June 2021 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on May 21, 2021, under section 337 of the Tariff Act of 1930, as amended, on behalf of Arigna Technology Limited of Ireland. Supplements were filed on May 26, 2021, June 9, 2021, June 10, 2021, and June 11, 2021. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain power inverters and converters, vehicles containing the same, and components thereof by reason of infringement of certain claims of U.S. Patent No. 8,247,867 (``the '867 patent'') and U.S. Patent No. 8,289,082 (``the '082 patent''). The complaint further alleges that an industry in the United States exists or is in the process of being established as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

EPA has authorized its contractor Avanti Corporation of Alexandria, VA, to access information which has been submitted to EPA under all Sections of the Toxic Substances Control Act (TSCA). Some of the information may be claimed or determined to be Confidential Business Information (CBI).

The Commodity Futures Trading Commission (CFTC) announces that on July 13, 2021, from 9:30 a.m. to 12:00 p.m. (Eastern Daylight Time), the Market Risk Advisory Committee (MRAC) will hold a public meeting via teleconference. At this meeting, the MRAC will receive reports from its CCP Risk and Governance and Interest Rate Benchmark Reform Subcommittees. In addition, the MRAC will vote on recommendations from the Interest Rate Benchmark Reform Subcommittee regarding a market best practice for switching interdealer trading conventions from LIBOR to the Secured Overnight Financing Rate for U.S. Dollar linear interest rate swaps.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Smallpox and Monkeypox Vaccine, Live and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Sponsor ResponsibilitiesSafety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/ Bioequivalence Studies.'' The draft guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies. In doing so, the guidance provides recommendations related to the two IND safety reporting provisions that require assessment of aggregate data to facilitate appropriate IND safety reporting practices. An earlier draft guidance for industry entitled ``Safety Assessment for IND Safety Reporting'' (December 2015) (the 2015 draft guidance) has been incorporated into this draft guidance. However, this content was revised to address feedback from stakeholders and comments received on the 2015 draft guidance. Concurrent with the publication of this draft guidance, we are withdrawing the 2015 draft guidance. Additionally, this draft guidance incorporates content from the final guidance for industry and investigators entitled ``Safety Reporting Requirements for INDs and BA/BE Studies'' (December 2012) (the 2012 final guidance). This incorporated content remains largely unchanged in this draft guidance.

The Eastern Idaho Resource Advisory Committee (RAC) will hold a virtual meeting by phone and/or video conference. The committee is authorized under the Secure Rural Schools and Community Self- Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act as well as make recommendations on recreation fee proposals for sites on the Caribou-Targhee National Forest within Bannack, Bear Lake, Bonneville, Caribou, Clark, Franklin, Fremont, Madison, 0neida, and Teton County, consistent with the Federal Lands Recreation Enhancement Act. RAC information and virtual meeting information can be found at the following website: https:// www.fs.usda.gov/main/ctnf/workingtogether/advisorycommittees.

This document contains a notice of an exemption issued by the Department of Labor (the Department) from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act). The exemption permits: (a) The sale (the Sale) by the Electrical Joint Apprenticeship and Training Trust (the EJAT Trust) of 5.11 acres of unimproved real property (the Property) to the Electrical Insurance Trustees Insurance Fund (the EIT Fund), a party in interest with respect to the EJAT Trust; and (b) the EIT Fund's granting of a right of first offer (the Right of First Offer) to the EJAT Trust to purchase the Property back from the EIT Fund, provided all of the conditions described below are satisfied.

In accordance with the Paperwork Reduction Act of 1995, we, the Office of Financial Management, Office of the Secretary, Department of the Interior are proposing to renew an information collection.

This document provides notice of the pendency before the Department of Labor (the Department) of a proposed individual exemption from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code).

AMRI Rensselaer, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

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 revision of 2021 Business Enterprise Research and Development Survey, prior to the submission of the information collection request (ICR) to OMB for approval.

