C.W. Bill Young Cell Transplantation Program: National Cord Blood Inventory; Recognition of Cord Blood Bank Accreditation Program(s), 24858-24859 [E6-6313]
Download as PDF
<![CDATA[
24858
Federal Register / Vol. 71, No. 81 / Thursday, April 27, 2006 / Notices
represent the agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information under §§ 640.61 and 640.66
was approved under OMB control
number 0910–0116.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit written or electronic comments
to the Division of Dockets Management
(see ADDRESSES) regarding the draft
guidance. Submit written or electronic
comments to ensure adequate
consideration in preparation of the final
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of the guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/cber/guidelines.htm or
https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: April 19, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–6314 Filed 4–26–06; 8:45 am]
rmajette on PROD1PC67 with NOTICES
BILLING CODE 4160–01–S
VerDate Aug<31>2005
15:13 Apr 26, 2006
Jkt 208001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
C.W. Bill Young Cell Transplantation
Program: National Cord Blood
Inventory; Recognition of Cord Blood
Bank Accreditation Program(s)
Health Resources and Services
Administration (HRSA), HHS.
AGENCY:
Notice of opportunity for public
comment through conference calls.
ACTION:
Public Law 109–129 requires
the Secretary of Health and Human
Services to recognize one or more cord
blood accreditation entities for the
accreditation of cord blood banks
participating in the collection and
maintenance of umbilical cord blood
units for the National Cord Blood
Inventory. These cord blood units will
be made available for unrelated donor
blood stem cell transplants through the
C.W. Bill Young Cell Transplantation
Program. The HRSA, Healthcare
Systems Bureau (HSB), Division of
Transplantation (DoT) is in the process
of information-gathering to assist in the
determination of which cord blood bank
accreditation program(s) to recognize on
an interim basis for the initial cycle of
funding for the National Cord Blood
Inventory. The purpose of this
solicitation is to receive public input on
the following: (1) Approaches to
accreditation required to ensure quality
cord blood bank operations (including
collection sites); (2) Utilization of
accreditation programs to ensure
product quality and best practices; (3)
Degree to which accreditation standards
are evidence based and supported by
published literature; (4) Extent to which
accreditation standards allow for
variations in cord blood bank practices;
(5) Criteria for the Secretary to consider
in recognizing cord blood bank
accrediting programs for the National
Cord Blood Inventory, C.W. Bill Young
Cell Transplantation Program.
The HRSA intends for this interim
process to be followed by a formal, more
comprehensive recognition process that
will include input from both the
Advisory Council, once it is established,
and the interested public as required in
the legislation. The purpose of this
Notice is to invite interested parties to
register for and participate in either of
two conference calls, described below,
that HRSA is scheduling to obtain
comment on factors relevant to
determining which accrediting
organization(s) to recognize for the
SUMMARY:
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
initial cycle of funding under the
National Cord Blood Inventory.
DATES: The conference calls will be held
on May 9, 2006, at 2 to 4 p.m. e.s.t. and
May 15, 2006, at 2 p.m. to 4 p.m. e.s.t.
Participants are asked to register for the
conference by contacting Anita Wabeke
at (301) 443–4747 or e-mail
awabeke@hrsa.gov. The registration
deadline is May 3, 2006 for both
conferences. Registration is not
guaranteed; it is on a first come basis.
Since the topics listed above will be
discussed on both calls, and to facilitate
hearing all points of view, HRSA
requests that organizations and
individuals wishing to participate do so
in only one of the calls. Due to the
limited number of lines available for the
calls, organizations with multiple
participants are encouraged to register
for one line to allow maximum
participation from all interested parties.
Parties wishing to submit written
comments should ensure that the
comments are postmarked or E-mailed
no later than May 17, 2006 for
consideration.
ADDRESSES: Please send all written
comments to James F. Burdick, M.D.,
Director, DoT, HSB, HRSA, Room 12C–
06, Parklawn Building, 5600 Fishers
Lane, Rockville, Maryland 20857;
telephone (301) 443–7577; fax (301)
594–6095; or e-mail: jburdick@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
James F. Burdick, M.D., Director, DoT,
HSB, HRSA, Parklawn Building, Room
12C–06, 5600 Fishers Lane, Rockville,
Maryland 20857; telephone (301) 443–
7577; fax (301) 594–6095; or e-mail:
jburdick@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Background
On December 20, 2005, the Stem Cell
Therapeutic Act of 2005 was enacted as
Public Law 109–129. The Act authorizes
the establishment of the National Cord
Blood Inventory and the C.W. Bill
Young Cell Transplantation Program as
the successor to the National Bone
Marrow Donor Registry. The National
Cord Blood Inventory is to be a high
quality, genetically diverse inventory of
cord blood units for patients who need
a blood stem cell transplant and who
lack an available related donor. The
cord blood units in the National Cord
Blood Inventory will be made available
for transplantation through the C.W. Bill
Young Cell Transplantation Program.
Cord blood banks collecting and
maintaining units for the National Cord
Blood Inventory must meet the statutory
definition of a qualified cord blood
bank, which includes a requirement that
cord blood banks be accredited by an
E:\FR\FM\27APN1.SGM
27APN1
Federal Register / Vol. 71, No. 81 / Thursday, April 27, 2006 / Notices
the Deputy Manager, National
Communications System, Department of
Homeland Security, IP/NCS/N5.
accreditation entity recognized by the
Secretary for this purpose.
Program Authority
The C.W. Bill Young Cell
Transplantation Program is authorized
by Public Law 109–129, which amends
Part I of the Public Health Service Act.
Dated: April 20, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6–6313 Filed 4–26–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. NCS–2006–0004]
Preparedness Directorate; National
Security Telecommunications
Advisory Committee
Preparedness Directorate, DHS.
Notice of partially closed
advisory committee meeting.
AGENCY:
rmajette on PROD1PC67 with NOTICES
ACTION:
SUMMARY: The President’s National
Security Telecommunications Advisory
Committee (NSTAC) will meet in a
partially closed session.
DATES: Wednesday, May 10, 2006, from
9:15 a.m. until 3:30 p.m.
ADDRESSES: The meeting will take place
at the Ronald Reagan Building and
International Trade Center, Washington,
DC. If you desire to submit comments,
they must be submitted by May 2, 2006.
Comments must be identified by NCS–
2006–0004 and may be submitted by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: NSTAC@dhs.gov. Include
docket number in the subject line of the
message.
• Mail: Office of the Manager,
National Communications System (N5),
Department of Homeland Security,
Washington, DC 20529.
Instructions: All submissions received
must include the words ‘‘Department of
Homeland Security’’ and NCS–2006–
0004, the docket number for this action.
Comments received will be posted
without alteration at https://
www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to
read background documents or
comments received by the NSTAC, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Ms.
Kiesha Gebreyes, Chief, Industry
Operations Branch at (703) 235–5525, email: kiesha.gebreyes@dhs.gov or write
VerDate Aug<31>2005
15:13 Apr 26, 2006
Jkt 208001
The
NSTAC advises the President of the
United States on issues and problems
related to implementing national
security and emergency preparedness
(NS/EP) telecommunications policy.
Notice of this meeting and the partial
closure thereof is given under the
Federal Advisory Committee Act
(FACA), Pub. L. 92–463, as amended (5
U.S.C. App. 1 et seq.).
At the upcoming meeting, between
9:15 a.m. and 10:15 a.m., the committee
will discuss ongoing NSTAC task force
work of the Emergency Communications
& Interoperability Task Force,
Telecommunications and Electric Power
Interdependency Task Force, Legislative
and Regulatory Task Force, and
Research and Development Task Force.
This portion of the meeting will be open
to the public.
Following the morning Business
Session, the committee will hold an
Executive Session between the hours of
10:30 a.m. and 3:30 p.m. to discuss
emergency communications &
interoperability, international
implications of the NGN, and regional
coordination, planning, and exercises.
The Executive Session will conclude
with a discussion of the findings and
conclusions reached during the meeting.
This portion of the meeting will be
closed to the public.
Basis for Closure: The Executive
Session will likely include discussions
of sensitive infrastructure information
concerning system threats and explicit
physical/cyber vulnerabilities related to
current emergency communications
capabilities and the use of national
security and emergency preparedness
services over the next generation
networks. Public disclosure of such
information would heighten awareness
of potential vulnerabilities and increase
the likelihood of exploitation by
terrorists or other motivated adversaries.
The Executive Session will occur
between 10:30 a.m. and 3:30 p.m. and
will involve sensitive information.
Pursuant to Section 10(d) of the Federal
Advisory Committee Act, Public Law
92–463, as amended (5 U.S.C. App. 1 et
seq.), the Department has determined
that this discussion will concern matters
which, if disclosed, would be likely to
frustrate significantly the
implementation of a proposed agency
action. Accordingly, the relevant
portion of this meeting will be closed to
the public pursuant to the authority set
forth in 5 U.S.C. 552b(c)(9)(B).
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
24859
Dated: April 5, 2006.
Peter M. Fonash,
Deputy Manager National Communications
System.
[FR Doc. 06–3994 Filed 4–26–06; 8:45 am]
BILLING CODE 4410–10–P
DEPARTMENT OF THE INTERIOR
Bureau of Land Management
Meeting of the California Desert
District Advisory Council
Bureau of Land Management,
Interior.
ACTION: Notice of public meeting.
AGENCY:
SUMMARY: Notice is hereby given, in
accordance with Public Laws 92–463
and 94–579, that the California Desert
District Advisory Council to the Bureau
of Land Management, U.S. Department
of the Interior, will participate in a field
tour of BLM-administered public lands
on Friday, June 23, 2006, from 7:30 a.m.
to 5 p.m., and meet in formal session on
Saturday, June 24 from 8 a.m. to 3 p.m.
in Continental Labor Hall at the Desert
Empire Fairgrounds, located at 520
South Richmond Road, Ridgecrest,
California.
The Council and interested members
of the public will depart for the field
tour at 7:30 a.m. from the parking lot of
the Best Western China Lake Inn,
located at 400 South China Lake
Boulevard in Ridgecrest. The public is
welcome to participate in the tour, but
should plan on providing their own
transportation, drinks, and lunch.
Agenda topics for the formal session
on Saturday will include updates by
Council members and reports from the
BLM District Manager and five field
office managers. Additional agenda
topics are being developed. Once
finalized, the field tour and meeting
agendas will be published in a news
release prior to the meeting and posted
on BLM’s state Web site at https://
www.blm.gov/ca/news/rac.html.
SUPPLEMENTARY INFORMATION: All Desert
District Advisory Council meetings are
open to the public. Public comment for
items not on the agenda will be
scheduled at the beginning of the
meeting Saturday morning. Time for
public comment may be made available
by the Council Chairman during the
presentation of various agenda items,
and is scheduled at the end of the
meeting for topics not on the agenda.
While the Saturday meeting is
tentatively scheduled from 8 a.m. to
3 p.m., the meeting could conclude
prior to 3 p.m. should the Council
conclude its presentations and
E:\FR\FM\27APN1.SGM
27APN1
]]>Agencies
[Federal Register Volume 71, Number 81 (Thursday, April 27, 2006)]
[Notices]
[Pages 24858-24859]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6313]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
C.W. Bill Young Cell Transplantation Program: National Cord Blood
Inventory; Recognition of Cord Blood Bank Accreditation Program(s)
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice of opportunity for public comment through conference
calls.
