0920-1011 Emergency GenIC Request Form

File Name: [GenIC#20220001-XXX]_[Undetermined risk factors for H5N1]_[Council of State and Territorial Epidemiologists]

Request for Approval Under the Generic Clearance for

Emergency Epidemic Investigation Data Collections
(0920-1011)

Instruction: This form should be completed by the primary contact person from the CDC CIO that will be sponsoring the investigation.

Determine if your investigation is appropriate for this Generic mechanism: Instruction: Before completing and submitting this form, determine first if the proposed investigation is appropriate for the EEI Generic ICR mechanism. Complete the checklist below. If you select “yes” to all criteria in Column A, the EEI Generic IR mechanism can be used. If you select “yes” to any criterion in Column B, the EEI Generic ICR mechanism cannot be used.

Column A	Column B
CDC epidemiological assistance is requested by one or more external partners (e.g., local, state, tribal, military, port, other federal agency, or international health authority or other partner organization). Yes No	The Investigation is initiated by CDC, without request from an external partner. Yes No
The investigation is urgent in nature (i.e., timely data are needed to inform rapid public health action to prevent or reduce injury, disease, or death). Yes No	The investigation is not urgent in nature. Yes No
The investigation is characterized by undetermined agent, undetermined source, undetermined mode of transmission, or undetermined risk factors. Yes No	The investigation is conducted for the primary purpose of program evaluation, surveillance, needs assessment, or research to contribute to generalizable knowledge. Yes No
One or more CDC staff (including trainees and fellows) will be deployed to the field. Yes No	CDC staff (including trainees or fellows) are not deployed to the field. Yes No
Data collection will be completed in 90 days or less. Yes No	Data collection expected to require greater than 90 days. Yes No

Did you select “Yes” to all criteria in Column A?

If yes, the EEI Generic ICR may be appropriate for your investigation. → You may proceed with this form.

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

If yes, the EEI Generic ICR is not appropriate for your investigation. → Stop completing this form now.

GenIC #

20220001

-

XXX

Date

04/08/2022

Title of Investigation: Instruction: Provide the title of the investigation in the following format: [Undetermined agent, undetermined source, undetermined mode of transmission, undetermined risk factor] for [disease/problem] among [subpopulation]—[State], [Year]

Undetermined risk factor for highly pathogenic avian influenza H5N1 among individuals exposed to infected birds – United States, 2022

Location of Investigation: Instruction: Indicate location where investigation will occur. If multiple locations, specify each one.

State:	Nationwide
City/County (if applicable)	N/A
Country	United States

Requesting Agency: Instruction: Indicate name of agency requesting epidemiological assistance and the name and position title of the requestor

Agency:	Council of State and Territorial Epidemiologists
Name and Position Title:	Janet Hamilton, Executive Director

Note: Attach the Letter of Invitation requesting support. The letter should include the following information: 1) background on the outbreak or event; 2) steps already taken toward prevention and control, if any; 3) request for CDC assistance, including objectives of the investigation; and 4) how data will be used to inform prevention and control measures. Sensitive information in the Letter of Invitation not appropriate for public dissemination should be redacted.

Description of Investigation

1. Problem to be Investigated: Instruction: Provide a summary of the outbreak or event. The summary should include all the information you know at this time about the outbreak or event and the investigation that is planned. At a minimum, please provide the following information: 1) background necessary to understand the importance of the outbreak or event, including a justification of the need for an investigation and why this issue requires an urgent response; 2) the objectives of the investigation, including how the information collected will be used to inform prevention and control measures; and 3) a brief overview of the investigation planned, including study design, respondents, mode of data collection. In the description, indicate whether a data collection instrument is attached with the GenIC request (refer to as Appendix 1, etc) and what instruments will be developed in the field. (Suggested length: 250-500 words).

