Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Members will participate via teleconference. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act'' (``revised draft guidance''). This revised draft guidance, when finalized, will describe how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to human drug products compounded by State- licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. First, it addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product. This draft guidance revises the draft guidance issued in 2016 entitled, ``Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act'' (``draft guidance''). FDA is revising the draft guidance to address stakeholder feedback and provide further clarification on policies regarding hospital and health system compounding. This revised draft guidance is not final nor is it in effect at this time.
Request for comments on the draft Department Strategic Plan for FY 2022-2026
The Department of Health and Human Services (HHS) is seeking public comment on its draft Strategic Plan for Fiscal Years 2022-2026 through the Department of Health and Human Services website at www.hhs.gov/about/draft-strategic-plan/index.html.
Request for Public Comments on the Development of the 2021-2022 IACC Strategic Plan for Autism Spectrum Disorder (ASD)
On behalf of the Interagency Autism Coordinating Committee (IACC), the National Institute of Mental Health (NIMH) Office of Autism Research Coordination (OARC) is seeking public comments to assist the IACC in identifying priorities for the 2021-2022 update of the IACC Strategic Plan for Autism Spectrum Disorder (ASD) as required by the Autism Collaboration, Accountability, Research, Education and Support (CARES) Act of 2019. The IACC is requesting public comments on research, services, and policy issues related to the seven topics addressed by the IACC Strategic Plan: Screening and Diagnosis, Biology, Risk Factors, Treatments and Interventions, Services, Lifespan Issues, and Infrastructure and Surveillance. The IACC is also requesting information on two additional issues related to autism described in two supplemental questions that are included in this Request for Public Comment.
Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services
The Office of Population Affairs (OPA) in the Office of the Assistant Secretary for Health issues this final rule to revise the regulations that govern the Title X family planning program (authorized by Title X of the Public Health Service Act) by readopting the 2000 regulations, with several revisions to ensure access to equitable, affordable, client-centered, quality family planning services for clients, especially low-income clients. The effect of this 2021 final rule is to revoke the requirements of the 2019 regulations, including removing restrictions on nondirective options counseling and referrals for abortion services and eliminating requirements for strict physical and financial separation between abortion-related activities and Title X project activities, thereby reversing the negative public health consequences of the 2019 regulations. OPA also makes several revisions to the 2000 regulations to increase access to equitable, affordable, client-centered, quality family planning services.
Requirements Related to Surprise Billing; Part II
This document sets forth interim final rules implementing certain provisions of the No Surprises Act, which was enacted as part of the Consolidated Appropriations Act, 2021. These interim final rules implement provisions of the No Surprises Act that provide for a Federal independent dispute resolution (IDR) (Federal IDR) process to permit group health plans and health insurance issuers offering group or individual health insurance coverage and nonparticipating providers, facilities, and providers of air ambulance services to determine the out-of-network rate for items and services that are emergency services, nonemergency services furnished by nonparticipating providers at participating facilities, and air ambulance services furnished by nonparticipating providers of air ambulance services, under certain circumstances. The Department of Health and Human Services (HHS), the Department of Labor (DOL), and the Department of the Treasury (collectively, the Departments) are issuing these interim final rules with largely parallel provisions that apply to group health plans and health insurance issuers offering group or individual health insurance coverage and certified IDR entities, providers, facilities, and providers of air ambulance services. In addition to the interim final rules issued jointly by the Departments, this document also includes interim final rules issued by the Office of Personnel Management (OPM) to clarify how certain No Surprises Act provisions apply to health benefits plans offered by carriers under the Federal Employees Health Benefits (FEHB) Act. In addition to the interim final rules issued jointly by the Departments and OPM, this document includes interim final rules issued by HHS that address good faith estimates of health care items and services for uninsured or self-pay individuals and the associated patient-provider dispute resolution process. The HHS-only interim final rules apply to selected dispute resolution (SDR) entities, providers, facilities, and providers of air ambulance services.