83 FR 63661 - Nominations to the Advisory Committee on Blood and Tissue Safety and Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 237 (December 11, 2018)

Page Range		63661-63662
FR Document		2018-26756

The Office of Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). ACBTSA is a Federal advisory committee within the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBTSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to four-year terms.

Federal Register, Volume 83 Issue 237 (Tuesday, December 11, 2018)

[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Notices]
[Pages 63661-63662]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26756]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Nominations to the Advisory Committee on Blood and Tissue Safety 
and Availability

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: The Office of Assistant Secretary for Health (OASH) is seeking 
nominations of qualified individuals to be considered for appointment 
as members of the Advisory Committee on Blood and Tissue Safety and 
Availability (ACBTSA). ACBTSA is a Federal advisory committee within 
the Department of Health and Human Services. Management support for the 
activities of this Committee is the responsibility of the OASH. The 
qualified individuals will be nominated to the Secretary of Health and 
Human Services for consideration of appointment as members of the 
ACBTSA. Members of the Committee, including the Chair, are appointed by 
the Secretary. Members are invited to serve on the Committee for up to 
four-year terms.

DATES: All nominations must be received no later than 4:00 p.m. ET on 
Friday, December 28 2018 at the address listed below.

ADDRESSES: All nominations should be sent to the ACBTSA email address 
at [email protected]. Alternatively, nominations can be mailed or 
delivered to: Mr. James Berger, Senior Advisor for Blood and Tissue 
Policy, Office of Assistant Secretary for Health, Department of Health 
and Human Services, 330 C Street SW, Room L001 Switzer Building, 
Washington, DC 20201. Telephone: (202) 795-7608; Email [email protected].

FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Senior Advisor for 
Blood and Tissue Policy. Contact information for Mr. Berger is provided 
above.
    A copy of the Committee charter and roster of the current 
membership can be obtained by contacting Mr. Berger or by

[[Page 63662]]

accessing the ACBTSA website at http://www.hhs.gov/bloodsafety.

SUPPLEMENTARY INFORMATION: The ACBTSA provides advice to the Secretary 
through the Assistant Secretary for Health. The Committee advises on a 
range of policy issues to include: (1) Broad public health, ethical and 
legal issues related to transfusion and transplantation safety, (2) 
risk communications related to blood transfusion and tissue 
transplantation, and (3) the identification of public health issues 
that affect the availability of blood, blood products, and tissues.
    The Committee consists of 23 voting members; 14 public members, 
including the Chair, and nine (9) individuals designated to serve as 
official representative members. The public members are selected from 
State and local organizations, patient advocacy groups, provider 
organizations, academic researchers, ethicists, physicians, surgeons, 
scientists, risk communication experts, consumer advocates, and from 
among communities of persons who are frequent recipients of blood or 
blood products or who have received tissues or organs. The nine 
individuals who are appointed as official representatives are selected 
to serve the interests of the blood, blood products, tissue and organ 
professional organizations or business sectors. The representative 
members are selected from the following groups: The AABB (formerly the 
American Association of Blood Banks); American Association of Tissue 
Banks; Eye Bank Association of America; Association of Organ 
Procurement Organizations; and one of either the American Red Cross or 
America's Blood Centers. The Committee composition can include 
additional representation from either the plasma protein fraction 
community or a trade organization; a manufacturer of blood, plasma, or 
other tissue/organ test kits; a manufacturer of blood, plasma or other 
tissue/organ equipment; a major hospital organization; or a major 
hospital accreditation organization. Where more than one company 
produces a specified product or process, representatives from those 
companies shall rotate on the same schedule as public members.
    All ACBTSA members are authorized to receive the prescribed per 
diem allowance and reimbursement for travel expenses that are incurred 
to attend meetings and conduct Committee-related business, in 
accordance with Standard Government Travel Regulations. Individuals who 
are appointed to serve as public members are authorized also to receive 
a stipend for attending Committee meetings and to carry out other 
Committee-related business. Individuals who are appointed to serve as 
representative members for a particular interest group or industry are 
not authorized to receive a stipend for the performance of these 
duties.
    This announcement is to solicit nominations of qualified candidates 
to five public member positions on the ACBTSA.

