Figure 1

Process for OHRP-FDA joint review of "407" referral (under 45CFR 46.407/21CFR50.54). A referral involving an FDA-regulated product is submitted to OHRP, which convenes a 407 panel, meanwhile posting the submission for public comment. The Pediatric Ethics Subcommittee of the FDA Pediatric Advisory Committee reviews the submission and, in a public forum, makes a recommendation to the FDA Pediatrics Advisory Committee. The recommendation of the latter is forwarded to the FDA Commissioner and OHRP, which submit their recommendation to the Secretary, HHS for approval (1), who then (2) directs OHRP to provide feedback (3) to the IRB. If OHRP feedback involves stipulations, the IRB responds directly to OHRP.