Proposed Data Collection Submitted for Public Comment and Recommendations, 43685-43687 [2018-18446]
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Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices
that consumer reporting agencies will
use third-party contractors (instead of
their own employees) to increase the
capacity of their systems. Because of the
way these contracts are typically
established, these costs will likely be
incurred on a continuing basis, and will
be calculated based on the number of
requests handled by the systems. Staff
estimates that the total annual amount
to be paid for services delivered under
these contracts is $13,919,400.9
H. Net Burden for FTC, After 50:50 Split
After halving the updated estimates to
split the PRA burden with the CFPB
regarding the Rule, the FTC’s burden
totals are 214,538 hours, $4,246,441 in
associated labor costs, and $6,959,700 in
non-labor/capital costs.
amozie on DSK3GDR082PROD with NOTICES1
Request for Comments
You can file a comment online or on
paper. For the FTC to consider your
comment, we must receive it on or
before October 26, 2018. Write
‘‘Paperwork Reduction Act: FTC File
No. P072108’’ on your comment. Your
comment—including your name and
your state—will be placed on the public
record of this proceeding, including, to
the extent practicable, on the public
Commission website, at https://
www.ftc.gov/policy/public-comments.
Postal mail addressed to the
Commission is subject to delay due to
heightened security screening. As a
result, we encourage you to submit your
comments online. To make sure that the
Commission considers your online
comment, you must file it at https://
ftcpublic.commentworks.com/ftc/
regulationVsubpartNpra by following
the instructions on the web based form.
If this Notice appears at https://
www.regulations.gov, you also may file
a comment through that website.
If you file your comment on paper,
write ‘‘Paperwork Reduction Act: FTC
File No. P072108’’ on your comment
and on the envelope, and mail it to the
following address: Federal Trade
Commission, Office of the Secretary,
600 Pennsylvania Avenue NW, Suite
CC–5610 (Annex J), Washington, DC
20580, or deliver your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW,
5th Floor, Suite 5610 (Annex J),
Washington, DC 20024. If possible,
submit your paper comment to the
9 This consists of an estimated $9,302,400 for
automated telephone cost ($1.36 per request × 6.84
million requests) and an estimated $4,617,000
($0.15 per request × 30.78 million requests) for
internet web service cost. Per unit cost estimates are
based on staff’s knowledge of the industry.
VerDate Sep<11>2014
17:51 Aug 24, 2018
Jkt 244001
Commission by courier or overnight
service.
Because your comment will be placed
on the publicly accessible FTC website
at https://www.ftc.gov, you are solely
responsible for making sure that your
comment does not include any sensitive
or confidential information. In
particular, your comment should not
include any sensitive personal
information, such as your or anyone
else’s Social Security number; date of
birth; driver’s license number or other
state identification number, or foreign
country equivalent; passport number;
financial account number; or credit or
debit card number. You are also solely
responsible for making sure that your
comment does not include any sensitive
health information, such as medical
records or other individually
identifiable health information. In
addition, your comment should not
include any ‘‘trade secret or any
commercial or financial information
which . . . . is privileged or
confidential’’—as provided by Section
6(f) of the FTC Act, 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—
including in particular competitively
sensitive information such as costs,
sales statistics, inventories, formulas,
patterns, devices, manufacturing
processes, or customer names.
Comments containing material for
which confidential treatment is
requested must be filed in paper form,
must be clearly labeled ‘‘Confidential,’’
and must comply with FTC Rule 4.9(c).
In particular, the written request for
confidential treatment that accompanies
the comment must include the factual
and legal basis for the request, and must
identify the specific portions of the
comment to be withheld from the public
record. See FTC Rule 4.9(c). Your
comment will be kept confidential only
if the General Counsel grants your
request in accordance with the law and
the public interest. Once your comment
has been posted on the public FTC
website—as legally required by FTC
Rule 4.9(b)—we cannot redact or
remove your comment from the FTC
website, unless you submit a
confidentiality request that meets the
requirements for such treatment under
FTC Rule 4.9(c), and the General
Counsel grants that request.
Visit the Commission website at
https://www.ftc.gov to read this Notice.
The FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before October 26, 2018. You can find
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43685
more information, including routine
uses permitted by the Privacy Act, in
the Commission’s privacy policy, at
https://www.ftc.gov/site-information/
privacy-policy.
Heather Hippsley,
Acting Principal Deputy General Counsel.
