[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.
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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