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From: TSS ()
Subject: Suspected CJD victim dies, others may sue
Date: August 13, 2007 at 10:07 am PST

Suspected CJD victim dies, others may sue

By MARY JANE BOLAND - Sunday Star Times | Sunday, 12 August 2007


Patients possibly infected with the fatal brain disease CJD may sue Auckland District Health Board because they say doctors didn't properly vet the woman at the centre of the scare.


The Sunday Star-Times can reveal the woman suspected of having Creutzfeldt Jakob Disease (CJD) died in Auckland City Hospital on July 19, four months after lapsing into a coma. She was 30.

In April, doctors told 32 adults and 11 children there was a slim risk they had CJD because the same sterilised surgical instruments used on the woman were used in their operations in March. It can take decades for the disease, which destroys brain cells and leaves patients comatose and with dementia, to appear. Sterilising surgical instruments does not necessarily kill prions that cause the disease.

Doctors suspected the woman had CJD after she failed to recover after surgery on March 8. She had Arnold Chiari malformation, a narrowing of where the spine meets the skull.

Brain tissue from the woman will be sent to Melbourne's Alfred Hospital for analysis by neuropathologist Dr Catriona McLean. McLean said confirmation of the disease was possible only after death but Auckland hospital doctors believe it is definitely CJD.

The woman had a brain operation in 1984 at the age of seven, when it is believed she received infected matter in a product called Lyodura, used to patch together the brain.

Thousands of patients had Lyodura grafts - made from dead people - in the 1980s but that was changed after its German maker Braun was told of a link with several CJD cases.

Patches are now usually synthetic.

Two New Zealand men died, in 1989 and 1995, from CJD linked to Lyodura but the Auckland case is the first to spark a health alert. Up to 300 New Zealanders had Lyodura grafts in the 1980s but very few would have received the same batch as the one that infected the woman who recently died.

At least two families in this year's scare are considering legal action against Auckland District Health Board.

One woman, whose son had surgery in March, said patients had been told at a meeting last month that doctors had not followed international guidelines for vetting patients who may have Lyodura patches.

The mother criticised the board, saying many of the patients did not know they could request details of the surgical instruments used on them and on the woman, and how many other patients had been treated between their operations. Those who had surgery soon after the woman's operation had a higher risk of contracting CJD.

Auckland mother Monique Lambermon, whose daughter Danielle is one of the 43 involved, is also considering a lawsuit. Danielle, who has a brain tumour, is refusing to have further surgery because of the risk of CJD infection or of activating the disease if it is in her brain.

"They can't treat us the way they have and get away with it. You're just like a number."

Both women said they were frustrated with lack of information from the board, learning only from the Star-Times that the woman had died.

Auckland DHB chief medical officer Dr David Sage said the length of time between the woman's previous surgery and the March operation meant there were no clinical suspicions that she had CJD. The previous use of Lyodura was not signalled in her current medical records, he said.

Sage said the health board had introduced new rules in the past few months, including screening for previous neurosurgery, assessing the feasibility of single-use instruments, and separating instruments for cleaning.

Neurosurgeon Dr Barry Snow said none of the 43 had developed signs of CJD, and the chances of anyone developing the disease were "almost negligible".

Head of the CJD register at Otago University, associate professor Martin Pollock, said the the case was particularly interesting due to the 22-year delay before the woman developed signs of the disease.

"I think CJD will almost certainly be confirmed but this will be the final word on it."


http://www.stuff.co.nz/4161675a6442.html

Guidance for Industry

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Biologics Evaluation and Research

August 2007

a.. E. What risk factors or conditions do I look for when screening a donor?
For all donors, you must review the relevant medical records and ask questions about the donor's medical history and relevant social behavior, including risk factors for relevant communicable disease agents and diseases, and communicable disease risks associated with xenotransplantation (§ 1271.75(a)).

