SARS-CoV-2 Epidemiologic Data Collections

Forms and Documents

Document Name	Status
General Public - Risk Factor Interview Form and Instruction	Unchanged
Epidemiologist - Pregnancy Module Form and Instruction	Modified
Homeless Shelter Staff - Homeless Symptom Follow-Up Form and Instruction	Unchanged
Homeless Shelter Staff - Homeless Shelter Modified Screener Form and Instruction	Unchanged
General Public - Household Close-Out Form Form and Instruction	Unchanged
General Public - Household Animal Queationnaire Form and Instruction	Unchanged
General Public - Household Member Symptom Diary Form and Instruction	Unchanged
General Public - Household Questionnaire Form and Instruction	Unchanged
General Public - Household Contact Questionnaire Instrument Form and Instruction	Unchanged
General Public - Case Investigation Form Form and Instruction	Unchanged
Change Request Memo 23SEP2020.docx Justification for No Material/Nonsubstantive Change	2020-09-24
22C. NRD_COVID-19 Pregnancy Module.pdf Supplementary Document	2020-04-30
22B. NRD_Homeless Shelter Screening.pdf Supplementary Document	2020-04-30
22A. Non-research determination.pdf Supplementary Document	2020-04-30
23. Homeless project verbal consent.docx Supplementary Document	2020-04-30
20.Assent_CHILD_27Apr2020_v1.4_CLEAN.docx Supplementary Document	2020-04-30
19. Consent_CASE_27Apr2020_v1.4_CLEAN.docx Supplementary Document	2020-04-30
18. Consent_HH MEMBER_27Apr2020_v1.4_CLEAN.docx Supplementary Document	2020-04-30
17. Consent_PARENT_27Apr2020_v1.4_CLEAN.docx Supplementary Document	2020-04-30
13. Risk Factor_ChartAbstraction0408_Instrument_OMB.docx Supplementary Document	2020-04-30
2. 60-day FRN.pdf Supplementary Document	2020-04-30
1. Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2020-04-30
SSB COVID epi forms - NO CF_Clean.docx Supporting Statement B	2020-04-29
SSA COVID epi forms - NO CF_Clean.docx Supporting Statement A	2020-04-29

IC Document Collections

IC ID	Document Title	Status
241646	General Public - Risk Factor Interview Form and Instruction	Unchanged
241645	Epidemiologist - Pregnancy Module Form and Instruction	Modified
241643	Homeless Shelter Staff - Homeless Symptom Follow-Up Form and Instruction	Unchanged
241642	Homeless Shelter Staff - Homeless Shelter Modified Screener Form and Instruction	Unchanged
241641	General Public - Household Close-Out Form Form and Instruction	Unchanged
241632	General Public - Household Animal Queationnaire Form and Instruction	Unchanged
241631	General Public - Household Member Symptom Diary Form and Instruction	Unchanged
241630	General Public - Household Questionnaire Form and Instruction	Unchanged
241629	General Public - Household Contact Questionnaire Instrument Form and Instruction	Unchanged
241628	General Public - Case Investigation Form Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-1297	ICR Reference No: 202009-0920-012
Status: Historical Active	Previous ICR Reference No: 202004-0920-016
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20HF
Title: SARS-CoV-2 Epidemiologic Data Collections
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 05/01/2020
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/28/2020
	Date Received in OIRA: 09/25/2020
Terms of Clearance: Previous terms continue: Approved consistent with the understanding that CDC will appropriate characterize and caveat the limitations and limited generalizability of the data in all publications and communications materials.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2020	11/30/2020	11/30/2020
Responses	36,230	0	26,980
Time Burden (Hours)	16,579	0	16,954
Cost Burden (Dollars)	0	0	0

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Abstract: This data collection is submitted in response to the COVID-19 pandemic by CDC to allow the development of tools that will serve a variety of purposes throughout the remainder of the emergency response. These activities will include filling gaps in knowledge around COVID-19 case characteristics, infection rate, point prevalence in people experiencing homelessness, risks for severe illness or adverse outcomes among pregnant individuals and their newborns, and risk factors for severe illness. The Intended use of the resulting data is to inform guidance on COVID-19. The Change Request submitted here is intended to incorporate several improvements have been identified by CDC that would improve data interpretation, data quality, and linkages with the standard COVID-19 case report form and between pregnancy and neonatal forms. Additionally, implementing jurisdictions have requested additions such as multiple response options for neonatal testing.

Emergency Justfication: This Emergency Request is submitted for a bundle of epidemiologic tools that will help CDC’s efforts to slow and stop the spread of SARS-CoV-2. Some of the data collection instruments for which OMB approval is sought were initially approved under OMB control no. 0920-1011 (exp. date 4/23/2020). This ICR will continue those forms’ clearance and add additional tools. The 0920-1011 gen-IC approved in January 2020 (exp. date 4/23/2020) included three data collection instruments: (1) COVID-19 case report form, whose data elements have been inherited by the NNDSS ICR (0920-0728); (2) persons under investigation form, which has been discontinued; and (3) a household transmission questionnaire, which is included in this ICR to extend its OMB clearance. As CDC’s response to the pandemic evolved over the last 90 days, the OMB-approved forms from the 0920-1011 gen-IC were repurposed for the ongoing studies and uses described in this ICR. The purpose of this ICR is to bring these new collections into compliance.

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Authorizing Statute(s): US Code: 42 USC 241 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
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 6546	02/05/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Epidemiologist - Pregnancy Module	NA, 0920-1297	Pregnancy Module ,   Pregnancy Module - Pregnant Women/Neonate Form) REVISED 16SEP2020
General Public - Case Investigation Form	NA	Case Investigation Form
General Public - Household Contact Questionnaire Instrument	NA	Household Contact Questionnaire
General Public - Household Questionnaire	NA	Household Quiestionnaire
General Public - Household Member Symptom Diary	NA	Household Member Symptom Diary
General Public - Household Animal Queationnaire	NA	Household Animal Questionnaire
General Public - Risk Factor Interview	NA	Risk Factor Interview
General Public - Household Close-Out Form	NA	Household Close-Out Form
Homeless Shelter Staff - Homeless Symptom Follow-Up	NA	Homeless Symptom Follow-Up
Homeless Shelter Staff - Homeless Shelter Modified Screener	NA	Homeless Shelter Modified Screener

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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	36,230	26,980	0	9,250	0	0
Annual Time Burden (Hours)	16,579	16,954	0	-375	0	0
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Non-Substantive Change Request is submitted to make changes to the Pregnancy Module (Pregnant Woman/Neonate Form).

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Annual Cost to Federal Government: $1,024,282

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: 09/25/2020

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