Data to Support Drug Product Communications

ICR 202101-0910-007

OMB: 0910-0695

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2021-01-25
Supporting Statement B
2021-01-25
Supporting Statement A
2021-01-25
ICR Details
0910-0695 202101-0910-007
Received in OIRA 201712-0910-001
HHS/FDA CDER
Data to Support Drug Product Communications
Extension without change of a currently approved collection   No
Regular 02/02/2021
  Requested Previously Approved
36 Months From Approved 02/28/2021
43,875 43,875
9,620 9,620
0 0

Testing of communication messages in advance of a communication campaign provides an important role in improving FDA communications as they allow for an in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings. The methods to be employed include individual in-depth interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and professional clinician focus group interviews. FDA will use these methods to test and refine its ideas and to help develop messages and other communications but will generally conduct further research before making important decisions, such as adopting new policies and allocating or redirecting significant resources to support these policies.

US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  85 FR 36591 06/17/2020
86 FR 5219 01/19/2021
No

0

  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 43,875 43,875 0 0 0 0
Annual Time Burden (Hours) 9,620 9,620 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$2,209,708
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
02/02/2021


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