Following is a list of conditions and behaviors that increase the donor's relevant communicable disease risk. Except as noted in this section, and in accordance with § 1271.75(d), you should determine to be ineligible any potential donor who exhibits one or more of the following conditions or behaviors.

snip...

1.. 19. Persons who have been diagnosed with vCJD or any other form of CJD (Refs. 3 and 75).
Note: Numbers 19 to 26 in this section are designed to screen for TSEs, including CJD and vCJD. If the living donor or the individual knowledgeable about the donor's medical and travel history is not familiar with the term "Creutzfeldt-Jakob Disease" or "variant Creutzfeldt-Jakob Disease," you may try to describe those in layman's terms. If the person being interviewed is still not familiar with those terms, you may consider the lack of familiarity with those terms as a negative response to questions using those terms.

1.. 20. Persons who have been diagnosed with dementia or any degenerative or demyelinating disease of the central nervous system or other neurological disease of unknown etiology (Refs. 3 and 75). Potential donors who have a diagnosis of delirium (e.g., delirium caused by toxic/metabolic diseases or recent head trauma) would not necessarily be considered to have a diagnosis of dementia and should be evaluated by the Medical Director. (HCT/Ps from donors with dementia confirmed by gross and microscopic examination of the brain to be caused by cerebrovascular accident or brain tumor and who are confirmed not to have evidence of TSE on microscopic examination of the brain may be acceptable based on an evaluation by the Medical Director).

1.. 21. Persons who are at increased risk for CJD (Refs. 3 and 75). Donors are considered to have an increased risk for CJD if they have received a non-synthetic dura mater transplant, human pituitary-derived growth hormone, or have one or more blood relatives diagnosed with CJD (see criterion 22 of this section).

18 Contains Nonbinding Recommendations

1.. 22. Persons who have a history of CJD in a blood relative (Refs. 3 and 75) unless:

1.. . The diagnosis of CJD was subsequently found to be an incorrect diagnosis;

2.. . The CJD was iatrogenic; or

3.. . Laboratory testing (gene sequencing) shows that the donor does not have a mutation associated with familial CJD.

1.. 23. Persons who spent three months or more cumulatively in the United Kingdom (U.K.) (see Appendix 5) from the beginning of 1980 through the end of 1996 (Refs. 3 and 75).

1.. 24. Persons who are current or former U.S. military members, civilian military employees, or dependents of a military member or civilian employee who resided at U.S. military bases in Northern Europe (Germany, Belgium, and the Netherlands) for 6 months or more cumulatively from 1980 through 1990, or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) for 6 months or more cumulatively from 1980 through 1996 (Refs. 3 and 75).

1.. 25. Persons who spent 5 years or more cumulatively in Europe (see Appendix 5) from 1980 until the present (note this criterion includes time spent in the U.K. from 1980 through 1996) (Refs. 3 and 75).

1.. 26. Persons who received any transfusion of blood or blood components in the U.K. or France between 1980 and the present (Refs. 3 and 75).

snip...

Contains Nonbinding Recommendations

a.. C. How do I assess a donor of dura mater for TSE?

1..

You must perform an adequate assessment for donors of dura mater to detect evidence of TSE (§ 1271.85(e)). After the dura mater has been removed, you should have a qualified pathologist perform an examination of the donor's brain. Following fresh examination, the brain should be fixed and sliced, gross examination of the entire brain should be conducted (including multiple cross sections), and multiple specimens of tissue should be obtained (from different parts of the brain) for histological examination. Exclude potential donors when any possible evidence of TSE-related changes is observed on histological examination. There are currently no FDA-licensed, approved, or cleared donor screening tests for prions.

snip...full text 70 pages ;

http://www.fda.gov/cber/gdlns/tissdonor.pdf

Update: Creutzfeldt-Jakob Disease Associated With Cadaveric Dura Mater Grafts-Japan, 1979-2003

JAMA. 2004;291:295-296.

