Data to Support Drug Product Communications

Forms and Documents

Document Name	Status
0695 83-C July 2022.docx Justification for No Material/Nonsubstantive Change	2022-06-30
0695 OMB Memo Template.docx Supplementary Document	2021-01-25
0695 Part B Supporting Statement 2021.docx Supporting Statement B	2021-01-25
0695 Part A Supporting Statement 2021.docx Supporting Statement A	2021-01-25

IC Document Collections

IC ID	Document Title	Status
252953	Rapid Message Testing with Consumers - Terminology Routinely Used in CDER Communications Other-Screener	Unchanged
252505	Formative Research Study to Understand the Impact of Generic Substitutes for Various Patient and Caregiver Populations Other-Sample Recruitment Media Advertisement Language	Unchanged
252325	Exploring Healthcare Providers' Practices, Perspectives, and Experiences Prescribing and Co-Prescribing Benzodiazepines and Opioid Analgesics Other-Focus Group Screener	Unchanged
250778	Prescription Drug Use Related Software Study (CDER) Other-Screeners	Unchanged
249548	Rapid Message Testing with Consumers - Terminology Routinely Used in CDER Communications Other-Interview Guide	Unchanged
249440	Exploring Healthcare Providers' Practices, Perspectives, and Experiences Prescribing and Co-Prescribing Benzodiazepines and Opioids (CDER) Other-Focus Group Screener	Unchanged
248298	One-on-One Interviews: Tradeoff Analysis of Risk, Benefit, and Adherence Claims in Direct to Consumer and HCP Promotion (CDER) Other-Screener	Unchanged
247939	Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient and Caregiver Interviews (CDER) Other-Advance Email	Unchanged
247710	Rapid Message Testing with Consumers and Healthcare Professionals - Children's Cough and Cold Consumer Update (CDER) Other-Screener	Unchanged
246610	Rapid Message Testing with Consumer Panel - Drug Safety Communication Landing Page and Format (CDER) Other-Screener	Unchanged
246208	Rapid Message Testing with Consumer Panel - Additional Testing of Drug Safety Communications About Misuse and Abuse of Over-the-Counter Medications (CDER) Other-Interview Guide	Unchanged

ICR Details

OMB Control No: 0910-0695	ICR Reference No: 202206-0910-015
Status: Received in OIRA	Previous ICR Reference No: 202101-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Data to Support Drug Product Communications
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/30/2022

	Requested	Previously Approved
Expiration Date	03/31/2024	03/31/2024
Responses	43,875	43,875
Time Burden (Hours)	9,620	9,620
Cost Burden (Dollars)	0	0

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Abstract: Testing of communication messages in advance of a communication campaign provides an important role in improving FDA communications as they allow for an in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings. The methods to be employed include individual in-depth interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and professional clinician focus group interviews. FDA will use these methods to test and refine its ideas and to help develop messages and other communications but will generally conduct further research before making important decisions, such as adopting new policies and allocating or redirecting significant resources to support these policies.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	85 FR 36591	06/17/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 5219	01/19/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Exploring Healthcare Providers' Practices, Perspectives, and Experiences Prescribing and Co-Prescribing Benzodiazepines and Opioid Analgesics
Exploring Healthcare Providers' Practices, Perspectives, and Experiences Prescribing and Co-Prescribing Benzodiazepines and Opioids (CDER)
Formative Research Study to Understand the Impact of Generic Substitutes for Various Patient and Caregiver Populations
One-on-One Interviews: Tradeoff Analysis of Risk, Benefit, and Adherence Claims in Direct to Consumer and HCP Promotion (CDER)
Prescription Drug Use Related Software Study (CDER)
Rapid Message Testing with Consumer Panel - Additional Testing of Drug Safety Communications About Misuse and Abuse of Over-the-Counter Medications (CDER)
Rapid Message Testing with Consumer Panel - Drug Safety Communication Landing Page and Format (CDER)
Rapid Message Testing with Consumers - Terminology Routinely Used in CDER Communications
Rapid Message Testing with Consumers - Terminology Routinely Used in CDER Communications
Rapid Message Testing with Consumers and Healthcare Professionals - Children's Cough and Cold Consumer Update (CDER)
Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient and Caregiver Interviews (CDER)

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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	43,875	43,875	0	0	0	0
Annual Time Burden (Hours)	9,620	9,620	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $2,209,708

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: 06/30/2022

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