Non-Substantive Change Request Justification - 08JUN2023

National Notifiable Diseases Surveillance System (NNDSS)

OMB Control Number 0920-0728

Expiration Date: 03/31/2026

Program Contact

Umed A. Ajani

Associate Director for Science

Division of Health Informatics and Surveillance

Office of Public Health Data, Surveillance, and Technology

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 1, 2023

Circumstances of Change Request for OMB 0920-0728

This is a non-substantive change request for OMB No. 0920-0728, expiration date 03/31/2026, for the reporting of Nationally Notifiable Diseases. Information on disease-specific data elements to be modified 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 NNDSS Data Elements to be Modified
Free-living Amebae (FLA) Infections	CSS			N	Y	0	72
Viral Hemorrhagic Fevers (VHF)	NNC			Y	Y	104	18

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 90 new disease-specific data elements: 72 new disease-specific data elements for free-living amebae infections and 18 new disease-specific data elements for viral hemorrhagic fevers.

Free-living Amebae (FLA)

The impetus/urgency for CDC to add data elements for this condition

Free-living amebae (FLA) including Acanthamoeba spp., Balamuthia mandrillaris, and Naegleria fowleri can cause severe and often life-threatening infections in humans. They primarily infect the central nervous system, causing amebic meningoencephalitis, but Balamuthia and Acanthamoeba can infect other organ systems as well. Acanthamoeba, Balamuthia, and Naegleria fowleri are commonly found in the environment, but infections are rare, occurring in approximately 30 individuals in the United States annually. FLA infections are nearly always fatal. In the United States, up to 97% of people with FLA infections have died. The low incidence and high mortality associated with FLA infections have resulted in a need for national surveillance efforts to assist in further understanding risk factors, epidemiology, transmission, treatment, and prevention of FLA infections. In the event an FLA infection is detected, national surveillance efforts are needed to confirm a case using a standardized case definition, characterize the epidemiology, and inform public health interventions for response and prevention strategies.

