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HHS/FDA | RIN: 0910-AB51 | Publication ID: Spring 2003 |
Title: Revisions to the General Safety Requirements for Biological Products; Final Rule | |
Abstract: The Food and Drug Administration (FDA) issued a direct final rule and companion proposed rule to amend the biologics regulations by adding "cellular therapy products" to the list of products excepted from the general safety test (GST) and by adding an administrative procedure for obtaining an exemption from the GST requirements for other biological products. Because the agency received significant adverse comment on the administrative procedure portion of the direct final rule, FDA withdrew that portion of the rule and confirmed the remaining portion. FDA intends to finalize the companion proposed rule to respond to the significant adverse comment on the administrative procedure portion of the rule. FDA is taking this action because the GST may not be relevant or necessary for all biological products, including cellular therapy products, currently in various stages of development. This action is part of FDA's continuing effort to achieve the objectives of the "Reinventing Government" initiative, and is intended to reduce the burden of unnecessary regulations on biological products without diminishing the protection of the public health. | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 610.11(g) | |
Legal Authority: 42 USC 351 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
Agency Contact: Stephen M. Ripley Team Leader Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-17), Rockville, MD 20852-1448 Phone:301 827-6210 |