View Information Collection Request (ICR) Package

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

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.

Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. PHSA

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	36,230	26,980	9,250
Annual Time Burden (Hours)	16,579	16,954	-375
Annual Cost Burden (Dollars)	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).

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

Agency Contact: Jeffrey Zirger 404 639-7118 wtj5@cdc.gov

View ICR - OIRA Conclusion