Data Element Name	Data Element Description	Value Set Code	CDC Priority1 (New)
Subject's Last Name	Patient Last Name	N/A	2
Subject's First Name	Patient First Name	N/A	2
Middle Initial	Patient Middle Initial	N/A	2
County of Treatment	County in which patient was treated	PHVS_County_FIPS_6-4	2
State of Treatment Hospital	State in which patient was treated	PHVS_State_FIPS_5-2	2
Recreational Water Exposure Questions Indicator	Any recreational water exposure	PHVS_YesNoUnknown_CDC	1
Recreational Water Exposure Within 14 Days Before Symptom Onset	Types of recreational water which patient was exposed	TBD	2
Recreational Water Exposure Date	Date of water exposure	N/A	2
Recreational Water Notes	Other recreational water exposure, specify	N/A	3
Other Recreational Water Exposure Date	Other recreational water exposure onset date	N/A	2
Recreational Water Activities	Patient participation in any recreational water activities	PHVS_YesNoUnknown_CDC	2
Activity Type	Types of recreational water activities patient participated in	TBD	2
Other Recreational Water Activities Specify	Other water activity, specify	N/A	3
Nasal Irrigation Exposure	Any nasal irrigation exposure	PHVS_YesNoUnknown_CDC	1
Nasal Irrigation Water Source	Water source used by patient for nasal irrigation	TBD	1
Nasal Irrigation Exposure Indicator	Types of nasal irrigation	TBD	2
Nasal Irrigation Exposure Date	Date when patient preformed nasal irrigation	N/A	2
Other Nasal Irrigation Exposure specify	Other nasal irrigation type, specify	N/A	3
Soil Exposure	Any soil exposure	PHVS_YesNoUnknown_CDC	1
Soil Exposure Indicator	Types of soil exposure	TBD	2
Soil Exposure Date	Date when patient was exposed to soil	N/A	2
Travel	Any travel within the last 2 years	PHVS_YesNoUnknown_CDC	2
International Destination of Travel	International travel destination	N/A	2
Travel State	Domestic travel destination	N/A	2
Date Of Arrival to Travel Destination​	Date of Arrival to Travel Destination	N/A	2
Date of Departure from Travel Destination	Date of Departure from Travel Destination	N/A	2
Treatment Type	List of treatment/drugs used by patient in the past 2 years	TBD	1
Treatment Information	If patient using other treatment/drugs, specify	N/A	2
Immunocompromised Associated Condition or Treatment	List of immunocompromised conditions experienced by patient	TBD	1
CD4 Count	If yes to HIV/AIDS, what is CD4 count (per mm3)	N/A	2
Cancer, specify	If the patient has cancer, specify the type of cancer	N/A	2
Hematologic disease	If patient has a hematologic disease, specify	N/A	2
Other autoimmune disease	If patient has other autoimmune disease, specify	N/A	2
Transplant Type	If patient had organ transplant, which organ	N/A	1
ENT/Respiratory Indicator	List of ENT/Respiratory conditions experienced by patient	TBD	1
Other ENT	Specify other ENT condition experienced by patient	N/A	2
Other Respiratory	Specify other respiratory condition experienced by patient	N/A	2
Underlying Conditions(s)	List of other health conditions experienced by patient	TBD	2
Other condition	Specify other condition experience by patient	N/A	2
Second Hospitalization	Other hospitalizations in the past 90 days	PHVS_YesNoUnknown_CDC	2
History of Present Illness	Description of patient’s clinical course prior to hospitalization	N/A	1
Patient Outcome	Did patient survive	PHVS_YesNoUnknown_CDC	1
Neurologic deficits	If survived, residual neurologic deficits	PHVS_YesNoUnknown_CDC	1
Neurologic Manifestations	Describe neurologic deficits	N/A	2
Cause of Death	Cause of death	TBD	1
Other cause of death	Specify other cause of death	N/A	2
Organs transplant donor	If died, were organs transplanted	PHVS_YesNoUnknown_CDC	1
Specify organs transplanted	Specify which organs were transplanted	N/A	2
Clinical Outcome	Description of patient’s clinical course	N/A	1
Sign and Symptoms	List of general and neurological signs and symptoms experienced by patient	TBD	1
Signs and Symptoms Indicator	Indicator for associated sign and symptom	PHVS_YesNoUnknown_CDC	1
Other Signs and Symptoms, Specify	Specify other general sign or symptoms	N/A	2
Onset date of neurological symptom	Onset date of first neurological sign/symptom	N/A	1
Other neurological sign/symptom	Specify other neurological sign/symptom	N/A	2
Skin lesions	Skin lesions present on patient	PHVS_YesNoUnknown_CDC	1
Character of Lesions	Type of lesion (ulcers, plaques, erythematous nodules)	TBD	2
Lesion location	Location of lesions	N/A	2
Total number of Lesions	Number of lesions	N/A	2
CSF Panel Testing Date	Date of CSF testing	N/A	1
CSF Panel Test Result	CSF Panel Test Result	TBD	1
Diagnostic imaging	Use of diagnostic imaging	PHVS_YesNoUnknown_CDC	1
Diagnostic imaging type indicator	Type of imaging preformed	TBD	2
Diagnostic imaging findings indicator	Findings of diagnostic imaging	TBD	2
Diagnostic imaging findings specify indicator	Other findings of diagnostic imaging, specify	N/A	3
Number of brain lesions	How many brain lesions	TBD	2
Ring-enhancing brain lesions	Were brain lesions ring-enhancing	PHVS_YesNoUnknown_CDC	2
Location of brain lesions	If yes to brain lesions, location of brain lesions	N/A	2
Surgical resection	Did surgical resection occur	PHVS_YesNoUnknown_CDC	1
Medications	Types of medication used to treat patient	TBD	1
Medication start date	When did medication start	N/A	2
Medication end date	When did medication end	N/A	2
Route of Administration	How was medication administered to patient	TBD	2

