Change Request Justification

OMB_0920-0728_Change Request_Multiple_Conditions_08022022.docx

National Notifiable Diseases Surveillance System (NNDSS)

Change Request Justification

OMB: 0920-0728

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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: August 2, 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 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

Arboviral

NNC



Y

Y

159

8

Carbon Monoxide Poisoning

NNC



Y

Y

50

13

Hepatitis

NNC



Y

Y

190

8

Malaria

NNC



Y

Y

100

1

Monkeypox

NNC



N

Y

0

59


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 89 new disease-specific data elements: 8 new disease-specific data elements for Arboviral, 13 new disease-specific data elements for Carbon Monoxide Poisoning, 8 new disease-specific data elements for Hepatitis, 1 new disease-specific data element for Malaria, and 59 new disease-specific data elements for Monkeypox.


Arboviral


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


  • To better align arboviral surveillance data collection with current practices for other notifiable conditions. Harmonization should decrease burden on jurisdictional public health partners in reporting notifiable conditions to CDC


  • To provide more information about vaccination history among arboviral disease cases

Data Element Name

Data Element Description

Value Set Code

CDC Priority1

Type of Complication

If the subject experienced severe complications due to this illness, specify the complication(s).

TBD

2

Type of Complications Indicator

Indicator for associated complication

PHVS_YesNoUnknown_CDC

2

Signs and Symptoms

Sign and symptoms associated with the illness being reported

TBD

2

Signs and Symptoms Indicator

Indicator for associated signs and symptoms

PHVS_YesNoUnknown_CDC

2

Clinical Finding

Clinical findings associated with the illness being reported

TBD

2

Clinical Finding Indicator

Indicator for associated clinical findings

PHVS_YesNoUnknown_CDC

2

Transmission Mode Detail

For rare arboviral transmission modes, indicate the determined source of infection following investigation of the case.

TBD

2

Manufacturer of Last Dose Prior to Illness Onset

Manufacturer of last vaccine dose against this disease prior to illness onset

TBD

2




Carbon Monoxide Poisoning


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


  • To make surveillance more comprehensive and informative for public health actions including public health policy.


  • Enhanced surveillance to learn about the effects of long-term exposures to low levels of CO, and monitor trends identify high risk groups.


  • Additional data would help to better targe outreach activities to those at increased risk for CO poisoning.

Data Element Name

Data Element Description

Value Set Code

CDC Priority2

Severe Weather

Was the carbon monoxide exposure related to a severe weather event?

PHVS_YesNoUnknown_CDC

1

Severe Weather Type

Identify the severe weather event(s) occurring when the patient was exposed to carbon monoxide.

TBD

1

Intent of Exposure

Was the intent of the carbon monoxide exposure self-harm/assault (intentional) or accidental (unintentional)?

TBD

1

Carbon Monoxide Level in Air

Carbon monoxide level in air measured in parts per million (PPM) at exposure site

N/A

3

Start Date of Treatment or Therapy

Provide the date and time of when the treatment started.

N/A

2

Underlying Condition(s) Indicator

Indicator for underlying condition(s)

PHVS_YesNoUnknown_CDC

2

Signs and Symptoms Indicator

Indicator for associated sign and symptom

PHVS_YesNoUnknown_CDC

1

Specimen Collection Date/Time

Date of collection of laboratory specimen used for diagnosis of health event reported in this case report. Time of collection should be sent if available.

N/A

2

Start Date of Treatment or Therapy

Provide the date and time of when the treatment started.

N/A

2

Type of Workers Compensation Claim

Indicate if the worker's compensation claim is submitted or paid with a finding, problem, diagnosis or other indication of exposure to carbon monoxide or carbon monoxide poisoning.

TBD

2

Test Type

Please specify Carboxyhemoglobin Level or Pulse CO-oximetry Measurement test.

TBD

1

Test Result Quantitative

Please send the test results for the selected test type. The unit of test result is percent (%).

N/A

2

Specimen Collection Date/Time

Date of collection of laboratory specimen used for diagnosis of health event reported in this case report. Time of collection should be sent if available.

N/A

2



Hepatitis



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


  • The data elements included in this change request will contribute to enhanced surveillance efforts for those jurisdictions funded through PS21-2103 “Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments”.

  • These data elements will improve standardization of data collection for CDC surveillance and improve the overall understanding of the population and factors contributing to viral hepatitis infection. The enhanced surveillance will be more comprehensive and informative for public health actions and will improve guidance on infection control and prevention.

Data Element Name

Data Element Description

Value Set Code

CDC Priority (New)


Alanine Aminotransferase (ALT) Result


What was the patient’s ALT level (IU/L)?

Note: The result of the ALT test performed on the same specimen as the positive hepatitis A, B or C lab result(s) or associated with the positive hepatitis A, B or C lab result(s).

CDC’s preference is for the qualitative result to be submitted when available rather than the quantitative option.

PHVS_AlanineATResult_Hepatitis

2


Vaccine Series Completed

Was the vaccine series completed?

