A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of
Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease
The summary for the A Creutzfeldt-Jakob Disease (CJD) Lookback Study:
Assessing the Risk of Blood Borne Transmission of Classic Forms of
Creutzfeldt-Jakob Disease Federal Grant is detailed below.
This summary states who is eligible for the grant, how much grant money
will be awarded, current and past deadlines, Catalog of Federal Domestic
Assistance (CFDA) numbers, and a sampling of similar government grants. Verify
the accuracy of the data FederalGrants.com provides by visiting the webpage
noted in the Link to Full Announcement section or by contacting the appropriate
person listed as the Grant Announcement Contact. If any section is incomplete,
please visit the website for the Centers for Disease Control and Prevention,
which is the government agency that is offering this grant. Federal Grant Title:
A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of Blood
Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease Federal Agency
Name: Centers for Disease Control and Prevention Grant Categories: Health Type
of Opportunity: Discretionary Funding Opportunity Number: RFA-CK-14-005 Type of
Funding: Cooperative Agreement CFDA Numbers: 93.084 CFDA Descriptions:
Prevention of Disease, Disability, and Death by Infectious Diseases Current
Application Deadline: Feb 25, 2014 Application Due Date: February 25, 2014, by
5:00 PM U.S. Eastern Time. Letter of Intent: Not Applicable Original Application
Deadline: Feb 25, 2014 Application Due Date: February 25, 2014, by 5:00 PM U.S.
Eastern Time. Letter of Intent: Not Applicable Posted Date: Jan 17, 2014
Creation Date: Jan 17, 2014 Archive Date: Mar 27, 2014 Total Program Funding:
$380000 Maximum Federal Grant Award: $76000 Minimum Federal Grant Award: $70000
Expected Number of Awards: 1 Cost Sharing or Matching: No
Grant Description The purpose of this funding opportunity announcement
(FOA) is for the American Red Cross (ARC) to continue an active, nationwide
study that began in 1995 of recipients of blood products from CJD donors to
assess the risk of blood borne transmission of CJD in the United Stated.
Applicants Eligible for this Grant Others (see text field entitled "Additional
Information on Eligibility" for clarification) Additional Information on
Eligibility Eligible Organizations: The American Red Cross Grant Announcement
Contact CDC Procurement and Grants Office (PGO) Technical Information Management
Section (TIMS) Phone: 770-488-2700 TECHNICAL INFORMATION MANAGEMENT SECTION
(TIMS)
Centers for Disease Control and Prevention 404-498-2015
Wednesday, December 11, 2013
*** Detection of Infectivity in Blood of Persons with Variant and Sporadic
Creutzfeldt-Jakob Disease ***
CJD LOOKBACK STUDY
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE MEETING
Thursday, June 2, 1999 CHAIRMAN BROWN:
My name is Dr. Paul Brown. Welcome to the FDA traveling road show. We are
asked yet once more by the FDA to consider a question of theoretical risk in the
absence of sufficient knowledge on which to base any firm conclusion. The issue
before us today is that of excluding categories of American blood donors who
have either visited or resided for longer periods of time in Great Britain. The
issue is sufficiently delicate, as you see that we have been moved outside the
Beltway. (Laughter.)snip... "Dr. Alan Williams is employed by the American Red
Cross, Holland Labs,and is Scientific Adviser for the Florida Blood Services and
Canadian Blood Services. In addition, he has financial interests in firms that
could be affected by the general discussions. "Dr. Richard Race has financial
interests in firms that could be affected by the general discussions and is a
public health science researcher. "In the event that the discussions involve
specific products or specific firms for which FDA participants have a financial
interest, the participants are aware of the need to exclude themselves from such
involvement. And their exclusion will be noted for the public record. A copy of
the waivers is available by written request under the Freedom of Information
Act. "With respect to all other meeting participants, we ask in the interest of
fairness that they address any current or previous financial involvement with
any firm whose product they may wish to comment upon." So ends the reading of
the conflict of interest statement. Dr. Brown, I turn the meeting over to
you.
snip...
