Sunday, March 09, 2014

A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease

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.
 
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
 
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

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