Nonsubstantive Change Request Justification

National Notifiable Diseases Surveillance System (NNDSS)

OMB Control Number 0920-0728

Expiration Date: 03/31/2024

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: July 2, 2021

Circumstances of Change Request for OMB 0920-0728

This is a non-substantive change request for OMB No. 0920-0728, expiration date 03/31/2024, 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
Campylobacteriosis	NNC			Y		14	5
Cryptosporidiosis	NNC			Y		154	5
Cyclosporiasis	NNC			Y		130	1
Hansen’s Disease	NNC			Y		76	7
Hepatitis	NNC			Y		131	48
Listeriosis	NNC			Y		1573	11
S. Paratyphi Infection	NNC			Y		62	2
S. Typhi Infection	NNC			Y		68	2
Salmonellosis	NNC			Y		154	3
Shiga toxin-producing Escherichia Coli (STEC)	NNC			Y		335	1
Shigellosis	NNC			Y		25	3

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 data elements: 1 new laboratory data element for all conditions, 1 new core data element for all conditions, and 88 new disease-specific data elements. The 89 new disease-specific data elements include: 5 new disease-specific data elements for Campylobacteriosis, 5 new disease-specific data elements for Cryptosporidiosis, 1 new disease-specific data element for Cyclosporiasis, 7 new disease-specific data elements for Hansen’s Disease, 48 new disease-specific data elements for Hepatitis, 11 new disease-specific data elements for Listeriosis, 2 new disease-specific data elements for S. Paratyphi Infection, 2 new disease-specific data elements for S. Typhi Infection, 3 new disease-specific data elements for Salmonellosis, 1 new disease-specific data element for Shiga toxin-producing Escherichia Coli (STEC), and 3 new disease-specific data elements for Shigellosis.

Core: 1 Data Element
The impetus/urgency for CDC to add data element for all conditions		To make surveillance more comprehensive and informative for public health actions To provide more information about risk factors (related cases and conditions, high acuity care needs, healthcare facility exposure, travel, and specimen testing) that have been associated with colonization or infection To monitor epidemiology To update guidance on infection control and prevention
Data Element Name	Data Element Description		Value Set Code	CDC Priorityi
NORS ID	CDC National Outbreak Reporting System (NORS) Outbreak ID Number		N/A	1

Laboratory: 1 Data Element
The impetus/urgency for CDC to add data element for all conditions			To make surveillance more comprehensive and informative for public health actions To provide more information about risk factors (related cases and conditions, high acuity care needs, healthcare facility exposure, travel, and specimen testing) that have been associated with colonization or infection To monitor epidemiology To update guidance on infection control and prevention
	Data Element Name	Data Element Description		Value Set Code	CDC Priorityi
	Isolate sent to State Public Health Lab	Was the isolate sent to a state public health laboratory? (Answer 'Yes' if it was sent to any state lab, even if it was sent to a lab outside of the case's state of residence)		PHVS_YesNoUnknown_CDC	TBD

Campylobacteriosis: 5 Data Elements
The impetus/urgency for CDC to add data elements for this condition	To make surveillance more comprehensive and informative for public health actions To monitor epidemiology To update guidance on infection control and prevention

Data Element Name	Data Element Description	Value Set Code	CDC Priorityi
Travel State	Domestic destination, state(s) traveled to	PHVS_State_FIPS_5-2	3
International Destination(s) of Recent Travel	International destination or countries the patient traveled to	PHVS_Country_ISO_3166-1	3
Date of Arrival to Travel Destination	Date of arrival to travel destination	N/A	3
Date of Departure from Travel Destination	Date of departure from travel destination	N/A	3
Reason for travel related to current illness	Reason for travel related to current illness	PHVS_TravelPurpose_FDD	3

Cryptosporidiosis: 5 Data Elements
The impetus/urgency for CDC to add data elements for this condition	To make surveillance more comprehensive and informative for public health actions To monitor epidemiology To update guidance on infection control and prevention

