Emerging Infections Program

Forms and Documents

Document Name	Status
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	Unchanged
Form 0920-0978 HAIC Multi-Site Gram-Negative Surveillance Initiative - Extended Spectrum Beta-Lactamase Producing Enterobacteriaceae (MuGSI-ESBL) Form and Instruction	Unchanged
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 HAIC Multi-Site Gram-Negative Bacilli Case Report Form for Carbapenem-Resistant Pseudomonas ajeruginosa (CR-PA) Form	Unchanged
Form 0920-0978 ABCs Severe GAS Infection Supplemental Form Form	Unchanged
Form 17AHK ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form and Instruction	Unchanged
HAIC Multi-Site Gram-Negative Bacilli Case Report Form (MuGSI-CRE/CRAB) Form	Unchanged
Form 0920-0978 HAIC CDI Case Report Form Form	Modified
ABCs Surveillance for Non-Invasive Pneumococcal Pneumonia (SNiPP) Case Report Form Form	Unchanged
Form 0920-0978 FoodNet Yersinia Form	Unchanged
Form 0920-0978 FoodNet Vibrio Form	Unchanged
Form 0920-0978 FoodNet Shigella Form	Unchanged
Form 0920-0978 FoodNet Shiga toxin producing E. coli Form	Unchanged
Form 0920-0978 FoodNet Salmonella Form	Unchanged
Form 0920-0978 FoodNet Listeria monocytogenes Form	Unchanged
Form 0920-0978 FoodNet Cyclospora Form	Unchanged
Form 0920-0978 FoodNet Cryptosporidium Form	Unchanged
Form 0920-0978 FoodNet Campylobacter Form	Unchanged
Form 0920-0978 Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English) Form and Instruction	Unchanged
FoodNet Hemolytic Uremic Syndrome (HUS) Form	Unchanged
Form 0920-0978 Influenza Hospitalization Surveilance Network Case Report Form Form	Unchanged
Form 17AHK ABCs Neonatal Infection Expanded Tracking Form Form and Instruction	Unchanged
Form 17AHK ABCs Invasive Pneumococcal Disease in Children Form and Instruction	Unchanged
Form 0920-0978 HAIC Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Form	Unchanged
Form 17AHK ABCs Case Report Form Form and Instruction	Unchanged
CDI_Non-sub change request_FINAL_20180524.doc Justification for No Material/Nonsubstantive Change	2018-05-31
02- 60-Day FRN.PDF Supplementary Document	2018-04-18
Part B_EIP OMB Revision 20MAR2018.docx Supporting Statement B	2018-03-29
Part A_EIP OMB 2018 Revision_FINAL 28MAR2018.docx Supporting Statement A	2018-03-29
Non-sub change request_FINAL_20180118.doc Justification for No Material/Nonsubstantive Change	2018-01-23
Final EIP Justification OMB 0920-0978 nonsubstantive ABCs only April262017 CLEAN.doc Justification for No Material/Nonsubstantive Change	2017-05-03
EIP OMB 0920-0978 nonsub change request.doc Justification for No Material/Nonsubstantive Change	2016-12-28
Att. B - FoodNet Variable List_2016_SiteTransmitted.pdf Supplementary Document	2016-12-28
EIP 2016 Change Request.docx Justification for No Material/Nonsubstantive Change	2016-03-02
Attachment_25_ CDI ASSENT for 13-15.pdf Supplementary Document	2015-07-07
Attachment_24_ADULT VERBAL CONSENT Assent 16_17 for CDI.PDF Supplementary Document	2015-07-07
EIP 2015 Change Request_justification_revised 2-17-15.docx Justification for No Material/Nonsubstantive Change	2015-02-17

