December 9, 2021 – Federal Register Recent Federal Regulation Documents

The FAA is adopting a new airworthiness directive (AD) for certain Rolls-Royce Deutschland Ltd. & Co KG (RRD) Trent 1000 model turbofan engines. This AD was prompted by the manufacturer revising the engine Time Limits Manual (TLM) life limits of certain critical rotating parts and direct accumulation counting data files. This AD requires the operator to revise the airworthiness limitation section (ALS) of their existing approved aircraft maintenance program (AMP) by incorporating the revised tasks of the applicable TLM for each affected model turbofan engine, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA is adopting a new airworthiness directive (AD) for all helicopters equipped with a radio (also known as radar) altimeter. This AD was prompted by a determination that radio altimeters cannot be relied upon to perform their intended function if they experience interference from wireless broadband operations in the 3.7-3.98 GHz frequency band (5G C-Band). This AD requires revising the limitations section of the existing rotorcraft flight manual (RFM) for your helicopter to incorporate limitations prohibiting certain operations requiring radio altimeter data when in the presence of 5G C-Band interference in areas as identified by Notices to Air Missions (NOTAMs). The FAA is issuing this AD to address the unsafe condition on these products.

Pursuant to the Privacy Act of 1974, as amended by the Computer Matching and Privacy Protection Act of 1988 and the Computer Matching and Privacy Protections Amendment of 1990 (Privacy Act), and Office of Management and Budget (OMB) guidance on the conduct of matching programs, notice is hereby given of the reestablishment of a matching program between the Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS), and the New Jersey Department of Labor and Workforce Development (NJ-LWD). NJ-LWD will match against DHS-USCIS data to verify the immigration status of non- U.S. citizens who apply for federal benefits (Benefit Applicants) under Unemployment Compensation (UC) programs that NJ-LWD administers to determine whether Benefit Applicants possess the requisite immigration status to be eligible for the UC it administers.

The Pacific Fishery Management Council (Pacific Council) has begun its annual preseason management process for the 2022 ocean salmon fisheries. This document announces the availability of Pacific Council documents, as well as the anticipated dates and locations of upcoming Pacific Council meetings and public hearings hosted by the Pacific Council. These documents and events comprise the Pacific Council's complete schedule for determining the annual proposed and final modifications to ocean salmon fishery management measures. The agendas for the March and April 2022 Pacific Council meetings will be published in subsequent Federal Register documents prior to the actual meetings.

Pursuant to the Privacy Act of 1974 and Office of Management and Budget Circular No. A-108, the U.S. Department of Agriculture (USDA) give notice that a component agency, the Animal and Plant Health Inspection Service (APHIS) proposes to modify an existing system of records notice titled Emergency Management Response System (EMRS), USDA/APHIS-11. This system, among other things, helps APHIS to manage and investigate incidents of foreign animal diseases within the United States.

Catalent Pharma Solutions, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

Noramco Coventry LLC, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

NMFS is prohibiting directed fishing for Pacific cod by hook- and-line catcher/processors in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2021 Pacific cod total allowable catch apportioned to hook-and-line catcher/ processors in the Western Regulatory Area of the GOA.

The National Science Foundation (NSF) is required to publish notice of permits issued under the Antarctic Conservation Act of 1978. This is the required notice.

As a result of the determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC) that revocation of the antidumping duty (AD) order on potassium permanganate from the People's Republic of China (China) 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 the AD order.

This is an amendment of the Presidential declaration of a major disaster for the State of New Jersey (FEMA-4614-DR), dated 09/05/ 2021. Incident: Remnants of Hurricane Ida. Incident Period: 09/01/2021 through 09/03/2021.

The Food and Drug Administration (FDA, the 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 aspects of the Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.

This is an amendment of the Presidential declaration of a major disaster for the State of New York (FEMA-4615-DR), dated 09/05/ 2021. Incident: Remnants of Hurricane Ida. Incident Period: 09/01/2021 through 09/03/2021.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of New Jersey (FEMA-4614-DR), dated 09/05/2021. Incident: Remnants of Hurricane Ida. Incident Period: 09/01/2021 through 09/03/2021.

The Environmental Protection Agency (EPA), published a document in the Federal Register of October 28, 2021, notifying the public about the opportunity to provide comment on its draft Strategy to Reduce Lead Exposures and Disparities in U.S. Communities. Corrections have been made since the publishing for comment.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.'' FDA is issuing this guidance as part of its Real-World Evidence (RWE) Program and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision making. FDA created a framework to evaluate the potential use of RWE to help support the approval of a new indication for a drug already approved under the FD&C Act or to help to support or satisfy postapproval study requirements. This guidance discusses the applicability of FDA's investigational new drug application (IND) regulations to various clinical study designs that utilize real-world data (RWD), and clarifies the Agency's expectations regarding clinical studies using RWD submitted to FDA in support of a regulatory decision regarding the effectiveness or safety of a drug (e.g., as part of a new drug application or a biologics license application) that are not subject to the IND regulations.

This action proposes to amend the Class E airspace at Corsicana, TX. The FAA is proposing this action as the result of an airspace review due to the decommissioning of the Powell non- directional beacon (NDB). The geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database.