October 28, 2020 – Federal Register Recent Federal Regulation Documents

TSA is extending the exemption from Renewal of the Hazardous Materials Endorsement Security Threat Assessment for Certain Individuals that TSA published on July 31, 2020 which was scheduled to expire on October 30, 2020, through December 31, 2020. Under this exemption, states may extend the expiration date of hazardous materials endorsements (HMEs) that expire on or after March 1, 2020, for 180 days, due to restrictions and business closures in place in response to the COVID-19 pandemic. If a state grants an extension, the individual with an expired HME must initiate the process of renewing his or her security threat assessment (STA) for the HME no later than 60 days before the end of the state-granted extension. Federal partners, state licensing agencies and related associations report ongoing difficulties in timely renewal of expiring HMEs and asked TSA to consider extending the exemption until the end of calendar year 2020. TSA has determined it is in the public interest to extend the exemption through December 31, 2020, which aligns with similar waivers issued by the U.S. Department of Transportation. TSA may extend this exemption at a future date depending on the status of the COVID-19 crisis.

The Federal Motor Carrier Safety Administration (FMCSA) announces its decision to grant the Samsara Networks, Inc. (Samsara) application for a limited 5-year exemption to allow its AI Dash Cam device to be mounted lower in the windshield on commercial motor vehicles (CMV) than is currently permitted. The Agency has determined that lower placement of the AI Dash Cam device would not have an adverse impact on safety and that adherence to the terms and conditions of the exemption would likely achieve a level of safety equivalent to, or greater than, the level of safety provided by the regulation.

This notice provides a notification of TRICARE Plan program changes for calendar year 2021. Changes or improvements to the TRICARE program benefits are provided in the supplementary information section.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

In accordance with the Paperwork Reduction Act of 1995, we, the Office of the Assistant SecretaryIndian Affairs are proposing to revise an information collection.

The U.S. Nuclear Regulatory Commission (NRC) has received an application from the Defense Threat Reduction Agency (DTRA) for a license which authorizes possession and use of Special Nuclear Materials (SNM) for analytical or scientific research and development. The license application request contains sensitive unclassified non- safeguards information (SUNSI).

The DoD is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Advisory Committee on Women in the Services (DACOWITS) will take place.

The U.S. Nuclear Regulatory Commission (NRC) is issuing Interim Staff Guidance (ISG), ``Micro-Reactor License Application COL- ISG-029, `Environmental Considerations Associated with Micro-Reactors.' '' The purpose of this ISG is to modify existing guidance and provide supplemental guidance to assist the NRC staff in determining the scope and scale of environmental reviews of micro-reactor applications.

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.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 22, 2020, under section 337 of the Tariff Act of 1930, as amended, on behalf of Q3 Networking LLC of Frisco, Texas. A supplement was filed on October 8, 2020. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain routers, access points, controllers, network management devices, other networking products, and hardware and software components thereof by reason of infringement of certain U.S. Patent No. 7,457,627 (``the '627 patent''); Patent No. 7,609,677 (``the '677 patent''); U.S. Patent No. 7,895,305 (``the '305 patent''); and U.S. Patent No. 8,797,853 (``the '853 patent''). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Ocean Energy Management (BOEM) is proposing to renew an information collection request.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Referencing Approved Drug Products in Abbreviated New Drug Application Submissions.'' Any person is permitted to submit an abbreviated new drug application (ANDA) in order to seek approval to market a generic version of a previously approved drug product. The purpose of this guidance is to provide information to potential applicants on how to identify a reference listed drug (RLD), a reference standard, and the basis of submission in an ANDA submission.

The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to proposed regulations that, if finalized, would govern the program of growing marihuana for scientific and medical research under DEA registration.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date.'' FDA is issuing this guidance to revise its compliance policy regarding the deadline for filing premarket approval (PMA) applications for previously cleared accessories necessary to the operation of automated external defibrillator (AED) systems.