[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)]
[Notices]
[Pages 43685-43687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substance and Disease Registry

[60Day-18-18AUZ; Docket No. ATSDR-2018-0008]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), 
Department of Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR), 
as part of its continuing effort to reduce public burden and maximize 
the utility of government information, invites the general public and 
other Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ``Human Health Effects of 
Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) 
at Pease International Tradeport, Portsmouth, NH (The Pease Study).'' 
The purpose of this research is to use sound study methods to see if 
drinking water exposure to PFAS is related to health outcomes in this 
New Hampshire community.

DATES: ATSDR must receive written comments on or before October 26, 
2018.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2018-0008 by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
    <bullet> Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and

[[Page 43686]]

Docket Number. ATSDR will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffery M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
<a href="/cdn-cgi/l/email-protection#147b7976547770773a737b62"><span class="__cf_email__" data-cfemail="f19e9c93b1929592df969e87">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:  Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

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 ([micro]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 [micro]g/L PFOA 
and 2.4 [micro]g/L PFOS) at levels well above what was to become the 
USEPA lifetime health advisory level (0.07 [micro]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 90% of the exposure group will be

[[Page 43687]]

enrolled in Wave 1 (n=1,215, or 405 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 of invitation to its former 
blood testing program participants. To achieve the desired sample size, 
the other 10 percent of the exposure group (n=135, or 45 per year) will 
be recruited in Wave 2. 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 1 and Wave 2. Wave 2 and Wave 3 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 5% 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 142 exposed people in Wave 2 (or 47 per year), and at least 
289 unexposed people in Wave 3 (or 96 per year). This will require an 
annual time burden of 124 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% 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 and 
educational record abstraction is estimated to be 125 hours for adult 
records and 118 hours for children's records.
    The total annualized time burden requested is 1,189 hours. There is 
no cost to the respondents other than their time.

                                                            Estimated Annualized Burden Hours
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                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
              Type of respondents                               Form name                   respondents    responses per   response  (in    (in hours)
                                                                                                            respondent        hours)
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Pease Study Participants.......................  Wave One Eligibility Screening Script..             526               1           10/60              88
                                                 Wave Two Eligibility Screening Script..              47               1           15/60              12
                                                 Wave Three Eligibility Screening Script              96               1           15/60              24
                                                 Appointment Reminder Telephone Script..             542               1            5/60              45
                                                 Update Contact Information Hardcopy                 542               1            5/60              45
                                                  Form.
                                                 Medication List........................             542               1            3/60              27
                                                 Body and Blood Pressure Measures Form..             542               1            5/60              45
                                                 Blood Draw and Urine Collection Form...             542               1           10/60              90
                                                 Adult Questionnaire....................             367               1           30/60             184
                                                 Child Questionnaire--Long Form.........             140               1           30/60              70
                                                 Child Questionnaire--Short Form........              35               1           15/60               9
                                                 Parent Neurobehavioral Test Battery....             175               1           15/60              44
                                                 Child Neurobehavioral Test Battery.....             175               1           90/60             263
Education Specialists..........................  Child School Record Abstraction Form...              15              12           20/60              60
Medical Record Specialists.....................  Medical Record Abstraction Form--Adult.              25              15           20/60             125
                                                 Medical Record Abstraction Form--Child.              25               7           20/60              58
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           1,189
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Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-18446 Filed 8-24-18; 8:45 am]
BILLING CODE 4163-18-P


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