Data to Support Food and Nutrition Product Communications as Used by the Food and Drug Administration

ICR 201105-0910-009

OMB: 0910-0710

Federal Form Document

IC Document Collections
ICR Details
0910-0710 201105-0910-009
Historical Active
Data to Support Food and Nutrition Product Communications as Used by the Food and Drug Administration
New collection (Request for a new OMB Control Number)   No
Approved without change 06/11/2012
Retrieve Notice of Action (NOA) 05/27/2011
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
16,448 0 0
2,860 0 0
0 0 0

FDA is seeking generic clearance for this collection of information and plans to use the data to inform its nutrition and foods communications campaigns. The informatiion will serve two major purposes. First as formative research, it will provide the critical knowlwdge needed about target audiences. Second, as initial testing, it will give FDA some information about the potential effectiveness of the messages and materials in reaching and successfully communicating with their intended audiences.

US Code: 21 USC 393 (d)(2) Name of Law: null

Not associated with rulemaking

  75 FR 82030 12/29/2010
76 FR 29760 05/23/2011


  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 16,448 0 0 16,448 0 0
Annual Time Burden (Hours) 2,860 0 0 2,860 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
Denver Presley 3018271462


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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