Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue, and Organ Safety; Public Workshop, 55244-55245 [E9-25802]
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55244
Federal Register / Vol. 74, No. 206 / Tuesday, October 27, 2009 / Notices
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 December 15, 2009, the
committee will discuss supplemental new
drug application (sNDA) 21–366, CRESTOR
(rosuvastatin calcium) tablets, AstraZeneca
Pharmaceuticals. CRESTOR is a member of
the statin drug class which lowers lipids (fats
that circulate in the bloodstream, including
cholesterol) by inhibiting HMG-CoA
reductase, an enzyme involved in producing
lipids in the body. The proposed indication
(use) of CRESTOR in this application is
primary prevention of cardiovascular disease
based on the results of JUPITER. JUPITER
was a clinical trial that studied individuals
who did not have obvious or overt
cardiovascular disease, but did have the
following characteristics: Low or normal
levels of the variety of cholesterol known as
low-density lipoprotein, or LDL; elevated
levels of C-reactive protein (hsCRP), a marker
of inflammation in the body, and at least one
of the conventional risk factors for
cardiovascular disease. (The ‘‘conventional
risk factors’’ are smoking, age, high blood
pressure, low levels of the good cholesterol,
HDL, and family history of heart disease). In
these individuals, JUPITER evaluated the
reduction of risk with rosuvastatin therapy
on the study’s combined objectives (known
as the study’s ‘‘composite endpoint’’) which
included: Death from heart disease (heart
attack) or vascular disease (stroke), heart
attack that did not result in death, stroke that
did not result in death, unstable angina
(when the heart does not get enough blood
flow, often a warning of heart attack), and
heart or blood vessel disease that necessitates
arterial revascularization, commonly known
as ‘‘bypass surgery.’’
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
December 1, 2009. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 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 November 20, 2009.
Time allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can be
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16:45 Oct 26, 2009
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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 23, 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 Paul Tran
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/About
AdvisoryCommittees/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: October 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25805 Filed 10–26–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0339]
Prescription Drug User Fee Rates for
Fiscal Year 2010; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
Frm 00064
Fmt 4703
Sfmt 4703
Dated: October 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25804 Filed 10–26–09; 8:45 am]
BILLING CODE 4160–01–S
SUMMARY: The Food and Drug
Administration is correcting a notice
that appeared in the Federal Register of
August 3, 2009 (74 FR 38451). The
document announced the fiscal year
2010 fee rates for the Prescription Drug
User Fee Act. The document was
published with errors. This document
corrects those errors.
FOR FURTHER INFORMATION CONTACT:
David Miller, Office of Financial
Management (HFA–100), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–3917.
SUPPLEMENTARY INFORMATION: In FR Doc.
E9–18457, appearing on page 38451, in
the Federal Register of Monday, August
3, 2009, the following corrections are
made:
1. On page 38451, in the first column,
in the SUMMARY section, the fifth
sentence ‘‘This notice establishes fee
rates for FY 2010 for application fees for
PO 00000
an application requiring clinical data
($1,405,500), for an application not
requiring clinical data or a supplement
requiring clinical data ($702,750), for
establishment fees ($457,200), and for
product fees ($77,720).’’ is corrected to
read ‘‘This notice establishes fee rates
for FY 2010 for application fees for an
application requiring clinical data
($1,405,500), for an application not
requiring clinical data or a supplement
requiring clinical data ($702,750), for
establishment fees ($457,200), and for
product fees ($79,720).’’
2. On page 38452, the title of table 2
is corrected to read ‘‘Table 2.—FDA
Personnel Compensation and Benefits
(PC&B) Each Year and Percent Change
(Dollars in Thousands)’’.
3. On page 38452, in table 2, in the
fourth column that begins ‘‘PC&B per
FTE’’, remove ‘‘,’’ everywhere it appears
and replace it with ‘‘.’’.
4. On page 38454, footnote 1 to table
3 is corrected to read ‘‘1 Table 3
published in the Federal Register of
August 1, 2008 (73 FR 45017), showed
the average number of active INDs for
the base years of 2002–2007 as 5,755.8.
FDA discovered that a small subset of
INDs had been double counted in the
number reported last year. That error
has been corrected in the revised
number of 5,528.2 reflected in the table
this year. Had the error not been made,
the workload adjustment in FY 2009
would have been 3.76 percent rather
than the 2.98 percent published in the
Federal Register last year.’’
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Emerging Arboviruses: Risk
Assessment for Blood, Cell, Tissue,
and Organ Safety; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Emerging Arboviruses: Risk
Assessment for Blood, Cell, Tissue and
Organ Safety.’’ The purpose of the
public workshop is to assess the risk
and discuss approaches to minimize the
incidence of transmission of arboviruses
E:\FR\FM\27OCN1.SGM
27OCN1
Federal Register / Vol. 74, No. 206 / Tuesday, October 27, 2009 / Notices
(arthropod-borne viruses), by
transfusion, infusion, implantation, or
transplantation in the United States.
The public workshop will feature
presentations and roundtable
discussions led by experts from
academic institutions, government, and
industry.
Date and Time: The public workshop
will be held on December 14, 2009, from
8:30 a.m. to 5:30 p.m. and December 15,
2009, from 8:30 a.m. to 5:30 p.m.
Location: The public workshop will
be held at the Natcher Conference
Center, Main Auditorium, Bldg. 45,
National Institutes of Health, 8800
Rockville Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 550N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or e-mail your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to the
Contact Person by November 20, 2009.
There is no registration fee for the
public workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 7:30
a.m.
If you need special accommodations
due to a disability, please contact
Rhonda Dawson (see Contact Person) at
least 7 days in advance.
Requests for Presentations of Data:
Interested persons are invited to present
data related to technologies for the
detection or inactivation of arboviruses
in blood products, organs, or tissues. If
you are interested in presenting, submit
a brief statement of the general nature of
the presentation to the Contact Person
by November 20, 2009 (see section II of
this document for additional
information).
SUPPLEMENTARY INFORMATION:
pwalker on DSK8KYBLC1PROD with NOTICES
I. Background
Arboviruses are a large group of
viruses that are spread by certain
invertebrate animals, most commonly
blood-sucking insects. Arboviruses are
found throughout the world, including
the United States. Arboviruses, such as
Dengue virus, Japanese Encephalitis
virus (JE), tick-borne encephalitis virus
(TBE), and West Nile virus (WNV), are
becoming increasingly widespread.
Transmission of WNV and Dengue virus
through blood transfusion has been well
documented. Transfusion transmission
of the Colorado tick fever (CTF) virus,
VerDate Nov<24>2008
16:45 Oct 26, 2009
Jkt 220001
a tick-borne agent present in the United
States, also has been reported. Other
arboviruses, including JE, TBE, and St.
Louis Encephalitis are of concern to
blood, cell, tissue, and organ safety
because of the possibility of viremia in
asymptomatic human infections.
Dengue outbreaks have recently
occurred in Texas, Hawaii, Puerto Rico,
and the U.S. Virgin Islands. Dengue
virus, as well as TBE, and JE, have the
potential to become endemic in certain
regions of the United States. Therefore,
proactive discussions among the
Department of Health and Human
Services public health agencies,
including the FDA, National Institutes
of Health, and the Centers for Disease
Control and Prevention, academia,
industry, blood establishments, cell and
tissue establishments, and other
stakeholders are necessary to address
blood, cell, tissue, and organ safety in
response to the emerging arboviruses.
The public workshop will facilitate a
scientific discussion on approaches to
reduce the risk of transmission of
arboviruses by transfusion, infusion,
implantation, or transplantation in the
United States. Topics to be discussed
include: (1) Biology and pathogenesis of
arboviruses; (2) epidemiology and
prevention of arbovirus vectors and
hosts in the United States; (3) laboratory
detection and prevention of arbovirus
infection in humans; (4) transfusion,
infusion, implantation or
transplantation transmission of
arboviruses in the United States; and (5)
potential approaches, including donor
testing and pathogen inactivation, to
reduce the risk of transfusion
transmission of arboviruses.
II. Requests for Presentations of Data
Interested persons are invited to
present data related to technologies for
the detection or inactivation of
arboviruses in blood products, organs,
or tissues. Those desiring to make
presentations at the workshop should
notify the Contact Person and submit a
brief statement of the general nature of
the presentation before November 20,
2009. Presentations will be scheduled
on the afternoon of December 15, 2009.
Time allotted for each presentation will
be limited depending on the number of
individuals requesting to speak.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page. A transcript of the public
workshop will be available on the
PO 00000
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Fmt 4703
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55245
Internet at https://www.fda.gov/Biologics
BloodVaccines/NewsEvents/Workshops
MeetingsConferences/Transcripts
Minutes/default.htm.
Dated: October 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25802 Filed 10–26–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0063] (formerly
Docket No. 2004N–0346)
Saccharomyces boulardii Eligibility for
Consideration To Be Added to the
Over-the-Counter Drug Monograph for
Antidiarrheal Drug Products; Request
for Safety and Effectiveness Data;
Withdrawal
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Withdrawal of notice of
eligibility and request for data and
information.
SUMMARY: We (Food and Drug
Administration (FDA)) are withdrawing
a notice of eligibility and call-for-data
for safety and effectiveness information.
The original notice published in the
Federal Register of August 23, 2004 (69
FR 51852). In that notice, we announced
that Saccharomyces boulardii (S.
boulardii) was eligible for consideration
to be added to the over-the-counter
(OTC) monograph for antidiarrheal drug
products.
FOR FURTHER INFORMATION CONTACT:
Michael L. Koenig, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5411,
Silver Spring, MD 20993–0002, 301–
796–2090.
SUPPLEMENTARY INFORMATION: In 2004,
we published a notice of eligibility for
consideration of the yeast S. boulardii in
the OTC drug monograph system. We
announced our intention to evaluate S.
boulardii for inclusion in the
monograph for OTC antidiarrheal drug
products (21 CFR part 335). The notice
also requested submission of data and
information on the safety and
effectiveness of S. boulardii for us to
determine whether it could be generally
recognized as safe and effective (GRAS/
E) and not misbranded for its proposed
OTC drug use.
S. boulardii for antidiarrheal use
meets the definition of a drug in the
Federal Food, Drug, and Cosmetic Act.
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 74, Number 206 (Tuesday, October 27, 2009)]
[Notices]
[Pages 55244-55245]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25802]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue,
and Organ Safety; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Emerging Arboviruses: Risk Assessment for Blood,
Cell, Tissue and Organ Safety.'' The purpose of the public workshop is
to assess the risk and discuss approaches to minimize the incidence of
transmission of arboviruses
[[Page 55245]]
(arthropod-borne viruses), by transfusion, infusion, implantation, or
transplantation in the United States. The public workshop will feature
presentations and roundtable discussions led by experts from academic
institutions, government, and industry.
Date and Time: The public workshop will be held on December 14,
2009, from 8:30 a.m. to 5:30 p.m. and December 15, 2009, from 8:30 a.m.
to 5:30 p.m.
Location: The public workshop will be held at the Natcher
Conference Center, Main Auditorium, Bldg. 45, National Institutes of
Health, 8800 Rockville Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 550N, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843,
e-mail: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or e-mail your registration information
(including name, title, firm name, address, telephone and fax numbers)
to the Contact Person by November 20, 2009. There is no registration
fee for the public workshop. Early registration is recommended because
seating is limited. Registration on the day of the public workshop will
be provided on a space available basis beginning at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Rhonda Dawson (see Contact Person) at least 7 days in advance.
Requests for Presentations of Data: Interested persons are invited
to present data related to technologies for the detection or
inactivation of arboviruses in blood products, organs, or tissues. If
you are interested in presenting, submit a brief statement of the
general nature of the presentation to the Contact Person by November
20, 2009 (see section II of this document for additional information).
SUPPLEMENTARY INFORMATION:
I. Background
Arboviruses are a large group of viruses that are spread by certain
invertebrate animals, most commonly blood-sucking insects. Arboviruses
are found throughout the world, including the United States.
Arboviruses, such as Dengue virus, Japanese Encephalitis virus (JE),
tick-borne encephalitis virus (TBE), and West Nile virus (WNV), are
becoming increasingly widespread. Transmission of WNV and Dengue virus
through blood transfusion has been well documented. Transfusion
transmission of the Colorado tick fever (CTF) virus, a tick-borne agent
present in the United States, also has been reported. Other
arboviruses, including JE, TBE, and St. Louis Encephalitis are of
concern to blood, cell, tissue, and organ safety because of the
possibility of viremia in asymptomatic human infections. Dengue
outbreaks have recently occurred in Texas, Hawaii, Puerto Rico, and the
U.S. Virgin Islands. Dengue virus, as well as TBE, and JE, have the
potential to become endemic in certain regions of the United States.
Therefore, proactive discussions among the Department of Health and
Human Services public health agencies, including the FDA, National
Institutes of Health, and the Centers for Disease Control and
Prevention, academia, industry, blood establishments, cell and tissue
establishments, and other stakeholders are necessary to address blood,
cell, tissue, and organ safety in response to the emerging arboviruses.
The public workshop will facilitate a scientific discussion on
approaches to reduce the risk of transmission of arboviruses by
transfusion, infusion, implantation, or transplantation in the United
States. Topics to be discussed include: (1) Biology and pathogenesis of
arboviruses; (2) epidemiology and prevention of arbovirus vectors and
hosts in the United States; (3) laboratory detection and prevention of
arbovirus infection in humans; (4) transfusion, infusion, implantation
or transplantation transmission of arboviruses in the United States;
and (5) potential approaches, including donor testing and pathogen
inactivation, to reduce the risk of transfusion transmission of
arboviruses.
II. Requests for Presentations of Data
Interested persons are invited to present data related to
technologies for the detection or inactivation of arboviruses in blood
products, organs, or tissues. Those desiring to make presentations at
the workshop should notify the Contact Person and submit a brief
statement of the general nature of the presentation before November 20,
2009. Presentations will be scheduled on the afternoon of December 15,
2009. Time allotted for each presentation will be limited depending on
the number of individuals requesting to speak.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Dated: October 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25802 Filed 10-26-09; 8:45 am]
BILLING CODE 4160-01-S
