Department of Health and Human Services December 27, 2023 – Federal Register Recent Federal Regulation Documents

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Stillbirth Working Group of Council is charged with identifying current knowledge on stillbirth and prevention, areas of improvement for data collection, current resources for families impacted by stillbirth, and next steps to gather data and lower the rate of stillbirth in the United States.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers.'' We are issuing this small entity compliance guide (SECG) in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the ``Direct-to- Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule'' (CCN Final Rule). The CCN Final Rule modifies FDA regulations to reflect the requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that human prescription drug advertisements presented directly to consumers (DTC) in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads) present the major statement relating to side effects and contraindications (major statement) in a clear, conspicuous, and neutral manner and establishes standards to help ensure this requirement is met. The term ``drugs'' in this guidance refers to prescription human drug and biological products.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZOKINVY 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 patents which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CYTALUX 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.

The invention listed below is directed to a T cell receptor (TCR) that specifically targets the Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1). This TCR may be used to develop novel immunotherapies against several common and aggressive epithelial cancers. It may also be possible to use portions of the KK-LC-1 TCR in chimeric proteins for cancer therapy and/or for antigen detection assays. This technology was discovered and is being developed by the National Cancer Institute (NCI). The NCI is currently seeking a licensee and/or collaborator to further develop this technology.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SCEMBLIX 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.