0920-1447 - GenIC Request Template Case Notification_New World Screwworm_NWS_06AUG2025

Case Notification MDN Form

REQUEST FOR APPROVAL UNDER THE GENERIC CLEARANCE FOR THE COLLECTION OF MINIMAL DATA NECESSARY FOR CASE DATA DURING AN EMERGENCY RESPONSE (0920-1447)

This form should be completed by the primary contact person for the emergency response.

DETERMINE IF THE DATA COLLECTION IS APPROPRIATE FOR THIS GENERIC CLEARANCE MECHANISM: Before completing and submitting this form, determine first if the proposed data collection is appropriate for the MDN for Case Data Generic ICR mechanism. Complete the checklist below. If you select “yes” to the criterion in Column A, the MDN Generic ICR mechanism can be used. If you select “yes” to the criterion in Column B, the MDN Generic ICR mechanism cannot be used.

Column A	Column B
Public harm is reasonably likely to result if normal clearance procedures are followed. [ X ] Yes [ ] No	Public harm is not reasonably likely to result if normal clearance procedures are followed. [ ] Yes [ ] No
An emergency has occurred. [ X ] Yes [ ] No	An emergency has not occurred. [ ] Yes [ ] No
The use of normal clearance procedures is reasonably likely to prevent or disrupt the collection of information. [ X ] Yes [ ] No	The use of normal clearance procedures is not reasonably likely to prevent or disrupt the collection of information. [ ] Yes [ ] No
Case data will be collected for a disease or condition that is the subject of an emergency response at CDC. [ X ] Yes [ ] No	Case data will be collected for a disease or condition that is not the subject of an emergency response at CDC. [ ] Yes [ ] No

Did you select “Yes” to the criterion in Column A?

If yes, the MDN Generic ICR may be appropriate for your data collection. → You may proceed with this form.

Did you select “Yes” to the criterion in Column B?

If yes, the MDN Generic ICR is not appropriate for your data collection. → Stop completing this form now.

TIMING OF OMB APPROVAL FOR THIS DATA COLLECTION: Indicate the approval time that OMB agreed to for this information collection.

[ ] 72 hours

[ ] 4 days

[X] 5 days

ESTIMATION OF LENGTH OF APPROVAL: Estimate the duration of this information collection.

Estimating a minimum of 18 months of data collection, though this is highly dependent on the distribution of cases spatially and temporally.

TITLE OF EMERGENCY RESPONSE: Reemergence of New World Screwworm

DESCRIPTION:

1. Description of the emergency response:

Include all information known at this time about the emergency response including background information that is necessary to understand the importance of the emergency response, a description of the disease or condition that is the subject of the emergency response, what prompted CDC to respond to the emergency, and how case data will be used.

New World Screwworm (Cochliomyia hominivorax) is a species of fly whose larvae (maggots) are obligate parasites of living flesh. Female flies lay eggs directly on existing wounds or exposed mucous membranes of warm-blooded animals, including humans. Hundreds of eggs can be deposited, hatching out hundreds of maggots that feed on the host’s living tissue, causing extensive tissue destruction, debilitation, and potentially death of the host. New World Screwworm (NWS) is primarily a pest of livestock, particularly cattle and horses, although any warm-blooded animal, including birds, pets, wildlife, and humans, are susceptible. NWS was previously endemic in the United States where it resulted in hundreds of millions of dollars in losses for the livestock industry annually. It was eradicated from the U.S. by the United States Department of Agriculture (USDA) in 1966 and then further southward through Mexico and Central America to Panama, where a biological barrier had been maintained at the Darién Gap in Panama since 2006. NWS remained endemic in South America, as well as some countries in the Caribbean.

In 2022, Panama began recording outbreaks of NWS beyond the Darién Gap. By July of 2023, the fly had moved from Panama into Costa Rica. In March of 2024 NWS was reported in Nicaragua, then in Honduras in September, Guatemala in October, and by late November it had reached southern Mexico. As of July 9, 2025, an animal NWS case was reported 370 miles south of the U.S./Mexico border.

