Data to Support Drug Product Communications

Forms and Documents

Forms and supporting documents for this ICR

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

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
264729	Rapid Message Testing CDER Tagline	Other-Recruitment	New
262529	Accelerated Approval Patient Information	Other-Survey Recruitment	New
261635	Dosage Form Presentations in Direct-to-Consumer Prescription Drug Television Advertisements: Semi-Structured Consumer Interviews	Other-Recruit and screener	New
261623	Rapid Message Testing with Consumers Cannabis Consumer Update	Other-Survey Recruitment	New
261229	Drug Disposal Message Communications	Other-Recruitment Screener	New
260667	Rapid Message Testing with Consumers Drug Shortage Infographic	Other-Recruitment	New
260030	Prescription Drug Promotional Landscape Interviews	Other-Interview Guide Consumer	New
259485	Exploring Healthcare Providers' Practices, Perspectives, and Experiences Prescribing and Co-Prescribing Benzodiazepines and Opioid Analgesics: Individual In-Depth Interviews	Other-Screener	New
258911	CDER Rapid Message Testing with Consumers – Prescription Stimulant Diversion Messaging	Other-Screener	New
257985	Focus Groups: Adherence Potential and Patient Preference in Prescription Drug Promotion (CDER)	Other-Screener	New
257170	Rapid Message Testing with Consumers - Interchangeable Biosimilars Information	Other-Screener	New
256912	One-On-One Interviews: Examination of Implied Claims in Direct-To-Consumer Prescription Drug Promotion	Other-Screener	New
256911	Combating the Infodemics Through Evidence-Based Misinformation Management Strategies – Phase I	Other-Recruitment email	New
254967	Exploring Barriers to Buprenorphine Access for Opioid Use Disorder	Other-Consent form	New
254749	Rapid Message Testing with Consumers - Paxlovid Information	Other-Patient eligibility screening checklist	New
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: Historical Active	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
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/05/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/30/2022
Terms of Clearance: Prior terms remain in effect. This generic clearance for FDA/CDER is approved for 3 years under the following conditions: (1) For individual "tests," FDA shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement in the template agreed to by OMB and FDA (including a statement of need, intended use of information, description of respondents, date(s) and location(s), collection procedures, justification for any proposed incentive, etc.); (b) participant screeners, and (c) instruments/moderator guides. (2) OMB will respond with clearance or questions within 10 working days.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2024	03/31/2024	03/31/2024
Responses	43,875	0	43,875
Time Burden (Hours)	9,620	0	9,620
Cost Burden (Dollars)	0	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: 26

table that charts list of burden

IC Title	Form No.	Form Name
Accelerated Approval Patient Information
CDER Rapid Message Testing with Consumers – Prescription Stimulant Diversion Messaging
Combating the Infodemics Through Evidence-Based Misinformation Management Strategies – Phase I
Dosage Form Presentations in Direct-to-Consumer Prescription Drug Television Advertisements: Semi-Structured Consumer Interviews
Drug Disposal Message Communications
Exploring Barriers to Buprenorphine Access for Opioid Use Disorder
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 Opioid Analgesics: Individual In-Depth Interviews
Exploring Healthcare Providers' Practices, Perspectives, and Experiences Prescribing and Co-Prescribing Benzodiazepines and Opioids (CDER)
Focus Groups: Adherence Potential and Patient Preference in Prescription Drug Promotion (CDER)
Formative Research Study to Understand the Impact of Generic Substitutes for Various Patient and Caregiver Populations
One-On-One Interviews: Examination of Implied Claims in Direct-To-Consumer Prescription Drug Promotion
One-on-One Interviews: Tradeoff Analysis of Risk, Benefit, and Adherence Claims in Direct to Consumer and HCP Promotion (CDER)
Prescription Drug Promotional Landscape Interviews
Prescription Drug Use Related Software Study (CDER)
Rapid Message Testing CDER Tagline
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 - Interchangeable Biosimilars Information
Rapid Message Testing with Consumers - Paxlovid Information
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 Cannabis Consumer Update
Rapid Message Testing with Consumers Drug Shortage Infographic
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

table that charts list of burden

	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	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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