COVID-19 Pandemic Response, Laboratory Data Reporting

Forms and Documents

Document Name	Status
Form 0920- LIMS Interface Configuration Form	New
Form 0920- HL7 Reporting Guide Form	New
Form 0920- CSV Format Guide Form and Instruction	New
2a. 0920-1299 60 Day Published.pdf Supplementary Document	2021-02-09
8. PIA.pdf Supplementary Document	2021-02-08
7. NonResearch determination.pdf Supplementary Document	2021-02-08
1b. CARES Act.pdf Supplementary Document	2021-02-08
1a. Section 301 of the Public Health Service Act 42 USC 241.pdf Supplementary Document	2021-02-08
SSB.122920.docx Supporting Statement B	2021-02-08
SSA.020821.docx Supporting Statement A	2021-02-09

IC Document Collections

IC ID	Document Title	Status
245685	LIMS Interface Configuration Form	New
245684	HL7 Reporting Guide Form	New
245683	CSV Format Guide Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202102-0920-006
Status: Received in OIRA	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: Regular	Date Submitted to OIRA: 02/09/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	26,764	0
Time Burden (Hours)	75,926	0
Cost Burden (Dollars)	0	0

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Abstract: The Centers for Disease Control and Prevention (CDC) requests a NEW 3-year approval for a information collection titled: COVID-19 Pandemic Response, Laboratory Data Reporting (0920-1299). This project was initially approved as an EMERGENCY, but the current submission will only include what CDC plans to do going forward. 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.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service 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
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 34633	06/05/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 8647	02/08/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
HL7 Reporting Guide	0920-	CSV File or HL7 messages (retrospective data entry)
LIMS Interface Configuration	0920-	LIMS Interface Configuration
CSV Format Guide	0920-	CSV File Input COVID 19

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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	26,764	0	0	26,764	0	0
Annual Time Burden (Hours)	75,926	0	0	75,926	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: The is a NEW information collection request (previously approved as an EMERGENCY under OMB No. 0920-1299).

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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.     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.     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? 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: 02/09/2021

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