[Federal Register Volume 88, Number 92 (Friday, May 12, 2023)]
[Notices]
[Pages 30747-30749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10189]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-23-0063]


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 Per- and Polyfluoroalkyl Substances (PFAS): 
A Multi-site Cross-sectional Study (The Multi-site 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 January 11, 2023, to obtain 
comments from the public and affected agencies ATSDR did not receive 
comments related to the previous notice. 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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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): A Multi-site Cross-sectional Study 
(The Multi-site Study) (OMB Control No. 0923-0063, Exp. Date 05/31/
2023)-Revision--Agency for Toxic Substances and Disease Registry 
(ATSDR).

Background and Brief Description

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
requesting a three-year Revision of the Paperwork Reduction Act (PRA) 
Information Collection Request (ICR) titled ``Human Health Effects of 
Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS): 
A Multi-site Cross-sectional Study (The Multi-site Study)'' (OMB 
Control No. 0923-0063, Exp. Date 05/31/2023).
    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 sixty million residents were served by 
66 public water supplies that had at least one sample at or above the 
U.S. 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), as amended by section 315 
of the John S. McCain National Defense Authorization Act for Fiscal 
Year 2019 (Pub. L. 115-232), first authorized and appropriated funds 
for ATSDR to conduct this study on the human health effects of PFAS 
contamination in drinking water. The existence of widespread 
contamination at many sites across the U.S. makes this a paramount 
effort in addressing the health effects of exposures to PFAS from 
contaminated drinking water. Currently, the study is funded through 
section 337 of the William M. (Mac) Thornberry National Defense 
Authorization Act for fiscal years 2019 through 2023 (Pub. L. 116-283).
    The Multi-site Study builds on research methods and activities 
developed for the proof-of-concept study at the Pease International 
Tradeport in Portsmouth, New Hampshire (the Pease Study) (OMB Control 
No. 0923-0061; Discontinued 08/31/2022). These methods and activities 
included developing data management systems and community engagement 
materials, modifying the childhood neurobehavioral test battery, 
adjusting blood collection volume, and modifying data collection 
materials such as the childhood questionnaire and medical records 
abstraction forms.
    ATSDR is conducting this cooperative research program under Notice 
of Funding Opportunity (NOFO) No. CDC-RFA-TS-19-002, titled ``Multi-
site Study of the Health Implications of Exposure to PFAS-Contaminated 
Drinking Water.'' The seven research recipients are University of 
Colorado School of Public Health, Michigan State Department of Health 
and Human Services, Pennsylvania Department of Health and RTI 
International, Rutgers School of Public Health, Silent Spring 
Institute, SUNY at Albany and the New York State Department of Health, 
and the University of California at Irvine.
    Under the cooperative agreement, each recipient proposed candidate 
study sites at communities whose drinking water was impacted by AFFF 
use or by industrial PFAS releases. Site selection considered the 
documented levels of PFAS drinking water concentrations. The aim was to 
include sites so that a

[[Page 30748]]

