[Federal Register Volume 88, Number 7 (Wednesday, January 11, 2023)]
[Notices]
[Pages 1584-1587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00333]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60Day-23-0063; Docket No. ATSDR-2022-0007]


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 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 March 13, 2023.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2022-0007 by either of the following methods:

[[Page 1585]]

     Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. ATSDR will post, without change, all relevant 
comments to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118; 
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;
    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; and
    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) (OMB Control No. 0923-0063, Exp. 5/31/2023)--
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 60 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., 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 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

[[Page 1586]]

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 that 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 ten 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 11/17/2022). The enrollment of 
children has been especially challenging during and following major 
closures and 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., 
ever firefighters or ever 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 in order 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. Recipients 
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 details about the child's exposure, 
pregnancy, and breastfeeding history. For purposes of time burden 
estimation, ATSDR assumes that 20% 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

[[Page 1587]]

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. Recipients will 
also seek permission to obtain information from the children's school 
records to supplement 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 2,490 hours.
    ATSDR is revising and updating portions of the protocol related to 
PFAS analytes. ATSDR has no plans to revise the previously approved 
data collection forms, nor the annual number of burden hours (n=8,149), 
respondents (n=27,949), and responses (n=35,121). 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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Public Water Purveyors........  Drinking Water                14               1              10             140
                                 Information
                                 Collection Form.
Environmental Protection        Drinking Water                 7               1               7              49
 Agencies.                       Information
                                 Collection Form.
Multi-site Study Participants.  Eligibility                7,982               1           10/60           1,330
                                 Screening
                                 Script.
                                Appointment                3,033               1            5/60             253
                                 Reminder
                                 Telephone
                                 Script.
                                Update Contact             3,033               1            5/60             253
                                 Information
                                 Hardcopy Form.
                                Medication List.           3,033               1            3/60             152
                                Body and Blood             3,033               1            5/60             253
                                 Pressure
                                 Measures Form.
                                Blood Draw and             3,033               1           10/60             506
                                 Urine
                                 Collection Form.
                                Adult                      2,333               1           30/60           1,167
                                 Questionnaire.
                                Child                        560               1           30/60             280
                                 Questionnaire--
                                 Long Form.
                                Child                        140               1           15/60              35
                                 Questionnaire--
                                 Short Form.
                                Parent                       700               1           15/60             175
                                 Neurobehavioral
                                 Test Battery.
                                Child                        700               1           90/60           1,050
                                 Neurobehavioral
                                 Test Battery.
Medical Office Administrators.  Request for                   70              43           20/60           1,003
                                 Medical Record
                                 Abstraction.
Medical Records Specialists...  Medical Record               150              16           20/60             800
                                 Abstraction
                                 Form--Adult.
                                Medical Record                50              14           20/60             233
                                 Abstraction
                                 Form--Child.
School Administrators.........  Request for                   30              23           20/60             230
                                 Child School
                                 Record
                                 Abstraction.
Education Specialists.........  Child School                  48              15           20/60             240
                                 Record
                                 Abstraction
                                 Form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           8,149
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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. 2023-00333 Filed 1-10-23; 8:45 am]
BILLING CODE 4163-70-P