Change Request for Addition of Data Elements for Laboratory Template

National Notifiable Diseases Surveillance System (NNDSS)

OMB Control Number 0920-0728

Expiration Date: 01/31/2019

Program Contact

Umed Ajani

Associate Director for Science

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: March 17, 2017

(Revised and Resubmitted on May 5, 2017)

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 three data elements for the laboratory template. A common set of laboratory data elements submitted by public health departments, identified as the “laboratory 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. Three new laboratory data elements have since been identified as applicable for inclusion in this laboratory template: Specimen Action Code, Parent Universal Service Identifier and Unique Identifier for Current Sample. The additional data elements requiring the change request are in the following table:

New Laboratory Data Elements

Data Element Name	Data Element Description
Specimen Action Code	HL7 version 2.x Specimen action code used in chapter(s) 4; HL7 table 065
Parent Universal Service Identifier	Parent universal service identifier is optionally allowed for laboratories that do not support unique placer or filler order numbers
Unique Identifier for Current Sample	Isolate identifier unique for each isolate within laboratory

Burden

The annualized burden hours and cost to reporting jurisdictions (states, cities, and territories) to submit these additional data elements 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. All reporting jurisdictions (except for Guam and the U.S. Virgin Islands) will send these additional data elements to CDC electronically through NNDSS since case notifications are submitted electronically from existing surveillance databases. This change request does not apply to Guam and the U.S. Virgin Islands since they do not yet send their case notifications electronically to CDC. The addition of laboratory data elements will add a minimal one-time burden. Many jurisdictions already collect this information through routine case reporting; for jurisdictions not currently collecting these data, future implementation will be prospective, not requiring re-coding or re-ascertainment of any new information for previously reported cases. A one-time average burden of 35 minutes will be incurred for jurisdictions to modify their electronic case notification message to accommodate up to 10 additional data elements. For the jurisdictions that do not already collect these data, an additional one-time average burden of 35 minutes will be incurred to add up to 10 additional data elements to their jurisdiction’s surveillance system. This one-time burden of up to 70 minutes (rounded up to 75 minutes as required) is noted in the following table:

One Time Burden to Add Up To 10 Data Elements to NNDSS

Respondents	Number of Respondents	Number of Responses per Respondent	Average One-Time Burden (in hours)	Total One-Time Burden (in hours)
States	50	1	75/60	63
Territories	3	1	75/60	4
Cities	2	1	75/60	3
Total				70

Since this increase in burden is one-time, minimal, and only applicable to those jurisdictions that transmit case notifications electronically, it does not affect the annualized burden hours and costs.

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	10	1,040	$35.63	$37,055
Total							$1,009,754

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