Justification for changes to IPD data elements

National Notifiable Diseases Surveillance System (NNDSS)

OMB Control Number 0920-0728

Expiration Date: 01/31/2019

Program Contact

Kim Gadsden-Knowles

Deputy Associate Director for Science

Division of Health Informatics and Surveillance

Center for Surveillance, Epidemiology and Laboratory Services

Centers for Disease Control and Prevention

2500 Century Parkway, MS-E97

Atlanta, GA 30033

Phone: (404) 498-0355

E-mail: klg6@cdc.gov

Submission Date: November 15, 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 four disease-specific data elements for Invasive Pneumococcal Disease only. The data elements included in this change request allow the program to collect the minimum information required to determine which culture-independent diagnostic tests (CIDTs) were used to diagnose the IPD case, and whether the tests being used by clinical laboratories have been validated and acceptable to diagnose invasive pneumococcal infections. There is no change in burden as the burden was accounted for at the time OMB No. 0920-0728 was originally submitted.

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

Varicella Data Elements

Data Element Identifier	Data Element Name	Data Element Description
TBD	Clinical syndrome	Clinical diagnoses associated with a case of IPD
TBD	Method(s) of laboratory testing	Type of laboratory test used to diagnose pneumococcal infection from a sterile site isolate
TBD	Name of CIDT test and manufacturer	Name of culture independent laboratory test used and manufacturer of the test
TBD	CLIA number of laboratory	CLIA number of the laboratory that conducted the testing

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 because States already collect this information. There will be no increase in burden for the reporting jurisdictions to send these data elements to CDC since most case notifications are submitted from already existing databases.

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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