This generic clearance for FDA is approved for 3 years under the following conditions: (1) For individual "surveys," FDA shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement in the template agreed to by OMB and FDA FDA (including the problem being investigated, the method of selecting the sample, any deviations from the methods, procedures, or uses described in the overall supporting statement, and the estimated burden); (b) participant screeners, and (c) instruments/moderator guides. (2) OMB will respond with clearance or questions within 10 working days (or quicker if desk officer is alerted to an urgent public health need).
Inventory as of this Action
Requested
Previously Approved
06/30/2014
36 Months From Approved
06/30/2011
60,000
0
6,000
30,000
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.
US Code:
21 USC 355
Name of Law: FD&C Act
US Code:
21 USC 360
Name of Law: Federal Food, Drug, and Cosmetic Act
The reason for expanding the number of respondents for each Rapid Response Survey is that, over the years, it has become increasingly easier to engage professional organizations to assist FDA with the process. The current number of 6,000 respondents was selected because it was time consuming for FDA staff to develop the respondent list, contact the respondents, perform follow-up, compile and analyze the results. Now that organizations help us by sending out the surveys on-line to their membership, de-identifying the responses, and performing follow-up as needed, FDA staff need only analyze the final results. This makes it easier for FDA to enlarge the respondent universe for each survey, thus improving the chances of hearing a variety of viewpoints. FDA is now requesting to increase the burden by 27,000 hours for a total of 30,000 hours.
The reason we have reduced the number of surveys from 10 per year to 6 per year is that we have never reached the limit of 10 per year. We have learned that 6 per year is a more realistic number.
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.
FDA Rapid Response Survey Streamlined Gen IC Memo Attachment D.doc
Rapid Response Survey -- Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)