Emergency Epidemic Investigation Data Collections - Expedited Reviews (Y3Q4)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920-1011 Specimen Manifest Form	Form	New	Available
Form 0920-1011 National Case Report Form - Abbreviated	Form and Instruction	New	Available
Form 0920-1011 National Case Report Form - Standard	Form and Instruction	New	Available
Form 0920-1011 Medical Chart Abstraction Short Form - CDC 29AUG2019	Form and Instruction	New	Available
Form 0920-1011 Case Interview Short Form - CDC 29AUG2019	Form and Instruction	New	Available
Form 0920-1011 Acute Flaccid Myelitis Case Questionnaire - Spanish	Form and Instruction	Unchanged	Available
Form 0920-1011 Acute Flaccid Myelitis Case Questionnaire - English	Form and Instruction	Unchanged	Available
Form 0920-1011 Patient Screening Questionnaire	Form and Instruction	Unchanged	Available
Form 0920-1011 Neurologic Exam Form	Form and Instruction	Unchanged	Available
Form 0920-1011 Patient Screening Questionnaire	Form and Instruction	Unchanged	Available
Form 0920-1011 Questionnaire - Valley Fever	Form and Instruction	Unchanged	Available
Form 0920-1011 Neurologial Examination Form	Form and Instruction	Unchanged	Available
Form 0920-1011 Patient Screening Questionnaire	Form and Instruction	Unchanged	Available
0920-1011 Non-Substantive Change Request Memo 7.1.2019.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2019-07-02	Available
Appendix 2. Data Collection Forms.pdf	Supplementary Document	Uploaded 2019-02-22	Available
Appendix 1. Burden Memos.pdf	Supplementary Document	Uploaded 2019-02-22	Available
0920-1011 Non-Substantive Change Request Memo 1.9.2019.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2019-02-22	Available
0920-1011 Non-Substantive Change Request Memo 10.9.2018.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2018-10-19	Available
0920-1011 Non-Substantive Change Request Memo 7.2.2018.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2018-07-05	Available
0920-1011 Non-Substantive Change Request Memo 4.1.2018.docx	Supplementary Document	Uploaded 2018-04-11	Available
0920-1011 Non-Substantive Change Request Memo 10.3.2017 (002).docx	Supplementary Document	Uploaded 2017-10-12	Available
0920-1011 Non-Substantive Change Request Memo.docx	Supplementary Document	Uploaded 2017-07-10	Available
0920-1011 Non-Substantive Change Request Memo_Final.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2017-06-07	Available
Appendix 2. Data Collection Forms.pdf	Supplementary Document	Uploaded 2017-02-06	Available
Appendix 1. Burden Memos.pdf	Supplementary Document	Uploaded 2017-02-06	Available
0920-1011 Non-Substantive Change Request Memo_Y3Q2.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2017-02-06	Available
EEI GenICR_Supporting Statement B.docx	Supporting Statement B	Uploaded 2016-10-13	Available
EEI GenICR 0920-13ZJ_App 6_Online Survey Case Finding Questionnaire_11-06-2013.docx	Supplementary Document	Uploaded 2013-11-20	Available
EEI GenICR 0920-13ZJ_App 5_Phone Interview Questionnaire Patient_11-06-2013_Subm.docx	Supplementary Document	Uploaded 2013-11-20	Available
EEI GenICR 0920-13ZJ_App 4_Q Fever Person Interview Questionnaire_11-14-2013_Subm.docx	Supplementary Document	Uploaded 2013-11-20	Available
EEI GenICR 0920-13ZJ_App 3 _Hantav Pulm Synd Questionnaire_11-14-2013_Subm.docx	Supplementary Document	Uploaded 2013-11-20	Available
EEI GenICR 0920-13ZJ_App 2_GBS Case Questionnaire_11-14-2013_Subm.docx	Supplementary Document	Uploaded 2013-11-20	Available
EEI GenICR 0920-13ZJ_App 1_Chart Abstract Form_11-14-2013_Subm.docx	Supplementary Document	Uploaded 2013-11-20	Available
EEI GenICR 0920-13ZJ_Attach H_Biospecimen Storage Consent_11-06-2013_Subm.docx	Supplementary Document	Uploaded 2013-11-20	Available
Attach G_Emer Epi Invest_IRB Letter.pdf	Supplementary Document	Uploaded 2016-10-13	Available
EEI Gen ICR 0920-13ZJ_Attach F_Epi Invest SORN_11-06-2013.doc	Supplementary Document	Uploaded 2013-11-20	Available
Attach E _Burden Memo.docx	Supplementary Document	Uploaded 2016-10-13	Available
Attach D_Request for Approval.docx	Supplementary Document	Uploaded 2016-10-13	Available
Attach C_ Steps Conduct Emer Epi Invest.docx	Supplementary Document	Uploaded 2016-10-13	Available
Att B_published 60d FRN.pdf	Supplementary Document	Uploaded 2016-10-13	Available
EEI GenICR_0920-13ZJ_Attach A_Auth Legis Emer Epi Invest_11-06-2013_Subm.pdf	Supplementary Document	Uploaded 2013-11-20	Available
EEI_GenICR_Supporting Statement A.docx	Supporting Statement A	Uploaded 2016-10-13	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
238702	E-cigarette associated Pulmonary Illness_Multi-State	Form	New	Specimen Manifest Form
238702	E-cigarette associated Pulmonary Illness_Multi-State	Form and Instruction	New	National Case Report Form - Abbreviated
238702	E-cigarette associated Pulmonary Illness_Multi-State	Form and Instruction	New	National Case Report Form - Standard
237570	E-cigarette associated pulmonary illness	Form and Instruction	New	Medical Chart Abstraction Short Form - CDC 29AUG2019
237570	E-cigarette associated pulmonary illness	Form and Instruction	New	Case Interview Short Form - CDC 29AUG2019
236444	Undetermined cause of Acute Flaccid Myelitis, multiple states, United States, 2018	Form and Instruction	Unchanged	Acute Flaccid Myelitis Case Questionnaire - Spanish
236444	Undetermined cause of Acute Flaccid Myelitis, multiple states, United States, 2018	Form and Instruction	Unchanged	Acute Flaccid Myelitis Case Questionnaire - English
234261	Multistate outbreak of coccidioidomycosis (Valley fever) in U.S. students and adults who traveled to Tijuana area, Mexico	Form and Instruction	Unchanged	Patient Screening Questionnaire
234030	Undetermined risk factors for long term sequela resulting from Rocky Mountain spotted fever-Arizona, 2018	Form and Instruction	Unchanged	Neurologic Exam Form
234030	Undetermined risk factors for long term sequela resulting from Rocky Mountain spotted fever-Arizona, 2018	Form and Instruction	Unchanged	Patient Screening Questionnaire
232840	Multistate outbreak of coccidioidomycosis (Valley fever) in U.S. students and adults who traveled to Tijuana area, Mexico	Form and Instruction	Unchanged	Questionnaire - Valley Fever
232337	Undetermined risk factors for long term sequela resulting from Rocky Mountain spotted fever-Arizona, 2018	Form and Instruction	Unchanged	Neurologial Examination Form
232337	Undetermined risk factors for long term sequela resulting from Rocky Mountain spotted fever-Arizona, 2018	Form and Instruction	Unchanged	Patient Screening Questionnaire

