Emerging Infections Program

Forms and Documents

Document Name	Status
Form 0920-0978 COVID-19 - CDI Case Report and Treatment Form Form and Instruction	Removed
Form 0920-0978 COVID-19 - Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form Form and Instruction	Removed
Form 0920-0978 COVID-19 - Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form Form and Instruction	Removed
Form 0920-0978 COVID-19 - MuGSI Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL) Form and Instruction	Removed
Form 0920-0978 COVID-19 - MuGSI Case Report Form for Carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB) Form and Instruction	Removed
Form 0920-0978 HAIC Candidemia Periodic Laboratory Survey Form and Instruction	Unchanged
Form 0920-0978 HAIC Invasive Staphylococcus aureus Annual Surveillance Officers Survey Form and Instruction	Unchanged
Form 0920-0978 HAIC Invasive Staphylococcus aureus Annual Laboratory Survey Form and Instruction	Unchanged
Form 0920-0978 HAIC CDI LTCF Survey Form and Instruction	Unchanged
Form 0920-0978 HAIC CDI Annual Surveillance Officers Survey Form and Instruction	Unchanged
Form 0920-0978 HAIC CDI Annual Laboratory Survey Form and Instruction	Unchanged
Form 0920-0978 Flu Surv NET Laboratory Survey Form and Instruction	Unchanged
Form 0920-0978 Foodnet Clinical Laboratory Practices and Testing Volume Form and Instruction	Unchanged
Form 0920-0978 HAIC Candidemia Case Report Form Form and Instruction	Unchanged
Form 0920-0978 HAIC Invasive Methicillin-Sensitive Staphylococcus aureus (MSSA) Form and Instruction	Modified
Form 0920-0978 HAIC Multi-Site Gram-Negative Surveillance Initiative - Extended Spectrum Beta-Lactamase Producing Enterobacteriaceae (MuGSI-ESBL) Form and Instruction	Modified
Form 0920-0978 Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults) Form and Instruction	Unchanged
Form 0920-0978 Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (Spanish) Form and Instruction	Unchanged
Form 0920-0978 ABCs Severe GAS Infection Supplemental Form Form and Instruction	Unchanged
Form 0920-0978 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form and Instruction	Unchanged
Form 0920-0978 HAIC Multi-Site Gram-Negative Bacilli Case Report Form (MuGSI-CRE/CRAB) Form and Instruction	Modified
Form 0920-0978 HAIC CDI Case Report Form Form and Instruction	Modified
Form 0920-0978 FoodNet Yersinia Form and Instruction	Unchanged
Form 0920-0978 FoodNet Vibrio Form and Instruction	Unchanged
Form 0920-0978 FoodNet Shigella Form and Instruction	Unchanged
Form 0920-0978 FoodNet Shiga toxin producing E. coli Form and Instruction	Unchanged
Form 0920-0978 FoodNet Salmonella Form and Instruction	Unchanged
Form 0920-0978 FoodNet Listeria monocytogenes Form and Instruction	Unchanged
Form 0920-0978 FoodNet Cyclospora Form and Instruction	Unchanged
Form 0920-0978 FoodNet Campylobacter Form and Instruction	Unchanged
Form 0920-0978 Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English) Form and Instruction	Unchanged
Form 0920-0978 FoodNet Hemolytic Uremic Syndrome (HUS) Form and Instruction	Unchanged
Form 0920-0978 Influenza Hospitalization Surveilance Network Case Report Form Form and Instruction	Unchanged
Form 0920-0978 ABCs Neonatal Infection Expanded Tracking Form Form and Instruction	Unchanged
Form 0920-0978 ABCs Invasive Pneumococcal Disease in Children Form and Instruction	Unchanged
Form 0920-0978 HAIC Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Form and Instruction	Modified
Form 0920-0978 ABCs Case Report Form Form and Instruction	Unchanged
0920-0978 Change Memo - EIP HAIC COVID-19 CRF additions_updated07242020_CLEAN.docx Justification for No Material/Nonsubstantive Change	2020-07-29
0920-0978 Change Memo - EIP HAIC COVID-19 CRF additions.docx Justification for No Material/Nonsubstantive Change	2020-06-24
Att24_Cross walk.pdf Supplementary Document	2019-12-10
Att23_Description of Changes.pdf Supplementary Document	2019-12-10
FoodNetSupplemental1_FN Highlights_FDD MMG cross walk_ALL_20190815.xlsx Supplementary Document	2019-10-25
FoodNetSupplemental2_FoodNet Variable List_mapping to MMG DRAFT.XLSX Supplementary Document	2019-10-25
Non-Sub ChgReq_0920-0978(121019)_OMBupdates (002).doc Justification for No Material/Nonsubstantive Change	2019-12-12
Privacy Act Checklist.docx Supplementary Document	2019-02-22
Attachment 33 - Non-research determination.pdf Supplementary Document	2019-02-22
Att 32- Flu PIA.pdf Supplementary Document	2019-02-22
Att 31- ABCs PIA.pdf Supplementary Document	2019-02-22
Att 30 - FoodNet PIA.pdf Supplementary Document	2019-02-22
Att 29- HAIC PIA.pdf Supplementary Document	2019-02-22
60 Day FRN.pdf Supplementary Document	2019-02-22
Att 1- Authorizing_Regulations_T42_section_241.pdf Supplementary Document	2019-02-22
Non-sub change request_2018.doc Justification for No Material/Nonsubstantive Change	2018-09-13
CDI_Non-sub change request_FINAL_20180524.doc Justification for No Material/Nonsubstantive Change	2018-05-31
Part B_EIP OMB 2018 Revision_20180926.docx Supporting Statement B	2019-02-22
Part A_EIP OMB 2018 Revision_20180926 ICRO revised.docx Supporting Statement A	2019-02-22

