October 20, 2022 – Federal Register Recent Federal Regulation Documents

The Board and the Bureau (collectively, the Agencies) are finalizing amendments to the official interpretations and commentary for the Agencies' regulations that implement the Consumer Leasing Act (CLA). The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) amended the CLA by requiring that the dollar threshold for exempt consumer leases be adjusted annually by the annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). Under regulations adopted by the Agencies, if there is no annual percentage increase in the CPI-W, the Agencies will not adjust this exemption threshold from the prior year. Additionally, in years following a year in which the exemption threshold was not adjusted because the CPI-W decreased, the threshold is calculated by applying the annual percentage change in the CPI-W to the dollar amount that would have resulted, after rounding, if the decreases and any subsequent increases in the CPI-W had been taken into account. Based on the annual percentage increase in the CPI-W as of June 1, 2022, the exemption threshold will increase from $61,000 to $66,400 effective January 1, 2023. Because the Dodd-Frank Act also requires similar adjustments in the Truth in Lending Act's threshold for exempt consumer credit transactions, the Agencies are making similar amendments to each of their respective regulations implementing the Truth in Lending Act elsewhere in the Rules section of this issue of the Federal Register.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry #253 entitled ``Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products.'' FDA's Center for Veterinary Medicine (CVM) is issuing this guidance to provide establishments that manufacture animal cells, tissues, and cell- and tissue-based products (ACTPs) with recommendations for meeting requirements for current good manufacturing practice (CGMP). All new animal drugs, including ACTPs, are required to be manufactured in accordance with CGMP to ensure that such drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, and have the identity, strength, quality, and purity characteristics, which they purport to or are represented to possess. This guidance also provides FDA's recommendations for those aspects of manufacturing specific to ACTPs in accordance with existing CGMP regulations, as applicable, and with the FD&C Act. In this guidance, we specifically address the methods, facilities, and controls used for manufacturing ACTPs.

The Federal Trade Commission (``FTC'' or ``Commission'') is extending the deadline for filing comments on its advance notice of proposed rulemaking (``ANPR'') regarding whether the Commission should prescribe new trade regulation rules or other regulatory alternatives concerning commercial surveillance and data security practices that are prevalent and unfair or deceptive.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is updating the identifying information on its Specially Designated Nationals and Blocked Persons List (SDN List) for one entity whose property and interests in property subject to U.S. jurisdiction are blocked pursuant to Executive Order 13224.

The New England Fishery Management Council (Council) is scheduling a public meeting of its Skate Committee via webinar to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

The Department of Veterans Affairs, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

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 additional 30 days of public comment.

In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for its review and approval. This ICR will enable FMCSA to document the burden associated with the marking regulations, ``Marking of Self-Propelled CMVs and Intermodal Equipment.'' These regulations require marking of vehicles and intermodal equipment by motor carriers, freight forwarders, and intermodal equipment providers (IEPs) engaging in interstate transportation and motor carriers that transport hazardous materials (HM) in intrastate transportation.

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Semiconductors Devices Having Layered Dummy Fill, Electronic Devices, and Components Thereof, DN 3649; 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 Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an Exempted Fishing Permit (EFP) application contains all of the required information and warrants further consideration. The EFP would allow commercial fishing vessels to fish outside fishery regulations in support of research conducted by the applicant. Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed EFPs.

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The seventh iteration of the Prescription Drug User Amendments (PDUFA VII), included as part of the FDA User Fee Reauthorization Act of 2022, highlights the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. The Food and Drug Administration (FDA or Agency) is announcing the continuation of the paired meeting program established under the sixth iteration of PDUFA that affords sponsors, who are selected, the opportunity to meet with Agency staff to discuss the use of complex innovative trial design (CID) approaches in medical product development. Meetings under the program will be conducted by FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) during fiscal years 2023 to 2027. For each sponsor whose meeting request is granted, two meetings will be held between the sponsor and CDER or CBER that will provide an opportunity for medical product developers to discuss their CID proposals. To promote innovation in this area, trial designs developed through the paired meeting program may be presented by FDA (e.g., in a guidance or public workshop) as case studies, including trial designs for drugs that have not yet been approved by FDA.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect qualitative data to examine innovative and promising consumer education strategies that Child Care and Development Fund (CCDF) Lead Agencies are using to help families search for and select child care and early education (CCEE). This information collection aims to present an internally valid description of the experiences of up to six, purposively selected case study sites, not to promote statistical generalization to different sites or service populations.

The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting renewal with revisions of an approved information collection: Domestic Victims of Human Trafficking (DVHT) Program Data (OMB #0970-0542; expiration date 3/31/2023).

The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACF-Tribal Maternal, Infant, and Early Childhood Home Visiting (Tribal MIECHV) Program Form 2: Grantee Performance Measures (Office of Management and Budget (OMB) #0970-0500; Expiration date Feb 28, 2023). There are no changes requested to the form.

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), Department of Justice (DOJ), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed collection OMB 1140-0055 (Identification of Explosive Materials) is being revised due to a reduction in the number of respondents, the total responses and public burden hours associated with this IC, since the last renewal in 2019.

USIP announces the next meeting of the Board of Directors. USIP also announces a change in the method of public notification regarding future meetings of the Board of Directors. Announcements of future meetings of the Board of Directors will no longer be published in the Federal Register. Instead, USIP will post notice of meetings of the Board of Directors on the USIP website.