Agency Forms Undergoing Paperwork Reduction Act Review, 70544-70547 [2019-27550]
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Federal Register / Vol. 84, No. 246 / Monday, December 23, 2019 / Notices
preserved. Accordingly, the
recordkeeping requirement associated
with these forms is contained in 17 CFR
404.4, which requires state member
banks and uninsured state branches or
state agencies of foreign banks, as well
as other institutions, to retain these
forms for three years after the financial
institution notifies its ARA that it has
ceased to function as a government
securities broker or dealer. Although
Treasury’s recordkeeping requirement
does not explicitly apply to foreign
banks, Edge corporations, or commercial
lending companies that are owned or
controlled by foreign banks, the Board
has the authority to ‘‘issue such rules
and regulations with respect to
transactions in government securities as
may be necessary to prevent fraudulent
and manipulative acts and practices and
to promote just and equitable principles
of trade’’ (15 U.S.C. 78o–5(b)(3)(A)).
Imposing a recordkeeping requirement
on foreign banks, Edge corporations,
and commercial lending companies
owned or controlled by foreign banks is
necessary for the public interest and
protection of investors in order to
ensure that the proper notification has
been provided when these institutions
are transacting in government securities
(15 U.S.C. 78o–5(a)(1)(B)). In addition,
the Board is authorized to impose a
recordkeeping requirement on foreign
banking organizations 5 (12 U.S.C.
3108), on Edge corporations (12 U.S.C.
625), and on commercial lending
companies that are owned or controlled
by foreign banks (12 U.S.C. 3106, as
applied through 12 U.S.C. 1844(c)).
The obligation to file the Form G–FIN
and Form G–FINW with the Board, and
the obligation for the government
securities broker or dealer to retain a
copy of the Form G–FIN and Form G–
FINW, is mandatory for those financial
institutions for which the Board serves
as the ARA, unless the financial
institution is exempt from the reporting
requirement under Treasury’s
regulations. The filing of these forms
and the records retention period is
event-generated.
Under the Act, each ARA is instructed
to make these forms available to the
SEC, and the SEC is instructed to make
the notices available to the public (15
U.S.C. 78o-5(a)(l)(B)(iii)). Thus, the
information collected on Form G–FIN
and Form G–FINW is ordinarily not
treated as confidential. However, given
5 A foreign banking organization is a foreign bank
that operates a branch, agency, or commercial
lending company subsidiary in the United States;
controls a bank in the United States; or controls an
Edge corporation acquired after March 5, 1987; and
any company of which the foreign bank is a
subsidiary.
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that Item 6 of Form G–FIN instructs the
filer to attach copies of the confidential
Form G–FIN–4, or if applicable, to
attach copies of any previously filed
confidential Form MSD–4 or
confidential Form U–4, these
attachments may be treated as
confidential under exemptions 4 and/or
6 of the Freedom of Information Act,
which protect, respectively, ‘‘trade
secrets and commercial or financial
information obtained from a person
[that is] privileged or confidential’’ and
information about individuals in
‘‘personnel and medical files and
similar files’’ when the disclosure of
such information ‘‘would constitute a
clearly unwarranted invasion of
personal privacy’’ (5 U.S.C. 552(b)(4)
and 5 U.S.C. 552(b)(6)).
Current actions: On August 29, 2019,
the Board published a notice in the
Federal Register (84 FR 45491)
requesting public comment for 60 days
on the extension, with revision, of the
Notice by Financial Institutions of
Government Securities Broker or
Government Securities Dealer Activities
and the Notice by Financial Institutions
of Termination of Activities as a
Government Securities Broker or
Government Securities Dealer (Form G–
FIN and Form G–FINW). The changes
proposed include revising the Form G–
FIN and Form G–FINW to (1) require
respondents to submit PDF versions of
the forms and any attachments to a
designated email address, and (2) to
correct cross-references on the following
forms: G–FIN–4, Form MSD–4, and
Form U–4, which are incorporated by
reference in Item 7 of the Form G–FIN.
The comment period for this notice
expired on October 28, 2019. One public
comment was received, but it was
outside the scope of the Board’s review
under the PRA.
