[NCEZID] Emerging Infections Program

Forms and Documents

Document Name	Status
Form HAIC.400.13 Data Elements Transferred to CDC for the HAIC Death Ascertainment Project Form and Instruction	Modified
Form HAIC.400.3 2024 HAIC Multi-site Gram-negative Surveillance Initiative (MuGSI) Supplemental Surveillance Officer Survey Form and Instruction	Modified
Form HAIC.400.2 Community-Associated CP-CRE Interview Form and Instruction	Modified
Form HAIC.400.12 HAIC_2024 LABORATORY TESTING PRACTICES FOR CANDIDEMIA QUESTIONNAIRE Form and Instruction	Modified
Form HAIC.400.6 2023 HAIC Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey Form and Instruction	Modified
Form HAIC.400.5 CDC's Healthcare-Associated Infections Community Interface (HAIC) Staphylococcus aureus 2024 Laboratory Survey Form and Instruction	Modified
Form HAIC.400.10 Emerging Infections Program C. difficile Surveillance Nursing Home Telephone Survey Form and Instruction	Modified
Form HAIC.400.9 HAIC-Surveillance Officer's Survey Form and Instruction	Modified
Form HAIC.400.8 Annual Survey of Laboratory Testing Practices for C. difficile Infection Form and Instruction	Modified
Form FSN.300.4 FluSurv-NET Laboratory Survey 2023–2024 Season Form	Modified
Form FN.200.10 FoodNET Lab Survey Variable List 2024 Form	Modified
Form HAIC.400.11 CANDIDEMIA 2024 CASE REPORT FORM Form and Instruction	Modified
Form HAIC.400.4 Invasive Staphylococcus aureus Healthcare-Associated Infections Community Interface (HAIC) Case Report – 2024 Form and Instruction	Modified
Form FSN.300.3 FLUSURV-NET: PROVIDER PEDIATRIC VACCINATION HISTORY REQUEST LETTER/FORM Form and Instruction	Modified
Form 0920-0978 Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (Spanish) Form and Instruction	Removed
Form ABC.100.4 ABCs Severe GAS Infection: Supplemental Form Form and Instruction	Modified
Form ABC.100.3 2019 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form and Instruction	Modified
Form HAIC.400.1 2024 (MuGSI) Healthcare-Associated Infections Community Interface (HAIC) Case Report Form	Modified
Form HAIC.400.7 CLOSTRIDIOIDES DIFFICILE INFECTION (CDI) SURVEILLANCE EMERGING INFECTIONS PROGRAM CASE REPORT Form and Instruction	Modified
Form FN.200.8 FoodNet Variable List, 2024_ (YERSINIA) Form and Instruction	Modified
Form FN.200.7 FoodNet Variable List, 2024_ (VIBRIO) Form and Instruction	Modified
Form FN.200.6 FoodNet Variable List, 2024_ (SHIGELLA) Form and Instruction	Modified
Form FN.200.5 FoodNet Variable List, 2024_ (SHIGA TOXIN PRODUCING E.COLI) Form and Instruction	Modified
Form FN.200.4 FoodNet Variable List, 2024_ (SALMONELLA) Form and Instruction	Modified
Form FN.200.3 FoodNet Variable List, 2024_ (LISTERIA MONOCTOGENES) Form and Instruction	Modified
Form FN.200.2 FoodNet Variable List, 2024_ (CYCLOSPORA) Form and Instruction	Modified
Form FN.200.1 FoodNet Variable List, 2024_(CAMPYLOBACTER) Form and Instruction	Modified
Form FSN.300.2 FLUSURV-NET: CONSENT FORM FOR PATIENT/PROXY INTERVIEW (English/Spanish) Form and Instruction	Modified
Form ABC.200.9 FoodNet Hemolytic Uremic Syndrome (HUS) Form and Instruction	Modified
Form FSN.300.1 FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form Form and Instruction	Modified
Form ABC.100.5 Active Bacterial Core Surveillance (ABCs) Neonatal Infection Expanded Tracking Form Form and Instruction	Modified
Form ABC.100.2 ABCs Invasive Pneumococcal Disease in Children and Adults Form and Instruction	Modified
Form ABC.100.1 2024 Active Bacterial Core Surveillance (ABCs) Case Report Form and Instruction	Modified
Att. 6-Explanation for Program Changes.docx Supplementary Document	2024-07-11
Att. 5-Human Subjects Determination Memo.pdf Supplementary Document	2024-07-11
Att. 4a-Privacy Impact Assessment.pdf Supplementary Document	2024-07-11
Att. 2-Federal Register 60day FRN.pdf Supplementary Document	2024-07-11
Att. 1-Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2024-07-11
2. Supporting Statement B_EIP OMB 2024 Revision.docx Supporting Statement B	2024-07-11
1. Supporting Statement A_EIP OMB 2024 Revision.docx Supporting Statement A	2024-07-11

