Non-Substantive Change Request Justification

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: May 25, 2018

Circumstances of 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). 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: 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 a change to the disease-specific data elements for HAIC only. As a result of proposed minor change, the estimated annualized burden is expected not to change. The data element and justifications are described below. The form for which approval for change is sought is the 2018 Clostridium difficile Infection (CDI) Case Report Form (attached).

Description of Changes

• Question 11c: the data field for “Facility ID” would be added

• Question 14: The option to answer “Unknown” would be added”

Justification for changes

The changes made to the HAIC CDI form 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 was previously on the 2017 form but were inadvertently dropped from the 2018 form. We are requesting an amendment to the 2018 form to add these data fields back, as they will help maintain data collectors’ ability in capturing data in a standardized fashion to improve accuracy and to track changes over time.

Cross walk

Approved Form	Requested change
11c. Was the patient admitted from a LTCF or a LTACH? Yes (HCFO - go to 11d.) No (CO - Complete CRF)	11c. Was the patient admitted from a LTCF or a LTACH? Yes (HCFO - go to 11d.) No (CO - Complete CRF) Facility ID_______________________
14. Hospitalized (overnight) in the 12 weeks before the date of incident C. diff+ stool collection. Date of most recent discharge: ______ /______ /______	14. Hospitalized (overnight) in the 12 weeks before the date of incident C. diff+ stool collection. Date of most recent discharge: ______ /______ /______ □ Unknown

The unchanged burden table is below for reference. The relevant form is highlighted.

Type of Respondent	Form Name	No. of respondents	No. of responses per respondent	Avg. burden per response (in hours)	Total burden (in hours)
State Health Department	ABCs Case Report Form	10	809	20/60	2697
	ABCs Invasive Pneumococcal Disease in Children Case Report Form	10	22	10/60	37
	ABCs Surveillance for Non-Invasive Pneumococcal Pneumonia (SNiPP) Case Report Form	10	125	10/60	208
	ABCs H.influenzae Neonatal Sepsis Expanded Surveillance Form	10	6	10/60	10
	ABCs Severe GAS Infection Supplemental Form – NEW FORM	10	136	20/60	453
	ABCs Neonatal Infection Expanded Tracking Form	10	37	20/60	123
	FoodNet Campylobacter	10	850	21/60	2975
	FoodNet Cryptosporidium	10	130	10/60	217
	FoodNet Cyclospora	10	3	10/60	5
	FoodNet Listeria monocytogenes	10	13	20/60	43
	FoodNet Salmonella	10	827	21/60	2895
	FoodNet Shiga toxin producing E. coli	10	190	20/60	633
	FoodNet Shigella	10	290	10/60	483
	FoodNet Vibrio	10	25	10/60	42
	FoodNet Yersinia	10	30	10/60	50
	FoodNet Hemolytic Uremic Syndrome	10	10	1	100
	Influenza Hospitalization Surveillance Network Case Report Form	10	1000	25/60	4167
	Influenza Hospitalization Surveillance Project Vaccination Phone Script Consent Form (English)	10	333	5/60	278
	Influenza Hospitalization Surveillance Project Vaccination Phone Script Consent Form (Spanish)	10	333	5/60	278
	Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults)	10	333	5/60	278
	HAIC CDI Case Report Form	10	1650	30/60	8250
	HAIC Multi-site Gram-Negative Bacilli Case Report Form (MuGSI-CRE/CRAB)	10	500	20/60	1667
	HAIC Multi-site Gram-Negative Bacilli Case Report Form for Carbapenem-resistant Pseudomonas aeruginosa(CR-PA) – NEW FORM	10	344	45/60	2580
	HAIC Multi-site Gram-Negative Surveillance Initiative – Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (MuGSI-ESBL) – NEW FORM	10	1200	20/60	4000
	HAIC Invasive Methicillin-resistant Staphylococcus aureus (MRSA)—previously listed under ABCs, now included in the HAIC activity	10	609	20/60	2030
	HAIC Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) – NEW FORM	10	1,035	20/60	3450
	HAIC Candidemia Case Report Form – NEW FORM	9	800	20/60	2400
Total					40,347