Department of Health and Human Services September 30, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Vaccines and Related Biological Products Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This meeting was announced in the Federal Register of August 28, 2020. The amendment is being made to reflect changes in the ADDRESSES portion of the document.
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic PotentialQuestions and Answers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance contains revised questions and answers (Q&As) for the ICH guidance for industry ``E14 Clinical Evaluation of the QT/ QTc Interval Prolongation and Proarrhythmic Potential for Non- Antiarrhythmic Drugs'' and new Q&As for the ICH guidance for industry ``S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals'' that provide recommendations on considerations for an integrated risk assessment combining nonclinical and clinical datain particular, at later stages of drug development when clinical data are available. The draft guidance is intended to provide a harmonized approach to integrate nonclinical and clinical information for proarrhythmia risk assessment to streamline drug development and provide clarity on regulatory decision making.
Patient-Focused Drug Development for Stimulant Use Disorder; Public Meeting; Request for Comments
In the Federal Register notice published on March 19, 2020, the Food and Drug Administration (FDA, the Agency, or we) announced the cancellation of the meeting entitled ``Patient-Focused Drug Development for Stimulant Use Disorder'' originally scheduled to occur on March 10, 2020, as announced in the Federal Register on February 18, 2020. FDA is announcing a new date for the meeting, to occur in a virtual format. The purpose of the public meeting is to allow FDA to obtain stakeholder perspectives on the impact of stimulant use disorder and views on treatment approaches for stimulant use disorder.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Strengthening U.S. Response to Resistant Gonorrhea, which is to intended to enhance U.S. state and local public health surveillance and program infrastructure, build capacity to support rapid detection and public health response to antibiotic-resistant gonorrhea (an urgent public health threat), and advance the understanding of epidemiological factors contributing to antibiotic-resistant gonorrhea. CDC is requesting a three-year approval.
Availability of Draft Toxicological Profile for Ethylene Oxide
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on the Draft Toxicological Profile for Ethylene Oxide.
Submission for OMB Review; National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (NAC) Recommendations and State Self-Assessment Survey (NEW)
The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new survey, the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (NAC) Recommendations and State Self- Assessment Survey.
Notice To Announce Supplemental Awards To Support Training and Technical Assistance To Address Intimate Partner Violence
HRSA provided supplemental funding to two current National Training and Technical Assistance Partners award recipients to advance HRSA's Strategy to Address Intimate Partner Violence by expanding critical training and technical assistance (T/TA) to health centers.
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