CASPER GenIC - Request for Approval

Attachment G. Request for Approval under Generic Clearance for CASPER Data Collections

REQUEST FOR APPROVAL UNDER THE GENERIC CLEARANCE FOR COMMUNITY ASSESSMENT FOR PUBLIC HEALTH EMERGENCY RESPONSE (CASPER) DATA COLLECTIONS (0920-1036)

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 CLEARANCE MECHANISM: Instruction: Before completing and submitting this form, determine first if the proposed investigation is appropriate for the CASPER Generic ICR mechanism. Complete the checklist below. If you select “yes” to all criteria below, the CASPER Generic ICR mechanism can be used.

Criteria

Request is for a Community Assessment for Public Health Emergency Response (CASPER).

[X] Yes [ ] No

CASPER methodology (probability-based, two stage 30x7 cluster sampling methodology and administration of the questionnaire at the household level) for sample selection and data collection, or an approved alternative (e.g., oversampling, selecting more than 30 clusters, or census) will be utilized.

[X] Yes [ ] No

CDC 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).

[X] Yes [ ] No

One or more CDC staff (including trainees and fellows) will be deployed to the field.

[X] Yes [ ] No

Data collection will be completed in 180 days or less.

[X] Yes [ ] No

The data collection instruments can and will be administered in-person.

[X] Yes [ ] No

Did you select “Yes” to all criteria above? Yes

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

If no, the CASPER Generic ICR is not appropriate for your investigation. → Stop completing this form now.

TITLE OF INFORMATION COLLECTION: Undetermined health effects among persons affected by flooding – West Virginia, 2016

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Problem to be Investigated: On June 23, 2016, a band of severe thunderstorms and heavy rain throughout the state of West Virginia overwhelmed numerous rivers and streams, causing extensive flooding throughout the state. A state of emergency was declared in 44 counties, and a federal disaster declaration was granted for 12 of these counties. Twenty-three lives were lost and 3,800 homes were damaged or destroyed, with more than 230 businesses impacted. Approximately 3,500 persons were displaced and living with family, in group shelters, or in tents. Extensive damage to critical infrastructure hampered some early response efforts. Over 10,000 doses of tetanus toxoid vaccine were requested to meet initial demand for tetanus prophylaxis. Currently, the affected population’s access to routine health care and public health systems, information sources, water sources, and health impacts due to flooding and flood damage is unclear. There is an urgent need for information on the aforementioned topics to focus ongoing public health response efforts in the affected communities. The West Virginia Department of Health and Human Services, Bureau for Public Health requests assistance from the Centers for Disease Control and Prevention (CDC) in conducting a Community Assessment for Public Health Emergency Response (CASPER) in the affected communities. Data from the CASPER will be used to inform the continued response activities including access to health care; communication and messaging regarding water sources, cleanup activities, and other response-related activities; and allocation of public health resources.

2. Characteristics of the Assessment:

[ ] 24 hour approval is requested for this assessment.

[ x ] 72 hour approval is requested for this assessment.

[ ] Standard approval (within 5 business days) is requested for this assessment.

Instruction: If a 24- or 72-hour approval is requested, an explanation must be provided as to why it is needed. Specifically, CDC must make a case as to why collection must begin within 24 to 72 hours, and it must be related to a public health need.

A 72-hour approval is requested due to the need for rapid data collection to inform the current response efforts. Currently, the affected population’s access to routine health care and public health systems, information sources, water sources, and health impacts due to flooding and flood damage is unclear. These poses a public health threat to the community and data is needed to inform the response efforts to address these issues. The CASPER is set to begin August 1, 2016 to help inform the rapid response of the public health department in meeting the needs of the community.

3. Location of Assessment: Instruction: Indicate location where assessment will occur. If multiple locations, specify each one.

State: West Virginia

City/County (if applicable):

Country: United States

4. Agency Requesting Assistance/Name and Position Title of Requestor:

Agency: West Virginia Bureau for Public Health

Name: Dr. Loretta E. Haddy

Position Title: State Epidemiologist and Director, Office of Epidemiology and Prevention Services

Note: Attach the Letter of Invitation requesting support. The letter should include the following information: 1) background on the event and 2) request for CDC assistance. Sensitive information in the Letter of Invitation not appropriate for public dissemination should be redacted.

