Emergency Epidemic Investigation Data Collections- -Expedited Review (Y3Q4)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920-1011 Aggregate counts of persons exposed to highly pathogenic avian influenza (HPAI)	Form and Instruction	New	Repair queued
Form 0920-1011 Appendix 8: Domestic Hepatitis-Adenovirus Investigation Consent - SPANISH	Form and Instruction	New	Repair queued
Form 0920-1011 Appendix 7: Pediatric Hepatitis of Unknown Etiology- Exposures Questionnaire (Parental Interview) - SPANISH	Form and Instruction	New	Repair queued
Form 0920-1011 Appendix 6: Domestic Hepatitis-Adenovirus Investigation Consent: Controls (residual blood)	Form and Instruction	New	Repair queued
Form 0920-1011 Appendix 5: Pediatric Hepatitis of Unknown Etiology- Exposures Questionnaire: Controls (Parental Interview)	Form and Instruction	New	Repair queued
Form 0920-1011 Appendix 4: Pediatric Hepatitis of Unknown Etiology Medical Record Abstraction Form: Controls (CRF)	Form and Instruction	New	Repair queued
Form 0920-1011 Appendix 3: Domestic Hepatitis-Adenovirus Investigation Consent	Form and Instruction	New	Repair queued
Form 0920-1011 Appendix 2: Pediatric Hepatitis of Unknown Etiology- Exposures Questionnaire (Parental Interview)	Form and Instruction	New	Repair queued
Form 0920-1011 Appendix 1: Pediatric Hepatitis of Unknown Etiology Medical Record Abstraction Form (CRF)	Form and Instruction	New	Repair queued
Form 0920-1011 Aggregate counts of persons exposed to highly pathogenic avian influenza (HPAI)	Form and Instruction	New	Repair queued
Form 0920-1011 CDC Pediatric Brain Abscess Case Reporting Form	Form and Instruction	New	Repair queued
Form 0920-1011 2022 Case Report Form_MPX	Form and Instruction	New	Repair queued
Form 0920-1011 Consent Form	Form and Instruction	New	Repair queued
Form 0920-1011 Pediatric Hepatitis of Unknown Etiology Exposures Questionnaire	Form and Instruction	New	Repair queued
Form 0920-1011 Pediatric Hepatitis of Unknown Etiology Case Report Form	Form and Instruction	New	Repair queued
Form 0920-1011 Human Sera Collection Guidelines for Flu Serology	Form and Instruction	New	Available
Form 0920-1011 HPAI H5 Self Swab Instructions (Spanish)	Form and Instruction	New	Available
Form 0920-1011 HPAI H5 Self Swab Instructions (English)	Form and Instruction	New	Available
Form 0920-1011 Highly Pathogenic Avian Influenza A (H5N1) Exposure Questionnaire (Spanish)	Form and Instruction	New	Available
Form 0920-1011 Highly Pathogenic Avian Influenza A (H5N1) Exposure Questionnaire (English)	Form and Instruction	New	Available
Form 0920-1011 Avian Influenza Initial Case Investigation Form (Spanish)	Form and Instruction	New	Available
Form 0920-1011 Avian Influenza Initial Case Investigation Form (English)	Form and Instruction	New	Available
Form 0920-1011 HPAI H5 Consent Form (Spanish)	Form and Instruction	New	Available
Form 0920-1011 HPAI H5 Consent Form (English)	Form and Instruction	New	Available
Form 0920-1011 Aggregate counts of persons exposed to HPAI	Form and Instruction	New	Available
0920-1011 Non-Substantive Change Request Memo_Oct-Dec 2021.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2022-01-13	Repair queued
0920-1011 Non-Substantive Change Request Memo.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-10-20	Repair queued
0920-1011 Non-Substantive Change Request Memo.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-08-31	Repair queued
Change Request 01JAN-31MAR2021.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-04-28	Repair queued
Appendix 1 Burden Memos.pdf	Supplementary Document	Uploaded 2021-01-21	Repair queued
