NOTICE TO NIH GRANTEES/CONTRACTORS REGARDING LETTERS OR NOTICES FROM THE FOOD AND DRUG ADMINISTRATION (FDA) Release Date: September 22, 2000 NOTICE: OD-00-053 National Institutes of Health Many NIH grantees/contractors conduct clinical research that involves a drug, biologic or device for which there is a Food and Drug Administration (FDA) Investigational New Drug Application (IND) and/or Investigational Device Exemption (IDE). When the NIH funds all, or part, of a clinical study that is being conducted under an IND and/or IDE, it is important that the NIH be knowledgeable about any significant communications with the FDA about that study. In order to keep the NIH informed and comply with 45 CFR 74.51(f), the awardee institution must report FDA communications to the awarding Institute(s) or Center(s) within 72 hours of receiving (through the principal investigator or any other person acting on behalf of the awardee) a copy of the communication or upon being informed (through the principal investigator or any other person acting on behalf of the awardee) of the FDA communication, whichever occurs first. Failure to comply with this requirement may result in corrective and/or enforcement action. By statute, the FDA communicates with the sponsor of the IND or IDE. The sponsor may, or may not, be the NIH awardee institution or NIH-funded principal investigator. FDA regulation, 21 CFR 312.55, outlines the responsibilities of sponsors to keep each participating investigator informed during the course of the study. Thus this notice to the awarding Institute(s) and Center(s) serves to complete the information loop. Awardee institutions must immediately notify the awarding Institute(s) and/or Center(s) of any of the following communications from the FDA regarding that research. (1) Warning letters: letters that are sent to you and/or to the commercial sponsor(s). (2) Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE letters) (3) Notice of Opportunity for Hearing (NOOH) (4) Notice of Disqualification (5) Consent Agreements (6) Clinical hold letters that pertain to breaches of either Good Manufacturing Practices, Good Clinical Practices or other major issues requiring significant changes in the protocol. The notification should be made in writing, but may be done by phone, if a written notice would delay the notification. The notification shall include a statement of the action taken or contemplated and the assistance needed to resolve the situation. The awarding Institute(s) and Center(s), NIH and HHS shall, pursuant to 45 CFR 74.53, have access to the FDA communications received by the grantee/contractor and other records of the grantee/contractor that are pertinent to the grant/contract. The NIH Grants Policy (https://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#chgproj) requires the grantee to obtain prior approval from NIH for changes in scope, direction, type of training, or other areas that constitute a significant change from the aims, objectives, or purposes of the approved project. Consistent with this policy, grantees must inform the funding Institute or Center, if the clinical hold results in significant changes in the protocol. For changes made outside the scope of a contract, the regulations at 48 CFR 43.2 or 48 CFR 6.3 shall apply.
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