2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is extending the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that have not entered into a standard memorandum of understanding (MOU) with FDA addressing certain distributions of compounded human drug products. FDA is extending the period, which was scheduled to end on October 27, 2022, until the effective date of a final rule regarding certain distributions of compounded human drug products and publication of an updated standard MOU.

EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.

This Final Sale Notice (FSN) contains information pertaining to the areas available for commercial wind energy leasing on the Outer Continental Shelf (OCS) offshore California. Specifically, this FSN details certain provisions and conditions of the leases, auction details, the lease form, criteria for evaluating competing bids, award procedures, appeal procedures, and lease execution. The Bureau of Ocean Energy Management (BOEM) will offer five leases for sale using a multiple-factor bidding auction format: Lease OCS-P 0561, Lease OCS-P 0562, Lease OCS-P 0563, Lease OCS-P 0564, and Lease OCS-P 0565 (Lease Areas). The issuance of any lease resulting from this sale would not constitute approval of project-specific plans to develop offshore wind energy. Such plans, if submitted by the Lessee, would be subject to subsequent environmental, technical, and public reviews prior to a BOEM decision on whether the proposed development should be authorized.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Department of Labor (DOL) is submitting this Office of Workers' Compensation Programs (OWCP)-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.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

The National Park Service is soliciting electronic comments on the significance of properties nominated before October 8, 2022, for listing or related actions in the National Register of Historic Places.

The Office of Research Integrity (ORI) announces the opportunity for non-federal public and private sector entities to co- sponsor ORI conferences, workshops, symposia, meetings, roundtables, or other such events (collectively, ``Events''). ORI co-sponsors a limited number of events with non-federal entities each year. Potential co- sponsors must have demonstrated interest and experience in the responsible conduct of research or handling allegations of research misconduct. Potential co-sponsors must be willing to participate substantively in the co-sponsored event.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Refusal of Inspection by a Foreign Food Establishment or Foreign Government.'' The guidance will provide information for foreign food establishments subject to our inspection, as well as foreign governments, on when we may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by us as provided in the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Multiple Endpoints in Clinical Trials.'' This guidance provides sponsors and review staff with the Agency's thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. This guidance finalizes the draft guidance of the same title issued on January 13, 2017.

Pursuant to the Federal Insurance Office Act of 2010 (FIO Act), the Federal Insurance Office (FIO) of the U.S. Department of the Treasury (Treasury) intends to request approval from the Office of Management and Budget (OMB) for the collection of information from certain property & casualty (P&C) insurers regarding their current and historical underwriting data on homeowners' insurance, as described below. The proposed data collection will assist FIO's assessment of climate-related exposures and their effects on insurance availability for policyholders, including whether climate change may create the potential for any major disruptions of private insurance coverage in regions of the country particularly vulnerable to climate change impacts. FIO will also seek to assess any related effects on insurance affordability for policyholders. The Paperwork Reduction Act of 1995 (PRA) requires federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare.'' FDA has developed this draft guidance to propose select updates to the guidance that clarify how the program may be applicable to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health and/or healthcare disparities. This draft guidance is not final nor is it for implementation at this time.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements to the 54 grant recipients funded under the FY 2022 Cooperative Agreements for States and Territories to Build Local 988 Capacity (988 State and Territory Grants) Notice of Funding Opportunity (NOFO) SM-22-015, which have a project end date of April 2024. This supplemental funding is within scope and is expected to increase and/or expand original workforce capacity, ease of access to services, contact demand, including coverage area, through phone, chat, and text, and contact answer rates for 988 crisis care. The 988 State and Territory Cooperative Agreement grant recipients are eligible to apply for awards from $458,333 to $2,000,000 for a total funding of $50,000,000 from the Bipartisan Safer Communities Act (BSCA). The supplements will support 988 response and workforce expansion by improving 988 collaborations, infrastructure, hiring and retention, communications and marketing, and evaluation activities. These awards will help improve 988 and 911 coordination, especially in cases of emergency intervention due to suicidal behavior, improve state/ territory infrastructure to answer 988 Lifeline chat and text request initiated within their state or territory, align communications and marketing of the 988 Lifeline in conjunction with SAMHSA and HHS's 988 communications and marketing strategy, help streamline access to mobile crisis and crisis response teams for all 988 crisis centers, assist the development and expansion of human resource systems to increase the pace of 988 recruitment and hiring, conduct root cause analyses on identified critical incidents contacting through the 988 system, support continuity of care throughout the larger crisis response system and improve follow up and referral outcomes to decrease suicide and ensure individuals are connected to post-contact care. This is not a formal request for application. Assistance will only be provided to the 54 recipients funded in FY 2022 under the 988 State and Territory Cooperative Agreement NOFO SM-22-015 based on the receipt of a satisfactory application and associated budget that is approved by a review group. Funding Opportunity Title: FY 2022 Cooperative Agreements for States and Territories to Build Local 988 Capacity NOFO SM 22-015. Assistance Listing Number: 93.243. Authority: Section 520E-3 of the Public Health Services (PHS) Act [290bb-36c], as amended. Justification: SAMHSA is limiting eligibility for this supplemental funding to the 988 State and Territory grant recipients, which were funded in FY 2022 under the Cooperative Agreements for States and Territories to Build Local 988 Capacity, SM-22-015. These recipients provide leadership and oversee the current 988 and state- and territory-wide local crisis service systems. In addition, the recipients have the required active relationships with and can quickly provide fiscal resources directly to local and statewide Lifeline crisis centers for 988 response; thereby reducing burden on the nationwide network of Lifeline crisis centers, ensuring all those needing 988 services have awareness and access to localized care. Due to the requirements of the FY 2022 Cooperative Agreements for States and Territories to Build Local 988 Capacity, recipients are the only entities that can utilize these funds to successfully complete the required activities to improve 988 Lifeline crisis center workforce response and meet defined state and territory key performance indicators. Contact: James Wright, LPC, Chief of Crisis Center Operations, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockville, MD 20857, telephone 240-276-1615; email: james.wright@samhsa.hhs.gov.

