60 day FRN

AppndxB Pease 60-day FRN.pdf

Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease Study)

60 day FRN

OMB: 0923-0061

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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.

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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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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:

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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: [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

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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

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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

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

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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:

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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:

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