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 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 Paperwork Reduction Act This draft guidance refers to previously approved collections of information found in FDA regulations.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 Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time.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persons may submit written or electronic comments to the Division of Dockets Management (see ADDRESSES) regarding the draft guidance.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 http:// www.fda.gov/cber/guidelines.htm or http://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: http:// 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 http:// 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 http://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 http:// 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]


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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