October 2021 – Federal Register Recent Federal Regulation Documents

In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Land Management (BLM) has submitted a new information collection request (ICR) to the Office of Management and Budget (OMB) for review.

Notice is hereby given that the U.S. International Trade Commission (the ``Commission'') has determined that: (i) The respondents have violated section 337 of the Tariff Act of 1930, as amended, by importing, selling for importation, or selling in the United States after importation certain laparoscopic surgical staplers, reload cartridges, and components thereof that infringe complainants' U.S. Patent No. 9,844,379 (``the '379 patent''); (2) the appropriate remedies are a limited exclusion order and cease and desist orders; and (3) enforcement of said remedial orders will be suspended pending final resolution of a Final Written Decision by the Patent Trial and Appeal Board (``PTAB'') that the asserted claims of the '379 patent are unpatentable. This investigation is terminated.

We, the U.S. Fish and Wildlife Service, have received applications for permits to conduct activities intended to enhance the propagation and survival of endangered species under the Endangered Species Act of 1973, as amended. We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing the requested permits, we will take into consideration any information that we receive during the public comment period.

Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition ``Revealing Krishna: Journey to Cambodia's Sacred Mountain'' at the Cleveland Museum of Art, Cleveland, Ohio, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.

In the Federal Register notice that was originally published on October 12, 2021, (Volume 86, Number 194, Page 56759) the day for this meeting has been corrected from Thursday to Wednesday, November 10, 2021 at 11:00 a.m. Eastern Time. All other meeting details remain unchanged.

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.

Through this notice the Bureau of Land Management (BLM) is segregating public lands included in the right-of-way application for the Rough Hat Nye County Solar Project from appropriation under the public land laws, including the Mining Law, but not the Mineral Leasing or Material Sales Acts, for a period of 2 years from the date of publication of this notice, subject to valid existing rights. This segregation is to allow for the orderly administration of the public lands to facilitate consideration of development of renewable energy resources. The public lands segregated by this Notice total 7,075.93 acres.

Through this notice the Bureau of Land Management (BLM) is segregating public lands included in the right-of-way application for the Rough Hat Clark County Solar Project from appropriation under the public land laws, including the Mining Law, but not the Mineral Leasing or Material Sales Acts, for a period of 2 years from the date of publication of this notice, subject to valid existing rights. This segregation is to allow for the orderly administration of the public lands to facilitate consideration of development of renewable energy resources. The public lands segregated by this notice total 3,273.96 acres.

The Bureau of Land Management (BLM) hereby updates the filing fee for Applications for Permits to Drill (APD) on Federal oil and gas leases. The updated APD fee amount is $10,900, reflecting the adjustment for inflation as required by statute.

This document corrects technical and typographical errors in the final rule that appeared in the August 13, 2021, issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program.''

This notification grants the petition for rulemaking submitted by the Airports Council International-North America (ACI-NA) requesting that DOT initiate rulemaking to revise and update agency rules pertaining to Participation of Disadvantaged Business Enterprise in Airport Concessions.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditional new animal drug applications (cNADAs) during January, February, and March 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.

In this document, the Commission announces the effective date of an information collection associated with a rule contained in the Commission's Call Authentication Trust Anchor, Second Report and Order (Order). This document is consistent with the Commission's Call Authentication Trust Anchor, Second Report and Order (Order) which stated that the Commission would publish a document in the Federal Register announcing the effective date of that rule.

The Food and Drug Administration (FDA, we, or the Agency) is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids. Specifically, we propose to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with a new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that would become obsolete as a result of changes to the hearing aid requirements. This action, if finalized, would more clearly define prescription hearing aids; however, it would not change the classification of existing device types. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.