IC Document Collections

IC ID	Document Title	Status
231114	HAIC Candidemia Case Report Form Form and Instruction	Unchanged
231113	HAIC Invasive Methicillin-Sensitive Staphylococcus aureus (MSSA) Form and Instruction	Unchanged
231112	HAIC Multi-Site Gram-Negative Surveillance Initiative - Extended Spectrum Beta-Lactamase Producing Enterobacteriaceae (MuGSI-ESBL) Form and Instruction	Unchanged
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
230870	HAIC Multi-Site Gram-Negative Bacilli Case Report Form for Carbapenem-Resistant Pseudomonas ajeruginosa (CR-PA) Form	Unchanged
230869	ABCs Severe GAS Infection Supplemental Form Form	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	Unchanged
217334	HAIC CDI Case Report Form Form	Modified
215016	ABCs Surveillance for Non-Invasive Pneumococcal Pneumonia (SNiPP) Case Report Form Form	Unchanged
207663	FoodNet Yersinia Form	Unchanged
207662	FoodNet Vibrio Form	Unchanged
207661	FoodNet Shigella Form	Unchanged
207660	FoodNet Shiga toxin producing E. coli Form	Unchanged
207659	FoodNet Salmonella Form	Unchanged
207658	FoodNet Listeria monocytogenes Form	Unchanged
207657	FoodNet Cyclospora Form	Unchanged
207656	FoodNet Cryptosporidium Form	Unchanged
207655	FoodNet Campylobacter Form	Unchanged
207653	Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English) Form and Instruction	Unchanged
207652	FoodNet Hemolytic Uremic Syndrome (HUS) Form	Unchanged
207651	Influenza Hospitalization Surveilance Network Case Report Form Form	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	Unchanged
207646	ABCs Case Report Form Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-0978	ICR Reference No: 201805-0920-010
Status: Historical Active	Previous ICR Reference No: 201803-0920-010
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0978-18AKP
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 without change	Conclusion Date: 06/05/2018
	Date Received in OIRA: 06/05/2018
Terms of Clearance: Previous terms continue: Approved consistent with the understanding that this consolidation will result in the modification and/or discontinuation of related CDC ICRs.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2021	05/31/2021	05/31/2021
Responses	115,600	0	115,600
Time Burden (Hours)	40,349	0	40,349
Cost Burden (Dollars)	0	0	0

---

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 non-substantive change request is for a change to the disease-specific data elements for HAIC only. The form for which approval for change is sought is the 2018 Clostridium difficile Infection (CDI) Case Report Form. Description of Changes • Question 11c: the data field for “Facility ID” would be added • Question 14: The option to answer “Unknown” would be added” The changes made to the HAIC CDI form under this non-substantive request will aid in improving surveillance efficiency and data quality to clarify the burden of disease and possible risk factors for disease. As a result of proposed minor change, the estimated annualized burden is expected not to change.

---

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

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:
	82 FR 60608	12/21/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 17412	04/19/2018
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 27