Reappearance of NWS in the United States would constitute a One Health emergency that would require an emergency response and initiation of an eradication campaign. USDA would be the lead agency on a domestic response with CDC support for human case surveillance and diagnosis, as well as raising awareness and providing guidance to physicians, healthcare providers, and public health partners. Although animal infestations have outnumbered human infestations in endemic countries and countries experiencing NWS outbreak in Central America and Mexico, humans can still become infested and serve as reservoirs to spread the flies to new areas. Considerable morbidity may result from NWS infestations in humans, depending on the severity and location of the infestation. At least six human deaths have been reported from NWS in Honduras and Costa Rica.

2. Is the disease or condition that is the subject of the emergency response a nationally notifiable condition or a condition under standardized surveillance?

[ ] Yes [ X ] No, CDC requests permission to collect MDN data elements

3. How is this information collection essential to the mission of the agency?

Data are needed for confirmed, probable, and suspected human cases of NWS to adequately respond to reports of human infestation (cases). Timely notification by health departments to CDC of cases is critical to provide situational awareness at the federal level to support decision making and prevention of spread of the fly. Data are needed to ensure that CDC receives sufficient information to develop and implement effective prevention and control strategies to minimize adverse health consequences and hasten re-eradication of NWS.

RESPONSE-SPECIFIC DATA ELEMENTS TO BE COLLECTED:

In the table below or on an attached spreadsheet, list each response-specific data element, its definition, and its value set. Include the precedent for using the definition and value set, including whether the definition and value set are currently used for routine surveillance (e.g., definition and value set used for routine influenza surveillance) and the situation or event where the definition and value set were used in the past (e.g., definition used during the COVID-19 response; value set used in the United States Core Data for Interoperability (USCDI)). Include dates of use. Include an overall justification for using the data element and include what information and insight it will provide that is not already provided. Note that the definition and value set precedent and overall justification can apply to more than one data element.

