View Rule
| Printer-Friendly Version Download RIN Data in XML |
| HHS/FDA | RIN: 0910-AA89 | Publication ID: Spring 2003 |
| Title: Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients | |
| Abstract: The final rule would establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the best interest of military personnel engaged in specific military operations. Under Federal law, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's informed consent requirements in military operations, if the President finds that obtaining consent is infeasible, contrary to the best interests of recipients, or contrary to national security interests. | |
| 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; 21 CFR 312 | |
| Legal Authority: 21 USC 321; 21 USC 346; 21 USC 346a; 21 USC 348; 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: Federal |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
|
Agency Contact: Philip L. Chao Senior Policy Analyst Department of Health and Human Services Food and Drug Administration Room 15-61 (HF-23), Office of Policy and Planning (HF-23), Room 14C-17, 5600 Fishers Lane, Rockville, MD 20857 Phone:301 827-0587 Fax:301 827-4774 Email: philip.chao@fda.hhs.gov |
|
