Att D - Request for Approval

Attachment D. Request for Approval under Generic Clearance for Emergency Epidemic Investigation Data Collections

REQUEST FOR APPROVAL UNDER THE GENERIC CLEARANCE FOR EMERGENCY EPIDEMIC INVESTIGATION DATA COLLECTIONS
(0920-XXXX)

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 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.

TITLE OF INFORMATION COLLECTION: 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]

DESCRIPTION OF THIS SPECIFIC COLLECTION

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. At a minimum, please provide the following information: 1) background necessary to understand the importance of the outbreak or event; 2) justification of the need for an investigation, including a description of any data already available or data gaps that exist; 3) justification as to why this issue requires an urgent response; and 3) an explanation of how the information collected will be used to inform prevention and control measures. Use as much space as necessary (suggested length: 250-500 words).

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

[ ] Undetermined agent

[ ] Undetermined source

[ ] Undetermined mode of transmission

[ ] Undetermined risk factor

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

State:

City/County (if applicable):

Country:

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

Agency:

Name:

Position Title:

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.

5. 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):

[ ] Healthcare staff (describe):

[ ] Laboratory staff (describe):

[ ] Patients (describe):

[ ] Restaurant staff (describe):

[ ] Other (describe):

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.

7. 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):

[ ] Cross-sectional Study (describe):

[ ] Cohort Study (describe):

[ ] Case-Control Study (describe):

[ ] Other (describe):

[ ] Environmental Assessment (describe):

[ ] Laboratory Testing (describe):

[ ] Other (describe):

8. 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):

[ ] Telephone Interview (describe):

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

[ ] Self-administered Internet Questionnaire (describe):

[ ] Other (describe):

[ ] Medical Record Abstraction (describe):

[ ] Biological Specimen Sample

[ ] Environmental Sample

[ ] Other (describe):

9. 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):

[ ] Clinical information/symptoms (describe):

[ ] Contact information (describe):

[ ] Demographic information (describe):

[ ] Environmental factors (describe):

[ ] Exposures (describe):

[ ] Medical history (describe):

[ ] Risk factors (describe):

[ ] Specimen/lab information (describe):

[ ] Travel history (describe):

[ ] Other (describe):

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

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

Name:

Title:

Affiliation:

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:

Name of CDC Sponsoring Program Primary Contact Person:

Title of CDC Sponsoring Program Primary Contact Person:

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

[ ] Office phone:

[ ] Home phone:

[ ] Cell phone/Blackberry:

[ ] E-mail:

[ ] 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 prevention and control measures.

CDC Sponsoring Program Primary Contact Name:

Date of Certification:

REQUESTED APPROVAL DATE (MM/DD/YYYY): Instruction: Indicate the date by which approval is needed.

DATE SUBMITTED TO INFORMATION COLLECTION REQUEST LIAISON (MM/DD/YYYY): Instruction: Please indicate the date the request is submitted to the ICRL.

E-mail the completed form to the Information Collection Request Liaison (ICRL), FIRST LAST, at [email protected]. If submitting outside business hours and immediate approval is needed, call XXX-XXX-XXXX to notify the ICRL of the submission.

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