Data and Data Needs To Advance Risk Assessment for Emerging Infectious Diseases Relevant to Blood and Blood Products; Public Workshop, 63308-63309 [2011-26295]
Download as PDF
<![CDATA[
63308
Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS—Continued
Date
Submit electronic or
written comments.
Electronic address
Submit comments
by November 29,
2011.
Address (non electronic)
Federal eRulemaking Portal:
https://www.regulations.gov.
Follow the instructions for
submitting comments.
Other information
FDA: FAX: 301–827–6870.
Mail/Hand delivery/Courier
(for paper, disk, or CD–
ROM submissions): Division
of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers
Lane, rm. 1061, Rockville,
MD 20852.
FSIS: Docket Clerk, U.S. Department of Agriculture,
Food Safety and Inspection
Service, George Washington
Carver Center, 5601 Sunnyside Ave., Mailstop 547,
Beltsville, MD 20705–5464.
All comments must include the
Agency name and the docket number (see table 2 of
this document for a list of
Agencies and corresponding
docket numbers). All received comments may be
posted without change to
https://www.regulations.gov,
including any personal information provided. FDA and
FSIS encourage the submission of electronic comments
by using the Federal
eRulemaking Portal. For additional information on submitting comments, see the
‘‘Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of this document.
.
jlentini on DSK4TPTVN1PROD with NOTICES
IV. Comments
V. Transcripts
FDA: Regardless of attendance at the
public meeting, interested persons may
submit to FDA’s Division of Dockets
Management (see Addresses in table 1 of
this document) either electronic or
written comments for consideration at
or after the meeting, in addition to, or
in place of, a request for an opportunity
to make an oral presentation. It is only
necessary to send one set of comments.
It is no longer necessary to send two
copies of mailed comments. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
FSIS: Regardless of attendance at the
public meeting, interested persons may
submit to FSIS’s Docket Clerk (see
Addresses in table 1 of this document)
either electronic or written comments
regarding this document. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the FSIS Docket Room between
8:30 a.m. and 4:30 p.m., Monday
through Friday.
Because two docket numbers are
associated with this document, please
include with your comments the docket
number that corresponds with the
appropriate Agency. Comments
submitted for inclusion in both dockets
should be separately submitted to each
identified docket number to ensure
consideration by both Agencies.
Please be advised that as soon as a
transcript is available, it will be posted
on FDA’s Sodium Reduction Web page
at https://www.fda.gov/Food/
FoodIngredientsPackaging/
ucm253316.htm. It may also be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857.
VerDate Mar<15>2010
17:43 Oct 11, 2011
Jkt 226001
Dated: October 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy,
Food and Drug Administration.
Dated: October 4, 2011.
Alfred V. Almanza,
Administrator, Food Safety and Inspection
Service.
[FR Doc. 2011–26371 Filed 10–11–11; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Data and Data Needs To Advance Risk
Assessment for Emerging Infectious
Diseases Relevant to Blood and Blood
Products; 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: ‘‘Data and Data Needs to
Advance Risk Assessment for Emerging
Infectious Diseases Relevant to Blood
and Blood Products.’’ The purpose of
the public workshop is to discuss data
and data sources currently used by FDA,
possible new sources of data, and
development of new studies and
information through collaboration with
stakeholders. The public workshop will
include presentations and panel
discussions with experts from
stakeholders, academia, regulated
industry, and government.
Date and Time: The public workshop
will be held on November 29, 2011,
from 8:30 a.m. to 5 p.m.
Location: The public workshop will
be held at the Gaithersburg Hilton, 620
Perry Pkwy., Gaithersburg, MD 20877,
301–977–8900.
Contact Person: Lou Gallagher, Center
for Biologics Evaluation and Research
(HFM–210), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
E:\FR\FM\12OCN1.SGM
12OCN1
jlentini on DSK4TPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices
301–827–5988, e-mail:
lou.gallagher@fda.hhs.gov.
Registration: Mail, fax, or e-mail your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to Lou
Gallagher (see Contact Person) by
November 10, 2011. 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 8 a.m.
If you need special accommodations
due to a disability, please contact Lou
Gallagher (see Contact Person) at least 7
days in advance.
SUPPLEMENTARY INFORMATION:
Quantitative risk assessments (QRAs)
are an important tool for evaluating the
risks associated with new emerging
infectious diseases (EIDs) that are
relevant to blood and blood products
and the benefits of mitigation options.
QRAs make it possible for
decisionmakers to develop policy for
blood and blood product safety and
availability using sound science and the
best data and information available.
Rapid data collection, information
sharing, and analyses estimating the
magnitude and probability of risk can be
expedited by proactively building and
maintaining critical relationships both
within the Center for Biologics
Evaluation and Research (CBER) and
with external stakeholders. In this
public workshop, CBER is seeking
access to accurate, reliable data on
factors such as disease prevalence,
incubation periods, behavioral risks
associated with disease transmission,
potential donor exposure risks, and
susceptibility to EIDs, product handling,
usage, and other factors.
Lack of data and information is a
major challenge FDA faces when there
is a new EID. The public workshop will:
(1) Provide a forum for discussion of
data used in conducting quantitative
risk assessments for EIDs, (2) address
approaches to facilitate the timely
access to data required to evaluate
public health measures designed to
reduce the potential risk associated with
EIDs that are relevant to blood and
blood products, and (3) provide a forum
for discussion of the development of
new data sources and enhanced access
to already existing data sources.
Transcripts: Please be advised that as
soon as possible after a transcript of the
public workshop is available, it will be
accessible on the Internet at: https://
www.fda.gov/BiologicsBloodVaccines/
NewsEvents/
WorkshopsMeetingsConferences/
VerDate Mar<15>2010
17:43 Oct 11, 2011
Jkt 226001
TranscriptsMinutes/default.htm.