The U.S. Department of Health and Human Services' (HHS) Office of Disease Prevention and Health Promotion (ODPHP) invites public and private sector organizations that support Healthy People 2030 (HP2030), the nation's disease prevention and health promotion plan, to become a Healthy People 2030 Champion (HP2030 Champion). Eligibility: Any organization may apply to be a HP2030 Champion. The selected HP2030 Champions will be recognized for their commitment and work toward achieving HP2030's vision of a society in which all people can achieve their full potential for health and well-being across the lifespan. HP2030 Champions. HP2030 Champions can be public and private organizations such as those at the state, local, county, and tribal levels, non-governmental organizations, non-profit organizations, businesses, academic organizations, organizations that impact health outcomes, philanthropic organizations, and tribal organizations that identify themselves as being aligned with or promoting HP2030, HP2030's vision, and HP2030's overarching goals. All organizations may apply. Applicants for HP2030 Champions shall submit a letter of interest and identify how they address or support health promotion, disease prevention, social determinants of health (SDOH), health disparities, health equity, and/or well-being and work in alignment with HP2030 through activities, donations, or other means. Applicants for HP2030 Champions will be evaluated according to the organization's commitment to support the overarching goals of Healthy People 2030 and the Healthy People 2030 objectives. Individuals are not eligible to be HP2030 Champions. HP2030 Champions will receive recognition from ODPHP on Health.gov/ healthypeople2030, a digital HP2030 Champion badge for their website to highlight their support of HP2030, and HP2030 information, tools and resources for dissemination. The following activities may be considered as an organization's demonstrated commitment to HP2030's overarching goals and objectives: Promoting and increasing access to disease prevention and health promotion activities; Providing access to training or certification programs for disease prevention and health promotion; Addressing SDOH, eliminating disparities, achieving health equity, and/or promoting well-being; Providing training and other necessary resources to adapt or modify disease prevention and health promotion activities to meet the needs of diverse populations, address SDOH, eliminate disparities, achieve health equity, and/or promote well-being; Developing partnerships across a variety of sectors, including business, community, academia, education, faith-based, government, health care, media, public health, and technology; Working across sectors to address SDOH, eliminate disparities, and achieve health equity; Evaluating health promotion and disease prevention programs or partnering with academic institutions or public health organizations to evaluate health promotion and disease prevention activities; Including information in their public facing materials about programs for disease prevention, health promotion, addressing SDOH, eliminating disparities, achieving health equity, and/or promoting well-being in community needs assessments; Adopting or implementing the HP2030 framework (i.e., vision, mission, overarching goals, foundational principles), Leading Health Indicators (LHIs), Overall Health and Well-Being Measures (OHMs) and/or HP2030 objectives in their strategic plan; Promoting HP2030; providing opportunities and venues for disease prevention and health promotion activities; Partnering with national, state, tribal, or local volunteer organizations to provide education, training, or programs regarding health promotion, disease prevention, SDOH, health disparities, health equity, and well-being; Supporting an entity with the responsibility to organize and coordinate efforts within and across sectors to foster health promotion and well-being; Promoting collaboration across all levels, including neighborhoods, communities, tribes, cities, states, counties, and localities, to increase and expand participation in health promotion and disease prevention activities; Disseminating through a variety of platforms messaging about the benefits of and resources available to promote disease prevention, health promotion, well-being and the importance of addressing SDOH, health disparities, and health equity; Supporting the coordination and standardization of data to enable comparisons across national, state, local, county, and/or tribal levels; Providing grants, funding opportunities, and other resources to programs that address disease prevention, health promotion, well-being, SDOH, health equity, and health disparities. Funds: None. Neither HHS nor ODPHP will provide funds to support HP2030 Champions. Applicants and HP2030 Champions will not be expected to contribute funds. Application: Organizations may apply to be an HP2030 Champion. Organizations should submit a letter of interest acknowledging their support of the HP2030 vision of a society in which all people can achieve their full potential for health and well-being across the lifespan and HP2030's overarching goals. Organizations interested in being HP2030 Champions shall identify in their letters of interest those activities from the list noted above that demonstrate commitment to HP2030's overarching goals and objectives and indicate how they address or support health promotion, disease prevention, SDOH, health disparities, health equity, and well-being and work in alignment with HP2030 through activities, donations, or other means.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Surface Transportation Board (Board) gives notice of its intent to request from the Office of Management and Budget (OMB) approval without change of the six existing collections described below.

The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, ``US NRC Acquisition Regulation.''

Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on an expiring information collection request (ICR) with minor edits, Request for Change to Unreduced Annuity, RI 20-120.

In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Land Management (BLM) proposes a new information collection.

We, the U.S. Fish and Wildlife Service, have received applications for permits to conduct activities intended to enhance the propagation or survival of endangered or threatened species under the Endangered Species Act. We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.