[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Notices]
[Pages 16857-16859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08150]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substance and Disease Registry

[60-Day-19-19ACF; Docket No. ATSDR-2019-0004]


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): 
A multi-site cross-sectional study (The Multi-site 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.

DATES: ATSDR must receive written comments on or before June 24, 2019.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2019-0004 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     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 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: 
[email protected].

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): A multi-site cross-sectional study 
(The Multi-site Study)--NEW--Agency for Toxic Substances and Disease 
Registry (ATSDR).

Background and Brief Description

    Per- and polyfluoroalkyl substances (PFAS) are a family of 
chemicals used in industrial applications and consumer products. PFAS 
contamination of drinking water is widespread in the U.S. Some 
estimates indicate that at least

[[Page 16858]]

sixty million residents were served by 66 public water supplies that 
had at least one sample at or above the US Environmental Protection 
Agency (EPA) Lifetime Health Advisory for perfluorooctanoic acid (PFOA) 
and perfluorooctane sulfonic acid (PFOS) (individually or combined), 
which is 70 nanograms per liter (ng/L) of water. Industrial facilities 
that manufacture or use PFAS have contaminated drinking water in 
surrounding communities in several states. In addition, PFOS, PFOA, 
perfluorohexane sulfonic acid (PFHxS) and other PFAS chemicals are 
constituents in aqueous film-forming foam (AFFF), used to extinguish 
flammable liquid fires. The use of AFFF at military bases and other 
sites may have resulted in the migration of PFAS chemicals through 
soils to ground water and/or surface water sources of drinking water 
for the bases and/or surrounding communities around the country.
    In response to growing awareness of the extent of PFAS 
contamination across the U.S., the Section 316(a) of the 2018 National 
Defense Authorization Act (Pub. L. 115-91) 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. The 
existence of widespread contamination at many sites around the U.S. 
makes this a paramount effort in addressing the health effects of 
exposures to PFAS from contaminated drinking water. Consequently, ATSDR 
is requesting a three-year Paperwork Reduction Act (PRA) clearance for 
the Multi-site Study. The Multi-site Study will build on the preceding 
proof-of-concept study at the Pease International Tradeport in 
Portsmouth, New Hampshire.
    ATSDR will conduct this research using a cooperative agreement 
titled ``Multi-site Study of the Health Implications of Exposure to 
PFAS-Contaminated Drinking Water'' (Notice of Funding Opportunity 
[NOFO] No. CDC-RFA-TS-19-002). The expected number of research 
recipients (e.g., entities selected for funding) is six. The program 
will be administered by the CDC Extramural Research Program Office 
(ERPO) at the National Center for Injury Prevention and Control 
(NCIPC). The research under this cooperative agreement will be a two-
part program. First, a mandatory core research protocol for all 
recipients is designed to aggregate data across all sites and designed 
to compare data between sites. Next, each recipient will have the 
option to propose additional investigator-initiated research questions 
and hypotheses related to the overall goals of this NOFO.
    The main goal of this cross-sectional multi-site study is to 
evaluate associations between measured and reconstructed historic serum 
levels of PFAS including PFOA, PFOS, and PFHxS, and selected health 
outcomes. The health outcomes of interest include 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, 
the study will investigate PFAS differences in sex hormones and sexual 
maturation, vaccine response, and neurobehavioral outcomes in children. 
In adults, additional outcomes of interest include cardiovascular 
disease, osteoarthritis and osteoporosis, endometriosis, and autoimmune 
disease.
    Under the cooperative agreement, each recipient shall propose 
candidate study sites at communities whose drinking water was impacted 
by AFFF use or by industrial PFAS emissions. Site selection will 
consider the documented levels of PFAS drinking water concentrations. 
The aim will be to include sites so that a wide range in PFAS exposures 
levels are included in the study. This will enable the evaluation of 
exposure-response trends including effects at the lower range of 
exposures. Ground water contaminant fate and transport models and water 
system distribution system models may be necessary to identify the 
areas with contaminated drinking water, to determine the period when 
the drinking water was contaminated, and to reconstruct historical PFAS 
contaminant concentrations.
    For exposure estimation, participants will be categorized based on 
their measured serum concentration of PFAS compounds or on modeled 
estimated historical serum levels (e.g., referent or low, medium, 
high). Measured and estimated PFAS serum levels will also be evaluated 
as continuous variables. At sites with prior PFAS biomonitoring data, 
the study will evaluate changes in PFAS concentration over time.
    Each recipient shall reconstruct historic serum PFAS 
concentrations. This may be done by estimating half-lives and 
elimination rates as well as by water contamination modeling to inform 
pharmacokinetic (PK) or physiologically based pharmacokinetic (PBPK) 
models. Historical serum PFAS reconstruction will enable the evaluation 
of exposure lags and vulnerable periods as well as statistical analyses 
that can control for confounding and reverse causation due to 
physiological factors.
    Each recipient shall identify and enumerate all households served 
by the contaminated drinking water supply in the selected community to 
recruit potential participants and to meet the sample size requirements 
for children and adults. If the selected community is served by a PFAS-
contaminated public water system, then the recipient will obtain a list 
of households served by the water purveyor from its billing records. If 
the community is served by contaminated private wells, then the 
recipient will obtain a list of households with contaminated wells from 
the local and/or state health and environmental agencies.
    Statistical sampling methods (e.g., a two-stage cluster sample) may 
be used for recruitment of study participants if all the affected 
households can be enumerated. If the PFAS drinking water concentrations 
vary widely across the community, then the recipient should consider 
using targeted sampling approaches--including oversampling of areas 
with higher PFAS concentrations--to ensure a sufficiently wide 
distribution of exposure levels among study participants to evaluate 
exposure-response trends. If enumeration of all households is not 
feasible, or if participation rates are expected to be low, then the 
recipient can consider non-probabilistic sampling approaches such as 
``judgment'' and ``snowball'' sampling approaches.
    The recipients should consider requesting assistance from local and 
state health departments in its recruitment efforts. In addition, the 
recipient should engage community organizations to assist in conducting 
outreach about the study and recruitment of participants and consider 
establishing a community assistance panel (CAP). The CAP could provide 
comments on any additional investigator-initiated research questions 
and hypotheses and facilitate the involvement of the affected community 
in decisions related to outreach about the study, participant 
recruitment strategies, and study logistics. The CAP could also assist 
the recipient in the dissemination of study findings to the community.
    In total, ATSDR seeks to enroll at least 8,000 participants (6,000 
adults and 2,000 children and their parents) from communities exposed 
to PFAS-contaminated drinking water over the first three years of the 
five-year cooperative agreement program. Annualized estimates are 2,667 
participants (2,000 adults and 667 children). To restrict this study to 
drinking water exposures, adults occupationally exposed to PFAS will 
not be eligible for the study (e.g., ever firefighters or ever workers 
in an

