Department of Health and Human Services October 18, 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices
The Food and Drug Administration (FDA, the Agency, or we), with the Department of the Treasury's concurrence, is amending its regulations to require that certain data elements be submitted for veterinary devices that are being imported or offered for import in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by U.S. Customs and Border Protection (CBP), in order for CBP to process the filing and to help FDA in determining the admissibility of those veterinary devices. This final rule will make the submission of the general data elements currently required to be submitted in ACE for other FDA-regulated products at the time of entry also required in ACE for veterinary devices being imported or offered for import into the United States. This final rule will increase effective and efficient admissibility review by FDA of those entry lines containing a veterinary device, which will protect public health by allowing the Agency to focus its limited resources on FDA-regulated products that may be associated with a greater public health risk.
Request for Information on Research Opportunities Related to the National Institutes of Health Scientific Workshop on Gender-Affirming Care for Transgender and Gender-Diverse Populations
Through this Request for Information (RFI), the Sexual & Gender Minority Research Office (SGMRO) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), invites feedback from stakeholders throughout the scientific research community, clinical practice communities, patient and family advocates, scientific or professional organizations, federal partners, internal NIH stakeholders, and other interested constituents on research opportunities related to the upcoming NIH Scientific Workshop on Gender-Affirming Care for Transgender and Gender-Diverse Populations. Current evidence-based clinical practices are available for health professionals to assist transgender and gender-diverse populations but additional research is needed to advance this area of care. The overarching purpose of this workshop is to identify and prioritize key infrastructure and research needed to further our understanding of gender affirming care for transgender and gender diverse populations across the life course. Various populations (e.g., people with HIV, people with other co-morbidities and complications, racial and ethnic minorities, etc.) and settings (academic medical centers, Federally Qualified Health Centers, community hospitals, HIV care settings, etc.) will be considered.
Meeting of the Tick-Borne Disease Working Group
The Office of the Assistant Secretary for Health published a notice of an upcoming meeting of the Tick-Borne Disease Working Group (TBDWG) in the Federal Register on September 16, 2022. This addendum provides notice of an additional day added to the October 25, 2022 meeting. The 24th meeting of the TDBWG will now take place from October 24-25, 2022. The September 16th Federal Register notice can be accessed at https://www.federalregister.gov/documents/2022/09/16/2022-200 88/ meeting-of-the-tick-borne-disease-working-group.
Tissue Agnostic Drug Development in Oncology; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Tissue Agnostic Drug Development in Oncology.'' For the purpose of this guidance, the term ``tissue agnostic oncology drug'' refers to a drug that targets a specific molecular alteration(s) (a kind of biomarker) across multiple cancer types as defined, for example by organ, tissue, or tumor type. This draft guidance describes the development of tissue agnostic drugs, scientific considerations in determining when tissue agnostic oncology drug development may be appropriate, and, if appropriate, issues to be addressed during such development. Tissue agnostic drug development may expedite or enable the development of new therapies for patients with rare cancer types.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Warning Plans for Smokeless Tobacco Products
The Food and Drug Administration (FDA or we) 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.
Gregory Settino: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Gregory Settino from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Settino was convicted of a felony under Federal law for conduct that relates to the regulation of any drug product under the FD&C Act. Mr. Settino was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of August 15, 2022 (30 days after receipt of the notice), Mr. Settino had not responded. Mr. Settino's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.
Blood Products Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA, Agency, or we) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues related to blood and products derived from blood. At least one portion of the meeting will be closed to the public.
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.'' This guidance is intended to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukemia (AML). This guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for the development of drugs and biological products to support an indication of treatment of AML, including indications limited to an individual phase of treatment (for example, maintenance, transplantation preparative regimen, etc.). The guidance addresses the topics of general drug development, efficacy endpoints, and exploratory and confirmatory trial considerations for AML drug development. In addition, the guidance addresses investigational new drug applications, new drug applications, and biologics licensing applications for AML drugs. This guidance finalizes the draft guidance of the same title ``Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment'' issued August 2020.
Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.'' This guidance is intended for sponsors of cancer immunotherapeutic drugs that modulate the endogenous immune system and may break immunologic tolerance to normal organs and tissues; it provides recommendations regarding the data that should be collected and evaluated to assess whether adverse events are immune-mediated adverse reactions (imARs) and the data on imARs that should be included in a new drug application (NDA) or biologics license application (BLA) for a cancer immunotherapeutic drug.
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