COVID-19 by PCR Requisition Form

Forms and Documents

Document Name	Status
Emergency ICR SSA_COVID19 Lab Requistion Form_4.22.20 (omb)corrected.docx Supporting Statement A	2020-04-23
Attachment B_ Nasal, Self-Swab Informed Consent.pptx Supplementary Document	2020-04-23

IC Document Collections

IC ID	Document Title	Status
241502	COVID-19 Registrtion Form Other-Registration Form	New

ICR Details

OMB Control No: 0937-0210	ICR Reference No: 202004-0937-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/OASH	Agency Tracking No:
Title: COVID-19 by PCR Requisition Form
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: 04/23/2020
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/24/2020
	Date Received in OIRA: 04/23/2020
Terms of Clearance: OMB is approving this information collection request for a period of 6 months during which time the agency will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	6 Months From Approved
Responses	200,000	0	0
Time Burden (Hours)	13,333	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Collecting information on the PCR Lab Requisition form is necessary for the Office of the Assistant Secretary for Health (OASH) to perform its mission-critical work of ensuring that Community Based Testing Sites are properly managed and run. The data will inform the agency’s ability to tailor the national response, effectively manage the CBTS program, ensure the contracted laboratories and call center have the requisite information to process individual laboratory tests, and ensure individuals are quickly and accurately informed of their COVID-19 lab results.

Emergency Justfication: This is a request for the Office of Management and Budget (OMB) approval for a new one time collection of data from individuals who are participating in the federally supported, state managed, locally executed Community Based Testing Site (CBTS) program funded from March to May FY2020. CBTSs are focused on testing individuals who have symptoms of COVID-19 and healthcare facility workers and first responders who don’t have symptoms. CBTSs are another tool for states, local public health systems and healthcare systems to use as they work together to stop the spread of COVID-19 in their communities.

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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

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
COVID-19 Registrtion Form

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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	200,000	0	0	200,000	0	0
Annual Time Burden (Hours)	13,333	0	0	13,333	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: New Collection

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Annual Cost to Federal Government: $100,000

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: 04/23/2020

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