83 FR 12583 - Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 56 (March 22, 2018)

Page Range		12583-12584
FR Document		2018-05833

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).

Federal Register, Volume 83 Issue 56 (Thursday, March 22, 2018)

[Federal Register Volume 83, Number 56 (Thursday, March 22, 2018)]
[Notices]
[Pages 12583-12584]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05833]


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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: http://www.hhs.gov/advcomcfs/charter/index.html.
    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

Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Notices 12583

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB Control Date approval
Title of collection No. expires

Infant Formula Recall Regulations .......................................................................................................................... 0910–0188 12/31/2020
State Petitions for Exemptions from Preemption .................................................................................................... 0910–0277 12/31/2020
Guidance for Industry: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and
744K of the Federal Food, Drug, and Cosmetic Act ........................................................................................... 0910–0776 12/31/2020
Guidance for Industry: Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B
of the Federal Food, Drug, and Cosmetic Act ..................................................................................................... 0910–0777 12/31/2020
Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed
With, or Otherwise Containing, Material from Cattle ........................................................................................... 0910–0623 1/31/2021
Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for
Young Children Manufactured/Processors with Interest in Exporting to China .................................................. 0910–0839 1/31/2021

Dated: March 16, 2018. Assistant Secretary for Health, The Committee composition consists of
Leslie Kux, Department of Health and Human thirteen members:
Associate Commissioner for Policy. Services, 200 Independence Avenue • Seven biomedical research
[FR Doc. 2018–05797 Filed 3–21–18; 8:45 am] SW, Room 728F6, Washington, DC scientists with demonstrated expertise
BILLING CODE 4164–01–P 20201. Nomination materials, including in biomedical research applicable to
attachments, may be submitted ME/CFS;
electronically to cfsac@hhs.gov. • at least three patients or caregivers
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: CDR affected by ME/CFS; and
HUMAN SERVICES Gustavo Ceinos, Designated Federal • three individuals with expertise in
Officer, Chronic Fatigue Syndrome health care delivery, private health care
Solicitation for Applications From Advisory Committee, Office on services or insurers, or voluntary
Individuals Interested in Being Women’s Health, Office of the Assistant organizations concerned with the
Appointed to the Chronic Fatigue Secretary for Health, Department of problems of individuals with ME/CFS.
Syndrome Advisory Committee The breakdown of the six vacant
Health and Human Services, 200
positions OASH is seeking is as follows:
AGENCY: Office of the Assistant Independence Ave. SW, Room 728F6, • Four positions for biomedical
Secretary for Health, Office of the Washington, DC 20201. Inquiries may research scientists with demonstrated
Secretary, Department of Health and also be made to cfsac@hhs.gov. expertise in biomedical research
Human Services. SUPPLEMENTARY INFORMATION: CFSAC applicable to ME/CFS;
ACTION: Notice. was established on September 5, 2002. • one position for patients or
The purpose of the CFSAC is to provide caregivers affected by ME/CFS; and
Authority: 42 U.S.C. 217a, Section 222 of advice and recommendations to the • one position for an individual with
the Public Health Service Act, as amended. Secretary of HHS, through the ASH, on expertise in health care delivery, private
The Committee is governed by the provisions issues related to ME/CFS. The CFSAC health care services or insurers, or
of the Federal Advisory Committee Act, advises and makes recommendations on voluntary organizations concerned with
Public Law 92–463, as amended (5 U.S.C. a broad range of topics including: (1) the problems of individuals with ME/
App.), which sets forth standards for the
formation and use of advisory committees.
Opportunities to improve knowledge CFS.
and research about the epidemiology, Individuals selected for appointment
SUMMARY: The Office of the Assistant etiologies, biomarkers and risk factors to the Committee will serve as voting
Secretary for Health (OASH), within the for ME/CFS; (2) research on the members and may be invited to serve for
Department of Health and Human diagnosis, treatment, and management a period of four years. CFSAC members
Services (HHS), is seeking nominations of ME/CFS and potential impact of are authorized to receive a stipend for
of six qualified candidates to be treatment options; (3) strategies to conducting committee related business
considered for appointment as members inform the public, health care including attending Committee
of the Chronic Fatigue Syndrome professionals, and the biomedical meetings. Committee members also are
Advisory Committee (CFSAC). CFSAC academic and research communities authorized to receive per diem and
provides advice and recommendations about ME/CFS advances; (4) reimbursement for travel expenses
to the Secretary of HHS, through the partnerships to improve the quality of incurred for conducting Committee
Assistant Secretary for Health (ASH), on life of ME/CFS patients; and (5) related business. To qualify for
a broad range of issues and topics strategies to insure that input from ME/ consideration of appointment to the
related to myalgic encephalomyelitis/ CFS patients and caregivers is Committee, an individual must possess
chronic fatigue syndrome (ME/CFS). incorporated into HHS policy and demonstrated experience and
DATES: Applications for individuals to research. The CFSAC charter is knowledge in the designated fields or
be considered for appointment to the available at: http://www.hhs.gov/ disciplines, as well as expert knowledge
Committee must be received no later advcomcfs/charter/index.html. of the broad issues and topics pertinent
than 5 p.m. EDT on April 23, 2018 at the Management and support services for to ME/CFS.
daltland on DSKBBV9HB2PROD with NOTICES

