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

ICR 202002-0910-001

OMB: 0910-0796

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2020-02-06
Supporting Statement B
2018-07-31
Supporting Statement A
2018-07-31
Supplementary Document
2018-05-16
ICR Details
0910-0796 202002-0910-001
Historical Active 201805-0910-001
HHS/FDA CTP
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 02/13/2020
Retrieve Notice of Action (NOA) 02/06/2020
FDA will submit a mini-supporting statement for each individual Gen IC submission. The mini-supporting statement must describe the specific purpose of the collection, including the way that the resulting data will be used (i.e., identify the activity that the developmental work will inform, and broader purpose of the activity that is being informed by the developmental work being conducted in the particular Gen IC). When incentives are used, FDA will provide a justification.
  Inventory as of this Action Requested Previously Approved
07/31/2021 07/31/2021 07/31/2021
11,589 0 11,589
9,293 0 9,293
0 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 393 Name of Law: FFDCA
   US Code: 21 USC 355 Name of Law: Family Smoking Prevention And Tobacco Control Act
  
None

Not associated with rulemaking

  82 FR 54351 11/17/2017
83 FR 22690 05/16/2018
Yes

  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 11,589 11,589 0 0 0 0
Annual Time Burden (Hours) 9,293 9,293 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
FDA has updated the existing burden from 6,184 to an estimated 9,293 hours. This is based on our experience the last three years and forecasting the generics to be submitted during the next approval. Additionally, we have also updated the cost burden estimate and the cost to the Federal government based on current salary figures. FDA is also noting that the burden figures in ROCIS (24,050 responses and 29,059 hours) are incorrect. An error was made after approval and the updated burden was not entered into ROCIS. The burden should have been updated to 14,800 responses and 6,184 hours.

$1,026,460
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  No

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.
02/06/2020


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