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| HHS/FDA | RIN: 0910-AC25 | Publication ID: Spring 2005 |
| Title: Exception From General Requirements for Informed Consent; Request for Comments and Information | |
| Abstract: FDA is proposing to 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 | |
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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 | |
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Agency Contact: Gail Schmerfeld Regulatory Counsel Department of Health and Human Services Food and Drug Administration 14-101-11, 9200 Corporate Boulevard, Rockville, MD 20850 Phone:877 287-1373 Fax:240 276-3904 Email: gail.schmerfeld@fda.hhs.gov |
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