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HHS/FDA

RIN: 0910-AI08

Publication ID: Spring 2018

Title: ●Institutional Review Boards; Cooperative Research
Abstract: This proposed rule would replace current FDA requirements for cooperative research such that any institution located in the United States (U.S.) participating in multisite cooperative research would need to rely on approval by a single Institutional Review Board (IRB) for that portion of the research that is conducted in the U.S., with some exceptions. This proposed rule would also establish an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution.
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: No	Unfunded Mandates: No
EO 13771 Designation: Other
CFR Citation: 21 CFR 56
Legal Authority: 21 U.S.C. 321 21 U.S.C. 343 21 U.S.C. 346 and 346a 21 U.S.C. 348 21 U.S.C. 350a and 350b 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360c to 360f 21 U.S.C. 360h to 360j 21 U.S.C. 371 21 U.S.C. 379e 21 U.S.C. 381 42 U.S.C. 216 42 U.S.C. 241 42 U.S.C. 262 42 U.S.C. 263b to 263n

Legal Deadline:

Action	Source	Description	Date
NPRM	Statutory	Final Rule	12/13/2019

Overall Description of Deadline: Section 3023 of the 21st Century Cures Act

Timetable:

Action	Date	FR Cite
NPRM	12/00/2018

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: None
Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: Bridget Foltz Health Scientist Policy Analyst Department of Health and Human Services Food and Drug Administration Office of Good Clinical Practice, 10903 New Hampshire Avenue, WO 32, Room 5174, Silver Spring, MD 20993 Phone:301 796-8348 Email: bridget.foltz@fda.hhs.gov