60 day FRN

Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices
Affected Public: Individuals; Business
or Other For-Profit Institutions; Not-ForProfit Institutions; State or Local
Government.
Estimated Annual Number of
Respondents: 45,000.
Projected average burden estimates for
the next three years:
Average Expected Annual Number of
Activities: 40.
Average Number of Respondents per
Activity: 1,125.
Responses per Respondent: 1.
Annual Responses: 45,000.
Average Minutes per Response: 3
minutes.
Annual Burden Hours: 2,250 hours.
Frequency: On occasion.
Request for Comments: Agency and
public comment is again invited
specifically on the need for and
practical utility of this information
collection, the accuracy of OGE’s
burden estimate, the enhancement of
quality, utility and clarity of the
information collected, and the
minimization of burden (including the
use of information technology). The
comments will become a matter of
public record.
Approved: July 11, 2018.
David Apol,
General Counsel and Acting Director, U.S.
Office of Government Ethics.
[FR Doc. 2018–15411 Filed 7–18–18; 8:45 a.m.]
BILLING CODE 6345–03–P

GULF COAST ECOSYSTEM
RESTORATION COUNCIL
[Docket No.: 107162018–1111–03]

Notice of Proposed Subaward Under a
Council-Selected Restoration
Component Award
Gulf Coast Ecosystem
Restoration Council.
ACTION: Notice.
AGENCY:

The Gulf Coast Ecosystem
Restoration Council (RESTORE Council)
publishes notice of proposed subawards
from the Mississippi Department of
Environmental Quality (MDEQ) to the
Mississippi Wildlife Federation and the
Partnership for Gulf Coast Land
Conservation, two Mississippi nonprofit
organizations, for the purpose of
education and outreach in accordance
with the Sea Grant Education and
Outreach (EOE) Award, as approved in
the Initial Funded Priority List.
FOR FURTHER INFORMATION CONTACT:
Please send questions by email to
joshua.easton@restorethegulf.gov.
SUPPLEMENTARY INFORMATION: Section
1321(t)(2)(E)(ii)(III) of the RESTORE Act

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SUMMARY:

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(33 U.S.C. 1321(t)(2)(E)(ii)(III)) and
Treasury’s implementing regulation at
31 CFR 34.401(b) require that, for
purposes of awards made under the
Council-Selected Restoration
Component, a State or Federal award
recipient may make a grant or subaward
to or enter into a cooperative agreement
with a nongovernmental entity that
equals or exceeds 10 percent of the total
amount of the award provided to the
State or Federal award recipient only if
certain notice requirements are met.
Specifically, at least 30 days before the
State or Federal award recipient enters
into such an agreement, the Council
must publish in the Federal Register
and deliver to specified Congressional
Committees the name of the recipient
and subrecipient; a brief description of
the activity, including its purpose; and
the amount of the award. This notice
accomplishes the Federal Register
requirement.
Description of Proposed Action
As specified in the Initial Funded
Priority List, which is available on the
Council’s website at https://
www.restorethegulf.gov/councilselected-restoration-component/fundedpriorities-list, RESTORE Act funds in
the amount of $750,000 will support the
Sea Grant Education and Outreach
(EOE) Award to MDEQ. As part of this
project, MDEQ will provide a subaward
in the amount of $84,150 to the
Mississippi Wildlife Federation for
enhancement of the Mississippi Habitat
Stewards Program. Through the
subaward, the Mississippi Wildlife
Federation will expand an existing
curriculum that relays the ecosystem
benefits of upstream land conservation,
habitat restoration and water quality
restoration. The expanded curriculum
will be offered for three different
targeted audiences at different levels:
Habitat steward volunteers; youth, ages
9–12; and local high school
environmental clubs.
MDEQ will also provide a subaward
in the amount of $99,050 to the
Partnership for Gulf Coast Land
Conservation (PGCLC). The PGCLC will
conduct an outreach initiative that
includes three components: The
development of science-based
communication products for use with a
general audience that summarize and
explain the benefits of land
conservation in the Gulf coast region in
lay terminology; field visits that bring
together stakeholders to illustrate, in the
field and by boat, the connectivity that
land conservation practices along our
coastal streams have to water quality in
the northern Gulf of Mexico and to our
marine and estuarine living resources;

