Data to Support Communications Usability Testing, as Used by the Food and Drug Administration

ICR 201108-0910-009

OMB: 0910-0712

Federal Form Document

Forms and Documents
Supporting Statement B
Supporting Statement A
IC Document Collections
ICR Details
0910-0712 201108-0910-009
Historical Active
Data to Support Communications Usability Testing, as Used by the Food and Drug Administration
New collection (Request for a new OMB Control Number)   No
Approved with change 06/11/2012
Retrieve Notice of Action (NOA) 08/25/2011
This generic clearance for FDA/CFSAN is approved for 2 years under the following conditions: (1) For individual "tests," FDA shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement in the template agreed to by OMB and FDA (including a statement of need, intended use of information, description of respondents, date(s) and location(s), collection procedures, justification for any proposed incentive, and estimated burden); (b) participant screeners, and (c) instruments/moderator guides. (2) OMB will respond with clearance or questions within 10 working days. (3) OMB and FDA will jointly evaluate the generic clearance in 18-months; FDA will provide a summary of each collection approved under the generic clearance (e.g., use of information) and an overview of the studies likely to be submitted in the next 18-months. (4) FDA will not use this information gained from this collection for policy formation, nor will it release the information to the public.
  Inventory as of this Action Requested Previously Approved
06/30/2014 36 Months From Approved
75,000 0 0
41,041 0 0
0 0 0

FDA plans to use the data collected under this generic clearance to inform its communications campaigns on a variety of topics related to products that the FDA regulates. FDA expects the data to help staff message developers achieve FDA communication objectives. FDA also plans to use the data to help tailor print, broadcast, and electronic media communications in order for them to have powerful and desired impacts on target audiences. The data will not be used for the purposes of making policy or regulatory decisions.

US Code: 42 USC 241 Name of Law: Public Health Service Act
   EO: EO 12862 Name/Subject of EO: Setting Customer Service Standards

Not associated with rulemaking

  76 FR 34083 06/10/2011
76 FR 52332 08/22/2011


  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 75,000 0 0 75,000 0 0
Annual Time Burden (Hours) 41,041 0 0 41,041 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
This is a new collection of information to set up a new generic request.

Yes Part B of Supporting Statement
Johnny Vilela 301 796-3792 [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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