Emerging Infections Program

Forms and Documents

Document Name	Status
Form CDC 10-2015 2015 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form	New
Resistant Gram-Negative Bacilli Case Report Form Form	Modified
CDI Treatment Form Form	Unchanged
CDI Case Report Form Form	Modified
ABCs Non Bacteremic Pneumococcal Disease Form	Modified
FluSurv-Net Project Consent Form Form	Unchanged
Influenza Hospitalization Surveillance Project Vaccination Telephone Survey Form	Unchanged
FluSurv-NET Influenza Hospitalization Surveilance Project Case Report Form Form	Modified
Legionellosis ABCs Case Report Form	Unchanged
ABCs Neonatal Infection Expanded Tracking Form Form	Unchanged
ABCs Invasive Pneumococcal Disease in Children Form	Unchanged
Invasive Methicillin - Resistant - Staphylococcus aureus ABCs Case Report Form Form	Modified
ABCs Case Report Form Form	Modified
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
Att. 4- FoodNet Variable List.pdf Supplementary Document	2016-03-02

IC Document Collections

IC ID	Document Title	Status
220380	2015 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form	New
217339	CDI Telephone Interview Other-Telephone Interview	Unchanged
217338	CDI Screening Form Other-Interview Screen	Unchanged
217336	Resistant Gram-Negative Bacilli Case Report Form Form	Modified
217335	CDI Treatment Form Form	Unchanged
217334	CDI Case Report Form Form	Modified
215016	ABCs Non Bacteremic Pneumococcal Disease Form	Modified
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) Other-WORD	Unchanged
207651	FluSurv-NET Influenza Hospitalization Surveilance Project Case Report Form Form	Modified
207650	Legionellosis ABCs Case Report Form	Unchanged
207649	ABCs Neonatal Infection Expanded Tracking Form Form	Unchanged
207648	ABCs Invasive Pneumococcal Disease in Children Form	Unchanged
207647	Invasive Methicillin - Resistant - Staphylococcus aureus ABCs Case Report Form Form	Modified
207646	ABCs Case Report Form Form	Modified

ICR Details

OMB Control No: 0920-0978	ICR Reference No: 201603-0920-001
Status: Historical Active	Previous ICR Reference No: 201507-0920-003
Agency/Subagency: HHS/CDC	Agency Tracking No: 16SA
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: 03/03/2016
	Date Received in OIRA: 03/02/2016
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	81,420	0	81,110
Time Burden (Hours)	22,806	0	22,755
Cost Burden (Dollars)	0	0	0

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Abstract: This is a revision request seeking inclusion of additional core EIP activities to include Healthcare Associated Infections-Community (HAIC); active population-based surveillance for healthcare associated pathogens and infections (including Clostridium difficile infection). There are no changes being made to other parts of the EIP (ABCs, FoodNet or Influenza) included in this revision request..

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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: 25

IC Title	Form No.	Form Name
Shiga toxin producing E. coli
Shigella
Vibrio
Yersinia
Resistant Gram-Negative Bacilli Case Report Form	VERSION:01-2016, NA	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
CDI Case Report Form	CDC Rev.10-2015, NA	Clostridium Difficile Infection (CDI) Surveillance Emerging Infections Program Case Report ,   Clostridium Difficile Infection (CDI) Surveillance Emerging Infections Program Case Report
CDI Treatment Form	NA	EIP CDI Surveillance: CDI Case Treatment Questionnaire
CDI Telephone Interview
CDI Screening Form
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
2015 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form	CDC 10-2015	2015 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form
ABCs Case Report Form	none, CDC 52.15A REV. 10-2015	ABCsCRF 2015 ,   2016 Active Bacterial Core Surveillance (ABCs) 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	none, CDC 52.15B Rev 10-2015	Invasive Methicillin-Resistant Staph ,   Healthcare-Associated Infections Community Interface (HACI) Case Report -2016
ABCs Invasive Pneumococcal Disease in Children	none	Invasive Pneumococcal 2015
ABCs Neonatal Infection Expanded Tracking Form	none	Neonatal Tracking
Legionellosis ABCs Case Report	none	Legionellosis Case Report
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)

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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	81,420	81,110	0	310	0	0
Annual Time Burden (Hours)	22,806	22,755	0	51	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: No

Burden Reduction Due to:

Short Statement: The requested changes have minimal impact on the burden of this data collection. Minor changes to certain forms are being made in order to enhance disease surveillance. In total, this non-substantive change request accounts for an additional 51 burden hours.

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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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 03/02/2016

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