Solicitation of Nominations for Appointment to the Tick-Borne Disease Working Group, 57739-57740 [2018-25082]
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Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices
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. 2018–25070 Filed 11–15–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Notice is hereby given that on
October 22, 2018, the U.S. Department
of Health and Human Services (HHS)
Debarring Official, on behalf of the
Secretary of HHS, issued a final notice
of debarment based on an
Administrative Law Judge’s finding of
research misconduct against Rakesh
Srivastava, Ph.D., former Eminent
Scholar and Professor, University of
Kansas Medical Center (KUMC). Dr.
Srivastava engaged in research
misconduct in research proposed or
reported in grant application 1 R01
CA175776–01, submitted to the
National Cancer Institute (NCI),
National Institutes of Health (NIH), on
June 5, 2012. The administrative
actions, including two (2) years of
debarment, were implemented
beginning on October 22, 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.
SUPPLEMENTARY INFORMATION:
Rakesh Srivastava, Ph.D., University
of Kansas Medical Center: Based on the
evidence and findings of an
investigation conducted by KUMC and
additional information obtained by the
Office of Research Integrity (ORI) during
its oversight review, ORI found by a
preponderance of the evidence that Dr.
Rakesh Srivastava (Respondent), former
Eminent Scholar and Professor, KUMC,
intentionally and knowingly submitted
extensive plagiarized text in grant
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SUMMARY:
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17:19 Nov 15, 2018
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application 1 R01 CA175776–01,
‘‘Regulation of Mitochondrial
Metabolism by SIRT4,’’ submitted to
NCI, NIH, to obtain U.S. Public Health
Service (PHS) funds. Specifically, ORI
found that the Respondent intentionally
and knowingly plagiarized scientifically
significant text from the Specific Aims
and Research Strategy sections of a grant
application under review at NIH into his
own grant application, 1 R01
CA175776–01, submitted to NIH eight
months later. Significant text was
included in Respondent’s grant
application, with plagiarized text
accounting for 40% of the Specific Aims
and 50% of the Research Strategy
sections.
ORI issued a charge letter making a
finding of research misconduct and
proposing HHS administrative actions.
Dr. Srivastava subsequently requested a
hearing before an Administrative Law
Judge (ALJ) of the Departmental Appeals
Board to dispute the finding. ORI moved
for summary judgment. On September 5,
2018, the ALJ granted summary
judgment in favor of ORI and issued his
recommended decision, finding that
Respondent intentionally committed
research misconduct by submitting to
NIH a grant application that included
plagiarized words, which included
significant text from another principal
investigator’s grant application that was
contained in the Specific Aims and
Research Strategy sections of the
Respondent’s grant application without
attribution to the other principal
investigator. The ALJ held that
appropriate administrative actions
included a two-year debarment from
any contracting or subcontracting with
any agency of the United States
Government and from eligibility for or
involvement in nonprocurement
programs of the United States
Government referred to as ‘‘covered
transactions.’’ 2 CFR parts 180 and 376.
The ALJ held that it was an appropriate
administrative action to also impose a
two-year prohibition from serving in
any capacity to PHS including, but not
limited to, service on any PHS advisory
committee, board, or peer review
committee, or as a consultant. Under the
regulation, the ALJ’s recommended
decision went to the Assistant Secretary
for Health, who did not modify it and
forwarded it to the HHS Debarring
Official, who is the deciding official for
the debarment. The ALJ decision
constituted the findings of fact to the
HHS Debarring Official in accordance
with 2 CFR 180.845(c). On October 22,
2018, the HHS Debarring Official issued
a final notice of debarment to begin on
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57739
October 22, 2018, and end on October
21, 2020.
Thus, the research misconduct
finding set forth above became effective,
and the following administrative actions
have been implemented for a period of
two (2) years, beginning on October 22,
2018:
(1) Dr. Srivastava is debarred from any
contracting or subcontracting with any
agency of the United States Government
and from eligibility or involvement in
nonprocurement programs of the United
States Government referred to as
‘‘covered transactions’’ pursuant to
HHS’ Implementation (2 CFR part 376)
of Office of Management and Budget
(OMB) Guidelines to Agencies on
Governmentwide Debarment and
Suspension (2 CFR part 180); and
(2) Dr. Srivastava is prohibited from
serving in any advisory capacity to PHS
including, but not limited to, service on
any PHS advisory committee, board,
and/or peer review committee, or as a
consultant.
Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2018–25065 Filed 11–15–18; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Appointment to the Tick-Borne
Disease Working Group
Office of HIV/AIDS and
Infectious Disease Policy, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
This notice will serve to
announce that the U.S. Department of
Health and Human Services (HHS) is
seeking nominations of non-federal
individuals who represent diverse
scientific disciplines and views and are
interested in being considered for
appointment to the Tick-Borne Disease
Working Group (Working Group).
Resumes or curricula vitae from
qualified individuals who wish to be
considered for appointment as a
member of the Working Group are
currently being accepted.
DATES: Nominations must be received
no later than 5:00 p.m. EST, on
December 14, 2018.
ADDRESSES: All nominations should be
sent to the Tick-Borne Disease Working
Group email address at
tickbornedisease@hhs.gov. Alternately,
nominations can be sent by mail to:
SUMMARY:
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57740
Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices
James Berger, MS, MT (ASCP), SBB,
Senior Advisor for Blood and Tissue
Policy, Office of HIV/AIDS and
Infectious Disease Policy, Office of the
Assistant Secretary for Health, U.S.
Department of Health and Human
Services, 330 C Street SW, Room L001
Switzer Building, Washington, DC
20201.
FOR FURTHER INFORMATION CONTACT:
James Berger, MS, MT (ASCP), SBB,
Senior Advisor for Blood and Tissue
Policy; Telephone: (202) 795–7608; Fax:
(202) 691–2101; Email address:
tickbornedisease@hhs.gov. Website
information about activities of the
Working Group, as well as the charter
for the Working Group, which has been
filed with the Library of Congress, can
be found at https://www.hhs.gov/ash/
advisory-committees/tickbornedisease/
index.html.
SUPPLEMENTARY INFORMATION: Section
2062 of the 21st Century Cures Act
requires establishment of the Tick-Borne
Disease Working Group. The Working
Group is governed by provisions of the
Federal Advisory Committee Act, Public
Law 92–463, as amended (5 U.S.C.
App.), which sets forth standards for the
formation and use of federal advisory
committees. The 21st Century Cures Act
is intended to advance the research and
development of new therapies and
diagnostics and make substantial federal
investments in a wide range of health
priorities. The Working Group is a nondiscretionary federal advisory
committee.
Objectives and Scope of Activities.
The Secretary of Health and Human
Services is responsible for ensuring the
conduct of and support for
epidemiological, basic, translational,
and clinical research related to vectorborne diseases, including tick-borne
diseases. The Working Group provides
assistance for this effort. The Working
Group membership provides expertise
and reviews all efforts within the
Department of Health and Human
Services related to all tick-borne
diseases, to help ensure interagency
coordination and minimize overlap, and
to examine research priorities.
Membership and Designation. The
Working Group consists of 14 voting
members who represent diverse
scientific disciplines and views. The
composition includes seven federal
members and seven public members.
The federal members consist of one or
more representatives of each of the
following HHS agencies: Office of the
Assistant Secretary for Health, the Food
and Drug Administration, the Centers
for Disease Control and Prevention, and
the National Institutes of Health. The
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17:19 Nov 15, 2018
Jkt 247001
non-federal public members consist of
representatives of the following
categories: Physicians and other medical
providers with experience in diagnosing
and treating tick-borne diseases;
scientists or researchers with expertise;
patients and their family members; and
nonprofit organizations that advocate
for patients with respect to tick-borne
disease. Individuals who are appointed
to represent federal entities are
classified as regular government
employees. The public members are
classified as special government
employees. Invitations of membership is
extended to other agencies and offices of
the Department of Health and Human
Services and other individuals as
determined by the Secretary to be
appropriate and beneficial for
accomplishing the mission of the
Working Group.
The federal members are appointed to
serve for the duration of time that the
Working Group is authorized to operate.
Participation of the appointed federal
members is at the discretion of their
respective agency head. The public
members are invited to serve
overlapping terms of up to four years.
