Request for one time addition of 4 data elements

OMB_0920-0728_Change Request_Cyclo_Mal_Trich_03122018.doc

National Notifiable Diseases Surveillance System (NNDSS)

Request for one time addition of 4 data elements

OMB: 0920-0728

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National Notifiable Diseases Surveillance System (NNDSS)

OMB Control Number 0920-0728

Expiration Date: 01/31/2019




Program Contact


Umed 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: March 12, 2018



Circumstances of Change Request for OMB 0920-0728


This is a nonmaterial/non-substantive change request for OMB No. 0920-0728, expiration date 02/28/2021, for the reporting of Nationally Notifiable Diseases. 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 the Council of State and Territorial Epidemiologists (CSTE) has officially designated as either “nationally notifiable” or as under “national surveillance.”


The NNDSS facilitates the submission and aggregation of case notification data voluntarily submitted to CDC from 60 jurisdictions: 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). NNDSS also facilitates relevant data management, analysis, interpretation and dissemination of the information. The data are used to monitor health 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 4 new disease-specific data elements: 1 new data element for cyclosporiasis, 1 new data element for malaria and 2 new data elements for trichinellosis.



The first request is for the addition of 1 new data element for cyclosporiasis. CDC would like to collect information about co-infections, and would like to add 1data element with a text field response option to obtain this information. There has been an increase in the use of gastro-intestinal (GI) polymerase chain reaction (PCR) panels, and we have received reports from multiple states about co-infections found using these testing methods. Understanding the proportion of cases with co-infection will allow CDC to better understand the true burden of illness attributed to cyclosporiasis.

The new data element requiring the change request is in the following table:







New Cyclosporiasis Data Element

Data Element Identifier

Data Element Name

Data Element Description

FDD_Q_1139

Other Organism from Specimen

If other non-Cyclospora organism(s) identified from stool specimen(s), indicate the organism


The second request is for the addition of 1 new disease-specific data element for malaria. This requested data element will enhance CDC’s surveillance efforts by facilitating the linkage of epidemiological case information with the laboratory results from specimens provided to the CDC diagnostic lab.


The new data element requiring the change request is in the following table:

New Malaria Data Element

Data Element Identifier

Data Element Name


Data Element Description

TBD

CSID

10-digit, de-identified specimen number generated after submission of the 50.34 form for CDC diagnostic assistance (Example data: 3000123456)


The third request is for 2 new data elements for trichinellosis. These data elements will contribute to enhanced surveillance efforts on the part of the CDC program and allow the program to perform additional epidemiological analyses for trichinellosis. The first new data element collects information about where the meat suspected of causing illness was tested (e.g., for identification of larva). The second new data element is a free text (comments) field where jurisdictions can provide additional detail about the suspected source of exposure.


The new data elements requiring the change request are in the following table:


New Trichinellosis Data Elements

Data Element Identifier

Data Element Name


Data Element Description

TBD

Where Meat Tested


Where was the suspected meat tested?

TBD

Meat Comments

Use this field, if needed, to communicate anything unusual about the suspect meat, which is not already covered with the other data elements (e.g., additional details about where eaten, if consumed while traveling outside of the U.S., where wild game was hunted, etc.).






Burden


Reporting jurisdictions will send these additional cyclosporiasis, malaria and trichinellosis data elements to CDC electronically through NNDSS, since cyclosporiasis, malaria and trichinellosis case notifications from these reporting jurisdictions are submitted electronically from existing surveillance databases. This change request does not apply to the territories and freely associated states since they do not yet send their cyclosporiasis, malaria and trichinellosis case notifications electronically to CDC. The addition of cyclosporiasis, malaria and trichinellosis data elements will add a minimal one-time burden for reporting jurisdictions. Many jurisdictions already collect this information through routine case reporting; for jurisdictions not currently collecting these data, future implementation will be prospective, not requiring re-coding or re-ascertainment of any new information for previously reported cases. A one-time average burden of 35 minutes will be incurred for jurisdictions to modify their electronic case notification message to accommodate the 4 additional data elements. For the jurisdictions that do not already collect these data, an additional one-time average burden of 35 minutes will be incurred to add the 4 additional data elements to their jurisdiction’s surveillance system. This one-time burden of up to 70 minutes is noted in the following table:


One Time Burden to Add 4 Data Elements to NNDSS

Type of Respondents

Number of Respondents

Number of Responses per Respondent

Average One-Time Burden (in hours)

Total One-Time Burden (in hours)

States

50

1

70/60

58

Territories

5

N/A

N/A

0

Freely Associated States

3

N/A

N/A

0

Cities

2

1

70/60

2

Total




60



Since this increase in burden is one-time, minimal, and only applicable to those jurisdictions that transmit case notifications electronically, its effect on the annualized burden hours is 20 hours (19 hours for states and 1 hour for cities).








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

8

419*

Territories

Weekly (Automated)

1

52

20/60

17

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

1

1

10/60

0**

Freely Associated States

Weekly, Quarterly (Non-automated)

3

56

20/60

56

Freely Associated States

Annual

3

1

5

15

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

8

17*

Total


18,548


*An incremental amount of time was added to the average burden per response to equal the one-time addition of burden hours.

**Table A12A in Supporting Statement A shows 1 burden hour but ROCIS rounded it down to 0.


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

$44.05

$38,191

States


Weekly (Non-automated)

10

52

2

1,040

$37.37

$38,865

States

Weekly (NMI Implementation)

50

52

4

10,400

$44.05

$458,120

States

Annual

50

1

75

3,750

$37.37

$140,138

States

One-time Addition of Diseases and Data Elements

50

1

8

419



$44.05



$18,457

Territories


Weekly (Automated)

1

52

20/60

17

$44.05

$749

Territories


Weekly, Quarterly (Non-automated)

5

56

20/60

93

$37.37

$3,475

Territories

Weekly (NMI Implementation)

5

52

4

1,040

$44.05

$45,812

Territories

Annual

5

1

5

25

$37.37

$934

Territories

One-time Addition of Diseases and Data Elements

1

1

10/60

1



$44.05



$44

Freely Associated States

Weekly, Quarterly (Non-automated)

3

56

20/60

56

$37.37

$2,093

Freely Associated States

Annual

3

1

5

15

$37.37

$561

Cities

Weekly (Automated)

2

52

20/60

35

$44.05

$1,542

Cities

Weekly (Non-automated)

2

52

2

208

$37.37

$7,773

Cities


Weekly (NMI Implementation)

2

52

4

416

$44.05

$18,325

Cities

Annual

2

1

75

150

$37.37

$5,606

Cities

One-time Addition of Diseases and Data Elements

2

1

8

17



$44.05



$749

Total







$781,434


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