Change to the Definition of “Human Organ” Under Section 301 of the National Organ Transplant Act of 1984; Withdrawal

by the Health and Human Services Department on 11/27/2018.

This document withdraws a proposed rule published in the Federal Register on October 2, 2013. The proposed rule sought public comment on the proposed change in the definition of ``human organ'' in section 301 of the National Organ and Transplant Act of 1984, as amended, (NOTA) to explicitly incorporate hematopoietic stem cells within peripheral...

Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies; Extension of Timeline for Publication of Final Rule

by the Centers for Medicare & Medicaid Services on 11/02/2018.

This document announces the extension of the timeline for publication of the ``Medicare and Medicaid Program; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies'' final rule. We are issuing this document in accordance with section 1871(a)(3)(B) of the Social Security Act (the Act),...

Withdrawal of the Laser Products; Proposed Amendment to Performance Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices

by the Food and Drug Administration on 11/01/2018.

The Food and Drug Administration (FDA, Agency, we) is announcing the withdrawal of two proposed rules that published in the Federal Register. These proposed rules are not currently considered viable candidates for final action. FDA is taking this action because these proposed rules need to be reconsidered based on public comments received and...

Apprehension, Processing, Care, and Custody of Alien Minors and Unaccompanied Alien Children

by the Homeland Security Department and the Health and Human Services Department on 09/07/2018.

The U.S. Department of Homeland Security (DHS) and the Department of Health and Human Services (HHS) (``the Departments'') propose to amend regulations relating to the apprehension, processing, care, custody, and release of alien juveniles. In 1985, plaintiffs in a class action lawsuit, Flores v. Reno, challenged the policies of the legacy...

Medicare Program; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; Correction

by the Centers for Medicare & Medicaid Services on 06/15/2018.

This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on April 16, 2018 titled ``Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the...

National Institute of Nursing Research; Notice of Meeting

by the National Institutes of Health on 12/03/2018.

Evaluating the Therapeutic Potential of Cannabinoids: How To Conduct Research Within the Current Regulatory Framework

by the National Institutes of Health on 12/03/2018.

This workshop on December 8, 2018, sponsored by the National Center for Complementary and Integrative Health (NCCIH), a component of the National Institutes of Health (NIH), will bring together researchers, governmental officials, and industry representatives to discuss the processes and issues related to conducting cannabinoid research.

National Advisory Council on Nurse Education and Practice

by the Health Resources and Services Administration on 12/03/2018.

HHS is hereby giving notice that the charter for the National Advisory Council on Nurse Education and Practice (NACNEP) has been renewed. The effective date of the renewed charter is November 30, 2018.

Agency Information Collection Request; 60-Day Public Comment Request

by the Health and Human Services Department on 12/03/2018.

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.

Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

by the Food and Drug Administration on 11/30/2018.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic 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...

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting

by the National Institutes of Health on 11/30/2018.

Meeting of the Advisory Commission on Childhood Vaccines

by the Health Resources and Services Administration on 11/30/2018.

The Advisory Commission on Childhood Vaccines (ACCV) has scheduled a public meeting. Information about the ACCV and the agenda for this meeting can be found on the ACCV website at: http:// www.hrsa.gov/advisorycommittees/childhoodvaccines/index.html. This notice is being published less than 15 days prior to the meeting date due to unexpected...

Determination of Regulatory Review Period for Purposes of Patent Extension; KEVZARA

by the Food and Drug Administration on 11/30/2018.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KEVZARA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for...

Determination of Regulatory Review Period for Purposes of Patent Extension; PROVAYBLUE

by the Food and Drug Administration on 11/30/2018.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PROVAYBLUE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce,...

Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction

by the Centers for Medicare & Medicaid Services on 11/30/2018.

This document corrects an error that appeared in the final rule with comment period published in the Federal Register on November 21, 2018, entitled ``Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs.'' Specifically, this document corrects the...