Request for Approval - Change Request SSA

Emerging Infections Programs (EIP)

OMB Control Number 0920-0978

Expiration Date: 02/28/2026

Program Contact

Sonja Mali Nti-Berko, MPH

Emerging Infections Program

Rapid Response Research and Surveillance Branch (R3SB) (acting approved)

Division of Infectious Disease Readiness and Innovation (DIDRI) (acting approved)

National Center for Emerging and Zoonotic Infectious Disease (NCEZID)

U.S. Centers for Disease Control and Prevention (CDC)

1600 Clifton Rd NE, MS C18

Atlanta, GA 30333

office 770.488.4780

Submission Date: 09/8/2023

Table of Contents and Attachments

1. Non-Substantive Change Request Justification Document

2. Description of Changes (Attachment #1)

3. Cross-Walk 2023 to 2024 (Attachment #2)

4. ABCs: ABCs Case Report Form (Attachment #3)

5. ABCs: ABCs Invasive Pneumococcal disease in Children and Adults Case Report Form (Attachment #4)

6. FoodNet: FoodNet Active Surveillance Data Elements List (Attachment #5)

7. FluSurv-NET: Influenza Hospitalization Surveillance Network Case Report Form (Attachment #6)

8. FluSurv-NET: FluSurv-NET/RSV-NET Hospital Laboratory Survey (Attachment #7)

9. FluSurv-NET: COVID-19 Vaccination Status on FluSurv-NET Cases (Attachment #8)

10. HAIC: Multi-site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (CRF)

(Attachment #9)

11. HAIC: Multi-site Gram-Negative Surveillance Initiative (MuGSI) Community-Associated Carbapenemase-Producing Carbapenem-Resistant Enterobacterales (CA CP-CRE) Health interview (Attachment #10)

12. HAIC: Multi-site Gram-Negative Surveillance Initiative (MuGSI) Supplemental Surveillance Officer Survey (Attachment #11)

13. HAIC: Invasive Staphylococcus aureus Infection Case Report Form (Attachment #12)

14. HAIC: Invasive Staphylococcus aureus Supplemental Surveillance Officer (Attachment #13)

15. HAIC: Invasive Staphylococcus aureus Laboratory Survey: Use of Nucleic Acid Amplification Testing (NAAT) (Attachment #14)

16. HAIC: Clostridiodies difficile Infection (CDI) Case Report and Treatment Form (Attachment #15)

17. HAIC: Clostridiodies difficile Infection (CDI) Annual Surveillance Officers Survey (Attachment #16)

18. HAIC: Annual Survey of Laboratory Testing Practices for C. difficile Infections (Attachment #17)

19. HAIC: Candidemia Case Report Form (Attachment #18)

20. HAIC: Laboratory Testing Practices for Candidemia Questionnaire (Attachment #19)

Justification for Change Request for OMB 0920-0978

This is a nonmaterial/non-substantive change request for OMB No. 0920-0978, expiration date 02/26/2026, 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 increase by 35 hours, from 55,786 to 55,821. The data elements and justifications are described below.

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

ABCs:

1. ABCs Case Report Form

2. ABCs Invasive Pneumococcal disease in Children and Adults Case Report Form

Food Net:

1. FoodNet Active Surveillance Data Elements List

FluSurv-NET:

1. FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form

2. FluSurv-NET/RSV-NET Laboratory Survey

3. COVID-19 Vaccination Status on FluSurv-NET Cases (optional form) - This is an optional supplemental portion of the FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form. Because this project will involve automated linkage of FluSurv-NET cases to the state immunization registry, there are no additional burden hours.