Transcripts of the public workshop may
also be requested in writing from the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857.
Dated: October 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–26295 Filed 10–11–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
Human Phospho-Serine134
Glucocorticoid Receptor Polyclonal
Antibody: Useful for the
Characterization of Glucocorticoid
Signaling Processes, e.g., in Cancer and
Inflammation
Description of Technology: The
glucocorticoid receptor (GR) functions
as a hormone-dependent transcription
factor that is involved in the
maintenance of basal and stress-related
homeostasis. Serine 134 is a newly
discovered phosphorylation target on
the human glucocorticoid receptor that
becomes phosphorylated during stressactivating conditions such as ultraviolet
irradiation, nutrient starvation, and
oxidative stress. The inventors have
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
63309
developed a rabbit polyclonal antibody
that specifically recognizes the Ser 134
phosphorylated form of the human
glucocorticoid receptor. This antibody
may be particularly useful for a variety
of basic research applications, such as
the characterization and study of
glucocorticoid signaling in cancer,
inflammation, and other diseases.
The antibody is available as crude
antisera and has been epitope purified;
it has cross reactivity with human, rat,
and mouse tissues.
Potential Commercial Applications:
Western analysis, immunoprecipitation,
and immunofluorescence studies.
Inventors: Amy Beckley and John
Cidlowski (NIEHS).
Related Publication: Molecular and
Cellular Biology, In Press.
Intellectual Property: HHS Reference
No. E–182–2011/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Status: This technology is
available as a research tool under a
Biological Materials License.
Licensing Contact: Tara Kirby Ph.D.;
301–435–4426; tarak@nih.gov.
Collaborative Research Opportunity:
The NIEHS, Molecular Endocrine
Group, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize Human PhosphoSerine134 Glucocorticoid Receptor
Polyclonal Antibody. Please contact
Elizabeth M. Denholm at
denholme@niehs.nih.gov for more
information.
Infectious Hepatitis E Virus Genotype 3
Recombinants—Prospective Vaccine
Candidates and Vector System
Description of Technology: Infection
by Hepatitis E virus (HEV) is a relevant
health issue in a number of developing
countries and it is also an emerging
food-borne disease of industrialized
countries. Genotype 1 and 2 infections
are found exclusively in humans while
genotype 3 and 4 viruses have been
found not only in humans, but also
swine, deer, mongoose, cattle, and
rabbits. In particular, genotype 3 and 4
viruses are ubiquitously found in swine
and undercooked pork is thought to be
one of the sources of infection for cases
of human infections in industrialized
countries.
This technology is a recombinant,
infectious genotype 3 HEV that has been
adapted to grow in cell culture and can
potentially be used to develop vaccines
against HEV or as a vector system to
insert exogenous sequences into HEV.
The virus (strain Kernow-C1, genotype
3) originated from a chronically infected
E:\FR\FM\12OCN1.SGM
12OCN1
]]>Agencies
[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63308-63309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26295]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Data and Data Needs To Advance Risk Assessment for Emerging
Infectious Diseases Relevant to Blood and Blood Products; 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: ``Data and Data Needs to Advance Risk Assessment for
Emerging Infectious Diseases Relevant to Blood and Blood Products.''
The purpose of the public workshop is to discuss data and data sources
currently used by FDA, possible new sources of data, and development of
new studies and information through collaboration with stakeholders.
The public workshop will include presentations and panel discussions
with experts from stakeholders, academia, regulated industry, and
government.
Date and Time: The public workshop will be held on November 29,
2011, from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held at the Gaithersburg
Hilton, 620 Perry Pkwy., Gaithersburg, MD 20877, 301-977-8900.
Contact Person: Lou Gallagher, Center for Biologics Evaluation and
Research (HFM-210), Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852-1448,
[[Page 63309]]
301-827-5988, e-mail: lou.gallagher@fda.hhs.gov.
Registration: Mail, fax, or e-mail your registration information
(including name, title, firm name, address, telephone and fax numbers)
to Lou Gallagher (see Contact Person) by November 10, 2011. 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 8 a.m.
If you need special accommodations due to a disability, please
contact Lou Gallagher (see Contact Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: Quantitative risk assessments (QRAs) are an
important tool for evaluating the risks associated with new emerging
infectious diseases (EIDs) that are relevant to blood and blood
products and the benefits of mitigation options. QRAs make it possible
for decisionmakers to develop policy for blood and blood product safety
and availability using sound science and the best data and information
available.
Rapid data collection, information sharing, and analyses estimating
the magnitude and probability of risk can be expedited by proactively
building and maintaining critical relationships both within the Center
for Biologics Evaluation and Research (CBER) and with external
stakeholders. In this public workshop, CBER is seeking access to
accurate, reliable data on factors such as disease prevalence,
incubation periods, behavioral risks associated with disease
transmission, potential donor exposure risks, and susceptibility to
EIDs, product handling, usage, and other factors.
Lack of data and information is a major challenge FDA faces when
there is a new EID. The public workshop will: (1) Provide a forum for
discussion of data used in conducting quantitative risk assessments for
EIDs, (2) address approaches to facilitate the timely access to data
required to evaluate public health measures designed to reduce the
potential risk associated with EIDs that are relevant to blood and
blood products, and (3) provide a forum for discussion of the
development of new data sources and enhanced access to already existing
data sources.
Transcripts: Please be advised that as soon as possible after a
transcript of the public workshop is available, it will be accessible
on the Internet at: https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Transcripts of the public workshop may also be requested in writing
from the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Rockville, MD 20857.
Dated: October 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-26295 Filed 10-11-11; 8:45 am]
BILLING CODE 4160-01-P
