Request for Approval

Emerging Infections Programs (EIP)

OMB Control Number 0920-0978

Expiration Date: 05/31/2021

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]

Date: December 10, 2019

Table of Contents and Attachments

1. Justification for Non-Substantive Change Request Document

2. 2020 ABCs Case Report Form (Att. 1)

3. 2020 ABCs Neonatal Infection Expanded Tracking Form (Att. 2)

4. 2020 ABCs Severe GAS Infection: Supplemental Form (Att. 3)

5. 2020 ABCs Invasive Pneumococcal Disease in Children (Att. 4)

6. FoodNet Active Surveillance Data Elements List (Att. 5)

7. Foodborne and Diarrheal Diseases Message Mapping Guide (FDD MMG - FoodNet only portion) (Att. 6)

8. Diagnostic Laboratory Practices and Volume Data Elements List (Att. 7)

9. Influenza Hospitalization Surveillance Network Case Report Form (Att. 8)

10. FluSurv-NET/RSV Hospital Laboratory Survey (Att. 9)

11. 2020 Resistant Gram-Negative Bacilli (MuGSI) Case Report Form for Carbapenem-resistant Enterobacteriaceae and Acinetobacter baumannii (Att 10)

12. 2020 Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL) (Att.11)

13. 2020 Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form (Att. 12)

14. 2020 Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form (Att. 13)

15. 2020 CDI Case Report and Treatment Form (Att. 14)

16. 2020 HAIC Candidemia Case Report (Att. 15)

17. HAIC- Annual Survey of Laboratory Testing Practices for C. difficile Infections (Att. 16)

18. HAIC- CDI Annual Surveillance Officer Survey (Att. 17)

19. HAIC- Emerging Infections Program C. difficile Surveillance Nursing Home Telephone Survey (LTCF) (Att. 18)

20. HAIC- Invasive Staphylococcus aureus Laboratory Survey: Use of Nucleic Acid Amplification Testing (NAAT) (Att. 19)

21. HAIC- Invasive Staphylococcus aureus Supplemental Surveillance Officers Survey (Att. 20)

22. HAIC- Laboratory Testing Practices for Candidemia Questionnaire (Att. 21)

23. FDD MMG Supplemental Variable Table (Att. 22)

24. Description of Changes (Att 23)

25. Cross-Walk 2019 to 2020 (Att 24)

Justification for Change Request for OMB 0920-0978

This is a nonmaterial/non-substantive change request for OMB No. 0920-0978, expiration date 05/31/2021, 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. Larger changes are being packaged together into a revision ICR that will be submitted later 2019.

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 the 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 3,017 hours, from 40,601 to 37,584. The data elements and justifications are described below.

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

ABCs:

26. 2020 ABCs Case Report Form (Att. 1)

27. 2020 ABCs Neonatal Infection Expanded Tracking Form (Att. 2)

28. 2020 ABCs Severe GAS Infection: Supplemental Form (Att. 3)

29. 2020 ABCs Invasive Pneumococcal Disease in Children (Att. 4)

Food Net:

5. FoodNet Active Surveillance Data Elements List (Att. 5)

6. Foodborne and Diarrheal Diseases Message Mapping Guide (FDD MMG - FoodNet only portion) (Att. 6)

7. Diagnostic Laboratory Practices and Volume Data Elements List (Att. 7)

FluSurv-NET:

5. Influenza Hospitalization Surveillance Network Case Report Form (Att. 8)

6. FluSurv-NET/RSV Hospital Laboratory Survey (Att. 9)

HAIC:

10. 2020 Resistant Gram-Negative Bacilli (MuGSI) Case Report Form for Carbapenem-resistant Enterobacteriaceae and Acinetobacter baumannii (Att 10)

11. 2020 Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL) (Att.11)

12. 2020 Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form (Att. 12)

13. 2020 Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form (Att. 13)

14. 2020 CDI Case Report and Treatment Form (Att. 14)

15. 2020 HAIC Candidemia Case Report (Att. 15)

16. HAIC- Annual Survey of Laboratory Testing Practices for C. difficile Infections (Att. 16)

17. HAIC- CDI Annual Surveillance Officer Survey (Att. 17)

18. HAIC- Emerging Infections Program C. difficile Surveillance Nursing Home Telephone Survey (LTCF) (Att. 18)

19. HAIC- Invasive Staphylococcus aureus Laboratory Survey: Use of Nucleic Acid Amplification Testing (NAAT) (Att. 19)

20. HAIC- Invasive Staphylococcus aureus Supplemental Surveillance Officers Survey (Att. 20)

21. HAIC- Laboratory Testing Practices for Candidemia Questionnaire (Att. 21)

Estimated Annualized Burden Hours

As a result of proposed changes to forms highlighted in yellow, the estimated annualized burden is expected to decrease by 2,287 hours, from 40,601 to 38,314.

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

Type of Respondent	Form Name	No. of respondents	No. of responses per respondent	Avg. burden per response (in hours)	Current Total Burden	After Proposed Changes
State Health Department	ABCs Case Report Form	10	809	20/60	2697	2697
	ABCs Invasive Pneumococcal Disease in Children Case Report Form	10	22	10/60	37	37
	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	850	21/60	3297	3297
	FoodNet Cyclospora	10	3	10/60	272	272
	FoodNet Listeria monocytogenes	10	13	20/60	50	50
	FoodNet Salmonella	10	827	21/60	2761	2761
	FoodNet Shiga toxin producing E. coli	10	190	20/60	683	683
	FoodNet Shigella	10	290	10/60	355	355
	FoodNet Vibrio	10	25	10/60	56	56
	FoodNet Yersinia	10	30	10/60	80	80
	FoodNet Hemolytic Uremic Syndrome	10	10	1	100	100
	FoodNet Clinical Laboratory Practices and Testing Volume	10	70	20/60	233	233
	Influenza Hospitalization Surveillance Network Case Report Form (Att 4)	10	1000	25/60	4167	4167
	Influenza Hospitalization Surveillance Project Vaccination Phone Script Consent Form (English)	10	333	5/60	278	278
	Influenza Hospitalization Surveillance Project Vaccination Phone Script Consent Form (Spanish)	10	333	5/60	278	278
	Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults)	10	333	5/60	278	278
	FluSurv-NET Laboratory Survey	10	23	10/60	38	38
	MuGSI Case Report Form for Carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB) (Att 5)	10	500	25/60	1667	2083
	MuGSI Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL) (Att 6)	10	1104	25/60	5000	4600
	Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form (Att 7)	10	340	25/60	1975	1417
	Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form (Att 8)	10	584	25/60	3142	2433
	CDI Case Report and Treatment Form (Att 9)	10	1650	35/60	9625	9625
	HAIC Candidemia Case Report (Att 10)	10	200	30/60	2400	1000
	HAIC- Annual Survey of Laboratory Testing Practices for C. difficile Infections.	10	16	15/60	27	40
	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: Use of Nucleic Acid Amplification Testing (NAAT)	10	11	20/60	15	37
	HAIC- Invasive Staphylococcus aureus Supplemental Surveillance Officers Survey	10	10	10/60	2	17
	HAIC- Laboratory Testing Practices for Candidemia Questionnaire	10	120	10/60	45	45
TOTAL					40,601	37,584

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