Change Request Memo 15SEP2022

National Notifiable Diseases Surveillance System (NNDSS)

OMB Control Number 0920-0728

Expiration Date: 07/31/2025

Program Contact

Umed A. 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: September 15, 2022

Circumstances of Change Request for OMB 0920-0728

This is a non-substantive change request for OMB No. 0920-0728, expiration date 07/31/2025, for the reporting of Nationally Notifiable Diseases. Information on proposed disease-specific data element to be added through this non-substantive change request is enumerated in the table below:

Disease Name in NNDSS Collection	Nationally Notifiable (NNC) OR Under Standardized Surveillance (CSS)	Current Case Notification (Y/N)	Proposed Case Notification (Y/N)	Current Disease-specific Data Elements (Y/N)	Proposed Disease-specific Data Elements (Y/N)	Number of Existing Data Elements in NNDSS	Proposed Number of new NNDSS Data Elements
Monkeypox	NNC			Y	Y	59	1

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 CDC and the Council of State and Territorial Epidemiologists (CSTE) officially designate as “nationally notifiable” or as under “standardized surveillance.” The NNDSS program creates the infrastructure for the surveillance system and facilitates the submission and aggregation of case notification data voluntarily submitted to CDC from 60 jurisdictions: public health departments in every U.S. state, New York City, Washington DC, 5 U.S. territories (American Samoa, the Commonwealth of Northern Mariana Islands, Guam, Puerto Rico, and the U.S. Virgin Islands), and 3 freely associated states (Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau). The NNDSS also facilitates relevant data management, analysis, interpretation and dissemination of the information. The data are used to monitor the 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 1 new disease-specific data element for monkeypox.

Monkeypox
The impetus/urgency for CDC to add data elements for this condition	The CDC emergency response team has a new priority regarding understanding the effectiveness of the vaccine against monkeypox. There is FDA emergency use authorization (dated 8/9/2022) to administer the vaccine using an alternate method (intradermal, in addition to subcutaneous). This information needs to be captured to inform the efficacy of the vaccine and associated vaccine recommendations.

Data Element Name	Data Element Description	Value Set Code	CDC Priority1
Vaccine Route of Administration	The route of administration of the vaccine	PHVS_RouteOfAdministration_IIS	2

Burden

The burden to add 1data element to NNDSS is applicable to all 50 states, 5 territories, 3 freely associated states, and 2 cities. Although not all territories and freely associated states use electronic, automated transmission for their case notifications, it is expected that they will adopt electronic, automated transmission in the next three years. This burden includes the one-time burden incurred by the respondents to add the data element to their surveillance system and modify their case notification message. A one-time average burden of 1 hour is incurred for respondents to add 1 data element to their surveillance system and modify their electronic case notification message to accommodate the one additional data element. This one-time burden of 1 hour is noted in the following table:

One-Time Burden to Add 1 Data Element to NNDSS:

Type of Respondents	Number of Respondents	Number of Responses per Respondent	Average Burden Per Response (in hours): One-time Addition of 1 Data Element
States	50	1	1
Territories	5	1	1
Freely Associated States	3	1	1
Cities	2	1	1
Total

The total annualized one-time burden is 21 hours (17 hours for states, 2 hours for territories, 1 hour for freely associated states and 1 hour for cities) as noted in the table below.

Annualized One-Time Burden to Add 1 Data Element to NNDSS

Type of Respondents	Number of Respondents	Number of Responses per Respondent	Average Burden Per Response (in hours): Annualized One-time Addition of 1 Data Element	Total Annualized One-Time Burden (in hours)
States	50	1	1	17
Territories	5	1	1	2
Freely Associated States	3	1	1	1
Cities	2	1	1	1
Total				21

21 hours were added to the existing burden hours in Table A.12A and Table A.12B below.

A.12A. Estimates of Annualized Burden Hours

Type of Respondents	Form Name	Number of Respondents	Number of Responses per Respondent	Average Burden Per Response (in hours)	Total Burden (in hours)
States	Weekly (Automated)	50	52	20/60	867
States	Weekly (Non- automated)	10	52	2	1,040
States	Weekly (NMI Implementation)	50	52	4	10,400
States	Annual	50	1	75	3,750
States	One-time Addition of Diseases and Data Elements	50	1	1	217
Territories	Weekly (Automated)	5	52	20/60	87
Territories	Weekly, Quarterly (Non-automated)	5	56	20/60	93
Territories	Weekly (NMI Implementation)	5	52	4	1,040
Territories	Annual	5	1	5	25
Territories	One-time Addition of Diseases and Data Elements	5	1	1	22
Freely Associated States	Weekly (Automated)	3	52	20/60	52
Freely Associated States	Weekly, Quarterly (Non-automated)	3	56	20/60	56
Freely Associated States	Annual	3	1	5	15
Freely Associated States	One-time Addition of Diseases and Data Elements	3	1	1	13
Cities	Weekly (Automated)	2	52	20/60	35
Cities	Weekly (Non-automated)	2	52	2	208
Cities	Weekly (NMI Implementation)	2	52	4	416
Cities	Annual	2	1	75	150
Cities	One-time Addition of Diseases and Data Elements	2	1	1	9
Total					18,495

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 (Automated)	50	52	20/60	867	$49.14	$42,604
States	Weekly (Non-automated)	10	52	2	1,040	$41.70	$43,368
States	Weekly (NMI Implementation)	50	52	4	10,400	$49.14	$511,056
States	Annual	50	1	75	3,750	$41.70	$156,375
States	One-time Addition of Diseases and Data Elements	50	1	1	200	$49.14	$10,663
Territories	Weekly (Automated)	5	52	20/60	87	$49.14	$4,275
Territories	Weekly, Quarterly (Non-automated)	5	56	20/60	93	$41.70	$3,878
Territories	Weekly (NMI Implementation)	5	52	4	1,040	$49.14	$51,106
Territories	Annual	5	1	5	25	$41.70	$1,043
Territories	One-time Addition of Diseases and Data Elements	5	1	1	20	$49.14	$1,081
Freely Associated States	Weekly (Automated)	3	52	20/60	52	$49.14	$2,555
Freely Associated States	Weekly, Quarterly (Non-automated)	3	56	20/60	56	$41.70	$2,335
Freely Associated States	Annual	3	1	5	15	$41.70	$626
Freely Associated States	One-time Addition of Diseases and Data Elements	3	1	1	12	$49.14	$639
Cities	Weekly (Automated)	2	52	20/60	35	$49.14	$1,720
Cities	Weekly (Non-automated)	2	52	2	208	$41.70	$8,674
Cities	Weekly (NMI Implementation)	2	52	4	416	$49.14	$20,442
Cities	Annual	2	1	75	150	$41.70	$6,255
Cities	One-time Addition of Diseases and Data Elements	2	1	1	8	$49.14	$442
Total							$869,137

1 R=Required; 1=Priority 1, 2=Priority 2, 3=Priority 3

1