December 9, 2022 – Federal Register Recent Federal Regulation Documents

NMFS is proposing to modify an incidental harassment authorization (IHA) that was issued to the United States Navy (Navy) on March 15, 2022 in association with construction activities related to the replacement of Pier 3 at Naval Station Norfolk in Norfolk, Virginia. As a result of necessary changes to the Navy's construction plan, NMFS is proposing to modify the Navy's IHA to increase authorized take by Level B harassment for bottlenose dolphins and take by Level A harassment for harbor seals. NMFS is also proposing to include appropriate, additional shutdown mitigation provisions for all species in the modified IHA. The monitoring and reporting measures remain the same as prescribed in the initial IHA. NMFS will also consider public comments on the requested modification prior to making any final decision and agency responses will be summarized in the final notice of our decision.

On November 9, 2022, the National Marine Fisheries Service published a Notice of Availability and request for comments on Amendment 123 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP), but inadvertently did not include the supporting Amendment text. With this notice, NMFS is extending the public comment period by 60 days to February 7, 2023, to afford the public with additional time to provide comments on Amendment 123.

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.

Pursuant to a delegation of authority from the Secretary of Transportation, the Maritime Administrator is authorized to issue an Aquaculture Support Operations Waiver to U.S. documented vessels with registry endorsements or foreign flag vessels in operations that treat aquaculture fish or protect aquaculture fish from disease, parasitic infestation, or other threats to their health upon a finding that suitable vessels of the United States are not available that could perform those operations. MARAD has received an Aquaculture Support Operations waiver request and is publishing this notice to solicit comments that may assist MARAD in determining whether suitable vessels of the United States are available that could perform the proposed aquaculture support operations set forth in the request. A brief description of the proposed aquaculture support operations is listed in the SUPPLEMENTARY INFORMATION section below.

The Internal Revenue Service (IRS), 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 information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Application to Participate in the Income Verification Express Service (IVES) Program.

The National Marine Fisheries Service will hold a series of in-person workshops on January 23, January 24, January 25, and January 26, 2023.

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.

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Components for Certain Environmentally-Protected LCD Digital Displays and Products Containing Same, DN 3658; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

The National Science Foundation (NSF) is announcing plans to renew this collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, we are providing opportunity for public comment on this action. After obtaining and considering public comments, NSF will prepare the submission requesting OMB clearance of this collection for three years.

The Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on an extension, with change, of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the After Action Report/Improvement Plans, Integrated Preparedness Plans, and Support Request Forms to the National Exercise Program which are used to validate current preparedness capabilities and support future national exercise efforts.

The Department of Commerce (Commerce) determines that Industeel Belgium S.A. (Industeel) made sales of subject merchandise at less than normal value during the period of review (POR), May 1, 2020, through April 30, 2021.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations on investigational new drug applications (INDs) to exempt from the IND requirements certain clinical investigations of lawfully marketed foods for human consumption (including both conventional foods and dietary supplements) and cosmetics when the product is to be studied to evaluate its use as a drug. Under the proposal, clinical studies to evaluate a drug use of such products would not have to be conducted under an IND when, among other things, the study is not intended to support a drug development plan or a labeling change that would cause the lawfully marketed product to become an unlawfully marketed drug, and the study does not present a potential for significant risk to the health, safety, or welfare of subjects. Though exempt from the IND requirements, such investigations would still be subject to other regulations designed to protect the rights and safety of subjects, including requirements for informed consent and review by institutional review boards (IRBs). By exempting from the IND requirements certain clinical investigations of products lawfully marketed as a food or cosmetic, the proposed provisions are intended to reduce the regulatory burden of conducting such studies while retaining protections for human subjects.

This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums and Obstacle Departure procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

A final rule was published in the Federal Register on December 5, 2022, amending Class E surface airspace and Class E airspace extending upward from 700 feet above the surface for Edward F. Knapp State Park Airport, Montpelier, VT, by creating a cutout of the airspace around Warren-Sugarbush Airport. This action corrects the Class E airspace extending upward from 700 feet above the surface description by adding Warren-Sugarbush Airport to the Class E description header.

The Environmental Protection Agency (EPA) is preparing an Integrated Science Assessment (ISA) as part of the review of the primary (health-based) National Ambient Air Quality Standards (NAAQS) for oxides of nitrogen. For gaseous oxides of nitrogen (i.e., oxidized nitrogen compounds), which also include nitric oxide (NO) and gases produced from reactions involving NO and NO2, the primary NAAQS are specified in terms of nitrogen dioxide (NO2). The ISA will be developed by EPA's Center for Public Health and Environmental Assessment (CPHEA) within the Office of Research and Development. When final, this ISA is intended to update the previous Integrated Science Assessment for Oxides of NitrogenHealth Criteria (EPA/600/R-15/068, 2016), published on January 28, 2016 (2016 ISA). Interested parties are invited to assist EPA in developing and refining the scientific information base for the review of the primary NO2 NAAQS by submitting research studies and data that have been published in the peer-reviewed scientific literature, accepted for publication, or presented at a public scientific meeting since May 15, 2015.

This document contains final regulations that except certain partnership-related items from the centralized partnership audit regime created by the Bipartisan Budget Act of 2015, and sets forth alternative rules that will apply to the examination of excepted items by the IRS. The centralized partnership audit regime does not apply to a partnership-related item if the item involves a special enforcement matter described in these regulations. Additionally, these regulations make changes to the existing centralized partnership audit regime regulations to account for changes to the Internal Revenue Code (Code) as well as changes that clarify those regulations. The regulations affect partnerships and partners to whom special enforcement matters apply.

As a result of the determinations by the Department of Commerce (Commerce) and the U.S. International Trade Commission (ITC) that revocation of the antidumping duty (AD) order on hot-rolled flat- rolled carbon-quality steel products (hot-rolled steel) from the Russian Federation (Russia) would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, Commerce is publishing a notice of continuation of this AD order.

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

The United States Patent and Trademark Office (USPTO or Office) is implementing the Cancer Moonshot Expedited Examination Pilot Program to replace the Cancer Immunotherapy Pilot Program, which expedited examination for eligible patent applications pertaining to methods of treating a cancer using immunotherapy. The new pilot program broadens the scope of qualifying technologies. Applications accepted into the new pilot program will be advanced out of turn (accorded special status) for examination until a first Office action. The new pilot program supports the renewed national Cancer Moonshot initiative that aims to reduce the cancer mortality rate by at least 50% within 25 years. This notice outlines the conditions, eligibility requirements, and guidelines of the new pilot program.