Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee, 12583-12584 [2018-05833]
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Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Notices
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Guidance for Industry: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and
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Dated: March 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05797 Filed 3–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation for Applications From
Individuals Interested in Being
Appointed to the Chronic Fatigue
Syndrome Advisory Committee
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
Authority: 42 U.S.C. 217a, Section 222 of
the Public Health Service Act, as amended.
The Committee is governed by the 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 advisory committees.
The Office of the Assistant
Secretary for Health (OASH), within the
Department of Health and Human
Services (HHS), is seeking nominations
of six qualified candidates to be
considered for appointment as members
of the Chronic Fatigue Syndrome
Advisory Committee (CFSAC). CFSAC
provides advice and recommendations
to the Secretary of HHS, through the
Assistant Secretary for Health (ASH), on
a broad range of issues and topics
related to myalgic encephalomyelitis/
chronic fatigue syndrome (ME/CFS).
DATES: Applications for individuals to
be considered for appointment to the
Committee must be received no later
than 5 p.m. EDT on April 23, 2018 at the
address listed below.
ADDRESSES: All nominations should be
mailed or delivered to Commander
(CDR) Gustavo Ceinos, MPH, Designated
Federal Officer, Chronic Fatigue
Syndrome Advisory Committee, Office
on Women’s Health, Office of the
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:32 Mar 21, 2018
Jkt 244001
Assistant Secretary for Health,
Department of Health and Human
Services, 200 Independence Avenue
SW, Room 728F6, Washington, DC
20201. Nomination materials, including
attachments, may be submitted
electronically to cfsac@hhs.gov.
FOR FURTHER INFORMATION CONTACT: CDR
Gustavo Ceinos, Designated Federal
Officer, Chronic Fatigue Syndrome
Advisory Committee, Office on
Women’s Health, Office of the Assistant
Secretary for Health, Department of
Health and Human Services, 200
Independence Ave. SW, Room 728F6,
Washington, DC 20201. Inquiries may
also be made to cfsac@hhs.gov.
SUPPLEMENTARY INFORMATION: CFSAC
was established on September 5, 2002.
The purpose of the CFSAC is to provide
advice and recommendations to the
Secretary of HHS, through the ASH, on
issues related to ME/CFS. The CFSAC
advises and makes recommendations on
a broad range of topics including: (1)
Opportunities to improve knowledge
and research about the epidemiology,
etiologies, biomarkers and risk factors
for ME/CFS; (2) research on the
diagnosis, treatment, and management
of ME/CFS and potential impact of
treatment options; (3) strategies to
inform the public, health care
professionals, and the biomedical
academic and research communities
about ME/CFS advances; (4)
partnerships to improve the quality of
life of ME/CFS patients; and (5)
strategies to insure that input from ME/
CFS patients and caregivers is
incorporated into HHS policy and
research. The CFSAC charter is
available at: https://www.hhs.gov/
advcomcfs/charter/.
Management and support services for
Committee activities are provided
within the OASH. The ASH provides
direction and guidance for services
performed to support CFSAC activities
and operation.
Nominations: OASH is requesting
nominations to fill six CFSAC positions.
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Date approval
expires
0910–0188
0910–0277
12/31/2020
12/31/2020
0910–0776
12/31/2020
0910–0777
12/31/2020
0910–0623
1/31/2021
0910–0839
1/31/2021
The Committee composition consists of
thirteen members:
• Seven biomedical research
scientists with demonstrated expertise
in biomedical research applicable to
ME/CFS;
• at least three patients or caregivers
affected by ME/CFS; and
• three individuals with expertise in
health care delivery, private health care
services or insurers, or voluntary
organizations concerned with the
problems of individuals with ME/CFS.
The breakdown of the six vacant
positions OASH is seeking is as follows:
• Four positions for biomedical
research scientists with demonstrated
expertise in biomedical research
applicable to ME/CFS;
• one position for patients or
caregivers affected by ME/CFS; and
• one position for an individual with
expertise in health care delivery, private
health care services or insurers, or
voluntary organizations concerned with
the problems of individuals with ME/
CFS.
Individuals selected for appointment
to the Committee will serve as voting
members and may be invited to serve for
a period of four years. CFSAC members
are authorized to receive a stipend for
conducting committee related business
including attending Committee
meetings. Committee members also are
authorized to receive per diem and
reimbursement for travel expenses
incurred for conducting Committee
related business. To qualify for
consideration of appointment to the
Committee, an individual must possess
demonstrated experience and
knowledge in the designated fields or
disciplines, as well as expert knowledge
of the broad issues and topics pertinent
to ME/CFS.
