0923-0049 Change Request Justification 20131205 use

Anniston Community Health Survey: Follow-up Study and Dioxin Analyses

Circumstances of Change Request for OMB #0923-0049

This is a nonmaterial/non-substantive change request for OMB #0923-0049 (expiration date: November 30, 2015). OMB approval was granted for data collection for a follow-up study in the Anniston, Alabama, community.

We are requesting to change the wording in one section of the consent form. The language regarding storage of blood for future tests in the consent form has been revised in accordance with CDC IRB recommendations for the protocol.

Based on recent feedback from our field research and clinical partners, we are requesting to make minor additions to the invitation letter, study fact sheet, and reminder materials (telephone scripts and reminder cards). In the invitation letter and study fact sheet, we now indicate that recipients may call the study’s toll-free number to set up appointments, rather than just wait to be contacted. We have added statements in the study fact sheet and reminder materials (reminder telephone scripts and cards) to say that potential participants may drink water during the eight-hour fast prior to the blood draw. We have also updated the recruitment telephone script to correct the new incentive amount for participation in the interview only ($50, as approved by OMB), and we have used clearer wording in the recruitment voicemail script.

Attached please find the revised consent form (Attachment 3.8), invitation letter (Att 3.1), study fact sheet (Att 3.2), recruitment telephone and voicemail scripts (Att 3.3), reminder cards (Att 3.5), and reminder telephone scripts (Att 3.6), which incorporate the changes described above.

There will be no change to the methods or to the requested burden hours. As such, we would appreciate OMB’s expedited consideration of this request.