Department of Health and Human Services February 20, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 23 of 23
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics.'' This guidance expands upon, consolidates, and supplements the recommendations on nonclinical immune system assessments provided across multiple guidance documents, most notably the International Conference on Harmonization (ICH) guidance for industry ``S8 Immunotoxicity Studies for Human Pharmaceuticals.'' The topics covered include various aspects of immune suppression, modulation, and stimulation. This guidance replaces the withdrawn guidance entitled ``Immunotoxicology Evaluation of Investigational New Drugs.''
Medical Imaging Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Medical Imaging Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pulmonary-Allergy Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Submission for OMB Review; Tribal Child Support Enforcement Direct Funding Request: 45 CFR 309-Plan (OMB #0970-0218)
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting a 3-year extension of the 45 CFR 309-Plan (OMB #0970-0218, expiration 3/21/2020). There are no changes requested to this form.
Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Reopening of Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability that published in the Federal Register on November 20, 2019. In that notice, FDA requested comments on the draft guidance for industry (GFI) #256 entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' FDA is reopening the comment period to update comments and to receive any new information.
HHS Notice of Committee Establishment, Notice of Intent To Convene, and Call for Nominations for the NIH Human Fetal Tissue Research Ethics Advisory Board for Fiscal Year 2020
The U.S. Department of Health and Human Services (HHS) announces the establishment of, and intent to convene, the National Institutes of Health (NIH) Human Fetal Tissue Research Ethics Advisory BoardFY 2020 (Ethics Board or Board), as authorized by section 492A of the Public Health Service (PHS) Act, as amended. HHS is soliciting nominations of individuals for appointment to the Ethics Board for fiscal year 2020. Nominations for qualified individuals for appointment to the Ethics Board are currently being accepted.
Medicaid Program; Preadmission Screening and Resident Review
This proposed rule would modernize the requirements for Preadmission Screening and Resident Review (PASRR), currently referred to in regulation as Preadmission Screening and Annual Resident Review, by incorporating statutory changes, reflecting updates to diagnostic criteria for mental illness and intellectual disability, reducing duplicative requirements and other administrative burdens on State PASRR programs, and making the process more streamlined and person- centered.
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