Nomination materials should be
typewritten. If mailed, please submit
original documents. The nomination
materials should be submitted
(postmarked or received) no later than
5:00 p.m. EDT on the specified date.
The following information must be part
E:\FR\FM\22MRN1.SGM
22MRN1
daltland on DSKBBV9HB2PROD with NOTICES
12584
Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Notices
of the nomination package submitted for
each individual being nominated:
(1) A nomination letter clearly stating:
a. Name and affiliation of the
nominee;
b. qualifications of the nominee
related to the focus area(s) described
above (i.e., specific attributes which
qualify the nominee for service in this
capacity);
c. area (out of the three listed above)
the nominee is interested in
representing based on his/her
experience and background;
d. statement that the nominee is
willing to serve as a member of the
Committee;
(2) The nominator’s name, address,
and daytime telephone number;
(3) The home and/or work address,
telephone number, and email address of
the individual being nominated;
(4) A current copy of the nominee’s
curriculum vitae or resume. The vitae or
resume may be condensed to highlight
the experience of the nominee related to
the focus areas described above.
An individual may self-nominate to
be on the Committee. Federal employees
should not be nominated for
consideration of appointment to this
Committee. Nominations that do not
contain all of the above information will
not be considered.
Electronic submissions: Nomination
materials, including attachments, may
be submitted electronically to cfsac@
hhs.gov. An email from the CFSAC
Support Team will be sent to the
nominating individual or nominee to
confirm receipt of the nomination. If the
email confirmation is not received
within two working days, please call
202–690–7650.
Regular, Express, or Overnight Mail:
Written documents may be submitted to
the following addressee only: CDR
Gustavo Ceinos, MPH, Designated
Federal Officer, CFSAC, Office on
Women’s Health, Office of the Assistant
Secretary for Health, Department of
Health and Human Services, 200
Independence Ave. SW, Room 728F6,
Washington, DC 20201.
Telephone and facsimile submissions
cannot be accepted.
The Department makes every effort to
ensure that the membership of federal
advisory committees is fairly balanced
in terms of points of view represented.
Appointment to this Committee shall be
made without discrimination on the
basis of age, race, ethnicity, gender,
sexual orientation, disability, and
cultural, religious, or socioeconomic
status. Nominations must state that the
nominee is willing to serve as a member
of CFSAC and appears to have no
conflict of interest that would preclude
VerDate Sep<11>2014
19:32 Mar 21, 2018
Jkt 244001
membership. Candidates who are
selected for appointment to the
committee are required to provide
detailed information concerning such
matters as financial holdings,
consultancies, and research grants or
contracts for an ethics analysis to be
conducted to identify potential conflicts
of interest.
Dated: March 14, 2018.
Gustavo Ceinos,
CDR, USPHS, Designated Federal Officer,
Chronic Fatigue Syndrome Advisory
Committee.
[FR Doc. 2018–05833 Filed 3–21–18; 8:45 am]
BILLING CODE 4150–42–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Findings of research
misconduct have been made on the part
of Bhagavathi Narayanan, Ph.D., former
Research Associate Professor,
Department of Environmental Medicine,
New York University (NYU). Dr.
Narayanan engaged in research
misconduct in research supported by
National Cancer Institute (NCI),
National Institutes of Health (NIH),
grants R03 CA107813, R01 CA106296,
R01 CA106296–05S1, R03 CA133929,
and P30 CA017613. The administrative
actions, including debarment for a
period of three (3) years, were
implemented beginning on February 26,
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: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Bhagavathi Narayanan, Ph.D., New
York University: Based on the report of
an investigation conducted by NYU and
analysis conducted by ORI in its
oversight review, ORI found that Dr.
Bhagavathi Narayanan, former Research
Associate Professor, Department of
Environmental Medicine, NYU, engaged
in research misconduct in research
supported by NCI, NIH, grants R03
CA107813, R01 CA106296, R01
CA106296–05S1, R03 CA133929, and
P30 CA017613.
