Disclosures of Descriptive Presentation in Professional Oncology Prescription Drug Promotion

ICR 201809-0910-003

OMB: 0910-0864

Federal Form Document

Forms and Documents
Supporting Statement B
Supporting Statement A
ICR Details
0910-0864 201809-0910-003
Disclosures of Descriptive Presentation in Professional Oncology Prescription Drug Promotion
New collection (Request for a new OMB Control Number)   No
Approved with change 12/19/2018
Retrieve Notice of Action (NOA) 11/15/2018
Any modifications to the main study as a result of pretesting should be submitted as a change request prior to fielding the main study.
  Inventory as of this Action Requested Previously Approved
12/31/2021 36 Months From Approved
5,880 0 0
839 0 0
0 0 0

As a part of the ongoing evaluation of FDA's regulations in this area, FDA is proposing to study the impact of disclosures as they relate to presentations of preliminary and/or descriptive scientific and clinical data in promotional labeling and advertising for oncology products. The use of disclosures is one method of communicating information to health care professionals about scientific and clinical data, the limitations of that data, and practical utility of that information for use in treatment. These disclosures may influence prescriber comprehension and decision making, and may affect how and what treatment they prescribe for their patients. To address these questions, FDA has designed a study that will be conducted in three independent phases, each phase examining a data display in a promotional piece for a unique oncology or hematology product. Independent variables will include: (1) Specific disclosure (technical, non-technical, none), (2) general statement (present, absent), and (3) specialty (PCPs, oncologists). Outcome (dependent) variables will focus on the assessment of the data display as a whole as well as attention to the disclosure, if present.


Not associated with rulemaking

  82 FR 27845 06/19/2017
83 FR 56845 11/14/2018

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 5,880 0 0 5,880 0 0
Annual Time Burden (Hours) 839 0 0 839 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
This is a new data collection.

Yes Part B of Supporting Statement
Ila Mizrachi 301 796-7726 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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