2020 – Federal Register Recent Federal Regulation Documents

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 This guidance finalizes the draft guidance announced in the Federal Register on November 3, 2017, and replaces the guidance for industry ``Controlled Correspondence Related to Generic Drug Development''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.

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0031, Plan Approval and Records for Electrical Engineering Regulations; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0092, Sewage and Graywater Discharge Records for Certain Cruise Vessels Operating on Alaskan Waters; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Delaware (FEMA-4566-DR), dated 10/02/2020. Incident: Tropical Storm Isaias. Incident Period: 08/04/2020 through 08/07/2020.

This is a Notice of the Presidential declaration of a major disaster for the State of Alabama (FEMA-4573-DR), dated 12/10/2020. Incident: Hurricane Zeta. Incident Period: 10/28/2020 through 10/29/2020.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Texas (FEMA-4572- DR), dated 12/09/2020. Incident: Hurricane Laura. Incident Period: 08/23/2020 through 08/27/2020.