wide range in PFAS exposures levels were 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 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.
    The Multi-site Study is designed to aggregate data across all 
recipient sites. The main goal of this cross-sectional 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.
    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 is reconstructing historic serum PFAS 
concentrations. This is being 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. Over the first three years of the five-year 
cooperative agreement program, the recipients have prepared working 
group support documents describing the methods used by sites for the 
historical reconstruction and for the whole consortium for the PBPK 
modeling. Both documents are undergoing external peer review as 
required by ATSDR.
    If feasible, each recipient is identifying and enumerating 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. ATSDR estimates that up to 14 public 
water purveyors will spend 10 hours each to retrieve lists of 
households they serve per year (n=140 hours total). 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. ATSDR estimates that up to seven 
environmental protection agencies will spend seven hours each to 
retrieve lists of households with contaminated private wells per year 
(n=49 hours total).
    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 can use 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 their recruitment efforts. In addition, the 
recipients 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 cumulatively enroll approximately 9,100 
participants (7,000 adults and 2,100 children and their parents) from 
communities exposed to PFAS-contaminated drinking water. In total, each 
recipient will attempt to meet a target recruitment of 1,000 adults and 
300 children. Annualized estimates are 3,033 participants (2,333 adults 
and 700 children). Over the first three years of the five-year 
cooperative agreement program, the recipients have enrolled over 3,000 
adults and over 300 children (as of 03/08/2023). The child enrollment 
has been especially challenging during and following major closure and 
obstacles and of access to schools and other educational facilities due 
to the COVID-19 pandemic.
    To restrict this study to drinking water exposures, adults 
occupationally exposed to PFAS are not eligible for the study (e.g., 
firefighters or workers in an industry using PFAS chemicals in its 
manufacturing process). Likewise, children whose birth mothers were 
occupationally exposed will not be eligible.
    Assuming a 95% eligibility rate and a 40% response rate, ATSDR 
estimates that the recipients will screen 7,982 people (6,140 adults 
and 1,842 children) each year across all sites to recruit the target 
sample size of 3,033 participants (2,333 adults and 700 children), 
using an annual time burden of 1,330 hours. The recipients will provide 
appointment reminder calls for each eligible person who agrees to be 
enrolled (n=3,033 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=3,033 adults and 
700 children per year). Ideally, the parent will be the child's birth 
mother, as ATSDR will ask

[[Page 30749]]

details about the child's exposure, pregnancy, and breastfeeding 
history. For purposes of time burden estimation, ATSDR assumes that 20 
percent of parents (n=140 per year) will also enroll as adults and can 
take the child short form questionnaire; therefore, 560 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=700 per year). The time burden for responding to questionnaires is 
1,482 hours, and for neurobehavioral assessments is 1,225, 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 verify participants' medical 
conditions to confirm self-reported health outcomes. The recipient will 
also seek permission to obtain information from the children's school 
records to supplements their behavioral assessment results. Based on 
ATSDR's experience from the Pease Study (OMB Control No. 0923-0061; 
Discontinued 08/31/2022), ATSDR estimates that it will take 30 school 
administrators, 48 education specialists, 70 medical office 
administrators, and 150 adult and 50 pediatric medical record 
specialists to complete health condition and school information 
verification and abstractions across all study sites. The annual time 
burden for medical and educational record abstraction is estimated to 
be 2,506 hours.
    The total annualized time burden requested is 8,149 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)
----------------------------------------------------------------------------------------------------------------
Public Water Purveyors................  Drinking Water                        14               1              10
                                         Information Collection
                                         Form.
Environmental Protection Agencies.....  Drinking Water                         7               1               7
                                         Information Collection
                                         Form.
Multi-site Study Participants.........  Eligibility Screening              7,982               1           10/60
                                         Script.
                                        Appointment Reminder               3,033               1            5/60
                                         Telephone Script.
                                        Update Contact                     3,033               1            5/60
                                         Information Hardcopy
                                         Form.
                                        Medication List.........           3,033               1            3/60
                                        Body and Blood Pressure            3,033               1            5/60
                                         Measures Form.
                                        Blood Draw and Urine               3,033               1           10/60
                                         Collection Form.
                                        Adult Questionnaire.....           2,333               1           30/60
                                        Child Questionnaire--                560               1           30/60
                                         Long Form.
                                        Child Questionnaire--                140               1           15/60
                                         Short Form.
                                        Parent Neurobehavioral               700               1           15/60
                                         Test Battery.
                                        Child Neurobehavioral                700               1           90/60
                                         Test Battery.
Medical Office Administrators.........  Request for Medical                   70              43           20/60
                                         Record Abstraction.
Medical Records Specialists...........  Medical Record                       150              16           20/60
                                         Abstraction Form--Adult.
                                        Medical Record                        50              14           20/60
                                         Abstraction Form--Child.
School Administrators.................  Request for Child School              30              23           20/60
                                         Record Abstraction.
Education Specialists.................  Child School Record                   48              15           20/60
                                         Abstraction Form.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-10189 Filed 5-11-23; 8:45 am]
BILLING CODE 4163-70-P