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and the development of a short digital
film that illustrates the connection
between riparian and wetland forests
and marine and estuarine living
resources in the northern Gulf of
Mexico.
Keala J. Hughes,
Director of External Affairs & Tribal Relations,
Gulf Coast Ecosystem Restoration Council.
[FR Doc. 2018–15451 Filed 7–18–18; 8:45 am]
BILLING CODE 6560–58–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substance and
Disease Registry
[60Day–18–18AJK Docket No. ATSDR–
2018–0002]

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 ‘‘Per- or
Polyfluoroalkyl Substances (PFAS)
Exposure Assessments.’’ ATSDR and the
CDC National Center for Environmental
Health (NCEH) will conduct a minimum
of eight exposure assessments (EAs) at
current or former military installations
with known PFAS contamination in
drinking water, groundwater, or another
water source.
DATES: ATSDR must receive written
comments on or before September 17,
2018.
SUMMARY:

You may submit comments,
identified by Docket No. ATSDR–2018–
0002 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.

ADDRESSES:

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Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices

Instructions: All submissions received
must include the agency name and
Docket Number. ATSDR will post,
without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact 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
Per- or Polyfluoroalkyl Substances
(PFAS) Exposure Assessments—New—

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Agency for Toxic Substances and
Disease Registry (ATSDR) and the
National Center for Environmental
Health (NCEH), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Per- and polyfluoroalkyl substances
(PFAS) are a large group of man-made
chemicals that have been used in
industry and consumer products
worldwide since the 1950s. Although
some PFAS are no longer produced in
the United States, they many remain in
the environment and may impact
people’s health. Thus, PFAS are
contaminants that have gained national
prominence over the last decade.
Under Section 8006 of the
Consolidated Appropriations Act, 2018,
the Agency for Toxic Substances and
Disease Registry and CDC National
Center for Environmental Health
(ATSDR/NCEH) are requesting a threeyear Paperwork Reduction Act clearance
for a new information collection request
(ICR). ATSDR/NCEH will conduct EAs
at current or former domestic military
installations known to have PFAS in
drinking water, groundwater, or any
other sources of water. The annualized
number of EAs assumes the following.
ATSDR/NCEH will conduct a minimum
of eight EAs, but ATSDR/NCEH may
complete an additional seven for a total
of 15 EAs. Therefore, ATSDR/NCEH
anticipates conducting five PFAS EAs
each year for three years.
All eligible respondents will be
consented before being included in each
EA. The consent forms will include
adult consent, and parental permission
and child assent forms, as appropriate.
Each consented respondent will provide
a serum and a urine sample. In addition,
heads of households from ten percent of
households using tap water for their
drinking water will consent to provide
tap water and indoor dust samples. The
consent forms will include permission
to store some biospecimens and
environmental samples for future
analysis and will include permission to
recontact respondents for potential
investigations or studies in the future.
ATSDR will also collect contact
information to provide respondents
with their individual sampling results.
Household Eligibility Screener:
ATSDR/NCEH will conduct the PFAS
EAs in communities with populations
living on or near current or former
military installations. ATSDR/NCEH
will recruit a desired sample size of 379
respondents per EA (1,895 total per
year) using statistical household
sampling methods. Eligibility criteria for
individuals include specific age
intervals (i.e., children older than three

