Generic Clearance for Quick Turnaround Testing of Communication Effectiveness

Forms and Documents

Document Name	Status
Supporting Statement Part B Quick Turnaround Testing Communciation Effecttiveness 2019.docx Supporting Statement B	2019-08-14
Supporting Statement Part A Quick Turnaround Testing Comm 2019.docx Supporting Statement A	2019-08-14

IC Document Collections

IC ID	Document Title	Status
237304	Focus Group/Small Group Discussion Other-Template	New
237303	Focus Group/Small Group Participant Screening Other-Template	New
237302	Focus Group/Small Group, Cognitive Groups Other-Template	New
237301	Focus Group/Small Group, Cognitive Groups Screener Other-Template	New
237300	Self-Administered Surveys Other-Template	New
237299	Self-Administered Surveys - Study Screener Other-Template	New
237298	Pretest Survey Other-Template	New
237297	Pretest Survey Screener Other-Template	New
237296	Survey Cognitive Interviews Other-Template	New
237295	Survey Cognitive Interviews Screener Other-Template	New
237294	In-Depth Interviews Other-Template	New
237293	In-Depth Interviews Screener Other-Template	New
237292	In-Depth Interviews, Cognitive Interviews Other-Template	New
237291	In-Depth Interviews, Cognitive Interviews Screener Other-Template	New

ICR Details

OMB Control No: 0910-0876	ICR Reference No: 201908-0910-004
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/10/2019
	Date Received in OIRA: 08/16/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2022	36 Months From Approved
Responses	93,288	0	0
Time Burden (Hours)	10,881	0	0
Cost Burden (Dollars)	529,699	0	0

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Abstract: This information collection request supports the creation of an information collection for the development of a “Generic Clearance for Quick Turnaround Testing of Communication Effectiveness.” Section 1003(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)) of the Federal Food, Drug, and Cosmetic Act authorizes the FDA to conduct food research and educational and public information programs relating to the safety of the nation’s food supply. The generic studies covered by this request will be used to test FDA communications and educational messages related to FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed when there is a need for a quick OMB clearance turnaround during matters requiring urgent public health communications. Collecting information from consumers and other stakeholders during urgent public health matters will help ensure that FDA’s messaging has reached the target audience and has been understood. Data will be collected using self-report web-based surveys, focus groups, and one-on-one in-depth interviews.

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Authorizing Statute(s): US Code: 21 USC 393(d)(2) Name of Law: FD&C 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:
	84 FR 12617	04/02/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 35392	07/23/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 14

IC Title	Form No.	Form Name
Pretest Survey Screener
In-Depth Interviews, Cognitive Interviews Screener
Survey Cognitive Interviews
Survey Cognitive Interviews Screener
Focus Group/Small Group, Cognitive Groups
Focus Group/Small Group Discussion
Pretest Survey
Self-Administered Surveys - Study Screener
In-Depth Interviews Screener
In-Depth Interviews
Focus Group/Small Group, Cognitive Groups Screener
Focus Group/Small Group Participant Screening
Self-Administered Surveys
In-Depth Interviews, Cognitive Interviews

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ICR Summary 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	93,288	0	0	93,288	0	0
Annual Time Burden (Hours)	10,881	0	0	10,881	0	0
Annual Cost Burden (Dollars)	529,699	0	0	529,699	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new collection of information.

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Annual Cost to Federal Government: $949,610

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? Uncollected

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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: 08/16/2019

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