Nominations

    In accordance with the charter, persons nominated for appointment 
as members of the ACBTSA should be among authorities knowledgeable in 
blood banking, tissue banking, transfusion medicine, organ or tissue 
transplantation, plasma therapies, transfusion and transplantation 
safety, bioethics, socioeconomics, health policy/law, and/or related 
disciplines. Nominations should be typewritten. The following 
information should be included in the package of material submitted for 
each individual being nominated for consideration of appointment: (a) 
The name, return address, daytime telephone number and affiliation(s) 
of the individual being nominated, the basis for the individual's 
nomination, the category for which the individual is being nominated, 
and a statement bearing an original signature of the nominated 
individual that, if appointed, he or she is willing to serve as a 
member of the Committee; (b) the name, return address, and daytime 
telephone number at which the nominator may be contacted. 
Organizational nominators must identify a principal contact person in 
addition to the contact; and (c) a copy of a current curriculum vitae 
or resume for the nominated individual.
    Individuals can nominate themselves for consideration of 
appointment to the Committee. All nominations must include the required 
information. Incomplete nominations will not be processed for 
consideration. The letter from the nominator and certification of the 
nominated individual must bear original signatures; reproduced copies 
of these signatures are not acceptable.
    The Department is legally required to ensure that the membership of 
HHS Federal advisory committees is fairly balanced in terms of points 
of view represented and the functions to be performed by the advisory 
committee. Every effort is made to ensure that the views of women, all 
ethnic and racial groups, and people with disabilities are represented 
on HHS Federal Advisory committees and, therefore, the Department 
encourages nominations of qualified candidates from these groups. The 
Department also encourages geographic diversity in the composition of 
the committee. 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.
    The Standards of Ethical Conduct for Employees of the Executive 
Branch are applicable to individuals who are appointed as public 
members of Federal advisory committees. Individuals appointed to serve 
as public members of Federal advisory committees are classified as 
special government employees (SGEs). SGEs are government employees for 
purposes of the conflict of interest laws. Therefore, individuals 
appointed to serve as public members of the ACBTSA are subject to an 
ethics review. The ethics review is conducted to determine if the 
individual has any interests and/or activities in the private sector 
that may conflict with performance of their official duties as a member 
of the Committee. Individuals appointed to serve as public members of 
the committee will be required to disclose information regarding 
financial holdings, consultancies, and research grants and/or 
contracts.

    Dated: October 19, 2018.
James J. Berger,
Senior Advisor for Blood and Tissue Policy, Designated Federal Officer, 
Advisory Committee on Blood and Tissue Safety and Availability.
[FR Doc. 2018-26756 Filed 12-10-18; 8:45 am]
 BILLING CODE 4150-41-P

Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices 63661

of Federal Claims No: 18–1590V Court of Federal Claims No: 18–1636V 114. Joan Neptune, Franklin, Tennessee,
53. Lisa Sinko, Farmington Hills, Michigan, 83. Virginia Powell, Dallas, Texas, Court of Court of Federal Claims No: 18–1681V
Court of Federal Claims No: 18–1592V Federal Claims No: 18–1638V 115. Lindsey Miller, Los Angeles, California,
54. Travis Reitter, Oakland, California, Court 84. Kathleen Mitzner, Livingston, Montana, Court of Federal Claims No: 18–1682V
of Federal Claims No: 18–1593V Court of Federal Claims No: 18–1639V 116. April L. Strang-Kutay, Lancaster,
55. Connie Tregle, Lake Charles, Louisiana, 85. Azusa Nash on behalf of U.C.N., Pennsylvania, Court of Federal Claims
Court of Federal Claims No: 18–1596V Richmond, Virginia, Court of Federal No: 18–1683V
56. Scott Skiles and Misty Skiles on behalf Claims No: 18–1640V [FR Doc. 2018–26760 Filed 12–10–18; 8:45 am]
of M. S., Boston, Massachusetts, Court of 86. Christopher W. Lindbloom, Richmond,
Virginia, Court of Federal Claims No: 18– BILLING CODE 4165–15–P
Federal Claims No: 18–1597V
57. Brenda L. Slay, Salina, Kansas, Court of 1642V
Federal Claims No: 18–1598V 87. Francesca Ohanian, Foster City,
58. Michele Bernardo, West Chester, California, Court of Federal Claims No: DEPARTMENT OF HEALTH AND
Pennsylvania, Court of Federal Claims 18–1643V HUMAN SERVICES
No: 18–1599V 88. Rebecca Huffman, Fort Wayne, Indiana,
59. Lisa Whitehead-Williams, Chicago, Court of Federal Claims No: 18–1646V Nominations to the Advisory
Illinois, Court of Federal Claims No: 18– 89. Brenda Rae Smith, Bethesda, Maryland, Committee on Blood and Tissue Safety
1600V Court of Federal Claims No: 18–1648V and Availability
60. Linda Chervenok, Paterson, New Jersey, 90. Betty Jeter on behalf of Estate of Rexford
Court of Federal Claims No: 18–1601V N. Jeter, Deceased, Montgomery, AGENCY: Office of HIV/AIDS and
61. Andres Nieves, Novi, Michigan, Court of Alabama, Court of Federal Claims No: Infectious Disease Policy, Office of the
Federal Claims No: 18–1602V 18–1649V Assistant Secretary for Health, Office of
62. Jimmie L. Foster, Asheville, North 91. Tina Walker, Fredericksburg, the Secretary, Department of Health and
Carolina, Court of Federal Claims No: Pennsylvania, Court of Federal Claims
Human Services.
18–1605V No: 18–1650V
63. Jesus Romo-Villanueva, Tucson, Arizona, 92. Rosanne Ledet, Washington, District of ACTION: Notice.
Court of Federal Claims No: 18–1609V Columbia, Court of Federal Claims No:
64. Frances Basler, Spokane Valley, 18–1651V SUMMARY: The Office of Assistant
Washington, Court of Federal Claims No: 93. Nancy Spotanski, Ballwin, Missouri, Secretary for Health (OASH) is seeking
18–1614V Court of Federal Claims No: 18–1653V nominations of qualified individuals to
65. Richard Brieseacher, Mount Vernon, 94. Gareth Acton, Pittsburgh, Pennsylvania, be considered for appointment as
Illinois, Court of Federal Claims No: 18– Court of Federal Claims No: 18–1654V members of the Advisory Committee on
1616V 95. John R. Harnisch, Pleasant Prairie, Blood and Tissue Safety and
66. Deborah Ann Dunatov, Douglasville, Wisconsin, Court of Federal Claims No: Availability (ACBTSA). ACBTSA is a
Georgia, Court of Federal Claims No: 18– 18–1656V Federal advisory committee within the
