SARS-CoV-2 Epidemiologic Data Collections

ICR 202009-0920-012

OMB: 0920-1297

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Unchanged
Form and Instruction
Modified
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Justification for No Material/Nonsubstantive Change
2020-09-24
Supplementary Document
2020-04-30
Supplementary Document
2020-04-30
Supplementary Document
2020-04-30
Supplementary Document
2020-04-30
Supplementary Document
2020-04-30
Supplementary Document
2020-04-30
Supplementary Document
2020-04-30
Supplementary Document
2020-04-30
Supplementary Document
2020-04-30
Supplementary Document
2020-04-30
Supplementary Document
2020-04-30
Supporting Statement B
2020-04-29
Supporting Statement A
2020-04-29
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 wtj5@cdc.gov

  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


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