Emerging Infections Program

Forms and Documents

Document Name	Status
Form 17AHK 2015 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form and Instruction	Unchanged
Form 0920-09078 Resistant Gram-Negative Bacilli Case Report Form Form	Modified
CDI Treatment Form Form	Removed
Form 0920-0978 CDI Case Report Form Form	Modified
ABCs Non Bacteremic Pneumococcal Disease Form	Unchanged
FluSurv-Net Project Consent Form Form	Unchanged
Influenza Hospitalization Surveillance Project Vaccination Telephone Survey Form	Unchanged
Hemolytic Uremic Syndrome (HUS) Form	Unchanged
FluSurv-NET Influenza Hospitalization Surveilance Project 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
Invasive Methicillin-Resistant - Staphylococcus aureus ABCs Case Report Form Form	Modified
Form 17AHK ABCs Case Report Form Form and Instruction	Unchanged
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
60 day published.pdf Supplementary Document	2015-07-07
Part B_EIP OMB 2015 Revision_SMN 23Feb2016.docx Supporting Statement B	2016-02-24
Part A_EIP OMB 2015 Revision_SMN 23Feb2016.docx Supporting Statement A	2016-02-24
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
220380	2015 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form and Instruction	Unchanged
217339	CDI Telephone Interview Other-Telephone Interview	Removed
217338	CDI Screening Form Other-Interview Screen	Removed
217336	Resistant Gram-Negative Bacilli Case Report Form Form	Modified
217335	CDI Treatment Form Form	Removed
217334	CDI Case Report Form Form	Modified
215016	ABCs Non Bacteremic Pneumococcal Disease Form	Unchanged
207663	Yersinia Other-WORD	Unchanged
207662	Vibrio Other-WORD	Unchanged
207661	Shigella Other-WORD	Unchanged
207660	Shiga toxin producing E. coli Other-WORD	Unchanged
207659	Salmonella Other-WORD	Unchanged
207658	Listeria monocytogenes Other-WORD	Unchanged
207657	Cyclospora Other-WORD	Unchanged
207656	Cryptosporidium Other-WORD	Unchanged
207655	Campylobacter Other-WORD	Unchanged
207654	FluSurv-Net Project Consent Form Form	Unchanged
207653	Influenza Hospitalization Surveillance Project Vaccination Telephone Survey Form	Unchanged
207652	Hemolytic Uremic Syndrome (HUS) Form	Unchanged
207651	FluSurv-NET Influenza Hospitalization Surveilance Project 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	Invasive Methicillin-Resistant - Staphylococcus aureus ABCs Case Report Form Form	Modified
207646	ABCs Case Report Form Form and Instruction	Unchanged

ICR Details

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
	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

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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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