Department of Health and Human Services September 2022 – Federal Register Recent Federal Regulation Documents

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 (the 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 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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ZTALMY (ganaxolone), manufactured by Marinus Pharmaceuticals, Inc., meets the criteria for a priority review voucher.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Child Hospital Consumer Assessment of Healthcare Providers and Systems (Child HCAHPS) Survey Database.'' This proposed information collection was previously published in the Federal Register on June 3rd, 2022, and allowed 60 days for public comment. AHRQ did not receive comments from members of the public during this period. The purpose of this notice is to allow an additional 30 days for public comment.

This final notice announces our decision to approve Det Norske Veritas for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance of Senior Executive Service (SES) members, title 42 (T42) executives, and Senior Level (SL) employees for Fiscal Year 2022.

This is a notice of intent to award supplemental funding to the Suicide Prevention Resource Center (SPRC) recipient funded in FY 2020 under Notice of Funding Opportunity (NOFO) SM-20-11. This is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting an administrative supplement, which is consistent with the scope of the initial award, of up to $1,609,838, for one-year to the SPRC recipient, University of Oklahoma Health Sciences Center. This recipient was funded in FY 2020 under the SPRC Notice of Funding Opportunity (NOFO) SM-20-011 with a project end date of November 30, 2025. This supplement will provide continued support for the HHS Behavioral Health Coordinating Committee's, Comprehensive Community Suicide Prevention Workgroup in the development of recommendations to increase the community-based suicide prevention infrastructure; provide staff support and technical assistance on a new platform that will be used to train the suicide prevention workforce on approaches to address the needs of individuals at risk for suicide; provide additional suicide prevention technical assistance for states, tribes, territories, and community-based organizations in the implementation of suicide prevention; and conduct an evaluation, in coordination with the National Action Alliance for Suicide Prevention, of 988 call centers to ensure 988 implementation, programmatic and messaging efforts are well informed by the unique needs of populations at high risk or disproportionately impacted by suicide-related behaviors. This is not a formal request for application. Assistance will only be provided to the SPRC Grant recipient, University of Oklahoma Health Sciences Center, based on the receipt of a satisfactory application and associated budget. Funding Opportunity Title: Suicide Prevention Resource Center (SPRC) NOFO SM-20-011. Assistance Listing Number: 93.243. Authority: The SPRC grant is authorized under Section 520A and 520C of the Public Health Service Act, as amended. Justification: Eligibility for this supplemental funding is limited to the University of Oklahoma Health Sciences Center which was funded in FY 2020 under the SPRC NOFO SM-20-011. The University of Oklahoma Health Sciences Center since they are currently providing technical assistance on suicide prevention and have specialized expertise conducting needs assessments to understand the attitudes, knowledge, and beliefs regarding suicide of various groups and populations. Contact: Brandon J. Johnson, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockville, MD 20857, telephone (240) 276-1222; email: brandon.johnson1@samhsa.hhs.gov.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the teleconference (information below). The audio conference line has 150 ports for callers.

This is a notice of intent to award supplemental funding to the National Center of Excellence for Infant and Early Childhood Mental Health Consultation (COE-IECMH) recipient funded in FY 2019 under Notice of Funding Opportunity (NOFO) SM-19-010. This is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting an administrative supplement, which is consistent of the initial award, up to $900,000 (for one-year to Georgetown University). This supplement will provide continued support for the IECMH grantees in their efforts to strengthen their IECMH systems; working with state-level systems and leaders to integrate grantee innovations into ongoing initiatives, policies, and sustainable funding streams, and/or participate in the development of new IECMH efforts; share best practices and advances in infant and early childhood mental health with the early childhood field through webinars, presentations at conferences, and/or development of materials about specific grant programs that can be shared with local, Tribal, and state stakeholders; and conduct a virtual grantee meeting or policy academy to engage all grantees in peer learning and technical assistance. This is not a formal request for application. Assistance will only be provided to the COE-IECMH. This recipient was funded in FY 2019 under National Center of Excellence for Infant and Early Childhood Mental Health Consultation Grant, NOFO SM-19-010 with a project end date of April 30, 2023. This is not a formal request for application. Assistance will only be provided to the COE-IECMH grant recipient, Georgetown University, based on the receipt of a satisfactory application and associated budget that is approved by a review group.

Through a Notice of Funding Opportunity, ``Analyses, Research, and Studies to Assess the Impact of Centers for Medicare & Medicaid Services (CMS) Programs on American Indians/Alaska Natives (AI/ANs) and the Indian Health Care System Serving AI/AN Beneficiaries,'' CMS has sought an application from the National Indian Health Board (NIHB)for a single source cooperative agreement. The funding CMS anticipates awarding under this single source cooperative agreement will support research to assess the impact of CMS programs that affect AI/ANs and the Indian Health Care System.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.