MMWR. 2003;52:1179-1181

2 figures omitted

In 1997, a nongovernment surveillance group for Creutzfeldt-Jakob disease (CJD) in Japan supported financially by the Ministry of Health and Welfare* (MHW) reported 43 cases of CJD associated with receipt of cadaveric dura mater grafts.1 In all but one case, the most probable vehicle of transmission was a single brand of dural graft (LYODURA® [B. Braun Melsungen AG, Melsungen, Germany]) produced before May 1987. As of March 2003, ongoing surveillance in Japan had identified an additional 54 dura mater graft-associated cases. This report summarizes the investigation of the 97 cases, which indicated that during 1983-1987, the estimated minimum risk for CJD within 17 years of receipt of the implicated product in Japan was approximately one case per 1,250 grafts. No cases have been reported among patients who received their first dural graft after 1991; however, because of the long latency period between graft placement and symptom onset, additional cases of graft-associated CJD are likely to be reported.

During 1996-2003, cases of CJD were identified in Japan by using (1) a mail survey of neurologic, psychiatric, and neuropathologic institutions (overall response rate: 74%)1 and (2) subsequent reporting of CJD patients by clinicians to MHW. During this period, 97 cadaveric dura mater graft-associated CJD cases were identified. A case of dura mater-associated CJD was defined as a case in which a patient received a cadaveric dura mater graft and subsequently had CJD diagnosed by a physician and reviewed and accepted as CJD by a surveillance panel of neurologists.

The 97 CJD patients had illness onset during September 1985-April 2002 (Figure 1). Median age at onset was 58 years (range: 15-80 years); mean age was 55 years. Mean age at onset was younger than that reported for sporadic CJD in Japan (66 years). A total of 58 (60%) patients were female. Neuropathologic confirmation of CJD diagnosis was obtained for 20 (21%) patients; 65 (84%) of the other 77 patients with physician-diagnosed CJD had an electroencephalogram with a periodic synchronous discharge pattern consistent with CJD.

All 97 patients received dura mater grafts during 1978-1991 (Figure 2). Three patients received more than one dural graft during this period, including one patient reported previously.1 In all three cases, the first graft was considered to be the source of infection. Medical conditions leading to the use of dural grafts in these patients included tumor (n = 46), brain hemorrhage (n = 14), Jannetta procedure for facial palsy (n = 13) and for trigeminal neuralgia (n = six), intracranial aneurysm (n = eight), unspecified anomalies (n = five), hematoma (n = three), injury (n = one), and ossification of the spinal posterior longitudinal ligament (n = one).

Latency periods ranged from 14 months (receipt in 1987 and onset in 1989) to 275 months (receipt in 1978 and onset in 2001). The median and mean latency periods were 122 and 125 months, respectively. A total of 93 patients received dural grafts during 1978-1987. In 1987, the manufacturer revised collection and processing procedures for the implicated product to reduce the risk for CJD transmission. Four patients received grafts during 1988-1991. No cases have been reported among patients who received their first dural graft after 1991. A total of 86 (89%) patients were documented to have received LYODURA®; the brand name of dural graft was unknown for 11 patients. A total of 81 (84%) of the 97 patients received their dural grafts during 1983-1987, during which time an estimated 100,000 patients received LYODURA® grafts in Japan. All 81 patients died from CJD within 17 years after receipt of the grafts. Lot numbers of the dura mater grafts used for the 97 patients could not be identified. As of September 2003, five additional cases were under investigation in Japan for suspected dural graft-associated CJD.

Reported by:

Y Nakamura, MD, M Watanabe, MD, K Nagoshi, MD, Dept of Public Health, Jichi Medical School, Minamikawachi; T Kitamoto, MD, Dept of Neuropathology, Tohuku Univ School of Medicine, Sendai; T Sato, MD, Kohnodai Hospital, National Center for Neurology and Psychiatry, Ichikawa; M Yamada, MD, Dept of Neurology, Kanazawa Univ Graduate School of Medical Science, Kanazawa; H Mizusawa, MD, Dept of Neurology, Tokyo Medical and Dental Univ School of Medicine, Tokyo, Japan. R Maddox, MPH, J Sejvar, MD, E Belay, MD, LB Schonberger, MD, Div of Viral and Rickettsial Diseases, National Center for Infectious Diseases, CDC.

