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HHS/FDA | RIN: 0910-AC25 | Publication ID: Fall 2009 |
Title: Exception From General Requirements for Informed Consent; Request for Comments and Information | |
Abstract: This final rule will affirm the interim final rule's exception from the general requirement for informed consent in certain circumstances involving the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents in a potential terrorist event or other public health emergency. The agency is issuing this rule because it is concerned that, during a potential terrorism event or other 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 chemical, biological, radiological, or nuclear agent. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 50.23 | |
Legal Authority: 21 USC 321 21 USC 343 21 USC 346 to 346a 21 USC 348 21 USC 350a to 350b 21 USC 352 21 USC 353 21 USC 355 21 USC 360 21 USC 360c to 360f 21 USC 360h to 360j 21 USC 371 21 USC 379e 21 USC 381 42 USC 216 42 USC 241 42 USC 262 42 USC 263b to 263n |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: State |
Small Entities Affected: No | Federalism: Yes |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Claudia M. Gaffey Medical Officer Department of Health and Human Services Food and Drug Administration Room 314/HFZ-314, Center for Devices and Radiological Health, WO66, Room 5516, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-6196 Fax:301 847-8144 Email: claudia.gaffey@fda.hhs.gov |