2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of the draft guidance entitled ``Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' FDA recognizes that it will take time for device manufacturers, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the declared public health emergency (PHE) to normal operations. To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA's general recommendations for a phased transition process with respect to devices that fall within enforcement policies issued during the COVID-19 PHE, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices. FDA is concurrently issuing a companion guidance to describe FDA's recommendations for this transition process with respect to devices issued Emergency Use Authorizations (EUAs) during the COVID-19 PHE. This draft guidance is not final nor is it in effect at this time.

The Indian Health Service published a Notice of Funding Opportunity in the Federal Register of November 4, 2021, for the Substance Abuse Prevention, Treatment, and Aftercare grant program. The notice was missing a section in the description of the required Project Narrative that applicants must submit with their application. The Project Narrative will have a fourth section added, Statement of Need, and the page limit for the Project Narrative increased from 15 to 17 pages.

The FAA is adopting a new airworthiness directive (AD) for all Airbus SAS Model A350-941 and -1041 airplanes. This AD was prompted by reports of slat transmission jams caused by frozen slat geared rotary actuators (SGRAs) at slat 5 track 12. This AD requires repetitive water drainage and plug cleaning of the left- and right-hand SGRAs having a certain part number installed on slat 5 track 12 with certain functional item numbers, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology.'' Physiologic Closed-Loop Control (PCLC) devices are intended for automatic control of a physiologic variable(s) through delivery of energy or substance using feedback from physiologic sensors. PCLC devices may play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during emergency response and medical surge situations. This draft guidance provides technical considerations for PCLC technology in order to promote development and availability of safe and effective PCLC medical devices. This draft guidance is not final nor is it in effect at this time.

The Department of Commerce (Commerce) preliminarily determines that, with the exception of the three companies with no shipments, the companies under review sold subject merchandise at less than normal value during the period of review (POR), December 1, 2019, through November 30, 2020. Additionally, Commerce is rescinding this review with respect to three companies. Interested parties are invited to comment on these preliminary results of review.

The South Atlantic Fishery Management Council (Council) submitted Amendment 10 to the Fishery Management Plan (FMP) for the Dolphin and Wahoo Fishery of the Atlantic (Dolphin and Wahoo FMP) for review, approval, and implementation by NMFS. If approved by the Secretary of Commerce, Amendment 10 to the Dolphin and Wahoo FMP (Amendment 10) would revise the acceptable biological catch (ABC), annual catch limits (ACLs), sector allocations, accountability measures (AMs), and additional management measures for dolphin and wahoo. The additional management measures would address commercial trip limits, authorized fishing gear, the operator permit (card) requirement for dolphin and wahoo, and the recreational vessel limit for dolphin. The purpose of Amendment 10 is to base conservation and management measures for dolphin and wahoo on the best scientific information available and increase net benefits from the fishery.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

The Export-Import Bank of the United States (EXIM) is soliciting comments and feedback concerning a recommendation resulting from Executive Order 14017 on America's Supply Chains. The report ``Building resilient supply chains, revitalizing American manufacturing, and fostering broad-based growth'', recommends that EXIM consider developing an option to provide financing in support of the establishment and/or expansion of U.S. manufacturing facilities and infrastructure projects in the United States that would facilitate U.S. exports. EXIM requests: (1) Comments on the usefulness of such an option and need for EXIM to extend its medium and long-term loans and guarantees to domestic projects as described in the E.O. 14017 Report recommendation; and (2) Feedback on the hypothetical parameters of such an EXIM program as described in the ``supplementary information'' below.

The Committee for the Implementation of Textile Agreements (``CITA'') has determined that certain 100% polyester 3-layered bonded fabric, as specified below, is not available in commercial quantities in a timely manner in the CAFTA-DR countries. The product will be added to the list in Annex 3.25 of the CAFTA-DR Agreement in unrestricted quantities.

This Notification announces the decision of the Secretary of Homeland Security (Secretary) to lift the temporary restrictions that apply to non-essential travel by certain individuals. Specifically, the Secretary has lifted such restrictions for individuals who have been fully vaccinated against COVID-19, can present proof of COVID-19 vaccination status, and are seeking to enter the United States via land ports of entry (POEs) and ferry terminals along the U.S.-Mexico border. The lifting of restrictions for such fully vaccinated individuals does not affect U.S. citizens and lawful permanent residents returning to the United States, regardless of whether the individual is fully vaccinated, because such travel is currently defined as essential travel.

The Copyright Royalty Judges published for comment a proposed settlement governing royalty rates and terms for the retransmission of over-the-air television and radio broadcast stations by cable television systems to their subscribers. Having received no comments, the Judges adopt the existing rates and terms as proposed by the settlement.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new collection.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of a person who has been removed from the list of Specially Designated Nationals and Blocked Persons (SDN List). Their property and interests in property are no longer blocked pursuant to Executive Order 13818 of December 20, 2017, ``Blocking the Property of Persons Involved in Serious Human Rights Abuse or Corruption'' (``E.O. 13818''), and U.S. persons are no longer generally prohibited from engaging in transactions with them. The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's List of Specially Designated Nationals and Blocked Persons (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

FMCSA amends its Hazardous Materials Safety Permits regulations to incorporate by reference the updated Commercial Vehicle Safety Alliance (CVSA) handbook containing inspection procedures and Out-of-Service Criteria (OOSC) for inspections of shipments of transuranic waste and highway route controlled quantities of radioactive material. The OOSC provide enforcement personnel nationwide, including FMCSA's State partners, with uniform enforcement tolerances for inspections. Through this rule, FMCSA incorporates by reference the April 1, 2021, edition of the handbook.

The Department of Commerce (Commerce) determines that an exporter of cast iron soil pipe from the People's Republic of China made sales at prices below normal value during the period of review (POR) August 31, 2018, through April 30, 2020.

The Department of Health and Human Services released the 15th Report on Carcinogens (RoC) to the public on December 21, 2021. The report is available on the RoC website at: https://ntp.niehs.nih.gov/ go/roc or from the Office of the RoC (see ADDRESSES below).

Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 12) of the presiding administrative law judge (``ALJ'') granting complainants' unopposed motion to terminate the investigation in its entirety based on a settlement agreement. The investigation is terminated.

FinCEN is inviting the public to nominate financial institutions, trade groups, and non-federal regulators or law enforcement agencies for membership on the Bank Secrecy Act Advisory Group. New members will be selected for three-year membership terms.