Justification for Change Request

National Notifiable Diseases Surveillance System (NNDSS)

OMB Control Number 0920-0728

Expiration Date: 01/31/2019

Program Contact

Umed Ajani

Associate Director for Surveillance

Division of Health Informatics and Surveillance

Center for Surveillance, Epidemiology and Laboratory Services

Centers for Disease Control and Prevention

1600 Clifton Rd, MS-E91

Atlanta, GA 30329

Phone: (404) 498-0258

E-mail: [email protected]

Submission Date: April 19, 2016

Circumstances of Change Request for OMB 0920-0728

This is a nonmaterial/non-substantive change request for OMB No. 0920-0728, expiration date 01/31/2019, for the reporting of Nationally Notifiable Diseases. The National Notifiable Diseases Surveillance System (NNDSS) is the nation’s public health surveillance system that enables all levels of public health (local, state, territorial, federal and international) to monitor the occurrence and spread of the diseases and conditions that the Council of State and Territorial Epidemiologists (CSTE) has officially designated as either “nationally notifiable” or as under “national surveillance.” The NNDSS facilitates the submission and aggregation of case notification data voluntarily submitted to CDC from 57 jurisdictions: health departments in every U.S. state, New York City, Washington DC, and 5 U.S. territories (American Samoa, the Commonwealth of Northern Mariana Islands, Guam, Puerto Rico, and the U.S. Virgin Islands). NNDSS also facilitates relevant data management, analysis, interpretation and dissemination of the information. The data are used to monitor health occurrence of notifiable conditions and to plan and conduct prevention and control programs at the state, territorial, local and national levels.

This request is for the addition of one new disease-specific data element for varicella, and the addition of two new data elements for the vaccine template.

The new data element requested for varicella is “Reason for Hospitalization.” As the national varicella vaccination program matures, surveillance for severe disease, including whether those cases require hospitalization, has become increasingly important to help public health programs determine the extent of varicella hospitalizations occurring among vaccinated persons. During the mature varicella vaccination era, surveillance that describes the reasons for hospitalization also helps guide vaccination policy by providing a better understanding of the trends in severe disease.

The new data element requiring the change request is in the following table:

New Varicella Data Element

Data Element Identifier	Data Element Name	Data Element Description
New TBD	Reason for Hospitalization	If the subject was hospitalized because of this event, indicate the reason(s). For example, varicella-specific reasons for hospitalization include Severe Varicella Presentation, Administration of IV Treatment, and Non-varicella Hospitalization.

A common set of vaccine data elements submitted by public health departments, identified as the “vaccine template”, was included in the approved ICR for OMB No. 0920-0728, expiration date 01/31/2019. These data elements were added since they are necessary for routine surveillance and apply to a number of nationally notifiable conditions and can be standardized across these conditions for efficiency. Two new vaccine data elements have since been identified as applicable for inclusion in this vaccine template: National Drug Code (NDC) and Vaccination Record Identifier.

The additional data elements requiring the change request are in the following table:

New Vaccine Data Elements

Data Element Identifier	Data Element Name	Data Element Description
VAC153 (proposed)	National Drug Code (NDC)	NDC from the vaccine's bar code can be used to obtain vaccine brand name and manufacturer.
VAC102 (proposed)	Vaccination Record Identifier	Vaccination record identifier

Burden

The annualized burden hours and cost to reporting jurisdictions to submit these data to CDC does not change from the original estimates in the “Estimates of Annualized Burden Hours and Costs” section in A.12 of OMB No. 0920-0728. The addition of new vaccine and disease-specific data elements will not add any additional burden because the reporting jurisdictions already collect those data elements. There will be no increase in burden for the reporting jurisdictions to send those data elements to CDC since most case notifications are submitted electronically from already existing databases via automated electronic transfers. CSTE recommends that jurisdictions collect these data for their own surveillance purposes. Requesting jurisdictions to submit these data (that they will already collect) to CDC will not increase the burden to the jurisdictions.

A.12A. Estimates of Annualized Burden Hours

Respondents	Number of Respondents	Number of Responses per Respondent	Average Burden Per Response (in hours)	Total Burden (in hours)
Weekly and Annual Submissions
States	50	52	10	26000
Territories	5	52	5	1300
Cities	2	52	10	1040
Total				28,340

A.12B. Estimates of Annualized Cost Burden

Type of Respondents	Form Name	Number of Respondents	Number of Responses per Respondent	Average Burden Per Response (in hours)	Total Burden Hours	Hourly Wage Rate	Respondent Cost
States	Weekly and Annual	50	52	10	26,000	$35.63	$926,380
Territories	Weekly and Annual	5	52	5	1,300	$35.63	$46,319
Cities	Weekly and Annual	2	52	2	1,040	$35.63	$37,055
Total							$1,009,754

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