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

ICR 202105-0910-001

OMB: 0910-0796

Federal Form Document

IC Document Collections
ICR Details
0910-0796 202105-0910-001
Received in OIRA 202007-0910-005
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
Extension without change of a currently approved collection   No
Regular 06/16/2021
  Requested Previously Approved
36 Months From Approved 07/31/2021
28,174 11,589
14,934 9,293
0 0

The Food and Drug Administration (FDA) is requesting approval of a new generic for collecting information through the use of qualitative methods for studies about tobacco products. FDA will employ qualitative research, including individual in-depth interviews (IDIs), small group discussions, and focus groups to explore 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.

US Code: 21 USC 355 Name of Law: Family Smoking Prevention And Tobacco Control Act
   US Code: 21 USC 393 Name of Law: FFDCA

Not associated with rulemaking

  85 FR 60999 09/29/2020
86 FR 31328 06/11/2021


  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 28,174 11,589 0 16,585 0 0
Annual Time Burden (Hours) 14,934 9,293 0 5,641 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
Our estimated burden for the information collection reflects an overall increase of 5,641 hours and a corresponding increase of 16,585 responses The burden is now estimated to be 14,934 hours.

Yes Part B of Supporting Statement
Ila Mizrachi 301 796-7726 [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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