Name	Definition	Value Set	Definition and Value Set Precedent	Overall Justification
Date First Electronically Submitted	Date/time the notification was first electronically sent to CDC. This value does not change after the original notification.	N/A - datetime data element	Data element used in generic v2 MMG, a format widely adopted by STLTs and used across all notifiable conditions for >9 years.	Used to track if this is an update to existing case or a new case and how long this case has been known by CDC.
Country of Usual Residence	Where does the person usually live (defined as their residence).	PHVS_Country_ISO_3166-1	Data element used in generic v2 MMG, a format widely adopted by STLTs and used across all notifiable conditions for >9 years.	Used to know if case is coming from a country in which condition is endemic
Current Employment	Is the person currently employed?	PHVS_YesNoUnknown_CDC	This data element is not routinely captured in other data collections or standards and is unique to NWS.	Occupation is a large risk factor for NWS. This is leading question for other employment questions in NWS. This also allows STLTs to indicate person is not employed, which otherwise cannot be conveyed.
Person Immunocompromised	At the time of diagnosis, was the patient immunocompromised?	PHVS_YesNoUnknown_CDC	This data element is routinely captured by several conditions in NNDSS and is consistent with use across conditions.	Important as immunocompromised individuals are often more susceptible to condition and require higher level of care.
Wound History	Did the person have recent history (e.g., in the two weeks prior to symptom onset) of unhealed wounds, open sores, or were they recovering from surgery?	PHVS_YesNoUnknown_CDC	This data element is not routinely captured in other data collections or standards and is unique to NWS.	Flys lay eggs directly on wounds. This is important risk factor for NWS.
Location of Infestation	Was the person's infestation in a wound, body orifice (mucus membrane), or surgical site?	PHVS_InfestationLocation_NWS	This data element is not routinely captured in other data collections or standards and is unique to NWS.	Capturing this information informs who is at risk, screening guidelines, and provides insight into where flies are most likely to lay eggs.
Detailed Location of Infestation	Where on the body was the NWS infestation?	NA – text data element	This data element is not routinely captured in other data collections or standards and is unique to NWS.	Capturing this information informs who is at risk, screening guidelines, and provides insight into where flies are most likely to lay eggs.
Infestation Treatment	Was the infestation treated by removal of larvae from the infestation?	PHVS_YesNoUnknown_CDC	This data element is not routinely captured in other data collections or standards and is unique to NWS.	Only treatment of NWS is removal of larvae. Important to know if infestation was properly treated.
Start Date of Treatment	If treated, provide the date when the treatment started.	N/A - date data element	Data element routinely used in capturing treatment in case notifications to CDC and is consistent across conditions	Used to capture timeliness of treatment.
Other Treatment	List any other treatment(s) for this infestation.	N/A - text data element	This data element is not routinely captured in other data collections or standards and is unique to NWS.	Only treatment of NWS is removal of larvae. Want to know if further treatment being offered.
Larvae Dissemination	Were there any larvae that fell out of or were removed from the person’s infestation that were not collected by a healthcare provider?	PHVS_YesNoUnknown_CDC	This data element is not routinely captured in other data collections or standards and is unique to NWS.	Provides insight whether further transmission is likely.
Living Situation	In the 10 days before symptom onset/development of lesion, where did the patient reside (spend at least one night)?	TBD	Data element and value set standardized for future use by STLTs, CDC, and CSTE	Important for understanding where case may have acquired condition and whether others are at risk of infection.
Living Situation Other	If "Other" specified for living situation or if reporting jurisdiction's values are not mapped to living situation value set, specify value here in text.	N/A - text DE	Data element and value set standardized for future use by STLTs, CDC, and CSTE	Important for understanding where case may have acquired condition and whether others are at risk of infection.
International Travel Before Symptom Onset	Indicator that person spent time outside of the US in the 10 days before symptom onset or development of lesion	PHVS_YesNoUnknown_CDC	Using the travel block standardized by STLTs/CDC/CSTE for all case notifications capturing travel information moving forward.	Travel information is important for understanding where case person might have acquired the infection
Domestic Travel Before Symptom Onset	Indicator that the person spent time domestically outside of their jurisdiction of residence, but within the US in the 10 days before symptom onset or development of lesion	PHVS_YesNoUnknown_CDC	Using the travel block standardized by STLTs/CDC/CSTE for all case notifications capturing travel information moving forward.	Travel information is important for understanding where case person might have acquired the infection
International Destination(s) of Recent Travel	International destination or countries the person spent time within	PHVS_Country_ISO_3166-1	Using the travel block standardized by STLTs/CDC/CSTE for all case notifications capturing travel information moving forward.	Travel information is important for understanding where case person might have acquired the infection
State of Recent Travel	Domestic destination, state(s) the person spent time within outside of the jurisdiction of residence	PHVS_State_FIPS_5-2	Using the travel block standardized by STLTs/CDC/CSTE for all case notifications capturing travel information moving forward.	Travel information is important for understanding where case person might have acquired the infection
County of Recent Travel	Domestic destination, county(s) the person spent time within outside of the jurisdiction of residence	PHVS_County_FIPS_6-4	Using the travel block standardized by STLTs/CDC/CSTE for all case notifications capturing travel information moving forward.	Travel information is important for understanding where case person might have acquired the infection
Date of Arrival to Travel Destination	Date of arrival at destination	N/A - date data element	Using the travel block standardized by STLTs/CDC/CSTE for all case notifications capturing travel information moving forward.	Travel information is important for understanding where case person might have acquired the infection
Date of Departure from Travel Destination	Date of departure from destination	N/A - date data element	Using the travel block standardized by STLTs/CDC/CSTE for all case notifications capturing travel information moving forward.	Travel information is important for understanding where case person might have acquired the infection
Exposure Details	If reporting exposures, provide details of exposure here.	N/A - text data element	Standard text field used to capture details beyond coded exposure data element	Important to capture relevant details that cannot be communicated otherwise.
Specimen Collection Datetime	Date (and time as available) a clinical specimen was collected from the patient for the laboratory testing relevant to the disease or condition being reported to a public health agency.	N/A - datetime data element	Using the data element standardized by STLTs/CDC/CSTE for all case notifications capturing lab information moving forward.	Laboratory testing is critical to diagnosing NWS. Information on the timing of testing is used to monitor for speed of diagnosis
Datetime of Lab Result	Date (and time as available) the latest result was released for reporting.	N/A - datetime data element	Using the data element standardized by STLTs/CDC/CSTE for all case notifications capturing lab information moving forward.	Laboratory testing is critical to diagnosing NWS. Information on the timing of testing is used to monitor for speed of diagnosis
Performing Laboratory Type	Performing laboratory type	PHVS_PerformingLabType_NWS	This data element is routinely captured by several conditions in NNDSS. Value set tailored for labs performing NWS testing.	Laboratory testing is critical to diagnosing NWS and can only be done by certain labs. This information allows CDC to know where testing is occurring.
Performing Laboratory Type Other	If "Other" specified for Performing Laboratory Type or if reporting jurisdiction's values are not mapped to Performing Laboratory Type value set, specify value here in text.	N/A - text data element	This data element is routinely captured by several conditions in NNDSS. Value set tailored for labs performing NWS testing.	Laboratory testing is critical to diagnosing NWS and can only be done by certain labs. This information allows CDC to know where testing is occurring.
Stage of Larvae	If NWS larvae were identified, what stage larvae were identified?	PHVS_LarvaeStage_NWS	This data element is not routinely captured in other data collections or standards and is unique to NWS.	The stage of larvae is used to understand the stage of infection and risk of further transmission.
Comment	Use this field, if needed, to communicate anything unusual about this case, which is not already covered with the other data elements.	N/A - text data element	Data element used in generic v2 MMG, a format used across all notifiable conditions for 9 years.	Used in case any additional context exists for case that was not otherwise noted.

