This generic clearance for FDA focus groups is approved for 3 years consistent with the FDA revised supporting statement and under the following conditions: 1) FDA shall submit memos for individual surveys (e.g., statement of need for rapid response, intended use of information, description of respondents, information collection procedures, expected response rate, justification for incentive, estimated burden, survey instrument) 2) OMB will respond with clearance or questions within 10 working days 3) OMB and FDA will jointly evaluate the generic clearance upon resubmission in 3 years. Upon resubmission, FDA will provide a summary of each collection approved under the generic clearance (e.g., actual response rate, representativeness of data, use of information).
OMB notes that this generic information collection request has been expanded to include CFSAN-related uses. OMB will work with FDA throughout the clearance period to ensure a mutual understanding of the appropriate uses of this clearance in the new context. OMB further notes that the milk rapid response survey is not approved at this time. However, FDA may resubmit it as an individual item under this generic approval without delay.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
01/31/2011
36 Months From Approved
01/31/2008
6,000
0
6,000
3,000
0
3,000
0
0
0
This program will obtain data on safety information to support quick-turnaround decision-making about potential safety problems or risk management solutions. This information will be collected from health professionals, hospitals, and other user facilities (e.g., nursing homes, ambulatory surgical facilities and outpatient diagnostic and treatment facilities, etc.), consumers, sponsors and manufacturers of biologics, drugs and medical products, distributors, and importers when FDA must quickly determine whether or not a problem with a medical product impacts the public health.
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.
0500 ss 12-11-2007 part A.doc
Rapid Response Survey for "Negative Pressure Wound Therapy Device Used in the Home Environment"