83 FR 57739 - Solicitation of Nominations for Appointment to the Tick-Borne Disease Working Group

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 222 (November 16, 2018)

Page Range		57739-57740
FR Document		2018-25082

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.

Federal Register, Volume 83 Issue 222 (Friday, November 16, 2018)

[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)]
[Notices]
[Pages 57739-57740]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25082]


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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/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 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]
BILLING CODE 4150-28-P

Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices 57739

HRSA specifically requests comments application 1 R01 CA175776–01, October 22, 2018, and end on October
on: (1) The necessity and utility of the ‘‘Regulation of Mitochondrial 21, 2020.
proposed information collection for the Metabolism by SIRT4,’’ submitted to Thus, the research misconduct
proper performance of the agency’s NCI, NIH, to obtain U.S. Public Health finding set forth above became effective,
functions; (2) the accuracy of the Service (PHS) funds. Specifically, ORI and the following administrative actions
estimated burden; (3) ways to enhance found that the Respondent intentionally have been implemented for a period of
the quality, utility, and clarity of the and knowingly plagiarized scientifically two (2) years, beginning on October 22,
information to be collected; and (4) the significant text from the Specific Aims 2018:
use of automated collection techniques and Research Strategy sections of a grant (1) Dr. Srivastava is debarred from any
or other forms of information application under review at NIH into his contracting or subcontracting with any
technology to minimize the information own grant application, 1 R01 agency of the United States Government
collection burden. CA175776–01, submitted to NIH eight and from eligibility or involvement in
Amy P. McNulty, months later. Significant text was nonprocurement programs of the United
included in Respondent’s grant States Government referred to as
Acting Director, Division of the Executive
Secretariat. application, with plagiarized text ‘‘covered transactions’’ pursuant to
accounting for 40% of the Specific Aims HHS’ Implementation (2 CFR part 376)
[FR Doc. 2018–25070 Filed 11–15–18; 8:45 am]
and 50% of the Research Strategy of Office of Management and Budget
BILLING CODE 4165–15–P
sections. (OMB) Guidelines to Agencies on
Governmentwide Debarment and
ORI issued a charge letter making a Suspension (2 CFR part 180); and
DEPARTMENT OF HEALTH AND finding of research misconduct and
HUMAN SERVICES (2) Dr. Srivastava is prohibited from
proposing HHS administrative actions. serving in any advisory capacity to PHS
Office of the Secretary Dr. Srivastava subsequently requested a including, but not limited to, service on
hearing before an Administrative Law any PHS advisory committee, board,
Findings of Research Misconduct Judge (ALJ) of the Departmental Appeals and/or peer review committee, or as a
Board to dispute the finding. ORI moved consultant.
AGENCY: Office of the Secretary, HHS. for summary judgment. On September 5,
ACTION: Notice. 2018, the ALJ granted summary Wanda K. Jones,
judgment in favor of ORI and issued his Interim Director, Office of Research Integrity.
SUMMARY: Notice is hereby given that on
recommended decision, finding that [FR Doc. 2018–25065 Filed 11–15–18; 8:45 am]
October 22, 2018, the U.S. Department
of Health and Human Services (HHS) Respondent intentionally committed BILLING CODE 4150–31–P

