Nominations to the Advisory Committee on Blood and Tissue Safety and Availability, 8459-8460 [2014-02940]
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Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Notices
after publication of this notice. All
nominations must be submitted in
sufficient time to be received by 5 p.m.
Eastern Standard Time on the closing
date March 14, 2014 and be addressed
to email address ken.sandler@gsa.gov.
Dated: February 5, 2014.
Kevin Kampschroer,
Federal Director, Office of Federal HighPerformance Green Buildings, Office of
Government-wide Policy.
[FR Doc. 2014–02979 Filed 2–11–14; 8:45 am]
BILLING CODE 6820–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Nominations to the Advisory
Committee on Blood and Tissue Safety
and Availability
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services..
ACTION: Notice.
AGENCY:
The Office of the Assistant
Secretary for Health (OASH) is seeking
nominations of qualified members of the
public 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 (HHS). 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 fouryear terms.
DATES: All nominations must be
received no later than 4 p.m. EST on
March 7, 2014, at the address listed
below.
ADDRESSES: All nominations should be
mailed or delivered to Mr. James Berger,
Senior Advisor for Blood and Tissue
Safety Policy; Office of the Assistant
Secretary for Health; Department of
Health and Human Services; 1101
Wootton Parkway, Suite 250; Rockville,
MD 20852. Telephone: (240) 453–8803.
FOR FURTHER INFORMATION CONTACT: Mr.
James Berger, Senior Advisor for Blood
and Tissue Safety Policy. Contact
information for Mr. Berger is provided
above.
A copy of the Committee charter and
roster of the current membership can be
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SUMMARY:
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17:11 Feb 11, 2014
Jkt 232001
obtained by contacting Mr. Berger or by
accessing the ACBTSA Web site at
https://www.hhs.gov/ash/bloodsafety/
advisorycommittee/.
SUPPLEMENTARY INFORMATION: The
ACBTSA shall provide advice to the
Secretary through the Assistant
Secretary for Health. The committee
shall advise on a range of policy issues
to include: (1) Identification of public
health issues through surveillance of
blood, and tissue safety issues with
national biovigilance data tools; (2)
identification of public health issues
that affect availability of blood, blood
products, and tissues; (3) broad public
health, ethical and legal issues related to
the safety of blood, blood products, and
tissues; (4) the impact of various
economic factors (e.g., product cost and
supply) on safety and availability of
blood, blood products, and tissues; (5)
risk communications related to blood
transfusion and tissue transplantation;
and (6) identification of infectious
disease transmission issues for blood,
organs, blood stem cells and tissues.
The Committee consists of 23 voting
members; 14 public members, including
the Chair, and 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, legal
organizations, 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 representative
members are selected to serve the
interests of the blood, blood products,
tissue, and organ professional
organizations or business sectors. The
representative members will be from the
AABB (formerly the American
Association of Blood Banks); American
Association of Tissue Banks; Eye Bank
Association of America; an organ
procurement organization; and one of
either the American National Red Cross
or America’s Blood Centers on a rotating
basis. 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; and a major hospital
organization or major hospital
accreditation organization. Where more
than one company produces a specified
product or process, representatives from
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8459
those companies will 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 Committeerelated 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
fill two (2) upcoming vacant public
member positions. Public members on
the ACBTSA are classified as special
government employees (SGEs).
Nominations
In accordance with the charter,
persons nominated for appointment as
members of the ACBTSA should be
among authorities knowledgeable in
tissue banking, tissue transplantation,
tissue/organ transplant safety, blood
banking, transfusion medicine, plasma
therapies, transfusion safety, bioethics,
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.
E:\FR\FM\12FEN1.SGM
12FEN1
8460
Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Notices
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. 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 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: February 6, 2014.
James J. Berger,
Senior Advisor for Blood and Tissue Safety
Policy.
[FR Doc. 2014–02940 Filed 2–11–14; 8:45 am]
BILLING CODE 4150–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
mstockstill on DSK4VPTVN1PROD with NOTICES
[30Day–14–13AHB]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
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Jkt 232001
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to Leroy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Risk Factors for CommunityAssociated Clostridium difficile
Infection through the Emerging
Infections Program (EIP)—New ICR—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The epidemiology of C. difficile has
changed dramatically during recent
years, with increases in incidence and
severity of disease being reported across
several countries. In addition,
populations previously thought to be at
low risk, such as young, healthy
individuals residing in the community,
are now being identified with severe C.
difficile infection (CDI). Communityassociated CDI is estimated to represent
32% of all CDI based on populationbased CDI surveillance data, with an
incidence of 30–40 per 100,000
population in the United States.
Previous reports have shown that
approximately 40% of patients
acquiring community-associated CDI
(CA–CDI) were not exposed to
antibiotics, which is a well-recognized
risk factor for CDI; suggesting that
additional factors may contribute to
infections. Other factors such as proton
pump inhibitors have been raised as a
risk factor for CDI in the community and
on February 8, 2012 the U.S. Food and
Drug Administration issued a
communication advising physicians to
consider the diagnosis of CDI among
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patients taking proton pump inhibitors.
