GenIC Request for Approval - Template

Attachment 7. GenIC Request for Approval Form for Poison Center Collaborations for Public Health Emergencies

Attachment 7 - GenIC Request for Approval Form for Poison Center Collaborations for Public Health Emergencies

(0920-1166; expiration date 02/29/2020)

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 Poison Center Generic ICR mechanism. Complete the checklist below. If you select “yes” to all criteria, the Poison Center Generic IR mechanism can be used.

	Public Health Emergency Selection Criteria for Investigation
1	The event is a public health emergency that causes adverse health effects. [ ] Yes [ ] No
2	Timely data are urgently needed to inform rapid public health action to prevent or reduce injury, disease, or death. [ ] Yes [ ] No
3	The event is characterized by (1) a natural or man-made disaster, (2) contaminated food/water, (3) a new or existing consumer product, or (4) an emerging public health threat. [ ] Yes [ ] No
4	The event has resulted in calls to a poison center, and the poison center agrees to conduct the call-back data collection. [ ] Yes [ ] No
5	The event is domestic. [ ] Yes [ ] No
6	Data collection will be completed in 60 days or less. [ ] Yes [ ] No

Did you select “Yes” to all criteria?

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

If no, the Poison Center 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: [natural disaster, man-made disaster, contaminated food/water, a new or existing consumer product, or emerging health threat] for [disease/problem] among [subpopulation] — [State], [Year]

REQUESTED TYPE OF EXPEDITED APPROVAL AND EFFECTIVE DATE:

[ ] 5 day [ ] 72-hour [ ] 24-hour Requested Approval Date: [insert]

JUSTIFICATION: [insert reason why 72 or 24-hour approval is requested and a description of the public health need]

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 prevent further morbidity and/or mortality. Use as much space as necessary (suggested length: 250-500 words).

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

[ ] Natural disaster

[ ] Man-made disaster

[ ] Contaminated food/water

[ ] New/existing consumer product

[ ] Emerging health threat

[ ] Other (describe)

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

State:

City/County (if applicable):

Country:

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.

5. 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.

[ ] Demographic information (describe):

[ ] Exposure information (describe):

[ ] Health effects and medical treatment (describe):

[ ] Health messaging (describe):

[ ] Other (describe):

6. 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), Stephanie Davis, at [email protected] or submit through the S3P System, as appropriate. If submitting outside business hours and immediate approval is needed, call 404-213-2967 to notify the ICRL of the submission.

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