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On October 9, 2019, the President issued Executive Order (EO) 13891 entitled Promoting the Rule of Law through Improved Agency Guidance Documents (84 FR 552350). The EO requires HHS to establish a single, searchable, indexed database that contains links to all of HHS’s guidance documents currently in effect. Guidance documents come in a variety of formats, including interpretive memoranda, policy statements, manuals, bulletins, advisories, and more. Please note, the contents of this database do not have the force and effect of law and are not meant to bind the public in any way. These documents are intended only to provide clarity to the public regarding existing requirements under the law or HHS policies.

HHS Guidance Submissions

Title Subtitle OpDiv/StaffDiv Guidance Status
Policy for Distribution of Limited Access Datasets From NIMH Clinical Trials Guidance for the supported NIMH data collection from participants in numerous clinical trials. These data from well-characterized clinical samples constitute an important scientific resource. It is the view of the NIMH that their full value can only be realized if they are made available, under appropriate terms and conditions, in a timely manner to the wider scientific community. National Institutes of Health (NIH) Final
NIMH Guidance on Risk-Based Monitoring Guidance for clarifying risk level definitions associated with NIMH-supported human subjects research and defines NIMH’s monitoring expectations to mitigate those risks. National Institutes of Health (NIH) Final
NIMH NRSA Practices and Guidance Guidance for prospective applicants for National Research Service Award (NRSA) programs (F30, F31, F32, T32) supported by NIMH National Institutes of Health (NIH) Final
NIMH Recruitment of Participants in Clinical Research Policy Guidance instituted by NIMH outlining the Policy for the Recruitment of Participants in Clinical Research to monitor the recruitment of participants in NIMH-sponsored clinical research studies that expect to enroll 150 or more participants in a single study National Institutes of Health (NIH) Final
Policy for the NIMH Data Archive (NDA) Guidance for the NIMH Data Archive which provides an infrastructure for data collection, retrieval, and results reporting related to human subject research National Institutes of Health (NIH) Final
Guidelines for Developing Social Media Content Guidelines for Developing Social Media Content National Institutes of Health (NIH) Final
NIMHD RFI Summary NIMHD RFI Summary National Institutes of Health (NIH) Final
NIAMS Data and Safety Monitoring (DSM) Report Template for Multi-Site Studies - Open Session Guidance for grantees who need to create a data and safety monitoring plan - multi-site - open session National Institutes of Health (NIH) Final
NIMHD Health Disparities Research Institute The HDRI aims to support the research career development of promising early-career minority health/health disparities research scientists, and stimulate research in the disciplines supported by health disparities science. National Institutes of Health (NIH) Final
NIMHD William G. Coleman, Jr., Ph.D. Minority Health and Health Dirsparities Innovation Award This competitive award program is designed to support 1-year innovative research projects contributed by postdoctoral fellows, staff scientists, and staff clinicians within the NIH IRP that have the potential for high impact in any area of minority health and health disparities research. National Institutes of Health (NIH) Final