Compliance Alert – October 2022
- October 26th, 2022
- in Newsletter, Regulations
Proposed Rules
Institutional Review Boards; Cooperative Research
The Food and Drug Administration (FDA or we) is proposing to replace current requirements for FDA-regulated cooperative research with new requirements that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on review and approval by a single institutional review board (IRB) for that portion of the research that is conducted in the United States, with some exceptions. FDA is also proposing an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution. FDA is proposing these revisions to streamline the IRB review process and decrease administrative burdens and inefficiencies for investigators and IRBs without compromising human subject protections. This proposed rule would harmonize FDA’s requirements for cooperative research and IRB records, to the extent practicable and consistent with statutory provisions, with the “Federal Policy for the Protection of Human Subjects” (revised Common Rule) and is being issued in accordance with a provision of the 21st Century Cures Act (Cures Act).
Federal Agency: Food and Drug Administration, Health and Human Services (HHS)
Affected Area: ORED, ORC
Comments Due: 11/28/2022
Protection of Human Subjects and Institutional Review Boards
The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations to modernize, simplify, and enhance the current system for oversight of FDA-regulated human subject research. This proposed rule, if finalized, would harmonize certain sections of FDA’s regulations on human subject protection and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule), in accordance with the 21st Century Cures Act (Cures Act). We believe the proposed changes, if finalized, will reduce regulatory burden on IRBs, sponsors, and investigators. In addition, we propose related changes to the investigational device exemption (IDE) regulations to clarify and update the requirements for the submission of progress reports.
Federal Agency: Food and Drug Administration, HHS
Affected Area: ORED, ORC
Comments Due: 11/28/2022
Employee or Independent Contractor Classification Under the Fair Labor Standards Act
The U.S. Department of Labor (the Department) is proposing to modify Wage and Hour Division regulations to revise its analysis for determining employee or independent contractor classification under the Fair Labor Standards Act (FLSA or Act) to be more consistent with judicial precedent and the Act’s text and purpose.
Federal Agency: Department of Labor
Affected Area: HR
Comments Due: 11/28/2022
Notices
The Wage and Hour Division (WHD) of the U.S. Department of Labor (the Department) is issuing this notice to announce the applicable minimum wage rate for workers performing work on or in connection with federal contracts covered by Executive Order 13658, Establishing a Minimum Wage for Contractors (the Executive Order or the order), beginning January 1, 2023. Beginning on that date, the Executive Order 13658 minimum wage rate that generally must be paid to workers performing work on or in connection with covered contracts will increase to $12.15 per hour, while the required minimum cash wage that generally must be paid to tipped employees performing work on or in connection with covered contracts will increase to $8.50 per hour. Covered contracts that are entered into on or after January 30, 2022, or that are renewed or extended (pursuant to an option or otherwise) on or after January 30, 2022, are generally subject to a higher minimum wage rate established by Executive Order 14026 of April 27, 2021, Increasing the Minimum Wage for Federal Contractors.
Federal Agency: Wage and Hour Division, Department of Labor
Affected Area: HR
The Wage and Hour Division (WHD) of the U.S. Department of Labor (the Department) is issuing this notice to announce the applicable minimum wage rate for workers performing work on or in connection with federal contracts covered by Executive Order 14026, Increasing the Minimum Wage for Federal Contractors (the Executive Order or the order). Beginning on January 1, 2023, the Executive Order 14026 minimum wage rate that generally must be paid to workers performing work on or in connection with covered contracts will increase to $16.20 per hour, while the required minimum cash wage that generally must be paid to tipped employees performing work on or in connection with covered contracts will increase to $13.75 per hour. Similar contracts that were entered into, renewed, or extended prior to January 30, 2022, are generally subject to a lower minimum wage rate established by Executive Order 13658 of February 12, 2014, Establishing a Minimum Wage for Contractors.
Federal Agency: Wage and Hour Division, Department of Labor
Affected Area: HR
The Department of Education (the Department) developed the Application for Approval to Participate in the Federal Student Financial Aid Programs to comply with statutory requirements of collecting necessary information under the Higher Education Act of 1965, as amended. This new collection is a request to continue use of the version of the application that was last approved in 2019 under 1845-0012. That information collection is undergoing clearance to reflect the revision of the information collection as the Department transitions to an electronic webform housed on the FSA Partner Connect system. The revision may not be ready for implementation by the current form expiration date of November 30, 2022. The Department is therefore requesting approval of the currently approved form/format in this new collection.
Federal Agency: Department of Education
Affected Area: Student Financial Aid
Comments Due: 11/14/2022
Items of Interest
National Urban and Community Forestry Advisory Council
The United States Department of Agriculture (USDA) is seeking nominations for members to the National Urban and Community Forestry Advisory Council (NUCFAC) pursuant the 1990 Farm Bill, Cooperative Forestry Assistance Act, the Cooperative Forestry Assistance Act (the Act), and the Federal Advisory Committee Act (FACA). Additional information on NUCFAC can be found by visiting the NUCFAC website at: https://www.fs.usda.gov/managing-land/urban-forests/ucf/nucfac.
The Director of the Census Bureau (Director) is seeking nominations for the National Advisory Committee on Racial, Ethnic and Other Populations (NAC). The purpose of the NAC is to provide advice to the Director on the full range of economic, housing, demographic, socioeconomic, linguistic, technological, methodological, geographic, behaviorial and operational variables affecting the cost, accuracy and implementation of Census Bureau programs and surveys, including the decennial census. The Director has determined that the work of the NAC is in the public interest and relevant to the duties of the Census Bureau. Therefore, the Director is seeking nominations to fill vacancies on the NAC. Additional information concerning the NAC can be found by visiting the NAC’s website at: https://www.census.gov/about/cac/sac.html.
Comments Due: 11/18/2022
National Call for Nominations for Resource Advisory Councils
The purpose of this notice is to request public nominations for 13 of the Bureau of Land Management’s (BLM) statewide and regional Resource Advisory Councils (RAC) that have vacant positions or members whose terms are scheduled to expire. These RACs provide advice and recommendations to the BLM on land use planning and management of the National System of Public Lands within their geographic areas.
Comments Due: 11/4/2022