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HHS/FDA | RIN: 0910-AA89 | Publication ID: Spring 2002 |
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 |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal |
Federalism: No | |
Included in the Regulatory Plan: No | |
Agency Contact: Philip L. Chao Supervisory Regulatory Counsel Department of Health and Human Services Food and Drug Administration Room 15-61 (HF-23), Center for Food Safety and Applied Nutrition, 5001 Campus Drive, College Park, MD 20740 Phone:240 400-4053 Email: philip.chao@fda.hhs.gov |