Department of Health and Human Services March 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring George Kuiper for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Kuiper was convicted of multiple felony offenses: One count of smuggling, one count of conspiracy to smuggle goods into the United States and to introduce into interstate commerce unapproved drugs, and one count of introduction into interstate commerce of unapproved drugs. The factual basis supporting Mr. Kuiper's convictions, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Kuiper was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of December 8, 2021 (30 days after receipt of the notice), Mr. Kuiper had not responded. Mr. Kuiper's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Department of Health and Human Services' Office of Infectious Disease and HIV/AIDS Policy in the Office of the Assistant Secretary for Health announces that the draft Vaccines Federal Implementation Plan 2021-2025 is available for public comment. The Vaccines Federal Implementation Plan is a companion document to the Vaccines National Strategic Plan 2021-2025 (VNSP), which was published in January 2021. The Vaccines Federal Implementation Plan is a compilation of federal agency immunization activities that collectively advance the goals of the VNSP. Its target audience is other federal agencies and external partners who work in the area of vaccination. The public will be interested in how the implementation plan documents federal agency efforts. It does not outline mandates or other COVID-19 response measures.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders.'' This guidance document describes the processes available to mammography facilities to request additional review of an adverse appeals decision on a facility's accreditation, and/or a suspension or revocation of certificate, and/or a patient and physician notification order. This guidance supersedes section 4.5 of the Center for Devices and Radiological Health (CDRH) Appeals Processes guidance document dated July 2, 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.'' This guidance provides advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first- in-human trials, intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. In contrast to traditional trial designs, where a single drug is tested in a single disease population in one clinical trial, master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple substudies, allowing for efficient and accelerated drug development.

The Food and Drug Administration (FDA, Agency, or we) 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 collection of information associated with new animal drug applications and veterinary master files.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #258 entitled ``Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds.'' Tracers are ingredients added to animal food, medicated feed, and Type A medicated articles to identify a particular product. The purpose of this document is to provide guidance on the use of tracers in animal food, medicated feeds, and Type A medicated articles. When finalized, this guidance will replace Compliance Policy Guide (CPG) Sec. 680.100 Tracers in Animal Feed.

This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS in making coverage determinations under the Medicare program. The MEDCAC's fundamental purpose is to support the principles of an evidence-based determination process for Medicare's coverage policies. MEDCAC panels provide advice to CMS on the strength of the evidence available for specific medical treatments and technologies through a public, participatory, and accountable process.

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, Annual Reporting of the Rape Prevention and Education (RPE) Program. The RPE Program is the principal federally funded program focused on sexual violence (SV) prevention. This data collection allows CDC to collect information about the implementation and outcomes of CE19-1902 cooperative agreement.

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), as part of its continuing effort to reduce public burden, invites the general public and other federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Preferences for Longer- Acting Preexposure Prophylaxis (LA-PrEP) Methods Among Persons in U.S. Populations at Highest Need: A Discrete Choice Experiment. The proposed project is designed to understand preferences for LA-PrEP products for HIV prevention among potential users and providers.

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).

The Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF-118A: Child Care and Development Fund Plan for Tribes (OMB #0970-0198, expiration 06/30/ 2022) for FFY 2023-2025. There are minor changes requested to the form to improve formatting and clarify and streamline questions.

The Food and Drug Administration (FDA, Agency, or we) is classifying the screw sleeve bone fixation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the screw sleeve bone fixation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.