E8-366. Notice of Meeting of the Advisory Council on Blood Stem Cell Transplantation

AGENCY:

Health Resources and Services Administration, HHS.

ACTION:

Notice of meeting of the Advisory Council on Blood Stem Cell Transplantation.

SUMMARY:

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the first meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on January 28, 2008, and from 9 a.m. to 5 p.m. on January 29, 2008, at the Hilton Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, MD 20852. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

SUPPLEMENTARY INFORMATION:

Pursuant to Public Law 109-129, 42 U.S.C. 274k (section 379 of the Public Health Service Act, as amended) the ACBSCT was established to advise the Secretary of HHS and the Administrator, HRSA, on matters related to the activities of the C.W. Bill Young Cell Transplantation Program (Program) and the National Cord Blood Inventory (NCBI) Program. ACBSCT is composed of up to 25 members, including the Chair, serving as Special Government Employees. The current membership includes 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.

ACBSCT will hear presentations on and discuss cord blood bank accreditation for the NCBI Program; the Food and Drug Administration's (FDA) Draft Guidance for Cord Blood Bank Licensure; Program confidentiality policies; Program registry size and composition; the Related Cord Blood Donor Demonstration Project; and the scientific factors that define a high quality cord blood unit.

The draft meeting agenda will be available on January 15, 2008, on the HRSA's Program Web site at http://bloodcell.transplant.hrsa.gov/​.

A registration form will be available on January 7, 2008, on the HRSA's Program Web site at http://bloodcell.transplant.hrsa.gov/​. The completed registration form should be submitted by facsimile to Professional and Scientific Associates (PSA), the logistical support contractor for the meeting, at fax number [phone]. Individuals without access to the Internet who wish to register may call Sowjanya Kotakonda with PSA at [phone]. Registration can also be completed electronically at https://www.team-psa.com/​dot/​2008/​acbsct/​. Individuals who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the ACBSCT Executive Secretary, Remy Aronoff, in advance of the meeting. Mr. Aronoff may be reached by telephone at 301-443-3264, e-mail: [e-mail] or in writing at the address provided below. Management and support services for ACBSCT functions are provided by the Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Parklawn Building, Room 12C-06, Rockville, Maryland 20857; telephone number 301-443-7577.

After the presentations and Council discussions, members of the public will have an opportunity to provide comments. Because of the Council's full agenda and the timeframe in which to cover the agenda topics, public comment will be limited. All public comments will be included in the record of the ACBSCT meeting. Meeting summary notes will be made available on the HRSA's Program Web site at http://bloodcell.transplant.hrsa.gov/​.

Dated: January 7, 2008.

Elizabeth M. Duke,

Administrator.