Appendix 2 Data Collection Forms.pdf	Supplementary Document	Uploaded 2021-01-21	Repair queued
0920-1011 Non-Substantive Change Request Memo.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-01-21	Repair queued
Appendix 2. Data Collection Forms.pdf	Supplementary Document	Uploaded 2020-12-11	Repair queued
Appendix 1. Burden Memos.pdf	Supplementary Document	Uploaded 2020-12-11	Repair queued
0920-1011 Non-Substantive Change Request Memo.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-12-11	Repair queued
Change Request.Increase Respondents. 11.5.2020 (003).docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-12-04	Repair queued
Change Request 8.24.2020.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-09-01	Repair queued
Appendix 2. Data Collection Forms.pdf	Supplementary Document	Uploaded 2020-04-15	Repair queued
Appendix 1. Burden Memos.pdf	Supplementary Document	Uploaded 2020-04-07	Repair queued
0920-1011 Non-Substantive Change Request Memo.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-04-07	Repair queued
Appendix 1. Burden Memos.pdf	Supplementary Document	Uploaded 2020-02-12	Repair queued
0920-1011 Non-Substantive Change Request Memo.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-02-12	Repair queued
EEI_GenICR_SupSta A_FINAL.docx	Supporting Statement A	Uploaded 2020-01-15	Repair queued
EEI GenICR_Sup St B.docx	Supporting Statement B	Uploaded 2020-01-15	Repair queued
EEI GenICR 0920-13ZJ_App 6_Online Survey Case Finding Questionnaire_11-06-2013.docx	Supplementary Document	Uploaded 2013-11-20	Repair queued
EEI GenICR 0920-13ZJ_App 5_Phone Interview Questionnaire Patient_11-06-2013_Subm.docx	Supplementary Document	Uploaded 2013-11-20	Repair queued
EEI GenICR 0920-13ZJ_App 4_Q Fever Person Interview Questionnaire_11-14-2013_Subm.docx	Supplementary Document	Uploaded 2013-11-20	Repair queued
EEI GenICR 0920-13ZJ_App 3 _Hantav Pulm Synd Questionnaire_11-14-2013_Subm.docx	Supplementary Document	Uploaded 2013-11-20	Repair queued
EEI GenICR 0920-13ZJ_App 2_GBS Case Questionnaire_11-14-2013_Subm.docx	Supplementary Document	Uploaded 2013-11-20	Repair queued
EEI GenICR 0920-13ZJ_App 1_Chart Abstract Form_11-14-2013_Subm.docx	Supplementary Document	Uploaded 2013-11-20	Repair queued
EEI GenICR 0920-13ZJ_Attach H_Biospecimen Storage Consent_11-06-2013_Subm.docx	Supplementary Document	Uploaded 2013-11-20	Repair queued
Attach G _Emer Epi Invest_IRB Letter.pdf	Supplementary Document	Uploaded 2019-11-20	Repair queued
EEI Gen ICR 0920-13ZJ_Attach F_Epi Invest SORN_11-06-2013.doc	Supplementary Document	Uploaded 2013-11-20	Repair queued
Attach E _Burden Memo.docx	Supplementary Document	Uploaded 2016-10-13	Repair queued
Attach D_Request for Approval.docx	Supplementary Document	Uploaded 2019-11-20	Repair queued
Attach C_ Steps Conduct Emer Epi Invest.docx	Supplementary Document	Uploaded 2016-10-13	Repair queued
60dy191011 Published_2019-19019.pdf	Supplementary Document	Uploaded 2020-01-15	Available
EEI GenICR_0920-13ZJ_Attach A_Auth Legis Emer Epi Invest_11-06-2013_Subm.pdf	Supplementary Document	Uploaded 2013-11-20	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
256232	Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	Form and Instruction	New	Aggregate counts of persons exposed to highly pathogenic avian influenza (HPAI)
254913	Undetermined agent for hepatitis among children <10 years of age – United States, 2022	Form and Instruction	New	Appendix 8: Domestic Hepatitis-Adenovirus Investigation Consent - SPANISH
254913	Undetermined agent for hepatitis among children <10 years of age – United States, 2022	Form and Instruction	New	Appendix 7: Pediatric Hepatitis of Unknown Etiology- Exposures Questionnaire (Parental Interview) - SPANISH
