Notice2023-10189
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 12, 2023
Issuing agencies
Health and Human Services DepartmentAgency for Toxic Substances and Disease Registry
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 92 (Friday, May 12, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 92 (Friday, May 12, 2023)]
[Notices]
[Pages 30747-30749]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-10189]
-----------------------------------------------------------------------
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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
</pre></body>
</html>Indexed from Federal Register on May 12, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.