Request for change 6.24.2019

National Notifiable Diseases Surveillance System (NNDSS)

OMB Control Number 0920-0728

Expiration Date: 04/30/2022

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: June 21, 2019

Circumstances of Change Request for OMB 0920-0728

This is a non-substantive change request for OMB No. 0920-0728, expiration date 04/30/2022, for the reporting of Nationally Notifiable Diseases. Information on proposed disease-specific data elements 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
Plague	NNC			Y		3	47
Tularemia	NNC			N		0	50

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 97 new disease-specific data elements: 47 new data element for Plague and 50 new data elements for Tularemia.

Plague
The impetus/urgency for CDC to add data elements for this condition	To make surveillance more comprehensive and informative for public health actions To provide more information about risk factors (healthcare facility exposure, travel, and specimen testing) that have been associated with colonization or infection To update guidance on infection control and prevention

Data Element Name		Data Element Description		Value Set Code		CDC Priority1
Immunocompromised	If patient has any immunocompromising conditions, specify		N/A		P
Date first medical	Date that the patient was first seen by medical person.		N/A		P
Fever/sweats/chills	Did the patient's illness include the symptom of fever/sweats/chills?		PHVS_YesNoUnknown_CDC		P
Confusion/delirium	Did the patient's illness include the symptom of confusion/delirium?		PHVS_YesNoUnknown_CDC		P
Vomiting / diarrhea / abdominal pain	Did the patient's illness include the symptom of vomiting/diarrhea/abdominal pain?		PHVS_YesNoUnknown_CDC		P
Sore throat	Did the patient's illness include the symptom of sore throat?		PHVS_YesNoUnknown_CDC		P
Cough	Did the patient's illness include the symptom of cough?		PHVS_YesNoUnknown_CDC		P
Chest Pain	Did the patient's illness include the symptom of chest pain?		PHVS_YesNoUnknown_CDC		P
Shortness of breath	Did the patient's illness include the symptom of shortness of breath?		PHVS_YesNoUnknown_CDC		P
Other symptoms	Did the patient's illness include other symptoms not listed?		PHVS_YesNoUnknown_CDC		P
Other symptoms (specify)	Which other symptoms did the patient’s illness include?		N/A		P
Bubo	Did patient have bubo?		PHVS_YesNoUnknown_CDC		P
Type of Bubo	Specify type of bubo		TBD		P
Location/description Bubo	Describe location and appearance of bubo		N/A		P
Insect bites/skin ulcer	Did patient have any insect bites/skin ulcer		PHVS_YesNoUnknown_CDC		P
Location/description insect bites/skin ulcer	Describe location and appearance of insect bites/skin ulcer		N/A		P
Chest X-ray	Results of chest x-ray		TBD		P
Antibiotic	Did patient receive an effective antibiotic for illness?		TBD		P
Antibiotic start date	Date each antibiotic started		N/A		P
Illness outcome	Outcome of illness		TBD		P
Primary plague type	Classification of primary clinical manifestation of infection		TBD		P
Secondary pneumonic plague	Did patient have secondary pneumonic plague?		PHVS_YesNoUnknown_CDC		P
Y. pestis cultured	Was Y. pestis cultured?		PHVS_YesNoUnknown_CDC		P
Specimen source	Source of culture		N/A		P
Date specimen collected	Date specimen was collected		N/A		P
Y. pestis detected	Was Y. pestis detected by other tests?		PHVS_YesNoUnknown_CDC		P
Test performed	Test used to detect Y. pestis		N/A		P
Specimen source	Specimen source in which Y. pestis was detected		N/A		P
Date specimen collected	Date of specimen collection		N/A		P
Serology	Serology results		TBD		P
First Serum titer	Titer of first serum specimen		N/A		P
Second Serum titer	Titer of second serum specimen		N/A		P
Date first serum drawn	Date first serum drawn		N/A		P
Date second serum drawn	Date second serum drawn		N/A		P
Epi-linked to any other plague cases	Was this illness epi-linked to any other plague cases?		PHVS_YesNoUnknown_CDC		P
Likely location of exposure	Most likely location of exposure		TBD		P
Animal contact	Did patient have any animal contact in the 2 weeks preceding illness?		PHVS_YesNoUnknown_CDC		P
Nature of contact	Nature of animal contact in the 2 weeks preceding illness		TBD		P
Type of animal contact	Was animal domestic or wild		TBD		P
Flea bite or insect bites	Did patient have flea or insect bites in the 2 weeks preceding illness?		PHVS_YesNoUnknown_CDC		P
Wild animal	Specify wild animal that patient had contact with in the 2 weeks preceding illness		N/A		P
Domestic animal	Specify domestic animal that patient had contact with in the 2 weeks preceding illness		N/A		P
Evidence of infected animals or fleas	Evidence of infected animals or fleas in the likely exposure location		PHVS_YesNoUnknown_CDC		P
Specify infected animals or fleas	Describe evidence of Y. pestis infected animals or fleas in likely exposure location		N/A		P
Other exposure	Specify any other exposures in the two weeks preceding illness		N/A		P
Comments	Additional comments		N/A		P
Person to person transmission	Evidence of person to person transmission from a known plague patient		PHVS_YesNoUnknown_CDC		P