254913	Undetermined agent for hepatitis among children <10 years of age – United States, 2022	Form and Instruction	New	Appendix 6: Domestic Hepatitis-Adenovirus Investigation Consent: Controls (residual blood)
254913	Undetermined agent for hepatitis among children <10 years of age – United States, 2022	Form and Instruction	New	Appendix 5: Pediatric Hepatitis of Unknown Etiology- Exposures Questionnaire: Controls (Parental Interview)
254913	Undetermined agent for hepatitis among children <10 years of age – United States, 2022	Form and Instruction	New	Appendix 4: Pediatric Hepatitis of Unknown Etiology Medical Record Abstraction Form: Controls (CRF)
254913	Undetermined agent for hepatitis among children <10 years of age – United States, 2022	Form and Instruction	New	Appendix 3: Domestic Hepatitis-Adenovirus Investigation Consent
254913	Undetermined agent for hepatitis among children <10 years of age – United States, 2022	Form and Instruction	New	Appendix 2: Pediatric Hepatitis of Unknown Etiology- Exposures Questionnaire (Parental Interview)
254913	Undetermined agent for hepatitis among children <10 years of age – United States, 2022	Form and Instruction	New	Appendix 1: Pediatric Hepatitis of Unknown Etiology Medical Record Abstraction Form (CRF)
254452	Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	Form and Instruction	New	Aggregate counts of persons exposed to highly pathogenic avian influenza (HPAI)
254169	Pediatric Brain Abscesses, Epidural Empyemas, and Subdural Empyemas Associated with Streptococcal Species	Form and Instruction	New	CDC Pediatric Brain Abscess Case Reporting Form
253927	2022_Monkeypox Response	Form and Instruction	New	2022 Case Report Form_MPX
253054	Undetermined agent for hepatitis among children <10 years of age – United States, 2022	Form and Instruction	New	Consent Form
253054	Undetermined agent for hepatitis among children <10 years of age – United States, 2022	Form and Instruction	New	Pediatric Hepatitis of Unknown Etiology Exposures Questionnaire
253054	Undetermined agent for hepatitis among children <10 years of age – United States, 2022	Form and Instruction	New	Pediatric Hepatitis of Unknown Etiology Case Report Form
252724	Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	Form and Instruction	New	Human Sera Collection Guidelines for Flu Serology
252724	Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	Form and Instruction	New	HPAI H5 Self Swab Instructions (Spanish)
252724	Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	Form and Instruction	New	HPAI H5 Self Swab Instructions (English)
252724	Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	Form and Instruction	New	Highly Pathogenic Avian Influenza A (H5N1) Exposure Questionnaire (Spanish)
252724	Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	Form and Instruction	New	Highly Pathogenic Avian Influenza A (H5N1) Exposure Questionnaire (English)
252724	Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	Form and Instruction	New	Avian Influenza Initial Case Investigation Form (Spanish)
252724	Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	Form and Instruction	New	Avian Influenza Initial Case Investigation Form (English)
252724	Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	Form and Instruction	New	HPAI H5 Consent Form (Spanish)
252724	Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	Form and Instruction	New	HPAI H5 Consent Form (English)
252724	Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	Form and Instruction	New	Aggregate counts of persons exposed to HPAI

