Department of Health and Human Services September 26, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Providing Regulatory Submissions for Medical Devices in Electronic FormatSubmissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.'' Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the FDA Reauthorization Act of 2017 (FDARA) require that certain presubmissions and submissions for devices be submitted in electronic format specified by FDA beginning on such date as specified in final guidance. It also mandates that FDA issue draft guidance not later than October 1, 2019, providing for further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements. In addition, in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter from the Secretary of Health and Human Services to Congress, FDA committed to developing electronic submission templates and issuing a draft guidance on the topic. This guidance is intended to satisfy the draft guidance documents referenced in FDA regulations and the MDUFA IV Commitment Letter. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing a public meeting entitled ``International Council on Harmonisation (ICH) Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials.'' The purpose of the public meeting is to provide information on the draft revised E8(R1) Guideline ``General Considerations for Clinical Trials'' (ICH E8 Guideline) following the closing of the FDA comment period and closing of the regional consultations conducted in other ICH regions. The ICH E8 Guideline is being revised to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources being employed to support regulatory and other health policy decisions, while retaining the underlying principles of human subject protection and data quality.

The Food and Drug Administration is correcting a document entitled ``Modified Risk Tobacco Product Applications for VLN\TM\ King and VLN\TM\ Menthol King, Combusted, Filtered Cigarettes, Submitted by 22nd Century Group, Inc.'' that published in the Federal Register of July 25, 2019. The document announced the availability of modified risk tobacco product applications for public comment. The document published with incorrect submission tracking numbers. This document corrects that error.