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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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SOPP 8203: Appendix A: Cost Recovery-INDs and IDEs

  CFR Prior FDA approval/review needed Costs recoverable that require prior FDA approval Time limitation Who may recover costs
IND-clinical study 21 CFR 312.8 Yes- amount also must be justified, documented and supported by independent CPA. FDA approval for cost recovery must be in writing Direct costs -Ex. Raw materials, labor and nonreusable supplies and equipment used to manufacture the quantity of product used in the clinical study. Costs to obtain the product from another manufacturer. Shipping/handling costs for the product being investigated in the study. Can charge throughout clinical study once authorized by FDA unless agency specifies time limitation. Sponsors/ sponsor-investigators
IND expanded access 21 CFR 312.8 Yes as above. Direct costs as above. Monitoring, reporting and other administrative requirements related to the expanded access IND also may be included. One year unless shorter time specified by FDA. Can then be renewed for additional time periods. As above
IDE

21 CFR 812.7;

 

21 CFR 820(b)(8)

No- The regulations do not require a separate prior FDA approval before cost recovery begins or a CPA statement.  The proposed amount to be charged and the reason why sale does not constitute commercialization may be submitted in the original IDE application. Manufacturing, research, development and handling None specified except to extent sponsors may not “unduly prolong” an investigation. 812.7 applies to sponsors, investigators and/or those acting on behalf of sponsors

Note: In some cases, as with labor/personnel costs, costs could be considered either direct or indirect depending on the specific product and how it is manufactured and distributed.