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View ICR - OIRA Conclusion

OMB Control No: 0910-0892	ICR Reference No: 202012-0910-004
Status: Historical Active	Previous ICR Reference No: 202007-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Health Care Providers Understanding of Opioid Analgesic Abuse-Deterrent Formulations: Phase 2 and 3 Surveys
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/04/2021
	Date Received in OIRA: 12/14/2020
Terms of Clearance: Terms continue: The ICR will need to be updated if changes are made between phases or between pretests and the main studies.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	08/31/2023	08/31/2023
Responses	10,135	0	8,163
Time Burden (Hours)	2,131	0	1,823
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	10,135	8,163	1,972
Annual Time Burden (Hours)	2,131	1,823	308
Annual Cost Burden (Dollars)	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The estimated annual reporting burden for Phase 2, formerly estimated as 868 hours, has increased by 308 hours to a new total estimate annual hourly burden of 1,176 hours.

Annual Cost to Federal Government: $1,040,002

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: Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

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