Sunday, June 3, 2012
A new neurological disease in primates inoculated with prion-infected blood
or blood components
Friday, June 29, 2012
Highly Efficient Prion Transmission by Blood Transfusion
price of prion poker goes up again
$$$ Monday, June 11, 2012
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance
for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
by Blood and Blood Products”
Thursday, August 16, 2012
Blood products, collected from a donor who was at risk for variant
Creutzfeldt-Jakob disease ( vCJD) USA JUNE, JULY, AUGUST 2012
Saturday, August 18, 2012
RedCross Request Jerome H. Holland Laboratory is collecting small volumes
of blood from patients afflicted with various forms of transmissible spongiform
encephalopathies (TSE)/prion diseases and their blood-related family members
2012
Friday, August 16, 2013
*** Creutzfeldt-Jakob disease (CJD) biannual update August 2013 U.K. and
Contaminated blood products induce a highly atypical prion disease devoid of
PrPres in primates
Wednesday, December 11, 2013
*** Detection of Infectivity in Blood of Persons with Variant and Sporadic
Creutzfeldt-Jakob Disease ***
2014 CWD UPDATE
*** PRICE OF CWD TSE PRION POKER GOES UP 2014 ***
Transmissible Spongiform Encephalopathy TSE PRION update January 2, 2014
*** chronic wasting disease, there was no absolute barrier to conversion of
the human prion protein.
*** Furthermore, the form of human PrPres produced in this in vitro assay
when seeded with CWD, resembles that found in the most common human prion
disease, namely sCJD of the MM1 subtype.
Wednesday, January 01, 2014
Molecular Barriers to Zoonotic Transmission of Prions
*** chronic wasting disease, there was no absolute barrier to conversion of
the human prion protein.
*** Furthermore, the form of human PrPres produced in this in vitro assay
when seeded with CWD, resembles that found in the most common human prion
disease, namely sCJD of the MM1 subtype.
*** The potential impact of prion diseases on human health was greatly
magnified by the recognition that interspecies transfer of BSE to humans by beef
ingestion resulted in vCJD. While changes in animal feed constituents and
slaughter practices appear to have curtailed vCJD, there is concern that CWD of
free-ranging deer and elk in the U.S. might also cross the species barrier.
Thus, consuming venison could be a source of human prion disease. Whether BSE
and CWD represent interspecies scrapie transfer or are newly arisen prion
diseases is unknown. Therefore, the possibility of transmission of prion disease
through other food animals cannot be ruled out. There is evidence that vCJD can
be transmitted through blood transfusion. There is likely a pool of unknown size
of asymptomatic individuals infected with vCJD, and there may be asymptomatic
individuals infected with the CWD equivalent. These circumstances represent a
potential threat to blood, blood products, and plasma supplies.
Thursday, January 2, 2014
*** CWD TSE Prion in cervids to hTGmice, Heidenhain Variant
Creutzfeldt-Jacob Disease MM1 genotype, and iatrogenic CJD ??? ***
SNIP...
Subtype 1: (sCJDMM1 and sCJDMV1)
This subtype is observed in patients who are MM homozygous or MV
heterozygous at codon 129 of the PrP gene (PRNP) and carry PrPSc Type 1.
Clinical duration is short, 3‑4 months.32 The most common presentation in
sCJDMM1 patients is cognitive impairment leading to frank dementia, gait or limb
ataxia, myoclonic jerks and visual signs leading to cortical blindness
(Heidenhain’s syndrome)...
Animals injected with iatrogenic Creutzfeldt–Jakob disease MM1 and genetic
Creutzfeldt–Jakob disease MM1 linked to the E200K mutation showed the same
phenotypic features as those infected with sporadic Creutzfeldt–Jakob disease
MM1 prions...
*** our results raise the possibility that CJD cases classified as VV1 may
include cases caused by iatrogenic transmission of sCJD-MM1 prions or food-borne
infection by type 1 prions from animals, e.g., chronic wasting disease prions in
cervid. In fact, two CJD-VV1 patients who hunted deer or consumed venison have
been reported (40, 41). The results of the present study emphasize the need for
traceback studies and careful re-examination of the biochemical properties of
sCJD-VV1 prions. ***
SNIP...SEE FULL TEXT ;
Thursday, January 2, 2014
*** CWD TSE Prion in cervids to hTGmice, Heidenhain Variant
Creutzfeldt-Jacob Disease MM1 genotype, and iatrogenic CJD ??? ***
Thursday, February 20, 2014
Unnecessary precautions BSE MAD COW DISEASE Dr. William James FSIS VS Dr.
Linda Detwiler 2014
WHAT about the sporadic CJD TSE proteins ?
WE now know that some cases of sporadic CJD are linked to atypical BSE and
atypical Scrapie, so why are not MORE concerned about the sporadic CJD, and all
it’s sub-types $$$
Creutzfeldt-Jakob Disease CJD cases rising North America updated report
August 2013
*** Creutzfeldt-Jakob Disease CJD cases rising North America with Canada
seeing an extreme increase of 48% between 2008 and 2010 ***
Sunday, October 13, 2013
*** CJD TSE Prion Disease Cases in Texas by Year, 2003-2012
Tuesday, October 05, 2010
Large-scale immunohistochemical examination for lymphoreticular prion
protein in tonsil specimens collected in Britain
05 Oct 2010 14:46
Friday, February 10, 2012
Creutzfeldt-Jakob disease (CJD) biannual update (2012/1) potential
iatrogenic (healthcare-acquired) exposure to CJD, and on the National Anonymous
Tonsil Archive
Monday, August 13, 2012
Summary results of the second national survey of abnormal prion prevalence
in archived appendix specimens August 2012
Monday, October 14, 2013
*** Researchers estimate one in 2,000 people in the UK carry variant CJD
proteins ***
Thursday, January 23, 2014
Medical Devices Containing Materials Derived from Animal Sources (Except
for In Vitro Diagnostic Devices) [Docket No. FDA–2013–D–1574]
Tuesday, February 11, 2014
Novant Health Forsyth Medical Center Information on potential CJD exposure
Thursday, February 06, 2014
Commons Science and Technology Committee announce new inquiry on blood,
tissue and organ screening Parliament exposure vcjd and blood risk while still
ignoring recent risks factors of sporadic CJD
Friday, February 14, 2014
Creutzfeldt-Jakob disease (CJD) biannual update (February 2014), with
briefing on novel human prion disease National CJD Research and Surveillance
Unit NCJDRSU
Friday, January 10, 2014
*** vpspr, sgss, sffi, TSE, an iatrogenic by-product of gss, ffi, familial
type prion disease, what it ???
Sunday, January 19, 2014
National Prion Disease Pathology Surveillance Center Cases Examined1 as of
January 8, 2014
Sunday, August 09, 2009
CJD...Straight talk with...James Ironside...and...Terry Singeltary... 2009
CJD QUESTIONNAIRE USA
FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW ON THE TSE PRION DISEASE
Sent: Wednesday, February 05, 2014 9:29
AM
Subject: RE: 8720 FW: Blood, tissue and organ screening
SINGELTARY SUBMISSION
Dear Mr.
Singeltary:
Thank you for your recent inquiry to
the Center for Biologics Evaluation and Research (CBER). CBER, one of seven
centers within the Food and Drug Administration (FDA), is responsible for the
regulation of many biologically-derived products, including blood intended for
transfusion, blood components and derivatives, vaccines, allergenic extracts,
and cell, tissue and gene therapy products. We hope the following information
will be helpful.
Currently, there are no TSEAC meetings
on the schedule for 2014, but that does not mean there aren’t going to be any
meetings this year. You can sign up for notifications of Advisory Committee
meetings at the following website: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.
Alternatively, you can check the Advisory Committee Calendar posted on the same
page.
Additional information is also available through the OC-Advisory Committee Oversight and Management Staff. For your convenience, I have copied their contact information below:
OC-Advisory Committee Oversight and Management Staff
Food and Drug Administration
10903 New Hampshire
Avenue
WO32 - 5129
Silver Spring, MD
20993-0002
Phone:
301-443-0572
Phone:
1-800-741-8138
We hope this information has been
helpful.
Sincerely,
Hope Anderson
Consumer Safety
Officer
Consumer Affairs
Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Follow us on Twitter: http://www.twitter.com/fdacber
This informal communication represents my best judgment at this time. It does not constitute an advisory opinion in accordance with 21 CFR 10.85, and does not necessarily represent the formal position of FDA or otherwise obligate the agency to the views expressed.
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Follow us on Twitter: http://www.twitter.com/fdacber
This informal communication represents my best judgment at this time. It does not constitute an advisory opinion in accordance with 21 CFR 10.85, and does not necessarily represent the formal position of FDA or otherwise obligate the agency to the views expressed.
From: Terry S. Singeltary Sr.
[mailto:flounder9@verizon.net]
Sent: Thursday, January 30, 2014 11:05 AM
To: CBER OCOD Consumer Account
Cc: Emery, Bryan (CBER); Monser, Martha; mmturner@gwu.edu; pschwartz@choc.org; parisi.joseph@mayo.edu; bcaughey@nih.gov; patrick.bosque@dhha.org; APPLEBB@ccf.org
Subject: Fw: Blood, tissue and organ screening SINGELTARY SUBMISSION
Sent: Thursday, January 30, 2014 11:05 AM
To: CBER OCOD Consumer Account
Cc: Emery, Bryan (CBER); Monser, Martha; mmturner@gwu.edu; pschwartz@choc.org; parisi.joseph@mayo.edu; bcaughey@nih.gov; patrick.bosque@dhha.org; APPLEBB@ccf.org
Subject: Fw: Blood, tissue and organ screening SINGELTARY SUBMISSION
Greetings FDA TSEAC et al,
I am concerned about recent revelations with TSE
prion science, disturbing new risk factors, and the fact I see no upcoming TSEAC
meetings about these risk factors.
could you please tell me when the next TSEAC
meeting will be, and if there will be any in 2014, and if you will addressing
any of these new risk factors ???