[FR Doc. 2018–18448 Filed 8–24–18; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substance and
Disease Registry
[60Day–18–18AUZ; Docket No. ATSDR–
2018–0008]
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:
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 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) at Pease International Tradeport,
Portsmouth, NH (The Pease 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 in this New Hampshire
community.
DATES: ATSDR must receive written
comments on or before October 26,
2018.
You may submit comments,
identified by Docket No. ATSDR–2018–
0008 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
ADDRESSES:
E:\FR\FM\27AUN1.SGM
27AUN1
amozie on DSK3GDR082PROD with NOTICES1
43686
Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices
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 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) at
VerDate Sep<11>2014
17:51 Aug 24, 2018
Jkt 244001
Pease International Tradeport,
Portsmouth, NH (The Pease Study)—
NEW—Agency for Toxic Substances and
Disease Registry (ATSDR).
Background and Brief Description
Per- and polyfluoroalkyl substances
(PFAS) are a family of environmentally
and biologically persistent chemicals
used in industrial applications such as
aqueous film-forming foam (AFFF),
used to extinguish flammable liquid
fires. Since the 1970s, military bases in
the U.S. have used AFFF with PFAS
constituents for firefighting training as
well as to extinguish fires. At some
military bases, AFFF use has resulted in
the migration of PFAS chemicals
through soils to ground water and/or
surface water sources of drinking water
for bases and/or surrounding
communities. In 2016, the U.S.
Environmental Protection Agency
(USEPA) issued a lifetime health
advisory level of 0.07 total micrograms
of perfluorooctanoate (PFOA) and
perfluorooctane sulfonate (PFOS)
combined per liter of drinking water
(mg/L). In response to growing
awareness of the extent of PFAS
contamination across the U.S., Section
8006 of the Consolidated
Appropriations Act, 2018, 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.
In response, ATSDR is requesting a
three-year Paperwork Reduction Act
(PRA) clearance for the Pease Study,
which will serve as a proof-of-concept
model for a national multi-site study of
PFAS health effects. The existence of a
large body of state and local
environmental monitoring and
population blood testing data makes the
Pease community in Portsmouth, NH,
particularly suitable as ATSDR’s initial
PFAS research study site. From
approximately 1970 until 1991, the Air
Force used AFFF for firefighting and
training at Pease Air Force Base. The
base closed in 1991, and was converted
to a large business and aviation
industrial park in 1993, the Pease
International Tradeport. In 2014, PFAS
drinking water concentrations were
detected (0.35 mg/L PFOA and 2.4 mg/L
PFOS) at levels well above what was to
become the USEPA lifetime health
advisory level (0.07 mg/L PFOA/PFOS).
In 2015–7, the New Hampshire
Department of Health and Human
Services (NH DHHS) offered a PFAS
blood testing program to the
community. The blood testing program
showed that the Pease population had
concentrations of some types of PFAS
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
that were two to three times higher than
national estimates.
The Pease Study will be crosssectional in design, drawing from a
convenience sample of people with and
without exposure to PFAScontaminated drinking water from
Pease. The main goals of the study are
to: (1) Evaluate the study procedures
and methods to identify any issues that
need to be addressed before embarking
on a national multi-site study; and (2)
examine associations between health
outcomes and measured and historically
reconstructed serum levels of PFAS.
ATSDR will examine the association
between PFAS compounds and 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, ATSDR
will investigate if PFAS is related to
differences in sex hormones and sexual
maturation, vaccine response, and
neurobehavioral outcomes in children.
In adults, additional outcomes of
interest include cardiovascular disease,
osteoarthritis, osteoporosis,
endometriosis, and autoimmune
disease. Adults will be 18 years or older,
and children will be 4–17 years of age
at enrollment.
In total, ATSDR seeks to enroll 1,625
participants (1,100 adults and 525
children and their parents). Annualized
estimates are 542 participants (367
adults and 175 children).
For the exposure group (n=1,350),
ATSDR will enroll 1,000 adults and 350
children. Annualized estimates are 450
exposed participants (333 adults and
117 children). Eligible participants had
to work at, live on, or attend childcare
at the former Pease Air Force Base or the
Pease International Tradeport, or live in
a nearby home that was served by a
PFAS-contaminated private well.
Drinking water exposures must have
occurred at some time between 2004
and May 2014, after which remediation
of the public water supply occurred.
