Change request justification 8SEP2020

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]

Submission Date: August 27, 2020

Table of Contents and Attachments

1. Non-Substantive Change Request Justification Document

2. Description of Changes (Att 1)

3. Cross-Walk (Att 2)

4. 2021 ABCs Neonatal Infection Expanded Tracking Form (Att 3)

5. FoodNet: FoodNet Active Surveillance Data Elements List (Att.4)

6. FoodNet: Diagnostic Laboratory Practices and Volume Data Elements List (Att. 5)

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

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

9. HAIC: Resistant Gram-Negative Bacilli (MuGSI) Case Report Form for Carbapenem-resistant Enterobacteriaceae and Acinetobacter baumannii (Att 8)

10. HAIC: Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL) (Att. 9)

11. HAIC: Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form (Att. 10)

12. HAIC: Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form (Att. 11)

13. HAIC: CDI Case Report and Treatment Form (Att. 12)

14. HAIC: Annual Survey of Laboratory Testing Practices for C. difficile Infections (Att. 13)

15. HAIC: Candidemia Case Report (Att. 14)

16. HAIC: Laboratory Testing Practices for Candidemia Questionnaire (Att. 15)

17. HAIC: Invasive Staphylococcus aureus Laboratory Survey: Use of Nucleic Acid Amplification Testing (NAAT) (Att. 16)

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 ABC, 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 790 hours, from 39,673 to 38,883. The data elements and justifications are described below.

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

ABC:

• 2021 ABCs Neonatal Infection Expanded Tracking Form (Attachment 3)

Food Net:

• FoodNet Active Surveillance Data Elements List (Attachment 4)

• Diagnostic Laboratory Practices and Volume Data Elements List (Attachment 5)

FluSurv-NET:

• Influenza Hospitalization Surveillance Network Case Report Form (Attachment 6)

• FluSurv-NET/RSV Hospital Laboratory Survey (Attachment 7)

HAIC:

• Resistant Gram-Negative Bacilli (MuGSI) Case Report Form for Carbapenem-resistant Enterobacteriaceae and Acinetobacter baumannii (Attachment 8)

• 2020 Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL) (Attachment 9)

• 2020 Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form (Attachment 10)

• 2020 Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form (Attachment 11)

• CDI Case Report and Treatment Form (Attachment 12)

• Annual Survey of Laboratory Testing Practices for C. difficile Infections (Attachment 13)

• Candidemia Case Report (Attachment 14)

• Laboratory Testing Practices for Candidemia Questionnaire (Attachment 15)

• Invasive Staphylococcus aureus Laboratory Survey: Use of Nucleic Acid Amplification Testing (NAAT) (Attachment 16)

Estimated Annualized Burden Hours

As a result of proposed changes to forms highlighted in yellow, the estimated annualized burden is expected to decrease by 790 hours from 39,673 to 38,883.

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 (Current)	No. of responses per respondent (Corrected)	Avg. burden per response (in hours)	Current Proposed Changes		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 Campylobacter¹		10	850	970	21/60	3297		3395
	FoodNet Cyclospora¹		10	3	42	10/60	272		70
	FoodNet Listeria monocytogenes¹		10	13	16	20/60	50		53
	FoodNet Salmonella¹		10	827	855	21/60	2761		2993
	FoodNet Shiga toxin producing E. coli¹		10	190	290	20/60	683		967
	FoodNet Shigella¹		10	290	234	10/60	355		390
	FoodNet Vibrio¹		10	25	46	10/60	56		77
	FoodNet Yersinia¹		10	30	55	10/60	80		92
	FoodNet Hemolytic Uremic Syndrome		10	10		1	100		100
	FoodNet Clinical Laboratory Practices and Testing Volume		10	70	n/a	20/60	233		233
	FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form		10	977	n/a	17/60	4167		2768
	FluSurv-Net Influenza Hospitalization Surveillance Project Vaccination Phone Script Consent Form (English)		10	333		5/60	278		278
	FluSurv-Net Influenza Hospitalization Surveillance Project Vaccination Phone Script Consent Form (Spanish)		10	333		5/60	278		278
	FluSurv-Net Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults)		10	333		5/60	278		278
	FluSurv-NET Laboratory Survey		10	23	n/a	10/60	38		38
	HAIC - MuGSI Case Report Form for Carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB)		10	500	n/a	28/60	2333		2333
	HAIC - MuGSI Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL)		10	1104	n/a	28/60	5152		5152
	HAIC - Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form		10	340	n/a	28/60	1587		1587
	HAIC - Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form		10	584	n/a	28/60	2725		2725
	HAIC - CDI Case Report and Treatment Form		10	1650	n/a	38/60	10450		10450
	HAIC Candidemia Case Report²		10	200	170	40/60	1000		1134
	HAIC- Annual Survey of Laboratory Testing Practices for C. difficile Infections.		10	16	n/a	15/60	40		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	n/a	20/60	37		37
	HAIC- Invasive Staphylococcus aureus Supplemental Surveillance Officers Survey		10	1		10/60	17		17
	HAIC- Laboratory Testing Practices for Candidemia Questionnaire³		10	120	20	11/60	45		37
TOTAL								39,673		38,883

¹FoodNet pathogens (highlighted in table below in red) response numbers have been updated. The number of responses submitted with the non-substantive change for 2020 were inconsistent with what was submitted in 2019’s revision, but the total burden was consistent with the 2019 revision. However, the number of responses per respondent continues to change each year as the number of enteric pathogens has been increasing. The number of responses per respondent now reflects the average number of reports for the last 3 years (2017-2019) sent to FoodNet as yearly variation, sometimes with large swings, can occur due to outbreaks or other unpredicted changes such as use of more sensitive diagnostic tests. In order to provide the best estimate each year, the number of responses per respondent for FoodNet pathogens under surveillance will be updated yearly using a 3 year rolling average. As a result of updating the No. of responses per respondent the annualized burden is expected to increase by 483 hours (7,554 to 8,037).

² HAIC Candidemia Case Report: The requested changes to the data collection form are estimated to increase the time required for data collection by 10 minutes per case report form. Despite the changes to the data collection tool, the overall burden estimate has increased by only 133 hours total across all sites. The number of records from each site was overestimated in last year’s burden table (previous estimate of 200). The new estimated number of responses is based on 2019 surveillance data and is approximately 170 case report forms per site. We have updated the number of records in the burden table, resulting in an overall minor increase in burden hours from the previous year.

³ HAIC- Laboratory Testing Practices for Candidemia Questionnaire: The requested changes to the survey tool are estimated to increase the time required for data collection by 1 minute per response. The new estimate is 11 minutes per response. Despite the changes to the data collection tool, the overall burden estimate has decreased as the number of respondents per site was overestimated in prior years. The number of records from each site was overestimated in last year’s burden table (previous estimate of 120). The new estimated number of responses is based on the 2019 surveillance data (number of labs in each surveillance site) and is approximately 20 respondents per site. We have updated the number of records in the burden table, resulting in an overall decrease in burden hours from the previous year.