address listed below. Committee activities are provided Nomination materials should be
ADDRESSES: All nominations should be within the OASH. The ASH provides typewritten. If mailed, please submit
mailed or delivered to Commander direction and guidance for services original documents. The nomination
(CDR) Gustavo Ceinos, MPH, Designated performed to support CFSAC activities materials should be submitted
Federal Officer, Chronic Fatigue and operation. (postmarked or received) no later than
Syndrome Advisory Committee, Office Nominations: OASH is requesting 5:00 p.m. EDT on the specified date.
on Women’s Health, Office of the nominations to fill six CFSAC positions. The following information must be part

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12584 Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Notices

of the nomination package submitted for membership. Candidates who are following three (3) published papers
each individual being nominated: selected for appointment to the and seven (7) grant applications
(1) A nomination letter clearly stating: committee are required to provide submitted to NIH:
a. Name and affiliation of the detailed information concerning such • Clin. Cancer Res. 9:3503–3513, 2003
nominee; matters as financial holdings, (hereafter referred to as ‘‘Clin. Cancer
b. qualifications of the nominee consultancies, and research grants or Res. 2003’’)
related to the focus area(s) described contracts for an ethics analysis to be • Anticancer Res. 31(12):4347–4358,
above (i.e., specific attributes which conducted to identify potential conflicts 2011 (hereafter referred to as
qualify the nominee for service in this of interest. ‘‘Anticancer Res. 2011’’)
capacity); Dated: March 14, 2018. • Int. J. Oncol. 40:13–20, 2012 (hereafter
c. area (out of the three listed above) referred to as ‘‘Int. J. Oncol. 2012’’)
Gustavo Ceinos,
the nominee is interested in • R01 CA163381–01
representing based on his/her CDR, USPHS, Designated Federal Officer,
Chronic Fatigue Syndrome Advisory • R01 CA138741–01A1
experience and background; Committee. • R01 CA106296–06A1
d. statement that the nominee is • R01 CA106296–06A2
[FR Doc. 2018–05833 Filed 3–21–18; 8:45 am]
willing to serve as a member of the • R03 CA158253–01A1
BILLING CODE 4150–42–P
Committee; • R21 CA170314–01
(2) The nominator’s name, address, • R01 ES024139–01
and daytime telephone number;
DEPARTMENT OF HEALTH AND ORI found that Respondent fabricated
(3) The home and/or work address,
HUMAN SERVICES and/or falsified Western blot data for
telephone number, and email address of
protein expression levels in cancer
the individual being nominated; Findings of Research Misconduct
(4) A current copy of the nominee’s tissues and/or cells in fifty-eight (58)
curriculum vitae or resume. The vitae or AGENCY: Office of the Secretary, HHS. blot panels included in twenty-two (22)
resume may be condensed to highlight ACTION: Notice. figures reported in three (3) papers and
the experience of the nominee related to seven (7) grant applications submitted
the focus areas described above. SUMMARY: Findings of research to NIH. In the absence of valid Western
An individual may self-nominate to misconduct have been made on the part blot images, the quantitative data
be on the Committee. Federal employees of Bhagavathi Narayanan, Ph.D., former presented in associated bar graphs and
should not be nominated for Research Associate Professor, statistical analyses also are false.
consideration of appointment to this Department of Environmental Medicine, Specifically, Respondent trimmed
Committee. Nominations that do not New York University (NYU). Dr. and/or copied Western blot images from
contain all of the above information will Narayanan engaged in research unrelated sources, manipulated them to
not be considered. misconduct in research supported by obscure their origin, and reused and
