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OMB Control No: 0923-0061	ICR Reference No: 201908-0923-001
Status: Historical Active	Previous ICR Reference No: 201812-0923-002
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-18AUZ
Title: Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease Study)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/28/2019
	Date Received in OIRA: 08/16/2019
Terms of Clearance: Consistent with the Supporting Statement, the statistical power and sampling frame of this proof of concept study limits ATSDR’s 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 NCHS’s disclosure review board for NHANES on the PEAS disclosure review board.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved
Responses	5,852	0	0
Time Burden (Hours)	1,454	0	0
Cost Burden (Dollars)	42,227	0	0

Abstract: 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 ATSDR’s 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).

Authorizing Statute(s): PL: Pub.L. 115 - 141 8006 Name of Law: Consolidated Appropriations Act
   US Code: 42 USC 9604 Name of Law: CERCLA
   US Code: 42 USC 301 Name of Law: PHSA

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 43685	08/27/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 3449	02/12/2019
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	5,852	5,852
Annual Time Burden (Hours)	1,454	1,454
Annual Cost Burden (Dollars)	42,227	42,227

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a resubmission of a new ICR.

Annual Cost to Federal Government: $1,912,122

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Shari Steinberg 404 639-4942 shari.steinberg@cdc.hhs.gov

View ICR - OIRA Conclusion