View Information Collection Request (ICR) Package

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: 0955-0022	ICR Reference No: 202403-0955-003
Status: Active	Previous ICR Reference No: 202305-0955-001
Agency/Subagency: HHS/ONC	Agency Tracking No:
Title: Insights Condition and Maintenance of Certification (45 CFR 170.407)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/31/2024
	Date Received in OIRA: 03/08/2024
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time the agency will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2027	36 Months From Approved
Responses	53	0	0
Time Burden (Hours)	1,461,154	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	53	53
Annual Time Burden (Hours)	1,461,154	1,461,154
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: There are estimated high-end averages which may vary dependent on how many products a developer of certified health IT may be required to submit responses for. We expect the costs and burden for health IT developers to submit responses, in accordance with the established Insights Condition of Certification requirements, to be mitigated due to the following factors. First, we plan to minimize burden for health IT developers by providing a web-based submission form and method to simplify the process for response submission. We intend to provide developers with templates that enable the submission of data in a structured, electronic format such as comma-separated values (CSV) or JavaScript Object Notation (JSON). We also intend for the independent entity who is collecting the response submissions on behalf of ONC to have minimal burden by automating parts of the response review and submission process via an online tool.

Annual Cost to Federal Government: $1,498,995

Does this IC contain surveys, censuses, or employ statistical methods? No

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: Stephanie Lee 202 260-2068 stephanie.lee@hhs.gov

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