Attachment C - 60 day FRN Published

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Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Notices

Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–12005 Filed 6–4–18; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: The
Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children’s Public Health System
Assessment Surveys OMB No. 0906–
0014, Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than August 6, 2018.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N–39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
The Secretary’s Advisory Committee on
Heritable Disorders in Newborns and

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SUMMARY:

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Children’s Public Health System
Assessment Surveys OMB No. 0906–
0014—Revision.
Abstract: The purpose of the public
health system assessment surveys is to
inform the Secretary’s Advisory
Committee on Heritable Disorders in
Newborns and Children (Committee) on
states’ ability to add newborn screening
for particular conditions, including the
feasibility, readiness and overall
capacity to screen for a new condition.
The Committee was established under
Section 1111 of the Public Health
Service Act, 42 U.S.C. 300b-10, as
amended in the Newborn Screening
Saves Lives Reauthorization Act of
2014. The Committee is governed by the
provisions of the Federal Advisory
Committee Act, as amended (5 U.S.C.
App.), which sets forth standards for the
formation and use of advisory
committees. The purpose of the
Committee is to provide the Secretary
with recommendations, advice, and
technical information regarding the
most appropriate application of
technologies, policies, guidelines, and
standards for: (a) Effectively reducing
morbidity and mortality in newborns
and children having, or at risk for,
heritable disorders; and (b) enhancing
the ability of state and local health
agencies to provide for newborn and
child screening, counseling, and health
care services for newborns and children
having, or at risk for, heritable
disorders. Specifically, the Committee
makes systematic evidence-based
recommendations on newborn screening
for conditions that have the potential to
change the health outcomes for
newborns.
The Committee tasks an external
workgroup to conduct systematic
evidence-based reviews for conditions
being considered for addition to the
Recommended Uniform Screening
Panel, and their corresponding newborn
screening test(s), confirmatory test(s),
and treatment(s). Reviews also include
an analysis of the benefits and harms of
newborn screening for a selected
condition at a population level and an
assessment of state public health
newborn screening programs’ ability to
implement the screening of a new
condition.
Need and Proposed Use of the
Information: The surveys are
administered by the Committee’s
Evidence Review Group to collect data
from state newborn screening programs

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in the United States. The surveys have
been developed to capture the
following: (1) Readiness of state public
health newborn screening programs to
expand newborn screening to include
the target condition; (2) specific
requirements of screening for a
condition that could hinder or facilitate
implementation in each state; and (3)
estimated timeframes needed for each
state to complete major milestones
toward full implementation of newborn
screening for the condition.
The data gathered informs the
Committee on the following: (1)
Feasibility of implementing populationbased screening for the target condition;
(2) readiness of state newborn screening
programs to adopt screening for the
condition; (3) gaps or limitations related
to the feasibility or readiness of states to
screen for a condition; and (4) areas of
technical assistance and resources
needed to facilitate screening for
conditions with low feasibility or
readiness.
HRSA anticipates the following
revisions will be made to the surveys:
(1) Editing and adding response choices
as needed, to provide more informative
options; (2) revising language
throughout the survey to ensure the
survey can accommodate different types
of conditions that may be nominated; (3)
reorder current questions as needed;
and (4) add new questions as needed.
Likely Respondents: The respondents
to the survey will be state and territorial
newborn screening programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
Total Estimated Annualized Burden
Hours:

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26065

Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Notices

Number of
respondents

Form name

Number of
responses per
respondent

Total
responses

Average burden per
response
(in hours)

Total burden
hours

INITIAL Survey of the Secretary’s Discretionary Advisory
Committee on Heritable Disorders in Newborns and
Children’s Public Health System Assessment 1 ...............
FOLLOW–UP Survey of the Secretary’s Discretionary Advisory Committee on Heritable Disorders in Newborns
and Children’s Public Health System Assessment ..........

59

1

59

10

590

2 30

1

30

2

60

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

89

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

89

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

650

1 The

respondents to the survey will be State and territorial newborn screening programs.
2 Up to 30 States and/or Territories will be asked to complete a follow-up survey.

HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–12019 Filed 6–4–18; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Tick-Borne Disease
Working Group
Office of the Secretary, Office
of the Assistant Secretary for Health,
Office of HIV/AIDS and Infectious
Disease Policy, Department of Health
and Human Services.
ACTION: Notice.
AGENCY:

The Department of Health and
Human Services (HHS) announces the
sixth meeting of the Tick-Borne Disease
Working Group (Working Group) on
June 21, 2018, from 9:30 a.m. to 6:00
p.m., Eastern Time. The sixth meeting
will be an on-line meeting held via
webcast. The Working Group will focus
on subcommittee findings and will
review and provide input on the content
of the five chapters that will be
submitted into the Working Group
Congressional Report.
DATES: The on-line meeting will be held
on June 21, 2018, from 9:30 a.m. to 6:00
p.m. Eastern Time.
ADDRESSES: This will be an on-line
meeting that is held via webcast.
Members of the public may attend the
meeting via webcast. Instructions for
attending this virtual meeting will be

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posted prior to the meeting at: https://
www.hhs.gov/ash/advisory-committees/
tickbornedisease/index.html.
FOR FURTHER INFORMATION CONTACT:
James Berger, Office of HIV/AIDS and
Infectious Disease Policy, Office of the
Assistant Secretary for Health,
Department of Health and Human
Services; via email at tickbornedisease@
hhs.gov or by phone at 202–795–7697.
SUPPLEMENTARY INFORMATION: The
Working Group invites public comment
on issues related to the Working Group’s
charge. Comments may be provided
over the phone during the meeting or in
writing. Persons who wish to provide
comments by phone should review
directions at https://www.hhs.gov/ash/
advisory-committees/tickbornedisease/
meetings/index.html before submitting a
request via email at tickbornedisease@
hhs.gov on or before June 18, 2018.
Phone comments will be limited to
three minutes each to accommodate as
many speakers as possible. A total of 30
minutes will be allocated to public
comments. If more requests are received
than can be accommodated, speakers
will be randomly selected. The nature of
the comments will not be considered in
making this selection. Public comments
may also be provided in writing.
Individuals who would like to provide
written comment should review
directions at https://www.hhs.gov/ash/
advisory-committees/tickbornedisease/
meetings/index.html before sending
their comments to tickbornedisease@
hhs.gov on or before June 18, 2018.
During the meeting, the Working
Group will review and discuss the
content of the five draft chapters that
will be part of the Report to Congress.
Persons who wish to receive the draft
document should email the
tickbornedisease@hhs.gov and request a
copy. The document will be available
prior to the meeting.
Background and Authority: The TickBorne Disease Working Group was
established on August 10, 2017, in
accordance with section 2062 of the 21st
Century Cures Act, and the Federal

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Advisory Committee Act, 5 U.S.C. App.,
as amended, to provide expertise and
review all HHS, DoD and VA efforts
related to tick-borne diseases to help
ensure interagency coordination and
minimize overlap, examine research
priorities, and identify and address
unmet needs. In addition, the Working
Group is required to submit a report to
the Secretary and Congress on their
findings and any recommendations for
improving the federal response to tickborne disease prevention, treatment and
research, and addressing gaps in those
areas.
Dated: May 31, 2018.
James Berger,
Office of HIV/AIDS and Infectious Disease
Policy, Designated Federal Officer, TickBorne Disease Working Group.
[FR Doc. 2018–12045 Filed 6–4–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

Findings of research
misconduct have been made on the part
of Shiladitya Sen, former graduate
student, Department of Chemistry and
Biochemistry, The Ohio State University
(OSU). Mr. Sen engaged in research
misconduct in research supported by
National Institute of General Medical
Sciences (NIGMS), National Institutes of
Health (NIH), grant R01 GM083114. The
administrative actions, including
debarment for a period of three (3)
years, were implemented beginning on
May 16, 2018, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr.P.H., Interim
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8200.
SUMMARY:

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