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HHS/FDA | RIN: 0910-AH57 | Publication ID: Fall 2019 |
Title: Definition of the Term "Biological Product" | |
Abstract:
The Food and Drug Administration (FDA) proposes to amend its regulation that defines biological product to conform to the statutory definition (42 U.S.C. 262(j)) adopted in the Biologics Price Competition and Innovation Act of 2009. |
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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: Final Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Deregulatory | |
CFR Citation: 21 CFR 600.3 | |
Legal Authority: 21 U.S.C. 371 42 U.S.C. 262 Pub. L. 111–148, title VII, sec. 7002(e), Mar. 23, 2010, 124 Stat. 817 |
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: Daniel Gottlieb Regulatory Counsel Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, Building 51, Room 6210, Silver Spring, MD 20993 Phone:301 796-6650 Email: daniel.gottlieb@fda.hhs.gov |