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Federal forms, ICRs, and supporting documents

OMB control number

Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites

OMB 0910-0872 · HHS/FDA.

OMB 0910-0872

This study will examine the effect of the presence, language, and prominence of a disclosure communicating information related to a prescription drug’s accelerated approval in direct-to-consumer promotional materials. We plan to conduct one pretest (N = 385) and one main study (N = 633) not longer than 20 minutes, administered via Internet panel. We will vary the presence and prominence of the disclosure (e.g., varying the presence, size, color, and location of the disclosure) on a website for a fictitious prescription drug. Participants will view the website and then answer questions about the drug information, including the disclosure.

The latest form for Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites expires 2020-06-30 and is listed under ICR 201908-0910-019.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
0872 NonSub Change Request 2022.docx Justification for No Material/Nonsubstantive Change
0872 NonSub Change Request 2022.docx Justification for No Material/Nonsubstantive Change
CDER NEW Accelerated Approval Study II APRIL 2022 SSB.docxSupporting Statement B
CDER NEW Accelerated Approval Study II APRIL 2022 SSB.docxSupporting Statement B
CDER NEW Accelerated Approval Study II APRIL 2022 SSA.docxSupporting Statement A
CDER NEW Accelerated Approval Study II APRIL 2022 SSA.docxSupporting Statement A
Study Instruments: Consent; Pre- and Main Test; Questionnaire; Recruitment e-mail Other-Study Collection Instruments

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202211-0910-004 No material or nonsubstantive change to a currently approved collection 2022-11-22 Approved without change
202204-0910-010 Reinstatement with change of a previously approved collection 2022-04-08 Approved without change
201908-0910-019 No material or nonsubstantive change to a currently approved collection 2019-09-12 Approved without change
201905-0910-001 New collection (Request for a new OMB Control Number) 2019-05-09 Approved with change

OMB Details

Pretesting Screener

Federal Enterprise Architecture: Health - Consumer Health and Safety