[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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


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