For the referent group (n=275),
ATSDR will enroll 100 adults and 175
children. Annualized estimates are 92
referent participants (34 adults and 58
children). Eligible participants, never
exposed to PFAS-contaminated drinking
water from Pease, will come from other
areas of Portsmouth, NH. Birth mothers
of referent children likewise must never
have had PFAS drinking water
exposure.
ATSDR will recruit, screen for
eligibility, and enroll in three waves.
The exposure group will be recruited in
Waves One and Two. ATSDR estimates
that 90% of the exposure group will be
E:\FR\FM\27AUN1.SGM
27AUN1
43687
Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices
enrolled in Wave 1 (n=1,215, or 405 per
year), that is, will be past participants of
the 2015–7 NH DHHS PFAS blood
testing program. NH DHHS will assist
ATSDR by sending out letters of
invitation to its former blood testing
program participants. To achieve the
desired sample size, the other 10
percent of the exposure group (n=135,
or 45 per year) will be recruited in Wave
2. These will be people who were
eligible for the PFAS blood testing
program but did not take part. The
referent group will be recruited in Wave
Three (n=275, or 92 per year), which
can occur concurrently with Wave 1 and
Wave 2. Wave 2 and Wave 3 recruits
will call to volunteer after ATSDR opens
those waves to enrollment.
To restrict this study to drinking
water exposures, any adult
occupationally exposed to PFAS will
not be eligible for the study (i.e. ever
firefighters or in chemical manufacture).
Likewise, children whose birth mothers
were occupationally exposed will not be
eligible. This restriction applies to both
enroll as adults; therefore, 420 parents
will take the child questionnaire long
form (n=140 per year), while 105
parents will take the short form to
reduce burden (n=35 per year). Parents
and children will also complete
assessments of the child’s attention and
behaviors. After eligibility screening,
the annual time burden for participation
in the study is 58 hours for adults and
208 hours for children and their parents.
ATSDR will ask for permission to
compare adults’ and children’s medical
histories with their medical records.
ATSDR will also ask for permission to
check children’s school records to
compare their behavioral assessment
results. The annual time burden for
medical and educational record
abstraction is estimated to be 125 hours
for adult records and 118 hours for
children’s records.
The total annualized time burden
requested is 1,189 hours. There is no
cost to the respondents other than their
time.
the exposure and the referent group.
ATSDR assumes that 5% of the people
who volunteer will not meet eligibility
requirements. ATSDR will screen the
1,578 people from the NH DHHS PFAS
blood testing program in Wave One
(n=526 per year). ATSDR will screen at
least 142 exposed people in Wave 2 (or
47 per year), and at least 289 unexposed
people in Wave 3 (or 96 per year). This
will require an annual time burden of
124 hours for eligibility screening.
At enrollment, ATSDR will obtain
adult consent, parental permission, and
child assent before data collection
begins. Each child will enroll with a
parent, who ideally will be the child’s
birth mother, as ATSDR will ask details
about the child’s exposure, pregnancy,
and breastfeeding history.
For each participant, ATSDR will take
body measures, collect blood and urine
samples for chemical and biomarker
analysis, and administer a questionnaire
on exposures and medical history. For
purposes of burden estimation, ATSDR
assumes that 20% of parents will also
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Pease Study Participants
Wave One Eligibility Screening Script .................
Wave Two Eligibility Screening Script .................
Wave Three 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 ...........
526
47
96
542
542
542
542
542
367
140
35
175
175
15
25
1
1
1
1
1
1
1
1
1
1
1
1
1
12
15
10/60
15/60
15/60
5/60
5/60
3/60
5/60
10/60
30/60
30/60
15/60
15/60
90/60
20/60
20/60
88
12
24
45
45
27
45
90
184
70
9
44
263
60
125
Medical Record Abstraction Form—Child ...........
25
7
20/60
58
..............................................................................
........................
........................
........................
1,189
Education Specialists ....
Medical Record Specialists.
Total ........................
amozie on DSK3GDR082PROD with NOTICES1
Number of
respondents
Type of respondents
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–18446 Filed 8–24–18; 8:45 am]
[CDC–2017–0104; Docket Number NIOSH–
304]
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
Final National Occupational Research
Agenda for Traumatic Injury
Prevention
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
AGENCY:
VerDate Sep<11>2014
17:51 Aug 24, 2018
Jkt 244001
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Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION:
Notice of availability.
SUMMARY: NIOSH announces the
availability of the final National
Occupational Research Agenda for
Traumatic Injury Prevention.
