Prescription Drug Advertisements and Product Communications

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
263161	Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format	Unchanged
232749	IC recommended in FDA guidance Other-Agency Guidance	Modified
196331	Prescription Drug Advertisements 3rd Party Disclosure	Unchanged
196327	Prescription Drug Advertisements Reporting	Unchanged

ICR Details

OMB Control No: 0910-0686	ICR Reference No: 202501-0910-004
Status: Received in OIRA	Previous ICR Reference No: 202406-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Prescription Drug Advertisements and Product Communications
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/07/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	11/30/2026
Responses	204,599	240,444
Time Burden (Hours)	29,832,614	30,363,915
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports implementation of statutory and regulatory requirements that govern prescription drug advertisements.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: FFDCA
  

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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 73031	10/24/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 1046	01/07/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
IC recommended in FDA guidance
Prescription Drug Advertisements 3rd Party Disclosure
Prescription Drug Advertisements Reporting
Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format

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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	204,599	240,444	0	-35,845	0	0
Annual Time Burden (Hours)	29,832,614	30,363,915	0	-531,301	0	0
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The information collection includes a program change pertaining to disclosure burden we attribute to agency guidance. Although we have included the disclosure activities within the collection element “IC recommended in FDA guidance” and accounted for attendant burden; we reduced the overall number of respondents from 1181 to 747 based on current information. This results in an overall decrease of 35,845 responses and 531,301 hours annually.

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Annual Cost to Federal Government: $5,600,000

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 01/07/2025

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