View Information Collection Request (ICR) Package
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View Information Collection (IC) List
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View Generic ICR - OIRA Conclusion
OMB Control No:
0910-0500
ICR Reference No:
201012-0910-003
Status:
Historical Active
Previous ICR Reference No:
200710-0910-002
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Generic FDA Rapid Response Surveys
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
06/13/2011
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/20/2010
Terms of Clearance:
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
Expiration Date
06/30/2014
36 Months From Approved
06/30/2011
Responses
60,000
0
6,000
Time Burden (Hours)
30,000
0
3,000
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
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
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
75 FR 47599
08/06/2010
30-day Notice:
Federal Register Citation:
Citation Date:
75 FR 78251
12/15/2010
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
FDA's Center for Tobacco Products State Department of Health Electronic Cigarette Adverse Event Survey
Rapid Response Survey -- Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)
ICR Summary of Burden
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
60,000
6,000
0
54,000
0
0
Annual Time Burden (Hours)
30,000
3,000
0
27,000
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
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.
Annual Cost to Federal Government:
$5,000
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov
Common Form ICR:
No
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
12/20/2010
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