View Rule
| Printer-Friendly Version Download RIN Data in XML |
| HHS/FDA | RIN: 0910-AC25 | Publication ID: Spring 2008 |
| Title: Exception From General Requirements for Informed Consent; Request for Comments and Information | |
| Abstract: This final rule will add an 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. | |
| 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; 21 USC 346a; 21 USC 348; 21 USC 350a; 21 USC 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 |
|||||||||
Timetable:
|
| 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, 10903 New Hampshire Avenue, WO66 Room 5516, Silver Spring, MD 20993 Phone:301 796-6196 Fax:301-847-8144 Email: claudia.gaffey@fda.hhs.gov |
|
