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

ICR 202101-0910-013

OMB: 0910-0810

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2021-01-19
Supplementary Document
2019-07-09
Supplementary Document
2019-07-09
Justification for No Material/Nonsubstantive Change
2019-07-09
Supplementary Document
2018-08-10
Supplementary Document
2018-08-10
Supporting Statement B
2018-08-10
Supporting Statement A
2021-01-19
ICR Details
0910-0810 202101-0910-013
Received in OIRA 201907-0910-006
HHS/FDA CTP
Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
No material or nonsubstantive change to a currently approved collection   No
Regular 01/21/2021
  Requested Previously Approved
10/31/2021 10/31/2021
157,500 157,500
25,041 19,741
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
  
None

Not associated with rulemaking

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

  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
Yes
Miscellaneous Actions
No
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.

$525,238
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

  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.
01/21/2021


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