OMB CY 08

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Emerging Infections Programs (EIP)
 OMB Control Number 0920-0978
Expiration Date:09/30/2027



Program Contact

Sonja Mali Nti-Berko, MPH
Emerging Infections Program
Rapid Response Research and Surveillance Branch (RRRSB)
Division of Infectious Disease Readiness and Innovation (DIDRI)
National Center for Emerging and Zoonotic Infectious Disease (NCEZID)
U.S. Centers for Disease Control and Prevention (CDC)
1600 Clifton Rd NE
Atlanta, GA 30333
office 770.488.4780

Submission Date: 09/24/2024

 
Table of Contents and Attachments



    1. Non-Substantive Change Request Justification Document
    2. Explanation of Changes (Attachment #1)
    3. Cross-Walk (Attachment #2)
    4. Data Collection Instruments
        a. ABC.100.1 ABCs Case Report Form
        b. ABC.100.2 ABCs Invasive Pneumococcal Disease in Children and Adults Case Report Form
        c. ABC.100.5 ABCs Neonatal Infection Expanded Tracking Form
        d. FN200.1-200.8 FoodNet Variable List
        e. FSN.300.1 FluSurv-NET Case Report Form
        f. HAIC.400.1 Multi-Site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form 
        g. HAIC.400.4 Invasive Staphylococcus aureus HAIC Case Report 
        h. HAIC.400.6 HAIC Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey 
        i. HAIC.400.7 CDI Case Report and Treatment Form   
        j. HAIC.400.8  Annual Survey of Laboratory Testing Practices for C. difficile Infections 
        k. HAIC.400.9 CDI Annual Surveillance Officers Survey  
        l. HAIC.400.11 Candidemia CRF 
        m. HAIC.400.12 Laboratory Testing Practices for Candidemia


Justification for Change Request for OMB 0920-0978

This is a nonmaterial/non-substantive change request for OMB No. 0920-0978, expiration date 09/30/2027, for the Emerging Infections Programs (EIP).  All requested changes represent minor modifications to already-approved instruments including revised formatting, rewording, new answer options, and the addition/subtraction of a limited number of questions. 

The Emerging Infections Programs (EIPs) are population-based centers of excellence established through a network of state health departments collaborating with academic institutions, local health departments, public health and clinical laboratories, infection control professionals, and healthcare providers.  EIPs assist in local, state, and national efforts to prevent, control, and monitor the public health impact of infectious diseases.  

Activities of the EIPs fall into the following general categories:  (1) active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) flexible response to public health emergencies.  Activities of the EIPs are designed to: (1) address issues that the EIP network is particularly suited to investigate; (2) maintain sufficient flexibility for emergency response and new problems as they arise; (3) develop and evaluate public health interventions to inform public health policy and treatment guidelines; (4) incorporate training as a key function; and (5) prioritize projects that lead directly to the prevention of disease.

Activities in the EIP Network in which all applicants must participate are:
    • 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 Hospitalization Surveillance Network (FluSurv-NET): active population-based surveillance for laboratory confirmed influenza-related hospitalizations.
    • Healthcare-Associated Infections-Community Interface (HAIC) surveillance: active population-based surveillance for healthcare-associated pathogens and infections. 

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 decrease by 1,470 hours, from 41,483 to 40,013. The data elements and justifications are described below. 

The forms for which approval for changes are being sought include:


ABCs:
ABC.100.1 ABCs Case Report Form
ABC.100.2 ABCs Invasive Pneumococcal Disease in Children and Adults Case Report Form
ABC.100.5 ABCs Neonatal Infection Expanded Tracking Form

Food Net:
FN200.1-FN200.8 FoodNet Active Surveillance Data Elements List

FluSurv-NET: 
FSN.300.1 FluSurv-NET Case Report Form

HAIC:
HAIC.400.1 Multi-Site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form 
HAIC.400.4 Invasive Staphylococcus aureus HAIC Case Report 
HAIC.400.6 Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey 
HAIC.400.7 CDI Case Report and Treatment Form   
HAIC.400.8  Annual Survey of Laboratory Testing Practices for C. difficile Infections 
HAIC.400.9 CDI Annual Surveillance Officers Survey  
HAIC.400.11 Candidemia CRF 
HAIC.400.12 Laboratory Testing Practices for Candidemia



Estimated Annualized Burden Hours
As a result of proposed changes to forms highlighted in yellow, the estimated annualized burden is expected to decrease by 1,470 hours, from 41,483 to 40,013.  

