Department of Health and Human Services January 9, 2024 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) 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 award of the priority review voucher. FDA has determined that CASGEVY (exagamglogene autotemcel), manufactured by Vertex Pharmaceuticals, Inc., meets the criteria for a priority review voucher.

The Task Force on Maternal Mental Health (Task Force), which is being implemented as a subcommittee of the SAMHSA Advisory Committee for Women's Services (ACWS), solicits public comments on a set of questions concerning the context, policies, effectiveness, promising practices, and limitations and gaps related to prevention and treatment of maternal mental health conditions and substance use disorders (inclusive of alcohol use/misuse) and its complications. The Task Force is required to solicit public comments, as appropriate, from stakeholders for the purposes of developing a report that analyzes and evaluates the state of maternal mental health programs at the Federal level and identifies best practices with respect to maternal mental health and substance use disorders as well as a national strategy for improving maternal mental health. The taskforce will be highlighting recommendations that fall within the pregnancy and postpartum (up to 1 year after birth) periods for individuals with or at risk for mental health and substance use conditions.

The Food and Drug Administration (FDA or Agency) 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 qualitative data on tobacco products and communications.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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 Port Therapeutics, Inc. (``Port''). Port incorporated in Delaware and is presently headquartered in Los Angeles, California.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates or any other aspect of this collection of information, including: the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.