-----------------------------------------------------------------------
SUMMARY: Public Law 109-129 requires the Secretary of Health and Human
Services to recognize one or more cord blood accreditation entities for
the accreditation of cord blood banks participating in the collection
and maintenance of umbilical cord blood units for the National Cord
Blood Inventory. These cord blood units will be made available for
unrelated donor blood stem cell transplants through the C.W. Bill Young
Cell Transplantation Program. The HRSA, Healthcare Systems Bureau
(HSB), Division of Transplantation (DoT) is in the process of
information-gathering to assist in the determination of which cord
blood bank accreditation program(s) to recognize on an interim basis
for the initial cycle of funding for the National Cord Blood Inventory.
The purpose of this solicitation is to receive public input on the
following: (1) Approaches to accreditation required to ensure quality
cord blood bank operations (including collection sites); (2)
Utilization of accreditation programs to ensure product quality and
best practices; (3) Degree to which accreditation standards are
evidence based and supported by published literature; (4) Extent to
which accreditation standards allow for variations in cord blood bank
practices; (5) Criteria for the Secretary to consider in recognizing
cord blood bank accrediting programs for the National Cord Blood
Inventory, C.W. Bill Young Cell Transplantation Program.
The HRSA intends for this interim process to be followed by a
formal, more comprehensive recognition process that will include input
from both the Advisory Council, once it is established, and the
interested public as required in the legislation. The purpose of this
Notice is to invite interested parties to register for and participate
in either of two conference calls, described below, that HRSA is
scheduling to obtain comment on factors relevant to determining which
accrediting organization(s) to recognize for the initial cycle of
funding under the National Cord Blood Inventory.
DATES: The conference calls will be held on May 9, 2006, at 2 to 4 p.m.
e.s.t. and May 15, 2006, at 2 p.m. to 4 p.m. e.s.t. Participants are
asked to register for the conference by contacting Anita Wabeke at
(301) 443-4747 or e-mail awabeke@hrsa.gov. The registration deadline is
May 3, 2006 for both conferences. Registration is not guaranteed; it is
on a first come basis. Since the topics listed above will be discussed
on both calls, and to facilitate hearing all points of view, HRSA
requests that organizations and individuals wishing to participate do
so in only one of the calls. Due to the limited number of lines
available for the calls, organizations with multiple participants are
encouraged to register for one line to allow maximum participation from
all interested parties. Parties wishing to submit written comments
should ensure that the comments are postmarked or E-mailed no later
than May 17, 2006 for consideration.
ADDRESSES: Please send all written comments to James F. Burdick, M.D.,
Director, DoT, HSB, HRSA, Room 12C-06, Parklawn Building, 5600 Fishers
Lane, Rockville, Maryland 20857; telephone (301) 443-7577; fax (301)
594-6095; or e-mail: jburdick@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, DoT,
HSB, HRSA, Parklawn Building, Room 12C-06, 5600 Fishers Lane,
Rockville, Maryland 20857; telephone (301) 443-7577; fax (301) 594-
6095; or e-mail: jburdick@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Background
On December 20, 2005, the Stem Cell Therapeutic Act of 2005 was
enacted as Public Law 109-129. The Act authorizes the establishment of
the National Cord Blood Inventory and the C.W. Bill Young Cell
Transplantation Program as the successor to the National Bone Marrow
Donor Registry. The National Cord Blood Inventory is to be a high
quality, genetically diverse inventory of cord blood units for patients
who need a blood stem cell transplant and who lack an available related
donor. The cord blood units in the National Cord Blood Inventory will
be made available for transplantation through the C.W. Bill Young Cell
Transplantation Program. Cord blood banks collecting and maintaining
units for the National Cord Blood Inventory must meet the statutory
definition of a qualified cord blood bank, which includes a requirement
that cord blood banks be accredited by an
[[Page 24859]]
accreditation entity recognized by the Secretary for this purpose.
Program Authority
The C.W. Bill Young Cell Transplantation Program is authorized by
Public Law 109-129, which amends Part I of the Public Health Service
Act.
Dated: April 20, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6-6313 Filed 4-26-06; 8:45 am]
BILLING CODE 4165-15-P
