Department of Health and Human Services July 12, 2023 – Federal Register Recent Federal Regulation Documents
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Reorganization of the Office of Readiness and Response
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.
Reorganization of the Office of Laboratory Science and Safety
CDC has modified its structure. This notice announces the reorganization of the Office of Laboratory Science and Safety and the establishment of the Center for Laboratory Systems and Response.
Reorganization of the Office of Communications
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.
Reorganization of the National Center for Health Statistics
CDC has modified its structure. This notice announces the reorganization of the National Center for Health Statistics (NCHS).
Reorganization of the Office of Public Health Data, Surveillance, and Technology
CDC has modified its structure. This notice announces the reorganization of the Office of Public Health Data, Surveillance, and Technology (OPHDST).
Reorganization of the Strategic Business Initiatives Unit
CDC has modified its structure. This notice announces the reorganization of the Strategic Business Initiatives Unit (SBI). SBI converted from an activity within the Office of the Director of the Office of the Chief Operating Officer to a stand-alone business service office known as the Office of Strategic Business Initiatives.
Reorganization of the Office of Safety, Security and Asset Management
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.
Reorganization of the Office of the Chief Information Officer
CDC has modified its structure. This notice announces the reorganization of the Office of the Chief Information Officer (OCIO). OCIO restructured to optimize support for the CDC Moving Forward reorganization and Data Modernization Initiatives.
Reorganization of the Office of Financial Resources
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.
Reorganization of the Human Resources Office
CDC has modified its structure. This notice announces the reorganization of the former Human Resources Office. In addition to functional realignments and new functional entities, the Human Resources Office was retitled to the Office of Human Resources.
Nonprescription Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
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.
Reorganization of the Global Health Center
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.
Reorganization of the National Center for State, Tribal, Local, and Territorial Public Health Infrastructure and Workforce
CDC has modified its structure. This notice announces the reorganization of the State, Tribal, Local, and Territorial Public Health Infrastructure and Workforce, henceforth referred to as the Public Health Infrastructure Center (PHIC). PHIC reorganized to enhance and enable coordination for partners collectively working to bolster the Nation's public health infrastructure.
Reorganization of the National Center for Emerging and Zoonotic Infectious Diseases
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.
Reorganization of the National Center on Birth Defects and Developmental Disabilities
CDC has modified its structure. This notice announces the reorganization of the National Center on Birth Defects and Developmental Disabilities (NCBDDD). NCBDDD realigned the Office of Genomics and Precision Public Health from the Office of Science to the NCBDDD, retitled and made mission and functional statements updates to some organizational entities.
Request for Information Regarding Medical Payment Products
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.
National Vaccine Injury Compensation Program; List of Petitions Received
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorization of Medical Products and Related Authorities
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rapid Uptake of Disseminated Interventions (RUDI) Evaluation OMB No. 0915-xxxx-[New]
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.
Replacement of 2015 Statement of Organization, Functions, and Delegations of Authority; Office of the Assistant Secretary for Public Affairs
This notice provides an updated Statement of Organization, Functions, and Delegations of Authority for HHS' Office of the Assistant Secretary for Public Affairs, replacing the statement as last amended in 2015. The statement is republished in full.
Government-Owned Inventions; Availability for Licensing and Collaboration for Phase 3 Study
The invention described below will be a first-in-class, reversible, hormonal contraceptive method for males and is co-owned by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, and The Population Council, Inc., a New York not-for-profit corporation based in New York City (``Population Council''). The co-owners will complete the Phase 2b clinical stage of development in 2024 and are seeking a licensee and investor/collaborator for the Phase 3 clinical stage, anticipated to begin as early as 2024.
Short-Term, Limited-Duration Insurance; Independent, Noncoordinated Excepted Benefits Coverage; Level-Funded Plan Arrangements; and Tax Treatment of Certain Accident and Health Insurance
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.
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.'' This draft guidance describes FDA's current recommendations for optimizing and standardizing dietary management in clinical trials for the development of drug products intended to treat inborn errors of metabolism (IEM) when dietary management is a key component of patients' metabolic control. Optimizing and standardizing dietary management in these patients before they enter clinical trials and during clinical trials is essential to providing an accurate evaluation of the efficacy of new drug products. This guidance revises the draft guidance of the same name issued on July 24, 2018.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
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.
Submission for OMB Review; Income Withholding for Support Order (OMB No.: 0970-0154)
The Office of Child Support Services (OCSS) (formerly the Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) to extend approval of the Income Withholding for Support Order (IWO), with minor changes, for an additional three years. The current OMB approval expires September 30, 2023.
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