Data Element Name	Data Element Description	Value Set Code	CDC Priorityi
Travel State	Domestic destination, state(s) traveled to	PHVS_State_FIPS_5-2	3
International Destination(s) of Recent Travel	International destination or countries the patient traveled to	PHVS_Country_ISO_3166-1	3
Date of Arrival to Travel Destination	Date of arrival to travel destination	N/A	3
Date of Departure from Travel Destination	Date of departure from travel destination	N/A	3
Reason for travel related to current illness	Reason for travel related to current illness	PHVS_TravelPurpose_FDD	3

Cyclosporiasis: 1 Data Element
The impetus/urgency for CDC to add data elements for this condition	To make surveillance more comprehensive and informative for public health actions To monitor epidemiology To update guidance on infection control and prevention

Data Element Name	Data Element Description	Value Set Code	CDC Priorityi
Reason for travel related to current illness	Reason for travel related to current illness	PHVS_TravelPurpose_FDD	3

	Hansen’s Disease: 7 Data Elements
	The impetus/urgency for CDC to add data elements for this condition		Improve CDC’s understanding of Hansen’s disease epidemiology. Identify challenges to diagnoses. Possibly prevent further transmission and lifelong neuropathy and disability given the increase in disease incidence, and lack of information related to medication dosages, recipients, duration, and frequency of administration that is received via current notifications.
Data Element Name		Data Element Description		Value Set Code	CDC Priorityi
Medication Frequency		Frequency of medication administered for this condition.		N/A	2
Medication Frequency Unit		Unit of measure for the frequency of medication administered (e.g. daily, weekly, monthly).		TBD	2
Medication Duration		Duration of medication treatment or post-exposure prophylaxis.		N/A	2
Medication Duration Units		Unit of measure for the duration of medication administered (e.g. days, weeks, months).		TBD	2
Medication Recipient		Specify recipient of medication for Hansen’s disease (e.g. household contact, case subject).		TBD	1
Medication Dose		Dosage of medication received.		N/A	2
Medication Dosage Unit		Unit of measure for medication received (e.g. milligram [mg], milligram/kilogram [mg/kg])		TBD	2