Electronic submissions: Nomination National Cancer Institute (NCI), relabeled them to represent different
materials, including attachments, may National Institutes of Health (NIH), experimental results in:
be submitted electronically to cfsac@ grants R03 CA107813, R01 CA106296, • Figures 5C, 6C, and 7C in Clin. Cancer
hhs.gov. An email from the CFSAC R01 CA106296–05S1, R03 CA133929, Res. 2003
Support Team will be sent to the and P30 CA017613. The administrative • Figures 2c, 4b, 6a, and 6b in Int. J.
nominating individual or nominee to actions, including debarment for a Oncol. 2012
confirm receipt of the nomination. If the period of three (3) years, were • Figure 2B in Anticancer Res. 2011,
email confirmation is not received implemented beginning on February 26, also as Figure 1C in R01 CA163381–
within two working days, please call 2018, and are detailed below. 01
202–690–7650. FOR FURTHER INFORMATION CONTACT: • Figure 2A in Anticancer Res. 2011,
Regular, Express, or Overnight Mail: Wanda K. Jones, Dr. P.H., Interim also as Figure 1B in R01 CA163381–
Written documents may be submitted to Director, Office of Research Integrity, 01
the following addressee only: CDR 1101 Wootton Parkway, Suite 750, • Figure 5D in Anticancer Res. 2011,
Gustavo Ceinos, MPH, Designated Rockville, MD 20852, (240) 453–8200. also as Figure 8 in R01 CA163381–01
Federal Officer, CFSAC, Office on SUPPLEMENTARY INFORMATION: Notice is • Figure 1A in R01 CA163381–01
Women’s Health, Office of the Assistant hereby given that the Office of Research • Figure 6 in R01 CA138741–01A1
Secretary for Health, Department of Integrity (ORI) has taken final action in • Figure 4 in R01 CA106296–06A1
Health and Human Services, 200 the following case: • Figure 4 in R01 CA106296–06A2
Independence Ave. SW, Room 728F6, Bhagavathi Narayanan, Ph.D., New • Figures 3 and 6 in R03 CA158253–
Washington, DC 20201. York University: Based on the report of 01A1
Telephone and facsimile submissions an investigation conducted by NYU and • Figures 3 and 4 in R21 CA170314–01
cannot be accepted. analysis conducted by ORI in its • Figures 8A and 8B in R01 ES024139–
The Department makes every effort to oversight review, ORI found that Dr. 01
ensure that the membership of federal Bhagavathi Narayanan, former Research Dr. Narayanan entered into a
advisory committees is fairly balanced Associate Professor, Department of Voluntary Exclusion Agreement and
in terms of points of view represented. Environmental Medicine, NYU, engaged voluntarily agreed, beginning on
Appointment to this Committee shall be in research misconduct in research February 26, 2018:
made without discrimination on the supported by NCI, NIH, grants R03 (1) To exclude herself for a period of
daltland on DSKBBV9HB2PROD with NOTICES

basis of age, race, ethnicity, gender, CA107813, R01 CA106296, R01 three (3) years from any contracting or
sexual orientation, disability, and CA106296–05S1, R03 CA133929, and subcontracting with any agency of the
cultural, religious, or socioeconomic P30 CA017613. United States Government and from
status. Nominations must state that the ORI found that Respondent engaged eligibility or involvement in
nominee is willing to serve as a member in research misconduct by knowingly nonprocurement programs of the United
of CFSAC and appears to have no and intentionally falsifying and/or States Government referred to as
conflict of interest that would preclude fabricating data reported in the ‘‘covered transactions’’ pursuant to

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Document Created: 2018-03-22 01:25:06
Document Modified: 2018-03-22 01:25:06

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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,
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]
FR Citation		83 FR 12583