Department of Health and Human Services December 7, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Department of Health and Human Services Good Guidance Practices
The Department of Health and Human Services finalizes its proposed regulations governing the agency's release and maintenance of guidance documents. These regulations will help to ensure that the public receives appropriate notice of new guidance and that the Department's guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that DANYELZA (naxitamab-gqgk) manufactured by Y-mAbs Therapeutics, Inc., (Cato Research LLC., US Agent) meets the criteria for a priority review voucher.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion
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.
Office of Child Support Enforcement; Statement of Organization, Functions, and Delegations of Authority
Statement of Organization, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Office of Child Support Enforcement. This reorganization realigns the functions of the Office of Child Support Enforcement. It eliminates the Division of Performance and Statistical Analysis and moves the functions to the Division of Federal Systems.
Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants-Update
This advisory is to update the submission date listed in the previous Federal Register document published on September 17, 2020, titled ``Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for CliniciansRequest for Current Billing Information for Qualifying APM Participants'' that provides information to certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current billing information needed to disburse the payment. This update allows these clinicians to provide information to CMS regarding their billing information by December 13, 2020 in order to receive this payment.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Final Policy Changes and Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals; Correction
This document corrects technical and typographical errors in the final rule that appeared in the September 18, 2020 issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Final Policy Changes and Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals''.
Flexibility for Head Start Designation Renewals in Certain Emergencies
This interim final rule adds a new provision to the Head Start Program Performance Standards (HSPPS) to establish parameters by which ACF may make designation renewal determinations during a federally declared major disaster, emergency, or public health emergency (PHE) and in the absence of all normally required data.
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