Insights Condition and Maintenance of Certification (45 CFR 170.407)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
HTI-1_NPRM_PRASupportingStatement_Final_4-25-2023.docx	Supporting Statement A	Uploaded 2023-05-05	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
260071	Insights Condition and Maintenance of Certification for Independent Entity		New
260069	Insights Condition and Maintenance of Certification (45 CFR 170.407)		New

ICR Details

OMB Control No: 0955-0022	ICR Reference No: 202305-0955-001
Status: Historical Inactive	Previous ICR Reference No:
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: Comment filed on proposed rule	Conclusion Date: 10/17/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/15/2023
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: As a Condition of Certification in § 170.407(a), a health IT developer must submit responses and report in accordance with the established Insights Condition of Certification requirements with respect to all applicable certified health technology a health IT developer offers under the Certification Program. As a Maintenance of Certification in § 170.407(b), health IT developers of certified health IT must submit responses every six months (i.e., two times per year).

---

Authorizing Statute(s): US Code: 42 USC 300jj-11 Name of Law: Public Health Service Act (PHSA)
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0955-AA03	Proposed rulemaking	88 FR 23746	04/18/2023

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Insights Condition and Maintenance of Certification (45 CFR 170.407)
Insights Condition and Maintenance of Certification for Independent Entity

---

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: Section 4002(c) of the Cures Act, which amended section 3001(c)(5) of the Public Health Service Act (PHSA) (42 U.S.C. 300jj–11) requires the Secretary of HHS, through notice and comment rulemaking, to establish Conditions and Maintenance of Certification requirements for the ONC Health IT Certification Program (Certification Program). Specifically, the Cures Act requires health IT developers, as Condition and Maintenance of Certification requirements under the Certification Program, to submit reporting criteria on certified health IT in accordance with the EHR Reporting Program established under section 3009A of the PHSA, as added by the Cures Act.

---

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

---

Common Form ICR:  No

---

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: 06/15/2023

---