Department of Health and Human Services March 10, 2020 – Federal Register Recent Federal Regulation Documents
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Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control.'' This draft guidance replaces the guidance for industry entitled ``Diabetes MellitusEvaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes'' and the draft guidance for industry ``Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention,'' both of which are being withdrawn. This draft guidance outlines the Agency's current recommendations on the evaluation of safety for new drugs and biologics to improve glycemic control in patients with type 2 diabetes. Publication of this guidance is intended to provide clarity on the expectations for the development of drugs and biologics to improve glycemic control and to serve as a focus for commentary and feedback.
Fiscal Year 2020 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FY 2020 Generic Drug Regulatory Science Initiatives.'' The purpose of the public workshop is to provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholdersindustry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2021 regulatory science initiatives.
Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period only for the agency information collection activity associated with proposed rulemaking entitled ``Premarket Tobacco Product Applications and Recordkeeping Requirements,'' which appeared in the Federal Register of September 25, 2019. FDA is not reopening the comment period associated with any other aspects of the proposed rulemaking. The Agency is taking this action to seek comment on an additional proposed form to collect information that would be required under certain provisions of the proposed rule. This proposed form would allow for easier identification of each new tobacco product contained in a grouped submission of premarket tobacco product applications (PMTAs). FDA is reopening the comment period only on the proposed agency information collection activity to allow interested persons additional time to submit comments on this form.
Emergency Use Declaration
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On February 4, 2020, the Secretary determined, pursuant to his authority under section 564 of the FD&C Act, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
Submission for OMB Review; Survey of Youth Transitioning From Foster Care (New Collection)
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect data on human trafficking and other victimization experiences among youth recently or currently involved in the child welfare system. The goal of the one-time survey is to better understand trafficking experiences; to identify modifiable risk and protective factors associated with trafficking victimization; and to inform child welfare policy, programs, and practice.
Advisory Committee; Gastrointestinal Drugs Advisory Committee, Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Gastrointestinal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Gastrointestinal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 3, 2022.
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