Department of Health and Human Services August 30, 2018 – Federal Register Recent Federal Regulation Documents

This document announces a public hearing to receive information and comments regarding the notice of proposed rulemaking (NPRM) titled ``National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table.''

The sixth iteration of the Prescription Drug User Fee Act (PDUFA VI), incorporated as part of the FDA Reauthorization Act of 2017 (FDARA), highlights the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. The Food and Drug Administration (FDA or Agency) is announcing a pilot meeting program that affords sponsors who are selected the opportunity to meet with Agency staff to discuss the use of complex innovative trial design (CID) approaches in medical product development. Meetings under the pilot program will be conducted by FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) during fiscal years 2018 to 2022. This pilot meeting program fulfills FDA's commitment under PDUFA VI. For each sponsor whose meeting request is granted as part of the pilot, FDA will grant two meetings between the sponsor and CDER or CBER that will provide an opportunity for medical product developers and FDA to discuss regulatory approaches for CID. To promote innovation in this area, trial designs developed through the pilot meeting program may be presented by FDA (e.g., in a guidance or public workshop) as case studies, including trial designs for drugs that have not yet been approved by FDA.

This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is by webcast only and is open to the public. Registration is requested for oral comment and is required to access the webcast. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.