Background: Highly Pathogenic Avian Influenza (HPAI) is endemic among wild aquatic birds and can be transmitted from migrating waterfowl to poultry. Human infections with avian A(H5N1) virus are rare but have occurred in persons with close contact with infected birds. Previous human infections with A(H5N1) viruses have been associated with a range of illness from mild to severe. Beginning in January 2022, HPAI A(H5N1) viruses have been detected in U.S. wild aquatic birds, commercial poultry, and backyard flocks (https://www.cdc.gov/flu/avianflu/avian-flu-summary.htm). This lineage of A(H5N1) viruses is currently believed to pose a low risk to the general public, however individuals who are exposed and who develop symptoms should be tested for H5N1 to guide treatment. Additionally, it is unknown if the virus detected in the nasal cavity represented virus infection that has the potential to be transmitted to others or nasal contamination due to heavy environmental contamination. Understanding whether symptomatic or asymptomatic infection occurs among individuals who are exposed to infected birds will inform the US public health response to avian outbreaks.

Objectives are twofold: 1) to track the numbers of exposed individuals who are being monitored by state health departments and 2) to test for infection in a subset of people who have been exposed (including asymptomatic and symptomatic people).

Overview of investigation: USDA notifies the CDC when H5N1 outbreaks are detected among commercial or backyard farms in birds. CDC then works with state health departments to ensure that people who have been exposed to H5N1 are appropriately monitored for symptom development. Health departments typically monitor exposed people for symptoms for 10 days following their last exposure. CDC does not conduct the monitoring itself but will collect aggregate data from state health departments on the numbers of people who were exposed and who were monitored for symptoms on a weekly basis (Appendix 1). A subset of exposed individuals (including symptomatic and asymptomatic) will be interviewed by public health officials to complete additional questionnaires (Appendices 2-7) and tested for H5N1 (Appendices 8-10). CDC staff will be deployed to sites that are obtaining the additional questionnaires and testing.

The following data collection instruments are attached:

Appendix 1: Aggregate counts of persons exposed to HPAI

Appendix 2: HPAI H5 Consent Form

Appendix 3: HPAI H5 Consent Form (Spanish)

Appendix 4: Avian Influenza Initial Case Investigation Form

Appendix 5: Avian Influenza Initial Case Investigation Form (Spanish)

Appendix 6: Highly Pathogenic Avian Influenza A(H5N1) Exposure Questionnaire

Appendix 7: Highly Pathogenic Avian Influenza A(H5N1) Exposure Questionnaire (Spanish)

Appendix 8: HPAI H5 Self Swab Instructions

Appendix 9: HPAI H5 Self Swab Instructions (Spanish)

Appendix 10: Human Sera Collection Guidelines for Flu Serology

2. Characteristics of Outbreak or Event (Check all that Apply):

Undetermined agent

Undetermined source

Undetermined mode of transmission

Undetermined risk factor

3. Respondents: Instruction: Select all that apply. For each respondent type selected, provide a brief description. Be sure to include a description of control respondents, if applicable. Use as much space as necessary for each description.

General public (describe):

Persons in the general public exposed to H5N1 will follow instructions of self-swabbing (Appendices 8-9) to provide a sample for lab testing.

Healthcare staff (describe):

Laboratory staff (describe):

Patients (describe):

Restaurant staff (describe):

Other (describe):

State Health Department staff will report the counts of people they have monitored and that they are currently monitoring for symptoms following exposure to H5N1-infected birds (Appendix 1). State Health Department staff will also complete the Avian Influenza Initial Case Investigation Form (Appendices 4-5). Finally, State Health Department staff will conduct face-to-face interviews to collect participants’ consent (Appendices 2-3), assess their exposure via the Highly Pathogenic Avian Influenza A(H5N1) Exposure Questionnaire (Appendices 6-7), and collect human sera (if exposed) (Appendix 10)

4. Selection of Respondents: Instruction: Provide a brief description of how respondents will be identified and selected. Use as much space as necessary for the description.

All states that have either 1) had confirmed H5N1 in a commercial or backyard flock or 2) monitored individuals who mobilized in response to an out-of-state outbreak will be included. CDC will be notified of these states by the USDA.

