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 ICR - OIRA Conclusion

OMB Control No: 0910-0586	ICR Reference No: 201106-0910-006
Status: Historical Active	Previous ICR Reference No: 201005-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Devices; Exception from General Requirements for Informed Consent
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/05/2011
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/24/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2014	08/31/2013	08/31/2013
Responses	1,350	0	900
Time Burden (Hours)	1,463	0	1,350
Cost Burden (Dollars)	200	0	100

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	1,350	900	450
Annual Time Burden (Hours)	1,463	1,350	113
Annual Cost Burden (Dollars)	200	100	100

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: FDA is making one change to the interim final rule, in response to comments that the rule did not protect against misuse of this limited exception from informed consent requirements. In response to those concerns, FDA is adding one new requirement (amending the regulation) that investigators also send the documentation required in paragraph (e)(1) or (e)(2) to FDA, not just to the reviewing IRB. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. The final rule will add 150 respondents, 450 total annual responses, and 113 burden hours.