5. Respondents: Instruction: Provide a brief description of your respondent population.

The respondent universe is comprised of any member of a household within the chosen geographic area of interest (sampling frame) who is aged 18 years or older. The sampling frame for the CASPER includes the flood affected communities in one county in West Virginia.

Note: Define sampling frame.

6. 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.

Standard CASPER Selection Methodology

Other CASPER Selection Methodology

The preferred sampling method for CASPER is a probability-based, two stage cluster design (30x7 cluster sampling methodology). In the first stage of selection, 30 clusters (e.g., census blocks) within the sampling frame are selected, with their probability for being chosen proportional to the estimated number of housing units in each cluster. In the second stage, each trained, two-person interview team applies systematic random sampling to select seven housing units for the purpose of conducting interviews in each of the 30 clusters.

Please describe approved alterations (e.g., oversampling, selecting more than 30 clusters or census) in CASPER selection methodology used.

The standard CASPER selection methodology, a probability-based two-stage cluster design, will be employed. In the first stage of selection, 30 clusters (e.g., census blocks) within the sampling frame were selected, with their probability for being chosen proportional to the estimated number of households in each cluster. In the second stage, each trained, two-person interview team applies systematic random sampling to select seven households for the purpose of conducting interviews in each of the 30 clusters. The goal is 210 interviews.

7. Data Collection Mode:

The survey methodology used for a CASPER lends itself to only one main mode of data collection, the in-person interview. Trained interview teams deploy into the field to select households within each cluster and obtain verbal consent from one resident aged 18 years or older in each selected household. After verbal consent is given, the interviewer reads the questions from the questionnaire aloud to the interviewee and records the interviewee’s responses on a paper. The majority of questions are close-ended (e.g., yes/no, multiple choice), but a few are open-ended allowing for free text answers. The average length of an interview is 30 minutes. After returning from the field, data are entered into a database (Epi Info) for cleaning and analysis.

[X] Questionnaire responses will be collected on paper forms.

[ ] Questionnaire responses will be collected on electronic forms (Please specify, e.g., laptops).

8. Type of Information to be Collected: Instruction: Please attach (draft) data collection forms (i.e., questionnaire).

See attached draft forms.

9. Duration of Data Collection (number of days): 3 days

10. FEMA Coordination:

State Emergency Operations Center (EOC) is activated: [ ] Yes [X] No

If yes, FEMA is involved in the disaster/emergency: [ ] Yes [X] No

If yes, provide State public health department EOC liaison contact:

Name:

Title:

Contact:

INVESTIGATION LEAD: Instruction: Indicate the name, title, and affiliation of the person who will be leading the investigation.

Name: Joel Massey, MD

Title: Epidemic Intelligence Service Officer (EISO)

Affiliation: CDC EISO assigned to West Virginia Bureau for Public Health

CDC SPONSORING PROGAM 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: NCEH/DEHHE/HSB

Name of CDC Sponsoring Program Primary Contact Person: Amy Helene Schnall, MPH

Title of CDC Sponsoring Program Primary Contact Person: Staff Epidemiologist

Contact Information: Provide complete contact information. Check box for preferred method(s) of contact during the OMB approval process.

[X] Office phone: 770.488.3422

[ ] Home phone:

[ ] Cell phone/Blackberry:

[X] E-mail: [email protected]

[ ] Other:

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 response, recovery, preparedness, or mitigation measures.

4. No representative statistics will be collected.

CDC Sponsoring Program Primary Contact Name: Amy Helene Schnall, MPH

Date of Certification: 7/16/16

REQUESTED APPROVAL DATE (MM/DD/YYYY): 7/25/16

DATE SUBMITTED TO INFORMATION COLLECTION REQUEST LIAISON (MM/DD/YYYY): 7/20/2016

E-mail the completed form to the Information Collection Request Liaison (ICRL), Stephanie I. Davis, at [email protected] and [email protected]. If submitting outside business hours and immediate approval is needed, call 404-213-2967 to notify the ICRL of the submission.