ICR Details

OMB Control No: 0920-1011	ICR Reference No: 201907-0920-001
Status: Historical Active	Previous ICR Reference No: 201902-0920-013
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: 07/09/2019
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/03/2019
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.

table that charts list comparision

	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 allows CDC to responsd 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 01APR2019 - 31JUN2019.

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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: 7

table that charts list of burden

IC Title	Form No.	Form Name
E-cigarette associated Pulmonary Illness_Multi-State	0920-1011, 0920-1011, 0920-1011	National Case Report Form - Standard ,   National Case Report Form - Abbreviated ,   Specimen Manifest Form
E-cigarette associated pulmonary illness	0920-1011, 0920-1011	Case Interview Short Form - CDC 29AUG2019 ,   Medical Chart Abstraction Short Form - CDC 29AUG2019
Multistate outbreak of coccidioidomycosis (Valley fever) in U.S. students and adults who traveled to Tijuana area, Mexico	0920-1011	Questionnaire - Valley Fever
Multistate outbreak of coccidioidomycosis (Valley fever) in U.S. students and adults who traveled to Tijuana area, Mexico	0920-1011	Patient Screening Questionnaire
Undetermined cause of Acute Flaccid Myelitis, multiple states, United States, 2018	0920-1011, 0920-1011	Acute Flaccid Myelitis Case Questionnaire - English ,   Acute Flaccid Myelitis Case Questionnaire - Spanish
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
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

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ICR Summary of Burden

table that charts list 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: Non-Substantive Change Request is being submitted to comply with the stated procedures in the approved EEI Generic ICR package to reflect the actual burden for the two investigations completed during this quarter was 124 respondents and 41 burden hours.

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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: 07/03/2019

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