Regulations.gov document

Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional…

Other · FDA-2022-D-0142 · posted Mar 31, 2023

Key facts

Document ID FDA-2022-D-0142-0002
Title Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections, Guidance for Institutional Review Boards, Investigators, and Sponsors; Draft Guidance for Industry; Availability
Document type Other
Subtype Guidance
Agency FDA
Docket FDA-2022-D-0142
Posted Mar 31, 2023
Comment period opens Mar 31, 2023
Comments due May 31, 2023

At a glance

  • No Open for comment
  • 1–9 Public comments on this docket

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Regulations.gov documents

Regulations.gov holds the rulemaking and other documents federal agencies post for public comment. Only agency documents are published here; public submissions are not.

Source: Regulations.gov (U.S. General Services Administration eRulemaking Program) · Source date:

Browse all Regulations.gov documents