Viral hemorrhagic fevers (VHF)

The impetus/urgency for CDC to add data elements for this condition

Viral hemorrhagic fevers (VHFs) are a group of diseases that affect the organ systems of the body, damaging the overall cardiovascular system, and may result in bleeding, or hemorrhaging. The number of viruses known to cause disease in humans around the globe is ever-increasing, and the way VHF viruses spread is likely to shift due to globalization, international travel, and climate change. Due to these dynamics of viral spread, the risk of introducing a VHF into the United States is increasing. Therefore, the need for national notifiable disease surveillance to assist in understanding the transmission and epidemiology of VHFs in U.S. jurisdictions is critical. In the event a VHF case is detected in the United States, nationwide disease surveillance is necessary to provide consistent case identification and classification, measure the potential burden of illness, characterize the epidemiology of medically attended VHFs in the United States, detect community transmission, and inform public health response to clusters of illness and efficacy of population-based non-pharmaceutical interventions during the outbreak.

Data Element Name	Data Element Description	Value Set Code	CDC Priority2 (New)
Travel	Did the patient travel outside the United States in the 3 weeks before becoming ill?	PHVS_YesNoUnknown_CDC	1
Contact with Case	Has the patient had contact with a symptomatic VHF case (suspect or confirmed), or VHF survivor in the 3 weeks before becoming ill?	PHVS_YesNoUnknown_CDC	1
Contact with Case Start Date	Contact with VHF case start date	N/A	1
Contact with Case End Date	Contact with VHF end date	N/A	1
Provide Care for ill patient	Did the patient care for someone who was sick or died in the 3 weeks before becoming ill?	PHVS_YesNoUnknown_CDC	1
Provide Care for ill patient Start Date	Care for sick person start date	N/A	1
Provide Care for ill patient End Date	Care for sick person end date	N/A	1
Attend Funeral	Did the patient attend a funeral outside of the United States in the 3 weeks before becoming ill?	PHVS_YesNoUnknown_CDC	1
Consumed Meat	Did the patient consume any meat harvested from wild animals outside of the United States in the 3 weeks before becoming ill?	PHVS_YesNoUnknown_CDC	1
Reported Pathogen	Select VHF pathogen reported	TBD	1
Reported Pathogen Other	Other VHF pathogen reported	TBD	1
Tick Mosquito Contact	Did the patient experience any tick or mosquito bites while outside of the United States?	PHVS_YesNoUnknown_CDC	1
Specify Tick Mosquito Type	Specify tick and/or mosquito contact	TBD	1
Tick Mosquito Location Country	Tick/Mosquito location country	TBD	2
Tick Mosquito Location District	Tick/Mosquito location district	TBD	3
Last Date of Tick Contact	Last date of tick bite (or tick removal)	N/A	2
Last Date of Mosquito Contact	Last date of mosquito bite	N/A	2
Positive Results Pathogen	Positive results for which pathogen	TBD	1

Burden

The burden to add 90 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 9 hours is incurred for respondents to add 90 data elements to their surveillance system and modify their electronic case notification message to accommodate those 90 additional data elements. This one-time burden of 9 hours is noted in the following table:

One-Time Burden to Add 90 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 90 Data Elements
States	50	1	9
Territories	5	1	9
Freely Associated States	3	1	9
Cities	2	1	9
Total

The total annualized one-time burden is 180 hours (150 hours for states, 15 hours for territories, 9 hours for freely associated states and 6 hours for cities) as noted in the table below.

Annualized One-Time Burden to Add 90 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 90 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	9	450
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	9	45
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	9	27
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	9	18
Total					18,774

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	9	450	$49.14	$22,113
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	9	45	$49.14	$2,211
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	9	27	$49.14	$1,327
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	9	18	$49.14	$885
Total							$882,848

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

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

1