Information Collection Request

SARS-CoV-2 Epidemiologic Data Collections

ICR 202009-0920-012 · OMB 0920-1297 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
General Public - Risk Factor Interview Form and Instruction Unchanged Repair queued
Epidemiologist - Pregnancy Module Form and Instruction Modified Repair queued
Homeless Shelter Staff - Homeless Symptom Follow-Up Form and Instruction Unchanged Available
Homeless Shelter Staff - Homeless Shelter Modified Screener Form and Instruction Unchanged Available
General Public - Household Close-Out Form Form and Instruction Unchanged Repair queued
General Public - Household Animal Queationnaire Form and Instruction Unchanged Available
General Public - Household Member Symptom Diary Form and Instruction Unchanged Repair queued
General Public - Household Questionnaire Form and Instruction Unchanged Repair queued
General Public - Household Contact Questionnaire Instrument Form and Instruction Unchanged Available
General Public - Case Investigation Form Form and Instruction Unchanged Available
Change Request Memo 23SEP2020.docx Justification for No Material/Nonsubstantive Change Uploaded 2020-09-24 Available
22C. NRD_COVID-19 Pregnancy Module.pdf Supplementary Document Uploaded 2020-04-30 Available
22B. NRD_Homeless Shelter Screening.pdf Supplementary Document Uploaded 2020-04-30 Available
22A. Non-research determination.pdf Supplementary Document Uploaded 2020-04-30 Available
23. Homeless project verbal consent.docx Supplementary Document Uploaded 2020-04-30 Available
20.Assent_CHILD_27Apr2020_v1.4_CLEAN.docx Supplementary Document Uploaded 2020-04-30 Available
19. Consent_CASE_27Apr2020_v1.4_CLEAN.docx Supplementary Document Uploaded 2020-04-30 Available
18. Consent_HH MEMBER_27Apr2020_v1.4_CLEAN.docx Supplementary Document Uploaded 2020-04-30 Repair queued
17. Consent_PARENT_27Apr2020_v1.4_CLEAN.docx Supplementary Document Uploaded 2020-04-30 Available
13. Risk Factor_ChartAbstraction0408_Instrument_OMB.docx Supplementary Document Uploaded 2020-04-30 Repair queued
2. 60-day FRN.pdf Supplementary Document Uploaded 2020-04-30 Available
1. Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document Uploaded 2020-04-30 Available
SSB COVID epi forms - NO CF_Clean.docx Supporting Statement B Uploaded 2020-04-29 Repair queued
SSA COVID epi forms - NO CF_Clean.docx Supporting Statement A Uploaded 2020-04-29 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
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
0920-1297 202009-0920-012
Historical Active 202004-0920-016
HHS/CDC 0920-20HF
SARS-CoV-2 Epidemiologic Data Collections
No material or nonsubstantive change to a currently approved collection   No
Emergency 05/01/2020
Approved without change 09/28/2020
Retrieve Notice of Action (NOA) 09/25/2020
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
11/30/2020 11/30/2020 11/30/2020
36,230 0 26,980
16,579 0 16,954
0 0 0

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.
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.

US Code: 42 USC 241 Name of Law: U.S. PHSA
  
None

Not associated with rulemaking

  85 FR 6546 02/05/2020
Yes

  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
No
Yes
Miscellaneous Actions
Non-Substantive Change Request is submitted to make changes to the Pregnancy Module (Pregnant Woman/Neonate Form).

$1,024,282
No
    Yes
    Yes
No
No
No
Yes
Jeffrey Zirger 404 639-7118 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
09/25/2020