Thank You,
kind regards,
terry
From: CBER OCOD Consumer Account
Sent: Friday, January 13, 2012 3:14 PM
Subject: RE: 5043 FW: TSEAC
Dear Mr. Singeltary:
Thank you for your recent inquiry to the Center for Biologics Evaluation
and Research (CBER). CBER, one of seven centers within the Food and Drug
Administration (FDA), is responsible for the regulation of many
biologically-derived products, including blood intended for transfusion, blood
components and derivatives, vaccines, allergenic extracts, and cell, tissue and
gene therapy products. We hope the following information will be helpful.
*** There are no TSEAC meetings on the schedule yet for 2012, but that does
not mean there aren’t going to be any meetings this year. You can sign up for
notifications of Advisory Committee meetings at the following website: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.
Alternatively, you can check the Advisory Committee Calendar posted on the same
page.
On July 29, 2011, FDA published a Public Notice requesting that any
consumer organizations interested in participating in the selection of voting
and/or nonvoting consumer representatives to serve on its advisory committees or
panels, notify FDA in writing. A copy of this Notice is available at the
following web address: http://www.gpo.gov/fdsys/pkg/FR-2011-07-29/html/2011-19066.htm.
Additional information is also available through the OC-Advisory Committee
Oversight and Management Staff. For your convenience, I have copied their
contact information below: OC-Advisory Committee Oversight and Management Staff
Food and Drug Administration 10903 New Hampshire Avenue
WO32 - 5129
Silver Spring, MD 20993-0002
Phone: 301-443-0572
Phone: 1-800-741-8138
We hope this information has been helpful.
Sincerely,
Jill Burkoff
Consumer Safety Officer Consumer Affairs Branch Division of Communication
and Consumer Affairs Center for Biologics Evaluation and Research US Food and
Drug Administration
This communication is consistent with 21 CFR 10.85 (k) and constitutes an
informal communication that represents my best judgment at this time but does
not constitute an advisory opinion, does not necessarily represent the formal
position of FDA, and does not bind or otherwise obligate or commit the agency to
the views expressed.
‘FDA TRAVELING ROAD SHOW’, OR what I call the FDA TRAVELING THREE RING
CIRCUS I.E. FDA, USDA, CDC.
(8:30 a.m.)
CHAIRMAN BROWN: My name is Dr. Paul Brown. Welcome to the FDA traveling
road show. We are asked yet once more by the FDA to consider a question of
theoretical risk in the absence of sufficient knowledge on which to base any
firm conclusion.
The issue before us today is that of excluding categories of American blood
donors who have either visited or resided for longer periods of time in Great
Britain. The issue is sufficiently delicate, as you see that we have been moved
outside the Beltway.
(Laughter.)
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE MEETING
Thursday, June 2, 1999
CHAIRMAN BROWN: My name is Dr. Paul Brown. Welcome to the FDA traveling
road show. We are asked yet once more by the FDA to consider a question of
theoretical risk in the absence of sufficient knowledge on which to base any
firm conclusion. The issue before us today is that of excluding categories of
American blood donors who have either visited or resided for longer periods of
time in Great Britain. The issue is sufficiently delicate, as you see that we
have been moved outside the Beltway. (Laughter.)snip... "Dr. Alan Williams is
employed by the American Red Cross, Holland Labs,and is Scientific Adviser for
the Florida Blood Services and Canadian Blood Services. In addition, he has
financial interests in firms that could be affected by the general discussions.
"Dr. Richard Race has financial interests in firms that could be affected by the
general discussions and is a public health science researcher. "In the event
that the discussions involve specific products or specific firms for which FDA
participants have a financial interest, the participants are aware of the need
to exclude themselves from such involvement. And their exclusion will be noted
for the public record. A copy of the waivers is available by written request
under the Freedom of Information Act. "With respect to all other meeting
participants, we ask in the interest of fairness that they address any current
or previous financial involvement with any firm whose product they may wish to
comment upon." So ends the reading of the conflict of interest statement. Dr.
Brown, I turn the meeting over to you.snip...
CJD VOICE
layperson
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
flounder9@verizon.net