The following table is updated for the entire 0920-0978 burden table. The forms included in this change request are highlighted:

2024 - Estimated Annualized Burden Hours 

Table A.12-A1. Estimated Annualized Burden Hours

Type of Respondent
Form Number
Form Name
No. of respondents
No. of responses per respondent 
Avg. burden per response (in hours)
Current
Total burden (in hours)
State Health Department
ABC.100.1
ABCs Case Report Form
10
809
20/60
2697

ABC.100.2
ABCs Invasive Pneumococcal Disease in Children and Adults Case Report Form
10
127
10/60
212

ABC.100.3
ABCs H. influenzae Neonatal Sepsis Expanded Surveillance Form 
10
6
10/60
10

ABC.100.4
ABCs Severe GAS Infection Supplemental Form
10
136
20/60
453

ABC.100.5
ABCs Neonatal Infection Expanded Tracking Form 
10
37
20/60
123

FN.200.1
FoodNet Campylobacter
10
550
21/60
1925

FN.200.2
FoodNet Cyclospora
10
42
10/60
70

FN.200.3
FoodNet Listeria monocytogenes
10
16
20/60
53

FN.200.4
FoodNet Salmonella
10
855
21/60
2993

FN.200.5
FoodNet Shiga toxin producing E. coli
10
290
20/60
967

FN.200.6
FoodNet Shigella
10
234
10/60
390

FN.200.7
FoodNet Vibrio
10
46
10/60
77

FN.200.8
FoodNet Yersinia
10
55
10/60
92

FN.200.9
FoodNet Hemolytic Uremic Syndrome
10
10
1
100

FN.200.10
FoodNet Clinical Laboratory Practices and Testing Volume
10
70
10/60
117

FSN.300.1
FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form
15
576
25/60
3600

FSN.300.2
FluSurv-Net Influenza Hospitalization Surveillance Project Vaccination Phone Script and Consent Form (English/Spanish)
13
16
10/60
34

FSN.300.3
FluSurv-Net Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults) and notification letter
13
126
5/60
136

FSN.300.4
FluSurv-NET Laboratory Survey
15
16
10/60
40

HAIC.400.1
HAIC- Multi-site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (CRF)
11
1581
29/60
8406

HAIC.400.2
HAIC MuGSI CA CP-CRE Health interview 
10
10
30/60
50

HAIC.400.3
HAIC MuGSI Supplemental Surveillance Officer Survey 
11
1
20/60
4

HAIC.400.4
HAIC- Invasive Staphylococcus aureus Infection Case Report Form
10
788
29/60
3809

HAIC.400.5
HAIC- Invasive Staphylococcus aureus Laboratory Survey
10
11
9/60
17

HAIC.400.6
HAIC- Invasive Staphylococcus aureus Supplemental Surveillance Officers Survey
10
1
11/60
2

HAIC.400.7
HAIC - CDI Case Report and Treatment Form 
10
1650
38/60
10450

HAIC.400.8
HAIC- Annual Survey of Laboratory Testing Practices for C. difficile Infections
10
16
17/60
45

HAIC.400.9
HAIC- CDI Annual Surveillance Officers Survey
10
1
15/60
3

HAIC.400.10
HAIC- Emerging Infections Program C. difficile Surveillance Nursing Home Telephone Survey (LTCF)
10
45
5/60
38

HAIC.400.11
HAIC Candidemia Case Report Form
10
170
40/60
1133

HAIC.400.12
HAIC- Laboratory Testing Practices for Candidemia Questionnaire
10
20
14/60
47

HAIC.400.13
HAIC Death Ascertainment Project 
10
8
24
1,920
TOTAL

40,013