ORI found that Respondent engaged
in research misconduct by knowingly
and intentionally falsifying and/or
fabricating data reported in the
SUMMARY:
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
following three (3) published papers
and seven (7) grant applications
submitted to NIH:
• Clin. Cancer Res. 9:3503–3513, 2003
(hereafter referred to as ‘‘Clin. Cancer
Res. 2003’’)
• Anticancer Res. 31(12):4347–4358,
2011 (hereafter referred to as
‘‘Anticancer Res. 2011’’)
• Int. J. Oncol. 40:13–20, 2012 (hereafter
referred to as ‘‘Int. J. Oncol. 2012’’)
• R01 CA163381–01
• R01 CA138741–01A1
• R01 CA106296–06A1
• R01 CA106296–06A2
• R03 CA158253–01A1
• R21 CA170314–01
• R01 ES024139–01
ORI found that Respondent fabricated
and/or falsified Western blot data for
protein expression levels in cancer
tissues and/or cells in fifty-eight (58)
blot panels included in twenty-two (22)
figures reported in three (3) papers and
seven (7) grant applications submitted
to NIH. In the absence of valid Western
blot images, the quantitative data
presented in associated bar graphs and
statistical analyses also are false.
Specifically, Respondent trimmed
and/or copied Western blot images from
unrelated sources, manipulated them to
obscure their origin, and reused and
relabeled them to represent different
experimental results in:
• Figures 5C, 6C, and 7C in Clin. Cancer
Res. 2003
• Figures 2c, 4b, 6a, and 6b in Int. J.
Oncol. 2012
• Figure 2B in Anticancer Res. 2011,
also as Figure 1C in R01 CA163381–
01
• Figure 2A in Anticancer Res. 2011,
also as Figure 1B in R01 CA163381–
01
• Figure 5D in Anticancer Res. 2011,
also as Figure 8 in R01 CA163381–01
• Figure 1A in R01 CA163381–01
• Figure 6 in R01 CA138741–01A1
• Figure 4 in R01 CA106296–06A1
• Figure 4 in R01 CA106296–06A2
• Figures 3 and 6 in R03 CA158253–
01A1
• Figures 3 and 4 in R21 CA170314–01
• Figures 8A and 8B in R01 ES024139–
01
Dr. Narayanan entered into a
Voluntary Exclusion Agreement and
voluntarily agreed, beginning on
February 26, 2018:
(1) To exclude herself for a period of
three (3) years 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
E:\FR\FM\22MRN1.SGM
22MRN1
]]>Agencies
[Federal Register Volume 83, Number 56 (Thursday, March 22, 2018)]
[Notices]
[Pages 12583-12584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05833]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation for Applications From Individuals Interested in
Being Appointed to the Chronic Fatigue Syndrome Advisory Committee
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
Authority: 42 U.S.C. 217a, Section 222 of the Public Health
Service Act, as amended. The Committee is governed by the 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 advisory committees.
SUMMARY: The Office of the Assistant Secretary for Health (OASH),
within the Department of Health and Human Services (HHS), is seeking
nominations of six qualified candidates to be considered for
appointment as members of the Chronic Fatigue Syndrome Advisory
Committee (CFSAC). CFSAC provides advice and recommendations to the
Secretary of HHS, through the Assistant Secretary for Health (ASH), on
a broad range of issues and topics related to myalgic
encephalomyelitis/chronic fatigue syndrome (ME/CFS).
DATES: Applications for individuals to be considered for appointment to
the Committee must be received no later than 5 p.m. EDT on April 23,
2018 at the address listed below.
ADDRESSES: All nominations should be mailed or delivered to Commander
(CDR) Gustavo Ceinos, MPH, Designated Federal Officer, Chronic Fatigue
Syndrome Advisory Committee, Office on Women's Health, Office of the
Assistant Secretary for Health, Department of Health and Human
Services, 200 Independence Avenue SW, Room 728F6, Washington, DC 20201.
Nomination materials, including attachments, may be submitted
electronically to [email protected].
FOR FURTHER INFORMATION CONTACT: CDR Gustavo Ceinos, Designated Federal
Officer, Chronic Fatigue Syndrome Advisory Committee, Office on Women's
Health, Office of the Assistant Secretary for Health, Department of
Health and Human Services, 200 Independence Ave. SW, Room 728F6,
Washington, DC 20201. Inquiries may also be made to [email protected].
SUPPLEMENTARY INFORMATION: CFSAC was established on September 5, 2002.