IC Document Collections

IC ID	Document Title	Status
253051	Data Elements Transferred to CDC for the HAIC Death Ascertainment Project Form and Instruction	Modified
253049	2024 HAIC Multi-site Gram-negative Surveillance Initiative (MuGSI) Supplemental Surveillance Officer Survey Form and Instruction	Modified
253048	Community-Associated CP-CRE Interview Form and Instruction	Modified
235058	HAIC_2024 LABORATORY TESTING PRACTICES FOR CANDIDEMIA QUESTIONNAIRE Form and Instruction	Modified
235057	2023 HAIC Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey Form and Instruction	Modified
235056	CDC's Healthcare-Associated Infections Community Interface (HAIC) Staphylococcus aureus 2024 Laboratory Survey Form and Instruction	Modified
235055	Emerging Infections Program C. difficile Surveillance Nursing Home Telephone Survey Form and Instruction	Modified
235054	HAIC-Surveillance Officer's Survey Form and Instruction	Modified
235053	Annual Survey of Laboratory Testing Practices for C. difficile Infection Form and Instruction	Modified
235052	FluSurv-NET Laboratory Survey 2023–2024 Season Form	Modified
235051	FoodNET Lab Survey Variable List 2024 Form	Modified
231114	CANDIDEMIA 2024 CASE REPORT FORM Form and Instruction	Modified
231113	Invasive Staphylococcus aureus Healthcare-Associated Infections Community Interface (HAIC) Case Report – 2024 Form and Instruction	Modified
231111	FLUSURV-NET: PROVIDER PEDIATRIC VACCINATION HISTORY REQUEST LETTER/FORM Form and Instruction	Modified
231110	Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (Spanish) Form and Instruction	Removed
230869	ABCs Severe GAS Infection: Supplemental Form Form and Instruction	Modified
220380	2019 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form and Instruction	Modified
217336	2024 (MuGSI) Healthcare-Associated Infections Community Interface (HAIC) Case Report Form	Modified
217334	CLOSTRIDIOIDES DIFFICILE INFECTION (CDI) SURVEILLANCE EMERGING INFECTIONS PROGRAM CASE REPORT Form and Instruction	Modified
207663	FoodNet Variable List, 2024_ (YERSINIA) Form and Instruction	Modified
207662	FoodNet Variable List, 2024_ (VIBRIO) Form and Instruction	Modified
207661	FoodNet Variable List, 2024_ (SHIGELLA) Form and Instruction	Modified
207660	FoodNet Variable List, 2024_ (SHIGA TOXIN PRODUCING E.COLI) Form and Instruction	Modified
207659	FoodNet Variable List, 2024_ (SALMONELLA) Form and Instruction	Modified
207658	FoodNet Variable List, 2024_ (LISTERIA MONOCTOGENES) Form and Instruction	Modified
207657	FoodNet Variable List, 2024_ (CYCLOSPORA) Form and Instruction	Modified
207655	FoodNet Variable List, 2024_(CAMPYLOBACTER) Form and Instruction	Modified
207653	FLUSURV-NET: CONSENT FORM FOR PATIENT/PROXY INTERVIEW (English/Spanish) Form and Instruction	Modified
207652	FoodNet Hemolytic Uremic Syndrome (HUS) Form and Instruction	Modified
207651	FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form Form and Instruction	Modified
207649	Active Bacterial Core Surveillance (ABCs) Neonatal Infection Expanded Tracking Form Form and Instruction	Modified
207648	ABCs Invasive Pneumococcal Disease in Children and Adults Form and Instruction	Modified
207646	2024 Active Bacterial Core Surveillance (ABCs) Case Report Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0978	ICR Reference No: 202406-0920-004
Status: Received in OIRA	Previous ICR Reference No: 202312-0920-011
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0978
Title: [NCEZID] Emerging Infections Program
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/26/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2026
Responses	92,358	127,703
Time Burden (Hours)	41,483	56,133
Cost Burden (Dollars)	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.