CDC Editorial Note:

Dural graft-associated CJD cases continue to be identified in Japan. The estimated minimum risk within 17 years after receipt of LYODURA® is approximately one case per 1,250 recipients. The precise number of dura mater grafts used in Japan is unknown, but an estimated 20,000 grafts per year might have been used during 1983-1987. The widespread use of LYODURA® during neurosurgical procedures in Japan is the most probable source of the unusually high number of dural graft-associated CJD cases in Japan.2 Dural graft recipients have symptom onset at a younger age compared with age at onset in sporadic cases of CJD in Japan. The identification of additional cases over time has resulted in an expected increase in the latency period between dural graft placement and symptom onset. The mean and range for this latency of CJD from contaminated grafts is unknown, but the upper limit now exceeds 22 years. The occurrence of new cases, the increase in the mean and range of the latency period, and the identification of suspected cases under investigation all suggest that this outbreak is ongoing.

No cases in Japan were reported to be related to receipt of a dural graft other than LYODURA®. For 11 cases, the manufacturer brand name was unknown. Although LYODURA®, or in one case either LYODURA® or a dural graft from another manufacturer (Tutoplast® [Pfrimmer-Viggo GmbH & Co., Erlangen, Germany]), was suspected in these cases, documentation of a specific source was unavailable. Four patients received dural grafts after collection and processing procedures were revised by the manufacturer in 1987, but whether the implicated dural grafts were LYODURA® produced before 1987 is unknown. That all LYODURA®-associated CJD cases to date occurred among patients who received grafts before 1992 suggests that all implicated grafts likely were processed before 1987; the implicated product's expiration date is 5 years after processing.

LYODURA® never was produced by the manufacturer for distribution in the United States, and relatively few LYODURA® grafts were used in this country. In May 1987, after identification of the first dural graft-associated CJD case in a U.S. patient who had received the implicated product,

======================================

the manufacturer revised its procedures for collecting and processing dura mater grafts to reduce the risk for CJD transmission (e.g., by discontinuing the commingling of dura and disinfecting them with sodium hydroxide).3-4

======================================

Subsequently, numerous other dura mater graft-associated cases were identified worldwide; nearly all patients had received the implicated product, including one additional U.S. patient. In 1997, the report of 43 cases of dura mater graft-associated CJD in Japan represented the largest cluster of such cases in any one country.1

In one of the CJD cases reported in Japan, the implicated graft was used in a spinal (not an intracranial) procedure. This case suggests that transmission from contaminated dura might occur in areas of the neuraxis outside of the cranial vault.

In 1997, the Food and Drug Administration's Transmissible Spongiform Encephalopathy Advisory Committee (TSEAC) recognized that the use of human dura mater in the United States carries an inherent risk for transmitting CJD. However, the committee recommended that the use of such grafts be left to the discretion of the treating neurosurgeon, provided that the human dura mater is procured and processed according to appropriate safety measures.5 In 1997, an estimated 4,500 dural grafts were distributed for use in the United States.6 After the TSEAC recommendations were issued, the number of dural grafts distributed for use in the United States declined to an estimated 900 grafts in 2002 (B.E. Buck, M.D., Miami Tissue Bank, personal communication, 2003).

The cases described in this report indicate that recipients of contaminated dura mater grafts might remain at risk for CJD for >22 years after receiving grafts. CDC continues to conduct surveillance for cases of CJD in the United States. Patients with a rapidly progressive dementia consistent with CJD and a history of dural graft implantation should be reported through local or state health departments to CDC, telephone 404-639-3091.

