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From: TSS ()
This guidance is for comment purposes only. Submit comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:www.fda.gov/dockets/ecomments. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. Additional copies of this draft guidance are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448 or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at http://www.fda.gov/cber/guidelines.htm. For questions on the content of this guidance, contact Dr. Sharyn Orton, Division of Blood Applications at 301-827-3524. U.S. Department of Health and Human Services Table of Contents INTRODUCTION -------------------------------------------------------------------------------- Contains Nonbinding Recommendations Draft - Not for Implementation Guidance for Industry This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. INTRODUCTION This draft guidance applies to Whole Blood and blood components intended for transfusion, and blood components intended for use in further manufacturing into injectable products, including recovered plasma, Source Leukocytes and Source Plasma. Special provisions apply to donors of blood components intended solely for manufacturing of non-injectable products (see section III). Within this document, "donors" refers to donors of Whole Blood and blood components and "you" refers to blood collecting establishments. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required. Return to Table of Contents BACKGROUND Available data suggest that large amounts of U.K. beef exported to France during the peak years of the U.K. BSE epidemic constituted a substantial source of exposure in France to the BSE agent. An estimated 60% of U.K. bovine carcasses were exported to France (Ref. 3) accounting for approximately 6% of French consumption of beef products (Ref. 4). It is believed that the first recognized vCJD cases in France were infected by consuming imported U.K. beef because: 1) none of the individuals had lived in the U.K.; 2) the indigenous French BSE epidemic is relatively small and more recent than that in the U.K.; and 3) travels to the U.K. accounted for only 2% of the French total exposure to the BSE agent (Ref 3). There have been a total of three presumptive cases of transfusion-transmitted vCJD, and all have been in the U.K. The first presumptive transfusion-transmitted case of vCJD by red blood cells was reported to the U.K. Parliament on December 17, 2003 (Ref. 5). A second presumptive case was reported in the U.K. in 2004 (Ref. 6). A third presumptive case was publicly announced by authorities in the U.K. in 2006 (Ref. 7). On February 8, 2005, the Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC) discussed the available data and recommendations for deferral of U.S. donors transfused since 1980 in France and in other European countries. The TSEAC voted for deferral of blood donors who have received a transfusion of blood or blood components in France since 1980 but against deferral of Source Plasma donors with that same history. The TSEAC did not support deferral of blood donors or Source Plasma donors with history of transfusion in other European countries since 1980 (Ref. 8). The incubation period for classical CJD may be as long as 38.5 years. Accumulating evidence suggests that the asymptomatic incubation periods of vCJD may be very long as well (sometimes exceeding 12 years from the time of exposure to the BSE agent), and blood collected as long as three years before otherwise healthy blood donors showed any sign of illness is presumed to have transmitted vCJD infection to recipients (Refs. 5 and 6). While the risk of dietary exposure to the BSE agent in France, as in the U.K. and other European countries, has almost certainly decreased in recent years thanks to successful efforts to control the BSE epidemic in cattle and to protect food from contamination with the BSE agent, an unknown but possibly significant number of blood donors might have already been infected in France during the peak years of the BSE outbreak in Europe. These considerations led FDA, consistent with the recommendations of the TSEAC, to conclude that it would be a prudent preventive measure to indefinitely defer blood donors who have received transfusions of blood or blood components in France since 1980. Laboratory studies using model TSE agents have demonstrated that TSE infectivity may be reduced by certain plasma fractionation manufacturing steps (Ref. 9). While experimental studies are reassuring, not all products have been thoroughly studied. In