Proposed Data Collection Submitted for Public Comment and Recommendations, 1584-1587 [2023-00333]
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Federal Register / Vol. 88, No. 7 / Wednesday, January 11, 2023 / Notices
Chief of Staff, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS H21–10, Atlanta, Georgia
30329–4027, Telephone: (404) 639–
0390; Email Address: ACDirector@
cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The Advisory Committee to
the Director (ACD), CDC, shall advise
the Secretary, HHS, and the Director,
CDC, on policy and broad strategies that
will enable CDC to fulfill its mission of
protecting health through health
promotion, prevention, and
preparedness. The committee
recommends ways to prioritize CDC’s
activities, improve results, and address
health disparities. It also provides
guidance to help CDC work more
effectively with its various private and
public sector constituents to make
health protection a practical reality.
Matters To Be Considered: The
agenda will include discussions on
CDC’s current work and priorities as
they relate to health equity and data and
surveillance recommendations to the
Department of Health and Human
Services and CDC Director. The agenda
also includes a laboratory workgroup
update with recommended action steps
to the full ACD Committee, along with
an update on the public health
infrastructure grant. Agenda items are
subject to change as priorities dictate.
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Public Participation
Interested persons or organizations
are invited to participate by submitting
written views, recommendations, and
data. Please note that comments
received, including attachments and
other supporting materials, are part of
the public record and are subject to
public disclosure. Comments will be
posted on https://www.regulations.gov.
Therefore, do not include any
information in your comment or
supporting materials that you consider
confidential or inappropriate for public
disclosure. If you include your name,
contact information, or other
information that identifies you in the
body of your comments, that
information will be on public display.
CDC will review all submissions and
may choose to redact, or withhold,
submissions containing private or
proprietary information such as Social
Security numbers, medical information,
inappropriate language, or duplicate/
near duplicate examples of a mass-mail
campaign. CDC will carefully consider
all comments submitted into the docket.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
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delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2023–00408 Filed 1–10–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
BILLING CODE 4163–18–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
RFA–IP–23–001, Public Health
Epidemiology, Prevention and Control
of Influenza and Other Respiratory
Pathogens in China, RFA–IP–23–004,
Developing, Implementing, and
Evaluating Protocols to Increase Routine
Adult Immunization Coverage Among
Persons Who are Incarcerated, and
RFA–IP–23–005, Approach to Adult
Vaccine Counseling.
Date: April 11–12, 2023.
Time: 10 a.m.–5 p.m., EDT.
Place: Teleconference, Centers for
Disease Control and Prevention, Room
1077, 8 Corporate Boulevard, Atlanta,
Georgia 30329.
Agenda: To review and evaluate grant
applications.
For Further Information Contact:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, National
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Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2023–00242 Filed 1–10–23; 8:45 am]
Notice of Closed Meeting
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Center for HIV, Viral Hepatitis, STD,
and TB Prevention, CDC, 1600 Clifton
Road NE, Mailstop US8–1, Atlanta,
Georgia 30329–4027; Telephone: (404)
718–8833; Email: GAnderson@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
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 for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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 Crosssectional 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:
SUMMARY:
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Federal Register / Vol. 88, No. 7 / Wednesday, January 11, 2023 / Notices
• 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: 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 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,
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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 Crosssectional 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
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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 exposureresponse 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
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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 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. 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
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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 exposureresponse 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
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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
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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
Form name
Public Water Purveyors .............
Education Specialists ................
Drinking Water Information Collection
Form.
Drinking Water Information Collection
Form.
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 .........
Request for Medical Record Abstraction
Medical Record Abstraction Form—Adult
Medical Record Abstraction Form—Child
Request for Child School Record Abstraction.
Child School Record Abstraction Form ...
Total ...................................
..................................................................
Environmental Protection Agencies.
Multi-site Study Participants ......
Medical Office Administrators ...
Medical Records Specialists .....
School Administrators ...............
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2022–N–3351]
Authorization of Emergency Use of an
In Vitro Diagnostic Device in Response
to an Outbreak of Mpox; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
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Number of
responses per
respondent
Number of
respondents
Type of respondents
Frm 00032
Fmt 4703
Total burden
(in hours)
14
1
10
140
7
1
7
49
7,982
3,033
3,033
1
1
1
10/60
5/60
5/60
1,330
253
253
3,033
3,033
1
1
3/60
5/60
152
253
3,033
2,333
560
140
700
700
70
150
50
30
1
1
1
1
1
1
43
16
14
23
10/60
30/60
30/60
15/60
15/60
90/60
20/60
20/60
20/60
20/60
506
1,167
280
35
175
1,050
1,003
800
233
230
48
15
20/60
240
........................
........................
........................
8,149
announcing the issuance of an
Emergency Use Authorization (EUA)
(the Authorization) under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) in response to an outbreak of mpox.
FDA has issued an Authorization for an
in vitro diagnostic device as requested
by Life Technologies Corporation (a part
of Thermo Fisher Scientific Inc.). The
Authorization contains, among other
things, conditions on the emergency use
of the authorized product. The
Authorization follows the August 9,
2022, determination by the Secretary of
Health and Human Services (HHS) that
there is a public health emergency, or a
significant potential for a public health
emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
U.S. citizens living abroad, and that
involves monkeypox virus. On the basis
of such determination, the Secretary of
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burden per
response
(in hours)
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HHS declared, on September 7, 2022,
that circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection and/or
diagnosis of infection with the
monkeypox virus, including in vitro
diagnostics that detect and/or diagnose
infection with non-variola
Orthopoxvirus, pursuant to the FD&C
Act, subject to terms of any
authorization issued under that section.
The Authorization, which includes an
explanation of the reasons for issuance,
is reprinted in this document.
DATES: The Authorization is effective as
of December 13, 2022.
ADDRESSES: Submit written requests for
a single copy of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
