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
75,200
0
0
4,758
0
0
0
0
0
Under section 903 (b)(2) of the Federal Food, Drug and Cosmetic Act ( FFDCA)( 21 U.S.C. 393 (b)(2), the Food and Drug Administration ( FDA) is authorized to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the Nation`s food supply.
FDA is proposing to survey U.S. consumers using a web-based panel of U.S. households to collect information on consumers "real time" knowledge, perceptions, beliefs, and self- reported behaviors for up to five foodborne illness outbreaks or food recalls a year.
Collecting information quickly during a foodborne illness outbreak or food recall is important because erroneous perceptions or misinterpreted information about outbreak or recall can impede consumer adoption of recommended protective behaviors.
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.