USDA notifies CDC of confirmed H5N1 detected in commercial or backyard birds via daily email alerts. These alerts include the state, county, flock type, flock size, and confirmation date. CDC provides this information to state health departments to aid in identifying people who were exposed to infected flocks. State health departments will then report back to the CDC the numbers of people exposed, monitored, ill, and tested by their role in the outbreak.

USDA also mobilizes staff and contractors to respond to these outbreaks depopulating flocks and decontaminating facilities. These responders are mobilized from around the United States to impacted areas. After finishing these activities, responders demobilize and return to their home states. The responder’s home state then becomes responsible for symptom monitoring. USDA provides CDC information on returning responders so that CDC can coordinate with states to conduct monitoring.

As of April 7, there have been 25 states with confirmed H5N1 detected in commercial or backyard flocks; and an additional 18 states monitoring returning responders for a total of 43 states that have already monitored people exposed to H5N1. We expect this number to increase—potentially to 50 states—as outbreaks spread to new states in birds, and as responders travel to these outbreaks from additional states.

A subset of these exposed individuals will be tested for A(H5N1) virus infection among persons with contact with infected flocks, respiratory specimens, including nasal swabs, will be collected and tested for human and avian influenza A viruses shortly after the exposure and regardless of symptoms; current CDC RT-PCR testing protocols for A(H5N1) virus infections will be used. To detect asymptomatic infections, including those not detected by viral testing, blood specimens will be collected as soon as possible after exposure to infected birds or onset of respiratory symptoms and ~21 days later to test for antibodies to A(H5N1) viruses. All persons with substantial exposure to A(H5N1) virus (e.g., working directly with infected birds, working for sustained periods where birds are housed) will be monitored for symptoms for 10 days and tested for A(H5N1) per the standard public health protocol (https://www.aphis.usda.gov/animal_health/downloads/animal_diseases/ai/ai-monitoring-plan.pdf).

If H5N1 virus is detected in the nasal cavity, we will assess for evidence of an antibody response to infection. This protocol will allow for the detection of asymptomatic cases and understand the potential asymptomatic spread of H5N1 by differentiating persons with nasal contamination of H5N1 (i.e., from workplace exposure) versus a serological response suggesting infection. All A(H5N1) viruses identified from human cases will be tested for adaptations in the A(H5N1) virus. This project will also inform future public health response to avian outbreaks.

5. Study Design: Instruction: Select all that apply. For each study design planned, provide a brief description. Use as much space as necessary for the description.

Epidemiologic Study (indicate which type(s) below)

Descriptive Study (describe):

We will describe the numbers of individuals who have been exposed, monitored, ill, and tested for H5N1 by state each week. In addition, questionnaires and testing for infection (both symptomatic and asymptomatic) among persons exposed to infected birds will estimate risk of infection (i.e., attack rate) among those persons, identify symptoms and exposures, and identify potential risk and protective factors associated with infection, including behavioral and environmental factors. Additionally, we will determine if symptomatic or asymptomatic infections with avian A(H5N1) virus occur among exposed persons and determining the antibody response to A(H5N1) viruses after detection by RT-PCR from nasal swabs and the correlation with the presence of symptoms.

Cross-sectional Study (describe):

Cohort Study (describe):

Case-Control Study (describe):

Other (describe):

Environmental Assessment (describe):

Laboratory Testing (describe):

Other (describe):

6. Data Collection Mode: Instruction: Select all that apply. For each data collection mode planned, provide a brief description. Use as much space as necessary for the description.

Survey Mode (indicate which mode(s) below):

Face-to-face Interview (describe):

An interview in English or Spanish by State Health Department staff to assess characteristics and timelines of symptoms, exposures, and risk factors potentially associated with H5N1 infection (e.g., duration and nature of work with infected poultry). This activity is supplemental to the standard response to avian outbreaks which includes monitoring exposed persons for 10 days and testing if symptomatic.

Telephone Interview (describe):

Self-administered Paper-and-Pencil Questionnaire (describe):

Self-administered Internet Questionnaire (describe):

Other (describe):

State health department staff will enter aggregate data into a Microsoft Word form and email the form to [email protected].

