Emergency Epidemic Investigation Data Collections - Expedited Reviews (Y3Q4)

Forms and Documents

Document Name	Status
Form 0920-1011 2019-nCoV Investigation, United States, 2020 Form and Instruction	Modified
Appendix 1. Burden Memos.pdf Supplementary Document	2020-02-12
0920-1011 Non-Substantive Change Request Memo.docx Justification for No Material/Nonsubstantive Change	2020-02-12
EEI_GenICR_SupSta A_FINAL.docx Supporting Statement A	2020-01-15
EEI GenICR_Sup St B.docx Supporting Statement B	2020-01-15
EEI GenICR 0920-13ZJ_App 6_Online Survey Case Finding Questionnaire_11-06-2013.docx Supplementary Document	2013-11-20
EEI GenICR 0920-13ZJ_App 5_Phone Interview Questionnaire Patient_11-06-2013_Subm.docx Supplementary Document	2013-11-20
EEI GenICR 0920-13ZJ_App 4_Q Fever Person Interview Questionnaire_11-14-2013_Subm.docx Supplementary Document	2013-11-20
EEI GenICR 0920-13ZJ_App 3 _Hantav Pulm Synd Questionnaire_11-14-2013_Subm.docx Supplementary Document	2013-11-20
EEI GenICR 0920-13ZJ_App 2_GBS Case Questionnaire_11-14-2013_Subm.docx Supplementary Document	2013-11-20
EEI GenICR 0920-13ZJ_App 1_Chart Abstract Form_11-14-2013_Subm.docx Supplementary Document	2013-11-20
EEI GenICR 0920-13ZJ_Attach H_Biospecimen Storage Consent_11-06-2013_Subm.docx Supplementary Document	2013-11-20
Attach G _Emer Epi Invest_IRB Letter.pdf Supplementary Document	2019-11-20
EEI Gen ICR 0920-13ZJ_Attach F_Epi Invest SORN_11-06-2013.doc Supplementary Document	2013-11-20
Attach E _Burden Memo.docx Supplementary Document	2016-10-13
Attach D_Request for Approval.docx Supplementary Document	2019-11-20
Attach C_ Steps Conduct Emer Epi Invest.docx Supplementary Document	2016-10-13
60dy191011 Published_2019-19019.pdf Supplementary Document	2020-01-15
EEI GenICR_0920-13ZJ_Attach A_Auth Legis Emer Epi Invest_11-06-2013_Subm.pdf Supplementary Document	2013-11-20

IC Document Collections

IC ID	Document Title	Status
239474	2019-nCoV Investigation, United States, 2020 Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1011	ICR Reference No: 202002-0920-005
Status: Historical Active	Previous ICR Reference No: 202001-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1011-20IQ
Title: Emergency Epidemic Investigation Data Collections - Expedited Reviews (Y3Q4)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/18/2020
	Date Received in OIRA: 02/12/2020
Terms of Clearance: Previous terms continue: Approved consistent with the understanding that GenICs under this generic will be limited to acute public health emergencies resulting from outbreaks or events with undetermined agent, source, mode of transmission, or risk factors. Data collection for investigations conducted under this generic will not exceed 90 days. Investigations conducted for the primary purpose of program evaluation, surveillance, needs assessment, or research (e.g., to contribute to generalizable knowledge) are excluded from this generic pathway.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	01/31/2023	01/31/2023
Responses	36,000	0	36,000
Time Burden (Hours)	18,000	0	18,000
Cost Burden (Dollars)	0	0	0

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Abstract: This non-substantive change request is submitted to comply with the stated procedures in the approved EEI Generic ICR package (as specified in point 5 under Special Circumstances Relating to the Guidelines of 5 CFR 1320.5), “CDC maintains a library of data collection instruments that includes all final data collection instruments conducted under this generic ICR. This library and the updated burden numbers based on data collected via the “Burden Memo” are submitted to OMB quarterly as a non-substantive change to the generic ICR.” This non-substantive change request includes the following: Burden Memos (Appendix 1) and final data collection forms (Appendix 2) for the investigations conducted under 0920-1011 for which data collection was completed from October 1, 2019 to December 31, 2019. The EEI Generic ICR is specifically designed to support CDC mission-critical functions by allowing CDC to deploy to the field to conduct Emergency Epidemic Investigations (EEIs) at the request of, and under the public health authority of, external partners seeking support for a rapid response to urgent public health problems. Data collection methods will vary depending on the circumstances and needs of the investigation and will include epidemiologic investigations, environmental assessment, and laboratory testing. The respondent universe is the population to which results will be generalized, and will vary depending on the outbreak or event, but is not a mechanism to collect data that can be generalized to the broader population. The population to which results are generalizable is limited to those potentially exposed to or affected by the health event under investigation.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: 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:
	84 FR 46535	09/04/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 66908	12/06/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
2019-nCoV Investigation, United States, 2020	0920-1011, 0920-1011, 0920-1011, 0920-1011	2019 nCoV Case Report Form ,   2019 nCoV PUI Form ,   2019 nCoV Household Close Contact Investigation ,   Severe Pulmonary Disease Associatd with E-Cigarette Use Outbreak (Case Interview Short Form (CDC))

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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	36,000	36,000	0	0	0	0
Annual Time Burden (Hours)	18,000	18,000	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $1,586,352

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.     No

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? 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: 02/12/2020

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