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HHS/FDA | RIN: 0910-AH49 | Publication ID: Spring 2018 |
Title: Removal of Time of Inspection and Duties of Inspector Regulations for Biological Products | |
Abstract:
The Food and Drug Administration is amending the general biologics regulations by removing mandatory inspection requirements for biologics. FDA is taking this action to remove outdated requirements and allow inspection frequency based on risk. This action is part of FDA’s retrospective review of its regulations and will better target Agency resources. |
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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 |
EO 13771 Designation: Deregulatory | |
CFR Citation: 21 CFR 600.21 21 CFR 600.22 | |
Legal Authority: 42 U.S.C. 216 42 U.S.C. 262 to 263a 42 U.S.C. 264 42 U.S.C. 300aa-25 21 U.S.C. 321 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 356c 21 U.S.C. 356e 21 U.S.C. 360 21 U.S.C. 360i 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 379k-l |
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: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Melissa Segal Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301, Silver Spring, MD 20993 Phone:240 402-7911 Email: melissa.segal@fda.hhs.gov |