	Hepatitis: 48 Data Elements
	The impetus/urgency for CDC to add data elements for this condition	To improve the collection and sending of data elements for those jurisdictions funded through PS21-2103 “Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments” To make surveillance more comprehensive and informative for public health actions To monitor perinatal hepatitis C using the new Council of State and Territorial Epidemiologists/CDC definition To provide more information about risk factors (related cases and conditions, incarceration, travel, not prescribed injection/non-injection drug use, contact with a hepatitis confirmed/suspected person, and homelessness) To describe the epidemiology and risk factors for hepatitis A related to unprecedented multi-state outbreaks To update guidance on infection control and prevention
Data Element Name			Data Element Description	Value Set Code	CDC Priorityi
CSTE Case Definition			Did the patient meet the CSTE case definition(s) for any of the following in a previous reporting year? (select all that apply)	TBD	2
Information Source for Data			Source of Laboratory Test: (select all that apply)	TBD	2
Signs and Symptoms			Signs and symptoms associated with the illness being reported	TBD	1
Signs and Symptoms Indicator			Response for each of the signs and symptoms.	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Date of Symptom Onset			The date and time, if available, of the symptom onset (clinical manifestation)	N/A	1
Date of Jaundice Onset			What was the date of jaundice onset?	N/A	1
Case Patient a Healthcare Worker			Was the patient employed as a healthcare worker during the TWO WEEKS prior to onset of symptoms to ONE WEEK after onset of JAUNDICE? (If no jaundice, use two weeks after onset of symptoms)	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	2
Patient Epidemiological Risk Factors			Exposed risk factors for the patient - Please provide a response for all risk factors in the value set with an associated indicator. In the 15 to 50 days before symptom onset date for hepatitis A. In the 60 to 150 days (2 to 5 months) before symptom onset date for hepatitis B. In the 14 to 182 days (2 weeks to 6 months) before symptom onset date for hepatitis C.	TBD	1
Patient Epidemiological Risk Factors Indicator			Provide a response for each value in the patient epidemiological risk factors value set.	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Contact Type			If the patient was a contact of a person with confirmed or suspected hepatitis virus infection, was the contact: (select all that apply)	TBD	2
Men who have Sex with Men			Was the patient a man who reported sexual activity with men?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Multiple Sex Partners			Did the patient report multiple sex partners?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Previous STD History			Was the patient diagnosed with a sexually transmitted disease?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	2
Antiviral Medication			Did the gestational parent receive hepatitis B antiviral therapy during the third trimester of pregnancy?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Birth Weight (unit)			The patient's birth weight units	TBD	1
Vaccinated within 12 Hours of Birth			Did the patient receive the hepatitis B vaccine within 12 hours of birth?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Treatment within 12 Hours of Birth			Did the patient receive the hepatitis B immune globulin within 12 hours of birth?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Seroconversion			If hepatitis B case, did the patient meet the acute hepatitis B seroconversion criteria? (i.e., documented negative HBsAg laboratory test result within 6 months prior to a positive test [HBsAg, HBeAg, or nucleic acid test for HBV DNA (including qualitative, quantitative, and genotype testing)] in someone without a prior diagnosis of HBV infection) If hepatitis C case, did the patient meet the acute hepatitis C seroconversion criteria? (e.g., documented negative anti-HCV followed within 12 months by a positive anti-HCV test; or documented negative anti-HCV or negative HCV detection test [in someone without a prior diagnosis of HCV infection] followed within 12 months by a positive HCV detection test; or, in the case of presumed reinfection, at least two sequential negative HCV detection tests [in someone with a prior diagnosis of HCV infection] followed by a positive HCV detection test).	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Occupation and Industry Category			Was the patient employed as a food handler or a healthcare worker during the TWO WEEKS prior to onset of symptoms to ONE WEEK after the onset of JAUNDICE? (If no jaundice, use two weeks after onset of symptoms)	TBD	2
Occupation and Industry Category Indicator			Please indicate for each occupation:	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	2
Positive Results 6 Months Apart			Did the patient have two positive results at least 6 months apart from any of the following tests: (1) HBsAg; (2) nucleic acid test for HBV DNA (including qualitative, quantitative, and genotype testing); (3) HBeAg?  (Any combination of these positive tests performed at least 6 months apart is acceptable)	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Mother's Local Record ID			Provide the local record ID used for reporting mother's case of hepatitis (DE Identifier "N/A: OBR-3"). This will be used for linking the reported perinatal case to the mother's reported hepatitis case.	N/A	3
Mother Nucleic Acid Test			For hepatitis B, perinatal, did the gestational parent receive nucleic acid testing for HBV DNA during pregnancy? For hepatitis C, perinatal, did the gestational parent receive nucleic acid testing for HCV RNA (including qualitative or quantitative PCR, or genotype testing) during pregnancy?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	2
Mother Nucleic Acid Test Result			For hepatitis B, perinatal, if the gestational parent received nucleic acid testing for HBV DNA during pregnancy, then indicate the result. For hepatitis C, perinatal, if the gestational parent received nucleic acid testing for HCV RNA (including qualitative or quantitative PCR, or genotype testing) during pregnancy, then indicate the result.	TBD	2
Mother Nucleic Acid Test Viral Load			If the gestational parent received nucleic acid testing for HBV DNA during pregnancy, then indicate the viral load:	TBD	2
Mother HBeAg Test			Did the gestational parent receive HBeAg testing during pregnancy?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	2
Mother HBeAg Test Result			If the gestational parent received HBeAg testing during pregnancy, indicate the result.	TBD	2
Infant HBsAg Test			Did the patient receive an HBsAg test between age 1–24 months (only if ≥4 weeks after the last dose of hepatitis B vaccine)?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Infant HBsAg Test Result			If the patient received an HBsAg test between age 1–24 months (only if ≥4 weeks after the last dose of hepatitis B vaccine), indicate the result.	TBD	1
Infant HBsAg Positive Date			If positive, then indicate the date of the first positive HBsAg test between age 1-24 months.	N/A	1
Infant HBeAg Test			Did the patient receive an HBeAg test between age 9–24 months?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Infant HBeAg Test Result			If the patient received an HBeAg test between age 9–24 months, indicate the result.	TBD	1
Infant HBeAg Positive Date			If positive, then indicate the date of the first positive HBeAg test between age 9-24 months.	N/A	1
Infant HBV DNA Test			Did the patient receive an HBV DNA test between age 9–24 months?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Infant HBV DNA Test Result			If the patient received an HBV DNA test between age 9–24 months, indicate the result.	TBD	1
Infant HBV DNA Positive Date			If detected/positive, then indicate the date of the first positive HBV DNA test between age 9-24 months.	N/A	1
Infant anti-HCV Test			Did the patient receive an anti-HCV test between age 18-36 months?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Infant anti-HCV Test Result			If the patient received an anti-HCV test between age 18-36 months, indicate the result.	TBD	1
Infant anti-HCV Positive Date			If positive, then indicate the date of the first positive anti-HCV test between age 18-36 months.	N/A	1
Infant Nucleic Acid Test			Did the patient receive nucleic acid testing for HCV RNA (including qualitative or quantitative PCR, or genotype testing) between age 2-36 months?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Infant Nucleic Acid Test Result			If the patient received nucleic acid testing for HCV RNA (including qualitative or quantitative PCR, or genotype testing) between age 2-36 months, indicate the result.	TBD	1
Infant Nucleic Acid Positive Date			If detected/positive, then indicate the date of the first positive nucleic acid test for HCV RNA between age 2-36 months.	N/A	1
Infant HCV Antigen Test			Did the patient receive HCV antigen test between age 2-36 months?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Infant HCV Antigen Test Result			If the patient received HCV antigen test between age 2-36 months, indicate the result.	TBD	1
Infant HCV Antigen Positive Date			If positive, then indicate the date of the first positive HCV antigen test between age 2-36 months.	N/A	1
Tissue or organ transplant			Did the patient receive tissue or organ transplant(s)?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	2
Non-injection Drug Use			Did the patient use non-injection drugs not prescribed by a doctor or engage in nonmedical use of prescription drugs? v1.0 only: During the 2-6 weeks prior to the onset of symptoms, did the subject inject drugs not prescribed by a doctor?	Yes No Unknown (YNU) https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.114222.4.11.888	1
Specimen From Mother or Infant			Is the specimen from the gestational parent or the infant?	PHVS_SpecimenFromMotherOrInfant_CRS	1

