Non-Substantive Change Request Memo 15APR2025

Non-Substantive Change Request

Generic Clearance for the Collection of Minimal Data Necessary for Case Data During an

Emergency Response

OMB Control Number 0920-1447

Expiration Date: 10/31/2027

Program Contact

Lynda Rowe 

Acting Director, Detect and Monitor Division 

Office of Public Health Data, Surveillance, and Technology

Centers for Disease Control and Prevention

E-mail: maa8@cdc.gov

Submission Date: April 9, 2025

Circumstances of Change Request for OMB 0920-1447

This is a non-substantive change request for OMB No. 0920-1447, expiration date 10/31/2027, for the Generic Clearance for the Collection of Minimal Data Necessary for Case Data During an

Emergency Response.

During a public health emergency response, state, tribal, local, and territorial (STLT) health departments and CDC need to exchange data on confirmed, probable, and suspected cases rapidly. Timely notifications of cases from STLT to CDC are critical to provide situational awareness at the federal level to support decision making, particularly for public health threats that escalate quickly and cross jurisdictions. To this end, collecting the minimum data necessary will provide standardization and consistency among technical approaches and Agency-wide processes. The Generic Clearance for the Collection of Minimal Data Necessary for Case Data During an Emergency Response includes approval for CDC to collect the minimum data necessary for confirmed, probable, and suspected cases of any disease or condition that is the subject of an emergency response. The respondent population consists of 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). Data may be sent to CDC by STLT health departments through Data Collation and Integration for Public Health Event Response (DCIPHER) or other automated or non-automated mechanisms including but not limited to fax, email, secure file upload, and data entry to a secure website. Data will be used for ongoing situational awareness and to monitor the occurrence and spread of the disease or condition. Other uses may include identifying populations or geographic areas at high risk; planning prevention and control programs and policies; and allocating resources appropriately. The data may also be used by CDC to obtain travel histories and other information to describe and manage outbreaks and conduct public health follow-up to minimize the spread of disease.

This request is for the addition of 11 new disease-specific data elements:

Minimal Data Necessary for Case Data During an Emergency Response

The impetus/urgency for CDC to add data elements for this information collection

Seven of the 11 added data elements are ‘other’ data elements. These data elements are associated with a coded data element of a similar name (e.g., Age Units and Age Units Other). These added fields give jurisdictions the option to send either coded data elements in the coded field or text data in the text field. This makes it easier for jurisdictions as they do not need to map to the CDC value set in order to send. First and Last Date of Exposure are important data elements to collect as understanding the time from exposure to symptom onset or infection provides important information for responding to and modeling outbreaks. Outbreak Case Status is critical as a definition of a case can differ in an outbreak and in routine data collection and it is very important to know whether a case meets the outbreak definition in addition to whether the case meets the routine definition. CDC Outbreak Name is important so that outbreaks that cross state lines can be tracked as a single outbreak, whereas the previously approved ‘Case Outbreak Name’ is state-assigned and could differ for the same outbreak.

Data Element Name	Data Element Description	Value Set Code	CDC Priority1 (New)
Age Units Other	If "Other" specified for age units or if reporting jurisdiction's values are not mapped to age units value set, specify value here in text.	N/A	2
Race Category Other	If "Other" specified for race category or if reporting jurisdiction's values are not mapped to race category value set, specify value here in text.	N/A	2
Ethnic Group Other	If "Other" specified for ethnic group or if reporting jurisdiction's values are not mapped to ethnic group value set, specify value here in text.	N/A	2
Person Address County Other	If "Other" specified for person address county or if reporting jurisdiction's values are not mapped to person address county value set, specify value here in text.	N/A	2
Person Address State Other	If "Other" specified for person address state or if reporting jurisdiction's values are not mapped to person address state value set, specify value here in text.	N/A	2
Outbreak Case Status	Status of the case/event as suspect, probable, confirmed, or not a case per outbreak case definition.	N/A	2
CDC Outbreak Name	A CDC-assigned name for an identified outbreak.	N/A	2
Case Disease Imported Code Other	If reporting jurisdiction's values are not mapped to case disease imported code value set, specify value here in text.	N/A	2
Disability Type Other	If reporting jurisdiction's values are not mapped to disability type value set, specify value here in text.	N/A	2
First Date of Exposure	The first date the exposure occurred.	N/A	2
Last Date of Exposure	The last date the exposure occurred.	N/A	2

Burden

CDC projects 10 emergency responses annually that will require states, territories, freely associated states, and cities to submit case data to CDC daily. The annual burden estimates below include the time that states, territories, freely associated states, and cities will incur to submit confirmed, probable, and suspected case data (MDN and response-specific data elements) for diseases or conditions for 10 emergency responses. The estimated annual burden for the 60 respondents is 109,510 hours. The cost of the information collection is $5,833,598. The average burden per response of 30 minutes is the same regardless of the number of data elements. The number of data elements will fluctuate by emergency response since each emergency response may require a different number of response-specific data elements depending on the condition. Therefore, the addition of 11 new data elements will not affect the burden.

Table A2. Estimated Annualized Burden Hours

Type of Respondent	Form Name	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in hours)	Total Burden (in hours)
States	Submission of case data	50	3650	30/60	91,250
Territories	Submission of case data	5	3650	30/60	9,130
Freely Associated States	Submission of case data	3	3650	30/60	5,480
Cities	Submission of case data	2	3650	30/60	3,650
Total					109,510

Table B. Estimated Annualized Burden Cost

Type of Respondent	Form Name	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in hours)	Total Burden (in hours)	Hourly Wage Rate	Respondent Cost
States	Submission of case data	50	365	30/60	9,1250	$53.27	$4,860,888
Territories	Submission of case data	5	365	30/60	9130	$53.27	$486,355
Freely Associated States	Submission of case data	3	365	30/60	5,480	$53.27	$291,920
Cities	Submission of case data	2	365	30/60	3,650	$53.27	$194,436
Total					109,510		$5,833,598

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

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