The purpose of the CFSAC is to provide advice and recommendations to
the Secretary of HHS, through the ASH, on issues related to ME/CFS. The
CFSAC advises and makes recommendations on a broad range of topics
including: (1) Opportunities to improve knowledge and research about
the epidemiology, etiologies, biomarkers and risk factors for ME/CFS;
(2) research on the diagnosis, treatment, and management of ME/CFS and
potential impact of treatment options; (3) strategies to inform the
public, health care professionals, and the biomedical academic and
research communities about ME/CFS advances; (4) partnerships to improve
the quality of life of ME/CFS patients; and (5) strategies to insure
that input from ME/CFS patients and caregivers is incorporated into HHS
policy and research. The CFSAC charter is available at: https://www.hhs.gov/advcomcfs/charter/.
Management and support services for Committee activities are
provided within the OASH. The ASH provides direction and guidance for
services performed to support CFSAC activities and operation.
Nominations: OASH is requesting nominations to fill six CFSAC
positions. The Committee composition consists of thirteen members:
Seven biomedical research scientists with demonstrated
expertise in biomedical research applicable to ME/CFS;
at least three patients or caregivers affected by ME/CFS;
and
three individuals with expertise in health care delivery,
private health care services or insurers, or voluntary organizations
concerned with the problems of individuals with ME/CFS.
The breakdown of the six vacant positions OASH is seeking is as
follows:
Four positions for biomedical research scientists with
demonstrated expertise in biomedical research applicable to ME/CFS;
one position for patients or caregivers affected by ME/
CFS; and
one position for an individual with expertise in health
care delivery, private health care services or insurers, or voluntary
organizations concerned with the problems of individuals with ME/CFS.
Individuals selected for appointment to the Committee will serve as
voting members and may be invited to serve for a period of four years.
CFSAC members are authorized to receive a stipend for conducting
committee related business including attending Committee meetings.
Committee members also are authorized to receive per diem and
reimbursement for travel expenses incurred for conducting Committee
related business. To qualify for consideration of appointment to the
Committee, an individual must possess demonstrated experience and
knowledge in the designated fields or disciplines, as well as expert
knowledge of the broad issues and topics pertinent to ME/CFS.
Nomination materials should be typewritten. If mailed, please
submit original documents. The nomination materials should be submitted
(postmarked or received) no later than 5:00 p.m. EDT on the specified
date. The following information must be part
[[Page 12584]]
of the nomination package submitted for each individual being
nominated:
(1) A nomination letter clearly stating:
a. Name and affiliation of the nominee;
b. qualifications of the nominee related to the focus area(s)
described above (i.e., specific attributes which qualify the nominee
for service in this capacity);
c. area (out of the three listed above) the nominee is interested
in representing based on his/her experience and background;
d. statement that the nominee is willing to serve as a member of
the Committee;
(2) The nominator's name, address, and daytime telephone number;
(3) The home and/or work address, telephone number, and email
address of the individual being nominated;
(4) A current copy of the nominee's curriculum vitae or resume. The
vitae or resume may be condensed to highlight the experience of the
nominee related to the focus areas described above.
An individual may self-nominate to be on the Committee. Federal
employees should not be nominated for consideration of appointment to
this Committee. Nominations that do not contain all of the above
information will not be considered.
Electronic submissions: Nomination materials, including
attachments, may be submitted electronically to [email protected]. An email
from the CFSAC Support Team will be sent to the nominating individual
or nominee to confirm receipt of the nomination. If the email
confirmation is not received within two working days, please call 202-
690-7650.
Regular, Express, or Overnight Mail: Written documents may be
submitted to the following addressee only: CDR Gustavo Ceinos, MPH,
Designated Federal Officer, CFSAC, Office on Women's Health, Office of
the Assistant Secretary for Health, Department of Health and Human
Services, 200 Independence Ave. SW, Room 728F6, Washington, DC 20201.
Telephone and facsimile submissions cannot be accepted.
The Department makes every effort to ensure that the membership of
federal advisory committees is fairly balanced in terms of points of
view represented. Appointment to this Committee shall be made without
discrimination on the basis of age, race, ethnicity, gender, sexual
orientation, disability, and cultural, religious, or socioeconomic
status. Nominations must state that the nominee is willing to serve as
a member of CFSAC and appears to have no conflict of interest that
would preclude membership. Candidates who are selected for appointment
to the committee are required to provide detailed information
concerning such matters as financial holdings, consultancies, and
research grants or contracts for an ethics analysis to be conducted to
identify potential conflicts of interest.
Dated: March 14, 2018.
Gustavo Ceinos,
CDR, USPHS, Designated Federal Officer, Chronic Fatigue Syndrome
Advisory Committee.
[FR Doc. 2018-05833 Filed 3-21-18; 8:45 am]
BILLING CODE 4150-42-P