Board of Governors of the Federal Reserve
System, December 17, 2019.
Michele Taylor Fennell,
Assistant Secretary of the Board.
[FR Doc. 2019–27600 Filed 12–20–19; 8:45 am]
BILLING CODE 6210–01–P
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
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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 omb@cdc.gov. 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
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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
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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 PFASContaminated 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 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.
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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.
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 PFAScontaminated 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
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Federal Register / Vol. 84, No. 246 / Monday, December 23, 2019 / Notices
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 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=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
Type of
respondents
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 ...............
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 .........
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Medical Office Administrators .........................
Medical Record Specialists .............................
School Administrators .....................................
Education Specialists ......................................
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Number of
respondents
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7,982
3,033
3,033
3,033
3,033
3,033
2,333
560
140
700
700
70
150
50
30
48
23DEN1
Number of
responses per
respondent
1
1
1
1
1
1
1
1
1
1
1
43
16
14
23
15
Average
burden per
response
(in hours)
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
20/60
20/60
Federal Register / Vol. 84, No. 246 / Monday, December 23, 2019 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substance and
Disease Registry
[60Day–20–0057; Docket No. ATSDR–19–
0009]
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 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 ‘‘APPLETREE
Performance Measures,’’ which ATSDR
will use to manage its next three-year
cooperative agreement program under
Notice of Funding Opportunity (NOFO)
No. CDC–RFA–TS20–2001.
DATES: ATSDR must receive written
comments on or before February 21,
2020.
ADDRESSES: You may submit comments,
identified by Docket No. ATSDR–2019–
0009 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
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SUMMARY:
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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–
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 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
APPLETREE Performance Measures
(OMB Control No. 0923–0057, Exp. 07/
31/2020)—Revision—Agency for Toxic
Substances and Disease Registry
(ATSDR).
Background and Brief Description
The Agency for Toxic Substances and
Disease Registry (ATSDR) seeks to build
and sustain the capacity to evaluate
exposures to hazardous waste across the
country. Releases from hazardous waste
sites are a major source of harmful
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70547
exposures in homes, schools,
workplaces, and communities. These
exposures are often complex and may be
difficult to identify and control.
Hazardous waste sites may involve
various toxic substances, exposure
pathways, and health impacts. ATSDR’s
primary goal is to keep communities
safe from harmful exposures and related
diseases. To accomplish this goal, the
agency works closely with partnering
agencies to evaluate exposures at
hazardous waste sites, educate
communities, and seek new ways to
better protect public health.
ATSDR’s Partnership to Promote
Local Efforts to Reduce Environmental
Exposure (APPLETREE) Program is
critical to ATSDR’s success in
accomplishing its mission in
communities nationwide. ATSDR’s
recipients will use APPLETREE funding
to advance ATSDR’s primary goal of
keeping communities safe from harmful
environmental exposures and related
diseases. APPLETREE gives recipients
the resources to build their capacity to
assess and respond to site-specific
issues involving human exposure to
hazardous substances in the
environment. APPLETREE helps
recipients identify exposure pathways at
specific sites; educate affected
communities about site contamination
and potential health effects; make
recommendations to prevent exposure;
review health outcome data to evaluate
potential links between site
contaminants and community health
outcomes. APPLETREE facilitates the
implementation of state-level programs
to ensure that potential early care and
education facilities are in areas free
from harmful environmental exposures.
It also encourages recipients in the
innovation of progressive public health
interventions that prevent exposures to
environmental contamination. Because
of APPLETREE recipients’ local
connections and partnerships,
community engagement and
implementation of recommendations is
improved. This program is authorized
under Sections 104(i)(15) of the
Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA) of 1980, as amended by
the Superfund Amendments and
Reauthorization Act (SARA) of 1986 [42
U.S.C. 9604(i)(15)].
Under the next three-year
APPLETREE cooperative agreement
(NOFO No. CDC–RFA–TS20–2001),
eligible applicants include federally
recognized American Indian/Alaska
Native tribal governments; American
Indian/Alaska native tribally designated
organizations; political subdivisions of
states (in consultation with states); and
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]]>Agencies
[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
