Emergency Epidemic Investigation Data Collections - Expedited Reviews

Forms and Documents

Document Name	Status
EEI GenICR_Supporting Statement B.docx Supporting Statement B	2016-10-13
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	2016-10-13
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	2016-10-13
Attach C_ Steps Conduct Emer Epi Invest.docx Supplementary Document	2016-10-13
Att B_published 60d FRN.pdf Supplementary Document	2016-10-13
EEI GenICR_0920-13ZJ_Attach A_Auth Legis Emer Epi Invest_11-06-2013_Subm.pdf Supplementary Document	2013-11-20
EEI_GenICR_Supporting Statement A.docx Supporting Statement A	2016-10-13

IC Document Collections

IC ID	Document Title	Status

ICR Details

OMB Control No: 0920-1011	ICR Reference No: 201610-0920-006
Status: Historical Active	Previous ICR Reference No: 201608-0920-012
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1011
Title: Emergency Epidemic Investigation Data Collections - Expedited Reviews
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/19/2017
	Date Received in OIRA: 10/13/2016
Terms of Clearance: 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	01/31/2020	36 Months From Approved	03/31/2017
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 Generic ICR requests extension of an approved ICR to conduct Emergency Epidemic Investigations. In response to external partner requests for assistance during outbreaks or other urgent events, EEI data collections aim to identify the agents, sources, modes of transmission, or risk factors to effectively implement rapid prevention and control measures.

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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:
	81 FR 46675	07/18/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 66028	09/26/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 0

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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: $1,547,376

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 10/13/2016

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