Department of Health and Human Services August 4, 2023 – Federal Register Recent Federal Regulation Documents

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Waivers, Exceptions, and Exemptions from the Requirements of section 582 of the Federal Food, Drug, and Cosmetic Act.'' This guidance describes the process an authorized trading partner or other stakeholder should use to request a waiver, exception, or exemption from the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as the factors FDA intends to consider when evaluating such requests from an authorized trading partner or other stakeholder, and when determining FDA-initiated exceptions and exemptions. Additionally, this guidance describes the process the FDA intends to follow once every 2 years to review and make determinations on the appropriateness of renewing a previously approved waiver, exception, or exemption, where applicable. This guidance finalizes the draft guidance of the same title issued on May 9, 2018.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VERCISE DEEP BRAIN STIMULATION SYSTEM (VERCISE DBS SYSTEM) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DELSTRIGO, new drug application (NDA) 210807, and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.