However, the data on the association of
CDI with proton pump inhibitors are
still controversial and studies to
quantify this association are needed. In
addition to the understanding of the
factors that predispose patients to CDI,
further evaluation of potential C.
difficile exposure sources in the
community is necessary to guide
prevention efforts.
The sources of C. difficile and the
risks for developing CDI in previously
thought to be low-risk community
populations are not well defined.
Although initial evaluation of CA–CDI
cases identified several potential risk
factors (e.g., outpatient healthcare
exposures, infants in the home, and
proton pump inhibitor use), the
magnitude of association of these risks
with disease development using a
control population has not been
evaluated to date. This proposed casecontrol study will enable investigators
to evaluate these associations and focus
future investigations and prevention
strategies on those factors identified as
significantly associated with disease
development.
CDC requests OMB approval to collect
information from the public using a
standardized questionnaire over a threeyear period. The study will have a
pediatric and an adult component given
that C. difficile exposure sources in the
community may vary by age. For
example, C. difficile has been isolated
from daycare centers’ environment
which may be a potential source for C.
difficile acquisition in pediatric
population, but less likely to be a source
for adults.
For this project, we estimate that 129
persons ≥ 18 years of age with C.
difficile infection (case-patients) will be
contacted for the CDI study interview
annually. Of those, 71 will agree and be
eligible to participate in the study and
will proceed to the full telephone
interview. A total of 142 persons ≥ 18
years of age without C. difficile infection
(control-patients) will be contacted for
the interview annually. Of those, 71 will
agree and be eligible to participate in
the study and will complete the full
interview. Among the pediatric group,
we estimate that 141 and 194 parents of
children between 1 and 5 years of age
with and without C. difficile infection
will be contacted for the interview,
respectively. Among the case- and
control-patients, we estimate that 78 in
each group will agree and be eligible to
participate in the study and will
proceed to the full interview. We
anticipate the screening questions to
take about 5 minutes and the telephone
interview 30 minutes per respondent in
E:\FR\FM\12FEN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Notices]
[Pages 8459-8460]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02940]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Nominations to the Advisory Committee on Blood and Tissue Safety
and Availability
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services..
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Office of the Assistant Secretary for Health (OASH) is
seeking nominations of qualified members of the public 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 (HHS).
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 p.m. EST on
March 7, 2014, at the address listed below.
ADDRESSES: All nominations should be mailed or delivered to Mr. James
Berger, Senior Advisor for Blood and Tissue Safety Policy; Office of
the Assistant Secretary for Health; Department of Health and Human
Services; 1101 Wootton Parkway, Suite 250; Rockville, MD 20852.
Telephone: (240) 453-8803.
FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Senior Advisor for
Blood and Tissue Safety 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 accessing the
ACBTSA Web site at https://www.hhs.gov/ash/bloodsafety/advisorycommittee/.
SUPPLEMENTARY INFORMATION: The ACBTSA shall provide advice to the
Secretary through the Assistant Secretary for Health. The committee
shall advise on a range of policy issues to include: (1) Identification
of public health issues through surveillance of blood, and tissue
safety issues with national biovigilance data tools; (2) identification
of public health issues that affect availability of blood, blood
products, and tissues; (3) broad public health, ethical and legal
issues related to the safety of blood, blood products, and tissues; (4)
the impact of various economic factors (e.g., product cost and supply)
on safety and availability of blood, blood products, and tissues; (5)
risk communications related to blood transfusion and tissue
transplantation; and (6) identification of infectious disease
transmission issues for blood, organs, blood stem cells and tissues.
The Committee consists of 23 voting members; 14 public members,
including the Chair, and 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, legal organizations, 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 representative members are
selected to serve the interests of the blood, blood products, tissue,
and organ professional organizations or business sectors. The
representative members will be from the AABB (formerly the American
Association of Blood Banks); American Association of Tissue Banks; Eye
Bank Association of America; an organ procurement organization; and one
of either the American National Red Cross or America's Blood Centers on
a rotating basis. 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; and a major hospital organization or major hospital
accreditation organization. Where more than one company produces a
specified product or process, representatives from those companies will
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 fill two (2) upcoming vacant public member positions. Public members
on the ACBTSA are classified as special government employees (SGEs).
Nominations
In accordance with the charter, persons nominated for appointment
as members of the ACBTSA should be among authorities knowledgeable in
tissue banking, tissue transplantation, tissue/organ transplant safety,
blood banking, transfusion medicine, plasma therapies, transfusion
safety, bioethics, 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.
[[Page 8460]]
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. 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
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: February 6, 2014.
James J. Berger,
Senior Advisor for Blood and Tissue Safety Policy.
[FR Doc. 2014-02940 Filed 2-11-14; 8:45 am]
BILLING CODE 4150-41-P