*Subsequently named the Ministry of Health, Labor, and Welfare.

REFERENCES

1. CDC. Creutzfeldt-Jakob disease associated with cadaveric dura mater grafts-Japan, January 1979-May 1996. MMWR. 1997;46:1066-9. PUBMED
2. Brown P, Preece M, Brandel JP, et al. Iatrogenic Creutzfeldt-Jakob disease at the millennium. Neurology. 2000;55:1075-81. FREE FULL TEXT
3. Thadani V, Penar PL, Partington J, et al. Creutzfeldt-Jakob disease probably acquired from a cadaveric dura mater graft. J Neurosurg. 1988;69:766-9. ISI | PUBMED
4. CDC. Epidemiologic notes and reports update: Creutzfeldt-Jakob disease in a patient receiving a cadaveric dura mater graft. MMWR. 1987;36:324-5. PUBMED
5. U.S Food and Drug Administration. Class II Special Controls Guidance Document: Human Dura Mater; Draft Guidance for Industry and FDA. Rockville, Maryland: U.S. Food and Drug Administration, 2002.
6. Solomon R. Methods used in human cells, tissues, and cellular and tissue-based product (HCT/P) establishments. Available at http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3969t2.pdf.

http://jama.ama-assn.org/cgi/content/full/291/3/295

[Federal Register: January 12, 2007 (Volume 72, Number 8)]
[Proposed Rules]
[Page 1581-1619]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja07-25]

[[Page 1581]]

----------------------------------------------------------

Part II

Department of Health and Human Services

----------------------------------------------------------

Food and Drug Administration

----------------------------------------------------------

21 CFR Parts 211, 226, 300, et al.

Use of Materials Derived from Cattle in Medical Products Intended for
Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule

[[Page 1582]]

----------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 211, 226, 300, 500, 530, 600, 895, and 1271

[Docket No. 2005N-0373]
RIN 0910-AF54

Use of Materials Derived from Cattle in Medical Products Intended
for Use in Humans and Drugs Intended for Use in Ruminants

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

----------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to
prohibit the use of certain cattle material in, or in the manufacture
(including processing) of, drugs, biologics, and medical devices
intended for use in humans and human cells, tissues, and cellular and
tissue-based products (HCT/Ps) (collectively, medical products for
humans), and in drugs intended for use in ruminant animals (drugs for
ruminants). FDA is also proposing new recordkeeping requirements for
medical products for humans and drugs for ruminants that are
manufactured from or otherwise contain material from cattle. FDA is
proposing these actions as part of its continuing efforts to strengthen
defenses against the potential risk of exposure to, and spread of,
bovine spongiform encephalopathy (BSE) and related human disease in the
United States.

DATES: Submit written or electronic comments on the proposed rule by
March 13, 2007. Submit written comments on the information collection
requirements by February 12, 2007. Requests for an informal hearing on
the proposed ban related to medical devices must be submitted by
February 12, 2007.

ADDRESSES: You may submit comments, identified by Docket No. 2005N-0373
and RIN number 0910-AF54, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.

Follow the instructions for submitting comments.
Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.

Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
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.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm
, including any personal information provided. For detailed

instructions on submitting comments and additional information on the
rulemaking process, see section VII ``Effective Date and Opportunity
for Public Comment'' in the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm

and insert the docket number(s), found in brackets in the heading of
this document, into the ``Search'' box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Information Collection Provisions: To ensure that comments on the
information collection are received, Office of Management and Budget
(OMB) recommends that written comments be faxed to the Office of
Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:
202-395-6974.

FOR FURTHER INFORMATION CONTACT:
For information concerning products regulated by the Center for
Drug Evaluation and Research: Vikki Kinsey, Center for Drug Evaluation
and Research (HFD-006), Food and Drug Administration, 5515 Security
Lane, rm. 5110, Rockville, MD 20852, 301-443-5578, e-mail:
vikki.kinsey@fda.hhs.gov.

