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HHS/FDA | RIN: 0910-AH57 | Publication ID: Fall 2017 |
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 (21 U.S.C. 262) 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: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
EO 13771 Designation: Regulatory | |
CFR Citation: 21 CFR 600.3 | |
Legal Authority: 42 U.S.C. 216 42 U.S.C. 262 42 U.S.C. 263 42 U.S.C. 263a 42 U.S.C. 264 42 U.S.C. 300aa-25 Pub. L. 111–148, title VII, 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 Orr Regulatory Counsel Department of Health and Human Services Food and Drug Administration Building 51, Room 5199, 10993 New Hampshire Avenue, Silver Spring, MD 20993 Phone:240 402-0979 Email: daniel.orr@fda.hhs.gov |