Regulations.gov document
Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional…
Notice · FDA-2022-D-0142 · posted Mar 31, 2023
Key facts
| Document ID | FDA-2022-D-0142-0001 |
|---|---|
| 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and Office for Human Research Protections, Guidance for Institutional Review Boards, Investigators, and Sponsors; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-2022-D-0142 |
| Posted | Mar 31, 2023 |
| Federal Register citation | 88 FR 19310 |
| FR document number | 2023-06649 |
| Comment period opens | Mar 31, 2023 |
| Effective date | Mar 31, 2023 |
At a glance
- 1–9 Pages
- 1–9 Public comments on this docket
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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