Department of Health and Human Services March 2, 2022 – Federal Register Recent Federal Regulation Documents

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.