[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3449-3451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01992]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[30Day-19-18AUZ]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Agency
for Toxic Substances and Disease Registry (ATSDR) has submitted the
information collection request titled ``Human Health Effects of
Drinking Water Exposures to
[[Page 3450]]
Per- and Polyfluoroalkyl Substances (PFAS) at Pease International
Tradeport, Portsmouth, NH (The Pease Study)'' to the Office of
Management and Budget (OMB) for review and approval. ATSDR previously
published a ``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on August 27, 2018 to obtain comments from the
public and affected agencies. ATSDR received 11 comments related to the
previous notice, of which two were posted in duplicate. This notice
serves to allow an additional 30 days for public and affected agency
comments.
ATSDR will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
Human Health Effects of Drinking Water Exposures to Per- and
Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport,
Portsmouth, NH (The Pease Study)--New--Agency for Toxic Substances and
Disease Registry (ATSDR).
Background and Brief Description
Per- and polyfluoroalkyl substances (PFAS) are a family of
environmentally and biologically persistent chemicals used in
industrial applications such as aqueous film-forming foam (AFFF), used
to extinguish flammable liquid fires. Since the 1970s, military bases
in the U.S. have used AFFF with PFAS constituents for firefighting
training as well as to extinguish fires. At some military bases, AFFF
use has resulted in the migration of PFAS chemicals through soils to
ground water and/or surface water sources of drinking water for bases
and/or surrounding communities. In 2016, the U.S. Environmental
Protection Agency (USEPA) issued a lifetime health advisory level of
0.07 total micrograms of perfluorooctanoate (PFOA) and perfluorooctane
sulfonate (PFOS) combined per liter of drinking water ([mu]g/L). In
response to growing awareness of the extent of PFAS contamination
across the U.S., Section 8006 of the Consolidated Appropriations Act,
2018, authorized the Agency for Toxic Substances and Disease Registry
(ATSDR) to conduct a study on the human health effects of PFAS
contamination in drinking water.
In response, ATSDR is requesting a three-year Paperwork Reduction
Act (PRA) clearance for the Pease Study, which will serve as a proof-
of-concept model for a national 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. From approximately 1970 until 1991, the Air Force
used AFFF for firefighting and training at Pease Air Force Base. The
base closed in 1991, and was converted to a large business and aviation
industrial park in 1993, the Pease International Tradeport. In 2014,
PFAS drinking water concentrations were detected (0.35 [mu]g/L PFOA and
2.4 [mu]g/L PFOS) at levels well above what was to become the USEPA
lifetime health advisory level (0.07 [mu]g/L PFOA/PFOS). In 2015-7, the
New Hampshire Department of Health and Human Services (NH DHHS) offered
a PFAS blood testing program to the community. The blood testing
program showed that the Pease population had concentrations of some
types of PFAS that were two to three times higher than national
estimates.
The Pease Study will be cross-sectional in design, drawing from a
convenience sample of people with and without exposure to PFAS-
contaminated drinking water from Pease. The main goals of the study are
to: (1) Evaluate the study procedures and methods to identify any
issues that need to be addressed before embarking on a national multi-
site study; and (2) examine associations between health outcomes and
measured and historically reconstructed serum levels of PFAS. ATSDR
will examine the association between PFAS compounds and 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. In addition,
ATSDR will investigate if PFAS is related to differences in sex
hormones and sexual maturation, vaccine response, and neurobehavioral
outcomes in children. In adults, additional outcomes of interest
include cardiovascular disease, osteoarthritis, osteoporosis,
endometriosis, and autoimmune disease. Adults will be 18 years or
older, and children will be 4-17 years of age at enrollment.
In total, ATSDR seeks to enroll 1,625 participants (1,100 adults
and 525 children and their parents). Annualized estimates are 542
participants (367 adults and 175 children).
For the exposure group (n=1,350), ATSDR will enroll 1,000 adults
and 350 children. Annualized estimates are 450 exposed participants
(333 adults and 117 children). Eligible participants had to work at,
live on, or attend childcare at the former Pease Air Force Base or the
Pease International Tradeport, or live in a nearby home that was served
by a PFAS-contaminated private well. Drinking water exposures must have
occurred at some time between 2004 and May 2014, after which
remediation of the public water supply occurred.
