Justification for HAIC Changes (Jan 2021)

Emerging Infections Programs (EIP)

OMB Control Number 0920-0978

Expiration Date: 4/30/2022

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: November 23, 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. HAIC: Resistant Gram-Negative Bacilli (MuGSI) Case Report Form for Carbapenem-resistant Enterobacteriaceae and Acinetobacter baumannii (Att 3)

5. HAIC: Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL) (Att. 4)

6. HAIC: Annual Survey of Laboratory Testing Practices for C. difficile Infections (Att. 5)

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.

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 only 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 increase by 11 hours, from 38,883 to 38,894. The data elements and justifications are described below.

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

HAIC:

• Resistant Gram-Negative Bacilli (MuGSI) Case Report Form for Carbapenem-resistant Enterobacteriaceae and Acinetobacter baumannii (Attachment 3)

• 2020 Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL) (Attachment 4)

• Annual Survey of Laboratory Testing Practices for C. difficile Infections (Attachment 5)

The changes for Resistant Gram-Negative Bacilli (MuGSI) Case Report Form for Carbapenem-resistant Enterobacteriaceae and Acinetobacter baumannii (Attachment 3) and

2020 Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL) (Attachment 4) will be effective and implemented on 01/01/2021. The Annual Survey of Laboratory Testing Practices for C. difficile Infections (Attachment 5) will be administered in 2021.

Estimated Annualized Burden Hours

As a result of proposed changes to forms highlighted in yellow, the estimated annualized burden is expected to increase by11 hours, from 38,883 to 38,894.

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)	Avg. burden per response (in hours) (Current)	Avg. burden per response (in hours) (After Changes)	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 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	20/60		233	233
	FluSurv-Net Influenza Hospitalization Surveillance Network Case Report Form	10	977	17/60		2768	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	10/60		38	38
	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)	10	1104	28/60		5152	5152
	HAIC - Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form	10	340	28/60		1587	1587
	HAIC - Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form	10	584	28/60		2725	2725
	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	15/60	19/60	40	51
	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		37	37
	HAIC- Invasive Staphylococcus aureus Supplemental Surveillance Officers Survey	10	1	10/60		17	17
	HAIC- Laboratory Testing Practices for Candidemia Questionnaire	10	20	11/60		37	37
TOTAL						38,883	38,894