For information concerning products regulated by the Center for
Biologics Evaluation and Research: Stephen M. Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, rm 594N, Rockville, MD 20852-1448,
301-827-6210, e-mail: stephen.ripley@fda.hhs.gov.
For information concerning products regulated by the Center for
Devices and Radiological Health: Scott G. McNamee, Center for Devices
and Radiological Health, Food and Drug Administration, 2094 Gaither
Rd., rm. 230, Rockville, MD 20850, 240-276-0105, e-mail:
scott.mcnamee@fda.hhs.gov.

For information concerning products regulated by the Center for
Veterinary Medicine: Michael J. Popek, Center for Veterinary Medicine
(HFV-144), Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 301-827-6462, e-mail: michael.popek@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. Background
A. Transmissible Spongiform Encephalopathies
B. Bovine Spongiform Encephalopathy
C. Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
D. BSE Risk Assessments
1. Harvard-Tuskegee Study
2. USDA Surveillance Program
3. BSE Testing for Product Safety Purposes
4. BSE Infectivity via Medical Products for Humans and Drugs for
Ruminants
E. Cattle Materials
1. Specified Risk Material
2. Small Intestine
3. Mechanically Separated Beef
4. Nonambulatory Disabled Cattle
5. Cattle Not Inspected and Passed for Human Consumption
6. Tallow and Tallow Derivatives
7. Fetal Calf Serum
8. Additional Requirements
F. Medical Products for Humans and Drugs for Ruminants That May
Contain Cattle Material
1. Drugs for Humans
2. Biologics for Humans
3. HCT/Ps
4. Medical Devices for Humans
5. Drugs for Ruminants
III. USDA/FSIS IFR
IV. FDA Actions on BSE
A. Regulations
1. FDA 1997 Ruminant Feed Rule
2. FDA/USDA Animal Feed ANPRM and FDA 2005 Animal Feed Proposed
Rule
3. Foods IFR
4. Foods Recordkeeping/Access Final

[[Page 1583]]

Rule
B. FDA Guidance
V. Description of Proposed Rule
A. Definitions
B. Proposed Requirements for Prohibited Cattle Materials and
Permission for an Exception or Alternative to These Requirements
C. Tallow and Tallow Derivatives
D. Proposed Requirements Regarding Extralabel Drug Use in Animals
E. Proposed Recordkeeping Requirements
1. Types of Records
2. Proposed Periods for Records Retention
3. Location of Records
VI. Legal Authority
VII. Effective Date and Opportunity for Public Comment
VIII. Analysis of Impacts
A. Need for the Proposed Rule
B. Scope of the Proposed Rule
C. Costs of the Proposed Rule
1. Potential Market Adjustments
2. Cost of Requests for Exception or Alternatives to the Limitation
on the Use of Prohibited Cattle Material
3. Cost of Substitutes
4. Recordkeeping Requirements of the Proposed Rule
5. Labeling Costs for Drugs Prohibited from Extralabel Use
6. Summary of the Cost for the Proposed Rule
D. Benefits of the Proposed Rule
1. Reduced Risk of Exposure to BSE Infectivity
2. Value of the Potential Reduction of Human Illness
E. Summary of the Potential Costs and Benefits of the Proposed Rule
F. Regulatory Options Considered
G. Regulatory Flexibility Analysis
IX. Paperwork Reduction Act Analysis
X. Environmental Impact Analysis
XI. Federalism
XII. References

