Emerging Infections Program

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
Retrieve Notice of Action (NOA)	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

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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 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.

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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:
	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

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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)

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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	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:

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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.     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

Agency Contact: Jeffrey Zirger 404 639-7118 [email protected]

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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: 06/05/2018

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