Department of Health and Human Services April 6, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Patient- Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making.'' This draft guidance (Guidance 4) is the fourth in a series of four methodological patient- focused drug development (PFDD) guidance documents that describe how stakeholders (patients, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.
Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.'' The draft guidance is intended to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients (API) that may, in turn, help the Agency in its efforts to prevent or mitigate shortages. The draft guidance also explains how FDA communicates information about products in shortage to the public. This draft guidance is not final nor is it in effect at this time.
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients (APIs)) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies one bulk drug substance that FDA has considered and is including on the list at this time: quinacrine hydrochloride (HCl) to compound drug products for oral use only. This notice also identifies 10 bulk drug substances that FDA has considered and is not including on the list at this time: hydroxyzine HCl, mannitol, methacholine chloride, metoclopramide HCl, nalbuphine HCl, potassium acetate, procainamide HCl, sodium bicarbonate, sodium nitroprusside, and verapamil HCl. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing the availability of a draft guidance for industry that appeared in the Federal Register of February 13, 2023. In that notice, FDA requested comments on the draft guidance for industry entitled ``Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.'' The Agency is taking this action to allow interested persons additional time to submit comments.
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements in scope of the parent award for the 11 eligible grant recipients funded in FY 2018 under the Mental Health Technology Transfer Centers (MHTTCs) Cooperative Agreements, Notice of Funding Opportunity (NOFO) SM-18-005. The MHTTC National Coordinating Center may receive up to $900,000 and the 10 MHTTC Regional Centers may receive up to $1,045,454 each. These recipients have a project end date of September 29, 2023. The supplemental funding will extend the project period by one-year and will continue to support resource development and dissemination, training and technical assistance, and workforce development to the field and provide direct technical assistance and training on the delivery of mental health services in schools and school systems to CMHS Project AWARE grantees.
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements in scope of the parent award for the 11 eligible grant recipients funded in FY 2017, under the Addiction Technology Transfer Centers (ATTC) Cooperative Agreements, Notice of Funding Opportunity (NOFO) TI-17-005. Recipients may receive up to $743,757 each, for a total of $8,181,327. These recipients have a current project end date of September 29, 2023. The supplemental funding will extend the project period by one-year and will continue training and technical assistance for providers who are serving patients with substance use disorder by improving their capacity and understanding of evidence-based practices, especially practices that are effective in combating substance misuse, including the opioid crisis.
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements in scope of the parent award for the 11 eligible grant recipients funded in FY 2019 under the Prevention Technology Transfer Centers (PTTCs) Cooperative Agreements, Notice of Funding Opportunity (NOFO) SP-19-001. The PTTC National Coordinating Center may receive up to $493,966 and the 10 PTTC Regional Centers may receive up to $600,000 each for a total of $6,492,160. These recipients have a project end date of September 29, 2023. The supplemental funding will extend the project period by one-year and will continue providing training and technical assistance services and quality improvement activities to the substance abuse prevention workforce including professionals and pre-professionals, organizations, and others in the prevention community.
Supplemental Evidence and Data Request on Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents, which is currently being conducted by the AHRQ's Evidence- based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Reopening of the Comment Period
The Food and Drug Administration (FDA or we) is reopening the comment period for the draft guidance entitled ``Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry,'' which was announced in the Federal Register of January 25, 2023. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Prospective Grant of an Exclusive Patent License: Manufacture, Distribution, Sale and Use of T-Cell-Based Immunotherapies for Solid Tumors
The Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Cancer Institute, both institutes of the National Institutes of Health, Department of Health and Human Services, are 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 EnZeta Inc. of the State of Delaware.
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