[[Page 16859]]

industry using PFAS chemicals in its manufacturing process). Likewise, 
children whose birth mothers were occupationally exposed will not be 
eligible. ATSDR assumes that 5 percent of the people who volunteer will 
not meet eligibility requirements; therefore, a total of 8,400 people 
will be screened. To complete the data collection in three years, 
annualized estimates for eligibility screening are 2,800 people (2,100 
adults and 700 children) and an annual time burden of 467 hours. The 
recipients will provide appointment reminder calls for each eligible 
person who agrees to be enrolled (n = 2,667 per year) for a time burden 
of 222 hours per year.
    At enrollment, each recipient will obtain adult consent, parental 
permission, and child assent before data collection begins. For each 
participant, the recipient will take body measures, collect blood 
samples to measure PFAS serum levels and several effect biomarkers such 
as lipids, and thyroid, kidney, immune and liver function. The 
recipient will also obtain urine samples from participants to measure 
PFAS levels and kidney function biomarkers. The study will archive 
leftover serum and urine samples for additional analyses of PFAS 
chemicals and specific effect biomarkers. The National Center for 
Environmental Health (NCEH) laboratory will perform blood and urine 
PFAS analyses for all Multi-site Study participants. Thus, issues of 
inter-laboratory variability for exposure measures will be eliminated.
    Adult participants and a parent of child participants will complete 
a questionnaire that includes residential history, medical history, 
occupational history, and water consumption habits (n=2,000 adults and 
667 children per year). Ideally, the parent will be the child's birth 
mother, as ATSDR will ask details about the child's exposure, 
pregnancy, and breastfeeding history.
    For purposes of time burden estimation, ATSDR assumes that 20 
percent of parents will also enroll as adults and can take the child 
short form questionnaire (n=133 per year); therefore, 534 parents will 
take the child long form questionnaire per year. Parents and children, 
with administration by trained professionals, will also complete 
neurobehavioral assessments of the child's attention and behaviors 
(n=667 per year).
    To facilitate access to medical and school records, each recipient 
will reach out to local medical societies, public school systems, and 
private schools, to enlist their cooperation with the study. The 
recipient will ask for permission to abstract participants' medical 
records to confirm self-reported health outcomes. The recipient will 
also seek permission to abstract and compare children's school records 
to their behavioral assessment results. Based on ATSDR's experience 
from the Pease proof of concept study, ATSDR estimates that it will 
take 48 education specialists and 150 adult and 50 pediatric medical 
record specialists to complete record abstractions across all study 
sites. Given the goal to enroll at least 2,000 adults and 667 children 
per year, the annual time burden for medical and educational record 
abstraction is estimated to be 1,091 hours.
    The total annualized time burden requested is 5,269 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    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Multi-site Study Participants.  Eligibility                2,800               1           10/60             467
                                 Screening
                                 Script.
                                Appointment                2,667               1            5/60             222
                                 Reminder
                                 Telephone
                                 Script.
                                Update Contact             2,667               1            5/60             222
                                 Information
                                 Hardcopy Form.
                                Medication List.           2,667               1            3/60             133
                                Body and Blood             2,667               1            5/60             222
                                 Pressure
                                 Measures Form.
                                Blood Draw and             2,667               1           10/60             444
                                 Urine
                                 Collection Form.
                                Adult                      2,000               1           30/60           1,000
                                 Questionnaire.
                                Child                        537               1           30/60             268
                                 Questionnaire--
                                 Long Form.
                                Child                        133               1           15/60              33
                                 Questionnaire--
                                 Short Form.
                                Parent                       667               1           15/60             167
                                 Neurobehavioral
                                 Test Battery.
                                Child                        667               1           90/60           1,000
                                 Neurobehavioral
                                 Test Battery.
Education Specialists.........  Child School                  48              14           20/60             224
                                 Record
                                 Abstraction
                                 Form.
Medical Record Specialists....  Medical Record               150              13           20/60             650
                                 Abstraction
                                 Form--Adult.
                                Medical Record                50              13           20/60             217
                                 Abstraction
                                 Form--Child.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           5,269
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-08150 Filed 4-22-19; 8:45 am]
BILLING CODE 4163-18-P