Emerging Infections Program

OMB Control No: 0920-0978	ICR Reference No: 201801-0920-004
Status: Historical Active	Previous ICR Reference No: 201705-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0978-18LX
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: 01/29/2018
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/24/2018
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	02/28/2019	02/28/2019	02/28/2019
Responses	62,820	0	80,420
Time Burden (Hours)	22,090	0	22,473
Cost Burden (Dollars)	0	0	0

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Abstract: disease-specific data elements for HAIC only. As a result of proposed changes, the estimated annualized burden is expected to decrease by 383 hours, from 22,473 to 22,090. The forms for which approval for changes and additions are being sought include: 1. 2018 Resistant Gram-Negative Bacilli (MuGSI) Case Report Form for Carbapenem-resistant Enterobacteriaceae and Acinetobacter baumannii (Att. 1) 2. 2018 Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form (Att. 2) 3. 2018 Clostridium difficile Infection (CDI) Case Report Form (Att. 3). NOTE: the 2018 form combines two approved 2017 forms (the CDI Case Report Form and the CDI Treatment Form) into a single form. 4. Persons in the Community with Clostridium difficile infection (CDI): Screening Form (discontinued) 5. Persons in the Community with Clostridium difficile infection (CDI): Telephone Interview Form (discontinued)

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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:
	80 FR 26051	05/06/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 39780	07/10/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 21

IC Title Form No. Form Name CDI Screening Form CDI Telephone Interview Shigella Vibrio Yersinia CDI Treatment Form NA EIP CDI Surveillance: CDI Case Treatment Questionnaire Resistant Gram-Negative Bacilli Case Report Form VERSION: 11/2017, VERSION:01-2016, NA, 0920-09078 2018 Multi-Site Gram-Negative Surveillance Initiative (MuGSI) Healthcare Associated Infection Community Interface (HAIC) Case Report ,   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 CDI Case Report Form CDC Rev 09-2016, CDC Rev.10-2015, NA, 0920-0978 Clostridium Difficile Infection (CDI) Surveillance Emerging Infections Program Case Report ,   Clostridium Difficile Infection (CDI) Surveillance Emerging Infections Program Case Report ,   Clostridium Difficile Infection (CDI) Surveillance Emerging Infections Program Case Report ,   CLOSTRIDIUM DIFFICILE INFECTION (CDI) SURVEILLANCE EMERGING INFECTIONS PROGRAM CASE REPORT Shiga toxin producing E. coli 2015 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 Non Bacteremic Pneumococcal Disease CDC, none Non Bacteremic Pneumococcal 2015 ,   2016 Surveillance for Non-Invasive Penumococcal Pneumonia (SNiPP) Invasive Methicillin-Resistant - Staphylococcus aureus ABCs Case Report Form 0920-0978, CDC 52.15B Rev 09-2016, none, CDC 52.15B Rev 10-2015 Invasive Methicillin-Resistant Staph ,   Invasive Methicillin-Resistant Staphylococcus aureaus Healthcare-Associated Infections Community Interface(HAIC) Case Report - 2018 ,   Healthcare-Associated Infections Community Interface (HACI) Case Report -2016 ,   Invasive Methicillin-Resistant Staphylococcus aureus HAIC Case Report - 2017 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 FluSurv-NET Influenza Hospitalization Surveilance Project Case Report Form CDC Rev 07-2015, none FluSurv-NET Influenza Hospital Surveillance Project ,   2015-16 FluSurv-NET Influenza Hospitalization Surveillance Project Case Report Form Hemolytic Uremic Syndrome (HUS) NA FoodNet Hemolytic Uremic Syndrome (HUS) Surveillance Influenza Hospitalization Surveillance Project Vaccination Telephone Survey none Vaccination Telephone Survey - English FluSurv-Net Project Consent Form none Consent Campylobacter Cryptosporidium Cyclospora Listeria monocytogenes Salmonella

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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	62,820	80,420	0	-17,600	0	0
Annual Time Burden (Hours)	22,090	22,473	0	-383	0	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: Yes

Burden Reduction Due to: Changing Forms

Short Statement: The submission of this Non-Substantive Change Request entails an overall decrease in Burden Hours due to the changes in the following forms associated with 0920-0978 Emerging Infections Program: 2018 Resistant Gram-Negative Bacilli (MuGSI) Case Report Form 2018 Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form 2018 Clostridium difficile Infection (CDI) Case Report Form Additionally the following instruments were discontinued: Clostridium difficile infection (CDI): Screening Form Clostridium difficile infection (CDI): Telephone Interview Form

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Annual Cost to Federal Government: $20,221,865

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: 01/24/2018

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