Department of Health and Human Services January 13, 2022 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Updates to Lists Related to Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Conditions of Payment
This document announces the updated Healthcare Common Procedure Coding System (HCPCS) codes on the Master List of DMEPOS Items Potentially Subject to Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements. It also announces the initial selection of HCPCS codes on the Required Face-to- Face Encounter and Written Order Prior to Delivery List and the updates the HCPCS codes on the Required Prior Authorization List.
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities
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 information collection provisions of the Agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.
Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards
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 information collection provisions of the Manufactured Food Regulatory Program Standards.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model; Correction
This document corrects technical errors in the final rule with comment period that appeared in the Federal Register on November 16, 2021, titled ``Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model.''
Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Becton, Dickinson & Company (BD) for the BioGX SARS-CoV-2 Reagents for BD MAX System, Boston Medical Center for the BMC-CReM COVID-19 Test, and Akron Children's Hospital for the Akron Children's Hospital SARS-CoV-2 Assay. FDA revoked these Authorizations on December 8, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
Acquisition Regulations: Buy Indian Act; Procedures for Contracting
The Secretary of the Department of Health and Human Services (HHS) is finalizing regulations guiding implementation of the Buy Indian Act, which provides the Indian Health Service (IHS) with authority to set-aside procurement contracts for Indian-owned and controlled businesses. This rule supplements the Federal Acquisition Regulations (FAR) and the Department of Health and Human Services Acquisition Regulations (HHSAR).
Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox, a carcinogenic new animal drug used in swine feed.
Proposed Information Collection Activity; Head Start Program Information Report (OMB #0970-0427)
The Administration for Children and Families' (ACF) Office of Head Start (OHS) is requesting a 3-year extension of the Head Start Program Information Report (PIR), Monthly Enrollment reporting instrument, and Center Locations and Contacts instrument (OMB #0970- 0427, expiration 4/30/2022). OHS has made updates to these instruments, as described below.
Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs). This final rule discontinues the publication in the Federal Register after each quarter of a list of PMA and HDE approvals and denials announced in that quarter. We will continue to post approval and denial notices for PMAs and HDEs on FDA's home page on the internet and will also continue to make available on the internet and place on public display summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA is taking this action to improve the efficiency of announcing approvals and denials of PMAs and HDEs and to eliminate duplication in the current process for announcing this information. We are also updating Agency contact information and statutory references in certain sections of the PMA and HDE regulations for purposes of accuracy, clarity, and consistency.
French Dressing; Revocation of a Standard of Identity
The Food and Drug Administration (FDA or we) is revoking the standard of identity for French dressing. This action, in part, responds to a citizen petition submitted by the Association for Dressings and Sauces (ADS). We conclude that this standard no longer promotes honesty and fair dealing in the interest of consumers. Revocation of the standard of identity for French dressing will provide greater flexibility in the product's manufacture, consistent with comparable, nonstandardized foods available in the marketplace.
Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to May 25, 2005. The revocation does not affect the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) recovered on or after May 25, 2005. The rule is being finalized because these regulations are obsolete or no longer necessary to achieve public health goals.
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