Emergency Epidemic Investigation Data Collections - Expedited Reviews (Y3Q4)

Forms and Documents

Document Name	Status
Form 0920-1011 Multistate outbreak of coccidioidomycosis (Valley fever) in U.S. students and adults who traveled to Tijuana area, Mexico Form and Instruction	New
Form 0920-1011 Undetermined risk factors for long term sequela resulting from Rocky Mountain spotted fever-Arizona, 2018 Form and Instruction	New
Form 0920-1011 Multistate outbreak of coccidioidomycosis (Valley fever) in U.S. students and adults who traveled to Tijuana area, Mexico Form and Instruction	Unchanged
Form 0920-1011 Undetermined risk factors for long term sequela resulting from Rocky Mountain spotted fever-Arizona, 2018 Form and Instruction	Unchanged
0920-1011 Non-Substantive Change Request Memo 10.9.2018.docx Justification for No Material/Nonsubstantive Change	2018-10-19
0920-1011 Non-Substantive Change Request Memo 7.2.2018.docx Justification for No Material/Nonsubstantive Change	2018-07-05
0920-1011 Non-Substantive Change Request Memo 4.1.2018.docx Supplementary Document	2018-04-11
0920-1011 Non-Substantive Change Request Memo 10.3.2017 (002).docx Supplementary Document	2017-10-12
0920-1011 Non-Substantive Change Request Memo.docx Supplementary Document	2017-07-10
0920-1011 Non-Substantive Change Request Memo_Final.docx Justification for No Material/Nonsubstantive Change	2017-06-07
Appendix 2. Data Collection Forms.pdf Supplementary Document	2017-02-06
Appendix 1. Burden Memos.pdf Supplementary Document	2017-02-06
0920-1011 Non-Substantive Change Request Memo_Y3Q2.docx Justification for No Material/Nonsubstantive Change	2017-02-06
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
234261	Multistate outbreak of coccidioidomycosis (Valley fever) in U.S. students and adults who traveled to Tijuana area, Mexico Form and Instruction	New
234030	Undetermined risk factors for long term sequela resulting from Rocky Mountain spotted fever-Arizona, 2018 Form and Instruction	New
232840	Multistate outbreak of coccidioidomycosis (Valley fever) in U.S. students and adults who traveled to Tijuana area, Mexico Form and Instruction	Unchanged
232337	Undetermined risk factors for long term sequela resulting from Rocky Mountain spotted fever-Arizona, 2018 Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-1011	ICR Reference No: 201810-0920-007
Status: Historical Active	Previous ICR Reference No: 201807-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1011
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: 10/25/2018
	Date Received in OIRA: 10/25/2018
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	01/31/2020	01/31/2020	01/31/2020
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. This request is the quarterly report of inventory for 01APR2018 - 30JUN2018.

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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: 4

IC Title	Form No.	Form Name
Undetermined risk factors for long term sequela resulting from Rocky Mountain spotted fever-Arizona, 2018	0920-1011, 0920-1011	Patient Screening Questionnaire ,   Neurologic Exam Form
Multistate outbreak of coccidioidomycosis (Valley fever) in U.S. students and adults who traveled to Tijuana area, Mexico	0920-1011	Questionnaire - Valley Fever
Undetermined risk factors for long term sequela resulting from Rocky Mountain spotted fever-Arizona, 2018	0920-1011, 0920-1011	Patient Screening Questionnaire ,   Neurologial Examination Form
Multistate outbreak of coccidioidomycosis (Valley fever) in U.S. students and adults who traveled to Tijuana area, Mexico	0920-1011	Patient Screening Questionnaire

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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

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? 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: 10/25/2018

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