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| HHS/FDA | RIN: 0910-AF55 | Publication ID: Spring 2005 |
| Title: Requirements for Human and Animal Medical Products Manufactured From, Processed With, or Otherwise Containing Material From Cattle | |
| Abstract: This is a companion rulemaking to FDA’s rule entitled "Use of Materials Derived From Cattle in Human and Animal Medical Products," to be published in the same issue of the Federal Register. The rule would propose recordkeeping requirements for human and animal medical products that contain cattle material. Manufacturers and sponsors of such products would have to establish and maintain records to demonstrate that prohibited materials were not used in their manufacture. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 500; 21 CFR 600.16; 21 CFR 895; 21 CFR 1271.465; 21 CFR 1271.470 | |
| Legal Authority: Not Yet Determined | |
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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: Undetermined |
| Included in the Regulatory Plan: No | |
| Related RINs: Merged with 0910-AF54 | |
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Agency Contact: Eric Flamm Senior Policy Advisor, Office of Policy Department of Health and Human Services Food and Drug Administration Office of the Commissioner, WO1, Room 4315B, 10903 New Hampshire Ave., Silver Spring, MD 20993 Phone:301 796-4726 Fax:301 847-3541 Email: eric.flamm@fda.hhs.gov |
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