Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting, 62843-62844 [2010-25646]
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Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices
08869, 908–526–2400/800–437–4986,
(Formerly: Roche Biomedical
Laboratories, Inc.)
Laboratory Corporation of America
Holdings, 1904 Alexander Drive,
Research Triangle Park, NC 27709,
919–572–6900/800–833–3984,
(Formerly: LabCorp Occupational
Testing Services, Inc., CompuChem
Laboratories, Inc.; CompuChem
Laboratories, Inc., A Subsidiary of
Roche Biomedical Laboratory; Roche
CompuChem Laboratories, Inc., A
Member of the Roche Group).
Laboratory Corporation of America
Holdings, 1120 Main Street,
Southaven, MS 38671, 866–827–8042/
800–233–6339, (Formerly: LabCorp
Occupational Testing Services, Inc.;
MedExpress/National Laboratory
Center).
LabOne, Inc. d/b/a Quest Diagnostics,
10101 Renner Blvd., Lenexa, KS
66219, 913–888–3927/800–873–8845,
(Formerly: Quest Diagnostics
Incorporated; LabOne, Inc.; Center for
Laboratory Services, a Division of
LabOne, Inc.,).
Maxxam Analytics*, 6740 Campobello
Road, Mississauga, ON, Canada L5N
2L8, 905–817–5700, (Formerly:
Maxxam Analytics Inc., NOVAMANN
(Ontario), Inc.)
MedTox Laboratories, Inc., 402 W.
County Road D, St. Paul, MN 55112,
651–636–7466/800–832–3244.
MetroLab-Legacy Laboratory Services,
1225 NE 2nd Ave., Portland, OR
97232, 503–413–5295/800–950–5295.
Minneapolis Veterans Affairs Medical
Center,
Forensic Toxicology Laboratory, 1
Veterans Drive, Minneapolis, MN
55417, 612–725–2088.
National Toxicology Laboratories, Inc.,
1100 California Ave., Bakersfield, CA
93304, 661–322–4250/800–350–3515.
One Source Toxicology Laboratory, Inc.,
1213 Genoa-Red Bluff, Pasadena, TX
77504, 888–747–3774, (Formerly:
University of Texas Medical Branch,
Clinical Chemistry Division; UTMB
Pathology-Toxicology Laboratory).
Pacific Toxicology Laboratories, 9348
DeSoto Ave., Chatsworth, CA 91311,
800–328–6942, (Formerly: Centinela
Hospital Airport Toxicology
Laboratory).
Pathology Associates Medical
Laboratories, 110 West Cliff Dr.,
Spokane, WA 99204, 509–755–8991/
800–541–7891x7.
Phamatech, Inc., 10151 Barnes Canyon
Road, San Diego, CA 92121, 858–643–
5555.
Quest Diagnostics Incorporated, 1777
Montreal Circle, Tucker, GA 30084,
800–729–6432, (Formerly: SmithKline
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Beecham Clinical Laboratories;
SmithKline Bio-Science Laboratories).
Quest Diagnostics Incorporated, 400
Egypt Road, Norristown, PA 19403,
610–631–4600/877–642–2216,
(Formerly: SmithKline Beecham
Clinical Laboratories; SmithKline BioScience Laboratories).
Quest Diagnostics Incorporated, 8401
Fallbrook Ave., West Hills, CA 91304,
800–877–2520, (Formerly: SmithKline
Beecham Clinical Laboratories).
S.E.D. Medical Laboratories, 5601 Office
Blvd., Albuquerque, NM 87109,
505–727–6300/800–999–5227.
South Bend Medical Foundation, Inc.,
530 N. Lafayette Blvd., South Bend,
IN 46601, 574–234–4176 x1276.
Southwest Laboratories, 4625 E. Cotton
Center Boulevard, Suite 177, Phoenix,
AZ 85040, 602–438–8507/800–279–
0027.
St. Anthony Hospital Toxicology
Laboratory, 1000 N. Lee St.,
Oklahoma City, OK 73101, 405–272–
7052.
STERLING Reference Laboratories, 2617
East L Street, Tacoma, Washington
98421, 800–442–0438.
Toxicology & Drug Monitoring
Laboratory, University of Missouri
Hospital & Clinics, 301 Business Loop
70 West, Suite 208, Columbia, MO
65203, 573–882–1273.
Toxicology Testing Service, Inc., 5426
N.W. 79th Ave., Miami, FL 33166,
305–593–2260.
U.S. Army Forensic Toxicology Drug
Testing Laboratory, 2490 Wilson St.,
Fort George G. Meade, MD 20755–
5235, 301–677–7085.
* The Standards Council of Canada
(SCC) voted to end its Laboratory
Accreditation Program for Substance
Abuse (LAPSA) effective May 12, 1998.
Laboratories certified through that
program were accredited to conduct
forensic urine drug testing as required
by U.S. Department of Transportation
(DOT) regulations. As of that date, the
certification of those accredited
Canadian laboratories will continue
under DOT authority. The responsibility
for conducting quarterly performance
testing plus periodic on-site inspections
of those LAPSA-accredited laboratories
was transferred to the U.S. HHS, with
the HHS’ NLCP contractor continuing to
have an active role in the performance
testing and laboratory inspection
processes. Other Canadian laboratories
wishing to be considered for the NLCP
may apply directly to the NLCP
contractor just as U.S. laboratories do.
Upon finding a Canadian laboratory to
be qualified, HHS will recommend that
DOT certify the laboratory (Federal
Register, July 16, 1996) as meeting the
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minimum standards of the Mandatory
Guidelines published in the Federal
Register on April 30, 2010 (75 FR
22809). After receiving DOT
certification, the laboratory will be
included in the monthly list of HHScertified laboratories and participate in
the NLCP certification maintenance
program.
Dated: October 6, 2010.
Elaine Parry,
Director, Office of Management, Technology,
and Operations, SAMHSA.
[FR Doc. 2010–25705 Filed 10–12–10; 8:45 am]
BILLING CODE 4160–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Council on Blood Stem Cell
Transplantation; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Council on Blood Stem
Cell Transplantation.
Date and Times: November 15, 2010, 8:30
a.m. to 4:30 p.m.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, Bethesda, Maryland
20814.
Status: The meeting will be open to the
public.
Purpose: Pursuant to Public Law 109–129,
42 U.S.C. 274k (section 379 of the Public
Health Service Act, as amended) the
Advisory Council on Blood Stem Cell
Transplantation (ACBSCT) advises 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.
Agenda: The Council will hear reports
from five ACBSCT Work Groups: Cord Blood
Bank Collections, Realizing the Potential of
Cord Blood, Scientific Factors Necessary to
Define a Cord Blood Unit as High Quality,
Cord Blood Thawing and Washing, and
Access to Transplantation. The Council also
will hear presentations and discussions on
the following topics: Arizona reimbursement
concerns for Medicaid beneficiaries,
Myelodysplastic Syndromes (MDS) coverage,
Medicare reimbursement for costs for
allogeneic or autologous transplants,
legislative reauthorization and
appropriations bills, and Program
performance measures. Agenda items are
subject to change as priorities indicate.
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
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Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Notices
record of the ACBSCT meeting. Meeting
summary notes will be made available on the
HRSA’s Program Web site at https://
bloodcell.transplant.hrsa.gov/ABOUT/
Advisory_Council/.
Those planning to attend are requested to
register in advance. The draft meeting agenda
and a registration form are available on the
HRSA’s Program Web site at https://
bloodcell.transplant.hrsa.gov/ABOUT/
Advisory_Council/.
Registration also can be completed
electronically at https://www.acbsct.com or
submitted by facsimile to Lux Consulting
Group, Inc., the logistical support contractor
for the meeting, at fax number (301) 585–
7741 Attn: Tristan Alexander. Individuals
without access to the Internet who wish to
register may call Tristan Alexander at (301)
585–1261.
FOR FURTHER INFORMATION CONTACT:
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Carmen Villar, M.S.W., Designated Federal
Officer, ACD, CDC, 1600 Clifton Road, NE.,
M/S D–14, Atlanta, Georgia 30333.
Telephone 404/639–7000. E-mail:
GHickman@cdc.gov. The deadline for
notification of attendance is October 25,
2010.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: October 5, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Patricia Stroup, Executive Secretary,
Healthcare Systems Bureau, Health
Resources and Services Administration,
5600 Fishers Lane, Room 12C–06,
Rockville, Maryland 20857; telephone
(301) 443–1127.
[FR Doc. 2010–25703 Filed 10–12–10; 8:45 am]
Dated: October 6, 2010.
Wendy Ponton,
Director, Office of Management.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–25646 Filed 10–12–10; 8:45 am]
Food and Drug Administration
BILLING CODE 4165–15–P
[Docket No. FDA–2010–N–0001]
Innovations in Technology for the
Treatment of Diabetes: Clinical
Development of the Artificial Pancreas
(an Autonomous System); Public
Workshop
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention (CDC)
mstockstill on DSKH9S0YB1PROD with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the CDC announces
the following meeting of the
aforementioned committee:
Time and Date: 8:30 a.m.–3 p.m., October
28, 2010.
Place: CDC, 1600 Clifton Road, NE.,
Building 21, Rooms 1204 A/B, Atlanta,
Georgia 30333.
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 50 people. The
public is welcome to participate during the
public comment period. The public comment
period is tentatively scheduled for 2:30 to
2:45 p.m.
Purpose: The committee will provide
advice to the CDC Director on strategic and
other broad issues facing CDC.
Matters to be Discussed: The ACD, CDC
will receive updates from the Global
Workgroup; State, Tribal, Local and
Territorial Workgroup; Surveillance and
Epidemiology Workgroup; and the Policy
Workgroup. The Ethics Subcommittee and
National Biosurveillance Advisory
Subcommittee will provide updates on their
current activities.
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) and the National Institutes of
Health (NIH) are announcing a public
workshop entitled ‘‘Innovations in
Technology for the Treatment of
Diabetes: Clinical Development of the
Artificial Pancreas (an Autonomous
System).’’ The topics to be discussed are
the current state of device systems for
autonomous systems for the treatment of
diabetes mellitus, the challenges in
developing this expert system using
existing technology, a discussion of the
clinical expectations and success
criteria for these systems, and a
discussion of development plans for the
transition of this device system toward
an outpatient setting.
