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: 202308-0910-001
Status: Active	Previous ICR Reference No: 202008-0910-019
Agency/Subagency: HHS/FDA	Agency Tracking No: Generic
Title: Rapid Response Surveys
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/22/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/31/2023
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 (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.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2027	36 Months From Approved	02/29/2024
Responses	10,000	0	60,000
Time Burden (Hours)	5,000	0	30,000
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	10,000	60,000	-50,000
Annual Time Burden (Hours)	5,000	30,000	-25,000
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: We have adjusted the total burden hours that results in a decrease of 50,000 responses and 25,000 total hours. This reduction in burden is a result of fewer rapid response surveys being conducted.

Annual Cost to Federal Government: $338,464

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. 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? No

Agency Contact: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov