Advisory Council on Blood Stem Cell Transplantation; Request for Nominations for Voting Members, 10056-10057 [E9-4927]
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Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices
Dated: February 17, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–4914 Filed 3–6–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Council on Blood Stem Cell
Transplantation; Request for
Nominations for Voting Members
dwashington3 on PROD1PC60 with NOTICES
AGENCY: Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice.
SUMMARY: The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill expected
vacancies on the Advisory Council on
Blood Stem Cell Transplantation.
The Advisory Council on Blood Stem
Cell Transplantation was established
pursuant to Public Law 109–129, 42
U.S.C. 274k (section 379 of the Public
Health Service Act, as amended). In
accordance with Public Law 92–463, the
Council was chartered on December 19,
2006.
DATES: The agency must receive
nominations on or before April 8, 2009.
ADDRESSES: All nominations should be
submitted to the Executive Secretary,
Advisory Council on Blood Stem Cell
Transplantation, Healthcare Systems
Bureau, HRSA, Parklawn Building,
Room 12–105, 5600 Fishers Lane,
Rockville, Maryland 20857. Federal
Express, Airborne, or UPS, mail delivery
should be addressed to Executive
Secretary, Advisory Council on Blood
Stem Cell Transplantation, Healthcare
Systems Bureau, HRSA, at the above
address.
FOR FURTHER INFORMATION CONTACT:
Remy Aronoff, Executive Secretary,
Advisory Council on Blood Stem Cell
Transplantation, at (301) 443–3264 or email Remy.Aronoff@hrsa.hhs.gov or
Robert Baitty, Director, Blood Stem Cell
Transplantation Program, Division of
Transplantation, at (301) 443–2612 or email Robert.Baitty@hrsa.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Council was established to implement a
statutory requirement of the Stem Cell
Therapeutic and Research Act of 2005
(Pub. L. 109–129). The Council is
governed by the Federal Advisory
Committee Act, as amended (5 U.S.C.
Appendix 2), which sets forth standards
for the formation and use of advisory
committees.
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The Advisory Council advises the
Secretary and the Administrator, HRSA,
on matters related to the activities of the
C.W. Bill Young Cell Transplantation
Program and the National Cord Blood
Inventory Program.
The Council shall, as requested by the
Secretary, discuss and make
recommendations regarding the C.W.
Bill Young Cell Transplantation
Program (Program). It shall provide a
consolidated, comprehensive source of
expert, unbiased analysis and
recommendations to the Secretary on
the latest advances in the science of
blood stem cell transplantation. The
Council shall advise, assist, consult and
make recommendations, at the request
of the Secretary, on broad Program
policy in areas such as the necessary
size and composition of the adult donor
pool available through the Program and
the composition of the National Cord
Blood Inventory, requirements regarding
informed consent for cord blood
donation, accreditation requirements for
cord blood banks, the scientific factors
that define a cord blood unit as high
quality, public and professional
education to encourage the ethical
recruitment of genetically diverse
donors and ethical donation practices,
criteria for selecting the appropriate
blood stem source for transplantation,
Program priorities, research priorities,
and the scope and design of the Stem
Cell Therapeutic Outcomes Database. It
also shall, at the request of the
Secretary, review and advise on issues
relating more broadly to the field of
blood stem cell transplantation, such as
regulatory policy including
compatibility of international
regulations, and actions that may be
taken by the State and Federal
Governments and public and private
insurers to increase donation and access
to transplantation. The Advisory
Council also shall make
recommendations regarding research on
emerging therapies using cells from
bone marrow and cord blood.
The Council consists of up to 25
members, including the Chair. Members
of the Advisory Council shall be chosen
to ensure objectivity and balance, and
reduce the potential for conflicts of
interest. The Secretary shall establish
bylaws and procedures to prohibit any
member of the Advisory Council who
has an employment, governance, or
financial affiliation with a donor center,
recruitment organization, transplant
center, or cord blood bank from
participating in any decision that
materially affects the center, recruitment
organization, transplant center, or cord
blood bank; and to limit the number of
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members of the Advisory Council with
any such affiliation.
The members and Chair shall be
selected by the Secretary from
outstanding authorities and
representatives of marrow donor centers
and marrow transplant centers;
representatives of cord blood banks and
participating birthing hospitals;
recipients of a bone marrow transplant;
recipients of a cord blood transplant;
persons who require such transplants;
family members of such a recipient or
family members of a patient who has
requested the assistance of the Program
in searching for an unrelated donor of
bone marrow or cord blood; persons
with expertise in bone marrow and cord
blood transplantation; persons with
expertise in typing, matching, and
transplant outcome data analysis;
persons with expertise in the social
sciences; basic scientists with expertise
in the biology of adult stem cells;
ethicists, hematology and transfusion
medicine researchers with expertise in
adult blood stem cells; persons with
expertise in cord blood processing; and
members of the general public.
