Justification for Change

OMB 0920-0728 change request_HPS 06012016.doc

(NNDSS) Rubella (Data Elements)

Justification for Change

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 Surveillance

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 1, 2016

Circumstances of Change Request for OMB 0920-0728


This is a nonmaterial/non-substantive change request for OMB No. 0920-0728, expiration date 01/31/2019, 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 57 jurisdictions: health departments in every U.S. state, New York City, Washington DC, and 5 U.S. territories (American Samoa, the Commonwealth of Northern Mariana Islands, Guam, Puerto Rico, and the U.S. Virgin Islands). 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 32 new disease-specific data element for Hantavirus Pulmonary Syndrome (HPS).


Previously, only core NNDSS data elements were collected for HPS. A new HPS-specific tab has been created within the NNDSS data spreadsheet (Attachment 7). Information on a patient’s background, exposure information, clinical information, and specimen information are necessary to properly identify cases of HPS. The inclusion of data indicating use of extracorporeal membrane oxygenation (ECMO) for patient treatment follows from hospitals’ increasingly routine use of this intervention, where blood is oxygenated outside the body, to improve outcomes. The question on whether patient sought treatment before hospitalization is a tool to learn whether a patient may have visited a traditional healer before coming to the hospital, and whether such postponement of hospital treatment influences outcome.


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


New HPS Data Elements


Data Element Identifier

Data Element Name

Data Element Description

TBD

Last Name


Patient's last name

TBD

First Name

Patient's first name

TBD

Middle Initial

Patient's middle initial


TBD

Occupation

Patient's occupation

TBD

History of rodent exposure 8 weeks prior to illness onset

Did patient have history of rodent exposure during 8 week period prior to illness onset?

TBD

If yes, type of rodent exposure

If rodent exposure occurred, what was the type of exposure?

TBD

Exposure occurred while cleaning

Did exposure occur while cleaning?

TBD

Exposure occurred while working

Did exposure occur while working?

TBD

Exposure during recreational activity (camping, hiking)

Did exposure occur during a recreational activity?

TBD

Other exposure?


Other types of exposure? (Explain)

TBD

Fever >101F (38.3C)

Did patient have a fever >101F (38.3C)?

TBD

Thrombocytopenia (<150,000)

Did patient have thrombocytopenia (<150,000)?

TBD

Elevated hematocrit

Did patient have elevated hematocrit?

TBD

Elevated creatinine

Did patient have elevated creatinine?

TBD

Outcome of illness

What was the outcome of the illness?

TBD

Autopsy performed

If patient died, was autopsy performed?

TBD

Autopsy findings

Describe autopsy findings

TBD

Did patient seek care before admission

Did patient seek care before admission?

TBD

Date of pre-hospital treatment

Date of pre-hospital treatment

TBD

Outcome of treatment

What was the outcome of treatment (sent home, diagnosed as flu, etc)?

TBD

Supplemental oxygen required

Did the patient require supplemental oxygen?

TBD

Was patient on ECMO

Was patient on extracorporeal membrane oxygenation (ECMO)?

TBD

Was patient intubated

Was the patient intubated?

TBD

CXR with unexplained bilateral interstitial infiltrates or suggestive of ARDS

Did patient have chest x-ray (CXR) with unexplained bilateral interstitial infiltrates or suggestive of acute respiratory distress syndrome (ARDS)?

TBD

Notes on clinical course of illness

Describe clinical course of illness

LAB163

Specimen collection date

Specimen collection date

LAB203

Type of specimen

Type of specimen collected

LAB143

If specimen tested, at which laboratory

If specimen tested, at which laboratory?

LAB208

Test results

Test results (i.e. titer, IgM, IgG)

TBD

Name of patient’s physician

Name of patient’s physician

TBD

Physician's email

Physician's email

TBD

Physician's phone number

Physician's phone number



Burden


The annualized burden hours and cost to reporting jurisdictions to submit these data to CDC does not change from the original estimates in the “Estimates of Annualized Burden Hours and Costs” section in A.12 of OMB No. 0920-0728. The addition of new disease-specific data elements will not add any additional burden because the reporting jurisdictions already collect those data elements. There will be no increase in burden for the reporting jurisdictions to send those data elements to CDC since most case notifications are submitted electronically from already existing databases via automated electronic transfers. CSTE recommends that jurisdictions collect these data for their own surveillance purposes. Requesting jurisdictions to submit these data (that they will already collect) to CDC will not increase the burden to the jurisdictions.


A.12A. Estimates of Annualized Burden Hours

Respondents

Number of Respondents

Number of Responses per Respondent

Average Burden Per Response (in hours)

Total Burden (in hours)

Weekly and Annual Submissions

States

50

52

10

26000

Territories

5

52

5

1300

Cities

2

52

10

1040

Total

 

 

 

28,340



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 and Annual

50

52

10

26,000

$35.63

$926,380

Territories

Weekly and Annual

5

52

5

1,300

$35.63

$46,319

Cities

Weekly and Annual

2

52

2

1,040

$35.63

$37,055

Total







$1,009,754


5

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