addition, it remains uncertain whether the models accurately reflect the form of infectivity in blood, which has not been characterized. Therefore, as an added safeguard and prudent preventive measure, we also recommend that Source Plasma donors who have received a transfusion of blood or blood components in France since 1980 be indefinitely deferred. However, we believe that blood components collected solely for manufacturing into non-injectable products (e.g., materials used in in vitro diagnostic test kits) need not be deferred. We will continue to monitor the BSE epidemic and re-evaluate the necessity of deferring donors transfused in other European countries. Return to Table of Contents RECOMMENDATIONS NOTE: Donors who are otherwise deferred based upon this recommendation should continue to donate if they are participating in a CBER-approved program that allows collection of blood components solely for use in manufacturing of non-injectable products. We recommend special labeling for products obtained from such donors (see section VII.A of the CJD/vCJD guidance). All other recommendations from the CJD/vCJD guidance remain unchanged. Return to Table of Contents IMPLEMENTATION Return to Table of Contents REFERENCES FRANCE ??? IT'S like the pot calling the kettle black, WHAT ABOUT THE USA ??? CJD WATCH MESSAGE BOARD PRODUCT ______________________________ ______________________________ ______________________________ http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html http://disc.server.com/discussion.cgi?disc=167318;article=2971;title=CJD%20WATCH (please note steady increase in sporadic cjd from 1997 to 2004 with steady increase in type 'UNKNOWN' CJD? also, seems like they could come up with a better, more readable chart. ...TSS) TSEs have been rampant in the USA for decades in many Creutzfeldt-Jakob disease ratio of protease-resistant prion protein (PrPSc), and type 2 PrPSc display unglycosylated core fragments of acids 82 and 97, respectively. Methods We generated anti-PrP monoclonal antibodies to K cleavage sites. These antibodies, which were Findings We studied 114 brain samples from 70 patients Every patient classified as CJD type 2, and all variant cerebellum and other PrPSc-rich brain areas, with a Interpretation The regular coexistence of multiple electrophoretic PrPSc mobilities as surrogates for classifications. ... This study characterizes the type and timing of Historically, psychiatric manifestations have been Personal Communication either variant CJD-like or sporadic CJD Date: Thu, 28 -0000 From: "Asante, Emmanuel A" To: Dear Terry, I have been asked by Professor Collinge to respond to a Senior Scientist in the MRC Prion Unit and the lead paper. I have attached a pdf copy of the paper for your you for your interest in the paper. In respect of your first question, the simple answer will find in the paper, we have managed to associate phenotype to type 2 PrPSc, the commonest sporadic CJD. It is too early to be able to claim any further respect of Heidenhain variant CJD or Vicky Rimmer's take further studies, which are on-going, to establish sub-types to our initial finding which we are now point of the paper is that, as well as leading to the variant CJD phenotype, BSE transmission to the can lead to an alternate phenotype which is 2 PrPSc. can be of any further assistance please to not hesitate <> ____________________________________ Dr. Emmanuel A Asante MRC Prion Unit & Neurogenetics College School of Medicine (St. Mary's) Norfolk Place, Tel: +44 (0)20 7594 3794 Fax: +44 (0)20 7706 3272 email: e.asante@ic.ac.uk (until 9/12/02) New e-mail: e.asante@prion.ucl.ac.uk (active from now) ____________________________________ Freas, William Monday, January 08,200l 3:03 PM freas@CBS5055530.CBER.FDA.GOV CJDIBSE (aka madcow) Human/Animal TSE’s--U.S.--Submission To Scientific Advisors and Consultants Staff January 2001 Meeting (short version) Greetings again Dr. Freas and Committee Members, I wish to submit the following information to the Scientific Advisors and Consultants Staff 2001 Advisory Committee (short version). I understand the reason of having to shorten my submission, but only hope that you add it to a copy of the long version, for members to take and read at their pleasure, (if cost is problem, bill me, address below). So when they realize some time in the near future of the 'real' risks i speak of from human/animal TSEs and blood/surgical products. I cannot explain the 'real' risk of this in 5 or 10 minutes at some meeting, or on 2 or 3 pages, but will attempt here: remember AIDS/HIV, 'no