PHVS_YesNoUnknown_CDC

2


Donor Screening

Patient was determined to have viral hepatitis during screening for blood, organ, or tissue donation. Please indicate the donation type.

PHVS_DonorScreening_Hepatitis

2


Travel Outside USA Prior to Illness Onset (within Program Specific Timeframe)

Did the patient travel or live internationally in the 15 to 50 days before symptom onset date?


Note: If the symptom onset date is unknown, then the date that the patient first tested positive for hepatitis A virus (HAV) can be used as a proxy for symptom onset date.

PHVS_YesNoUnknown_CDC

1


Specify Different Travel Exposure Window

If the travel exposure window used by the jurisdiction is different from that stated in the travel exposure questions, specify the time interval in days here. Otherwise, leave blank.

N/A (text field)

1


International Destination(s) of Recent Travel

International destination or countries the patient traveled to or lived in, in the 15 to 50 days before symptom onset

Note: If the symptom onset date is unknown, then the date that the patient first tested positive for hepatitis A virus (HAV) can be used as a proxy for symptom onset date.

PHVS_Country_ISO_3166-1

1


Date of Arrival to Travel Destination

Date of arrival to travel destination

N/A (Date)

3


Date of Departure from Travel Destination

Date of departure from travel destination

N/A (Date)

3




Malaria


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


  • Link reported congenital malaria cases to the mother’s reported malaria case to gain a better understanding and more complete picture of risk factors.


  • Assist in improving CDC’s epidemiologic understanding of the rare condition of congenital malaria and disease trends over time.

Data Element Name

Data Element Description

Value Set Code

CDC Priority (New)

Mother's Local Record ID

Provide the local record ID used for reporting mother's case (DE Identifier "N/A: OBR-3" in the Generic portion of the message). This will be used for linking the reported congenital case to the mother's reported case.

N/A

3



Monkeypox


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


  • Since January 2022, clusters of monkeypox cases, have been reported in 71 countries that do not normally have monkeypox. As of this writing (29 July, 2022) there are over 21,148 confirmed cases globally. The number of confirmed cases in the U.S. is rapidly increasing. Since January, 4,906 confirmed cases in the U.S. have been identified. Most of U.S. cases do not have direct travel-associated exposure risks (i.e., travel to monkeypox endemic countries). Transmission during close contact and intimate contact is thought to be a major transmission route.

  • NNDSS reporting will enhance the speed, accuracy, and comparability of data capture for monkeypox case notifications during this outbreak, particularly as new states are onboarded.

  • Data collected will inform public health interventions to interrupt disease transmission and identify risk factors for infection.

Data Element Name

Data Element Description

Value Set Code

CDC Priority

(New)

Tribal Residence

If you reside in a Tribal Area, please specify

TBD

2

Tribal Name

If the selected race is American Indian or Alaska Native, what is the tribal affiliation?

PHVS_TribeName_NND

3

Gender Identity

Do you currently describe yourself as male, female, or transgender?

PHVS_GenderIdentity_USCDI

1

Sexual Orientation

Patient identified sexual orientation (i.e., an individual's physical and/or emotional attraction to another individual of the same gender, opposite gender, or both genders).

PHVS_SexualOrientation_USCDI

2

Birth Sex

What sex were you assigned at birth, on your original birth certificate?

PHVS_Sex_MFU

1

Reason Vaccine Administered

Reason individual received a vaccine against this condition

TBD

2

Sexual Contact

Did you engage in any sex and/or close intimate contact before your first symptom appeared?

PHVS_YesNoUnknown_CDC

2

Sex with Male Partners

Sex with male partners?

PHVS_YesNoUnknown_CDC

2

Number of Male Sexual Partners

Number of male partners or description if no number is provided

N/A

2

Numerical Range of Male Partners

If individual is unable to specify, provide a range of options for the number of male partners

TBD

2

Sex with Female Partners

Sex with female partners?

PHVS_YesNoUnknown_CDC

2

Number of Female Sexual Partners

Number of female partners or description if no number is provided

N/A

2

Numerical Range of Female Partners

If individual is unable to specify, provide a range of options for the number of female partners

TBD

2

Sex with Transgender Female Partners

Sex with transgender female partners?

PHVS_YesNoUnknown_CDC

2

Number of Transgender Female Partners

Number of transgender female partners or description if no number is provided

N/A

2

Numerical Range of Female Transgender Partners

If individual is unable to specify, provide a range of options for the number of transgender female partners

TBD

2

Sex with Transgender Male Partners

Sex with transgender male partners?

PHVS_YesNoUnknown_CDC

2

Number of Transgender Male Partners

Number of transgender male partners or description if no number is provided

N/A

2

Numerical Range of Transgender Male Partners

If individual is unable to specify, provide a range of options for the number of transgender male partners

TBD

2

Sex with Other Gender Identity Partners

Sex with other gender identity partners?