I. Introduction

On January 26, 2004, the U.S. Department of Health and Human
Services announced its plan to establish new safeguards to strengthen
existing firewalls against transmission of BSE in the United States.
Consumption of products contaminated with the agent that causes BSE has
been linked to the human disease variant Creutzfeldt-Jakob disease
(vCJD). Current protections against the spread of BSE in the United
States include:
FDA's ruminant feed regulation (the 1997 ruminant feed
rule) (62 FR 30936, June 5, 1997) (see section V.A.8 of this document
for definition of ruminant),
U.S. Department of Agriculture's (USDA's) Food Safety and
Inspection Service (FSIS) interim final rule banning specified risk
materials (SRMs) and certain other cattle material in human food (the
USDA/FSIS IFR) (69 FR 1862, January 12, 2004; as amended, 70 FR 53043,
September 7, 2005),
FDA's interim final rule banning the use of SRMs and
certain other cattle material in human food, including dietary
supplements, and cosmetics (the Foods IFR) (69 FR 42256, July 14, 2004;
as amended, 70 FR 53063, September 7, 2005), and
Import controls.
FDA also has requirements for establishment and maintenance of
records concerning use of materials derived from cattle in human food
and cosmetics (the Foods Recordkeeping/Access final rule) (71 FR 59653,
October 11, 2006). In addition, FDA, in conjunction with USDA, issued
an advance notice of proposed rulemaking (ANPRM) to solicit comment on
additional measures under consideration, including measures related to
animal feeds (the joint ANPRM) (69 FR 42288, July 14, 2004). On October
6, 2005 (70 FR 58570), we issued a proposed rule that would prohibit
certain cattle materials from all animal feed (FDA 2005 Animal Feed
proposed rule).
In this medical products proposed rule, FDA is proposing to
prohibit use of SRMs and certain other cattle material in, or in the
manufacture (including processing) of, medical products for humans and
drugs for ruminants because of the risk of transmission of BSE. FDA is
also proposing recordkeeping requirements for medical products for
humans and drugs for ruminants that are manufactured from or otherwise
contain material from cattle to ensure compliance with the prohibitions
in this proposed rule. The proposed requirements are consistent with
the requirements in the USDA/FSIS IFR and the Foods IFR, as well as
those in the Foods Recordkeeping/Access final rule. The proposed
requirements in this medical products proposed rule only apply to
medical products for humans and drugs for ruminants. They do not apply
to any other product regulated by FDA.

II. Background

A. Transmissible Spongiform Encephalopathies

snip...full text ;

http://www.fda.gov/cber/rules/catruminant.htm

http://www.fda.gov/cber/rules/catruminant.pdf

Subject: U.S.A. - 50 STATE BSE CONFERENCE CALL JAN. 9, 2001 (my notes)
Date: January 10, 2001 at 1:36 pm PST

Subject:
BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date:
Tue, 9 Jan 2001 16:49:00 -0800
From:
"Terry S. Singeltary Sr."
Reply-To:
Bovine Spongiform Encephalopathy
To:
[log in to unmask]

######### Bovine Spongiform Encephalopathy #########

Greetings List Members,

I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.

I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly
so.

"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."

and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.

(understand, these are taken from my notes for now.
the spelling of names and such could be off.)

[host Richard Barns]
and now a question from Terry S. Singeltary of
CJD Watch.

[TSS]
yes, thank you,

U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]

[host Richard]
could you repeat the question?

[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[not sure whom ask this]
what group are you with?

[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.

[not sure who is speaking]
could you please disconnect Mr. Singeltary

[TSS]
you are not going to answer my question?

[not sure whom speaking]
NO

from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;

[unknown woman]
what group are you with?

[TSS]
CJD Watch and my Mom died from hvCJD
we are trying to tract down CJD and other
human TSE's world wide. i was invited to
sit in on this from someone inside the USDA/APHIS
and that is why i am here. do you intend on banning
me from this conference now?

at this point the conference was turned back up,
and i got to finish listening. They never answered
or even addressed my one question, or even addressed
the issue. BUT, i will try and give you a run-down
for now, of the conference.

IF i were another Country, I would take heed to my
notes, BUT PLEASE do not depend on them. ask for
transcript from;

[log in to unmask]
301-827-6906

he would be glad to give you one ;-)

Rockville Maryland,
Richard Barns Host

snip...full text ;

http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0701&L=sanet-mg&P=5318


TSS






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