Blood Products Advisory Committee; Notice of Meeting, 49880-49881 [E9-23434]
Download as PDF
<![CDATA[
49880
Federal Register / Vol. 74, No. 187 / Tuesday, September 29, 2009 / Notices
MSC 7890, Bethesda, MD 20892, 301–435–
2514, stassid@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: September 21, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–23240 Filed 9–28–09; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0443]
Anti-Infective Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
jlentini on DSKJ8SOYB1PROD with NOTICES
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Anti-Infective Drugs
Advisory Committee.
General Function of the Committee: To
provide advice and recommendations to the
agency on FDA’s regulatory issues.
Date and Time: The meeting will be held
on October 26, 2009, from 8:30 a.m. to 4 p.m.
Addresses: Electronic comments should be
submitted to https://www.regulations.gov.
Enter ‘‘FDA–2009–N–0443’’ and follow the
prompts to submit your statement. Written
comments should be submitted to the
Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. All
comments received will be posted without
change, including any personal information
provided. Comments received on or before
October 5, 2009, will be provided to the
committee before the meeting.
Location: Hilton Washington DC/Silver
Spring, The Ballrooms, 8727 Colesville Rd.,
Silver Spring, MD. The hotel phone number
is 301–589–5200.
Contact Person: Minh Doan, Center for
Drug Evaluation and Research (HFD–21),
Food and Drug Administration, 5600 Fishers
Lane (for express delivery, 5630 Fishers
Lane, rm. 1093), Rockville, MD 20857, 301–
827–7001, FAX: 301–827–6776, e-mail:
Minh.Doan@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–741–
8138 (301–443–0572 in the Washington DC
area), code 3014512530. Please call the
Information Line for up-to-date information
on this meeting. A notice in the Federal
Register about last minute modifications that
impact a previously announced advisory
committee meeting cannot always be
VerDate Nov<24>2008
16:18 Sep 28, 2009
Jkt 217001
published quickly enough to provide timely
notice. Therefore, you should always check
the agency’s Web site and call the
appropriate advisory committee hot line/
phone line to learn about possible
modifications before coming to the meeting.
Agenda: The committee will discuss
updating susceptibility test information in
systemic antibacterial drug product labeling.
FDA intends to make background material
available to the public no later than 2
business days before the meeting. If FDA is
unable to post the background material on its
Web site prior to the meeting, the background
material will be made publicly available at
the location of the advisory committee
meeting, and the background material will be
posted on FDA’s Web site after the meeting.
Background material is available at https://
www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate
advisory committee link.
Procedure: Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
October 16, 2009. Oral presentations from the
public will be scheduled between
approximately 12:45 p.m. and 1:45 p.m.
Those desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of the
general nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and an
indication of the approximate time requested
to make their presentation on or before
October 9, 2009. Time allotted for each
presentation may be limited. If the number of
registrants requesting to speak is greater than
can be reasonably accommodated during the
scheduled open public hearing session, FDA
may conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 12, 2009.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee meetings
and will make every effort to accommodate
persons with physical disabilities or special
needs. If you require special accommodations
due to a disability, please contact Minh Doan
at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct
of its advisory committee meetings. Please
visit our Web site at https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under the
Federal Advisory Committee Act (5 U.S.C.
app. 2).
Dated: 9/23/09.
David Horowitz,
Assistant Commissioner for Policy
[FR Doc. E9–23437 Filed 9–28–09; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Blood Products
Advisory Committee.
General Function of the Committee: To
provide advice and recommendations to the
agency on FDA’s regulatory issues.
Date and Time: The meeting will be held
on November 16, 2009, from 8 a.m. to 5:30
p.m. and on November 17, 2009, from 8 a.m.
to 5 p.m.
Location: Bethesda Marriott Hotel, 5151
Pooks Hill Rd., Bethesda, MD 20814.
Contact Person: William Freas or Pearline
K. Muckelvene, Center for Biologics
Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike
(HFM–71), Rockville, MD 20852, 301–827–
0314, or FDA Advisory Committee
Information Line, 1–800–741–8138 (301–
443–0572 in the Washington, DC area), code
3014519516. Please call the Information Line
for up-to-date information on this meeting. A
notice in the Federal Register about last
minute modifications that impact a
previously announced advisory committee
meeting cannot always be published quickly
enough to provide timely notice. Therefore,
you should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn about
possible modifications before coming to the
meeting.
Agenda: On November 16, 2009, in the
morning the Committee will hear updates on
the following topics: the HHS Advisory
Committee on Blood Safety and Availability,
Dengue virus outbreak, and 2009 A/H1N1
Pandemic and the impact on blood safety and
availability. The Committee will then discuss
blood donor deferral for malaria risk
associated with travel to Mexico. In the
afternoon the Committee will discuss the
design of a new phase III study of pathogen
inactivation of human platelets using the
Cerus, INTERCEPT Blood System. On
November 17, 2009, in the morning the
Committee will discuss blood pressure and
pulse as blood donor eligibility criteria, and
in the afternoon the committee will discuss
the public health need and performance
characteristics of over-the-counter home-use
HIV test kits.