Any public member who is appointed to
fill the vacancy of an unexpired term
will be appointed to serve for the
remainder of that term. A non-federal
public member may serve after the
expiration of their term until their
successor has taken office, but no longer
than 180 days. Terms of more than two
years are contingent upon renewal of
the charter of the Working Group.
Pursuant to advance written agreement,
public members of the Working Group
will receive no stipend for the advisory
service that they render as members of
the Working Group. However, public
members will receive per diem and
reimbursement for travel expenses
incurred in relation to performing duties
for the Working Group, as authorized by
law under 5 U.S.C. 5703 for persons
who are employed intermittently to
perform services for the federal
government and in accordance with
federal travel regulations.
Estimated Number and Frequency of
Meetings. The Working Group will meet
not less than twice a year. The meetings
will be open to the public, except as
determined otherwise by the Secretary,
or another official to whom authority
has been delegated, in accordance with
the guidelines under Government in the
Sunshine Act, 5 U.S.C. 552b(c).
Nominations: Nominations, including
self-nominations, of individuals who
have the specified expertise and
knowledge will be considered for
appointment as public voting members
of the Working Group. A nomination
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
should include, at a minimum, the
following for each nominee: (1) A letter
of nomination that clearly states the
name and affiliation of the nominee, the
basis for the nomination, and a
statement from the nominee that
indicates that the individual is willing
to serve as a member of the Working
Group, if selected; (2) the nominator’s
name, address, and daytime telephone
number, and the address, telephone
number, and email address of the
individual being nominated; and (3) a
current copy of the nominee’s
curriculum vitae or resume, which must
be limited to no more than 10 pages.
Every effort will be made to ensure
that the Working Group is a diverse
group of individuals with representation
from various geographic locations, racial
and ethnic minorities, all genders, and
persons living with disabilities.
Individuals being considered for
appointment as public voting members
will be required to complete and submit
a report of their financial holdings. An
ethics review must be conducted to
ensure that individuals appointed as
public voting members of the Working
Group are not involved in any activity
that may pose a potential conflict of
interest for the official duties that are to
be performed. This is a federal ethics
requirement that must be satisfied upon
entering the position and annually
throughout the established term of
appointment on the Working Group.
Dated: November 5, 2018.
James J. Berger,
Senior Advisor for Blood and Tissue Policy,
Designated Federal Officer, Tick-Borne
Disease Working Group.
[FR Doc. 2018–25082 Filed 11–15–18; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
E:\FR\FM\16NON1.SGM
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Agencies
[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)]
[Notices]
[Pages 57739-57740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25082]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Nominations for Appointment to the Tick-Borne
Disease Working Group
AGENCY: Office of HIV/AIDS and Infectious Disease Policy, Office of the
Assistant Secretary for Health, Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice will serve to announce that the U.S. Department of
Health and Human Services (HHS) is seeking nominations of non-federal
individuals who represent diverse scientific disciplines and views and
are interested in being considered for appointment to the Tick-Borne
Disease Working Group (Working Group). Resumes or curricula vitae from
qualified individuals who wish to be considered for appointment as a
member of the Working Group are currently being accepted.
DATES: Nominations must be received no later than 5:00 p.m. EST, on
December 14, 2018.
ADDRESSES: All nominations should be sent to the Tick-Borne Disease
Working Group email address at [email protected]. Alternately,
nominations can be sent by mail to:
[[Page 57740]]
James Berger, MS, MT (ASCP), SBB, Senior Advisor for Blood and Tissue
Policy, Office of HIV/AIDS and Infectious Disease Policy, Office of the
Assistant Secretary for Health, U.S. Department of Health and Human
Services, 330 C Street SW, Room L001 Switzer Building, Washington, DC
20201.
FOR FURTHER INFORMATION CONTACT: James Berger, MS, MT (ASCP), SBB,
Senior Advisor for Blood and Tissue Policy; Telephone: (202) 795-7608;
Fax: (202) 691-2101; Email address: [email protected]. Website
information about activities of the Working Group, as well as the
charter for the Working Group, which has been filed with the Library of
Congress, can be found at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/.
