Health Scientist Policy Analyst

0910-AI08 201904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Institutional Review Boards; Cooperative Research

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.

]]> Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes Undetermined Deregulatory 21 CFR 56 21 U.S.C. 343 21 U.S.C. 346 21 U.S.C. 348 21 U.S.C. 350a and 350b 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360c 21 U.S.C. 360e - 360j 21 U.S.C. 360hh - 360pp 21 U.S.C 360rr - 360ss 21 U.S.C. 371 21 U.S.C. 379e 42 U.S.C. 262 Statutory NPRM 12/13/2019 Section 3023 of the 21st Century Cures Act No NPRM 08/00/2019 Undetermined None No No No No Bridget Foltz Health Scientist Policy Analyst 0910 Food and Drug Administration FDA 301 796-8348 bridget.foltz@fda.hhs.gov Office of Good Clinical Practice, 10903 New Hampshire Avenue, WO 32, Room 5174, Silver Spring MD 20993