December 17, 2020 – Federal Register Recent Federal Regulation Documents

This regulation establishes tolerances for residues of broflanilide in or on multiple commodities that are identified and discussed later in this document. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

On July 16, 2019, the Department of Justice and the Department of Homeland Security (``DOJ,'' ``DHS,'' or, collectively, ``the Departments'') published an interim final rule (``IFR'') governing asylum claims in the context of aliens who enter or attempt to enter the United States across the southern land border between the United States and Mexico (``southern land border'') after failing to apply for protection from persecution or torture while in a third country through which they transited en route to the United States. This final rule responds to comments received on the IFR and makes minor changes to regulations implemented or affected by the IFR for clarity and correction of typographical errors.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products.'' The guidance provides recommendations to sponsors and applicants on interacting with FDA on complex innovative trial design (CID) proposals for drugs or biological products. FDA is issuing this guidance to satisfy, in part, a mandate under the 21st Century Cures Act (Cures Act). In accordance with the Cures Act mandate, this guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on technical issues related to modeling and simulation, and the types of quantitative and qualitative information that should be submitted for review. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development.'' This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA's controlled correspondence response and the Agency's process for responding to those requests. This guidance finalizes the draft guidance announced in the Federal Register on November 3, 2017, and replaces the guidance for industry ``Controlled Correspondence Related to Generic Drug Development'' issued in September 2015.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Small Business Administration's intentions to request approval on a new and/or currently approved information collection.

We are advising the public that we have prepared a pest risk analysis and treatment evaluation document relative to the importation into the United States of citrus fruit from additional areas of production in Australia. Based on the findings of these documents, we are proposing to authorize the importation of citrus fruit from additional areas of production in Australia, and revise the conditions under which citrus fruit from authorized areas of production in Australia may be imported into the United States. We are making the pest risk analysis and treatment evaluation document available to the public for review and comment.

The Department of Commerce, in accordance with the Paperwork Reduction Act (PRA) of 1995, invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment on the proposed extension of the Quarterly Survey of Plant Capacity Utilization prior to the submission of the information collection request (ICR) to OMB for approval.

In this notice, the Office of Self-Governance (OSG) establishes the deadline for Indian Tribes/consortia to submit completed applications to begin participation in the Tribal self- governance program in fiscal year 2022 or calendar year 2022.

The U.S. Department of Commerce (Commerce) is issuing a correction to the previously published Federal Register notices pertaining to the antidumping duty orders on forged steel fittings from India and the Republic of Korea (Korea) and the countervailing duty order on forged steel fittings from India.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of New Jersey (FEMA- 4574-DR), dated 12/11/2020. Incident: Tropical Storm Isaias. Incident Period: 08/04/2020.

The Export-Import Bank of the United States (Ex-Im Bank), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.

HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meeting will be open to the public via webex and teleconference; a pre- registered public comment session will be held during the meeting. Pre- registration is required for members of the public who wish to attend the meeting via webex/teleconference. Individuals who wish to send in their pre-recorded or written public comments should send an email to CARB@hhs.gov. Registration information is available on the website https://www.hhs.gov/paccarb and must be completed by February 8, 2021. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/paccarb on the Meetings page.

HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA), as amended, notification is hereby given that NMFS has issued a modified incidental harassment authorization (IHA) to Dominion Energy Virginia (Dominion) to incidentally harass marine mammals incidental to marine site characterization surveys conducted in the areas of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS) Offshore Virginia (Lease No. OCS-A-0483) as well as in coastal waters where an export cable corridor will be established in support of the Coastal Virginia Offshore Wind Commercial (CVOW Commercial) Project.