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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:
	89 FR 14501	02/27/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 58736	07/19/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 32

IC Title	Form No.	Form Name
2019 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form	ABC.100.3	2019 ABC H. Influenzae Neonatal Sepsis Expanded Surveillance Form
2023 HAIC Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey	HAIC.400.6	2023 HAIC Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey
2024 (MuGSI) Healthcare-Associated Infections Community Interface (HAIC) Case Report	HAIC.400.1	2024 Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare-Associated Infections Community Interface (HAIC) Case Report
2024 Active Bacterial Core Surveillance (ABCs) Case Report	ABC.100.1	2024 Active Bacterial Core Surveillance (ABCs) Case Report
2024 HAIC Multi-site Gram-negative Surveillance Initiative (MuGSI) Supplemental Surveillance Officer Survey	HAIC.400.3	2024 HAIC Multi-site Gram-negative Surveillance Initiative (MuGSI) Supplemental Surveillance Officer Survey
ABCs Invasive Pneumococcal Disease in Children and Adults	ABC.100.2	ACTIVE BACTERIAL CORE SURVEILLANCE (ABCs) INVASIVE PNEUMOCOCCAL DISEASE IN CHILDREN (aged ≥2 months to <5 years) AND ADULTS (aged ≥65 years)
ABCs Severe GAS Infection: Supplemental Form	ABC.100.4	ABCs Severe GAS Infection: Supplemental Form
Active Bacterial Core Surveillance (ABCs) Neonatal Infection Expanded Tracking Form	ABC.100.5	ACTIVE BACTERIAL CORE SURVEILLANCE (ABCs) NEONATAL INFECTION EXPANDED TRACKING FORM
Annual Survey of Laboratory Testing Practices for C. difficile Infection	HAIC.400.8	Annual Survey of Laboratory Testing Practices for C. difficile Infection
CANDIDEMIA 2024 CASE REPORT FORM	HAIC.400.11	CANDIDEMIA 2024 CASE REPORT FORM
CDC's Healthcare-Associated Infections Community Interface (HAIC) Staphylococcus aureus 2024 Laboratory Survey	HAIC.400.5	CDC’s Healthcare-Associated Infections Community Interface (HAIC) Staphylococcus aureus 2024 Laboratory Survey
CLOSTRIDIOIDES DIFFICILE INFECTION (CDI) SURVEILLANCE EMERGING INFECTIONS PROGRAM CASE REPORT	HAIC.400.7	CLOSTRIDIOIDES DIFFICILE INFECTION (CDI) SURVEILLANCE EMERGING INFECTIONS PROGRAM CASE REPORT
Community-Associated CP-CRE Interview	HAIC.400.2	Community-Associated CP-CRE Interview
Data Elements Transferred to CDC for the HAIC Death Ascertainment Project	HAIC.400.13	Data Elements Transferred to CDC for the HAIC Death Ascertainment Project
Emerging Infections Program C. difficile Surveillance Nursing Home Telephone Survey	HAIC.400.10	Emerging Infections Program C. difficile Surveillance Nursing Home Telephone Survey
FLUSURV-NET: CONSENT FORM FOR PATIENT/PROXY INTERVIEW (English/Spanish)	FSN.300.2	FLUSURV-NET: CONSENT FORM FOR PATIENT/PROXY INTERVIEW
FLUSURV-NET: PROVIDER PEDIATRIC VACCINATION HISTORY REQUEST LETTER/FORM	FSN.300.3	FLUSURV-NET: PROVIDER PEDIATRIC VACCINATION HISTORY REQUEST LETTER/FORM