On August 30, 2022, the U.S. Department of Commerce (Commerce) published the notice of initiation and preliminary results of changed circumstances reviews (CCR) of the antidumping duty (AD) and countervailing duty (CVD) orders on certain cold-rolled steel flat products (cold-rolled steel) and certain corrosion-resistant steel products (CORE) from the Republic of Korea (Korea). For these final results, Commerce continues to find that KG Steel Corporation (dba KG Dongbu Steel Co., Ltd.) (KG Steel) is the successor-in-interest to KG Dongbu Steel Co., Ltd. (KG Dongbu Steel) in the context of the AD and CVD orders on cold-rolled steel and CORE from Korea. Furthermore, KG Steel is entitled to KG Dongbu Steel's AD and CVD cash deposit rates with respect to entries of subject merchandise in each of the above- referenced proceedings.

On October 11, 2022, the U.S. Department of Commerce (Commerce) published a notice in the Federal Register, in which Commerce amended its notice of final results for the 2020 administrative review of the countervailing duty (CVD) order on certain softwood lumber products (softwood lumber) from Canada. This notice inadvertently contained an incorrect rate applicable to companies not selected for individual examination in the 2020 administrative review (non-selected companies).

Pursuant to the Privacy Act of 1974, notice is hereby given that the Department of Veterans Affairs (VA) is amending the system of records entitled, ``VA Police Badge and Training Records System-VA'' (83VA07). VA is amending the system by updating the following sections: System Name and Number; System Manger(s); Categories of Individuals Covered by the System; Categories of Records in the System; Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of Such Uses; Policies and Practices for Retrieval of Records; Policies and Practices for Retention and Disposal of Records; Records Access Procedures; Contesting Record Procedures; Notification Procedures; History. VA is republishing the system notice in its entirety.

The Department of the Army is publishing this notice to announce the following Federal Advisory Committee meeting of the Advisory Committee on Arlington National Cemetery (ACANC). This meeting is open to the public via virtual media. For more information, please visit: https://www.arlingtoncemetery.mil/About/Advisory-Committee-on- Arlington-National-Cemetery/ACANC-Meetings.

Pursuant to the Federal Advisory Committee Act, the Bureau of Economic Analysis (BEA) announces a meeting of the Bureau of Economic Analysis Advisory Committee (BEAAC or the Committee). The meeting will address proposed improvements, extensions, and research related to BEA's economic accounts. In addition, the meeting will include an update on recent statistical developments.

The FAA, in cooperation with the National Park Service (NPS), has initiated development of a voluntary agreement pursuant to the National Parks Air Tour Management Act of 2000 (the Act) and its implementing regulations. The Act allows the FAA and NPS to enter into voluntary agreements with commercial air tour operators. A voluntary agreement manages commercial air tour operations over a national park by establishing conditions for the conduct of the commercial air tour operations. Implementation of a voluntary agreement helps protect park resources and the visitor experience without compromising aviation safety or the air traffic control system. This notice announces the public availability of the proposed voluntary agreement for Statue of Liberty National Monument and Governors Island National Monument (collectively referred to as the Parks).