SUPPLEMENTARY INFORMATION: Section 2062 of the 21st Century Cures Act
requires establishment of the Tick-Borne Disease Working Group. The
Working Group is governed by provisions of the Federal Advisory
Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), which
sets forth standards for the formation and use of federal advisory
committees. The 21st Century Cures Act is intended to advance the
research and development of new therapies and diagnostics and make
substantial federal investments in a wide range of health priorities.
The Working Group is a non-discretionary federal advisory committee.
Objectives and Scope of Activities. The Secretary of Health and
Human Services is responsible for ensuring the conduct of and support
for epidemiological, basic, translational, and clinical research
related to vector-borne diseases, including tick-borne diseases. The
Working Group provides assistance for this effort. The Working Group
membership provides expertise and reviews all efforts within the
Department of Health and Human Services related to all tick-borne
diseases, to help ensure interagency coordination and minimize overlap,
and to examine research priorities.
Membership and Designation. The Working Group consists of 14 voting
members who represent diverse scientific disciplines and views. The
composition includes seven federal members and seven public members.
The federal members consist of one or more representatives of each of
the following HHS agencies: Office of the Assistant Secretary for
Health, the Food and Drug Administration, the Centers for Disease
Control and Prevention, and the National Institutes of Health. The non-
federal public members consist of representatives of the following
categories: Physicians and other medical providers with experience in
diagnosing and treating tick-borne diseases; scientists or researchers
with expertise; patients and their family members; and nonprofit
organizations that advocate for patients with respect to tick-borne
disease. Individuals who are appointed to represent federal entities
are classified as regular government employees. The public members are
classified as special government employees. Invitations of membership
is extended to other agencies and offices of the Department of Health
and Human Services and other individuals as determined by the Secretary
to be appropriate and beneficial for accomplishing the mission of the
Working Group.
The federal members are appointed to serve for the duration of time
that the Working Group is authorized to operate. Participation of the
appointed federal members is at the discretion of their respective
agency head. The public members are invited to serve overlapping terms
of up to four years. Any public member who is appointed to fill the
vacancy of an unexpired term will be appointed to serve for the
remainder of that term. A non-federal public member may serve after the
expiration of their term until their successor has taken office, but no
longer than 180 days. Terms of more than two years are contingent upon
renewal of the charter of the Working Group. Pursuant to advance
written agreement, public members of the Working Group will receive no
stipend for the advisory service that they render as members of the
Working Group. However, public members will receive per diem and
reimbursement for travel expenses incurred in relation to performing
duties for the Working Group, as authorized by law under 5 U.S.C. 5703
for persons who are employed intermittently to perform services for the
federal government and in accordance with federal travel regulations.
Estimated Number and Frequency of Meetings. The Working Group will
meet not less than twice a year. The meetings will be open to the
public, except as determined otherwise by the Secretary, or another
official to whom authority has been delegated, in accordance with the
guidelines under Government in the Sunshine Act, 5 U.S.C. 552b(c).
Nominations: Nominations, including self-nominations, of
individuals who have the specified expertise and knowledge will be
considered for appointment as public voting members of the Working
Group. A nomination should include, at a minimum, the following for
each nominee: (1) A letter of nomination that clearly states the name
and affiliation of the nominee, the basis for the nomination, and a
statement from the nominee that indicates that the individual is
willing to serve as a member of the Working Group, if selected; (2) the
nominator's name, address, and daytime telephone number, and the
address, telephone number, and email address of the individual being
nominated; and (3) a current copy of the nominee's curriculum vitae or
resume, which must be limited to no more than 10 pages.
Every effort will be made to ensure that the Working Group is a
diverse group of individuals with representation from various
geographic locations, racial and ethnic minorities, all genders, and
persons living with disabilities.
Individuals being considered for appointment as public voting
members will be required to complete and submit a report of their
financial holdings. An ethics review must be conducted to ensure that
individuals appointed as public voting members of the Working Group are
not involved in any activity that may pose a potential conflict of
interest for the official duties that are to be performed. This is a
federal ethics requirement that must be satisfied upon entering the
position and annually throughout the established term of appointment on
the Working Group.
Dated: November 5, 2018.
James J. Berger,
Senior Advisor for Blood and Tissue Policy, Designated Federal Officer,
Tick-Borne Disease Working Group.
[FR Doc. 2018-25082 Filed 11-15-18; 8:45 am]
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