FDA intends to make background material
available to the public no later than 2
business days before the meeting. If FDA is
unable to post the background material on its
Web site prior to the meeting, the background
E:\FR\FM\29SEN1.SGM
29SEN1
jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 187 / Tuesday, September 29, 2009 / Notices
material will be made publicly available at
the location of the advisory committee
meeting, and the background material will be
posted on FDA’s Web site after the meeting.
Background material is available at https://
www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate
advisory committee link.
Procedure: On November 16, 2009, from 8
a.m. to 5:30 p.m. and on November 17, 2009,
from 8 a.m. to 3:15 p.m., the meeting is open
to the public. Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
November 9, 2009. Oral presentations from
the public will be scheduled between
approximately 11 a.m. and 11:30 a.m. and
between 4 p.m. and 4:30 p.m. on November
16, 2009, and between approximately 10:30
a.m. and 11 a.m., and 2:15 and 2:45 p.m. on
November 17, 2009. Those desiring to make
formal oral presentations should notify the
contact person and submit a brief statement
of the general nature of the evidence or
arguments they wish to present, the names
and addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation on or
before October 30, 2009. Time allotted for
each presentation may be limited. If the
number of registrants requesting to speak is
greater than can be reasonably
accommodated during the scheduled open
public hearing session, FDA may conduct a
lottery to determine the speakers for the
scheduled open public hearing session. The
contact person will notify interested persons
regarding their request to speak by November
2, 2009.
Closed Committee Deliberations : On
November 17, 2009, from approximately 3
p.m. until 5 p.m., the meeting will be closed
to permit discussion and review of trade
secret and/or confidential commercial
information (5 U.S.C. 552b(c)(4)). The
committee will hear presentations and
discuss sponsor, trade secret and confidential
information.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee meetings
and will make every effort to accommodate
persons with physical disabilities or special
needs. If you require special accommodations
due to a disability, please contact William
Freas or Pearline K. Muckelvene at least 7
days in advance of the meeting.
FDA is committed to the orderly conduct
of its advisory committee meetings. Please
visit our Web site at https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under the
Federal Advisory Committee Act (5 U.S.C.
app. 2).
VerDate Nov<24>2008
16:18 Sep 28, 2009
Jkt 217001
Dated: September 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–23434 Filed 9–28–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
‘‘CORRECTED Version of Request for
Information Regarding Development
and Operation of a Transplantation
Sentinel Network’’
AGENCY: Office of Blood, Organ and
Other Tissue Safety, Division of
Healthcare Quality Promotion, Center
for Preparedness, Detection, and Control
of Infectious Diseases, Centers for
Disease Control and Prevention,
Department of Health and Human
Services.
ACTION: Request for information notice.
SUMMARY: The Centers for Disease
Control and Prevention (CDC) is seeking
information on development and
operation of a national transplantation
sentinel network (TSN) for the United
States, including resources needed for
management of such a system. The
purpose of the network is to detect and
prevent disease transmission from organ
and tissue allografts recovered for
transplantation.
In June 2005, the CDC announced a
Request for Application (RFA) through
a cooperative agreement for
development of a TSN for organizations
that recover, process, distribute, and
implant organs and tissues. The overall
goal of the system was to improve
patient safety for organ and tissue
recipients. The RFA objectives were to:
(1) Identify and track organs and tissues
to facilitate intervention following
recognition of infections among
recipients or donors; (2) improve
communication among those in the
transplant community, healthcare
facilities and public health agencies
concerning potential risks for
transmission of infections; and (3)
improve pathologic and microbiologic
capabilities on cadaveric donor
specimen samples through shared
resources. Development and field
testing of the prototype was completed
in 2008.
For this RFI, respondents are asked to
describe experiences, plans or opinions
regarding aspects of completing and
operating a TSN system; system
governance, security, and marketing;
user training; and operational and
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
49881
infrastructure management. Responses
need not address every aspect of this
RFI; responses may be limited to
address specific components or portions
of a section. The specific sections
requested for comments are: (1)
Transition of Transplantation
Transmission Sentinel Network (TTSN)
Prototype to Full Production; (2)
Standardization and Compatibility
Issues; (3) Reporting Criteria; (4)
Interoperability and Interfacing with
Existing Data Sources; (5) System
Operation and Infrastructure
Management; (6) Analysis Plan
including Feedback to Users; (7) Patient
Health Information Privacy and
Security; and (8) System Governance.
DATES: Comments must be submitted on
or before December 11, 2009.
