Att G Steps for Conductiong an ACE Investigation

Attachment G - Step-by-Step How to Use the Generic Clearance for
Assessment of Chemical Exposures (ACE) Investigations Data Collections¹

To conduct an ACE investigation:

1. Review the ACE Investigations Data Collections Generic ICR OMB Package (OMB No. 0923- XXXX).

2. Complete the “Attachment D Request for Assessment of Chemical Exposures Investigation” Form.

3. E-mail the following to the ACE investigation Information Collection Request Liaison (ICRL):

   • Completed “Attachment D Request for Assessment of Chemical Exposures Investigation” Form

   • Letter of invitation from the local, tribal, or state health authority

   • The NCEH-ATSDR Research Determination Form (http://intranet.cdc.gov/nceh-atsdr/os2/human_subjects.htm)

   • A complete Supporting Statement B describing the proposed sampling plan and statistical methods for the GenIC.

4. Contact the ACE Investigations ICRL so they may notify the OMB Desk officer immediately via e-mail regarding the ACE Investigation. If a more rapid approval timeline is needed, notify the ACE Investigations ICRL so they may notify OMB of this need.

5. If the request is sent outside business hours and immediate approval is needed, notify the ICRL by phone that the request has been submitted. Hard copies of original, signed documents should be personally delivered to the ICRL.

6. The ICRL will review the request and determine whether it meets the criteria for the ACE investigations clearance.

7. If it is deemed appropriate, the ICRL will submit the request to the CDC Information Collection Review Office (ICRO) for OMB approval.

8. The OMB desk officer responds with approval or comments on the proposed ACE Investigation within 5 days of receipt of the final data collection instrument, unless the request is for a shorter time frame (i.e., 72 or 24 hours). If a 72 or 24-hour approval is requested, an advance email notification must be sent, and an explanation must be provided as to why it is needed. Specifically, ATSDR must make a case as to why collection must begin within 72 to 24 hours, and it must be related to a public health need. Data collection cannot begin until OMB has approved the information. OMB may provide approval and comments orally (followed by e-mail for written documentation) or e-mail directly to ATSDR.

9. ATSDR staff may deploy and begin planning the investigation once the request is submitted to OMB.

10. The ACE Investigation lead or designee must be available to respond to questions about the investigation during OMB’s 5 business day review period.

11. Upon receiving OMB approval, data collection may proceed for up to 90 days.

12. On the cover or first page of each data collection instrument, include the OMB number and expiration date (0923-XXXX; expires XX/XX/XXXX) in the upper right corner and the public reporting burden statement in the footer.

13. 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.

14. Within 5 business days of the completion of data collection, submit to the ICRL (via e-mail and personal hardcopy delivery) a final copy of all data collection instrument(s) and the completed “Burden Memo.”

Questions or Comments? Contact the ACE Information Collection Request Liaison (ICRL):

Stephanie I. Davis, MSPH

OMB-PRA Contact

NCEH/ATSDR Office of Science

Office: 770-488-3676

BlackBerry: 404-213-2967

[email protected]