FluSurv-NET Laboratory Survey 2023–2024 Season	FSN.300.4	FluSurv-NET Laboratory Survey 2023–2024 Season
FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form	FSN.300.1	Influenza Hospitalizatin Surveillance Network (FluSurv-NET) Case Report Form
FoodNET Lab Survey Variable List 2024	FN.200.10	FoodNET Lab Survey Variable List, 2024
FoodNet Hemolytic Uremic Syndrome (HUS)	ABC.200.9	FoodNet CDC's FoodNet Hemolytic Uremic Syndrome (HUS) Surveillance Case Report Form
FoodNet Variable List, 2024_ (CYCLOSPORA)	FN.200.2	FoodNet Variable List, 2024_ (CYCLOSPORA)
FoodNet Variable List, 2024_ (LISTERIA MONOCTOGENES)	FN.200.3	FoodNet Variable List, 2024_ (LISTERIA MONOCYTOGENES)
FoodNet Variable List, 2024_ (SALMONELLA)	FN.200.4	FoodNet Variable List, 2024_ (SALMONELLA)
FoodNet Variable List, 2024_ (SHIGA TOXIN PRODUCING E.COLI)	FN.200.5	FoodNet Variable List, 2024_ (SHIGA TOXIN PRODUCING E.COLI)
FoodNet Variable List, 2024_ (SHIGELLA)	FN.200.6	FoodNet Variable List, 2024_ (SHIGELLA)
FoodNet Variable List, 2024_ (VIBRIO)	FN.200.7	FoodNet Variable List, 2024_ (VIBRIO)
FoodNet Variable List, 2024_ (YERSINIA)	FN.200.8	FoodNet Variable List, 2024_ (YERSINIA)
FoodNet Variable List, 2024_(CAMPYLOBACTER)	FN.200.1	FoodNet Variable List, 2024_ (CAMPYLOBACTER)
HAIC-Surveillance Officer's Survey	HAIC.400.9	HAIC Surveillance Officer’s Survey
HAIC_2024 LABORATORY TESTING PRACTICES FOR CANDIDEMIA QUESTIONNAIRE	HAIC.400.12	2024 LABORATORY TESTING PRACTICES FOR CANDIDEMIA QUESTIONNAIRE
Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (Spanish)	0920-0978	FluSurv NET Vaccination Phone Script
Invasive Staphylococcus aureus Healthcare-Associated Infections Community Interface (HAIC) Case Report – 2024	HAIC.400.4	Invasive Staphylococcus aureus Healthcare-Associated Infections Community Interface (HAIC) Case Report – 2024

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ICR Summary of Burden

	Total Request	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	92,358	127,703	0	-32,015	-3,330	0
Annual Time Burden (Hours)	41,483	56,133	0	-14,372	-278	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: This is a request for a revision. There are 13 total forms being changed as a part of this revision and no new forms being added. Most of the collection activities remain the same, however, there are a few proposed revisions including minor revised language and rewording to improve clarity and readability of the data collection forms. Details of each collection instrument for the revision are included in attachment entitled Explanation for Program Changes (Attachment 6).

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Annual Cost to Federal Government: $41,699,051

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.     Yes

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? No

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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: 07/26/2024

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