Medical Record Abstraction (describe):

Biological Specimen Sample

Environmental Sample:

Other (describe):

7. Type of Information to be Collected: Instruction: Select all that apply. For each type of information to be collected, provide a brief description. Use as much space as necessary for the description.

Behaviors (describe):

Duration and nature of work with/exposure to infected birds.

Clinical information/symptoms (describe):

The aggregate number of exposed individuals that developed symptoms compatible with HPAI (fever or feeling feverish/chills; cough; sore throat; runny or stuffy nose; eye tearing, redness, irritation (“pink eye”); sneezing; difficulty breathing; shortness of breath; fatigue (feeling very tired); muscle or body aches; headaches; nausea; vomiting; diarrhea; seizures; or rash) will be reported by each state weekly.

Individual clinical information will be collected on a subset of individuals via questionnaire.

Contact information (describe):

Phone contact to be collected on consent form.

Demographic information (describe):

Age, sex, race, ethnicity

Environmental factors (describe):

Type of environment (farm, residence), type of birds worked with, number of birds on the premises.

Exposures (describe):

Aggregate information on exposure type will be collected based on role in the outbreak. Counts of the numbers of USDA/contract responders; state/producer responders; unaffiliated with response; and other type of role will be obtained. Different roles would be associated with different types of exposures.

Medical history (describe):

Risk factors (describe):

The above categories (e.g., exposures, demographics, environmental factors), will all be assessed descriptively as potential risk factors.

Specimen/lab information (describe):

Biospecimen collection will involve (1) a nasal swab for respiratory specimen collected by a state/local health department or CDC staff member in appropriate PPE or self-collected by participant as soon as possible after exposure, (2) a serum specimen collected by state health department, local health department, or CDC staff members as soon as possible after exposure to identify the baseline presence of H5N1-specific antibodies, and (3) follow-up sera specimens collected at 21 days after last exposure (for asymptomatic persons) or ~21 days after symptom onset (for symptomatic persons). Convalescent serum will be priorities over acute serum, if the participants choses.

Travel history (describe):

Other (describe):

8. Duration of Data Collection (number of weeks):

90 days

Research Determination: Instruction: Indicate the research determination decision. If the decision is research, provide the research determination letter and IRB approval, if required.

Research

Not Research

CDC Investigation Lead: Instruction: Indicate the name, title, and affiliation of the person who will serve as the CDC lead for this investigation.

Name:	Kelsey Sumner
Title:	EIS Officer
Affiliation:	CDC, Influenza Division

CDC Sponsoring Program and Primary Contact Person: Instruction: Indicate the sponsoring CIO/Division/Branch for this investigation. Indicate the name, title, and contact information of the CDC Primary Contact Person for this investigation. Indicate the preferred method of contact during the OMB approval process. Note, contact person or a designee must be available during the OMB approval process in case questions arise.

CIO/Division/Branch:	NCIRD/Influenza Division, Epidemiology and Prevention Branch
Name:	Nathaniel Lewis
Title:	Health Scientist

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 CDC Primary Contact Person for this Investigation.

I, [insert name of CDC sponsoring program contact], certify the following to be true:

1. The collection is voluntary.

2. Respondents will not be personally identified in any published reports of the study.

3. Information gathered will be primarily used to inform effective prevention and control measures.

CDC Sponsoring Program Primary Contact Name:	Nathaniel Lewis
Date of Certification:	4/8/2022

Requested Approval Date (mm/dd/yyyy): Instruction: Indicate the date by which approval is needed.

04/12/2022

E-mail the completed form to the Information Collection Request Liaison (ICRL) or EIS program ICRL designee.

EEI Information Collection Request Liaison:

Danice Eaton, PhD, MPH

EIS Program Staff Epidemiologist

EWB/DSEPD/CDC

2400 Century Center, MS E-92

Office: 404.498.6389
[email protected]

For internal use. Do not complete.

Date/Time initial GenIC received by ICRL
Date/Time final GenIC received by ICRL
Date/Time submitted to OMB
Date/Time approved

Date Form Revised: GenIC 6.16.14 5