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 

(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   
( 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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