect on November 27, 2023, standards for the interoperable data exchange of product tracing information, requests for product tracing information or verification from FDA for the purpose of investigating suspect or illegitimate products or for recalls, steps taken to build capacity for package-level tracing, pharmaceutical distribution supply chain best practices, and, in general, the impact that the Drug Supply Chain Security Act (DSCSA) requirements would have on public health, including patient safety and access to prescription drugs, and on stakeholders, in terms of costs, benefits, and regulatory burden.

The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.

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.

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 Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Ocean Energy Management (BOEM) is proposing this information collection request (ICR) to renew the Office of Management and Budget (OMB) Control Number 1010-0176.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.