US Core Data for Interoperability New Data Element Submission Form

Forms and Documents

Document Name	Status
Form 1 US Core Data for Interoperability (USCDI) New Data Element Submission Form Form	New
0955-USCDI 30-DAY FRN.pdf Supplementary Document	2020-04-20
Published 60-day FRN 0955-USCDI.pdf Supplementary Document	2020-04-20
0955-ONC Supporting Statement A - USCDI Expansion Submission Process _Final 7.14.20.docx Supporting Statement A	2020-07-14

IC Document Collections

IC ID	Document Title	Status
239374	US Core Data for Interoperability (USCDI) New Data Element Submission Form Form	New

ICR Details

OMB Control No: 0955-0020	ICR Reference No: 202001-0955-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/ONC	Agency Tracking No:
Title: US Core Data for Interoperability New Data Element Submission Form
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: 07/17/2020
	Date Received in OIRA: 04/21/2020
Terms of Clearance:

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

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Abstract: The Office of the National Coordinator for Health Information Technology is seeking the approval for a new information collection request item the “United States Core Data for Interoperability (USCDI) 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. This certification is required for participation in some federal healthcare payment plans. In order to insure the USCDI remains current and reflects the needs of the health IT community, ONC has 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 and classes. 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. ONC is seeking approval to collect this information throughout each year from health IT stakeholders. 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 publically 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.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 7764	02/11/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 21862	04/20/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
US Core Data for Interoperability (USCDI) New Data Element Submission Form	1	USCDI Submission Form

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	100	0	0	100	0	0
Annual Time Burden (Hours)	33	0	0	33	0	0
Annual Cost Burden (Dollars)	0	0	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 burden increase is because this is a new IC.

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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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 04/21/2020

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