Change Request Memo 08OCT2024

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

   1. ABC.100.1 ABCs Case Report Form

   2. ABC.100.2 ABCs Invasive Pneumococcal Disease in Children and Adults Case Report Form

   3. ABC.100.5 ABCs Neonatal Infection Expanded Tracking Form

   4. FN200.1-200.8 FoodNet Variable List

   5. FSN.300.1 FluSurv-NET Case Report Form

   6. HAIC.400.1 Multi-Site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form

   7. HAIC.400.4 Invasive Staphylococcus aureus HAIC Case Report

   8. HAIC.400.6 HAIC Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey

   9. HAIC.400.7 CDI Case Report and Treatment Form

   10. HAIC.400.8 Annual Survey of Laboratory Testing Practices for C. difficile Infections

   11. HAIC.400.9 CDI Annual Surveillance Officers Survey

   12. HAIC.400.11 Candidemia CRF

   13. 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