In accordance with the requirements of the Privacy Act of 1974 (the Privacy Act) and the Food and Drug Administration's (FDA's) regulations for the protection of privacy, FDA is publishing notice of a new Privacy Act system of records entitled "FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC" System No. 09-10-0020. Under the Department of Health and Human Services' (HHS' or the Department's) Public Health Service Policies on Research Misconduct, FDA has responsibilities for addressing research integrity and misconduct issues related to FDA supported activities. This system contains records related to the processing and reviewing of allegations of scientific research misconduct levied against an individual (the respondent) who is an agent of, or affiliated by contract or agreement with, FDA, or an FDA employee involved in intramural research. Research misconduct proceedings include allegation assessments, inquiries, investigations, oversight reviews by HHS' Office of
A formal finding of research misconduct under 42 CFR part 93 (HHS) or equivalent agency policy. The respondent was found to have engaged in fabrication, falsification, or plagiarism of research data. The federal grant funds involved are typically identified in the FR notice, along with the administrative actions (debarment, supervised research, manuscript correction or retraction requirements).