2021 – Federal Register Recent Federal Regulation Documents

This Public Land Order (PLO) withdraws 82.50 acres of National Forest System land from location and entry under the United States mining laws, but not from leasing under the mineral leasing laws, for a period of 20 years to protect the recreation resources at the Spanish Creek Campground located in the Plumas National Forest, California. The land has been and will remain open to such forms of disposition allowed by law on National Forest System land.

The Food and Drug Administration (FDA, Agency, or we) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III.

FMCSA announces its decision to renew exemptions for 16 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket notification, specifically, single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is designating special controls for these three types of blood lancets based on the determination that general controls only are not sufficient and there is sufficient information to establish special controls to provide a reasonable assurance of their safety and effectiveness. FDA is also reclassifying a fourth type of blood lancet, multiple use blood lancets for multiple patient use, from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is reclassifying these four types of blood lancets on its own initiative based on new information.

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into class II (general controls and special controls), subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named ``hepatitis C virus (HCV) antibody tests.'' FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices.

The Food and Drug Administration (FDA or Agency) has extended the comment period for the over-the-counter (OTC) monograph proposed order (order ID OTC000008) entitled ``Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use'' (Proposed Order), which was issued on September 24, 2021. A notice of availability for the Proposed Order appeared in the Federal Register of September 27, 2021. FDA issued the Proposed Order to amend and revise the deemed final administrative order concerning nonprescription sunscreen drug products (Deemed Final Order) established by the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The Proposed Order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It would also set forth certain characteristics that would establish that a sunscreen drug product is not GRASE. FDA has extended the comment period for the Proposed Order in response to a request for an extension to allow interested persons additional time to submit comments.

This document announces the reapportionment of 34,645 metric tons of Pacific whiting from the tribal allocation to the non-tribal commercial fishery sectors via automatic action on September 15, 2021. This reapportionment is to allow full utilization of the Pacific whiting resource.

NMFS is proposing to establish a uniform, nationally consistent minimum insurance standard that would apply in regional regulatory programs that authorize an observer provider to deploy a person in any mandatory or voluntary observer program and that specify responsibilities of authorized providers. NMFS has concluded that this action is necessary to clarify the types of insurance that are appropriate to address the financial risks that observer coverage presents in any federally managed fishery that is subject to observer coverage. The proposed standard would establish a nationally consistent suite of insurance coverages that an observer provider seeking authorization, or that has been authorized, must have to mitigate the financial risks associated with providing observer services; specifically observer deployments to fishing vessels or shoreside locations such as processing facilities, and those that arise with training personnel for these deployments. Through compliance with this minimum standard, observer providers would be properly insured, thereby mitigating the financial risks that fishing vessels, first receivers, and shoreside processors have when complying with observer coverage requirements. This proposed rule would also revise regional observer program regulations to reference the newly established national minimum insurance standard, but existing regional observer program regulatory procedures that specify how an observer provider demonstrates compliance with insurance requirements would not be modified.

Based on affirmative final determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC), Commerce is issuing antidumping duty orders on thermal paper from Germany, Japan, the Republic of Korea (Korea), and Spain.

We are proposing to request an extension from the Office of Management and Budget (OMB) of three currently approved information collections. People use the first information collection to request permission to film, photograph, or videotape at a NARA facility for news purposes. People use the second and third information collections to request permission to use NARA facilities for events in the Washington, DC, area, at a Federal records center, or at a Presidential library. Previously, we have handled each of these last two items as separate information collections, but we have recently revised the underlying regulation and the processes for requesting use of different kinds of NARA facilities, so we are proposing to combine these two into one ICR. All three collections are based on requirements in the same regulation. We invite you to comment on these proposed information collections pursuant to 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 FAA proposes to adopt a new airworthiness directive (AD) for certain Stemme AG TSA-M Model S6 and S6-RT gliders. This proposed AD was prompted by mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as a new version of the propeller gearbox tooth belt with a reduced life limit. This proposed AD would require establishing a life limit of 5 years for certain propeller gearbox tooth belts. The FAA is proposing this AD to address the unsafe condition on these products.

The Federal Emergency Management Agency (FEMA) is extending the public comment period for its request for information published October 12, 2021, and will hold an additional virtual public meeting via web conference to solicit feedback on the request for information The October request for information sought input from the public on the floodplain management standards that communities should adopt to result in safer, stronger, and more resilient communities. It also sought input on how the National Flood Insurance Program (NFIP) can better promote protection of and minimize any adverse impact to, threatened and endangered species, and their habitats.

The DoD is publishing this notice to announce that it is amending the Defense Policy Board (``the Board'').

In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Land Management (BLM) proposes to renew an information collection.

The National Towing Safety Advisory Committee (Committee) will meet via teleconference to discuss the election of officers, issuance of new task statements, and stand-up of the Task Statement Vetting Committee. The Committee will also discuss new tasking to include the draft final report for Towing Safety Advisory Committee Task 16-01, Subchapter M Implementation, Workgroup Item #1 that sought to identify the parameters Coast Guard officials should use to determine whether a vessel inspected under subchapters other than Subchapter M is performing ``Occasional Towing''. The meeting will be open to the public.

This notice announces a meeting of the ARAC.