Department of Health and Human Services July 2023 – Federal Register Recent Federal Regulation Documents

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the National Council on Aging for the Strengthening the Direct Care Workforce: A Technical Assistance and Capacity Building Initiative. The administrative supplement for FY 2023 will be in the amount of $1,974,846, bringing the total award for FY 2023 to $3,269,466. The supplement will provide sufficient resources to enable the grantee and their partners to increase funding for technical assistance (TA) to state aging and disability partnerships to collaborate with workforce entities to strengthen the Direct Care Workforce (DCW). The funding will enable the grantee to support additional states, including at more robust levels than originally planned. The funding will also enable additional work to strengthen the self-direction workforce by identifying gaps in knowledge and highlighting best practices to support and sustain those who self- direct, for dissemination via the DCW resource hub to a national audience.

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 ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.''

CDC has modified its structure. This notice announces the reorganization of the Office of Readiness and Response (ORR). ORR reorganized to improve rapid response to disease outbreaks and public health emergencies within the United States and around the world. It is critical for CDC's internal emergency response structure and readiness capabilities align with the changing public health landscape in order to best protect populations that are at increased risk of death, disability, and disease before, during, and after responses.

CDC has modified its structure. This notice announces the reorganization of the Office of Communications (OC). OC has established the Office of Emergency Risk Communications by realigning the Emergency Risk Communications Branch formerly of the Center for Preparedness and Response, Division of Emergency Operations. Additionally, OC retitled and updated mission and functional statements updates to some organizational entities.

CDC has modified its structure. This notice announces the reorganization of the Office of Public Health Data, Surveillance, and Technology (OPHDST).

CDC has modified its structure. This notice announces the reorganization of the Office of Safety, Security and Asset Management (OSSAM). OSSAM realigned internal emergency management functions with related functions such as public health emergency response functions to a single leader.

CDC has modified its structure. This notice announces the reorganization of the Office of Financial Resources (OFR). OFR established an activity in the Office of the Director, established two branches, and renamed existing branches within the Office of Acquisition Services.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Nonprescription Drugs Advisory Committee (the 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.

CDC has modified its structure. This notice announces the reorganization of the Global Health Center (GHC). GHC reorganized to ensure optimal strategic planning and implementation of CDC's global health work to protect the United States and achieve global public health impact.

CDC has modified its structure. This notice announces the reorganization of the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID). NCEZID reorganized to improve collaboration between science and public health programs within NCEZID as well as with our partners across and outside the agency, which will increase our public health impact.

The CFPB, an independent agency, HHS, and the Treasury (collectively, the agencies), are soliciting comments from the public and interested parties on medical credit cards, loans, and other financial products used to pay for health care. The agencies seek to understand the prevalence, nature, and impact of these products, including disparities across different demographic groups. The agencies also seek to understand the effects these products may have on patients and on the health care system. In particular, the agencies seek comment on whether these products may allow health care providers to operate outside of a broad range of patient and consumer protections. The agencies also seek comment on whether these products may contribute to health care cost inflation, displace hospitals' provision of financial assistance, lead patients to pay inaccurate or inflated medical bills, increase the amount patients must pay due to financing costs, or otherwise harm patients' mental, physical, and financial well-being, including through downstream credit reporting and debt collection practices. In line with the agencies' work to lower health care costs and reduce the burden of medical debt, the agencies also seek comment on policy options to protect consumers from harm.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This document sets forth proposed rules that would amend the definition of short-term, limited-duration insurance, which is excluded from the definition of individual health insurance coverage under the Public Health Service Act. This document also sets forth proposed amendments to the requirements for hospital indemnity or other fixed indemnity insurance to be considered an excepted benefit in the group and individual health insurance markets. This document further sets forth proposed amendments to clarify the tax treatment of certain benefit payments in fixed amounts received under employer-provided accident and health plans. Finally, this document solicits comments regarding coverage only for a specified disease or illness that qualifies as excepted benefits, and comments regarding level-funded plan arrangements.

The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups.

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.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

Notice is given for the August 29, 2023, virtual meeting of SAMHSA's Tribal Technical Advisory Committee (TTAC). TTAC meetings are exclusively between federal officials and elected officials of Tribal governments (or their designated employees) to exchange views, information, or advice related to the management or implementation of SAMHSA programs. The public may attend but are not allowed to participate in the meeting. Immediately following the TTAC meeting, SAMHSA will host American Indian and Alaska Native (AI/AN) Federally Recognized Tribes for a virtual Tribal Consultation session on the BEHAVIORAL HEALTH AND SUBSTANCE USE DISORDER RESOURCES FOR NATIVE AMERICANS PROGRAM.

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), proposes to amend its foreign quarantine regulation to provide additional clarity and safeguards to address the public health risk of dog-maintained rabies virus variant (DMRVV) associated with the importation of dogs into the United States. The United States has been DMRVV-free since 2007, and reintroduction poses significant risk to human and animal health. The close relationship between dogs and people means there is a direct public health risk to individuals that interact with inadequately vaccinated dogs imported from countries at high risk of DMRVV (high- risk countries). The notice of proposed rulemaking (NPRM) also addresses the importation of cats because both dogs and cats are included in the current regulation. Cats are not required to have proof of rabies vaccination and CDC is not proposing new substantive changes relating to the importation of cats.