SimpleReport Mobile Application

Forms and Documents

Document Name	Status
Repeat Tests on Existing Users - Long Term Program Form	New
Input Patient Data and Test Result Reporting - Long Term Program Form	New
User Training - Long Term Program Form	New
Repeat Tests on Existing Users - SimpleReport Use Form	New
Input Patient Data and Test Result Reporting - SimpleReport Use Form	New
User Training - SimpleReport Use Form	New
Simple Report Application Emergency Request_03312021.docx Supplementary Document	2021-03-31
Supporting Statement_- SimpleReportPRA.docx Supporting Statement A	2021-03-31

IC Document Collections

IC ID	Document Title	Status
246541	Repeat Tests on Existing Users - Long Term Program Form	New
246540	Input Patient Data and Test Result Reporting - Long Term Program Form	New
246539	User Training - Long Term Program Form	New
246535	Repeat Tests on Existing Users - SimpleReport Use Form	New
246533	Input Patient Data and Test Result Reporting - SimpleReport Use Form	New
246531	User Training - SimpleReport Use Form	New

ICR Details

OMB Control No:	ICR Reference No: 202103-0920-012
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-21EJ
Title: SimpleReport Mobile Application
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 04/02/2021
Date Submitted to OIRA: 04/01/2021

	Requested	Previously Approved
Expiration Date	6 Months From Approved
Responses	3,640,000	0
Time Burden (Hours)	379,600	0
Cost Burden (Dollars)	0	0

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Abstract: SimpleReport is a free web-based application that provides an easy way to manage the testing workflow, to record results for rapid point of care COVID tests, to report the results to the appropriate public health department on behalf of the testing site, and to comply with existing requirements.

Emergency Justfication: SimpleReport is a free web-based application that provides an easy way to manage the testing workflow, to record results for rapid point of care COVID tests, to report the results to the appropriate public health department on behalf of the testing site, and to comply with existing requirements. The data collected through this app is crucial for public health departments to take action during the current health crisis. Currently, many point of care tests are reported on paper, on fax, or are not reported at all. The Diagnostics and Testing task force, estimates that only 10% of point of care tests are being reported today.

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Authorizing Statute(s): US Code: 42 USC 353 Name of Law: U.S. PHSA
  

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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Input Patient Data and Test Result Reporting - Long Term Program	NA	SimpleReport Mobile Application
Repeat Tests on Existing Users - Long Term Program	NA	SimpleReport Mobile Application
Input Patient Data and Test Result Reporting - SimpleReport Use	NA	SimpleReport Mobile Application
Repeat Tests on Existing Users - SimpleReport Use	NA	SimpleReport Mobile Application
User Training - Long Term Program	NA	SimpleReport Mobile Application
User Training - SimpleReport Use	NA	SimpleReport Mobile Application

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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	3,640,000	0	0	0	0	3,640,000
Annual Time Burden (Hours)	379,600	0	0	0	0	379,600
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: $1,500,000

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? Yes

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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: 04/01/2021

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