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July 9, 1998
FDA Laboratory (Center or ORA) Negotiates with Outside Collaborator(s)
The Laboratory Director (Center or ORA) is strongly encouraged to contact OFACS/Technology Transfer, other Centers/Offices, Ethics Branch for advice and assistance as appropriate, to facilitate and to expedite the review of the proposed agreement during the FDA-imposed 20 day comment period.
Comments from FDA Centers, ORA, Ethics Branch, Office of Financial Management
The Laboratory Director sends an unsigned copy of the proposed CRADA summary statement and transmittal memo to:
FDA Centers and ORA for review for possible organizational conflict
Ethics Branch for organizational, individual or appearance of conflict of interest.
OFM for funding considerations
Within 20 days, the Centers and ORA respond with "No Organizational Conflict" or "Possible Organizational Conflict" and return CRADA to proposing Laboratory.
OFM and OFACS return the agreement with any comments. (FDA 20-day clock)
Agreement is signed by FDA Laboratory and Outside Collaborator(s)
After revisions are made to resolve conflicts and concerns from the Centers, ORA, Ethics and OFM, the agreement is prepared for signature.
Three originals of the agreement are signed by the collaborating Laboratory Director and the outside collaborator(s). The cooperative agreement with a brief executive summary, addressing all comments, is assembled into a package.
The Laboratory Director submits one original and five copies of this package to the Executive Secretary, FDA Review Board. The Laboratory Director is encouraged to do so within 10 days after receipt of comments.
Information copies of the executive summary will be distributed to those organizations which provided comments.
Signed CRADA is presented to the FDA CRADA Review Board
The Board either recommends approval, disapproval, or modifications. The Board chairperson may send the agreement to the Commissioner or return the agreement (with written explanation) to the Collaborating Laboratory Director as disapproved or for modifications.
Evidence of no pre-submission review by the Centers, ORA can be grounds for disapproval.
Signed CRADA is reviewed by the Commissioner
The Commissioner reviews the signed CRADA package and comments from the Review Board, and either accepts the agreement without objection, disapproves the agreement (w/written explanation), or requires modifications to the agreement (w/written explanation), and returns the package to the collaborating Laboratory Director via the Review Board (Executive Secretary).
If modified, the final agreement is signed by FDA Laboratory Director and outside collaborator(s). If no action is taken by the Commissioner within 30 days from the date the proposed CRADA is presented to the Review Board, the agreement becomes effective according to its terms. (Statutory 30-day clock).