P_Att19_RequestMedicalRecAbstrctn_20190813 clean

Pease Study

Request Medical Record Abstraction

Flesch-Kincaid Readability Score – 12.5

Attachment 19 - Request for Medical Record Abstraction

[ON AGENCY LETTERHEAD]

Form Approved

OMB No. 0923-xxxx

Exp. Date xx/xx/201x

[DATE]

[NAME OF PROVIDER]

[ADDRESS]

[CITY, STATE ZIP CODE]

Subject: Medical verification and records review for Pease Study

Dear [NAME OF PROVIDER]:

The Agency for Toxic Substances and Disease Registry (ATSDR) is conducting a research study to see if per- and polyfluoroalkyl substances (PFAS) in the drinking water at the Pease International Tradeport In New Hampshire might affect human health. . We are working with the assistance of your local health department, the New Hampshire Department of Health and Human Services (NH DHHS), and [name of all other partners]. ATSDR is conducting this research study with oversight from the CDC/ATSDR Institutional Review Board (IRB) under CDC Protocol No. 7161.

Under Section 8006 of the 2018 Consolidated Appropriations Act, Congress authorized ATSDR to study the potential health impact of exposures to PFAS in drinking water. The first part of our study will focus on Pease to see if exposure to PFAS in the drinking water might affect human health.

ATSDR will include about 1,000 adults and 350 children served by the Pease Tradeport Water System during the time of PFAS contamination. We have included a comparison group of about 100 adults and 175 children from Portsmouth, NH who were not exposed to the PFAS-contaminated drinking water at Pease.

[ADULT PARTICIPANT’S NAME or PARENT OR GUARDIAN’S NAME] has given the study investigators authorization to conduct a medical records review. ATSDR is interested in more information about [ADULT PARTICIPANT’S NAME/CHILD PARTICIPANT’S NAME]’s self-reported health conditions that may be related to chemical exposure. We have included an abstraction form for your office to fill out and return to us in the enclosed return envelope.

If we need additional information, the ATSDR study team may wish to review the medical records in your office. We would appreciate your assistance if this is necessary.

ATSDR is an agency of the U.S. Department of Health and Human Services. ATSDR is performing this activity as a public health authority as defined by the Health Insurance Portability and Accountability Act (HIPAA) [45 CFR §164.501]. The requested information represents the minimum necessary to carry out the public health purposes of this study as described in 45 CFR §164.514(d) of the Privacy Rule. The research is also covered by a Certificate of Confidentiality under Section 301(d) of the Public Health Service (PHS) Act, as amended by Section 2012 of the 21st Century Cures Act, P.L. 114-255 (42 U.S.C. 241(d))

For questions about this research study, please call the ATSDR study lead, Dr. Marian Pavuk, at [study telephone number]. Please leave a message with your name and a telephone number or address.

Thank you for your assistance.

Marian Pavuk, MD, PhD Frank Bove, DSc

Co-Principal Investigators

Pease Study

ATSDR estimates the average public reporting burden for this collection of information as 20 minutes per response, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/information needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB Control Number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0923-xxxx).