4. Influenza Hospitalization Surveillance Project Vaccination Telephone Script / Consent Form (English)-Deleted

HAIC:

1. Multi-site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (CRF) - This form is a consolidation of the Multi-Site Gram-Negative Bacilli Case Report Form (MuGSI) -CRE/CRAB) and the MuGSI Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL/iEC)

2. Multi-site Gram-Negative Surveillance Initiative (MuGSI) Community-Associated Carbapenemase-Producing Carbapenem-Resistant Enterobacterales (CA CP-CRE) Health interview

3. Multi-site Gram-Negative Surveillance Initiative (MuGSI) Supplemental Surveillance Officer Survey

4. Invasive Staphylococcus aureus Infection Case Report Form - This form is a consolidation of the Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Case Report Form and the Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form

5. Invasive Staphylococcus aureus Supplemental Surveillance Officer

6. Invasive Staphylococcus aureus Laboratory Survey: Use of Nucleic Acid Amplification Testing (NAAT)

7. Clostridioides difficile Infection (CDI) Case Report and Treatment Form

8. Clostridioides difficile Infection (CDI) Annual Surveillance Officers Survey

9. Annual Survey of Laboratory Testing Practices for C. difficile Infections

10. Candidemia Case Report Form

11. Laboratory Testing Practices for Candidemia Questionnaire

Estimated Annualized Burden Hours

As a result of proposed changes to forms highlighted in yellow, the estimated annualized burden is expected to increase by 2,034 hours, from 53,784 to 55,818.

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 Name	No. of respondents	No. of responses per respondent	Avg. burden per response (in hours)	Current Total burden (in hours)
State Health Department	ABCs Case Report Form	10	809	20/60	2697
	ABCs Invasive Pneumococcal Disease in Children and Adults Case Report Form	10	127	10/60	212
	ABCs H. influenzae Neonatal Sepsis Expanded Surveillance Form	10	6	10/60	10
	ABCs Severe GAS Infection Supplemental Form	10	136	20/60	453
	ABCs Neonatal Infection Expanded Tracking Form	10	37	20/60	123
	FoodNet Campylobacter	10	970	21/60	3395
	FoodNet Cyclospora	10	42	10/60	70
	FoodNet Listeria monocytogenes	10	16	20/60	53
	FoodNet Salmonella	10	855	21/60	2993
	FoodNet Shiga toxin producing E. coli	10	290	20/60	967
	FoodNet Shigella	10	234	10/60	390
	FoodNet Vibrio	10	46	10/60	77
	FoodNet Yersinia	10	55	10/60	92
	FoodNet Hemolytic Uremic Syndrome	10	10	1	100
	FoodNet Clinical Laboratory Practices and Testing Volume	10	70	10/60	117
	FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form	15	727	25/60	4544

	COVID Vaccination Status on FluSurv-NET cases (optional)	7	727	0	0
	FluSurv-Net Influenza Hospitalization Surveillance Project Vaccination Phone Script and Consent Form (English/Spanish)	14	16	10/60	37
	FluSurv-Net Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults)	14	126	5/60	147
	FluSurv-NET Laboratory Survey	15	16	10/60	40
	HAIC - MuGSI Case Report Form	10	4700	28/60	21933
	HAIC - Invasive Staphylococcus aureus Infection Case Report Form	10	780	28/60	3640
	HAIC - CDI Case Report and Treatment Form	10	1650	38/60	10450
	HAIC Candidemia Case Report Form	10	170	40/60	1133
	HAIC- Annual Survey of Laboratory Testing Practices for C. difficile Infections	10	16	17/60	45
	HAIC- CDI Annual Surveillance Officers Survey	10	1	15/60	3
	HAIC- Emerging Infections Program C. difficile Surveillance Nursing Home Telephone Survey (LTCF)	10	45	5/60	38
	HAIC- Invasive Staphylococcus aureus Laboratory Survey	10	11	20/60	37
	HAIC- Invasive Staphylococcus aureus Supplemental Surveillance Officers Survey	10	1	10/60	2
	HAIC- Laboratory Testing Practices for Candidemia Questionnaire	10	20	14/60	47
	HAIC MuGSI CA CP-CRE Health interview	10	10	30/60	50
	HAIC MuGSI Supplemental Surveillance Officer Survey	10	1	15/60	3
	HAIC Death Ascertainment Project	10	8	1440/60	1,920
TOTAL					55,818