Tularemia
The impetus/urgency for CDC to add data elements for this condition	To make surveillance more comprehensive and informative for public health actions To provide more information about risk factors (healthcare facility exposure, travel, and specimen testing) that have been associated with colonization or infection To update guidance on infection control and prevention

Data Element Name		Data Element Description		Value Set Code		CDC Priority
Immunocompromised	If patient has any immunocompromising conditions, specify		N/A		P
Date first medical	Date that the patient was first seen by medical person.		N/A		P
Fever/sweats/chills	Did the patient's illness include the symptom of fever/sweats/chills?		PHVS_YesNoUnknown_CDC		P
Confusion/delirium	Did the patient's illness include the symptom of confusion/delirium?		PHVS_YesNoUnknown_CDC		P
Vomiting / diarrhea / abdominal pain	Did the patient's illness include the symptom of vomiting/diarrhea/abdominal pain?		PHVS_YesNoUnknown_CDC		P
Sore throat	Did the patient's illness include the symptom of sore throat?		PHVS_YesNoUnknown_CDC		P
Cough	Did the patient's illness include the symptom of cough?		PHVS_YesNoUnknown_CDC		P
Chest Pain	Did the patient's illness include the symptom of chest pain?		PHVS_YesNoUnknown_CDC		P
Shortness of breath	Did the patient's illness include the symptom of shortness of breath?		PHVS_YesNoUnknown_CDC		P
Other symptoms	Did the patient's illness include other symptoms not listed?		PHVS_YesNoUnknown_CDC		P
Other symptoms (specify)	Which other symptoms did the patient's illness include?		N/A		P
Lymphadenopathy	Did the patient have lymphadenopathy?		PHVS_YesNoUnknown_CDC		P
Describe lymphadenopathy	If lymphadenopathy present, provide location and description.		N/A		P
Skin lesions	Did the patient have skin lesion?		PHVS_YesNoUnknown_CDC		P
Describe skin lesions	If skin lesion present, provide location and description.		N/A		P
Conjunctivitis	Did the patient have conjunctivitis?		PHVS_YesNoUnknown_CDC		P
Pharyngitis/tonsillitis	Did the patient have pharyngitis/tonsillitis?		PHVS_YesNoUnknown_CDC		P
Chest X-ray	Results of chest x-ray		TBD		P
Antibiotic	Did patient receive an effective antibiotic for illness?		TBD		P
Antibiotic start date	Date each antibiotic started		N/A		P
Illness outcome	Outcome of illness		TBD		P
Primary clinical syndrome	Classification of primary clinical manifestation of infection		TBD		P
F. tularensis cultured	Was F. tularensis cultured?		PHVS_YesNoUnknown_CDC		P
Specimen source	Source of culture		N/A		P
Date specimen collected	Date specimen was collected		N/A		P
F. tularensis detected	Was F. tularensis detected by other tests?		PHVS_YesNoUnknown_CDC		P
Test performed	Test used to detect F. tularensis		N/A		P
Specimen source	Specimen source in which F. tularenisis was detected		N/A		P
Date specimen collected	Date of specimen collection		N/A		P
F. tularensis subspecies	Subspecies of F. tularensis detected		TBD		P
Serology	Serology results		TBD		P
First Serum titer	Titer results		N/A		P
Second Serum titer	Titer results		N/A		P
Date first serum drawn	Date first serum drawn		N/A		P
Date second serum drawn	Date second serum drawn		N/A		P
Epi-linked to other cases	Was this illness epi-linked to any other tularemia cases?		PHVS_YesNoUnknown_CDC		P
Epi-link specify	Describe epi-linked case		N/A		P
Travel associated	Was this illness associated with travel?		PHVS_YesNoUnknown_CDC		P
Travel specify	Describe travel		N/A		P
Animal contact	Did patient have any animal contact in the 2 weeks preceding illness?		PHVS_YesNoUnknown_CDC		P
Domestic animal	Indicate if domestic animal contact occurred and specify domestic animals that patient had contact with in the 2 weeks preceding illness		N/A		P
Type of animal contact	Was animal domestic or wild		TBD		P
Wild animal	Indicate if wild animal contact occurred and specify wild animals that patient had contact with in the 2 weeks preceding illness		N/A		P
Nature of contact	Nature of animal contact		TBD		P
Tick or deerfly bite	Did patient have tick or deerfly bite in the two weeks preceding illness?		TBD		P
Contact with or ingestion of untreated water	Did patient have contact with or ingestion of untreated water in the two weeks preceding illness?		PHVS_YesNoUnknown_CDC		P
Environmental aerosol generating activities	Did patient participate in any environmental aerosol generating activities in the two weeks preceding illness		PHVS_YesNoUnknown_CDC		P
Specify environmental aerosol generating activities	Specify environmental aerosol generating activities		N/A		P
Other exposure	Specify any other exposures in the two weeks preceding illness		N/A		P
Comments	Additional comments		N/A		P

