Department of Health and Human Services June 28, 2024 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies." FDA is issuing this draft guidance as mandated under the Food and Drug Omnibus Reform Act of 2022 (FDORA) which requires that FDA update or issue guidance relating to the format and content of Diversity Action Plans required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by FDORA. This guidance describes the format and content of Diversity Action Plans, including the timing and process for submitting such plans by application or notification type. In addition, this draft guidance describes the criteria and process by which FDA will evaluate sponsors' requests for waivers from the FD&C Act. Because FDA is required by statute to specify the form and manner for the submission of Diversity Action Plans in guidance, insofar as this draft guidance specifies the form and manner for submission of Diversity Action Plans, when this guidance is finalized, it will have binding effect.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed extension of the information collection requirements relating to the State Plan of Assistive Technology (OMB Control Number 0985-0048).

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting one supplement (in scope of the parent award) for the Cooperative Agreement for National Suicide Prevention Lifeline and Disaster Distress Helpline recipient, Mental Health Association of New York City, Inc. (DBA Vibrant Emotional Health), funded in FY 2021 under Notice of Funding Opportunity (NOFO) SM 21-005. The recipient may receive up to $80,000,000 and has a project end date of September 29, 2026. The supplemental funding will be used to maintain 988 operations and services, both at local levels and across all backup, chat, text, LGBTQI+ youth, Spanish language, and videophone based services. This funding will ensure continuation of all 988 services and supports.

The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) is requesting a 3-year extension of the Refugee Support Services (RSS) and RSS Set Aside Sub-Agency List (Office of Management and Budget #0970-0556). ORR is not proposing any changes to the form.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Assessing Adoption and Implementation of the National Institute of Occupational Safety and Health's (NIOSH) Outputs. NIOSH proposes using surveys, interviews, and focus groups to improve awareness, understanding, and assess the impact of adoption and implementation practices by users of NIOSH research efforts and products.