July 28, 2021 – Federal Register Recent Federal Regulation Documents

The Department of Education (Department) is issuing a notice inviting applications for fiscal year (FY) 2021 for the EIR program Early-phase Grants, Assistance Listing Number 84.411C (Early-phase Grants). This notice relates to the approved information collection under OMB control number 1894-0006.

The Department of Education (Department) announces priorities and definitions under the Education Innovation and Research (EIR) program, Assistance Listing Numbers 84.411A/B/C. The Department may use these priorities and definitions for competitions in fiscal year (FY) 2021 and in later years.

Based on an agreement reached between the Department of the Treasury (Treasury) and the State Bank of Vietnam (SBV) regarding Vietnam's currency practices, the U.S. Trade Representative has determined that no action under the Section 301 investigation is warranted at this time because Vietnam's agreement with Treasury provides a satisfactory resolution of the matter subject to this investigation. The U.S. Trade Representative, in coordination with Treasury, will monitor Vietnam's implementation of its commitments under the agreement and associated measures.

This regulation establishes a tolerance for residues of fludioxonil in or on banana. Syngenta Crop Protection, LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), National Study of Nutrient Removal and Secondary Technologies: Publicly Owned Treatment Works (POTW) Screener Questionnaire (EPA ICR Number 2553.03, OMB Control Number 2040-0294) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through July 31, 2021. Public comments were previously requested via the Federal Register on February 24, 2021 during a 60-day comment period. No comments were received. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA II directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2021, through September 30, 2022.

This notice amends STRL Personnel Demonstration Project reduction-in-force (RIF) procedures. STRL RIF procedures will ensure employees involuntarily separated through a RIF are separated primarily based on performance, as determined under any applicable performance- management system.

We, the U.S. Fish and Wildlife Service (Service), announce our intention to conduct a 5-year status review under the Endangered Species Act of 1973, as amended, for the Eskimo curlew. A 5-year status review is based on the best scientific and commercial data available at the time of the review. We are requesting submission of any new information that has become available since the last review of the species in 2016.

The Secretary of Commerce, through the Office of Trade and Economic Analysis (``OTEA''), issued an Export Trade Certificate of Review to FCE on July 12, 2021.

This action approves and implements Framework Adjustment 61 to the Northeast Multispecies Fishery Management Plan. This rule revises the status determination criteria for Georges Bank and Southern New England-Mid Atlantic winter flounder, implements a revised rebuilding plan for white hake, sets or adjusts catch limits for 17 of the 20 multispecies (groundfish) stocks, and implements a universal exemption for sectors to target Acadian redfish. This action is necessary to respond to updated scientific information and to achieve the goals and objectives of the fishery management plan. The final measures are intended to help prevent overfishing, rebuild overfished stocks, achieve optimum yield, and ensure that management measures are based on the best scientific information available.

In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on a renewal of currently approved information collection, FERC-537 (Gas Pipeline Certificates: Construction, Acquisition, and Abandonment), which will be submitted to the Office of Management and Budget (OMB) for review.

We, the U.S. Fish and Wildlife Service (Service), announce the receipt and availability of an application for an enhancement of survival permit (permit) under the Endangered Species Act (ESA) and an associated draft programmatic Safe Harbor Agreement (SHA). Additionally, consistent with the requirements of the National Environmental Policy Act (NEPA), we have prepared a draft environmental action statement supporting our preliminary determination that the proposed permit action qualifies for a categorical exclusion under NEPA. The Nevada Department of Wildlife (applicant) has applied for a permit under the ESA for the enhancement activities within the SHA, which will contribute to the recovery of the Pahrump poolfish (Empetrichthys latos). The permit would authorize the take of one species incidental to the enhancement and restoration of private and public lands. We invite the public and local, State, Tribal, and Federal agencies to comment on the proposed SHA, and NEPA categorical exclusion determination documentation. Before issuing the requested permit, we will take into consideration any information that we receive during the public comment period.

This document corrects the Regulation Identifier Number that appeared in a final rule published in the Federal Register on July 15, 2021, regarding the inspection of yak and other bovidae, cervidae, and camelidae species.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2022 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2022 rates for the small business establishment fee ($5,824), the non-small business establishment fee ($18,999), and the reinspection fee ($17,472) for outsourcing facilities; provides information on how the fees for FY 2022 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2021, and will remain in effect through September 30, 2022.

In accordance with the Paperwork Reduction Act and Office of Management and Budget (OMB) regulations, this notice announces the intention of the Agricultural Research Service (ARS) to seek approval to collect information in support of research and related activities.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2022 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, 2021, and will remain in effect through September 30, 2022.

The U.S. Environmental Protection Agency's (EPA) Office of General Counsel/External Civil Rights Compliance Office (OGC/ECRCO) is giving notice that it proposes to modify a system of records pursuant to the provisions of the Privacy Act of 1974. External Compliance Case Tracking System (EXCATS) is being modified to accurately notify the public about the change of administrative location of the EXCATS from its former administrative location, the Office of the Administrator, to the Office of the General Counsel, effective, December 2016. EXCATS is also being modified to support and enhance the discrimination complaint process, including the investigation and resolution of complaints, and to provide for a discrimination complaint form to enable the public to file electronically discrimination complaints directly to the EXCATS. The purpose of EXCATS is to assist OGC/ECRCO in collecting and maintaining case-related information and provide the EPA OGC/ECRCO with the ability to more effectively manage program information needs and integrate the office's various business processes. The EXCATS assists OGC/ECRCO in the collection and maintenance of compliance-related data and other information needed by the OGC/ECRCO to complete case investigation and resolution activities and issue civil rights-related determinations.

We are advising the public that we are withdrawing a final environmental assessment and finding of no significant impact that the Animal and Plant Health Inspection Service prepared under the National Environmental Policy Act relative to a national approach for the control of highly pathogenic avian influenza outbreaks within the United States. We are withdrawing the final environmental assessment and the associated finding of no significant impact pending further evaluation.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide.'' The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for olodaterol hydrochloride; tiotropium bromide inhalation spray.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Justin Ash for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Ash was convicted of one felony count under Federal law for conspiracy to commit offenses against the United States. The factual basis supporting Mr. Ash's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Ash was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of April 4, 2021 (30 days after receipt of the notice), Mr. Ash had not responded. Mr. Ash's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.