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HHS/FDA | RIN: 0910-AC25 | Publication ID: Fall 2005 |
Title: Exception From General Requirements for Informed Consent; Request for Comments and Information | |
Abstract: This interim 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 351 21 USC 352 21 USC 355 21 USC 360 21 USC 360bbb 21 USC 360c 21 USC 360d 21 USC 360e 21 USC 360f 21 USC 360h 21 USC 360i 21 USC 360j 21 USC 371 21 USC 381 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
Agency Contact: Darin Achilles Regulatory Counsel Department of Health and Human Services Food and Drug Administration 14-101-11, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993 Phone:877 287-1373 Fax:301 595-1426 Email: ctpregulations@fda.hhs.gov |