problem to heterosexuals in the U.S.? no need to go into that, you know of this blunder: DO NOT make these same stupid mistakes again with human/animal TSE's aka MADCOW DISEASE. I am beginning to think that the endless attempt to track down and ban, potentia.1 victims from known BSE Countries from giving blood will be futile. You would have to ban everyone on the Globe eventually? AS well, I think we MUST ACT SWIFTLY to find blood test for TSE's, whether it be blood test, urine test, .eyelid test, anything at whatever cost, we need a test FAST. , DO NOT let the incubation time period of these TSEs fool you. To think of Scrapie as the prime agent to compare CJD, but yet overlook the Louping-ill vaccine event in 1930's of which 1000's of sheep where infected by scrapie from a vaccine made of scrapie infected sheep brains, would be foolish. I acquired this full text version of the event which was recorded in the Annual Congress of 1946 ational Vet. Med. Ass. of Great Britain and Ireland. " I rom the BVA and the URL is posted in my (long version). U.S.A. should make all human/animal TSE's notifiable at all ages, with requirements for a thorough surveillance and post-mortem examinations free of charge, if you are serious about eradicating this horrible disease in man and animal. There is histopathology reports describing o florid plaques" in CJD victims in the USA and some of these victims are getting younger. I have copies of such autopsies, there has to be more. PLUS, sub-clinical human TSE's will most definitely be a problem. SNIP... THEN think of vaccineCJD in children and the bovine tissues used in the manufacturing process, think of the FACT that this agent surviving 6OO*C. PNAS -- Brown et al. 97 (7): 3418 scrapie agent live at 600*C Then think of the CONFIDENTIAL documents of what was known of human/animal TSE and vaccines in the mid to late 8Os, it was all about depletion of stock, to hell with the kids, BUT yet they knew. To think of the recall and worry of TSE's from the polio vaccine, (one taken orally i think?), but yet neglect to act on the other potential TSE vaccines (inoculations, the most effective mode to transmit TSEs) of which thousands of doses were kept and used, to deplete stockpile, again would be foolish. --Oral polio; up to 1988, foetal calf serum was used from UK and New Zealand (pooled); since 1988 foetal calf serum only from New Zealand. Large stocks are held. --Rubella; bulk was made before 1979 from foetal calf serum from UK and New Zealand. None has been made as there are some 15 years stock. --Diphtheria; UK bovine beef muscle and ox heart is used but since the end of 1988 this has been sourced from Eire. There are 1,250 litres of stock. . . --Tetanus; this involves bovine material from the UK mainly Scottish. There are 21,000 litres of stock. --Pertussis; uses bovine material from the UK. There are 63,000 litres of stock. --They consider that to switch to a non-UK source will take a minimum of 6-18 months and to switch to a non-bovine source will take a minimum of five years. 3. XXXXXXXXXXX have measles, mumps, MMR, rubella vaccines. These are sourced from the USA and the company believes that US material only is used. 89/2.14/2.1 ============ BSE3/1 0251 4. XXXXXXXXXXX have a measles vaccine using bovine serum from the UK. there are 440,000 units of stock. They have also got MMR using bovine serum from the UK. 5. XXXXXXXXXXX have influenza, rubella, measles,' MMR vaccines likely to be used in children. Of those they think that only MMR contains bovine material which is probably a French origin. 6. XXXXXXXXXXX have diphtheria/tetanus and potasses on clinical trial. hese use veal material, some of which has come from the UK and has been ade by XXXXXXXXXXX (see above). I have documents of imports from known BSE Countries, of ferments, whole blood, antiallergenic preparations, 2 human blood plasma, normal human blood sera, human immune blood sera, fetal bovine serum, and other blood fractions not elsewhere specified or included, imported glands, catgut, vaccines for both human/animal, as late as 1998. Let us not forget about PITUITARY EXTRACT. This was used to help COWS super ovulate. This tissue was considered to be of greatest risk of containing BSE and consequently transmitting the disease. ANNEX 6 MEETING HELD ON 8 JUNE 1988 TO DISCUSS THE IMPLICATIONS OF BSE TO BIOLOGICAL PRODUCTS CONTAINING BOVINE - EXTRACTED MATERIAL How much of this was used in the U.S.? SNIP...FULL TEXT ; http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf TSS
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