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OMB Control No: 0955-0021	ICR Reference No: 202103-0955-002
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/ONC	Agency Tracking No:
Title: ACCESS, EXCHANGE, AND USE OF SOCIAL DETERMINANTS OF HEALTH DATA IN CLINICAL NOTES
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: 08/01/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/28/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2025	36 Months From Approved
Responses	1,900	0	0
Time Burden (Hours)	426	0	0
Cost Burden (Dollars)	0	0	0

Abstract: The Department of Health and Human Services (HHS), Office of the Secretary, Office of the National Coordinator for Health Information Technology (ONC), promotes the access, exchange, and use of electronic health information to improve health care. There are ongoing efforts to determine what types of information should be recorded in patients’ electronic medical records and how that information can be utilized to improve health and healthcare. Data reflecting Social Determinants of Health (SDOH) – the conditions in which people live, learn, work, and play – is limited across healthcare yet is vital to collect and understand for both individual care and public health. There is a growing recognition that by capturing and accessing SDOH data during the course of care, providers can more easily address non-clinical factors, such as food, housing, and transportation insecurities, which can have a profound impact on a person's overall health. The 21st Century Cures Act (Cures Act) requires HHS and ONC to improve the interoperability of health information. ONC's Cures Act final rule identifies important data elements that should be made electronically available and exchanged through the use of health information technology (IT). In support of these efforts, ONC seeks to better understand patients’ and health care providers’ knowledge of SDOH, how SDOH data are currently documented in the electronic health record and how this information is used in patient care. Additionally, ONC seeks to understand challenges experienced and preferences for SDOH data collection, sharing and utilization from both the provider and patient perspectives. A series of 20 focus groups, a mix of asynchronous (discussion board) and synchronous (live), will be conducted among groups of healthcare professionals (10 groups) and patients/care partners (10 groups), representing various backgrounds, demographics, and healthcare professions, to learn more about their experiences and thoughts relating to the capture and utilization of SDOH data. A prescreening questionnaire will be sent to 1,500 individuals and 200 of those 1,500 people will be chosen to participate in the focus groups. Each individual will participate in one 90-minute focus group. This is a 3-year request for OMB approval.

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:
	86 FR 13908	03/11/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 58285	10/21/2021
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	1,900	1,900
Annual Time Burden (Hours)	426	426
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: There is no burden increase because this is a new IC

Annual Cost to Federal Government: $332,123

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: Carmelita Marshall 202 691-2062 carmelita.marshall@hhs.gov

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