View Information Collection Request (ICR) Package

OMB Control No: 0955-0020	ICR Reference No: 202304-0955-001
Status: Active	Previous ICR Reference No: 202001-0955-001
Agency/Subagency: HHS/ONC	Agency Tracking No:
Title: US Core Data for Interoperability New Data Element Submission Form
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/17/2023
	Date Received in OIRA: 05/11/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2026	36 Months From Approved	07/31/2023
Responses	200	0	100
Time Burden (Hours)	67	0	33
Cost Burden (Dollars)	0	0	0

Abstract: The Office of the National Coordinator for Health Information Technology is seeking the approval for a revision of a currently approved collection request titled the “United States Core Data for Interoperability New Data Element Submission Form.” The USCDI is a standardized set of health data classes and constituent data elements used to support nationwide, interoperable health information exchange. When published, the USCDI will become the required standard data elements set to which all health IT developers must conform to obtain ONC certification. The ONC certification is required for participation in some federal healthcare payment plans. To insure the USCDI remains current and reflects the needs of the health IT community, ONC established a predictable, transparent, and collaborative process to solicit broad stakeholder input to expand the USCDI. Anyone, including ONC staff, staff from other federal agencies, and other stakeholders may submit proposals for new data elements. ONC will evaluate each submission and provide feedback to the submitter. ONC will draft a new version of the USCDI based on these submissions and this draft will undergo review by ONC's federal advisory committee, the Health Information Technology Advisory Committee (HITAC), as well as by the general public. Upon approval by the National Coordinator for Health Information Technology, new data classes and data elements from these submissions will be added to the newest version of the USCDI standard for integration into health information technology products such as electronic health records. Based on feedback and policy changes since this data collection began in 2020, ONC proposes to make some revisions to this data collection instrument. These changes do not change the overall data collection burden on respondents. The information collected from this submission system is needed as it will comprise the sum total of the items ONC will evaluate for addition to the next version of the USCDI. The requested data will provide supporting documentation to justify addition of the data elements to the USCDI, and, if the documentation does justify addition to the USCDI, to one of several levels of candidate data elements for future development and consideration. The requested data and ONC's evaluation of the data will be publicly available for review at any time to provide transparency and predictability in the USCDI expansion process. It will contain information about the submitter to allow ONC to provide direct feedback to submitters on ONC's evaluation of such submission.

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 36334	06/16/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 29672	05/08/2023
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	200	100	200	-100
Annual Time Burden (Hours)	67	33	67	-33
Annual Cost Burden (Dollars)	0	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: No

Burden Reduction Due to:

Short Statement: The annual burden time increases by 34, increasing from 33 to 67. The increase is due to the number of annual responses changing from 100 to 200.

Annual Cost to Federal Government: $75,000

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: Wendy Kilgore 202 407-2247 wendy.kilgore@hhs.gov

View ICR - OIRA Conclusion