PHVS_YesNoUnknown_CDC

2

Number of Other Gender Identity Partners

Number of other gender identity partners or description if no number is provided

N/A

2

Numerical Range of Other Identity Gender Partners

If individual is unable to specify, provide a range of options for the number of other gender identity partners

TBD

2

Epi Linked

Specify if this case is epidemiologically linked to another confirmed or probable case

PHVS_YesNoUnknown_CDC

1

CDC Event Case ID

This ID is used to track information about the case-patient in CDC data systems and must be provided on all forms or specimens related to this individual

N/A

3

Linked Case Number

Provide State assigned Case ID

N/A

3

Contact Type

Type of contact

TBD

1

Specify Other Contact Type

Other contact type

N/A

1

Did The Case Travel Domestically Prior To Illness Onset?

Did you spend time (within the US) outside your home state or territory during the [time period] before your first symptom appeared (also called symptom onset)?

PHVS_YesNoUnknown_CDC

3

Travel State

State traveled to

PHVS_State_FIPS_5-2

3

Date Of Departure From Travel Destination

Date of departure (MM/DD/YYYY)

N/A

3

Date Of Arrival To Travel Destination

Date of return (MM/DD/YYYY)

N/A

3

Sexual Contact During Domestic Travel

Did you have intimate or sexual contact with new partners on domestic trip?

PHVS_YesNoUnknown_CDC

3

Domestic Travel Comment

Any additional comments on travel within the US that may be important

N/A

3

Travel Outside USA Prior To Illness Onset Within Program Specific Timeframe

Did you spend time in a country outside the US during the [time period] before your first symptom appeared (also called symptom onset)?

PHVS_YesNoUnknown_CDC

3

International Destination(s) of Recent Travel

Country traveled to

PHVS_Country_ISO_3166-1

3

Sexual Contact During International Travel

Did you have any intimate or sexual contact with new partners on international trip?

PHVS_YesNoUnknown_CDC

3

International Travel Comment

Any additional comments on travel outside the US that may be important?

N/A

3

Case Patient a Healthcare Worker

Is this individual a health care worker who was exposed at work?

PHVS_YesNoUnknown_CDC

1

Location of Exposure

Please provide the suspect location of exposure

TBD

1

Exposure Comment

Please provide any additional details on the location of exposure (e.g., health care setting, large gathering, private party)

N/A

1

Number of Household Contacts

Please provide the number of identified contacts this case may have exposed (either named or anonymous)

N/A

2

Signs and Symptoms

Signs and symptoms associated with the illness being reported

TBD

3

Signs and Symptoms Indicator

Indicator for associated sign and symptom

PHVS_YesNoUnknown_CDC

3

Skin Lesion(s) (disorder)

Did you have a rash during the course of your illness?

PHVS_YesNoUnknown_CDC

3

Rash Onset Date

If yes, what was the date of rash onset (i.e., the date the rash first appeared)?

N/A

3

Body Region(s) of Rash

If yes, where on your body is the rash? (choose all that apply)

TBD

3

Ocular Manifestations

Any evidence of ocular involvement (ocular lesions, keratitis, conjunctivitis, eyelid lesions)?

TBD

3

Co-infection

Has this individual been diagnosed with any acute infections other than [condition] during this current illness/or within [time period]?

PHVS_YesNoUnknown_CDC

3

Co-infection Type

Specify other co-infections

TBD

3

HIV Status

What is the individual's HIV status?

PHVS_HIVStatus_STD

1

HIV Viral Load Undetectable

If HIV positive, was the individual's viral load undetectable when it was last checked?

PHVS_YesNoUnknown_CDC

2

Patient Immunocompromised

Does the individual have any known immunocompromising conditions (excluding HIV) or take immunosuppressive medications?

PHVS_YesNoUnknown_CDC

1

Immunocompromised Condition or Treatment

Describe the associated immunocompromising condition or treatment

TBD

1

Reason for Hospitalization

Reason for the hospitalization? (choose all that apply)

TBD

2

Receiving HIV Pre-exposure Prophylaxis

Is the individual currently receiving HIV pre-exposure prophylaxis?

PHVS_YesNoUnknown_CDC

2

Currently Breastfeeding

Are you currently breastfeeding?

PHVS_YesNoUnknown_CDC

2

Household pets

Do any pets live in your household?

PHVS_YesNoUnknown_CDC

2

Type of animal(s)

Which type of animal(s) in household? (select all that apply)

TBD

2

Other pet(s)

Please specify other pet(s)

N/A

2



Burden


The burden to add 89 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 89 data elements to their surveillance system and modify their electronic case notification message to accommodate those 89 additional data elements. This one-time burden of 9 hours is noted in the following table


One-Time Burden to Add 89 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 89 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 89 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 89 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

4

200

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

4

20

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

4

12

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

4

8

Total


18,474


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

4

200

$49.14

$9,828

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

4

20

$49.14

$982.80

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

4

12

$49.14

$589.68

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

4

8

$49.14

$393.12

Total







$868,106




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


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