Request for Approval Non-substantial Change

Emerging Infections Programs (EIP)

OMB Control Number 0920-0978

Expiration Date: 02/28/2026

Non-Substantive Change Request

Submission Date: 02/08/2023

Program Contact

Sonja Mali Nti-Berko

Emerging Infections Programs (EIP)

Division of Preparedness and Emerging Infections

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Rd, MS-C18

Atlanta, GA 30329

Phone: (404) 488-4780

E-mail: [email protected]

Table of Contents and Attachments

1. Non-Substantive Change Request Justification Document

2. Description of Changes (Attachment #1)

3. Cross-Walk 2022 to 2023 (Attachment #2)

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

5. ABCs: ABCs Neonatal Infection Expanded Tracking Form (Attachment #4)

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

7. FoodNet: FoodNet Hemolytic Uremic Syndrome (Attachment #6)

8. FoodNet: Diagnostic Laboratory Practices and Volume Data Elements List (Attachment #7)

9. FluSurv-NET: Influenza Hospitalization Surveillance Network Case Report Form (Attachment #8)

10. FluSurv-NET: FluSurv-NET/RSV-NET Hospital Laboratory Survey (Attachment #9)

11. FluSurv-NET: COVID-19 Vaccination Status on FluSurv-NET Cases (Attachment #10)

12. HAIC: Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form (Attachment #11)

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

14. HAIC: Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacterales / Invasive Escherichia coli (iEC) Multi-site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (CRF) (Attachment #13)

15. HAIC: Carbapenem-Resistant Enterobacterales (CRE) and Carbapenem-Resistant Acinetobacter baumannii (CRAB) Multi-site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (CRF) (Attachment #14)

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

17. HAIC: 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 (Attachment #18)

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

21. HAIC: Invasive Staphylococcus aureus Supplemental Surveillance Officer (Attachment #20)

22. HAIC: Invasive Staphylococcus aureus Laboratory Survey: Use of Nucleic Acid Amplification Testing (NAAT) (Attachment #21)

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 392 hours, from 55,394 to 55,786. The data elements and justifications are described below.

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

ABCs:

1. 2023 ABCs Case Report Form

2. 2023 ABCs Neonatal Infection Expanded Tracking Form

Food Net:

3. FoodNet Active Surveillance Data Elements List

4. FoodNet Hemolytic Uremic Syndrome

5. Diagnostic Laboratory Practices and Volume Data Elements List

FluSurv-NET:

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

4. FluSurv-NET/RSV-NET Laboratory Survey

5. COVID-19 Vaccination Status on FluSurv-NET Cases (optional form)

6. Patient/Proxy Influenza Vaccination Phone Script and Consent Form (Pediatric/Adult) in Spanish (Form deleted)

HAIC:

3. 2020 Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form

4. 2020 Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form

5. Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacterales / Invasive Escherichia coli (iEC) Multi-site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (CRF)

6. Carbapenem-Resistant Enterobacterales (CRE) and Carbapenem-Resistant Acinetobacter baumannii (CRAB) Multi-site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (CRF)

7. CDI Case Report and Treatment Form

8. CDI Annual Surveillance Officers Survey

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

10. Candidemia Case Report

11. Laboratory Testing Practices for Candidemia Questionnaire

12. Invasive Staphylococcus aureus Supplemental Surveillance Officer

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

Estimated Annualized Burden Hours

As a result of proposed changes to forms highlighted in yellow, the estimated annualized burden is expected to increase by 392 hours, from 55,394 to 55,786. The figures highlighted in red are the forms where there was a change in burden hours.

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

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)	Proposed Total burden (in hours)
State Health Department	ABCs Case Report Form	10	809	20/60	2697	2697
	ABCs Invasive Pneumococcal Disease in Children and Adults Case Report Form	10	127	10/60	212	212
	ABCs H. influenzae Neonatal Sepsis Expanded Surveillance Form	10	6	10/60	10	10
	ABCs Severe GAS Infection Supplemental Form	10	136	20/60	453	453
	ABCs Neonatal Infection Expanded Tracking Form	10	37	20/60	123	123
	FoodNet Campylobacter	10	970	21/60	3395	3395
	FoodNet Cyclospora	10	42	10/60	70	70
	FoodNet Listeria monocytogenes	10	16	20/60	53	53
	FoodNet Salmonella	10	855	21/60	2993	2993
	FoodNet Shiga toxin producing E. coli	10	290	20/60	967	967
	FoodNet Shigella	10	234	10/60	390	390
	FoodNet Vibrio	10	46	10/60	77	77
	FoodNet Yersinia	10	55	10/60	92	92
	FoodNet Hemolytic Uremic Syndrome	10	10	1	100	100
	FoodNet Clinical Laboratory Practices and Testing Volume	10	70	10/60	233	117
	FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form	14	776	25/60	3183	4526

	FluSurv-Net Influenza Hospitalization Surveillance Project Vaccination Phone Script and Consent Form (English/Spanish)	14	22	10/60	278	51
	FluSurv-Net Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults)	14	70	5/60	278	82
	FluSurv-NET Laboratory Survey	14	16	10/60	26	37
	COVID Vaccination Status on FluSurv-NET cases (optional) – (new form)	7	776	0		0
	HAIC - MuGSI Case Report Form for Carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB)	10	500	28/60	2333	2333
	HAIC - MuGSI Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL/iEC)	10	4200	25/60	19,600	19,600
	HAIC - Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form	10	322	28/60	1605	1503
	HAIC - Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form	10	466	28/60	2217	2175
	HAIC - CDI Case Report and Treatment Form	10	1650	38/60	10450	10450
	HAIC Candidemia Case Report	10	170	40/60	1134	1134
	HAIC- Annual Survey of Laboratory Testing Practices for C. difficile Infections	10	16	17/60	51	46
	HAIC- CDI Annual Surveillance Officers Survey	10	1	15/60	3	3
	HAIC- Emerging Infections Program C. difficile Surveillance Nursing Home Telephone Survey (LTCF)	10	45	5/60	38	38
	HAIC- Invasive Staphylococcus aureus Laboratory Survey	10	11	20/60	37	37
	HAIC- Invasive Staphylococcus aureus Supplemental Surveillance Officers Survey	10	1	10/60	2	2
	HAIC- Laboratory Testing Practices for Candidemia Questionnaire	10	20	14/60	43	47
	HAIC MuGSI CA CP-CRE Health interview	10	10	30/60	50	50
	HAIC MuGSI Supplemental Surveillance Officer Survey	10	1	15/60	3	3
	HAIC Death Ascertainment Project	10	8	1440/60	1,920	1,920
TOTAL					55,394	55,786