Information Collection Request

Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials

ICR 202109-0910-005 · OMB 0910-0902 · Received in OIRA

Forms and Documents

Document Name	Status
Supporting Statement Part B - Secondary Claim Disclosures and Biosimilar Disclosures 2021.docx Supporting Statement B	2021-09-15
Supporting Statement Part A - Secondary Claim Disclosures and Biosimilar Disclosures 2021.docx Supporting Statement A	2021-09-15

IC Document Collections

IC ID	Document Title	Status
249302	Phase 2 Main Study Completes (Consumers) Other-Informed Consent	New
249301	Phase 2 - Main Study Completes (HCPs) Other-Informed Consent	New
249300	Phase 2 - Main Study Screeners (Consumers) Other-Recruitment Email and Screeners	New
249299	Phase 2 - Main Study Screener (HCPs) Other-Recruitment Email and Screeners	New
249298	Phase 1 - Main Study Completes (Consumers) Other-Informed Consent	New
249297	Phase 1 - Main Study Completes (HCPs) Other-Informed Consent	New
249296	Phase 1 - Main Study Screeners (Consumers) Other-Recruitment Email and Screeners	New
249295	Phase 1 - Main Study Screeners (HCPs) Other-Recruitment Email and Screeners	New
249294	Phase 2 - Pretest Completes (Consumers) Other-Informed Consent	New
249293	Phase 2 - Pretest Completes (HCPs) Other-Informed Consent	New
249292	Phase 2 - Pretest Screeners (Consumers) Other-Recruitment Email and Screeners	New
249291	Phase 2 Pretest Screeners (HCPs) Other-Recruitment Email and Screeners	New
249290	Phase 1 - Pretest Completes (Consumers) Other-Informed Consent	New
249289	Phase 1 - Pretest Completes (HCPs) Other-Informed Consent	New
249288	Phase 1 - Pretest Screeners (Consumers) Other-Recruitment Email and Screener 1 and 2	New
249286	Phase 1 - Pretest Screener (HCPs) Other-Recruitment Email and Screeners 1 and 2	New

ICR Details

Status	Received in OIRA
Agency/Subagency	HHS/FDA
OMB Control No	0910-0902
Type of Information Collection	New collection (Request for a new OMB Control Number)
Agency Tracking No	CDER
Date Submitted to OIRA	1969-12-31
Requested Expiration Date	1969-12-31