Department of Health and Human Services March 10, 2022 – Federal Register Recent Federal Regulation Documents

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP).'' This proposed information collection was previously published in the Federal Register on January 3rd, 2021 and allowed 60 days for public comment. During the 60 days, no substantive comments from members of the public were received by AHRQ. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance entitled ``Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.'' This revised draft guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, this revised draft guidance covers the statutory verification system requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. The revised draft guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser (also referred to as ``trading partners'') after a suspect product investigation because it is determined that the product is not an illegitimate product. Finally, the revised draft guidance addresses the statutory requirement for responding to requests for verification and processing saleable returns.