Request for change - 2.2020

February 5, 2020

Change Request #3 for OMB # 0923-0059: Per- or Polyfluoroalkyl Substances Exposure Assessments (PFAS EAs)

Justification/Brief Explanation for the Change Request

This is a non-material/non-substantive change request for “Pre-and Polyfluoroalkyl Substances Exposure Assessments (PFAS EAs)“ (OMB Control No. 0923-0059; expiration date: June 30, 2022).

We are requesting an administrative change to the protocol. On the OMB RegInfo.gov website, the final approved protocol was provided as a single file, including all appendices. The individual files for the protocol appendices currently located on the OMB website are not the final versions approved in the protocol.

Therefore, we are providing the currently approved protocol body plus the protocol appendices as individual files to be uploaded to the OMB RegInfo.gov website. No changes were made to the content of the appendices.

There is one change to the protocol body. As we were conducting our first EA, we realized that a high proportion of available phone numbers to be used for recruitment were not valid. Therefore, the team decided that we would ask the eligibility questions in-person in one door-to-door recruitment effort instead of on the phone for those homes we were unable to reach by number. A sentence has been added to the protocol reflecting the additional recruitment effort.

Attached please find the revised protocol body (clean and track-changes) and clean versions of the OMB-approved appendices, except for Appendices G1 and G2 which were previously approved by OMB as a change request #2 on 01/31/2020.

The overall number of respondents and requested burden hours remain the same.

Below is the change request cross-walk table. As such, we would appreciate your expedited consideration of this request.

Attachment	Requested Change	Justification
Protocol	All appendices have been removed from the protocol and provided as individual files The following statement has been added to the Procedures and Methods/Biological Sampling Eligibility Criteria and Recruitment section (page 20 of 45) “For randomly selected households we are unable to reach by phone, we will attempt one in-person visit to recruit EA participants.”	The protocol on the current OMB website as well as changes to Appendices G1 and G2 have been approved by OMB. The protocol appendices currently provided as individual files on the OMB website do not reflect the final, approved appendices and should be replaced by those provided. During recruitment at our first location, it was clear that the phone numbers we were using for recruitment were often not valid. Therefore, we determined that we would ask the eligibility questions in-person instead of over the phone for those households we were unable to reach by phone. This strategy will be employed at all 8 EA locations.
Protocol Attachments	The currently approved protocol appendices should replace the ones that require updating on RegInfo.gov: A1-A4, B1-B6, C1-C2, D, E, F1-F2, H & I	See Item 1 above.

1