[Federal Register Volume 84, Number 246 (Monday, December 23, 2019)]
[Notices]
[Pages 70544-70547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27550]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[30Day-20-19ACF]
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 April 23, 2019 to obtain
comments from the public and affected agencies. ATSDR received two
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 or send an email to [email protected]. 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)--NEW--Agency for
[[Page 70545]]
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 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), as amended by Section 315
of the John S. McCain National Defense Authorization Act for Fiscal
Year 2019 (Pub. L. 115-232), authorized and appropriated funds for 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 across
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 builds on activities undertaken in preparing
and conducting the data collection for the proof-of-concept study at
the Pease International Tradeport in Portsmouth, New Hampshire (the
Pease Study) (OMB Control No. 0923-0061; expiration date 08/31/2022).
These 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. Based on peer reviewer and OMB comments on
the Pease Study, the Multi-site Study protocol now includes additional
data analyses to address potential biases such as selection bias and
confounding.
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). Seven research recipients have been
selected: 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.
The Multi-site Study is designed to aggregate data across all
recipient sites and is designed to compare data between 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.
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.
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.
If feasible, 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 their recruitment efforts. In addition, the
recipients should engage community organizations to assist in
conducting outreach about the study and
[[Page 70546]]
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 approximately 9,100 participants
(7,000 adults and 2,100 children and their parents) from communities
exposed to PFAS-contaminated drinking water over the first three years
of the five-year cooperative agreement program. 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).
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 industry using PFAS
chemicals in its manufacturing process). Likewise, children whose birth
mothers were occupationally exposed will not be eligible.
Assuming a 95 percent eligibility rate and a 40 percent 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. 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 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 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 Study (OMB Control No. 0923-0061; expiration date 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 record
abstractions across all study sites. The annual time burden for medical
and educational record abstraction is estimated to be 2,490 hours.
The total annualized time burden requested is 7,960 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)
----------------------------------------------------------------------------------------------------------------
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 Record 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.
----------------------------------------------------------------------------------------------------------------
[[Page 70547]]
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-27550 Filed 12-20-19; 8:45 am]
BILLING CODE 4163-18-P