In addition, representatives from the
Division of Transplantation of the
Health Resources and Services
Administration, the Department of
Defense Marrow Recruitment and
Research Program operated by the
Department of the Navy, the Food and
Drug Administration, the National
Institutes of Health, the Centers for
Medicare & Medicaid Services, and the
Centers for Disease Control and
Prevention serve as non-voting ex officio
members.
Specifically, HRSA is requesting
nominations for voting members of the
Advisory Council on Blood Stem Cell
Transplantation in these categories:
Marrow donor centers and transplant
centers representatives; cord blood
banks and participating hospitals
representatives; family members of bone
marrow transplant and cord blood
transplant recipients or family members
of a patient who has requested
assistance by the Program in searching
for an unrelated donor; persons with
expertise in bone marrow or cord blood
transplantation; persons with expertise
in typing, matching, and transplant
outcome data analysis; basic scientists
with expertise in the biology of adult
stem cells; researchers in hematology
and transfusion medicine with expertise
in adult blood stem cells; persons with
expertise in cord blood processing; and
members of the general public.
Nominees will be invited to serve a 2to 6-year term beginning after January 1,
2010.
E:\FR\FM\09MRN1.SGM
09MRN1
Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices
HHS will consider nominations of all
qualified individuals to ensure that the
Advisory Council includes the areas of
subject matter expertise noted above.
Individuals may nominate themselves
or other individuals, and professional
associations and organizations may
nominate one or more qualified persons
for membership on the Advisory
Council. Nominations shall state that
the nominee is willing to serve as a
member of the Council. Potential
candidates will be asked to provide
detailed information concerning
financial interests, consultancies,
research grants, and/or contracts that
might be affected by recommendations
of the Council to permit evaluation of
possible sources of conflicts of interest.
In addition, nominees will be asked to
provide detailed information concerning
any employment, governance, or
financial affiliation with any donor
centers, recruitment organizations,
transplant centers, and/or cord blood
banks.
A nomination package should be sent
in hard copy accompanied by an
electronic version of the documents on
compact disc. A nomination package
should include the following
information for each nominee: (1) A
letter of nomination stating the name,
affiliation, and contact information for
the nominee, the basis for the
nomination (i.e., what specific attributes
recommend him/her for service in this
capacity), and the nominee’s field(s) of
expertise; (2) a biographical sketch of
the nominee and a copy of his/her
curriculum vitae; and (3) the name,
return address, e-mail address, and
daytime telephone number at which the
nominator can be contacted.
The Department of Health and Human
Services has special interest in assuring
that women, minority groups, and the
physically disabled are adequately
represented on advisory committees;
and therefore, extends particular
encouragement to nominations for
appropriately qualified female,
minority, or disabled candidates.
dwashington3 on PROD1PC60 with NOTICES
Dated: February 27, 2009.
Elizabeth M. Duke,
Administrator.
[FR Doc. E9–4927 Filed 3–6–09; 8:45 am]
BILLING CODE 4165–15–P
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15:28 Mar 06, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; REDS–II Donor Iron Status
Evaluation (RISE) Study
SUMMARY: 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
National Heart, Lung, and Blood
Institute (NHLBI), the National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to the Office of Management
and Budget (OMB) for review and
approval.
Proposed Collection
Title: REDS–II Donor Iron Status
Evaluation (RISE) Study. Type of
Information Collection Request:
Revision of a currently approved
collection. OMB control # 0925–0581.
Expiration Date: 05/31/2009. Need and
Use of Information Collection: Although
the overall health significance of iron
depletion in blood donors is uncertain,
iron depletion leading to iron deficient
erythropoiesis and lowered hemoglobin
levels results in donor deferral and,
occasionally, in mild iron deficiency
anemia. Hemoglobin deferrals represent
more than half of all donor deferral,
deferring 16% of women. The RISE
Study is a longitudinal study of iron
status in two cohorts of blood donors: a
first time/reactivated donor cohort in
which baseline iron and hemoglobin
status can be assessed without the
influence of previous donations, and a
frequent donor cohort, where the
cumulative effect of additional frequent
blood donations can be assessed. Each
cohort’s donors will donate blood and
provide evaluation samples during the
study period.
The primary goal of the study is to
evaluate the effects of blood donation
intensity on iron and hemoglobin status
and assess how these are modified as a
function of baseline iron/hemoglobin
measures, demographic factors, and
reproductive and behavioral factors.