The final document was
published on August 20, 2018 on the
CDC website.
DATES:
The document may be
obtained at the following link: https://
ADDRESSES:
E:\FR\FM\27AUN1.SGM
27AUN1
]]>Agencies
- DEPARTMENT OF HEALTH AND HUMAN SERVICES
- Agency for Toxic Substance and Disease Registry
[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)]
[Notices]
[Pages 43685-43687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18446]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substance and Disease Registry
[60Day-18-18AUZ; Docket No. ATSDR-2018-0008]
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 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)
at Pease International Tradeport, Portsmouth, NH (The Pease 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 in this
New Hampshire community.
DATES: ATSDR must receive written comments on or before October 26,
2018.
ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2018-0008 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
[[Page 43686]]
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:
[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; 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) at Pease International Tradeport,
Portsmouth, NH (The Pease Study)--NEW--Agency for Toxic Substances and
Disease Registry (ATSDR).
Background and Brief Description
Per- and polyfluoroalkyl substances (PFAS) are a family of
environmentally and biologically persistent chemicals used in
industrial applications such as aqueous film-forming foam (AFFF), used
to extinguish flammable liquid fires. Since the 1970s, military bases
in the U.S. have used AFFF with PFAS constituents for firefighting
training as well as to extinguish fires. At some military bases, AFFF
use has resulted in the migration of PFAS chemicals through soils to
ground water and/or surface water sources of drinking water for bases
and/or surrounding communities. In 2016, the U.S. Environmental
Protection Agency (USEPA) issued a lifetime health advisory level of
0.07 total micrograms of perfluorooctanoate (PFOA) and perfluorooctane
sulfonate (PFOS) combined per liter of drinking water ([micro]g/L). In
response to growing awareness of the extent of PFAS contamination
across the U.S., Section 8006 of the Consolidated Appropriations Act,
2018, 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.
In response, ATSDR is requesting a three-year Paperwork Reduction
Act (PRA) clearance for the Pease Study, which will serve as a proof-
of-concept model for a national multi-site study of PFAS health
effects. The existence of a large body of state and local environmental
monitoring and population blood testing data makes the Pease community
in Portsmouth, NH, particularly suitable as ATSDR's initial PFAS
research study site. From approximately 1970 until 1991, the Air Force
used AFFF for firefighting and training at Pease Air Force Base. The
base closed in 1991, and was converted to a large business and aviation
industrial park in 1993, the Pease International Tradeport. In 2014,
PFAS drinking water concentrations were detected (0.35 [micro]g/L PFOA
and 2.4 [micro]g/L PFOS) at levels well above what was to become the
USEPA lifetime health advisory level (0.07 [micro]g/L PFOA/PFOS). In
2015-7, the New Hampshire Department of Health and Human Services (NH
DHHS) offered a PFAS blood testing program to the community. The blood
testing program showed that the Pease population had concentrations of
some types of PFAS that were two to three times higher than national
estimates.
The Pease Study will be cross-sectional in design, drawing from a
convenience sample of people with and without exposure to PFAS-
contaminated drinking water from Pease. The main goals of the study are
to: (1) Evaluate the study procedures and methods to identify any
issues that need to be addressed before embarking on a national multi-
site study; and (2) examine associations between health outcomes and
measured and historically reconstructed serum levels of PFAS. ATSDR
will examine the association between PFAS compounds and 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,
ATSDR will investigate if PFAS is related to differences in sex
hormones and sexual maturation, vaccine response, and neurobehavioral
outcomes in children. In adults, additional outcomes of interest
include cardiovascular disease, osteoarthritis, osteoporosis,
endometriosis, and autoimmune disease. Adults will be 18 years or
older, and children will be 4-17 years of age at enrollment.
In total, ATSDR seeks to enroll 1,625 participants (1,100 adults
and 525 children and their parents). Annualized estimates are 542
participants (367 adults and 175 children).
For the exposure group (n=1,350), ATSDR will enroll 1,000 adults
and 350 children. Annualized estimates are 450 exposed participants
(333 adults and 117 children). Eligible participants had to work at,
live on, or attend childcare at the former Pease Air Force Base or the
Pease International Tradeport, or live in a nearby home that was served
by a PFAS-contaminated private well. Drinking water exposures must have
occurred at some time between 2004 and May 2014, after which
remediation of the public water supply occurred.
