Investigation of SARS-CoV-2 Seroprevalence and Factors Associated with Seropositivity in a Community Setting

Forms and Documents

Document Name	Status
Household Questionnaire Form	New
Individual Questionnaire Form	New
Emergency Review Request Memo_Seroprevalence Investigation_signed.pdf Supplementary Document	2020-04-22
Att7_Research Determination.pdf Supplementary Document	2020-04-22
Att5_Investigation Protocol.docx Supplementary Document	2020-04-22
Att4b_Consent Form.docx Supplementary Document	2020-04-22
Att1_Authorizing Legislation.docx Supplementary Document	2020-04-22
SSB_Seroprevalence_clean_20200424.docx Supporting Statement B	2020-04-24
SSA_Seroprevalence_clean_20200424.docx Supporting Statement A	2020-04-24

IC Document Collections

IC ID	Document Title	Status
241512	Household Questionnaire Form	New
241511	Blood collection (no form) Other-Sample Collection - No Form	New
241479	Individual Questionnaire Form	New

ICR Details

OMB Control No: 0920-1293	ICR Reference No: 202004-0920-015
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20ND
Title: Investigation of SARS-CoV-2 Seroprevalence and Factors Associated with Seropositivity in a Community Setting
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: 04/27/2020
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/27/2020
	Date Received in OIRA: 04/27/2020
Terms of Clearance: Approved consistent with CDC’s commitment to transparently report the impacts of test characteristics (including sensitivity and specificity) and sampling error on the precision of the results from each site

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	6 Months From Approved
Responses	9,680	0	0
Time Burden (Hours)	2,420	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of this information collection is to (1) determine the extent of infection in communities as determined by overall SARS-CoV-2 seroprevalence; and (2) determine factors associated with SARS-CoV-2 seropositivity among persons residing in areas with evidence of community transmission. The resulting data will be used to inform decisions about prevention and control strategies as well as community mitigation interventions.

Emergency Justfication: An Emergency Request is being submitted for data that will be used immediately by CDC’s emergency COVID-19 response at the national level, and by state and local health departments, to understand the cumulative incidence in a given population within their jurisdiction. Additionally, antibody seropositivity data could supplement data on medically attended infection rates and contribute to describing the overall burden of COVID-19. Data collected during this investigation is essential to developing and assessing public health prevention measures by contributing to modeling estimates to inform decisions about prevention and control strategies as well as community mitigation interventions in the U.S. response to COVID-19; thus, improving the overall public health response.

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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: 3

IC Title	Form No.	Form Name
Individual Questionnaire	n/a	Individual Questionnaire 24APR2020
Blood collection (no form)
Household Questionnaire	NA	Household Questionnaire 24APR2020

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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	9,680	0	0	9,680	0	0
Annual Time Burden (Hours)	2,420	0	0	2,420	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 Emergency Request titled, “Investigation of SARS-CoV-2 Seroprevalence and Factors Associated with Seropositivity in a Community Setting”.

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Annual Cost to Federal Government: $901,168

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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.     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? Uncollected

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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: 04/27/2020

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