Date and Time: The public workshop
will be held on November 10, 2010,
from 8 a.m. to 5 p.m. Persons interested
in attending this meeting must register
by 5 p.m. on November 3, 2010.
Location: The meeting will be held at
the Hilton Washington, DC North/
Gaithersburg Hotel, 620 Perry Pkwy.,
Gaithersburg, MD 20877.
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Contact: Charles Zimliki, Food and
Drug Administration, Center for Devices
and Radiological Health (CDRH), 10903
New Hampshire Ave., Bldg. 66, rm.
2556, Silver Spring, MD 20993–0002,
301–796–6297, Fax: 301–847–8109, email: Charles.Zimliki@fda.hhs.gov.
Registration: Registration is free and
will be on a first-come, first-served
basis. To register for the public
workshop, webinar or onsite attendance,
please visit the following Web site:
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
ucm226251.htm (select the appropriate
meeting from the list). Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, e-mail, and
telephone number. For those without
Internet access, please call Victoria
Wagman at 301–796–6581 to register.
Registration requests should be received
by 5 p.m. on November 3, 2010. Early
registration is recommended because
seating is limited and therefore FDA/
NIH may limit the number of
participants from each organization. If
time and space permits, onsite
registration on the day of the public
meeting will be provided beginning at 7
a.m.
If you need special accommodations
due to a disability, please contact Susan
Monahan (e-mail:
Susan.Monahan@fda.hhs.gov) at least 7
days in advance.
SUPPLEMENTARY INFORMATION:
I. Background
CDRH has undertaken an initiative to
proactively facilitate medical device
innovation to address unmet public
health needs. As part of this initiative,
CDRH with NIH have focused on the
development of the artificial pancreas
(or Autonomous System) for the
treatment of diabetes mellitus. An
artificial pancreas is a medical device
that links a glucose monitor to an
insulin infusion pump where the pump
automatically takes action (using a
control algorithm) based upon the
glucose monitor reading. As control
algorithms can vary significantly, there
are a variety of artificial pancreas
systems currently under development.
These systems can range from low
glucose suspend, to control-to-range, to
control-to-target, to bihormonal control
where each device has different
purposes or intended uses for
controlling blood sugars. In addition,
most research in this area uses existing
medical device technology, which might
limit the performance and evaluation of
these systems. Given these device
limitations, preliminary research has
focused on evaluating these systems in
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[Federal Register Volume 75, Number 197 (Wednesday, October 13, 2010)]
[Notices]
[Pages 62843-62844]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25646]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Council on Blood Stem Cell Transplantation; Notice of
Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
Name: Advisory Council on Blood Stem Cell Transplantation.
Date and Times: November 15, 2010, 8:30 a.m. to 4:30 p.m.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center,
Bethesda, Maryland 20814.
Status: The meeting will be open to the public.
Purpose: Pursuant to Public Law 109-129, 42 U.S.C. 274k (section
379 of the Public Health Service Act, as amended) the Advisory
Council on Blood Stem Cell Transplantation (ACBSCT) advises 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.
Agenda: The Council will hear reports from five ACBSCT Work
Groups: Cord Blood Bank Collections, Realizing the Potential of Cord
Blood, Scientific Factors Necessary to Define a Cord Blood Unit as
High Quality, Cord Blood Thawing and Washing, and Access to
Transplantation. The Council also will hear presentations and
discussions on the following topics: Arizona reimbursement concerns
for Medicaid beneficiaries, Myelodysplastic Syndromes (MDS)
coverage, Medicare reimbursement for costs for allogeneic or
autologous transplants, legislative reauthorization and
appropriations bills, and Program performance measures. Agenda items
are subject to change as priorities indicate.
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
[[Page 62844]]
record of the ACBSCT meeting. Meeting summary notes will be made
available on the HRSA's Program Web site at https://bloodcell.transplant.hrsa.gov/ABOUT/Advisory_Council/.
Those planning to attend are requested to register in advance.
The draft meeting agenda and a registration form are available on
the HRSA's Program Web site at https://bloodcell.transplant.hrsa.gov/ABOUT/Advisory_Council/.
Registration also can be completed electronically at https://www.acbsct.com or submitted by facsimile to Lux Consulting Group,
Inc., the logistical support contractor for the meeting, at fax
number (301) 585-7741 Attn: Tristan Alexander. Individuals without
access to the Internet who wish to register may call Tristan
Alexander at (301) 585-1261.
FOR FURTHER INFORMATION CONTACT: Patricia Stroup, Executive Secretary,
Healthcare Systems Bureau, Health Resources and Services
Administration, 5600 Fishers Lane, Room 12C-06, Rockville, Maryland
20857; telephone (301) 443-1127.
Dated: October 6, 2010.
Wendy Ponton,
Director, Office of Management.
[FR Doc. 2010-25646 Filed 10-12-10; 8:45 am]
BILLING CODE 4165-15-P