Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease Study)
ICR 201909-0923-001 · OMB 0923-0061 · Historical Active
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0923-0061 can be found here:
Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease Study)
No material or nonsubstantive change to a currently approved collection
Previous terms continue: Consistent with the Supporting Statement, the statistical power and sampling frame of this proof of concept study limits ATSDRâs ability to detect moderate differences (between exposed and nonexposed individuals) in many of health conditions queried in this collection. Approval for the collection of information about conditions for which there is not adequate statistical power is provided specifically for the purposes of evaluating the study procedures, methods, and hypotheses for a future multi-site study. Approval is provided contingent upon a commitment to investigate other contributing environmental factors when associations or trends are observed between PFAS exposure and health conditions. Approval is also provided contingent upon a commitment to work with the National Center for Health Statistics on disclosure review procedures and include a member of NCHSâs disclosure review board for NHANES on the PEAS disclosure review board.
Inventory as of this Action
Requested
Previously Approved
08/31/2022
08/31/2022
08/31/2022
5,852
0
5,852
1,454
0
1,454
42,227
0
42,227
The Pease Study will serve as a proof-of-concept model for a multi-site study of PFAS health effects. The existence of a large body of state and local environmental monitoring and population blood testing data makes the Pease community in Portsmouth, NH particularly suitable as ATSDRâs initial PFAS research study site. The main goals of the research study are to: 1) evaluate the study procedures and methods to identify any changes to the design or protocol that need to be made before embarking on a multi-site study; and 2) examine associations between a limited number of health outcomes for which statistical power is adequate and measured and historically reconstructed serum levels of PFAS (e.g., lipids, renal function and kidney disease, thyroid hormones and disease, liver function and disease, glycemic parameters and diabetes, as well as immune response and function in both children and adults). Request for change to retain leftover blood with participant consent.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Medical Record Abstraction - Child
P_Att09b_InformedConsentPacket_20190823 clean.docx
1 - AppndxE IRB Apprvl Memos 20190903.pdf
Request for Medical Record Abstraction