For the referent group (n=275), ATSDR will enroll 100 adults and
175 children. Annualized estimates are 92 referent participants (34
adults and 58 children). Eligible participants, never exposed to PFAS-
contaminated drinking water from Pease, will come from other areas of
Portsmouth, NH. Birth mothers of referent children likewise must never
have had PFAS drinking water exposure.
ATSDR will recruit, screen for eligibility, and enroll in three
waves. The exposure group will be recruited in Waves One and Two. ATSDR
estimates that 90% of the exposure group will be
[[Page 43687]]
enrolled in Wave 1 (n=1,215, or 405 per year), that is, will be past
participants of the 2015-7 NH DHHS PFAS blood testing program. NH DHHS
will assist ATSDR by sending out letters of invitation to its former
blood testing program participants. To achieve the desired sample size,
the other 10 percent of the exposure group (n=135, or 45 per year) will
be recruited in Wave 2. These will be people who were eligible for the
PFAS blood testing program but did not take part. The referent group
will be recruited in Wave Three (n=275, or 92 per year), which can
occur concurrently with Wave 1 and Wave 2. Wave 2 and Wave 3 recruits
will call to volunteer after ATSDR opens those waves to enrollment.
To restrict this study to drinking water exposures, any adult
occupationally exposed to PFAS will not be eligible for the study (i.e.
ever firefighters or in chemical manufacture). Likewise, children whose
birth mothers were occupationally exposed will not be eligible. This
restriction applies to both the exposure and the referent group. ATSDR
assumes that 5% of the people who volunteer will not meet eligibility
requirements. ATSDR will screen the 1,578 people from the NH DHHS PFAS
blood testing program in Wave One (n=526 per year). ATSDR will screen
at least 142 exposed people in Wave 2 (or 47 per year), and at least
289 unexposed people in Wave 3 (or 96 per year). This will require an
annual time burden of 124 hours for eligibility screening.
At enrollment, ATSDR will obtain adult consent, parental
permission, and child assent before data collection begins. Each child
will enroll with a parent, who ideally will be the child's birth
mother, as ATSDR will ask details about the child's exposure,
pregnancy, and breastfeeding history.
For each participant, ATSDR will take body measures, collect blood
and urine samples for chemical and biomarker analysis, and administer a
questionnaire on exposures and medical history. For purposes of burden
estimation, ATSDR assumes that 20% of parents will also enroll as
adults; therefore, 420 parents will take the child questionnaire long
form (n=140 per year), while 105 parents will take the short form to
reduce burden (n=35 per year). Parents and children will also complete
assessments of the child's attention and behaviors. After eligibility
screening, the annual time burden for participation in the study is 58
hours for adults and 208 hours for children and their parents.
ATSDR will ask for permission to compare adults' and children's
medical histories with their medical records. ATSDR will also ask for
permission to check children's school records to compare their
behavioral assessment results. The annual time burden for medical and
educational record abstraction is estimated to be 125 hours for adult
records and 118 hours for children's records.
The total annualized time burden requested is 1,189 hours. There is
no cost to the respondents other than their time.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pease Study Participants....................... Wave One Eligibility Screening Script.. 526 1 10/60 88
Wave Two Eligibility Screening Script.. 47 1 15/60 12
Wave Three Eligibility Screening Script 96 1 15/60 24
Appointment Reminder Telephone Script.. 542 1 5/60 45
Update Contact Information Hardcopy 542 1 5/60 45
Form.
Medication List........................ 542 1 3/60 27
Body and Blood Pressure Measures Form.. 542 1 5/60 45
Blood Draw and Urine Collection Form... 542 1 10/60 90
Adult Questionnaire.................... 367 1 30/60 184
Child Questionnaire--Long Form......... 140 1 30/60 70
Child Questionnaire--Short Form........ 35 1 15/60 9
Parent Neurobehavioral Test Battery.... 175 1 15/60 44
Child Neurobehavioral Test Battery..... 175 1 90/60 263
Education Specialists.......................... Child School Record Abstraction Form... 15 12 20/60 60
Medical Record Specialists..................... Medical Record Abstraction Form--Adult. 25 15 20/60 125
Medical Record Abstraction Form--Child. 25 7 20/60 58
---------------------------------------------------------------
Total...................................... ....................................... .............. .............. .............. 1,189
--------------------------------------------------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of
Scientific Integrity, Office of the Associate Director for Science,
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-18446 Filed 8-24-18; 8:45 am]
BILLING CODE 4163-18-P
