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HHS/FDA | RIN: 0910-AG16 | Publication ID: 2012 |
Title: Amendments to Sterility Testing Requirements for Biological Products | |
Abstract: The Food and Drug Administration (FDA) is issuing a rule to amend the sterility testing requirements for biological products. This rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of-the-art methodologies to ensure the safety of biological products. | |
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 600 21 CFR 610 21 CFR 680 | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 371 21 USC 374 42 USC 262 42 USC 264 |
Legal Deadline:
None |
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Timetable:
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Additional Information: Includes Retrospective Review under E.O.13563. | |
Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Paul E. Levine Regulatory Counsel Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-17), Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, Rockville, MD 20852 Phone:301 827-6210 |