For the referent group (n=275), ATSDR will enroll 100 adults and
175 children. Annualized estimates are 92 referent participants (34
adults and 58 children). Eligible participants, never exposed to PFAS-
contaminated drinking water from Pease, will come from other areas of
Portsmouth, NH. Birth mothers of referent children likewise must never
have had PFAS drinking water exposure.
ATSDR will recruit, screen for eligibility, and enroll in three
waves. The exposure group will be recruited in Waves One and Two. ATSDR
estimates that 89 percent of the exposure group will be enrolled in
Wave One (n=1,200, or 400 per year), that is, will be past participants
of the 2015-7 NH DHHS PFAS blood testing program. NH DHHS will assist
ATSDR by sending out letters
[[Page 3451]]
of invitation to its former blood testing program participants. To
achieve the desired sample size, the other 11 percent of the exposure
group (n=150, or 50 per year) will be recruited in Wave Two. These will
be people who were eligible for the PFAS blood testing program but did
not take part. The referent group will be recruited in Wave Three
(n=275, or 92 per year), which can occur concurrently with Wave One and
Wave Two. Wave Two and Wave Three recruits will call to volunteer after
ATSDR opens those waves to enrollment.
To restrict this study to drinking water exposures, any adult
occupationally exposed to PFAS will not be eligible for the study
(i.e., ever firefighters or in chemical manufacture). Likewise,
children whose birth mothers were occupationally exposed will not be
eligible. This restriction applies to both the exposure and the
referent group. ATSDR assumes that five percent of the people who
volunteer will not meet eligibility requirements. ATSDR will screen the
1,578 people from the NH DHHS PFAS blood testing program in Wave One
(n=526 per year). ATSDR will screen at least 198 exposed people in Wave
Two (or 66 per year), and at least 362 unexposed people in Wave Three
(or 121 per year). This will require an annual time burden of 134 hours
for eligibility screening.
At enrollment, ATSDR will obtain adult consent, parental
permission, and child assent before data collection begins. Each child
will enroll with a parent, who ideally will be the child's birth
mother, as ATSDR will ask details about the child's exposure,
pregnancy, and breastfeeding history.
For each participant, ATSDR will take body measures, collect blood
and urine samples for chemical and biomarker analysis, and administer a
questionnaire on exposures and medical history. For purposes of burden
estimation, ATSDR assumes that 20 percent of parents will also enroll
as adults; therefore, 420 parents will take the child questionnaire
long form (n=140 per year), while 105 parents will take the short form
to reduce burden (n=35 per year). Parents and children will also
complete assessments of the child's attention and behaviors. After
eligibility screening, the annual time burden for participation in the
study is 58 hours for adults and 208 hours for children and their
parents.
ATSDR will ask for permission to compare adults' and children's
medical histories with their medical records. ATSDR will also ask for
permission to check children's school records to compare their
behavioral assessment results. The annual time burden for medical
record abstraction is estimated to be 183 hours. The annual time burden
for school record abstraction is estimated to be 60 hours.
The total annualized time burden requested is 1,199 hours. There is
no cost to the respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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Pease Study Participants.............. Wave One Eligibility 526 1 10/60
Screening Script.
Wave Two Eligibility 66 1 15/60
Screening Script.
Wave Three Eligibility 121 1 15/60
Screening Script.
Appointment Reminder 542 1 5/60
Telephone Script.
Update Contact 542 1 5/60
Information Hardcopy
Form.
Medication List......... 542 1 3/60
Body and Blood Pressure 542 1 5/60
Measures Form.
Blood Draw and Urine 542 1 10/60
Collection Form.
Adult Questionnaire..... 367 1 30/60
Child Questionnaire-- 140 1 30/60
Long Form.
Child Questionnaire-- 35 1 15/60
Short Form.
Parent Neurobehavioral 175 1 15/60
Test Battery.
Child Neurobehavioral 175 1 90/60
Test Battery.
Education Specialists................. Child School Record 15 12 20/60
Abstraction Form.
Medical Record Specialists............ Medical Record 25 15 20/60
Abstraction Form--Adult.
Medical Record 25 7 20/60
Abstraction Form--Child.
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Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-01992 Filed 2-11-19; 8:45 am]
BILLING CODE 4163-18-P