Investigation of Consumer Perceptions of Expressed Modified Risk Claims

Forms and Documents

Document Name	Status
IRB Approval letter.pdf Supplementary Document	2018-10-30
Investigation of Consumer Perceptions of Expressed Modified Risk Claims PIA.pdf Supplementary Document	2018-10-30
Supporting Statement_Part B_OMB.docx Supporting Statement B	2019-06-14
Supporting Statement_Part A.docx Supporting Statement A	2019-06-14

IC Document Collections

IC ID	Document Title	Status
233740	Study: Adults (Ages 26+) Other-Advertisement Images	New
233739	Study: Young Adults (Ages 18-25) Other-Advertisement Images	New
233738	Consent and Screener: Adults (Ages 26+) Other-Expressed Claims Screener	New
233737	Consent and Screener: Young Adults (Ages 18-25) Other-Expressed Claims Screener	New
233736	Invitation: Adults (Ages 26+) Other-Expressed Claims Study Invitation	New
233735	Invitation: Young Adults (Ages 18-25) Other-Expressed Claims Study Invitation	New

ICR Details

OMB Control No: 0910-0873	ICR Reference No: 201810-0910-014
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Investigation of Consumer Perceptions of Expressed Modified Risk Claims
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 with change	Conclusion Date: 06/27/2019
	Date Received in OIRA: 10/30/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2022	36 Months From Approved
Responses	92,100	0	0
Time Burden (Hours)	6,088	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The study is designed to evaluate and report on two expressed modified risk tobacco product (MRTP) claims for two tobacco product types (e-cigarettes and snuff) among young adult and adult tobacco users and non-users.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 2 Name of Law: The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act
   US Code: 21 USC 387 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:
	83 FR 23464	05/21/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 54356	10/29/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Invitation: Young Adults (Ages 18-25)
Invitation: Adults (Ages 26+)
Consent and Screener: Young Adults (Ages 18-25)
Consent and Screener: Adults (Ages 26+)
Study: Young Adults (Ages 18-25)
Study: Adults (Ages 26+)

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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	92,100	0	0	0	92,100	0
Annual Time Burden (Hours)	6,088	0	0	0	6,088	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: New collection

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Annual Cost to Federal Government: $353,445

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.     Yes

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: 10/30/2018

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