Department of Health and Human Services December 16, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that BEOVU (brolucizumab-dbll), approved October 7, 2019, meets the redemption criteria.

The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule amending requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. This action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA's premarket submission program for medical devices.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to T-CURX GmbH (T- CURX), located in W[uuml]rzburg, Germany.

The Food and Drug Administration (FDA or Agency) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the availability of a draft guidance for industry and FDA staff entitled ``Qualification Process for Drug Development Tools.'' Under the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, a new section was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which defined a three-stage qualification process for drug development tools (DDTs). This guidance meets the Cures Act's mandate to issue guidance on this qualification process and related Prescription Drug User Fee Act (PDUFA) VI commitments. It elaborates on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other DDTs, and the draft guidance of the same name issued January 7, 2014, is withdrawn.

This final notice announces our decision to approve The Joint Commission (TJC) for initial recognition as a national accrediting organization for home infusion therapy (HIT) suppliers that wish to participate in the Medicare program. An HIT supplier that participates must meet the Medicare conditions for coverage (CfCs).

The Food and Drug Administration (FDA), Center of Drug Evaluation and Research (CDER) has modified its structure. This new organizational structure was approved by the Secretary of Health and Human Services on September 25, 2019.