Hemoglobin levels, a panel of iron
protein, red cell and reticulocyte indices
will be measured at baseline and at a
final follow-up visit 15–24 months after
the baseline visit. A DNA sample will be
obtained once at the baseline visit to
assess three key iron protein
polymorphisms. Donors will also
complete a self-administered survey
assessing past blood donation, smoking
history, use of vitamin/mineral
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10057
supplements, iron supplements, aspirin,
frequency of heme rich food intake, and,
for females, menstrual status and
pregnancy history at these two time
points. This study aims to identify the
optimal laboratory measures that would
predict the development of iron
depletion, hemoglobin deferral, and/or
iron deficient hemoglobin deferral in
active whole blood and double red cell
donors at subsequent blood donations.
The data collected will help evaluate
hemoglobin distributions in the blood
donor population (eligible and deferred
donors) and compare them with
NHANES data. Other secondary
objectives include elucidating key
genetic influences on hemoglobin levels
and iron status in a donor population as
a function of donation history; and
establishing a serum and DNA archive
to evaluate the potential utility of future
iron studies and genetic
polymorphisms.
This study will develop better
predictive models for iron depletion and
hemoglobin deferral (with or without
iron deficiency) in blood donors; allow
for the development of improved donor
screening strategies and open the
possibility for customized donation
frequency guidelines for individuals or
classes of donors; provide important
baseline information for the design of
targeted iron supplementation strategies
in blood donors, and improved
counseling messages to blood donors
regarding diet or supplements; and by
elucidating the effect of genetic iron
protein polymorphisms on the
development of iron depletion, enhance
the understanding of the role of these
proteins in states of iron stress, using
frequent blood donation as a model.
This request for modification is to add
eleven questions to the RISE study final
visit questionnaire that will include
questions about Restless Leg Syndrome
(RLS) and pica, two disorders associated
with iron deficiency. RLS is a
neurologic movement disorder in which
patients complain of crawling, aching or
indescribable feelings in their legs or
just have the need to move. Pica is an
eating disorder defined as compulsive
ingestion of non-food substances. Blood
donation results in the removal of 200–
250 mg of iron from the donor. It is well
established that repeated blood
donation can produce iron deficiency,
yet the prevalence of RLS and pica
among blood donors is unknown. The
REDS–II RISE study subjects are an
ideal study population for the
investigation of RLS and pica in blood
donors. About 2,400 subjects with
variable donation intensity (e.g.
frequency with which a person donates
blood) are currently enrolled in the RISE
E:\FR\FM\09MRN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 44 (Monday, March 9, 2009)]
[Notices]
[Pages 10056-10057]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4927]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Council on Blood Stem Cell Transplantation; Request for
Nominations for Voting Members
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration (HRSA) is
requesting nominations to fill expected vacancies on the Advisory
Council on Blood Stem Cell Transplantation.
The Advisory Council on Blood Stem Cell Transplantation was
established pursuant to Public Law 109-129, 42 U.S.C. 274k (section 379
of the Public Health Service Act, as amended). In accordance with
Public Law 92-463, the Council was chartered on December 19, 2006.
DATES: The agency must receive nominations on or before April 8, 2009.
ADDRESSES: All nominations should be submitted to the Executive
Secretary, Advisory Council on Blood Stem Cell Transplantation,
Healthcare Systems Bureau, HRSA, Parklawn Building, Room 12-105, 5600
Fishers Lane, Rockville, Maryland 20857. Federal Express, Airborne, or
UPS, mail delivery should be addressed to Executive Secretary, Advisory
Council on Blood Stem Cell Transplantation, Healthcare Systems Bureau,
HRSA, at the above address.
FOR FURTHER INFORMATION CONTACT: Remy Aronoff, Executive Secretary,
Advisory Council on Blood Stem Cell Transplantation, at (301) 443-3264
or e-mail Remy.Aronoff@hrsa.hhs.gov or Robert Baitty, Director, Blood
Stem Cell Transplantation Program, Division of Transplantation, at
(301) 443-2612 or e-mail Robert.Baitty@hrsa.hhs.gov.
SUPPLEMENTARY INFORMATION: The Council was established to implement a
statutory requirement of the Stem Cell Therapeutic and Research Act of
2005 (Pub. L. 109-129). The Council is governed by the Federal Advisory
Committee Act, as amended (5 U.S.C. Appendix 2), which sets forth
standards for the formation and use of advisory committees.
The Advisory Council advises the Secretary and the Administrator,
HRSA, on matters related to the activities of the C.W. Bill Young Cell
Transplantation Program and the National Cord Blood Inventory Program.