ICR Details

OMB Control No: 0920-1011	ICR Reference No: 202201-0920-010
Status: Historical Active	Previous ICR Reference No: 202110-0920-009
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1011-22BV
Title: Emergency Epidemic Investigation Data Collections- -Expedited Review (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: 01/18/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/13/2022
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	01/31/2023	01/31/2023	01/31/2023
Responses	805,759	0	805,759
Time Burden (Hours)	402,874	0	402,874
Cost Burden (Dollars)	0	0	0

---

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.” In this quarter there were no EEIs to report, so this non-substantive change request has zero burden to report from July 1, 2021 to September 30, 2021.

---

Authorizing Statute(s): US Code: 42 USC 301 Name of Law: 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:
	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

---

Number of Information Collection (IC) in this ICR: 7

table that charts list of burden

IC Title	Form No.	Form Name
2022_Monkeypox Response	0920-1011	2022 Case Report Form_MPX
Pediatric Brain Abscesses, Epidural Empyemas, and Subdural Empyemas Associated with Streptococcal Species	0920-1011	CDC Pediatric Brain Abscess Case Reporting Form
Undetermined agent for hepatitis among children <10 years of age – United States, 2022	0920-1011, 0920-1011, 0920-1011, 0920-1011, 0920-1011, 0920-1011, 0920-1011, 0920-1011	Appendix 1: Pediatric Hepatitis of Unknown Etiology Medical Record Abstraction Form (CRF) ,   Appendix 2: Pediatric Hepatitis of Unknown Etiology- Exposures Questionnaire (Parental Interview) ,   Appendix 3: Domestic Hepatitis-Adenovirus Investigation Consent ,   Appendix 4: Pediatric Hepatitis of Unknown Etiology Medical Record Abstraction Form: Controls (CRF) ,   Appendix 5: Pediatric Hepatitis of Unknown Etiology- Exposures Questionnaire: Controls (Parental Interview) ,   Appendix 6: Domestic Hepatitis-Adenovirus Investigation Consent: Controls (residual blood) ,   Appendix 7: Pediatric Hepatitis of Unknown Etiology- Exposures Questionnaire (Parental Interview) - SPANISH ,   Appendix 8: Domestic Hepatitis-Adenovirus Investigation Consent - SPANISH
Undetermined agent for hepatitis among children <10 years of age – United States, 2022	0920-1011, 0920-1011, 0920-1011	Pediatric Hepatitis of Unknown Etiology Case Report Form ,   Pediatric Hepatitis of Unknown Etiology Exposures Questionnaire ,   Consent Form
Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	0920-1011, 0920-1011, 0920-1011, 0920-1011, 0920-1011, 0920-1011, 0920-1011, 0920-1011, 0920-1011, 0920-1011	Aggregate counts of persons exposed to HPAI ,   HPAI H5 Consent Form (English) ,   HPAI H5 Consent Form (Spanish) ,   Avian Influenza Initial Case Investigation Form (English) ,   Avian Influenza Initial Case Investigation Form (Spanish) ,   Highly Pathogenic Avian Influenza A (H5N1) Exposure Questionnaire (English) ,   Highly Pathogenic Avian Influenza A (H5N1) Exposure Questionnaire (Spanish) ,   HPAI H5 Self Swab Instructions (English) ,   HPAI H5 Self Swab Instructions (Spanish) ,   Human Sera Collection Guidelines for Flu Serology
Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	0920-1011	Aggregate counts of persons exposed to highly pathogenic avian influenza (HPAI)
Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022	0920-1011	Aggregate counts of persons exposed to highly pathogenic avian influenza (HPAI)

---

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	805,759	805,759	0	0	0	0
Annual Time Burden (Hours)	402,874	402,874	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: This non-substantive change request includes reporting for data collection completed from July 1, 2020 to September 30, 2020. The actual burden for the one investigation completed during this quarter was 1,414 respondents and 1,081 burden hours.

---

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

---

Common Form ICR:  No

---

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: 01/13/2022

---