August 3, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2021. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2021, which apply from October 1, 2020, through September 30, 2021. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2021, you should not submit a Small Business Certification Request. This document provides information on how the fees for FY 2021 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2021 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). This fee is effective August 1, 2020, and will remain in effect through September 30, 2021.

The New England Fishery Management Council is convening a meeting of its Groundfish Advisory Panel via webinar to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is withdrawing approval of an abbreviated new drug application (ANDA) for oxycodone hydrochloride and ibuprofen tablets. The basis for the withdrawal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA. The holder of the ANDA has waived its opportunity for a hearing.

California State University, Sacramento, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural items listed in this notice meet the definition of unassociated funerary objects. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request to the California State University, Sacramento. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

The Baylor University's Mayborn Museum Complex (formerly Baylor University's Strecker Museum; formerly Baylor University Museum) has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and associated funerary objects and any present-day Indian Tribes or Native Hawaiian organizations. Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to Baylor University's Mayborn Museum Complex. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the Indian Tribes or Native Hawaiian organizations stated in this notice may proceed.

The U.S. Department of the Interior, National Park Service, Effigy Mounds National Monument has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to Effigy Mounds National Monument. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.

The Peabody Museum of Archaeology and Ethnology and Warren Anatomical Museum, Harvard University, have completed an inventory of human remains, in consultation with the appropriate Indian Tribes, and have determined that there is a cultural affiliation between the human remains and present-day Indian Tribes. Representatives of any Indian Tribe that believes itself to be culturally affiliated with the human remains may contact the Peabody Museum of Archaeology and Ethnology, Harvard University. Repatriation of the human remains to the Indian Tribes stated below may occur if no additional claimants come forward.

This is a notice of the Presidential declaration of a major disaster for the State of Arkansas (FEMA-4556-DR), dated July 10, 2020, and related determinations.

This is a notice of the Presidential declaration of a major disaster for the State of Alabama (FEMA-4554-DR), dated July 10, 2020, and related determinations.

This is a notice of the Presidential declaration of a major disaster for the State of North Dakota (FEMA-4553-DR), dated July 9, 2020, and related determinations.

This is a notice of the Presidential declaration of a major disaster for the State of Tennessee (FEMA-4550-DR), dated July 9, 2020, and related determinations.

This is a notice of the Presidential declaration of a major disaster for the State of Utah (FEMA-4548-DR), dated July 9, 2020, and related determinations.

This is a notice of the Presidential declaration of a major disaster for the State of Mississippi (FEMA-4551-DR), dated July 9, 2020, and related determinations.

The Commission hereby gives notice that it has instituted a review pursuant to the Tariff Act of 1930 (``the Act''), as amended, to determine whether revocation of the antidumping duty order on diamond sawblades and parts thereof from China would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission.

The National Highway Traffic Safety Administration (NHTSA) invites public comments about our intention to request approval from the Office of Management and Budget (OMB) for a reinstatement with modification of a previously approved collection of information. Before a Federal agency can collect certain information from the public, it must receive approval from OMB. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatements of previously approved collections. This document describes an Information Collection Request (ICR) for which NHTSA intends to seek OMB approval.

The FAA is adopting a new airworthiness directive (AD) for certain Airbus SAS Model A320-214, -216, -231, -232, -233, -251N, and - 271N airplanes. This AD was prompted by a report that following the installation of a second cargo fire extinguishing bottle, insufficient clearance between the cargo compartment fire extinguishing pipes was found. This AD requires inspection and modification of the cargo compartment fire extinguishing pipes, and on-condition actions if necessary, 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.

Notice is hereby given that the Commonwealth of Massachusetts, the State of Connecticut and the State of New Hampshire are revising their respective approved Public Water System Supervision (PWSS) programs to meet the requirements of the Safe Drinking Water Act (SDWA).

Notice is hereby given that the U.S. International Trade Commission (``Commission'') has determined to review in part a final initial determination (``ID'') of the presiding administrative law judge (``ALJ''). The Commission requests written submissions from the parties on the issues under review and submissions from the parties, interested government agencies, and interested persons on the issues of remedy, the public interest, and bonding, under the schedule set forth below. The target date is extended to September 28, 2020.

As required by the Marine Mammal Protection Act (MMPA), NMFS has considered public comments for revisions of the 2019 marine mammal stock assessment reports (SARs). This notice announces the availability of 65 final 2019 SARs that were updated and finalized.

The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft NUREG, NUREG-2240, ``Development of an Ex Situ Performance Testing Protocol for Nuclear Power Plant Flood Penetration Seals.'' This draft NUREG summarizes a research project that developed a test protocol for evaluating flood penetration seals using simulated flooding conditions in a laboratory setting.

The ``Identity Management System (IDMS) Records, State-72'', which is being rescinded, contains information used to ensure the safety and security of Department of State facilities, systems, or information, and its occupants and users; verify that all persons entering federal facilities, using federal information resources, or accessing classified information are authorized to do so; and track and control PIV cards issued to persons entering and exiting the facilities, using systems, or accessing classified information.