COVID-19 Pandemic Response, Laboratory Data Reporting

Forms and Documents

Document Name	Status
Form 0920-20OS CDC-provided CSV file or HL7 messages (retrospective data entry) Form and Instruction	New
Form 0920-20OS CDC-provided CSV file or HL7 messages Form and Instruction	New
Emergency review request memo p 2 (signed).jpg Supplementary Document	2020-05-28
Emergency review request memo p 1 (signed).jpg Supplementary Document	2020-05-28
8. PIA.pdf Supplementary Document	2020-05-28
7. Non-research determination.pdf Supplementary Document	2020-05-28
1B. CARES Act.pdf Supplementary Document	2020-05-28
1A. Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2020-05-28
Supporting Statement B - CARES Act lab data 5.28.2020 CLEAN.docx Supporting Statement B	2020-05-28
Supporting Statement A - CARES Act lab data 5.28.2020 CLEAN.docx Supporting Statement A	2020-05-28

IC Document Collections

IC ID	Document Title	Status
241982	LIMS Interface Configuration Other-Info sheet	New
241981	CDC-provided CSV file or HL7 messages (retrospective data entry) Form and Instruction	New
241976	CDC-provided CSV file or HL7 messages Form and Instruction	New

ICR Details

OMB Control No: 0920-1299	ICR Reference No: 202005-0920-012
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20OS
Title: COVID-19 Pandemic Response, Laboratory Data Reporting
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 05/29/2020
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/01/2020
	Date Received in OIRA: 05/28/2020
Terms of Clearance: CDC will work with OMB regarding the disclosure board protocol and any other protocols associated with the retrospective collection of lab data.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2020	6 Months From Approved
Responses	16,774	0	0
Time Burden (Hours)	65,936	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Ensuring a rapid and thorough public health response to the COVID-19 pandemic necessitates comprehensive laboratory testing data. These data contribute to understanding disease incidence and trends: initiating epidemiology case investigations, assisting with contact tracing, assessing availability and use of testing resources, and identifying supply chain issues for reagents and other material. Laboratory testing data, in conjunction with case reports and other data, also provide vital guidance for mitigation and control activities.

Emergency Justfication: This information is essential to ensuring a rapid and thorough public health response to the COVID-19 pandemic. Comprehensive laboratory testing data contribute to understanding disease incidence and trends: initiating epidemiologic case investigations, assisting with contact tracing, assessing availability and use of testing resources, and identifying of supply chain issues for reagents and other material. Laboratory testing data, in conjunction with case reports and other data, also provide vital guidance for mitigation and control activities. CDC cannot reasonably comply with the normal clearance given the ongoing public health emergency. Laboratory data serve not only as important information to support decision making related to the public health emergency, but also as a critical piece to better understanding the performance of tests in real-world conditions, the effectiveness of clinical interventions, and patient outcomes and interventions. Better understanding the characteristics and performance of specific tests can help ensure that healthcare providers are equipped with the maximum information necessary to make clinical decisions, develop recommendations and provide the most appropriate care for their patients. Additionally, with widespread use of electronic health records (EHR), closing the loop by incorporating information related to laboratory testing can add to the robustness of data that will eventually serve as the backbone for clinical research to inform treatments, better understand outcomes, improve the quality and performance of diagnostic tests over time, and shape clinical understanding of COVID-19.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
   PL: Pub.L. 116 - 136 18115(a) Name of Law: CARES Act
  

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: 3

IC Title	Form No.	Form Name
CDC-provided CSV file or HL7 messages	0920-20OS, 0920-20OS	CSV Format Guide ,   HL7 Reporting Guide
CDC-provided CSV file or HL7 messages (retrospective data entry)	0920-20OS	CSV Format Guide
LIMS Interface Configuration

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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	16,774	0	0	16,774	0	0
Annual Time Burden (Hours)	65,936	0	0	65,936	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: This is a new collection.

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Annual Cost to Federal Government: $2,000,000

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.     Yes

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.     Yes

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: 05/28/2020

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