BURDEN TABLE

The burden table below is the standard burden table that is used for each GenIC under the MDN Generic ICR. This burden table estimates the burden incurred by states, territories, freely associated states, and cities to submit case data to CDC daily. The burden table does not need to be modified and will accommodate all condition(s) and data element(s) that are specified on this form.

At this time, CDC is not able to change the race and ethnicity questions in this generic ICR to match the new OMB standard (SPD-15) as it will cause undue burden for the jurisdictions, cost to the government, and substantial delays in CDC’s Response Readiness for Case Data project. Since CDC will not be collecting primary data for GenICs under this proposed generic ICR, CDC’s ability to report accurate data for the required categories is dependent on the case data that the jurisdictions send to us. CDC does see the value of the new standard and plans to implement it in our next revision of the MDN Message Mapping Guide, estimated to occur by fall 2027

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	365	30/60	9,125
Territories	Submission of case data	5	365	30/60	913
Freely Associated States	Submission of case data	3	365	30/60	548
Cities	Submission of case data	2	365	30/60	365
Total					10,950

EMERGENCY RESPONSE LEAD: Indicate the name, title, and Affiliation (CIO, Division, and Branch) of the person who will be leading the emergency response.

Name: Megin Nichols, DVM, MPH, DACVPM

Title: Director

Affiliation: Division of Foodborne, Waterborne, and Environmental Diseases

CERTIFICATION: Please read the certification carefully. Type your name to validate that you are providing certification. Note: If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved. Certification should be signed by the Emergency Response Lead.

I, Megin Nichols certify the following to be true:

1. The collection is voluntary.

2. Information gathered will be primarily used to provide situational awareness at the federal level to support decision making, particularly for public health threats that escalate quickly and cross jurisdictions.

3. The MDN, GenV2, and response-specific data elements (if applicable) will be collected for the duration of the response.

4. A final and complete Response-Specific Data Elements Form will be submitted within 30 days of the conclusion of the response. The form will include a complete list of response-specific data elements that were collected during the response including those that were not listed on this initial request form.

Emergency Response Lead Name: Megin Nichols

Date of Certification: 5 Aug 2025

REQUESTED APPROVAL DATE (MM/DD/YYYY): Instruction: Indicate the date by which approval is needed. This date must be in the timeframe (between 72 hours and 5 days) that was previously agreed to with OMB

08/08/2025 or ASAP

DATE SUBMITTED TO INFORMATION COLLECTION REQUEST LIAISON (MM/DD/YYYY): 08/06/2025

E-mail the completed form to the Information Collection Request Liaison (ICRL) email at edx@cdc.gov.

11