The Council shall, as requested by the Secretary, discuss and make
recommendations regarding the C.W. Bill Young Cell Transplantation
Program (Program). It shall provide a consolidated, comprehensive
source of expert, unbiased analysis and recommendations to the
Secretary on the latest advances in the science of blood stem cell
transplantation. The Council shall advise, assist, consult and make
recommendations, at the request of the Secretary, on broad Program
policy in areas such as the necessary size and composition of the adult
donor pool available through the Program and the composition of the
National Cord Blood Inventory, requirements regarding informed consent
for cord blood donation, accreditation requirements for cord blood
banks, the scientific factors that define a cord blood unit as high
quality, public and professional education to encourage the ethical
recruitment of genetically diverse donors and ethical donation
practices, criteria for selecting the appropriate blood stem source for
transplantation, Program priorities, research priorities, and the scope
and design of the Stem Cell Therapeutic Outcomes Database. It also
shall, at the request of the Secretary, review and advise on issues
relating more broadly to the field of blood stem cell transplantation,
such as regulatory policy including compatibility of international
regulations, and actions that may be taken by the State and Federal
Governments and public and private insurers to increase donation and
access to transplantation. The Advisory Council also shall make
recommendations regarding research on emerging therapies using cells
from bone marrow and cord blood.
The Council consists of up to 25 members, including the Chair.
Members of the Advisory Council shall be chosen to ensure objectivity
and balance, and reduce the potential for conflicts of interest. The
Secretary shall establish bylaws and procedures to prohibit any member
of the Advisory Council who has an employment, governance, or financial
affiliation with a donor center, recruitment organization, transplant
center, or cord blood bank from participating in any decision that
materially affects the center, recruitment organization, transplant
center, or cord blood bank; and to limit the number of members of the
Advisory Council with any such affiliation.
The members and Chair shall be selected by the Secretary from
outstanding authorities and representatives of marrow donor centers and
marrow transplant centers; representatives of cord blood banks and
participating birthing hospitals; recipients of a bone marrow
transplant; recipients of a cord blood transplant; persons who require
such transplants; family members of such a recipient or family members
of a patient who has requested the assistance of the Program in
searching for an unrelated donor of bone marrow or cord blood; persons
with expertise in bone marrow and cord blood transplantation; persons
with expertise in typing, matching, and transplant outcome data
analysis; persons with expertise in the social sciences; basic
scientists with expertise in the biology of adult stem cells;
ethicists, hematology and transfusion medicine researchers with
expertise in adult blood stem cells; persons with expertise in cord
blood processing; and members of the general public.
In addition, representatives from the Division of Transplantation
of the Health Resources and Services Administration, the Department of
Defense Marrow Recruitment and Research Program operated by the
Department of the Navy, the Food and Drug Administration, the National
Institutes of Health, the Centers for Medicare & Medicaid Services, and
the Centers for Disease Control and Prevention serve as non-voting ex
officio members.
Specifically, HRSA is requesting nominations for voting members of
the Advisory Council on Blood Stem Cell Transplantation in these
categories: Marrow donor centers and transplant centers
representatives; cord blood banks and participating hospitals
representatives; family members of bone marrow transplant and cord
blood transplant recipients or family members of a patient who has
requested assistance by the Program in searching for an unrelated
donor; persons with expertise in bone marrow or cord blood
transplantation; persons with expertise in typing, matching, and
transplant outcome data analysis; basic scientists with expertise in
the biology of adult stem cells; researchers in hematology and
transfusion medicine with expertise in adult blood stem cells; persons
with expertise in cord blood processing; and members of the general
public. Nominees will be invited to serve a 2- to 6-year term beginning
after January 1, 2010.
[[Page 10057]]
HHS will consider nominations of all qualified individuals to
ensure that the Advisory Council includes the areas of subject matter
expertise noted above. Individuals may nominate themselves or other
individuals, and professional associations and organizations may
nominate one or more qualified persons for membership on the Advisory
Council. Nominations shall state that the nominee is willing to serve
as a member of the Council. Potential candidates will be asked to
provide detailed information concerning financial interests,
consultancies, research grants, and/or contracts that might be affected
by recommendations of the Council to permit evaluation of possible
sources of conflicts of interest. In addition, nominees will be asked
to provide detailed information concerning any employment, governance,
or financial affiliation with any donor centers, recruitment
organizations, transplant centers, and/or cord blood banks.
A nomination package should be sent in hard copy accompanied by an
electronic version of the documents on compact disc. A nomination
package should include the following information for each nominee: (1)
A letter of nomination stating the name, affiliation, and contact
information for the nominee, the basis for the nomination (i.e., what
specific attributes recommend him/her for service in this capacity),
and the nominee's field(s) of expertise; (2) a biographical sketch of
the nominee and a copy of his/her curriculum vitae; and (3) the name,
return address, e-mail address, and daytime telephone number at which
the nominator can be contacted.
The Department of Health and Human Services has special interest in
assuring that women, minority groups, and the physically disabled are
adequately represented on advisory committees; and therefore, extends
particular encouragement to nominations for appropriately qualified
female, minority, or disabled candidates.
Dated: February 27, 2009.
Elizabeth M. Duke,
Administrator.
[FR Doc. E9-4927 Filed 3-6-09; 8:45 am]
BILLING CODE 4165-15-P
