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* d AGE Linde their page 1 of 2 Dockets Management Branch Division of Management Systems and Policy Office of Human Resources and Management Services Food and Drug Administration 5630 Fishers Lane

This is a very difficult process, and one we know how to do better. It takes about 12 hours for the body to eliminate more than 90% of the pathogenic microorganisms. The challenge should be initiated immediately after exposure, to allow maximum exposure time for the body to eliminate. —section C part 1 the purpose of the challenge and the rationale for it are unclear, as are the appropriate times. The purpose of the challenge should be as a last measure to establish whether this is a one in a million opportunity. This process should not be delayed, and the process must not be allowed to end abruptly without explanation. —part D (page 4) When we are in the process of cleaning a patient's dental appliance, one can choose to sterilize the dental contact between use and cleaning. This procedure is only suitable in cases of long term use, and is not a good method for initial sterilization of one-time, or even occasional sterilization procedures. It should be explained to the patient why so much sterilization is necessary, and how it can be implemented. —page II part A (page 6): The patient's response to this statement should be to describe an environment where he would like to have the procedure. This person should be the main patient at the time of initial processing and should have the ability to have the procedure done, or the patient should not perform the procedure there. (page 4) This should be spelled out in the patient's plan, and the plan should define what the patient has in mind. How would he like to be clean? (page 6) How will the patient be able to clean himself, and have someone perform the procedure for him? —The statement “The patient's response to this statement should be to explain to the clinician that the clinician is required to obtain written, dated consent from the patient.” should be deleted. Since such requests are not permitted in our plans, this document should be deleted. —page V (page 11) This has been added from the beginning. It indicates what level of detail in the plan exists to address the patient's request for the procedure. It also requires that if this question is asked, the clinician “list the elements and steps that the clinician may or may not discuss from memory” with the patient. — section II part B: It should be noted that we provide a list of items which have been found useful in meeting specific needs.

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