21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program

Forms and Documents

Document Name	Status
CuresFR_PRA Supporting Statement_FINAL_5-5-2020.docx Supporting Statement A	2020-05-05

IC Document Collections

IC ID	Document Title	Status
235209	Records and Information Retention 45 CFR 170.402	Unchanged

ICR Details

OMB Control No: 0955-0018	ICR Reference No: 202005-0955-001
Status: Received in OIRA	Previous ICR Reference No: 201902-0955-001
Agency/Subagency: HHS/ONC	Agency Tracking No:
Title: 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/05/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	458	0
Time Burden (Hours)	47,632	0
Cost Burden (Dollars)	0	0

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Abstract: This is a new information collection request which pertains to a records and information retention requirement found at 45 CFR 170.402(b)(1). The purpose and use of this records and information retention requirement is to verify, as necessary, health IT developer compliance with the ONC Health IT Certification Program (Program) requirements, including certification criteria and Conditions of Certification. Specifically, a health IT developer must, for a period of 10 years beginning from the date each of a developer’s health IT is first certified under the Program, retain all records and information necessary that demonstrate initial and ongoing compliance with the requirements of the Program.

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Authorizing Statute(s): PL: Pub.L. 114 - 255 4002 Name of Law: 21st Century Cures Act
  

Citations for New Statutory Requirements: PL: Pub.L. 114 - 255 4002 Name of Law: 21st Century Cures Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0955-AA01	Final or interim final rulemaking	85 FR 25642	05/01/2020

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Federal Register Notices & Comments

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
Records and Information Retention 45 CFR 170.402

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ICR Summary of Burden

	Total Request	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	458	0	458	0	0	0
Annual Time Burden (Hours)	47,632	0	47,632	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $76,860

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)? Yes

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: 05/05/2020

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