IC Title	Form No.	Form Name
HAIC CDI Case Report Form	0920-0978	Clostridium Difficile Infection (CDI) Surveillance Emerging Infections Program Case Report
FoodNet Shiga toxin producing E. coli	0920-0978	FoodNet Variable List (site transmitted variables)
ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form	17AHK	Att. 2 - ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form_HiNSES
ABCs Case Report Form	17AHK	Att. 1 - 2017 ACTIVE BACTERIAL CORE SURVEILLANCE CASE REPORT
ABCs Surveillance for Non-Invasive Pneumococcal Pneumonia (SNiPP) Case Report Form	none, CDC	Non Bacteremic Pneumococcal 2015 ,   2016 Surveillance for Non-Invasive Penumococcal Pneumonia (SNiPP)
HAIC Invasive Methicillin-resistant Staphylococcus aureus (MRSA)	0920-0978	Invasive Methicillin-Resistant Staphylococcus aureaus Healthcare-Associated Infections Community Interface(HAIC) Case Report - 2018
ABCs Invasive Pneumococcal Disease in Children	17AHK	Att. 4 - ACTIVE BACTERIAL CORE SURVEILLANCE (ABCs) INVASIVE PNEUMOCOCCAL DISEASE IN CHILDREN
ABCs Neonatal Infection Expanded Tracking Form	17AHK	Att. 3 - ACTIVE BACTERIAL CORE SURVEILLANCE (ABCs) Neonatal Infection Expanded Tracking Form
Influenza Hospitalization Surveilance Network Case Report Form	0920-0978	2017-18 FluSurv-NET Influenza Hospitalization Surveillance Project Case Report Form
FoodNet Hemolytic Uremic Syndrome (HUS)	NA	FoodNet Hemolytic Uremic Syndrome (HUS) Surveillance
Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English)	0920-0978, 0920-0978	FluServ-NET Consent Form - English ,   FluSurv-NET Vaccination Phone Script (English/Spanish)
FoodNet Campylobacter	0920-0978	FoodNet Variable List (site transmitted variables)
FoodNet Cryptosporidium	0920-0978	FoodNet Variable List (site transmitted variables)
FoodNet Cyclospora	0920-0978	FoodNet Variable List (site transmitted variables)
FoodNet Listeria monocytogenes	0920-0978	FoodNet Variable List (site transmitted variables)
FoodNet Salmonella	0920-0978	FoodNet Variable List (site transmitted variables)
FoodNet Shigella	0920-0978	FoodNet Variable List (site transmitted variables)
FoodNet Vibrio	0920-0978	FoodNet Variable List (site transmitted variables)
FoodNet Yersinia	0920-0978	FoodNet Variable List (site transmitted variables)
HAIC Multi-Site Gram-Negative Bacilli Case Report Form (MuGSI-CRE/CRAB)	VERSION:01-2016, NA, 0920-09078, VERSION: 11/2017	2015 Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare Associated Infection Community Interface (HAIC) Case Report ,   2016 Multi-site Gram Negative Surveillance Initiative (MuGSI) Healthcare Associated Infection Community Interface (HAIC) Case Report ,   2017 Multi-site Gram-Negative Surveillance Initiative (MuGSI) HAIC Case Report ,   2018 Multi-Site Gram-Negative Surveillance Initiative (MuGSI) Healthcare Associated Infection Community Interface (HAIC) Case Report
ABCs Severe GAS Infection Supplemental Form	0920-0978	ABCs - Severe GAS Infection: Supplemental Form
HAIC Multi-Site Gram-Negative Bacilli Case Report Form for Carbapenem-Resistant Pseudomonas ajeruginosa (CR-PA)	0920-0978	Carbapenem-resistant Pseudomonas aeruginosa Multi-Site Gram-Negative Surveillance (MuGSI) Case Report
HAIC Multi-Site Gram-Negative Surveillance Initiative - Extended Spectrum Beta-Lactamase Producing Enterobacteriaceae (MuGSI-ESBL)	0920-0978	Surveillance for Extended-Spectrum Beta- Lactamase-Producing Enterobacteriaceae Multi-Site Gram-Negative Bacilli Surveillance (MuGSI) Healthcare Associated Infection Community Interface (HAIC) CRF
HAIC Invasive Methicillin-Sensitive Staphylococcus aureus (MSSA)	0920-0978	Invasive Methicillin-Sensitive Staphylococcus aureus Healthcare-Associated Infections Community Interface (HAIC) Case Report – 2018
HAIC Candidemia Case Report Form	0920-0978	CANDIDEMIA - CASE REPORT FORM
Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults)	0920-0978	FluServ-NET Provider Vaccination History Fax Form
Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (Spanish)	0920-0978, 0920-0978	FluServ-NET Consent Form - Spanish ,   FluSurv-NET Vaccination Phone Script (English/Spanish)

---

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	115,600	115,600	0	0	0	0
Annual Time Burden (Hours)	40,349	40,349	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:

---

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.     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

---

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: 06/05/2018

---