IC Document Collections

IC ID	Document Title	Status
242442	COVID-19 - CDI Case Report and Treatment Form Form and Instruction	Removed
242439	COVID-19 - Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form Form and Instruction	Removed
242425	COVID-19 - Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form Form and Instruction	Removed
242423	COVID-19 - MuGSI Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL) Form and Instruction	Removed
242413	COVID-19 - MuGSI Case Report Form for Carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB) Form and Instruction	Removed
235058	HAIC Candidemia Periodic Laboratory Survey Form and Instruction	Unchanged
235057	HAIC Invasive Staphylococcus aureus Annual Surveillance Officers Survey Form and Instruction	Unchanged
235056	HAIC Invasive Staphylococcus aureus Annual Laboratory Survey Form and Instruction	Unchanged
235055	HAIC CDI LTCF Survey Form and Instruction	Unchanged
235054	HAIC CDI Annual Surveillance Officers Survey Form and Instruction	Unchanged
235053	HAIC CDI Annual Laboratory Survey Form and Instruction	Unchanged
235052	Flu Surv NET Laboratory Survey Form and Instruction	Unchanged
235051	Foodnet Clinical Laboratory Practices and Testing Volume Form and Instruction	Unchanged
231114	HAIC Candidemia Case Report Form Form and Instruction	Unchanged
231113	HAIC Invasive Methicillin-Sensitive Staphylococcus aureus (MSSA) Form and Instruction	Modified
231112	HAIC Multi-Site Gram-Negative Surveillance Initiative - Extended Spectrum Beta-Lactamase Producing Enterobacteriaceae (MuGSI-ESBL) Form and Instruction	Modified
231111	Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults) Form and Instruction	Unchanged
231110	Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (Spanish) Form and Instruction	Unchanged
230869	ABCs Severe GAS Infection Supplemental Form Form and Instruction	Unchanged
220380	ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form and Instruction	Unchanged
217336	HAIC Multi-Site Gram-Negative Bacilli Case Report Form (MuGSI-CRE/CRAB) Form and Instruction	Modified
217334	HAIC CDI Case Report Form Form and Instruction	Modified
207663	FoodNet Yersinia Form and Instruction	Unchanged
207662	FoodNet Vibrio Form and Instruction	Unchanged
207661	FoodNet Shigella Form and Instruction	Unchanged
207660	FoodNet Shiga toxin producing E. coli Form and Instruction	Unchanged
207659	FoodNet Salmonella Form and Instruction	Unchanged
207658	FoodNet Listeria monocytogenes Form and Instruction	Unchanged
207657	FoodNet Cyclospora Form and Instruction	Unchanged
207655	FoodNet Campylobacter Form and Instruction	Unchanged
207653	Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English) Form and Instruction	Unchanged
207652	FoodNet Hemolytic Uremic Syndrome (HUS) Form and Instruction	Unchanged
207651	Influenza Hospitalization Surveilance Network Case Report Form Form and Instruction	Unchanged
207649	ABCs Neonatal Infection Expanded Tracking Form Form and Instruction	Unchanged
207648	ABCs Invasive Pneumococcal Disease in Children Form and Instruction	Unchanged
207647	HAIC Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Form and Instruction	Modified
207646	ABCs Case Report Form Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-0978	ICR Reference No: 202007-0920-014
Status: Historical Active	Previous ICR Reference No: 202006-0920-015
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0978-20QT
Title: Emerging Infections Program
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 with change	Conclusion Date: 07/31/2020
	Date Received in OIRA: 07/29/2020
Terms of Clearance: Previous terms continue: OMB is approving this information collection request for a period of three years during which time CDC will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action. Similarly, any changes to EIP as a result of ETEC pilot will be submitted for review and approval prior to fielding the data collection. Finally, approval is consistent with the understanding that CDC will continue to add language to its website and reports that clearly caveats the interpretation of longitudinal trends due to changes in the number and characteristics of participating hospitals

