Department of Health and Human Services April 11, 2018 – Federal Register Recent Federal Regulation Documents

This is a correction to the meeting announcement of the Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee published on the Federal Register, Vol. 83, No. 66/Thursday, April 5, 2018/Notices. FR Doc. 2018-06913. The notice of the meeting should have included the following statement: Members of the public can attend the meeting via telephone or webcast only, and not in person. The Secretary of Health and Human Services (Secretary), in accordance with section 6031 of the 21st Century Cures Act, announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting is open to the public and will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED), including data evaluation, and recommendations for action. Committee members will also discuss ISMICC member relationship to implementation workgroups, establishing the prevalence of SMI and SED, communication with non-federal organizations to engage non-federal support for ISMICC, and future meetings. Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee.

The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore encourages nominations of appropriately qualified candidates from these groups.

In accordance with the court order on July 19, 2016 (Kort v. Burwell), this notice provides further explanation on the National Coverage Determinations for positron emission tomography (PET) neuroimaging for dementia.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population'' (E11(R1) addendum or addendum). The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance is an addendum to the guidance published in 2000 entitled ``E11 Clinical Investigation of Medicinal Products in the Pediatric Population'' (ICH E11 (2000)), and provides updates to the original guidance. This addendum does not alter the scope of the original guidance, which outlines an approach to the safe, efficient, and ethical study of medicinal products in the pediatric population. This addendum complements and provides clarification and current regulatory perspective on topics in pediatric drug development. The guidance is intended to provide high-level guidance on the implementation of important approaches in pediatric drug development. This harmonized addendum will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions for the acceptance of data generated in pediatric global drug development programs and ensure timely access to medicines for children.