March 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FY 2021 Generic Drug Science and Research Initiatives Workshop.'' The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholdersindustry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its Fiscal Year (FY) 2022 GDUFA science and research initiatives.

On September 10, 2014, we, NMFS, listed 15 Indo-Pacific coral species as threatened under the Endangered Species Act (ESA). We are convening a workshop to solicit facts and information from experts to help identify and guide recovery needs for these species under section 4(f) of the ESA. We will not be asking for a consensus recommendation on how to recover these species. This workshop will be open to the public.

EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.

The U.S. Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the TN Americas LLC Standardized NUHOMS[supreg] Horizontal Modular Storage System listing within the ``List of approved spent fuel storage casks'' to include Renewed Amendment No. 17 to Certificate of Compliance No. 1004. Because this amendment is subsequent to the renewal of the TN Americas LLC Standardized NUHOMS[supreg] Horizontal Modular System Certificate of Compliance No. 1004 and, therefore, subject to the Aging Management Program requirements of the renewed certificate, it is referred to as ``Renewed Amendment No. 17.'' Renewed Amendment No. 17 revises the certificate of compliance technical specifications to add Heat Load Zoning Configurations 11-13 for the 61BTH Type 2 dry shielded canister and change the maximum assembly heat load from 1.2 kW to 1.7 kW. This amendment also makes minor clarifications to the certificate of compliance.

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 Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on a revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the charge to FEMA and the Department of Homeland Security (DHS) to meet FEMA strategic priorities, and FEMA's program management to improve the public's knowledge and actions for preparedness and resilience. Information from this collection will be used to track changes in knowledge, attitudes, and behaviors related to preparedness in the general public. The Individual and Community Preparedness Division analyzes and uses data collected in FEMA Form 008-0-15, National Disaster Preparedness Survey to identify progress and gaps in individual and community preparedness to better understand the motivators and barriers to preparedness in general and about specific hazards. The survey measures the public's knowledge, attitudes, and behaviors relative to preparing for a wide range of hazards.

The Department of Commerce (Commerce) is conducting an administrative review of the antidumping duty order on carbon and alloy steel cut-to-length plate from the Republic of Korea. The period of review (POR) is May 1, 2018, through April 30, 2019. The review covers one producer/exporter of the subject merchandise, POSCO/POSCO International Corporation and its affiliated companies (collectively, the POSCO single entity). We determine that sales of subject merchandise by the POSCO single entity were not made at prices below normal value (NV).

The Department of Commerce (Commerce) determines that producers and/or exporters subject to this administrative review made sales of subject merchandise at less than normal value during the period of review (POR), May 1, 2018, through April 30, 2019. Additionally, Commerce determines that a company for which we initiated a review had no shipments during the POR.

The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies one bulk drug substance that FDA has considered and proposes to include on the 503B Bulks List: Quinacrine hydrochloride (``quinacrine''). This notice identifies four bulk drug substances that FDA has considered and proposes not to include on the list: Bromfenac sodium, mitomycin-C, nepafenac, and hydroxychloroquine sulfate. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and may be the subject of future notices.

The Safer Choice program in the Environmental Protection Agency (EPA) is accepting submissions for its 2021 Safer Choice Partner of the Year Awards. EPA developed the Partner of the Year Awards to recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design, manufacture, selection, and use of products with safer chemicals, that further outstanding or innovative source reduction. EPA especially encourages submission of award applications that show how the applicant's work in the design, manufacture, selection and use of those products promotes environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, or improves drinking water quality. All Safer Choice stakeholders and program participants in good standing are eligible for recognition. Interested parties who would like to be considered for this award should submit to EPA information about their accomplishments and contributions during 2020. There is no form associated with this year's application. EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony in the fall of 2021.

Notice is hereby given that Freedive Pictures, Ltd, St. Stephens Avenue Bristol, United Kingdom, BS1 1YL, (Responsible Party: Sophie Morgan), has applied in due form for a permit to conduct commercial or educational photography on marine mammals.

This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums and Obstacle Departure procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

The Food and Drug Administration (FDA or Agency) is publishing a list of premarket approval applications (PMAs) that have been approved from October 1, 2018, through December 31, 2020. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.

The Natural Resources Conservation Service (NRCS) Wisconsin State Office announces its intent to prepare an EIS for the West Fork Kickapoo Watershed Project in the proximity of Cashton, Westby, Viroqua, and Liberty, Wisconsin. NRCS is requesting comments to identify significant issues and alternatives to be addressed in the EIS from all interested individuals. The EIS process will examine existing flood control measures and evaluate additional (new) alternatives identified during scoping.

The Department of Defense is publishing the unclassified text of an arms sales notification.

In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval for a new information collection. The collection involves study on relationships between aircraft noise events and the probability of awakening.

The Department of Labor (DOL) is submitting this Occupational Safety and Health Administration (OSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

In compliance with the Paperwork Reduction Act of 1995, the DOL is soliciting public comments regarding this ODEP-sponsored information collection to the Office of Management and Budget (OMB) for review and approval.

The Department of Labor's (DOL) Employment and Training Administration (ETA) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, ``Experience Rating Report.'' This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).

In this notice, OSHA announces the final decision to expand the scope of recognition for TUV Rheinland of North America, Inc., as a Nationally Recognized Testing Laboratory (NRTL).

The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an amendment to Facility Operating License No. NPF-96, issued to Tennessee Valley Authority (TVA), for operation of the Watts Bar Nuclear Plant (Watts Bar or WBN), Unit 2. The proposed amendment would revise the Watts Bar Updated Final Safety Analysis Report (UFSAR) to apply a temperature adjustment to the growth rate calculation used to determine the end-of-cycle distribution of indications of axial outer diameter stress corrosion cracking (ODSCC) at steam generator (SG) tube support plates in support of the Watts Bar, Unit 2 operational assessment. The proposed revision to the UFSAR would apply to Unit 2 only. For this amendment request, the NRC proposes to determine that it involves no significant hazards consideration. Because this amendment request contains sensitive unclassified non- safeguards information (SUNSI), an order imposes procedures to obtain access to SUNSI for contention preparation.