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

Forms and Documents

Document Name	Status
CDER NEW Accelerated Approval Study II APRIL 2022 SSB.docx Supporting Statement B	2022-04-07
CDER NEW Accelerated Approval Study II APRIL 2022 SSA.docx Supporting Statement A	2022-04-07

IC Document Collections

IC ID	Document Title	Status
236002	Main Study Other-Consent Form	Removed
236001	Study Instruments: Consent; Pre- and Main Test; Questionnaire; Recruitment e-mail Other-Study Collection Instruments	Modified
236000	Study Screener Other-Screener	Removed
235999	Pretesting Screener Other-Screener	Removed

ICR Details

OMB Control No: 0910-0872	ICR Reference No: 202204-0910-010
Status: Received in OIRA	Previous ICR Reference No: 201908-0910-019
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER/OPDP
Title: Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/08/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	25,410	0
Time Burden (Hours)	2,335	0
Cost Burden (Dollars)	0	0

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Abstract: The study will examine the effect of a disclosure communicating information related to a prescription drug’s accelerated approval in direct-to-consumer promotional materials. Participants will view a website for a fictitious oncology prescription drug and answer questions about it.

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Authorizing Statute(s): US Code: 21 USC 393(d)(2)(C) Name of Law: FDA; General Powers; Research relating to food and drugs.
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 31323	06/11/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 16743	03/24/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Main Study
Pretesting Screener
Study Instruments: Consent; Pre- and Main Test; Questionnaire; Recruitment e-mail
Study Screener

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ICR Summary of Burden

	Total Request	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	25,410	0	0	0	22,354	3,056
Annual Time Burden (Hours)	2,335	0	0	0	1,932	403
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Although the proposed study does not duplicate, it builds upon previous research conducted under this control number and we are therefore submitting our request as a reinstatement with change. We explain this more fully in our justification at Question 1 of our Supporting Statement Part A.

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Annual Cost to Federal Government: $270,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 04/08/2022

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