Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration

A new law has been enacted to expand the scope of ClinicalTrials.gov. This notice provides information for NIH grantees on new responsibilities related to the first part of the law, the registration of clinical trials. The trials that must be registered are called "applicable clinical trials." Under the statute, these trials generally include: (1) Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and (2) Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric postmarket surveillance. You should review the statutory definition of applicable clinical trial to identify if any of your trials must be registered to comply with the law [http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws
&docid=f:publ085.110.pdf]. To read all of the guidance information pertaining to this law, click here: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html.

Change of NIGMS MBRS Support of Competitive Research (SCORE) Program to Electronic Submission and Standard Receipt Dates

Future applications for MBRS-SCORE Awards (SC1, SC2, and SC3) must be submitted electronically, through Grants.gov. Submission of SC applications in paper format is no longer allowed. In conjunction with this change in application process, standard "S" mechanism submission dates will be used. The standard submission dates for all (new, renewal, resubmission, revision) applications are available at http://grants.nih.gov/grants/funding/submissionschedule.htm. To read this complete announcement, click here: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-115.html.

The National Institute of Mental Health (NIMH) Strategic Plan is Available for Comment through 12/21/2007

The National Institute of Mental Health launched the process to develop a new Strategic Plan that will serve as a guide to the Institute for advancing mental health science over the next 3-5 years. The Institute has now completed a draft of this Strategic Plan, and seeks public feedback before the main text is finalized. The draft Plan can be accessed at the following website: http://www.nimh.nih.gov/about/strategic-planning-reports/nimh-draft-strategic-plan.shtml. Comments will be accepted by email through December 21, 2007.

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