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Oct. 20 — The FDA plans to update its regulatory language (21 C.F.R. Part 50) in concert with the governmentwide effort to modernize rules governing the use of human subjects in research, the agency's good clinical practice director said Oct. 20.
Joanne Less said the Food and Drug Administration's revisions will be harmonized with the Department of Health and Human Services' proposed changes to its human subject protection regulations known as the Common Rule (45 C.F.R. Part 46). The FDA wasn't one of the 16 agencies listed on the notice of proposed rulemaking that went out Sept. 2.
During an HHS public town hall meeting on the proposed rule, Less said the FDA has received a number of inquiries about the status of its regulations. She confirmed that the agency is working on a parallel effort with the NPRM and asked that any comments on the HHS proposal also take the FDA's regulations into account.
Less is the director of the FDA Office of Good Clinical Practice. She is also the FDA's ex-officio member of the HHS Secretary's Advisory Committee on Human Subject Protections.
The NPRM, “Federal Policy for the Protection of Human Subjects,” is designed to update regulations that have been in place since 1991 to account for the evolution of the research enterprise and new disciplines and new technologies, such as whole genome sequencing. The HHS, along with the 15 other federal departments and agencies, whose authority to oversee clinical trials would broaden under the proposed rule, said in the summary that the changes are designed to build public trust in the research system.
There are currently 18 federal entities signed on to the Common Rule, but Jerry Menikoff, director of the HHS Office for Human Research Protections, said during the town hall meeting that the list is set to expand as the Department of Labor has agreed to adopt the rule as well. The DOL was among the departments and agencies listed in the NPRM.
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More information on the proposed rule, including the town hall meeting, is available at http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html.
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