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| HHS/FDA | RIN: 0910-AA20 | Publication ID: Fall 2001 |
| Title: Medical Foods | |
| Abstract: The Food and Drug Administration is considering development of regulations for medical foods, as defined by the Orphan Drug Act Amendments of 1988 (21 U.S.C. 360ee(b)(3)) to assure, among other things, the safety and effectiveness of these products, proper labeling of the nutrient content and purported uses, including adequate and appropriate directions for use, and quality control and good manufacturing practices. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Long-Term Actions |
| Major: No | Unfunded Mandates: No |
| CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: 21 USC 321; 21 USC 360ee; 21 USC 371; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 350; 21 USC 350a; 21 USC 351; 21 USC 352; 21 USC 355 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Federal, State |
| Small Entities Affected: Businesses | Federalism: Undetermined |
| Included in the Regulatory Plan: No | |
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Agency Contact: Sue A. Anderson Department of Health and Human Services Food and Drug Administration (HFS-831), Center for Food Safety and Applied, Nutrition, 200 C Street SW., Washington, DC 20204 Phone:202 205-4240 |
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