Burden

The burden to add 97 data elements 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 elements to their surveillance system and modify their case notification message. A one-time average burden of 10 hours is incurred for respondents to add 97 data elements to their surveillance system and modify their electronic case notification message to accommodate those 97 additional data elements. This one-time burden of 10 hours is noted in the following table:

One-Time Burden to Add 97 Data Elements to NNDSS

Type of Respondents	Number of Respondents	Number of Responses per Respondent	Average Burden Per Response (in hours): One-time Addition of 97 Data Elements
States	50	1	10
Territories	5	1	10
Freely Associated States	3	1	10
Cities	2	1	10
Total

The total annualized one-time burden is 180 hours (150 hours for states, 15 hours for territories, 3 hours for freely associated states and 2 hours for cities) as noted in the table below.

Annualized One-Time Burden to Add 97 Data Elements to NNDSS

Type of Respondents	Number of Respondents	Number of Responses per Respondent	Average Burden Per Response (in hours): Annualized One-time Addition of 97 Data Elements	Total Annualized One-Time Burden (in hours)
States	50	1	3	150
Territories	5	1	3	15
Freely Associated States	3	1	3	9
Cities	2	1	3	6
Total				180

180 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	24	1,200
States	One-time SO/GI Survey	12	1	5/60	1
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	13	65
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	10	30
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	24	48
Total					19,578

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	$44.59	$38,660
States	Weekly (Non-automated)	10	52	2	1,040	$36.65	$38,116
States	Weekly (NMI Implementation)	50	52	4	10,400	$44.59	$463,736
States	Annual	50	1	75	3,750	$36.65	$137,438
States	One-time Addition of Diseases and Data Elements	50	1	24	1,200	$44.59	$53,508
States	One-time SO/GI Survey	12	1	5/60	1	$36.65	$37
Territories	Weekly (Automated)	5	52	20/60	87	$44.59	$3,879
Territories	Weekly, Quarterly (Non-automated)	5	56	20/60	93	$36.65	$3,408
Territories	Weekly (NMI Implementation)	5	52	4	1,040	$44.59	$46,374
Territories	Annual	5	1	5	25	$36.65	$916
Territories	One-time Addition of Diseases and Data Elements	5	1	13	65	$44.59	$2,898
Freely Associated States	Weekly (Automated)	3	52	20/60	52	$44.59	$2,319
Freely Associated States	Weekly, Quarterly (Non-automated)	3	56	20/60	56	$36.65	$2,052
Freely Associated States	Annual	3	1	5	15	$36.65	$550
Freely Associated States	One-time Addition of Diseases and Data Elements	3	1	10	30	$44.59	$1,338
Cities	Weekly (Automated)	2	52	20/60	35	$44.59	$1,561
Cities	Weekly (Non-automated)	2	52	2	208	$36.65	$7,623
Cities	Weekly (NMI Implementation)	2	52	4	416	$44.59	$18,549
Cities	Annual	2	1	75	150	$36.65	$5,498
Cities	One-time Addition of Diseases and Data Elements	2	1	24	48	$44.59	$2,140
Total							$830,600

1 R=Required; P=Preferred, O=Optional

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