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View ICR - OIRA Conclusion

OMB Control No: 0910-0912	ICR Reference No: 202408-0910-001
Status: Active	Previous ICR Reference No: 202301-0910-016
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/17/2025
	Date Received in OIRA: 09/06/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2026	36 Months From Approved
Responses	73	0	0
Time Burden (Hours)	65	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	73	73
Annual Time Burden (Hours)	65	65
Annual Cost Burden (Dollars)	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: This is a new information collection that FDA did not have an opportunity to complete before the OMB approval expiration date. Substantial turnover in the graduate students administering the survey made it necessary to bring in a new cohort of students and train them in the issues relevant to the survey. As a result, we were unable to field the B12 Pediatrics survey before the OMB approval expiration date and are seeking a reinstatement to complete data collection. To better ensure timely completion of the data collection, the Yale CERSI team has shifted responsibility for conducting the survey and other aspects of the study to a Yale Staff Associate Research Scientist.

Annual Cost to Federal Government: $595,122

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. Yes

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

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