Department of Health and Human Services February 19, 2021 – Federal Register Recent Federal Regulation Documents
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Authorizations of Emergency Use of Certain Drug and Biological Products During the COVID-19 Pandemic; Availability
The Food and Drug Administration (FDA) is announcing the issuance of five Emergency Use Authorizations (EUAs) (the Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for drug and biological products for use during the COVID-19 pandemic. FDA issued one Authorization for a drug as requested by Baxter Healthcare Corporation (Baxter); one Authorization for a biological product as requested by the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (ASPR/HHS); an Authorization for a drug and an Authorization for a biological product as requested by Eli Lilly and Company; and one Authorization for biological products as requested by Regeneron Pharmaceuticals, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of HHS that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS-CoV-2, causes the illness COVID- 19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
Medical Device User Fees; Stakeholder Meetings on Medical Device User Fee Amendments of Fiscal Years 2023 to 2027 Reauthorization; Request for Notification of Stakeholder Intention to Participate
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholdersincluding patient and consumer advocacy groups, healthcare professionals, and scientific and academic expertsnotify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Medical Device User Fee Amendments (MDUFA). The statutory authority for MDUFA expires in September 2022. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent public stakeholder representation.
Guidance Documents Related to Coronavirus Disease 2019; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.
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.
Notice for Public Comment on Administration for Native Americans' Program Policies and Procedures
Pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy and to give notice of the proposed changes no less than 30 days before such changes become effective. In accordance with notice requirements of NAPA, ANA herein describes proposed interpretive rules and general statements of policy that relate to ANA's funding opportunities in Fiscal Year (FY) 2021. Changes to FY 2021 funding opportunity announcements (FOAs) will be based on the following previously published programs: Environmental Regulatory Enhancement (ERE), HHS-2021-ACF-ANA-NR-1907; Native American Language Preservation and Maintenance-Esther Martinez Immersion (EMI), HHS-2021-ACF-ANA-NB-1958; Native American Language Preservation and Maintenance (P&M), HHS-2021-ACF-ANA-NL-1924; Social and Economic Development Strategies (SEDS), HHS-2021-ACF-ANA-NA-1906; Social and Economic Development Strategies-Alaska (SEDS-AK), HHS-2021-ACF-ANA-NK- 1902; and Social and Economic Development Strategies-Growing Organizations (SEDS-GO), HHS-2021-ACF-ANA-NN-1918.
Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees; Delayed Effective Date
As required by an order issued by the U.S. District Court for the District of Columbia, this action provides notice of the delay of the effective date of certain amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in a final rule (``Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals And Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees'') published on November 30, 2020. The new effective date for these certain amendments is January 1, 2023.
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