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Statement of Need: The agency is proposing this action because it is concerned that, during a potential terrorism event or other similar public health emergency, delaying testing of specimens to obtain informed consent may threaten the life of the subjects or others who have been exposed to or who may be at risk of exposure to, a dangerous threat agent.

Summary of the Legal Basis: FDA has already determined that the statutory authority provided in the Federal Food, Drug, and Cosmetic Act (the Act) allows a limited exception to the requirement of obtaining informed consent in life-threatening situations such as those considered here. Section 520(g)(3)(D) of the Act provides specifically for an exception from informed consent for investigational devices, subject to such conditions as the agency may prescribe. That section requires informed consent of the subject unless the clinical investigator determines in writing that: 1) there exists a life-threatening situation involving the human subject of such testing which necessitates the use of such device; 2) it is not feasible to obtain informed consent from the subject; and 3) there is not sufficient time to obtain such consent from his or her representative. Further, a licensed physician uninvolved in the testing must agree with this three-part determination before using the product, unless immediate use of the device is required to save the life of the human subject of such testing and there is not sufficient time to get such concurrence.

Alternatives: The other option available to the agency is to work within the existing regulatory scheme. FDA believes that this option may result in improper or no diagnosis, and improper or no treatment for persons exposed to these threat agents because health professionals may not use these investigational products because of their inability to obtain informed consent.

Anticipated Costs and Benefits: The minimal burdens imposed by this rule are offset by the fact that, in the absence of this rule, the sponsor may be required to obtain informed consent, which is just as burdensome, if not more so. The rule would permit use of investigational products without which patients' lives might be threatened. Because of uncertainty about the nature or extent of any chemical or biological terrorism event, FDA cannot estimate the extent of the benefits of this rule.

Risks: The primary risk addressed by this rule is the risk that patients may go untreated or may be improperly treated because health professionals may not use an investigational product in the absence of informed consent. FDA cannot determine the extent of this risk without knowing the nature or extent of any chemical or biological terrorism event.