Debarring Official, on behalf of the research misconduct by submitting to
Secretary of HHS, issued a final notice NIH a grant application that included
plagiarized words, which included DEPARTMENT OF HEALTH AND
of debarment based on an
significant text from another principal HUMAN SERVICES
Administrative Law Judge’s finding of
research misconduct against Rakesh investigator’s grant application that was
Solicitation of Nominations for
Srivastava, Ph.D., former Eminent contained in the Specific Aims and
Appointment to the Tick-Borne
Scholar and Professor, University of Research Strategy sections of the
Disease Working Group
Kansas Medical Center (KUMC). Dr. Respondent’s grant application without
Srivastava engaged in research attribution to the other principal AGENCY: Office of HIV/AIDS and
misconduct in research proposed or investigator. The ALJ held that Infectious Disease Policy, Office of the
reported in grant application 1 R01 appropriate administrative actions Assistant Secretary for Health, Office of
CA175776–01, submitted to the included a two-year debarment from the Secretary, Department of Health and
National Cancer Institute (NCI), any contracting or subcontracting with Human Services.
National Institutes of Health (NIH), on any agency of the United States ACTION: Notice.
June 5, 2012. The administrative Government and from eligibility for or
actions, including two (2) years of involvement in nonprocurement SUMMARY: This notice will serve to
debarment, were implemented programs of the United States announce that the U.S. Department of
beginning on October 22, 2018, and are Government referred to as ‘‘covered Health and Human Services (HHS) is
detailed below. transactions.’’ 2 CFR parts 180 and 376. seeking nominations of non-federal
FOR FURTHER INFORMATION CONTACT: The ALJ held that it was an appropriate individuals who represent diverse
Wanda K. Jones, Dr. P.H., Interim administrative action to also impose a scientific disciplines and views and are
Director, Office of Research Integrity, two-year prohibition from serving in interested in being considered for
1101 Wootton Parkway, Suite 750, any capacity to PHS including, but not appointment to the Tick-Borne Disease
Rockville, MD 20852, (240) 453–8200. limited to, service on any PHS advisory Working Group (Working Group).
SUPPLEMENTARY INFORMATION: committee, board, or peer review Resumes or curricula vitae from
Rakesh Srivastava, Ph.D., University committee, or as a consultant. Under the qualified individuals who wish to be
of Kansas Medical Center: Based on the regulation, the ALJ’s recommended considered for appointment as a
evidence and findings of an decision went to the Assistant Secretary member of the Working Group are
investigation conducted by KUMC and for Health, who did not modify it and currently being accepted.
additional information obtained by the forwarded it to the HHS Debarring DATES: Nominations must be received
amozie on DSK3GDR082PROD with NOTICES

Office of Research Integrity (ORI) during Official, who is the deciding official for no later than 5:00 p.m. EST, on
its oversight review, ORI found by a the debarment. The ALJ decision December 14, 2018.
preponderance of the evidence that Dr. constituted the findings of fact to the ADDRESSES: All nominations should be
Rakesh Srivastava (Respondent), former HHS Debarring Official in accordance sent to the Tick-Borne Disease Working
Eminent Scholar and Professor, KUMC, with 2 CFR 180.845(c). On October 22, Group email address at
intentionally and knowingly submitted 2018, the HHS Debarring Official issued tickbornedisease@hhs.gov. Alternately,
extensive plagiarized text in grant a final notice of debarment to begin on nominations can be sent by mail to:

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57740 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices

James Berger, MS, MT (ASCP), SBB, non-federal public members consist of should include, at a minimum, the
Senior Advisor for Blood and Tissue representatives of the following following for each nominee: (1) A letter
Policy, Office of HIV/AIDS and categories: Physicians and other medical of nomination that clearly states the
Infectious Disease Policy, Office of the providers with experience in diagnosing name and affiliation of the nominee, the
Assistant Secretary for Health, U.S. and treating tick-borne diseases; basis for the nomination, and a
Department of Health and Human scientists or researchers with expertise; statement from the nominee that
Services, 330 C Street SW, Room L001 patients and their family members; and indicates that the individual is willing
Switzer Building, Washington, DC nonprofit organizations that advocate to serve as a member of the Working
20201. for patients with respect to tick-borne Group, if selected; (2) the nominator’s
FOR FURTHER INFORMATION CONTACT: disease. Individuals who are appointed name, address, and daytime telephone
James Berger, MS, MT (ASCP), SBB, to represent federal entities are number, and the address, telephone
Senior Advisor for Blood and Tissue classified as regular government number, and email address of the
Policy; Telephone: (202) 795–7608; Fax: employees. The public members are individual being nominated; and (3) a
(202) 691–2101; Email address: classified as special government current copy of the nominee’s
tickbornedisease@hhs.gov. Website employees. Invitations of membership is curriculum vitae or resume, which must
information about activities of the extended to other agencies and offices of be limited to no more than 10 pages.
Working Group, as well as the charter the Department of Health and Human Every effort will be made to ensure
for the Working Group, which has been Services and other individuals as that the Working Group is a diverse
filed with the Library of Congress, can determined by the Secretary to be group of individuals with representation
be found at https://www.hhs.gov/ash/ appropriate and beneficial for from various geographic locations, racial
advisory-committees/tickbornedisease/ accomplishing the mission of the and ethnic minorities, all genders, and
index.html. Working Group. persons living with disabilities.
The federal members are appointed to Individuals being considered for
SUPPLEMENTARY INFORMATION: Section serve for the duration of time that the appointment as public voting members
2062 of the 21st Century Cures Act Working Group is authorized to operate. will be required to complete and submit
requires establishment of the Tick-Borne Participation of the appointed federal a report of their financial holdings. An
Disease Working Group. The Working members is at the discretion of their ethics review must be conducted to
Group is governed by provisions of the respective agency head. The public ensure that individuals appointed as
Federal Advisory Committee Act, Public members are invited to serve public voting members of the Working
Law 92–463, as amended (5 U.S.C. overlapping terms of up to four years. Group are not involved in any activity
App.), which sets forth standards for the Any public member who is appointed to that may pose a potential conflict of
formation and use of federal advisory fill the vacancy of an unexpired term interest for the official duties that are to
committees. The 21st Century Cures Act will be appointed to serve for the be performed. This is a federal ethics
is intended to advance the research and remainder of that term. A non-federal requirement that must be satisfied upon
development of new therapies and public member may serve after the entering the position and annually
diagnostics and make substantial federal expiration of their term until their throughout the established term of
investments in a wide range of health successor has taken office, but no longer appointment on the Working Group.
priorities. The Working Group is a non- than 180 days. Terms of more than two
discretionary federal advisory Dated: November 5, 2018.
years are contingent upon renewal of
committee. the charter of the Working Group. James J. Berger,
Objectives and Scope of Activities. Pursuant to advance written agreement, Senior Advisor for Blood and Tissue Policy,
The Secretary of Health and Human public members of the Working Group Designated Federal Officer, Tick-Borne
Services is responsible for ensuring the will receive no stipend for the advisory Disease Working Group.
conduct of and support for service that they render as members of [FR Doc. 2018–25082 Filed 11–15–18; 8:45 am]
epidemiological, basic, translational, the Working Group. However, public BILLING CODE 4150–28–P
and clinical research related to vector- members will receive per diem and
borne diseases, including tick-borne reimbursement for travel expenses
diseases. The Working Group provides incurred in relation to performing duties DEPARTMENT OF HEALTH AND
assistance for this effort. The Working for the Working Group, as authorized by HUMAN SERVICES
Group membership provides expertise law under 5 U.S.C. 5703 for persons
and reviews all efforts within the National Institutes of Health
who are employed intermittently to
Department of Health and Human perform services for the federal Center for Scientific Review; Notice of
Services related to all tick-borne government and in accordance with Closed Meetings
diseases, to help ensure interagency federal travel regulations.
coordination and minimize overlap, and Estimated Number and Frequency of Pursuant to section 10(d) of the
to examine research priorities. Meetings. The Working Group will meet Federal Advisory Committee Act, as
Membership and Designation. The not less than twice a year. The meetings amended, notice is hereby given of the
Working Group consists of 14 voting will be open to the public, except as following meetings.
members who represent diverse determined otherwise by the Secretary, The meetings will be closed to the
scientific disciplines and views. The or another official to whom authority public in accordance with the
composition includes seven federal has been delegated, in accordance with provisions set forth in sections
members and seven public members. the guidelines under Government in the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
amozie on DSK3GDR082PROD with NOTICES

The federal members consist of one or Sunshine Act, 5 U.S.C. 552b(c). as amended. The grant applications and
more representatives of each of the Nominations: Nominations, including the discussions could disclose
following HHS agencies: Office of the self-nominations, of individuals who confidential trade secrets or commercial
Assistant Secretary for Health, the Food have the specified expertise and property such as patentable material,
and Drug Administration, the Centers knowledge will be considered for and personal information concerning
for Disease Control and Prevention, and appointment as public voting members individuals associated with the grant
the National Institutes of Health. The of the Working Group. A nomination applications, the disclosure of which

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Document Created: 2018-11-16 07:22:23
Document Modified: 2018-11-16 07:22:23

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		Nominations must be received no later than 5:00 p.m. EST, on December 14, 2018.
Contact		James Berger, MS, MT (ASCP), SBB, Senior Advisor for Blood and Tissue Policy; Telephone: (202) 795-7608;
FR Citation		83 FR 57739