Department of Health and Human Services September 1, 2020 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
This proposed rule would establish a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). After the final rule is effective, the Medicare Coverage of Innovative Technology (MCIT) pathway would begin national Medicare coverage on the date of FDA market authorization and would continue for 4 years. We are also proposing regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B.
Advisory Commission on Childhood Vaccines
The original Federal Register Notice announcing the September 2020 Advisory Commission on Childhood Vaccines (ACCV) meeting indicated that this meeting would be held on September 3-4, 2020. This meeting is not being conducted over 2 days, and instead will only take place only on September 4, 2020. The ACCV will hold a public meeting on September 4, 2020, at 10:00 a.m. ET. The meeting will be held via Adobe Connect and telephone conference. This will not be an in-person meeting. The public can join the meeting by: 1. (Audio Portion) Calling the conference phone number 888-790-1734 and providing the following information:
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
The Food and Drug Administration (FDA) 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: Coronavirus 2019 Data Report
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.
Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed extension of the collection of information concerning requirements relating to FDA's Adverse Experience Reporting System (FAERS) for licensed biological products, and general records associated with the manufacture and distribution of biological products.
Determination of Regulatory Review Period for Purposes of Patent Extension; LUMOXITI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LUMOXITI 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 the extension of patents which claims that human biological product.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Standards of Care for Chimpanzees Held in the Federally Supported Sanctuary System
This document contains technical amendments to the Health and Human Services (HHS) regulation regarding the Standards of Care for Chimpanzees Held in the Federally Supported Sanctuary System. The regulatory content is being amended to correct references that are made throughout the regulation regarding delegated authorities and activities of the National Center for Research Resources (NCRR) of the National Institutes of Health (NIH). With the abolishment of NCRR in 2011, the Director, NIH, delegated these authorities to the Office of Research Infrastructure Programs (ORIP) within the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), NIH. The ORIP/DPCPSI now has the lead responsibility for coordinating all efforts on behalf of HHS concerning the sanctuary system for surplus chimpanzees from both federal and non-federal sources. The references to NCRR throughout the regulation are corrected to reflect ORIP/DPCPSI, the definition of National Primate Research Center is corrected to reflect the correct number of currently existing centers, and the office address provided for ORIP/DPCPSI in the regulation is corrected.
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