Non-substantive Change Request Justification

0923-0061 Change Request 3 Justification 20210928.docx

Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease Study)

Non-substantive Change Request Justification

OMB: 0923-0061

Document [docx]
Download: docx | pdf

Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, NH

OMB Control No. 0923-0061; expiration date 08/31/2022

CDC Protocol #7161

Date: 09/28/2021


Change Request Justification –

This is a non-substantive non-material change request. There are no changes to the time burden, number of respondents, or data collection methods.

This amendment was reviewed and approved by the CDC IRB on 09/07/2021. The following files are updated:

  • Appendix E (IRB Approval Memo)

  • Protocol body

  • Attachment 3 (Biochemical Analytical Plan)

  • Attachment 24 (PFAS Chemical Report)

The current protocol amendment updates Att24 PFASChemReport with reference ranges for 2017-2018 NHANES data used to compare participants' results with national age groups. Children 12-19 year old and adults 20+ year old reference ranges were updated.

The analytical method was updated by the CDC laboratory (Kato et al., 2018) and changes in PFAS analytes to be measured in Pease Study were made in the study protocol, Att24, and Att3 BiochemAnalPlan.

Details of the protocol changes are itemized in Appendix E.


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorAuthor
File Modified0000-00-00
File Created2021-10-07

© 2024 OMB.report | Privacy Policy