Appendix B: 60-day Federal Register Notice

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Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Notices
ATSDR will collect urine samples
pre- and post-activity. The urine
samples will be analyzed for
polyaromatic hydrocarbons and will
also be archived in case of future

development of new analytical methods
for potential chemicals of interest.
The research study will screen a total
of 220 participants for eligibility. The
target sample size is 150 for synthetic
turf field users and is 50 for the natural

grass field users. The total burden hours
for the research study is 184 hours
among all of the 220 respondents. There
is no cost to the respondents other than
their time in the study.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Adult/Adolescent Field Users ..........................

Eligibility Screening Form ..............................
Adult and Adolescent Questionnaire .............
Exposure Measurement Form .......................
Eligibility Screening Form ..............................
Youth and Child Questionnaire ......................
Exposure Measurement Form .......................

Parents/Guardians of Youth/Child Field Users
Youth/Child Field Users ..................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–08147 Filed 4–22–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substance and
Disease Registry
[60-Day–19–19ACF; Docket No. ATSDR–
2019–0004]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).

AGENCY:

ACTION:

Notice with comment period.

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 proposed and/or
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.

SUMMARY:

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Number of
respondents

Type of respondents

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ATSDR must receive written
comments on or before June 24, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. ATSDR–2019–
0004 by any of the following methods:
• Federal eRulemaking Portal:
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–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. ATSDR will post,
without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(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 Jeffery M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
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
DATES:

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Number of
responses per
respondent

110
100
100
110
100
100

Average
burden per
response
(in hrs.)

1
1
1
1
1
1

5/60
30/60
20/60
5/60
30/60
20/60

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; and
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.
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)—NEW—Agency for
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

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Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Notices

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) authorized 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 around 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 will build on the
preceding proof-of-concept study at the
Pease International Tradeport in
Portsmouth, New Hampshire.
ATSDR will conduct this research
using a cooperative agreement titled
‘‘Multi-site Study of the Health
Implications of Exposure to PFASContaminated Drinking Water’’ (Notice
of Funding Opportunity [NOFO] No.
CDC–RFA–TS–19–002). The expected
number of research recipients (e.g.,
entities selected for funding) is six. The
program will be administered by the
CDC Extramural Research Program
Office (ERPO) at the National Center for
Injury Prevention and Control (NCIPC).
The research under this cooperative
agreement will be a two-part program.
First, a mandatory core research
protocol for all recipients is designed to
aggregate data across all sites and
designed to compare data between sites.
Next, each recipient will have the
option to propose additional
investigator-initiated research questions
and hypotheses related to the overall
goals of this NOFO.

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The main goal of this cross-sectional
multi-site 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 shall propose candidate
study sites at communities whose
drinking water was impacted by AFFF
use or by industrial PFAS emissions.
Site selection will consider the
documented levels of PFAS drinking
water concentrations. The aim will be to
include sites so that a wide range in
PFAS exposures levels are 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
system 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 halflives 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.
Each recipient shall identify and
enumerate all households served by the

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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 its
recruitment efforts. In addition, the
recipient 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 enroll at least
8,000 participants (6,000 adults and
2,000 children and their parents) from
communities exposed to PFAScontaminated drinking water over the
first three years of the five-year
cooperative agreement program.
Annualized estimates are 2,667
participants (2,000 adults and 667
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

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Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Notices
industry using PFAS chemicals in its
manufacturing process). Likewise,
children whose birth mothers were
occupationally exposed will not be
eligible. ATSDR assumes that 5 percent
of the people who volunteer will not
meet eligibility requirements; therefore,
a total of 8,400 people will be screened.
To complete the data collection in three
years, annualized estimates for
eligibility screening are 2,800 people
(2,100 adults and 700 children) and an
annual time burden of 467 hours. The
recipients will provide appointment
reminder calls for each eligible person
who agrees to be enrolled (n = 2,667 per
year) for a time burden of 222 hours 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 interlaboratory 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=2,000 adults and 667 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 will also enroll as
adults and can take the child short form
questionnaire (n=133 per year);
therefore, 534 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=667 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 proof of
concept study, ATSDR estimates that it
will take 48 education specialists and
150 adult and 50 pediatric medical
record specialists to complete record
abstractions across all study sites. Given
the goal to enroll at least 2,000 adults
and 667 children per year, the annual
time burden for medical and
educational record abstraction is
estimated to be 1,091 hours.
The total annualized time burden
requested is 5,269 hours. There is no
cost to the respondents other than their
time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Multi-site Study Participants ..............................

Eligibility Screening Script ................................
Appointment Reminder Telephone Script .........
Update Contact Information Hardcopy Form ....
Medication List ..................................................
Body and Blood Pressure Measures Form ......
Blood Draw and Urine Collection Form ............
Adult Questionnaire ..........................................
Child Questionnaire—Long Form .....................
Child Questionnaire—Short Form .....................
Parent Neurobehavioral Test Battery ...............
Child Neurobehavioral Test Battery ..................
Child School Record Abstraction Form ............
Medical Record Abstraction Form—Adult ........
Medical Record Abstraction Form—Child ........

2,800
2,667
2,667
2,667
2,667
2,667
2,000
537
133
667
667
48
150
50

1
1
1
1
1
1
1
1
1
1
1
14
13
13

10/60
5/60
5/60
3/60
5/60
10/60
30/60
30/60
15/60
15/60
90/60
20/60
20/60
20/60

467
222
222
133
222
444
1,000
268
33
167
1,000
224
650
217

...........................................................................

........................

........................

........................

5,269

Education Specialists ........................................
Medical Record Specialists ...............................
Total ............................................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–08150 Filed 4–22–19; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

BILLING CODE 4163–18–P

[60-Day–19–0457; Docket No. CDC–2019–
0032]

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Number of
responses per
respondent

Type of respondents

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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The Centers for Disease
Control and Prevention (CDC), 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 proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on
Aggregate Reports for Tuberculosis
Program Evaluation. The goal of the
study is to allow CDC to collect and
monitor indicators for key program
activities, such as finding tuberculosis
infections in recent contacts of cases

SUMMARY:

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