Information Collection Request

[NCEZID] Emerging Infections Program

ICR 202309-0920-002 · OMB 0920-0978 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Form 0920-0978 HAIC Death Ascertainment Project Form and Instruction Unchanged Repair queued
Form C5342262-A HAIC (MuGSI) Supplemental Surveillance Officer Survey Form and Instruction Modified Repair queued
Form 0920-0978 HAIC (MuGSI) Community-Associated CP-CRE Interview Form Modified Repair queued
Form 0920-0978 HAIC -Labortary Testing Practices for Candidemia Questionnaire Form Modified Repair queued
Form 0920-0978 HAIC Invasive Staphylococcus aureus Annual Surveillance Officers Survey Form and Instruction Modified Repair queued
Form 0920-0978 HAIC Invasive Staphylococcus aureus Annual Laboratory Survey Form Modified Repair queued
Form 0920-0978 HAIC CDI LTCF Survey Form and Instruction Unchanged Available
Form 0920-0978 HAIC - CDI Annual Surveillance Officers Survey Form Modified Repair queued
Form 0920-0978 HAIC CDI Annual Laboratory Survey Form Modified Missing upstream
Form CS 341327-A FluSrv-NET Laboratory Survey (2023-24) Form Modified Repair queued
Form 0920-0978 Foodnet Clinical Laboratory Practices and Testing Volume Form and Instruction Modified Repair queued
Form Short Form 2024 HAIC Candidemia Case Report Form Form Modified Repair queued
Form 0920-0978 HAIC Invasive Methicillin-Sensitive Staphylococcus aureus (MSSA) Form and Instruction Removed Repair queued
Form 0920-0978 HAIC Multi-Site Gram-Negative Surveillance Initiative - Extended Spectrum Beta-Lactamase Producing Enterobacteriaceae (MuGSI-ESBL) Form Removed Repair queued
Form 0920-0978 FluSurv-NET Hospitalization Surveillance Project History Fax Form (Children/Adults) Form and Instruction Modified Repair queued
Form 0920-0978 FluServ-NET Hospitalization Surveillance Project Vaccination PhoneScript / Consent Form (English/Spanish) Form and Instruction Modified Missing upstream
Form 0920-0978 ABCs Severe GAS Infection Supplemental Form Form and Instruction Unchanged Repair queued
Form 0920-0978 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form and Instruction Unchanged Repair queued
Form CS342262-A HAIC- Multi-Site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (CFR) Form Modified Repair queued
Form CS 342179-A HAIC CDI Case Report Form Form and Instruction Modified Missing upstream
Form 0920-0978 FoodNet Active Surveillance Data Element - [Yersinia] Form Modified Repair queued
Form 0920-0978 FoodNet Active Surveillance Data Element - [Vibrio] Form Modified Repair queued
Form 0920-0978 FoodNet Active Surveillance Data Element - [Shigella] Form Modified Repair queued
Form 0920-0978 FoodNet Active Surveillance Data Element - [Shiga toxin producing E. coli] Form Modified Repair queued
Form 0920-0978 FoodNet Active Surveillance Data Element - [Salmonella] Form Modified Repair queued
Form 0920-0978 FoodNet Active Surveillance Data Element - [Listeria monocytogenes] Form Modified Repair queued
Form 0920-0978 FoodNet Active Surveillance Data Element - [Cyclospora] Form Modified Repair queued
Form 0920-0978 FoodNet Active Surveillance Data Element [Campylobacter] Form Modified Repair queued
Form 0920-0978 Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English) Form and Instruction Removed Repair queued
Form 0920-0978 FoodNet Hemolytic Uremic Syndrome (HUS) Form and Instruction Unchanged Repair queued
Form CS340190-A FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form (CFR) Form and Instruction Modified Repair queued
Form 0920-0978 Active Bacterial Core Surveillance (ABCs) Neonatal Infection Expanded Tracking Form Form and Instruction Unchanged Repair queued
Form CDC 52.15A Active Bacterial Core Surveillance (ABCs) Invasive Pneumococcal Disease in Children (aged ≥2 months to Form and Instruction Modified Repair queued
Form CDC 52.15B HAIC Invasive Staphylococcus aureus Infection Case Report Form Form Modified Repair queued
Form CDC 52.12A 2024 Active Bacterial Core Surveillance (ABCs) Case Report Form and Instruction Modified Repair queued
Att1_EIP2024_NonSub_DescriptionChanges_Sept2023.docx Supplementary Document Uploaded 2023-09-11 Repair queued
Att2_EIP2024_NonSub_Crosswalk_Sept2023.docx Supplementary Document Uploaded 2023-09-11 Repair queued
EIP 0920-0978_Non-sub change request_SEP092023(v3).docx Justification for No Material/Nonsubstantive Change Uploaded 2023-09-11 Repair queued
Att10_COVID-19 Vaccination Status on FluSurv-NET Cases_20220808.pdf Supplementary Document Uploaded 2023-02-28 Repair queued
