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

ICR 201907-0910-006

OMB: 0910-0810

Federal Form Document

Forms and Documents
Supplementary Document
Supplementary Document
Justification for No Material/Nonsubstantive Change
Supplementary Document
Supplementary Document
Supporting Statement B
Supporting Statement A
ICR Details
0910-0810 201907-0910-006
Active 201901-0910-002
Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
No material or nonsubstantive change to a currently approved collection   No
Approved without change 07/11/2019
Retrieve Notice of Action (NOA) 07/09/2019
  Inventory as of this Action Requested Previously Approved
10/31/2021 10/31/2021 10/31/2021
157,500 0 157,500
19,741 0 19,741
0 0 0

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.

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

Not associated with rulemaking

  83 FR 6190 02/13/2018
83 FR 39449 08/09/2018

  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 157,500 157,500 0 0 0 0
Annual Time Burden (Hours) 19,741 19,741 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
The burden for this information collection is proposed to increase by 10,311 hours from the current inventory. The burden increase is result of including screeners as a method of collection, an increase in the number of respondents and the categories of respondents.

Yes Part B of Supporting Statement
Amber Sanford 301 796-8867 [email protected]


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:
    (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;
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.

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