1617V 96. Kristine Rucker-Morrow, Chicago,
67. Carol McCarvell, Austin, Texas, Court of Illinois, Court of Federal Claims No: 18–
Department of Health and Human
Federal Claims No: 18–1618V 1657V Services. Management support for the
68. Kelsey Rathjen, Littleton, Colorado, Court 97. Cecilia Ruzzene, Knoxville, Tennessee, activities of this Committee is the
of Federal Claims No: 18–1619V Court of Federal Claims No: 18–1658V responsibility of the OASH. The
69. Dawn Brooks, Millville, New Jersey, 98. Claudine Carter, South Euclid, Ohio, qualified individuals will be nominated
Court of Federal Claims No: 18–1620V Court of Federal Claims No: 18–1659V to the Secretary of Health and Human
70. Michele Nelson Ruppert, San Francisco, 99. Sheree Kaufman, Greensboro, North Services for consideration of
California, Court of Federal Claims No: Carolina, Court of Federal Claims No: appointment as members of the
18–1621V 18–1661V ACBTSA. Members of the Committee,
71. Michael Francesco, Maiden, North 100. Angela Holt, Stafford, Virginia, Court of
Carolina, Court of Federal Claims No: Federal Claims No: 18–1662V
including the Chair, are appointed by
18–1622V 101. Anne Jacqueline Kite, Spotsylvania, the Secretary. Members are invited to
72. Robert G. Canady and Sita S. Canady on Virginia, Court of Federal Claims No: 18– serve on the Committee for up to four-
behalf of A.G.C., Fredericksburg, 1663V year terms.
Virginia, Court of Federal Claims No: 18– 102. Eric Larson, Columbia, Maryland, Court DATES: All nominations must be
1624V of Federal Claims No: 18–1666V received no later than 4:00 p.m. ET on
73. Roy Romero, San Antonio, Texas, Court 103. Robert Tafuri, Marlborough, Friday, December 28 2018 at the address
of Federal Claims No: 18–1625V Massachusetts, Court of Federal Claims
74. William Lederer, Norwalk, Connecticut, No: 18–1667V
listed below.
Court of Federal Claims No: 18–1627V 104. Dawn Halley, Cranbury, New Jersey, ADDRESSES: All nominations should be
75. Allison Ferrini on behalf of W.F., Morton Court of Federal Claims No: 18–1668V sent to the ACBTSA email address at
Grove, Illinois, Court of Federal Claims 105. Madeleine Soares, Dallas, Texas, Court ACBTSA@hhs.gov. Alternatively,
No: 18–1628V of Federal Claims No: 18–1669V nominations can be mailed or delivered
76. Patricia Moore on behalf of Dr. Timonthy 106. Karlee Tessmer, Pewaukee, Wisconsin, to: Mr. James Berger, Senior Advisor for
Moore, Deceased, Phoenix, Arizona, Court of Federal Claims No: 18–1672V Blood and Tissue Policy, Office of
Court of Federal Claims No: 18–1629V 107. Tonya Clark, Junction City, Kansas,
Court of Federal Claims No: 18–1673V
Assistant Secretary for Health,
77. Glenda Lee Stewart, Chicago, Illinois,
Court of Federal Claims No: 18–1630V 108. Martha Walker, Ocean City, New Jersey, Department of Health and Human
78. Cheryl Kraemer, Madison Heights, Court of Federal Claims No: 18–1674V Services, 330 C Street SW, Room L001
Michigan, Court of Federal Claims No: 109. Deborah Flynn, Annapolis, Maryland, Switzer Building, Washington, DC
18–1631V Court of Federal Claims No: 18–1675V 20201. Telephone: (202) 795–7608;
79. Douglas F. Crawford, Panorama City, 110. Cecilia Nuss, St. Charles, Illinois, Court Email ACBTSA@hhs.gov.
amozie on DSK3GDR082PROD with NOTICES1