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2022	04/30/2022	04/30/2022
Responses	99,955	0	138,735
Time Burden (Hours)	39,673	0	40,816
Cost Burden (Dollars)	0	0	0

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Abstract: The Emerging Infections Programs (EIP) is to 1) detect and monitor emerging pathogens, the diseases they cause, and the factors influencing their emergence, and respond to problems as they are identified, 2) integrate laboratory science and epidemiology to optimize public health practice, 3) strengthen infrastructure to support surveillance and research and to implement prevention and control programs, and to 4) ensure implementation of prevention strategies and communication of public health information about emerging diseases. Surveillance efforts of the core EIP activities generate reliable estimates of the incidence of certain infections and provide the foundation for a variety of epidemiologic studies. This is a request for a non-substantive change. Requested changes represent minor modifications to already-approved instruments to include a limited number of data elements pertaining to COVID-19.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: Public Health Service Act
  

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:
	83 FR 57488	11/15/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 5685	02/22/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 32

IC Title	Form No.	Form Name
COVID-19 - MuGSI Case Report Form for Carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB)	0920-0978	COVID-19 - Carbapenem Resistant Enterobacteriaceae (CRE)/ Carbapenem Resistant A. baumannii (CRAB) MUGSI-HAIC
COVID-19 - MuGSI Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL)	0920-0978	COVID-19 42020 Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteriaceae MuGSI-HAIC
COVID-19 - Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form	0920-0978	COVID-19 Invasive Methicillin-Resistant Staphylococcus aureus Healthcare-Associated Infections Community Interface (HAIC) Case Report – 2020
COVID-19 - Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form	0920-0978	COVID -19 Invasive Methicillin-Sensitive Staphylococcus aureus Healthcare-Associated Infections Community Interface (HAIC) Case Report – 2020
COVID-19 - CDI Case Report and Treatment Form	0920-0978	COVID-19 CLOSTRIDIOIDES DIFFICILE INFECTION (CDI) SURVEILLANCE
Flu Surv NET Laboratory Survey	0920-0978	FluSurv-NET Laboratory Survey 2019-2020 Season
HAIC CDI LTCF Survey	0920-0978	Emerging Infections Progrom C. difficile Surveillance Nuring Home Telephone Call Survey
Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English)	0920-0978, 0920-0978	FluSurv NET Vaccination Phone Script ,   FluSurv NET Consent From English
HAIC Invasive Staphylococcus aureus Annual Laboratory Survey	0920-0978	HAIC Staphylococcus aureus Laboratory Survey: Use of Nucleic Acid Amplificaiton Testing (NAAT)
HAIC Invasive Staphylococcus aureus Annual Surveillance Officers Survey	0920-0978	2019 HAIC Invasive Staphylococcus aureus Supplemental Surveiallance Officer Survey
ABCs Neonatal Infection Expanded Tracking Form	0920-0978	ABC Neonatal Infection Expanded Tracking Form
Influenza Hospitalization Surveilance Network Case Report Form	0920-0978	2019-2020 FluSurv-NET Influenza Hospitalization Surveillance Project Case Report Form
FoodNet Hemolytic Uremic Syndrome (HUS)	0920-0978	FoodNet HUS CRF