EIP 0920-0978_Non-sub change request_Oct2022FOR2023.docx Justification for No Material/Nonsubstantive Change Uploaded 2023-02-28 Repair queued
Att1_EIP2023_NonSub_DescriptionChanges_OCT2022.docx Justification for No Material/Nonsubstantive Change Uploaded 2023-02-28 Repair queued
Att2_EIP2023_NonSub_Crosswalk_OCT2022.docx Supplementary Document Uploaded 2023-02-28 Repair queued
Att23- HAIC CA CP-CRE interview project manual.pdf Supplementary Document Uploaded 2022-04-25 Repair queued
EIP CDI ICMS PIA Signed 2.pdf Supplementary Document Uploaded 2022-04-25 Missing upstream
MuGSI PIA Signed.pdf Supplementary Document Uploaded 2022-04-25 Repair queued
Att2- 60-Day FRN_2022.docx Supplementary Document Uploaded 2022-04-25 Missing upstream
Att1- Authorizing_Regulations_T42_section_241.pdf Supplementary Document Uploaded 2022-04-25 Repair queued
SSB_EIP 2022 Revision_04052022.docx Supporting Statement B Uploaded 2022-04-25 Repair queued
SSA_EIP 2022 Revision_04212022_SMN_Clean final_Updated_020723_highlighted edits_final OMB_final.docx Supporting Statement A Uploaded 2023-02-08 Missing upstream
IC Document Collections
IC IDCollectionTypeStatusForm
253051 HAIC Death Ascertainment Project Form and Instruction Unchanged
253049 HAIC (MuGSI) Supplemental Surveillance Officer Survey Form and Instruction Modified
253048 HAIC (MuGSI) Community-Associated CP-CRE Interview Form Modified
235058 HAIC -Labortary Testing Practices for Candidemia Questionnaire Form Modified
235057 HAIC Invasive Staphylococcus aureus Annual Surveillance Officers Survey Form and Instruction Modified
235056 HAIC Invasive Staphylococcus aureus Annual Laboratory Survey Form Modified
235055 HAIC CDI LTCF Survey Form and Instruction Unchanged
235054 HAIC - CDI Annual Surveillance Officers Survey Form Modified
235053 HAIC CDI Annual Laboratory Survey Form Modified
235052 FluSrv-NET Laboratory Survey (2023-24) Form Modified
235051 Foodnet Clinical Laboratory Practices and Testing Volume Form and Instruction Modified
231114 HAIC Candidemia Case Report Form Form Modified
231113 HAIC Invasive Methicillin-Sensitive Staphylococcus aureus (MSSA) Form and Instruction Removed
231112 HAIC Multi-Site Gram-Negative Surveillance Initiative - Extended Spectrum Beta-Lactamase Producing Enterobacteriaceae (MuGSI-ESBL) Form Removed
231111 FluSurv-NET Hospitalization Surveillance Project History Fax Form (Children/Adults) Form and Instruction Modified
231110 FluServ-NET Hospitalization Surveillance Project Vaccination PhoneScript / Consent Form (English/Spanish) Form and Instruction Modified
230869 ABCs Severe GAS Infection Supplemental Form Form and Instruction Unchanged
220380 ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form Form and Instruction Unchanged
217336 HAIC- Multi-Site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (CFR) Form Modified
217334 HAIC CDI Case Report Form Form and Instruction Modified
207663 FoodNet Active Surveillance Data Element - [Yersinia] Form Modified
207662 FoodNet Active Surveillance Data Element - [Vibrio] Form Modified
207661 FoodNet Active Surveillance Data Element - [Shigella] Form Modified
207660 FoodNet Active Surveillance Data Element - [Shiga toxin producing E. coli] Form Modified
207659 FoodNet Active Surveillance Data Element - [Salmonella] Form Modified
207658 FoodNet Active Surveillance Data Element - [Listeria monocytogenes] Form Modified
207657 FoodNet Active Surveillance Data Element - [Cyclospora] Form Modified
207655 FoodNet Active Surveillance Data Element [Campylobacter] Form Modified
207653 Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English) Form and Instruction Removed
207652 FoodNet Hemolytic Uremic Syndrome (HUS) Form and Instruction Unchanged
207651 FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form (CFR) Form and Instruction Modified
207649 Active Bacterial Core Surveillance (ABCs) Neonatal Infection Expanded Tracking Form Form and Instruction Unchanged
207648 Active Bacterial Core Surveillance (ABCs) Invasive Pneumococcal Disease in Children (aged ≥2 months to Form and Instruction Modified
207647 HAIC Invasive Staphylococcus aureus Infection Case Report Form Form Modified
207646 2024 Active Bacterial Core Surveillance (ABCs) Case Report Form and Instruction Modified
ICR Details
0920-0978 202309-0920-002
Received in OIRA 202302-0920-009
HHS/CDC 0920-0978-23HY
[NCEZID] Emerging Infections Program
No material or nonsubstantive change to a currently approved collection   No
Regular 09/12/2023
  Requested Previously Approved
02/28/2026 02/28/2026
124,293 132,520
55,818 53,784
0 0