Listeriosis: 11 Data Elements
The impetus/urgency for CDC to add data elements for this condition	To bring current LI Case Report Form in alignment with 2019 CSTE case definition changes To monitor trends related to presumptive and suspected cases in accordance to 2019 CSTE case definition change To track epi-linked maternal and neonatal cases more accurately To provide more information about risk factors of Listeriosis To monitor epidemiology

Data Element Name	Data Element Description	Value Set Code	CDC Priorityi
CaseStatusAPMother	Case classification of Pregnant mother	PHVS_CaseClassStatus_NND	TBD
CaseStatusAPNeonate	Case classification of Neonate	PHVS_CaseClassStatus_NND	TBD
CaseStatusNP	Case classification	PHVS_CaseClassStatus_NND	TBD
LabCriteria	Laboratory Criteria for Diagnosis	N/A	TBD
APNeonateAgeAtCollection	Neonatal age at time of laboratory specimen collection	N/A	TBD
ResultCulture	Result of culture-based test on specimen	PHVS_PosNegUnkNotDone_CDC	TBD
ResultCIDT	Result of CIDT-based test on specimen	PHVS_PosNegUnkNotDone_CDC	TBD
EpiLink	Indicates the case is epi-linked to a confirmed or probable case	PHVS_YesNoUnknown_CDC	TBD
PrInfantOutcomeDeathDate	Pregnant: If infant died, when was the date of death (Date)	N/A	TBD
LocalRecordIDMother	Pregnant: If mother and infant are counted as separate cases provide the State Epi Case ID of the mother	N/A	TBD
LocalRecordIDNeonate	Pregnant: If mother and infant are counted as separate cases provide the State Epi Case ID of the neonate	N/A	TBD

