Information Collection Request
Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites
ICR 202211-0910-004 · OMB 0910-0872 · Active
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 0872 NonSub Change Request 2022.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2022-11-15 | Available |
| 0872 NonSub Change Request 2022.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2022-11-15 | Repair queued |
| CDER NEW Accelerated Approval Study II APRIL 2022 SSB.docx |
Supporting Statement B | Uploaded 2022-04-07 | Available |
| CDER NEW Accelerated Approval Study II APRIL 2022 SSB.docx |
Supporting Statement B | Uploaded 2022-04-07 | Missing upstream |
| CDER NEW Accelerated Approval Study II APRIL 2022 SSA.docx |
Supporting Statement A | Uploaded 2022-04-07 | Available |
| CDER NEW Accelerated Approval Study II APRIL 2022 SSA.docx |
Supporting Statement A | Uploaded 2022-04-07 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 236001 |  Study Instruments: Consent; Pre- and Main Test; Questionnaire; Recruitment e-mail |
Other-Study Collection Instruments | Modified |
ICR Details
| Status | Active |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0872 |
| Type of Information Collection | No material or nonsubstantive change to a currently approved collection |
| Previous ICR Reference No | 202204-0910-010 |
| Agency Tracking No | CDER/OPDP |
| Date Submitted to OIRA | 2022-11-22 |
| Requested Expiration Date | 1969-12-31 |