Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications

Forms and Documents

Document Name	Status
0910-0810 change request Jan 21.docx Justification for No Material/Nonsubstantive Change	2021-01-19
REVISED 18-065CTP 11.1 Appendix III HPJ Questionnaire Clean.docx Supplementary Document	2019-07-09
REVISED 18-065CTP 11.1 Appendix II HPJ Clean.docx Supplementary Document	2019-07-09
OMB Change request Memo.docx Justification for No Material/Nonsubstantive Change	2019-07-09
0810_Gen IC Memo Quantitative data on Tobacco Products and Comminucations.docx Supplementary Document	2018-08-10
0810_Summaries of Generic Submissions 2018.docx Supplementary Document	2018-08-10
Generic Clearance SS B_0810 2018.docx Supporting Statement B	2018-08-10
Generic Clearance SS A_0810 2021 Clean.docx Supporting Statement A	2021-01-19

IC Document Collections

IC ID	Document Title	Status
244562	Monthly Monitoring Study (CTP) Other-Young Adult Consent - LCC	Unchanged
243926	Promising Themes Studies (CTP) Other-Survey	Unchanged
239960	FDA Tobacco Prevention Broad Quantitative Research Package (CTP) Other-Youth Assent Form	Unchanged
235670	Quantitative Study of Tobacco Facts Designed to Inform Youth Tobacco Prevention Messaging Other-Attachment E4 AI-AN Recruitment Ads (Social Media)	Unchanged
235300	Electronic Nicotine Delivery Systems Formative Data Collection to Inform Experimenter and Established User Definitions Other-Study Screener	Unchanged
235192	Hookah Purchase Journey: Online Hookah User Survey Other-Screener	Unchanged

ICR Details

OMB Control No: 0910-0810	ICR Reference No: 202101-0910-013
Status: Received in OIRA	Previous ICR Reference No: 201907-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Generic Clearance for the Collection of Quantitative Data on Tobacco Products and 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: 01/21/2021

	Requested	Previously Approved
Expiration Date	10/31/2021	10/31/2021
Responses	157,500	157,500
Time Burden (Hours)	25,041	19,741
Cost Burden (Dollars)	0	0

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Abstract: The Food and Drug Administration (FDA) is requesting approval of a new generic for collecting information through the use of quantitative methods for studies about tobacco products. FDA will need to employ quantitative research, including surveys and experimental studies to assess knowledge and perceptions about tobacco-related topics with specific target audiences. FDA will only submit an individual generic collection for approval under this generic clearance if the individual collection meets the outlined conditions.

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Authorizing Statute(s): PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
   US Code: 21 USC 372 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 393(d)(2)(D) Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 42 USC 241(a) Name of Law: Public Health Service Act
   US Code: 21 USC 355 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 6190	02/13/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 39449	08/09/2018
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
Electronic Nicotine Delivery Systems Formative Data Collection to Inform Experimenter and Established User Definitions
Quantitative Study of Tobacco Facts Designed to Inform Youth Tobacco Prevention Messaging
Hookah Purchase Journey: Online Hookah User Survey
FDA Tobacco Prevention Broad Quantitative Research Package (CTP)
Monthly Monitoring Study (CTP)
Promising Themes Studies (CTP)

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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	157,500	157,500	0	0	0	0
Annual Time Burden (Hours)	25,041	19,741	0	5,300	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: The Food and Drug Administration is submitting this non-substantive change request to add 5,300 burden hours. The new estimated total is 25,041 hours. FDA will use these hours to seek OMB approval for remaining studies prior to seeking an extension of the umbrella information collection. No other changes are occurring.

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Annual Cost to Federal Government: $525,238

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? 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: 01/21/2021

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