Instructions for Conducting a CSOI

Attachment F. Steps for Conducting a CSOI

Step-by-Step How to Use the Generic Clearance for
Emergency Cruise Ship Outbreak Investigations (CSOIs) Data Collections

To conduct a CSOI with more than 9 non-Federal participants, follow these steps:

1. Review the CSOI Generic Clearance OMB Package (OMB No. 0920-XXXX).

2. If you have questions about whether your proposed investigation meets the criteria for a CSOI, please contact the CSOI Information Collection Request Liaison (ICRL).

3. Complete the “Request for Approval Under the Generic Clearance of Emergency Cruise Ship Outbreak Investigations Data Collections” form.

4. E-mail the following to the ICRL:

   • Completed “Request for Approval Under the Generic Clearance for Emergency Cruise Ship Outbreak Investigations” form

   • The research determination form (if the investigation is determined to be research)

If the request is sent outside business hours and immediate approval is needed, notify the ICRL by phone that the request has been submitted.

5. The ICRL will review the request and determine whether it meets the criteria for the CSOI Generic Clearance. If the request meets the criteria, the ICRL will submit the request to the CDC Information Collection Review Office for OMB approval.

6. CDC staff may deploy and begin planning the investigation once the request is submitted to OMB.

7. Data collection cannot begin until OMB has approved the information collection or until 24 hours after OMB was notified of the investigation.

8. The investigation lead or designee must be available to respond to questions about the investigation during OMB’s 24-hour review period.

9. Upon receiving OMB approval, ICRL will notify the program and data collection may proceed for up to 30 days.

10. On the cover or first page of each data collection instrument, include the OMB number and expiration date (0920-XXXX; expires XX/XX/XXXX) in the upper right corner and the public reporting burden statement in the footer. The public reporting burden statement must include the burden estimate for each instrument.

11. Prior to data collection, investigators must inform respondents that participation is voluntary, that respondents will not be personally identified in any published reports of the study, and that their privacy will be protected to the extent allowed under federal law.

12. Within 7 business days of the completion of data collection, submit to the ICRL (via e-mail) a final copy of all data collection instrument(s) and the completed “Burden Memo.”