Department of Health and Human Services June 28, 2019 – Federal Register Recent Federal Regulation Documents
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Medicare and Medicaid Programs: Application by Accreditation Commission for Health Care for Continued CMS-Approval of Its Hospice Accreditation Program
This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organizations complete application, the Centers for Medicare & Medicaid Services publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare Program; Rechartering and Appointment of New Members to the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
This notice announces the rechartering and appointment of seven new members to the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the CDLT Panel). The purpose of the CDLT Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests.
Medicare and Medicaid Programs; Risk Adjustment Data Validation
This document summarizes actions taken to date, requests public comment on additional subjects, and announces that CMS is releasing additional material, including study data, related to the Risk Adjustment Data Validation (RADV) provisions of the proposed rule titled ``Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021'' that was published in the November 1, 2018 Federal Register, 83 FR 55037. The comment period for the RADV provisions of this proposed rule ends on August 28, 2019.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Advisory Council will spend the majority of time during the July 29, 2019 meeting considering recommendations made by each of the three subcommittees to present to the Secretary of HHS and Congress. Additional presentations will include updates on the latest biomedical research findings, an overview of the Healthy Brain Initiative: The Road Map for Indian Country, and a discussion of the progress made since 2011 through the National Plan to Address Alzheimer's Disease. Federal workgroups will also provide updates.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Data Collection Tool for State Offices of Rural Health Grant Program, OMB No. 0915-0322-Revision
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.
Treatment for Heart Failure: Endpoints for Drug Development; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Treatment for Heart Failure: Endpoints for Drug Development.'' This draft guidance clarifies that an effect on symptoms or physical function, without a favorable effect on survival or hospitalization, can be a basis for approving drugs to treat heart failure. It also provides recommendations to sponsors on the need to assess mortality effects of drugs under development to treat heart failure.
Endpoints for Drug Development in Heart Failure; Public Workshop
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop entitled ``Endpoints for Drug Development in Heart Failure.'' The purpose of this public meeting is to bring the stakeholder community together to discuss clinical endpoints for trials in heart failure that could be used to support FDA approval of drugs. The workshop will focus on endpoints related to symptoms and physical function. In addition, there will be discussion of the need to assess mortality effects of drugs under development for heart failure.
Biologics License Applications and Master Files
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations concerning the use of master files for biological products. This action, if finalized, will allow certain biological products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to continue to incorporate by reference information about drug substances, drug substance intermediates, or drug products contained in master files after those products are deemed to be licensed under the Public Health Service Act (PHS Act) on March 23, 2020. The proposed rule also codifies FDA's practice of permitting applications for biological products submitted under the PHS Act to incorporate by reference information other than drug substance, drug substance intermediate, or drug product information contained in a master file. In addition, the proposed rule codifies FDA's practice of permitting investigational new drug applications to incorporate by reference any information contained in a master file for products subject to licensure under the PHS Act.
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