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 Revision requests the use of two additional forms and including minor revised language and rewording to improve clarity and readability of the data collection forms. Programs covered by this ICR include: Active Bacterial Core surveillance (ABCs): active population-based laboratory surveillance for invasive bacterial diseases; Foodborne Diseases Active Surveillance Network (FoodNet): active population-based laboratory surveillance to monitor the incidence of select enteric diseases; Influenza: active population-based surveillance for laboratory confirmed influenza-related hospitalizations; and Healthcare Associated Infections-Community Interface (HAIC): active population-based surveillance for healthcare associated pathogens and infections (including Clostridium difficile infection).

US Code: 42 USC 301 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  87 FR 4891 01/31/2022
87 FR 24305 04/25/2022
No

32
IC Title Form No. Form Name
2024 Active Bacterial Core Surveillance (ABCs) Case Report CDC 52.12A 2024 Active Bacterial Core Surveillance (ABCs) Case Report
ABCs H. Influenzae Neonatal Sepsis Expanded Surveillance Form 0920-0978 ABC H. Influenzae Neonatal Sepsis Expanded Surveillance Form
ABCs Severe GAS Infection Supplemental Form 0920-0978 ABC Severe GAS Infection Supplemental Form
Active Bacterial Core Surveillance (ABCs) Invasive Pneumococcal Disease in Children (aged ≥2 months to <5 years) and Adults (aged ≥65 years) CDC 52.15A ACTIVE BACTERIAL CORE SURVEILLANCE (ABCs) INVASIVE PNEUMOCOCCAL DISEASE IN CHILDREN (aged ≥2 months to <5 years) AND ADULTS (aged ≥65 years)
Active Bacterial Core Surveillance (ABCs) Neonatal Infection Expanded Tracking Form 0920-0978 Active Bacterial Core Surveillance (ABCs) Neonatal Infection Expanded Tracking Form
FluServ-NET Hospitalization Surveillance Project Vaccination PhoneScript / Consent Form (English/Spanish) 0920-0978 APPENDIX 5B. CONTACTING PATIENTS, PROXIES OR PARENTS/GUARDIANS FOR VACCINATION STATUS
FluSrv-NET Laboratory Survey (2023-24) CS 341327-A FluSurv-NET Laboratory Survey 2023–2024 Season
FluSurv-NET Hospitalization Surveillance Project History Fax Form (Children/Adults) 0920-0978 APPENDIX 5A.2: PROVIDER ADULT VACCINATION HISTORY REQUEST LETTER/FORM
FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form (CFR) 0920-0978, CS340190-A 2022-23 FluSurv-NET Influenza Hospitalization Surveillance Project Case Report Form ,   Data Collection Elements for COVID-19 Vaccination Status on 2023-24 FluSurv-NET Cases
FoodNet Active Surveillance Data Element - [Cyclospora] 0920-0978 FoodNet Variable List, 2024
FoodNet Active Surveillance Data Element - [Listeria monocytogenes] 0920-0978 FoodNet Variable List, 2024
FoodNet Active Surveillance Data Element - [Salmonella] 0920-0978 FoodNet Variable List, 2024
FoodNet Active Surveillance Data Element - [Shiga toxin producing E. coli] 0920-0978 FoodNet Variable List, 2024
FoodNet Active Surveillance Data Element - [Shigella] 0920-0978 FoodNet Variable List, 2024
FoodNet Active Surveillance Data Element - [Vibrio] 0920-0978 FoodNet Variable List, 2024
FoodNet Active Surveillance Data Element - [Yersinia] 0920-0978 FoodNet Variable List, 2024
FoodNet Active Surveillance Data Element [Campylobacter] 0920-0978 FoodNet Variable List, 2024
FoodNet Hemolytic Uremic Syndrome (HUS) 0920-0978 FoodNet CDC's FoodNet Hemolytic Uremic syndrome (HUS) Surveillance Case Report Form
