Department of Health and Human Services May 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to BioFire Diagnostics, LLC for the BioFire Respiratory Panel 2.1 (RP2.1). FDA revoked this Authorization on March 17, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), in consideration of the De Novo classification order for the BioFire Respiratory Panel 2.1 (RP2.1) as a Class II (Special Controls) device under the generic name ``Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.'' The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This virtual meeting is open to the public, limited only by audio and web conference lines (300 audio and web conference lines are available). Registration is required. To register for this web conference, please go to: www.cdc.gov/hicpac. All registered participants will receive the meeting link and instructions shortly before the meeting.

This proposed rule proposes to delay for 6 months the January 1, 2022 effective date for amendatory instruction 10.a., which addresses the reporting by manufacturers of multiple best prices connected to a value based purchasing arrangement, of the final rule entitled, ``Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements'', published in the December 31, 2020 Federal Register. This proposed rule also proposes to delay for 2 years the April 1, 2022 effective date of inclusion (inclusion date) for U.S. territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) in the amended regulatory definitions of ``States'' and ``United States'' for purposes of the Medicaid Drug Rebate Program (MDRP), adopted in the interim final rule with comment period entitled, ``Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States'', published in the November 25, 2019 Federal Register to April 1, 2024. In the alternative, we are proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received. We are requesting public comment on the proposed delays of applicable effective date and inclusion date discussed in greater detail below.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for biological products for use during the COVID-19 pandemic. FDA has issued one Authorization for biological products as requested by Eli Lilly and Company and one Authorization for a biological product as requested by Janssen Biotech, 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 Health and Human Services (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.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.'' The existing postmarket surveillance guidance was issued in May 2016 to address certain postmarket surveillance requirements. This draft guidance is intended to update the 2016 guidance to increase transparency to stakeholders on FDA's approach to the issuance and tracking of these postmarket surveillance orders, and expectations for timely study completion. This draft guidance is not final nor is it in effect at this time.

HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Organ Transplantation (ACOT or Committee). ACOT provides advice and recommendations to the Secretary of HHS (Secretary) on matters pertaining to organ donation, procurement, allocation, and transplantation; maximizing the number of deceased donor organs available for transplantation; supporting the safety of living organ donation proposed policies of the Organ Procurement and Transplantation Network (OPTN) and OPTN operations; and the latest advances in the science of transplantation.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Evaluation of Mental Health Applications, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Office of Refugee Resettlement (ORR) is requesting a three-year extension of the ORR Cash and Medical Assistance (CMA) Program Quarterly Report on Expenditures and Obligations (ORR-2) (OMB #0970-0407, expiration 8/31/2021). There are no changes requested to the form.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Tuberculosis Data from Panel Physicians. This study collects Tuberculosis data gathered during overseas immigration medical exams.

The Children's Bureau, Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for an evaluation of the services provided to child welfare jurisdictions and Court Improvement Programs (CIP) by the Child Welfare Capacity Building Collaborative. This study uses instruments that build on previously approved OMB instruments, including satisfaction surveys, assessment tools, interview protocols, and service-specific feedback forms (OMB #0970-0484, expiration 11/30/ 22; OMB #0970-0494, expiration 2/28/23).

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Health Message Testing System (HMTS). The Health Message Testing System (HMTS), a generic information collection, enables programs across CDC to collect the information they require regarding testing of messages in a timely manner.