September 2021 – Federal Register Recent Federal Regulation Documents

As part of our (USDA) broader efforts on climate change, we are requesting information (comments) from the public on a Climate- Smart Agriculture and Forestry Partnership Program. In response to the Executive Order titled Tackling the Climate Crisis at Home and Abroad, we published a Federal Register notice on March 16, 2021, to request comments on a Climate-Smart Agriculture and Forestry (CSAF) strategy. Based on public comments received and our ongoing stakeholder engagement activities, we published a progress report in May 2021 on the CSAF strategy. As one element of the CSAF strategy, we are considering actions to expand the use of climate-smart farming practices and aid in the marketing of agricultural commodities. The term ``climate-smart commodity'' is used to refer to an agricultural commodity that is produced using farming practices that reduce greenhouse gas (GHG) emissions or sequester carbon. This requested information is intended to help test development of a Climate-Smart Agriculture and Forestry Partnership Program that could encourage adoption of CSAF practices and promote markets for climate-smart commodities. The Climate-Smart Agriculture and Forestry Partnership Program could be developed under the authority of the Commodity Credit Corporation Charter Act of 1933. This document requests comments on priorities and program design of the Climate-Smart Agriculture and Forestry Partnership Program that would facilitate the expansion of markets for agricultural commodities.

The SEDAR 77 assessment of the Atlantic stock of hammerhead sharks will consist of a stock identification (ID) process, data webinars/workshop, a series of assessment webinars, and a review workshop. See SUPPLEMENTARY INFORMATION.

The Pacific Fishery Management Council's (Pacific Council) Salmon Technical Team (STT) will host a joint online meeting with the Salmon Subcommittee of the Scientific and Statistical Committee and the Model Evaluation Workgroup. The meeting is open to the public.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for review of drug and biological products when those applications use a tropical disease priority review voucher. These vouchers are awarded to the sponsors of certain tropical disease product applications submitted after September 27, 2007, the enactment date of FDAAA, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each fiscal year based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2022 and outlines the payment procedures for such fees.

The National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995. This is the second notice for public comment; the first was published in the Federal Register and no comments were received. NSF is forwarding the proposed new submission to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.'' The guidance document provides FDA's current thinking on certain criteria that help determine sameness of human gene therapy products for the purpose of orphan-drug designation and orphan-drug exclusivity. The guidance is intended to assist stakeholders, including industry and academic sponsors who seek orphan-drug designation and orphan-drug exclusivity, in the development of gene therapies for rare diseases. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2020.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Draft Guidance for Industry.'' The draft guidance document provides recommendations to sponsors interested in studying multiple versions of a cellular or gene therapy product in an early phase clinical trial for a single disease. Sponsors have expressed interest in gathering preliminary evidence of safety and activity using multiple versions of a cellular or gene therapy product in a single clinical trial, where each version is a distinct product that should be submitted to FDA in a separate investigational new drug application (IND). The draft guidance describes the regulatory framework for conducting such studies, including recommendations on how to organize and structure the INDs, submit new information, and report adverse events.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of California (FEMA- 4610-DR), dated 09/24/2021. Incident: Wildfires. Incident Period: 07/14/2021 and continuing.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Investigator ResponsibilitiesSafety Reporting for Investigational Drugs and Devices.'' The draft guidance provides recommendations to help clinical investigators comply with the safety reporting requirements of investigational new drug application (IND) studies and investigational device exemption (IDE) studies. The guidance is intended to help clinical investigators of drugs identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to institutional review boards (IRBs) and to help clinical investigators of devices identify safety information that meets the requirements for reporting unanticipated adverse device effects (UADEs) to sponsors and to IRBs.

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Tunable Lenses and Products Containing the Same, DN 3566; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

The Commission hereby gives notice of the scheduling of an expedited review pursuant to the Tariff Act of 1930 (``the Act'') to determine whether revocation of the antidumping duty order on tissue paper from China would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.

The Department of Commerce (Commerce) determines that thermal paper from the Republic of Korea (Korea) is being, or is likely to be, sold in the United States at less than fair value (LTFV) for the period of investigation, October 1, 2019, through September 30, 2020.

The Department of Commerce (Commerce) determines that thermal paper from Germany is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation is October 1, 2019, through September 30, 2020.

The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft regulatory guide (DG), DG-1383, ``Acceptability of ASME Code Section XI, Division 2, `Requirements for Reliability and Integrity Management (RIM) Programs for Nuclear Power Plants,' for Non- Light Water Reactors.'' This proposed DG describes an approach that is acceptable to the NRC staff for the development and implementation of a preservice inspection (PSI) and inservice inspection (ISI) program for non-light water reactors (non-LWRs). It endorses, with conditions, the 2019 Edition of the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code (ASME Code), Section XI, ``Rules for Inservice Inspection of Nuclear Power Plant Components,'' Division 2, for non-LWR applications. This RG also describes a method that applicants can use to incorporate PSI and ISI programs into a licensing basis.

This notice provides information regarding FHWA's finding that it is appropriate to grant a Buy America waiver to the Iowa Department of Transportation (Iowa DOT) for procurement of foreign iron and steel components for two elevators or let-down structures for the pedestrian bridge associated with the I-74 Mississippi River Bridge Project in Bettendorf, Iowa, specifically including: (i) Traction elevator components; (ii) elevator guide rails; and (iii) certain auxiliary components of the elevators or let-down structures.

In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are proposing to renew an information collection.

In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are proposing to renew an information collection.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Fuel Use Requirements for Great Lakes Steamships (EPA ICR Number 2458.05, OMB Control Number 2060-0679) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is an extension of the ICR, which is currently approved through November 30, 2021. Public comments were previously requested via the Federal Register on March 19, 2021, during a 60-day comment period. This notice allows 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 Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), 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 preceding submission of the collection to OMB.