Foodnet Clinical Laboratory Practices and Testing Volume 0920-0978 FoodNET Clinical Lab Practices and Testing Volume
HAIC (MuGSI) Community-Associated CP-CRE Interview 0920-0978 CA CP-CRE Survey Questionnaire
HAIC (MuGSI) Supplemental Surveillance Officer Survey C5342262-A 2024 Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare-Associated Infections Community Interface (HAIC) Case Report
HAIC - CDI Annual Surveillance Officers Survey 0920-0978 Surveillance Officer's Survey- Clostridioides difficile Infection (CDI) Surveillance
HAIC -Labortary Testing Practices for Candidemia Questionnaire 0920-0978 2024 LABORATORY TESTING PRACTICES FOR CANDIDEMIA QUESTIONNAIRE
HAIC CDI Annual Laboratory Survey 0920-0978 Annual Survey of Laboratory Testing Practices for C. difficile Infection
HAIC CDI Case Report Form CS 342179-A CLOSTRIDIOIDES DIFFICILE INFECTION (CDI) SURVEILLANCE EMERGING INFECTIONS PROGRAM CASE REPORT
HAIC CDI LTCF Survey 0920-0978 Emerging Infections Progrom C. difficile Surveillance Nuring Home Telephone Call Survey
HAIC Candidemia Case Report Form Short Form 2024 CANDIDEMIA 2024 CASE REPORT FORM
HAIC Death Ascertainment Project 0920-0978 Death Ascertainment Project Variables
HAIC Invasive Methicillin-Sensitive Staphylococcus aureus (MSSA) 0920-0978 Invasive Methicillin-Resistant Staphylococcus aureus Healthcare-Associated Infections Community Interface (HAIC) Case Report – 2023
HAIC Invasive Staphylococcus aureus Annual Laboratory Survey 0920-0978 CDC’s Healthcare-Associated Infections Community Interface (HAIC) Staphylococcus aureus 2024 Laboratory Survey
HAIC Invasive Staphylococcus aureus Annual Surveillance Officers Survey 0920-0978 2023 HAIC Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey
HAIC Invasive Staphylococcus aureus Infection Case Report Form CDC 52.15B Invasive Staphylococcus aureus Healthcare-Associated Infections Community Interface (HAIC) Case Report – 2024
HAIC Multi-Site Gram-Negative Surveillance Initiative - Extended Spectrum Beta-Lactamase Producing Enterobacteriaceae (MuGSI-ESBL) 0920-0978 2023 MuGSI Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteriaceae/Omvasove Escjerocjoa coli (MuGSI) (HAIC) Case Report
HAIC- Multi-Site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (CFR) CS342262-A 2024 Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare-Associated Infections Community Interface (HAIC) Case Report
Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English) 0920-0978 FluSurv NET Vaccination Phone Script

  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 124,293 132,520 0 -8,227 0 0
Annual Time Burden (Hours) 55,818 53,784 0 2,034 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Changing Forms
This non-substantive change request is for changes to the disease-specific data elements for ABCs, FoodNet, FluSurv-NET, and HAIC. The changes made to all forms 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. This information can be used to inform strategies for preventing disease and negative outcomes. Specifically, changes were made for clarification purposes, to assist data collectors in capturing data in a standardized fashion to improve accuracy. As a result of proposed changes, the estimated annualized burden is expected to increase by 2,034 hours, from 53,784 to 55,818..

$36,032,895
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
No
Thelma Sims 4046394771

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
09/12/2023