FoodNet Campylobacter	0920-0978	FoodNet Active Surveillance Variable List
FoodNet Cyclospora	0920-0978	FoodNet Active Surveillance Variable List
FoodNet Listeria monocytogenes	0920-0978	FoodNet Active Surveillance Variable List
FoodNet Salmonella	0920-0978	FoodNet Active Surveillance Variable List
FoodNet Shigella	0920-0978	FoodNet Active Surveillance Variable List
FoodNet Vibrio	0920-0978	FoodNet Active Surveillance Variable List
FoodNet Yersinia	0920-0978	Foodborne and DIarrheal Diseases Message Mapping Guide (FDD MMG - FoodNet only portion)
HAIC Multi-Site Gram-Negative Bacilli Case Report Form (MuGSI-CRE/CRAB)	0920-0978	2020 Carbapenem Resistant Enterobacteriaceae (CRE) Carbapenem Resistant A. baumannii (CRAB) Multi-site Gram-Negative Bacilli Case Report Form (MuGSI-CRE/CRAB)
ABCs Severe GAS Infection Supplemental Form	0920-0978	ABC Severe GAS Infection Supplemental Form
HAIC Multi-Site Gram-Negative Surveillance Initiative - Extended Spectrum Beta-Lactamase Producing Enterobacteriaceae (MuGSI-ESBL)	0920-0978	2020 Extended-Spectrum Beta-Lactamase (ESBL)- Producting Enterobacteriaceae MuGSI (HAIC)
HAIC Invasive Methicillin-Sensitive Staphylococcus aureus (MSSA)	0920-0978	Invasive Methicillin-Sensitive Staphylococcus aureau (HAIC) Case Report 2020
HAIC Candidemia Case Report Form	0920-0978	Candidemia 2020 Case Report Form
HAIC Candidemia Periodic Laboratory Survey	0920-0978	2020 Laboratory Testing Practices for Candidemia Questionnaire
Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults)	0920-0978	FluSurv Net Provider Vaccination History Fax Form
Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (Spanish)	0920-0978, 0920-0978	FluSurv NET Vaccination Phone Script ,   FluSurv NET Consent Form Spanish
FoodNet Shiga toxin producing E. coli	0920-0978	FoodNet Active Surveillance Variable List 2019-2020
ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form	0920-0978	ABC H. Influenzae Neonatal Sepsis Expanded Surveillance Form
HAIC CDI Case Report Form	0920-0978	Clostridioides Difficile Infection (CDI Surveillance Emerging Infections Program Case Report
ABCs Case Report Form	0920-0978	2020 ABC Surveillance Case Report
HAIC Invasive Methicillin-resistant Staphylococcus aureus (MRSA)	0920-0978	Invasive Methicillin-Resistant Staphylococcus aureus (MRSA) HAIC Case Report
ABCs Invasive Pneumococcal Disease in Children	0920-0978	ABC Invasive Pneumococcal Disease in Children (age>2 months to <5 years
HAIC CDI Annual Laboratory Survey	0920-0978	Annual Survey of Laboratory Testing Practices for C. difficile Infection
HAIC CDI Annual Surveillance Officers Survey	0920-0978	Surveillance Officer's Survey
Foodnet Clinical Laboratory Practices and Testing Volume	0920-0978	Foodnet Lab Practices Volume

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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	99,955	138,735	0	0	-38,780	0
Annual Time Burden (Hours)	39,673	40,816	0	2,089	-3,232	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Addition of COVID-19 related questions to 0920-0978 EIP Forms results in increased burden hours for some instruments but an overall decrease due to entry error on last submission.

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Annual Cost to Federal Government: $31,091,990

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.     Yes

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: 07/29/2020

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