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years given the lack of NHANES
comparison data for younger children),
lack of bleeding disorders that would
prevent a blood draw, and time of
residency (i.e., at least one year in the
home).
Applying an average U.S. household
size of 2.5 members, per EA, ATSDR/
NCEH will enroll respondents from 152
eligible households (379/2.5). To
identify the 152 eligible households, we
further assume a 65 percent household
eligibility rate. This will require
administering a 5-minute eligibility
screener to 234 heads-of-households per
EA (152*100/65), or to 1,170 heads-ofhouseholds per year (234 × 5). The
annual time burden requested for
eligibility screening is 98 hours.
Exposure Assessment Questionnaire
for Biological and Environmental
Testing for Adults, Parents, or Children:
ATSDR/NCEH will administer an
exposure questionnaire to all consented
respondents that includes questions
associated with potential exposure to
PFAS both inside and outside the home
(e.g., work or school). In addition, the
adult questionnaire also includes
several questions associated with water
use and flooring type while the child
questionnaire includes questions
regarding playing in soil; these
questions are intended to evaluate
potential exposure and to support the
environmental testing. The time
associated with administering the
questionnaire and completing the
biological sampling is approximately 30
minutes for 1,440 adults (720 hours).
The time associated is 15 minutes for
264 parents responding for their
children, 3–11 years old (66 hours), and
for 191 children, 12–17 years old, who
respond for themselves (48 hours).
ATSDR/NCEH will use the
questionnaire and laboratory results to
identify likely exposure scenarios.
Household Recruitment Script for
Environmental Sampling: The
households providing environmental
samples will be randomly selected from
households that report using tap water
for drinking water. ATSDR/NCEH will
recruit 10 percent subset of these
eligible households to collect tap water
and indoor dust samples. Assuming a 65
percent response rate, ATSDR/NCEH
will administer a 5-minute recruitment
script to 23 heads-of households who
are eligible to take part in each EA (152/
10*100/65). The time required to
administer the recruitment script is 5
minutes. This will result in annual
recruitment from 117 heads-ofhouseholds and 10 hours for five EAs.
Environmental Sample Collection
Form: Again, assuming a 65 percent
response rate, to meet our sample size

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Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices
goal of 10 percent of eligible
households, ATSDR/NCEH will consent
and collect samples from approximately
15 households per EA or households
annually (152*10/100*5). The average
time burden is estimated as 15 minutes
per response, or 19 hours annually.
ATSDR estimates the total annualized
time burden is 961 hours. Participation

recommendations for public health
actions to reduce or eliminate harmful
levels of PFAS in the local environment.
These EAs are not intended to yield
information about PFAS exposure that
will be generalized beyond the defined
boundaries of each investigation;
however, ATSDR/NCEH will use these
EA findings to inform a future national
PFAS health study.

is voluntary, and there are no costs to
respondents other than their time.
Public health professionals,
environmental risk managers, and other
decision makers can use EA results to
make informed decisions about the
sources and impact of PFAS
contamination in environmental media
within their own community and
jurisdiction. The data will support their

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
hours

Form name

Potential EA Heads-of-Households ...
EA Adults ...........................................

Household Eligibility Screener .........
Exposure Questionnaire for Biological and Environmental Testing
(Adults).
EA Questionnaire for Biological
Testing (Child).
EA Questionnaire for Biological
Testing (Child).
Household Recruitment Script for
Environmental Sampling.
Environmental Sample Collection
Form.

1,170
1,440

1
1

5/60
30/60

98
720

264

1

15/60

66

191

1

15/60

48

117

1

5/60

10

76

1

15/60

19

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

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

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

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

961

EA Parents ........................................
EA Children .......................................
EA Heads-of-Households ..................

Total ...........................................

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. 2018–15437 Filed 7–18–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[Docket No. FDA–2016–D–1224]

Use of Electronic Health Record Data
in Clinical Investigations; Guidance for
Industry; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Use of
Electronic Health Record Data in
Clinical Investigations.’’ The guidance
provides recommendations for sponsors,
clinical investigators, contract research
organizations (CROs), institutional
review boards (IRBs), and other
interested parties on the use of
electronic health record (EHR) data in
FDA-regulated clinical investigations.

SUMMARY:

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The guidance finalizes the draft
guidance issued in May 2016.
DATES: The announcement of the
guidance is published in the Federal
Register on July 19, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions

Food and Drug Administration

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Number of
responses per
respondent

Number of
respondents

Type of respondent

Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you

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do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–1224 for ‘‘Use of Electronic
Health Record Data in Clinical
Investigations; Guidance for Industry;
Availability.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff office
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be

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