S. Paratyphi Infection: 2 Data Elements
The impetus/urgency for CDC to add data elements for this condition	To make surveillance more comprehensive and informative for public health actions To monitor epidemiology To update guidance on infection control and prevention

Data Element Name	Data Element Description	Value Set Code	CDC Priorityi
Date of Arrival to Travel Destination	Date of arrival to travel destination	N/A	3
Travel State	Domestic destination, state(s) traveled to	PHVS_State_FIPS_5-2	3

S. Typhi Infection: 2 Data Elements
The impetus/urgency for CDC to add data elements for this condition	To make surveillance more comprehensive and informative for public health actions To monitor epidemiology To update guidance on infection control and prevention

Data Element Name	Data Element Description	Value Set Code	CDC Priorityi
Date of Arrival to Travel Destination	Date of arrival to travel destination	N/A	3
Travel State	Domestic destination, state(s) traveled to	PHVS_State_FIPS_5-2	3

Salmonellosis: 3 Data Elements
The impetus/urgency for CDC to add data elements for this condition	To make surveillance more comprehensive and informative for public health actions To monitor epidemiology To update guidance on infection control and prevention

Data Element Name	Data Element Description	Value Set Code	CDC Priorityi
Date of Arrival To Travel Destination	Date of arrival to travel destination	N/A	3
Date of Departure From Travel Destination	Date of departure from travel destination	N/A	3
Reason for travel related to current illness	Reason for travel related to current illness	PHVS_TravelPurpose_FDD	3

Shiga toxin-producing Escherichia Coli (STEC): 1 Data Element
The impetus/urgency for CDC to add data elements for this condition	To make surveillance more comprehensive and informative for public health actions To monitor epidemiology To update guidance on infection control and prevention

Data Element Name	Data Element Description	Value Set Code	CDC Priorityi
Reason for travel related to current illness	Reason for travel related to current illness	PHVS_TravelPurpose_FDD	3

Shigellosis: 3 Data Elements
The impetus/urgency for CDC to add data elements for this condition		To make surveillance more comprehensive and informative for public health actions To monitor epidemiology To update guidance on infection control and prevention
Data Element Name	Data Element Description		Value Set Code	CDC Priorityi
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
Reason for travel related to current illness	Reason for travel related to current illness		PHVS_TravelPurpose_FDD	3

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	15	750
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	15	75
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	15	45
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	15	30
Total					19,134

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	$46.23	$40,081
States	Weekly (Non-automated)	10	52	2	1,040	$37.64	$39,146
States	Weekly (NMI Implementation)	50	52	4	10,400	$46.23	$480,792
States	Annual	50	1	75	3,750	$37.64	$141,150
States	One-time Addition of Diseases and Data Elements	50	1	15	750	$46.23	$34,673
Territories	Weekly (Automated)	5	52	20/60	87	$46.23	$4,022
Territories	Weekly, Quarterly (Non-automated)	5	56	20/60	93	$37.64	$3,501
Territories	Weekly (NMI Implementation)	5	52	4	1,040	$46.23	$48,079
Territories	Annual	5	1	5	25	$37.64	$941
Territories	One-time Addition of Diseases and Data Elements	5	1	15	75	$46.23	$3,467
Freely Associated States	Weekly (Automated)	3	52	20/60	52	$46.23	$2,404
Freely Associated States	Weekly, Quarterly (Non-automated)	3	56	20/60	56	$37.64	$2,108
Freely Associated States	Annual	3	1	5	15	$37.64	$565
Freely Associated States	One-time Addition of Diseases and Data Elements	3	1	15	45	$46.23	$2,080
Cities	Weekly (Automated)	2	52	20/60	35	$46.23	$1,618
Cities	Weekly (Non-automated)	2	52	2	208	$37.64	$7,829
Cities	Weekly (NMI Implementation)	2	52	4	416	$46.23	$19,232
Cities	Annual	2	1	75	150	$37.64	$5,646
Cities	One-time Addition of Diseases and Data Elements	2	1	15	30	$46.23	$1387
Total							$838,721

i R=Required; 1=Priority 1, 2=Priority 2, 3=Priority 3, TBD=To be determined

1