California, Court of Federal Claims No: of Federal Claims No: 18–1676V FOR FURTHER INFORMATION CONTACT: Mr.
18–1632V 111. Debra H. Childress, Midlothian,
James Berger, Senior Advisor for Blood
80. William S. Boylston, McMinnville, Virginia, Court of Federal Claims No: 18–
Oregon, Court of Federal Claims No: 18– 1677V and Tissue Policy. Contact information
1634V 112. Tamra K. Craig, Westfield, Indiana, for Mr. Berger is provided above.
81. Nancy Henderson, Myrtle Creek, Oregon, Court of Federal Claims No: 18–1678V A copy of the Committee charter and
Court of Federal Claims No: 18–1635V 113. Mary Finch, Chipley, Florida, Court of roster of the current membership can be
82. Helen Marie Pell, Indianapolis, Indiana, Federal Claims No: 18–1680V obtained by contacting Mr. Berger or by

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63662 Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices

accessing the ACBTSA website at http:// for attending Committee meetings and The Department also encourages
www.hhs.gov/bloodsafety. to carry out other Committee-related geographic diversity in the composition
SUPPLEMENTARY INFORMATION: The business. Individuals who are appointed of the committee. Appointment to this
ACBTSA provides advice to the to serve as representative members for a Committee shall be made without
Secretary through the Assistant particular interest group or industry are discrimination on the basis of age, race,
Secretary for Health. The Committee not authorized to receive a stipend for ethnicity, gender, sexual orientation,
advises on a range of policy issues to the performance of these duties. disability, and cultural, religious, or
include: (1) Broad public health, ethical This announcement is to solicit socioeconomic status.
and legal issues related to transfusion nominations of qualified candidates to The Standards of Ethical Conduct for
and transplantation safety, (2) risk five public member positions on the Employees of the Executive Branch are
communications related to blood ACBTSA. applicable to individuals who are
transfusion and tissue transplantation, Nominations appointed as public members of Federal
and (3) the identification of public advisory committees. Individuals
In accordance with the charter, appointed to serve as public members of
health issues that affect the availability persons nominated for appointment as
of blood, blood products, and tissues. Federal advisory committees are
members of the ACBTSA should be classified as special government
The Committee consists of 23 voting among authorities knowledgeable in
members; 14 public members, including employees (SGEs). SGEs are government
blood banking, tissue banking, employees for purposes of the conflict
the Chair, and nine (9) individuals transfusion medicine, organ or tissue
designated to serve as official of interest laws. Therefore, individuals
transplantation, plasma therapies, appointed to serve as public members of
representative members. The public transfusion and transplantation safety,
members are selected from State and the ACBTSA are subject to an ethics
bioethics, socioeconomics, health review. The ethics review is conducted
local organizations, patient advocacy policy/law, and/or related disciplines.
groups, provider organizations, to determine if the individual has any
Nominations should be typewritten. The interests and/or activities in the private
academic researchers, ethicists, following information should be
physicians, surgeons, scientists, risk sector that may conflict with
included in the package of material performance of their official duties as a
communication experts, consumer submitted for each individual being
advocates, and from among member of the Committee. Individuals
nominated for consideration of
communities of persons who are appointed to serve as public members of
appointment: (a) The name, return
frequent recipients of blood or blood the committee will be required to
address, daytime telephone number and
products or who have received tissues disclose information regarding financial
affiliation(s) of the individual being
or organs. The nine individuals who are holdings, consultancies, and research
nominated, the basis for the individual’s
appointed as official representatives are grants and/or contracts.
nomination, the category for which the
selected to serve the interests of the individual is being nominated, and a Dated: October 19, 2018.
blood, blood products, tissue and organ statement bearing an original signature James J. Berger,
professional organizations or business of the nominated individual that, if Senior Advisor for Blood and Tissue Policy,
sectors. The representative members are appointed, he or she is willing to serve Designated Federal Officer, Advisory
selected from the following groups: The as a member of the Committee; (b) the Committee on Blood and Tissue Safety and
AABB (formerly the American name, return address, and daytime Availability.
Association of Blood Banks); American telephone number at which the [FR Doc. 2018–26756 Filed 12–10–18; 8:45 am]
Association of Tissue Banks; Eye Bank nominator may be contacted. BILLING CODE 4150–41–P
Association of America; Association of Organizational nominators must
Organ Procurement Organizations; and identify a principal contact person in
one of either the American Red Cross or addition to the contact; and (c) a copy DEPARTMENT OF HEALTH AND
America’s Blood Centers. The of a current curriculum vitae or resume HUMAN SERVICES
Committee composition can include for the nominated individual.
additional representation from either Individuals can nominate themselves National Institutes of Health
the plasma protein fraction community for consideration of appointment to the
or a trade organization; a manufacturer Draft NTP Monograph on the
Committee. All nominations must
of blood, plasma, or other tissue/organ Systematic Review of Evidence of
include the required information.
test kits; a manufacturer of blood, Long-Term Neurological Effects
Incomplete nominations will not be
plasma or other tissue/organ equipment; Following Acute Exposure to the
processed for consideration. The letter
a major hospital organization; or a major Organophosphorus Nerve Agent Sarin;
from the nominator and certification of
hospital accreditation organization. Availability of Document; Request for
the nominated individual must bear
Where more than one company Comments; Notice of Peer-Review
original signatures; reproduced copies
produces a specified product or process, Meeting
of these signatures are not acceptable.
representatives from those companies The Department is legally required to AGENCY: National Institutes of Health,
shall rotate on the same schedule as ensure that the membership of HHS HHS.
public members. Federal advisory committees is fairly ACTION: Notice.
All ACBTSA members are authorized balanced in terms of points of view
to receive the prescribed per diem represented and the functions to be SUMMARY: The National Toxicology
allowance and reimbursement for travel performed by the advisory committee. Program (NTP) announces availability of
amozie on DSK3GDR082PROD with NOTICES1

expenses that are incurred to attend Every effort is made to ensure that the the Draft NTP Monograph on the
meetings and conduct Committee- views of women, all ethnic and racial Systematic Review of Evidence of Long-
related business, in accordance with groups, and people with disabilities are Term Neurological Effects Following
Standard Government Travel represented on HHS Federal Advisory Acute Exposure to the
Regulations. Individuals who are committees and, therefore, the Organophosphorus Nerve Agent Sarin
appointed to serve as public members Department encourages nominations of for public comment prior to peer
are authorized also to receive a stipend qualified candidates from these groups. review. In partnership with the National

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Document Created: 2018-12-11 01:07:27
Document Modified: 2018-12-11 01:07:27

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		All nominations must be received no later than 4:00 p.m. ET on
Contact		Mr. James Berger, Senior Advisor for Blood and Tissue Policy. Contact information for Mr. Berger is provided above.
FR Citation		83 FR 63661