ADDRESSES: The entire TSN RFI can be
accessed at https://www.cdc.gov/ncidod/
dhqp/pdf/ttsn/RFI_TSN_FedRegDoc_
9909.pdf. Electronic responses are
preferred and should be sent to
TransplantRFI@cdc.gov. Responses sent
in hard copy format must be securely
bound and sent to Debbie Seem, Office
of Blood, Organ and Other Tissue
Safety, Division of Healthcare Quality
Promotion, Centers for Disease Control
and Prevention, Building 16, MS–A07,
1600 Clifton Road, NE., Atlanta, GA
30329–4018, Telephone number: 404–
639–3234, E-mail Address:
gqi4@cdc.gov.
SUPPLEMENTARY INFORMATION: Each year
in the United States, more than 28,000
solid organs and 2 million tissues are
transplanted, including heart, lung,
liver, kidneys, pancreas, intestine, bone,
skin, heart valves, tendons, fascia and
corneas. Donor-derived infections have
been identified as a source of morbidity
and mortality among both solid organ
and tissue transplant recipients.
Infectious transmission identified in
the past few years among solid organs
have reflected a broad array of viruses,
bacteria, and parasites, resulting in a
high proportion of mortality amongst
infected recipients; examples include
HIV, hepatitis C virus (HCV),
lymphocytic choriomeningitis virus,
Mycobacterium tuberculosis,
Pseudomonas aeruginosa, Strongyloides
spp, and Trypanosoma cruzi, the
etiologic agent of Chagas Disease.
Malignancies also have been transmitted
by solid organs. The Health Resources
and Services Administration (HRSA)
oversees the transplantation of solid
organs through the Organ Procurement
and Transplantation Network (OPTN)
administered by the United Network for
Organ Sharing (UNOS). OPTN policy
requires reporting of all potential donorderived infections to UNOS and
E:\FR\FM\29SEN1.SGM
29SEN1
]]>Agencies
[Federal Register Volume 74, Number 187 (Tuesday, September 29, 2009)]
[Notices]
[Pages 49880-49881]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23434]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Blood Products Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.
Name of Committee: Blood Products Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on November 16, 2009,
from 8 a.m. to 5:30 p.m. and on November 17, 2009, from 8 a.m. to 5
p.m.
Location: Bethesda Marriott Hotel, 5151 Pooks Hill Rd.,
Bethesda, MD 20814.
Contact Person: William Freas or Pearline K. Muckelvene, Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike (HFM-71), Rockville, MD 20852,
301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), code 3014519516.
Please call the Information Line for up-to-date information on this
meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
Agenda: On November 16, 2009, in the morning the Committee will
hear updates on the following topics: the HHS Advisory Committee on
Blood Safety and Availability, Dengue virus outbreak, and 2009 A/
H1N1 Pandemic and the impact on blood safety and availability. The
Committee will then discuss blood donor deferral for malaria risk
associated with travel to Mexico. In the afternoon the Committee
will discuss the design of a new phase III study of pathogen
inactivation of human platelets using the Cerus, INTERCEPT Blood
System. On November 17, 2009, in the morning the Committee will
discuss blood pressure and pulse as blood donor eligibility
criteria, and in the afternoon the committee will discuss the public
health need and performance characteristics of over-the-counter
home-use HIV test kits.
FDA intends to make background material available to the public
no later than 2 business days before the meeting. If FDA is unable
to post the background material on its Web site prior to the
meeting, the background
[[Page 49881]]
material will be made publicly available at the location of the
advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: On November 16, 2009, from 8 a.m. to 5:30 p.m. and on
November 17, 2009, from 8 a.m. to 3:15 p.m., the meeting is open to
the public. Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 9, 2009. Oral presentations from the public will be
scheduled between approximately 11 a.m. and 11:30 a.m. and between 4
p.m. and 4:30 p.m. on November 16, 2009, and between approximately
10:30 a.m. and 11 a.m., and 2:15 and 2:45 p.m. on November 17, 2009.
Those desiring to make formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
October 30, 2009. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person
will notify interested persons regarding their request to speak by
November 2, 2009.
Closed Committee Deliberations : On November 17, 2009, from
approximately 3 p.m. until 5 p.m., the meeting will be closed to
permit discussion and review of trade secret and/or confidential
commercial information (5 U.S.C. 552b(c)(4)). The committee will
hear presentations and discuss sponsor, trade secret and
confidential information.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to
electrical outlets.
FDA welcomes the attendance of the public at its advisory
committee meetings and will make every effort to accommodate persons
with physical disabilities or special needs. If you require special
accommodations due to a disability, please contact William Freas or
Pearline K. Muckelvene at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory
committee meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for
procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23434 Filed 9-28-09; 8:45 am]
BILLING CODE 4160-01-S
